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1st commenting round

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					        Summary of comments received during the first round of the PEG consultation on the draft revised Guidance on requirements for substances in articles.
  Source      Topic          Comment                                                                                                                       Response
1 DK          Implementati   “First of all, we appreciate that the discussions on revision of chapter 4 and appendix 3 have been postponed. This
              on of the      in light of the work, presently going on among the Member States behind the dissenting views on the application of
              consultation   the 0,1 % threshold to the entire article. This work will end up in a report which will be handed over to ECHA this
              procedure      autumn.”
2 Orgalime    Implementati “We also agree with the proposed focus of this consultation, which particularly excludes discussions on chapters 4
              on of the    and 6.4 as well as the Appendix 3.”
              consultation
              procedure
3 EUROFER Implementati “This draft document is quite difficult to follow as only part of the Guidance is being revised […].”                               (Overall response to different comments received) The more sensitive parts
          on of the                                                                                                                                        of the Guidance, which were not part of the present consultation, will be
          consultation                                                                                                                                     submitted to the PEG for consultation at a later stage, as the revision of these
          procedure                                                                                                                                        parts depends on the outcome of projects which are currently still ongoing.
                                                                                                                                                           Having advanced the consultation on the remaining parts will allow the
                                                                                                                                                           second PEG consultation to run more swiftly and the whole guidance update
                                                                                                                                                           procedure to be finalised sooner.


4 Digital     Implementati “For future revision cycles we would like to suggest that it serves industry better if the update happens for the               (Overall response to different comments received) The more sensitive parts
  Europe      on of the    whole document at once and not in stages, leaving a more realistic period of time for revision.”                                of the Guidance, which were not part of the present consultation, will be
              consultation                                                                                                                                 submitted to the PEG for consultation at a later stage, as the revision of these
              procedure                                                                                                                                    parts depends on the outcome of projects which are currently still ongoing.
                                                                                                                                                           Having advanced the consultation on the remaining parts will allow the
                                                                                                                                                           second PEG consultation to run more swiftly and the whole guidance update
                                                                                                                                                           procedure to be finalised sooner.


5 ASD         Implementati “For revision purposes a revision tracking system highlighting the main text changes performed would have been                  (Overall response to different comments received) It is understood that in
              on of the    very helpful.”                                                                                                                  future a document highlighting the changes in the revised guidance
              consultation                                                                                                                                 compared to the former version of the guidance, would help the PEG
              procedure                                                                                                                                    members in their commenting task. Furthermore a document history table
                                                                                                                                                           (similar to the table in the Guidance on registration) will be added to the
                                                                                                                                                           document before publication.
6 UK          Implementati   “There is no comprehensive comparison with the existing text, leaving Member States to compare the whole                      (Overall response to different comments received) It is understood that in
              on of the      proposed draft with the existing text to identify changes. This makes it difficult to tell which parts of the original text   future a document highlighting the changes in the revised guidance
              consultation   have been retained or altered. In particular there could be subtle changes to the text that would be difficult to spot        compared to the former version of the guidance, would help the PEG
              procedure      but might have far reaching implications.”                                                                                    members in their commenting task. Furthermore a document history table
                                                                                                                                                           (similar to the table in the Guidance on registration) will be added to the
                                                                                                                                                           document before publication.
7 EDANA       Implementati “The review of version 2.0 of the document as compared to version 1.0 was extremely difficult since no table of                 (Overall response to different comments received) It is understood that in
              on of the    references where changes have been brought was provided. We recommend to include in this version a table                        future a document highlighting the changes in the revised guidance
              consultation summarising the changes that have been brought to the previous version of the document.                                         compared to the former version of the guidance, would help the PEG
              procedure                                                                                                                                    members in their commenting task. Furthermore a document history table
                                                                                                                                                           (similar to the table in the Guidance on registration) will be added to the
                                                                                                                                                           document before publication.
8 FI          Implementati “It would be of utmost importance to include a „document history‟ in the beginning of the document as can be found              (Overall response to different comments received) It is understood that in
              on of the    e.g. in the guidance on registration.”                                                                                          future a document highlighting the changes in the revised guidance
              consultation                                                                                                                                 compared to the former version of the guidance, would help the PEG
              procedure                                                                                                                                    members in their commenting task. Furthermore a document history table
                                                                                                                                                           (similar to the table in the Guidance on registration) will be added to the
                                                                                                                                                           document before publication.
 9 Cefic      Implementati   “(In the preface) it is said that the European Chemical Agency (ECHA) will update this guidance document                It is to be noted that the Guidance of May 2008 was not prepared following
              on of the      following the „Consultation procedure on guidance‟. However, from an industrial point of view, I already found a        the Consultation procedure on guidance, only the addition of a reference to
              consultation   major contradiction between the Guidance of May 2008 and the „Consultation procedure on guidance‟:                      the notified dissenting positions to the relevant parts of the guidance
              procedure      In the introduction of the „Consultation procedure on guidance‟ it is stated out, that it is of importance that the     document was based on this procedure (see preface of Guidance of May
                             guidance made available by ECHA is agreed by the concerned parties from authorities and from industry.                  2008). The Consultation procedure on guidance also did not play a role in RIP
                             However, with the introduction of „indicative questions for borderline cases‟, the majority of the industrial members   3.8.
                             in RIP 3.8 stated out, that the ECHA revision does not reflect their opinion and that, indeed, the TGD is a not
                             legally binding document. The fact, that the expressions „container‟ and „carrier material‟ are not defined in the
                             REACH legislation illustrate this objection.”




10 UK         Implementati   “The existing guidance documents were produced by large project teams over a long period, and were subject to a         It is acknowledged that the initial elaboration of the guidance documents was
              on of the      high level of scrutiny and comment by Member States/CARACAL/etc. The rewriting of a document that went                  a long and intensive period. However, in particular concerning the revision of
              consultation   through such a lengthy and at times difficult genesis should be the subject of wider and lengthier consultation and     already existing guidance documents, ECHA wants to deal quickly with the
              procedure      involvement with stakeholder authorities.”                                                                              shortcomings of the existing guidance given that stakeholders are basing
                                                                                                                                                     their actions on the publicly available guidance. In doing so ECHA of course
                                                                                                                                                     also wants to ensure adequate buy-in of the relevant actors. As announced in
                                                                                                                                                     the invitation to nominate experts for PEGs, it is foreseen that (in order to be
                                                                                                                                                     workable) the size of each PEG is 10 to 20 experts and that the commenting
                                                                                                                                                     time is around 2 weeks. In the case of the PEG consultation on the draft
                                                                                                                                                     Guidance on requirements for substances in articles, 18 experts were
                                                                                                                                                     selected for the PEG and the commenting time was 3 weeks. Against this
                                                                                                                                                     background, the PEG size and the time given for comments is considered to
                                                                                                                                                     be reasonable.


11 UK         Implementati “The revised draft was circulated to PEG nominees on 16th July – this being the first contact PEG nominees had            The purpose and scope of the SiA guidance (outlined in section 1.1 of the
              on of the    received on this issue and the first indication to Member States of the purpose and scope of the SiA guidance.”           revised guidance) have basically not changed compared to the guidance from
              consultation                                                                                                                           May 2008, and should not cause any surprise to somebody already familiar
              procedure                                                                                                                              with the earlier guidance.
12 ASD        General     “The changes in order and chapter structure of the document are very welcome and contribute to a better legibility
              comments on and understanding of the document.”
              the draft
              guidance
13 EDANA      General     “In general terms, we appreciate that the revised version of the document has been streamlined thus rendering the
              comments on reading of the user more comfortable.”
              the draft
              guidance
14 Orgalime   General     “We welcome that the ECHA Secretariat has in a number of areas seen fit to clarify the overall content of the
              comments on guidance and reduce its volume, thereby providing article producers with a more concise tool in order to help them
              the draft   fulfilling their legal obligations.”
              guidance
15 Digital    General     “We appreciate the attempt to reorganize the flow within the document, e.g. to start with the key question what an
   Europe     comments on article actually is. Having a single flowchart in v.2.0 is easier to understand than the multiple flowcharts in the 2008
              the draft   version.”
              guidance
16 NO         General        “We welcome an improved drafted revised guidance on substances in articles. The structure of the guidance gives
              comments on    a better overview with regard to the tasks connected to the item article in the REACH context and makes the
              the draft      guidance more readable and can hopefully act as a useful tool both for duty holders and enforcing authorities.
              guidance       Sorting out examples of borderline cases in separate appendix is an improvement.”
17 FI          General     “I much appreciate the work conducted by ECHA so far. In general, the new draft has been nicely improved in
               comments on sense of structure and clarity, where as it seems that not so many changes have been made on the content.”
               the draft
               guidance
18 AT          General       “To tighten the document and to skip unnecessary information is basically preferable. The structure of the existing
               comments on   guidance is probably not perfect but useful. Generally, the draft guidance seems to be an improvement regarding
               the draft     avoidance of redundancies and bringing related pieces of information together. However, with a view on the main
               guidance      users of this guidance – from my point of view SMEs which have no or very low experience on chemical legislation
                             – the reduction of information in some parts goes too far. We should consider the typical user of this guidance,
                             which in our opinion is in the majority different to the typical users of other guidance documents. The users are
                             very often employees in SMEs, which have not been and will not be affected by chemicals law a lot, as their
                             obligations under REACH are very limited.”


19 Cefic       General       “The „Consultation procedure on guidance‟ says, that ECHA is taking the responsibility to provide
               comments on   scientific/technical guidance, including the need to finalize and clarify the existing guidance document. However, in
               the draft     my opinion, the actual version is not always providing a scientific guidance and does not always clarify the legal
               guidance      text.”
20 EUROFER General     “The revised draft Guidance is, in my opinion, less helpful to producers and importers of metal semifinished
           comments on products than the current ECHA Guidance on substances in articles.”
           the draft
           guidance
21 EUROFER General     “This draft document is quite difficult to follow as […] many chapters from the original guidance document have               (Overall response to different comments received) Chapters from the original
           comments on been withdrawn.”                                                                                                              guidance document have been merged to have related pieces of information
           the draft                                                                                                                                 together (these were formerly distributed between different chapters of the
           guidance                                                                                                                                  guidance and a glossary) and to avoid redundancies between different
                                                                                                                                                     chapters. The new structure of the guidance is thus intended to reflect the
                                                                                                                                                     process of checking obligations for substances in articles better, providing the
                                                                                                                                                     necessary references to REACH Articles and to definitions right at the
                                                                                                                                                     relevant steps in this process. Concerning the former section 2.5 (“Timelines
                                                                                                                                                     under REACH”), it should be noted that section 3.3 in the revised guidance
                                                                                                                                                     does indicate that “the same distinction between phase-in substances and
                                                                                                                                                     non-phase-in substances, the same registration deadlines as well as the
                                                                                                                                                     same data sharing requirements apply to substances in articles as to
                                                                                                                                                     substances as such or in mixtures”. Following the general principle outlined in
                                                                                                                                                     the introductory chapter the revised guidance does not repeat what is in other
                                                                                                                                                     guidance documents, but refers in this case to the Guidance on registration
                                                                                                                                                     and the Guidance on data sharing. An additional Appendix providing an
                                                                                                                                                     overview on the parts of REACH, which are of particular relevance for
                                                                                                                                                     producers, importers and suppliers of articles, will be added to the document.
22 EDANA   General       “We however regret that useful information that was provided in Version 1.0 has not been kept in this second              (Overall response to different comments received) Chapters from the original
           comments on   version. This is particularly of importance for small and medium size companies who may not have the knowledge            guidance document have been merged to have related pieces of information
           the draft     and the broad overview of the REACH requirements and who may find still some interest to have in this document            together (these were formerly distributed between different chapters of the
           guidance      some general information such as definitions (e.g. Appendix 1 of version 1.0), summary of the relevant                    guidance and a glossary) and to avoid redundancies between different
                         requirements under the regulation, the updated timelines, etc. centralised into one specific section or Annex. We         chapters. The new structure of the guidance is thus intended to reflect the
                         therefore recommend to re-include these elements (requirements and relevant articles of REACH, timelines,                 process of checking obligations for substances in articles better, providing the
                         definitions…) into an Annex at the end of the document.”                                                                  necessary references to REACH Articles and to definitions right at the
                                                                                                                                                   relevant steps in this process. Concerning the former section 2.5 (“Timelines
                                                                                                                                                   under REACH”), it should be noted that section 3.3 in the revised guidance
                                                                                                                                                   does indicate that “the same distinction between phase-in substances and
                                                                                                                                                   non-phase-in substances, the same registration deadlines as well as the
                                                                                                                                                   same data sharing requirements apply to substances in articles as to
                                                                                                                                                   substances as such or in mixtures”. Following the general principle outlined in
                                                                                                                                                   the introductory chapter the revised guidance does not repeat what is in other
                                                                                                                                                   guidance documents, but refers in this case to the Guidance on registration
                                                                                                                                                   and the Guidance on data sharing. An additional Appendix providing an
                                                                                                                                                   overview on the parts of REACH, which are of particular relevance for
                                                                                                                                                   producers, importers and suppliers of articles, will be added to the document.
23 NO      General       “It is noticed that this draft has excluded text given in the in “present Guidance” (chapter 2) with an overview of the   (Overall response to different comments received) Chapters from the original
           comments on   legislative requirements on substances in articles under REACH. We support that it should be avoided to repeat            guidance document have been merged to have related pieces of information
           the draft     legislative text, however a short introduction (compiled overview) including all paragraphs of Article 7, Article 33      together (these were formerly distributed between different chapters of the
           guidance      and other relevant legislative text (e.g. entries in Annex XVII) would be preferred, specific with regard to Article 7    guidance and a glossary) and to avoid redundancies between different
                         mentioned thoroughly in this document.”                                                                                   chapters. The new structure of the guidance is thus intended to reflect the
                                                                                                                                                   process of checking obligations for substances in articles better, providing the
                                                                                                                                                   necessary references to REACH Articles and to definitions right at the
                                                                                                                                                   relevant steps in this process. Concerning the former section 2.5 (“Timelines
                                                                                                                                                   under REACH”), it should be noted that section 3.3 in the revised guidance
                                                                                                                                                   does indicate that “the same distinction between phase-in substances and
                                                                                                                                                   non-phase-in substances, the same registration deadlines as well as the
                                                                                                                                                   same data sharing requirements apply to substances in articles as to
                                                                                                                                                   substances as such or in mixtures”. Following the general principle outlined in
                                                                                                                                                   the introductory chapter the revised guidance does not repeat what is in other
                                                                                                                                                   guidance documents, but refers in this case to the Guidance on registration
                                                                                                                                                   and the Guidance on data sharing. An additional Appendix providing an
                                                                                                                                                   overview on the parts of REACH, which are of particular relevance for
                                                                                                                                                   producers, importers and suppliers of articles, will be added to the document.
24 AT   General     “the description and explanation of the legal requirements for substances in articles has been reduced too much.”          (Overall response to different comments received) Chapters from the original
        comments on                                                                                                                            guidance document have been merged to have related pieces of information
        the draft                                                                                                                              together (these were formerly distributed between different chapters of the
        guidance                                                                                                                               guidance and a glossary) and to avoid redundancies between different
                                                                                                                                               chapters. The new structure of the guidance is thus intended to reflect the
                                                                                                                                               process of checking obligations for substances in articles better, providing the
                                                                                                                                               necessary references to REACH Articles and to definitions right at the
                                                                                                                                               relevant steps in this process. Concerning the former section 2.5 (“Timelines
                                                                                                                                               under REACH”), it should be noted that section 3.3 in the revised guidance
                                                                                                                                               does indicate that “the same distinction between phase-in substances and
                                                                                                                                               non-phase-in substances, the same registration deadlines as well as the
                                                                                                                                               same data sharing requirements apply to substances in articles as to
                                                                                                                                               substances as such or in mixtures”. Following the general principle outlined in
                                                                                                                                               the introductory chapter the revised guidance does not repeat what is in other
                                                                                                                                               guidance documents, but refers in this case to the Guidance on registration
                                                                                                                                               and the Guidance on data sharing. An additional Appendix providing an
                                                                                                                                               overview on the parts of REACH, which are of particular relevance for
                                                                                                                                               producers, importers and suppliers of articles, will be added to the document.
25 FI   General     “Please reconsider the title of the guidance „Guidance on Requirements for Substances in Articles‟. REACH sets             It is preferred to keep the title as it is, since users of the guidance will have
        comments on requirements on different actors, not substances. Possible alternative tittles could be e.g. „Guidance on                  got used to it already, and changing it might suggest that a new guidance
        the draft   Requirements for Importers and Suppliers of Substances in Articles‟ or „Guidance on Substances in Articles‟”               document is issued, whereas it is just a revised version of the current
        guidance                                                                                                                               guidance document. The remark made is correct, but the more precise title
                                                                                                                                               „Guidance on Requirements for Producers, Importers and Suppliers of
                                                                                                                                               Substances in Articles‟ is regarded as too long. „Guidance on Substances in
                                                                                                                                               Articles‟, on the other hand, could be misleading as the guidance focuses on
                                                                                                                                               legal requirements and not on substances.


26 AT   General       “Since this guidance has been published a large number of companies used the document and came to a decision             The revision of the guidance was made taking particular care that it is in line
        comments on   based on the decision logic provided in this guidance. Also the experts of the national helpdesks provided answers       with the current answering practice of the REACH helpdesk(s) and it does not
        the draft     (very often in written form) based on this now well established document. Even if the impact of the changes of the       lead to conclusions different from those resulting from the application of the
        guidance      basic procedure for deciding what an article is maybe low, companies are provoked to check if the obligations for        current guidance. The consultation procedure foreseen gives precisely the
                      their products really will not change. In several countries authorities and/or associations provided translations of     opportunity to review this and analyse the impact of the changes proposed
                      this guidance. To change the guidance in the proposed way would cause the need of a complete restructuring of            together with interested parties. The fact that, when a guidance is revised,
                      the translations. […] The decision procedure („Deciding what is an article‟) is a very important and essential part of   translations of this guidance have to be revised as well in order to be up-to-
                      this guidance. Therefore I think it is crucial not to change it as significantly as suggested without discussing and     date, is in the nature of things and cannot be avoided. Likewise it is usual that
                      analysing the need and impact of those changes first. It is very difficult and time consuming to analyse the impact      industry verifies that decisions made based on a guidance are in line with the
                      of the changes on real examples.”                                                                                        latest version of this guidance (which, as mentioned before, should nearly
                                                                                                                                               always be the case). Thus, the need to update translations or to verify
                                                                                                                                               decisions taken earlier cannot be a reason for not revising a guidance
                                                                                                                                               document, if the revision leads to improvements and rectifies deficiencies of
                                                                                                                                               the guidance.


27 IE   Section 1.1   “Suggest stating more explicitly that it is industry‟s responsibility to determine their obligations under REACH with    A corresponding statement will be included.
                      regard to substances in articles.”
28 IE        Section 1.1   “Question whether „purchasing, production and sales managers‟ should be specifically mentioned. If so, consider       Many companies, in particular SMEs, do not have a separate REACH
                           making it a separate sentence as these groups are not necessarily a subgroup of the REACH Compliance section          compliance section. However, it is clear that the staff to be entrusted with the
                           of a company. For example. „…EEA). In addition, it may be useful for the purchasing, production and sales             task of ensuring REACH compliance of a company needs to have knowledge
                           managers in the company‟.”                                                                                            on the purchasing, production and sales activities of the company. The
                                                                                                                                                 wording chosen should thus indicate who the appropriate persons at a
                                                                                                                                                 company are to be tasked with the company‟s REACH compliance (i.e. who
                                                                                                                                                 to give the guidance to read), this being ideally a team of purchasing,
                                                                                                                                                 production and sales managers (as opposite e.g. to executive managers, who
                                                                                                                                                 might preferably read the Guidance in a nutshell on requirements for
                                                                                                                                                 substances in articles).


29 NO        Section 1.1   “The definition of an article (Article 3(3)) could also be mentioned in the text here.”                               The definition will be included.
30 Digital   Section 1.2   “The arrow „yes‟ from the exemptions check is leading to both end points (no obligations and one or more              Before the exemptions check a company might have found that different
   Europe                  obligations) instead of a clear guidance (which should be no obligations).”                                           requirements apply (e.g. notification requirements and communication
                                                                                                                                                 requirements). The exemptions check may show that the company can
                                                                                                                                                 benefit from an exemption (e.g. exemption from the obligation to notify on the
                                                                                                                                                 basis of Article 7(6)). However, the company might still not be exempted from
                                                                                                                                                 all obligations initially identified (e.g. it might still have to fulfil the Article 33
                                                                                                                                                 communication requirements). Thus, depending on which and how many
                                                                                                                                                 different requirements for substances in articles have initially been identified,
                                                                                                                                                 a “positive” exemptions check (i.e. showing that an exemption from an
                                                                                                                                                 obligation applies) does not necessarily lead to no obligations for substances
                                                                                                                                                 in articles at all. A remark will be added in the flowchart to clarify this issue.




31 IE        Section 1.2   “Suggest revising the names of the chapters to match the six questions outlined in Section 1.2.”                      To be consistent with the current Guidance, where possible the names of the
                                                                                                                                                 chapters of the Guidance of May 2008 were kept in the revised Guidance.
                                                                                                                                                 Furthermore, using the questions in section 1.2 as titles for the chapters of
                                                                                                                                                 the Guidance does not seem appropriate, as the questions are often too long.

32 ASD       Section 1.3   “Reference made […] to the fact that substances imported in articles cannot be subjected to authorisation but         Substances being an integral part of an article are outside the scope of Article
                           those same substances incorporated into an article by an article producer in the EU can is coherent with the          56 provisions. Therefore, there is no legal basis to consider them being
                           current interpretation of the regulation but seems unfair and a cause of market distortion. In the aerospace and      subject to authorisation.
                           defence sector there are cases of substances, for example in paints, that can be imported in objects manufactured
                           abroad (i.e. an aircraft) but cannot be used within preparations used for repainting of the same said aircraft. These
                           issues are likely to create numerous problems to maintenance, repair and overhaul companies and may lead to
                           delocalisation of activities out of the EU.”
33 NO        Section 1.3   “The „restrictions legislation‟ (REACH amended by (EC) no 552/2009) is a part of REACH and should be more                   The paragraph on restrictions in section 1.3 already points out that imported
                           included in the text of this guidance, not only mentioned in chapter 1.3 (Topics covered by other documents) and            articles are subject to restrictions (“the content of substances in articles can
                           listed in Appendix 6.                                                                                                       be restricted or banned under the restrictions procedure. Therefore, article
                           Restrictions cover a range of obligations/requirements also for importers of articles and with relevance for article        producers and importers have to follow the conditions outlined in Annex XVII
                           producers as well. […]                                                                                                      of the REACH Regulation.”).
                           The text as it is given in the drafted section 1.3 could be as it is, my proposal is to structure the section 1.3 in sub-   Obligations according to Article 31 and Article 32 do not apply to suppliers of
                           sections and complete with some additional text. „Notice that imported articles are subject to restrictions. […] If a       articles. Therefore it is considered that reference to these obligations of
                           restricted substance is acquired from the EEA market for producing articles, the supplier has to give this                  suppliers of substances/mixtures should not be included in the Guidance on
                           information in Section 15 of the safety data sheet or via information according to Article 32.‟”                            requirements for substances in articles. However, the guidance already
                                                                                                                                                       makes reference to chapter 13 of the Guidance for downstream users, which
                                                                                                                                                       makes clear that “Your supplier must specify, under heading 15 in the safety
                                                                                                                                                       data sheet, whether the substance that you use is subject to restriction. If you
                                                                                                                                                       do not receive a safety data sheet, your supplier is obliged to communicate
                                                                                                                                                       this separately, according to article 32 of REACH.”




34 Digital   Chapter 2     “As laid out in detail already during the Stakeholder Expert Group meetings for RIP 3.8 we do not support […] the           The Commission has developed a consistent line and criteria for deciding on
   Europe                  analysis (indicative questions) of whether products are substances, preparations, articles or articles with intended        the need for registration under Article 6 or Article 7(1), based on the legal
                           release has turned out as ambiguous during the past time of experience. It appears that the guidance has been               text. This has been reflected in the guidance providing a number of cases.
                           written with the objective of restricting the scope of Article 7.1 until it has almost no purpose and many of the
                           problems with the guidance result from this objective. We think we should make you aware that as a result the
                           guidance does not reflect the purpose of REACH in this area as evidenced by the wording of the Regulation and
                           the preparatory documents.”


35 DG ENTR   Chapter 2     “In the introductory part of Section 2 we would like to keep the sentence from the current version of the guidance,         We consider that this sentence would not help the reader of the guidance in
                           namely that „An article is to be understood as the article as produced or imported.‟ The sentence could be inserted         deciding on whether an object is an article or not. A distributor e.g. neither
                           before the existing sentence „It may be very simple, like a wooden chair but can also be very complex, like a               produces nor imports articles, thus for many actors it might be difficult (and
                           computer, consisting of many parts.‟ We consider that the concept of „article as produced or imported‟ is easily            not necessarily useful when applying the steps described in section 2.3 of the
                           understandable and should be emphasised also in the general discussion on the definition of article.”                       guidance) to identify who produced or imported an article and how.
                                                                                                                                                       Furthermore it is not clear at what stage of the decision making process (of
                                                                                                                                                       deciding if an object is an article or not) one should check if the object is still
                                                                                                                                                       “as produced or imported”.
                                                                                                                                                       However, the same issue is in principle taken up by the newly introduced
                                                                                                                                                       section 2.3.1 which based on Article 3(3) makes clear that “an article is an
                                                                                                                                                       object which during production is given a special shape, surface or design…”,
                                                                                                                                                       or in other words “an article is to be understood as the article as produced”.
36 Cefic     Section 2.1   “The term „function‟ as used in Article 3.3 of the legal text is not being defined in this Article. However, in Title XII,   The interpretation of the term “function” described in the draft version 2.0 of
                           specifically in Article 118 2b), it is used in connection with “precise use” and furthermore, also relates to Article        the guidance is not different from the approach taken in the current guidance
                           7(6).                                                                                                                        (section 3.1).
                           You advise to ignore a higher degree of technical sophistication leading to a higher quality in the result. But, in the      The term “function” used in Article 118(2)(b) refers to the “function […] of a
                           case of the Imaging Industry, lowering the degree of technical sophistication does not lead only to a lower quality in       substance or preparation” and can thus not be used to interpret the term
                           the result, but in a totally different result, as bringing ink onto paper is definitely not the same as bringing an image    “function” in the article definition.
                           onto paper and is not equivalent to the „precise use‟, respectively to the function of a printer cartridge.
                           With regard to this point, the European Imaging Industry has got an essentially different approach compared to the
                           one in the 2009 Draft Version 2.0.”



37 IE        Section 2.2   “According to Section 2.2 of the draft guidance surface is defined as „the outermost layer of an object‟. The draft          Surface means the outermost layer of an object. This applies whether the
                           guidance also states that „the shape, surface and design of an object represent its physical appearance and can              object to be assessed is in its “finished state” or an earlier “basic state”.
                           be understood as other than chemical characteristics‟. In some cases, the finished object will have an outermost             Treatments consisting of covering/coating of the object (e.g. to “finish” the
                           layer that consists of molecular covering/coating, but this chemical layer is intrinsic to the functioning of the object.    object) may result in a change in its overall chemical composition, but not in
                           The definitions in Section 2.2 led us to understand that only the surface of the object, in its most basic state (i.e.       the article status of the object.
                           the step before the finished state is achieved), should be taken into account when assessing whether the object „is
                           given a special shape, surface or design which determines its function to a greater degree than its chemical
                           composition‟. […] At this time, we are merely seeking a clarification and are not proposing to modify the definition
                           of surface.”


38 NO        Section 2.3   “Chapter 2 is easy to follow and presents a good methodology assessing the complexity of articles.”
39 FECC      Section 2.3   “Comparing with the previous text of the guidelines, I appreciated the simpler design of the step by step workflow
                           for deciding what falls into the category of article and what is instead to be regarded as an article functioning as a
                           carrier of a substance/mixture.”
40 ASD       Section 2.3   “The workflow in Fig 2 is better laid out, and much improved.”
41 AT        Section 2.3   “The new decision tree seems to be more simple and easier to understand.”
42 Digital   Section 2.3   “The Box „check indicative questions under step 6‟ is leading to multiple end points. In the text the term                   The flowchart will be modified to reflect the answers to the indicative
   Europe                  „predominately answering with yes indicates‟ is used. This should reflect in the flow chart.”                                questions that lead to one or another endpoint.
43 AT        Section 2.3   “Before starting the decision process there is no explanation on the possible borderlines between articles and               The reason for not introducing this section (“Deciding if an object is an article
                           substances/mixtures, which would be useful for inexperienced users.”                                                         or not”) with an explanation of borderlines, e.g. dividing the stages of a
                                                                                                                                                        processing sequence into articles and substances/mixtures, is that this
                                                                                                                                                        perspective is less practical when deciding if an object is an article or not. As
                                                                                                                                                        outlined in section 1.2, chapter 2 should essentially provide guidance for
                                                                                                                                                        answering the question: “Do I have an article?”. Thus to obtain this answer
                                                                                                                                                        the reader should be focused on the object in question, and not primarily on
                                                                                                                                                        borderlines.
44 Cefic   Section 2.3   “In Step 2, the following question is given: „Is a substance/mixture enclosed in the object or on its surface?‟          (Overall response to different comments received) The current guidance
                         As every object (furniture, clothes, vehicles, books, toys, kitchen equipment, etc.) has substances that are             makes clear that objects like a spray can with paint, a printer cartridge, a pen,
                         „enclosed‟, it is actually not possible to say „No‟ and to continue with Step 5.                                         etc. should be considered as “substances/preparations in a container” (the
                         Obviously, there are two different meanings of „enclosed‟, („enclosed‟ in the sense of cannot be separated and           container being an article itself). This interpretation is also commonly
                         „enclosed‟ in the sense of can be separated). I am sure that the author of the workflow wanted to express                communicated by REACH helpdesks.
                         something else than „enclosed‟ in the sense of cannot be separated. As not every reader will be aware of this            The workflow in section 3.3 of the current guidance, however, does not
                         difference, a minimum requirement would be to mark Step 2 with an asterisk (*) and to add an explanation, like for       ensure that the reader arrives at this interpretation. Only if the reader
                         example:                                                                                                                 considers he cannot decide or does not know how to answer the question “Is
                         * The term „enclosed‟ means that the relevant substance/mixture is not fixed within the object and can be                the chemical composition more relevant for the function than shape, surface
                         separated from it by methods of pouring out, wringing out, extracting or evaporating.                                    and design?” in Figure 2 of the current guidance, can he conclude that
                         This example of an additional explanation is not to be seen as an agreement with this term in general, as from my        objects like a spray can with paint, a printer cartridge, a pen, etc. are
                         point of view it is an additional example for introducing new circumstances into the TGD which are not included in       “substances/preparations in a container”. If he answers the question either
                         the original REACH text. This produces further legal uncertainties, instead of guiding through the legal text.”          with yes or no, he would arrive at the (wrong) conclusion that the whole object
                                                                                                                                                  is a substance/preparation or an article.
                                                                                                                                                  Thus, in order to ensure that the reader is not mislead by the workflow,
                                                                                                                                                  following the identification of the object‟s function the reader should check
                                                                                                                                                  whether his object is a borderline case of “substances/preparations in special
                                                                                                                                                  containers / on special carrier materials or as integral parts of articles”. This is
                                                                                                                                                  typically the case when a substance/preparation is “enclosed in the object”
                                                                                                                                                  (like e.g. the liquid in a thermometer) “or on its surface” (like e.g. the adhesive
                                                                                                                                                  layer of an adhesive tape).
                                                                                                                                                  The concept of objects consisting of a “container” or “carrier” and a
                                                                                                                                                  substance/preparation (“chemical content (that) can be separated from main
45 EDANA   Section 2.3   “Flowchart from version 1.0 was easier to follow and to understand. Step 2 in particular is really confusing, and        object”) was already introduced in the current guidance, current thus not new.
                                                                                                                                                  (Overall response to different comments received) The and is guidance
                         virtually, you could answer “yes” to any product. The term „enclosed‟ or „on the surface‟ are ambiguous and the          makes clear that objects like a spray can with paint, a printer cartridge, a pen,
                         description that the substance/mixture [can be solid, liquid or gaseous…] adds to the fact that the answer would         etc. should be considered as “substances/preparations in a container” (the
                         always be yes. For example, an aluminium chair encloses aluminium as it has it on its surface, thus the answer           container being an article itself). This interpretation is also commonly
                         would be yes and the next stage would be to check to step 3 and 4. In our opinion, step 2 brings no relevance to         communicated by REACH helpdesks.
                         the flowchart and can be deleted.                                                                                        The workflow in section 3.3 of the current guidance, however, does not
                         We suggest to revert back to the flowchart of version 1.0 of the document which follows the terms of the article         ensure that the reader arrives at this interpretation. Only if the reader
                         definition under REACH. […]                                                                                              considers he cannot decide or does not know how to answer the question “Is
                         We are still struggling with the workflow and indicative questions designed to qualify articles with                     the chemical composition more relevant for the function than shape, surface
                         substances/mixtures forming an integral part thereof, and articles (functioning as container or carrier material) with   and design?” in Figure 2 of the current guidance, can he conclude that
                         substances/mixtures contained within.                                                                                    objects like a spray can with paint, a printer cartridge, a pen, etc. are
                         Some questions cannot be answered with certainty while sometimes the answer can lead to the opposite                     “substances/preparations in a container”. If he answers the question either
                         conclusion to what you would expect following the definition of an article with intentional release. […]                 with yes or no, he would arrive at the (wrong) conclusion that the whole object
                         While we believe good work has been achieved during the development of the first version of the guidance to help         is a substance/preparation or an article.
                         companies resolve borderline issues, we are of the opinion that more thinking has to be brought to the topic while       Thus, in order to ensure that the reader is not mislead by the workflow,
                         we also recognize that the guidance cannot resolve all the cases that can be found and that expert judgment will         following the identification of the object‟s function the reader should check
                         be needed by companies to conclude on the status of their product. However, it is advisable that the guidance -          whether his object is a borderline case of “substances/preparations in special
                         which objective is to provide as much as possible understanding and thus certainty to companies and enforcement          containers / on special carrier materials or as integral parts of articles”. This is
                         bodies – tries to include tools and means for industry that are workable, validated and that cannot be challenged in     typically the case when a substance/preparation is “enclosed in the object”
                         the future when implemented practically.                                                                                 (like e.g. the liquid in a thermometer) “or on its surface” (like e.g. the adhesive
                         EDANA would appreciate that this section is reviewed again in the light of experiences encountered by companies          layer of an adhesive tape).
                         and/or reported to the ECHA so far and that a clearer process is designed that would allow conclusions to be taken       The concept of objects consisting of a “container” or “carrier” and a
                         with more certainty.”                                                                                                    substance/preparation (“chemical content (that) can be separated from main
                                                                                                                                                  object”) was already introduced in the current guidance, and is thus not new.
46 Digital   Section 2.3   “Though we are aware that there are articles without an intended release that may also have to be considered as       (Overall response to different comments received) The current guidance
   Europe                  substances in a container Step 2 is not helpful for this decision. On the one hand the question as such can be        makes clear that objects like a spray can with paint, a printer cartridge, a pen,
                           answered with yes for each substance/mixture in each article and as such does not create a decision. There would      etc. should be considered as “substances/preparations in a container” (the
                           not be a difference between glue on a tape and a metal shielding on a laptop surface. On the other hand the           container being an article itself). This interpretation is also commonly
                           concept of „enclosed or on surface‟ is not taken from the REACH text and creates more ambiguity than legal            communicated by REACH helpdesks.
                           certainty which should be the goal of the guidance. We recommend sticking with the workflow in current Guidance       The workflow in section 3.3 of the current guidance, however, does not
                           on Articles, page 23, where question 2 compares the chemical composition with the relevance of shape, surface         ensure that the reader arrives at this interpretation. Only if the reader
                           and design for the function (which is a REACH concept). We recommend not trying to regulate for all article uses      considers he cannot decide or does not know how to answer the question “Is
                           and scenarios as the regulation explicitly calls for industry to take greater responsibility in general.”             the chemical composition more relevant for the function than shape, surface
                                                                                                                                                 and design?” in Figure 2 of the current guidance, can he conclude that
                                                                                                                                                 objects like a spray can with paint, a printer cartridge, a pen, etc. are
                                                                                                                                                 “substances/preparations in a container”. If he answers the question either
                                                                                                                                                 with yes or no, he would arrive at the (wrong) conclusion that the whole object
                                                                                                                                                 is a substance/preparation or an article.
                                                                                                                                                 Thus, in order to ensure that the reader is not mislead by the workflow,
                                                                                                                                                 following the identification of the object‟s function the reader should check
                                                                                                                                                 whether his object is a borderline case of “substances/preparations in special
                                                                                                                                                 containers / on special carrier materials or as integral parts of articles”. This is
                                                                                                                                                 typically the case when a substance/preparation is “enclosed in the object”
                                                                                                                                                 (like e.g. the liquid in a thermometer) “or on its surface” (like e.g. the adhesive
                                                                                                                                                 layer of an adhesive tape).
                                                                                                                                                 The concept of objects consisting of a “container” or “carrier” and a
                                                                                                                                                 substance/preparation (“chemical content (that) can be separated from main
47 AT        Section 2.3   “The question in Step 2 of Figure 2 (p. 15) „Is a substance/mixture enclosed in the object or in its surface?‟ may    (Overall response to different comments received) The current guidance
                           cause further questions. What does „enclosed‟ mean? I think it should be read as „mechanically enclosed‟ (or          makes clear that objects like a spray can with paint, a printer cartridge, a pen,
                           contained). However, in case of substances on the surface of a carrier material it could be also a physical effect.   etc. should be considered as “substances/preparations in a container” (the
                           On the other hand also softener or filler in plastic products may also be regarded as enclosed in the polymer         container being an article itself). This interpretation is also commonly
                           matrix.”                                                                                                              communicated by REACH helpdesks.
                                                                                                                                                 The workflow in section 3.3 of the current guidance, however, does not
                                                                                                                                                 ensure that the reader arrives at this interpretation. Only if the reader
                                                                                                                                                 considers he cannot decide or does not know how to answer the question “Is
                                                                                                                                                 the chemical composition more relevant for the function than shape, surface
                                                                                                                                                 and design?” in Figure 2 of the current guidance, can he conclude that
                                                                                                                                                 objects like a spray can with paint, a printer cartridge, a pen, etc. are
                                                                                                                                                 “substances/preparations in a container”. If he answers the question either
                                                                                                                                                 with yes or no, he would arrive at the (wrong) conclusion that the whole object
                                                                                                                                                 is a substance/preparation or an article.
                                                                                                                                                 Thus, in order to ensure that the reader is not mislead by the workflow,
                                                                                                                                                 following the identification of the object‟s function the reader should check
                                                                                                                                                 whether his object is a borderline case of “substances/preparations in special
                                                                                                                                                 containers / on special carrier materials or as integral parts of articles”. This is
                                                                                                                                                 typically the case when a substance/preparation is “enclosed in the object”
                                                                                                                                                 (like e.g. the liquid in a thermometer) “or on its surface” (like e.g. the adhesive
                                                                                                                                                 layer of an adhesive tape).
                                                                                                                                                 The concept of objects consisting of a “container” or “carrier” and a
                                                                                                                                                 substance/preparation (“chemical content (that) can be separated from main
                                                                                                                                                 object”) was already introduced in the current guidance, and is thus not new.
48 UK   Section 2.3   “The revision of the questions and flow diagram now under section 2 is not helpful.                                  (Overall response to different comments received) The current guidance
                      The primary questions should, as in the existing guidance, aim to establish whether the shape/surface/design are     makes clear that objects like a spray can with paint, a printer cartridge, a pen,
                      more relevant for the function than the chemical composition, as this is the criteria used in the REACH „article‟    etc. should be considered as “substances/preparations in a container” (the
                      definition.                                                                                                          container being an article itself). This interpretation is also commonly
                      By first asking „is a substance/mixture enclosed in the object‟, readers may be diverted from the most important     communicated by REACH helpdesks.
                      question (now placed at step 5) and sent instead to steps 3 and 4, the answers to which can create more              The workflow in section 3.3 of the current guidance, however, does not
                      ambiguity rather than less.”                                                                                         ensure that the reader arrives at this interpretation. Only if the reader
                                                                                                                                           considers he cannot decide or does not know how to answer the question “Is
                                                                                                                                           the chemical composition more relevant for the function than shape, surface
                                                                                                                                           and design?” in Figure 2 of the current guidance, can he conclude that
                                                                                                                                           objects like a spray can with paint, a printer cartridge, a pen, etc. are
                                                                                                                                           “substances/preparations in a container”. If he answers the question either
                                                                                                                                           with yes or no, he would arrive at the (wrong) conclusion that the whole object
                                                                                                                                           is a substance/preparation or an article.
                                                                                                                                           Thus, in order to ensure that the reader is not mislead by the workflow,
                                                                                                                                           following the identification of the object‟s function the reader should check
                                                                                                                                           whether his object is a borderline case of “substances/preparations in special
                                                                                                                                           containers / on special carrier materials or as integral parts of articles”. This is
                                                                                                                                           typically the case when a substance/preparation is “enclosed in the object”
                                                                                                                                           (like e.g. the liquid in a thermometer) “or on its surface” (like e.g. the adhesive
                                                                                                                                           layer of an adhesive tape).
                                                                                                                                           The concept of objects consisting of a “container” or “carrier” and a
                                                                                                                                           substance/preparation (“chemical content (that) can be separated from main
49 IE   Section 2.3                                                                                                                        (Overall response to different comments received) The and is guidance
                      “Step 2 is unclear as it asks two questions. It may be possible to answer both yes and no to the respective parts of object”) was already introduced in the current guidance, current thus not new.
                      the question and to be directed to different sections of the guidance. Suggest breaking this question into 2 parts   makes clear that objects like a spray can with paint, a printer cartridge, a pen,
                      with clear instructions on where to go depending on answer to „enclosed in the object‟ or „on its surface‟.          etc. should be considered as “substances/preparations in a container” (the
                      Alternatively, remove questions and state „check indicative questions under Step 2‟ instead.”                        container being an article itself). This interpretation is also commonly
                                                                                                                                           communicated by REACH helpdesks.
                                                                                                                                           The workflow in section 3.3 of the current guidance, however, does not
                                                                                                                                           ensure that the reader arrives at this interpretation. Only if the reader
                                                                                                                                           considers he cannot decide or does not know how to answer the question “Is
                                                                                                                                           the chemical composition more relevant for the function than shape, surface
                                                                                                                                           and design?” in Figure 2 of the current guidance, can he conclude that
                                                                                                                                           objects like a spray can with paint, a printer cartridge, a pen, etc. are
                                                                                                                                           “substances/preparations in a container”. If he answers the question either
                                                                                                                                           with yes or no, he would arrive at the (wrong) conclusion that the whole object
                                                                                                                                           is a substance/preparation or an article.
                                                                                                                                           Thus, in order to ensure that the reader is not mislead by the workflow,
                                                                                                                                           following the identification of the object‟s function the reader should check
                                                                                                                                           whether his object is a borderline case of “substances/preparations in special
                                                                                                                                           containers / on special carrier materials or as integral parts of articles”. This is
                                                                                                                                           typically the case when a substance/preparation is “enclosed in the object”
                                                                                                                                           (like e.g. the liquid in a thermometer) “or on its surface” (like e.g. the adhesive
                                                                                                                                           layer of an adhesive tape).
                                                                                                                                           The concept of objects consisting of a “container” or “carrier” and a
                                                                                                                                           substance/preparation (“chemical content (that) can be separated from main
                                                                                                                                           object”) was already introduced in the current guidance, and is thus not new.
50 FR   Section 2.3   “We feel embarrassed by the interpretation of „similar type of object‟ or „similar type of substance/mixture‟: it is not   (Overall response to different comments received) It is proposed to delete the
                      easy to know what the word „similar‟ covers.                                                                               part “or changed from the object to a similar type of object” of the indicative
                      For example, regarding the thermometer:                                                                                    question 3a in order to make the question clearer and facilitate the answering.
                      - what could be a similar type of object? A glass tube without graduation? A graduated glass tube with different           The question would thus read: “If the substance/mixture were to be removed
                      diameters?                                                                                                                 or separated from the object and used independently from it, would the
                      - what could be a similar type of substance ? A substance with dilatation properties? Even if the molecular formula,       substance/mixture still be capable in principle (though perhaps without
                      the other physico-chemical properties, etc. ... are completely different?                                                  convenience or sophistication) of carrying out the function defined under step
                      If you try to answer the question 4a with the thermometer, you can answer as it is stated on page 44 that the              1?”
                      container loses its purpose without the liquid. But if you replace the liquid by another which have dilatation             The indicative question 4a would be modified accordingly, i.e. deleting the
                      properties, the answer is not so obvious and can lead to the contrary.”                                                    passage “or exchanged for a similar type of substance/mixture”.


51 IE   Section 2.3   “This question (question 3a) has two parts to it: „substance/prep were removed or separated…‟ and                          (Overall response to different comments received) It is proposed to delete the
                      „substance/prep exchanged for a similar type of substance/prep‟. Therefore, it is possible to answer yes to one part       part “or changed from the object to a similar type of object” of the indicative
                      and no to the other part. We think this indicative question should perhaps be separated out into two separate parts        question 3a in order to make the question clearer and facilitate the answering.
                      to avoid such a dual response.”                                                                                            The question would thus read: “If the substance/mixture were to be removed
                                                                                                                                                 or separated from the object and used independently from it, would the
                                                                                                                                                 substance/mixture still be capable in principle (though perhaps without
                                                                                                                                                 convenience or sophistication) of carrying out the function defined under step
                                                                                                                                                 1?”
                                                                                                                                                 The indicative question 4a would be modified accordingly, i.e. deleting the
                                                                                                                                                 passage “or exchanged for a similar type of substance/mixture”.


52 IE   Section 2.3   “(We have) in mind objects which work to aid the delivery of substance(s) other than those contained within the            First it should be noted that section 2.3.2 provides specific guidance on small
                      object itself. For example, objects which work on the same principle as ceramic beads/carrier beads which aid the          and “simple” objects such as toner beads.
                      delivery of toner to the page. The toner is delivered but the substances from which the beads are made and the             In general, question 3b refers to the release or controlled delivery of a
                      molecular species on the surface of the beads are not themselves used up or delivered. When answering                      substance/mixture enclosed in the object or on its surface (identified in step
                      Question 3b, should only the constituents of the object itself be considered or, should the function as a whole be         2), or of its reaction products, not of other substances.
                      considered (i.e. the controlled delivery of a different substance)?”


53 AT   Section 2.3   “A further alternative could be the rephrasing of question 3c: e.g.                                                        (Overall response to different comments received) It is proposed to rephrase
                      Question 3c: Is the substance/mixture predominantly consumed or eliminated during the use phase of the object,             the indicative question 3c as follows in order to avoid confusions concerning
                      so that at the end of the useful life of the object the substance/mixture is not anymore in the object as it was in the    the meaning of the terms “predominantly”, “consumed” and “eliminated”: “Is
                      beginning or it was chemically or physically modified?                                                                     the substance/mixture consumed (i.e. used up e.g. due to a chemical or
                      (Note: At the end of life time the substance/mixture is not able to fulfill the foreseen function anymore.)”               physical modification) or eliminated (i.e. released from the object) during the
                                                                                                                                                 use phase of the object, thereby rendering the object useless and leading to
                                                                                                                                                 the end of its useful life?”
                                                                                                                                                 In the cases described the answer to question 3c would be yes.
                                                                                                                                                 An activated carbon filter has a limited lifespan during which the activated
                                                                                                                                                 carbon is consumed (i.e. its useful properties are exhausted, used up), once
                                                                                                                                                 its adsorption capacity has been reached, it needs changing. Thus, also for
                                                                                                                                                 the activated carbon filter cartridge it would have to be concluded that it is a
                                                                                                                                                 “substance in a container” (3a - yes, 3b - no, 3c - yes).
54 IE   Section 2.3   “(What would be the answer to question 3c) in the case where (i) the substance is partly consumed, but the               (Overall response to different comments received) It is proposed to rephrase
                      remaining substance cannot be re-used, as it is a single use object, and/or (ii) the substance is partly consumed        the indicative question 3c as follows in order to avoid confusions concerning
                      by virtue of a new substance being generated, but both substances are disposed of with the object (as it primarily       the meaning of the terms “predominantly”, “consumed” and “eliminated”: “Is
                      functions as an indicator, as in the recent example of alcohol tests).”                                                  the substance/mixture consumed (i.e. used up e.g. due to a chemical or
                                                                                                                                               physical modification) or eliminated (i.e. released from the object) during the
                                                                                                                                               use phase of the object, thereby rendering the object useless and leading to
                                                                                                                                               the end of its useful life?”
                                                                                                                                               In the cases described the answer to question 3c would be yes.
                                                                                                                                               An activated carbon filter has a limited lifespan during which the activated
                                                                                                                                               carbon is consumed (i.e. its useful properties are exhausted, used up), once
                                                                                                                                               its adsorption capacity has been reached, it needs changing. Thus, also for
                                                                                                                                               the activated carbon filter cartridge it would have to be concluded that it is a
                                                                                                                                               “substance in a container” (3a - yes, 3b - no, 3c - yes).




55 UK   Section 2.3   “As an example, an activated carbon filter cartridge should in our view be a „substance in a container‟, as clearly      (Overall response to different comments received) It is proposed to rephrase
                      the function is determined by the chemical content (the activated carbon). The shape is much less relevant, being        the indicative question 3c as follows in order to avoid confusions concerning
                      mostly a matter of convenience.                                                                                          the meaning of the terms “predominantly”, “consumed” and “eliminated”: “Is
                      However, by being diverted to steps 3 and 4 and bearing in mind that at the end of its useful life the carbon            the substance/mixture consumed (i.e. used up e.g. due to a chemical or
                      remains in the container and has not been consumed as such, the following conclusions can be reached: 3a - yes,          physical modification) or eliminated (i.e. released from the object) during the
                      3b - no, 3c - no. Two „no‟ results and the reader can conclude that it is an article.”                                   use phase of the object, thereby rendering the object useless and leading to
                                                                                                                                               the end of its useful life?”
                                                                                                                                               In the cases described the answer to question 3c would be yes.
                                                                                                                                               An activated carbon filter has a limited lifespan during which the activated
                                                                                                                                               carbon is consumed (i.e. its useful properties are exhausted, used up), once
                                                                                                                                               its adsorption capacity has been reached, it needs changing. Thus, also for
                                                                                                                                               the activated carbon filter cartridge it would have to be concluded that it is a
                                                                                                                                               “substance in a container” (3a - yes, 3b - no, 3c - yes).




56 FR   Section 2.3   “We are a little bit troubled by the new flowchart (illustrating decision-making on whether an object is an article or   Concerning the example of the panty hose with a lotion, question 3a would
                      not) compared to the previous one. Indeed, on the contrary to the previous flowchart, the first question does not        have to be answered with no. The reasoning is that if the substance/mixture
                      deal with the article definition and it does not always seem to be a good strategy.                                      were to be removed or separated from the object and used independently
                      For example, in the case of the panty hose with a lotion : if you don't start by asking if the chemical composition is   from it or changed from the object to a similar type of object, the
                      more relevant for the function than shape, surface and design, you may chose for step 2 in the new flowchart the         substance/mixture (i.e. the lotion) would not be capable of carrying out the
                      branch YES since actually there is a mixture enclosed in the object or on its surface. As a consequence, you may         function defined under step 1 (i.e. to provide clothing). Or in other words, the
                      answer the questions for step 3 as follows: 3a=YES, 3b=NO, 3c=YES and you may conclude that panty hose with              lotion does not provide clothing.
                      a lotion is an article with a mixture contained within whereas the current guidance concludes that it is an article      With at least two of the indicative questions 3a to 3c answered with no, the
                      with intended release (this conclusion can be easily obtained by answering the question of the relevancy of the          whole panty hose with a lotion should be regarded as an article.
                      chemical composition compared to the shape, surface and design).”
57 EDANA    Section 2.3   “A typical example could be a scented cloth which is an article with substances intended to be released and not an         Assuming the main function of the cloth is to scent, as stated, then all
                          article functioning as a carrier material. If we apply the first series of indicative questions (3a, 3b, 3c), the answer   indicative questions 3a to 3c would have to be answered with yes, and the
                          to question 3a would be yes since the fragrance can act separately or used independently yet still having the same         cloth would clearly be a “carrier material with substances contained within”.
                          function of scenting. Answers to questions 3b and 3c would be „no‟.                                                        According to the guidance the release of fragrance would, however, not be an
                          The assessor would probably use the set of questions 4a, 4b and 4c since he had not obtained 3 „no‟ to the first           “intended release” as the release relates to the main function and not to an
                          series of questions. Answering series 4 questions, he can finally conclude that his article is an article with mixtures    accessory function.
                          forming an integral part thereof (with intentional release).
                          Though we understand that the exercise has to be taken as a whole, we are somewhat concerned that for a clear
                          and easy example of a scented cloth, doubt still subsists at the first stage of the workflow and we may assume that
                          for more difficult examples, the conclusion may be even more difficult to take.”



58 DE       Section 2.3   “The European Commission has classified a candle as a mixture using the indicative questions 3a, 3b and 3c (4 a,           (Overall response to different comments received) The sentence after the
                          4b and 4c in the old guideline). In this case there is no substance/mixture contained within an article, but an article    indicative questions 3a to 3c will be modified as proposed: “If you can answer
                          (the wick) contained in a mixture. We suggest, to change the wording in the following way: „If you can answer              these questions predominantly with yes (i.e. 2 of 3) rather than no, then the
                          these questions with yes rather than no, the object should be regarded as a combination of an article, functioning         object should be regarded as a combination of an article (functioning as a
                          as a container or a carrier material, and a substance/mixture‟.”                                                           container or a carrier material) and a substance/mixture. Importing such an
                                                                                                                                                     object would mean that the importer might not only have the obligations of
                                                                                                                                                     importers of articles described in this guidance document, but also the
                                                                                                                                                     obligations of importers of substances/mixtures. This means e.g. that the
                                                                                                                                                     substances combined (as such or in a mixture) with the article might have to
                                                                                                                                                     be registered by the importer. The obligations of importers of
                                                                                                                                                     substances/mixtures are explained in detail in the Guidance on registration.”
                                                                                                                                                     The term “contained within” will be replaced accordingly also in the rest of the
                                                                                                                                                     document.
                                                                                                                                                     The term “special container / special carrier material with a substance/mixture
                                                                                                                                                     contained within” or “substances/mixtures in containers” is not used anymore
                                                                                                                                                     in the draft updated guidance as it can lead to misunderstandings since: (1) It
                                                                                                                                                     suggests that, besides substances/mixtures and articles, the concepts of
                                                                                                                                                     container and carrier material exist. This is, however, not the case, as a
                                                                                                                                                     container or a carrier material is not different from an article. (2) It does not
                                                                                                                                                     make clear that such objects consist of a substance/mixture and an article,
59 DG ENV   Section 2.3   “Please restore the wording of the original guidance […] „special container / special carrier material with a              each of which mayto different comments received) Thean importer of the
                                                                                                                                                     (Overall response result in different obligations. Thus, sentence after
                          substance/mixture contained within‟.”                                                                                      indicative questions 3a to 3c will be modified as proposed: “If you can answer
                                                                                                                                                     these questions predominantly with yes (i.e. 2 of 3) rather than no, then the
                                                                                                                                                     object should be regarded as a combination of an article (functioning as a
                                                                                                                                                     container or a carrier material) and a substance/mixture. Importing such an
                                                                                                                                                     object would mean that the importer might not only have the obligations of
                                                                                                                                                     importers of articles described in this guidance document, but also the
                                                                                                                                                     obligations of importers of substances/mixtures. This means e.g. that the
                                                                                                                                                     substances combined (as such or in a mixture) with the article might have to
                                                                                                                                                     be registered by the importer. The obligations of importers of
                                                                                                                                                     substances/mixtures are explained in detail in the Guidance on registration.”
                                                                                                                                                     The term “contained within” will be replaced accordingly also in the rest of the
                                                                                                                                                     document.
                                                                                                                                                     The term “special container / special carrier material with a substance/mixture
                                                                                                                                                     contained within” or “substances/mixtures in containers” is not used anymore
                                                                                                                                                     in the draft updated guidance as it can lead to misunderstandings since: (1) It
                                                                                                                                                     suggests that, besides substances/mixtures and articles, the concepts of
                                                                                                                                                     container and carrier material exist. This is, however, not the case, as a
                                                                                                                                                     container or a carrier material is not different from an article. (2) It does not
                                                                                                                                                     make clear that such objects consist of a substance/mixture and an article,
                                                                                                                                                     each of which may result in different obligations. Thus, an importer of
60 EDANA   Section 2.3   “Since there is no criteria to decide when to apply the second set of indicative questions (series 4a, 4b and 4c) (eg   (Overall response to different comments received) The sentence after the
                         if at least one answer is yes, we should apply the second set of criteria 4a, b, c or only when you have 3 „no‟, the    indicative questions 3a to 3c will be modified as proposed: “If you can answer
                         conclusion is „an article with substances or mixtures forming an integral part thereof). […] (eg, if the answers to     these questions predominantly with yes (i.e. 2 of 3) rather than no, then the
                         question series 3 are 3a: yes, 3b: no and 3c: no and for questions 4a: yes, 4b: yes and 4c: no -> what would be         object should be regarded as a combination of an article (functioning as a
                         the conclusion ?)”                                                                                                      container or a carrier material) and a substance/mixture. Importing such an
                                                                                                                                                 object would mean that the importer might not only have the obligations of
                                                                                                                                                 importers of articles described in this guidance document, but also the
                                                                                                                                                 obligations of importers of substances/mixtures. This means e.g. that the
                                                                                                                                                 substances combined (as such or in a mixture) with the article might have to
                                                                                                                                                 be registered by the importer. The obligations of importers of
                                                                                                                                                 substances/mixtures are explained in detail in the Guidance on registration.”
                                                                                                                                                 The term “contained within” will be replaced accordingly also in the rest of the
                                                                                                                                                 document.
                                                                                                                                                 The term “special container / special carrier material with a substance/mixture
                                                                                                                                                 contained within” or “substances/mixtures in containers” is not used anymore
                                                                                                                                                 in the draft updated guidance as it can lead to misunderstandings since: (1) It
                                                                                                                                                 suggests that, besides substances/mixtures and articles, the concepts of
                                                                                                                                                 container and carrier material exist. This is, however, not the case, as a
                                                                                                                                                 container or a carrier material is not different from an article. (2) It does not
                                                                                                                                                 make clear that such objects consist of a substance/mixture and an article,
                                                                                                                                                 each of which may result in different obligations. Thus, an importer of
61 IE      Section 2.3   “(Step 3) Paragraph 2. (i) 1st sentence. Consider adding „predominantly‟ and „(i.e. 2 of 3)‟. i.e. „you can             (Overall response to different comments received) The sentence after the
                         predominantly answer yes (i.e. 2 of 3) rather than no…‟                                                                 indicative questions 3a to 3c will be modified as proposed: “If you can answer
                         (ii) Last sentence. Consider stating more explicitly that the importer may have registration (etc.) duties, rather than these questions predominantly with yes (i.e. 2 of 3) rather than no, then the
                         the indirect reference to the registration guidance document as a means of indicating the duties.”                      object should be regarded as a combination of an article (functioning as a
                                                                                                                                                 container or a carrier material) and a substance/mixture. Importing such an
                                                                                                                                                 object would mean that the importer might not only have the obligations of
                                                                                                                                                 importers of articles described in this guidance document, but also the
                                                                                                                                                 obligations of importers of substances/mixtures. This means e.g. that the
                                                                                                                                                 substances combined (as such or in a mixture) with the article might have to
                                                                                                                                                 be registered by the importer. The obligations of importers of
                                                                                                                                                 substances/mixtures are explained in detail in the Guidance on registration.”
                                                                                                                                                 The term “contained within” will be replaced accordingly also in the rest of the
                                                                                                                                                 document.
                                                                                                                                                 The term “special container / special carrier material with a substance/mixture
                                                                                                                                                 contained within” or “substances/mixtures in containers” is not used anymore
                                                                                                                                                 in the draft updated guidance as it can lead to misunderstandings since: (1) It
                                                                                                                                                 suggests that, besides substances/mixtures and articles, the concepts of
                                                                                                                                                 container and carrier material exist. This is, however, not the case, as a
                                                                                                                                                 container or a carrier material is not different from an article. (2) It does not
                                                                                                                                                 make clear that such objects consist of a substance/mixture and an article,
                                                                                                                                                 each of which may result in different obligations. Thus, an importer of
62 FECC   Section 2.3   “I do not see in the text a clear indication of what are the respective obligations under REACH.                              (Overall response to different comments received) The sentence after the
                        In my view, section 3.3.3 of the old guidelines (called Requirements for objects which are substances/preparations            indicative questions 3a to 3c will be modified as proposed: “If you can answer
                        in containers and not included in the new draft) clarified and underlined the consequences of applying the latter             these questions predominantly with yes (i.e. 2 of 3) rather than no, then the
                        definition.”                                                                                                                  object should be regarded as a combination of an article (functioning as a
                                                                                                                                                      container or a carrier material) and a substance/mixture. Importing such an
                                                                                                                                                      object would mean that the importer might not only have the obligations of
                                                                                                                                                      importers of articles described in this guidance document, but also the
                                                                                                                                                      obligations of importers of substances/mixtures. This means e.g. that the
                                                                                                                                                      substances combined (as such or in a mixture) with the article might have to
                                                                                                                                                      be registered by the importer. The obligations of importers of
                                                                                                                                                      substances/mixtures are explained in detail in the Guidance on registration.”
                                                                                                                                                      The term “contained within” will be replaced accordingly also in the rest of the
                                                                                                                                                      document.
                                                                                                                                                      The term “special container / special carrier material with a substance/mixture
                                                                                                                                                      contained within” or “substances/mixtures in containers” is not used anymore
                                                                                                                                                      in the draft updated guidance as it can lead to misunderstandings since: (1) It
                                                                                                                                                      suggests that, besides substances/mixtures and articles, the concepts of
                                                                                                                                                      container and carrier material exist. This is, however, not the case, as a
                                                                                                                                                      container or a carrier material is not different from an article. (2) It does not
                                                                                                                                                      make clear that such objects consist of a substance/mixture and an article,
63 UK     Section 2.3   “Under section 2.3, answers to steps 3 and 4 now tend toward the answer „article‟, and then make a distinction                each of which mayto different comments received) Thean importer of the
                                                                                                                                                      (Overall response result in different obligations. Thus, sentence after
                        between „integral‟ or „contained‟ substances in subordinate text. This is (strictly) correct in the terms of the „article-    indicative questions 3a to 3c will be modified as proposed: “If you can answer
                        ness‟ of the container, and it does encourage recognition that containers may attract REACH duties in their own               these questions predominantly with yes (i.e. 2 of 3) rather than no, then the
                        right. However, the existing guidance does not contradict or misrepresent these points. Reference has already                 object should be regarded as a combination of an article (functioning as a
                        been made to packaging – and hence to a container – being an article in its own right.                                        container or a carrier material) and a substance/mixture. Importing such an
                        There is no obviously compelling need to change the agreed guidance, and instead the amendment risks                          object would mean that the importer might not only have the obligations of
                        increased confusion by […] introducing a logically unsound distinction between substances which are „integral to‟             importers of articles described in this guidance document, but also the
                        versus „contained within‟, articles. In reality integral substances are, of course, also „contained within‟ the material      obligations of importers of substances/mixtures. This means e.g. that the
                        of an article. Further, this approach confuses an already poorly understood distinction between                               substances combined (as such or in a mixture) with the article might have to
                        substances/mixtures which are physically bound into the material of an article, and those present for lubrication,            be registered by the importer. The obligations of importers of
                        protection, etc., such as oils and greases. Unfortunately, the language used is also unhelpful. „Contained within‟: If        substances/mixtures are explained in detail in the Guidance on registration.”
                        an article „contains‟ a substance, it is not necessary to further use the word „within‟: it is either „contained within‟ or   The term “contained within” will be replaced accordingly also in the rest of the
                        it is not „contained‟ at all. We recognise this phrase appeared in the old version, but this reflects a lack of clarity       document.
                        there that should now be addressed, instead of being carried forward and compounded. […]                                      The term “special container / special carrier material with a substance/mixture
                        These linguistic contortions are only made necessary by the shift from „substance/mixture in a container‟.                    contained within” or “substances/mixtures in containers” is not used anymore
                        We assume these changes have been made, as those to the indicative criteria below, in order to reframe the way                in the draft updated guidance as it can lead to misunderstandings since: (1) It
                        guidance approaches substances in articles more consistently, by identifying and dealing with article requirements            suggests that, besides substances/mixtures and articles, the concepts of
                        first, and then substances in containers.                                                                                     container and carrier material exist. This is, however, not the case, as a
                        However, we suggest the guidance should revert to the original phrase and approach to substances/mixtures in                  container or a carrier material is not different from an article. (2) It does not
                        containers. All that is needed to emphasise the „article-ness‟ of the container is a reminder – emboldened if                 make clear that such objects consist of a substance/mixture and an article,
                        necessary – that a container, like packaging, is an article in its own right.”                                                each of which may result in different obligations. Thus, an importer of
64 IE     Section 2.3   “(Step 4) Result (last sentence). If the result is that the object is regarded as an article and the substance/mixture        (Overall response to different comments received) The last sentence on page
                        as an integral part thereof, what are the duties in relation to the substance/mixture regarding registration etc              16 will be changed to: “If you can answer these questions with yes rather than
                        (taking account of intended release/exposure etc...) Think it would be useful to include these here.”                         no, then the object is regarded as an article with an integral
                                                                                                                                                      substance/mixture (i.e. the substance/mixture forms an integral part of the
                                                                                                                                                      article). The substances (as such or in a mixture) that form an integral part of
                                                                                                                                                      the article have only to be registered under the conditions described in
                                                                                                                                                      section 3.2.”
                                                                                                                                                      The wording in other parts of the guidance will be changed accordingly.
65 UK        Section 2.3   “„Article with a substance forming an integral part thereof‟: While there is nothing strictly wrong with this grammar   (Overall response to different comments received) The last sentence on page
                           of this phrase, it is not very clear and will be difficult to understand for many native English-speaking readers.”     16 will be changed to: “If you can answer these questions with yes rather than
                                                                                                                                                   no, then the object is regarded as an article with an integral
                                                                                                                                                   substance/mixture (i.e. the substance/mixture forms an integral part of the
                                                                                                                                                   article). The substances (as such or in a mixture) that form an integral part of
                                                                                                                                                   the article have only to be registered under the conditions described in
                                                                                                                                                   section 3.2.”
                                                                                                                                                   The wording in other parts of the guidance will be changed accordingly.



66 DG ENTR   Section 2.3   “The draft Guidance doesn‟t sufficiently clarify the conclusion whether thermometer is an article with the substance The last sentence of Example 2 will be modified as follows: “So answering
                           as its integral part or an article with the substance contained within (functioning as container). It should be      these questions leads to the conclusion that a thermometer is an article and
                           emphasized that it is the former (as it is shown in the table in one of the Appendices).”                            the liquid within an integral part of it.”

67 IE        Section 2.3   “The note after the example indicates that „Appendix 1 provides further examples of borderline cases....”). This        In principle, any object identified in step 2 is a borderline case. That is why
                           suggests that a thermometer is considered a borderline case. Please clarify if a thermometer is considered as a         the indicative questions should be used to decide on the article status of
                           borderline case or, a clear example of an article and the substance/mixture as an integral part thereof.”               these objects. Consequently a thermometer is a borderline case, particularly
                                                                                                                                                   in comparison with a chair or a book which are definitely not borderline cases.
                                                                                                                                                   This does however not mean that the article status of borderline cases cannot
                                                                                                                                                   be clearly determined using the indicative questions of the guidance.


68 IE        Section 2.3   “(Step 5) states that „If the shape, surface or design is of equal or less importance than the chemical composition,    Step 5 is based on the article definition in REACH. This says that an article is
                           it is a substance or mixture‟. In this case, where the shape, surface or design is found to be of equal importance to   given a special shape, surface or design which determines its function to a
                           the chemical composition, does this not imply that the object should be regarded as an article and the                  greater degree than does its chemical composition. Thus, where the shape,
                           substance/mixture as an integral part thereof?”                                                                         surface or design is found to be just of equal (not greater) importance to the
                                                                                                                                                   chemical composition, the object is a substance or mixture and not an article.


69 UK        Section 2.3   “Further, a key strength of the „indicative criteria‟ approach is the consistent and systematic way the questions       Like the current guidance, the draft updated guidance follows a systematic
                           approach key characteristics of objects. The range of topics chosen as the basis for questions in the new step 6,       “indicative criteria” approach. The indicative criteria or indicative questions 6a
                           however, do not clearly relate one another or to earlier steps, and do not operate systematically to return a           to 6d, in particular, have hardly been modified compared to the current
                           „probably is‟ or „probably isn‟t‟ result in the same way as the earlier steps.                                          guidance. The main change was to rephrase two of the questions so as to
                           The concepts themselves, however, while they do not relate clearly to one another, are very useful – perhaps more       enable the reader to give a yes/no answer, which makes it easier to return a
                           useful than the indicative criteria themselves, as they are simpler to understand, simpler to answer, stand             result for step 6. Furthermore step 6 clearly relates to the preceding step 5, in
                           individually, and relate to the perspectives of most readers who will have to make these decisions – i.e. industry.     which the reader is asked to check if his object fulfils the article definition. In
                           We suggest that these questions be moved into a section of their own discussing the sort of consideration               case of doubt he should proceed with step 6, which contains indicative
                           businesses should go through before they apply the indicative criteria, which can help resolve uncertainty where        questions that facilitate decision-making in borderline cases. Therefore it
                           no clear answer can be reached.”                                                                                        makes sense to describe the whole decision-making on whether an object is
                                                                                                                                                   an article or not in one section.




70 IE        Section 2.3   “Examples provided (in step 6) are: raw materials & semi-finished products. The 1st sentence states that „In these      The latter is true.
                           cases, you may use the following indicative questions...‟ Does this mean the questions in Step 6 are intended           It will be clarified in the text that raw materials and semi-finished products are
                           ONLY be used for raw materials and semi-finished products, or does it mean that where making a decision might           just examples (although the most common ones) of objects where making a
                           be difficult for certain objects the questions in Step 6 can be used?”                                                  decision might be difficult.

71 IE        Section 2.3   “Suggest replacing the word „similar‟ (in question 6d) with „the same‟.”                                                The indicative question 6d will be modified as proposed.
72 IE       Section 2.3   “Examples given (under questions 6c and 6d) include „printing on the surface, painting, applying coatings, dyeing     As specified in question 6d, printing on the surface, painting, applying
                          etc‟. Coatings are currently listed in Table 2 under „light processing‟ whereas „light processing‟ is dealt with in   coatings, dyeing, etc. “may result in a change in the overall chemical
                          Question 6c. As coatings may change the chemical composition, is it appropriate to have them listed as light          composition (of the article), but not in the status of the object being an
                          processing in Table 2?”                                                                                               article”. Likewise, “light processing” does not result in a change in the status
                                                                                                                                                of an object being an article. Thus, coating can be regarded as “light
                                                                                                                                                processing” and therefore be listed accordingly in Table 2.
73 IE       Section 2.3   “Suggest adding (in step 6) the sentence „Predominantly answering No to the questions indicates that the object is The suggested sentence will be added.
                          a substance or mixture‟ after the bolded sentence at the top of the page.”
74 IE       Section 2.3   “It would be useful to include an example under both steps 5 and 6 (to illustrate the point if possible), as was done It is proposed to include under step 5 the example of a wax crayon (a
                          under steps 3 and 4.”                                                                                                 mixture). For step 6 examples are given in Appendix 2 as specified in the
                                                                                                                                                paragraph after the indicative questions.
75 Cefic    Section 2.3   “I agree that the introduction of “forming process” is consistent with the examples given in Appendix 2, but only for To determine whether their raw materials and “semi-finished products” are
                          the four industries described. The indicative questions 6a) to 6d) do not present a universally applicable guidance. articles or not, readers of the guidance should apply the rules given in the
                          The workflow of 2.3 in itself is confusing and should at least include the advice to read also the appendixes.”       main part of the guidance. In the text on page 18 reference is already made
                                                                                                                                                to Appendix 2. The examples provided Appendix 2, which are not universally
                                                                                                                                                applicable either, shall however just serve to illustrate how to apply the
                                                                                                                                                indicative questions 6a to 6d to different types of raw materials and “semi-
                                                                                                                                                finished products”.
                                                                                                                                                Therefore, the examples in Appendix 2 should be treated as what they are,
                                                                                                                                                namely as examples and not as general rules, as these are found in the main
                                                                                                                                                part of the guidance.



76 EUROFER Section 2.3    “The basis for this table (Table 2) is not explained. It would appear that the table is presented on the basis that Table 2 was created on the basis of the classification of manufacturing
                          forming processes introduce gross changes in shape in the object, while light processing has a minimal impact on processes according to standard DIN 8580.
                          the overall shape. If this premise is correct, then milling and turning could also be regarded as something other
                          than light processing as they are capable of introducing gross changes in shape, surface and design. What is the
                          basis upon which the forming operations were selected?
                          Furthermore, in metallurgical terms, casting and sintering are not normally regarded as forming processes.
                          However, discussions in the RIP 3.8 SEG (Stakeholder Expert Group) meetings concluded that, as substances
                          and mixtures are melted during casting and liquefied during sintering, their original shape, surface and design
                          were lost.”



77 EUROFER Section 2.3    “In addition, the RIP 3.8 SEG meetings discussed „light processing‟ as an indication that an object is an article.    The concept of “light processing” was already introduced in the current
                          Forming operations were not discussed in this context. Thus, the introduction of a list of forming operations is a    guidance. The existence of processes regarded as “light processing” of
                          significant change to the Guidance and it represents the introduction of a new criterion that has significant         course implies that other processes are not regarded as “light processing”.
                          influence in determining the borderline between a substance/mixture and an article for semi-finished products.        Thus, the term “forming processes” does not refer to a new concept
                          Incidentally, welding involves melting of the parent material in both semi-finished products and articles. In this    introduced by the draft updated guidance, it is just used to describe those
                          respect, it is no different from casting and sintering. Yet it is listed as light processing. […]                     processes not regarded as “light processing”.
                          The limited list of forming operations for semi-finished products has, therefore, introduced inconsistencies and a    To make these concepts more graspable a table with examples has been
                          greater degree of uncertainty for producers and importers of semi-finished products. It is recommended that the       included in the draft updated guidance. It is acknowledged that these lists are
                          list of forming operations and related text are deleted from the Guidance.”                                           limited and not complete, which however is not their purpose, as they are just
                                                                                                                                                supposed to provide examples.
                                                                                                                                                Welding, as well as soldering, is a joining process and thus different from
                                                                                                                                                forming processes like casting and sintering. Therefore they should not be
                                                                                                                                                listed together in Table 2.
78 EUROFER Section 2.3     “As their name implies, semi-finished products will generally undergo further processing (although an end use can          The guidance document does not say that objects undergoing forming
                           be identified for virtually every steel semi-finished product) and, in many cases, this will involve forming operations.   processes cannot be articles. The fact that an object undergoes forming
                           This fact does not disqualify a semi-finished product from meeting the REACH definition of an article and, indeed,         processes just plays a role in one of four indicative questions. Furthermore
                           the article definition does not place any restriction on further processing of objects. In the case of steel semi-         these questions (6a to 6d) do not have to be applied if it can be concluded
                           finished products, the shape and design determines the next process step (e.g. continuously cast slabs are given           that the shape/surface/design of the object are more relevant for the function
                           a rectangular cross-section, specific dimensions and surface finish for rolling into coil, plate and sheet, while          than its chemical composition, or that this is not the case. Thus, the fact
                           continuously cast billets are given a circular cross-section, specific dimensions and surface finish for rolling into      alone that many semi-finished products undergo further processing which
                           wire rod). This is consistent with draft Guidance Section 2.3.1 - Sets of objects which states:                            involves forming operations, does not disqualify them from being articles.
                           „According to Article 3(3) of the REACH Regulation an article is an object which during production is given a
                           special shape, surface or design which determines its function to a greater degree than its chemical composition.
                           This implies that the shape, surface or design must be deliberately determined and given during a production
                           step.‟
                           The forming operations listed in Table 2 of the draft Guidance are no different from those applied to an aluminium
                           or stainless steel coil or sheet (articles according to figure 4 and Table 10 of the draft Guidance) that are deep
                           drawn to form bowls, kidney dishes, saucepans, etc.”
79 UK       Section 2.3    “There is no obviously compelling need to change the agreed guidance, and instead the amendment risks                      What steers the reader either to the conclusion that he has a
                           increased confusion by:                                                                                                    substance/mixture in a container (and thus Article 6 obligations) or to the
                           - re-phrasing an agreed and (relatively) familiar concept – „substances/mixtures in containers‟ – making the „article‟     conclusion that he has an article (and thus only Article 7 obligations for this
                           the subject of the phrase rather than the substance, and so steering readers towards Article 7 requirements. In the        object) are the indicative questions 3a to 3c and 4a to 4c. These questions
                           phrase „substance/mixture in a container/on a carrier‟ the substance is the subject of the phrase, correctly steering      have been modified only marginally and should in particular not lead to
                           the reader correctly towards Article 6”                                                                                    different conclusions as compared to the indicative questions in the current
                                                                                                                                                      guidance.


80 Cefic    Section 2.3.1 “No disagreement with the additional explanation.”

81 ASD      Section 2.3.1 “Points 2.3.1. and 2.3.2 provide useful insight into the definition of an what is an article, particularly with reference   (Overall response to different comments received) Section 2.3.1 has been
                          to assembled articles. […] References in 2.3.1. to „the production steps of an article‟, which can be understood to         included in the draft updated guidance, because the current guidance does
                          include the assembly of a complex article is welcome as it seems to support the definition of complex articles such         not clarify how to deal with sets of objects (like a cookware set).
                          as an automobile or an aircraft as a single article defined by its function and thereby limiting the discussion as to       The issue concerning the application of the 0.1 % threshold to complex
                          how the 0.1% threshold is to be applied in complete manufactured articles.”                                                 articles (like a computer) is however not part of the present consultation, as
                                                                                                                                                      the related parts of the guidance (chapter 8 in the current guidance) still have
                                                                                                                                                      to be revised. This issue and the issue concerning sets of objects (like a
                                                                                                                                                      cookware set) should not be mixed up. In this sense, it is acknowledged that
                                                                                                                                                      the 3rd sentence of section 2.3.1 dealing with the production of complex
                                                                                                                                                      articles touches the issue of the application of the 0.1 % threshold. Thus, the
                                                                                                                                                      inclusion of this sentence in section 2.3.1 will be reconsidered after the
                                                                                                                                                      discussion on the application of the 0.1 % threshold to complex articles.
                                                                                                                                                      In the current guidance as well as in the draft updated guidance the term
                                                                                                                                                      “object” is used to define components for which it still has to be determined if
                                                                                                                                                      they are articles or not in the context of REACH. To make this clear, it will be
                                                                                                                                                      specified in the first sentence of chapter 2 that the term “object” can in
                                                                                                                                                      principle refer to any product in the supply chain.
                                                                                                                                                      In section 2.3.1 it will be specified that a set of objects (or a “kit”) can also
                                                                                                                                                      include substances/mixtures apart from articles. Furthermore it will be
                                                                                                                                                      clarified that objects which are supplied together in the same box and
                                                                                                                                                      designed to be used together or assembled into a single object (like a flat
                                                                                                                                                      pack furniture) are to be assessed separately concerning their article status
82 EDANA   Section 2.3.1 “The concept of „set of objects‟ which has been introduced in this revised version does not provide any value to the     (Overall response to different comments received) Section 2.3.1 has been
                         guidance while at the same time bringing confusion again to the definition of an article. Indeed, the term „object‟ is   included in the draft updated guidance, because the current guidance does
                         an element of the article‟s definition under REACH and as such, an object, which during production is not given a        not clarify how to deal with sets of objects (like a cookware set).
                         special shape or design which determines its function to a greater degree than its chemical composition is not to        The issue concerning the application of the 0.1 % threshold to complex
                         be considered as an article. Therefore a set of objects (or a „kit‟) can be composed of articles and                     articles (like a computer) is however not part of the present consultation, as
                         substances/preparations (eg, a painting kit is composed of painting brushes which are articles, a plastic paint          the related parts of the guidance (chapter 8 in the current guidance) still have
                         palette which also is an article and tubes of acrylic paints which are preparations)                                     to be revised. This issue and the issue concerning sets of objects (like a
                         We assume that the intention was to clarify the fact that a product sold or supplied in several parts all complying      cookware set) should not be mixed up. In this sense, it is acknowledged that
                         with the definition of an article is regarded as a group of articles and not only one whole article (for example a       the 3rd sentence of section 2.3.1 dealing with the production of complex
                         necklace kit made of pearls and a thread – all being individual articles sold together in a package). […]                articles touches the issue of the application of the 0.1 % threshold. Thus, the
                         We recommend to delete these sections from the guidance or at least not to use the term „object‟ to define               inclusion of this sentence in section 2.3.1 will be reconsidered after the
                         components which clearly meet the definition of an article since objects can be substances or preparations under         discussion on the application of the 0.1 % threshold to complex articles.
                         certain conditions in the context of REACH.”                                                                             In the current guidance as well as in the draft updated guidance the term
                                                                                                                                                  “object” is used to define components for which it still has to be determined if
                                                                                                                                                  they are articles or not in the context of REACH. To make this clear, it will be
                                                                                                                                                  specified in the first sentence of chapter 2 that the term “object” can in
                                                                                                                                                  principle refer to any product in the supply chain.
                                                                                                                                                  In section 2.3.1 it will be specified that a set of objects (or a “kit”) can also
                                                                                                                                                  include substances/mixtures apart from articles. Furthermore it will be
                                                                                                                                                  clarified that objects which are supplied together in the same box and
                                                                                                                                                  designed to be used together or assembled into a single object (like a flat
                                                                                                                                                  pack furniture) are to be assessed separately concerning their article status
                                                                                                                                                  (in a way they would be comparable to semi-finished products). For this, as
                                                                                                                                                  suggested, additional examples will be given in the guidance. The term “put
                                                                                                                                                  together” will be avoided.




83 NO      Section 2.3.1 “The use of the term object as a separate specific term could be confusing […] Do we need a „general‟ object             (Overall response to different comments received) Section 2.3.1 has been
                         interpretation?”                                                                                                         included in the draft updated guidance, because the current guidance does
                                                                                                                                                  not clarify how to deal with sets of objects (like a cookware set).
                                                                                                                                                  The issue concerning the application of the 0.1 % threshold to complex
                                                                                                                                                  articles (like a computer) is however not part of the present consultation, as
                                                                                                                                                  the related parts of the guidance (chapter 8 in the current guidance) still have
                                                                                                                                                  to be revised. This issue and the issue concerning sets of objects (like a
                                                                                                                                                  cookware set) should not be mixed up. In this sense, it is acknowledged that
                                                                                                                                                  the 3rd sentence of section 2.3.1 dealing with the production of complex
                                                                                                                                                  articles touches the issue of the application of the 0.1 % threshold. Thus, the
                                                                                                                                                  inclusion of this sentence in section 2.3.1 will be reconsidered after the
                                                                                                                                                  discussion on the application of the 0.1 % threshold to complex articles.
                                                                                                                                                  In the current guidance as well as in the draft updated guidance the term
                                                                                                                                                  “object” is used to define components for which it still has to be determined if
                                                                                                                                                  they are articles or not in the context of REACH. To make this clear, it will be
                                                                                                                                                  specified in the first sentence of chapter 2 that the term “object” can in
                                                                                                                                                  principle refer to any product in the supply chain.
                                                                                                                                                  In section 2.3.1 it will be specified that a set of objects (or a “kit”) can also
                                                                                                                                                  include substances/mixtures apart from articles. Furthermore it will be
                                                                                                                                                  clarified that objects which are supplied together in the same box and
                                                                                                                                                  designed to be used together or assembled into a single object (like a flat
                                                                                                                                                  pack furniture) are to be assessed separately concerning their article status
84 IE   Section 2.3.1 “In the example given, it is clear that a set of cookware is a collection of objects or articles. However, what about a
                                                                                                                                            (Overall response to different comments received) Section 2.3.1 has been
                      group of objects supplied together in the same box (just as the cookware) with no apparent individual function, but   included in the draft updated guidance, because the current guidance does
                      are designed to be assembled into a single object or article with a defined function upon receipt (by a professional  not clarify how to deal with sets of objects (like a cookware set).
                      user or consumer. For example, flat pack furniture)? Are these considered articles (as shipped) or is the end         The issue concerning the application of the 0.1 % threshold to complex
                      (professional) user a „producer of articles‟?”                                                                        articles (like a computer) is however not part of the present consultation, as
                                                                                                                                            the related parts of the guidance (chapter 8 in the current guidance) still have
                                                                                                                                            to be revised. This issue and the issue concerning sets of objects (like a
                                                                                                                                            cookware set) should not be mixed up. In this sense, it is acknowledged that
                                                                                                                                            the 3rd sentence of section 2.3.1 dealing with the production of complex
                                                                                                                                            articles touches the issue of the application of the 0.1 % threshold. Thus, the
                                                                                                                                            inclusion of this sentence in section 2.3.1 will be reconsidered after the
                                                                                                                                            discussion on the application of the 0.1 % threshold to complex articles.
                                                                                                                                            In the current guidance as well as in the draft updated guidance the term
                                                                                                                                            “object” is used to define components for which it still has to be determined if
                                                                                                                                            they are articles or not in the context of REACH. To make this clear, it will be
                                                                                                                                            specified in the first sentence of chapter 2 that the term “object” can in
                                                                                                                                            principle refer to any product in the supply chain.
                                                                                                                                            In section 2.3.1 it will be specified that a set of objects (or a “kit”) can also
                                                                                                                                            include substances/mixtures apart from articles. Furthermore it will be
                                                                                                                                            clarified that objects which are supplied together in the same box and
                                                                                                                                            designed to be used together or assembled into a single object (like a flat
85 UK   Section 2.3.1 “The term „put together‟ is used. In normal usage this implies assembly of component parts (for example final         (Overall response to different comments received) Section 2.3.1 has been
                      production of a complex article). The term is best avoided.                                                           included in the draft updated guidance, because the current guidance does
                      Several other examples would be more illustrative, and perhaps question the usefulness of the advice being given. not clarify how to deal with sets of objects (like a cookware set).
                      For example:                                                                                                          The issue concerning the application of the 0.1 % threshold to complex
                      - a mobile (cell) phone                                                                                               articles (like a computer) is however not part of the present consultation, as
                      - flat pack furniture                                                                                                 the related parts of the guidance (chapter 8 in the current guidance) still have
                      - a portable power tool (e.g. drill)                                                                                  to be revised. This issue and the issue concerning sets of objects (like a
                      All of these are supplied to the end user in parts, as part of a single package. In the case of the mobile phone we   cookware set) should not be mixed up. In this sense, it is acknowledged that
                      presume this is for safety reasons aimed at preventing any accidental discharge of the battery, for the flat pack     the 3rd sentence of section 2.3.1 dealing with the production of complex
                      furniture it is merely for convenience. In both cases there is a single act of assembly by the end user and the       articles touches the issue of the application of the 0.1 % threshold. Thus, the
                      items (parts) then form a single article for the remainder of their life. Are these then single or multiple articles? inclusion of this sentence in section 2.3.1 will be reconsidered after the
                      In common sense terms we might wish to identify a mobile phone (including battery) as one article, and the            discussion on the application of the 0.1 % threshold to complex articles.
                      charger as a separate article – and, for that matter, the packaging etc.                                              In the current guidance as well as in the draft updated guidance the term
                      Furniture would be most sensibly treated as a single article.                                                         “object” is used to define components for which it still has to be determined if
                      For the power tool, the battery may regularly be removed from the tool for recharging, and professional users often they are articles or not in the context of REACH. To make this clear, it will be
                      have multiple batteries. These then should be viewed as multiple articles (battery, tool & charger), although they    specified in the first sentence of chapter 2 that the term “object” can in
                      are intended to be used in combination, and indeed are of limited (or no) value when separated.                       principle refer to any product in the supply chain.
                      This guidance draft does not consider such everyday items and situations. It is necessary to consider articles        In section 2.3.1 it will be specified that a set of objects (or a “kit”) can also
                      which are disassembled for supply to end users, and to take into account that some articles will have removable       include substances/mixtures apart from articles. Furthermore it will be
                      parts. Parts can also be interchangeable, for example replacement or upgrade parts such as battery packs, mobile clarified that objects which are supplied together in the same box and
                      phone fascias, etc.                                                                                                   designed to be used together or assembled into a single object (like a flat
86 AT   Section 2.3.1 “The assembly of the components which are mechanically or physically bound when assembling a complex article             (Overall response to different comments received) Section 2.3.1 has been
                      has to be discussed in more depth. I suggest that the 3rd sentence „In this sense, the „production step‟ of an article   included in the draft updated guidance, because the current guidance does
                      can also be understood to include the assembly of the components…‟ can be omitted, as it is not necessary to             not clarify how to deal with sets of objects (like a cookware set).
                      explain the term „set of objects‟.”                                                                                      The issue concerning the application of the 0.1 % threshold to complex
                                                                                                                                               articles (like a computer) is however not part of the present consultation, as
                                                                                                                                               the related parts of the guidance (chapter 8 in the current guidance) still have
                                                                                                                                               to be revised. This issue and the issue concerning sets of objects (like a
                                                                                                                                               cookware set) should not be mixed up. In this sense, it is acknowledged that
                                                                                                                                               the 3rd sentence of section 2.3.1 dealing with the production of complex
                                                                                                                                               articles touches the issue of the application of the 0.1 % threshold. Thus, the
                                                                                                                                               inclusion of this sentence in section 2.3.1 will be reconsidered after the
                                                                                                                                               discussion on the application of the 0.1 % threshold to complex articles.
                                                                                                                                               In the current guidance as well as in the draft updated guidance the term
                                                                                                                                               “object” is used to define components for which it still has to be determined if
                                                                                                                                               they are articles or not in the context of REACH. To make this clear, it will be
                                                                                                                                               specified in the first sentence of chapter 2 that the term “object” can in
                                                                                                                                               principle refer to any product in the supply chain.
                                                                                                                                               In section 2.3.1 it will be specified that a set of objects (or a “kit”) can also
                                                                                                                                               include substances/mixtures apart from articles. Furthermore it will be
                                                                                                                                               clarified that objects which are supplied together in the same box and
                                                                                                                                               designed to be used together or assembled into a single object (like a flat
87 FR   Section 2.3.2 “We find that the conclusion of this paragraph is unclear. Are we supposed to understand that when the small             (Overall response to be assessed separately concerning their article status
                                                                                                                                               pack furniture) areto different comments received) The essence of section
                      object is single it is not an article but a substance/preparation and when there are many of these objects, they are     2.3.2 is that an object that only fulfils a particular function when used in large
                      considered as articles?”                                                                                                 numbers cannot be regarded as an article, but has to be treated as
                                                                                                                                               substance/mixture. The basis for this is the definition of an article in the
                                                                                                                                               REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                               that in order to be an article under REACH
                                                                                                                                               a (single) object (not objects) must have a function,
                                                                                                                                               it has to be given special shape, surface or design during production and
                                                                                                                                               its shape, surface or design has to determine its function to a greater degree
                                                                                                                                               than its chemical composition.
                                                                                                                                               Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                               importance, is not enough to regard the object as an article, if it does not
                                                                                                                                               have a particular function that it can fulfil as a single object.
                                                                                                                                               This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                               one of the examples already mentioned in the text will be explained more in
                                                                                                                                               detail.
                                                                                                                                               Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                               chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                               Like in other parts of the guidance the term “object” is used to define
                                                                                                                                               components for which it still has to be determined if they are articles or not in
                                                                                                                                               the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                               whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                               tiny articles, the term “object(s)” can be used. As mentioned above, it will be
                                                                                                                                               specified in the first sentence of chapter 2 that the term “object” can in
88 ASD     Section 2.3.2 “Points 2.3.1. and 2.3.2 provide useful insight into the definition of an what is an article, particularly with reference
                                                                                                                                              (Overall response to different comments received) The essence of section
                         to assembled articles. Mention in point 2.3.2 that „to be considered an article an object needs to have a particular 2.3.2 is that an object that only fulfils a particular function when used in large
                         function that it can fulfil as a single object‟ is a novel aspect to the definition of an article and it is not something
                                                                                                                                              numbers cannot be regarded as an article, but has to be treated as
                         that can be deduced straight away from the legal definition in Art. 3 and thereby may be problematic. Thereby        substance/mixture. The basis for this is the definition of an article in the
                         careful thought must be given to the phrasing of this sentence at its precise implications.”                         REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                              that in order to be an article under REACH
                                                                                                                                              a (single) object (not objects) must have a function,
                                                                                                                                              it has to be given special shape, surface or design during production and
                                                                                                                                              its shape, surface or design has to determine its function to a greater degree
                                                                                                                                              than its chemical composition.
                                                                                                                                              Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                              importance, is not enough to regard the object as an article, if it does not
                                                                                                                                              have a particular function that it can fulfil as a single object.
                                                                                                                                              This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                              one of the examples already mentioned in the text will be explained more in
                                                                                                                                              detail.
                                                                                                                                              Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                              chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                              Like in other parts of the guidance the term “object” is used to define
                                                                                                                                              components for which it still has to be determined if they are articles or not in
                                                                                                                                              the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                              whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                              tiny articles, the term “object(s)” can be used. As mentioned above, it will be
89 Cefic                                                                                                                                      (Overall in the first different of chapter received) The “object” of section
           Section 2.3.2 “I understand what the author tries to explain. However, it is not always as simple as this and could be misleading. specifiedresponse tosentence comments 2 that the term essencecan in
                         Example: a bicycle chain                                                                                             2.3.2 is that an object that only fulfils a particular function when used in large
                         A bicycle chain consists of many metal chain links. The chain links can be purchased individually. None of these     numbers cannot be regarded as an article, but has to be treated as
                         small objects are used individually, but only in a large number fulfilling their function as bicycle chain.          substance/mixture. The basis for this is the definition of an article in the
                         Nevertheless, page 19 is useful, even if the second sentence would be removed.”                                      REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                              that in order to be an article under REACH
                                                                                                                                              a (single) object (not objects) must have a function,
                                                                                                                                              it has to be given special shape, surface or design during production and
                                                                                                                                              its shape, surface or design has to determine its function to a greater degree
                                                                                                                                              than its chemical composition.
                                                                                                                                              Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                              importance, is not enough to regard the object as an article, if it does not
                                                                                                                                              have a particular function that it can fulfil as a single object.
                                                                                                                                              This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                              one of the examples already mentioned in the text will be explained more in
                                                                                                                                              detail.
                                                                                                                                              Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                              chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                              Like in other parts of the guidance the term “object” is used to define
                                                                                                                                              components for which it still has to be determined if they are articles or not in
                                                                                                                                              the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                              whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                              tiny articles, the term “object(s)” can be used. As mentioned above, it will be
90 EDANA   Section 2.3.2 “The section rather describes the situation of small and simple articles and it is confusing to include the term object   (Overall response to different comments received) The essence of section
                         to define products which fulfill in any case the definition of an article regardless of their size.                       2.3.2 is that an object that only fulfils a particular function when used in large
                         We recommend to delete these sections from the guidance or at least not to use the term „object‟ to define                numbers cannot be regarded as an article, but has to be treated as
                         components which clearly meet the definition of an article since objects can be substances or preparations under          substance/mixture. The basis for this is the definition of an article in the
                         certain conditions in the context of REACH.”                                                                              REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                                   that in order to be an article under REACH
                                                                                                                                                   a (single) object (not objects) must have a function,
                                                                                                                                                   it has to be given special shape, surface or design during production and
                                                                                                                                                   its shape, surface or design has to determine its function to a greater degree
                                                                                                                                                   than its chemical composition.
                                                                                                                                                   Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                                   importance, is not enough to regard the object as an article, if it does not
                                                                                                                                                   have a particular function that it can fulfil as a single object.
                                                                                                                                                   This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                                   one of the examples already mentioned in the text will be explained more in
                                                                                                                                                   detail.
                                                                                                                                                   Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                                   chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                                   Like in other parts of the guidance the term “object” is used to define
                                                                                                                                                   components for which it still has to be determined if they are articles or not in
                                                                                                                                                   the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                                   whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                                   tiny articles, the term “object(s)” can be used. As mentioned above, it will be
91 NO      Section 2.3.2 “The use of the term object as a separate specific term could be confusing […] Do we need a „general‟ object              specifiedresponse tosentence comments 2 that the term essencecan in
                                                                                                                                                   (Overall in the first different of chapter received) The “object” of section
                         interpretation?”                                                                                                          2.3.2 is that an object that only fulfils a particular function when used in large
                                                                                                                                                   numbers cannot be regarded as an article, but has to be treated as
                                                                                                                                                   substance/mixture. The basis for this is the definition of an article in the
                                                                                                                                                   REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                                   that in order to be an article under REACH
                                                                                                                                                   a (single) object (not objects) must have a function,
                                                                                                                                                   it has to be given special shape, surface or design during production and
                                                                                                                                                   its shape, surface or design has to determine its function to a greater degree
                                                                                                                                                   than its chemical composition.
                                                                                                                                                   Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                                   importance, is not enough to regard the object as an article, if it does not
                                                                                                                                                   have a particular function that it can fulfil as a single object.
                                                                                                                                                   This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                                   one of the examples already mentioned in the text will be explained more in
                                                                                                                                                   detail.
                                                                                                                                                   Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                                   chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                                   Like in other parts of the guidance the term “object” is used to define
                                                                                                                                                   components for which it still has to be determined if they are articles or not in
                                                                                                                                                   the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                                   whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                                   tiny articles, the term “object(s)” can be used. As mentioned above, it will be
                                                                                                                                                   specified in the first sentence of chapter 2 that the term “object” can in
92 Digital   Section 2.3.2 “Please provide more examples and a clear conclusion in section 2.3.2 „Small and simple objects‟. We are not sure (Overall response to different comments received) The essence of section
   Europe                  what problem the authors had in mind when creating this concept.”                                                    2.3.2 is that an object that only fulfils a particular function when used in large
                                                                                                                                                numbers cannot be regarded as an article, but has to be treated as
                                                                                                                                                substance/mixture. The basis for this is the definition of an article in the
                                                                                                                                                REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                                that in order to be an article under REACH
                                                                                                                                                a (single) object (not objects) must have a function,
                                                                                                                                                it has to be given special shape, surface or design during production and
                                                                                                                                                its shape, surface or design has to determine its function to a greater degree
                                                                                                                                                than its chemical composition.
                                                                                                                                                Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                                importance, is not enough to regard the object as an article, if it does not
                                                                                                                                                have a particular function that it can fulfil as a single object.
                                                                                                                                                This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                                one of the examples already mentioned in the text will be explained more in
                                                                                                                                                detail.
                                                                                                                                                Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                                chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                                Like in other parts of the guidance the term “object” is used to define
                                                                                                                                                components for which it still has to be determined if they are articles or not in
                                                                                                                                                the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                                whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                                tiny articles, the term “object(s)” can be used. As mentioned above, it will be
                                                                                                                                                specified in the first sentence of chapter 2 that the term “object” can in
93 IE        Section 2.3.2 “The term „simple‟ is not adequately defined here. In addition the examples given are confusing and appear           (Overall response to different comments received) The essence of section
                           contradictory. They appear to disregard the argument about the level of sophistication and more importantly a        2.3.2 is that an object that only fulfils a particular function when used in large
                           discussion on the assembly of objects into a „larger article‟. The alternative to the object being an article should numbers cannot be regarded as an article, but has to be treated as
                           also be discussed.”                                                                                                  substance/mixture. The basis for this is the definition of an article in the
                                                                                                                                                REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                                that in order to be an article under REACH
                                                                                                                                                a (single) object (not objects) must have a function,
                                                                                                                                                it has to be given special shape, surface or design during production and
                                                                                                                                                its shape, surface or design has to determine its function to a greater degree
                                                                                                                                                than its chemical composition.
                                                                                                                                                Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                                importance, is not enough to regard the object as an article, if it does not
                                                                                                                                                have a particular function that it can fulfil as a single object.
                                                                                                                                                This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                                one of the examples already mentioned in the text will be explained more in
                                                                                                                                                detail.
                                                                                                                                                Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                                chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                                Like in other parts of the guidance the term “object” is used to define
                                                                                                                                                components for which it still has to be determined if they are articles or not in
                                                                                                                                                the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                                whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                                tiny articles, the term “object(s)” can be used. As mentioned above, it will be
                                                                                                                                                specified in the first sentence of chapter 2 that the term “object” can in
94 UK          Section 2.3.2 “We generally agree with this point, but expressed in these terms it undermines previous agreement that recycled (Overall response to different comments received) The essence of section
                             aggregates can count as articles. It needs further work to fully explain what you are trying to get across without
                                                                                                                                              2.3.2 is that an object that only fulfils a particular function when used in large
                             endangering previous policy decisions.”                                                                          numbers cannot be regarded as an article, but has to be treated as
                                                                                                                                              substance/mixture. The basis for this is the definition of an article in the
                                                                                                                                              REACH Regulation, which every article has to fulfil as a whole. This means
                                                                                                                                              that in order to be an article under REACH
                                                                                                                                              a (single) object (not objects) must have a function,
                                                                                                                                              it has to be given special shape, surface or design during production and
                                                                                                                                              its shape, surface or design has to determine its function to a greater degree
                                                                                                                                              than its chemical composition.
                                                                                                                                              Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                              importance, is not enough to regard the object as an article, if it does not
                                                                                                                                              have a particular function that it can fulfil as a single object.
                                                                                                                                              This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                              one of the examples already mentioned in the text will be explained more in
                                                                                                                                              detail.
                                                                                                                                              Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                              chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                              Like in other parts of the guidance the term “object” is used to define
                                                                                                                                              components for which it still has to be determined if they are articles or not in
                                                                                                                                              the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                              whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                              tiny articles, the term “object(s)” can be used. As mentioned above, it will be
                                                                                                                                              specified in the first sentence of chapter 2 that the term “object” can in
95 EUROFER Section 2.3.2 “Chapter 2.3.2 of the draft Guidance implies that, by their failure to fulfill the requirement to function as single (Overall response to different comments received) The essence of section
                         objects, aggregates would not be considered as articles. However, the REACH Competent Authorities (CARACAL) 2.3.2 is that an object that only fulfils a particular function when used in large
                         section of the Europa website has a document posted (CA/24/2008 rev 3 - Follow-up to 5th Meeting of the              numbers cannot be regarded as an article, but has to be treated as
                         Competent Authorities for the implementation of Regulation (EC) 1907/2006 (REACH)) that is concerned with            substance/mixture. The basis for this is the definition of an article in the
                         waste and recovered substances. This document appears to present an interpretation that a recovered aggregate REACH Regulation, which every article has to fulfil as a whole. This means
                         as a unity can be seen as an article. We wonder whether the document CA/24/2008 rev 3 has been taken into            that in order to be an article under REACH
                         consideration in the preparation of the updated draft Guidance and that perhaps the view expressed in the            a (single) object (not objects) must have a function,
                         CARACAL document is deemed to be incorrect.”                                                                         it has to be given special shape, surface or design during production and
                                                                                                                                              its shape, surface or design has to determine its function to a greater degree
                                                                                                                                              than its chemical composition.
                                                                                                                                              Thus, arguing that an object‟s shape, surface or design is of special
                                                                                                                                              importance, is not enough to regard the object as an article, if it does not
                                                                                                                                              have a particular function that it can fulfil as a single object.
                                                                                                                                              This conclusion will be mentioned more explicitly in the guidance. In addition,
                                                                                                                                              one of the examples already mentioned in the text will be explained more in
                                                                                                                                              detail.
                                                                                                                                              Like metal spare parts for any machine, which typically are articles, metal
                                                                                                                                              chain links for a bicycle chain should by analogy also be regarded as articles.
                                                                                                                                              Like in other parts of the guidance the term “object” is used to define
                                                                                                                                              components for which it still has to be determined if they are articles or not in
                                                                                                                                              the context of REACH. Thus at the beginning of the decision-making on
                                                                                                                                              whether e.g. media for sandblasting is a substance/mixture or it consists of
                                                                                                                                              tiny articles, the term “object(s)” can be used. As mentioned above, it will be
96 Cefic   Section 2.3.3 “No disagreement with this simple and clear explanation.”                                                            specified in the first sentence of chapter 2 that the term “object” can in
97 ASD        Section 2.4   “Point 2.4. is somewhat confusing as on one hand it is highlighted that there are no specific record keeping             It is acknowledged that this paragraph might lead to confusions about the
                            requirements concerning articles, but on the other companies are advised to document their compliance checking.          actual necessity to keep records on REACH compliance checking. This will be
                            In fact most companies are investing very large amounts of effort in determining and documenting the presence of         clarified, in particular by making reference to Article 36 of the REACH
                            candidate list SVHC substances in articles above the 0.1% threshold, and developing complex IT systems to                Regulation.
                            manage the information. If this is not going to be necessary it should be stated clearly.”


98 Cefic      Section 2.4   “I absolutely agree with this statement, but would add that „decision making‟ can also be proven by industry             ECHA welcomes the initiative of industry associations and other
                            guidance documents published by the individual industry associations. […]                                                organisations to provide specific advice on REACH. Industry guidance
                            Associations of the various industry sectors have a high level of scientific and technical knowledge and would           documents published by the individual industry associations can also help
                            surely welcome the chance to clarify their sector specific questions in the scope of individual industry guidelines.”    companies to document their REACH compliance checking, e.g. by means of
                                                                                                                                                     checklists or other standardised tools. This remark will be added to the
                                                                                                                                                     Guidance on requirements for substances in articles.
99 EUROFER Section 3.1      “Paragraph 2 refers to, and provides an example of, an intended release as an accessory function of an article.          (Overall response to different comments received) The release of ink from
                            However, it appears in addition to refer to section 2.1 where presumably the printer cartridge is an example of an       printer cartridges is not to be seen as “intended release of a substance from
                            intended release as main function of an article. If, indeed, this is the case, section 2.1 should be amended to state    articles” (with respect to Article 7) as it fulfils the main function of the object.
                            clearly that “bringing ink to paper” is both the function of the article and an intended release.                        To be intended the release of substances from articles has to fulfil an
                            It is suggested that the first sentence of the second paragraph is amended as follows:                                   accessory function.
                            „A release of substances from articles is also intended if it fulfils an accessory function (to be differentiated from   As suggested, an explanation of why, if the release of a substance is the
                            the main function according to section 2.1) which is deliberately planned and would not be achieved if the               “main function” of the object, it is not relevant for the registration purposes,
                            substance were not released.‟”                                                                                           will be added.



100 DG ENTR   Section 3.1   “An intended release of a substance is immediately linked to the „accessory function‟ of the article. It should be       (Overall response to different comments received) The release of ink from
                            explained at this juncture why if the intended release of a substance is the “main function” of the article, it is not   printer cartridges is not to be seen as “intended release of a substance from
                            relevant for the registration purposes (because in case the intended release is the main function of the object that     articles” (with respect to Article 7) as it fulfils the main function of the object.
                            usually means that it should be considered as a substance in the container and not an article with intended release      To be intended the release of substances from articles has to fulfil an
                            of a substance).”                                                                                                        accessory function.
                                                                                                                                                     As suggested, an explanation of why, if the release of a substance is the
                                                                                                                                                     “main function” of the object, it is not relevant for the registration purposes,
                                                                                                                                                     will be added.


101 FR        Section 3.1   “The interpretation of these conditions (reasonably foreseeable conditions of use) have changed compared to the          (Overall response to different comments received) It is considered that
                            current guidance (page 70). They are more restrictive, accidents with high likelihood are not taken into account         adding the proposed sentence would cause confusion as (in the same section
                            although it could be better for safety reasons. The borderline is not obvious. Furthermore we wonder whether there       below) “a release in an accident” and “a release caused by a long-term,
                            will remain many articles with intended release with such as definition. It could be worth illustrating the paragraph    extremely intensive use” are given as examples where a release of
                            with examples.”                                                                                                          substances from an article is not considered to be an intended release.
                                                                                                                                                     As the examples given in the draft updated guidance as well as the in the
                                                                                                                                                     current one already clarify that “a release in an accident” and “a release
                                                                                                                                                     caused by a long-term, extremely intensive use” is not an intended release,
                                                                                                                                                     the revision of the guidance should have not effect on the number of articles
                                                                                                                                                     with intended release.
                                                                                                                                                     The example of a child biting or licking an object is an example of reasonably
                                                                                                                                                     foreseeable conditions of use, not of intended release.
                                                                                                                                                     Producers and importers of articles who want to check whether substances
                                                                                                                                                     are intended to be released from their articles have to check (1) if the release
                                                                                                                                                     of substances from their articles fulfils an accessory function and (2) if this
                                                                                                                                                     release happens under normal and reasonably foreseeable conditions of use.
                                                                                                                                                     This does not imply that they have to foresee every manner in which their
                                                                                                                                                     articles might be employed or treated in a way that was not intended.
102 DE       Section 3.1   “3.1, Intended Release from articles, last break (on page 20): The underlined insertion is suggested: „Reasonably        (Overall response to different comments received) It is considered that
                           foreseeable conditions of use mean conditions that can be anticipated as likely to occur because of the function         adding the proposed sentence would cause confusion as (in the same section
                           and appearance of the article (even though they are not normal conditions of use). This includes „accidents‟ of high     below) “a release in an accident” and “a release caused by a long-term,
                           likelihood, e.g. breakage of fragile containers, extremely intensive use and uses not in accordance with the             extremely intensive use” are given as examples where a release of
                           function, which can be anticipated. For example…‟”                                                                       substances from an article is not considered to be an intended release.
                                                                                                                                                    As the examples given in the draft updated guidance as well as the in the
                                                                                                                                                    current one already clarify that “a release in an accident” and “a release
                                                                                                                                                    caused by a long-term, extremely intensive use” is not an intended release,
                                                                                                                                                    the revision of the guidance should have not effect on the number of articles
                                                                                                                                                    with intended release.
                                                                                                                                                    The example of a child biting or licking an object is an example of reasonably
                                                                                                                                                    foreseeable conditions of use, not of intended release.
                                                                                                                                                    Producers and importers of articles who want to check whether substances
                                                                                                                                                    are intended to be released from their articles have to check (1) if the release
                                                                                                                                                    of substances from their articles fulfils an accessory function and (2) if this
                                                                                                                                                    release happens under normal and reasonably foreseeable conditions of use.
                                                                                                                                                    This does not imply that they have to foresee every manner in which their
                                                                                                                                                    articles might be employed or treated in a way that was not intended.



103 EUROFER Section 3.1    “The example of a child biting or licking an object is questioned on the basis that there is no intention to release     (Overall response to different comments received) It is considered that
                           the substance/mixture and that its release does not enhance or contribute to the function of the product, but            adding the proposed sentence would cause confusion as (in the same section
                           instead it is a „misuse‟ or unintentional use of the product. This example is inconsistent with Article 7(1)(b) which    below) “a release in an accident” and “a release caused by a long-term,
                           states „the substance is intended to be released under normal or reasonably foreseeable conditions of use‟. It is        extremely intensive use” are given as examples where a release of
                           also inconsistent with footnote 8 and the example in the revised draft Guidance is perhaps better taken to illustrate    substances from an article is not considered to be an intended release.
                           the requirements of Article 7(5). If there is a need to use the example of a child biting or licking an object, then a   As the examples given in the draft updated guidance as well as the in the
                           specific example should be provided (e.g. a scented eraser).”                                                            current one already clarify that “a release in an accident” and “a release
                                                                                                                                                    caused by a long-term, extremely intensive use” is not an intended release,
                                                                                                                                                    the revision of the guidance should have not effect on the number of articles
                                                                                                                                                    with intended release.
                                                                                                                                                    The example of a child biting or licking an object is an example of reasonably
                                                                                                                                                    foreseeable conditions of use, not of intended release.
                                                                                                                                                    Producers and importers of articles who want to check whether substances
                                                                                                                                                    are intended to be released from their articles have to check (1) if the release
                                                                                                                                                    of substances from their articles fulfils an accessory function and (2) if this
                                                                                                                                                    release happens under normal and reasonably foreseeable conditions of use.
                                                                                                                                                    This does not imply that they have to foresee every manner in which their
                                                                                                                                                    articles might be employed or treated in a way that was not intended.
104 UK         Section 3.1   “The last passage in the fourth paragraph under this heading relates to the meaning of „reasonably foreseeable          (Overall response to different comments received) It is considered that
                             condition of use‟. This passage could be misleading – for instance children licking or sucking things is not a „use‟,   adding the proposed sentence would cause confusion as (in the same section
                             and we would suggest that suppliers can‟t be expected to foresee every manner in which an object might be               below) “a release in an accident” and “a release caused by a long-term,
                             employed or treated in a way that was not intended. It is reasonably foreseeable that young children will misuse        extremely intensive use” are given as examples where a release of
                             things, but this is not part of what the REACH text says.”                                                              substances from an article is not considered to be an intended release.
                                                                                                                                                     As the examples given in the draft updated guidance as well as the in the
                                                                                                                                                     current one already clarify that “a release in an accident” and “a release
                                                                                                                                                     caused by a long-term, extremely intensive use” is not an intended release,
                                                                                                                                                     the revision of the guidance should have not effect on the number of articles
                                                                                                                                                     with intended release.
                                                                                                                                                     The example of a child biting or licking an object is an example of reasonably
                                                                                                                                                     foreseeable conditions of use, not of intended release.
                                                                                                                                                     Producers and importers of articles who want to check whether substances
                                                                                                                                                     are intended to be released from their articles have to check (1) if the release
                                                                                                                                                     of substances from their articles fulfils an accessory function and (2) if this
                                                                                                                                                     release happens under normal and reasonably foreseeable conditions of use.
                                                                                                                                                     This does not imply that they have to foresee every manner in which their
                                                                                                                                                     articles might be employed or treated in a way that was not intended.



105 Orgalime   Section 3.1   “Orgalime is concerned that the new section 3.1, which shortens the existing chapter 7 and the appendix 1 of the (Overall response to different comments received) As suggested, it will be
                             guidance, could lead to misunderstandings. In particular, it is no longer illustrated that both of the conditions of specified in the guidance that both conditions of Article 7.1b must be met,
                             article 7.1.b REACH must be met in order for registration requirements to apply, namely: a) the intention for        although in section 3.2.
                             release and b) the normal or reasonably foreseeable conditions of use. This is, however, clearly outlined in the
                             existing Guidance on requirements for substances in articles of May 2008, i.e.: page 42, first paragraph of chapter
                             7 and especially footnote 23 […]
                             Therefore, Orgalime proposes to re-introduce both, the introductory paragraph to chapter 7 (page 42) AND the
                             above mentioned footnote 23 (page 42) in the new section 3.1.”


106 Cefic      Section 3.1   “In comparison to the former section 7, the now shortened section 3.1 could be misleading. It is not illustrated        (Overall response to different comments received) As suggested, it will be
                             clearly enough anymore, that both conditions of Article 7.1b must be met: The intention for the release AND the         specified in the guidance that both conditions of Article 7.1b must be met,
                             normal or reasonable foreseeable conditions of use. This was clearly outlined in the version of May 2008, section       although in section 3.2.
                             7, first paragraph, and explicitly underlined in the foot note 23 on page 42.
                             The examples, on the other hand, are quite helpful in order to demonstrate situations of non intentional releases.”




107 IE         Section 3.1   “1st example on p21. „A size is added to a fabric…‟. We appreciate this may be a common term in the textile             A size is a chemical that is applied to a fabric to improve the strength and
                             industry, but what is a size?”                                                                                          abrasion resistance of the yarn and reduce its hairiness. After the weaving
                                                                                                                                                     process the fabric is desized (washed). This explanation will be added as a
                                                                                                                                                     footnote to the guidance.
108 Orgalime   Section 3.1   “On page 21 of the draft revised ECHA guidance it is clarified that a release of a substance that is an unavoidable     The wording of the second sentence of the third bullet point is misleading, as
                             side effect of the functioning of the article is not considered to be an intended release. This we support. Orgalime    it suggests that a substance release is essential for the article (e.g. break
                             proposes to add the following concrete example to this case: „the use of a lubricant to reduce the friction between     linings, tyres) to work. Therefore the third bullet point will be shortened to: “A
                             two moving parts‟.”                                                                                                     release of substances is an unavoidable side effect of the functioning of the
                                                                                                                                                     article, but the release does not contribute to the functioning of the article.”
                                                                                                                                                     The following example will be added to this bullet point: “leakage of lubricant
                                                                                                                                                     used to reduce the friction between two moving parts.”
109 Digital    Section 3.1   “We appreciate the effort to guide on the "intended release" in this document, though it may be debated what a       (Overall response to different comments received) The PEG members will be
    Europe                   "long term extremely intensive use" actually is.”                                                                    asked at the PEG meeting in November for input on an appropriate, more
                                                                                                                                                  specific example of a tool and its misuse.

                                                                                                                                                  Addendum after PEG meeting: At its meeting on 20 November 2009 the PEG
                                                                                                                                                  considered the possibility of providing a specific example of a tool and its
                                                                                                                                                  misuse leading to a non-intended release of substances from an article in
                                                                                                                                                  section 3.1. It was agreed not to provide such an example.



110 EUROFER Section 3.1      “The last example of a release of substance not considered to be intended reads as follows:                          (Overall response to different comments received) The PEG members will be
                             „A release caused by a long-term, extremely intensive use of an article. Example: release from a tool, which a       asked at the PEG meeting in November for input on an appropriate, more
                             consumer uses in disregard of the recommendations on operating time provided in the instructions of use.‟            specific example of a tool and its misuse.
                             This example would benefit from being more specific (i.e. provide a specific example of a tool and its misuse).”
                                                                                                                                                  Addendum after PEG meeting: At its meeting on 20 November 2009 the PEG
                                                                                                                                                  considered the possibility of providing a specific example of a tool and its
                                                                                                                                                  misuse leading to a non-intended release of substances from an article in
                                                                                                                                                  section 3.1. It was agreed not to provide such an example.



111 Orgalime   Section 3.1   “Also, Orgalime requests keeping in section 3.1 the below existing example that illustrates when a release of        The example mentioned is also in the draft updated guidance (last two bullet
                             substances from an article is not considered to be an intended release (page 68 of the existing Guidance on          points), although it was divided into two examples as in fact two different
                             requirements for substances in articles). This example currently reads as follows:                                   cases are described.
                             „A release is incidental, could be forced by undue use or in an accident.
                             Examples: release of substances from a thermometer which drops and breaks. This also includes any form of
                             misuse and inappropriate use which is not in accordance with the use instructions or functionality, even if it could
                             have been anticipated: (A release caused by a long term, extremely intensive use of e.g. a tool by a consumer,
                             who uses it in disregard of the recommendations in respect of operating time provided in the instructions of use).‟”




112 DE         Section 3.2   “The term „Conc‟ suggests „concentration‟ in the sense of „mass per volume‟. A term like FCprod („weight fraction    It is acknowledged that a concentration is strictly speaking the quotient of
                             of product‟) from the equations in Guidance R15 could avoid this misunderstanding and explain the values             mass and volume and not a weight fraction. However, the abbreviation
                             between 0 and 1.”                                                                                                    “Conc” is kept since it is already used in formulas in the existing Guidance on
                                                                                                                                                  requirements for substances in articles. Below the formulas it is, however,
                                                                                                                                                  specified that “Conc” refers to a weight fraction.
                                                                                                                                                  Likewise, the term “volume” or “Vol” frequently used in the same context to
                                                                                                                                                  describe imports is also scientifically not correct, as it stands for [t/a] and not
                                                                                                                                                  for [m3], still it is used as it has become commonly accepted.




113 NO         Section 3.2   “Chapter 3 includes a useful discussion about conditions of use. However 3.2 (Checking requirements for              The equation will be split in two for a better understanding.
                             substances intended to be released from articles) is not easy to read and need to be more structured, specific the
                             „set up‟ calculation/equation is challenging to sort out.”
114 Digital   Section 3.2   “Bullet 1 seems to say that for the registration tonnage calculation per article 7.1 both the substance intended to be   The interpretation that not only the amounts intended to be released but the
    Europe                  released and the same substance being an integral part in another part of the article, where it is not intended to be    total amount in the articles needs to be considered in order to determine if /
                            released, would have to be summed up. To use the example of the panty hose with lotion, if the same substance X          which tonnage threshold is exceeded is already communicated in the current
                            is contained in the lotion and the panty hose, both quantities would have to be summed up for the registration           guidance and without question.
                            check per article 7.1. Article 7.1 is ambiguous in whether it would require quantities in the panty hose to be           Concerning the example of the panty hose, it is to me noted that substances
                            included in the registration. However we think the correct interpretation is that the word „contained‟ applies to the    in the panty hose that have to be registered do not have to be additionally
                            substances intended for release and not to substances which are an integral part of the article or of which the          notified, as Article 7(6) would apply.
                            article is made. It seems clear that the intention behind Article 7.1 is that the quantities of substances that may be
                            released should be registered and that substances being an integral part of the article that cannot be released
                            should not be included in the registration. The interpretation in the guidance would result in a double regulation.
                            Substances in the panty hose would have to be registered and if they are candidate list substances they would
                            also have to be notified Article. 7.1.b) of REACH clearly defines its scope with „the substance is intended to be
                            released under normal or reasonably foreseeable conditions of use‟. We think this reflects the intention that only
115 ASD       Section 3.2   “The last paragraph in page 22 recites article 7(5) which indicates that ECHA may demand registration of a               Article 7(5) should be seen as a “safety net” provision. Therefore, it would in
                            substance from an article producer, if the substance exceeds 1 t, even if there is no intended release, if there is      any case not be helpful to define criteria and conditions as to when ECHA
                            suspicion that this may result in a risk to human health and the environment. Legally this seems very ambiguous          should (or will) request registration. This registration request is at the
                            and somewhat arbitrary. This guidance document would be a good place to put forward some more specific criteria          discretion of the Agency and there may be many different situations or
                            to define these cases.”                                                                                                  circumstances which could justify suspicions that a substance is released
                                                                                                                                                     from articles and that these releases may present a risk to human health or
                                                                                                                                                     the environment.
116 EUROFER Section 3.3     “It is suggested that the second to last sentence of this section is amended as follows (in line with the phraseology The modification proposed will be made.
                            used in the text of REACH):
                            „Apart from this, the same distinction between phase-in substances and non-phase-in substances, the same
                            registration deadlines as well as the same data sharing requirements apply to substances in articles as to
                            substances on their own or in mixtures.‟”


117 ASD       Chapter 5     “Chapter 5 relative to „obtaining information on substances in articles‟ might benefit from some clarification           The issue mentioned will be addressed in chapter 4 of the updated guidance.
                            regarding the phrasing of article 33(1) and 33(2): „… shall provide the recipient of the article with sufficient
                            information, available to the supplier, to allow safe use of…‟. . The meaning of „available to the supplier‟ has been
                            extensively interpreted but it is not clear exactly to what lengths a company has to go in investigating this, and how
                            this due diligence may be considered sufficiently documented. To make things worse at least one language
                            version of the regulation, that in Spanish, does not contain the clarification „available to the supplier‟ in neither of
                            the two points of article 33, thereby leading to further confusion and suggesting an absolute obligation. Although it
                            is true that legally the English version applies, some clarification to this respect in the new guidance would be very
                            welcome.”
118 Cefic   Chapter 5     “First of all, the content of chapter 5 is in general an improvement in comparison to the version of May 2008.            In order to check if obligations for substances in articles apply, it is sufficient
                          Therefore, the following comment should not be seen as a complaint, but furthermore as an attempt to point out,           to collect information on the substances intended to be released from articles
                          from an industry point of view, how to collect information on substances in articles and finally how to implement         and on the presence of substances of very high concern, but it is not
                          compliance procedures during the production of such articles. […]                                                         necessary to compile “a database with the complete part-list of ALL
                          In ANY case, the articles within this industry, (and this is not different to any other industry), can be divided into    components and subcomponents (of articles produced/imported/supplied)
                          two different types of articles:                                                                                          and make a breakdown for each of them to the „BOS‟ level”. This is also
                          a) Articles manufactured from the chemical building block based on a „bill of substances‟ (BOS) [example:                 expressed in the draft updated guidance: “In many cases the exact
                          photographic plates for the printing industry] and                                                                        composition of articles or mixtures is not needed to clarify whether
                          b) Articles manufactured in an assembly process of other articles based on a „bill of material‟ (BOM) [example:           requirements for substances in articles have to be fulfilled.” (sometimes the
                          photographic equipment, like small digital cameras or complex printing machines]                                          exact composition of a mixture intended to be released from articles might
                          A) „BOS‟ based systems:                                                                                                   have to be know).
                          For those articles in the imaging industry that are manufactured starting from the „chemical building blocks‟             Elements of the „BOM‟ based approach described are also contained in the
                          (substances and preparations) – such as photographic plates for the printing industry – the manufacturer is buying        draft updated guidance. The “list of substances subject to REACH
                          substances and mixtures in a very short supply chain, i.e. the manufacturer generally has the possibility to build up     obligations” (a) would correspond to the candidate list of substances for
                          a complete chemical substance inventory, including a breakdown of the articles to the substance level.                    authorisation. The “self declarations by suppliers” (b) as well as the
                          Conclusion: A „BOS‟ based system will allow verification regarding possible requirements under REACH at any               incorporation of certain requirements in technical specifications / terms of
                          time.                                                                                                                     conditions of components purchased (c and d) is taken up by the third bullet
                          B) „BOM‟ based systems:                                                                                                   point in section 5.1.2. The guidance also refers to the expert judgement
                          In many areas of the industry, (using here the example of a printing machine), we have however a second                   needed to identify REACH obligations (e), particularly if chemical analyses
                          category of articles – where the manufacturing is in fact an assembly process, building the final piece of equipment      are involved. Guidance on the additional gathering of information (f) is made
                          from parts and subparts. […]                                                                                              in particular in chapter 5 of the draft updated guidance.
                          For this type of articles the approach to build up a full substance inventory (BOS information) – i.e. compiling a        The term “homogeneous materials” is not used in the draft updated guidance.
                          database with the complete part-list of ALL components and subcomponents and making a breakdown for each of
                          them to the „BOS‟ level, (including information on weight fractions in the final equipment, etc.), – would NOT result
                          in a workable approach to fulfil possible REACH requirements.
                          Therefore – for such complex equipment – a „BOM‟ based approach is needed, representing a „process approach‟
                          as a pragmatic and workable solution ensuring legal compliance.
                          This process involves the following elements:
                          a) issuing a list of substances subject to REACH obligations, if present in articles (equipment) under certain
                          conditions
                          b) requesting self declarations by suppliers of components regarding this list, indicating either adherence to the list
                          or providing adequate information in case of non-adherence
                          c) incorporating such a requirement in the technical specifications of all components purchased
                          d) incorporating such a requirement in the terms of conditions for all components purchased
                          e) performing a risk assessment regarding potential REACH obligations for equipment produced or imported,
119 DE                    “Behind the expert sentence
            Section 5.1.1 based upon secondjudgment of break 5.1.1, a sentence like the following could be inserted: „This is also the case         It will be specified that a SDS or Article 32 information also has to be provided
                          if an object consists of a substance/preparation in a container.‟”                                                        for “a substance/preparation in a container”.
120 IE      Section 5.1.2 “Consider dividing these bullet points under headings that refer to „intended release‟ or „no intended release‟.”         Some of the bullet points are recommendations useful to obtain information
                                                                                                                                                    on substances intended to be released and on substances not intended to be
                                                                                                                                                    released, and would thus have to be included twice. Furthermore, in order to
                                                                                                                                                    identify one‟s obligations for substances in articles, it is necessary to check if
                                                                                                                                                    duties result from the substances intended to be released as well as from
                                                                                                                                                    substances not intended to be released. In case of articles, however, with no
                                                                                                                                                    intended release of substances, only the last bullet point would not be
                                                                                                                                                    relevant. However, this bullet point makes this clear already as it begins with
                                                                                                                                                    “Substances intended to be released…”.
121 Orgalime   Section 5.1.2 “We believe that Non-REACH related recommendations should be left out of the scope of the guidance.                      (Overall response to different comments received) The fourth bullet point will
                             From our point of view, the paragraph in chapter 5.1.2, fourth bullet point (page 35), which advises companies to        be rephrased to make it clearer that it just makes a recommendation, and
                             exclude or limit the presence of certain substances of their products instead of asking for the exact composition of     does not prescribe a certain data collection strategy. However the
                             articles or mixtures, should be removed from the draft revised guidance for the following reasons:                       recommendation made is still considered to be valid as it facilitates the supply
                             Today, companies are using different strategies and tools to collect material data depending on their business           chain communication of relevant information on substances in articles.
                             needs. The paragraph in question could give benefits for companies using certain material collection tools and           It is acknowledged that some of the recommendations for supply chain
                             strategies and thereby negatively affect companies that successfully use other tools.                                    communication made may not be practicable in different cases (e.g. due to
                             The details of requesting information in the supply chain for ensuring REACH compliance should in our view be left       lack of resources or contact information). However, it is considered that the
                             to the affected industry, and ECHA should not favour one particular tool of information reporting in the supply chain    approaches described can be useful to request information up the supply
                             against another.                                                                                                         chain in many situations.
                             Therefore, we request to remove this point from the draft revised guidance.”




122 FECC       Section 5.1.2 “(second bullet point) From a distributor point of view, I see there might be workability issues. Distributor's          (Overall response to different comments received) The fourth bullet point will
                             customers in fact often don't have the resources or the information to contact all the suppliers up their supply chain   be rephrased to make it clearer that it just makes a recommendation, and
                             and it is essential to rely on who is their direct supplier. Confidentiality issues are involved too. For the same       does not prescribe a certain data collection strategy. However the
                             reason I do appreciate on the other hand the needful consideration for workability and confidentiality issues in the     recommendation made is still considered to be valid as it facilitates the supply
                             following point (fourth bullet point). […]                                                                               chain communication of relevant information on substances in articles.
                             Moreover, still regarding communication in the supply chain, comparing with the previous text of the guidelines, I       It is acknowledged that some of the recommendations for supply chain
                             think the last paragraph of section 4.2 (on page 33 of the current guidance) should be retained.”                        communication made may not be practicable in different cases (e.g. due to
                                                                                                                                                      lack of resources or contact information). However, it is considered that the
                                                                                                                                                      approaches described can be useful to request information up the supply
                                                                                                                                                      chain in many situations.



123 DK         Section 5.1.2 “Page 35 third indent: „Suppliers could for example provide certificates which guarantee that the certain                The sentence quoted points out a valid way (this idea was already taken up in
                             substances are not used in the manufacture of their products or remain below certain concentrations in their             the current guidance) to facilitate the exchange of the information needed by
                             products‟.... This part should be formulated very carefully as it could remove focus from the actual content of          article producers/importers/suppliers for compliance checking. It is not
                             hazardous substances in an article. We have sympathy for the idea that the company could provide a certificate           considered that this recommendation narrows the responsibility of actors in
                             saying that no SVHC is used in the production or remain in the product. However, we often face misleading                the supply chain to communicate risk management information.
                             information from suppliers only focusing on what is not in the product and therefore giving no information about the
                             actual content and possible risk when handling the article.”


124 DE         Section        “As a result from the advice in break 5.1.2.1 formulators may use a greater number of ingredients with similar      Section 5.1.2.1 explains how to calculate the critical concentration level for
               5.1.2.1        chemical function in lower weight percentages. In our opinion this may not be in line with the intention of REACH.” substances in the mixture intended to be released, as this information helps
                                                                                                                                                  to make requests in supply chains on substances in mixtures intended to be
                                                                                                                                                  released in a more specific way. It does not advise formulators to increase
                                                                                                                                                  the number of substances in their mixtures. It is however acknowledged that
                                                                                                                                                  this might happen, although this would not be due to the guidance given. It is
                                                                                                                                                  basically the consequence of any regulative measure imposing duties
                                                                                                                                                  depending on the concentration of substances in a mixture, that formulators
                                                                                                                                                  will try to reduce the concentration of the substances in question.



125 NO         Section        “(This section) is confusing (including example 7!) and need to be explained in a better way.”                          The text will be rephrased and the sentences will be shortened to make it
               5.1.2.1                                                                                                                                more comprehensible.
126 DE       Section 5.2   “Chemical Analyses may be unavoidable, if information cannot be gathered otherwise, and they might help to            The current guidance (as well as the draft updated guidance) points out that
                           control quality and safety requirements for articles in the supply chain. In addition, they might help importers to   “there are no formal requirements on methods and/or laboratories to use” and
                           control the exclusion of SVHC above the concentration limit of 0,1Vol% in their products. There is a considerable     that “It is up to the producer/importer/supplier judge the appropriateness.” If
                           body of knowledge on chemical product analyses from product certifications and from enforcement of European           this understanding is to be kept in the updated guidance, it would not be
                           and national regulations on which suppliers and importers can rely, and there might be cases in which appropriate     appropriate to add that laboratories should be certified and analyses should
                           chemical analyses will be less costly than supply chain communication. It should be outlined therefore, that          meet existing standard methods. Furthermore, the draft updated guidance
                           chemical laboratories should be certified and analyses should meet existing standard methods from certification       already specifies that “a strategy should be developed in collaboration with
                           and standardisation, whenever they are appropriate for the substance and product in question. The former advises      experienced laboratories and based on available methods”.
                           on analyses of substances on the candidate list for authorization should be inserted again.”                          The advice on chemical analyses of substances on the candidate list for
                                                                                                                                                 authorization contained in section 5.2 of the current guidance is in principle
                                                                                                                                                 included in section 5.2 (and the sub-sections) of the draft updated guidance.
                                                                                                                                                 Other parts of section 5.2 of the current guidance, dealing mainly with
                                                                                                                                                 recommendations for obtaining information via the supply chain, have been
                                                                                                                                                 incorporated in other sections of chapter 5 of the draft updated guidance.




127 FI       Section 5.2   “In chapter 5.2 (page 36) conducting chemical analysis is recommended only as the „last resort‟ for               Depending on the final outcome of the project mentioned, rewording of this
                           checking/fulfilling REACH obligations in relation to the identity and the content of substances in an article.    passage may be considered.
                           However, in the framework of the Nordic project on substances in articles, Ököpol has gathered information that
                           seems to indicate that for some product groups and substances chemical analyses can be an efficient and
                           practical approach. Therefore, depending on the final outcome of the project, rewording of this passage should be
                           considered.”
128 IE       Chapter 6     “Consider that chapter six should re-iterate the possible duties associated with substances in articles and that       In line with the overall structure of the guidance document (see section 1.2)
                           „exemptions‟ should form a subsection of this chapter. In addition consider including a reference to the Articles that the possible duties associated with substances in articles are explained in
                           indicate where Title II etc. do not apply.”                                                                            chapters 3 and 4. However, in each section of chapter 6 it is specified to
                                                                                                                                                  which duties the particular conditions for exemption apply.
                                                                                                                                                  Reference to Article 2(7) will be made in sections 6.1 and 6.2



129 FI       Chapter 6     “please consider rewording chapter 6, first paragraph, in order to better reflect the objective of REACH to give      The modifications proposed will be made.
                           responsibility of safe use to companies. Suggested rewording can be found in capital letters below:
                           „Obligations to register or notify substances in articles identified as described in chapters 3 and 4 ARE SUBJECT
                           TO EXEMPTIONS (can still be avoided) in certain cases. This chapter explains what you have to check to
                           establish if you ARE COVERED BY (can benefit from) an exemption from registration or notification obligations
                           related to substances in articles.‟”



130 EUROFER Section 6.1    “It is suggested that the first sentence of this section is amended as follows (in line with the phraseology used in   The modification proposed will be made.
                           the text of REACH): „A number of substances are exempted in general (i.e. whether on their own, in mixtures or in
                           articles) from registration and notification as sufficient information is known about these substances or registration
                           and notification are simply deemed inappropriate or unnecessary.‟”


131 FR       Section 6.2   “The term „recovered material‟ should be replaced by „recovered substances‟ because there is no definition in         The modification proposed will be made.
                           REACH for that wording.”
132 FI     Section 6.3    “In chapter 6.3 (Exposure based exemption from notification), on page 38, the waste stage of an article should be        The term “waste stage” will be used instead of the term “disposal”.
                          mentioned:
                          „This means that a producer/importer wanting to demonstrate „exclusion of exposure‟ has to ensure that the
                          substance of very high concern on the candidate list does not come in contact with the users of the article or with
                          the environment, regardless of its dangerous properties. Note that all exposure routes at all life cycle stages
                          (service life of the article and disposal and WASTE STAGE) have to be considered.‟”



133 DE     Section 6.3    “6.3 Exposure based exemption from notification, last sentence.                                                     It will be specified that the justification should include the elements
                          It is suggested to add the following sentence: „The justification should include the substances names, their weight mentioned.
                          percentages and the parts of the article that contains them, normal and reasonably foreseeable use conditions and
                          corresponding considerations on exposure for humans and environment.‟”



134 FR     Section 6.3.1 “We have noticed that there is a paragraph 6.3.1 but no paragraph 6.3.2. The content of this paragraph could be           Section 6.3.1 in the draft updated guidance corresponds to section 8.8.2 of
                         inserted into the text above. Furthermore we find that the title „potential for intended release‟ is not appropriate      the current guidance. The title of both these sections is “Potential for release”
                         since it can create confusion with „intended release‟. This paragraph must refer more to exposure than to release         not making reference to “intended release”. The link between “exposure” as
                         according to article 7.3 of Reach.”                                                                                       used in Article 7(3) and “release” is explained in section 6.3.

135 NO     Appendix 1     “Well arranged and easy to follow (an improvement)”
136 IE     Appendix 1     “Not clear what is meant by the first sentence?”                                                                         The sentence is not really necessary for the understanding of Appendix 1 and
                                                                                                                                                   will therefore be deleted.
137 FECC   Appendix 1     “In my opinion, a reference to the relevant REACh articles would be a very useful.”                                      An Appendix providing an overview on the REACH Articles relevant for
                                                                                                                                                   producers, importers and suppliers of articles will be added to the document.

138 DE     Appendix 1     “In order to adapt to the Commission‟s recommendation on candles, the term „article (functioning as container or         The term reference is made to will be changed to: “combination of an article
                          carrier material) with substances or mixtures contained within‟ should be replaced by „combination of an article,        (functioning as a container or a carrier material) and a substance/mixture”.
                          functioning as container or carrier material, with substances or mixtures‟ in the whole appendix, including the          As proposed, the borderline case of a candle will be included.
                          tables. The example of a candle should be included in Table 4 and Table 8.”


139 IE     Appendix 1     “Suggest adding sentence „Please note that the examples of borderline cases in table 4 is not an exhaustive list,        It will be specified that the range of borderline cases included in Appendix 1 is
                          but should be as a basis when examining the object in question.‟”                                                        not exhaustive.
140 IE     Appendix 1     “Suggest adding „…in Appendix 1‟ to the title of table 4. i.e. „Summary of borderline cases described in Appendix        The modification proposed will be made.
                          1‟”
141 IE     Appendix 1     “Why are Tables 5 & 6 listed as Part 1 and Table 7 as part 2. Table 8 is not referred to by part. This differentiation   The remark “part 1” in the heading of table 6 will be deleted.
                          is not referred to in the text.”                                                                                         Tables 5 and 7 each show borderline cases of substances/mixtures in
                                                                                                                                                   containers. To avoid giving the same name to both tables, one was termed
                                                                                                                                                   “part 1” and the other “part 2”. The remark “part 1” will be replaced by the
                                                                                                                                                   remark “continued in table 7”, and the remark “part 2” will be replaced by the
                                                                                                                                                   remark “continuation of table 5”.
142 Orgalime   Appendix 1   “Orgalime does not agree with the interpretation that fire crackers should be regarded as articles with a                   Although an object is considered as an article in another directive this does
                            substance/mixture contained within.                                                                                        not need to be contradictory to REACH since REACH has like any other
                            From our point of view, the substances/preparations in fire cracker are an integral part of these articles for the         directive its own definitions. Consequently the view of the Commission that
                            following reasons:                                                                                                         firecrackers, rockets and other fireworks are to be treated as
                            The intended purpose of a firecracker, which is to emit a noisy crack, cannot be obtained if the                           substances/mixtures in containers can be maintained. This view was
                            substance/preparation is removed from the object. A fire cracker without the                                               supported by the Member States Competent Authorities (MSCAs) at the
                            substance/preparation is completely unable to fulfil its intended purpose. Also, exchange by a similar type of             meeting of the subgroup of the MSCAs on Substances in Articles on 3
                            substance/preparation cannot realise the desired effect, because the used substance/preparation and the design             October 2007.
                            of the object are strongly interdependent.                                                                                 The term “firecracker” will be replaced by the more generic term “fireworks”.
                            During the intended use, the substance/preparation is neither released nor delivered. A firecracker is not a
                            package for transportation or removal of the substance, it is a functional part of the article. Moreover, to be placed
                            on the market, articles cannot lose substances (according to the Directive 2007/23/EC).
                            Orgalime requests full legal consistency between the REACH Regulation and other European or international
                            regulations, e.g.: the UN Recommendations on the Transport of Dangerous Goods, the UN-GHS, the future GHS-
                            Regulation, Directive 2007/23/EC on pyrotechnic articles.
                            In all these regulations pyrotechnic articles, including fire crackers, are clearly defined as articles.”


143 Orgalime   Appendix 1   “We support sticking with the interpretation that batteries represent articles.”                                           (Overall response to different comments received) The example of a battery
                                                                                                                                                       will be added to table 6 to illustrate the cross-check to be made with questions
                                                                                                                                                       4a to 4c in this particular case.
144 IE         Appendix 1   “Suggest re-wording conclusion for battery example. „Cross-check with questions 4a to 4c. If the answers are               (Overall response to different comments received) The example of a battery
                            predominantly YES, the battery is an article with substances or mixtures forming an integral part thereof.‟”               will be added to table 6 to illustrate the cross-check to be made with questions
                                                                                                                                                       4a to 4c in this particular case.
145 Digital    Appendix 1   “We do not concur with the borderline case analysis for desiccant bags that is presented in Table 7 (page 45) of           (Overall response to different comments received) In order to determine the
    Europe                  the Draft Version 2.0. In our borderline analysis of desiccant bags using the criteria specified in Questions 3a-c of      article status of a desiccant bag the workflow described in section 3.3.2 of the
                            Table 7, we agree with the answer YES to Question 3a, we agree with the answer NO to Question 3b, but we do                current guidance should be followed. The function in line with section 3.1 of
                            not agree that the answer YES to Question 3c, excerpted below, applies to all desiccant bags.                              the guidance would be “to absorb air humidity”.
                            Question 3c: Is the substance/mixture predominantly consumed or eliminated during the use phase of the object,             Questions 4a to 4c (of the current guidance) would have to be answered as
                            so that at the end of the useful life of the object the sub-stance/mixture is not anymore in the object as it was in the   follows:
                            beginning?                                                                                                                 4a  Yes, if the substance/preparation were to be separated from the object
                            YES, the activity of the desiccant decreases with time, at the end of the useful life of the object the desiccant does     and used independently from it, the substance/preparation would still be
                            not adsorb humidity anymore.                                                                                               capable in principle (though perhaps without convenience or sophistication) of
                            There are many types of desiccants. Commonly encountered pre-packaged desiccants are solids, and work                      carrying out the function.
                            through absorption or adsorption of water, or a combination of the two. These desiccants themselves are not                4b  No, the object does not act as a container or carrier for release or
                            necessarily predominantly "consumed or eliminated", it is still present predominantly in the end as it was in the          controlled delivery of the substance/preparation or its reaction products.
                            beginning. Although the activity of these types of desiccants decreases with time, this decrease is not related to         4c  Yes, the substance/preparation is predominantly consumed during the
                            the consumption or elimination of the substance. Therefore, the answer for Question 3c would be NO, and such               use phase of the object. “Consumed” in this sense means “used up, rendered
                            desiccant bags should not be considered substances in container, but as articles themselves.                               unserviceable by use” (in order to avoid confusions concerning the meaning
                            For example, silica gel (silicon dioxide) has a high surface area with many active sites and is capable of adsorbing       of the term “consumed” in this indicative question, it is proposed to rephrase
                            water on the active sites. The silicon dioxide is not consumed or eliminated by the adsorption of water. At the end        it; see above). Thus, if the activity of desiccants decreases with time, at the
                            of its useful life, the same silicon dioxide that was present in the beginning is still predominantly inside. Therefore,   end of the use phase of the desiccant bag the desiccant will be “consumed”.
                            desiccant bags containing silica gel desiccant are articles.”                                                              Consequently desiccant bags should be regarded as a “special container
                                                                                                                                                       (article) with substances/preparations contained within” (the application of the
                                                                                                                                                       indicative questions 3a to 3c of the draft updated guidance leads to the same
                                                                                                                                                       conclusion).
                                                                                                                                                       It should also be remembered that “the definition of the status of objects
146 AT         Appendix 1   “Table 7: desiccant bag. To answer question 3c in this case is not as simple and clear. The answer may not be         (Overall response to different comments received) In order to determine the
                            „yes‟. The substance (in most cases silica gel) is neither consumed nor eliminated during the use phase. The water    article status of a desiccant bag the workflow described in section 3.3.2 of the
                            is physically adsorbed on the surface of the substance ( mixture?). The substance just loses the ability to adsorb   current guidance should be followed. The function in line with section 3.1 of
                            water during its life time. There is no chemical reaction of the substance with water molecules.                      the guidance would be “to absorb air humidity”.
                            Only if an indicator is used (mixture of silica gel with indicator) a chemical reaction takes place, and the mixture at
                                                                                                                                                  Questions 4a to 4c (of the current guidance) would have to be answered as
                            the end of the useful life of the object is not anymore as it was in the beginning.                                   follows:
                            In my opinion such desiccant bags are not simply articles. The decision that this is a substance/mixture in a         4a  Yes, if the substance/preparation were to be separated from the object
                            container can be made based on the article definition only. In case of desiccant bags the chemical composition of     and used independently from it, the substance/preparation would still be
                            the substance/mixture is more important for the function than the shape/ (macroscopic) surface/design of the          capable in principle (though perhaps without convenience or sophistication) of
                            bags.”                                                                                                                carrying out the function.
                                                                                                                                                  4b  No, the object does not act as a container or carrier for release or
                                                                                                                                                  controlled delivery of the substance/preparation or its reaction products.
                                                                                                                                                  4c  Yes, the substance/preparation is predominantly consumed during the
                                                                                                                                                  use phase of the object. “Consumed” in this sense means “used up, rendered
                                                                                                                                                  unserviceable by use” (in order to avoid confusions concerning the meaning
                                                                                                                                                  of the term “consumed” in this indicative question, it is proposed to rephrase
                                                                                                                                                  it; see above). Thus, if the activity of desiccants decreases with time, at the
                                                                                                                                                  end of the use phase of the desiccant bag the desiccant will be “consumed”.
                                                                                                                                                  Consequently desiccant bags should be regarded as a “special container
                                                                                                                                                  (article) with substances/preparations contained within” (the application of the
                                                                                                                                                  indicative questions 3a to 3c of the draft updated guidance leads to the same
                                                                                                                                                  conclusion).
                                                                                                                                                  It should also be remembered that “the definition of the status of objects
147 Orgalime   Appendix 1   “However, we do not agree with the proposed interpretation that desiccant bags should be regarded as articles         (Overall response to different comments received) In order to determine the
                            with a substance/mixture contained within, since such an interpretation in our view does not properly reflect the     article status of a desiccant bag the workflow described in section 3.3.2 of the
                            specificity of the product.                                                                                           current guidance should be followed. The function in line with section 3.1 of
                            Instead, we believe that desiccant bags should be regarded as articles with a substance/mixture forming an            the guidance would be “to absorb air humidity”.
                            integral part thereof for the following reasons:                                                                      Questions 4a to 4c (of the current guidance) would have to be answered as
                            Companies use desiccant bags as part of their packaging of products to avoid adverse affects of moisture during follows:
                            transport and storage, as well as receive desiccant bags as a part of protective packaging systems of raw             4a  Yes, if the substance/preparation were to be separated from the object
                            materials, components, semi-finished goods and finished products.                                                     and used independently from it, the substance/preparation would still be
                            Desiccant bags are commonly used in several industries, such as electric and electronic components,                   capable in principle (though perhaps without convenience or sophistication) of
                            pharmaceutical, nutraceutical, diagnostic and food industries.                                                        carrying out the function.
                            Desiccant bags are pouches made of non-woven polymer film materials containing a desiccant. While the                 4b  No, the object does not act as a container or carrier for release or
                            desiccant is the active component absorbing moisture, the formed nonwoven material assures integrity of the bag. controlled delivery of the substance/preparation or its reaction products.
                            It allows moisture to migrate into the bag and ensures mechanical stability to prevent release of the desiccant.      4c  Yes, the substance/preparation is predominantly consumed during the
                            The main function of desiccant bag is to protect goods during transport and they fulfil the criteria for packaging    use phase of the object. “Consumed” in this sense means “used up, rendered
                            (packaging aid) as defined in Article 3 (1) of directive 94/62/EC on packaging and packaging waste.                   unserviceable by use” (in order to avoid confusions concerning the meaning
                            As packaging is considered being an article under REACH (see chapter 2.7, page 20 of the Guidance on                  of the term “consumed” in this indicative question, it is proposed to rephrase
                            requirements for substances in articles, published by ECHA in May 2008), desiccant bags should be considered as it; see above). Thus, if the activity of desiccants decreases with time, at the
                            articles in the meaning of REACH, too.                                                                                end of the use phase of the desiccant bag the desiccant will be “consumed”.
                            It is not the purpose of the desiccant bag to deliver a substance or its reaction products, but to protect the supply Consequently desiccant bags should be regarded as a “special container
                            from damages caused by humidity. The desiccant bag is a functional unit and therefore not separated for disposal (article) with substances/preparations contained within” (the application of the
                            after use.                                                                                                            indicative questions 3a to 3c of the draft updated guidance leads to the same
                            Orgalime also takes the view that there is no intentional release of substance from desiccant bags and that           conclusion).
                            consequently the registration obligation according to the REACH Article 7(1) does not apply.                          It should also be remembered that “the definition of the status of objects
148 FR          Appendix 1     “We don't agree on the conclusion that breathalyzer is an article with substances or mixtures contained within.    According to ECHA‟s understanding, a breath alcohol tester is a single use
                               Concerning question 3a: we agree on the fact that in principle, the substance, if it was removed, could indicate   disposable device used to detect alcohol in breath. This type of object has to
                                                                                                                                                  be differentiated from multiple use equipment (portable or not) used to detect
                               alcohol in the breath but the result could not be interpretable in order to know if the regulatory threshold (to drive)
                               is exceeded. So the object could not play its role. The answer should be the same as the one for the thermometer.  alcohol in breath.
                                                                                                                                                  A breath alcohol tester contains a substance or mixture in a hermetically
                               It is a matter of definition of the function of the object: the function of breathalyzer is to indicate a level of alcohol in
                               the breath.                                                                                                        sealed container. Immediately prior to use, the container is opened or
                               Concerning this example we have provided an interpretation to the GRIP members. You will find enclosed the         ruptured to expose the substance/mixture to breath vapour. The
                               corresponding note. Some MS agree and others disagree.”                                                            substance/mixture then changes colour, if alcohol is present in the breath. By
                                                                                                                                                  comparing the colour with an unused tester or with a colour scale provided
                                                                                                                                                  together with the tester the subject‟s breath alcohol level can be estimated.
                                                                                                                                                  Based on the function mentioned (“to detect alcohol in breath”) questions 4a
                                                                                                                                                  to 4c (of the current guidance) would have to be answered as follows:
                                                                                                                                                  4a  Yes, if removed from the object, the substance/preparation would still in
                                                                                                                                                  principle be capable of carrying out its intended purpose of making a colour
                                                                                                                                                  reaction and indicate the presence of alcohol in breath.
                                                                                                                                                  4b  No, the object does not act as a container for release or controlled
                                                                                                                                                  delivery of the substance/preparation or its reaction products.
                                                                                                                                                  4c  Yes, the substance/preparation is predominantly consumed (i.e. its
                                                                                                                                                  useful properties are exhausted, used up) during the use phase of the object,
                                                                                                                                                  thereby rendering the object useless and leading to the end of its useful life.
                                                                                                                                                  At the end of the object‟s useful life, i.e. after the substance/preparation has
                                                                                                                                                  undergone the colour reaction, the substance/preparation is used up.
                                                                                                                                                  As two out of three of these questions could be answered with „yes‟ rather
                                                                                                                                                  than „no‟, the object should be regarded as a special container with a
149 IE          Appendix 1     “Suggest re-wording conclusion for adhesive tape for fixing carpets example. „Cross-check with questions 4a to 4c. A table analogous to table 6 will be added to illustrate the cross-check to be
                               If the answers are predominantly YES, the adhesive tape for fixing carpets is an article with substances or        made with questions 4a to 4c in this particular case.
                               mixtures forming an integral part thereof.‟”
150 NO          Appendix 2     “(Appendix 2 is) also improved with the indicative questions and some explanatory/supplementary text.”

151 EUROFER Appendix 2 - “It is disappointing to discover that the content of this position paper (entitled „Determining the borderline between                ECHA is aware of and has analysed the EUROFER position paper
            1            preparations and articles for steel and steel products‟) has been overlooked in the revised draft Guidance,                           determining the borderline between preparations/articles for steel and steel
                         especially as ECHA has circulated the document to all EU member state REACH helpdesks and iron/steel are                              products dated 29 August 2008. It explains why cast ingots should be
                         cited in Appendix 2 of the revised draft Guidance as an example where the borderline between                                          regarded as preparations under REACH and semi-finished products and
                         substances/mixtures and articles may differ from aluminium.                                                                           refined semi-finished products as articles. The reasoning presented in the
                         It is important mention that Eurofer has received many enquiries from non-EU steel producers and importers                            paper is in line with the rules given in the Guidance on requirements for
                         concerning the status of steel semi-finished products as articles under REACH. Russian steel producers and                            substances in articles. Thus the paper shows that by applying the available
                         importers, in particular, are seeking legal certainty in this respect and Eurofer is aware that they have contacted                   guidance a valid conclusion on the borderline between preparations/articles
                         the REACH Unit of DG Enterprise as well as DG Trade and raised the issue at the last EU-Russia dialogue.                              for steel and steel products can be drawn. Therefore ECHA does not consider
                         Eurofer has also received similar enquiries from steel producers and importers in Japan, Korea and the United                         that an inclusion of the example of the steel supply chain in the Guidance on
                         States. All of whom are seeking, as a minimum, specific information on steel semi-finished products as articles in                    requirements for substances in articles is necessary.
                         the revised Guidance. […]                                                                                                             The examples provided in Appendix 3 of the current Guidance on
                         It is further proposed that, as a minimum, the diagram entitled „main steel process stages‟ attached to Eurofer                       requirements for substances in articles (as well as in Appendix 2 of the draft
                         position paper „Determining the borderline between preparations and articles for steel and steel products‟ is                         updated guidance) are intended to illustrate the application of the rules given
                         introduced into the revised Guidance as an Informative Annex. Ideally, the Eurofer position paper entitled                            in the main part of the guidance to different types of raw materials and “semi-
                         „Determining the borderline between preparations and articles for steel and steel products‟ could be transformed                      finished products”. It is not the purpose and also beyond the means of the
                         into an industry guidance and published as an Informative Annex to the revised Guidance. This approach would go                       Guidance on requirements for substances in articles to reflect the whole
                         a long way towards providing the legal certainty being sought by both EU and non-EU steel producers and                               range of different supply chains. Readers of the guidance should thus apply
                         importers of steel semi-finished products.”                                                                                           the rules given in the main part of the document in order to determine
                                                                                                                                                               whether their raw materials and “semi-finished products” are articles or not.
                                                                                                                                                               The application of these rules to steel and steel products is well documented
152 EUROFER Appendix 2 - “Thus, the wording of question 6c in Table 10 (page 50) has introduced a significant change to the Guidance,                 The wording of the indicative question 6c in the draft updated guidance is
            1            which represents the introduction of new criterion that has significant influence in determining the borderline              based on a concept (“light processing”) that was already introduced in the
                         between substance/mixture and an article for semi-finished products.                                                         current guidance.
                         Furthermore, figure 4 (page 49) indicates that aluminium coil and sheet are articles. Yet coil and sheet materials           Also the answer to this indicative question is already given in the current
                         may be formed into many varied shapes by cupping, deep drawing or pressing. These too are forming operations                 guidance (“In any case a cutting or stamping process is required for achieving
                         that give rise to significant changes in shape. Does this mean that coil and sheet are substances or mixtures? If            a definite function. As this would generally be considered as light processing,
                         so, how could an importer of a coil know whether a coil or sheet will undergo light processing or a forming                  this question indicates towards the coil being an article. […] The cutting /
                         operation? Under these circumstances, there can be no legal certainty for the importer. The answer to question 6c            stamping and further processing of the coil only results in modifications of
                         assumes that coils/extrusion profiles only undergo light processing operations, whereas they can undergo forming             that basic shape and can be regarded as light processing.”). This view (that
                         processes.”                                                                                                                  coils and extrusion profiles are articles) is confirmed by the EUROFER
                                                                                                                                                      position paper determining the borderline between preparations/articles for
                                                                                                                                                      steel and steel products dated 29 August 2008.




153 EUROFER Appendix 2 - “The answer to this question (6c) is generally applicable to die castings, investment casting and sand castings,             According to the guidance continuous cast slabs, billets, etc. are “raw material
            1            while continuously cast slabs of aluminium, other metals and alloys are also cast into shapes but subjected to               types similar to the aluminium alloy cast piece” which is an article as clearly
                         further forming operations. However, the answer to question 6b in Table 11 also applies to continuously cast semi-           shown by the figure illustrating the aluminium processing. Consequently the
                         finished products. Therefore, the introduction of a list of forming processes indicating that continuous cast slabs,         guidance indicates that continuous cast slabs, billets, etc. are articles.
                         billets, etc are not articles is inconsistent with the answer to question 6b in table 11. It is also inconsistent with the   It is not considered that conclusions drawn by applying the rules in the draft
                         indicative questions on page 17 and the examples of semi-finished products as articles that follow table 11 on               updated guidance would be different from those presented in the EUROFER
                         page 52.                                                                                                                     position paper determining the borderline between preparations/articles for
                         Furthermore, this approach totally undermines the steel sector‟s position paper on steel semi-finished products,             steel and steel products dated 29 August 2008.
                         which ECHA has already circulated to all EU member state REACH helpdesks.”



154 IE           Appendix 2 -   “Suggest adding a „Conclusion‟ row to Table 10, as in the case of Tables 5 to 9 in Appendix 1. Same comment           The modification proposed will be made.
                 1              applies to Table 11, 12, 13 and 14.”
155 DE           Appendix 2 -   “The example does not fit for mineral, metal and certain special fibres. E.g. ceramic fibres are bought mainly        The modification proposed will be made.
                 2              because of their specific chemical and physical properties (heat insulation, fire prevention) and not because of
                                their shape or design. It is therefore suggested to add the underlined sentence: „Please note that this example
                                cannot be directly applied for all types of (man made) fibres. E.g. there are great differences between man made
                                mineral fibres and synthetic polymers.‟”
156 DK           Appendix 2 - “The examples in Appendix 2 shows in general the usefulness of the indicative questions 6a to 6d for identifying        Cabon-nanotubes, MMMF and asbestos would already have to be regarded
                 2            whether an object is to be regarded an article or a substance/raw material/preparation. However, in the case of         as substances/mixtures and not as articles based on the REACH definition of
                              part 2 of Appendix 2 "Textile and non-woven processing", we are not that convinced, that the indicative questions       an article as explained in section 2.3.2 of the draft updated guidance.
                              have the same usefulness for the man-made fibres. It could therefore be interesting to make the same exercise on        Therefore it is not considered to be useful to include these examples in
                              other fibres e.g. cabon-nanotubes and man-made-mineral fibres (MMMF), which in general are regarded to be               Appendix 2.
                              substances in the REACH-framework, to see how the conclusion will end up. Although asbestos is prohibited and
                              thus is not interesting or useful as an example in the guidance document, it could also be interesting to make the
                              exercise for „virtual substance‟ having similar properties in regard to the fibre properties as asbestos to see, how
                              the conclusion substance vs. articles will end up for such fibres.
                              If a parallel exercise on other fibres shows that the system is not always useful, we need to consider if and how the
                              guidance doc. need to be amended.”




157 FI           Appendix 2 - “In Figure 5 it is stated that polymer substances are exempted from registration. True enough, but it can be   The modification proposed will be made.
                 2            somewhat misleading, as the monomers in polymers need to be registered. Suggestion: delete „(exempted)‟ in the
                              figure from under „polymer substance‟ (on the right) and „substance‟ (on the left).”
158 DE   Appendix 5   “European Standards include other types of information sources like draft European Standards (prEN), CEN            The modification proposed will be made.
                      Workshops Agreements (CWA), Technical Specifications (TS) and Technical Reports (TR), which might be of
                      interest too. The following wording could be added to the introduction: „More information on analytical methods for
                      different sectors and products can be obtained on the websites of CEN (www.cen.eu/) and its national members.‟”

159 DE   Appendix 5   “The title „Methods for the analyses of substances in furniture‟ could be replaced by „Methods for the analyses of     The title “Methods for the analyses of substances in furniture” will be replaced
                      substances in building products, furniture, textile and leather‟ or „Methods for the analyses of substances in other   by “Methods for the analyses of substances in building products, furniture,
                      articles‟.”                                                                                                            textile and leather”.
160 DE   Appendix 5   “The Standards ISO 14184-1 and ISO 184 – 2 „Textiles – Determination of formaldehyde‟ are European standards           It will be specified that these standards can also be obtained as ENs from
                      too: EN ISO 14184-1 and EN ISO 184 – 2.”                                                                               national members of CEN.
161 DE   Appendix 5   “The following standards could be added to the list:                                                                   The modification proposed will be made.
                      EN ISO 16000-5, EN ISO 16000-9, EN ISO 16000-10, EN ISO 16000-11,                                                      (EN ISO 14362-1 and EN ISO 14362-2 are already included in the list)
                      EN ISO 14362- 1, EN ISO 14362-2”

162 NO   Appendix 6   “My proposal with respect to Appendix 6: Heading „Legislation restricting the use of substances in articles outside    The title will be changed to “Other legislation restricting the use of substances
                      the scope of REACH‟. Delete the first row in the table (relevance to Annex XVII)”                                      in articles”.
                                                                                                                                             The table will be changed as proposed and in section 1.3 a remark will be
                                                                                                                                             added to indicate the amendment of REACH Annex XVII by Regulation (EC)
                                                                                                                                             No 552/2009.
              Summary of comments received from the PEG on issues subject to the first consultation round brought forward by PEG members after the first consultation round
  Source    Topic         Comment                                                                                                                    Response
1 AT        Section 1.3   Last paragraph: It is very useful for the user of the GD to raise awareness for amendments and have a direct               At its meeting on 20 November 2009 the PEG agreed that the revised guidance should not refer to specific
                          reference (here on Annex XVII). However, we should consider that very soon further amendments of Annex XVII                amendments of the REACH Regulation but just indicate “as amended” in the text in section 1.3, highlight that
                          will follow, and the GD needs to be updated every time. It could be more practical to make a note to raise                 the REACH Regulation can change through legal amendments, and include a link to ECHA‟s website listing
                          awareness (e.g. “please be aware that Annex XVII has already been amended ...”) and provide a reference/link to            the amending Regulations.
                          a respective website, where the documents can be found.


2 AT        Section 2.1   In the current version of the GD the following in my opinion very helpful and simple consideration can be found:      This sentence as such is not included anymore in the guidance. However, what a producer/supplier/recipient
                          “The function of an object, which may or may not be an article, is determined by what its producer / supplier wants of an article wants it to do / to be used for could be considered to be equivalent to "the result of using an
                          it to be used for and what the person acquiring it expects it to do.”                                                 object", to which reference is already made in the first paragraph of section 2.1.
                          This sentence or at least its content should be as a basic principle for the decision what is an article added to the
                          revised version.


3 SE        Section 2.1   At the PEG meeting on 20 November 2009 SE proposed to add in section 2.1 the explanation given in section                  The explanation that an article should have a particular function that it can fulfill as a single object will be
                          2.3.2, that the article should have a particular function that it can fulfill as a single object.                          removed from the guidance.
4 SE        Section 2.2   At the PEG meeting on 20 November 2009 SE proposed to add in section 2.2 the explanation given in section                  Section 2.3.1 will be merged with section 2.2.
                          2.3.1, that the physical appearance should be deliberately determined and given in a production step.

5 Eurofer   Section 2.3   Table 2 is intended to differentiate between forming processes, where gross changes in shape occur, and              Table 2 will we removed and instead examples will be given in the text of Question 6c as suggested.
                          processes regarded as “light processing”. […]
                          As a minimum, EUROFER proposes that casting and sintering are deleted from Table 2 because these present
                          primary shaping processes rather than forming processes. Alternatively, although not recommended, the column
                          currently described as “forming processes” could be renamed “Processes not regarded as light processing”.
                          However, EUROFER recommends that preference is given to removing the column marked “Forming processes”
                          from Table 2. Especially, as previously stated, bending is regarded by DIN 8580 as a forming process rather than
                          light processing. If ECHA deem that examples of forming processes are necessary in the guidance, it is suggested
                          that these examples are given in the text. Furthermore, it is suggested that extrusion, forging and rolling are used
                          for this purpose because they embody the concept of gross changes in shape described by Member State
                          representatives in the original SEG meetings.



6 FR        Section 2.4   p.20, 1st paragraph: the two 1st sentences are confusing because the article 36.1 of the Reach regulation does             Section 2.4 will be revised to reflect that Article 36(1) does not apply to all article producers, but that the
                          not lay down any obligation concerning article importers or article producers (except if this production implies the       keeping of information is recommended to article producers and importers in general.
                          use of substances/mixtures).
7 UK        Section 2.4   At the PEG meeting on 20 November 2009 the UK expressed the need for further discussion of the guidance on                 A revised version of section 2.3 (particularly of the flowchart) elaborated on the basis of input from PEG
                          deciding whether an object is an article or not.                                                                           members will be included in the guidance document.
8 AT        Chapter 5     It should be basically pointed out very clearly that the importer is legally responsible to have relevant information on   An introductory paragraph will be included in chapter 4 (instead of chapter 5, as it is chapter 4 that deals with
                          SVHC in imported articles available. [...]                                                                                 SVHC), explaining the aims of REACH with regard to SVHC in articles and the responsibility of article
                          The reason for this comment is based on a general observation made during the last years. Everybody of us                  producers/importers/suppliers.
                          dealing with chemicals legislation every day is aware of the simple basic fact, that only companies located in the
                          EEA have duties under REACH. However, in our daily Helpdesk work and during seminars we often see that this
                          basic fact is not clear to all concerned companies especially smaller importers of articles and also importers of
                          substances/mixtures. Some uninformed EU importers blindly rely on information from non-EU-suppliers ignoring
                          their own responsibility. In some other cases non EEA-manufacturers think that they have to fulfill duties under
                          REACH.

9 NO        Chapter 5     Workability & enforceability depends, according to our experience, mainly on whether the companies have quality            The usefulness of quality management systems for obtaining information on substances in articles will be
                          management systems in place or not. Communication in the supply chain is crucial to collect the needed                     pointed out in the guidance by including an additional paragraph in the introduction to chapter 5.
                          information and with establishing routines among the actors to identify substances will reduce the number of
                          analysis as well as the cost.
10 SE       Section 5.1   This section should consider [...] that workability mainly depends on whether companies have quality management The usefulness of quality management systems for obtaining information on substances in articles will be
                          systems in place or not. Communication routines that ensure a flow of substance related information will demand pointed out in the guidance by including an additional paragraph in the introduction to chapter 5.
                          less effort once the basic management routines have been established.
11 Cefic      Section 5.1.2   The asking associations regard the differentiation between non-EEA suppliers and EEA suppliers not only                    The sentence mentioning that standardised information (described in section 5.1.1) will not necessarily be
                              discriminating, but also as a market barrier.                                                                              received from non-EEA suppliers, will be removed. However it is not regarded that this sentence is
                                                                                                                                                         discriminating or a market barrier as it is a matter of fact that REACH information requirements (e.g. Article
                                                                                                                                                         33) do not apply to non-EEA suppliers.
                                                                                                                                                         At its meeting on 20 November 2009 the PEG agreed that section 5.1.2 should start with the following
                                                                                                                                                         sentence: “Where the information received is not sufficient to check compliance with REACH, producers,
                                                                                                                                                         importers and suppliers of articles have to obtain the necessary information by pro-active requests in the
                                                                                                                                                         supply chain.”
12 Orgalime   Section 5.1.2   We would like to reiterate our position on requesting information up the supply chain (Chapter 5.1.2, third and            At its meeting on 20 November 2009 the PEG agreed to keep the third bullet point in section 5.1.2 as it is,
                              fourth bullet points, page 31), which we consider a business to business issue.                                            since the approach described can sometimes be of help particularly for SMEs.
                              From our point of view, it seems that ECHA has exceeded its authority when giving specific suggestions on HOW              Based on the same rationale the fourth bullet point was already rephrased after the first PEG consultation
                              to collect information in the supply chain and by explicitly stating that requests are targeting exclusion or limitation   round to make it clearer that it just makes a recommendation, and does not prescribe a certain data collection
                              of certain substances. In our view, ECHA should give only requirements on WHAT information to request or                   strategy. (see PEG comment from Orgalime during first consultation round and ECHA's response no. 121)
                              collect, but not as how to do it. Information needed depends to a great extent on the individual business
                              environment of a company, its different products or information gathering systems. Authorities should in our view
                              not give any preferences to a particular information gathering system.


13 SE         Section 5.1.2   The first sentence in the paragraph seems to be incorrect.                                                                 At its meeting on 20 November 2009 the PEG agreed that section 5.1.2 should start with the following
                                                                                                                                                         sentence: “Where the information received is not sufficient to check compliance with REACH, producers,
                                                                                                                                                         importers and suppliers of articles have to obtain the necessary information by pro-active requests in the
                                                                                                                                                         supply chain.”
14 Cefic      Section 5.2     Chemical analyses are not mentioned in the REACH text. Furthermore, there is neither an international analytical           Chemical analyses of substances in articles are not mentioned in the REACH Regulation, they are however
                              standard method, nor a European one for substances in articles.                                                            sometimes an option or necessary for the implementation of REACH (i.e. to identify which REACH obligations
                                                                                                                                                         apply) and thus worth to be mentioned in a guidance document.
15 Digital    Section 5.2     While there is in some circumstances merit to use analytical methods, it has to be pointed out that the lack of
   Europe                     standardized methods and the inherent errors with sampling makes exclusive use of analytical methods to
                              determine article 33 date not advisable. We therefore concur with the text pointing to analytical methods as a
                              costly "last resort" that do however not deliver results in a sufficient degree of accuracy.

16 AT         Section 5.2.1   It is nice to provide information on basic problems of chemical analysis which I am facing too, but it is not helpful at At its meeting on 20 November 2009 the PEG agreed not to delete section 5.2.1. However, section 5.2 should
                              all.                                                                                                                     make clear that chemical analyses can be an option in certain cases, and may even be mandatory for certain
                                                                                                                                                       articles (e.g. toys, shoes) under other legislation.
17 Cefic      Section 5.2.1   Chapter 5.2.1 is describing the difficulties without providing any solution. Therefore, it does not make any sense to At its meeting on 20 November 2009 the PEG agreed not to delete section 5.2.1. However, section 5.2 should
                              refer to chemical analysis of substances in articles.                                                                 make clear that chemical analyses can be an option in certain cases, and may even be mandatory for certain
                                                                                                                                                    articles (e.g. toys, shoes) under other legislation.
18 DE         Section 5.2.2   The underlined amendments are proposed:                                                                                    At its meeting on 20 November 2009 the PEG agreed that section 5.2.2 should advise to use existing
                              "Furthermore, it should be noted that there are no formal requirements on which methods and laboratories to use,           standard methods and accredited laboratories whenever possible and appropriate .
                              because they could not cover all possible substances and products; it is up to each company to judge the
                              appropriateness of methods and laboratories. However, certified laboratories and existing standard methods from
                              certification and standardisation should be used whenever they are appropriate for the substance and product in
                              question.


19 WWF        Section 6.3     In fact it is in particular the chapter R5 “Adaptation of information requirements” that describes some of these           REACH Annex XI amended by (EC) No 134/2009 specifies criteria for the justification of exposure based
                              details (on how to demonstrate that no exposure occurs).                                                                   waiving of testing.
                              The following sentence seems a useful addition:                                                                            The criteria for justification of the exemption from the obligation to notify based on the exclusion of exposure
                              "As part of a qualitative argumentation (i.e., without an exposure scenario and risk characterisation), a reference to     (Article 7(3)) are given in the Guidance on requirements for substances in articles.
                              (semi-)quantitative information demonstrating absent or non significant exposure, no leaching etc. may need to be          The criteria given in each of the cases are not identical. Adding a reference to REACH Annex XI or to chapter
                              included, or a reference can be made to already existing studies with appropriate quantitative information."               R5 of Guidance on information requirements and chemical safety assessment (dealing with exposure based
                              Also it could be relevant to insert a link somewhere to the new criteria in Annex XI (adopted on 16.2.2009), as            waiving) could therefore be misleading in the context of section 6.3.
                              points 3.2 b and c refer to exposure considerations for substances incorporated in an article.                             The guidance already mentions in section 6.3 that quantitative information demonstrating no exposure during
                                                                                                                                                         service life and disposal may be part of the argumentation (5th bullet point).


20 DK         Section 6.3.1   Insert an example in section 6.3.1. on how to demonstrate “no exposure” to the environment in the waste stage of           At its meeting on 20 November 2009 the PEG agreed not to include any example on how to demonstrate “no
                              an article.                                                                                                                exposure” to the environment during the waste stage of an article, as this was regarded as too complex.
21 Cefic      Appendix 1   Again, with the introduction of the “Indicative questions for borderline cases”, the majority of the industrial              Regarding the points mentioned the guidance is based on the outcome of the meeting of the subgroup of the
                           members in RIP 3.8 stated out that the ECHA revision does not reflect the members‟ opinion and that indeed the               Member State Competent Authorities (MSCAs) on 3 October 2007 (i.e. at the end of the REACH
                           TGD is a guideline which is not legally binding. The fact that the expressions „container‟ and „carrier material‟ are        Implementation Project 3.8). At this meeting the European Commission concluded that, despite some
                           not defined in the REACH legislation, illustrate this point.                                                                 reservations of two MSCAs, MSCAs in general see a printer cartridge as a substance in a container. Likewise
                           The function of a printer cartridge is still to make an image and not just to put ink on paper. Depending on the used        the indicative questions for borderline cases were generally supported.
                           technology, it can be both, a combination of a substance/mixture or an article with intentional release.


22 Digital    Appendix 1   The examples of printing cartridges in the text are not consistently referred to ink or toner. The table (4) mentions        The modification proposed will be made in the whole document.
   Europe                  in the first line „ink‟ and after in the rest of the table only „toner‟. It should be clear that the definition applies to
                           both ink and toner cartridges; therefore we would suggest that the table mentions both „ink and toner‟ all the
                           times.
23 FR         Appendix 1   As it has already been exposed previously we are very concerned about the interpretation provided concerning the             The example of the disposable breath alcohol tester was taken up in the draft revised Guidance on
                           status of breath alcohol testers. This issue should not be resolved in the framework of the review of the guidance           requirements for substances in articles also because of proposals of Members States (in particular IE and NL,
                           but has to be discussed at the level of the Competent Authorities as expressed at the last Caracal meeting in                see documents attached), besides it is considered to be a useful example of a borderline case where
                           October by several Member States. So we are strongly opposed to keep this example as it stands and do ask to                 guidance is appriopriate.
                           reconsider including it after the discussions at the next Caracal meeting in February. We plan to provide another            As explained by ECHA at the CARACAL meeting in October 2009, the Competent Authorities wishing to
                           paper to explain our interpretation.                                                                                         contribute arguments to the discussion on this issue at the present stage of the guidance update may do so
                                                                                                                                                        using the guidance feedback form available at ECHA‟s website. This is to channel the comments into one
                                                                                                                                                        discussion and avoid having discussions parallel to those foreseen in the Consultation procedure on
                                                                                                                                                        Guidance. One of those discussions foreseen is the consultation of the European Commission and the
                                                                                                                                                        MSCAs. Thus, the possibility to discuss the issue of the disposable breath alcohol tester and its article status
                                                                                                                                                        at the level of the Competent Authorities will indeed be given.
                                                                                                                                                        This approach allows it to present to CARACAL a version of the guidance for commenting that already takes
                                                                                                                                                        into account the view of the PEG and of the Forum, and should thus be more likely to find general consensus.


24 Orgalime   Appendix 1   We regret that the proposed draft still states that desiccant bags should be regarded as “a combination of an                The fact that desiccant bags are used as part of packaging systems does not imply that all elements of this
                           article (functioning as a container or a carrier material) and a substance/mixture”, since such an interpretation in         packaging system have to be regarded as articles. Some of the articles can contain/carry a substance or
                           our view does not properly reflect the specificity of the product.                                                           mixture that is not an integral part of an article. The assessment of the borderline case of desiccant bags
                           Instead, companies use desiccant bags as part of their packaging of products to avoid adverse affects of moisture            following the rules in the guidance document leads to the conclusion that desiccant bags should not be
                           during transport and storage, as well as receive desiccant bags as a part of protective packaging systems of raw             regarded as articles with an integral substance/mixture. (see PEG comment from Orgalime during first
                           materials, components, semi-finished goods and finished products.                                                            consultation round and ECHA's response no. 147)
                           We would like to repeat our request that desiccant bags should be classified as articles with an integral
                           substance/mixture in the table on borderline cases on page 41.
                                                                                   Summary of comments received during the second round of the PEG consultation
                                                      on chapter 4, example 8 in section 5.1.2, section 6.4 and appendix 3 of the draft revised Guidance on requirements for substances in articles
                                                                                          (parts of the guidance that have been modified since the first round)
   Source     Topic            Comment                                                                                                                     Response
 1 ASD        General          The changes in order and chapter structure of the document are very welcome and contributes to a better legibility
                               and understanding of the document.
 2 AT         General          In general the structure of the guidance document has been improved. However, I am not fully convinced that the
                               complete restructuring of the GD will cause only positive response by the users. It is for example very useful that the
                               information on “light processing” and “intended release of substances” has been moved from the appendices to the
                               respective chapters in the first part of the GD.

 3 DE         General          We would like to emphasize that, compared to RIP 3.8 the overall structure of current version has considerably been
                               improved. It´s far more stringent and the slim line will make it easier to the actors to understand the basic principles
                               and what the obligations are when bringing articles to the market (Exemption: chapt. 4).
 4 DK         General          First of all I would like to congratulate ECHA for the “rewriting” of the guidance. I see many improvements of the text,
                               so now it should be much easier for the users to be guided on this complex issue.
 5 EDANA      General          We are generally satisfied and happy of the revised version of the abovementioned sections which we believe clarify
                               better some aspects that were not addressed in the previous version (eg, case of exemptions for notification,
                               obligations according to Art 33 etc…).
 6 NO         General          The structure of the guidance is improved and it is easier to get an overview with respect to requirements/obligations
                               to an article supplier and decision making undertaken, either as an assembling producer or/and importer. I will also
                               like give positive feedback for presenting more relevant examples on the borderline cases (substance/mixtures in
                               containers or carrier materials).
 7 Orgalime   General          Following the first round of consultation, we welcome that the ECHA Secretariat has in a number of areas seen fit to
                               clarify the overall content of the guidance, thereby providing article producers with a more concise tool in order to
                               help them fulfilling their legal obligations. We also welcome that number of stakeholders‟ comments has been taken
                               into account and included in this second draft version.
 8 SE         General          The structure of the guidance is significantly improved and the introductory chapters now give very clear and helpful
                               guidance for determining if an object is an article.
 9 WWF        General          The guidance document has been improved and clarified in many places. Thank you for all these efforts.

10 ASD        Interpretation   Current wording proposed in section 4 regarding the application of the 0.1% threshold to candidate list substances
              of 0.1%          on the basis of the article as placed in the market, thereby maintaining the position adopted in the original guidance is
              threshold        welcome and supported. Under the light of the experience obtained in gathering information of SVHC in articles by
                               the aerospace sector, the application of supply chain information obligations at the level of homogeneous elements
                               or other sub-assembly levels is impracticable and does not seem to provide significant benefits for human or
                               environmental health protection, at least in this type of industrial setting.

11 AT         Interpretation   I cannot support the view that the substance concentration threshold of 0.1% (w/w) applies to the article as produced       Concerning the interpretation of the 0.1% threshold the legal opinion of the European Commission is
              of 0.1%          or imported in every case including complex articles.                                                                       determining for ECHA unless overruled by a decision of the Court of Justice.
              threshold        Applying the concentration threshold of 0.1% (w/w) also to complex articles would create a number of serious                At the PEG meeting of 20/11/09 the Commission explained that the current interpretation of the 0.1% threshold
                               problems. [...] For details see report “Assessment of applications of the 0.1% limit in REACH triggering information        was elaborated by the Commission‟s Legal Service and communicated to the Member State Competent
                               on Substances of Very High Concern (SVHC) in Articles” to be published on the website of the Nordic Council.                Authorities in Doc. CASG(SiA)/04/2007. According to the Commission, if the legislator would have wanted the
                               (a number of amendments related to the interpretation the 0.1 % threshold are proposed by AT)                               0.1% threshold to apply to homogeneous materials only, the legislator would have explicitly mentioned this (like
                                                                                                                                                           in certain provisions on restrictions in the REACH Regulation) and defined what is to be understood as a
                                                                                                                                                           homogeneous material.
12 Cefic      Interpretation   It is highly appreciated that version 2.0.1 clarifies the 0.1 w/w % issue […] Footnote 16 offers additional help
              of 0.1%          regarding this issue.
13 DE         threshold
              Interpretation   Our main concern is related to chapter 4, where the 0.1%-limit on SVHC`s is related to the article as a whole. As we        Concerning the interpretation of the 0.1% threshold the legal opinion of the European Commission is
              of 0.1%          stated earlier, the trigger for obligations should apply to components made from one material. Most of the special          determining for ECHA unless overruled by a decision of the Court of Justice.
              threshold        acts already account for this. REACH, as a leading ordinance, should not stay behind and give a bad example for             At the PEG meeting of 20/11/09 the Commission explained that the current interpretation of the 0.1% threshold
                               further legislation projects. [...] Further arguments [...] were given in the report of the Nordic Council Ministers. For   was elaborated by the Commission‟s Legal Service and communicated to the Member State Competent
                               the Commission should be clear, that the provision, as it is yet, would lead to a substantial discrimination of             Authorities in Doc. CASG(SiA)/04/2007. According to the Commission, if the legislator would have wanted the
                               producers. To sum up, we strongly plead for a re-writing of the relevant parts of Chapt. 4                                  0.1% threshold to apply to homogeneous materials only, the legislator would have explicitly mentioned this (like
                                                                                                                                                           in certain provisions on restrictions in the REACH Regulation) and defined what is to be understood as a
                                                                                                                                                           homogeneous material.

14 Digital    Interpretation   We fully agree with this interpretation of the 0.1% threshold. Per text of the REACH legislation itself as well as from
   Europe     of 0.1%          the analysis of the legal service of the Commission and other competent official bodies this is the only interpretation
              threshold        of the 0.1% reference we can accept without altering the legal text.

                                                                                                                                       Page 44
15 DK         Interpretation   A new report from Ökopol on the interpretation of how to apply the 0,1 % threshold has shown that the interpretation          Concerning the interpretation of the 0.1% threshold the legal opinion of the European Commission is
              of 0.1%          suggested in the current draft leads to less information on SVHC‟s in articles, and is not more workable for industry         determining for ECHA unless overruled by a decision of the Court of Justice.
              threshold        and enforcers and also is inconsistent with other legislation. Thus, the interpretation that the concentration threshold      At the PEG meeting of 20/11/09 the Commission explained that the current interpretation of the 0.1% threshold
                               is to be calculated as an average over a whole complex article is not supported. [...] Thus, I suggest the guidance is        was elaborated by the Commission‟s Legal Service and communicated to the Member State Competent
                               revised. One of the main arguments is that “an article never ceases to be an article disregarding you put it together         Authorities in Doc. CASG(SiA)/04/2007. According to the Commission, if the legislator would have wanted the
                               with another article into a complex article”. The status of the article as such cannot change during its use – this           0.1% threshold to apply to homogeneous materials only, the legislator would have explicitly mentioned this (like
                               seems to me to be very logical. In other words: Once an article, always an article. [...] It is recommended that the          in certain provisions on restrictions in the REACH Regulation) and defined what is to be understood as a
                               guidance should include a specific section on the 0,1 % trigger limit including an explanation on how to handle the           homogeneous material.
                               info requirements for complex articles.
                               (a number of amendments related to the interpretation of the 0.1 % threshold are proposed by DK)


16 EDANA      Interpretation   EDANA is in agreement and supports the clarification given under section 4.2 that “The substance concentration
              of 0.1%          threshold of 0.1% (w/w) applies to the article as produced or imported. It does not relate to the homogeneous
              threshold        materials or parts of an article, as it may in some other legislation, but relates to the article as such (i.e. as produced
                               or imported)”.
17 NO         Interpretation   The previous version of the Guidance includes link to six dissenting MS concerning the interpretation of what should          Concerning the interpretation of the 0.1% threshold the legal opinion of the European Commission is
              of 0.1%          apply to “0,1%” in an article and in what context should be regarded as a an article as itself (separate articles).           determining for ECHA unless overruled by a decision of the Court of Justice.
              threshold        Norway has interpreted and supported the MS dissenting views in this context. [...]                                           At the PEG meeting of 20/11/09 the Commission explained that the current interpretation of the 0.1% threshold
                               To my knowledge some of my collagues in the PEG consultation, representing the MS with dissenting views in the                was elaborated by the Commission‟s Legal Service and communicated to the Member State Competent
                               previous Guidance, have in their comments given contributions to improvements in relevant text, (specific under               Authorities in Doc. CASG(SiA)/04/2007. According to the Commission, if the legislator would have wanted the
                               Chapters 2, 4 & 5). From Norwegian point of view, we support most of these comments.                                          0.1% threshold to apply to homogeneous materials only, the legislator would have explicitly mentioned this (like
                               (a number of amendments related to the interpretation the 0.1 % threshold are proposed by NO)                                 in certain provisions on restrictions in the REACH Regulation) and defined what is to be understood as a
                                                                                                                                                             homogeneous material.


18 Orgalime   Interpretation   We especially welcome the given interpretation of the substance concentration threshold of 0.1% that applies to the
              of 0.1%          article as such, as produced or imported. We fully support this statement since the REACH legal text does not
              threshold        provide a basis for any other interpretation than that the 0.1% concentration value to be calculated, in view of fulfilling
                               notification (article 7.2) and communication (article 33) requirements for substances in articles, relates to the entire
                               article.
19 SE         Interpretation   Losses and gaps in the flow of SVHC related information have been shown in the aforementioned study ordered by                Concerning the interpretation of the 0.1% threshold the legal opinion of the European Commission is
              of 0.1%          the Member States that expressed dissenting views. Loss of information will occur at random, without any relation to          determining for ECHA unless overruled by a decision of the Court of Justice.
              threshold        exposure or risk. The level of protection may be affected and thereby also the general objectives of REACH                    At the PEG meeting of 20/11/09 the Commission explained that the current interpretation of the 0.1% threshold
                               Regulation.                                                                                                                   was elaborated by the Commission‟s Legal Service and communicated to the Member State Competent
                               It should be noted that these drawbacks largely can be avoided if the threshold is applied to components that are as          Authorities in Doc. CASG(SiA)/04/2007. According to the Commission, if the legislator would have wanted the
                               identified articles according to chapter 2.                                                                                   0.1% threshold to apply to homogeneous materials only, the legislator would have explicitly mentioned this (like
                               (a number of amendments related to the interpretation the 0.1 % threshold are proposed by SE)                                 in certain provisions on restrictions in the REACH Regulation) and defined what is to be understood as a
                                                                                                                                                             homogeneous material.
20 WWF        Interpretation   In our view further discussions are needed on the Commissions‟s legal interpretation of the 0.1% threshold, in                Concerning the interpretation of the 0.1% threshold the legal opinion of the European Commission is
              of 0.1%          particular taking into account of the two new studies carried out in the context of this guidance update, one                 determining for ECHA unless overruled by a decision of the Court of Justice.
              threshold        contracted by the Nordic Council of Ministers, the other by ECHA.                                                             At the PEG meeting of 20/11/09 the Commission explained that the current interpretation of the 0.1% threshold
                               This new information confirms the concerns that application according to the current guidance will mean less                  was elaborated by the Commission‟s Legal Service and communicated to the Member State Competent
                               information on SVHC's in articles and in the supply chain as well as less workability for industry and enforcers.             Authorities in Doc. CASG(SiA)/04/2007. According to the Commission, if the legislator would have wanted the
                               Moreover, it will not lead to the protection of environment and health from substances of very high concern in articles       0.1% threshold to apply to homogeneous materials only, the legislator would have explicitly mentioned this (like
                               and thus undermine the aims of REACH.                                                                                         in certain provisions on restrictions in the REACH Regulation) and defined what is to be understood as a
                                                                                                                                                             homogeneous material.
21 FR         Interpretation   As already explained previously we do not support the view that the substance concentration threshold of 0.1 %                Concerning the interpretation of the 0.1% threshold the legal opinion of the European Commission is
              of 0.1%          (w/w) shall apply to the article as produced/imported/supplied. Instead we would recommend to consider whether the            determining for ECHA unless overruled by a decision of the Court of Justice.
              threshold        article is composed by parts which could be in turn defined as articles as defined by the article 3.3 of the Reach            At the PEG meeting of 20/11/09 the Commission explained that the current interpretation of the 0.1% threshold
                               regulation and then to consider if the threshold is exceeded in all these articles. On the one hand this would avoid a        was elaborated by the Commission‟s Legal Service and communicated to the Member State Competent
                               lack of information concerning safety and on the other hand this would provide more equality between all the                  Authorities in Doc. CASG(SiA)/04/2007. According to the Commission, if the legislator would have wanted the
                               economic actors.                                                                                                              0.1% threshold to apply to homogeneous materials only, the legislator would have explicitly mentioned this (like
                               (a number of amendments related to the interpretation the 0.1 % threshold are proposed by FR)                                 in certain provisions on restrictions in the REACH Regulation) and defined what is to be understood as a
                                                                                                                                                             homogeneous material.




                                                                                                                                        Page 45
22 DK         Chapter 4     It should be borne in mind, that one of the basic aims of REACH is to make industry responsible for safe handling of        An introductory paragraph will be included in chapter 4, explaining the aims of REACH with regard to SVHC in
                            hazardous chemicals. One of the aims of the authorisation system and the candidate list-system is to give industry          articles.
                            the task of mapping where SVHC‟s, such as reproductive toxicants, are used in different sectors. Industry has been          To give the advice, however, that "Non-EU companies that are not willing or able to provide the necessary
                            given the task of finding the substances as this is a basic prerequisite for safe handling and sound management on a        information do not have a legal market in the EU" would go beyond the "No data, no market" principle stipulated
                            societal level. The guidance should include an introduction explaining the basic aims of the legislation and also           in REACH.
                            highlighting that those Non-EU companies that are not willing or able to provide the necessary information do not
                            have a legal market in the EU.

23 Orgalime   Chapter 4     We fully support the rewording and reshaping of the chapter 4 dedicated to requirements concerning substances of
                            very high concern.
24 SE         Chapter 4     We give some suggestions to indicate how the guidance would need to be improved. Should they not be accepted,               The draft revised guidance will mention the dissent among some Member States and the Commission on the
                            the links to dissenting views made in the current guidance would have to be included also in the revised version. […]       interpretation of the 0.1% threshold. Mention of this will be made in the cover note of the guidance as well as in
                            Footnote 16 on page 26 should be deleted or reworked. With the interpretation that is suggested here, we insist that        footnotes in the related sections. This dissent will also be highlighted in the letter to the Forum that will be used
                            the links to dissenting views should be included.                                                                           to launch the next consultation step.

25 WWF        Chapter 4     We are concerned, though, that the text in chapter 4 completely ignores the different legal interpretations on the          The draft revised guidance will mention the dissent among some Member States and the Commission on the
                            application of the 0.1 % threshold. Companies should be made aware of the fact that some Member States may                  interpretation of the 0.1% threshold. Mention of this will be made in the cover note of the guidance as well as in
                            enforce these rules differently, otherwise the guidance will not be helpful advice for them and rather give a distorted     footnotes in the related sections. This dissent will also be highlighted in the letter to the Forum that will be used
                            picture of the situation. [...]                                                                                             to launch the next consultation step.
                            Footnote 16 and parts of section 4.4 should not remain without making reference to the controversies concerning the
                            legal interpretation between European Commission and Member States.
26 DK         Section 4.1   The guidance should also include guidance on how to deal with the future expansion of the candidate list.                   The PEG members were aksed to propose links to sector specific databases, which provide information on
                            The guidance could benefit from providing information on current knowledge on which SVHC‟s may be expected in               SVHC in articles, that could be included in the guidance, but no proposals were brought forward by PEG
                            which articles and materials. This could be in the form of links to relevant sector specific databases as well as info to   members.
                            be provided by ECHA.                                                                                                        The information on substances in articles to be made publicly available by ECHA is determined by the
                                                                                                                                                        provisions in Articles 118 and 119. In this regard, a reference to ECHA's public database with information on
27 IE         Section 4.1   Suggest retaining first two paragraphs of Section 4.1 from Version 2.0 (obtaining information about substances of           The first two paragraphs of section 4.1 as well as the second paragraph onwards of section 4.2 from the earlier
                            very high concern on the CL) and also retain second paragraph onwards of Section 4.2 from Version 2.0. This                 draft revised version 2.0 of the guidance (i.e. sections 8.1 and 8.2 of the existing guidance) contain guidance on
                            information could then be merged into one subsection. i.e.                                                                  how to obtain information on substances in articles. Therefore and because chapter 4 deals rather with the
                            Section 4.1 Substances of very high concern contained in the candidate list                                                 REACH requirements as such, the content of the sections mentioned has been included in chapter 5, in order to
                            • Subsection 4.1.1 Notification according to article 7(2)                                                                   have all guidance on this topic together in one chapter.
                            • Subsection 4.1.2 Obligations according to Article 33                                                                      Sections 4.2 and 4.3 are not made subsections of section 4.1 as they deal with Article 7(2) and Article 33
                            • Subsection 4.1.3 Obtaining information about SVHCs on the CL                                                              requirements respectively and it is thus reasonable that they are subordinated directly to the main chapter on
                            This type of information will be very relevant to article importers who may have notification obligations under Article     requirements concerning SVHC.
                            7(2) and suppliers of articles who may have a duty to communicate information on substances in articles to
                            recipients or consumers, particularly SMEs.

28 IE         Section 4.1   Suggest moving sentence „If a substance is listed on the candidate list is contained in articles, this may trigger          This sentence has been placed before the last paragraph of section 4.1, because this paragraph refers to the
                            certain obligations for companies producing, importing and supplying these articles‟ to the final sentence of Section       obligations deriving from substances on the candidate list. Without mentioning before that substances on the
                            4.1.                                                                                                                        candidate list may trigger certain obligations for industry, it would be unclear why the information on updates of
                                                                                                                                                        the candidate list and the relation with the registry of intentions (explained in the last paragraph of section 4.1) is
                                                                                                                                                        relevant for industry.
29 IE         Section 4.1   Suggest inserting: These obligations are discussed further in the proceeding sections.                                      The modification proposed will be made.
30 IE         Section 4.1   Paragraph 2, Line 3: Consider inserting a reference/footnote indicating what the “certain obligations ” for companies       The insertion of the sentence "These obligations are discussed further in the proceeding sections." (see
                            are.                                                                                                                        comment no. 28) should make sufficiently clear where to find information on what the "certain obligations" for
                                                                                                                                                        companies are.
31 WWF        Section 4.1   Please change according to legal text, art 57: "These SVHC can be: carcinogenic, mutagenic or reprotoxic (CMR)              The wording will be changed to "substances meeting the criteria for classification as carcinogenic, mutagenic or
                            substances meeting the criteria for classification as category 1 or 2"                                                      reprotoxic (CMR) category 1 or 2".

32 FR         Section 4.1   General question about the case of multi-constituent/UVCB substances: if one constituent has been listed on the             Only substances listed in the Candidate List are subject to obligations according to Articles 7(2) and 33.
                            candidate list, how do the articles 7.2, 7.6 and 33 apply? For example, shall the article producer notify the constituent   Substances on the Candidate List can be monoconstituent, multiconstituent or UVCB substances. The presence
                            at stake or the multi-constituent/UVCB substance as such, taking into account that only the multi-constituent/UVCB          of a substance listed in the Candidate List in another multiconstituent or UVCB substance (not listed in the
                            substance as such may be involved all along the supply chain?                                                               Candidate List) which is then incorporated in an article does not trigger as such any obligations according to
                                                                                                                                                        Articles 7(2) and 33.




                                                                                                                                   Page 46
33 ASD        Section 4.1   Example 8 highlighted in section 5.1.2. mentions the IMDS tool developed by the automotive sector. Mass data-           For cases where the time window gained by checking the registry of intentions is deemed insufficient, the
                            gathering tools aimed at SVHCs in articles are also being developed by the aerospace sector which however places guidance will recommend that companies proactively identify substances used in their supply chain that have
                            special emphasis in anticipating, as much as possible, the substances that may reasonably be expected to be             the potential to be included in the candidate list, and give sources of information.
                            included in the candidate list in the future. In order to do this the industry has produced general and sector-specific
                            declarable substance lists of substances known or expected to meet SVHC criteria, against which suppliers are
                            requested to declare on a stepwise approach known as the phased declaration process. This extended declaration
                            request is imposed upon the sector by specific constraints brought about by lengthy and demanding product
                            certification processes, for which the time window given by the current alert system provided by the “registry of
                            intention” is deemed insufficient. We propose that mention is made in this new guidance to this peculiarity of the
                            aerospace and defence sectors and the approach used.


34 Cefic      Section 4.2   I would like to ask, if the following assumption is correct:                                                                  A footnote will be added in section 4.2 to clarify the calculation of yearly tonnages of substances in articles.
                            - A substance A is listed June 1st 2012 on the candidate list.                                                                The six months time after a substance has been included on the candidate list given for the notification of this
                            - The substance is in one article only and imported by one individual legal entity                                            substance are stipulated in Article 7(7) of the REACH Regulation. In order to notify a substance in articles it is
                            - The substance has already been imported since 2005 and the w/w % is > 0.1 %                                                 not required to gather "all possible information from the supply chain", but only specific information as specified
                            - The notification requirement does not start up before December 1st 2012                                                     in Article 7(4).
                            - If between June 1st 2012 and December 1st 2012 more than 1 ton of substance A has been imported, a
                            notification has to be made at the latest at December 1st 2012
                            - If between June 1st 2012 and December 1st 2012 less than 1 ton of substance A has been imported, there is no
                            notification requirement (…until the 1 t limit has been reached).
                            Such, or similar examples, would be quite helpful to clarify the situation already described in 4.2.
                            In practice, the timeframe of only 6 months is too short to gather ALL possible information from the supply chain, i.e.
                            the notification after 6 months can only be based on the available information of the supplier at that time - which
                            however, is still in line with the REACH text of Article 33 (1).
                            A confirmation and clarification of this would be helpful.

35 IE         Section 4.2   Suggest renumbering 4.2 to 4.1.1. This should be a sub-section of 4.1 as „notification according to article 7(2)‟ is an       Section 4.2 is not made a subsection of section 4.1 as it deals with Article 7(2) requirements and it is thus
                            obligation that follows on from a CL SVHC being in the article.                                                               reasonable that it is subordinated directly to the main chapter on requirements concerning SVHC.

36 IE         Section 4.2   After bullets, add sentence: „This notification requirement is an obligation of producers and importers of articles‟ .        It will be specified that notification of substances in articles is required of producers and importers of articles.
37 Orgalime   Section 4.2   It is proposed to add that “A notification is not required for a substance in articles which have been produced or            In section 4.2 it is already specified that "A notification is not required for a substance in articles which have
                            imported before the substance has been included on the candidate list for authorisation”.                                     been produced or imported before the substance has been included on the candidate list for authorisation".

38 SE         Section 4.2   Proposal to change the 2nd paragraph: "The substance concentration threshold of 0.1% (w/w) applies to the article The modification proposed will be made.
                            as produced or imported. It does not specifically relate to the homogeneous materials or parts of an article, as it may
                            in some other legislation, but relates to the article as identified according to chapter 2."
                            The third bullet point in section 4.3 and the first paragraph of section 4.4 should be changed accordingly.

39 WWF        Section 4.2   Please change the second paragraph as follows to clarify the difference in approaches of different legislation: "The    Examples of other legislation where a concentration threshold relates to the homogeneous materials or parts of
                            substance concentration threshold of 0.1% (w/w) applies to the article as produced or imported. It does not relate to an article will be given.
                            the homogeneous materials or parts of an article, as it may in some other legislation such as … (give examples), but It will be specified that the 0.1% threshold relates to the article as identified according to chapter 2.
                            relates to the article identified according to REACH and as described in chapter 2 of this guidance."
                            Please change the third bullet point in section 4.3, and the first paragrapph of section 4.4 accordingly, by specifying
                            that the article "identified according to REACH and described in chapter 2 of this guidance" is meant.

40 ASD        Section 4.3   Point 4.3. on Article 33 obligations defines the “recipient” concept. In this same context it would be helpful if a           At its meeting on 20 November 2009 the PEG discussed the necessity to provide in section 4.3 a definition for
                            definition of “consumer” was provided within the text or as a footnote.                                                       the term “consumer” in the context of Article 33. The general opinion was not to add any definition but leaving
                                                                                                                                                          the interpretation of this term to common sense. Consequently the guidance will not be changed in that respect.

41 ASD        Section 4.3   Point 4.3. regarding article 33 obligations states that “the obligations also apply to articles which were produced or        The generally accepted interpretation (and therefore already mentioned in the existing guidance) is that Article
                            imported before the substance was included in the candidate list and are supplied after the inclusion. Thus, the date         33 obligations apply at the date of supply. As the phrase proposed suggests a different understanding, it cannot
                            of supply of the article is the relevant date here”. This point significantly affects the aerospace industry which, due the   be added to the guidance text.
                            long life-cycle of its products and long-term commitment in terms of supply of spares, faces enormous difficulties in         Please note also that it is not the purpose of the guidance document to give sector specific (e.g. for the
                            complying with article 33, as many articles are held in stock belonging to programmes initiated 10 or even 20 years           aerospace industry) guidance. In order to be able to timely prepare for complying with Article 33 obligations it is
                            ago. We propose some form of observation in relation to this difficulty is included in the guidance, perhaps in the line      recommended to regularly check the registry of intentions referred to in section 4.1.
                            of indicating that such information will be provided “when information is available within reason” or something of the
                            kind.

42 AT         Section 4.3   The following bullet point (e.g. following the first) should be added: There is no obligation to communicate the exact        At its meeting on 20 November 2009 the PEG discussed the possibility to add the proposed bullet point. This
                            quantity/concentration of SVHC in an article, unless it is necessary information concerning the safe use of an article.       addition was not supported by all PEG members. It was pointed out that this point is already covered by the
                                                                                                                                                          sentence in section 4.3 “If no particular information is necessary…”. In consequence the proposed bullet point
                                                                                                                                                          will not be added.


                                                                                                                                     Page 47
43 DK        Section 4.3   Addition to 3rd paragraph: If no particular information is required to allow safe use, only the name(s) of the             The 3rd paragraph will be modified to express the requirement to communicate the name of the substance to
                           substances must be provided to the consumer.                                                                               the consumer, in case no particular information is necessary to allow safe use of the article.

44 DK        Section 4.3   2nd bullet point: Specify that packaging materials include food packaging.                                                 It is not considered that it requires special mention that food packaging is a type of packaging.
                                                                                                                                                      Examples of packaging materials are given in section 2.3.3.
45 IE        Section 4.3   Suggest re-numbering 4.3 to 4.1.2. This should be a sub-section of 4.1 as „obligations according to Article 33 ‟ is an     Section 4.3 is not made a subsection of section 4.1 as it deals with Article 33 requirements and it is thus
                           obligation that follows on from a CL SVHC being in the article.                                                            reasonable that it is subordinated directly to the main chapter on requirements concerning SVHC.

46 IE        Section 4.3   Paragraph 2: where the name (as a minimum) is to be provided, should this be the chemical name (e.g. IUPAC) or is It will be specified that the substance name to be communicated according to Article 33 is the one appearing on
                           the trade name acceptable?                                                                                           the candidate list for authorisation.
47 IE        Section 4.3   Paragraph 2: Consumers. In line with the 1st paragraph of Section 4.6 (p28) consider including the statement that The information to be forwarded to consumers upon request is described in paragraph 3, while in paragraph 2
                           “ the same type of information is to be forwarded to consumers upon request. ”                                       the information to be forwarded to recipients is described.
48 SE        Section 4.3   Please insert the following text after the third sentence: "This means that the supplier of the article must request If no particular information is necessary to allow safe use of the article containing a substance from the
                           information on name and content of the substances from the supply chain."                                            candidate list, as a minimum the name of the substance in question has to be communicated to the recipients.
                           Please also add accordingly in section 4.6 after the forth sentence: “So the supplier of the article must request    This, however, does not always mean that the supplier of the article must request information from the supply
                           information on name and content of SVHCs from the supply chain."                                                     chain, as he may obtain information on the name and content of the SVHC by other means (see section 5.1.1).


49 SE        Section 4.3   The following points should be added to this section:                                                                      At its meeting on 20 November 2009 the PEG discussed the possibility to add the first proposed bullet point.
                           - "There is no obligation to communicate the exact quantity/concentration of SVHC in an article, unless it is              This addition was not supported by all PEG members. It was pointed out that this point is already covered by the
                           necessary information concerning the safe use of an article."                                                              sentence in section 4.3 “If no particular information is necessary…”. In consequence this bullet point will not be
                           - "Even if it has been identified that no obligations under REACH apply, companies should consider documenting the         added.
                           results of their compliance checking. This includes documenting the decision-making on whether certain products are        Concerning the second proposed bullet point, these recommendations on documentation are already included in
                           articles, substances or mixtures as well as and the checking if specific requirements apply for these. Documenting         section 2.4. It is not considered that duplicating this information by including it also in section 4.3 provides
                           this facilitates demonstrating REACH compliance towards customers and (inspecting/enforcing) authorities." (from           additional guidance to the reader.
                           section 2.4)

50 FR        Section 4.3   last bullet: we are wondering whether the application of the article 33 to articles which were produced or imported        A supplier of articles will get the same information from his supplier of a substance whether this substance has
                           before the substance was included in the candidate list and are supplied after the inclusion is practicable, especially    been notified according to Article 7(2) or not. Hence, it is not considered that there is a link between the
                           when we consider what is stated on p.25: „A notification is not required for a substance in articles which have been       information available to a supplier of articles and the notification of a substance.
                           produced or imported before the substance has been included on the candidate list for authorisation‟. The question         Concerning the ways to obtain the information needed by the supplier of articles to comply with Article 33,
                           is: how will the supplier achieve this task if the information has not been provided to him because the substance was      guidance is provided in chapter 5.
                           not on the candidate list when supplied, taking into account that the article importer or the article producer are not
                           obliged to provide the information?


51 Cefic     Section 4.3   For the suppliers of articles on page 26, it is only mentioned that the EEA supplier has to provide available and          It is ECHA's understanding that an article supplier has to identify any risks arising from the SVHC in his articles,
                           relevant safety information according to Article 33.                                                                       and thus determine which information has to be provided to the user in order for him to control these risks. This
                           Does this mean that if this information is NOT AVAILABLE, suppliers are still in conformity with Article 33?               means that the information to be communicated according to Article 33 depends on what a user needs to know
                                                                                                                                                      to be able to use the article safely and not on how available this safety information is.

52 Cefic     Section 4.4   This is 100% in compliance with the existing REACH text and will also help to understand the necessary processes
                           and calculations.
53 AT        Section 4.4   It would be more useful if the information of chapter 5 “Obtaining information on substances in article” will be           Chapter 5 was deliberately placed after the chapter on requirements concerning SVHC, since it is initially
                           provided before explaining the method for calculation the concentrations of SVHCs (how to use the obtained                 assumed that sufficient information is available (best case) to check if requirements apply (this can include the
                           information).                                                                                                              calculation of the conc. of a SVHC in articles). The worse case that the information available is insufficient and
                           To use the method for calculating the concentration of an SVHC in a complex article consisting of several smaller          further information needs to be obtained (as described in chapter 5) is not the first assumption made. This is
                           articles, it is necessary to know the exact concentration of the SVHC in each relevant part. When applying the 0.1%        illustrated also by figure 1 in the guidance document.
                           threshold to a complex article, it will be necessary to obtain information on the SVHC-content present in all individual   It will be mentioned in section 4.4 that it is necessary to know the concentration of a particular SVHC in each
                           parts (being themselves articles), even if the concentration is less than 0.1% but above 0%. However, as there is no       component in order to calculate the concentration of this SVHC in the whole complex article.
                           reason for communicating SVHC contents in articles less than 0.1%, such information will normally not be available.

54 Digital   Section 4.4   Example 1 gives the impression that the legal (article 33) communication obligations of the EEA component                  The example in section 4.4 will be revised to reflect that in order to do the article 33 check the computer
   Europe                  producers would be sufficient to ensure the article 33 check of the computer producer. This is not the case as the         producer needs absolute quantities of candidate substances in the used components.
                           legal obligation of the component supplier is limited to a yes/no information in regards to crossing the 0.1 %             To conclude contractual agreements for obtaining information on substances in articles is one of the
                           threshold. In order to do the article 33 check the computer producer needs absolute quantities of candidate                recommendations made in section 5.1.2 (3rd bullet point).
                           substances in the used components. Thus for getting sufficient data from component producers contractual
                           agreements are always needed whether the component is imported or EEA-made.


55 DK        Section 4.4   It should be stressed that the producer of e.g. a computer would first have to find out the weight of each component       The example in section 4.4 will be revised to better reflect the steps to be followed in order to decide whether
                           to calculate the amount of each SVHC in each component, then add up the total amounts of SVHCs in the finished             the computer contains above 0.1% (w/w) of a SVHC from the candidate list.
                           computer and then calculate the final concentrations before he can decide whether the computer he places on the
                           market contains above or under 0.1% (w/w) of any SVHC.

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56 SE        Section 4.4   First paragraph should specify that the threshold refers to the calculated concentration.                                   It is considered that section 4.4 (which contains two formulas) and example 6 make sufficiently clear that the
                                                                                                                                                       determination of the concentration of a SVHC in articles with different components usually involves calculations.
                                                                                                                                                       However, the concentration of the SVHC does not always have to be calculated, but can also be determined, for
                                                                                                                                                       example, by means of chemical analyses. This is particularly the case when an article consists of a
                                                                                                                                                       homogenous material, but also for complex, small articles, shredding and testing of a sample might be a
                                                                                                                                                       feasible approach.
57 SE        Section 4.4   With the interpretation originally suggested in this paragraph [...] the paragraph should also describe that the            The example in section 4.4 will be revised to better reflect the steps to be followed in order to decide whether
                           producer of computers would first have to find out the weight of each component to calculate the amount of each             the computer contains above 0.1% (w/w) of a SVHC from the candidate list.
                           SVHC in each component, then add up the total amounts of SVHCs in the finished computer and calculate final
                           concentrations before he can decide whether the computer he places on the market contains above 0.1% (w/w) of
                           any SVHC.
                           These complications would be valid also for the control and enforcement authorities.
58 SE        Section 4.4   Should the interpretation originally suggested in section 4.4 apply, it would be logical to give guidance on how to         Chapter 5 was deliberately placed after the chapter on requirements concerning SVHC, since it is initially
                           obtain information on substances in articles, currently in chapter 5, before instead of after the detailed calculations     assumed that sufficient information is available (best case) to check if requirements apply (this can include the
                           described in chapter 4. The reader needs to be aware of possibilities and difficulties to get access to such detailed       calculation of the conc. of a SVHC in articles). The worse case that the information available is insufficient and
                           information before learning about the calculations. The guidance could also be structured according to the types of         further information needs to be obtained (as described in chapter 5) is not the first assumption made. This is
                           information needed for the different obligations. Obtaining information on substances that are intended to be released      illustrated also by figure 1 in the guidance document.
                           will involve less difficulty than on SVHCs.                                                                                 Besides, as chapter 5 describes steps to obtain information that can be as complex and laborious as chemical
                                                                                                                                                       analyses, it is considered that the reader needs to know first why he should put in all these efforts to obtain
                                                                                                                                                       information, namely to identify his obligations for substances in articles (as explained in the preceding chapters
                                                                                                                                                       of the guidance).
                                                                                                                                                       Concerning the proposal to structure the guidance (presumably chapter 5) according to the types of information
                                                                                                                                                       needed for the different obligations, it is considered that various of the approaches described in chapter 5 are
                                                                                                                                                       useful to obtain information on both, substances that are intended to be released as well as SVHC, and thus a
                                                                                                                                                       differentiation is not appropriate. In order to identify one‟s obligations for substances in articles, it is necessary
59 Cefic     Section 4.5   No disagreement.                                                                                                            anyway to check if duties result from both, substances intended to be released and SVHC.
60 EDANA     Section 4.5   EDANA appreciates the clarification that has been brought on how to calculate the tonnage threshold of SVHCs from
                           different articles where the reading makes it clear now that the summing of content between several articles should
                           consider only those articles where the concentration of SVHCs is above 0.1%.

61 ASD       Section 4.6   Point 4.6 of the guidance describes very briefly and in a narrative way the obligation to give case-by-case specific        Table 4 in the existing guidance document has not been included in the draft revised version of the guidance, as
                           information on safe use of articles. The exemplary table given to this respect in the original guidance has                 it suggests a particular content and format for the information to be communicated according to Article 33.
                           disappeared in this version, which in our opinion, is a loss. We propose the inclusion of examples on how to provide        However, as mentioned in the guidance REACH does not specify a format for Article 33 communication and
                           information on safe use of articles to professional users and consumers.                                                    including a specific format in the guidance document is not considered to be appropriate. Concerning the
                                                                                                                                                       content of the table it is regarded as questionable whether information such as a registration number, a CAS
                                                                                                                                                       number, or the precise concentration of a SVHC in the article (alone) would help to allow safe use of the article.
                                                                                                                                                       The information to be communicated according to Article 33 is supposed to allow safe use of the article, it is
                                                                                                                                                       therefore considered inappropriate to use these examples in the guidance. The considerations to be made on a
                                                                                                                                                       case by case basis in order to determine what information shall be provided according to Article 33 are
                                                                                                                                                       described in section 4.6.


62 Digital   Section 4.6   The 2nd paragraph should be clarified to ensure that the information required is necessary safe use information       It will be specified that the information to be provided according to Article 33 shall allow the user of the article to
   Europe                  resulting from the presence of the specific candidate list substance. Note that Article 33 uses the word "allow" and  control the risks arising from the SVHC in the article.
                           not the word "ensure". Furthermore safe use information is only then required when it is needed for a safe use of the
                           article in regards of the considered candidate list substance and not in every case.
63 Digital   Section 4.6   Article 33 does not require information relating to the waste phase of the article. Article 33 refers to "use of the        At its meeting on 20 November 2009 the PEG did not consider that the first bullet point in section 4.6 suggests
   Europe                  article". Use does not include waste management activities (placing into waste containers, collection,                      that Article 33 requires the provision of information on waste management activities, and thus recommeded not
                           transportation,treatment, storage, recovery, disposal). It is clear from the wording of Article 33 that this was not        to change the wording.
                           intended. No reference is made to "disposal" in contrast to Article 7.3 where disposal is expressly included. In any
                           event in Article 7.3 the reference to disposal must be limited to the user's act up until the user discards or intends to
                           discard the article i.e. up until the user places the article in a bin, to arrange collection by a waste management
                           contractor. This must be the case because as soon as a user discards or intends to discard the article it becomes
                           waste. Under Article 2(2) of REACH an "article" as defined under REACH cannot include anything that is waste.




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64 Digital    Section 4.6      In case of a (commercial) recipient with internet access the information is readily available when providing a link to a The guidance will mention that a link to a website is a possible format for providing information according to
   Europe                      website. Given that the candidate list can change frequently a recipient of an article can never be sure that            Article 33, provided that it is ensured that the Aricle 33 information is readily available to the recipient of the
                               information on a label or in a user manual is completely up to date as the candidate list might have changed as the      article or the consumer, always taking into account the particular situation of use.
                               product moves through the supply chain. It is unrealistic and impractical to expect all suppliers in the supply chain to
                               update all user manuals and stickers in response to a change in the candidate list.
                               Therefore in order to access up to date information a link to a website in our opinion is always the best solution,
                               provided recipients are provided with and made aware of the link.

65 DK         Section 4.6      It should be considered if a link to a fully updated web-site with clear information would not be sufficient in cases        The guidance will mention that a link to a website is a possible format for providing information according to
                               where no particular information is required to allow safe use. This would limit the burden on companies comply with          Article 33, provided that it is ensured that the Aricle 33 information is readily available to the recipient of the
                               the regulation.                                                                                                              article or the consumer, always taking into account the particular situation of use.

66 Orgalime   Section 4.6      We feel that the guidance should not go beyond the REACH text, in particular Article 33, by requesting the                  The guidance will mention that a link to a website is a possible format for providing information according to
                               information to professional user to be "readily available" and stating that thus a link to a web page would not be          Article 33, provided that it is ensured that the Aricle 33 information is readily available to the recipient of the
                               sufficient. [...] Electronic system as a webpage, if referenced in direct information to a professional user of an article, article or the consumer, always taking into account the particular situation of use.
                               is in our view appropriate to make recipient readily aware of this information according to Article 33.1.
67 SE         Section 4.6      At the PEG meeting on 20 November 2009 SE proposed to merge the first two paragraphs of section 4.3 with                     In order to have the explanation of the actual obligations according to Article 33 (section 4.3) and the guidance
                               section 4.6.                                                                                                                 on how to communicate information to comply with Article 33 (section 4.6) closer together, section 4.6 will be
                                                                                                                                                            included as a subsection in section 4.3.


68 IE         Section 4.7      Information in section 4.7 should be moved to section on notification according to Article 7(2).                             The modification proposed will be made.
69 AT         Example 8       This useful information system is limited to a special industrial sector. It should be mentioned, that information on         Example 8 will be extended by further information systems and platforms used in other sectors.
              (Section 5.1.2) concentration of substances is given in concentration ranges. The general concentration limit for declarable                  It is not the intention of the guidance to explain what information is given in each of these information systems
                              substances is 0.1%. Only in special cases it is less and individually defined.                                                and platforms and its degree of detail, but to mention tools used to obtain and communicate information on
                                                                                                                                                            substances in articles in an efficient manner. Any sector following one these examples and setting up an own
                                                                                                                                                            information systems or platforms, will determine the sort of information to be exchanged with it according to
                                                                                                                                                            sector specific needs.




70 Cefic      Example 8       Example 8 (IMDS) can be seen as another confirmation that a „system based solution‟ is acceptable and conform.
              (Section 5.1.2) ECHA‟s confirmation of this issue is quite important for the industry in order to continue with risk based solutions built
                              up on the „system approach‟. It is also a confirmation to continue with the experiences industry has gained by
                              working out the RoHS compliance.


71 Cefic      Example 8       At the PEG meeting on 20 November 2009 Cefic proposed to add further examples of industry initiatives to facilitate Two additional examples of information systems and platforms used by industry have been provided
              (Section 5.1.2) exchange of information on substances in articles (similar to example 8 in section 5.1.2), and agreed to come       (BOMcheck and JAMP) and will be included in section 5.1.2.
                              forward with such examples for the consideration of ECHA.


72 Cefic      Section 6.4      There is an agreement on the basic elements. However, looking at the actual SIEF formations and to the sameness              The PEG members were asked to provide input on this question, but no input was received from the PEG on
                               checks done within these processes, the relevant CAS and EINECS numbers should be sufficient as long as just one             how to find out more details on substance uses.
                               SIEF exists for the relevant substance. Just in case more than one SIEF does exist, the producer/importer has to             In the next consultation step the Forum will be asked for its opinion on this matter.
                               find additional criteria for his decision.
73 IE         Section 6.4      Paragraph 5, last sentence “the potential registrant or notifier has to compare the description of his use with those        Different sources of information that can help to determine if a substance is already registered for a particular
                               uses already registered for the substance” How can the potential registrant check those uses already registered for          use are given in section 6.4.1. However, in most cases direct communication with the actual registrants in the
                               the substance?                                                                                                               supply chain will be needed to check the uses already registered for the substance.

74 Orgalime   Section 6.4      The draft revised guidance should in our view be amended as follows (Chapter 6.4, fifth paragraph, page 37) as               Due to the generic architecture of the use descriptor system using only the elements of the use descriptor
                               follows: “Therefore, in case of doubt, the use in question by which the substance is included in articles has to be          system to describe a substance will not be sufficient to conclude on the sameness of two uses for the purpose
                               described more in detail than just by using elements of the use descriptor system”.                                          of establishing whether an exemption on the basis of Article 7(6) applies. Therefore, the use in question by
                                                                                                                                                            which the substance is included in articles (always) has to be described more in detail than just by using
                                                                                                                                                            elements of the use descriptor system.
75 Orgalime   Section 6.4      It is not clear to whom the potential registrant or notifier has to describe the process by which the substance is           The modification proposed will be made.
                               included in the article (Chapter 6.4, fifth paragraph, page 37). It should be clarified that the section describes an
                               internal process inside a company of an article producer/importer for the purpose of compliance demonstration.




                                                                                                                                        Page 50
76 Cefic      Section 6.4.1   The actual information exchange is mainly done via the use descriptor system, as explained in Chapter R.12.           Safety data sheets (SDS) contain information on uses of the substance or mixture as far as they are known by
                              Therefore, the SDS, as well as the relevant exposure scenarios, might not contain additional information. Information the supplier. In particular the operational conditions of use described in exposure scenarios attached to SDS
                              on companies‟ websites is usually related to the according articles and not to substances.                            can be relevant when comparing the uses of a substance.
                                                                                                                                                    Unlike suppliers of articles, which indeed would present information on their websites related to their articles and
                                                                                                                                                    not to substances, suppliers of substances or mixtures might choose to provide on their websites details on
                                                                                                                                                    uses for which their substances (as such or in mixtures) have been registered.


77 IE         Section 6.4.1   Consider the deleting the following sentence: This could potentially be done to improve the supplier‟s commercial       The modification proposed will be made.
                              position as compared to competitors ” as we do not consider this statement appropriate in an ECHA guidance
                              document.
78 Orgalime   Section 6.4.1   The flow of information along the supply chain would in our view have to require that the detailed information on the   REACH does actually not require registrants to communicate the uses they have registered their substances
                              registered use is made available by registrant down the chain.                                                          for to their downstream users.
79 Orgalime   Section 6.4.1   Please change the last sentence in the paragraph on SDS: "Therefore depending on the individual case confirmation       The paragraph will be revised to clarify that, in case no doubts on the sameness of two uses exist, no
                              of the sameness of both uses (i.e. the use by which the substance is included in articles and one of the uses           confirmation needs to be sought from the actual registrant up the supply chain.
                              registered) might be sought from the actual registrant up the supply chain."
80 Cefic      Appendix 3      The change from version 2.0 to version 2.0.1 is an improvement, because the “felt tip pen example”, (which
                              disappeared in version 2.0.1), was very confusing.
81 IE         Appendix 3      Consider including reference to the Danish EPA site (on page 57, line 21) where the lists can be found, or making       A link to the website of the Danish EPA has been included as suggested.
                              reference to the CLP Inventory (to be established).
82 IE         Appendix 3      Consider including (on page 59, point 4) the CLP equivalent terms in addition to R50/53 and R51/53 (and where           The modification proposed will be made.
                              relevant in the other examples).
83 Orgalime   Appendix 3      For several examples in the Appendix 3, it is assumed, that certain substances present in articles are on the           It will be clarified in examples 2 and 3 of Appendix 3 that the assumption that the metallic lead and the PAHs are
                              candidate list, i.e. metallic lead (page 61 to 64) and polycyclic aromatic hydrocarbons (page 65 to 68), which in       on the candidate list is made only for the purpose of these examples. It is considered that having stated that
                              reality, however, are not. We support giving a list of examples; however these should only quote substances that are    these examples are based on the assumption that certain substances are on the candidate list, they can still be
                              indeed listed on the candidate list.                                                                                    used to illustrate the checking of requirements under Article 7 and Article 33.
                              Consequently, we request to remove the examples of metallic lead and polycyclic aromatic hydrocarbons.




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