CLP_ENV_Complete_and_HH_Introduction_addressed_PEG_comments

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					                                    PEG members comments on the draft revised texts for Part 1, Part 4 and Part 5 (ENV classification chapters) and the annexes of the Guidance on the Application of the CLP Criteria
                                                                                             (Please use this format "as is" in the interests of fast processing and consolidation
                                                                                             of all comments)
     Source (Organisation Topic (Section in version of text being referred to)   Page     Line      Comment                                                                                           Response (by ECHA - please leave blank)
     / Member State)                                                             number   number

 1   AT                    general comment                                                          Perhaps there is the possibility to clarify what to do if a substance is "placed on the market" #ECHA agrees; a clarification has been inserted in section 1.1.6.1.
                                                                                                    for the testing of the classification. Ie a company, an university supplies a testing laboratory
                                                                                                    (third party) with a substance to get toxicity data for the classification. In our opinion up to
                                                                                                    now this is illegal. The guidance should help to clarify.

 2   CEFIC                 General                                               -        -         The CLP changes to REACH (see CLP Article 58) AND OTHER CHANGES TO REACH                   #This is more a question for REACH guidance, in particular for the
                                                                                                    (e.g. Regulation (EU) No 252/2011 amending REACH Annex I) refer to hazard classes by IR/CSA guidance. The relevant ECHA staff will be informed.
                                                                                                    Hazard class numbering, rather than by the full description or by the short codes given in
                                                                                                    Table 1.1 of Annex VI of CLP. This guidance needs to be revised to reflect that this Class
                                                                                                    numbering system is being used in REACH - though not within the main CLP provisions.
                                                                                                    E.g that REACH may refer to the "Acute toxicity class" as "Class 3.1". This could be done
                                                                                                    by addition of a correlation table early on in the guidance.

 3   CONCAWE/CEFI General                                                                           Propose Action: Consider Sharing the guidance with the relevant UN committees                     #The guidance is well known by MS CAs and EU stakeholder
     C                                                                                              responsible for GHS to promote global consistency in the interpretation and application of        organisations which are usually participating in the UN SCE GHS
                                                                                                    the GHS criteria. Explanation: Clearly communicated guidance on application of the GHS            sessions. Issues that need to be harmonised at UN level normally involve
                                                                                                    criteria will reduce subjectivity of self-assessments and hence reduce barriers to trade          discussions where also EU views as set out in guidance are expressed.
                                                                                                    within Europe. However, globalizing such guidance furthers the objectives on GHS and may          Further to this, the UN SCE GHS members are generally aware of
                                                                                                    resolve potential differences in application of the criteria and/or proliferation of guidance     ECHA's CLP webpages; where a UN member asks for a whole guidance
                                                                                                    documents by other implementing authorities around the world that may not necessarily be          document, ECHA actively shares the document wih the requesting party.
                                                                                                    harmonised.
 4   NL                    Data interpretation general                           -        -         At several points in the environment guidance it is stated that 'data should be treated with      #Please note the reference to IR/CSA, Chapter R.4 on the evaluation of
                                                                                                    care…', e.g. on page 115, line 24, where it is stated that 'Lower quality information showing     available information.
                                                                                                    no or low toxicity should specifically be treated with care…'. The guidance does not always
                                                                                                    clarify what this really means (do not use the data?) or where to find (if any available)
                                                                                                    specific guidance. Please check.
 5   DE                    Preface                                               2        30-33     It is suggested to clarify here that only part of the changes introduced by the 2nd ATP to        #A corresponding clarification has been inserted as a footnote to the
                                                                                                    the CLP Regulation are covered by this revision, whereas the part of the 2nd ATP referring        relevant sentence.
                                                                                                    to human health (respiraatory as well as skin sensitisation, aspiration) is not included in the
                                                                                                    update.

                                                                                                    In addition we would like to ask why this is so, and whether ECHA has started or is planning
                                                                                                    to draft a corresponding update for the human health part in the near future.
 6   DE                    List of abbreviations                                 24       Entry for The explanation for DIN is out-dated, German Industry Standard is no longer used because #The text has been changed in accordance with the comment.
                                                                                          'DIN'     the scope is much broader than in former times and does not apply to industry only. DIN
                                                                                                    stands for German Institute for standardisation and DIN in the title of a standard means
                                                                                                    "Standard of the German Institute for Standardization". The text therefore must be changed
                                                                                                    to:

                                                                                                    "DIN Norm des Deutschen Instituts für Normung (Standard of the German Institute for
                                                                                                    Standardization)"
 7   CEFIC                                                                                                                                                                                            #BMF and WSF added; no need to add TMF as it has been deleted from
                                                                                 25                 Add TMF, BMF and WSF in the list of abbreviations
                                                                                                                                                                                                      the guidance
 8   BE                    List of abbreviations                                 29       no line   Add the definition of UVCB found in the IR/CSA guidance: "Substances of Unknown or                #added
                                                                                                    Variable composition, Complex reaction products or Biological materials"
 9   BE                    1.1.1. The objective of the guidance document         30       11        As the CLP has been already updated to reflect the third revised edtion of the GHS (2009) #The text has been changed in accordance with the comment.
                                                                                                    and as this guidance is reflecting this updated version, this would be indicated here instead
                                                                                                    of having only a reference to the UN GHS 2007.
10   DE                    1.1.2                                                 31       33        At least acc. to http://oxforddictionaries.com it's either biennially or biannually.          #changed to "biannually"
11   ECETOC                Section 1.1.3                                         32       8         xyz section number missing                                                                    #A reference to section 1.1.6 has been inserted.
12   BE                    1.1.4.Timetable Classification                        32       21-26     No need to have this paragraph as the date of 1 December 2010 is over                             #ECHA agrees, and the paragraph has been deleted.
     Source (Organisation Topic (Section in version of text being referred to)   Page     Line      Comment                                                                                        Response (by ECHA - please leave blank)
     / Member State)                                                             number   number

13   ACEA                  Delete text passage (option)                          32       21 - 26   The following text passage maybe deleted because the date is already passed:              #ECHA agrees, and the paragraph has been deleted.
                                                                                                    Until 1 December 2010:
                                                                                                    Substances and mixtures shall be classified, labelled and packaged in accordance with
                                                                                                    DSD and DPD, respectively. They may also be classified, labelled and packaged in
                                                                                                    accordance with CLP. In that case they shall not be labelled and packaged according to
                                                                                                    DSD or DPD. When a substance or mixture is classified, labelled and packaged according
                                                                                                    to CLP the classification information according to both systems shall be provided in SDS.




14   AT                    correction                                            32       28 - 36   REACH Annex II 2.2: "In the case of a mixture, based on the classification, at least the       #ECHA agrees to refer also to DSD/DPD labelling information in the text.
                                                                                                    appropriate symbol(s), indication(s) of danger, risk phrase(s) and safety advice appearing     Further to this, a reference to the upcoming Guidance on the compilation
                                                                                                    on the label in accordance with Directive 1999/45/EC shall be provided. The symbol may         of Safety Data Sheets has been inserted.
                                                                                                    be provided as a graphical reproduction of the symbol in black and white." Thus to our
                                                                                                    mind the "old" symbols have to be included in the SDS. This shall be noted within the
                                                                                                    guidance.
15   AT                    general comment                                       33       14        It will be helpful to clarify the exemtions for scientific R & D. Especially on an academic    #A clarification has been inserted under the respective bullet point in
                                                                                                    level the knowledge on the obligations of CLP and REACH are limited.                           section 1.1.5.
16   BE                    1.1.5. Substances and Mixtures exempted from the 33            23        Replace Directive "98/79/EEC" by "Directive 98/79/EC"                                          #Corrected
                           classification requirements
17   DE                    1.1.5                                               34         2         ...feeding stuffs                                                                                  #Corrected
18   ACEA                  Modify sentence "Although CLP does not apply to     34         6 -8      It's not really correct that the criteria for classification are intended to be the same because #The word "normally" has been inserted as a qualifier.
                           the transport of dangerous goods by air, sea, road,                      there are some differences for example in the hazard class acute toxicity resp. Class 6.1,
                           rail or                                                                  especially inhalation toxicity. Transport takes the volatility into account, the dust content of a
                           7 inland waterways, as noted above the criteria for                      toxic solid, provides other units and exposure duration. Further differences found in class 8
                           classification are intended to be the same in                            (no extreme pH rule). perhaps it's better to modify the sentence, e.g.:
                           8 the two systems."                                                      "Although CLP does not apply to the transport of dangerous goods by air, sea, road, rail or
                                                                                                    inland waterways, as noted above the criteria for classification are in most cases intended
                                                                                                    the same for the hazard classes of both systems."???


19   BE                    1.1.6.1. Information for the classification of        34       27-29     for the clarity of the text and to avoid the repetition of "plant protection products", we     #The proposal has been accommodated.
                           substances                                                               suggest rewording this part of the phrase as follows "test data to be generated such as
                                                                                                    legislation on plant protection products (Regulation (EC) No 117/200932 and Directive
                                                                                                    91/414/EEC33 ) and biocidal products (Directive 98/8/EC34 ), or from various non-
                                                                                                    Community programmes."
20   DE                    1.1.6.1                                               35       3/4       …provided they are scientifically validated, sufficiently adequate, and reliable.              #Added
21   BE                    1.1.6.2. Data for the classification of mixtures      35       16        Is there a speficic reason to use "data" in case of mixtures instead of "information". We      #No, there is no reason. In the headline, "data" has been replaced by
                                                                                                    suggest to replace "data" by "information" like it was done in line 13 and 14 on page 34.      "Information relevant for".

22   BE                    1.1.6.2. Data for the classification of mixtures      35       24-28     This is not exactly reflecting what the CLP regulation says concerning the generation of       #The text has been changed in accordance with the proposal.
                                                                                                    new information. As a matter of fact, Article 8 of the CLP says: "For the purposes of
                                                                                                    determinig whether a substane or a mixture entails a health …..the manufacturer, .....may,
                                                                                                    provided that he has exhausted all other means of generating information including by
                                                                                                    applying the rules provided for in section 1 of Annex XI to Regulation (EC)No 1907/2006,
                                                                                                    perform new tests." When you look to this annex XI of this REACH regulation, you see that
                                                                                                    the "in vitro tests" are part of these rules. It means that "in vitro test data" are NOT to be
                                                                                                    included in the term "test data" . We suggest therefore to replace these 2 phrases by "If no
                                                                                                    in vivo test data are available on the mixutres themselves, such data should not normally
                                                                                                    be generated. Only when the manufacturer, importer or downstream user has exhausted all
                                                                                                    other means of generating information, new tests may be performed."
                                                                                                    For the clarity of the text, we suggest also to begin a new line with this part of the
                                                                                                    paragraph.


23   BE                    1.1.7.2. Influence of impurities,…                    36       footnote As we have suggested to add the definition of UVCB coming from the IR/CSA guidance in #The footnote has been deleted completely, as the definition has been
                                                                                          37       the list of abbreviations, we suggest to delete the definition in the footnote and to refer only included in the list of abbreviations.
                                                                                                   to IR/CSA guidance. Nb.: if the definition is kept, use the exact definition of the IR/CSA.

24   AT                    recommendation                                        37       29        It might be useful to indicate to "minimum classification" here as well because a lot of       #ECHA agrees; a corresponding insertion has been made in paragraph 2
                                                                                                    substances in Annex VI are classified by the Annex VII tables.                                 of this chapter.
     Source (Organisation Topic (Section in version of text being referred to)   Page     Line      Comment                                                                                        Response (by ECHA - please leave blank)
     / Member State)                                                             number   number

25   BE                    1.1.10. Interface between self-classification and     37       36-38     To be precise, we should add "for which data were available" after "Under DSD, as a rule       #ECHA agrees to the proposed change. A clarification in relation to
                           harmonised classification, and the list of harmonised                    all hazards" and have a full stop after "classifications" because the ending up harmonised     classification under DSD has been inserted.
                           classifications                                                          classification was not always a reflect of all hazards relevant for that substance.

26   AT                    correction                                            38       9 - 16    The deadline of 1 December has been reached already and this shall be considered here.         #The sentence referring to the time before 1 December 2010 has been
                                                                                                                                                                                                   deleted.
27   DE                    1.1.11                                                38       10/11    Given that we have now 2011, this sentence has become obsolete. Please delete or                #The sentence referring to the time before 1 December 2010 has been
                                                                                                   change to "…could have been notified…"                                                          deleted.
28   CEFIC                 1.1.11 C&L Inventory                                  38       10 & 11 Delete sentence "However, substances placed on the market before 1 December 2010                 #The sentence referring to the time before 1 December 2010 has been
                                                                                                   may be notified before that date." - no longer relevant.                                        deleted.
29   BE                    1.1.11. C&L inventory                                 38        10-11 "However, substances …before that date" This phrase is obsolete as the date of 1                  #The sentence referring to the time before 1 December 2010 has been
                                                                                                   December 2010 is over. We suggest to delete it.                                                 deleted.
30   CEFIC                 1.1.11 C&L Inventory                                  38       11 to 14 After "…if the same information has already been submitted as part of a registration under      #Inserted
                                                                                                   REACH", insert the words "by the same actor".
31   ACEA                                                                        38       after 23 Please explain in the ECHA Guidance how the "ID No of the C & L inventory" will look like,      #It is ECHA's understanding that this is not relevant for this guidance and
                                                                                                   whether it will be a new No or whether it's similar to the INDEX No or whether it is            will thus not be considered.
                                                                                                   identically with the CLP reference No.
32   DE                    1.1.12.2                                              38       38-44    Reference to the new pesticide regulation (Regulation (EC) 1107/2009) is missing. We            #ECHA agrees to expand on the issue of plant protection products in view
                                                                                                   believe that under the heading 'Relation of classification to other EU legislation', it is      of the new Regulation, and to amend the text of this section.
                                                                                                   important to mention that in contrast to the old PPP directive (91/414/EEC), in Annex II,
                                                                                                   section 3.6 of this new regulation so-called 'cut-off criteria' have been introduced, i. e.
                                                                                                   certain classifications (e. g. CMR, Cats. 1 A or 1 B, for C & R in case of non-negligible
                                                                                                   exposure of humans) which preclude approval of the respective substance as an active
                                                                                                   substance, safener, or synergist in plant protection products.

33   ACEA                  Insert additional explanation - please modify in an   39       after 7   However, in transport classification the rule of precedence hazards and substance specific     #A reference to section 1.7 (Annex VII translation tables) has been
                           appropriate way                                                          entries often plays a role what has to be taken in consideration if using those informations   inserted because these issues are shortly discussed in that section.
                                                                                                    for CLP classification.
34   BE                    1.2.3.1. Form or physical state / Physical hazards    41       7         add a "s" to "substance" in "self-reactive substance"                                          #Corrected

35   CEFIC/ECETOC          Section 1.4                                           44       16-19     Avoid repetition Annex XI, eg: Section 1 of Annex XI to REACH ..............when standard      #The text has been amended in accordance with the proposal.
                                                                                                    data are missing. This annex specifies the conditions..............for the classification of
                                                                                                    substances. It states that results ...............
36   CEFIC/ECETOC          Section 1.4.3 Read across                             46       24        Should be added : having same metabolites .........                                            #The sentence is correct to "This can be based on structural similarity
                                                                                                                                                                                                   (e.g. (Q)SAR) of a parent substance or its transformation products, and
                                                                                                                                                                                                   their bioavailability, bioaccessiblity, or known physico-chemical properties
                                                                                                                                                                                                   such as water solubility."
37   BE                    1.5.1. Specific concentration limits                  47       8-10      We suggest to delete this paragraph because the following paragraph (lines 11-13) is a         #The paragraph has been deleted in accordance with the proposal.
                                                                                                    repetition of the same thing.
38   CEFIC/ECETOC          Section 1.6 Mixtures                                  49       21-22     Green box : Second paragraph (a) : phrase not complete                                         #Phrase has been completed, and green colour added to the box.
39   CEFIC/ECETOC          figure 1.6.1                                          50       9 to 14   Classifying mixture based on mixture data: should include here as comment that this can        #This issue is already clarified by the sentence directly preceding the
                                                                                                    be done endpoint by endpoint and that in most cases this is not covered for all endpoints in   flowchart, stating: "The classification of mixtures follows the sequence
                                                                                                    a mixture. Those missing endpoints should be done by the other methods                         displayed in Figure 1.6.1, for each hazard class independently." As
                                                                                                                                                                                                   indicated in this response, ECHA has formatted the relevant part of the
                                                                                                                                                                                                   phrase in bold letters. In the text boxes on the right-hand side of the flow-
                                                                                                                                                                                                   chart, the text has been amended to be: "Classify the mixture for the
                                                                                                                                                                                                   relevant hazard."
40   CEFIC/ECETOC          Section 1.6.2                                         51       14-15     Please note .............a substance may differ from those shown by the normal standard        #ECHA has amended the text in line with the legal text in CLP Article
                                                                                                    tests in mixtures , such as.........                                                           12(a).
41   CEFIC/ECETOC          Section 1.6.2                                         51       14-15     Phrase is difficult to understand, some further explanation should be included                 #The phrasing of the sentence has been aligned with the corresponding
                                                                                                                                                                                                   text in one of the text boxes of section 12 of the Introductory Guidance on
                                                                                                                                                                                                   the CLP Regulation.
42   CEFIC/ECETOC          Section 1.6.3.2.1                                     53       18        Within the .............another classified mixture or sbustance with water or other non        #The legal text under point 4.1.3.4.3 of the 2nd ATP talks about "other
                                                                                                    classified material. Recommendation in CLP is always not to use words like "non toxic".        totally non-toxic material". This means that the absence of classification is
                                                                                                                                                                                                   not sufficient, but that the material needs to display minimum intrinsic
                                                                                                                                                                                                   hazards (actually none) only.
     Source (Organisation Topic (Section in version of text being referred to)   Page     Line        Comment                                                                                            Response (by ECHA - please leave blank)
     / Member State)                                                             number   number

43   ACEA                  Insert a sentence or footnote                         68       after 46 Note that after 1. June 2015 the application of the transition table in CLP annex VII is not          #The CLP legal text states in its Article 61(5)" Where a substance or
                                                                                                   anymore valid because the 1999/45/EC expired.                                                         mixture has been classified in accordance with Directive 67/548/EEC or
                                                                                                                                                                                                         1999/45/EC before 1 December 2010 or 1 June 2015 respectively,
                                                                                                                                                                                                         manufacturers, importers and downstream users may amend the
                                                                                                                                                                                                         classification of the substance or mixture using the conversion table in
                                                                                                                                                                                                         Annex VII to this Regulation." This means that even after 1 June 2015,
                                                                                                                                                                                                         the translation table can in principle be used where no data are available
                                                                                                                                                                                                         for "ordinary" CLP classification, see also chapter 1.7.2 of the guidance
                                                                                                                                                                                                         document, so no need for a change.

44   CONCAWE/CEFI Sections 4 and 5                                                                    one of the criteria for bioaccumulation potential is for a log Kow > 4. But there is no            #ECHA takes note of the comment. However, please note that neither
     C                                                                                                maximum value. hydrophobic chemicals with a log Kow > 7 do not bioaccumulate                       CLP nor the UN GHS foresee any 'maximum value' for a log Kow.
                                                                                                      effectively from water. Therefore the criteria should be a log Kow > 4 and < 7
45 CEFIC                   inappropriate reference                               103      10          replace http://webnet3.oecd.org/eChemPortal by http://www.echemportal.org/                         #Replaced.
46 CEFIC                   4.1.3.2.3.1                                           109           5      Delete /or                                                                                         #Deleted.
47 DE                      4.1.3.2.3.1                                           109      14          There is one comma too much. PLease leave out the comma after the word "substances".               #Deleted.

48   DE                    4.1.3.2.3.1                                           109      14          It should read (i.e. substances with a water solubility < 1 mg/l) instead of (water solubility <   #ECHA does not agree to the proposed changes as the current wording
                                                                                                      1 mg/l)                                                                                            is the same as used in the legal text (cf. Annex I, section 4.1.2.6, Note 4
                                                                                                                                                                                                         in the 2nd ATP to CLP). No changes are therefore required.
49   DE                    4.1.3.2.3.1                                           109      18/19    It should read "… and/or tests with a differing test duration could be used…"                         #Corrected.
50   DE                    4.1.3.2.3.1                                           109      24 to 27 This para does not relate very well to the text in this section.It should be left out.                #ECHA agrees to delete the paragraph as proposed.

51   CEFIC                                                                                                                                                                                               #ECHA does not agree to add a reference to a draft revised OECD
                                                                                                                                                                                                         guidance under this section of the guidance. However, a footnote has
                                                                                                      Reference can be done to the draft revised guideline 305 "Bioaccumulation in Fish:                 been added in the Annex related to Bioaccumulation stating the following:
                           4.1.3.2.3.3                                           113          33-40
                                                                                                      Aqueous and Dietary Exposure" which should be published in the near future.                        "Note that OECD 305 is currently under revision. All adopted OECD
                                                                                                                                                                                                         guidelines can be freely accessed via OECD iLibrary ."

52   NL                    Species                                               109      4           In this section an important interpretation is given that could be regarded to widen the           #ECHA takes note of this comment. The term organisms has been
                                                                                                      scope of the criteria in the CLP Regulation where fish, crustaceans and algae (or other            replaced by species in order to follow the legal text as implemented with
                                                                                 134      1           aquatic plants) are the three trophic levels to be considered. Here, in the guidance it is         the 2nd ATP to CLP. Consequently, the sentence reads as follows:
                                                                                                      stated that 'data on other organisms shall also be considered, provioded they represent            "Valid data for short- and long-term tests on other species at the same
                                                                                                      equivalent species...'. Other organisms in this respect literally means other than fish,           trophic level shall also be considered, … ."
                                                                                                      crustacea or algae (or other aquatic plant) species. The reader is left completely unclear
                                                                                                      here what is meant. Crustaceans are a representative taxa within the trophic level of
                                                                                                      (herbivorous) consumers (heterotrophs). In other words, it remains unclear what is meant
                                                                                                      with the term 'equivalent species'..
                                                                                                      See also example D on pp 134 where a Chironomid, an insect species is used in the
                                                                                                      classification dataset and as footnote 50 says 'representatives of other taxonomic groups
                                                                                                      than crustacea may be used...'. If such is the case, which is debatable since the legal text
                                                                                                      refrers specifically to Crustaceans as a taxonomic group, than this should be clarified in the
                                                                                                      main text of the guidance.
53   NL                    Difficult substances                                  109      12          It might be useful to provide more guidance on how ionisable compounds should be tested. #ECHA takes note of the proposal to provide more guidance on so-called
                                                                                                      The guidance document including Annex I is currently lacking more information on this.   'difficult substances', such as ionisable substances which could be
                                                                                                      Referal to the OECD TG document is advised.                                              considered in a future update of the CLP guidance document.

                                                                                                                                                                                                         As regards the referal to the OECD TG document please note that a
                                                                                                                                                                                                         reference is already made in the previous section 4.1.3.2.2 (Substances
                                                                                                                                                                                                         difficult to test), last para on page 108.

54   NL                    Bioaccumulation                                       113      29                                                                                                             #ECHA takes note of the proposal. The following text has been added:
                                                                                                                                                                                                         "For ionised organic substances problems may occur with e.g. changes
                                                                                                                                                                                                         in pH which may significantly affect the water solubility and partition
                                                                                                      It would also be useful to make reference to guidance on how to deal with
                                                                                                                                                                                                         coefficient of the substance. Further guidance on how to deal with such
                                                                                                      ionised organic substances, e.g. that the pH dependence of the Kow should be
                                                                                                                                                                                                         difficulties is provided in the OECD Guidance Document on aquatic
                                                                                                      investigated.
                                                                                                                                                                                                         toxicity testing of difficult substances and mixtures (OECD 2000)."
     Source (Organisation Topic (Section in version of text being referred to)   Page      Line      Comment                                                                                           Response (by ECHA - please leave blank)
     / Member State)                                                             number    number

55   NL                    Biomagnification                                      113       33-40                                                                                                       #The paragraph has been deleted in accordance with the proposal.
                                                                                                     It is mentioned that for very hydrophobic substances uptake from food becomes important,
                                                                                                     and therefore BMF and/or TMF values could be taken into account on a case-by case
                                                                                                     basis. Without further guidance this is very difficult to implement. This section should either
                                                                                                     be extended or deleted. Note that the remark '..criteria will need to be developed further.' is
                                                                                                     inappropriate for a guidance document and should be deleted.
56   CONCAWE/CEFI Section 4.1.3.2.4.3                                            115       32-38     Guidance is provided on determining a representative toxicity value when 4 or more reliable   #The use of a geometric mean for deriving a representative 'species
     C                                                                                               values are available for a given endpoint for a specific species (use of geometric means),    mean' when 4 or more reliable values are available is based on the
                                                                                                     but no guidance is provided for when 2 or 3 values are available. In either case, the use of  recommmendation . However, in order to follow the request for guidance
                                                                                                     a geometric mean could be suggested for when either 2 or 3 reliable values are also           for when 2 or 3 values are available, the following sentence has been
                                                                                                     available.                                                                                    added in the beginning of the paragraph:
                                                                                                                                                                                                   "Where more than one acceptable test is available for the same
                                                                                                                                                                                                   taxonomic group, the most sensitive (the one with the lowest L(E)C50 or
                                                                                                                                                                                                   NOEC/EC10) is generally used for classification. However, this must be
                                                                                                                                                                                                   dealt with on a case-by-case basis."
57   DE                    4.1.3.3                                               116 ff.   18 ff    Please write long-term or short-term throughout the document. In some places it is spelled #Replaced.
                                                                                                    long term or short term, e. p.118, line 3 and p. 119 first line in the box.
58   DE                    4.1.3.3.1                                             117       5 and 6 For better understanding, the sentence should be re-arranged to read as follows: " while        #The sentence has been re-written and the term removed.
                                                                                                    recognising that for packaged goods where environmental release would be limited in
                                                                                                    scope the long-term hazard represents the principal concern…" In fact the term "where
                                                                                                    environmental release would be limited in scope" could be left out.
59 CONCAWE/CEFI Section 4.1.3.3.1                                                118       5        Suggested rewrite: “….chronic data do not represent the species that is considered the         #Re-written.
   C                                                                                                most sensitive….”
60 CONCAWE/CEFI Section 4.1.3.3.1                                                118-      Annex I, Criteria only cite concentration endpoints and do not include loading endpoints (WAFs for      #Please note that the text in the green boxes reflects the legal text of the
   C                                                                             120       Table    UCVBs). This could be corrected by adding them to the table or adding a “Note” at the end 2nd ATP (which in turn is the text acc. to GHS) and thus, the proposed
                                                                                           4.1.0    of the table to identify their application for UVCBs and that the values should be considered changes can not be considered. However, a footnote has been added
                                                                                                    in line with the concentration criteria.                                                       under section 4.1.3.2.2.
61   NL                    Classification dataset (text below green box)         120       1-3      Referal to 'incomplete toxicity datasets' is incorrect since in CLP these can not exist except #ECHA agrees with the proposed changes. The sentence has been re-
                                                                                                    for physical hazards for which testing may be required. Proposal: 'Classification may also     written and the term 'provisional' was removed.
                                                                                                    be made in case data are not available on all three trophic levels.'.
                                                                                                    The term 'provisional' in 'provisional classification'this respect is also regarded as strange
                                                                                                    and we would prefer it to delete 'provisional'.

62   DE                    4.1.3.3.1                                             120       Note 1    Please delete the word "then" in the second sentence.                                             #Please note that the text in the green boxes reflects the legal text of the
                                                                                           in the                                                                                                      2nd ATP and thus, the proposed changes can not be considered.
                                                                                           box
63   CEFIC                 Classification categories for hazardous to the        page      Table     "Note 3" in this table states that "when no useful data on degradability are available, either    #ECHA does not agree with the comment. It is ECHA's understanding
                           aquatic environment                                   120       4.1.0     experimentally determined or estimated data, the substance should be regarded as not              that Note 3 of table 4.1.0 does neither exclude read across to other
                                                                                           Note 3    rapidly degradable". This appears to be a precautionary stance that doesn’t recognize the         substances nor does it prevent the application of e.g. (Q)SARs.
                                                                                                     importance of expert judgment, weight of evidence, alternative evidence, and use of read          Furthermore, since degradation is one of the standard information
                                                                                                     across. It is recommended that more guidance language is provided because such an                 requirements of Annex VII to REACH, it is unlikely that no useful data is
                                                                                                     assumption is likely to lead to significant overclassification or excessive testing when it is    available (or even that the wording leads to excessive testing).
                                                                                                     not necessarily scientifically justified.                                                         Finally, please note that the text in the green boxes reflects the legal text
                                                                                                                                                                                                       of the 2nd ATP (which is also in line with GHS).

64   NL                    Degradation products                                  121       8-22      It is mentioned that there may be occasions when a substance so tested may degrade to             #ECHA takes note of this comment. However, at this stage of the
                                                                                                     give rise to a more hazardous product. In these circumstances, the classification of the          process it is no longer possible to provide additional guidance but ECHA
                                                                                                     parent compound should take due account of the hazard of the degradation product, and             will take it further, as appropriate, in a future update of the guidance
                                                                                                     the rate at which it can be formed under normal environmental conditions. Though no               document.
                                                                                                     guidance is given how this should be done.
65   DE           4.1.3.3.2                                                      122       3         Please add "is assigned" after "category Chronic 4" at the end of the sentence.                   #Added.
66   CONCAWE/CEFI 4.1.3.3.3 Setting an M-Factor for highly toxic                 122       13 - 14   Proposed Action. Delete statement "It is important to also include that M-Factor(s) in the        #ECHA does not agree with the proposed action. Even though it is no
     C            substances                                                                         SDS as other users in the supply chain might need it, e.g. for classification of mixtures         requirement to include the M-factor(s) in SDSs, i.e. it is not literally
                                                                                                     containing that substance."                                                                       mentioned in the legal text, it is ECHA's understanding to inform on the
                                                                                                                                                                                                       importance of setting M-factor(s) for highly toxic substances. For this
                                                                                                     Explanation. The Legal requirements concerning the content of SDSs are defined in                 reason and for the fact that setting the M-factor(s) is part of the
                                                                                                     REACH Annex II and does not require M-Factors to be given in the SDS. The reference to            classification process the statement was included in the 'Guidance on the
                                                                                                     M-Factors in REACH Annex II is in the context of the disclosure criteria of hazardous             Application of the CLP criteria'. As such it should be understood as
                                                                                                     substances in section 3 of the SDS. It is inappropriate to introduce new requirements for         recommendation to include M-factor(s) in substance SDSs for the benefit
                                                                                                     SDSs in a guidance document focused on the Application of the CLP Criteria for physical,          of users who may need to derive classification for mixtures.
                                                                                                     health and environmental hazards.
     Source (Organisation Topic (Section in version of text being referred to)   Page     Line     Comment                                                                                          Response (by ECHA - please leave blank)
     / Member State)                                                             number   number

67   DE                    4.1.3.3.2                                             122      13 to 15 For better understanding, the sentence "It is important to also include the M-factor(s) in the #Considered.
                                                                                                   SDS as other users in the supply chain might need it, e.g. for classification of mixtures
                                                                                                   containing that substance." should be moved to be the last sentence in this para. In addition
                                                                                                   it should read "the M-factor(s)" instead of "that M-factor(s)".

68   ECETOC                4.1.3.3.3                                             122      24-27    It would be clearer to add that whenever the surrogate method is used for chronic                #This comment is taken into account and as a result the following
                                                                                                   classification, the M-factor derived for acute toxicity is also applied to the chronic           sentence was added: "In cases where chronic data is not available and
                                                                                                   classification.                                                                                  Table (a)(b, point iii) is used for defining long-term aquatic hazard, the
                                                                                                                                                                                                    resulting M-factor derived for acute aquatic toxicity is also applied to the
                                                                                                                                                                                                    chronic classification."

69   CONCAWE/CEFI Section 4.1.3.3.3                                              122      Annex I, Criteria only cite concentration endpoints and do not include loading endpoints (see above). #Please note that the text in the green boxes reflects the legal text of the
     C                                                                                    Table                                                                                                   2nd ATP (which in turn is the text acc. to GHS) and thus, the proposed
                                                                                          4.1.3                                                                                                   changes can not be considered. However, a footnote has been added
                                                                                                                                                                                                  under section 4.1.3.2.2.
70   CEFIC                                                                                                                                                                                        #ECHA takes note of this comment. However, at this stage of the
                                                                                          6-7 & 31- Neither guidance nor examples are provided for inorganic substances (other than metals        process it is no longer possible to provide additional guidance but ECHA
                           4.1.3.4                                               123
                                                                                             32     and metal compounds)                                                                          will take it further, as appropriate, in a future update of the guidance
                                                                                                                                                                                                  document.
71   ECETOC                Section 4.1.3.4.2 Example B                           128-     14-16     I am not sure this example is straight forward. The substance is readily biodegradable and #Biodegradation does not rule out high BCF. The given example
                                                                                 129                the BCF is based on total radioactivity, i.e. inculding metabolites. Furthermore the BCF is   demonstrates how the BCF data based on radiolabel only could be used
                                                                                                    very close to the cut off. I would expect in this case that the BCF of the substance is below in classification. It is also recommended elsehwere in the guidance (see
                                                                                                    500 and would not necessarily go for a chronic classification.                                Annex III 2.1.2.) and if analysis of the parent compound is not available,
                                                                                                                                                                                                  studies with radio labelled residues can be used.

72   CEFIC/NL                                                                                                                                                                                       #Corrected.
                           4.1.3.4.3                                             132         5     Typing mistake llog
73   CEFIC                                                                                                                                                                                          #Corrected.
                           4.1.3.4.3                                             132         13    Typing mistake Daphia -> Daphnia
74   ECETOC                Section 4.1.3.4.3 Example C                           133      13-17    Suggest to add that there is no long-term study available for the species/trophic level with  #The following sentence added (p. 135, row 12): In this example the
                                                                                                   the lowest acute toxicity value (Daphnia/crustacea). This strenghtens the argumet to go for absence of long-term study for the species/trophic level (i.e.
                                                                                                   the surrogate system.                                                                        Daphnia/Crustacea) with the lowest acute toxicity value supports using
                                                                                                                                                                                                the surrogate system.
75   CEFIC                                                                                                                                                                                      #ECHA agrees to the comment and the necessary changes have been
                                                                                                   In this example, Asellus aquaticus value is taken as the reference value for classification.
                                                                                                                                                                                                made.
                                                                                                   Test on this species is not standardized (and therefore is is unlikely to have GLP. This
                                                                                                   species seems to be a general outlier and is really more sensitive than others. The toxicity
                                                                                                   for this species seems thus not to be representative of the toxicity to invertebrates and is
                                                                                                   contradictory to the rule reported page 172 (lines 22-27): "Where the algal toxicity ErC50 [
                           4.1.3.4.4                                             134
                                                                                                   = EC50 (growth rate)] falls more than 100 times below the next most sensitive species and
                                                                                                   results in a classification based solely on this effect, consideration should be given to
                                                                                                   whether this toxicity is representative of the toxicity to aquatic plants. Where it can be
                                                                                                   shown that this is not the case, professional judgment should be used in deciding if
                                                                                                   classification should be applied."
76   DE                    4.1.4.1                                               142      6 and 7 The sentence should be left out. Double wording. It is the same first sentence as in the box      #Agree.
                                                                                                   underneath.
77   DE                    4.1.4.1                                               143      2        It should read "Horizontal arrow" instead of "Horizontal arrows".                                #Deleted 's'.
78   DE                    4.1.4.1                                               143      12 to 16 It should read: "In general, however, where either aquatic toxicity or classification data are   #The changes have been made as proposed.
                                                                                                   available for all relevant components of a mixture the aquatic hazard classification shall be
                                                                                                   made through the identification of the hazards of the respective components in a first
                                                                                                   step, and then in a second step through the summation of the quantities of these
                                                                                                   hazardous components, applying the summation method (see section 4.1.4.5. of this
                                                                                                   document)."
79   DE                    4.1.4.1                                               143      footnote For better understanding the sentence should read: "As manufacturers and importers are           #The proposed changes have been made (footnote 54).
                                                                                          52       obliged to classify all substances placed on the market within the EU, the summation
                                                                                                   method can usually be directly applied and the additivity formulas will be of limited
                                                                                                   application."
80   CEFIC                 Section 4.1.4.2                                       144               Generally, therefore, to derive the correct hazard classification for the final mixture the      #The proposed changes have been implemented.
                                                                                                   constituent substances classification should be used as basis.
     Source (Organisation Topic (Section in version of text being referred to)   Page     Line      Comment                                                                                          Response (by ECHA - please leave blank)
     / Member State)                                                             number   number

81   DE                    4.1.4.2                                               144      2 and 3 This first sentence, as it stands, seems to contradict was was said before on page 143,            #The sentence has been added.
                                                                                                  where the tiered approach is explained. Therefore, a first sentence should relate to step 1
                                                                                                  of the tiered approach, relating to the case if test data for the mixture as a whole is
                                                                                                  available. This first sentence should read: "Before a classification can be made, possibly
                                                                                                  available information on toxicity of the mixture as a whole as well as all the available
                                                                                                  information on the compostion ..."
82   NL                    overclassificating mixtures                           144      8       It is not true to state that it is not possible to derive the correct hazard classification when   #See response to comment no. 76 (Cefic).
                                                                                                  combining classified mixures. We prefer that it is clarified here that one runs the risk of
                                                                                                  over classifying when doing so.
83   NL                    Components of mixtures                                144      10      Without further explanation the last sentence of second paragraph "Generally, therefore,           #The sentence has been deleted.
                                                                                                  components are substances" has no meaning and can be deleted.
84   CEFIC                                                                                                                                                                                           #See response to comment no. 76 (Cefic).
                           4.1.4.2                                               144        8-11    Clarification is needed
85   ECETOC                Section 4.1.4.2                                       144      10-11     Generally, therefore, to derive the correct hazard classification for the final mixture the      #Corrected as proposed.
                                                                                                    constituent substances classification should be used as basis.
86   CEFIC                 4.1.4.2                                               144      24, 25,   Quoted text: "Note that generic concentration limits (GCLs) should be given in weight         #This has been corrected.
                                                                                          26        percentages except for certain gaseous mixtures where they may be best described in
                                                                                                    volume percentage, e.g. a single hazardous component in an inert diluent, e.g. nitrogen or
                                                                                                    helium." Comment from EIGA: For a gas mixture expressed in volume %, the classification
                                                                                                    will not vary if the same quantity (= the same number of moles) of active substance(s) is
                                                                                                    diluted in environmentally inert gases of different molar masses. If the mixture is expressed
                                                                                                    in w/w %, the classification of the same quantity of active substance(s) may vary if diluted
                                                                                                    in a gas with a low or a high molar weight; e.g. MW helium=4 or MW argon=44. The laws of
                                                                                                    physics applies to all mixtures and not to certain and not only for binary mixtures. EIGA
                                                                                                    proposes to make the note more generic and to align the wording to what has become the
                                                                                                    note to Table 1.1 with the 2nd ATP: Note that generic concentration limits (GCLs)
                                                                                                    should be given in weight percentages except for gaseous mixtures where they may
                                                                                                    be best described in volume percentage (see CLP, Annex I, Note to Table 1.1).

87   CEFIC                                                                                         This remark is also true for UVCB and multicomponent substances but it is mandatory to       #ECHA takes note of this comment.
                           4.1.4.3                                               145        3-11
                                                                                                   perform tests on this kind of complex substances.
88   DE                    4.1.4.3                                               145      9        For better understanding, it should read "Therefore, before such new testing has to be can #ECHA proposes to phrase "… before such new testing is conducted"
                                                                                                   be conducted…"
89   CONCAWE/CEFI Section 4.1.4.3                                                145-     Annex I, Criteria only site concentration endpoints and do not include loading endpoints (see above). #Please note that the text in the green boxes reflects the legal text of the
     C                                                                           146      4.1.3.3.                                                                                              2nd ATP (which in turn is the text acc. to GHS) and thus, the proposed
                                                                                          3-4                                                                                                   changes can not be considered. However, a footnote has been added
                                                                                                                                                                                                under section 4.1.3.2.2.
90 CONCAWE/CEFI Section 4.1.4.3                                                  146               References within page are only concentration endpoints and not loading endpoints (see       #A footnote has been added in the core part of the guidance document
   C                                                                                               above).                                                                                      (section 4.1.3.2.2).
91 CEFIC                                                                                           Quid of the substances that cannot be tested pure (e.g. organic peroxides that need to be #ECHA takes note of this remark.
                4.1.4.3                                                          146         1-9
                                                                                                   stabilised)
92   CONCAWE/CEFI 4.1.4.5 When hazard data (information on toxicity or 147                15 - 18 Propose Action: Reword sentence "These data and any associated M-factor(s) are                #ECHA does not agree with the proposed action. Even though it is no
     C            classification) are available for all the components of                          included in the Safety Data Sheets (SDS) and also in the Classification and Labelling        requirement to include the M-factor(s) in SDSs, i.e. it is not literally
                  the mixture                                                                      Inventory (C&L Inventory) established and maintained by the Agency in the form of a          mentioned in the legal text, it is ECHA's understanding to inform on the
                                                                                                   database [link to be added once the public Inventory is available]." to " These data are     importance of setting M-factor(s) for highly toxic substances. For this
                                                                                                   included in the safety Data Sheets (SDS) and also in the Classification and Labelling        reason and for the fact that setting the M-factor(s) is part of the
                                                                                                   Inventory (C&L Inventory) which also includes any associated M-Factors. The C&L              classification process the statement was included in the 'Guidance on the
                                                                                                   inventory is established and maintained by the Agency in the form of a data base [link to be Application of the CLP criteria'. As such it should be understood as
                                                                                                   added once the public Inventory is available]."                                              recommendation to include M-factor(s) in substance SDSs for the benefit
                                                                                                                                                                                                of users who may need to derive classifications for mixtures.
                                                                                                   Explanation. See comment related to page 122 line 13 -14.

93   ACEA                  Eliminate sentence                                    149      15-17     Eliminate this sentence because it refers to a regulation text which is now not anymore in       #The sentence is as valid as before. Additivity formula does not have the
                                                                                                    compliance with the 2nd ATP of CLP. Additivity formula does have the same priority as            same priority as summation method. The 2nd ATP of CLP (see section
                                                                                                    summation method. The sentence according to CLP Section 4.1.3.5.2 is not anymore                 4.1.3.5.1) stipulates "The classification of a mixture is based on
                                                                                                    existing.                                                                                        summation of the concentration of its classified components. The
                                                                                                                                                                                                     percentage of components classified as...is fed straight in to the
                                                                                                                                                                                                     summation method"; also section 4.1.3.5.2 states "Mixtures can be made
                                                                                                                                                                                                     of a combination of both components that are classified... and others for
                                                                                                                                                                                                     which adequate toxicity test data is available" that means the priority is
                                                                                                                                                                                                     given to summation method. This was thoroughly discussed by the
                                                                                                                                                                                                     expert group drafting the guidance. Therefore, no changes were made in
                                                                                                                                                                                                     this part.
      Source (Organisation Topic (Section in version of text being referred to)   Page     Line          Comment                                                                                        Response (by ECHA - please leave blank)
      / Member State)                                                             number   number

 94   CONCAWE/CEFI Section 4.1.4.5                                                150      Annex I, Calculations only cite the use of data from concentration endpoints and do not include data #ECHA takes note of this comment. However, please note that the text in
      C                                                                                    4.1.3.5. from loading endpoints (see above).                                                         the green boxes reflects the legal text of the 2nd ATP (which in turn is the
                                                                                           2                                                                                                    text acc. to GHS) and thus, the proposed changes cannot be considered.

 95   CONCAWE/CEFI Precautionary statements                                                              Are these labelling requirements ? Signal word and hazard statement text clearly state" the #The following sentence has been added in the beginning of section
      C            3 The precautionary statements (and the                                               label shall include signal word (or hazard statement) ...", but this section does not. Should 4.1.6: "In accordance with CLP Articles 17 and 22 the label shall include
                   Precautionary statement Codes) relevant for the                                       be added that this does or does not go on label.                                              the relevant precautionary statements."
                   hazard
                   4 class Hazardous to the Aquatic Environment are:
                   5 - Avoid release to the environment (P273)
                   6 - Collect spillage (P391)
                   7 - Dispose of contents/container to … (P501)

 96   ACEA                  Eliminate or modify sentence                          151      4 -7          Modify or eliminate because additivity does have same priority as summation method.        #See the reply No 93. Additivity formula does not have the same priority
                                                                                                         NOTICE: With the aquatic toxicity data at one hand the ingredient substance classification as summation method.
                                                                                                         and M-factor(s) could easily be gained by a direct comparison with the substance criteria,
                                                                                                         which then could be fed straight into the summation method. It will therefore usually not
                                                                                                         be necessary to use the additivity formula.

 97   DE                    4.1.4.6                                               151      9      Please delete one "only" in the heading.                                                              #Deleted.
 98   ACEA                  Eliminate Footnote 54                                 163      Exampl Eliminate Footnote 54, because additivity does have same priority as summation method                 #ECHA does not agree to delete the footnote (see comments above).
                                                                                           eD

 99   CEFIC                                                                                                                                                                                             #CLP, section 4.1.3.5.3 states when toxicity data for each component are
                                                                                                                                                                                                        not available in the same taxonomic group, the toxicity value of each
                                                                                                                                                                                                        component is selected in the same manner that toxicity values are
                                                                                                                                                                                                        selected for the classification of substances. Therefore, since in the
                                                                                                         When applying additivity method, why is it done by each trophic level for chronic toxicity and
                            4.1.4.7.5                                             164                                                                                                                   example acute toxicity data on algae only are available for the
                                                                                                         not for acute?
                                                                                                                                                                                                        components of the mixture (in contrast to chronic toxicity data where a full
                                                                                                                                                                                                        dataset is available for both components) the approach taken was to
                                                                                                                                                                                                        select the most sensitive species for each component.

100   CEFIC                 4.1.4.7.5                                             164          12        M factor should be 10 and not 1 (supposed not to be RB)                                      #Corrected.
101   CEFIC                                                                                                                                                                                           #ECHA takes note of this comment and will take it further, as appropriate,
                                                                                                         "Specific guidance has been issued by the European Chemicals Agency on how these data
                                                                                                                                                                                                      in a future update of the guidance document.
                                                                                                         for such substances may be used in meeting the requirements of the classification criteria.”
                                                                                           Green
                            4.1.5                                                 165                    Where is the guidance document for inorganic compounds? See also p179 lines 22-24
                                                                                           box (*)
                                                                                                          No guidance is available with regard to classification of inorganics for bioaccumulation or
                                                                                                         degradation.
102   CEFIC                 Table 4.1.6                                           167      1             H410 is proposed to appear on the label of substances that are classified with "Acute 1 and #ECHA would prefer to consult CARACAL on this later on in the
                                                                                                         Chronic 2", "Acute 1 and Chronic 3" as well as "Acute 1 and Chronic 4", respectively.       consultation process.
                                                                                                         This appears overly conservative and would lead to a significant number of labels
                                                                                                         suggesting a more severe hazard than actually is the case. With respect to labeling, the
                                                                                                         long-term hazard seems more relevant than acute effects are and should therefore receive
                                                                                                         more emphasis. Hence, it is proposed to assign the following H statemtents to substances
                                                                                                         classified as
                                                                                                         "Acute 1 and Chronic 2" => H411
                                                                                                         "Acute 1 and Chronic 3" => H412
                                                                                                         "Acute 1 and Chronic 4" => H413

103   CEFIC                                                                                                                                                                                             #Note the information provided in Annex V to the guidance document.
                            I.2                                                   171      12-14         check completeness of references page 178
104   CEFIC                                                                                                                                                                                           #ECHA takes note of this comment and therefore the following
                                                                                                         21 days is OK for Daphnia magna but other daphnid species as Ceriodaphnia dubia can be information has been added:
                                                                                  172                2
                                                                                                         tested for reproduction in 7 days                                                            "For daphnids, in particular Daphnia magna, 21 days is sufficient for
                                                                                                                                                                                                      maturation… ."
105   ECETOC                 Section 1.3.2 (of Annex I)                           174      11-16         b) in cases where data on 2 trophic levels are available and there is evidence that the most #The last sentence in section 1.3.2 of Annex I is replaced with the
                                                                                                         sensitive species in acute tests was covered, or there is no evidence of a considerable      following: "In cases where the chronic data do not represent the species
                                                                                                         difference between trophic levels, it should be possible to use the chronic data as well.    that is considerd the most sensitive in available short-term tests, the final
                                                                                                                                                                                                      classification shall be made according to the most stringent outcome."

106   CEFIC                                                                                                                                                                                             #ECHA takes note of the remark. No changes are deemed necessary.
                            I.3.3                                                 174               19 For algae test only batch cultures (static tests) can be carried out
      Source (Organisation Topic (Section in version of text being referred to)   Page     Line     Comment                                                                                           Response (by ECHA - please leave blank)
      / Member State)                                                             number   number

107   CONCAWE/CEFI I.4.2 Poorly soluble substances....(a) where the      176                        This needs to state the water solubility as < 1mg/L in order to satisfy Acute , Chronic           #ECHA takes note of the comment. However, the level of water solubility
      C            acute toxicity is recorded at levels in excess of the                            classification assignment                                                                         for substances considered being poorly soluble is already provided in the
                   water solubility,                                                                                                                                                                  first sentence of this section (on top of that a definition is also provided in
                   22 the L(E)C50 for classification purposes may be                                                                                                                                  the core part of the guidance, cf. Note 4 on page 125). Therefore, no
                   considered to be equal to or below the                                                                                                                                             changes are deemed necessary.
                   23 measured water solubility. In such circumstances
                   it is likely that category Chronic 1
                   24 and/or category Acute 1 should be applied.

108 CONCAWE/CEFI where chronic toxicity data are available, the same 176                            Text needed to clarify that a 'no observable effect treatment of 1mg/L must be                    #Text modified to provide more clarity.
    C            general rules should apply.                                                        proven/justified by statistical assement of test data if needed'. If effects were observed
                 43 In principle, only data showing no effects at the                               above 1 (ie, 1.2) mg/L , and can't be extrapolated to no effects at the 1 mg/L criteria, then
                 water solubility limit, or greater than                                            chronic classification can not be eliminated.
                 44 1 mg/l need be considered.
109 CONCAWE/CEFI I.4.5 Complex substances For this reason, such        177                          Reporting of L(E)C50 values is NOT recommended, endpoint effects are reported solely as #A footnote has been added in the core part of the guidance document
    C            complex substances are usually tested as a WSF or                                  L(E)L50 results. Strongly advise that L(E)L50 endpoint be added to ALL tables and       (section 4.1.3.2.2).
                 WAF,                                                                               decision flow charts for classsification.
                 39 and the L(E)C50 recorded based on the loading
                 or nominal concentrations..... The toxicity parameter
                 is sometimes referred to as LL50, related to the
                 lethal
                 42 loading level. This loading level from the WSF or
                 WAF may be used directly in the
                 43 classification criteria.
110 CEFIC                                                                                                                                                                                             #ECHA takes note of the comment. Please note that the current text
                                                                                                                                                                                                      follows the guidance provided in the 3rd revision of the GHS.
                                                                                                    Paragraph is not clear and not enough detailed.
                            I.4.4                                                 177       20-26                                                                                                     Apart from that examples could be considered in a future revision of the
                                                                                                    Give examples e.g. Ammonium Sulfate vs Sulfuric acid or Acetic acid vs Sodium acetate
                                                                                                                                                                                                      guidance document. For this reason ECHA kindly invites to provide
                                                                                                                                                                                                      examples for all difficult to test substances, as appropriate.
111   CEFIC                                                                                                                                                                                           #ECHA takes note of this comment, however, please note that the current
                                                                                                                                                                                                      text follows the guidance provided in the 3rd revision of the GHS.
                                                                                                    It is not sufficient to state that for inorganic substances the concept of degradability has no   Therefore ECHA kindly advises, if it is considered relevant and
                            II.1                                                  179      18-26    meaning: should all inorganics considered as "rapidly degradable" in the classification           proportionate, putting this comment forward to the UN Sub-Committe of
                                                                                                    scheme?                                                                                           experts on the GHS for further consideration. Subsequently this can be
                                                                                                                                                                                                      taken up in a future update of the CLP guidance document.

112   CEFIC        II.2.3.1                                              181               36       Provide reference of standardised test: OCDE 309                                                  #Reference has been added.
113   CONCAWE/CEFI II.2.3 Other convincing scientific evidence The       181                        Not proven that 1st order kinetics would apply to UVCBs/complex substances with                   #ECHA takes note of this comment. Please consider that section II.2.3
      C            fulfilment of criterion (c) of paragraph 4.1.2.9.5 of                            restricted solubility/bioavilability at test concentrations. Recommend ading cavaet to            gives a general overview on the interpretation of biodegradability data
                   CLP requires that the substance is                                               explain.                                                                                          whithout any reference to specific substances. Whereas section
                   17 degraded in the aquatic environment to a level of                                                                                                                               II.3.1describes general interpretation problems of complex substances in
                   > 70 % within a 28-day period. If first-order                                                                                                                                      particular. Hence, the cross-reference in section II.3.1 (last sentence) has
                   18 kinetics are assumed, which is reasonable at the                                                                                                                                been deleted.
                   low substance concentrations prevailing in
                   19 most aquatic environments, the degradation rate
                   will be relatively constant for the 28-day
                   20 period.

114   CONCAWE/CEFI II.2.3.11 Volatilisation....Because volatilisation only 184                      Unclear-guidance needs to clarify if gases should be classified for the environment or are        #ECHA takes note of the comment. As a consequence the last sentence
      C            represents removal of a chemical from the water                                  exempt under specific criteria                                                                    in Section II.2.3.11 has been deleted. However, there is seemingly no
                   phase, and not                                                                                                                                                                     statement in the legislation which would justify a statement that gases
                   33 degradation, the Henry's Law constant cannot be                                                                                                                                 should be exempted from the aquatic classification in certain cases.
                   used for assessment of degradation in
                   34 relation to aquatic hazard classification of
                   substances. Substances that are gases at ambient
                   35 temperature may however for example be
                   considered further in this regard
      Source (Organisation Topic (Section in version of text being referred to)   Page     Line      Comment                                                                                             Response (by ECHA - please leave blank)
      / Member State)                                                             number   number

115   CEFIC                                                                                                                                                                                    #ECHA takes note of the comment. While it is understood that for
                                                                                                                                                                                               inorganic substances no default exists like for organic substances and no
                                                                                                     Any guidance in the case of inorganics where Kow cannot be applied? should all inorganics data requirements for bioaccumulation apply (cf. REACH, Annex VII and
                            III.1                                                 189      10                                                                                                  indirectly Annex IX) ECHA would like to encourage industry to provide
                                                                                                     considered with no potential to bioaccumulate in the classification scheme?
                                                                                                                                                                                               guidance on this particular issue, which could then be considered in a
                                                                                                                                                                                               future update of the guidance document.
116   CONCAWE/CEFI Experimental BCF data on highly lipophilic             190                        Ambiguous guidance regarding substances with LogKow >6. Guidance should at least citee              #The current CLP Criteria for bioaccumulation have a threshold value for
      C            substances (e.g. with log Kow above 6) will have                                  REACH criteria for cut-off of bioaccumulation potential in REACH PBT critieria for 'B'              BCF ≥ 500 or a logKow ≥ 4 is not available. Therefore, the referred PBT
                   39 a higher level of uncertainty than BCF values                                  (Chapter 11) , Appendix R. 11-1: Indicators for limited bioconcentration for PBT                    criteria differ from the CLP criteria and cannot be used directly for
                   determined for less lipophilic substances. For                                    assessment, a number of factors can be used to rate a substance as having 'low potential            classification. Further to this, the high log Kow values have higher
                   40 highly lipophilic substances, e.g. with log Kow                                to bioaccumulate', including a log Kow >10                                                          uncertainty to predict bioaccumulation. This approach should be treated
                   above 6, experimentally derived BCF values                                        Text actually states:"Used within a weight of evidence approach and with expert judgment ,          on a case-by-case basis since it is not possible to give reliable guidance
                   41 tend to decrease with increasing log Kow.                                      a chemical may be considered as not B (i.e. unlikely to have a BCF > 2,000) using the               on applicability of high logKow values for classification purposes.
                   Conceptual explanations of this non-linearity                                     following types of evidence:
                   42 mainly refer to either reduced membrane                                        1. An average maximum diameter (Dmax aver) of greater than 1.7 nm plus a molecular
                   permeation kinetics or reduced biotic lipid solubility                            weight of greater than 1100
                   43 for large molecules. A low bioavailability and                                 2. a maximum molecular length (MML) of greater than 4.3 nm
                   uptake of these substances in the organism will                                   3. Octanol-water partition coefficient as log10 (log Kow) > 10
                   44 thus occur. Other factors comprise experimental                                4. a measured octanol solubility (mg/l) < 0.002 mmol/l × MW (g/mol) (without observed
                   artifacts, such as equilibrium not being                                          toxicity or other indicators of bioaccumulation)
                   45 reached, reduced bioavailability due to sorption
                   to organic matter in the aqueous phase, and
                   46 analytical errors.



117   CEFIC                 Upper bound for LogP/LogKow                           page     line 38   The language recognizes that BCF values decrease with increasing logKow above 6                     #See response to comment no. 110 (CONCAWE).
                                                                                  190                however it does not provide an upper bound cutoff of concern. The state of the science on
                                                                                                     logKow and BCF support a specific range of concern that includes both lower and upper
                                                                                                     cutoffs when using logKow to predict BCF potential. It is recommended that an upper
                                                                                                     bound cutoff of concern is provided in the guidance regarding CLP.

118   NL                    BCF in different test species                         191      4-14      It might be useful also to indicate that the use of small young fish also introduces the            #This comment is taken into account and the following text is included
                                                                                                     problem of growth dilution which if not accounted for could underestimate the BCF value.            under 1st paragraph, section III.2.1.1:
                                                                                                                                                                                                         "Also possible growth dilution should be taken into account when
                                                                                                                                                                                                         calculating the BCF values for smaller fish that grow during the
                                                                                                                                                                                                         bioconcentration studies."
119   NL                    BMF                                                   193      4-28      Referal to the use of BMF data in the classification scheme as stated in the introduction is        #ECHA agrees to delete paragraph III.2.2.3 specifically dealing with BMF.
                                                                                                     agreed (it is not recommended….).
                                                                                                     However, the paragraph III.2.2.3 specifically dealing with BMF should be deleted since it is
                                                                                                     not relevant for classification purposes and could cause unwanted confusion and
                                                                                                     inappropriate use. Especially since it is stated that ' ...an indication of a biomagnification is
                                                                                                     indicative of the potential to bioaccumulate for classification purposes.'.

120   CEFIC                 III.2.2.3                                             193          18    Typing error predater -> predator                                                                   #Irrelevant as the respective paragraph has been deleted.
121   CEFIC                 Software programs for the estimation of logKow        page     Table     Is the list of software programs for the estimation of logKow an exclusive/approved list or is      #The heading of Table III.2.2.2 has been modified and reads now:
                                                                                  193      III.2.2.2 it just an example of potential resources ? Other programs of potential use for estimation of       " Examples of software programs for the estimation of…"
                                                                                                     logKow include OECD Toolbox, CAESAR, and Accelrys
122   CEFIC                 High molecular weight substances                      page               Section III.3.3 recognizes the importance of molecular weight and its use to predict                #ECHA does not agree with the proposed text but prefers keeping the
                                                                                  195                bioconcentration potential however it does not reference a value specific MW value or               reference to relevant parts of already existing guidance (cf. IR/CSA,
                                                                                                     range of values. Instead, it references ECHA R11 guidance that present two cutoff values            Chapter R.11, ECHA 2008).
                                                                                                     for molecular weight with regard to bioconcentration potential and links them with BCF
                                                                                                     cutoff values that are different than CLP (i.e., R11 guidance states that a MW higher than
                                                                                                     1,100 g/mol is an indication that the aquatic BCF is lower than 2,000 L/kg and a MW higher
                                                                                                     than 700 is an indicator that the BCF is below 5,000). It is recommended that more
                                                                                                     guidance language is provided on specific high MW cutoffs for BCF with regard to CLP.
      Source (Organisation Topic (Section in version of text being referred to)    Page     Line     Comment                                                                                         Response (by ECHA - please leave blank)
      / Member State)                                                              number   number

123   CONCAWE/CEFI III.3.3 High molecular weight substances A number                                 Why not cite the actual text (see cell) above and give example to show application              #See response to comment no. 116 (Cefic).
      C            of regulatory systems use molecular weight as an
                   indicator for reduced or minimal
                   6 bioconcentration. It is, however, concluded in
                   IR/CSA (R.7C) 2008, Chapter 7.10.3.4 that
                   7 molecular mass and size should not be used in
                   isolation as confirmatory evidence of lack of
                   8 bioaccumulation (ECETOC 2005). However,
                   supported by other data and by employing
                   9 expert judgement, it may be concluded by a
                   weight of evidence argument that such
                   10 substances are unlikely to have a high
                   bioconcentration factor (regardless of the log Kow
                   11 value). More details can be found in PBT
                   assessment guidance (IR/CSA (R.11) 2008).

124   CEFIC                                                                                                                                                                                          #Updated.
                            IV.1                                                   199           5   Reference OECD 1998 is outdated, replace by the reference of 2001 (OECD series no 33)
125   DE                    section IV.1, 9th paragraph                            200      39       Please shift the comma from "… in this respect because, partitioning …" to "… in this           #Proposed correction implemented.
                                                                                                     respect, because partitioning …"
126   CEFIC                 IV1. Introduction                                      201      21       Please delete the word "therefore" give no connection with the previous paragraph or            #The entire sentence was deleted but added to the sentence in lines 9 to
                                                                                                     sentence.                                                                                       10, as follows:
                                                                                                                                                                                                     "Within the context of this guidance document, metals and metal
                                                                                                                                                                                                     compounds are characterised as follows , and therefore organo-metals
                                                                                                                                                                                                     are outside the scope of this section: "
127   CEFIC                 IV.2.1. Interpretation of aquatic data                 201      37       Please add "and metals" given that poorly soluble metal compounds and metals do both            #Proposed addition considered.
                                                                                                     not require moluecular weight correction.
128   CEFIC                 IV.2.1                                                 201         41    Delete dot after ion                                                                            #Proposed correction implemented.
129   CEFIC                 IV.2.2.2 Screening T/D test for assessing solubility   204      9-23     The validity of the 24h screening test for assessing if metal compounds hazard ID should        #ECHA does not see the need to amend the 24 Screening test conditions
                            of metal compounds                                                       be assessed as a poorly soluble metal compound or as a soluble metal compounds can be           based on the fact that categories Acute 2 and 3 are not implemented in
                                                                                                     questioned under the EU scheme. Indeed this screening test which is included in the UN          CLP. In contrast, this would lead to discrepancies between EU and other
                                                                                                     text was aimed for distinguishing the TDp kinetics at a 100 dosis under worst case              countries having implemented categories Acute 2 and 3. The high loading
                                                                                                     conditions given the cut of for acute 3 is 100 mg/l. However, Acute 3 and 2 does not exist in   rate of 100 mg/l was chosen in combination with a short duration (only 24
                                                                                                     the EU system but the screening test conditions were not amended accordignly. There             hours) although knowing that categories Acute 2 and Acute 3 are not
                                                                                                     exist as a consequence of this a significant discrimination between metals that are             normally used when considering packaged goods, but meant for transport
                                                                                                     assessed for acute toxicity at a maximal level of 1 mg/l and metal compounds that are           of bulk quantities. See also para A9.2.1 (Scope) on page 474-475 in the
                                                                                                     initially screened at 100 mg/l. It is therefore proposed for EU purposes to change the          fourth revised edition of the GHS document.
                                                                                                     loading for the screening test for metal compounds to 1 mg/l to ensure equal assessment         However, if a general amendment of the Screening test for metal
                                                                                                     and providing full recognition to the different EU acute scheme.                                compounds at UN elvel is proposed, ECHA recommends forwarding this
                                                                                                                                                                                                     via a representative at UNSCE GHS for consideration in the next
                                                                                                                                                                                                     biennium.
        Source (Organisation Topic (Section in version of text being referred to)    Page     Line      Comment                                                                                            Response (by ECHA - please leave blank)
        / Member State)                                                              number   number

129.1   CEFIC                 IV.2.2.2 Screening T/D test for assessing solubility   204      9-23      Comment from CEFIC concerning the Guidance on the Application of the CLP Criteria after #ECHA reply on Consolidated ENV PEG Comment N. 129:
                              of metal compounds                                                        ECHA consolidated ENV PEG Comments were presented on 20.10.2011:


                                                                                                                                                                                                           The screening test with a loading of 100 mg/l has not only been applied
                                                                                                        The issue of the relevancy of the 24 h Transformation dissolution screening test is an             under GHS but was extensively used already in the nineties for the EU
                                                                                                        important issue which we believe was not fully grasped in the RESPONS to comments. We              harmonized classification by the EU Commission. The strategies and
                                                                                                        therefore provided hereunder more explanation and justification followed by an example to          tests described by the EU included the 24 hour screening test for metal
                                                                                                        demonstrate the issue and its importance. In addition we propose 3 possible equivalent             compounds with a loading of 100 mg/l, despite the fact that there were no
                                                                                                        options for corrections and would consequently like to ask particularly to reconsider the          classification categories that corresponded to GHS Acute 2 and 3.
                                                                                                        issue and recognize the EU relevance of the comment.

                                                                                                        The 24h screening test for assessing metal compounds is indeed included in the UN GHS
                                                                                                        system and assesses if metal compounds (excluding metals in the metallic form) should be           Hence, the aquatic toxicity testing of the soluble forms is not related to
                                                                                                        classified accordingly to the classification of the soluble form, or allow to conduct further      any loading but to the actual concentration in the water and the Screening
                                                                                                        transformation dissolution testing to establish the kinetics and equilibrium that could classify   test in the metals strategy should be compared to the energy input which
                                                                                                        it as an acute 2, 3 or no classification under the GHS scheme.                                     normally could be used to realize the maximum solubility before
                                                                                                                                                                                                           conventional testing.
                                                                                                        The GHS/CLP 24h steering test uses worst case conditions in respect to loading (100 mg/l)
                                                                                                        and especially the stirring conditions (200 Industry). Experience as well as dissolution
                                                                                                        kinetic knowledge demonstrated that not the timing but the testing conditions determine the
                                                                                                                                                                                                    The 100 mg/l loading should not be connected with GHS aquatic hazard
                                                                                                        worst case nature of the test. For clarification, industry would not like to use the opportunity
                                                                                                        of the review and update of the CLP guidance, to contest the relevance of the Screening     categories Acute 1 to 3. One could of course see a connection between
                                                                                                        test under GHS. We agree in this respect that this can only be done at the appropriate      the loading of 100 mg/l as a worst case scenario, not necessarily to the
                                                                                                        OECD/UN level.                                                                              Acute 3 classification but this cut of is also found in the surrogate system
                                                                                                                                                                                                    where acute toxicity together with bioaccumulation and/or lack or rapid
                                                                                                        The challenge caused by the CLP in respect to this issue is that acute 2 and acute 3 do not degradation (transformation) form the classification for long-term aquatic
                                                                                                        exist so that the obligatory screening test for metal compounds becomes being               hazard into categories Chronic 1-3 (N; R50-53; N; R51-53; R52-53).
                                                                                                        discriminatory for series of metal compounds in comparison with metals in the metallic form
                                                                                                        or organics for which the WAF approach was used. The example below tries to explains
                                                                                                        this :

 130    CEFIC                 IV.2.2.3                                               204           27   Example dot soluble ion toxicity 0,4 mg/l. The soluble forms are therefore classified as
                                                                                                        Delete a 1 :                                                                                       #Proposed correction implemented.
 131    CEFIC                 IV.2.2.3 Full TD test                                  204      29        Please add for clarity reasons "acute" each time before the 3 acute loadings for the TDp           #ECHA has added the following information to the paragraph of concern:
                                                                                                        test mentioned.                                                                                    "… after 7 days (short-term test) for each of the three loadings… ." "…
                                                                                                                                                                                                           extended to 28 days (long-ter test)."

 132    CEFIC                 IV.2.3 Comparison of aquatic toxicity data and         205      1-17      This section provides guidance on how to compare between effects data and solubility data          #The introductory section of Annex IV , 1st paragraph, clearly outlines the
                              solubility data                                                           so in case of "metals" and "poorly metal compounds". No guidance is provided for "soluble          scope of the hazard classification scheme for metals and metal
                                                                                                        metal salts" or the "soluble metal ion". It can consequently be assumed that the generic           compounds. As a consequence it is also understood that section IV.2.3
                                                                                                        guidance would apply in case of "soluble metal ions". In addition this subdivision in pH           covers both "soluble metal salts" or the "soluble metal ion". However,
                                                                                                        classes (high and low) is only relevant if the toxicity is influenced by the pH. This is often     section IV2.3 does not apply to soluble metal compounds, since the
                                                                                                        (e.g. Zn, Ni, Cu, ...) but not always the case for metals (e.g. Cd, ...). These two issues can     strategy to compare aquatic toxicity data and solubility data is not used
                                                                                                        be resolved by adding the following two paragraphs : "3) for soluble metal salts/ions the          for them. Soluble metal compounds are classified direcly based on the
                                                                                                        same ruling applies as under 1) and 2) what the effects data concerns" and "4) no                  toxicity of the metal ion corrected for its moleculer weight.
                                                                                                        distinction in pH classes should be required if the toxicity was not significantly influenced by
                                                                                                        pH"

 133    DE                    section IV.2.3, 2nd paragraph                          205      5-10      For metals/metal compounds, where only a limited data set is available, all existing data          #ECHA agrees to the proposed changes. The sentence was rephrased
                                                                                                        should be used for classification irrespective of whether they were obtained at the same           and reads now as follows:
                                                                                                        pH. It is said, that the lowest data point should give the basis for classification. Does this     "This default approach may lead to the lowest toxicity data point
                                                                                                        only refer to toxicity data? If so, which data point should be selected for the dissolution        compared with the highest Transformation Dissolution result each
                                                                                                        data? In order to perform a conservative hazard assessment the highest dissolution value           derived at different pH levels used for the purposes of classification. "
                                                                                                        should be used together with the lowest toxicity data point as a default approach. Please
                                                                                                        specify this point. We would suggest to rephrase this as "... and the lowest data point for
                                                                                                        toxicity and the highest data point for dissolution should give the basis for classification."

 134    DE                    section IV.3, 3rd paragraph                            205      35-38     In the current guidance detailed instruction is given for the use of laboratory tests,             #The environmental expert group updating the guidance document has
                                                                                                        mesocosm studies and field data. This instruction is missing in this draft version and there       decided to delete this part of the text in section IV.3. Please see also the
                                                                                                        is no reference where further guidance can be found. Please explain why this text was              response to comment no.129 (NL) below.
                                                                                                        removed. It is not clear to us. In fact we would favour to keep it. From our point of view it
                                                                                                        would be better to have precise guidance. Please state clearly what tests are meant and
                                                                                                        give guidance for interpretation.
      Source (Organisation Topic (Section in version of text being referred to)   Page     Line       Comment                                                                                                 Response (by ECHA - please leave blank)
      / Member State)                                                             number   number

135   NL                    Removal of metals from the water phase                205      35-38      The drafting group of the chapter on metals intensively discussed the issue of rapid                    #ECHA takes note of this comment. As there is no scientific consensus
                                                                                                      removal from the water, as a surrogate for rapid degradation, without coming to an                      on this matter for the time being, the ECHA Secretariat has decided to
                                                                                                      agreement. Although the text has been reduced, the current guidance still makes it possible             delete this paragraph from the guidance until further discussions have
                                                                                                      to use laboratory tests evaluating changes of metal species to less soluble metal species,              taken place.
                                                                                                      laboratory/mesocosm studies, and field data and/or models to show removal of soluble
                                                                                                      metal species through precipitation/speciation processes over a range of environmentally
                                                                                                      relevant conditions, as mentioned in section IV 3, last paragraph.


136   NL                    Removal of metals from the water phase                205      35-38      It was accepted that precipitation of metals after reaction with water, like aluminium and iron, should #See response to the previous comment.
                                                                                                      be considered. However, a number of member states and the Commission were not convinced that
                                                                                                      the speciation processes of binding to suspended matter, partitioning to sediment and binding to
                                                                                                      acid volatile sulfide (AVS) should be considered as well. The following difficulties have been
                                                                                                      identified, which in our view need further in depth discussion to decide whether such an approach
                                                                                                      can be used in a classification and labeling system:
                                                                                                      - Deposition in sediment and adsorption to particles represent dissipation and not degradation or
                                                                                                      other irreversible removal of the substance from the environment. It could be argued that binding of
                                                                                                      metals to AVS in sediment is metal specific and will reduce the remobilization back to the water
                                                                                                      column. However, binding of organic compounds to organic matter might also reduce the
                                                                                                      remobilization significantly. This is not in accordance with the basic principle for organic substances,
                                                                                                      where dissipation and sorption to particles and sediment are not accepted as replacement data for
                                                                                                      degradation in the classification scheme even though this would have been
                                                                                                       the same process as the one now being proposed for metals and metal compounds (see UN-GHS
                                                                                                      Guidance Annex 9, p. 486-494).
                                                                                                      - The AVS content can vary due to several factors, including spatial and temporal variability and
                                                                                                      redox potential. For this reason, the industry proposes to use the 10th percentile of the Flanders
                                                                                                      data as a reasonable worst case. As such also the binding capacity is limited. This could mean
                                                                                                      that at higher loading, binding to sediment is less than at lower loading. If this is the case, the
                                                                                                      classification of the metal in question will not be dependent of the intrinsic properties of the
                                                                                                      substance only, which goes beyond the philosophy of the classification system.
                                                                                                      - Binding to sediment depends on water depth. When discussing whether volatilization would be a
                                                                                                      relevant removal process in relation to degradation when drafting the UN-GHS Guidance, it was
                                                                                                      agreed that because volatilization depends on water depth it should not be considered for
                                                                                                      classification. (see UN-GHS Guidance Annex 9, p. 490, Pedersen F. et al (1995)).
                                                                                                      - As the affinity of metals to AVS is metal specific, binding to AVS also depends on the presence
                                                                                                      of other metals. This would mean that removal of a single metal will be different with and without a
                                                                                                      metal with a higher affinity being available. As a consequence the classification of the single
                                                                                                      metal could be different from the classification of an alloy or other metal mixtures. This will
                                                                                                      complicate the classification system and might also not be understood by downstream users
                                                                                                      who will make these mixtures.
                                                                                                      We realize that the guidance of the UN-GHS environmental classification and labelling section
                                                                                                      currently
                                                                                                      also offers the possibility to take the removal approach into account. Since the UN-GHS and
                                                                                                      respective guidance form the basis of the EU CLP Regulation and the current guidance we think
137   CEFIC                                                                                           that a                                                                                                   #Added.
                            IV.4                                                  206          7-23   Add a reference to the homeostasis in the paragraph
138   CEFIC                 IV.5.1                                                207      13         We mean here mg dissolved ion given otherwise confusion with the metallic form may                      #ECHA takes note of the comment. However, the text as it reads now
                                                                                                      occur. Needs also consistency with the schemes. Suggested change : Thus while most                      reflects the current UN GHS text acc. to its 3rd revision. No changes
                                                                                                      metal data is expressed in, for example, mg dissolved metal (ion), this value will need to be           required.
                                                                                                      adjusted to the corresponding weight of the metal compound.
139   DE                    section IV.5, Figure IV.5.2.1, Figure IV.5.2.2b,      207-     23-3       In these figures it is illustrated that if certain data are not available classification for acute or   #In the draft revised guidance it is made clear (for example on page 206
                            Figure IV.5.3.1, Figure IV.5.3.2b                     208                 chronic aquatic hazard is not possible due to insufficient data. In the current guidance the            line 37) that acute and long-term hazard assessment are assessed
                                                                                                      non-availability of these data leads to the safety-net classification as Chronic 4. It is not           individually. Section IV.5.2.1 and Figure IV.5.2.1 only apply to the Acute
                                                                                                      clear to us, why this was changed. Please explain why this was changed.                                 hazard assessment for which we only have one category. In Figure
                                                                                                                                                                                                              IV.5.2.1 it says "Not possible to classify for acute aquatic hazard due to
                                                                                                                                                                                                              insufficient data. That does not mean that this metal may not be assigned
                                                                                                                                                                                                              a safety net category Chroinic 4. After considering acute hazard it is also
                                                                                                                                                                                                              necessary to consider lon-term hazard following section IV.5.2.2 (for
                                                                                                                                                                                                              metals) and IV.5.3.2 (for metal compounds). In those sections you will
                                                                                                                                                                                                              see that in lack of T/D data you may end up in "Chronic 4 unless Acute 1
                                                                                                                                                                                                              applies." The latter is because for substances the safety net classification
                                                                                                                                                                                                              only applies when "the data available do not allow classification under the
                                                                                                                                                                                                              formal criteria for acute 1 or chronic 1 to 3" (see section 4.1.2.4 of the
                                                                                                                                                                                                              new legal text.

140   DE                    section IV.5.2.2.1                                    209      1          This sentence ends with an "and" and is not finished, so it seems some information is                   #The "and" has been deleted.
                                                                                                      missing. Please complete the sentence.
      Source (Organisation Topic (Section in version of text being referred to)   Page     Line     Comment                                                                                          Response (by ECHA - please leave blank)
      / Member State)                                                             number   number

141   DE                    section IV.5.2.2.2, 2nd paragraph                     209      20-22    The sentence ends with an "if", so it seems as if some information is missing at the end of      #The sentence has been completed according to the original text in UN
                                                                                                    the sentence. Please complete the sentence or delete the "if".                                   GHS (3rd revision) - and as it is included in the current guidance - and
                                                                                                                                                                                                     reads now as follows:
                                                                                                                                                                                                     "... ; the safety net classification (Category Chronic 4) should be applied
                                                                                                                                                                                                     since the known classifiable toxicity of these soluble forms is
                                                                                                                                                                                                     considered to produce sufficient concern. "
142   CEFIC                 IV.5.2.2.2 The surrogate approach                     209      22      The text seems aborted and needs completion in accordance with fig. IV.5.2.2b (see                #See response to comment no. 135 (DE).
                                                                                                   underlined section) : ; the safety net classification (Category Chronic 4) should be applied
                                                                                                   if the metal is not classified as acute 1
143   CEFIC                 Fig. IV.5.2.2.b The surrogate approach                211              Surrogate approach : the box "is chronic ERV available and < 1 mg/l " need to be              #There may very well be chronic toxicity data (ERV) available but no
                                                                                                   eliminated because there are no chronic data under the surrogate scheme. This would also solubility data (using the T/D-protocol). Please note also the heading to
                                                                                                   bring it in line with the generic section on the surrogate approach (p.120)                   the figure which says "... appropriate chronic toxicity reference and/or
                                                                                                                                                                                                 T/Dp data."
144   CEFIC                 IV.5.3.1 Classification strategies for metal          212      11      Please delete "for the metal ions of concern" since not relevant here given we deal with the #Deleted.
                            compounds                                                              metal compound
145   DE                    section IV.5.3.2.1                                    215      19      This sentence ends with an "and" and is not finished, so it seems some information is         #The "and" has been deleted.
                                                                                                   missing. Please complete the sentence.
146   CEFIC                 IV.5.3.2.2 The surrogate approach                     216              The following section is missiing each time under a to d and should be added to p. 216 :      #Added.
                                                                                                   "unless rapid removal from the water-column and/or not bioaccumulative", to remain
                                                                                                   consistent with the generic approach of p120,
147   CEFIC                 IV.5.3.2.2 The surrogate approach                     216      1 and 2 Typo that needs correction : the "chronic ERV compound" reference under b) and c) needs #Changed to ''acute''.
                                                                                                   twice to be changed by "acute ERV compound", given this section handles about the
                                                                                                   surrogate approach. This is correctky mentioned under a) and also the loadings are
                                                                                                   correct.
148   CEFIC                 IV.5.3.2.2 The surrogate approach                     216      11      Please add underlined part : (Categorie chronic 4) should be applied                          #Correction has been made to ''has to'' be applied.
149   DE                    section IV.5.3.2.2, part on poorly soluble metal      216      9-13    Please add "has to" between "(Category Chronic 4)" and "be applied" at the end of the         #Corrected.
                            compounds, second and third paragraph                                  sentence in the second paragraph. Please delete "are" in the sentence of the third
                                                                                                   paragraph after "…relevant chronic ERV is"
150   CEFIC                 Fig. IV.5.3.2b                                        218              Typo's to be corrected in the right upper part of the figure : the 3 boxes following the "no" #Changed to ''acute''.
                                                                                                   arrows makes reference to the "chronic ERVcompound" while this should each time be
                                                                                                   "acute ERV compound"
151   CEFIC                 Fig. IV.5.3.2b                                        218              surrogate approach : the box "is chronic ERV available and < 1 mg/l" need to be eliminated #See response to comment no. 143, the same applies here.
                                                                                                   because there are no chronic data under the surrogate scheme. This would also bring it in
                                                                                                   line with the generic section on the surrogate approach (p.120)
152   DE                    section IV.5.4, 6th paragraph                         220      6-18    In the following sentence the verb is missing making the sentence not understandable: "The #Corrected.
                                                                                                   CSA as the surface area loading (mm2/l) to a medium that delivers a selected ecotoxicity
                                                                                                   reference value to that medium." Please rework this sentence.

153   CEFIC                 IV.5.5                                                220      36-39    This paragraph can probably be clearer stated as follows : Ores and concentrates and          #ECHA agrees: the proposed text has been inserted.
                                                                                                    inorganic UVCBs are considered substances under CLP. In absence of substance specific
                                                                                                    ecotoxicity data, their classification can be assessed applying the mixtures rule. The metals
                                                                                                    industry developed classification tools that allow for the hazard ID and environmental
                                                                                                    classification of these complex materials, by integrating all aspects of this guidance and
                                                                                                    knowledge on their mineralogical and other typical metal properties.


154   CEFIC                 IV.5.5.1.                                             221      27-28    biotic and biological binding sites should be replaced by abiotic and biological binding sites   #Corrected.
Source            Topic (Section in version of text    Page     Line    Comment                                                                                   Response (by ECHA - please leave blank)
(Organisation /   being referred to)                  number   number
Member State)


AT                                                                      We know this is a problem with the CLP Regulation; however, can the guidance              Could you please specify what you mean exactly?
                                                                        provide recommendations how to deal with the different possibilities to classify
                                                                        according to Table 3.1.1?
BfR/DE            Whole document                                        Please note that at this stage the comments by 'BfR/DE' provided below do not             The comments made by BfR will be treated as input to work on the draft texts
                                                                        constitute an official BfR (or German) position. Rather they reflect the consolidated     proposed for guidance update. The resulting consolidated version will not be the
                                                                        input of a number of BfR experts from different work areas related to risk                final text as the consultation procedure still foresees two further steps, the last
                                                                        assessment and classification and labelling.                                              one being the CARACAL consultation.

BfR/DE            Whole document                                        The main issues addressed below have also been summarised in a separate two-              ECHA will carefully consider the comments and consider how to proceed with
                                                                        page document.We kindly ask ECHA that it be carried along in the further course           the issues raised.
                                                                        of the review procedure.
CONCAWE           General comment                                       The GCLs set in the CLP Regulation are based on UN GHS. In particular                     This is an issue that might deserve the attention of the UN SCE GHS.
                                                                        (unusual) cases, SCLs have been set in Annex VI of the Regulation, but any
                                                                        increased use of SCLs will serve to further de-harmonise global GHS. The
                                                                        proposed guidance will surely serve to increase the use of SCLs.
CONCAWE           General comment                                       A wide variety of differing classifications have already been reported to the ECHA        ECHA takes note of the comment. However, self-classification including the
                                                                        Inventory for single substances, illustrating the difficulties of reaching unanimity on   setting of SCLs was intended by the legislator.
                                                                        interpretation of the relatively simple GCL rules. Introduction of self-classification
                                                                        with SCLs can only increase the level of confusion and disagreement, making it
                                                                        even harder to secure the goal of “one substance, one harmonised CLP
                                                                        classification”.
CONCAWE           General comment                                       The length and complexity of the proposed guidance will make compliance very              ECHA will carefully consider the comments and consider how to address this in
                                                                        difficult for SMEs and other companies without in-house specialists in regulatory         the context of the HH review as a whole.
                                                                        toxicology. This is especially true of section 3.7.2.5 and Annex VI (SCL setting for
                                                                        reproductive toxicity).
CEFIC             whole document                                        it looks as if the main changes are related to specific concentrations limits.            ECHA will carefully consider the comments and consider how to proceed with
                                                                        Whereas SCLs are in general helpful the method to define such SCLs especially             the issues raised.
                                                                        for reproductive toxicity in an official guidance document seems to be premature at
                                                                        this stage. A solid, science based and well documented expert judgement (case by
                                                                        case) might be more feasable in that context for complex endpoints as
                                                                        reproductive toxicity. The newely added part of the guidance document is very
                                                                        comprehensive, but nevertheless does not provide unequivocal guidance. In line
                                                                        with the complex nature of the potential effects throughout the document the
                                                                        uncertainty and the need for expert judgement for modification is highlighted.

ECETOC            general comment to the                                SCLs especially for reproductive toxicity in an official guidance document seem to ECHA will carefully consider the comments and consider how to proceed with
                  proposal on deriving SCL                              be premature at this stage. A solid, science based and well documented expert            the issues raised.
                  in particular on endpoints                            judgement (case by case) might be more feasable in that context for complex
                  related to toxicity to                                endpoints as reproductive toxicity. The newely added part of the guidance
                  reproduction                                          document is very comprehensive, but nevertheless does not provide unequivocal
                                                                        guidance. In line with the complex nature of the potential effects throughout the
                                                                        document the uncertainty and the need for expert judgement for modification is
                                                                        highlighted.
BfR/DE            Whole document                                        Editorial remarks:                                                                       The terms in vivo and in vitro have been italicised throughout the document
                                                                                                                                                                 (but not in the green boxes). For the other changes a layout check will be
                                                                        - The terms 'in vitro' and 'in vivo' need to be checked for italicisation throughout the performed before the document is finally published after the consultations have
                                                                        document.                                                                                been finalised.
                                                                        - Please re-check that numbers are consistently noted according to English style
                                                                        conventions, using '.' instead of ',' for decimal separation.
                                                                        - Please check that spacing between numerical operators and numbers is
                                                                        consistent throughout (e.g. < 3 or <3). Currently both notations are used at random
                                                                        (cf. p. 169).
                                                                        - Likewise please check the spacing between values and units (note that the SI
                                                                        system foresees spaces between number and unit, also for the percent sign).
                                                                        - Please apply or remove the italicisation for 'e.g.'/'i.e.' throughout the document.
                                                                        The current use is inconsistent (cf. p. 183).

MSCA DK           General comment                                       In general, we appreciate the outcome of the update of this guidance material. It is ECHA takes gratefully note of this appraisal.
                                                                        well written and well described. Thank you.
WIV-ISP           list of abbreviations                27               As the abbreviation MS CA has been added in the text, this abbreviation should be The proposal has been implemented.
(BE)                                                                    also added in the list.
          List of Abbreviations       27, 29           LVET should read Low Volume Eye Test, MetHb: same abbreviation used for 2                  LVET issue addressed, MetHB and MetHb and (first Capital B-
                                                       terms, the T25 defintion is not completely correct as well it should read: The T25         Methaemoglobinaemia; second with low-case b, Methaemoglobin]) these two
                                                       can be defined as the daily dose (expressed as mg/kg bw/day) resulting in a                abbreviations are different and also represent different words which we believe
ECETOC
                                                       tumour incidence of 25% at a specific tissue, after correction for spontaneous             are used in the correct context throughout.
                                                       incidence, within thestandard study period for that species.

WIV-ISP   General principles /         30       12     (UN GHS 2007): If the original version of the CLP was based on the second                  The text has been changed in accordance with the comment.
(BE)      introduction                                 revised edition of the GHS (2007), the 2nd ATP reflects the amendments brought
                                                       by the 3rd revised edition of the GHS (2009). This should be modified accordingly
                                                       in the guidance.
WIV-ISP   General principles /         32      21-26   The paragraph could be deleted in this new version of the guidance as the date of          ECHA agrees, and the paragraph has been deleted.
(BE)      introduction                                 1 December 2010 is over.
WIV-ISP   General principles /         33       23     Use the correct designation of this directive and replace Directive "98/79/EEC" by         Corrected
(BE)      introduction                                 "Directive 98/79/EC"
WIV-ISP   General principles /         33       24     Delete the parentheses                                                                     Deleted
(BE)      introduction
CONCAWE                                                                                                                                           The text has been changed in accordance with CLP Article 6(2).
                                                       As an underlying principle, data on mixtures should always prevail over data of
                                                       single components as interactions between molecules in the "matrix" can not be
          1.1.6.2                      35       15
                                                       accounted for when hazards of single components are extrapolated to the mixture
                                                       in which they are contained. This should be made more explicitly in the guidance.
WIV-ISP   General principles /         35      23-27   The phrase "If no test data are available…" is not specific for mixtures classified        The text has been changed in accordance with the proposal.
(BE)      introduction                                 for CMR effects but is a phrase for all other mixtures. For the clarity of the text, a
                                                       new paragraph should be started with this phrase.
WIV-ISP   General principles /         35      23-27   What is said in this paragraph is not reflecting what the CLP says. The CLP says           The text has been changed in accordance with the proposal.
(BE)      introduction                                 in article 8, point 1 : "1. For the purposes of determining whether a substance or a
                                                       mixture entails a health or environmental hazard as set out in Annex I to this
                                                       Regulation, the manufacturer, importer or downstream user may, provided that he
                                                       has exhausted all other means of generating information including by applying the
                                                       rules provided for in section 1 of Annex XI to Regulation (EC) No 1907/2006,
                                                       perform new tests." In this section 1 of Annex XI, the in vitro tests are clearly
                                                       involved in the means of generating information (see section 1.4 In vitro methods)
                                                       and thus, when it is said : "perform new tests", the "in vitro" tests are NOT
                                                       included. If "in vitro" tests exist, are reliable and can be used for the classification
                                                       of mixtures, there is no reason to prevent the performing of such in vitro tests for
                                                       mixtures. We suggest therefore to replace these 2 phrases by "If no in vivo test
                                                       data are available on the mixutres themselves, such data should not normally be
                                                       generated. Only when the manufacturer, importer or downstream user has
                                                       exhausted all other means of generating information, new tests may be
                                                       performed."
                                                       This is more faithful to the CLP text.
WIV-ISP   General principles /         37       4      As later in the text, the new version of the guidance has always used the                  The proposal has been implemented.
(BE)      introduction                                 abbreviation MS CA instead of CA, it is preferable to use this abbreviation here as
                                                       well.
WIV-ISP   General principles /         37       34     To be precise, under DSD, all hazards were evaluated on basis of the data                  ECHA agrees to the proposed change. A clarification in relation to
(BE)      introduction                                 available at the time of the evaluation and the new information coming later was           classifications under DSD has been inserted. At the end of the paragraph, a
                                                       not systematically revised for each entry. It is why, the harmonized classification is     "reminder" in line with CLP Art. 4(3) has been inserted.
                                                       not always complete and the reason why in the new ATP of the CLP, it was
                                                       decided to remove the Note H to oblige the classifier to review all existing data for
                                                       the hazard classes not covered by an entry in the harmonized classification list. I
                                                       think this is an important point to raise in this new guidance to draw the attention
                                                       on the fact that even for old classified substances, there is an obligation to review
                                                       all information available and if necessary to classify the substance for the hazard
                                                       classes or differentiations not covered by the entry in the harmonized list (Article
                                                       3).
WIV-ISP   General principles /         38       8-9    The phrase "However, substances placed on the market before 1 December 2010                The sentence referring to the time before 1 December 2010 has been deleted.
(BE)      introduction                                 may be notified before that date" is obsolete and we propose to delete it.
WIV-ISP   1.2.3.1. Form or physical    41       7      no reason to keep "self-reactive substance" in the singular, add an "s" to                 Corrected
(BE)      state / Physical hazards                     "substance".
CONCAWE                                                SCL should open an opportunity to accurately assess intrinsic hazaroudous
                                                       properties of chemicals using all avaialble data (see previous point). However, the
                                                       balance of the current guidace is heavily on the side of LOWER SCL. Higher SCL
                                                                                                                                           ECHA will carefully consider the comments and consider how to proceed with
          1.5                            46      37    are not addressed in the same detail, and it is still not clear what "execptinoal
                                                                                                                                           the issue raised in the context of the HH review as a whole.
                                                       circumstances" mean and how to deal with it. Setting SCL should be impartial to
                                                       both Lower and Higher SCL. Otherwise there is little benefit of setting SCL over
                                                       GCL.
WIV-ISP   Specific cocentration limits   47    11-12 This was just said in the paragraph before (see lines 8-9). Delete lines 11-12 or     The paragraph has been deleted in accordance with the proposal.
(BE)      and M-factors                                delete the phrase "Guidance…classes" in lines 8-9 to avoid repetitions.
CEFIC                                    47   18 to 19                                                                                     ECHA will carefully consider the comments and consider how to proceed with
                                                       Why only a lower SCL and not a higher SCL?
                                                                                                                                           the issue raised in the context of the HH review as a whole.
CONCAWE                                                This sentence "…, such as for STOT-SE and STOT-RE, and ONLY a lower SCL
                                                                                                                                           See also previous comments on SCL issue - ECHA will carefully consider the
                                                       can be set" implies that there are other endpoints which merit HIGHER SCL.
          1.5                            47      19                                                                                        comments and consider how to proceed with the issue raised in the context of
                                                       However, the guidance on higher SCL is not so well developed as that for lower
                                                                                                                                           the HH review as a whole.
                                                       SCL.
CEFIC                                    47   27 to 33
                                                                                                                                           See also previous comments on SCL issue - ECHA will carefully consider the
                                                       Why are available data normally not sufficient? I would think they are.             comments and consider how to proceed with the issue raised in the context of
                                                                                                                                           the HH review as a whole.

          1.5.1 specific concentration   47   27 to 33 The paragraph does not consider the setting of specific concentration limits for
          limits                                       irritation based on in vitro testing. This is however possible in cases where            See also previous comments on SCL issue - ECHA will carefully consider the
ECETOC                                                 sufficient data are available to correlate in vitro data with in vivo effects. In some   comments and consider how to proceed with the issue raised in the context of
                                                       cases sufficient in vivo data on dilutions are available and on e should be able to      the HH review as a whole.
                                                       use them.
CEFIC     1.5.1.Specific                 48       5    Table 1.5.1. Respiratory and skin sensitisation Category : should make mention of        A clarification has been inserted in form of a footnote in the preface and in
          concentration limits                         1A and 1B as is stipulated in 2nd ATP                                                    section 1.5.1 on SCLs, and as full text in the guidance chapter on
                                                                                                                                                respiratory/skin sensitisation.
CONCAWE   1.5                            48      5     Table 1.5.1. For skin sensitisation having Higher SCL, there is Yes, and it is           A footnote has been inserted in the table to clarify the situation. In the table, it is
                                                       suggested that guidace is available in section 3.4. However, that section currently      now indicated that guidance is to be provided in section 3.4, but no longer that it
                                                       reads (page 171, line 4) "However, there is currently no guidance on how to set          is already available.
                                                       SCL above the GCL".
WIV-ISP   Bridging principles/Dilution   54    17-19 As this text is exactly the same as in the CLP, it is preferable to use a "green box" Although this is correct, ECHA prefers to leave the text as it is, as its purpose is
(BE)                                                   starting with the reference where you can find it : Annex I : 4.1.3.4.3 and to explain here to provide guidance and not primarily to reflect the legal text. Also, to
                                                       under the green box that this is illustrated by the example C in section 4.1.4.7.         imbed the text in a green box would give it a higher weight than the other
                                                                                                                                                 preceding texts,
CEFIC                                    56   12 to 13 There may be a significant impact if a new evaluation is required even for non-           CLP does never require that testing is done for the purpose of human health or
                                                       hazardous substances. Basically Chapter 2 of Title II to CLP (see Article 15(1) of        environmental classification, see Articles 7 and 8.
                                                       CLP), article 15(3) should allow that no testing is done if scientifically justified.
                                                       However, potential impact is full retesting of a non-hazardous product.
CEFIC                                    56   21 to 23                                                                                           See also previous comments on SCL issue - ECHA will carefully consider the
                                                       Changes within the permitted variation: this is relevant for petroleum substances.
                                                                                                                                                 comments and consider how to proceed with the issue raised in the context of
                                                       What is the permitted variation?
                                                                                                                                                 the HH review as a whole.
WIV-ISP   1.6.3.4.3. Additivity of       61       7    "as far as no SCL has been set" : is correct if the SCL is lower but not if it is higher. The proposal has been implemented.
(BE)      hazards                                      Propose to replace by "as far as no lower SCL has been set".
BfR/DE    1.6.4.1                        63     1 ff   Although not subject of this review: formulas referring to sums need to use               This is editorial work that would be done directly before the revised document is
                                                       consistent variables and require a clear definition of the numerical space they refer published.
                                                       to. In the current form the sum refers to a variable n and the parameters to a
                                                       variable i. This syntax is mathematically wrong. Please change the syntax as
                                                       follows: replace 'n' by 'i = 1' below the sum and note 'n' above the sum. Please
                                                       apply the same notation to all subsequent formulas containing sums throughout the
                                                       document.

				
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