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					 REACH
What to do next?


       Registration, Evaluation,
            Authorisation
                   (and Restriction)

                   of Chemicals

               Workshop for the
              Aerospace Industry
   AGENDA
08:30   Registration and Coffee
09:15   Welcome – Terry Palmer, Lockheed Corporation
09:20   What is REACH, where we are up to in the timeline – Terry Palmer
09.40   Pre-Registration and Registration: what happens next?
        – Tony Harmsworth, Goodrich Corporation
10.20   Questions
10.25   Coffee
11.00   Authorisation and Restriction: The process – Kerrill Grealy, Meggitt
11.30   The Candidate List – Bhav Panchal, Lockheed Insys
11.50   Questions
11.55   Tools from the Sector to help with REACH – ?TBA
12.30   Questions
12.35   Lunch
1.15    HSE – Enforcement, Help and Advice - ?TBA

1.45    Optional Workshops on planning for REACH, INCLUDING defence exemption issues,
        discussions with presenters
                                                                                    2
4.00    close
What is REACH?




                                      Manufacture
                 Importation
                                 Placing on the market
                                          Use



                                of substances



On their own                   In preparations                 In articles



 Trichloroethylene              Paints, Sealants, Resins   Systems, Components, aircraft




                                                                                           3
REACH Key Words
Substance:
• A basic chemical, like iron, nickel,
  trichloroethylene, solvent naphtha, lead
  oxide…
• ANYTHING WITH A CAS No.
• It can be a pure substance or a distillate
  fraction mixture but it has have its own CAS
  No.
• These are the basic building blocks from
  which everything is made.
• It can be a solid, liquid or gas.

• ALL substances are affected by REACH.
  Even ones that are NOT HAZARDOUS in any
  way!
                                                 4
REACH Key Words
Preparation / Mixture:
• A mixture of substances, like steel, adhesive, resin, paint, an
   etchant, an NDT fluid.
• Anything that is a mixture of substances.
• It will contain more than one CAS No. substance.
• If the preparation is solid, then the shape isn‟t really important – it
   is more for delivery than anything. You can do whatever you are
   doing with it, even if it is a different shape.

Article:
• An object where the shape is more important than its chemical
   composition:
• A billet, a rod, a diesel engine, a gasket, a spare part, a submarine,
   a valve, a second hand product
• It could be an object made from a homogenous material, or it could
   be an object made from several other objects


                                                                            5
 What is REACH?

Supply Chain and manufacturing use of Substances                                                 Authorisation

                                       Registration                                              to use in specific
                                                                       Evaluation                   application
      Pre-registration
                                  Pre Registrants to submit
                                                                        By ECHA.
    Import substances into EU      Safety Assessment for
                                                                 For several substances
          >1tonne/year              each specific use of
                                                                  this may already exist
                                         substance                                                Restriction




                                 Substances of very High Concern (Candidate list)




Declaring Substances of Very High Concern in Articles to customers


                                0.1% of SVHCs                                   0.1% of SVHCs
           Supplier                In Articles          Your company               In Articles    Customer




                                                                                                                      6
    REACH Time Line

    Any > 1k tpa                                                                                                       End of
                                             Registration
   R50/53> 100 tpa                                                                                                     phase in
                                                 Evaluation
   CMR1/2 > 1 tpa
                          Pre-registration
                                                         Registration
   Any > 100 tpa
                                                                      Evaluation



                                                                           Registration
     Any > 1 tpa
                                                                                Evaluation



                                                                    Authorisation and Restriction

  Go live
                                             2009 2010 2011                     2013                            2018
            2007   2008          2009                 2010   2011   2012     2013   2014   2015   2016   2017   2018
                                              TODAY




  FIRST DEADLINE:                                             NEXT DEADLINE:
End of Preregistration:                                      First „Candidate List‟
     Nov 30 2008                                              Consultation ends                                                   7
                                                                 14 April 2009
                             Business Risks and REACH
Margin on sales of Product




                                                                    Cost of registration for
                                                                   the product constituents



                                Products are worth
                              the registration costs:
                                 Substances are
                                pre-registered and      Products are NOT worth the registration
                                 then registered.        costs. Substances are pre-registered
                                                            and then withdrawn prior to the
                                                                 registration deadline

                             1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21..
                                                                                   8
                                             Product lines
   Defence Exemption in REACH

 When could a Defence Exemption be used?


•Where a material (Preparation) is classified
•Where the use of a material is classified
•Where other legislation prevents supply of data to support
     REACH (e.g. International Traffic in Arms Regulations)
•Where the use of a SVHC is classified
•Where the defence uses of a materials is Authorised or
     Restricted
•Where defence related PPORD is classified
     Defence Exemptions
Member state   Status
Denmark        No progress

Finland        Realisation of need

Germany        Designated agency, no legislation

France         Designated agency, no legislation

Spain          Designated agency, no legislation

Greece         Designated agency, no legislation

Italy          Designated agency, legislation, but no actual
               exemptions in process
Netherlands    Designated agency, legislation, but exemptions in
               process, weaknesses
UK             Designated agency, legislation, but exemptions in
               process, weaknesses being addressed
REACH




Pre-Registration and Registration:
      what happens next?




                                     11
 REACH – legal overview

Supply Chain and manufacturing use of Substances                                                 Authorisation

                                      Registration                                               to use in specific
                                                                      Evaluation                    application
     Pre-registration
                                 Pre Registrants to submit
                                                                        By ECHA.
   Import substances into EU      Safety Assessment for
                                                                 For several substances
         >1tonne/year              each specific use of
                                                                  this may already exist
                                        substance                                                 Restriction




                                Substances of very High Concern (Candidate list)




Declaring Substances of Very High Concern in Articles to customers


                               0.1% of SVHCs                                    0.1% of SVHCs
          Supplier                In Articles           Rolls-Royce                In Articles    Customer




                                                                                                                      12
Pre-Registration

The pre-registration phase closed on 1st Dec 2008

    • 150k substances pre-registered

    • 65k companies

    • 2.7M pre-registrations
Preregistration


• What should have been pre registered?
• All substances and mixtures manufactured in the EU
  or imported into the EU in quantities of greater than 1
  tonne per legal entity

• Some exemptions
   • Waste, nuclear materials, medicines, etc
Preregistration


•Who should have pre registered
    • Manufacturers in EU placing substances on the
      market

    • Importers of substances in volume greater than 1
      tonne from outside the EU.

 • European Chemicals Agency (ECHA) has now
   published list of all substances pre registered
Preregistration

•Are your KEY substances pre registered?

•Has your non-EU supplier done the pre-registration for
you?

•The non-EU supplier is obliged to tell you if they are going
to establish an „Only representative‟ to do the pre-
registration for you. Have they contacted someone in your
company to tell you that they are going to do this?
  Pre-registering substances in
  Articles
Substances in articles required registration when the
substance is “intended to be released” and the mass of the
substance sold in articles is greater than 1 tonne per annum

   • The INTENTION is important !
   • The key test is whether the core function of the article is to release
     a substance. (Examples: a welding rod, packing grease, stop-off)
   • A hydraulic cylinder does not have an INTENDED release
   • Normal wear is not considered to be an intended release
   • Release during disposal is not an intended release
     The Aerospace and Defence sectors have an opinion on
              many grey areas – see your packs and
    http://www.asd-europe.org/content/default.asp?PageID=43                   17
  Pre-registering substances in
  Articles
The EU has developed guidance on articles - RIP 3.8.

The industry has prepared a document (GLOBAL AEROSPACE AND
DEFENCE INDUSTRY OPINION ON WHAT CONSTITUTES A
SUBSTANCE, PREPARATION AND ARTICLE) that provides guidance
on:
 • PREPARATIONS or SUBSTANCES
 • ARTICLES with intended release
 • ARTICLES with no intended release

A rationale has been provided for each assumption

This is industry best guidance – but cannot be presumed to be the
interpretation that the courts will place on the regulation. When decisions
are made in the European Courts, they will supersede this guidance.           18
If not pre registered what then?

Late preregistration is only permitted for :
 • Substances as listed on EINECS, being imported by the
   legal entity or manufactured in the EU for the first time

 • Substance manufactured in the EU, but not placed on
   the market, at least once in the past 15 years.
     • I.e. exported substance
     • Evidence of the conditions must be available

 • Substance is a so called „no longer polymer‟. These are
   chemicals that used to be considered polymers in the
   old regulation, but are now not considered to be
   polymers (See handout for information)
   Pre-registration or „Inquiry‟?
   EINECS or ELINCS?
EINECS:

Substances existing before 1981: phase-in – should be
preregistered.

ELINCS:

Substances invented post 1981: Should be registered already,
or will require registration. Ask your supplier if they have already
registered the substance.

The ELINCS and EINECS databases can be seen at
http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=ein

NEITHER ELINCS or EINECS: USE is illegal. You need to stop
using it, and make an inquiry to ECHA. See
http://echa.europa.eu/reachit/inquiry_en.asp              20
How to late preregister

•Go to the IT portal on the ECHA webpage

•You will require:
 • Name of substance, CAS, EINECS or other
   identification number

 • Name & address of contact person

 • Envisaged deadline for registration based tonnage band

 • Identifier of any structurally similar chemicals you may
   wish to rely on as part of registration process
REACH




        QUESTIONS




                    23
REACH




          Registration:
 If you are a Down stream user



                                 24
What is Registration?


• Pre registrants grouped together into SIEF‟s

   (Substance Information Exchange Forums)

• Assemble portfolio of specified information that shows

 how substance can be used safely

• Share costs of putting portfolio together

• Submit portfolio to ECHA by date determined by tonnage

  band.
Supply chain communication




                             26
          Supply chain communication




                     Management Measures
  Chemical                                                    Aircraft




                       MSDS and Risk
                         Information
Manufacturers                                               Manufacturer
 or importer




                                           INFORMATION
                                                           Major assembly
 Distributor 1                                                  OEM




                                           USES
 Formulator 1                                             Design / Make
                                                          System Supplier
 Formulator 2
     Distributor 2                                       Component
                                                          Supplier
       Formulator 3
                 Metal Basher / base component
                          Fabricator…
Registration as a Downstream User

EACH Registrant, will make sure all of their own uses, and all of the main
  downstream uses in their supply chain, are registered.


They are likely to include the obvious uses for the main markets:
•   Trichloroethylene as a degreaser.
•   Toluene and Xylene in paints.
•   Epoxy resin in adhesives.
They may not know about the less obvious uses:
•   The aerospace and defence sectors WILL have weird uses.


If your use is not covered in the registration, it will be ILLEGAL.
                                                                             28
  Uses not on the MSDS
This occurs when…
Substance use is outside the conditions described in the
    “exposure scenario”,

Exposure scenario: The way in which a person, or the
   environment, gets exposed to the substance. Such as:
   Inhalation, Ingestion, Into water courses, Into soil.
   Forms part of Registration dossier

How will they decide the Exposure Scenarios they will cover?

It depends on the likely routes. Substances in kettle heating
     elements could be ingested. Substances in paint could
     get into the body via inhalation, via dermal contact, and
     can get into water courses, and possibly into soil (when
     land filled)
Uses not on the MSDS
Options:
• Inform supplier: they then can create / modify
   exposure scenario for your use
• Change your conditions of use to those on the MSDS
• find another supplier that is covering your
   conditions of use,
• prepare a DU (Downstream User) chemical safety
   report yourself
• find an alternative substance, preparation or process
   and stop using the substance/preparation in
   question.
  What defines a “Use”?




Taken from
http://guidance.echa.europa.eu/docs/guidance_document/informat
ion_requirements_r12_en.pdf?vers=20_08_08
    What information should be sent to
    suppliers in relation to “uses”?
  CEFIC (the chemical industry in Europe) are setting up two
  standard ways to provide information to manufacturers and
  importers:
• Generic exposure scenarios – these are provided by
  companies to trade associations, who collate the
  information and then tell the chemicals sector: “SBAC
  members use substance X for purpose Y.”
• Specific exposure scenarios – using a standard form,
  companies inform their suppliers or M/I directly of their
  unusual uses of substances to ensure that the use is
  included in the exposure scenario
CEFIC guidance on this is in the handout and on the web at:
  http://cefic.org/Templates/shwStory.asp?NID=719&HID=714
Registration as a Downstream User

ACTION POINTS:
•   Identify each of your uses for each substance and preparation you
    cannot do without (strategically important substances).
•   Download the „use descriptor system‟ from the ECHA website:
    http://guidance.echa.europa.eu/docs/guidance_document/du_e
    n.pdf?vers=29_01_08
•   Identify the use, as defined in the descriptor system you have of
    each substance or preparation by trade name and supplier.
•   Find any health surveillance data or occupational hygiene data
    (non-person specific) that you have concerning the substances and
    preparations. Sanitize this so that individuals cannot be
    identified.

                                                                        33
    Registration as a Downstream User

ACTION POINTS:
•   Send your use descriptions to your supplier as soon as possible. Your
    supplier is not likely to be the registrant, and they will need to cascade
    the information up the supply chain, for use by the SIEFs when they are
    formed early in 2009.
•   You can also send the health surveillance data too, but be aware that
    this may have value, and so you may not wish to part with it for free ,
    just indicate that you have it.
•   For your own purposes, keep a record of who buys the strategically
    important substance / preparation and where in your facility it is used,
    and on which products. It could be useful information to have, if you
    have any continuity of supply issues, or the supplier refuses
    to register the use of the substance.
                                                                                 34
    Registration as a Downstream User

After sending in the uses of a substance, what happens next?


The manufacturer / importer doing the registration has THREE
   choices. They can…
•   Refuse to do the registration of the substance on economic
    grounds, whereupon they have to stop supplying you.
•   Do the registration of the substance for your use, and
    include your use in the MSDS.
•   Do the registration, but refuse to add the use to the MSDS,
    because it is a dangerous use. Advise you that it is
    dangerous. They can keep supplying you legally.               35
  Registration as a Downstream User

ACTION POINT:
If the Manufacturer / Importer does not include your use on the
MSDS, you can write your own Downstream Users‟ Chemical
Safety Report in order to ensure continued supply.


See the section on Downstream User Chemical Safety Reports
in the Downstream User guidelines
http://guidance.echa.europa.eu/docs/guidance_document/
du_en.pdf?vers=29_01_08


                                                                  36
REACH




            Registration:
If you are a Manufacturer / Importer



                                       39
     Doing Registration
     Estimated Registration cost for one Substance
      Volume tier                    Individual             Average testing
                                     registration           cost per substance
                                     (Euro)1                (Euro)2

      1 - 10 tonnes                  1,600                  56,360

      10 - 100 tonnes                4,300                  279,838

      100 - 1000 tonnes              11,500                 799,562

      > 1000 tonnes                  31,000                 1,582,616

      1DraftRegulation on Fees and Charges, Individual Submission under Article 6, 7, or 11, October
      2007, p. 16.
      2 Source: Fleischer, M.,”Testing Costs Testing Capacity According to REACH Requirements –

      Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland,”
      September 2007, pgs. 96-114

Some suppliers may look at these costs and decide that the cost of REACH
compliance is not worth it and terminate some products                                                 40
                                                                                                       40
Doing Registration

Suppliers/importers need information to write
chemical safety reports and identify
„Exposure Scenarios‟, including:
 • Epidemiological studies, animal testing

 • Typical uses and exposure data
EU manufacturers and importers must form
“Substance Information Exchange Fora”
(SIEFs) who must minimize testing.




                                                41
                       DRAFT April 25, 2008
Doing Registration
ACTION POINTS:

1. If you have determined that you are a manufacturer or
   importer and you are going to pre-register, you need to
   seriously examine your ability to participate in the SIEF.

   Do you have the right subject matter experts to participate
   in the debates on animal testing, toxicology,
   carcinogenicity?

   Do you know what tests are relevant to all your and your
   downstream user‟s uses are?

   Seriously think about employing expert assistance.

                                                                42
  Doing Registration
SIEFS and CONSORTIA

Each SIEF will comprise of a few large companies who
manufacture / import the majority of the substance, and a
myriad of companies (quite possibly thousands) who import
or use smaller amounts.

The larger companies will probably form consortia, to carry
out the animal testing that relates to the majority of their uses.
Where the uses that you need to register overlap, you will
need to buy the relevant data from the consortia as part of the
SIEF.

If the main consortia decides not to deal with the tests that
you need, you may have to develop your own mini-consortia
in the SIEF with others who need the same information.
                                                                     43
Doing Registration
ACTION POINT:

2. Decide if you should join the CONSORTIA?

   Advantages: You get to help set the agenda on what the
   tests carried out should be. This way, you stand a better
   chance of getting the tests you need, done in exactly the
   way you need to reflect your uses.

   You also are right in the thick of things – you know exactly
   what is going on with your strategically important
   substance.

   Disadvantages: You will really need an expert to
   participate in this. They will be expensive,
   especially if you do not already have one.
                                                               44
    IT Requirements

•   Registration submitted through IUCLID 5
•   This can be down loaded from ECHA website
•   System is used for many purposes and is very complex
•   Hence you will need training on its use
•   Guidance document also available for down loading




                                                           45
REACH




        QUESTIONS




                    46
Substances used in Research

Scientific research and development means any
scientific experimentation, analysis or chemical research
carried out under controlled conditions in a volume less
than 1 tonne per year (Article 3(23)).

Product and process oriented research and
development (PPORD) is defined as any scientific
development related to product development or the further
development of a substance, on its own, in preparations or
in articles in the course of which pilot plant or production
trials are used to develop the production process and/or to
test the fields of application of the substance (Article 3 (22)).
CSR Information requirements
CSR Guidance available
The Evaluation in REACH

• Once pre-registered, manufacturers and importers of
  substances have to prepare DOSSIERS that will be
  EVALUATED by the REACH Agency in Helsinki.

• This will decide whether registered substances are
  „nasties‟(substances of very high concern). If they are, then
  the European Commission could require them to go through
  Authorisation or Restriction.

• On the whole, there is nothing to be done by Manufacturers,
  Importers or Downstream Users for Evaluation.




                                                              53
REACH




        QUESTIONS




                    54
     REACH




             Authorisation and
                Restriction:
               The process
                  “Registry of intent”         “Priority list for
                                               Authorisation”
“Substances of Very                  Candidate                    “Authorised
  High Concern”                        List                       substances:   55
                                                                  Annex XIV”
  “Substances of Very High Concern”

  TO BE A SUBSTANCE OF VERY HIGH
  CONCERN (SVHC), MUST FALL INTO ONE OF
  THE 4 FOLLOWING CRITERIA:

 Carcinogens, Mutagens and Reproductive
  Toxins (CMRs)

 Persistent, Biocumulative and Toxic (PBT)

 Very Persistent and Very Bioaccumulative
  (vPvB)

 Substances of Equivalent Concern (Endocrine
  Disruptors)
 NB: ALL Substances contained on the
  „Candidate List‟ are SVHC‟s
Substances used in Products
and Processes
                                All substances
                         Substances that
  150,000              meet the SVHC criteria
        3,500
                            Registry of Intent
             7 current
            16 previous         Candidate List
                       15
                                  Priority CL
                            7
                                  Annex XIV

                                Annex XVII:
                                Restriction




                                                 57
Candidate List: what is it?

• The Candidate List is a list of substances that are
subject to the Authorisation process. Controlled by
ECHA.

• Currently the list contains 15 SVHC‟s…HOWEVER this
shall be updated periodically.

• The 15 is the current legal obligation on all companies
within the EU.

• The 1st List was published on 28th Oct 2008.

• The „Candidate List‟ can be found at:
      http://echa.europa.eu/chem_data/candidate_list_table_en.asp
Candidate List: what is it?

 • MS may let companies know of their intentions to
   propose substances to be on the „registry of intent‟
   (See ECHA website).


 • Registry contains 7 additional substances/families
   which may be added to the candidate list in 2009

 • MS nominate substances as fulfilling the criteria of
   being SVHC‟s & then with ECHA, they decide which
   will be incorporated in the Candidate List & which will
   be restricted.

 • Once on the candidate list the substance will definitely
   be subject to Authorisation eventually…
   Candidate List: what is it?
   1   Benzyl butyl phthalate                                The top 7
   2   Dibutyl phthalate
                                                              are the
   3   Bis (2-ethyl(hexyl)phthalate) (DEHP)
                                                            substances
   4   Short chain chlorinated paraffins
   5   4,4'- Diaminodiphenylmethane
                                                              ECHA
   6   Hexabromocyclododecane (alpha, beta, gamma)          propose to
   7   5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)    prioritise.
   8   Sodium dichromate, dihydrate or anhydrate            If you NEED
   9   Cobalt dichloride                                     Any of the
  10   Bis(tributyltin)oxide                                   Top 7 for
  11   Diarsenic trioxide
                                                               Product
  12   Diarsenic pentaoxide
                                                                Safety
  13 Lead hydrogen arsenate
                                                               reasons
  14 Triethyl arsenate
                                                              You need
  15 Anthracene
                                                            to tell ECHA
Priorities will appear on Annex XIV in June 2009                NOW
 Registry of Intent
    The 7 potential substances are on the „registry of intent‟ and
     may be added to the Candidate List or restricted in 2009


Residues (coal tar), pitch distn.
Distillates (coal tar), heavy oils
Distillates (coal tar), heavy oils, pyrene fraction
1.
Distillates (coal tar), pitch, pyrene fraction
Coal tar pitch, high temperature
Tris(2-chloroethyl) phosphate
Arsenic and its salts
Candidate List: Business risk

 • Your continued supply is at risk – Supplier may not
   consider it worthwhile continuing production.

 • If you have no alternative, your ability to manufacture
   your product is at risk. May need to start programs to
   find alternatives.

 • If you have any candidate list priority substances as
   essential substances within your product/processes
   or if your SUPPLIERS rely on the substance for
   production, you will need to take action quickly.
    Candidate List: Business Risk



•    Any of these substances ON THE LIST must not be
     USED, MANUFACTURED or IMPORTED without
     authorisation from ECHA once the substance has been
     included in Annex XIV of the REACH Legislation.

•    Authorisation is EXPENSIVE, TIME CONSUMING AND
     NOT GUARANTEED. IT IS NOT EVEN LIKELY IF THERE
     IS AN ALTERNATIVE OUT THERE SOMEWHERE.
     Candidate List: Article 33 Obligation

     Current obligation upon a supplier of articles.

      „Suppliers of articles which contain any SVHC which have a
      concentration higher than 0.1% w/w, regardless of the tonnage
      use must‟:

1.    To the END-USER: supply sufficient information for the safe-use of the
      article

2.    To the CONSUMER: supply sufficient information for the safe-use of the
      article within 45 days of the request.

     (Article 33 REACH)

     NB: This is a communication obligation.


     NOTE THAT CURRENTLY THE ‘ARTICLE’ is the PRODUCT or SPARE but
      interpretation by MEMBER STATES could mean ‘each constituent part’.
Authorisation vs restriction

            • Substances of very high concern will be
              identified and eventually be PHASED
              OUT.

            • Some substances will simply be banned –
              this is the RESTRICTION process.

            • Some substance cannot simply be banned
               • they are used too widely,

               • there are no „drop-in‟ replacements.

               • These substances will go through the
                 AUTHORISATION process.
                                                        66
Candidate List to “Annex XIV” and Authorisation

 •    Substances on Annex XIV are PROHIBITED unless your
     company has an AUTHORISATION to continue to use it.

 •    These AUTHORISATIONS are time limited.

 •    If the substance is a CMR and has a THRESHOLD value (it is
     known to be safe, if exposure is below a certain level), then
     you can continue with your authorisation BUT you will need a
     substitution plan.

 •     If the substance has NO THRESHOLD or is a PBT / vPvB, you
     MUST replace it. You will only be able to get an authorisation
     if

         There are no suitable alternatives AND

         You have written a socio-economic analysis, as well as a
         substitution plan.
Threshold / non threshold?
1  Benzyl butyl phthalate
2  Dibutyl phthalate                                  The
3  Bis (2-ethyl(hexyl)phthalate) (DEHP)          Highlighted
4  Short chain chlorinated paraffins              substances
5  4,4'- Diaminodiphenylmethane                    CANNOT
6 Hexabromocyclododecane (alpha, beta,
   gamma)
                                                   be used
                                                    if there
7 5-tert-butyl-2,4,6-trinitro-m-xylene (musk
   xylene)                                           is an
8 Sodium dichromate, dihydrate or anhydrate       alternative
9 Cobalt dichloride                                available
10 Bis(tributyltin)oxide                           once the
11 Diarsenic trioxide                             substance
12 Diarsenic pentaoxide
                                               is on Annex XIV
13 Lead hydrogen arsenate
14 Triethyl arsenate
15 Anthracene
Fees & Costs

• Tariffs dependant upon company size & if a joint dossier
  is being submitted.

• Cost of creation of Technical Reg Dossier / Technical
  Authorisation Dossier:
    • Estimated cost of a small dossier approx €80k,

    • Large dossier could cost several million Euro‟s.

• Charges shall be shared between companies submitting
  jointly, according to the tonnage of the substance used.

• Table on next slide shows fees of an Authorisation
  Dossier.
       Authorisation Fees
Fees for an Authorisation           Large       Medium     Small      Micro
Dossier                            Company     Company    Company    Company




Basic fee                        € 50,000    € 40,000    € 25,000   € 7,500


Additional fee per substance     € 10,000    € 8,000     € 5,000    € 1,500


Additional fee per utilisation   € 10,000    € 8,000     € 5,000    € 1,500


Additional fee per applicant

- The additional applicant is    € 37,500
not an SME
- The additional applicant is
a medium company                 € 30,000    € 30,000
- The additional applicant is
a small company                  € 18,750    € 18,750    € 18,750
- The additional applicant is    € 5,625     € 5,625     € 5,625    € 5,625
a microenterprise
Authorisation Costs

 •   50,000 EUROS
 •   PER SUBSTANCE
 •   PER USE
 •   Every 3 years or so

 •   Technical Dossier
     application for
     Authorisation (80 – Ms of
     EURO)
 •   Collaboration costs with
     other users and
     manufacturers
 •   Creation of in-house
     substitution plan
 •   RESEARCH AND
     DEVELOPMENT into
     alternatives for each use
 •   Socio-Economic Analysis
REACH




   What to do when you use a
Substance that is being Restricted:
     Dealing with Restriction



                                      72
Restriction vs Authorisation

• Authorisation can only apply to
  substances on their own or in
  preparations, before being incorporated
  into Articles.

• Article imports that contain a candidate
  list substance are not regulated under
  Authorisation. But can be banned from
  being imported via Restriction.




                                             73
Restriction
                           Taken from
              http://guidance.echa.europa.eu/docs/
              guidance_document/du_en.pdf?vers
                       =29_01_08 (page 112)
Dealing with Restriction

• Initially, many restrictions are being carried over from the
  Marketing and Use Directive, Dangerous Substances
  Directive etc. into REACH.

• When the Restrictions from the existing directives are
  imported into REACH, you cannot assume that any existing
  exemptions to the restrictions will still stand. They will need
  to be re-negotiated.

• Authorisation can only apply to substances on their own or
  in preparations, before being incorporated into Articles.

• Article imports that contain a candidate list substance are
  not regulated under Authorisation. But can be banned from
  being imported via Restriction.
                                                                 75
 Dealing with Restriction
• Companies may have to adopt internal
  actions similar to:-

• Removal of asbestos
• Elimination of nonylphenol in detergents
• Phase out of pentabrominated
  diphenylether (PBDE) in non-metallics
  etc.

• Very little will change from the way that
  substances have historically been
  restricted in the EU.




                                              76
 Dealing with Restriction
• For example substances could be
  restricted for sale to the general public,
  and authorisations required for use in the
  EU by industry.

• This is a likely area for the use of the
  Defence Exemption, by any jurisdictions
  that choose to have one. This will enable
  the MoD and other defence agencies to
  continue to use and maintain equipment in
  the field, until industry has viable
  alternatives to the substance for their
  applications.

• Example: There are still some defence
  uses of asbestos in the UK.


                                               77
REACH




        COFFEE BREAK




                       78
 REACH




       The requirement to declare
     Candidate List „Substances of
 Very High Concern‟ to your customer,
their customers, and in some cases, to
      ECHA: Making declarations
                                         83
REACH – legal overview

Supply Chain and manufacturing use of Substances                                                 Authorisation

                                      Registration                                               to use in specific
                                                                      Evaluation                    application
     Pre-registration
                                 Pre Registrants to submit
                                                                        By ECHA.
   Import substances into EU      Safety Assessment for
                                                                 For several substances
         >1tonne/year              each specific use of
                                                                  this may already exist
                                        substance                                                 Restriction




                                Substances of very High Concern (Candidate list)




Declaring Substances of Very High Concern in Articles to customers


                               0.1% of SVHCs                                    0.1% of SVHCs
          Supplier                In Articles           Rolls-Royce                In Articles    Customer




                                                                                                                      84
     Candidate List: Consequences

     This requirement is what many companies have been trying to find out as
      the following obligations apply from this:

      Suppliers of articles which contain any SVHC which have a
      concentration higher than 0.1% w/w, regardless of the tonnage
      use must:

1.    To the END-USER: supply sufficient information for the safe-use of the
      article

2.    To the CONSUMER: supply sufficient information for the safe-use of the
      article within 45 days of the request.

     (Article 33 REACH)
 Making Declarations:
 Notification of ECHA
You have a legal obligation to NOTIFY the REACH Agency
(ECHA) AND Customers about SVHCs contained within
YOUR product (REACH Article 7(2)) if the following apply:

    •   >0.1% w/w AND

    •   > 1 tonne sold (of SVHC per year) AND

    •   Cannot show that the substance will not be
        released at any point in the life cycle (including
        disposal) (REACH Article 7(3))

This is a subset of the information needed for the customer
                                                              86
   Making Declarations:
   Information flow
Substance of Very
  High Concern
  Candidate List
 (ECHA Website)
                    Exam Question:
Incorporated into
  a Preparation
                    What is the percentage
                    of the SVHC
Incorporated into
  a Component       a) In the component sold as a spare
  And sold as a     and
    spare part      b) in the article?

Incorporated into
    an Article                                        87
    REACH and the need for I.T
COLLECTING THE DATA REQUIRED FOR REACH FOR THE
ARTICLES YOU MAKE IS PROBABLY GOING TO NEED NEW
OR MODIFIED I.T.

•   How will you collect the „bill of substance‟ information for
    the articles you make?


•   How will you extract the information from the supply chain
    about the SVHCs in the articles you supply?




                                                                   88
    REACH and the need for IT:
ACTION POINTS:
Set up a REACH IT business project to enable you to get the
IT you need to store and manage REACH related data.
•   Develop an IT strategy for dealing with Declaration
•   Get an agreed policy for the declaration of substances in the articles you
    buy across stakeholders in your legal entities.
•   Implement contractual clauses to enable you to get the information you
    need from suppliers, as inputs to your IT
•   Create and issue a business requirements document for the IT to support
    declaration
•   Agree the concept design
•   Agree the detailed design
•   Go live on the IT
                                                                                 89
Substances used in Products
and Processes
                                All substances
                         Substances that
  150,000              meet the SVHC criteria
        3,500
                            Registry of Intent
             7 current
            16 previous         Candidate List
                       15
                                  Priority CL
                            7
                                  Annex XIV

                                Annex XVII:
                                Restricted




                                                 92
Substances in our Products and Processes

                            All substances
                          Substances that
                        meet the SVHC criteria
                        Declarable Substances
                SAE and ASD-STAN standard 9535 / 9536

                            Candidate List
                              Priority CL

                              Annex XIV

                          Annex XVII:
 Relevant to              Restricted
YOUR business




                                                        93
   The Declarable Substances list

A compilation of all the substances that have been identified as being…
    • CMRs category 1& 2 (annex 1 of directive 67-548 as amended) [CLP]

    • Substances defined as vPvB or PBT (OSPAR* listed substances)

    • Ozone Depleting Substances as defined by Montreal Protocol

    • Persistent Organic Pollutants as defined by the Stockholm Convention,
      etc.

    • Substances listed within Annex XVII (restricted substances)



   *OSlo/PARis Convention for the Protection of the Marine Environment of
                         the North East Atlantic
                                                                              94
     ACTIONS for everyone

ACTION POINTS

1.   Up-to-date COSHH inventories

•    CHECK that all substances / preparations you buy are supplied with an MSDS,
     and check that it goes to your HSE people

•    Are there people outside purchasing that have delegated authority to purchase
     substances and preparations?

•    How do you ensure these people get the MSDS to the HSE function?

•    Tighten up these processes!



                                                                                     95
   The Declarable Substances list
ACTION POINTS: How can you use this list?
   2. Go through all your MSDS‟s for your facilities, and see which of the
      substances on the declarable substances list you are using.

   3. Repeat the exercise for MSDSs with material specifications and with
      the non-metallic substances used to make your products.

   4. If you assemble products, the component articles you buy may contain
      SVHCs. You can either:

       •   Create a check list and ask your suppliers to confirm that none of the
           substances on the list are within the product they supply

       •   Apply TR 9535 and TR 9536 in contracts. This will tell you
           if there are SVHCs within the product.

                                                                                    96
   The Declarable Substances list
ACTION POINTS: How can you use this list?


   5. If you find a substance on the declarable substances list in
      an MSDS, in a material spec or in a component you can:

       •   See if there is something safer out there

       •   See if the supplier is likely to reformulate the preparation

       •   See if it is a strategically important substance, which is a
           significant risk to your business.

   6. Create a business continuity plan for each of the
      substances in each of the tradenames/specs /articles that is
      strategically important to you.
                                                                          97
REACH




        QUESTIONS




                    98
 REACH




ASD AIA JOINT APPROACH
TO MANAGING „SVHC‟ AND
       CANDIDATE
    LIST MATERIALS
   (other presentation)   99
    Tools for you to use…
Phased declaration List:

This list contains the most currently issued list of substances
known to be used in the sector. Issue 1 of this list (in your packs)
still contains a mixture of
Process A and B substances.

These are being split and declaration will only be against process
A substances in issue 2 of the list. The latest version can be
downloaded at…
www.asd-europe.org and click on the REACH link.

It is the recommendation from ASD-Europe‟s REACH group, that aerospace
and defence companies require their suppliers to declare any candidate list
substances in their articles (whole products and spareable items) immediately,
and that they develop the capability to declare against the process A list,
recognising that this list will be dynamic and will grow in length.
                                                                            100
   Tools for you to use…
The Declarable Substances Standards:
SAE AP 9535 and SAE ARP 9536 / ASD-STAN TR9353
  / TR9536
The standard comprises of 3 parts:

1. 9535 – This standard is intended to be used to require
   declaration of substances present in articles supplied
   to you.
      • Suppliers can declare ALL the substances in the article
      • Suppliers can declare whether the article contains any
        of the substances listed.
2. 9536 – This explains how to do the declaration using
   the spreadsheet form
3. The spreadsheet itself.                                   101
   Tools for you to use…
Using 9535
      • This standard can be called up in contracts,
        and you can choose to require either the total
        declaration or the declaration against the list
      • The next version of this standard will enable
        you to choose declaration against the
        candidate list or against the process A list.
      • Both the candidate list and the process A list
        will change, and suppliers will be expected to
        always declare against the latest version at the
        time of supply.
      • It will be important for suppliers to have
        systems in place to accommodate this in their
        declarations.                                     102
   Tools for you to use…
Using the spreadsheet
 The spreadsheet currently contains the Declarable Substances
 list, which at the time of issue, was the best estimate that the
 sector had, of substances that could one day be declared
 „substances of very high concern‟.
  • This list can be used as a searchable list to check the MSDS
    you have in your own facilities. If you have any of these
    „high risk‟ substances in preparations / mixtures that are
    business critical, you may wish to consider managing the
    business risk associated with continued use.
  • You can use the same list to check materials specifications
    called up in designs, to see if you have any articles that
    contain high risk substances. If you do, you may wish to
    consider the business risk and your development strategies
    for new uses of these materials.
                                                                103
    Tools for you to use…
The SBAC and ASD-Europe REACH groups:
 Groups exist for you to join, to help you with advice and to put you
 in touch with other companies using the same at-risk substance.
  • In the first instance, if you have a use of a priority candidate
    list substance that is safety critical, you should contact SBAC
    who will put you in touch with ASD-Europe‟s group for the
    substance. SBAC: kevin.morris@sbac.co.uk or
    anthony.burn@sbac.co.uk
  • You can also ask technical REACH questions and they will try
    to help you or put you in contact with an appropriate expert.
  • You can join the SBAC REACH group, and benefit directly
    from the experience around the table (contact Kevin / Anthony
    for details). ASD also has a REACH group comprising of
    trade associations like SBAC and large OEMs.
                                                                   104
Tools for you to use…
Work of the SBAC REACH group:
  • Seeking approval and informing members of progress
     at the ASD – Europe level.
  • Sharing best practice amongst the group at meetings
  • Input into SBAC lobbying activities and consultations
    in relation to REACH and other chemical regulations.
  • Producing useful guidance and advice on the website
    www.sbac.co.uk/reach
  • Organizing these workshops
  • Acting as a „hub‟ for companies wishing to seek
    funding for the development of technical alternatives
    for high risk substances where the project can best
    be done at a national level (for example, using BERR
    technology program funding)
                                                            105
Tools for you to use…
Work of the ASD-Europe group:
  • Creating tools like the REACH implementation
     working guidelines and annexes (in your packs).
   • Together with AIA in the US, creating the 9535 and
     9536 standards on materials declaration
   • Recognised stakeholder to the European Chemicals
     Agency
   • Lobbying and influencing developments on REACH,
     CLP and other chemicals regulations with the EC and
     European Parliament
   • Acting as a “hub” for companies interested in seeking
     EU funding („LIFE‟ or Framework 7 & 8) into technical
     alternatives to high risk substances, particularly those
     on the candidate list
                                                                106
Official sources of guidance
and advice
ECHA WEBSITE:
http://ec.europa.eu/echa/home_en.html
European Commission:
http://ecb.jrc.it/reach/
DEFRA:
http://www.defra.gov.uk/corporate/consult/reach-
enforce/index.htm
HSE: THE UK „Competent Authority‟:
0845 408 9575
UKREACHCA@hse.gsi.gov.uk

                                                   107
 Other sources of guidance and
 advice
http://www.reachready.co.uk
General Manufacturing Industry:
http://www.orgalime.org/publications/guides/reach.htm
Aviation/Automotive Industry:
http://www.asd-europe.org/Content/Default.asp?PageID=41
http://www.sbac.co.uk/reach
Chemicals Industry:
http://www.reachcentrum.org/
Coatings Industry:
http://www.coatings.org.uk and search on OutREACH
Metals Industry:


                                                          108
REACH




        QUESTIONS




                    109
REACH




        LUNCH




                110
REACH




     PRESENTATION
   BY THE REGULATOR




                      111
REACH




 AFTER LUNCH WORKSHOP:
REACH Programme Management




                             112
   Decision points for senior managers
1. If you lost a substance, preparation or article (it is no longer
   supplied to you) – Do you care?
     •   Will your senior managers provide the resources to manage the
         strategically important substances?


2. Are there any products in your portfolio that you will cease to
   produce because of REACH / CLP?
     •   Will your senior managers authorise the spend necessary to make
         your products comply with CLP and REACH?
           – SUBSTANCES and MIXTURES
           – ARTICLES / PARTS / PRODUCTS

 Most distributors and stockists who are importers ARE UNAWARE
 OF THEIR OBLIGATIONS (according to UK HSE & DEFRA). Many                  113
 smaller stockists intend to stop supplying, because of the costs!!
Assessing where you are at…
For stuff you supply – have you got enough
  information:
     1. SUBSTANCES / MIXTURES:
          • a compliant MSDS for the chemicals you supply
          • Labelling information for packaging
          • How you and your customers use each substance,
            so that your uses will continue to be legal
     2. ARTICLES:
          • information about safe use and 0.1%w/w of
            candidate list substances for REACH
          • Labelling requirements for articles packaging
 Most distributors and stockists who are importers ARE UNAWARE
 OF THEIR OBLIGATIONS (according to UK HSE & DEFRA). Many             114
 smaller stockists intend to stop supplying, because of the costs!!
ACTION POINTS

1. Inform senior managers about REACH and the risks it
   poses. Get them to appoint someone to manage it.

2. Hold a workshop inside your company, looking at REACH.
   How to run the workshop – see the „REACH Checklist‟
   handout

3. Start building a plan to manage REACH

4. Ask your supplier if they (OR THEIR UPSTREAM
   SUPPLY CHAIN) pre-registered AND if they intend to
   REGISTER the substances (or the substances within
   the preparations) that they supply to you.

                                                         115
  ACTION POINTS


5. Create an Inventory of all the substances you use
    • In preparations in your facilities
    • In articles you fabricate yourself
    • Start to consider the best way to collect the
      information for the composition of substances
      within the articles you buy.
                      – IT tool? Spreadsheet?


                                                       116
  ACTION POINTS
6. Decide on a course of action for each „At risk‟
   substance, preparation or article.

You can:
    • Trust your supplier to take care of you
    • Try to find other suppliers in the EU who will take care of
      you
    • Find the best person in your company to look into
      alternatives, and to look for others in the same sector who
      may be in the same boat, and willing to work with you.
    • If you are an SME, Discuss it with your customer, who
      may already be working on the same problem.

                                                                117
    ACTION POINTS:
    Authorisation
7. For these substances on the candidate list or registry of
   intent, identify ALL your uses of these substances
      •   In your product

      •   In your process chemicals

      •   In any quantity

      •   Whether there by accident or by design.




                                                               118
  Action Points:
  Authorisation
8. For each use of each substance, collect together any / all
   occupational hygiene, health surveillance, toxicological data
   and claims data.
9. Are any of these uses or candidate list substances,
   “substances of strategic importance” to your business?
      •   Is there a safer alternative you can use instead?

          •   Will changing to the alternative be cost-prohibitive to your
              business (watch your margins!)

      •   How long will it take your business to adapt to life without the
          substance?


                                                                             119
  Action Points:
  Authorisation
10. Does the substance have a threshold value, below which it
    is considered „safe‟?
      •   With a Threshold: you can prove you are using it
          safely, and write a substitution plan to develop and
          use alternatives

      •   Without a Threshold: you need to prove using a
          „Socio-Economic Analysis‟ that it is essential to be
          able to continue to use the substance.

 11. A problem shared? Can you collaborate to share R&D
          costs when proving alternatives will be OK?
      Actions for Everyone: Planning
Step Milestones for Activities
 1    All level 3 plans (site level) rolled out and governance in place
 2    a) Pre-Registration complete
      b) Registration complete
 3    a) Inventory of all preparations used and their manufacturing use code
      b) Inform our suppliers of preparations of our uses
      c) Continuity plans for all key preparations with substances on the
         Declarable Substance List
 4    Authorisation - awaiting clarification of legislation
 5    Agreed concept for all businesses to comply with Declaration (art. 33)
 6    a) Continuity plans for all substances in Articles which are also on the
         Declarable Substance List
      b) First candidate list:
      c) Continuity plans for all substances in Articles which are also on the
         Candidate List
 7    Communication completed to all internally affected areas
 8    New Quality Procedures issued and implemented
Actions for Everyone: Planning
         REACH level 1 Milestone Plan
                                                                                       2008                                       2009
 Section Activity                                                      A   M   J   J    A     S   O   N   D   J   F   M   A   M   J   J   A
         All level 3 plans (site level) rolled out and governance in
    1    place

         Pre-Registration complete
    2
         Registration complete

         Inventory of all preparations used and their
         manufacturing use code

    3    Inform our suppliers of preparations of our uses

         Contiunuity plans for all key preparations with
         substances on the Declarable Substance List

    4    Authorisation - awaiting clarification of legislation

         Agreed concept for all businesses to comply with
    5    Declaration (article 33)
         Continuity plans for all substances in Articles which are
         also on the Declarable Substance List

    6    Receive first candidate list

         Continuity plans for all substances in Articles which are
         also on the Candidate List
         Communication completed to all internally affected
    7    areas

    8    New GQPs issued and implemeted
         Actions for Everyone: Planning
          REACH Milestone Chart                                                                                                    Legal Entity :
V2        Last Updated :                                                                                                           Plan Owner :
         Step and Status
                                    Activities                                                                           Lead           Support
                                                                                                                                                              Apr   May
          Status           Status
                                    REACH Programme
                                                                                                                                                      plan
                   1.1              Define Point of Contact for legal entity                                          REACH Exec       Exec Team
                                                                                                                                                     actual
                                                                                                                                                      plan
                   1.2              Define scope of legal entity                                                          POC

 1                 1.3              Hold initial workshop                                                                 POC          Exec Team
                                                                                                                                                     actual
                                                                                                                                                      plan
                                                                                                                                                     actual
                                                                                                                                                      plan
                   1.4              Governance of Actions                                                                 POC          REACH PM
                                                                                                                                                     actual
                                    Pre-Registration and Registration
                                                                                                                                                      plan
                   2.1              Determine any Articles with intended release                                      Engineering
                                                                                                                                                     actual
                                                                                                                                                      plan
                   2.2              Determine what needs to be pre-registered (incl. analysis of imports)                 POC          Procurement
                                                                                                                                                     actual


     2             2.3              Determine how it will be preregistered (self, own rep etc)                            POC          Procurement
                                                                                                                                                      plan
                                                                                                                                                     actual
                                                                                                                                                      plan
                   2.4              Complete Pre - registration                                                        Corp HSE           POC
                                                                                                                                                     actual
                                                                                                                                                      plan
                   2.5              Complete registration                                                           Substance Owner    As required
                                                                                                                                                     actual
                                    Business Risk from Preparations
                                    Collate inventory of Substances and Preparations used in RR facility to                                           plan
                   3.1              manufacture product
                                                                                                                       Local HSE        Local Lab
                                                                                                                                                     actual
                                                                                                                                                      plan
                   3.2              Categorise the manufacturing use of each preparation (as defined by RIP3.2.2)      Local Lab       Local HSE
                                                                                                                                                     actual
                                                                                                                                                      plan
                   3.3              Inform suppliers of our uses and request that this use will be registered         Procurement
                                                                                                                                                     actual
                                                                                                                                                      plan
                   3.4              Analyse the Safety Data Sheets for substances also on the DSL                      Local HSE        Corp HSE
                                                                                                                                                     actual

     3             3.5              Contiunuity plans for substances in Safety Data Sheets and in DSL               Substance Owners    Local lab
                                                                                                                                                      plan
                                                                                                                                                     actual
                                                                                                                                                      plan
                   3.6              Risk Analysis of preparation suppliers and mitigation actions                     Procurement
REACH




        QUESTIONS




                    125
REACH




 AFTER LUNCH DISCUSSION:
REACH Defence Exemption issues




                                 126
    REACH – The Legal Overview
 Supply Chain and manufacturing use of Substances                                                    Authorisation

                                          Registration                                                to use in specific
                                                                        Evaluation                       application
        Pre-registration
           Manufacturer /            Pre Registrants to submit of
                                                                           By ECHA.
     Importer of substances into      Safety Assessment for
                                                                    For several substances
         EU >1 tonne/year              each specific use of
                                                                     this may already exist
                                       substance to ECHA                                              Restriction




                                             Substances of Very High Concern




Declaring Substances of Very High Concern in Articles to customers and ECHA


                                   0.1% of SVHCs                                   0.1% of SVHCs    Defence Agency
             Supplier                 In Articles        Defence Supplier             In Articles     and ECHA
Defence Exemption in REACH

  1) REACH applies in its entirety to all defence
     products through registration of all the
     substances that they are made from.

  2) A Defence Exemption has to be created in
     the law of a Member State to manage the
     Defence Security and Operational Capability
     issues compromised by REACH.

  3) Defence Exemptions have been included in
     REACH to help the Defence Agencies
     maintain security and capability – not to
     help industry ignore REACH.
   Defence Exemption in REACH

 When could a Defence Exemption be used?


•Where a material (Preparation) is classified
•Where the use of a material is classified
•Where other legislation prevents supply of data to support
     REACH (e.g. International Traffic in Arms Regulations)
•Where the use of a SVHC is classified
•Where the defence uses of a materials is Authorised or
     Restricted
•Where defence related PPORD is classified
    REACH – The Legal Overview
 Supply Chain and manufacturing use of Substances                                                    Authorisation

                                          Registration                                                to use in specific
                                                                        Evaluation                       application
        Pre-registration
           Manufacturer /            Pre Registrants to submit of
                                                                           By ECHA.
     Importer of substances into      Safety Assessment for
                                                                    For several substances
         EU >1 tonne/year              each specific use of
                                                                     this may already exist
                                       substance to ECHA                                              Restriction




                                             Substances of Very High Concern




Declaring Substances of Very High Concern in Articles to customers and ECHA


                                   0.1% of SVHCs                                   0.1% of SVHCs    Defence Agency
             Supplier                 In Articles        Defence Supplier             In Articles     and ECHA
  UK MoD Defence Exemption
UK MoD foremost in preparing a system for Defence
Exemptions in EU

Defence Exemption introduced into UK Law in 2008

Status for Applications
       Pre-registration          Complete
       Registration       To start – Draft process in place
       PPORD              Process under discussion
       Authorisation      Process under discussion
       Restriction*       Process under discussion
       Notification       Process under discussion


*MoD policy is to restrict material uses where EChA introduces
them, where capability is not compromised.
Defence Exemption in REACH

 The UK defence exemption does not allow suppliers to
 defence agencies to ignore REACH.

 The material or use must be classified, or capability
 compromised for MoD to provide Defence Exemption.

 It provides a mechanism for compliance that will:
     •Enable secrets to be kept secret
    •Enable products in the field to remain operational
    •Still permit the phasing out of „Substances of Very
     High Concern‟
  Security & Collaborative Projects
Concerns : Defence Collaborative Projects

1) Collaborative Projects between Member States
    a) Not all have Defence Exemptions.
         • Defence Collaborative Projects prejudiced –
            security implications
    b) Variation in Defence Exemption Frameworks
         • Issues in workability – concerns on security.

2) Collaborative Projects outside the EU
    a) Vital to the viability of the defence sector.
    b) Compromised if defence suppliers are unable to
        source non-EU classified defence materiel.
  Business Risks and REACH

Industry concerns

1) When an SVHC requires authorisation or restriction it
   will be lost to mainstream use, and difficult to source
   for Defence use.
2) Materiel substitution for defence products difficult &
   time consuming.
     a) Harsh operational environment
     b) Re-qualification requirements
3) The UK Chemical Industries Association believes
   registration for significant numbers of existing
   substances will not be economically viable (regardless
   as to whether the substance is hazardous or not).
     Defence Exemptions in the EU
Member state    Status
Denmark         No progress

Finland         Realisation of need

Germany         Designated agency, no legislation

France          Designated agency, no legislation

Spain           Designated agency, no legislation

Greece          Designated agency, no legislation

Italy           Designated agency, legislation, but no actual
                exemptions in process
Netherlands     Designated agency, legislation, but exemptions in
                process, weaknesses
UK              Designated agency, legislation, but exemptions in
                process, weaknesses being addressed
SBAC view on Defence Exemptions
  A Defence Exemption in all Member States
  is needed to ensure the long term
  maintenance of existing defence assets and
  battlefield capability.

   • The Defence Exemption should have common
     framework in all Member States.

   • A Defence Exemption raised by one Member
     State should be recognised as such in all
     others.

   • The Defence Exemption needs to ensure that
     classified information from any country (inside
     and outside the EU) is respected and not
     disclosed to others.
ACTION at EU level
Moves are being made to raise the awareness of
the issue at ASD-Europe (the EU level trade
association for our sector).
Actions:
 • You can get involved with other EU Defence businesses
   who are affected by the exemption (or lack of
   exemption).

 • Businesses can support ASD and SBAC in lobbying
   member states to enact their own defence exemption in
   line with our position, and to encourage the European
   Defence Agency to play a part.

 • The group can advise the UK MoD and other MoDs in
   the future direction of the exemption, with respect to
   ITAR interpretation, Authorisation and Restriction
   exemptions – which are still not addressed adequately.
REACH




        QUESTIONS




                    138
REACH




AFTER LUNCH DISCUSSION:
REACH and the CLP regulations




                                139
 REACH – legal overview with COSHH and MSDS
Supply Chain and manufacturing use of Substances                                       Authorisation

                                    Registration                                       to use in specific
                                                                 Evaluation               application
      Pre-registration
                                Pre Registrants to submit
                                                                    By ECHA.
    Import substances into EU    Safety Assessment for
                                                             For several substances
          >1tonne/year            each specific use of
                                                              this may already exist
                                       substance                                        Restriction




                    MSDS:                                        COSHH
                                                            Risk Assessments
        Legally Enforceable
   „Risk Management Measures‟



         Compliant technical controls (LEV), PPE etc.
                                                                                                            140
CLP Regulations:
Harmonisation of classification
• Suppliers of products containing
  Carcinogens, mutagens and reproductive
  toxins (CMRs) at category 1A, 1B or 2, or
  sensitisers (category 1) will be subject to
  HARMONISED Classification and Labelling
  according to the GHS. Packaging has to be
  marked accordingly.
• For these substances, the supplier MUST
  use the classification laid down in the CLP
  regulations and cannot use their own
  interpretation.
• This will apply to any supplier in any country
  applying the GHS.


                                                   141
   CLP – legal overview
  Supply Chain and manufacturing use of Substances                                          Authorisation

                                      Registration                                           to use in specific
                                                                  Evaluation                    application
        Pre-registration
                                  Pre Registrants to submit
                                                                     By ECHA.
      Import substances into EU    Safety Assessment for
                                                              For several substances
            >1tonne/year            each specific use of
                                                               this may already exist
                                         substance                                           Restriction




US information

EU information
                                                                                    UN Consensus on
                                                                                      Classification
Canadian information
                                                                                     For substance
   Chinese information
                                                                                     Classification
         Japanese information
                                                                                    Added in GHS,
                          Australian information                                 published by UN, and
                                                                                  added to the EU‟s
                                     Korean information
                                                                                       CLP Regs.                  142
CLASSIFICATION: CLP and GHS regulations
•   GHS AND CLP:
     • Flammable, explosive, oxidising

     • Carcinogenic, Mutagenic, Reprotoxin

     • Toxic (acute, chronic), specific organ

     • Corrosive, irritant

     • Respiratory / skin sensitizer

     • Environmental (aquatic)
•   CLP only:
     • Persistant Organic Pollutants (POPs), ozone
       depletants, vPvBs, PBTs.                      143
LABELLING: CLP and GHS regulations –
•   Results in consistent labelling for supply, use and
    transportation of chemicals.
•   Labelling requirements include:
     • Name, address and telephone no. of supplier

     • The name as given in the CLP list of harmonised
       substances, or if it is not listed, the „IUPAC‟ Name of
       the product

     • The CAS number(s), the product code and quantity

     • The specified signal word („danger‟), the hazard
       statement as required by the classification, the
       associated pictogram, and precautionary statements.

     • These are NOT the same as R and S codes, but have
       the same basic purpose.                           144
PACKAGING: CLP and GHS regulations –
•   Contents cannot escape
•   Contents will not damage / degrade the packaging
•   No hazardous products will be formed from interaction
    between contents and packaging
•   The packaging label will have all the „labelling‟
    information clearly visible
•   Information has to be shown on each packaging layer
    (unless the packaging is seethrough)
•   Some specific hazard phrases may have to be added to
    packaging if the risk is specifically to do with transport.
•   If the product is sold to the general public, there has to
    be a tactile warning added.


                                                                  145
CLP regulations legal overview
Producing MSDS in accordance with REACH and CLP Regulations

   Manufacture or                                                          Hazardous
                           NO LIMIT ON                                                             NOTIFY ECHA so
  formulation of a          QUANTITY                                    Substances on their
                                                                         own or in mixtures
                                                                                                   gets included in
    substance or            SUPPLIED
                                                                                                    the inventory
preparation / mixture
                                                    Identify ALL
                                                      relevant
                                                   toxicological
                                                 information and                                     PROVIDE the
  Manufacture of an                             uses information:                                      MSDS
    ARTICLE with a                                CLASSIFY the              CLASSIFIED
substance intended to                              substance in          Substances (GHS)
                                                accordance with         Restricted substances
    be released, or                                                       and SVHCs are
 containing an SVHC,                                    GHS
                          1 tonne limit                                        declared               LABEL the
 or where ECHA asks            p.a.                                                                 packaging using
   for registration /                                                                                GHS symbols,
   notification of a                                                                               hazard statements
substance in an article                                                                                   etc.


                                                                                                CUSTOMER INFORMS OF
                                                                                                     NEW USE
REACH
                                                                                                    Authorisation

       Pre-registration               Registration                  Evaluation
                                                                                                     Restriction


                                                                                                                       146
REACH “Substances of Very
High Concern” Labelling in
GHS / CLP

• Carcinogens, mutagens and

   reproductive toxins (CMRs)

• Persistent, Biocumulative and Toxic (PBT)



• THERE ARE CURRENTLY NO LABELS for very persistent
  and very bioaccumulative (vPvB) or for many substances of
  equivalent concern in GHS, CLP or in the rules for the
  transport of dangerous goods.

                                                         147
The positive outcomes of REACH
and the CLP regulations
REACH will have BENEFITS for human health, and the
environment because some really hazardous chemicals in use
will not be allowed in future.
 • More information will be available about the hazards and how
   to manage them (on the MSDS)

 • Greater consistency in classification and labelling for the
   same product supplied from all round the world

 • Most risk assessments will be easier to put together and to
   audit against – Users are required to follow the Risk
   Management Measures on the MSDS


                                                                 148
REACH




        QUESTIONS




                    149

				
DOCUMENT INFO
Description: Reach Msds Spreadsheet document sample