1. The Effects of REACH Regulation on the Nickel Plating Industry
Claire Mattelet
ENIA Environmental and Human Health technical Manager
Birmingham October 9th, 2007

2. What does this mean for the plating industry?
Introduction
New legislation for chemicals industry (including metals)
Main aim:
Ensure high level of protection of human health & the environment
Greater responsibility to industry:
Provide safety information on substances
Manage the risk from chemicals
Information to be passed up and down the supply chain
Reversal burden of proof from authorities to industry to
Assess
Document
Register
Communicate
What does this mean for the plating industry?
Birmingham October 9th, 2007

3. REACH requirements PBT CMR Registration Evaluation Authorisation
≥1000 tons and
Substances of
High concern
Producer/importer
≥1 ton
Producer/importer
≥100 tons
Producer/importer
PBT
CMR
CSR
CSR
>10 t
PERMIT
Birmingham October 9th, 2007

4. Scope Exemptions from Registration Exemptions from Authorisation
Uses covered by sectoral legislation (e.g. medicinal uses)
Ni plating industry not exempted
Identified individual substances (Annex IV):
E.g.: C, CO2…
Categories of substances (Annex V)
E.g.: By-products (unless they are imported or placed on the market), minerals, ores, ore concentrates (if they are not chemically modified)
Exemptions from Authorisation
Intermediates (e.g. Ni matte)
Birmingham October 9th, 2007

5. Registration – Authorisation
Volume based
Hazard-Risk based
One Registration per substance for all the uses
One Authorisation per USE of a substance
Access to market for a substance
Access to market for a use of a substance
Technical dossier (M/I) + Chemical Safety Report (M/I or DU)
Chemical Safety Report + Socio-economic analysis + Substitution plan
Time unlimited
Time limited
Birmingham October 9th, 2007

6. All M/I: pre-registration Authorisation – “candidate list”
REACH & DUs
For Ni REACH is 3,5 years (not 10 yrs !!)
All M/I: pre-registration
Authorisation – “candidate list”
Registration
> 1 t
Registration
> 1000 t
R50/53 > 100 t
CMR’s > 1t
Registration
> 100 t
Entry into force
31 May 2013
31 May 2018
1 June 2007
June 2009
1 June 2008
1 Dec 2008
30 Nov 2010
Birmingham October 9th, 2007

7. Pre-registration SIEF = Substance Info Exchange Forum
Who? Each legal entity of a M/I Company based in EU
Not applicable to platers unless they are importers.
When? 1 June December 2008
What?
Substance name
Potential Registrants details (or third party representative)
Deadline for registration
Name(s) of substance(s) relevant to apply grouping / read-across
Aim:
Create a database and the Substance Information Exchange Forum (SIEF)
SIEF = Substance Info Exchange Forum
All Manufacturers/Importers (M/I) who have submitted information to the Agency for the “same substance”
Operational until 2018!
Birmingham October 9th, 2007

8. Registration Scope Task of Registrant
Substances produced/imported > 1t/y/M-I
Task of Registrant
Obtain adequate information on intrinsic properties of the substance (e.g. existing data)
Perform Chemical Safety Assessment (CSA) for substances > 10 t/year (demonstrate adequate control per use) to draft the Chemical Safety Report (CSR)
Communication with platers is key
Send information to the Agency by deadline
OSOR principle (One Substance One Registration)
Birmingham October 9th, 2007

9. Ni substances already evaluated during the RA!
Evaluation – Overview
Dossier Evaluation
Substance Evaluation
Check test proposals
Compliance
Examine any information on a substance
Ni substances already evaluated during the RA!
Output:
Further information decisions
Other parts of REACH and other legislation
Birmingham October 9th, 2007

10. Authorisation Aims: Applications:
Risks from substances of very high concern properly controlled
Substances progressively replaced by suitable alternative substances or technologies economically and technically viable
Applications:
Applies to M/I and DUs placing a substance on the market for a use or use it himself
Time-limited review period: on a case-by-case basis upon Commission request
Birmingham October 9th, 2007

11. Authorisation: What’s new ?
Requires targeted RA per substance use !
Application
Must Include
Chemical Safety Report (the same as in the Registration dossier if the substance is registered)
analysis of alternatives (risks & technical and economical feasibility of substitution) and relevant R&D if appropriate
if suitable alternatives are available, a substitution plan
May include
Socio-Economic Analysis
Individual application by EACH manufacturer, importer or Downstream user
Birmingham October 9th, 2007

12. Worst case – No risk for Ni!
Restriction
Aim: Regulate Community wide, yet in a focused way, conditions for the manufacture, placing on the market or use of certain substances where there is an unacceptable risk to health or the environment or the prohibition of any of these activities, if necessary.
Process:
Existing restrictions are maintained
E.g.: ban on asbestos
Preparation of proposals of Restriction of a use of a substance by Member States or Agency on behalf of the Commission
Commenting period for the interested parties (e.g. Industry, DUs NGOs…)
Opinion of the Agency but decision by the Commission
N.B.: This procedure could be completely independent of Registration and Authorisation
Worst case – No risk for Ni!
Birmingham October 9th, 2007

13. Conclusion: REACH Deadlines
1 June 2007: Entry into Force
Action: SDS changes
1 June 2008: Start of Pre-registration
Action: Manufacturers/Importers pre-register
30 November 2008: End of Pre-registration
Action: /
1 January 2009: Publication of list of the Substances pre-registered on European CHemicals Agency (ECHA) website
Action: Identification of new stakeholders (data sharing)
30 November 2010: Registration deadline
Actions:
Manufacturers/Importers register: exsposure data gathering (env and HH) for the different use sectors, generic operational conditions are key.
Publication of CL&L on ECHA website
Birmingham October 9th, 2007

14. REACH and DUs
Birmingham October 9th, 2007

15. Chemical Safety Report (CSR)
Substance manufacture >10 T/y
Document Risk management measures and operational conditions for protecting humans and the environment including exposure scenarios (risk characterization for each identified use when needed)
Safety Data Sheet (SDS):
Communicate & summarize risk management measures to be implemented by downstream users for protecting humans and the environment (main body). Exposure scenarios annexed to SDS (eSDS) provide more details (e.g, list operational conditions).
Chemical Safety Assessment (CSA):
Determine if substance is dangerous (need of exposure scenarios) and which risk management measures and which operational conditions are necessary for protecting humans and the environment
Birmingham October 9th, 2007

16. ES template
Birmingham October 9th, 2007

17. DUs’obligations (hazardous substances)
Safety Data Sheet
(SDS)
SUPPLIER
Downstream User
SUPPLIER
Downstream User
INFORMATION
A Downstream user has to:
Notify “identified uses”
Provide workplace exposure data or exposure data on product use
Check the Safety Data Sheet (SDS) including an ES
Review CSR
Keep information up to date, communicate it with supplier
Communicate the information throughout the supply chain
Apply Authorisation
Birmingham October 9th, 2007

18. DUs’obligations (hazardous substances)
Chemical Safety Report
(CSR)
Downstream User
A Downstream User is obliged to prepare a Chemical Safety Report (CSR) for any use outside the conditions described in an exposure scenario communicated to him in a SDS or for any use his supplier advises against or for confidential reasons.
A CSR is provided directly to the Agency.
Birmingham October 9th, 2007

19. Key REACH requirements for DUs
PRE- REGISTRATION – REGISTRATION - EVALUATION
SIEF
Test
requirements
Exposure
Scenario’s
CSR
Evaluation
Identify uses
Report Exposures
> 2010
Tentative ES agreement
Agree on SDS
AUTHORISATION
CMR, EQ,
PBT
identification
Authorisation
announcement
Prioritisation
Authorisation
filing
“CSR” SEA &
Substitution
review
Authorisation
Check if use sector announced
Interact with M/I
Check if listed
REACH can be divided in clearly identifiable steps & work packs
Birmingham October 9th, 2007

20. Main risks for you as DU (1)
Risk of disappearance of critical substances IF:
Manufacturer/importer fails to Register
Substance required Authorisation and
No Authorisation requested/achieved by M/I
Substitute material does not fit for purpose
Default Risk scenario’s resulting in worst case exposure scenario’s IF:
DU sector did not provide adequate exposure data
Birmingham October 9th, 2007

21. Main risks for you as DU (2)
Need to prepare a CSR IF:
DU forgets to identify “identified use”
DU is importer
DU imports an article containing “substances” that are not produced in the EU
Drop in demand for products of DU IF:
Product contains “authorisable” substances
Ni plating industry: could happen (some Ni salts are CMRs: carc. cat 1 inhalation, repro 2)
BUT!!! NI legally prepared (NiRA) => unlikely that plating on candidate list in the 1st round
Birmingham October 9th, 2007

22. NI Communication Plan
Birmingham October 9th, 2007 22

23. Ni plating representative
Approach: Ni Plating case
Ni salts M/I
Cr M/I
Ni plating representative
Ni plating Industries NI
ICDA
Identify common uses in associations
Programs:
1, 2. Identify DUs representatives
3. Inventory of exsiting data for Use
ES Communication
4. ES development
4a. Tentative ES
INPUT
4b. Multi-Metal questionnaire
ES Refinement, Final ES
ES Communication
5a. Composite ES
Birmingham October 9th, 2007

24. Program 1: identify DU industry use sectors and single representative
Identify the use sectors and their associations
Establish (preferably) contact via a single representative per use
Ask Consortia members to identify uses (if use sector not organized)
Information on websites, Metal Bulletin…
Sept.-Oct.’07, ongoing until end Q for new uses
Birmingham October 9th, 2007

25. Mainly complete by end ’07, until Q1 2009 (new uses, new DUs)
Program 2: Communication of Information documents and training material to DUs
Prepare information on Nickel REACH Consortia
Benefits of joining Consortia : encourage Associate Membership of Consortia
Detail responsibilities of a DU representative in Consortia
Communicate information on Consortia
To DU associations
Challenge: DUs not organised into Associations and to potential new uses
Oct. ‘07
Mainly complete by end ’07, until Q (new uses, new DUs)
Birmingham October 9th, 2007 25

26. Obtain data consolidated by use process
Program 3: Prepare coordination with other associations for data gathering
Multi-metallic questionnaire & tentative ES to each DU representative requesting consolidated data
How to select DUs plants?
Obtain data consolidated by use process
Challenge: through associate members or appointment of consultant?
Workshop December 2007
Collect consolidated replies June 2008, ongoing until 2009 for new uses
Birmingham October 9th, 2007

27. Program 4: Communication support for collection of exposure data and drafting of Exposure Scenarios
A structured, iterative approach needed to collect exposure data & Exposure Scenarios draft
Outcomes of data collection to be presented to DU industries if risk identified for use: ad hoc meetings.
Regular communication with DUs on the draft Exposure Scenarios so that agreement is reached before Registration.
From mid-2009 until mid-2010
Birmingham October 9th, 2007 27

28. The Consortia concept
Birmingham October 9th, 2007

29. Introduction
The formation of Consortia is no longer mentioned in REACH!
BUT the “OSOR principle” still remains:
Mandatory joint submission: the technical dossier
Mandatory sharing of existing data: tests involving vertebrates
Voluntary joint submission: the Chemical Safety Report
Voluntary sharing of existing data: tests not involving vertebrates
N.B.: In case of non existing or not sharing of data: studies have to be conducted once only
Introduction of the Substance Information Exchange Forum (SIEF)
Birmingham October 9th, 2007

30. Consortium SIEF Voluntary = potential form of cooperation Mandatory
Timing: free
Timing: ?
Interested members
ALL the potential registrants + “data holders”
Scope: free
E.g.:
Pre-Registration
Preparation - guidance
Registration
Facilitate for the purposes of Registration the exchange of the information (including regarding the CSR)
Joint submission
Agree on Classification & Labelling
Authorization
Facilitate the fulfilling of the Authorization requirements …
Scope:
………………
Facilitate for the purposes of Registration, the data sharing, avoiding duplication of studies
Agree on Hazard Classification & Labelling
…………………
Birmingham October 9th, 2007

31. Reasons to join a Consortium
Legal certainty
Consortium agreement allows to know in advance the conditions of future collaboration
Possibility to include once and for all relevant safeguards
Pooling of resources and reducing redundancy
Existing Study reports
In-house expertise
Cost-efficiency
Grouping of substances
Credibility and efficiency in the communication
Uniform data set
Avoid divergent identity of substances
Disparate submission and information draws authorities attention to the substance
Possible to coordinate follow up Registration / Evaluation / Authorization
When? Now!
Anticipation and early preparation: list of substances pre-registered will be published in January 2009
=> Effective preparation time is less than 18 months for highest tonnages and CMR!
Birmingham October 9th, 2007

32. List of substances Consortium 1: Nickel metal Nickel chloride
Nickel nitrate
Nickel sulphate
(Closed list)
Consortium 2:
Nickel oxide
Nickel dihydroxide
Nickel hydroxicarbonate
Nickel oxyhydroxide,
Nickel acetate
Nickel sulphamate …
(Open list)
Consortium 3:
«Complex materials»
(e.g.: Ni matte as «», ferronickel as «special preparation».)
(Open list)
Birmingham October 9th, 2007

33. Next Steps? Communicate Collaborate Join a Consortium
Birmingham October 9th, 2007

34. Questions on REACH? Birmingham October 9th, 2007
Overall NI REACH Implementation coordination:
France Capon (assisted by Jeroen Van Hecke)
REACH Coordinator
Exposure Scenarios:
Claire Mattelet
Environment and Human Health Technical Manager
Science & policy: Hugo Waeterschoot, Secretary General, ENIA
Communication with Downstream Users
Peter Cutler
European Director, Market Support & Development
Socio economical Analysis
Michel Vander Straeten
Manager, EU Policy
Communication with Downstream Users
Paola Di Discordia
European EHS Policy Director
Birmingham October 9th, 2007