Impact of REACH on the Ni industry. France Capon Senior Advisor, Chemicals Management, Nickel Institute

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1 Impact of REACH on the industry France Capon Senior Advisor, Chemicals Management, Institute

2 Content 1. Registration and Evaluation 2. Annex XVII Restriction 3. Authorisation process 4. Authorisation: what does it mean for compounds? 5. Authorisation: key messages 6. Conclusions 2

3 Registration metal, sulphate, dinitrate, chloride, sulphide, hydroxycarbonate, subsulphide, sulphamate, acetate, dihydroxide, oxide, matte, Ash ALL substances have been registered in Voluntary Updates of Registration dossiers: -A procedurehas been developed: the Registration dossiers of and nickel compounds will be updated on a yearly basis Updates have been submitted in June Updates are under finalisation Fe specific CSR - waiting for final guidance 2012? Standard methodfor metals in alloys: handle alloys as a Special preparation by: Register the individual component substances including a CSR and an Exposure Scenario for the alloy AND Voluntarily demonstrate different properties of the alloy through testing Challenges: Guidance on Special Preparation assessment : Time to validate the SP assessment ona sciencepoint of view Time to validate the SP assessment on a politicalpoint of view 3 3

4 Registration and Evaluation metal, sulphate, dinitrate, chloride, sulphide, hydroxycarbonate, subsulphide, sulphamate, acetate, dihydroxide, oxide, matte, Ash Legal obligations Main challenge: uncertainties regarding timing and prioritization in Evaluation of dossier and Evaluation of substance: so far, no nickel substances on the CoRAP no ongoing Dossier Evaluation 4

5 Dossier Evaluation under REACH 2011 ECHA progress report Need to improve testing proposals Three main areas of attention: 1. Description of substance ID: could be an issue for metal in alloy! 2. Well described Read-across 3. Quality and validity of the CSA Report also contains specific section on Isolated Intermediates - ECHA/MSCA checked if substance meets definition of intermediate and fulfills SCC compliance. - The program ( verification of intermediates ) has already screened 400 dossiers with the majority not justifying choice. 40 letters have gone out to LR. 5

6 Substance Evaluation: 1 st CoRAP Published Feb Lists 91 substances (NO substance) to be evaluated during 2012 (36), 2013 (23) and 2014 (31). Includes 4 metal compounds (Ag, TiO 2 and SiO 2 mainly nano concerns/form tested; GaAs exposure) MAIN CRITERIA FOR SELECTING 90 SUBSTANCES: CMR Suspected Endocrine disruptors High exposure/rcr close to 1 Wide dispersive use high tonnage ENV PBT ENV chronic toxicity Nanoparticles/toxicity of different forms Lack of exposure assessment/risk characterisation Consumer use The next update is scheduled Feb th New substances could be added to the list of substance being evaluated in year 2013 and MS aim for substances/year. 6

7 Annex XVII - Restrictions September 2011: EU REACH Committee - Restrictions for substances placed on Annex VI of the CLP Regulation with a harmonised classification of category 1A or 1B carcinogen under the first Adaptation to Technical Progress (ATP) in 2009: nickel containing chemicals which are included in the 1 st ATP and are classified as CMR cat 1A and 1B The restriction of substances with such a classification will apply to consumer applications under Annex XVII (sections -30) of REACH. 138 containing chemicals are covered by this Restriction. However, only 23 of them have been registered under REACH. These chemicals have been registered in EU as intermediates or as substances without any identified consumer use. This means that none of the nickel containing chemicals included in the Restriction process are sold (or should be) to the consumers in EU. Entry into force: 1 st March

8 Authorisation: Introduction REACH Authorisation objective & focus: identifying substances of very high concern; listing them on a candidate list; subjecting them to authorizations with a strong focus on substitution. Political expectations and objectives of the REACH authorisation process are HIGH: Aim of article 55 of REACH Regulation - make sure that risks resulting from SVHCs will be properly managed and whenever possible these substances will be progressively substituted Already resulted in proliferation of lists (SIN, ETUC, DU sectors or individual company) Commission goal to have candidate list grow to 136 substances by end of 2012 (20 in January 2012 and 62 in August!) All relevant known SVHC will be on Candidate list by

9 Listing & Autorisation: process Member State or ECHA prepares an Annex XV dossier SVHC Status 73 Candidate List In February 13 additional proposals to dientify SVHC have been sent to ECHA Prioritisation Priority List Annex XIV Authorities and interested parties SVHC properties and uses Authorities and interested parties Priorities and exemptions 14 9

10 Status of Listing: trends in Member States 10 10

11 Status of Listing: trends in Member States has not been listed Nextimportant deadline 11 11

12 Key MS for production and use of and chemicals Sweden chemicals production downstream uses Highly active on authorization Finland chemicals production downstream uses Moderate activity on authorization UK chemicals production downstream uses highly active on authorization Spain downstream uses Moderate activity on authorization Netherlands downstream uses highly active on authorization Belgium chemicals production Moderate activity on authorization France chemicals production downstream uses highly active on authorization Denmark downstream uses highly active on authorization Poland chemicals production Germany Moderate activity on authorization chemicals production downstream uses Highly active on authorization Austria chemicals production Moderate activity at EU level Italy downstream uses Moderate activity at EU level 12

13 Authorisation: what does it mean for containing chemicals? Some figures On the basis of new CMR status after 1 st ATP to CLP circa100 nickel compounds could end up in the authorisation process Only 23nickel containing chemicalslisted in the 1 st ATP have been registered Current status of the Candidate list : 92 % of substances are CMR or atleast R, only8 % are PBT/vPvB and 44 % are metalscompounds. 13

14 Authorisation: what does it mean for containing chemicals? Risk for key nickel chemicals to be listed on the «Candidate list» but not «prioritized» on the Annex XIV because: chemicals are already well regulated (e.g.: restriction to consumer use) Low inherent hazardous properties of nickel sulphate (i.e., not a PBT or vpvb; substance with C and R properties with effect threshold...) Non-diffuse and the well-controlled use of nickel chemicals There is no consumer exposure There is to date no technically and economically viable substitution enabling achievement of the equivalent environmental performances and fitting a consistent sustainable development policy. Ongoing discussions on a Risk Management Option: OEL setting Moreover, ongoing discussions at MS, ECHA and EC level regarding the best Risk Management Options (Authorisation, Restriction or setting of exposure limit values): a workshop will be organized in May on this issue. 14

15 NI L&A WP: a precautionary approach! Engage proactively with the REACH L&A process to protect critical use of nickel containing chemicals and end uses Prevent stigmatisation of nickel Use in productsand articles Maintainaccessto market for critical nickel containing chemicals Support and defend criticaluses of nickel containing chemicals in EU 15

16 10 Key messages based on current experience in the Metals industry 1. Authorisation process is a learning by doing exercise for all of us 2. Input from manufactures & users in pre-consultation phase is very efficient for all parties and allows better scoping, Risk Management Option (RMO) assessment, prioritisation, More emphasis needed on efficiency by selecting right RMO 4. RMO analysis should occur as early as possible preferably before the inclusion in the Candidate list emphasising the most effective RM option and considering aspects like competitiveness, innovation, criticality, contribution to sustainability, Public Consultation objectives needs rethinking and reorientation 6. Opinion forming and conclusion at MSC needs more transparency, equality & discussion 7. Selection and prioritisation criteria should not be discriminatory and need review 8. Alternatives analysis should be use specific (where relevant) if this promotes the aimed substitutability 9. Grouping should be based on effective substitutability 10. Strategic discussion on exemptions (e.g. Essential Elements, catalysts that are used for their atomic shape,...) are crucial 16

17 Conclusions Registration: A positive and succesfull exercise allowing a better communication throughout the Supply Chain Authorisation is an extremely heavy and complex process Risk for key nickel compounds to be listed but other Risk Management Option exist if remaining risks are identifed Proactive involvement of the industry in Authorisation process is key Proactive involvement of the Institute in the preparation for Authorisation via different projects: Understanding of the Authorisation process SEA projects Substitution assessment Listing response plan available Communication program Active involvement of downstream use sectors in EU is crucial: but not only the first users! 17

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