Implementation of REACH & CLP: common challenges of national authorities and ECHA

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1 Implementation of REACH & CLP: common challenges of national authorities and ECHA Finnish Safety and Chemicals Agency (Tukes); Opening Seminar 9 February 2011, Tampere Geert Dancet Executive Director

2 Content Background on REACH The European Chemicals Agency and its role Overview of REACH & CLP processes Progress to date and key future milestones Key messages for Tukes 2

3 REACH - groundbreaking legislation REACH Regulation is a product of an almost 10 years legislative process Past: Authorities to prove chemicals pose risk REACH: Industry to prove chemicals are safe Ensures high level of protection of human health and the environment Promotes alternative methods for assessment and testing of chemicals Enhances competiveness and innovation Most ambitious chemicals legislation in the world Benchmark for our OECD partners 3

4 ECHA and its role 4

5 The European Chemicals Agency MISSION Manage REACH and CLP tasks Ensure a consistent implementation at EU/EEA level Provide the best possible scientific advice on safety and socio-economic aspects of the use of chemicals Ensure a credible decisionmaking process, using the best possible scientific, technical and regulatory capacities Work independently in an efficient, transparent and consistent manner ORGANISATION Management Board Executive Director Secretariat (currently staff of 435) Three Scientific Committees MSC, RAC, SEAC Forum on Enforcement Networks (HelpNet, RCN, SON) Board of Appeal 5

6 ECHA Organigramme

7 ECHA staff 435 (31 January 2011) From 25 EU countries (no Cypriots or Luxembourgish yet) Romanian 15; 3% Greek 18; 4% Polish 18; 4% Belgian 18; 4% Other 75; 18% Finnish 152; 35% Spanish 23; 5% British 26; 6% Italian 28; 6% French 30; 7% German 32; 7% 7

8 Overview of REACH & CLP processes 8

9 REACH and CLP processes MSs Pre-registration Data sharing Registration Self-Classification Evaluation Dossier evaluation Substance evaluation Industry gathers information and ensures responsible and well-informed management of the risks ECHA and MSCAs control and request for further info Authorisation Restriction Harmonised C&L COM, with support of ECHA and MSCAs, applies community wide risk management measures 9

10 REACH: Registration Core of REACH: EU/EEA manufacturers and importers of chemicals collectively obtain information per substance and use knowledge to ensure safe use Registration dossier: Technical Dossier (for all chemicals at 1 tonne per annum or more up to fields per dossier) Chemical Safety Report describing the full life cycle (for all substances at 10 tonnes per annum or more) Electronic submission via specialised IT-Portal (REACH-IT) paperless procedure 10

11 Registrations for 2010 deadline Lead Registrants DE, UK, BE, FR, NL Substances ~ 4300 substances covering 3400 phase-in substances ~ 4500 expected (inventory on ECHA s website) Dossiers ~ dossiers accepted (further received in Dec. 941) ~ dossiers planned ~ dossiers estimated 11

12 Next registration dead-line looming Pre-registration Old chemicals (phase-in) > 1000 t/y CMRs (> 1 t/y) Very aquatic toxic (R50/53) > 100 t/y) Entry into force Old chemicals (phase-in) t/y NEW CHEMICALS (non-phase-in) Old chemicals t/y 1 Jun Jun Dec Nov May May

13 Registration experiences Major challenge major success Huge work for industry excellent commitment Especially cooperation in SIEF s very demanding In ECHA nr 1 challenge of 2010 accomplished Stability of IT tools ensured Well trained staff Contingency planning in place Joint effort ECHA CA s - national helpdesks COM Close cooperation with industry associations 13

14 Evaluation MSCAs Dossier evaluation Substance evaluation * Evaluation of Testing Proposals Compliance Check Examine any information on a substance Draft decisions on further information (Final decisions with potential involvement of MSC) * Process in preparatory phase, evaluation to be started in 2012 MSCA = Member State Competent Authority; MSC = Member State Committee 14

15 Dossier Evaluation challenge of next years About 1000 compliance checks on HPV s to meet the 5 % target by 2013 Selection concern driven and random 580 dossiers with testing proposals received Covering 1500 hazard endpoints All of these to be examined by Dec 2012 ECHA will carry out scientific evaluation and submit draft decisions requesting further information from registrants Member States will comment on draft decision ECHA Member State Committee will conclude if MS s submit comments Major workload for ECHA Secretariat, MSCA s, and MSC 15

16 Substance evaluation will start ECHA is developing the first list of substances Member States to identify candidates CORAP list proposal by end of 2011 adoption Feb 2012 MS s to inform ECHA about capacity for evaluation ECHA will reimburse Member States for the work Substance evaluation should be used to identify candidate substances for risk management measures 16

17 Authorisation ECHA lists substances of very high concern (SVHCs) on the Candidate List after processing dossiers from Member States or ECHA (acting on request by COM). MSC consulted for finding agreement if the basis for identification of potential SVHC is challenged Substances from the Candidate List are transferred to Authorisation List (Annex XIV) by a Commission Decision based on prioritisation recommendations from ECHA MSC gives an opinion on ECHA s draft recommendation for Annex XIV A substance on the authorisation list cannot be used or marketed without authorisation granted by the Commission First authorisation list is expected to be published shortly Will trigger the application process 17

18 Authorisation first experiences The identification and selection process of SVHC works 46 substances on the candidate list in first 3 years Industry lodged actions for annulment against inclusion of 7 substances Two ECHA recommendations for inclusion to authorisation list submitted to the Commission (2009 and 2010) High expectations for more speedy process 40 new substances per year expected in 2011 and 2012 Will require considerably more proposals from MS s Application phase will start this year ECHA is on track with its preparations High workload for ECHA committees (RAC and SEAC) Support for Committee members expected from CA s 18

19 Restrictions The substance can only be manufactured, placed on the market or used under conditions. Member States can submit dossiers proposing restrictions or COM can ask ECHA to do this The decision on restrictions is made by COM based on a scientific opinion from ECHA Annex XVII of REACH names all such restrictions (current entries are from the previous legislation). 19

20 Restrictions first experiences Lead in jewellery (France) Di Methyl Fumerate (DMFU) in articles (France) Phenyl mercury substances (Norway) Mercury in measuring devices (ECHA on request of COM) Notification of intention to prepare a restriction report for four phthalates (DK) Expected to address potential mixture toxicity effects ECHA has capacity to process up to 10 restriction proposals per year 20

21 Classification & Labelling Classification and labelling - first step to define the hazards of chemicals and mixtures and to ensure that they are manufactured, used and disposed of safely CLP Regulation (EC) No 1272/2008 entered into force on 20 January 2009 Implementation of agreed UN-wide system Transitional period ; both classification systems to be used ECHA main role: establish & maintain C&L inventory Harmonise C&L, where proposed by national authorities or industry 21

22 CLP- progress so far Developing and managing the C&L inventory Industry notifies to ECHA the C&L of substances placed on market C&L notification deadline 3 Jan million notifications received Covering substances Public version of the inventory in spring 2011 Proposals for harmonised C&L In total 150 proposals by MSCAs received 90 proposal per year expected First proposal by industry arrived end 2010 ECHA opinions provide scientific basis for COM decisions 17 opinions of RAC finalised 22

23 ECHA Helpdesk, Guidance & Communication Helpdesk peak workload in questions resolved 15.1% REACH and 3.8% on CLP matters 60.7% on IT tools (REACH-IT, IUCLID 5, CHESAR) Rest (20.4%) on standard cases of dossier submissions HelpNet Secretariat supporting national helpdesks: Frequently Asked Questions: 7 Q&As published in 2010 Meetings and trainings ECHA publishes guidance documents for national authorities and industry see: Communications Translations: 190 documents available online in all languages 23

24 FORUM - For Exchange of Information on Enforcement Role of the FORUM under REACH and CLP Network of national enforcement authorities Exchange of information Coordinate harmonised activities related to enforcement Increased momentum for effective enforcement in st registration and CLP notification deadlines passed Support successful implementation and ensure level playing field for industry 24

25 Tasks of the FORUM Spreading good practice and highlighting problems at Community level Proposing, coordinating and evaluating harmonised enforcement projects and joint inspections Identifying enforcement strategies, as well as best practice in enforcement 25

26 New challenges coming New tasks for ECHA under preparation Proposal for Biocides Regulation in co-decision Role and tasks of ECHA increasing Export and import of dangerous chemicals (PIC) Tasks from COM/JRC expected to be transferred to ECHA Increased synergies expected Scientific challenges Development of non-test methods Risks of nanomaterials Endocrine disruptors Mixture toxicity 26

27 Key messages for Tukes Congratulations from ECHA and welcome as our new partner! Do not forget to formally register as MSCA and withdraw registration of the two former MSCA s Make sure to sign the framework contract that permits us to reimburse you for any work done for which this is foreseen I expect also that you can soon fulfil the requirements that permit you to seek access to REACH-IT Let us know before 1 March for how many substances Tukes will do the evaluation and SVHC identification in the next years 27

28 Key messages for Tukes Cooperation between all REACH and CLP actors involved is crucial to successful implementation of chemicals legislation ECHA and national authorities are in partnership in implementing REACH and CLP Finland has a strong history of using scarce resource wisely and ensuring good dialogue between stakeholders ensure continuity of this tradition As the MSCA from our home country we hope that you will become an active and leading partner in implementation and enforcement of REACH and CLP 28

29 Thank you for your attention! 29