REACH-asetuksen toimeenpano. Jukka Malm Jukka Malm Director of Assessment ECHA Helsinki, Finland

Transcription

1 REACH-asetuksen toimeenpano Tilannekatsaus TUKES:n vuosipäivä 4/11/2009 Jukka Malm Jukka Malm Director of Assessment ECHA Helsinki, Finland

2 Main elements in REACH Data sharing Registration R i t ti Industry provides information + Member States Evaluation Dossier evaluation Substance evaluation ECHA and Member States review and request further information Classification & labelling Authorisation Restriction European Commission, with support of ECHA and MS s, applies Community-wide risk management instruments 2

3 REACH and ECHA REACH Regulation entered into force 1 June 2007 ECHA was created by this Regulation ECHA became operational 1 June 2008 Building up phase till 2010 ECHA is managing the implementation of the REACH Regulation 1907/2006 Regulation 1272/2008 on the classification, labelling and packaging of substances and mixtures 3

4 ECHA: Organisation Management Board 1 per Member State (+ observers EEA/EFTA), 2 from EP and 3 from COM 3 interested party observers nominated by COM Secretariat lead by Executive Director Currently ca. 350 staff Scientific Committees Committee for Risk Assessment Committee for Socio-economic Analysis Member State Committee Forum for Exchange of Information on Enforcement Board of Appeal independent from the Secretariat 4

5 Registration of substances Pre-reg istration > 1000 t/y CMRs (> 1 t/y) Very aquatic toxic (R50/53) > 100 t/y) t/y Entry into t/y force Non-phase-in substances 1 Jun Jun Dec Nov May May

6 ECHA role in registration ECHA receives the dossiers electronically Performs technical completeness check and issues registration number Manages registration data-base Dossier statistics Mid Oct 2009 Dossier type Nr of dossiers Registration dossiers 139 Intermediates, on-site 62 Intermediates, transported 183 PPORD notifications 399 6

7 The clock is ticking form your SIEF now Launched on Stakeholders day on 27 May 2009 Nr of Active Lead Nr of Active Lead Registrants today: 1974

8 The clock is ticking form your SIEF now substances expected indicated to be registered by 2010 ca < 10% 20% have appointed the Lead Registrant Substance Exchange Information Forum (SIEF) 80% of all the SIEFs have between companies/ importers or legal entities Encourage to come forward as Lead registrant Get SIEFs working now 8

9 Evaluation processes ECHA: Dossier Evaluation ation Member States: Substance Evaluation ation Testing Proposal Compliance Check ( 5% in each tonnage band) 1st list of substances by 1 Dec 2011 Outcome: Decision requesting further information 9

10 Risk management & REACH Results from registration and/or evaluation may lead to Risk Management measures Authorisation Restriction Classification & Labelling 10

11 The authorisation procedure: a two step approach Step 1: Selection of substances for the authorisation process Scope: substances of very high concern (SVHC) CMR 1 and 2, PBT, vpvb, substances of equivalent concern Identification of substances candidate list Inclusion in Annex XIV authorisation list Step 2: Application for authorisation, granting of authorisation and review of authorisation To be started (~ >) 11

12 Authorisation procedure: latest figures The first 15 substances in the candidate list of Substances of Very High Concern (28 Oct 2008) 2nd batch of 15 substances proposed evaluation ongoing 7 substances prioritised in ECHA s recommendation to the European Commission (1st June 2009) 2nd recommendation to follow Regular updates for the candidate list and for authorisation list coming 12

13 Classification and labelling ECHA role Processing of proposals for harmonised C&L (CLH) Develop and manage the C&L inventory Provide guidance to industry Provide guidance and support to Member States Figures Estimated 90 CLH proposals per year So far 36 proposals submitted Estimated nr of C&L notifications 2 million Dead-line 3 Jan

14 ECHA Helpdesk figures Nr of Helpdesk questions/month Average resolution time) 8,2 days 1st level questions 14

15 REACH Questions from non-eu Shows September

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17 ECHA Website Users One stop shop for all information on REACH & ECHA Most Popular Pages in Sep 2009 ECHA home page List of pre-reg. substances authorisation/candidate list consultation REACH Opportunities 17

18 Thank you for your attention!