Update from ECHA REACH Implementation Workshop X 13 December 2011 Laurence Hoffstadt ECHA Substance Identification & Data Sharing
Overview Update registrations/ dissemination Summary Analysis 2010- substances not registered Dissemination C&L inventory ECHA priorities for 2012 2013 Act Now Campaign Dedicated webpage LR WS 2012 Webinar programme http://echa.europa.eu 2
Registration - Dossiers Cumulative Dossiers Registered by Month 30 000 24 164 24 507 24 726 25 029 25 231 25 456 25 682 25 925 26 144 26 383 26 585 26 735 25 000 20 000 15 000 10 000 5 000 Individual Member Lead 0 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 http://echa.europa.eu 3
Registration - Substances Cumulative Substances Registered by Month 6 000 5 000 4 420 4 548 4 626 4 711 4 791 4 852 4 907 4 995 5 071 5 138 5 208 5 242 4 000 3 000 2 000 1 000 NonPhaseIn PhaseIn 0 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 http://echa.europa.eu 4
Registration - Statistics 5 242 Registered Substances (for which a REACH registration dossier has been received) + 2 397 Registered Substances (Notified under Directive 67/548, claimed since Jun 2008) Only as Full * 2 842 Only as OSII * 422 Only as TII * 1 000 Full & OSII 118 Full & TII 335 OSII & TII 259 Full, OSII & TII 266 Registered as Full Registration Registered as Intermediate Only 3 561 1 681 Phase-in substances 3 597 Non-phase-in 1 645 Total 5 242 Of which are NONS 1 175 EINECS substances 2 759 Substances from Joint Submissions Substances from Individual Subm. 3 047 2 195 Germany 2 934 United Kingdom 1 343 France 1 073 Belgium 1 131 The Netherlands 1 047 Italy 917 Spain 828 Sweden 369 Poland 359 Finland 354 Registered substances by registration type * Registered substances by category / class / source Top 10 countries by number of substances registered All numbers for 'Substances' are determined automatically using unique substance identifiers (EC Number / List Number). As substance identities are verified the numbers reported for substances may change. * 'Full' indicates a registration under REACH Article 10 as a full dossier; 'OSII' under REACH Article 17 as an on-site isolated intermediate; 'TII' under REACH Article 18 as a transported isolated intermediate. Substances previously notified under Directive 67/548/EEC ('NONS' substances) which have been claimed and updated with a REACH registration dossier; these are counted with the 5242 REACH registrations Numbers indicated in this table are the number of substances registered in a country (by at least one legal entity) from the total figure of 5242 substances for which REACH registrations have been received. Data as of 02 Dec 2011 http://echa.europa.eu 5
Analysis after the 2010 deadline Overall number of registrations in line with expectations Number of substances registered is lower than expected Industry and ECHA surveys early 2010 Gap of 1500 substances Analysis done to evaluate market impact Publication Autumn 2011 http://www.echa.europa.eu/chem_data/list_registration_2010_en.asp#download Explanations found for ca. 800 substances Registration postponed, better understanding of REACH obligations (e.g. exemptions), merge/ split of SIEFs, etc. Conclusion Useful tool: 70% prediction Market surveys ahead of next deadline http://echa.europa.eu 6
% of Registered Dossiers Dissemination - Dossiers % of Registered Dossiers Disseminated Dissemination Progress 100% 90% 80% Target: 80% JS Lead: 97% JS Member: 93% All Dossiers: 89% 70% 60% Individual: 55% 50% 40% 30% 20% 10% 0% Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 http://echa.europa.eu 7
% of Registered Substances Dissemination Substances % of Registered Substances Disseminated Dissemination Progress 100% Phase-in: 97% 90% 80% Target: 80% All Substances: 80% 70% 60% 50% 40% Non-phase-in: 39% 30% 20% 10% 0% Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 http://echa.europa.eu 8
Dissemination next developments http://apps.echa.europa.eu/registered/registered-sub.aspx Disclaimer: for information only- not for registration purposes Increase availability of information Decision taken to also publish company name registration number outcome of PBT / vpvb assessment Modifications to IUCLID and REACH-IT to prepare for broadening of the interpretation of other information in the safety data sheet and dissemination (Spring 2012) Transitional period foreseen: registrants to resubmit after tools available Assessment of confidentiality claims ongoing Ca. 1600 received of which 1000 assessed Ca. 50% decisions sent/ 50% await update from registrants http://echa.europa.eu 9
Public C&L Inventory (1) Basis CLP regulation- Art. 58(7)(a) 2 phases: only hazardous substances (IUPAC+EINECS names) Addition of substances with hazard classes not mentioned in Article 119(1)(a) (EINECS name) Current status Launch on 15 December 2011 (as part of new ECHA website) Contains information on ca. 105 000 substances (phase 1) Substance name + numerical identifier Self-classification and labelling Whether it is a joint entry between registrants Harmonised classification and labelling http://echa.europa.eu 10
Public C&L Inventory (2) C&L Inventory Unique Substances Notified 115 971 C&L Notifications Submitted 3 438 860 Submitting Companies 12 754 All data as of 2 Dec 2011 Top 10 countries by % of notifications Germany 37% United Kingdom 20% France 9% Belgium 7% Spain 6% The Netherlands 6% Italy 5% Austria 2% Poland 1% Hungary 1% All data as of 2 Dec 2011 http://echa.europa.eu 11
Overview Update registrations/ dissemination Summary Analysis 2010- substances not registered Dissemination C&L inventory ECHA priorities for 2012 2013 Act Now Campaign Dedicated webpage LR WS 2012 Webinar programme http://echa.europa.eu 12
ECHA staff 494 (30Nov11) From 25 EU countries (no Cypriot, no Luxembourger), Iceland and Norway http://echa.europa.eu 13
Challenges and Priorities for 2012 Ensure readiness for 2013 of ECHA Enhance communication with the general public and SMEs & reinforce involvement of stakeholders Optimise Guidance, IT tools and helpdesk for 2013 deadline Complete the dissemination portal & the assessment of confidentiality claims from the 2010 and 2013 deadlines Publish public information from all registrations C&L inventory Focus on Evaluation Dossier evaluation to meet deadlines of testing proposals, and the compliance check target of 5% for highest tonnage bands Play central role in substance evaluation by prioritising substances, coordinating the process and supporting MSCAs (adoption of CoRAP) Support substantial increase of Committee work on SVHC and CLH dossiers, restrictions and possibly authorisation Prepare for new Biocides and PIC Regulations http://echa.europa.eu 14
Overview Update registrations/ dissemination Summary Analysis 2010- substances not registered Dissemination C&L inventory ECHA priorities for 2012 2013 Act Now Campaign Dedicated webpage LR WS 2012 Webinar programme http://echa.europa.eu 15
2013 Act Now Campaign Five Scenarii 2010 LR 2013 registrants for substance registered in 2010 2013 LR 2013 registrants for substance to be registered in 2013 2013 registrants with no other interested SIEF participant http://echa.europa.eu 16
SIEF progress (1Jun11 30 Nov11) Date 2013 2018 SIEF Progress - Notifications from lead registrants to ECHA 04/03/2011 377 193 07/04/2011 459 201 1200 29/04/2011 493 202 1000 30/05/2011 532 204 04/07/2011 641 213 800 03/08/2011 767 232 600 31/08/2011 806 240 20/09/2011 857 222 400 17/10/2011 916 219 200 16/11/2011 1021 238 30/11/2011 1106 247 0 04/03/2011 01/04/2011 29/04/2011 27/05/2011 24/06/2011 22/07/2011 19/08/2011 16/09/2011 14/10/2011 11/11/2011 DL=2013 DL= 2018 https://comments.echa.europa.eu/comments/leadregistrantnomination.aspx http://echa.europa.eu 17
Lead registrants Notifications Purpose is to facilitate communication between SIEF members Voluntary basis No endorsement of lead registrant information by ECHA ECHA encourages companies to de-activate pre-registrations if no intention to register in 2013 Webform will be updated to increase information provided ECHA welcome all information and their update until 2013 If authorised, names of lead registrants to be forwarded to SIEF participants upon request If authorised, names of lead registrants to be published in list on ECHA website New list and numbers will be published in 2012 Invitations to the 2013 campaign supporting activities NB: please inform the supply chain that your SIEF is functioning and your substance will be registered http://echa.europa.eu 18
2013 campaign supporting activities Webinars For LR (9 in total) 2011: Substance identification/ SIEF activities and Data sharing and disputes Early 2012: Information requirements and chemical safety assessment Autumn 2012 - Spring 2013: Dossier preparation, tools and submission For other SIEF participants (3 in total) Early 2012: Substance identification/ SIEF activities and Data sharing and disputes Spring 2013: Dossier preparation, tools and submission LR workshops 2012 By invitation only 2-3 February 2012 in collaboration with industry associations Feedback and lessons learnt from 2010 Registration management: case studies related, substance identity and data sharing, data quality. SIEF formation and challenges: case studies and available tools Autumn 2012 Chemical safety assessment, dossier compilation and successful submission http://echa.europa.eu 19
535 days to 31 May 2013 http://echa.europa.eu 20