Feedback from 2010 Lead Registrant Workshop 2 February 2012 Christel Musset Director of Registration
Outcome of registration in 2011
Registration 2010 in a nutshell Major co-operation effort Excellent commitment by industry Close cooperation between key players to narrow down uncertainties & clarify open questions (Directors Contact Group) Successful management of the deadline ca. 25 000 dossiers corresponding to 4300 (3300 phase-in) substances Majority of large companies: 86 % Submission by Only Representatives: 19 % Joint Registrations: 94 % 25% substances with intermediate use only 3
Lessons learnt from SIEF formation to submission of the joint dossier: What worked? What can be improved?
Registrations intentions! 2010: Less substances registered than announced by industry in April 2010 Reasons for non registration: later registration, better understanding of REACH obligations (e.g. exemptions), merge/split of SIEFs, etc. Results were published on ECHA website in September 2011 Market surveys for next deadline early enough to identify difficulties Initiated by ECHA in Q4/2011, 18 months before the deadline In total pre-registrants intend to register ~ 3,200 substances (28% already registered in 2010) New phase-in substances for the 2013 deadline amount to ~ 2,300 Additional feedback will be sought from industry associations 5
SIEF formation and data-sharing Pre-registration in 2008 managed successfully but failed to meet its aims Registrants: Large SIEFs difficult to administer DUs: No certainty on which of their substances will be registered Challenges on data & cost sharing for smaller players or non EU manufacturers 15 data sharing disputes lodged with ECHA Despite challenges in SIEF formation, 94% joint registrations 6
SIEF formation and data-sharing How to improve? Encourage companies to de-activate or remove preregistration in REACH-IT if no intention to register in 2013 Service provided by ECHA to de-activate/remove in bulk 40 000 pre-registrations removed in September 2011, ~100 000 more will soon be removed Start SIEF work for 2013 deadline early enough; Encourage early nomination of Lead Registrants 1583 Lead Registrants have identified within their SIEFs (surveys + ECHA Lead Registrants database) Increase transparency, promote best practice and fairness Update of the Guidance on data sharing Publication in April 2012 7
SIEF progress (2011 30 Jan 12) Date 2013 2018 04/03/11 377 193 1800 SIEF Progress 2013 2018 07/04/11 459 201 29/04/11 493 202 1500 30/05/11 532 204 04/07/11 641 213 1200 03/08/11 767 232 900 31/08/11 806 240 20/09/11 857 222 600 17/10/11 916 219 16/11/11 1021 238 300 30/11/11 1106 247 09/12/11 1138 248 13/01/12 1214 251 0 01/03/11 01/04/11 01/05/11 01/06/11 01/07/11 01/08/11 01/09/11 01/10/11 01/11/11 01/12/11 01/01/12 01/02/12 30/01/12 1583 253 8
SIEF formation in 2009-2010 SIEF in Progress 3000 2500 2009-2010 2000 2011-1500 1000 500 0 Apr-09-18 months Jun-09 Aug-09 Oct-09-12 months Dec-09 Feb-10 Apr-10-6 months Jun-10 Aug-10 Oct-10 Deadline 9
Joint submission For 2010 registrations Multiple joint submissions for the same substance observed Individual submissions for substances with joint submissions observed! Not in line with the REACH principle one substance, one registration Encourage Lead registrants to make their names known on ECHA web site for increasing transparency Already consulted those participating in the survey, and positive reactions received More advice provided on the 2013 webpage at http://echa.europa.eu/reach2013 10
Registration 1. Ensure the substance identity for the whole joint submission Critical for data sharing and compliance of data submitted However, each member must identify his own detailed substance composition 2. Collect information on uses in organised manner Ensure meaningful communication in the supply chain afterwards 3. Gather information on data available in the SIEF Identify data gaps, agree who provides the missing information 4. Agree on classification and labelling Opt-out from common classification needs to be justified 5. Decision whether to prepare CSR jointly or individually Ensure that the CSR represents a safety assessment on realistic conditions of use Consider forthcoming updates Keep the members up-to-date on the anticipated contents of the lead dossier 11
Submission timing in 2010 Accepted for Processing by Week vs Projections Data as of 02-Dec-10 4 500 No. of Dossiers 4 000 3 500 3 000 2 500 2 000 1 500 30 000 25 000 20 000 15 000 10 000 5 000 0 Cumulative Accepted for Processing 1 5 9 13 17 21 25 29 33 37 41 45 1 000 500 0 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 Actual Data Current Week (48) Baseline Projection Medium Projection 12
Dossier submission to ECHA IT tools and Guidance stabilised well ahead of deadline IUCLID 5.4 Q2/2012 Chesar Q3/2012 REACH-IT Q4/2012 Update of the Guidance on Registration Publication in April 2012 ECHA support to registrants Two Lead Registrant workshops Webinar programme running through Q4/2011-Q2/2013 Helpdesks (ECHA Helpdesk and 30 national helpdesks) 13
Effect of publishing TCC plug-in in 2010 Registration Dossiers Initial TCC Failure Rate by Week Data as of 02-Dec-10 100% 80% 60% 40% 20% 0% 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 100% Intermediate Dossiers 80% 60% 40% 20% 0% 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 Past Data Current Week (48) 14
Business Rule Failures Phone contact in 2010 15
Prepare for post registration Getting the registration number is not the end The registration dossier must be kept up-to-date Updates can be done spontaneously or requested by authorities Dossier compliance check will follow Dissemination ECHA will make registration information available on its website at http://echa.europa.eu/web/guest/information-onchemicals/registered-substances 16
Conclusions Registration is a big but manageable task Prepare in a timely manner and keep your SIEF members informed Be prepared for post-registration activities prior to the submission Make full use of ECHA support to the registrants 17
Thank You! Christel Musset christel.musset@echa.europa.eu