German Competent Authority Experiences and Expectations from a Member State s Perspective

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1 German Competent Authority Experiences and Expectations from a Member State s Perspective Warszawa, November 2011 Dr. Ann Bambauer Federal Office for Chemicals/Authorisation of Biocides

2 Outline 1. German Helpdesk Experiences 2. Feedback 1st registration deadline substances ID - SIEF/data sharing Intermediates Dossier Quality 3. Key issues to come Authorisation Substance Evaluation Quality of Dossiers: Improvement Enforcement 2nd Registration deadline 2

3 German Helpdesk Activities Member State task / obligation: establish a national helpdesk Aim: advice to companies on their responsibilities and obligations under REACH, in particular on registration Cooperation German Helpdesk: Institute for Occupational Safety and Health (BAuA) Federal Institute for Risk Assessment (BfR) Federal Environmental Agency (UBA) Federal Institute for Materials Research and Testing (BAM) 3

4 German Helpdesk Activities Speaking at chambers of industry and commerce, national associations, etc. Organisation of REACH - CLP information events Information brochures, flyers Establishment of an internet portal Answering directly to questions Expert meetings/consultation 4

5 5 German Helpdesk Enquiries ( ) Sep 06 Okt 06 Nov 06 Dez 06 Jan 07 Feb 07 Mrz 07 Apr 07 Mai 07 Jun 07 Jul 07 Aug 07 Sep 07 Okt 07 Nov 07 Dez 07 Jan 08 Feb 08 Mrz 08 Apr 08 Mai 08 Jun 08 Jul 08 Aug 08 Sep 08 Okt 08 Nov 08 Dez 08 Jan 09 Feb 09 Mrz 09 Apr 09 Mai 09 Jun 09 Jul 09 Aug 09 Sep 09 Enter into Force Start of pre-registration End of pre-registration

6 6 Helpdesk Enquiries Jul. 11 Aug. 11 Sep. 11 Apr. 11 Mai 11 Jun Helpdesk enquiries Oct. 09 Nov. 09 Dec. 09 Jan. 10 Feb. 10 Mar. 10 Apr. 10 Mai 10 Jun. 10 Jul. 10 Aug. 10 Sep. 10 Oct. 10 Nov. 10 Dec. 10 Jan. 11 Feb. 11 Mar

7 REACH Helpdesk Enquiries Main Topics of received enquiries REACH IT 4% SDS 8% others 2% CLP 24% Inform/Supply chain/du 12% Application 5% Auth/Restr 6% Pre-reg 5% Registration 25% Class/Lab 9% 7

8 Registrations Registrations Deadline published in ECHA s Newsletter No 6 December 2010 Registrations Transported isolated intermediate On-Site isolated intermediate Total Europa Germany * 921 * 368 * = 23% Phase-in Substances Ca * source: REACH-IT These Dossiers were submitted by companies indicating a phase-in substance meeting the criteria for the 2010 deadline. Criteria: Substances 1000 t/a, CMR-Substances 1 t/a and substances, which are harmful for the environment 100 t/a 8

9 Registrations - Substances: German Numbers Numbers of registration dossiers of phase-in and non-phase-in substances excl. Updates (till ) source: REACH-IT Registrations Transported isolated intermediate On-Site isolated intermediate Total (EU=22 259) Substances = 23% * * published in ECHA s Newsletter No 5 October Ca German companies registered 9

10 Feedback on the 1st Registration deadline Substance ID SIEF / Data Sharing Substance Identity: key and basis for answering questions related to what to register and to include in IUCLID criteria how to handle many different compositions of substances in one registration dossier to be used for SIEF formation / sameness of substances SIEF: Typical complaints : Lead Registrant wants too much for the letters of access (loa) Member Registrants are free riders do not want to share Fair, transparent, non discriminatory (Article 30) 10

11 Status: Intermediates Fulfilling the requirements? 400 intermediates acc. to Art. 17/18 were examined, 86% insufficient request for clarifying information in accordance with article 36(1) 1.) definition intermediates = substances used for chemical processing to be transformed into another substance 2.) SCC and risk management measures (RMMs) rigorously contained by technical means during whole life cycle (SCC) Conclusion: only by ensuring containment, reduced information requirements apply 11

12 Registration: Quality of Dossiers MSCA fulfill their obligations: Identify SVHC, substances for restriction and for evaluation, harmonised classification Basis in REACH: Information submitted in the registration dossiers first screening of dossiers by German CA Unclear Substance ID Incomplete (eco)toxicological endpoints, status of reliability? Incorrect deriving of DMEL/DNEL/PNEC, although data base is sufficient Insufficient exposure and risk assessments Inconsistencies related to information of use categories and exposure scenarios 12

13 Dossier Quality - Compliance Check ECHA: 5% compliance checks (CCH) of all registration dossiers Planned are 920 dossiers for the deadline 2010 Evaluation deadline In % in compliance In 2011: 291 Dossiers were examined - follow-up activities: Quality Observation Letter (QOBL) or draft decision, first sent to registrants were finalised (dossier upgrade or tonnage downgrade) draft decisions (32 DE-Dossiers) were submitted to the Member States Competent Authorities 65 were targeted to substance identity (58%) Data sources: ECHA s Newsletter No 5 October 2011, The operation of REACH and CLP Report

14 Key Issues to come 1. SVHC/authorisation 2. Substance evaluation 3. Quality of Dossiers: Improvement 4. Enforcement 5. 2nd Registration deadline 14

15 Candidate list: the first step of authorisation procedure immediate legal obligations, mainly information on substances of very high concern (SVHC) in articles currently 53 SVHCs are published 6th list (draft): after next Member State Commitee 7-9 December 2011 (18-20 substances) DE: submitted 22, published 13, in prep.10 (4 in cooperation with other MSCA) Intended aim: 136 substances at the end of 2012? 15

16 Authorisation Inclusion of substances into Annex XIV 6 substances on Annex XIV included (18 February 2011) 8 substances to be included into Annex XIV (Draft Commission) 13 substances to be included into Annex XIV (Recommendation by ECHA probably in December 2011) Applications should be submitted to ECHA 18 months before the sunset date - start with 2 substances on 21 February 2013 (latest application date) Guidance: Guidance on the preparation of an Application for Authorisation, published in OJ (2011/C 28/01) Data Submission Manual: Part 22: How to prepare and submit an application for authorisation using IUCLID 5 16

17 Substance Evaluation Substance Evaluation First Community Rolling Action Plan First CoRAP includes 91 substances for 3 years, will be published on 28 February 2012 Start in 2012 with 36 substances 5 substances will be evaluated by Germany 2013 intended 24 substances 2014 intended 31 substances 17

18 Substance Evaluation Substance Evaluation First Community Rolling Action Plan Challenge for MSCA: After publication: MSCA max. 12 months for evaluation: - assessment of several dossiers - check of the substance identification correct grouping of same substances - hopefully on the basis of a good joint registration dossier covering the relevant endpoints in case further information is required a draft decision must be prepared commented by the involved company, accepted by MSC 18

19 Dossier Quality Improvements Further Development of specific documents Evaluation under REACH progress report 2010 recommendation for registrants Different Practical Guides for example How to report robust study summaries Intensive Communication to industry Better understanding of the principles of derivation of DNEL/DMEL/PNEC, by using the data adequately Responsibilty of industry to improve documentation of safe uses in the chemical safety report 19

20 Dossier Quality Improvements Supplementary examination of dossiers - quality management prior to submission by industry - raising the contingent of compliance checks - checking selectively critical endpoint/information Support by MSCA in addition to ECHA examination of dossiers when screening for regulative measures Intensive cooperation between ECHA and MSCA, exchange of information ECHA emphasize to check the substance ID at a very early stage and provide feedback, in cases of severe non-compliance prove the possiblity to reject(withdraw) a registration(number) 20

21 Enforcement in Germany Overview Organizational Structure - 16 Federal States - responsible for enforcement, 21 ChemG* *ChemG = Chemikaliengesetz, German Chemicals Act Harmonization & Strategic decisions Working Committee of the Federal Government and the States on Chemical Safety (BLAC) 21

22 Enforcement in Germany Projects REACH-EN-FORCE 1: Inspections covering registration, pre-registration and Safety Data Sheets 440 inspections, 8 20 % non-compliance found * * 20 % in 2009, 8 % in 2010/2011 (prolongation phase) REACH-EN-FORCE 2: Inspections focusing on obligations of downstream users (communication in the supply chain, Safety Data Sheets) 185 inspections ongoing (operational phase ends March 2012) REACH-EN-FORCE 3: Planned topics: Registration of importers, cooperation with customs 22

23 Enforcement in Germany Intermediates Actions taken by ECHA: - Intermediates screening: status doubtful for 86 % of registered intermediates - Follow-up: data requests sent out to registrants (Art. 36(1)-decisions) in September 2011 Enforcement actions in MS: Forum pilot project on Intermediates planned, especially: follow-up on ECHA-decisions. 23

24 Key Issues to come 2nd Registration deadline What to expect: 2010 deadline: ca substances registered mostly by experienced HPV producing companies 2013 deadline: many more substances expected to be registered companies may be newcomers? Many questions and a new challenge! 24

25 Key Issues to come - 2nd Registration deadline Conclusions long and tedious to harmonise answers and guidance: therefore: stability of already agreed criteria, definitions and answers increasing need for harmonised and clear cut answers Support to companies by national authorities national helpdesks Good communication of deficiencies to the actual registrants in order to improve failings/defaults Industry s committment to improve the dossier quality regarding complete data, sound risk assessment and description of all uses ECHA emphasize to check the substance ID at a very early stage and provide feedback, direct reactions in cases of severe non-compliance (rejection of dossier, withdrawal of registration numbers) 25

26 Thank you for your attention! Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Federal Institute for Occupational Safety and Health Friedrich-Henkel-Weg Dortmund

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