EU Authority Guidelines: Supervisory Expectations & Best Practices
This content delves into supervisory expectations, experiences, and good practice guidelines from the perspective of an EU authority, specifically focusing on chemical enforcement projects, safety data sheet regulations, and the harmonization of enforcement efforts. Highlights include insights into the Forum for Exchange of Information on Enforcement (ECHA Forum) and the enforcement of regulations related to substances, mixtures, and articles sold online. The emphasis is on the enforcement of Regulation (EU) 2020/878 amending REACH Annex II, with a spotlight on the quality of information in Safety Data Sheets.
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Presentation Transcript
Supervisory expectations, experiences and good practice guidelines from an EU authority perspective Mag. Semira Hajrlahovi Mehi
Content ECHA, Forum Enforcement on chemicals in EU REF projects Forum Projects on Safety Data Sheet Enforcement of Safety Data Sheet latest Relevant regulation provisions Target for inspections Expected outcomes 2
ECHA, Forum ECHA Forum for Exchange of Information on Enforcement (Forum): a network of authorities responsible for the enforcement of the REACH, CLP, and PIC, POP and Biocidal Product regulations in the EU, Norway, Iceland and Liechtenstein In 2017, the Forum set up the Forum Biocidal Products Regulation Subgroup (BPRS) for coordination and harmonisation of enforcement of BPR 3
Forum enforcement projects Forum coordinates enforcement projects REACH-EN-FORCE REF projects which are designed to harmonised enforcement in MS REF-projects are carried out by inspectors based in the national MS authorities The resulting information is collected by ECHA and the Forum Working Group Final report 4
REF projects & SDS SDS as a chemical ID REF-5: Exposure Scenarios, extended SDS, RMM and OC REF-6: Classification and labelling of mixtures REF-8: Enforcement of CLP, REACH and BPR duties related to substances, mixtures and articles sold on-line Ref-9: Enforcement of authorisation REF-10: Integrated chemical control of products REF-11: Enforcement on SDS 5
REF-11: Enforcement on SDS - Background New regulation Regulation (EU) 2020/878 (amending REACH Annex II) Came into force: 1stJanuary 2020 Transition period: 31stDecember 2022 Why focus on Annex II o Annex II main determinant of the quality of information in SDS o A number of changes o Some new requirements 6
REF-11: Enforcement on SDS - Scope The main objective of REF-11: to assess whether duty holders have updated and provided the SDS in accordance with the new requirements of Annex II of REACH Regulation amended by Regulation (EU) 2020/878 The project focus: on the placing on the market of substances and mixtures in EU/EEA All suppliers (as defined in REACH) Downstream users (end-users) Online suppliers of substances/mixtures 7
Main changes (new parts) in the SDS The amendment includes provisions regarding: Nanoforms in subsections 1.1, 3.1 and 3.2 respectively, and section 9 The unique formula identifier (UFI) in subsection 1.1 The supplier of the safety data sheet in subsection 1.3 Endocrine disrupting properties and the acute toxicity estimates in subsection 3.1 and 3.2 respectively subsections 2.3, 3.2, 11.2 and 12.6 Specific concentration limits, M-factors in subsection 3.2 A new structure and expansion of information on physical and chemical properties in subsections 9.1 and 9.2 An update to transport information in subsections 14.2 and 14.7 Information authorisations in subsection 15.1 on authorisation and relevant conditions of 8
Target for inspections All suppliers (as defined in REACH) Downstream users (end-users) Online suppliers of substances/mixtures Each MS decided on No of inspections conducted as well as the No of SDS and type of substances/mixtures to be targeted Operational phase: 1 January 2023 31 December 2023 9
Timelines of REF-11 project January- March 2024 NCs Results reporting Q2 2025 Workshop with ASOs Enforcement guide January- December 2022 Preparatory phase January- December 2023 Operational phase April- December 2024 Reporting phase 10
Expected outcome of the REF-11 project Improving the quality of the information in the SDS in the supply chain Increase the awareness of the new requirements of Annex II Development of cooperation with related enforcement networks and authorities Exchange best practice between National Enforcement Authorities (NEAs) of the participating MS Increase awareness of the other duties inspected during the project Create a harmonised approach and best practices related to inspections of the duties checked in the REF-11 project Assess the size and scale of the issue of compliance with the provisions investigated in the project. 11
Preliminary Results 28 Countries More than 2500 SDS controlled 12
Expected Results (1) Numbers of inspections per MS Characterisation of companies ( M, I, DU, D) Does the supplier provide the recipient of chemicals with an SDS? Does the SDS checked comply with the new format required by Reg. 2020/878? If Yes: does the supplier have routines to provide updated SDS to former recipients ? 13
Expected Results ( 2) Language of controlled SDS Contact details of the supplier For Mixtures, o Is UFI code provided o Correct classification of the components o Are acute toxicity estimates (ATE), Specific concentration limits (SCL), M-factor and Occupational exposure limits (OELs) provided 14
Expected Results (3) Where authorisation is relevant is the authorisation number provided o Is this information is provided in section 15.1. Specification of required Personal Protection Equipment (PPEs) If a substance in nanoform is present in the substance or mixture, does the SDS contain the information required in sections 1.1, 3.1/3.2 and 9? If a substance with endocrine disrupting properties is present in the substance or mixture, does the SDS contain the information required in all the relevant subsections, i.e., 2.3, 3.2, 11.2 and 12.6? 15
Expected Results (4) From general consideration of the content of the SDS, is any information that can be considered as incorrect or not plausible Non-compliance: Language ES annexsed No SDS Enforcement actions: Initiated 16
Follow-up activities Final Report Workshop with ASOs Enforcement guidance 17
