Ensure Compliance with EU Regulatory Requirements in Chemical Industry
Learn about common regulatory requirements for chemical companies in the EU, such as REACH, CLP, and PIC regulations. Explore key aspects of compliance including registration, safety data sheets, personal protective equipment, and more. Stay informed to demonstrate adherence to industry regulations effectively.
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Presentation Transcript
How to ensure and demonstrate compliance with regulatory requirements (during supervision) an EU industry perspective Jan Mervart, DEZA, a.s.
Common regulatory requirements for chemical companies in the EU Regulation 1907/2006 (REACH) Regulation 1272/2008 (CLP) Regulation 649/2012 (PIC) Other legislations HSE, IPPC permits, Seveso, CM directive etc. New requiremens (2026) Directive 2024/1760 (CSDD corporate sustainability due diligence)
Inspection: REACH regulation (1) Registration of manufactured/imported chemicals Valid registration numbers (ECHA issues decision on registration) Safety data sheets with Exposure Scenarios Valid format of SDS, checks whether ES is in line with handling of substance in the company ECHA practical guidance 13 Strictly controlled conditions for intermediates Registration of intermediates pursuant to Articles 18 and 19 of REACH Closed system including sampling, no emissions, Guidance on intermediates, ECHA practical guidance 16 Personal protective equipment Gloves with resistance to the substance, protection for acids, need of hal- masks, respirators
Inspection: REACH regulation (2) Compliance with ECHA decisions (Article 41) Testing, dossier update, deadlines in decisions Cease of the manufacture / import Misuse of the procedure by Only Representatives due to ECHA testing requirements Lowering the tonnage band Intentional due to ECHA testing requirements Authorization Use of authorized substances, check of conditions set by the COM in the decision on authorization Restriction Annex XVII of REACH, mostly articles
Inspection: CLP regulation Labelling on packaging Dimensions of symbols, colour, H-sentences Classification of the substance/mixture Conformity of SDS classification with harmonised C&L/registered C&L CLP notifications
Inspection: PIC regulation Prior Informed Consent for export and import of dangerous Chemicals Companies intending to export chemicals listed in under PIC to non- EU countries, need to notify their intention to export and get a confirmation that the export is allowed before it can take place
