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Chemical Regulations, Amendments and Simplification of Certain Requirements and Procedures for Chemical Products

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On 8 July 2025, the European Commission published its Omnibus Proposal – COM (2025) 531 final, introducing targeted amendments to several foundational EU regulations. The aim: to reduce regulatory burden without weakening the EU’s rigorous standards for human and environmental safety. This proposal is part of the EU’s Better Regulation Agenda, aligning with its Chemicals Strategy for Sustainability (CSS) and European Green Deal.

 

Why These Changes Matter

By modernising existing legislation, the EU seeks to:

  • Promote safe, sustainable-by-design chemicals

  • Minimise unnecessary compliance barriers, especially for SMEs

  • Enhance digitalisation and transparency in the supply chain

  • Maintain the precautionary principle and high safety standards


Key Changes by Regulation

Cosmetic Products Regulation (EC) No 1223/2009

Proposed Amendment Reference: COM (2025) 531 final, Chapter II, Article 2

Key updates include:

  • CMR derogation process modernized, with defined scientific criteria and clear timelines

  • Ending of nanomaterial pre-notification under Article 16; safety data will now be consolidated into the Product Information File (PIF)

  • Enhanced procedures for updating Annexes IV–VI (e.g., colorants, preservatives, UV filters)

  • Glossary requirement (Article 33) replaced with reliance on CosIng database nomenclature

  • Introduction of transitional measures for implementing new ingredient restrictions


Regulatory Note: This aligns with Article 1 and 2 of the proposed revision and supports the objectives of Regulation (EC) No 1223/2009 as amended.


CLP Regulation (EC) No 1272/2008

Proposed Amendment Reference: COM (2025) 531 final, Chapter I, Articles 1–5

Notable changes:

  • Adaptable labelling rules to replace mandatory formatting (Annex I, Sections 1.2 & 1.3)

  • Renewed provisions for small packaging and fuel pumps

  • Digital options for labelling and contact details in line with the EU Digital Strategy

  • Hazard communication in advertising simplified to eliminate redundancy (Article 48)


Regulatory Note: These amendments are intended to streamline communication while preserving clarity and hazard visibility per Article 17–33 of the original CLP Regulation.


Fertilising Products Regulation (EU) 2019/1009

Proposed Amendment Reference: COM (2025) 531 final, Chapter III, Articles 6–8

Key proposals:

  • Deletion of extended REACH registration obligations for fertilising substances (Article 34)

  • Faster pathways for microbial plant biostimulants under Annex I

  • Mandatory digital documentation and declarations for harmonised compliance


Regulatory Note: These changes simplify cross-border market access under Regulation (EU) 2019/1009 and are consistent with REACH simplification objectives (Regulation (EC) No 1907/2006).


A Win for Innovation, Sustainability, and Safety

The proposal supports the European Commission’s goal to reduce administrative burden by:

  • 25% for all companies

  • 35% for SMEs

It aims to foster a more resilient, competitive, and sustainable internal market—without weakening the core principles of chemical safety and environmental protection.


At THB we believe regulatory progress must walk hand-in-hand with safety, science, and responsibility. Whether you manufacture cosmetics, classify chemicals, or develop sustainable plant inputs, we help you stay compliant, informed, and future-ready.


Need help preparing for the new regulatory landscape?

Contact us for expert regulatory strategy and safety assessment support.


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