Regulation 1223/2009 review: key legal changes for the cosmetics industry

The European Commission has proposed a revision of Regulation (EC) No 1223/2009, aiming to modernise the regulatory framework for cosmetic products. This initiative is part of a broader simplification effort that also affects Regulations No 1272/2008 and 2019/1009.

The goal is to improve cosmetic regulatory compliance and reduce unnecessary administrative burdens for both companies and authorities. Key proposed updates include:

1. Clarification of obligations and removal of redundant requirements.
Existing obligations are defined more clearly, simplifying compliance procedures.

2. Update to Article 15 regarding CMR substances.
The exemption process for the use of substances classified as CMR in cosmetics is revised to address issues encountered in recent years:

    • Substances no longer need to be authorised for food use to be approved for cosmetics.

    • Alternatives must be realistic and beneficial for all parties involved.

    • Natural extracts containing CMR-classified substances will not be automatically banned, but must be evaluated by the SCCS.

    • The ban will only apply if the CMR classification involves dermal exposure.

    • New deadlines: 12 months to place the product on the market, 24 months for full availability.

3. New article for adding ingredients to Annexes IV, V and VI.
A streamlined process is introduced to facilitate the inclusion of new colourants, preservatives and UV filters, encouraging innovation.

4. Removal of specific pre-notification for products with nanomaterials.
The requirement under Article 16 is eliminated, simplifying product registration without compromising safety.

5. Digitalisation of the glossary of common ingredients.
A digital format will ensure accurate and consistent labelling while minimising regulatory risks.

Annex I is also updated to reinforce requirements related to product stability, nanomaterial toxicology, and key technical data.

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