Cosmetic products placed on the European Union (EU) market are subject to one of the most dynamic regulatory frameworks worldwide. Regulation (EC) No 1223/2009 is continuously updated to reflect new scientific evidence, particularly regarding ingredient safety and consumer protection.
For manufacturers and brand owners, compliance is no longer a one-time exercise. Instead, it requires ongoing monitoring of regulatory updates, proactive reformulation strategies, and careful management of product labelling and documentation.
In this blog, we outline the key regulatory developments affecting cosmetic products today and highlight the practical actions companies should take to remain compliant and market-ready.
Key Regulatory Updates
Restrictions on Ingredients and Safety Assessments
Recent updates to the EU Cosmetics Regulation have introduced stricter controls on several ingredient groups, including:
- Vitamin A derivatives (such as retinol and retinyl esters).
- Arbutin and Alpha-Arbutin.
- Kojic Acid.
- Substances with potential endocrine-disrupting properties.
These changes impose specific concentration limits and conditions of use, particularly for leave-on products.
Key takeaway: Manufacturers should ensure that all formulations currently on the market comply with the latest Annex III restrictions and that any required warnings or conditions are correctly reflected in the Product Information File (PIF).
Prohibition of Certain Substances
Some substances previously used in cosmetic formulations have now been fully prohibited and included in Annex II of the Regulation.
A notable example is 4-Methylbenzylidene Camphor (4-MBC), which is no longer allowed in cosmetic products.
Key takeaway: Companies should treat these bans as already in force from an operational perspective, ensuring that no non-compliant products remain in the supply chain.
Nanomaterials Under Increased Scrutiny
Recent regulatory updates have also focused on the use of nanomaterials, introducing:
- Restrictions on substances such as Hydroxyapatite (nano).
- Bans on several nano-forms of materials added to Annex II.
These changes reflect increasing concern around the safety and characterisation of nano-scale ingredients.
Key takeaway: It is essential to verify that raw material specifications, safety assessments, and supplier documentation fully align with regulatory requirements for nanomaterials.
CMR Substances (Omnibus Updates)
The EU continues to update the Cosmetics Regulation to reflect classifications of carcinogenic, mutagenic, or toxic for reproduction (CMR) substances.
These updates result in the automatic prohibition of newly classified substances, unless specific exemptions apply.
Key takeaway: Manufacturers must regularly screen their formulations and raw materials to ensure that no newly classified CMR substances are present, including as impurities or part of reaction mixtures.
Labelling and Marketing
While many ingredient-related changes are already in effect, labelling requirements are the next major area of impact for cosmetic brands.
Fragrance Allergen Labelling
The EU has expanded the list of fragrance allergens that must be declared on product labels. This change will significantly affect:
- Ingredient lists (INCI labelling).
- Packaging design and space constraints.
- Communication with fragrance suppliers.
Key dates to consider:
- New products must comply from July 2026.
- Existing products benefit from a transition period until July 2028.
Updated Ingredient Name Glossary
From July 2026, cosmetic labels must follow an updated glossary of common ingredient names.
This means that even compliant products may require label updates to ensure correct terminology is used.
Key takeaway: Labelling compliance should be planned well in advance, as it often requires coordination across regulatory, artwork, and supply chain teams.
Strategic Considerations for Manufacturers
Maintaining compliance in the EU cosmetics market requires a structured and proactive approach. Companies should:
- Monitor regulatory updates regularly, particularly changes to Annex II–VI.
- Review formulations proactively to identify potential compliance risks.
- Coordinate closely with suppliers to obtain updated ingredient data.
- Plan labelling updates early, especially ahead of major regulatory deadlines.
- Maintain accurate and up-to-date documentation, including PIFs and safety assessments.
Conclusion
The EU cosmetics regulatory framework continues to evolve, with increasing focus on ingredient safety, transparency, and consumer protection.
For manufacturers and brands, the priority is no longer tracking past deadlines, but ensuring that products currently on the market, and those in development, fully align with the latest regulatory requirements and upcoming labelling changes.
A proactive approach to compliance not only reduces regulatory risk but also supports long-term market access and consumer trust.