Regulation 1223/2009 has been the cornerstone of cosmetic safety in the EU for over a decade. On 8 July 2025, the European Commission introduced proposal COM(2025) 531, which suggests updates to streamline procedures, foster innovation, and support digitalization in the cosmetics sector.
The proposal affects key articles, from the authorization of new ingredients to market surveillance, and responds to the need for more efficient processes in a context of globalization and rapid technological change.
In this article, we review the main proposed changes, their potential impact on the industry, the expected benefits for manufacturers and authorities, and the challenges they pose for safety and regulatory oversight.
Key Changes to Regulation 1223/2009 in Cosmetics
The proposal COM(2025) 531 introduces several amendments that directly affect Regulation 1223/2009. The most relevant include:
New Substances Under Regulation 1223/2009
A new article defines the procedure to request the inclusion of colorants, preservatives, and UV filters in the relevant annexes. This change is designed to streamline the authorization of ingredients, providing greater clarity on the steps manufacturers must follow and reducing delays in the market entry of innovative products.
CMR Substances in Regulation 1223/2009
The proposal clarifies the rules concerning Carcinogenic, Mutagenic, or Reprotoxic (CMR) substances. Up to now, vague criteria created unnecessary burdens. The revision specifies that restrictions for CMR 1A or 1B will apply only when there is significant dermal exposure. This is particularly important for natural-origin ingredients, which will no longer face automatic bans if no real exposure risk exists.
In such cases, scientific evaluation by the Scientific Committee on Consumer Safety (SCCS) remains the key mechanism to decide whether an ingredient can be used.
Nanomaterials Regulation 1223/2009
One of the most significant updates is the removal of the six-month pre-notification requirement for products containing nanomaterials. Previously, manufacturers had to wait half a year before marketing such products. Under the proposal, information on nanomaterials will be integrated directly into the Cosmetic Product Safety Report (CPSR), eliminating duplication and accelerating product commercialization.
Market Surveillance in Regulation 1223/2009
The obligation for Member States to submit regular market surveillance reports is removed. Instead, the proposal strengthens the use of digital platforms such as ICSMS (Information and Communication System for Market Surveillance). This will reduce administrative burdens for national authorities and improve cross-border coordination.
INCI and Ingredient Rules in Regulation 1223/2009
The mandatory glossary of ingredients is abolished, as it often led to inconsistencies. Instead, the proposal requires alignment with the internationally recognized INCI (International Nomenclature of Cosmetic Ingredients). This will improve global harmonization and facilitate international trade.
Annex I (CPSR)
Annex I is updated to require more detailed information on nanomaterials in Part A of the CPSR, including IUPAC name, physicochemical properties, and other relevant characteristics.
Impact of Regulation 1223/2009 on the Cosmetics Industry
The main objective of proposal COM(2025) 531 is to reduce administrative burdens that for years have slowed processes and increased costs in bringing new products to market. The expected benefits include:
- Faster innovation: simplified inclusion of new ingredients and removal of the six-month waiting period for nanomaterials will enable quicker product launches.
- Cost reduction: fewer administrative requirements mean more resources can be allocated to research and development.
- International harmonization: the exclusive use of INCI avoids duplication and improves competitiveness in global markets.
- Digital transition: the integration of platforms such as ICSMS enhances transparency and efficiency in market surveillance.
This reform will be particularly beneficial for SMEs in cosmetics, which often lack resources to handle complex procedures and lengthy regulatory deadlines.
Risks and Precautions
While the simplification of regulation is widely welcomed, it also raises challenges and potential risks:
- CMR substances: more flexible rules could spark debate, as some groups argue that exceptions may increase risks if not thoroughly assessed.
- Nanomaterials: removing pre-notification should not compromise rigorous safety evaluations.
- Digital surveillance: reliance on systems like ICSMS requires ensuring that all Member States have sufficient technological and human resources for effective monitoring.
The role of the SCCS will remain essential to ensure that, even in a more agile framework, ingredients continue to meet the highest safety standards.
Connection With the European Regulatory Framework
Regulation 1223/2009 does not exist in isolation. Its modifications must be considered in relation to other EU legislation, such as:
- REACH (Regulation 1907/2006) on the registration, evaluation, and authorization of chemicals.
- CLP (Regulation 1272/2008) on classification, labeling, and packaging of substances.
- Regulation (EU) No 528/2012 on biocidal products, which sets parallel requirements for disinfectants.
Proposal COM(2025) 531 reinforces the importance of consistency across EU legislation to avoid contradictions and duplication.
Conclusion and Next Steps
The proposed revision of Regulation 1223/2009 represents a step toward a more agile, digital, and innovation-friendly cosmetics regulation.
The next steps will depend on the EU legislative process: debate in the Parliament and Council, possible amendments, and eventual adoption and entry into force of the changes.
For manufacturers, this reform is an opportunity to accelerate processes, reduce costs, and strengthen competitiveness in an increasingly demanding market. At the same time, maintaining a strong commitment to consumer safety remains the foundation of the Cosmetics Regulation.
At SHAPYPRO, we closely monitor regulatory updates to support laboratories and companies in the sector. You can learn more about our commitment in the certificates section.