On July 16, 2025, the European Union (EU) submitted notification G/TBT/N/EU/1148 to the World Trade Organization (WTO), aiming at simplification of the certain provisions and procedures of the following acts:
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (“CLP Regulation”);
- Regulation (EC) No 1223/2009 on cosmetic products (“the Cosmetic Products Regulation”); and
- Regulation (EU) 2019/1009 laying down rules on the making available on the market of EU fertilising products (“Fertilising Products Regulation”)
The following is a summary of the key proposed amendments to the Cosmetics Regulation (EC) No 1223/2009.
Key Proposed Amendments to the EU Cosmetics Regulation (EC) No 1223/2009
1. A procedure will be established for the inclusion of colorants, preservatives, and UV filters in Annexes IV, V, and VI of the Cosmetics Regulation (EC) No 1223/2009
Companies may submit applications to the European Commission, accompanied by scientific data and supporting documentation. Upon receipt of the application, the Commission will consult the Scientific Committee on Consumer Safety (SCCS) for its opinion on the safety of the substance for use in cosmetic products. The SCCS shall complete its assessment and deliver an opinion within 12 months. If additional information is required, the Commission may extend the assessment period accordingly.
2. Optimisation of the Regulation and Derogation Process for Carcinogenic, Mutagenic or Reprotoxic (CMR) Substances
(1) Companies should submit a derogation application to the European Commission within three months after the substance has been officially classified as a CMR substance. The Commission shall grant the derogation where all of the following conditions are fulfilled:
- There are no suitable alternative substances available as documented in ananalysis of alternatives;
- The substances have been evaluated and found safe by the SCCS for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and of vulnerable population groups.
(2) If the classification of a CMR substance is based on oral or inhalation routes of exposure, its use is not automatically prohibited. However, if incidental ingestion or inhalation of the substance in the product may pose a risk to human health, the European Commission will mandate the SCCS to carry out a safety assessment of its use in the relevant product types.
(3) CMR substances derived from plants or parts of plants and not chemically modified are not subject to prohibition. However, if the use of such extracts in cosmetic products may pose a potential risk to human health, the European Commission may still request the SCCS to conduct a safety assessment.
(4) If a cosmetic product contains a substance classified as CMR category 1A, 1B, or 2, and the substance has been prohibited or restricted, companies may continue to place the product on the market for up to 12 months from the date of entry into force of the relevant amendment to the Annexes, and the product may remain on the market for a maximum of 24 months.
3. Standardization of Nomenclature
To further standardize the nomenclature system for cosmetic ingredients, the International Nomenclature of Cosmetic Ingredients (INCI) names are adopted as the standard expression for ingredient labeling. Also, the digitalization of the Glossary of Common Ingredient Names could help to further harmonize the cosmetic ingredient nomenclature system and reduce compliance risks.
4. Simplification of Notification Procedures
The additional “prior notification” requirement for cosmetic products containing nanomaterials has been removed.
5. Introduction of the ICSMS System to Accelerate Information Sharing
According to Article 22 of the previous regulation, EU Member States are obligated to regularly review and assess the implementation of their market surveillance activities and communicate the results to other Member States and the European Commission. To enhance regulatory efficiency and coordination, the EU has introduced the Information and Communication System for Market Surveillance (ICSMS), enabling faster and more effective information sharing and exchange among Member States.
About CIRS
The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.
Our Services
- EU Cosmetic Product Formula and Label Review
- EU Cosmetic Responsible Person
- Product Information File (PIF)
- EU Cosmetic Safety Assessment (CPSR)
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Further Information
Https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/EU1148.pdf&Open=True