Colorants, preservatives and UV filters: acceptance according to the EU Cosmetics Regulation

In the EU, ingredients that are intended to be used as colorants, preservatives or UV-filters in cosmetic products must be listed in Annexes IV, V and VI, respectively, of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products). Otherwise their use in such products is prohibited.

It is possible to get a substance included in the cited annexes through an amendment to the Regulation. This is a lengthy process involving the European Commission’s Standing Committee on Cosmetic Products, as well as public consultations through the World Trade Organization, and there are some initial steps a company must take before the process starts.

Safety evaluation

Before a Regulation amendment can be proposed, the ingredient must be evaluated for safety by the European Commission’s Scientific Committee on Consumer Safety (SCCS).

The SCCS provides opinions on health and safety risks on non-food consumer products including cosmetic products. The SCCS has no regulatory status, but its advice is taken into account in the drafting of amendments to the EU Cosmetics Regulation. If the SCCS releases a positive opinion, that is, that an ingredient is safe for its intended use in cosmetics, then it may undergo the legal process of inclusion into the Regulation’s annexes.

Toxicological dossier

In order for the SCCS to assess an ingredient, a toxicological dossier must be submitted. The dossier must include a description of the basic physicochemical properties of the ingredient, as well as toxicological data on endpoints like skin and eye irritation potential, skin sensitisation potential, genotoxicity or carcinogenicity, among others.

“Ensuring that the dossier is complete, accurate, and there are no data gaps will greatly speed the process,” says Helena Eixarch, Cosmetics & Toxicology Consultant at TSG Consulting. “Data gaps, or missing experimental data on some toxicological endpoints, is what usually slows the process down and in some cases can lead to the dossier being refused.”

It is therefore important to identify any data gaps, and then evaluate the best route to fill them. “Sometimes new tests will need to be performed,” explains Helena. “However, other times a thorough toxicological assessment of the available data may help fill in data gaps and waive the need for new tests. This is a money-saver and also speeds things up.”

UK Cosmetics Regulation

The process to get an ingredient listed is comparable in the UK. The Office for Product Safety and Standards (OPSS), which has a regulatory role, uses the advice of the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) when working on changes to the UK Cosmetics Regulation.

“After a dossier has been submitted, the SCCS or SAG-CS may request additional data or may want to discuss the toxicological evaluation as submitted,” continues Helena. “Clients value our toxicology experts being on hand to assist in these discussions and answer any technical questions.”

How TSG Consulting can help

Our team of cosmetics regulatory consultants and toxicologists are experienced in preparing applications for SCCS evaluation. We can assist in all stages of a SCCS / SAG-CS dossier preparation and evaluation including:

• Assessment of the initially available data and data gap analysis
• Advise on testing options to fill data gaps
• Study monitoring
• Preparation of the full toxicological dossier
• Submission of the dossier and follow up until final opinion publication

Get in touch at [email protected] to arrange an informal chat with our cosmetics regulatory consultants and find out how we can support you.