April 2, 2024. When developing a cosmetic formulation is key to ensure the ingredients are allowed for use in the targeted market. Additionally, for brands selling their cosmetic products in several markets, it is very often essential to have one formulation suitable for all territories. For this reason, it is important to know how cosmetic substances are regulated around the world. Hence, in this article, we will provide some information on the regulatory status of cosmetic ingredients in the European Union and United States highlighting the differences.
European Union: Annexes to Regulation (EC) 1223/2009
In the European Union, cosmetic products are regulated by Regulation (EC) 1223/2009, usually referred to as the EU Cosmetics Regulation. The regulatory status of a substance can be found in the Annexes to the Regulation. In this sense there are two negative lists:
- Annex II – the list of substances prohibited for use in cosmetic products, with more than 1700 entries! And
- Annex III – the list of substances that can only be used according to the restrictions specified there, namely the list of restricted substances. The restrictions laid down in Annex III are of different kinds: concentration and product type limits, additional labelling and warnings requirements, user constraints, etc.
On top of this, there are three positive lists:
- Annex IV – the list of colorants allowed for use.
- Annex V – the list of preservatives allowed for use.
- Annex VI – the list of UV filters allowed for use.
Importantly, Member States cannot unilaterally limit the use of a cosmetic substance as ruled by the Court of Justice of the European Union in 2022.
A scientific and uniform safety assessment system
In the European Union, the European Commission mandates the Scientific Committee on Consumer Safety (SCCS) to assess the safety of substances of concern. The SCCS is an independent scientific advisory body that follows a risk assessment approach comprising the following steps:
- Hazard identification
- Exposure assessment
- Dose-response assessment
The SCCS conclusions are the basis for the European Commission’s decision on how to regulate the use of a substance in cosmetic products throughout the EU Single market.
At the same time, colorants, preservatives, and UV filters can be added to the relevant Annexes only after a positive opinion by the SCCS.
United States: States powers
In the United States, most ingredients are regulated at state-level, not federal level. As a matter of fact, very few substances are prohibited or restricted by federal laws. They are the following:
- Bithionol
- Chlorofluorocarbon propellants
- Chloroform
- Halogenated salicylanilides
- Methylene chloride
- Prohibited cattle materials
- Vinyl chloride
- Zirconium-containing complexes
- Mercury compounds
- Hexachlorophene
Furthermore, the FDA establishes an approval system for color additives, except coal-tar hair dyes. The FDA approves color additives and these must meet the specifications and requirements set in the regulations. Additionally, certain color additives must pass a batch certification.
MoCRA, the latest major amendment to the cosmetic legislation in the United States, did not change the ingredients management. MoCRA preemption clause prevents states from enacting laws that differ from the federal framework on registrations, GMP, adverse events, and safety substantiation. Nevertheless, the preemption does not concern ingredients, and states can continue to ban and restrict them under state laws.
Regarding this, some states, such as California and New York, are more active than others in banning and restricting cosmetic substances. Therefore, when you market cosmetic products in the United States, you shall ensure your formula meet both federal and states requirements.
Do you need help with regulatory compliance in the European Union, United Kingdom, or United States? Contact us today.
References:
- Code of Federal Regulations. (2024). Title 21 – Food and Drugs. Chapter 1, Subchapter G, Part 700, Subpart B – Requirements for Specific Cosmetic Products. Retrieved on 11/03/2024
- FDA. (2022). Color Additives and Cosmetics: Fact Sheet. Retrieved on 11/03/2024
- SCCS. (2023). The SCCS notes of guidance for testing of cosmetic ingredients and their safety evaluation – 12th revision. Retrieved on 11/03/2024
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