The safety of the cosmetic product is based on the safety of its ingredients. To ensure a high level of protection for human health, "Regulation (EC) No 1223/2009" (Cosmetics Regulation) compiles annexes for concerned cosmetic ingredients, respectively:
No. In Cosmetics Regulation, "preamble to Annexes II to VI" illustrates that substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned. Up till now, the EU Commission has authorized 4 UV-filters as nanomaterials, including Methylene Bis-benzotriazolyl Tetramethylbutylphenol (MBBT), Titanium Dioxide, Zinc Oxide and Tris-biphenyl Triazine. It also allows carbon black (nano) for use as a colourant in cosmetic products.
EU cosmetics legislation contains provisions on the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) in cosmetic products. As a general principle, substances classified as CMR substances (category 1A, 1B, or 2) under Part 3 of Annex VI to Regulation (EC) No 1272/2008 are banned for use in cosmetic products. Exceptions to this general rule are possible under the conditions in Article 15 of the Cosmetics Regulation.
Yes. For cosmetics containing ingredients not included in the ingredient annexes, the Responsible Person (RP) shoulders the responsibility to guarantee the cosmetics' safety. As defined by Cosmetics Regulation, prior to placing cosmetics on the market, the RP shall ensure that the product has undergone safety assessments for all ingredients contained.
Where there is a potential risk to human health arisen from the use of certain ingredient in cosmetic products, the Commission will request the Scientific Committee on Consumer Safety (SCCS) to give its opinion. After consulting the SCCS, where it appears necessary, the Commission will amend Annexes II to VI accordingly. ChemLinked will keep tracking the amendments. Please stay tuned to get the updates.
The ingredient annexes to Cosmetics Regulation lay down clear limitations and requirements for the cosmetic ingredients of potential concern for human health. In contrast, the "Glossary of Common Ingredient Names" (Glossary) does not constitute a list of ingredients safe or authorized for use in cosmetic products. Instead, it is compiled and updated to make sure the cosmetic products on the EU market are labelled with correct ingredient names. In short, the ingredient annexes are established to define ingredient's regulatory status, while the Glossary is compiled to standardize the labelling of ingredients.
Heavy metals and microorganisms are not included in the regulatory database of EU cosmetic ingredients. But in the production process of cosmetics, there are restrictions on these substances. Please refer to specific lists under Cosme-list for more details.