Prohibited Cosmetic Substances — Annex II

Annex II is the shortest kind of answer the regulation gives. A substance listed here may not be used as a cosmetic ingredient, and there is no concentration at which that changes. Where other annexes set limits and conditions, this one sets none, because there is nothing to condition.

The nuance people look for lives in Article 17 rather than in the annex. It provides that the unintended presence of a small quantity of a prohibited substance is permitted where it is technically unavoidable under good manufacturing practice and the product remains safe under Article 3. That is a provision about impurities and residues — what arrives with a raw material, what forms during manufacture, what migrates from packaging. It is not a tolerance to formulate against, and a deliberate addition at a low level is not covered by it.

Just over a thousand of these entries carry a CMR classification — carcinogenic, mutagenic or toxic for reproduction under the CLP Regulation. That is the route by which most of them arrived: Article 15 prohibits CMR substances in cosmetics, with a narrow derogation procedure that is rarely used, so a CLP classification generally becomes an Annex II entry in due course.

The most common misreading is the opposite of the list's own logic. A substance not found in Annex II has not been assessed and permitted. It has not been assessed at all. Most cosmetic ingredients appear in no annex, and their acceptability rests on the safety assessment the responsible person is required to hold.