Division 3.4.2 Evidence of the technical unavoidability of traces of prohibited substances

While the procedure outlined in paragraph 3.4.1 should be followed for all known impurities and traces to evaluate their toxicological impact, further investigation is required for prohibited substances present as traces in the finished product^f1.

When such presence is technically unavoidable, the cosmetics manufacturers are required to provide evidence of the technical unavoidability. That means they have to justify the presence of those traces by all necessary means. The presence of traces of prohibited substances should be kept as low as is reasonably achievable under good manufacturing practices. In addition, the safety assessor has to decide whether their levels are toxicologically acceptable and whether the product is still safe.

Especially in the case of non-threshold genotoxic and carcinogenic substances^f2, the cosmetic industry should keep improving its best practices in order to eliminate these substances (ALARA principle^f3) in the finished cosmetic product. The main concern is to ensure the protection of human health, as required by Article 3 of Regulation (EC) No 1223/2009.

Traces generated by the degradation of substances within the final product (stability issues), by preservation or transport problems, or by the interaction of raw materials should be avoided through good manufacturing practices, or possibly through re-formulation of the product.