Division 3.4.1 Purity of substances and mixtures

The presence of unintended substances, such as impurities and traces, can have an impact on the safety of the finished product. The cosmetic product safety report is to include data on the purity of raw materials (substances and mixtures) and the identification of the toxicologically relevant unintended substances. These substances should be taken into account in the safety assessment of the product.

Impurities are unintended substances in raw materials.

A trace is a small quantity of an unintended substance in the finished product.

The presence of traces in the finished product can be evaluated in two ways:

1. (a)

   through the specifications/technical data for each raw material, based on knowledge of the process for manufacturing the raw material (origin of substance, production process, synthesis route, extraction process, solvent used, etc.);

2. (b)

   through a physico-chemical analysis of possible impurities in raw materials and, if necessary, in the final product (e.g. nitrosamines which are potentially generated during or after the manufacturing process).

Traces of prohibited substances are dealt with in paragraph 3.4.2 of these Guidelines.

Some traces have regulatory concentration limits. For the presence of traces of substances that are not prohibited, and for which there are no regulatory concentration limits, but which could be expected to impact consumer safety, the safety assessment needs to be carried out by the safety assessor.