Division 3.8.1 General considerations concerning the toxicological profile as part of the safety assessment

The relevant elements of the toxicological profile of each substance or mixture should be described in detail in the cosmetic product safety information (Part A) and assessed in the safety assessment (Part B), bearing in mind the exposure situation, the intrinsic toxicity (or hazard) of each substance, and the specific conditions of use of the product.

Human experiences, animal studies or alternative methods to animal testing are helpful in understanding the health risk for humans exposed to dangerous substances. For the toxicological profiles, toxicological studies are used to identify the hazards which could be associated with a risk to humans. It is essential to consider the quality and limitations of the studies that have been performed. The validity of a study should be taken into consideration in determining whether there is a need for new information to understand the risk to human health^f1. Studies conducted in accordance with international guidelines are the most useful, but unfortunately not all studies meet these standards. Thus, the limitations of such studies should be considered in assessing the toxicological profile for each substance.

The safety assessor should ensure that the experimental data comply with the requirements of Article 18 of Regulation (EC) No 1223/2009 concerning animal testing. The Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics outlines the Commission’s interpretation of those requirements^f2.