Division 4.3 Reasoning

The reasoning is the core of the safety assessment, as its aim is to clearly and accurately explain how the safety assessor reaches his or her conclusions on the safety of the cosmetic product from the data gathered under Part A of Annex I to Regulation (EC) No 1223/2009.

The safety assessment is to be performed on a case-by-case basis for each individual cosmetic product and be the result of an expert evaluation of the available data. The safety assessor should ensure that all the information (s)he needs to carry out a safety assessment is available; (s)he should check the relevance of the data provided on the product to be assessed; and (s)he should justify the absence of data required under Part A, when (s)he considers they are not relevant or necessary.

In order to draw conclusions on the safety of a cosmetic product, the safety assessor is required to evaluate the safety of the individual substances or mixtures present in the formulation and the safety of the finished product. His/her conclusions are to be based on a body of evidence showing that, for all the hazards identified, the product can be considered safe in terms of human health.

The safety assessor may accept, reject, or accept under specific conditions the formulation under consideration. A product that does not comply with Regulation (EC) No 1223/2009 is to be rejected and not marketed.

The reasoning for the safety assessment sets out the considerations that lead the safety assessor, based on all available safety-related information, to an overall conclusion on the safety of a product.

In their reasoning, the safety assessor is required to take into account all the hazards identified, the intended and reasonably foreseeable exposure conditions of the individual substances or mixtures present in the formulation and of the finished cosmetic product.

Analysis and evaluation of the validity/reliability of all existing information is the task of the safety assessor. By conducting this analysis, the safety assessor is able to decide whether the available data are sufficient to perform a safety assessment or whether additional data need to be obtained on an individual substance or the finished cosmetic product.

The reasoning is based on the data compiled in Part A of the cosmetic product safety report and takes into account the safety evaluation of substances and mixtures, carried out by the Scientific Committee for Consumer Safety when the substances appear in the Annexes to Regulation (EC) No 1223/2009, by other competent scientific committees or panels, or by the safety assessor him/herself, and the safety evaluation of the cosmetic product.