Division 3.8.7 Identification of the sources of information

The determination of the toxicological profile requires a minimum of information on the substance to be evaluated.

This information can be collected from toxicological studies. If data from human experience exist, they should be taken into account.

Other tools such as quantitative structure-activity relationship (QSAR) or bridging approaches are only estimations of toxicity, and the weight of evidence should be substantiated and justified.

The following sources of data should be taken into consideration:

1. (a)

   Safety and quality data which may be on file with the respective suppliers of the raw materials in the formulation, and which the supplier should share with the manufacturer of the cosmetic product. This is an important element in considering the availability of relevant data to demonstrate the safety of each cosmetic ingredient in the final product formulation;

2. (b)

   If an opinion of the SCCS exists, the NOAEL used in the opinion should be used. The safety assessor should take into account the most up-to-date scientific opinion;

3. (c)

   If an opinion of another authoritative scientific committee exists, the NOAEL used in the opinion could be used, provided that the conclusions and limitations are applicable to the expected use (the use taken into account for calculating the margin of safety can be different). The safety assessor should take into account the most up-to-date scientific opinion;

4. (d)

   If no scientific opinion exists, it will be necessary to provide information to characterise the toxicological profile of each substance. The data can be obtained from several databases or literature (see the Appendix)^f1;

5. (e)

   Classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council^f2;

6. (f)

   Studies performed or obtained by the manufacturer of the product;

7. (g)

   In silico prediction (QSAR);

8. (h)

   Bridging approach;

9. (i)

   Assessments of non-cosmetic uses of the substance (foodstuffs, food additive, food contact materials, biocides, Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)…) may also be used in order to complete information on the toxicological profile of the substance.

10. (j)

    When available, the CSR (Chemical Safety Report) or the robust study summaries submitted pursuant to Regulation (EC) No 1907/2006 (REACH).

A number of substances and/or mixtures have not been studied sufficiently to determine all the pertinent toxicological parameters. For these missing parameters, or where the risk characterisation is based on an approach using toxicological data acquired for other substances (for example similar structures) or for uses other than cosmetics (food, biocides, pharmaceutical products, etc.), justifications should be included in the report.