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Directorate-General for Health and Food Safety
Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers concerning Basic requirements for toxicological dossiers to be evaluated by the SCCNFP adopted by the SCCNFP during the 11th plenary meeting of 17 February 2000
SCCNFP BASIC REQUIREMENTS
1. For Cosmetic Industries when preparing and submitting a dossier for an ingredient to be evaluated by SCCNFP for its possible inclusion in one of the Annexes III, IV, VI and VII of Council Directive 76/768/EEC, the basic and minimal specifications for any ingredient should be:
- purity of the chemical,
- characterisation of the impurities or accompanying contaminants,
- solubility,
- partition coefficient (Log Pow).
This information must be included in each of the toxicological studies in the form of a certificate of analysis, for a definite characterisation of the sample employed in the study.
2. In the case of a UV-light adsorbing cosmetic ingredient the UV-light absorption spectrum must be included in the dossier; moreover, all the studies relating to the phototoxic potential of the ingredient must be performed by applying the corresponding UV-light wavelenghts.
3. As stated in chapter 9 of the "Notes of Guidance for Testing of Cosmetic Ingredients for Their Safety Evaluation" (SCCNFP/0119/99 Final) toxicity studies should be performed according to the Guidelines laid down by the European Commission (Commission Directives 87/032/EEC and 92/69/EEC) or by the OECD, as well as in "accordance with the principles of Good Laboratory Practice (Council Directive 87/032/EEC)" as requested by the Sixth Amendment (Council Directive 93/35/EEC). All possible deviations from this set of rules must be explained and scientifically justified.
4. All new cosmetic ingredients, whose dossiers are submitted to SCCNFP's approval for their inclusion in the Annexes of Council Directive 76/768/EEC must contain studies for their in vitro assessment of percutaneous absorption, following the basic criteria indicated by the SCCNFP in Annex 10 of the "Notes of Guidance for Testing of Cosmetic Ingredients for Their Safety Evaluation".
5. All UV-light absorbing new cosmetic ingredients whose dossiers are submitted to SCCNFP's approval for their inclusion in Annex VII of Council Directive 76/768/EEC must include, besides toxicological information required by Annex I, the reports of the in vitro studies on photogenotoxicity/mutagenicity, and on phototoxicity, by following the recommendations provided by the SCCNFP. The in vitro phototoxicity studies must be performed by applying the 3T3 NRU PT Test, according to the guidelines submitted by ECVAM to OECD.
6. In vitro methods for the assessment of potentially cutaneous irritants, sensitising cosmetic ingredients or mixtures of ingredients have currently not been validated yet. Animal studies to predict the above said effects are reliable and well documented in scientific literature.
7. The use of human volunteers in the confirmatory testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients are subjected to ethical concern. The use of human volunteers in the predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients, as a contribution to human safety is questionable in comparison with animal testing. Moreover, in these studies a risk for human volunteers cannot be excluded and there is still a lack of information on the severity and frequency of adverse effects.
On the basis of our experience, it is the opinion of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) to define a set of actions to be considered by Cosmetic Industries when preparing and submitting a dossier for an ingredient to be evaluated by the SCCNFP for its possible inclusion in one of the Annexes III, IV, VI and VII of Council Directive 76/768/EEC.
SCCNFP BASIC REQUIREMENTS
1. For Cosmetic Industries when preparing and submitting a dossier for an ingredient to be evaluated by SCCNFP for its possible inclusion in one of the Annexes III, IV, VI and VII of Council Directive 76/768/EEC, the basic and minimal specifications for any ingredient should be:
- purity of the chemical,
- characterisation of the impurities or accompanying contaminants,
- solubility,
- partition coefficient (Log Pow).
This information must be included in each of the toxicological studies in the form of a certificate of analysis, for a definite characterisation of the sample employed in the study.
2. In the case of a UV-light adsorbing cosmetic ingredient the UV-light absorption spectrum must be included in the dossier; moreover, all the studies relating to the phototoxic potential of the ingredient must be performed by applying the corresponding UV-light wavelenghts.
3. As stated in chapter 9 of the "Notes of Guidance for Testing of Cosmetic Ingredients for Their Safety Evaluation" (SCCNFP/0119/99 Final) toxicity studies should be performed according to the Guidelines laid down by the European Commission (Commission Directives 87/032/EEC and 92/69/EEC) or by the OECD, as well as in "accordance with the principles of Good Laboratory Practice (Council Directive 87/032/EEC)" as requested by the Sixth Amendment (Council Directive 93/35/EEC). All possible deviations from this set of rules must be explained and scientifically justified.
4. All new cosmetic ingredients, whose dossiers are submitted to SCCNFP's approval for their inclusion in the Annexes of Council Directive 76/768/EEC must contain studies for their in vitro assessment of percutaneous absorption, following the basic criteria indicated by the SCCNFP in Annex 10 of the "Notes of Guidance for Testing of Cosmetic Ingredients for Their Safety Evaluation".
5. All UV-light absorbing new cosmetic ingredients whose dossiers are submitted to SCCNFP's approval for their inclusion in Annex VII of Council Directive 76/768/EEC must include, besides toxicological information required by Annex I, the reports of the in vitro studies on photogenotoxicity/mutagenicity, and on phototoxicity, by following the recommendations provided by the SCCNFP. The in vitro phototoxicity studies must be performed by applying the 3T3 NRU PT Test, according to the guidelines submitted by ECVAM to OECD.
6. In vitro methods for the assessment of potentially cutaneous irritants, sensitising cosmetic ingredients or mixtures of ingredients have currently not been validated yet. Animal studies to predict the above said effects are reliable and well documented in scientific literature.
7. The use of human volunteers in the confirmatory testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients are subjected to ethical concern. The use of human volunteers in the predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients, as a contribution to human safety is questionable in comparison with animal testing. Moreover, in these studies a risk for human volunteers cannot be excluded and there is still a lack of information on the severity and frequency of adverse effects.
