Edition of 1997
Pages 1. 2. 3. Introduction General Approach Ingredients 3.1 Ingredients to be avoided 3.2 Sources of toxicological data 3.3 Conditions of use and exposure Safety Evaluation of Finished Products Safety Claims Responsibilities of the Safety Assessor References 1 2 3
4. 5. 6. 7.
6 7 8 10 11Appendix Commission of the European Communities, Scientific Committee for Cosmetology Notes of Guidance for Testing of Cosmetic Ingredients for their Safety Evaluation (first revision) Annex 1 Guidelines for Assessing the Potential for Toxicity of Compounds Used as Sunscreen Agents in Cosmetics Annex 2 General Toxicological Requirements for Cosmetic Ingredients and Finished Products
19Although every effort is made to ensure that the information and concepts presented here are correct to the best knowledge of the authors and editors, neither they nor Colipa accept responsibility for any actions taken on the basis of this information, nor accept any liability for any omissions or errors this publication may contain. All rights reserved. No part of this publication may be reproduced ortranslated in any form, mechanical, electronic or otherwise, without prior permission of Colipa. August 1997
When complete studies and the results obtained are submitted, it shall be stated that the tests were conducted using the substance of the same physical and chemical characteristics of that to be included in the finished cosmetic product. The dossier of the information must include dataon the identity of the substance and its physicochemical, as specified in the Annex VII of the 79/831/EEC Directive.
B. Each cosmetic finished product is an individual and unique combination of ingredients. The number of the finished products is extremely large when compared to the number of cosmetic ingredients.
The dossier of a finished product or of a group of finished products shouldcontain adequate information to make possible a safety evaluation of the finished product. In general, this would he obtained by the knowledge of the toxicity of the cosmetic ingredients. Toxicity information on the ingredients should include the evaluation of the most relevant toxicological end points. In few cases, however, as, for instance, when the formulations used in the finished product weredifferent from the solvents employed in the toxicity studies of the ingredients and they were likely to increase considerably the penetration or the irritancy of some of the ingredients, additional information on finished products to allow a better safety evaluation would be needed. If a potentiation of the toxic effects of the ingredients, or if toxic effects resulting from chemical interactionbetween individual ingredients, would be likely to occur, specific toxicological information on the finished products would be required. Conversely, as indicated previously, any claim of decreased absorption or potential hazard of some ingredient, due to the formulation, should be supported by adequate information. When the combination of the ingredients present in the finished product makes highlyprobably the formation of new substance of toxicological concern, additional toxicological information on finished product would be needed.
GENERAL TOXICOLOGICAL REQUIREMENTS FOR COSMETIC INGREDIENTS AND FINISHED PRODUCTS A. When requested, the manufacturer shall provide the Commission with the information set out below:
1. Acute toxicity (oral or by inhalation in case ofvolatile substances); 2. Dermal absorption; 3. Dermal irritation; 4. Mucous membrane irritation; 5. Skin sensitisation; 6. Sub-chronic toxicty (oral or by inhalation in case of volatile substances); 7. Mutagenicity (bacterial test for gene mutations and in vitro mammalian cell culture for chromosome aberrations); 8. Phototoxicity (in case of UV-Light absorbing substances); 9. Human data (if...