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Trimethylammonium Chloride SCCS/1246/09 Scientific Committee on Consumer Safety SCCS OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72 The SCCS adopted this opinion at its 5th plenary on 8 December 2009 SCCS/1246/09 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Evaluation Agency (EMEA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCCS The Committee shall provide opinions on questions concerning all types of health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.). Scientific Committee members Jürgen Angerer, Ulrike Bernauer, Claire Chambers, Qasim Chaudhry, Gisela Degen, Gerhard Eisenbrand, Corrado Galli, Thomas Platzek, Suresh Chandra Rastogi, Vera Rogiers, Christophe Rousselle, Tore Sanner, Kai Savolainen, Jacqueline Van Engelen, Maria Vinardell, Rosemary Waring, Ian R. White Contact: European Commission Health & Consumers Directorate C: Public Health and Risk Assessment Unit C7 - Risk Assessment Office: B232 B-1049 Brussels [email protected] © European Commission 2010 (ISSN) The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm 2 SCCS/1246/09 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses ACKNOWLEDGMENTS Prof. J. Angerer Dr. U. Bernauer Dr. C. Chambers Dr. Q. Chaudhry Prof. G. Degen Dr. S.C. Rastogi Prof. V. Rogiers (rapporteur) Prof. T. Sanner (chairman) Dr. J. van Engelen Prof. R. Waring Dr. I.R. White This opinion has been subject to a commenting period of four weeks after its initial publication. All comments received during this time have been considered by the SCCS and discussed in the subsequent plenary meeting. Where appropriate, the text of the relevant sections of the opinion has been modified or explanations have been added. In the cases where the SCCS after consideration and discussion of the comments, has decided to maintain its initial views, the opinion (or the section concerned) has remained unchanged. Keywords: SCCS, scientific opinion, preservative, alkyl (C16, C18,C22) trimethylammonium chloride, P72, CAS 112-02-7; 112-03-8; 17301-53-0, EINECS 203-928-6; 203-929-1; 241-327-0 Opinion to be cited as: Opinion of the SCCS on Alkyl (C16, C18, C22) trimethylammonium chloride, other uses than as a preservative, 8 December 2009 3 SCCS/1246/09 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses TABLE OF CONTENTS ACKNOWLEDGMENTS ........................................................................................... 3 1. BACKGROUND ............................................................................................. 5 2. TERMS OF REFERENCE.................................................................................. 6 3. OPINION..................................................................................................... 7 4. CONCLUSION ............................................................................................ 59 5. MINORITY OPINION.................................................................................... 59 6. REFERENCES............................................................................................. 59 4 SCCS/1246/09 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 1. BACKGROUND Cosmetic products marketed in the European Union may only contain those preservatives which are listed in Annex VI of the Cosmetics Directive 76/768/EEC, “List of preservatives which cosmetic products may contain”. The preamble of the Annex states that preservatives marked with the symbol (+) may also be added to cosmetic products in concentrations other than those laid down in the Annex for other specific purposes apparent from the presentation of the products. Alkyl (C12-22) trimethyl ammonium, bromide and chloride, (COLIPA1 P72) bears the symbol (+) and can therefore be used in cosmetics at higher concentrations, as long as it is not employed as preservative. Alkyl (C12-22) trimethyl ammonium, bromide and chloride is currently authorized as a preservative up to a maximum concentration of 0.1% (Annex VI, Part 1, No. 44). In its opinion of 17 February 1999 concerning the restrictions on materials listed in Annex VI of Directive 76/768/EEC on cosmetic products, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) stated that those substances indicated by (+) in Annex VI, when incorporated into cosmetic formulations for non-preservative functions, should be subjected to the same restrictions in usage levels and warnings as when used for preservative effects. If a preservative marked with the symbol (+) is added for non-preservative purpose to a cosmetic product in a concentration higher than that laid down in the Annex VI, data to substantiate its safety should be submitted to the SCCS. In 2004, the European Commission received a submission from industry (Submission I) proposing that Alkyl (C16, C18, C22) trimethylammonium chloride can be used for non- preservative purposes as specified in the safety dossier: cetrimonium chloride (C16), steartrimonium chloride (C18): Rinse-off hair care products up to 2.5% Leave-on hair care products up to 1.0% Leave-on facial cream products up to 0.5% behentrimonium chloride (C22): Rinse-off hair care products up to 5.0% Leave on hair care and facial cream products up to 3.0% In 2006, the SCCP adopted opinion SCCP/0917/05, which, after some pertinent comments from the applicant, was reviewed and updated by SCCP/1087/07. The Committee concluded as follows: "As far as systemic and local toxicity are concerned, the chemical analogy between the three compounds seems to permit a read-across approach for cetrimonium chloride, steartrimonium chloride and behentrimonium chloride. The calculation of the Margin of Safety [..] leads to a value of 192. Nevertheless, this value does not apply in cases where the final formulation (finished cosmetic products) containing cetrimonium chloride, steartrimonium chloride and/or behentrimonium chloride is irritating to the skin and thus may increase the dermal absorption of the ingredient(s). Moreover, single human patch tests clearly showed that all combinations of quaternary ammonium compound concentrations and formulations lead to diverging results. Considering the fact 1 COLIPA - European Cosmetics Toiletry and Perfumery Association 5 SCCS/1246/09 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses that quaternary ammonium compounds are known to be irritating, combination effects should also be taken into account. Therefore the following concentration limits should apply for rinse-off cosmetic products: - the sum of the cetrimonium and steartrimonium chloride concentrations should not exceed 0.5%, and - the total sum of behentrimonium, cetrimonium and/or steartrimonium chloride should not exceed a maximum level of 3%. The submission requests evaluation of the use of these quaternary ammonium derivatives in leave-on (face)-cream products. This dossier only allows the safety evaluation of quaternary ammonium compounds in leave-on cosmetic products when present in a maximum level of 0.1% (preservative or non-preservative). The safety evaluation of the leave-on (face)-cream products containing these substances needs to be assessed on a case by case basis." Recently, a further submission was received. The applicant provided argumentation and market surveillance data with the aim to support the safety of these preservatives at the use concentrations originally applied for. 2. TERMS OF REFERENCE 1. On the basis of the data provided, does the SCCS consider that Alkyl (C16, C18, C22) trimethylammonium chloride is safe for consumers, when used in cosmetic products for non-preservative purposes in the concentrations specified above? 2. Does the SCCS have any further scientific concerns in relation to its use in the cosmetic products? 6 SCCS/1246/09 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 3. OPINION The present opinion combines the major part of SCCP/1087/07 with the newly introduced information, thus presenting a full overview of the data introduced for
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