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Opinion on Hydrogen Peroxide, in Its Free Form Or When Released, in Oral Hygiene Products and Tooth Whitening Products

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Opinion on Hydrogen Peroxide, in Its Free Form Or When Released, in Oral Hygiene Products and Tooth Whitening Products Scientific Committee on Consumer Products SCCP OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products The SCCP adopted this opinion at its 14th plenary of 18 December 2007 1 SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 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 Products (SCCP), 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). SCCP Questions concerning the safety of consumer products (non-food products intended for the consumer). In particular, the Committee addresses questions related to the safety and allergenic properties of cosmetic products and ingredients with respect to their impact on consumer health, toys, textiles, clothing, personal care products, domestic products such as detergents and consumer services such as tattooing. Scientific Committee members Claire Chambers, Gisela Degen, Ruta Dubakiene, Bozena Jazwiec-Kanyion, Vassilios Kapoulas, Jean Krutmann, Carola Lidén, Jean-Paul Marty, Thomas Platzek, Suresh Chandra Rastogi, Jean Revuz, Vera Rogiers, Tore Sanner, Günter Speit, Jacqueline Van Engelen, Ian R. White Contact European Commission Health & Consumer Protection DG Directorate C: Public Health and Risk Assessment Unit C7 - Risk Assessment Office: B232 B-1049 Brussels [email protected] © European Commission 2007 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/ph_risk/risk_en.htm 2 SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products ACKNOWLEDGMENTS Dr. C. Chambers Prof. G. Degen Dr. B. Jazwiec-Kanyion Prof. V. Kapoulas Prof. J.-P. Marty Prof. T. Platzek Dr. S.C. Rastogi Prof. J. Revuz Prof. V. Rogiers Prof. T. Sanner (Chairman and rapporteur) Dr. J. van Engelen Dr. I.R. White Keywords: SCCP, scientific opinion, hydrogen peroxide, oral hygiene, tooth whitening, CAS 7722-84-1 (Hydrogen peroxide), CAS 124-43-6 (carbamide peroxide), EINECS 231-765-0 (Hydrogen peroxide), EINECS 204-701-4 (Carbamide peroxide), directive 76/768/EEC Opinion to be cited as: SCCP (Scientific Committee on Consumer Products), Opinion on hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products, 18 December 2007 3 SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products TABLE OF CONTENTS ACKNOWLEDGMENTS ........................................................................................... 3 1. BACKGROUND ............................................................................................. 5 2. TERMS OF REFERENCE.................................................................................. 6 3. OPINION................................................................................................... 10 4. CONCLUSION ............................................................................................ 70 5. MINORITY OPINION.................................................................................... 72 6. REFERENCES............................................................................................. 72 7. APPENDIX................................................................................................. 86 4 SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 1. BACKGROUND The Scientific Committee on Cosmetics and Non Food Products intended for Consumers (SCCNFP), replaced by the Scientific Committee on Consumer Products (SCCP), by Commission Decision 2004/210/CE1, has been consulted and expressed its view in several occasions on the safety of hydrogen peroxide, in its free form or when released, in oral hygiene products, and, in particular, in tooth whitening products. Its latest opinion is from 15 March 2005 (SCCP/0844/04) in which it concluded that: “tooth whitening products containing up to 0.1% hydrogen peroxide * The use of tooth whitening products up to 0.1% hydrogen peroxide is safe. tooth whitening products containing > 0.1% to 6.0% hydrogen peroxide * The proper use of tooth whitening products containing > 0.1 to 6.0 % hydrogen peroxide (or equivalent for hydrogen peroxide releasing substances) is considered safe after consultation with and approval of the consumer's dentist. - The use of tooth whitening products is not recommended prior to or immediately after dental restoration. - Particular care should be taken in using tooth whitening products by persons with gingivitis and other periodontal diseases or defective restorations. Conditions such as pre-existing oral tissue injury or concurrent use of tobacco and/or alcohol may exacerbate the toxic effects of hydrogen peroxide (see e.g. section 3.3.13.1). * There is an absence of good clinical data and long-term epidemiological studies that assess the possible adverse effects within the oral cavity. * The new additional data supplied does not provide the necessary reassurance in terms of risk assessment to support the safety of hydrogen peroxide up to 6 % in tooth whitening products freely and directly available to the consumer in various application forms (strips, trays, etc…). SCCP cannot quantify the risk of potential serious adverse effects in relation to the use of tooth whitening products”. At the request of the Commission services, in order to ensure that industry would carry out relevant and good clinical data and long-term epidemiological studies that assess the possible adverse effects within the oral cavity, the SCCP delivered “a guidance document on epidemiological and clinical studies on tooth whitening products” on 28.03.2006 (SCCP/0974/06). Commission services were then informed by a Member of the European Parliament and by the Council of European Dentists, formerly EU Dental Liaison Committee, of the existence of scientific articles which have not been considered by the SCCP. All relevant stakeholders were at that time asked to provide to the Commission services all available scientific articles 2 on the matter. Norway and COLIPA forwarded documents. 1 OJ L 66, 4.3.2004, p.45 2 COLIPA - European Cosmetics Toiletry and Perfumery Association 5 SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 2. TERMS OF REFERENCE 2.1. Context of the question The SCCP clarified in its opinion of March 2005, that for the purpose of its opinion, the terms “tooth whitening products” and “tooth bleaching products” define the same kind of products. In this request, neither do the Commission services draw a distinction. In its opinion of 23.06.1999 (SCCNFP/0158/99), the SCCNFP has reviewed the use of hydrogen peroxide in tooth pastes and mouth rinses. It then concluded that “an increase of hydrogen peroxide (and equivalent) in tooth paste and mouth-rinses to 3.6% is not permissible […]”. In parallel, in its opinion of 17.02.1999 (SCCNFP/0058/99), the SCCNFP considered the use of hydrogen peroxide (and equivalent) in tooth whitening products. It was this opinion which has been reviewed at several occasions. Therefore, in order to ensure consistency, this request concerns the safe use of hydrogen peroxide, in its free form or when released, in oral hygiene products (tooth whitening products and tooth pastes and mouth-rinses). Currently, Council directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (the Cosmetics Directive) provides in Annex III, part 1, n°12 a limit of 0.1% of hydrogen peroxide (or equivalent for substances that release hydrogen peroxide) in oral hygiene products. The Cosmetics Directive provides several options in order to ensure the safety of consumer when using cosmetic products. Those management options include: - the requirement for a specific labelling; - the requirement for the first use of a product by a professional; - the requirement for the exclusive use by the professional. In order to determine which of these options the appropriate one is, the Commission services need to know from the SCCP, within its scientific assessment, possible concerns and how scientifically these concerns can be handled. 2.2. Request Considering all data, those already submitted in support of previous opinions and those identified since its last opinion (15 March 2005, SCCP/0844/04) and submitted to the SCCP, can the Committee assess the possible health risks
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