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Oak Moss / Tree Moss Scientific Committee on Consumer Products SCCP OPINION ON Oak moss / Tree moss (sensitisation only) The SCCP adopted this opinion at its 15th plenary of 15 April 2008 SCCP/1131/07 Opinion on oak moss / tree moss (sensitisation only) 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 2008 (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/ph_risk/risk_en.htm 2 SCCP/1131/07 Opinion on oak moss / tree moss (sensitisation only) 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 Dr. J. van Engelen Dr. I.R. White (Chairman and rapporteur) Keywords: SCCP, scientific opinion, oak moss / tree moss, directive 76/768/ECC, CAS 9000-50-4 (oak moss), 68648-41-9 (tree moss), EINECS 289-861-3, 283- 658-3, 289-860-8 Opinion to be cited as: SCCP (Scientific Committee on Consumer Products), Opinion on oak moss / tree moss (sensitisation only), 15 April 2008 3 SCCP/1131/07 Opinion on oak moss / tree moss (sensitisation only) TABLE OF CONTENTS ACKNOWLEDGMENTS ………………………………………………………………………………... 3 1. BACKGROUND …………………………………………………………………………………. 5 2. TERMS OF REFERENCE …………………………………………………………………………………. 5 3. OPINION …………………………………………………………………………………. 6 4. CONCLUSION …………………………………………………………………………………. 22 5. MINORITY OPINION …………………………………………………………………………………. 22 6. REFERENCES …………………………………………………………………………………. 23 4 SCCP/1131/07 Opinion on oak moss / tree moss (sensitisation only) 1. BACKGROUND The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted at its 14th plenary meeting of 24 October 2000 an opinion (SCCNFP/0421/00) concerning Oakmoss/Treemoss, that "… oakmoss/treemoss extracts, present in cosmetic products, have a well-recognised potential to cause allergic reactions in the consumer as fragrance ingredients…" Based on the submission by EFFA1 of a study "Local nymph Node Assay (LLNA)- Sensitisation dossier on Atranol and Chloroatranol", the Scientific Committee on Consumer Products (SCCP) adopted at its 2nd plenary meeting of 7 December 2004 an opinion (SCCP/0847/04) on Atranol and Chloroatranol present in natural extracts (e.g. Oakmoss and Treemoss extract) with the conclusion: “Because chloroatranol and atranol are components of a botanical extract, oakmoss absolute, it has been impossible to trace exposure. Chloroatranol was shown to cause elicitation of reactions by repeated open exposure at the ppm level (0.0005%) and at the ppb level on patch testing (50% elicit at 0.000015%). As chloroatranol and atranol are such potent allergens (and chloroatranol particularly so), they should not be present in cosmetic products." Oak-/treemoss extracts are regulated in Annex III, entries 91 and 92 respectively, for labelling purposes when present in concentrations above 10 ppm for leave-on products and 100 ppm for rinse-off products. In December 2005, EFFA submitted submission II on Oakmoss only. Submission III from December 2006 is a sensitisation dossier on oakmoss/treemoss, treated to remove selectively atranol and chloroatranol. According to the current IFRA2 standards Oakmoss extracts (e.g. absolute, resinoid, concrete, etc) are obtained from Evernia prunastri, and Treemoss extracts (e.g. absolute, resinoid, concrete, etc) are obtained from Usnea and Pseudevernia furfuracea. Therefore, qualities marketed as cedar moss are also covered. 2. TERMS OF REFERENCE 1. Does the SCCP consider oakmoss/treemoss extracts safe for consumers when used in cosmetic products in a total concentration up to 0.1% as currently recommended by IFRA, taken into account the scientific data provided? 2. Does the SCCP recommend any further restrictions with regard to the use of oakmoss/treemoss extract in cosmetic products? 1 EFFA – European Flavour & Fragrance Association 2 IFRA – International Fragrance Association 5 SCCP/1131/07 Opinion on oak moss / tree moss (sensitisation only) 3. OPINION 3.1. Chemical and Physical Specifications 3.1.1. Chemical identity 3.1.1.1. Primary name and/or INCI name Oakmoss absolute (Evernia spp.) Treemoss absolute (Pseudevernia furfuracea) The lichen Evernia furfuracea found on Pine trees is also collected from cedar trees and extracts from lichens obtained from this tree are called Cedar moss extracts. Cedar moss is included based on this relationship. 3.1.1.2. Chemical names Oakmoss Evernia prunastri (oakmoss) extract; Evernia prunastri, ext.; Evernia absolute; oakmoss resinoid (Evernia spp.); oakmoss concrete (so-called); Evernia resinoid; Evernia prunastri (oakmoss) extract. Treemoss Pseudevernia furfuracea extract; Treemoss concrete (Pseudevernia furfuracea); Treemoss resinoid (Pseudevernia furfuracea) 3.1.1.3. Trade names and abbreviations / 3.1.1.4. CAS / EINECS number CAS: 9000-50-4 Oakmoss 68648-41-9 Treemoss EINECS: 289-861-3 (registered as CAS No. 90028-68-5) Evernia prunastri, ext. 283-658-3 (registered as CAS No. 84696-53-7), Usnea barbata, ext 289-860-8 (registered as CAS No. 90028-67-4) Evernia furfuracea, ext. 3.1.1.5. Structural formula Not applicable 3.1.1.6. Empirical formula Not applicable 3.1.2. Physical form Oakmoss absolute is a dark green, semi-solid to solid mass or a dark brownish-green liquid. Oakmoss resinoid is an almost black-green or brownish-green waxy mass. Treemoss absolute is a dark green, semi-solid to solid mass or a dark brownish-green liquid. 6 SCCP/1131/07 Opinion on oak moss / tree moss (sensitisation only) 3.1.3. Molecular weight Not applicable 3.1.4. Purity, composition and substance codes / 3.1.5. Impurities / accompanying contaminants / 3.1.6. Solubility / 3.1.7. Partition coefficient (Log Pow) Log Pow: / 3.1.8. Additional physical and chemical specifications Melting point: / Boiling point: / Flash point: / Vapour pressure: (calculated): <0.01 mm Hg at 20°C (Oakmoss) (calculated): 0.01 mm Hg at 20°C (Treemoss) Density: / Viscosity: / pKa: / Refractive index: / UV Absorbance: λmax below 300 nm 3.2. Function and uses Characterization: oakmoss is the lichen, Evernia Prunastri which grows primarily on oak trees. Extracts are produced from the botanical material and include concretes (produced by extraction with hydrocarbon solvents), absolutes (produced by alcohol extraction of the concrete) and resinoids (produced by hot alcohol extraction). The IFRA Standard on Treemoss extracts (e.g. absolute, resinoid, concrete, etc.), Usnea and Pseudevernia furfuracea* (* The Standard therefore also covers qualities marketed as cedar moss), states that the material should not be used such that the level in consumer products exceeds 0.1%. 7 SCCP/1131/07 Opinion on oak moss / tree moss (sensitisation only) 3.3. Toxicological Evaluation 3.3.1. Acute toxicity Not applicable 3.3.2 Irritation and corrosivity 3.3.2.1. Skin irritation Not applicable 3.3.2.2. Mucous membrane irritation Not applicable 3.3.3. Skin sensitisation OAKMOSS, LLNA Guideline: OECD 429 Group: 28 female CBA/J mice 5 groups of 4 mice for test substance, 1 group of 4 for vehicle control, 1 group of 4 for positive control Substance: Mousse Chêne DM HYP Purity: / Atranol/chloroatranol content: < 50 ppm each (undocumented in report) Batch: 119459 Vehicle: Dimethyl formamide (DMF) Dilutions: 2.5, 5, 10, 25 and 50% Controls: negative – DMF Positive – 25% α-hexylcinnamaldehyde in acetone/olive oil (4/1 v/v) GLP: in compliance Date: 29 June – 13 July 2004 For the main study, oakmoss absolute, treated to lower the level of atranol and chloroatranol, was tested at five concentrations: 50%, 25%, 10%,
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