SCCP/1155/08 Scientific Committee on Consumer Products SCCP OPINION ON Tea tree oil The SCCP adopted this opinion at its 18th plenary of 16 December 2008 SCCP/1155/08 Opinion on tea tree oil 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/1155/08 Opinion on tea tree oil ACKNOWLEDGMENTS Dr. C. Chambers Prof. G. Degen Dr. B. Jazwiec-Kanyion Prof. V. Kapoulas Prof. J.-P. Marty Prof. T. Platzek (rapporteur) Dr. S.C. Rastogi Prof. J. Revuz Prof. V. Rogiers Prof. T. Sanner (chairman) Dr. J. van Engelen Dr. I.R. White Keywords: SCCP, scientific opinion, tea tree oil, directive 76/768/ECC, CAS 68647-73-4, EINECS 285-377-1 Opinion to be cited as: SCCP (Scientific Committee on Consumer Products), Opinion on tea tree oil, 16 December 2008 3 SCCP/1155/08 Opinion on tea tree oil TABLE OF CONTENTS ACKNOWLEDGMENTS ………………………………………………………………………………... 3 1. BACKGROUND …………………………………………………………………………………. 5 2. TERMS OF REFERENCE …………………………………………………………………………………. 5 3. OPINION …………………………………………………………………………………. 6 4. CONCLUSION …………………………………………………………………………………. 36 5. MINORITY OPINION …………………………………………………………………………………. 36 6. REFERENCES …………………………………………………………………………………. 36 4 SCCP/1155/08 Opinion on tea tree oil 1. BACKGROUND The Scientific Committee on Consumer Product (SCCP) adopted a scientific opinion (SCCP/0834/04) on Tea Tree Oil (TTO) on its 2nd plenary meeting of 7 December 2004 with the following conclusion: "The sparse data available suggest that the use of undiluted Tea Tree Oil as a commercial product is not safe. The safety dossier of Tea Tree Oil is incomplete. The stability of Tea Tree Oil in cosmetic formulations is questionable. A standardized method for the specification of Tea Tree Oil is needed. Industry should develop an analytical testing method based on typical degradation products to ensure and control the stability of the material. Skin and eye irritation was not assessed by adequate methods. There are relevant data gaps with regard to subchronic toxicity, percutaneous absorption, genotoxicity/carcinogenicity and reproductive toxicity. The safe use of Tea Tree Oil as cosmetic ingredient cannot be assessed. A complete dossier of a representative standardized material to all relevant toxicological endpoints is required by the end of 2005; an opinion based on the information available at that time will be given." As a response to the above scientific opinion a complete new dossier was submitted by the end of March 2007. Tea tree oil is the essential oil obtained from Melaleuca alternifolia, Melaleuca linariifolia and Melaleuca dissitiflora as well as other species of Melaleuca provided that the oil conforms to the requirements given in ISO 4730-2004. The following types of application for cosmetic products are given in the dossier: Skin - care products incl. post-waxing treatments up to 1.25% Hair - care products up to 2.0% Nail - care products up to 20% Oral hygiene up to 0.2% Personal hygiene including shaving products up to 2% The undiluted might be used for other purposes as well i.e. aromatherapy. 2. TERMS OF REFERENCE 1. On the basis of the data provided, does the SCCP consider the use of Tea Tree Oil safe for the consumers when used in cosmetic products in concentrations as mentioned above? 2. Does the SCCP have any safety concerns for the use of Tea Tree Oil as an undiluted product? 5 SCCP/1155/08 Opinion on tea tree oil 3. OPINION 3.1. Chemical and Physical Specifications 3.1.1. Chemical identity 3.1.1.1. Primary name and/or INCI name Tea Tree Oil Melaleuca alternifolia (Tea Tree) Leaf Oil (INCI) 3.1.1.2. Chemical names / 3.1.1.3. Trade names and abbreviations Australian Tea Tree Oil 3.1.1.4. CAS / EINECS number CAS: 68647-73-4 (Oils, tea-tree) EINECS: 285-377-1 3.1.1.5. Major constituents, contents and chemical structures The European Inventory of cosmetic ingredients contains 3 Melaleuca-type ingredients (INCI names): Melaleuca alternifolia oil (antimicrobial), Melaleuca cajuputi extract (tonic), Melaleuca leucadendron extract (tonic). Tea Tree Oil is the essential oil obtained by steam distillation of the foliage and terminal branchlets of Melaleuca alternifolia, Melaleuca linariifolia and Melaleuca dissitiflora as well as other species of Melaleuca provided that the oil obtained conforms to the requirements given in the International Standard (ISO 4730- 2004). Tea Tree Oil from Melaleuca alternifolia contains various mono- and sesquiterpenes as well as aromatic compounds. The monoterpenes terpinen-4-ol, α-terpinene, α-terpinene, 1,8-cineole, p-cymene, α-terpineol, α-pinene, terpinolenes, limonene and sabinene account for 80 - 90% of the oil. The natural content of the individual terpenes in Tea Tree Oil may vary considerably depending on the Melaleuca alternifolia population used, the climate, the leaf maceration, the age of the leaves and the duration of distillation. Its major constituents are presented in Table 1. The chemical structures for these major constituents are shown in Figure 1. Table 1: Main constituents of Tea Tree Oil (From ISO 4730-2004) Constituent Minimum Maximum (%) (%) Terpinolene 1.5 5 1,8-Cineole (eucalyptol) Trace 15 α-Terpinene 5 13 γ-Terpinene 10 28 p-Cymene 0.5 8 Terpinen-4-ol 30 48 α-Terpineol 1.5 8 Limonene 0.5 1.5 Sabinene Trace 3.5 Aromadendrene Trace 3 δ-Cadinene Trace 3 6 SCCP/1155/08 Opinion on tea tree oil Constituent Minimum Maximum (%) (%) Globulol Trace 1 Viridiflorol Trace 1 α-Pinene 1 6 Ledene (syn. viridiflorene) Trace 3 Ref.: 1 7 SCCP/1155/08 Opinion on tea tree oil Figure 1: Chemical structures of the main constituents of Tea Tree Oil CH3 CH3 CH3 O H3C CH3 H C CH 3 3 H C CH 3 3 Terpinolene (C10H16) 1,8-Cineole (C10H18O) α-Terpinene (C10H16), MW=136 MW=160 MW=136 Log P = 4.52 ± 0.22 Log P = 2.82 ± 0.27 Log P = 4.52 ± 0.22 CH3 CH3 CH3 HCHO 3 H C CH H3C CH3 3 3 H C 3 γ-Terpinene (C10H16) p-Cymene (C10H14) (+)-Terpinen-4-ol (C10H18O) MW=136 MW=134 MW=154 Log P = 4.36 ± 0.24 Log P = 4.58 ± 0.24 Log P = 4.52 ± 0.22 CH3 CH3 H2C CH3 CH3 OH H CH H3C CH3 3 (+)-α-Terpineol (C10H18O) D-Limonene (C10H16) (+)-Sabinene (C10H16) MW=160 MW=136.24 MW=136.23 Log P = 2.73 ± 0.22 Log P = 4.23 Log P = 4.13 ± 0.24 CH3 OH H H H H H H H C H C 3 H 3 H H H CH3 H3C H C CH3 3 (+)-Aromadendrene (C15H24) δ-Cadinene (C15H24) (-)-Globulol (C15H26O) MW=204.35 MW=204 MW=222.37 Log P = 6.41± 0.25 Log P = 6.64 ± 0.24 Log P = 4.81 ± 0.26 HO H H C H 3 H H H H H H3C CH3 H C 3 (+)-Viridiflorol (C15H26O) (+)-ledene (syn. viridiflorene) α-Pinene (C10H16) MW=222.37 (C15H24) MW=136.23 Log P = 4.81 ± 0.26 MW=204 Log P = 4.37± 0.24 8 SCCP/1155/08 Opinion on tea tree oil 3.1.2. Physical properties Colourless to pale-yellow liquid 3.1.3. Molecular weight Tea Tree Oil is a mixture of several constituents. The main constituents have MW ranging from 134 to 222 g/mol. 3.1.4. Purity, composition and substance codes The purity, composition and physico-chemical properties of Tea Tree Oil are defined in several standards and monographs. The following pharmacopoeia and composition standards are available: - ISO 4730:2004 - Oil of Melaleuca, terpinen-4-ol type (Tea Tree oil) - Technical Corrigendum 1:1997 to ISO 4730:2005 - Australian Standard AS 2782-1997: Oil of Melaleuca, terpinen-4-ol type (Tea Tree oil) - French Standard T75-358 - Deutscher Arzneimittel Codex (DAC 1986) 8th supplement, 1996 - European Pharmacopoeia - British Pharmacopoeia - Martindale Extra Pharmacopoeia − Aetheroleum Melaleucae Alternifoliae, in WHO Monographs on Selected Medicinal Plants Vol.