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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : Methyleugenol
1.2 CAS no : 93-15-2
EINECS n° : 202-223-0
1.3 Use : Methyleugenol is used as a component of fragrances used in cosmetic products. It is not currently added to cosmetic products directly as an ingredient, it enters cosmetics only through its use as a fragrance raw material. Other information indicate that methyleugenol is used as a flavouring agent in jellies, baked goods, non-alcoholic beverages, chewing gum, candy, pudding, relish, and ice cream.
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
Change in Annex III, part 1, n° 12 to Council Directive 76/768/EEC to set limits for methyleugenol in cosmetic products.
2.2 Request to the SCCNFP
The safety of methyleugenol should be examined to determine whether it should be placed on Annex II of the Cosmetic Directive 76/768/EEC II "List of substances which must not form part of the composition of cosmetic products". Whilst the material is not added directly to cosmetic products, but rather it features as a component of fragrances, such materials have been reviewed previously (e.g. musks) and it is thought appropriate that use of the material should be prohibited if it poses a health risk.
The following questions are posed to the SCCNFP :
* Does the safety profile of methyleugenol support its use as a fragrance raw material used in cosmetic products following current uses and practices?
* Does the SCCNFP recommend restrictions in the use of methyleugenol in cosmetic products?
3. Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of genotoxicity, (in vitro/ in vivo) and carcinogenicity have shown that methyleugenol can only be safely used under the conditions stated in the Opinion.
4. Opinion
The Opinion has only considered the genotoxicity and carcinogenicity of methyleugenol. A risk assessment has been made on the basis of a long-term carcinogenicity study on rats.
Methyleugenol should not be intentionally added as a cosmetic ingredient
However, when fragrance compounds containing methyleugenol naturally present in essential oils are used as components in cosmetic products, the highest concentration of methyleugenol in the finished products must not exceed 0.01 % in fine fragrance, 0.004 % in eau de toilette, 0.002 % in a fragrance cream, 0.0002 % in other leave-on products and in oral hygiene products, and 0.001% in rinse-off products.
5. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
The extend to which these validated methods are applicable to cosmetic products and its ingredients is a matter of the SCCNFP.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
1. General data
1.1 Identity of the ingredient : Methyleugenol
1.2 CAS no : 93-15-2
EINECS n° : 202-223-0
1.3 Use : Methyleugenol is used as a component of fragrances used in cosmetic products. It is not currently added to cosmetic products directly as an ingredient, it enters cosmetics only through its use as a fragrance raw material. Other information indicate that methyleugenol is used as a flavouring agent in jellies, baked goods, non-alcoholic beverages, chewing gum, candy, pudding, relish, and ice cream.
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
Change in Annex III, part 1, n° 12 to Council Directive 76/768/EEC to set limits for methyleugenol in cosmetic products.
2.2 Request to the SCCNFP
The safety of methyleugenol should be examined to determine whether it should be placed on Annex II of the Cosmetic Directive 76/768/EEC II "List of substances which must not form part of the composition of cosmetic products". Whilst the material is not added directly to cosmetic products, but rather it features as a component of fragrances, such materials have been reviewed previously (e.g. musks) and it is thought appropriate that use of the material should be prohibited if it poses a health risk.
The following questions are posed to the SCCNFP :
* Does the safety profile of methyleugenol support its use as a fragrance raw material used in cosmetic products following current uses and practices?
* Does the SCCNFP recommend restrictions in the use of methyleugenol in cosmetic products?
3. Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of genotoxicity, (in vitro/ in vivo) and carcinogenicity have shown that methyleugenol can only be safely used under the conditions stated in the Opinion.
4. Opinion
The Opinion has only considered the genotoxicity and carcinogenicity of methyleugenol. A risk assessment has been made on the basis of a long-term carcinogenicity study on rats.
Methyleugenol should not be intentionally added as a cosmetic ingredient
However, when fragrance compounds containing methyleugenol naturally present in essential oils are used as components in cosmetic products, the highest concentration of methyleugenol in the finished products must not exceed 0.01 % in fine fragrance, 0.004 % in eau de toilette, 0.002 % in a fragrance cream, 0.0002 % in other leave-on products and in oral hygiene products, and 0.001% in rinse-off products.
5. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
The extend to which these validated methods are applicable to cosmetic products and its ingredients is a matter of the SCCNFP.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
