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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : Ketoconazole
1.2 CAS n° : 65277-42-1
1.3 Field of application : Topical cosmetic : 1 % of ketoconazole in rinse-off and leave-on products
1.4 Other usage data : 2 % Ketoconazole-containing licensed shampoo
2. Terms of reference
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.
Technical adaptation to Annex III of Directive 76/768/EEC, List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down.
3. Safety Assessment & Classification
The assessment followed the SCCNFP Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of acute toxicity (oral, dermal, intravenous), repeated dose toxicity (dermal), skin and mucous membrane irritation, sub-chronic toxicity (oral, dermal), reproductive toxicity (oral), genotoxicity, chronic toxicity (oral, dermal), percutaneous absorption and also dose-dependent endocrine and other adverse effects have shown that the compound can be safely used under the conditions stated in the Opinion.
4. Opinion
The SCCNFP is of the opinion that Ketoconazole can be used safely in both rinse-off and leave on cosmetic products, excluding oral care products. According to the existing data, its maximum authorised concentration in the finished cosmetic product should be restricted to 2.0 %.
In order to avoid any risk by accidental intake, cosmetic products containing Ketoconazole should not be used by nursing mothers.
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.
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 : Ketoconazole
1.2 CAS n° : 65277-42-1
1.3 Field of application : Topical cosmetic : 1 % of ketoconazole in rinse-off and leave-on products
1.4 Other usage data : 2 % Ketoconazole-containing licensed shampoo
2. Terms of reference
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.
Technical adaptation to Annex III of Directive 76/768/EEC, List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down.
3. Safety Assessment & Classification
The assessment followed the SCCNFP Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of acute toxicity (oral, dermal, intravenous), repeated dose toxicity (dermal), skin and mucous membrane irritation, sub-chronic toxicity (oral, dermal), reproductive toxicity (oral), genotoxicity, chronic toxicity (oral, dermal), percutaneous absorption and also dose-dependent endocrine and other adverse effects have shown that the compound can be safely used under the conditions stated in the Opinion.
4. Opinion
The SCCNFP is of the opinion that Ketoconazole can be used safely in both rinse-off and leave on cosmetic products, excluding oral care products. According to the existing data, its maximum authorised concentration in the finished cosmetic product should be restricted to 2.0 %.
In order to avoid any risk by accidental intake, cosmetic products containing Ketoconazole should not be used by nursing mothers.
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.
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.
