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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : Titanium dioxide
1.2 CAS n° : 13463-67-7
1.3 Use : Sunscreen products. Cosmetic formulations can contain up to 25% w/w
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.
Request for inclusion of Titanium dioxide (S75) in Annex VII, part 1 – List of UV filters which Cosmetic Products may contain – to Council Directive 76/768/EEC.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Does the SCCNFP consider the safety profile of titanium dioxide to be sufficient to permit the listing of this material in part I of Annex VII?
* Does the SCCNFP concur with the proposed concentration limit of up to 25% or is a different figure recommended?
* Does the SCCNFP recommend additional requirements for its use 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 acute toxicity (oral, dermal), skin and mucous membrane irritation, sensitisation, sub-chronic toxicity (oral, dermal), chronic (oral, dermal), reproductive toxicity (oral), photo-toxicity, genotoxicity, photo-genotoxicity, carcinogenicity, percutaneous absorption 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 titanium dioxide is safe for use in cosmetic products at a maximum concentration of 25% in order to protect the skin from certain harmful effects of UV radiation.
This opinion concerns crystalline titanium dioxide, whether or not subjected to various treatments (coating, doping, etc.), irrespective of particle size, provided only that such treatments do not compromise the safety of the product.
The SCCNFP proposes no further restrictions or conditions for its use in cosmetic 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 : Titanium dioxide
1.2 CAS n° : 13463-67-7
1.3 Use : Sunscreen products. Cosmetic formulations can contain up to 25% w/w
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.
Request for inclusion of Titanium dioxide (S75) in Annex VII, part 1 – List of UV filters which Cosmetic Products may contain – to Council Directive 76/768/EEC.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Does the SCCNFP consider the safety profile of titanium dioxide to be sufficient to permit the listing of this material in part I of Annex VII?
* Does the SCCNFP concur with the proposed concentration limit of up to 25% or is a different figure recommended?
* Does the SCCNFP recommend additional requirements for its use 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 acute toxicity (oral, dermal), skin and mucous membrane irritation, sensitisation, sub-chronic toxicity (oral, dermal), chronic (oral, dermal), reproductive toxicity (oral), photo-toxicity, genotoxicity, photo-genotoxicity, carcinogenicity, percutaneous absorption 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 titanium dioxide is safe for use in cosmetic products at a maximum concentration of 25% in order to protect the skin from certain harmful effects of UV radiation.
This opinion concerns crystalline titanium dioxide, whether or not subjected to various treatments (coating, doping, etc.), irrespective of particle size, provided only that such treatments do not compromise the safety of the product.
The SCCNFP proposes no further restrictions or conditions for its use in cosmetic 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.
