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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : 4-Isopropylbenzyl salicylate
1.2 CAS n° :
1.3 Use : sunscreen formulations at a maximum concentration of 4%
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 S16 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 :
* Is 4-Isopropylbenzyl salicylate safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Toxicological Evaluation & Characterisation
3.1 Acute toxicity (dermal, oral, i.v., i.p.) : not applicable
3.2 Chronic/sub-chronic toxicity : not applicable
3.3 Reproductive toxicity : not applicable
3.4. Percutaneous absorption : not applicable
3.5 Irritation and corrosivity : not applicable
3.6 Allergenicity and sensitisation : not applicable
3.7 Genotoxicity/carcinogenicity : not applicable
4. Opinion
By letter of 27 January 1999, COLIPA, The European Cosmetic Toiletry and Perfumery Association, informed the European Commission that the manufacturer of 4-Isopropylbenzyl salicylate (COLIPA n° S16 - n° 29, part 2 of Annex VII of Directive 76/768/EEC) has ceased the production of this ingredient as UVB filter.
Therefore, the requests for information on S16 made by the SCCNFP will not be answered.
It follows that COLIPA will not be requesting the prolongation of the provisional use of 4-Isopropylbenzyl salicylate nor the inclusion of the substance in Annex VII part 1 of Directive 76/768/EEC.
As a consequence, the SCCNFP ceased the evaluation procedure on the use of 4-Isopropylbenzyl salicylate in cosmetic sunscreen formulations.
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 : 4-Isopropylbenzyl salicylate
1.2 CAS n° :
1.3 Use : sunscreen formulations at a maximum concentration of 4%
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 S16 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 :
* Is 4-Isopropylbenzyl salicylate safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Toxicological Evaluation & Characterisation
3.1 Acute toxicity (dermal, oral, i.v., i.p.) : not applicable
3.2 Chronic/sub-chronic toxicity : not applicable
3.3 Reproductive toxicity : not applicable
3.4. Percutaneous absorption : not applicable
3.5 Irritation and corrosivity : not applicable
3.6 Allergenicity and sensitisation : not applicable
3.7 Genotoxicity/carcinogenicity : not applicable
4. Opinion
By letter of 27 January 1999, COLIPA, The European Cosmetic Toiletry and Perfumery Association, informed the European Commission that the manufacturer of 4-Isopropylbenzyl salicylate (COLIPA n° S16 - n° 29, part 2 of Annex VII of Directive 76/768/EEC) has ceased the production of this ingredient as UVB filter.
Therefore, the requests for information on S16 made by the SCCNFP will not be answered.
It follows that COLIPA will not be requesting the prolongation of the provisional use of 4-Isopropylbenzyl salicylate nor the inclusion of the substance in Annex VII part 1 of Directive 76/768/EEC.
As a consequence, the SCCNFP ceased the evaluation procedure on the use of 4-Isopropylbenzyl salicylate in cosmetic sunscreen formulations.
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.
