Executive Summary
1. General data
1.1 Identity of the ingredient :
Acrylamide [CH2=CH-CONH2]
1.2 CAS n° :
Acrylamide CAS n°. : 79-06-1
EINECS n° : 202-173-7
1.3 Use : Productions of water-soluble polyacrylamides are the largest application of acrylamide. These high molecular weight polymers are produced to give non-ionic, cationic and anionic properties for specific uses. Polyacrylamides are used in some cosmetic preparations due to the ability of these substances to function in many different ways such as stabilisers, foam builders, binders, film formers, antistatic agents and hair fixatives. Polyacrylamides contain small amounts of unreacted acrylamide.
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 residual acrylamide in cosmetic products containing polyacrylamide
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Does acrylamide residues caused by the presence of polyacrylamide in cosmetics pose a risk of cancer to the user?
* Does the SCCNFP propose any restrictions or conditions for use of cosmetic products containing polyacrylamide?
3. Safety Assessment & Classification
The assessment followed the SCCNFP Notes of Guidance under scientific 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, sub-chronic toxicity (oral, dermal, inhalation), reproductive toxicity (oral), genotoxicity, carcinogenicity, sensitisation, percutaneous absorption have shown that polyacrylamide can be safely used in cosmetics under the conditions stated in the opinion.
4. Opinion
Lifelong use of cosmetic products containing polyacrylamide may represent an unacceptable high lifetime risk of cancer due to residual acrylamide in the polyacrylamide preparations. This conclusion is based on two longtime rat studies of acrylamide and on the genotoxic properties of acrylamide. In order that the lifetime use of cosmetics containing polyacrylamide should not pose a significant cancer risk the theoretical content of residual acrylamide [calculated from the amount of polyacrylamide added to the product and the content of acrylamide in the polyacrylamide used] should be <0.1 ppm in body care leave-on products and <0.5 ppm in other 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.
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 :
Acrylamide [CH2=CH-CONH2]
1.2 CAS n° :
Acrylamide CAS n°. : 79-06-1
EINECS n° : 202-173-7
1.3 Use : Productions of water-soluble polyacrylamides are the largest application of acrylamide. These high molecular weight polymers are produced to give non-ionic, cationic and anionic properties for specific uses. Polyacrylamides are used in some cosmetic preparations due to the ability of these substances to function in many different ways such as stabilisers, foam builders, binders, film formers, antistatic agents and hair fixatives. Polyacrylamides contain small amounts of unreacted acrylamide.
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 residual acrylamide in cosmetic products containing polyacrylamide
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Does acrylamide residues caused by the presence of polyacrylamide in cosmetics pose a risk of cancer to the user?
* Does the SCCNFP propose any restrictions or conditions for use of cosmetic products containing polyacrylamide?
3. Safety Assessment & Classification
The assessment followed the SCCNFP Notes of Guidance under scientific 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, sub-chronic toxicity (oral, dermal, inhalation), reproductive toxicity (oral), genotoxicity, carcinogenicity, sensitisation, percutaneous absorption have shown that polyacrylamide can be safely used in cosmetics under the conditions stated in the opinion.
4. Opinion
Lifelong use of cosmetic products containing polyacrylamide may represent an unacceptable high lifetime risk of cancer due to residual acrylamide in the polyacrylamide preparations. This conclusion is based on two longtime rat studies of acrylamide and on the genotoxic properties of acrylamide. In order that the lifetime use of cosmetics containing polyacrylamide should not pose a significant cancer risk the theoretical content of residual acrylamide [calculated from the amount of polyacrylamide added to the product and the content of acrylamide in the polyacrylamide used] should be <0.1 ppm in body care leave-on products and <0.5 ppm in other 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.
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.