Safety evaluation of cosmetics in the EU: Reality and challenges for the toxicologist

Toxicology Letters

Volumn 151, Issue 1, 2004, Pages 7-17

  Pauwels, Marleen ^a   Rogiers, Vera ^a  

^a VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

Author keywords

Alternative methods; Animal experimentation; Cosmetic products; Regulatory safety testing; Risk assessment; Safety evaluation

Indexed keywords

COSMETIC;

CONSUMER; COSMETIC INDUSTRY; EXPOSURE; HEALTH CARE POLICY; HEALTH HAZARD; HUMAN; LAW; MANDATORY TESTING; MATERIALS; MEDICAL SPECIALIST; METHODOLOGY; NONHUMAN; PACKAGING; PERCEPTION; PRIORITY JOURNAL; RESEARCH ETHICS; REVIEW; RISK ASSESSMENT; SAFETY; TOXICITY;

ANIMAL TESTING ALTERNATIVES; ANIMALS; CONSUMER PRODUCT SAFETY; COSMETICS; EUROPEAN UNION; HUMANS; PRODUCT LABELING; RISK ASSESSMENT; TOXICITY TESTS;

ANIMALIA;

EID: 2942576117     PISSN: 03784274     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.toxlet.2004.01.026     Document Type: Review

References (26)

1. 67/548/EEC - Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official J. 196, 16 August 1967, pp. 1-98.
2. 76/768/EEC - Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. Official J. L262, 27 September 1976, pp. 169-200.
3. 91/155/EEC - Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC. Official J. L076, 22 March 1991, pp. 35-41.
4. 91/414/EEC - Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. Official J. L230, 19 August 1991, pp. 1-32.
5. 92/32/EEC - Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC (1967) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official J. L154, 5 June 1992, pp. 1-29.
6. 93/35/EEC - Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official J. L151, 23 June 1993, pp. 32-37.
7. 93/112/EC - Commission Directive 93/112/EC of 10 December 1993 amending Commission Directive 91/155/EEC (1991) defining and laying down detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Council Directive 88/379/EEC. Official J. L314, 16 December 1993, pp. 38-43.
8. 95/17/EC - Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products. Official J. L140, 23 June 1995, pp. 26-29.
9. 97/18/EC - Commission Directive 97/18/EC of 17 April 1997 postponing the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products. Official J. L114, 1 May 1997, pp. 43-44.
10. 98/8/EC - Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. Official J. L123, 24 April 1998, pp. 1-63.
11. 2000/41/EC - Commission Directive 2000/41/EC of 19 June 2000 postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products. Official J. L145, 20 June 2000, pp. 25-26.
12. 2001/58/EC - Commission Directive 2001/58/EC of 27 July 2001 amending for the second time Directive 91/155/EEC (1991) defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 14 of European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets). Official J. L212, 7 August 2001, pp. 24-33.
13. 2001/83/EC - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official J. L311, 28 November 2001, pp. 67-128.
14. 2003/15/EC - Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official J. L66, 11 March 2003, pp. 26-35.
15. Bolt H.M., Guhe C., Degen G.H. Comments on in vitro and in vivo estrogenicity of UV-screens. Environ. Health Perspect. 109:2001;A358-A361
16. Bremmer, H.J., Prud'Homme de Lodder, L.C.H., van Engelen, J.G.M., 2003. Cosmetics fact sheet to assess the risks for the consumer, Draft RIVM report 6128100/2003.
17. Masson, P., 1999. The contribution of the European Cosmetics Directive towards international harmonization: impact on the evaluation of safety and efficacy. In: Elsner, P., Merk, H.F., Maibach, H.I. (Eds.), Cosmetics: Controlled Efficacy Studies and Regulation. Springer-Verlag, Berlin, pp. 20-35.
18. Nater, J., De Groot, A.C., 1985. Side effects of cosmetics. In: Nater, J., De Groot A.C. (Eds.), Unwanted Effects of Cosmetics and Drugs Used in Dermatology. Elsevier, Amsterdam, pp. 282-388.
19. Rogiers, V., 1999. Training product safety assessors. In: Clark, D.G., Lisansky, S.G., Macmillan, R. (Eds.), Proceedings of the Second International Scientific Conference organized by the European Scientific Cosmetic Industry, Brussels, Belgium. CPL Scientific Publishing Services Ltd., Berkshire, UK, pp. 100-106.
20. Rogiers V., 2001. Example of a framework for a technical information file of a cosmetic product. In: Rogiers, V. (Ed.), Safety Assessment of Cosmetics in the EU. Training Course. Vrije Universiteit Brussel, Brussels, pp. 79-101.
21. SCCNFP/0003/98, Final: guidelines on the use of human volunteers in the testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients, adopted by the plenary session of the SCCNFP of 25 November 1998.
22. SCCNFP/0068/98, Final: guidelines on the use of human volunteers in compatibility testing of finished cosmetic products, adopted by the SCCNFP during the plenary session of 23 June 1999.
23. SCCNFP/0120/99, Final: opinion concerning the predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients, adopted by the SCCNFP during the 11th plenary session of 17 February 2000.
24. SCCNFP/0483/01, Final: opinion on the evaluation of potentially estrogenic effects of UV filters, adopted by the SCCNFP during the 17th plenary meeting of 12 June 2001.
25. SCCNFP/0690/03, Final: notes of guidance for testing of cosmetic ingredients for their safety evaluation, adopted by the SCCNFP during the 25th plenary meeting of 20 October 2003.
26. Schlumpf M., Cotton B., Conscience M., Haller V., Steinmann B., Lichtensteiger W. In vitro and in vivo estrogenicity of UV screens. Environ. Health Perspect. 109:2001;239-244