Human health safety evaluation of cosmetics in the EU: A legally imposed challenge to science

Toxicology and Applied Pharmacology

Volumn 243, Issue 2, 2010, Pages 260-274

  Pauwels, M ^a   Rogiers, V ^a  

^a VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

Author keywords

76 768 EEC; Cosmetics; EU legislation; Hazard assessment; Human health safety evaluation; Risk assessment

Indexed keywords

COSMETIC;

ANIMAL; DRUG LABELING; DRUG LEGISLATION; EUROPEAN UNION; HUMAN; REVIEW; RISK ASSESSMENT;

ANIMALS; COSMETICS; DRUG LABELING; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; RISK ASSESSMENT;

EID: 77949407864     PISSN: 0041008X     EISSN: 10960333     Source Type: Journal    
DOI: 10.1016/j.taap.2009.12.007     Document Type: Article

References (80)

1. Bodar, C.W., Berthault, F., de Bruijn, J.H., van Leeuwen, C.J., Pronk, M.E., Vermeire, T.G., Evaluation of EU risk assessments existing chemicals (EC Regulation 793/93). Chemosphere 8 (2003), 1039–1047.
2. De Smedt A., 2007. In vitro 3T3 NRU Phototoxicity test. Oral communication during the Annual conference 2007 of the European Partnership for Alternative Approaches to Animal Testing: "Regulatory Acceptance". 5 November 2007 Brussels, Belgium, electronically available through http://ec.europa.eu/enterprise/epaa/conf_2007.htm (consulted Nov 2009).
3. DG SANCO, 2003. Guidance Document on the Relationship between the General Product Safety Directive (GPSD) and certain Sector Directives with Provisions on Product Safety. European Commission Directorate General Health and Consumer Protection (DG SANCO), November 2003, available through http://ec.europa.eu/consumers/cons_safe/prod_safe/gpsd/guidance_gpsd_en.pdf (consulted Dec 2009).
4. DG SANCO, 2009. The Scientific Committees on Consumer Safety (SCCS), Health and Environment Risks (SCHER) and Emerging and Newly Identified Health Risks (SCENIHR) Rules of Procedure. European Commission, Health and Consumers Directorate General, May 2009, available through http://ec.europa.eu/health/ph_risk/documents/rules_procedure_en.pdf (consulted Dec 2009).
5. ECB, 2003. European Chemicals Bureau. Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) No 1488/94 on Risk Assessment for existing substances and Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Doc. EUR 20418 EN/1, European Communities (2003).
6. th Meeting of 26 27-April 2007 at ECVAM, Ispra, Italy.
7. th Meeting of 26‑27 April 2007 at ECVAM, Ispra, Italy.
8. th Meeting of 9-10 March 2009 at ECVAM, Ispra, Italy.
9. st Meeting of 7‑8 July 2009 at ECVAM, Ispra, Italy.
10. EU, 1967. 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. OJ P196, 16 August 1967, 1–98.
11. EU, 1975. Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers. OJ L147, 9 June 1975, 40–47.
12. EU, 1976a. Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products. OJ L046, 21 February 1976, 1–11.
13. EU, 1976b. Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. OJ L262, 27 September 1976, 169–200.
14. EU, 1979. Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. OJ L262, 27 September 1976, 201–203.
15. EU, 1980. Council Directive 80/232/EEC of 15 January 1980 on the approximation of the laws of the Member States relating to the ranges of nominal quantities and nominal capacities permitted for certain prepackaged products. OJ L051, 25 February 1980, 1–7.
16. EU, 1986. Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. OJ L358, 18 December 1986, 1–28.
17. EU, 1987. Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers. OJ L192, 11 July 1987, 49–50.
18. EU, 1989a. Council Directive 89/48/EEC of 21 December 1988 on a general system for the recognition of higher-education diplomas awarded on completion of professional education and training of at least three years' duration. OJ L019, 24 January 1989, 16–23.
19. EU, 1989b. Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. OJ L040, 11 February 1989, 27–33.
20. EU, 1991a. 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. OJ L76, 22 March 1991, 35–41.
21. EU, 1991b. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L230, 19 August 1991, 1–32.
22. EU, 1992. Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. OJ L154, 5 June 1992, 1–29.
23. EU, 1993a. Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. OJ L84, 5 April 1993, 1–75.
24. EU, 1993b. 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. OJ L151, 23 June 1993, 32–7.
25. EU, 1993c. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L169, 12 July 1993, 1–43.
26. EU, 1993d. Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC. OJ L227, 8 September. 1993, 9–18.
27. EU, 1993e. Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC. OJ L294, 30 November 1993, 21–28.
28. EU, 1994a. Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93. OJ L161, 29 June 1994, 3–11.
29. EU, 1994b. European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs. OJ L237, 10 September 1994, 3–12.
30. EU, 1994c. European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs. OJ L237, 10 September 1994, 13–29.
31. EU, 1995. European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners. OJ L61, 18 March 1995, 1‑40.
32. EU, 1998. 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. OJ L123, 24 April 1998, 1–63.
33. EU, 1999. Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. OJ L200, 30 July 1999, 1–68.
34. EU, 2001a. Commission Directive 2001/58/EC of 27 July 2001 amending for the second time Directive 91/155/EEC 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). OJ L212, 7 August 2001, 24–33.
35. EU, 2001b. 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. OJ L311, 28 November 2001, 67–128.
36. EU, 2002. Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. OJ L011, 15 January 2002, 4–17.
37. EU, 2003. 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. OJ L066, 11 March 2003, 26–35.
38. EU, 2004. Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents. OJ L104, 8 April 2004, 1–35.
39. EU, 2005a. Opinion of Advocate General Geelhoed delivered on 17 March 2005. Case C-244/03: French Republic versus European Parliament and Council of the European Union. Direct actions - Annulment of Article 1(2) of Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ 2003 L 66, p. 26) in so far as it introduces a new Article 4a into Council Directive 76/768/EEC (OJ 1976 L 53, p. 30) on the approximation of the laws of the Member States relating to cosmetic products.
40. EU, 2005b. Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’). OJ L149, 11 June 2005, 22-39.
41. EU, 2006a. Resolution ResAP(2006)1 on a vigilance system for undesirable effects of cosmetic products (“cosmetovigilance”) in Europe in order to protect public health. Adopted by the Committee of Ministers on 8 November 2006 at the 979th meeting of the Ministers’ Deputies. Available through http://www.coe.int/ (consulted Dec 2009).
42. EU, 2006b. Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising. OJ L376, 27 December 2006, 21–27.
43. EU, 2006c. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. OJ L396, 30 December 2006, 1‑849. Corrigendum in OJ L136, 29 May 2007, 3–280.
44. EU, 2007. Directive 2007/45/EC Of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for prepacked products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC. OJ L247, 21 September 2007, 17–20.
45. EU, 2008a. Commission of the European Communities proposal for a Regulation of the European Parliament and of the Council on cosmetic products (recast). {SEC(2008)117 & SEC(2008)118}, COM(2008) 49 final, 2008/025 (COD), Brussels, 5 February 2008.
46. EU, 2008b. Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L142, 31/05/2008, 1-739.
47. EU, 2008c. Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes. COM(2008) 543 final, 2008/0211 (COD). Commission of the European Communities, 5 November 2008, 1-87.
48. EU, 2008d. Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC of the European Parliament and of the Council in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. OJ L345, 23/12/2008, 68-74.
49. EU, 2008e. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L353, 31/12/2008, 1-1355.
50. EU, 2008f. Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. OJ L354, 31/12/2008, 1–6.
51. EU, 2009a. Commission Decision 2009/146/EC of 19 February 2009 on the appointment of the members and advisors of the Scientific Committees and the Pool set up by Decision 2008/721/EC. OJ L49, 20/2/2009, 33-42.
52. EU, 2009b. P6_TA(2009)0158—European Parliament Legislative Resolution of 24 March 2009 on the proposal for a regulation of the European Parliament and of the Council on cosmetic products (recast). (COM(2008)0049)—C6-0053/2008 - 2008/0035(COD).
53. EU, 2009c. PE-CONS 3623/09. Regulation of the European Parliament and of the Council on cosmetic products (recast). Brussels, 10 November 2009. Available through http://register.consilium.europa.eu/pdf/en/09/st03/st03623.en09.pdf (consulted Dec 2009).
54. EU, 2009d. Press release IP/09/1837. President Barroso unveils his new team. Brussels, 27 November 2009. Available through http://europa.eu/rapid/ (consulted Dec 2009).
55. EU, 2009e. Keywords. The European Convention. Available through http://european-convention.eu.int/glossary.asp?lang=EN (consulted Dec 2009).
56. Lelièvre, D., Justine, P., Christiaens, F., Bonaventure, N., Coutet, J., Marrot, L., Cotovio, J., The episkin phototoxicity assay (EPA): Development of an in vitro tiered strategy using 17 reference chemicals to predict phototoxic potency. Toxicol. in Vitro 21 (2007), 977–995.
57. Liebsch, M., Spielmann, H., Pape, W., Krul, C., Deguercy, A., Eskes, C., UV-induced effects. ATLA 33:Suppl. 1 (2005), 131–146.
58. OECD, 2003. Descriptions of selected key generic terms used in chemical hazard/risk assessment. ENV/JM/MONO(2003)15—OECD Series on Testing And Assessment Number 44. Organization for Economic Cooperation and Development, Paris, adopted 30 October 2003.
59. OECD, 2004. OECD Guideline for testing of chemicals - Guideline 428: Skin absorption: In vitro method. Organization for Economic Cooperation and Development, Paris, adopted 13 April 2004.
60. OECD, 2009. Guidance document for using the OECD (Q)SAR application toolbox to develop chemical categories according to the OECD guidance on grouping of chemicals. ENV/JM/MONO(2009)5—Series on Testing and Assessment Number 102. Organization for Economic Cooperation and Development, Paris, adopted 24 February 2009.
61. Pauwels, M, Rogiers, V, Database search for safety information on cosmetic ingredients. Regul. Toxicol. Pharmacol. 49 (2007), 208–216.
62. Pauwels, M., Dejaegher, B., Vander Heyden, Y., Rogiers, V., Critical analysis of the SCCNFP/SCCP safety assessment of cosmetic ingredients (2000–2006). Food Chem. Toxicol. 47 (2009), 898–905.
63. Rogiers, V., Pauwels, M., (eds.) Curr Probl Dermatol. 36: Safety Assessment of Cosmetics in Europe, 2008, S. Karger, Basel, Switzerland 978-3-8055-8655-9.
64. th plenary meeting of 25 November 1998.
65. th plenary meeting of 23 June 1999.
66. th plenary meeting of 23 June 1999.
67. th plenary meeting of 17 February 2000.
68. th plenary meeting of 20 October 2003.
69. th plenary meeting of 28 March 2006.
70. th plenary meeting of 19 December 2006.
71. th plenary meeting of 19 June 2007.
72. th plenary of 18 December 2007.
73. th plenary meeting of 18 December 2007.
74. th plenary meeting of 18 December 2007.
75. th plenary of 24 June 2008.
76. SCCP, 2008b. SCCP/1171/08—SCHER/SCCP/SCENIHR scientific opinion on the use of the Threshold of Toxicological Concern (TTC) approach for the safety assessment of chemical substances - Preliminary report, agreed by SCHER, SCCP and SCENIHR on 19 November 2008 by written procedure.
77. th plenary meeting of 21 January 2009.
78. th plenary on 21 January 2009.
79. Spielmann, H., Balls, M., Dupuis, J., Pape, W.J.W., De Silva, O., Holzhütter, H.G., Gerbereick, F., Liebsch, M., Lowell, W.W., Pfannenbecker, V., A study on UV filter chemical from annex VII of the European Union Directive 76/768 /EEC in the in vitro NTR Phototoxicity test. ATLA 26 (1998), 679–708.
80. WHO. Principles for the safety assessment of food additives and contaminants in food. IPCS Environmental Health Criteria 70, 1987, WHO, Geneva.