Council Directive 76/768/EEC of 27 July 1976 was the primary European Union law governing the safety of cosmetic products, established under Article 100 of the Treaty of Rome and also applied in the European Economic Area. It defined a cosmetic product as any substance intended for contact with external parts of the body or oral cavity for cleaning, perfuming, protecting, or changing appearance (Art. 1.1). This directive was repealed by EC Regulation 1223/2009 on cosmetics with effect from 11 July 2013, except for Article 4b, which was repealed earlier on 1 December 2010.
Main parts
The main part of the directive was the different lists of substances in the annexes:
- substances that are banned from use in cosmetics (Annex II)
- substances that are subject to restrictions on their use (Annex III): such substances might only be permitted for certain types of cosmetics, or in certain concentrations, or subject to warning labels, etc.
- permitted colourings (Annex IV)
- permitted preservatives (Annex VI)
- permitted UV filters (Annex VII)
The annexes were regularly amended (57 times up until April 2008) to take account of new data on the safety of particular substances.3
Animal testing
The 7th amendment to the law 4 introduced provisions in relation to animal testing. It introduced a legal requirement to the labelling of 26 specific ingredients at certain concentration thresholds.56 It also prohibited the animal testing for cosmetic products since 2004 and cosmetic ingredients since March 2009. The amendment also prohibited, since 11 March 2009, to market cosmetic products containing ingredients which have been tested on animals.7 The amendment does not prohibit companies to use animal testing to fulfill regulatory requirements in other countries.
New Cosmetics Regulation
The Cosmetics Directive is replaced by the new Cosmetics Regulation of 30 November 2009.8 It has to be applied entirely from 11 July 2013 (with some parts earlier).
External links
Wikimedia Commons has media related to EU cosmetics symbols.- Consolidated version of the directive (to 2008-04-24)
- Cosmetics and Medical Devices Unit of the European Commission
References
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. OJEC L262 of 1976-09-27, pp. 169–200. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31976L0768 ↩
Art. 23 and Chapter XVI of Annex II, "Agreement on the European Economic Area". Archived from the original on 2 August 2009. signed in Oporto, 2 May 1992; came into force 1994-01-01. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:21994A0103(52):EN:NOT ↩
See, for example, Commission Directive 2008/42/EC of 3 April 2008 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress. OJEC L93 of 2008-04-04, pp. 13–23. Corrigendum. OJEC L136 of 2008-05-24, p. 52. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32005L0042 ↩
Directive 2003/15/EC of 27 February 2003 was the 7th amendment to the law. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32003L0015 ↩
0.001% (10 mg/kg) for leave-on products and 0.01% (100 mg/kg) for rinse-off products. ↩
"Technical Guidance Document for the Determination of Fragrance Materials in Cosmetic Products, 2006". Cosmetics Europe. Retrieved 20 May 2015. https://www.cosmeticseurope.eu/publications-cosmetics-europe-association/guidelines.html?view=item&id=31 ↩
"Full EU ban on animal testing for cosmetics enters into force". European Commission. 11 March 2013. Retrieved 20 May 2015. https://ec.europa.eu/commission/presscorner/detail/en/IP_13_210 ↩
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009R1223 ↩