|European Union directive|
|Title||Directive on the approximation of the laws of the Member States relating to cosmetic products|
|Made under||Art. 100 (EEC)|
|Journal reference||L262, 1976-09-27, pp. 169–200|
|Came into force||1976-07-30|
|Commission proposal||Com 72/0851 Final|
|EESC opinion||C60, 1973-07-26, p. 16|
|EP opinion||OJ C40, 1974-04-08, p. 71|
|Amended by||External list|
Council Directive 76/768/EEC of 1976-07-27 on the approximation of the laws of the Member States relating to cosmetic products (as amended) is the main European Union law on the safety of cosmetics. It was made under Art. 100 (ex Art. 94) of the Treaty of Rome. By agreement, it is also applicable in the European Economic Area.
The directive defines a "cosmetic product" as "any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours." (Art. 1.1)
The main part of the directive is 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 are regularly amended (57 times up until April 2008) to take account of new data on the safety of particular substances.
The 7th amendment to the law introduced provisions in relation to animal testing. It introduced a legal requirement to the labelling of 26 specific ingredients at certain concentration thresholds. 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. The amendment does not prohibit companies to use animal testing to fulfill regulatory requirements in other countries.
- The old Art. 100 of the EEC treaty has since been renumbered to Art. 94.
- 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.
- Art. 23 and Chapter XVI of Annex II, PDF signed in Oporto, 1992-05-02; came into force 1994-01-01.
- 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.
- Directive 2003/15/EC of 27 February 2003 is the 7th amendment to the law.
- 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.
- "Full EU ban on animal testing for cosmetics enters into force". European Commission. March 11, 2013. Retrieved May 20, 2015.
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