National laws applicable to cosmetic products are harmonised at European level in order to facilitate the free movement of these products within the European Union’s (EU) internal market. This Directive lays down rules on the composition, labelling and packaging of cosmetic products. It also introduces a ban on animal testing and on the marketing of products that have been tested on animals.

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words "perfume" or "aroma", except where these have been identified as a significant cause of allergic reactions.

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 76/768/EEC	30.7.1976	30.1.1978	OJ L 262 of 27.9.1976

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 79/661/EEC	26.7.1979	30.7.1979	OJ L 192 of 31.7.1979
Directive 82/368/EEC	19.5.1982	31.12.1983	OJ L 167 of 15.6.1982
Directive 83/574/EEC	4.11.1983	31.12.1984	OJ L 332 of 28.11.1983
Directive 88/667/EEC	14.1.1989	31.12.1989	OJ L 382 of 31.12.1988
Directive 89/679/EEC	3.1.1990	3.1.1990	OJ L 398 of 30.12.1989
Directive 93/35/EEC	23.6.1993	14.6.1995	OJ L 151 of 23.6.1993
Directive 2003/15/EC	11.3.2003	11.9.2004	OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version has a purely documentary value.

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.

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].