EUROPA

SUMMARY

A cosmetic product is any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or correcting body odours, and/or protecting them or keeping them in good condition. Such products, listed in Annex 1 (illustrative list), must not be harmful to human health when they are applied under normal or foreseeable conditions of use.

Member States take all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive are placed on the market. The marketing of such products may not be refused, prohibited or restricted. However, if a Member State notes that a product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It must then immediately inform the other Member States and the Commission thereof, giving the reasons for its decision. The Commission must consult the Member States concerned, deliver its opinion without delay and take the appropriate steps.

This Directive shall be replaced by Regulation (EC) No 1223/2009 from 2013 onwards. Some of the provisions of the Regulation shall be applicable from 1 December 2010. They relate to substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR category 2, 1A and 1B), banned (Annex II) or restricted substances, certain dyes, preservatives and ultra-violet filters.

Ingredients/composition

The Directive sets out a list of substances which cannot be included in the composition of cosmetic products (Annex II) and a list of substances which cosmetic products may contain only under the restrictions and conditions laid down (Annex III).

The Directive also contains lists of colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII) permitted in cosmetic products.

Labelling

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

• the name or trade name and address or registered office of the manufacturer or of the person responsible for marketing the cosmetic product within the Community;
• the nominal contents at the time of packaging, by weight or by volume;
• for products with a minimum durability of less than 30 months: the date of minimum durability indicated by “Best used before the end of ...”;
• for products with a minimum durability of more than 30 months: the period of time after opening for which the product can be used without any harm to the consumer (this information is indicated by a special symbol representing an open cream jar);
• particular precautions for use;
• the batch number or product reference to permit identification;
• the product function.

This information must be in the national or official language or languages of the respective Member State.

Moreover, the label must contain a list of ingredients, in descending order, preceded by the word "Ingredients". Perfume and aromatic compositions must be referred to only by the word "perfume" or "aroma", except where these have been identified as a significant cause of allergic reactions in sensitive consumers.

With regard to the list of ingredients, Member States may require these to be labelled with the common ingredients nomenclature.

Market surveillance

The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing an imported cosmetic product on the Community market, must keep certain product and safety information at the disposal of the competent monitoring authorities.

Member States must check the safety of the product and take all necessary measures to ensure that neither manufacturers nor importers established in the Community place on the market products which do not comply with the Directive. Member States must also ensure that cosmetic products are not attributed characteristics which they do not possess.

Notification to the competent authority

The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing an imported cosmetic product on the Community market, must notify the competent authority of the Member State of the place of manufacture of the cosmetic product or of the place where it was first imported into the Community before being placed on the Community market.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

• testing finished cosmetic products and ingredients on animals (testing ban);
• marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

The testing ban on finished cosmetic products has applied since 11 September 2004, whereas the testing ban on ingredients or combinations of ingredients is applied progressively as alternative methods are validated and adopted. The deadline is 11 March 2009 (six years after entry into force of the Directive).

The marketing ban is applied progressively as alternative methods are validated and adopted through European Union (EU) legislation, with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD). The deadline is 11 March 2009 (six years after entry into force of the Directive) for products tested for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics. For these specific health effects, the deadline is 11 March 2013 (10 years after entry into force of the Directive).

The deadlines for both the testing ban and the marketing ban will apply irrespective of the availability of alternative non-animal tests.

Comitology

In managing the provisions on cosmetic products, the Commission is assisted by the Standing Committee on Cosmetic Products.