Cosmetic products (from July 2013)
From 11 July 2013, this Regulation will replace the “Cosmetics Directive” which until now ensured that products circulate freely whilst guaranteeing a high level of protection for consumers. The provisions of the Regulation aim at ensuring that consumers’ health is protected and that they are well informed by monitoring the composition and labelling of products. The Regulation also provides for the assessment of product safety and the prohibition of animal testing.
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance).
Cosmetic products are substances or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) 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, protecting them, keeping them in good condition or correcting body odours.
Free movement of these products in the internal market is permitted if they comply with this Regulation.
A responsible person established in the Community shall be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.
In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.
In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.
If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.
Limitations for certain substances
The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also prohibited.
The Regulation prohibits the use of substances recognized as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products.
Product labeling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering. This information concerns:
- the name or registered name and the address of the responsible person;
- the country of origin for imported products;
- the weight or volume of the content at the time of packaging;
- a use-by date for products kept in appropriate conditions;
- precautions for use, including for cosmetics for professional use;
- the batch number of manufacture or the reference for identifying the cosmetic product;
- the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.
The language of the information shall be determined by the Member State where the product is made available to the end user.
Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:
ingredients or combinations of ingredients.
The Regulation also prohibits the placing on the European Union market of:
products where the final formulation has been the subject of animal testing;
products containing ingredients or combinations of ingredients which have been the subject of animal testing.
A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics.
In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.
The Commission shall be assisted by the Standing Committee on Cosmetic Products.
This Regulation recasts Directive 76/768/EEC due to the many amendments made to it and the new amendments that were required.
The new Regulation shall apply in 2013. However, some of its provisions will apply from 1 December 2010: they concern substances which are carcinogenic, mutagenic or toxic for reproduction (classified as CMR).
- Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
- Toxicokinetics: study of the long-term effects of toxic substances in the body.
- Last updated: 18.02.2010
- Act: Regulation (EC) No 1223/2009
- Entry into force: 11.7.2013
- 1.12.10 (Articles 15 paragraphs 1 and 2, Articles 14, 16, 31 and 32)
- 11.1.2013 (Article 16, paragraph 3, second section)
Official Journal: OJ L 342 of 22.12.2009