New Regulation on Cosmetic Products

Since July 11, 2013 the requirements of cosmetic products in EU are regulated by Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

The new Regulation strengthens certain elements of the regulatory framework for requirements for cosmetic products, their handling and in-market surveillance.

"Cosmetic product" means any substance or mixture intended to be placed in contact with the 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 mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

According to the Regulation, the main requirements for cosmetic products are:

  • Cosmetic products must be safe for human health;
  • Cosmetic products must be packaged and labelled in order to meet the requirements of this Regulation, including warnings and instructions for use and disposal.

The Regulation on cosmetic products prohibits animal testing of finished cosmetic products and of ingredients or combinations of ingredients in order to meet the requirements of this Regulation, and marketing of such products in the Member States.

The Regulation establishes certain definitions concerning cosmetic products, which help the economic operators to define their exact role in the supply chain and their respective obligations provided for in the Regulation.

Regulation establishes the economic operators in the supply chain:

  • Manufacturer - any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;
  • Importer - any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;
  • Distributor - any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;
  • End user -  either a consumer or professional using the cosmetic product.

Regulation clarifies important definitions like "making available on the market" and "placing on the market":

  • "making available on the market"-  any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;
  • "placing on the market" - the first making available of a cosmetic product on the Community market.

Regulation establishes obligations for enterprises operating in the supply chain and the requirements for cosmetic products. Articles 4 and 5 of the Regulation establish the obligations of the responsible person, who usually is the manufacturer established within the Community. For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market. The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected. Article 6 establishes the obligations of the distributor.

Responsible persons  and distributors have the obligation to be able to identify the supply chain for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor.

According to Article 11, the responsible person shall keep a product information file for each cosmetic product with all necessary technical documentation, including cosmetic product safety report in accordance to Annex I and cosmetic product safety assessment. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

Article 13 requires that the responsible persons submit through the CPNP (Cosmetic Products Notification Portal) some information about the products they place or make available on the European market. Article 16 makes it mandatory for the responsible person to notify a product containing nanomaterials at least 6 months prior to the placing of products on the market and to clearly indicate all ingredients present in the form of nanomaterials in the list of ingredients. The names of such ingredients shall be followed by the word "nano" in brackets.

Article 20 establishes that in the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have. This is regulated by Regulation (EU) No 655/2013, which establishes common criteria for the use of product claims. The Regulation can be found here.

Article 23 makes it mandatory for the responsible persons and distributors to notify the competent authority of the Member State about any serious undesirable effects. Serious undesirable effect is an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.  For the implementation of Article 23, the Estonian Health Board has created an electronic notification form, which will be introduced to the interest groups in October 2013.

Additionally, for the indication of date of minimum durability on product labels is possible to use the hourglass symbol shown in point 3 of Annex VII or the words: "best used before the end of".

More information about the requirements for cosmetic products can be found on the EC website and on the website of Cosmetics Europe.

Viimati uuendatud:  kolmapäev, 25 september 2013 15:24