Cosmetic Products Regulation

Regulation (EC) no 1223/2009


The Cosmetic Products Regulation, (EC) no 1223/2009 governs the regulatory framework for cosmetic products placed on the EU market. The regulation replaced the Cosmetic products Directive, 76/768/EC, which had been subject to substantial revision since it was first introduced in 1976. 

Regulations are directly acting in Member States (MS) i.e. do not require transposition into national legislation.

A Cosmetic is:

"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".  

The Cosmetics Regulation introduced a number of changes from Directive 76/768/EC, including a requirement to establish a Responsible Person (RP) within the Community, before placing a cosmetic product on the market.

In most instances, the RP will be the manufacturer. However, for imported cosmetic products from third countries, each importer is required to be the RP for the cosmetic product being placed on the market. 

Distributors may also gain RP status, in the case that the cosmetic product is modified, affecting compliance, or placed on the market under the distributor name, or trade mark. Distributors that do not have RP statues are still required to undertake a number of duties e.g. to ensure that the labelling is in conformance with requirements.

Duties of Responsible persons 

  • Ensure the requirements set out in the Annexes to the regulation are complied with for the selection of ingredients, observing any restrictions e.g. on substances classified as CMR;
  • Ensure that a safety assessment is conducted prior to placing the cosmetic product on the market, keeping it up to date with new and relevant information;
  • Retain a product information file for each product place on the market (must be retained for 10 years after the last batch was supplied to market); 
  • Notify the cosmetic product to Cosmetic Products Notification Portal before placing the cosmetic on the market (6 months earlier for cosmetic products containing nanomaterials);
  • Communicate any serious undesirable effects (SUE) to the Competent Authority of the MS, where the  effect was reported;
  • Cooperate with MS Competent Authorities in information exchange processes;
  • Comply with labelling requirements.

Colourants, preservatives and UV-filters, including those that are nanomaterials, must be explicitly authorised for use in cosmetic products.


The following information is required according to Article 19 of the CPR:

  • Name, or registered name and address of the RP;
  • Country of origin for imported products;
  • Nominal content by weight or by volume – not required for packaging contain less than 5 g or ml, free samples and single-application packs, or for pre-packages sold as a number of items, where weight or volume is not significant. In the latter case, the number of items incorporated should be displayed on the packaging, unless the number of items contained is visible, or the product is normally sold individually;
  • Use by date, stored under appropriate conditions (minimum date of durability), either the month and year, or day, month and year, preceded by the egg timer symbol or the words ‘Best used before the end of’. Information on conditions to guarantee durability should be included if necessary;
  • The Period after opening symbol to be displayed alternatively, if minimum date of durability exceeds 30 months. An indication of safe usability period in months and/or years is required, unless no relevant expiry date;
  • Conditions to be observed during use;
  • Batch number or reference for identifying the product (on the packaging if space limited);
  • Function of the cosmetic product, unless clear;
  • List of ingredients, preceded by ‘ingredients’ (on label or packaging) in descending order of weight (any order for concentrations less than 1%), include ‘nano’ in brackets, for relevant nanomaterial constituents;
  • Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’.
  • The presence of substances mentioned in column H of Annex III (Other), are required to be indicated in the list of ingredients in addition to the terms parfum or aroma.
  • Colorants, other than hair colorants may be listed in any order after the cosmetic ingredients. For decorative cosmetic products supplied in several colour shades, all colorants may be listed, provided the words ‘may contain’ or +/- symbol is added (except hair colorants). The Colour Index nomenclature is to be used, where applicable.

Where it is impossible to include the information on the label for practical reasons e.g. container size, the information may be included within an attached leaflet, label, tape, tag or card. It may also be enclosed with the cosmetic product.

MS are responsible for determining the requirements for unpackaged products, packaged at point of sale.

Page published 03 January 2020