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Legislation

Main legislation

The new EU Regulation 1223/2009 (Cosmetics Regulation) has been in force since 11 July 2013. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. The Regulation simplifies proceduresto the extent that the internal market of cosmetic products is now a reality.

The new Regulation replaces Directive 76/768/EC, which was adopted in 1976 and had been substantially revised on numerous occasions. It provides a robust, internationally recognised regime, which reinforces product safety while taking into consideration the latest technological developments, including the possible use of nanomaterials. The previous rules on the ban of animal testing were not modified.

The most significant changes introduced by the new Cosmetics Regulation include:

  • Strengthened safety requirements for cosmetic products
    Manufacturers need to follow specific requirements in the preparation of a product safety report prior to placing a product on the market.
  • Introduction of the notion of “responsible person”
    Only cosmetic products for which a legal or natural person is designated within the EU as a “responsible person” can be placed on the market. The new Cosmetics Regulation allows the precise identification of the responsible person is and clearly outlines their obligations.
  • Centralised notification of all cosmetic products placed on the EU market
    Manufacturers will need to notify their products only once – via the EU Cosmetic Products Notification Portal (CPNP).
  • Introduction of reporting of serious undesirable effects (SUE)
    A responsible person will have an obligation to notify serious undesirable effects to national authorities. The authorities will also collect information coming from users, health professionals, and others. They will be obliged to share the information with other EU countries. More information on reporting of SUE.
  • New rules for the use of nanomaterials in cosmetic products
    Colorants, preservatives and UV-filters, including those that are nanomaterials, must be explicitly authorised. Products containing other nanomaterials not otherwise restricted by the Cosmetics Regulation will be the object of a full safety assessment at EU level if the Commission has concerns. Nanomaterials must be labelled in the list of ingredients with the word “nano” in brackets following the name of the substance, e.g. “titanium dioxide (nano)”.

See the most important changes as an infographicjpeg(3 MB).

Other applicable EU legislation

The Cosmetics Regulation is the main regulatory framework for finished cosmetic products when placed on the EU market. Other EU-legislation applies for specific aspects however, some of which are listed in the reference documents section.

Guidelines and Claims

Amendments to the Cosmetics Regulation

  • Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Parabens)
  • Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (MCI-MI)
  • Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano))
  • Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano))
  • Commission Regulation (EU) No 358/2014 of 9 April 2014 amending annexes Ⅱ and Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (parabens & triclosan)
  • Commission Regulation (EU) No 1197/2013 of 25 November 2013 amending Annex Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair and eyelash dyes)
  • Commission Regulation (EU) No 658/2013 of 10 July 2013 amending Annexes Ⅱ and Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair dye products)
  • Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex Ⅲ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Polidocanol)
  • Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes Ⅱ, Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products