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Regulatory framework

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Legislation

On 11 July 2013 the new EU Regulation 1223/2009 pdf-Cosmetics Regulation- came into force strengthening the safety of cosmetic products and streamlining the framework for all operators in the sector. The Regulation simplifies procedures to the extent that the internal market of cosmetic products is now a reality. The Cosmetics Regulation, adopted in 2009, replaces Directive 76/768/EC that was adopted in 1976 and has been substantially revised on no less than 7 occasions.

The Cosmetics Regulation provides a robust, internationally recognised regime, which reinforces product safety 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 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 "responsible person" can be placed on the market. The new Cosmetics Regulation allows the precise identification of who the responsible person is and clearly outlines the obligations.
  • Centralized notification of all cosmetic products placed on the EU market
    Manufacturer will need to notify its product only once - via the EU Cosmetic Products Notification Portal (CPNP).
  • Introduction of reporting of serious undesirable effects
    A responsible person will have an obligation to notify serious undesirable effects to competent national authorities. The authorities will also collect information coming from e.g. users and health professionals, and will be obliged to share the information with other EU Member States. For more information click here.
  • New rules for the use of nanomaterials in cosmetic products
    Colorants, preservatives and UV-filters, including those that are nanomaterials, must be explicitly authorized. Products containing other nanomaterials not otherwise restricted by the Cosmetics Regulation will be the object of a full safety assessment at the 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)".
View the most important changes as infographicsjpeg(3 MB)

Commission Implementing Decision 2013/674/EU of 25 November 2013 in Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliement and of the Council on cosmetic products

Commission Regulation (EU) No 655/2013pdf of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products

Guidelines to Commission Regulation (EU) No 655/2013 pdfof 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products

Amendments to the Cosmetics Regulation

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 1197/2013pdf 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 pdfof 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 pdfof 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 pdfof 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

Other applicable EU legislation

The Cosmetics Regulation is the main regulatory framework for a finished cosmetic product as defined therein when placed on the EU market. However, apart from the Cosmetics Regulation, other EU-legislation applies for specific aspects, some of which are listed in the section "Reference documents".