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Legislation

Legislation

Main legislation

Regulation (EC) N° 1223/2009 ;on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market. It strengthens the safety of cosmetic products and streamlines 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 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 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
    Colourants, 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 infographic.

Guidelines and Claims

Amendments to the Cosmetics Regulation

Other applicable EU legislation

Apart from the main regulatory framework for finished cosmetic products, additional requirements covered by other EU legislation might apply. Some of them are listed below.

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