Safer cosmetics for people in the EU

KEY POINTS

• All cosmetic products need a safety report before they can be placed on the market.
• There must be a ‘responsible person’ for each product:
  • businesses can only sell cosmetic products in the EU when a natural or legal person within the Union is designated as a ‘responsible person’;
  • the responsible person must ensure the product meets all the relevant safety requirements under Regulation (EC) No 1223/2009.
• All cosmetic products must be registered only once, in the EU’s Cosmetic Products Notification Portal.
• There is now a specific requirement to report serious undesirable effects:
  • responsible persons and distributors are required to report such effects to their national competent authorities;
  • national authorities must then share this information – together with any they receive from other sources (such as users or health professionals) – with their counterparts in other EU Member States.
• Packaging must include a range of information, including the name and the address of the responsible person, the contents, precautions for use and the list of ingredients.
• The regulation sets out rules for the use of nanomaterials.
• It also includes lists of substances which are prohibited, restricted or authorised for use in cosmetics.
• Distributors must check that labelling, including the use-by date, and language requirements are all in order.
• Labelling information on cosmetic products must include a list of ingredients; the ingredients are to be expressed using the common ingredient names set out in a glossary to be compiled and updated by the European Commission. The glossary, set out in the annex to Implementing Decision (EU) 2022/677, must take account of internationally recognised nomenclatures, including the International Nomenclature of Cosmetic Ingredients.
• The various annexes to the regulation have been updated many times. These changes have been incorporated into the consolidated version of the regulation.
• In addition, since in some cases it is difficult to distinguish between medical devices and cosmetic products, Article 119 of Regulation (EU) 2017/745 (see summary) amends Regulation (EC) No 1223/2009 by making it possible to take an EU-wide decision on the regulatory status of a product. As of 26 May 2021, the Commission may, at the request of a Member State or on its own initiative, decide whether or not a specific product or group of products falls within the definition of a ‘cosmetic product’.