WHAT IS THE AIM OF THE REGULATION?
- It makes cosmetic products sold in the European Union (EU) safer by providing strict safety requirements for protecting human health.
- It simplifies procedures for companies and regulatory authorities in the sector and ensures that cosmetic products can freely circulate in the single market.
- It updates the rules to take account of the latest technical and scientific developments, including the possible use of nanomaterials.
- It bans animal testing.
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’.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 11 July 2013.
BACKGROUND
For more information, see:
MAIN DOCUMENT
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, pp. 59–209).
Successive amendments to Regulation (EC) No 1223/2009 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Implementing Decision (EU) 2022/677 of 31 March 2022 laying down rules for the application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the glossary of common ingredient names for use in the labelling of cosmetic products (OJ L 127, 29.4.2022, pp. 1–442).
Report from the Commission to the European Parliament and the Council on the use of nanomaterials in cosmetics and on the review of Regulation (EC) No 1223/2009 on cosmetic products as regards nanomaterials (COM(2021) 403 final, 22.7.2021).
Report from the Commission to the European Parliament and the Council on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2018) (COM(2019) 479 final, 15.10.2019).
Report from the Commission to the European Parliament and the Council – Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with endocrine-disrupting properties (COM(2018) 739 final, 7.11.2018).
Report from the Commission to the European Parliament and the Council on product claims made based on common criteria in the field of cosmetics (COM(2016) 580 final, 19.9.2016).
Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics (COM(2013) 135 final, 11.3.2013).
