Safer cosmetics for EU citizens
Regulation (EC) No 1223/2009 on cosmetic products
WHAT IS THE AIM OF THE REGULATION?
Makes cosmetics products sold in the EU safer by tightening safety requirements.
Simplifies procedures for companies and regulatory authorities in the sector.
Updates the rules to take account of the latest technological developments, including the possible use of nanomaterials.
Maintains the existing ban on animal testing.
Extra requirements for manufacturers in compiling the safety report they need to place a product on the market.
New concept of ‘responsible person’ for each product:
- businesses can only sell cosmetic products in the EU when a natural or legal person 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.
Red tape for manufacturers is reduced as they have to register their products only once, with the EU’s Cosmetic Products Notification Portal.
New requirement to report serious undesirable effects:
- responsible persons and distributors are required to report such effects to their national authorities;
- national authorities must then share this information — together with any they receive from other sources (users, 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.
New rules for the use of nanomaterials.
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.
The main points of the regulation are summarised in this infographic. The regulation repealed and replaced Directive 76/768/EEC.
The various annexes to the regulation have been amended 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 regulatory status of a product. Since 26 May 2021, the European 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 ‘cosmetic product’.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 11 July 2013.
For more information, see:
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.
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)
last update 18.05.2021