Public consultation
The Commission launched a public consultation on the upcoming targeted revision of the EU rules on cosmetic products. It seeks feedback from all interested parties to further improve existing provisions relevant to the safety of various hazardous substances and their exceptional and stringent use in cosmetics. It also gauges the views on other topics such as nanomaterials, simplified labelling and how to set a more efficient process for the safety assessment of chemical substances by scientific committees. The consultation was open until 21 June.
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
- Commission Implementing Decision 2013/674/EU of 25 November 2013 in guidelines on annex Ⅰ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (guidelines on the cosmetic products safety report)
- Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products
- Technical document on cosmetic claims (version of 03 July 2017)
- Report from the Commission to the European Parliament and the Council on product claims made based on common criteria in the field of cosmetics
Amendments to the cosmetics regulation
- Commission Regulation (EU) 2022/135 of 31 January 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Methyl-N-methylanthranilate)
- Commission Regulation (EU) 2021/1902 of 29 October 2021 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Omnibus IV)
- Commission Regulation (EU) 2021/1099 of 5 July 2021 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (DHA/Deoxy)
- Corrigendum to Commission Regulation (EU) 2021/1099 of 5 July 2021 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Omnibus III)
- Corrigendum to Commission Regulation (EU) 2021/850 of 26 May 2021 amending and correcting Annex II and amending Annexes III, IV and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Omnibus III)
- Commission Regulation (EU) 2021/850 of 26 May 2021 amending and correcting Annexes II and amending Annexes III, IV and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Corrigendum to Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Corrigendum to Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Commission Regulation (EU) 2020/1682 of 12 November 2020 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Commission Regulation (EU) 2020/1684 of 12 November 2020 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Corrigendum to Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Omnibus)
- Commission Regulation (EU) 2019/1858 of 6 November 2019 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (HEPB)
- Commission Regulation (EU) 2019/1966 of 27 November 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Omnibus)
- Commission Regulation (EU) 2019/1857 of 6 November 2019 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (titanium dioxide nano)
- Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Omnibus)
- Commission Regulation (EU) 2019/698 of 30 April 2019 amending Annexes III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Climbazole)
- Commission Regulation (EU) 2019/680 of 30 April 2019 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Phenylene Bis-Diphenyltriazine)
- Commission Regulation (EU) 2019/681 of 30 April 2019 amending Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (2-Chloro-p-Phenylenediamine)
- Commission Regulation (EU) 2019/701 of 5 April 2019 establishing a glossary of common ingredient names for use in the labelling of cosmetic products
- Commission Regulation (EU) 2018/1847 of 26 November 2018 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (O-Phenylphenol)
- Corrigendum to Commission Regulation (EU) 2018/978 of 9 July 2018 amending Annexes II andIII to Regulation (EC) No 1223/2009 of the European Parliament and of theCouncil on cosmetic products (Tagetes)
- Commission Regulation (EU) 2018/978 of 9 July 2018 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Tagetes)
- Commission Regulation (EU) 2018/885 of 20 June 2018 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (MBBT (nano))
- Corrigendum to Commission Regulation (EU) 2017/2228 of 4 December 2017 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (peanut oil and hydrolysed wheat proteins)
- Commission Regulation (EU) 2017/2228 of 4 December 2017 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (peanut oil and hydrolysed wheat proteins)
- Commission Regulation (EU) 2017/1413 of 3 August 2017 amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (ZnO (colorant))
- Commission Regulation (EU) 2017/1410 of 2 August 2017 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (HICC, (chloro)atranol)
- Commission Regulation (EU) 2017/1224 of 6 July 2017 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Methylisothiazolinone)
- Commission Regulation (EU) 2017/238 of 10 February 2017 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Benzophenone-3)
- Commission Regulation (EU) 2017/237 of 10 February 2017 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of theCouncil on cosmetic products (hair and eyelash dyes)
- Corrigendum to Commission Regulation (EU) 2016/314 of 4 March 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Commission Regulation (EU) 2016/1198 of 22 July 2016 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic (MI)
- Commission Regulation (EU) 2016/1143 of 14 July 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic (Titanium Dioxide )
- Commission Regulation (EU) 2016/1121 of 11 July 2016 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Ethyl Lauroyl Arginate HCl)
- Commission Regulation (EU) 2016/1120 of 11 July 2016 amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Carbon Black)>
- Commission Regulation (EU) 2016/622 of 21 April 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (KOH)
- Commission Regulation (EU) 2016/621 of 21 April 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (ZnO)
- Commission Regulation (EU) 2016/314 of 4 March 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (DEGEE)
- Commission Regulation (EU) 2015/1298 of 28 July 2015 amending Annexes II and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (3-Benzylidene Camphor)
- Commission Regulation (EU) 2015/1190 of 20 July 2015 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (hair dyes)
- Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Parabens)
- Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex Ⅴ to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (MCI-MI)
- Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano))
- Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes Ⅲ, Ⅴ and Ⅵ to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (alkyl (C16, C18, C22) trimethylammonium chloride, citric acid (and) silver citrate, ETH-50 (nano))
- 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 1197/2013 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 of 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 of 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 of 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
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.
- Chemicals website of the European Commission including information on restrictions on the marketing and use of certain dangerous substances and preparations
- Climate website of the European Commission regarding ozone-depleting substances contained in aerosol products
- Pressure and gas website of the European Commission relating to aerosol dispensers
- Legal metrology and pre-packaging website of the European Commission with information on nominal quantities and nominal capacities permitted for certain prepackaged products
- Environment website of the European Commission on packaging and packaging waste