Cosmetics in Europe are regulated by the Regulation (EC) No 1223/2009 and it applies since July 11, 2013.1 It replaces Directive 76/768/EC. The Cosmetics Regulation is the main regulatory framework for finished products when placed on the EU market.
EC 1223/2009 is a law and its provisions are of application in the European Economic Area (EEA), i.e. all 28 EU Member States plus Iceland, Liechtenstein and Norway. This regulation harmonizes the rules in the EU in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health (Article 1).
‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours (Art. 2).
Safety for human health is a key goal of the regulation: “A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use” (Article 3). Cosmetic products placed on the EU market must be safe, regardless of the manufacturing process or the channels of distribution, and the manufacturer or importer is responsible for the safety of the products. Guidance for the testing of cosmetic substances and their safety evaluation has been provided by the European Commission in November 20132 and a recent new revision by the Scientific Committee on Consumer Safety (SCCS) in September 2015.3
The Regulation EC No 1223/2009 comprises key elements to consider and comply with when marketing cosmetic products in Europe:
- Responsible Person (Article 4). A legal or natural person within the EU must be designated as “responsible person” to represent the manufacturer. For each cosmetic product placed in the EU market, the responsible person shall ensure compliance with the obligations set out in the regulation.
- Safety assessment and Product Information File (Article 10 and 11). To establish that a cosmetic product is safe and complies with Article 3, the regulation requires that it undergoes a safety assessment and that a cosmetic product safety report is set up as part of a Product Information File (PIF).
- Notification to authorities (Article 13). Prior to being placed on the EU market, cosmetic products must be notified using a central electronic system, the Cosmetic Products Notification Portal (CPNP).
- Ban on animal testing (Article 18). Since March 2004 the EU prohibits testing finished products on animals (testing ban) and marketing finished products in the EU which were tested on animals (marketing ban). In March 2009 the EU extended this marketing and testing ban to all cosmetic products including raw materials.
- Consumer information: labeling and product claims (Articles 19 and 20). The information required on the container and packaging is listed. The general rule for the claims is that in the labeling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have. Claims must be documented in the PIF.
- Market surveillance: in-market control and communication of serious undesirable effects (Articles 22 and 23). Serious undesirable effects (SUE) must be notified to the national authorities.
These key elements of the Cosmetics Regulation will be reviewed in detail in upcoming regulatory columns in C&T. In the meantime, visit the European Commission website: http://ec.europa.eu/growth/sectors/cosmetics/legislation/index_en.htm
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Cosmetics Regulation) http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009R1223
- 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) http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R1197
- SCCS’s note of guidance for the testing of cosmetic ingredients and their safety evaluation, 9th revision, September 29, 2015 (SCCS/1564/15) http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_190.pdf
Pascal Yvon, PharmD, MBA, has more than 25 years of global experience in the life sciences industries, including the cosmetics, biotech, pharmaceutical and diagnostic sectors. He has authored a number of trade journal articles and speaks at leading industry events and conferences. Yvon holds a doctorate in pharmacy from the Pharmacy University, Paris, and an executive MBA from Rutgers University, New Jersey. He is a member of the Society of Cosmetic Chemists, New York Chapter.