The Cosmetics Regulation (EC) No 1223/20091 is the main regulatory framework for finished products when placed on the EU market. The regulation introduces the notion of the “Responsible Person” (RP) in its Article 4: in order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the EU. “Only cosmetic products for which a legal or natural person is designated within the Community as “responsible person” shall be placed on the market” (Article 4.1). The regulation allows the precise identification of the RP and clearly outlines their obligations.
The “Responsible Person” is a person or company established within the EU that has the legal responsibility of a cosmetic product placed on the EU market.
Identification of the Responsible Person
- The EU manufacturer or a EU person designated by the EU manufacturer (Article 4.3) or designated by a non-EU manufacturer with product(s) manufactured in the EU (Article 4.4)
- The EU importer or a EU person designated by the EU importer (Article 4.5)
- The distributor (Article 4.6)
Obligations of the Responsible Person
For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in the regulation (Article 4.2) and is the focus of Article 5. This involves many regulation articles listed in Article 5.1 and presented below.
. Cosmetic product safety, with safety assessment, safety report and PIF (Art. 3,10,11)
Ensures the overall safety for human health, including that a safety assessment is completed, that a safety report is set up, and that the Product Information File is complete and updated as necessary
. GMP, Sampling and analysis (Art. 8,12)
Ensures the compliance with Good Manufacturing Practice, and that sampling and analysis are performed in reliable and reproducible manner
. Notification (Art.13)
Ensures that, prior to its placement on the market, information about the product is submitted to the Commission via a central electronic system, the Cosmetic Product Notification Portal
. Restrictions for certain substances (Art.14,15,16,17)
Ensures that cosmetic products do not contain certain substances
. Animal testing (Art.18)
Ensures compliance with the ban of animal testing (testing ban and marketing ban)
. Labeling (Art.19)
Ensures compliance with labeling requirements; cosmetic products shall be made available on the market only where the container and packaging bear the required information
. Product Claims (Art.20)
Ensures that in the labeling, making available on the market and advertising of cosmetic products, texts, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have
. Access to information for the public (Art.21)
Ensures that information about the composition of the cosmetic product as well as undesirable effects from its use are made easily accessible to the public
. Communication of serious undesirable effects (Art.23)
Ensures that they without delay notify serious undesirable effects to the competent authority
. Information on substances (Art.24)
Ensures communication with the competent authority in the event of serious doubt re. the safety of any substance contained in cosmetic products
Particularly, the responsible person ensures that a safety evaluation of the cosmetic product is completed, that this safety evaluation is carried out by a qualified toxicologist and it follows an appropriate method based on the weight-of-evidence approach that uses data from all existing sources.
Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with the regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate. Where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the national authorities of the Member States (Article 5.2). Responsible persons shall cooperate with these authorities, at their request, on any action to eliminate the risks (Article 5.3).
For U.S. companies and manufacturers planning to market their product(s) in Europe, the RP will be their legal representative in Europe and the initial point of contact for European authorities. Thus, selecting a suitable responsible person is critical and companies need to perform their due diligence.
1. 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
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.