Registration of cosmetics on the European Union market is regulated by the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, applicable as from July 11, 2013. The Ordinance replaced the provisions of the Cosmetics Act (Journal of Laws 2001 No. 72, item 473, as amended) and Council Directive 76/768 / EEC, as amended. The regulation contains a set of legal requirements for cosmetic products, in particular their ingredients, labelling, manufacturing, documentation and, above all, their safety in all countries of the European Union. A product made in one EU country can be registered easily for sale in any other EU country, provided that local language requirements are satisfied.
Cosmetic product
Regulation 1223 only applies to cosmetic products for human use. Pursuant to Article 2, a cosmetic product is any substance or mixture intended to come into contact with the external layers of the human body, i.e. the epidermis, hair, lips, nails, as well as the external genitalia or the teeth and mucous membranes of the oral cavity, the sole or main purpose of which is to maintain clean, perfumed, changed in appearance, protected (e.g. against radiation), kept in good condition, or changed body odour. A substance or mixture which is intended for consumption, inhalation, implantation or injection into the human body and intended for the treatment or prevention of diseases is by definition not a cosmetic product within the meaning of the Regulation.
Responsible person
Article 2 of the Regulation states that a manufacturer is “any natural or legal person who manufactures a cosmetic product or has a cosmetic product designed or manufactured by another entity, and places this product on the market under its own name or trademark”. Placing on the market means ” to make a cosmetic product available for the first time on the Common market”. According to Article 4, each product placed on the market must have an established responsible person, the so-called Safety Assessor, that is a legal or natural person based in the territory of the Community. The responsible person can be an importer, manufacturer or distributor. The responsible person guarantees, prior to placing the cosmetic on the market, compliance with the provisions of Regulation No. 1223/2009/. This assurance concerns, amongst others: ensuring that the product is safe (Art. 3), that a Safety Assessment has been carried out (Art. 10), that the composition of the product complies with the legislation (Art. 14, 15 and Annexes II, VI), ensuring that the product dossier is complete (Art. 11), compiling the safety report in accordance with Annex I of the Regulation, ensuring that the product is manufactured in accordance with Good Manufacturing Practice (GMP), submitting the cosmetic product to the Cosmetic Products Notification Portal (CPNP), ensure correct labelling of the product in language of the country concerned, ensure the truthfulness and accuracy of the declared characteristics of the cosmetic, ensure compliance with the prohibition of animal testing, ensure unrestricted access to information on the composition of the product and on incidences of disease, make information on possible side effects caused by the use of the product available to the relevant authorities, ensure access to information and product documents for state authorities.
Safety of the cosmetic product
The cosmetic product must be safe for users under normal or reasonably foreseeable conditions of use. The safety of a cosmetic product for humans is confirmed by a Safety Assessment carried out by the Safety Assessor on the basis of a review of the dossier and a comparison of the composition of the product with the list of substances prohibited or restricted for use in cosmetic products, laboratory tests of the cosmetic (physico-chemical tests, cosmetic stability tests, microbiological tests and preservation test) and finally dermatological tests of the cosmetic. The Safety Assessment is prepared in accordance with Article 10 and Annex I to Regulation (EC) 1223/2009.
Composition of the cosmetic product
The cosmetic product must not contain:
– carcinogenic and mutagenic substances and substances classified as toxic for reproduction (CMR substances)
– UV-filters (except those listed in Annex VI)
– preservatives other than those listed in Annex V; the use of preservatives requires meeting certain requirements
– colorants other than those listed in Annex IV; their use also requires meeting the relevant requirements
– restricted substances which are not used in accordance with the restrictions listed in Annex III (list of substances which may be included in cosmetic products only subject to certain restrictions),
– prohibited substances listed in Annex II
Cosmetics product information file (PIF)
Completing and storing documentation and information on the cosmetic is the responsibility of the responsible person placing the cosmetic on the market. The collection of documents for a given cosmetic product is usually called the PIF (product information file) or simply the Cosmetic Product Documentation. The cosmetic product information file must contain the following data:
– a detailed description of the cosmetic product allowing for an unambiguous allocation to a given product
– cosmetic product safety report
– description of the production process in accordance with GMP (Good Manufacturing Practice)
– if the manufacturer claims a specific effect of the cosmetic product, this shall be duly confirmed and documented by laboratory tests,
– data on any animal testing performed by the manufacturer or his agents or suppliers
A cosmetic product file must be kept at the address of the responsible person. If requested by the competent authorities of any Member State, the responsible person must give access to all documents at his disposal.
The most important element of the cosmetic product file is the Cosmetic Product Safety Report prepared by a qualified expert, the so called Safety Assessor. Particularly important is the Cosmetic Safety Assessment prepared in accordance with Annex I of Regulation ( EC) 1223/ 2009. The qualifications of the Safety Assessor are defined in Art. 10 of the Regulation. A cosmetic product may be placed on the market only if the Safety Assessor confirms that the cosmetic is safe for humans, that is, fully compliant with the applicable legislation.
Product information
According to Article 20 of Regulation ( EC) No.1223/2009, cosmetic product information must not contain elements which suggest that the product has properties which it does not have in reality. The person responsible for the cosmetic product declares that the statements given are true, lawful, reliable, honest and allow the consumer to make a conscious choice.
Side effects
The person responsible for the cosmetic and all distributors have an absolute obligation to inform about the occurrence of a serious undesirable effect resulting from the use of a cosmetic product. The report is forwarded to the competent supervisory authority of the Member State where the adverse reaction occurred. The notification should include all available data on side effects, the name of the cosmetic product that allows for its unambiguous identification and, if necessary, information on the corrective actions taken.
Marketing authorisation
In the case of cosmetic products, there are no regulations allowing the product to be marketed by state supervision authorities. Full responsibility for the safety of the cosmetic product remains with the responsible person. Actions connected with the registration of a cosmetic product are in the nature of a transfer of information to government agencies. Supervision over compliance of cosmetics with legal regulations in Poland is exercised by the State Sanitary Inspectorate. Supervision over labelling, adulteration and marketing of cosmetic products is exercised by the State Trade Inspectorate.
Registration of cosmetics in the Cosmetic Product Notification Portal (CPNP)
Registration of a new cosmetic product can be made on the basis of a safety report prepared by the Safety Assessor based on the results of laboratory and dermatological tests. After obtaining a positive assessment, the cosmetic product is reported through us to the CPNP database (Cosmetic Product Notification Portal). After obtaining confirmation of entry into the database one can start selling the product throughout the European Union.
More details on testing and safety assessment of cosmetics and CPNP registration are available on http://badaniekosmetykow.pl. For registration offer of cosmetics in CPNP database feel free to contact Customer Service at +48 22 379 25 20 or biuro@wptheme.ekolabos.pl
