Registration of cosmetics
The registration of cosmetics for the European Union market is regulated by Regulation No. 1223/2009/EC of the European Parliament and of the Council of November 30, 2009 on cosmetic products, in force since July 11, 2013. The regulation 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 regarding cosmetic products, in particular their composition, labeling, manufacturing, documentation and, above all, the safety of cosmetics in all European Union countries. A product manufactured in one EU country can be freely registered for trading in any other EU country, provided that local language requirements are met.
Cosmetic product
Regulation 1223 only applies to cosmetic products intended for humans. Pursuant to Article 2, a cosmetic product is any substance or mixture intended to come into contact with the outer coverings of the human body, i.e. the epidermis, hair, lips, nails, as well as the external genital organs or with the teeth and mucous membranes of the oral cavity, with the sole or main purpose of maintaining keeping them clean, perfuming them, changing their appearance, protecting them (e.g. against radiation), keeping them in good condition, or changing their body odor. A substance or mixture that is intended to be ingested, inhaled, implanted or injected into the human body and intended to treat or prevent diseases is not, by definition, 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 product designed or manufactured and places that product on the market under his name or trademark.” Placing on the market means “making a cosmetic product available on the Community market for the first time”. Pursuant to Article 4, each product placed on the market must have a responsible person, the so-called Safety Assessor who is a legal or natural person established in the Community. The responsible person may be either the importer, manufacturer or distributor. Before placing the cosmetic on the market, the responsible person guarantees compliance with the provisions of the Regulation. 1223/2009/. This assurance will include, among others: ensuring that the product is safe (Article 3), that a Safety Assessment has been carried out (Article 10), that the product composition complies with the regulations (Articles 14, 15 and Annexes IIVI), ensures that the product documentation is completed (Article 11), preparation of a safety report in accordance with the guidelines of Annex I to the Regulation, ensures that the product is manufactured in accordance with the principles of Good Manufacturing Practice [GMP], reports the cosmetic to the Cosmetic Products Notification Portal (CPNP), ensures proper labeling of the product in the language applicable in a given country, ensures the truthfulness and reliability of the declared properties of the cosmetic, ensures compliance with the ban on animal testing, provides unlimited access to information on the product’s composition and cases of illness, provides the competent authorities with information on possible side effects caused by the use of the product, provides access to the authorities state control for product information and documents.
Cosmetic product safety
A 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 the Safety Assessment prepared by the Safety Assessor based on a review of documentation and comparison of the product composition with the list of substances banned or restricted for use in cosmetic products, laboratory tests of the cosmetic (physicochemical tests, cosmetic stability tests, microbiological tests and preservation tests) and finally, based on dermatological tests of cosmetics. The Security Assessment shall be prepared in accordance with Article 10 and Annex I of Regulation 1223.
Composition of a cosmetic product
A cosmetic product cannot contain:
– substances that are carcinogenic and mutagenic and classified as toxic to reproduction (CMR)
– radiation protective substances (except those listed in Annex VI)
– preservatives other than those listed in Annex V; the use of preservatives requires meeting certain requirements
– dyes other than those listed in Annex IV, their use also requires compliance with appropriate requirements
– restricted substances that are not used in accordance with the restrictions set out in Annex III (list of substances that may be contained in cosmetic products only subject to certain restrictions), – prohibited substances listed in Annex II
Cosmetic product documentation
Completing and storing documentation and information about the cosmetic is the responsibility of the person responsible for placing the cosmetic on the market. The set of documents regarding a given cosmetic product is usually called PIF (product information file) or simply Cosmetic Product Documentation. The cosmetic documentation must contain the following data:
– a detailed description of the cosmetic product allowing for a clear assignment to a given product
– cosmetic product safety report
– description of the production process in accordance with GMP (good manufacturing practice)
– if the manufacturer declares specific effects of a cosmetic product, this should be appropriately confirmed by laboratory tests and documented
– data on any animal tests carried out by the manufacturer or its representatives or suppliers
The documentation of the cosmetic must be kept at the address of the Responsible Person. At the request of the competent authorities of any Member State, the responsible person must provide access to all documents in his possession.
The most important element of cosmetic documentation is the Cosmetic Product Safety Report prepared by a qualified expert, the so-called Safety Assessor. The safety assessment of the cosmetic prepared in accordance with Annex I to Regulation 1223 is particularly important. The qualifications of the Safety Assessor are specified in Article 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, i.e. fully compliant with applicable law.
Product information
Pursuant to Art. 20 of Regulation 1223, information about a cosmetic product may not contain elements suggesting that the product has properties that it does not actually have. The person responsible for the cosmetic declares that the declarations provided are true, legal, reliable, honest and that they allow the Consumer to make an informed choice.
Side effects
The person responsible for the cosmetic and all distributors have an absolute obligation to inform about the occurrence of a serious side effect as a result of the use of a cosmetic product. The report is submitted to the competent supervisory authority in the Member State where the adverse reaction occurred. The report should include all available data on adverse reactions, the name of the cosmetic product enabling its clear identification and possible information on corrective actions taken.
Admission to trading
In the case of cosmetic products, there are no regulations allowing the product to be admitted to trading by state supervision bodies. Full responsibility for the safety of the cosmetic rests with the Responsible Person. Activities related to the registration of a cosmetic product involve transmitting information to state authorities.
The State Sanitary Inspection supervises the compliance of cosmetics with legal regulations in Poland. The National Trade Inspectorate supervises labeling, adulteration and trade in cosmetic products.
Registration of cosmetics in CPNP
Registration of a new cosmetic product can be made on the basis of a safety report prepared by a Safety Assessor based on the results of laboratory and dermatological tests. After obtaining a positive assessment, the cosmetic is reported through us to the CPNP (Cosmetic Product Notification Portal) database. After obtaining confirmation of entry into the database, you can start selling the product throughout the EU.
More details regarding the testing and assessment of the safety of cosmetics as well as registration in CPNP can be found at http://badaniekosmetykow.pl
Regarding the offer of registering cosmetics in the CPNP database, please contact the Customer Service Office at 22 379 25 20 or biuro@ekolabos.pl
