In accordance with the Regulation, cosmetic products, besides their undoubtedly beneficial impact on human organism, can also show unfavourable or even harmful influence. Cosmetics, due to their method of use, are chemical mixtures of specific type and they are subject to some strict regulations. From the point of view of the legislation applicable in EU, the whole responsibility for quality and all the potential negative results of cosmetic product’s impact on the user, rests (to varying degrees) with manufacturers and importers or distributors of this product. In compliance with European legal regulations, they bear full consequences of placing on the market of a cosmetic product non-compliant with the specific requirements (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products).
This Regulation influences mostly the manufacturers and importers, who usually play role of “person responsible”. Each manufacturer and importer intending to place a cosmetic product on the market is obliged to make available, for the purpose of inspection, documented information concerning the product, kept in the appointed location.
The core element of the documentation is the Cosmetic Product Safety Report, representing the result of conducted safety assessment. Moreover, each manufacturer, importer, and in some cases also distributor, is obliged to, before placing the cosmetic product on the market, submit it to the European Communion via CPNP portal (Cosmetic Products Notification Portal). Both, new cosmetics, and these which were submitted in the national procedure (in Poland, to the National Registration System for Cosmetic Products; KSIOK) before 11 July 2013, are subject to the European notification.
It must be stressed, that submitting the cosmetic product to the CPNP portal is not equivalent to getting the marketing authorisation and does not constitute any confirmation, that such cosmetic product meets the requirements of the Regulation 1223/2009/EC.
Apart from preparation of the Safety Report and submitting the products to the CPNP portal, all cosmetics placed on the market should be properly marked and labelled.
THETA Doradztwo Techniczne, thanks to our professional team of experts (Safety Assessors), certified to prepare the Cosmetic Product Safety Reports, and owing to the cooperation with experienced analytical laboratories, is able to guarantee, that your products’ dossier will always be developed in a reliable manner and in accordance with all the current regulations.
Within the framework of obligations, which must be met while placing cosmetic product on the market, we offer:
- verification of documents owned by the customer (evaluation of their usefulness for the process of cosmetic dossier preparation);
- verification of the cosmetic product components, regarding the presence of substances prohibited to be used in cosmetics or permitted in limited quantities;
- determination of cosmetic product’s composition in accordance with INCI nomenclature (based on the raw material SDSs);
- determination of scope of cosmetic product’s tests necessary for dossier preparation, ordering and delivery of samples to selected laboratories, supervision of process, conducting studies and final evaluation of tests;
- determination of tests (among others, depending on the necessities: dermatological tests, microbiological test, physical and chemical tests, load tests, SPF measurement and other) necessary for cosmetic product dossier preparation and monitoring of their course;
- preparation of complete cosmetic product dossier together with the Cosmetic Product Safety Report (Safety Assessment): overall evaluation of cosmetic product’s impact on human safety confirmed with the obligatory opinion issued by the Safety Assessor;
- preparation of labelling content for the cosmetic product packaging, verification of marketing content regarding the conformity with applicable regulations (Regulations 1223/2009 and 655/2013),
- notification of a cosmetic product via CPNP portal;
- update of available documentation of cosmetic product regarding the Regulation 1223/2009/EC;
- Consulting and legal support in scope of placing cosmetic products on the market and interpretation of relevant Polish and EU regulations, support with drawing up declaration concerning product, compilation of official letters;
- preparation of safety data sheets (SDS) of cosmetic raw materials.
