Chementors as a gate opener:
Chementors opens the gates to the European market. You need to notify your products and indicate they are safe for the user. We make the process as smooth and comfortable as possible for you. We take care of the whole process from scratch or just parts of it, depending on your preferences. We handle communication with the authorities and perform all necessary testing and paperwork. We advise or train your employees. We can also supply you with cost estimates and action plans. Foreign producers/importers need a representative – a “Responsible Person” – within the EU. We have the experience, knowledge and expertise to take over the responsibilities as the Responsible Person for your products.
Our ultimate mission is to enable you to focus on your own profitable business, leaving all the regulatory issues to us, on a turnkey basis. This gives you the competitive edge you need for your journey in Europe.
Welcome to Europe!
Regulation (EC) No 1223/2009
on cosmetic products has been applicable since 11 July 2013. The main reason for laying down the regulation was to improve the safety of the products, and to simplify and clarify the rules and procedures. The elements of the regulation are presented below.
Usually the manufacturer or importer assumes the identity of the “responsible person”. The distributor within the EU could also be required to take on the role of responsible person, if they place a cosmetic product on the market under their own name or trademark or if they modify a product already on the market. Alternatively, the manufacturer or importer may authorise a representative to act on their behalf as a responsible person. A foreign manufacturer cannot act as a responsible person on their own within the EEA. The obligations of the responsible person are to ensure that the product is safe for its intended use and that it is used in a safe way, and to ensure that all requirements under the regulation are fulfilled. The obligations are detailed in articles 4 and 5 of the regulation.
The Cosmetic Product Safety Report (CPSR) is divided into two parts. Part A provides information on safety and important properties of the product, in addition to an evaluation of the toxicological profile of its components. Part B comprises an overall safety assessment of the product, taking into account known hazards and exposures leading to an evaluation of risks and margin of safety (MoS) in order to determine acceptable ways of use. A CPSR needs to be compiled for all cosmetic products on the market.
Product Information File (PIF)
The product information file comprises the following parts: the Cosmetic Product Safety Report (CPSR), a description of the cosmetic product, manufacturing methods and a statement of compliance with GMP, proof of efficiency statements used in marketing, and data on any animal tests completed after September 2004. The responsible person has the obligation to maintain PIFs for all of their cosmetic products.
An electronic notification database, the Cosmetics Products Notification Portal (CPNP), has been set up. The objective is to harmonise the procedure for notifying cosmetic products and their properties entering the EU market, and to have a system where all cosmetic products are connected to a responsible person. Poison centres and different authorities have access to the portal. All cosmetic products on the EU market are notified in the portal.
Chementors experts have over 20 years of knowledge and experience of providing R&D, safety and laboratory services for the health care and techno-chemical industries – supporting development and innovative solutions through to manufacturing and market introduction. Partnership with Chementors brings you access to expertise that facilitates a faster route to market through cost effective services, all from a convenient one-stop shop. Chementors’ R&D and regulatory experts provide a comprehensive range of services aimed at ensuring the quality, safety and efficacy of your products.
(Assignment of responsible person) – Data search – Stability testing – Microbiological challenge test Safety assessment – Labelling and information – Notification to CPNP