Cosmetics Notification in the EU: A How-To Guide
Bringing a new cosmetic product to the European market can, in the minds of some, be a long and arduous process with many hurdles to leap over along the way. While, to ensure quality and safety standards are adhered to, there are certainly factors each manufacturer must comply with, being put off or intimidated by the whole process is simply unnecessary. In this blog, we will try to put some worries to rest on the issue of notification and the European market.
One of the main things to remember when bringing a new or rebranded product to the European market is Regulation EC 1223/2009 and the implications it has for pre-market notification. According to the regulation, notification must come only from the designated Responsible Person and only after the Product Information File has been disclosed containing all evidence of conformity.
I. Appointing Responsible Person (EU RP)
For the sake of clarity, a Responsible Person is one assigned to ensure that all obligations related to product conformity have been carried out prior to placing the product onto the European Market and to act as the Cosmeto-Vigilance contact point in Europe in regards the cosmetic product they are responsible for. Their duties include:
- Ensuring compliance with regulatory requirements (such as: safety, GMP, PIF, notification, composition, labelling, claims, and communication of serious undesirable effects).
- Enacting immediate corrective measures or withdrawal/recall (where appropriate) in case of non-conformities.
- Communicating immediate information to Competent Authorities (CA) and other economic operators in case of risk to protection of human health.
- Providing information and documentation to demonstrate conformity as per requests by competent and national authorities.
- Keeping the PIF readily accessible to the Competent Authorities for a period of 10 years after the last product batch was placed on the market.
II. Compiling Product Information File (PIF)
The Product Information File (PIF) is a comprehensive document containing information pertaining to the nature of the product, the methods of manufacture, Good Manufacturing Practice (GMP), labels and the Cosmetic Product Safety Report. Additional information contained within the PIF can include: proof of claimed effect, data on animal testing, data on undesirable effects, and more.
III. CPNP Notification
Once two aforementioned steps have been carried out, the manufacturer is then free to proceed to the notification stage by adding their product to the European Commission’s centralized database – the Cosmetic Products Notification Portal (outlined in a previous blog post). The portal, initiated in January 2012, is open for use to all Responsible Persons, distributors, Competent Authorities, and anti-poison centers. The one-time notification/submission to the Cosmetic Products Notification Portal (CPNP) then, provided all product labelling is in conformity with each European state’s language requirements, will consist of some of (though is not limited to) the following information:
- Product category and name(s) enabling specific identification
- Name and address of the Responsible Person where the PIF is made readily accessible
- Country of origin (for imported products)
- Member State where the product will be first placed on the market
- Presence of Nano-Materials
- Presence of CMR 1A/1B substances
- Frame formulation
Once the product has been notified in the CPNP and if it is is meeting the language requirements for the labelling in the respective countries, it is ready to enter the EU market. It is granted to all the 28 EU Member States with no national registrations required.If you have any questions, or would like to receive more information on the notification and compliance process for cosmetics, feel free to contact us today. With 30 years of professional expertise on EU Regulations, Obelis expert consultants will gladly assist you.