Selling personal care products in the European market is about to become quite a bit more challenging for manufacturers across the globe, especially if they are located outside the EU. In a little over 1 year, the new European Cosmetic Regulation, EC 1223/2009, will go into force on July 11, 2013, requiring all manufacturers selling any product in the 27 countries that make up the European Union to follow a new set of guidelines if they want to keep their products on the EU shelves…
I had the pleasure of meeting and interviewing Doram Elkayam, COO of Obelis, at The In-Cosmetics conference in Barcelona last week. Doram explained the intricacies of how his company acts as the Responsible Person for cosmetics manufacturers around the globe. Doram outlined that in order to be in compliance and keep your products on EU shelves come July 2013, you must meet the mandatory requirement to complete a Pre-Market Notification of a Cosmetic product. This entails:
- Pre-market notification must be completed and filed by a designated Responsible Person (RP), who is located in the EU, for each and every product you make. This includes scent variations of a product.
- For example, if you make 4 scents of body lotion using the same base formula, each of the 4 scent variations must be registered individually.
- The Responsible Person is a mandatory requirement and must be listed at the address (located within the EU) specified on the label.
- The RP must be valid for 10 years after the last batch was put on the market.
The RP’s main duty is to ensure compliance with the requirements of the European Cosmetic Regulation and hold the evidence of compliance, the Product Information File (PIF), for each product, readily available for inspection by the Authorities. The PIF includes but is not limited to:
- product description & categories
- Safety Report: information & assessment
- Method on Manufacturing including statement of compliance with GMP outlined by Coplia or Council of Europe Guidelines
- the exact formula for the product: both quantitative and qualitative composition
- data on animal testing, batch & micro testing
- data on serious undesirable effects
- label info and labeling claims (Doram pointed out that 99% of problems start with the label….)
- The PIF, while being a “live document” requiring constant care and update, lasts for the life of the product, as long as the product is not changed.
The Responsible Person, as the official “Cosmetovigilance” contact point in Europe also:
- should take immediate corrective measures in the case of non-conformity- withdrawal/recall if appropriate
- should provide the requested information and documentation to demonstrate conformity as per requests by competent & national authorities.
- Should ensure communication & dissemination of information between all the economic operators (manufacturer, importer, distributors, producers, raw material suppliers, authorities and users);
- should keep the PIF readily accessible to the CA for 10 years after the last batch was placed on the market.
The new portal that will house this info in the EU has already “opened its doors” as of January 11, 2012. Companies have just over 1 year (until July 11, 2013) to notify what products they currently have on the market in the portal and to designate and comply with the Responsible Person requirements and PIFs. Companies located within the EU can appoint someone within the company or act as their own RP, but those located outside Europe will have to comply with appointing a RP located in the European Union if they want to continue selling products on EU shelves.
Doram helped clarify many areas I was either unsure or unaware of when it comes to the new regulation requirements for manufacturers. Like Personal Care Truth, Obelis believes strongly in education. Obelis focuses on their job of educating clients on how to comply and what they need to do to keep their products on the shelves in Europe. You will find Obelis listed under our European Union Resources in the “resources” tab above or you can visit their site to learn more.