Responsible Person for Europe
EU Responsible Person
As of 11 July 2013, it has become legally mandatory to have a Responsible Person in order to place a cosmetic product on the market in Europe. The role of the Responsible Person is to ensure that the product complies with cosmetic regulations and its safety for human health.
The Responsible Person, as defined in Article 4 of Regulation EC No 1223/2009, is the legal person or company who ensures that each cosmetic product on the European market complies with the relevant obligations set out in this legislation. Among his numerous obligations, the Responsible Person must ensure that:
* Preparation of the Safety Assessment Report and Product Information File and/or checking the compliance of the existing document with the legislation,
* The safety of the product in terms of human health,
* Compliance with the Good Manufacturing Practices (GMP),
* Notifications of products on the CPNP portal,
* Continuous monitoring and control of the product, including reporting of undesirable or serious side effects to the relevant authorities.
* To keep the Product Information File for 10 years and updating the relevant documentation in case of a product-specific revision.
As Omni Danışmanlık, we can provide Europe Responsible Person service for the cosmetic products that you want to sell in the Europe and provide fast and complete support during this process.