WHO IS THE RESPONSIBLE PERSON FOR THE COSMETIC PRODUCT?
Article 4 of Regulation (EC) 1223/2009 on cosmetic products indicates that a Responsible Person must be appointed in the European Community who will have to ensure compliance with the requirements set out in that Regulation.
The Responsible Person can be a physical or legal person based in the European Union and who will act as the legally responsible person for a cosmetic product in Europe.
WHAT ARE HIS/HER RESPONSIBILITIES?
The Responsible Person is very important as he/she has to fulfil a number of responsibilities as described below:
- Must have the updated PIF in its facilities in electronic or other format available to the health authorities. The PIF must be kept for 10 years after the last batch marketed.
- Must ensure that the Cosmetic Product Safety Report (CPSR) is kept up to date. Changes in the formulation, type of packaging, labelling, adverse effect reporting (Cosmetovigilance), changes in the manufacturing method, are sufficient reasons to update both the Product Safety Assessment and the PIF.
- Must notify the product to the CPNP Portal.
- Must be sure to include his/her/its name and address on the primary and secondary packaging (if present).
- Must ensure the product labelling complies with legal requirements.
It is important to take into consideration that an importer, when importing a cosmetic product from a non-EU country for the first time, automatically becomes the Responsible Person.
On the other hand, a distributor selling products within the EU that are already notified will not become the Responsible Person, since the products have been previously notified by the Responsible Person.
However, in both cases, the obligations are the same:
- Ensure that the product is registered in Europe. This means having a Responsible Person selected, having the product’s PIF up to date and available on site, and having a CPNP Notification number.
- Ensure that the labelling is translated into the official languages of the countries where the product is distributed or sold and that it complies with legal requirements.
Companies that are registered outside the European Union will need to choose a Responsible Person in the EU to sell their products. Therefore, a company outside the EU will have two options to be able to market its products in Europe:
- Establish a company in an EU country and remain the Responsible Person also on European soil.
- Delegate the responsibility to another company already based in one of the 27 countries of the European Union.
SHAPYPRO SUPPORT YOU
Shapypro can act as a Responsible Person in Europe for the marketing of your cosmetics in compliance with all legal requirements. Do not hesitate to contact our team for further information.
Now you can dowNload our free e-book which helps to you to register cosmetics in EU in 4 key steps with a minimun effords.
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