How cosmetic products regulation applies to your business in the UK and EU
We’ve just launched our new services to help cosmetic product brands navigate the testing and cosmetic products regulation involved in getting your products on the market, and indeed keeping them on the market, as well as acting as the Responsible Person in both the UK and EU for cosmetic products from our UK and EU offices.
Cosmetic product regulation applies to all products which are intended for use on the skin’s surface, such as cleansers, sunscreen and makeup, which do not have a therapeutic effect or use medical products.
Do you need a Responsible Person?
For cosmetic products manufactured in the UK and sold within the EU (and Northern Ireland) a Responsible Person located in the EU will be required as the UK has now left the European Union.
The Responsible Person will ensure that the following is in place for your cosmetic products:
- Physical address in the EU/UK where the Product Information File is kept readily accessible to the local competent authority in a language easily understood by that competent authority for inspection even 10 years after the last batch of the product has been placed on the market.
- Product claims substantiation and evidence thereof.
- Correct cosmetic product labelling.
- Product Information File (PIF) compliance with the Regulation, that the products were produced according to Good Manufacturing Practice (GMP), that the safety assessment has been conducted, etc.
- Cosmetic Product notification through the appropriate portal.
- Communication of any undesirable or serious undesirable effects to the competent authorities.
- In case of non-conformity of the product with the EU/UK regulation, take any appropriate measures including recall, removal of the products or taking corrective action to bring that product into conformity. At the request of the competent authorities, the Responsible person must cooperate with the former to eliminate the risk posed by cosmetic products which they are the Responsible person for.
Cosmetics products sold in both the EU and UK markets will need to be notified to both the UK notification system and the European portal, along with a named Responsible Person, to be allowed for sale.
How we can help your cosmetic products get, and stay, on the market
At Inter Scientific, we provide a thorough, five step service to ensure that your products comply with the regulations, whether you sell your products in the EU, the UK, or both.
Step 1: We’ll create a legal agreement between Inter Scientific and your company to ensure complete product conformity.
Step 2: Our expert team will review the Product Information File (PIF), or generate a PIF as required.
Step 3: We will analyse your product labels and packaging to ensure compliance of label claims.
Step 4: We will upload the product notification to the appropriate portal.
Step 5: We will provide you with ongoing annual support and act as the Responsible Person on behalf of your cosmetic products.
Other services we offer for cosmetic products regulation:
In addition to providing you with an appropriate Responsible Person, we offer a range of products to help ensure your cosmetic products comply with regulations.
- Cosmetovigilance – postmarket surveillance of cosmetic products to ensure that they are safe for consumers
- Cosmetic Product Safety Reports – CPSRs are required for all cosmetic products marketed in the EU and UK and are essentially an assessment of the safety of your product
- Lab services – shelf-life studies, microbiological, durability and AMES testing to ensure product safety
- Manufacturing quality – Quality Management System for manufacturing and manufacturing audits
If the list of regulatory requirements for cosmetics seems overwhelming, help is at hand.