EU Cosmetic Product Registration
Since July 11, 2013, EU Regulation 1223/2009 has been in force, replacing the former Cosmetics Directive (76/768/EC). Its main goal is to guarantee a high level of protection for European consumers and facilitate the free movement of cosmetic products within the EU. Unlike the directive, which could only exert pressure on member states to apply it, the regulation is directly binding. This ensures that the 32 countries that have signed it must apply it uniformly, promoting consistency in EU cosmetics registration.
In January 2021, the UK officially left the European Union, relieving itself of the obligations imposed by the EU Regulation. However, even though the UK is no longer obligated to follow the regulations for registering cosmetics Europe, it still requires cosmetic products to undergo a positive Safety Assessment and possess a Product Information File (PIF), as was the case in the past. On this view only, the UK still follows the EU cosmetic product registration.
To understand what specific requirements the UK cosmetics registration implies, consult the dedicated services page.
OUR REGISTRATION SERVICES
As a full-service solutions provider, we clear the path towards the safety and compliance of your cosmetics with our leading-edge PIF, Safety Assessment and Responsible Person services.
The registration process consists of 5 steps
EU COSMETIC PRODUCT REGISTRATION PROCESS
STEP 1
Formula Checks
The first step of every cosmetics registration in Europe process always begins with the full assessment of the formula of the product to confirm it meets the EU requirements.
During this step, our Safety Assessors will:
- Check all documents related to the ingredient (MSDS/COA/Non-animal testing/IFRA, etc.)
- Verify that the ingredients do not have restrictions established by European regulations and that the limits of use (if there are any) are in compliance.
- Check that the ingredients used are suitable for cosmetics (cosmetic grade ingredients).
- Check the toxicological profile of each ingredient
- Verify if the ingredient contains any impurity
- Check the SCCS opinions, industry guidelines and other regulations (REACH, CLP)
- Calculation of the MoS (Margin of Safety) for each ingredient and/or search for supporting documents (reliable literature) that declare each ingredient safe at the added dose in the finished product
After this step is completed, we are able to certify if your formula is EU/UK compliant or if you need to adapt anything to it so it meets the requirements.
STEP 2
Designing Safety Assessment, CPSR & Product Information File
After the formula has been assessed, the second step of the cosmetics registration in Europe is to ensure the finished product complies with all requirements. After having checked all the documents related to the ingredients and finished product (Part-A), our Safety Assessors perform the full Safety Assessment and sign the conclusion of the report (Part-B). Once the CPSR is complete, all documents are organized into a Product Information File (PIF).
STEP 3
Label & Claims Check
Here is the last part of the compliance check of a product: the label and claims check. During this step, our experts will advise on the elements to appear on your labels and will tell you which claims can be used for cosmetic use and how they need to be sustained. A full report is handed over to you so you can make the necessary updates on your artworks.
STEP 4
CPNP & SCPN notification
Once the full compliance of the product is certified, the product is ready to be notified on the official portals. As your Responsible Person in the EU, we notify your product on the CPNP “Cosmetic Products Notification Portal”. As your UK Responsible Person, we notify your product on the UK portal, the SCPN.
STEP 5
EU Responsible Person service
The final step of the process is to appoint a Responsible Person. This person needs to be located in one of the EU-27 to be responsible for your products in Europe and be located in the UK to be liable for your products in the UK. The Responsible Person service also includes cosmetovigilance to monitor any change in the ever-evolving regulation to ensure your products remain compliant at all times.
EXPERT GUIDANCE FOR SEAMLESS COSMETICS REGISTRATION IN EUROPE
While we understand that registering cosmetics in Europe can be complex, our expertise in regulatory consulting for cosmetics businesses can provide seamless guidance for cosmetics registration in Europe.
Why Navigate Alone?
Registering cosmetics in Europe demands meticulous attention to detail and strict adherence to regulations. Our comprehensive services offer:
READY TO UNLOCK EUROPE’S POTENTIAL?
Contact us today to discuss your specific needs and benefit from our regulatory consulting for cosmetics businesses. We’ll help you achieve EU cosmetics registration and your European expansion goals with confidence and compliance.
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