FAQ - market access in europe - regulatory affairs consulting

FAQ

How long does a registration process take?

The time needed to register a product depends on 2 things:

–        How fast you can provide us with the documents we need to be able to work (please see the list in the handout you can download from the home page)

–       If the results of the mandatory tests (stability/compatibility test and challenge test) are already available or not.

If the stability test has not been performed yet, then, the registration process will take more than 3 months. If all documents are ready, then, the process can be finished in less than a month.

What are the steps of the process?

We divide the process into 5 steps:

1.   Formula Check – toxicological analysis of the ingredients

2.   CPSR – Safety Assessment of the product

3. Label & Claims Check

4.   Portal Notification

5.   Responsible Person Service

Formula Check

Toxicological analysis of the ingredients

This step involves our Safety Assessors carefully checking the toxicological profile of every ingredient, going through necessary documents, checking impurities, etc., to certify whether the formula is compliant with UK/EU Regulation or not.

CPSR

Safety assessment of the product

Next, our Safety Assessors will create the Cosmetic Product Safety Report, which offers information on:  

  • Quantitative and qualitative composition  
  • Physical and chemical properties and stability  
  • Storage conditions  
  • Microbiological quality  
  • Impurities, traces, and information about the packaging material  
  • Normal and reasonably foreseeable use  
  • Cosmetic product exposure  
  • Substance exposure  
  • Substance toxicity profiles  
  • Undesirable effects and serious undesirable effects – cosmetovigilance information  
  • Assessment conclusion  
  • Packaging warnings and instructions for use  
  • Reasoning  
  • Evaluator credentials  

We advise that all the elements appear on the labels during this step. We also recommend using claims and verifying them before proceeding to the next stage. 

Label & Claims check
LABEL

Our experts check that every mandatory element on your labels is present:  

  • Name and Address of Responsible Person 
  • Country of Origin 
  • Nominal Content 
  • Expiration Date 
  • Precautions of Use & Warnings 
  • Required batch Number for product identification 
  • Product Function 
  • Ingredients List 
  • Labels in official language(s) of countries where products are sold 
  • Leaflet for Specific Information when space is limited 
  • Symbols that are free to use or license 
CLAIMS

Claims in cosmetic products are vital for conveying their characteristics to consumers. However, they are regulated by the European Regulation to ensure accuracy and compliance. Claims must align with the definition of a cosmetic product in the EU and should not imply medical properties. Manufacturers need to follow a registration process outlined by the regulation. 

To prepare for registration, a concrete plan is necessary. A checklist is provided, starting with product classification to determine if it falls under cosmetic regulations or other categories like biocides or medical devices. Claims must be evidence-based, objective, and non-discriminatory towards legally used ingredients. If a claim is incorrect, we will offer you an alternative that complies with the regulations. 

Portal Notification

Upon completion of the Product Information File (PIF) and ensuring accurate labelling, the final step in the registration process is the CPNP notification. This step should only be undertaken once the PIF demonstrates a positive Safety Assessment. 

The CPNP notification is conducted through a platform accessible exclusively to authorities and the Responsible Person. Following notification, the product is assigned a distinctive CPNP number. 

In Europe, the product is notified through the CPNP portal, while in the UK, notification is done via the SCNP. This formalizes the regulatory compliance of the product, marking its readiness for market distribution. 

Responsible Person Service

The Responsible Person (RP) in the EU ensures product safety and compliance with regulations. Responsibilities include: 

  • Displaying name and address on product packaging. 
  • Keeping the Product Safety Report (CPSR) updated. 
  • Ensuring claims and labels comply with regulations. 
  • Notifying products on the CPNP. 
  • Maintaining the Product Information File (PIF) for 10 years. 
  • Only one RP per product is allowed. 
  • EU-based entities can choose to be their RP or delegate to a company. 

Taobé Consulting can serve as a RP in the EU and UK, aiding in regulatory compliance. 

We are a brand located in Europe and want to remain our own RP, can you take care of the PIF only?

Yes, we can take care of all the steps of the registration process or just the ones you need. We may prepare the PIFs of your products and you can notify the products on the portal and be your own responsible person.

We already have PIFs for our products and are looking for a RP

We can become the Responsible Person for your products! Here are the steps to appoint us your RP:

1-   Provide us with the PIFs of your products so we audit them to make sure they are complete and compliant

2-   We will hand over the PIF audit report listing any missing data or document that will need to be handed over to us.

3-   Once the PIF is complete, we will notify the product on the portal or proceed to a transfer if they are already notified

4-   We will sign the Responsible Person Service Agreement to officially appoint us the RP

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