How to Gain EU Compliance in 3 steps

Introduction

I’d like to take you on an imaginative journey for a moment, shall we? Let’s set off together to discover the old continent. Wow, France with its Eiffel Tower, without mentioning the magnificent Rialto Bridge in Venice and finally the flowering tulip fields in Holland. It certainly gives us some breathtaking views, I could spend hours listing the wonders we have.

So, what if I gave you a new challenge? Would you agree to export your cosmetic products to Europe? Who would agree?

1. Product Information File (PIF)

But what does a cosmetic really need in order to comply with European Regulation 1223/2009 and thus be safe? How many times have you asked yourself this question?

It’s easy, every product first needs a Product Information File (PIF).

What should a PIF include? First of all, it should preferably be in English. The most important document it must contain is the CPSR (Cosmetics Product Safety Report) consisting of part A and part B, the latter signed by a Safety Assessor.

And with the PIF, we’ve done, is everything clear up to here?

To see a detailed explanation of the Product Information File (PIF), please click on the button below:

2. Legal Representation
(Responsible Person)

The second step to comply with the European Cosmetics Regulation is the Legal Representation, also called Responsible Person, based in Europe. Following Brexit, if we also want our products to be fully compliant and sold in the United Kingdom, it is necessary to have a Responsible Person based in the UK too.

It is advisable to choose a Responsible Person carefully and with full knowledge of the facts.

What are the duties of the Responsible Person? The Responsible Person must:

  • Protect your brand against compliance issues.
  • Assist you with legal matters related to the European Cosmetics Regulation.
  • Answer all questions from National Competent Authorities (27 EU Member States + United Kingdom).
  • Manage all inspections of cosmetic product decided by the Supervisory Competent Authorities.

In relation to this, I refer you to our article :

  • Keep a close eye on regulatory developments and changes and keep you up to date by providing assessments that detail in depth the impact this may have on your products.
  • Handle all cosmetovigilance issues (undesirable effects) by following-up with consumers and ensuring the best course of action.
  • Maintain all cosmetic product files.

3.CPNP and/or SCPN Notification

And finally, we need the CPNP notification to the European portal and, if our target is also the UK, we also need the SCPN notification to the UK portal. These two notifications are made by the Responsible Person.

And finally, we need the CPNP notification to the European portal and, if our target is also the UK, we also need the SCPN notification to the UK portal. These two notifications are made by the Responsible Person.

The 5 steps and the BIORIUS’ Expertise on EU regulation

BIORIUS, Your Regulatory Expert can offer you assistance from A to Z.

To meet the above requirements, we propose a five-step process:

  1. Formula Review;
  2. Cosmetic Product Safety Report (A&B) signed by a Safety Assessor;
  3. Label and Claims Review;
  4. Preparation of PIF and notification to the European and English portal;
  5. Acting as your Responsible Person in Europe and United Kingdom.

BIORIUS works hard to deliver the highest quality service for each of our clients by employing highly-qualified, multilingual experts who can advise and guide you through complex procedures. Delivering a qualitative service ensures that you, your brand and your manufacturers will have peace-of-mind knowing your products are safe.

A lot of well-known brands trusted in us and keep on trusting, here some references.  

For more information, please contact us via the Request Form or by email: info@biorius.com

Contact

Avenue Leonard de Vinci, 14
1300 Wavre, Belgium

+32 2 888 40 10
+44 20 3866 1208

info@biorius.com

Google Maps

© Copyright - 2008 – 2021 BIORIUS