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Selling cosmetics in Europe: To do list

Do you want to place your cosmetic products on the European Market? The Cosmetics Regulation has set up requirements before you do. Even though if the Product Information File (PIF) and the CPNP notification are the end of the compliance journey and authorize you to put your product on the shelves, you must go through numerous steps to meet the European requirements. Follow our to-do –list and be ready to gain market- access to 31 countries!


6 key steps to place your cosmetic product on the market.


1- Assess data gap with your manufacturer


The first step is to ensure you’ll be able to gather all the data required from your manufacturer. You can also ask your manufacturer if he knows the European Regulations and if he is aware about the requirements. You’ll need to gather (non-exhaustive list)


This step will allow you to save time and money!


2- List the product for export to Europe and budget your compliance


Before starting your project to export to Europe, be sure your product portfolio is ready. This crucial step will help you budget the costs of your compliance. You should therefore ask yourself:

  • How many products you want to put on the market?
  • How many shades you have for each product?
  • What the type of products you want to export - Perfume, make-up, cream, essential oils, UV filters, aerosols, etc.?

3- Budget your compliance


The compliance process is the first step before access to the European market. It is always a good choice to schedule and budget upstream. This work can be done by a consultant. Depending on the products you want to place throughout the European market the consultant will provide you with a quote with different options.

The quote usually includes (non-exhaustive):


4- Designate your Responsible Person (RP)


The European Regulation 1223/2009 defines the Responsible Person (RP) in the article 4 as a legal or natural person based in the European Union who will act as the unique representative throughout the EU. The RP’s role is to ensure that each product marketed in the EU complies with the Cosmetics Regulation 1223/2009 which aims to establish that the cosmetic product is safe for use.

The Responsible Person can be:

  • The manufacturer
  • The importer
  • The distributor
  • Any person established in the European Union (a consultant for example)

5- Data collection with manufacturer(s)


To review a formula you will have to gather information available from your manufacturer as:

  • Raw material breakdown formula
  • INCI name
  • Function
  • CAS number
  • Exact percentage

If you choose a consultant, his works will consist in verifying if the INCI names and CAS numbers tie in but also if the ingredients contained in your products respect the threshold imposed by the European Regulation but also he will inform you about the forbidden ingredients.

He will also check the product’s function E.G. UV filters, preservatives, Antimicrobial, Deodorant, Foaming, Solvent, Tonic, Skin protecting, Emollient, etc.

At the same time, the manufacturer must provide a dossier for each raw material which is composed of:

  • Certificate of Analysis (COA)
  • Impurity profile
  • Safety Data Sheets (MSDS)
  • Technical data Sheets

But also other information in accordance with the composition and the claims (E.g. if your product is formulated with natural ingredients)

At this stage, you must list the allergens (vegetal extract, essentials oils, and fragrance) that the raw material contains and produce an allergen statement and/or IFRA certificate. Both are required when raw material is a perfume or an essential oil. The list of ingredients must appear on the label and include the allergens.

The phase two of the data collection requires:

  • Certificate of Analysis & Microbial specifications
  • Stability test & DOMD conclusion
  • Challenge test
  • PAO
  • Manufacturing Method
  • SOP (Standard Operating Procedures)
  • Clinical tolerance test

Data collection : Brand obligations

  • Exposure data

You must proceed to claim substantiation by proving the effects claimed. The test can be:

  • Clinical tests
  • Consumer perception test
  • Etc

The packaging of your product must be safe. Your packaging supplier must provide a certificate that proves that the packaging is free from SVHCs, CMRs, or other forbidden substances.

After all these steps, the Product information File and the Safety Assessment can be performed. While the Safety Assessment allows you to place your product on the European market, the Responsible Person will notify the product on the CPNP and as soon as the certificate is issued, you’re good to go!


6- Anticipate reformulations and labeling update


In order to keep your product on the shelves, be sure to frequently check the list of prohibited substances in Annex II of the regulation but also all modifications of Cosmetics Regulation 1223/2009 Annexes:

  • Annex I: Cosmetic Product Safety Report
  • Annex II: List of substances prohibited in cosmetics products
  • Annex III: List of substance which cosmetic product must not contain except subject to the restrictions laid down
  • Annex IV: List of colorant allowed in cosmetic products
  • Annex V: List of preservatives allowed in cosmetics
  • Annex VI: List of UV filters allowed in cosmetics products
  • Annex VII: Symbol used on packaging/container
  • Annex VIII: List of validated alternative methods to animal testing

There are currently more than 1,300 of them. Also, don’t forget to update as necessary when your product (formula/composition, claims, labels etc.) evolve.


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Do not hesitate to contact our expert Sylvain De Backer by phone on +33 (0)1 83 64 20 54 for Europe and for North America please dial + 1 (778) 231-1607 or send an email at [email protected].


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Comments

  • Saila Laitinen
    Commentaire

    I am about to establish a company in Finland and bring eco-cosmetics maqnufatucred in Croatia to scandinavia and other EU countries. What sort of regulations to apply to my business?

    Mon 18/09/2017 - 10:01
  • Alix Perrier
    Commentaire

    Hi Saila Laitinen,

    The cosmetics regulation EC 1223/2009 applies to your business.

    Best regards,

    Alix

    Fri 22/09/2017 - 10:45
  • Peter
    Commentaire

    Dear Sabine,

    I am currently in the following situation. I want to sell thru my E-Commerce website cosmetic products (creams, make-up) of a brand outside the EU Community, the brand's products are not registered in the EU. In this case, what is the next step in order to assure I can sell the products on my E-Commerce website?

    Fri 20/10/2017 - 08:28
  • Chargée de Communication, Magali a rejoint les équipes d'EcoMundo au mois d'octobre 2017.

    Magali Francisco
    Commentaire

    Dear Peter,

    Thank you for your comment.

    In order for you to be able to sell products in the EU market, you have to create the Product Information File (PIF) and then notify it on the CPNP portal.
    We encourgae you to read the artciles bellow, they will help you understand the procedures to follow.
    - The 5 steps to place your cosmetic product on the European market
    - How to create my PIF
    - Documents needed to create my PIF

    Best regards,
    Magali

    Fri 08/12/2017 - 11:50
  • HellenOu
    Commentaire

    Hello ~ If I wanted to sell Tissue mask in Europe, does it count as cosmetics?
    What are the needed certifications or regulation to follow?
    Thank you!

    [email protected]
    Tue 28/08/2018 - 04:09
  • Chargée de Communication, Magali a rejoint les équipes d'EcoMundo au mois d'octobre 2017.

    Magali Francisco
    Commentaire

    Hello,

    Thank you for your comment.
    If your tissue masks are soaked with cosmetic serum, they are considered as a skincare product. Thus, you need to make them compliante to the EU Cosmetic regulation.

    Have a great day!

    [email protected]
    Wed 02/01/2019 - 16:42
  • ronac shah
    Commentaire

    Hello,

    I am Ronac shah, MD at bic products India, One of the major exporters to Africa and Middle east of Wellness products and such. I wanted to have a little more information on the EU market as we are currently exploring the possibilities of entering the market and also need a consultation for the same. Please let me know how we can take this forward.

    Thank you.

    [email protected]
    Mon 29/10/2018 - 06:59
  • Chargée de Communication, Magali a rejoint les équipes d'EcoMundo au mois d'octobre 2017.

    Magali Francisco
    Commentaire

    Dear Ronac,

    Thank you for your comment.

    Could you please send us your questions at [email protected]? We would be delighted to answer you! You can address your message directly to Mrs. Nataliya Muller.

    Best,
    Magali

    [email protected]
    Thu 03/01/2019 - 10:20
  • Kasey
    Commentaire

    Hello Sabine,

    If I apply for approval on the German market, for example (going through the BVL and submitting all documents), would that automatically cover me for all EU (EEA) countries? Only for cosmetics, but not for other things such as vitamins or essential oils?

    Thanks,
    Kasey

    [email protected]
    Tue 30/10/2018 - 12:14
  • Chargée de Communication, Magali a rejoint les équipes d'EcoMundo au mois d'octobre 2017.

    Magali Francisco
    Commentaire

    Hi Kasey,

    Thank you for your comment.
    Could you please send us a detailed email at [email protected] with your questions? Our experts will reply as soon as possible.

    Have a great day!

    [email protected]
    Thu 03/01/2019 - 17:56
  • Jeroen Visser
    Commentaire

    Hi, I am trying to export a Dutch cosmetic Brand outside the EU (Mexico). The already existing registrered EU-brand complies all the requirements in Europe, What kind of procedure do I need to follow? Is there for example a - 5 steps to place your cosmetic product on a NON European market - ? Thank you in advance

    [email protected]
    Mon 03/12/2018 - 23:47
  • Chargée de Communication, Magali a rejoint les équipes d'EcoMundo au mois d'octobre 2017.

    Magali Francisco
    Commentaire

    Dear Jeroen,

    Please reach out to our experts using the following address: [email protected]. They will advise you on the process.

    Best,
    Magali

    [email protected]
    Thu 03/01/2019 - 16:36

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