How to import a cosmetic product into Europe?
When you import cosmetic products on the European market, they must comply with the Cosmetic Regulation No 1223/2009, no exceptions, even if your cosmetic product complies with another cosmetic regulation (e.g. FDA rules).
To comply with the European cosmetic Regulation every cosmetic product placed on the EU market must have a Product Information File (PIF) which include a Safety Assessment (SA). All products (including imported cosmetic product) must comply with Good Manufacturing Practices. Also, ingredients contained in the cosmetic formula must be authorized in the EU by the Cosmetic Regulation No. 1223/2009. Finally, Labeling and claims are specific in Europe, you must provide compliant labels and make sure your claims are made in accordance with the 6 commons criteria set by the Regulation 655/2013.
6 steps to import your cosmetics
EcoMundo has summarized in 6 steps the process to successfully import your cosmetic product on the EU market:
1- Endorse the role of the Responsible Person
If you import a cosmetic product, you become by default the Responsible Person of the cosmetic product, unless you designate someone to take on that responsibility.
- Am I the Responsible Person if I distribute an imported cosmetic product?
As a distributor you will not be the Responsible Person. Nevertheless, as mentioned in article 4 of the EU Cosmetic Regulation: “The distributor shall be the Responsible Person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such way that compliance with the requirements may be affected.”
EcoMundo acts as a Responsible Person! Our experts ensure the compliance of your cosmetic product and will be the main point of contact of the European authorities.
2- Gather all documents
All products placed on the European market (including imported cosmetic product) must comply with the Cosmetic Regulation 1223/2009. You should gather all the required documents to create the Product Information File. Data collection must be accomplished with the help of your manufacturer. The commonly required data is:
- Raw material breakdown formula (Quantitative and Qualitative formula)
- INCI name
- Function
- CAS Number
- Exact percentage
- Certificate of analysis
- Impurity Profile
- Safety Data Sheets (MSDS)
- Technical data Sheets
- PAO and challenge Test
- Stability Test and DOMD conclusion
- SOP
Note: This list is a non-exhaustive list.
3- Formula review
The regulatory compliance process implies to verify the formula in the light of the EU Regulation No. 1223/2009 and its Annexes. This step allows you to be sure your cosmetic products do not contain any prohibited ingredients but also to verify the threshold range. You’ll be able to reformulate the product if the product is not compliant. However, if the formula review allows you to move on in the compliance process, you can’t place the cosmetic product on the European Market at this stage.
Note: the annexes of the Regulation are regularly updated (every 3months in average).
4- Label review
The European Regulation No 1223/2009 defines the rules for a compliant cosmetic label on Article 19.
Note: The EU cosmetic Regulation applies to 31 European countries representing more than 24 different official languages. You must translate the function of the product, the precautions of use and warnings but also the nominal content in the language of the country you plan to export to. All elements required by the regulation must be on the label. In some specific case, a leaflet/tag/card can be attached to the primary packaging and must be referred with the “hand-in-book symbol”.
5- Draft the PIF
When the compliance process is done, i.e., the formula is reviewed and compliant with the Regulation and Annexes, the labels are checked and comply with the Cosmetic Regulation and Claims Regulation, and all the data is gathered, the Safety Assessor can start the PIF. The Product Information file gathers all the “process” in one single document and includes the Safety Assessment made by a pharmacist or a toxicologist to prove that the product is safe for the human health and compliant to the regulation. If the Safety assessor gives the green light, the product is almost ready to be sold on the EU market.
6- Register the product on the CPNP
Last but not least, you must notify your product on the CPNP (Cosmetic Products Notification Portal). This step allows you to place your product on the market, by notifying your product to the authorities. The Cosmetic Regulation 1223/2009 under article 13 defines the rules and obligations. Only one notification is necessary to access the EU market (31 countries) and the notification is made by the Responsible Person.
/!\ Once you have notified your imported product on the CPNP, you can sell it in Europe.
How to import a cosmetic product into Europe?
When you import cosmetic products on the European market, they must comply with the Cosmetic Regulation No 1223/2009, no exceptions, even if your cosmetic product complies with another cosmetic regulation (e.g. FDA rules).
To comply with the European cosmetic Regulation every cosmetic product placed on the EU market must have a Product Information File (PIF) which include a Safety Assessment (SA). All products (including imported cosmetic product) must comply with Good Manufacturing Practices. Also, ingredients contained in the cosmetic formula must be authorized in the EU by the Cosmetic Regulation No. 1223/2009. Finally, Labeling and claims are specific in Europe, you must provide compliant labels and make sure your claims are made in accordance with the 6 commons criteria set by the Regulation 655/2013.
6 steps to import your cosmetics
EcoMundo has summarized in 6 steps the process to successfully import your cosmetic product on the EU market:
1- Endorse the role of the Responsible Person
If you import a cosmetic product, you become by default the Responsible Person of the cosmetic product, unless you designate someone to take on that responsibility.
- Am I the Responsible Person if I distribute an imported cosmetic product?
As a distributor you will not be the Responsible Person. Nevertheless, as mentioned in article 4 of the EU Cosmetic Regulation: “The distributor shall be the Responsible Person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such way that compliance with the requirements may be affected.”
EcoMundo acts as a Responsible Person! Our experts ensure the compliance of your cosmetic product and will be the main point of contact of the European authorities.
2- Gather all documents
All products placed on the European market (including imported cosmetic product) must comply with the Cosmetic Regulation 1223/2009. You should gather all the required documents to create the Product Information File. Data collection must be accomplished with the help of your manufacturer. The commonly required data is:
- Raw material breakdown formula (Quantitative and Qualitative formula)
- INCI name
- Function
- CAS Number
- Exact percentage
- Certificate of analysis
- Impurity Profile
- Safety Data Sheets (MSDS)
- Technical data Sheets
- PAO and challenge Test
- Stability Test and DOMD conclusion
- SOP
Note: This list is a non-exhaustive list.
3- Formula review
The regulatory compliance process implies to verify the formula in the light of the EU Regulation No. 1223/2009 and its Annexes. This step allows you to be sure your cosmetic products do not contain any prohibited ingredients but also to verify the threshold range. You’ll be able to reformulate the product if the product is not compliant. However, if the formula review allows you to move on in the compliance process, you can’t place the cosmetic product on the European Market at this stage.
Note: the annexes of the Regulation are regularly updated (every 3months in average).
4- Label review
The European Regulation No 1223/2009 defines the rules for a compliant cosmetic label on Article 19.
Note: The EU cosmetic Regulation applies to 31 European countries representing more than 24 different official languages. You must translate the function of the product, the precautions of use and warnings but also the nominal content in the language of the country you plan to export to. All elements required by the regulation must be on the label. In some specific case, a leaflet/tag/card can be attached to the primary packaging and must be referred with the “hand-in-book symbol”.
5- Draft the PIF
When the compliance process is done, i.e., the formula is reviewed and compliant with the Regulation and Annexes, the labels are checked and comply with the Cosmetic Regulation and Claims Regulation, and all the data is gathered, the Safety Assessor can start the PIF. The Product Information file gathers all the “process” in one single document and includes the Safety Assessment made by a pharmacist or a toxicologist to prove that the product is safe for the human health and compliant to the regulation. If the Safety assessor gives the green light, the product is almost ready to be sold on the EU market.
6- Register the product on the CPNP
Last but not least, you must notify your product on the CPNP (Cosmetic Products Notification Portal). This step allows you to place your product on the market, by notifying your product to the authorities. The Cosmetic Regulation 1223/2009 under article 13 defines the rules and obligations. Only one notification is necessary to access the EU market (31 countries) and the notification is made by the Responsible Person.
/!\ Once you have notified your imported product on the CPNP, you can sell it in Europe.
