EU COSMETICS REGULATION

Each cosmetic product placed on any EU country must meet the EU cosmetics regulation (EC No. 1223/2009) which covers the 27 EU countries + Norway + Iceland + Lichtenstein (EEA). After Brexit, the Great Britain market follows the new UK cosmetic regulation. Northern Ireland, however, are regulated by the EU regulation.

If you plan to sell your cosmetics around the world, you must know that the EU cosmetic regulation is one of the strictest laws in this sector in the world.

Don’t panic, knowing the right partner makes it a piece of cake and Cosmeservice makes the process easier for you.

eu regulation

STEPS

1

  Formula and label revision

The EU cosmetics regulation has different annexes with millions of prohibited and restricted ingredients. Also, it states the information required to be printed on the cosmetic label (Article 19) and the criteria for the justification of claims (655/2013). A preliminary formula and labelling revision are essential to ensure that the cosmetic complies with the requirements of the EU regulation before it can be placed on the EU market.

2

  Product Information File and Safety Assessment

As a brand looking to sell your cosmetic products in the EU market, it is important to know that a Product Information File (PIF) is required per product. This document is essential to ensure compliance with EU regulation and it is a compilation of all the necessary information about the product. Your Responsible Person will be liable for keeping the PIF available and up-to-date. The PIF includes important sections such as product details, its manufacturing process, proof of product efficacy and a safety assessment report confirming that your product is safe for use.

3

  CPNP notification

The CPNP (Cosmetic Product Notification Portal) is an online system where products must be notified before being sold in the EU market. The information submitted is subject to be reviewed by the Competent Authorities and shall be updated with each change applied to the product. Only one notification per product will be valid for all EU countries as long as national requirements (language, recycling…) are followed. A notification shall only be made once the product has been evaluated as safe.

4

  Product testing

Before the cosmetic enters the EU market, certain tests must be conducted to check the safety of the product, such as challenge, stability and compatibility (which are mandatory depending on the nature of the product and its packaging), or to check efficacy and substantiate marketing claims.

More information >>

5

  EU Responsible Person (RP)

An EU-based legal representative (the so-called Responsible Person) should be linked to every cosmetic product sold in any EU country verifying the compliance and safety of the product. It is indispensable to have a formal RP that is up to date with regulations and monitors the products they act for to avoid any possible problem. It represents the brand to the competent authorities when the brand is inspected and complaints are lodged by consumers, managing also the post-market surveillance (cosmetovigilance).

More information >>

1

  Formula and label revision

The EU regulation has different annexes with millions of prohibited and restricted ingredients. Also, it states the information required to be printed on the cosmetic label (Article 19) and the criteria for the justification of claims (655/2013). A preliminary formula and labelling revision are essential to ensure that the cosmetic complies with the requirements of the EU regulation before it can be placed on the EU market.

2

  Product Information File and Safety Assessment

As a brand looking to sell your cosmetic products in the EU market, it is important to know that a Product Information File (PIF) is required per product. This document is essential to ensure compliance with EU regulation and it is a compilation of all the necessary information about the product. Your Responsible Person will be liable for keeping the PIF available and up-to-date. The PIF includes important sections such as product details, its manufacturing process, proof of product efficacy and a safety assessment report confirming that your product is safe for use.

3

  CPNP notification

The CPNP (Cosmetic Product Notification Portal) is an online system where products must be notified before being sold in the EU market. The information submitted is subject to be reviewed by the Competent Authorities and shall be updated with each change applied to the product. Only one notification per product will be valid for all EU countries as long as national requirements (language, recycling…) are followed. A notification shall only be made once the product has been evaluated as safe.

4

  Product testing

Before the cosmetic enters the EU market, certain tests must be conducted to check the safety of the product, such as challenge, stability and compatibility (which are mandatory depending on the nature of the product and its packaging), or to check efficacy and substantiate marketing claims.

More information >>

5

  EU Responsible Person (RP)

An EU-based legal representative (the so-called Responsible Person) should be linked to every cosmetic product sold in any EU country verifying the compliance and safety of the product. It is indispensable to have a formal RP that is up to date with regulations and monitors the products they act for to avoid any possible problem. It represents the brand to the competent authorities when the brand is inspected and complaints are lodged by consumers, managing also the post-market surveillance (cosmetovigilance).

More information >>

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FAQS

The European Responsible Person (RP) is a mandatory figure in the European Union (EU) cosmetic regulation. They are responsible for ensuring that cosmetic products marketed in the EU comply with the established regulations and requirements. The RP must be established in the EU and is required to fulfill a series of legal obligations, such as maintaining records and being available to the competent authorities.

The EU cosmetics regulation is a set of standards and laws established by the European Commission to ensure the safety and quality of cosmetic products sold in the European market. This regulation is mandatory and applies to all cosmetic products marketed in the EU.

Cosmetic products marketed in Europe must meet a series of requirements, including: not being harmful to human health, having a clear and legible label in the language of the country where they are marketed, and complying with the safety and quality guidelines established by the European Commission.

Manufacturers and distributors of cosmetic products are responsible for ensuring that their products comply with European regulations. Additionally, EU member states have the obligation to oversee the market and take action in case of non-compliance.

Manufacturers or distributors who do not comply with European regulations can receive sanctions that include fines, product withdrawal from the market, and even legal actions by affected consumers. Additionally, the company’s reputation may be affected, and they may lose customers for not complying with established safety and quality standards.

As soon as you have CPNP notifications, product information file (PIF) and the corresponding distributor,they must designate the responsable person of the products by written mandate. After this moment, the products can be marketed in EU.

The product information file (PIF) has an expiry date of 10 years, after that, if the product continues in the market a new evaluation has to be done in order to update it.

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