Are you a cosmetic brand or manufacturer based outside the European Union and want to sell your cosmetic products in the EU? Before a cosmetic product can be placed on the European market, an EU Responsible Person (RP) must be designated.

Certified Cosmetics can act as your EU Responsible Person for cosmetic products, providing your business with an established EU representative and helping you meet the regulatory requirements of Regulation (EC) No 1223/2009 on cosmetic products.

What is an EU Responsible Person?

Under Article 4 of Regulation (EC) No 1223/2009, only cosmetic products for which a legal or natural person within the European Union has been designated as the Responsible Person may be placed on the EU market.

The Responsible Person is more than a contact address. The RP has a legal responsibility to ensure that the cosmetic products for which it is designated comply with the applicable requirements of the EU Cosmetics Regulation.

For companies located outside the European Union, appointing an EU Responsible Person provides an EU-based entity that can represent the cosmetic products for regulatory purposes and communicate with the relevant competent authorities.

What does our EU Responsible Person service include?

When Certified Cosmetics is appointed as your EU Responsible Person, we help manage the regulatory responsibilities associated with placing your cosmetic products on the EU market.

• EU Responsible Person designation – Certified Cosmetics is formally appointed as the Responsible Person for the agreed cosmetic products.
• EU compliance review – We verify that the required regulatory documentation is available and review the product against the applicable EU cosmetic requirements.
• CPSR verification – We verify that a valid Cosmetic Product Safety Report (CPSR) is available before the product is placed on the market.
• Product Information File (PIF) – We verify and maintain access to the required Product Information File for the products under our responsibility.
• CPNP notification – We ensure the required Cosmetic Products Notification Portal notification is completed for the products covered by our service.
• Cosmetic label review – We review the required cosmetic labelling information, including the Responsible Person details, ingredients and applicable warnings or instructions.
• Regulatory authority contact – We act as the EU regulatory contact for competent authorities regarding the products for which we are designated.
• Compliance support – We assist with regulatory questions and required compliance actions relating to the covered cosmetic products.
• Serious Undesirable Effects – Where applicable, we support the regulatory handling and reporting obligations associated with serious undesirable effects.

Your EU Responsible Person address on the cosmetic label

The name and address of the Responsible Person must appear on the cosmetic product labelling in accordance with the EU Cosmetics Regulation. When Certified Cosmetics acts as your Responsible Person, the agreed Responsible Person details can therefore be used on the labels of the cosmetic products covered by our service.

Who needs an EU Responsible Person?

Our EU Responsible Person service is particularly suitable for cosmetic brands and manufacturers located outside the European Union, including businesses in the United Kingdom, United States, Canada, Australia, Asia and other non-EU countries that want to place cosmetic products on the EU market.

For imported cosmetic products, the importer is normally the Responsible Person for the specific cosmetic product it places on the market unless another EU-established person has been designated as Responsible Person by written mandate and has accepted that role in writing.

Requirements before we can act as your EU cosmetic representative

Because the Responsible Person has regulatory responsibility for the products, we must verify that the products and their documentation meet the applicable EU requirements before accepting the appointment.

Depending on the product, we may require:

• Complete qualitative and quantitative formulation
• Cosmetic Product Safety Report (CPSR)
• Product Information File (PIF) documentation
• Raw-material and ingredient documentation
• Finished-product specifications
• Microbiological and/or challenge testing where applicable
• Stability and compatibility information where applicable
• Evidence of Good Manufacturing Practice (GMP)
• Final product label and packaging artwork
• Supporting documentation for cosmetic claims where applicable
• Information about the manufacturer and supply chain

If documentation is missing, Certified Cosmetics can also assist with services such as CPSR preparation, PIF preparation, CPNP notification, cosmetic label review and laboratory testing.

One partner for EU cosmetic compliance

Working with Certified Cosmetics as your EU Responsible Person means that your regulatory documentation and EU representation can be coordinated through one specialist partner. Instead of using separate providers for your CPSR, PIF, CPNP notification, label review and Responsible Person service, we can help manage the complete EU cosmetic compliance process.

Planning to sell cosmetics in the European Union? Appoint Certified Cosmetics as your EU Responsible Person and let our regulatory team help you prepare your products for the EU market.

Frequently Asked Questions

Is an EU Responsible Person mandatory for cosmetics?

Yes. A cosmetic product may only be placed on the EU market when a legal or natural person established within the EU is designated as the Responsible Person for that product.

Do non-EU cosmetic companies need an EU Responsible Person?

A cosmetic product imported into the EU must have an EU-based Responsible Person. The importer is normally the Responsible Person for the product it places on the market, but another EU-established person may be designated by written mandate and accept the role in writing.

Does the Responsible Person address have to appear on the label?

Yes. The name and address of the Responsible Person must appear on the cosmetic product labelling in accordance with the EU Cosmetics Regulation.

Can Certified Cosmetics act as our Responsible Person?

Yes. Subject to acceptance of the product and verification of the required compliance documentation, Certified Cosmetics can act as the EU Responsible Person for your cosmetic products.

Can you also prepare the CPSR and PIF?

Yes. Certified Cosmetics can combine the Responsible Person service with CPSR preparation, PIF preparation, CPNP notification, label review and other cosmetic compliance services.

Can we use your address on our cosmetic packaging?

Once Certified Cosmetics has formally accepted the Responsible Person appointment for the relevant products, the agreed Responsible Person name and address can be used on the product labelling in accordance with the applicable requirements.

How long does an EU Responsible Person appointment last?

The duration depends on the Responsible Person agreement. The regulatory responsibilities continue for the products covered by the appointment while they are placed on the market and are subject to the applicable record-keeping and post-market obligations.