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EU(CPNP)

Europe

UK(SCPN) EU(CPNP)

Asia-Pacific

NZ(EPA) TW(TFDA) CN(NMPA) AU(TGA) JP(PMDA)

North America

CN(CNF) US(FDA)

Middle East

Africa

Southeast Asia

SG(HSA) MY(MDA) PH(PFDA) VM(MOH) ID(BPOM) TH(TFDA)

South America

BR(ANVISA)

Regulatory Authority for Cosmetic Products in the European Union

Cosmetic products in the European Union are regulated by the European Commission, which is responsible for formulating cosmetic regulatory frameworks and conducting overall product regulatory oversight.

Official Portal of the Cosmetic Products Notification Portal (CPNP): https://webgate.ec.europa.eu/cpnp/

Regulatory Legislation

REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products

Definition of Cosmetic Products in the EU

A cosmetic product is defined as any substance or mixture intended to come into contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity. Its exclusive or main purposes include cleaning, perfuming, modifying appearance, protecting, maintaining in good condition, or eliminating body odours.

Prerequisites for Market Access

GMP compliance or ISO 22716 certification

Information of the EU Responsible Person

The first Member State where the product is placed on the market

Full product ingredient list

Compliant product labeling

Cosmetic Product Safety Report (CPSR)

Product Information File (PIF)

Registration language

English

Responsible Person

For manufacturers established outside the European Union, they may designate a legal entity based within the EU as the Responsible Person via written authorization, which shall be formally accepted in writing by the designated party.

The Responsible Person bears full statutory responsibility for product safety and regulatory compliance. It shall complete the CPNP notification before the product is placed on the market, and its name and address must be clearly indicated on the product label. In addition, the Responsible Person shall retain the complete PIF and CPSR for inspection by competent authorities; update the CPNP notification and PIF accordingly when changes occur; and promptly report Serious Undesirable Effects (SUE) in the post-market phase, among other mandatory obligations.

Required Documentation for Notification

Full product ingredient list

Product packaging materials

Registration process, cycle & Government fee

1. Registration flow chart

2. Registration period and official fees

The EC currently does not charge official fees and the registration period is 1-2 weeks.

Chapter 3 FAQ

Q：What is CPNP（Cosmetic Products Notification Portal）?

A：The CPNP is a product registration system created for the implementation of REGULATION (EC) No 1223/2009 of the European Parliament and of the Cosmetics Council.

Q：How long is the validity period of EU cosmetics after the completion of the filing?

A：The validity of the cosmetic notice is related to the time of agreement of the UK agent. PIF is kept for at least 10 years after the last batch of products is released.

Q：Can the EU cosmetics record be renewed after expiration?

A：It is only related to the agent agreement, and the replacement agent needs to be updated.

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