AxeRegel

Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products

No therapeutic benefit is expected from cosmetic products.

What are cosmetic products?

Click on the above image to learn the brief definition of cosmetic products.

Cosmetic products portal (CPNP)

In the EU, responsible persons are required to register cosmetic products on the cosmetic products notification portal (CPNP) before placing it on the market.

Cosmetovigilance in the EU is under the scope of Regulation (EC) No 1223/2009 on cosmetic products.

Learn  about cosmetovigilance here

Cosmetic products regulation

Legal obligations have to be accomplished before and after the commercialisation of cosmetic products.

A Cosmetic Product Information File (PIF) demonstrating the safety of the cosmetic product must be available before a cosmetic product is placed on the market.

What is a cosmetic product?

A cosmetic product is any substance or mixture intended to be placed in 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 with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protect­ing them, keeping them in good condition or correcting body odours.

(Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009)

A cosmetic product cannot be presented as having proprieties to cure, treat, or prevent disease, or affect the structure or any function of the human body.

Products that intent to be ingested, inhaled, injected or implanted in the organism are not considered as cosmetic products.

Examples of cosmetic products:

  • Products for the skin (cremes, lotions, gels and skin oils, make-up, sun products)
  • Hygiene products (soaps, oral hygiene products, deodorants)
  • Hair products (hair colourants, hair straightening products, hair cleansing products)
  • Other (perfumes, depilatories, products for nail care and make-up)

The European legislation of cosmetic products

The European legislation of the cosmetic products is based on the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Cosmetics Regulation). The annexes of this regulation are often updated by European Commission regulations.

How cosmetic products are controlled in France

In France, the surveillance of the cosmetic products market is ensured by the French National Agency for Medicines and Health Products Safety (ANSM) and the General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF).

Marketing Authorizations are not required for the commercialisation of cosmetic products in France. The safety of the cosmetic product is the responsibility of the manufacturer or of the legal representative of the cosmetic product.

The requirements for the commercializing of a cosmetic product in France concern:

  • the designation of a cosmetic product responsible person
  • the composition of the cosmetic product
  • the manufacture of the cosmetic product
  • the availability of a cosmetic product Product Information File (PIF)
  • the packaging labelling rules
  • the notification of the company to ANSM
  • the notification to the European Commission

The responsible person needs to make a notification to the European Commission before the cosmetic product is placed on the market.

The notification is done electonically through the Portal dedicated to cosmetic products marketed in the European Union: Cosmetic Products Notification Portal (CPNP).

The informations to transmit are the following:

  • the cosmetic product category and its full commercial name
  • the name and adresse of the responsible person where the Product Information File (PIF) is available to the authorities
  • the country of importation (for cosmetic products coming from outside the EU)
  • the member state where the cosmetic product will be placed on the market
  • the contact details of a physical person to contact
  • the identification and the exposition conditions to nanomaterials (if applicable)
  • the ingredients name and the CAS or EC number (for CMR substances from categories 1A or 1B)
  • the frame formulation
  • the original label
  • a photo of the package

Certain of the transmitted informations will be accessible to the national competent authorities and to the poison centers.

What is a nanomaterial?

A nanomaterial is an insoluble or biopersistant and inten­tionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to    100 nm.

Catalogue of nanomaterials used in cosmetic products

Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products.

Learn more about AxeRegel cosmetic consulting services

Cosmetic products responsible person

In the EEA, only cosmetic products for which a legal or natural person is designated as "responsible person" can be placed on the market.

Responsible persons are manufacturers, importers or third persons appointed by them.

If the product is manufactured within the EEA, the manufacturer established within the EEA is considered the Responsible Person.

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