Cosmetic products

Cosmetic products

Legal framework

The rules relating to cosmetic products have been fully harmonized in the EU. The general rules are laid down in Regulation (EC) No 1223/2009 on cosmetic products.

 

A cosmetic product is defined in the Regulation as 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.

 

Only cosmetic products for which a legal or natural person is designated within the EU as responsible person may be placed on the market. For each cosmetic product placed on the market, the responsible person must ensure compliance with the relevant obligations set out in the Regulation.

 

The responsible person must, prior to placing on the market, ensure that a cosmetic product safety report, composed of the cosmetic product safety information and the cosmetic product safety assessment, is set up for the cosmetic product.

 

When a cosmetic product is placed on the market, the responsible person must keep a product information file for it. The product information file must be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. The product information file contains the cosmetic product safety report and other relevant information about the cosmetic product. The responsible person must make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member Statein which the file is kept.

 

Prior to placing the cosmetic product on the market, the responsible person must submit a notification to the European Commission via the Cosmetic Products Notification Portal (CPNP).

 

The Regulation requires the manufacture of cosmetic products to comply with good manufacturing practice.

 

The Regulation contains lists of substances the use of which is prohibited or restricted in cosmetic products. In addition, the Regulation also contains exhaustive lists of substances that may be used and may only be used as colorants, preservatives, or UV-filters in cosmetic products. The latter lists also contain conditions that these substances must comply with.

 

The Regulation contains rules on the use in cosmetic products of substances classified as carcinogenic, mutagenic, or toxic for reproduction and of nanomaterials.

 

The Regulation prohibits the placing on the market of cosmetic products the final formulation and/or individual ingredients of which have been the subject of animal testing in order to meet the requirements of the Regulation and the performance of animal testing of finished cosmetics products and/or individual ingredients in order to meet the requirements of the Regulation.

 

The Regulation also contains rules on labelling and product claims.

 

How we can assist

We can set up a product information file for your product in line with EU law.

• The product information file is composed of the cosmetic product safety report and other relevant information about the cosmetic product. The cosmetic product safety report is composed of the cosmetic product safety information and the cosmetic product safety assessment.

 

We can review the label of your product in line with EU law.

• Our comprehensive report indicates the labelling requirements and the legal status of each particular on the label, including claims, together with the underlying legal reasoning. The report also includes the proposed legally compliant and translated label text.

 

We can review the marketing materials of your product in line with EU law.

• Our comprehensive report indicates the legal status of each marketing statement, together with the underlying legal reasoning. The report also includes the proposed legally compliant and translated marketing text.

 

We can submit a notification for your product to the European Commission via the CPNP prior to placing the product on the market and/or update the notification when the relevant information changes.

• We let you know which information and documentation is needed for the notification and submit the notification on your behalf.