Q&A - How are Cosmetics Regulated in Europe?

Sağlık Hukuku
  • Is there any regulation on cosmetic products in the EU?

Yes, it is regulated by EU Commission. Regulation (EC) No 1223/2009 (“1223/2009”) cosmetic products are the main regulatory framework for finished cosmetic products placed on the EU market. You can find the all legislation about the cosmetic sector which is regulated by EU Commission.


  • What does “Cosmetic Product” mean under EU regulation?

According to 1223/200 Article 2/1. a ‘cosmetic product’ means 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.

  • What is the PIF?

The PIF is the product information file. The responsible person shall keep the product information file for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

  • What must PIF include?

- A description of the cosmetic product which enables the product.information file to be clearly attributed to the cosmetic product

- The cosmetic product safety report

- A description of the method of manufacturing and a statement on compliance with good manufacturing practice

- Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product

- Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

  • Is there any notification procedure?

Regulation (EC) No 1223/2009 (Article 13) requires that the responsible persons and, under certain circumstances, the distributors of cosmetic products submit some information about the products they place or make available on the European market through the cosmetic products notification portal ("CPNP"). CPNP is a free of charge online notification system When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.

  • Is there any substance that is not allowed to sell or use in cosmetic products?

With the last information dated 16th November, there are 2455 substances that are banned from use in any cosmetic products marketed for sale or use in the EU. You can reach the substances that are banned on the list via the link below.


  • Is it allowed to produce and sell cosmetics products in Europe which are tested on animals?

It is regulated a ban on testing on animals on products and ingredients. Additionally, there is a marketing ban on these products. So, producing and selling cosmetic products which are tested on animals is not allowed.

Kind Regards,

Zumbul Attorneys at Law