Comments to document

In order to regulate cosmetic products in the EU, the European Parliament and the Council adopted Regulation (EU) No 1223/2009 on cosmetic products, which was put into effect on July 11, 2013, along with the repeal of Council Directive 76/768.

This Regulation is binding in its entirety and directly applicable in all Member States of the EU.

Regulation (EU) No 1223/2009 includes:
• Submission of "pre-sales" notification of cosmetics products (notifications) by a "responsible persons"
to the European market. An online notification system (CPNP) has been created to provide a pre-sale notice to the Competent Authorities (for monitoring, market analysis and consumer awareness) and for toxicological centers or similar bodies established by Member States. (for medical treatment purposes).
• Specific labelling requirements, content and format of the safety assessment report and "information files" on cosmetic products.
• Strengthening the coordinated efforts of the competent authorities of the Member States to oversee the market. Competent authorities in each state are responsible for reviewing the safety assessment and product control on the market.

Key requirements of Regulation (EU) No 1223/2009 on cosmetic products:
1. There must be a "responsible person" for each cosmetic product placed on the EU market
2. An assessment of the safety of the final cosmetic product must be made before the product is placed
on the EU market and, in content and form, meet the established requirements;
3. The cosmetic dossier must be available to the competent authorities at the address indicated by the "responsible person" and contain the following information:
– Characteristics of cosmetic product;
– Safety assessment of product;
– Compliance with GMP requirements;
– Confirmation of the effectiveness of cosmetic product;
– Information about animal testing.
4. Some of the latest technological developments, including the possibility of using nanomaterials, have been taken into account.

A new draft of technical regulation for cosmetic products in Ukraine was developed on the basis of EU Regulation No. 1223/2009. The document should eliminate legal differences, as well as administrative and technical barriers to trade between Ukraine and the countries of the European Union.

Due to the new technical regulations Ukrainians will use high-quality and safe cosmetic products. Today the list of prohibited ingredients for cosmetic products is 400 points, but the technical regulations sets 1328 points, and also provides for the use of only authorized dyes, preservatives, UV filters.