Technical Regulation on cosmetic products comes into force in Ukraine

Technical Regulation on cosmetic products comes into force in Ukraine on August 03, 2022.

This Technical Regulation is developed based on the Cosmetics Regulation 1223/2009 of the European Parliament and Council dated November 30, 2009.

Only safe cosmetic products can be supplied on the Ukrainian market.

Authorized person and procedure for bringing cosmetic products on the Ukrainian market

Only an authorized person can bring cosmetic products on the Ukrainian market.

The authorized person ensures compliance with relevant obligations set out in the Technical Regulation for each cosmetic product placed on the market.

In case of introduction of cosmetic products, the authorized person must keep the documentation for these products. The documentation for relevant cosmetic products should be kept for the next ten years after the date of introduction of the last batch of these products.

Documentation for cosmetic products

The documentation for cosmetic products should, if necessary, be updated and contain the following information:

• description of cosmetic products allowing us to unequivocally establish that the documentation refers to the cosmetic products involved;
• Cosmetic Product Safety Report specified in clause 24 of this Technical Regulation;
• description of manufacturing methods and statement on compliance of cosmetic product manufacture with good manufacturing practice according to clauses 21-22 of this Technical Regulation;
• confirmation of the claimed effectiveness of cosmetic products, where this is justified by the nature of impact of cosmetic products;
• information on animal testing performed by the manufacturer or authorized persons of the manufacturer or suppliers concerning development or assessment of safety of cosmetic products or their ingredients, including any animal testing performed to comply with legal or regulatory requirements of other countries.

Good manufacturing practice

The manufacture of cosmetic products should comply with good manufacturing practice to meet the objectives of clause 1 of this Technical Regulation.

Safety of cosmetic products

To prove the compliance of cosmetic products with imposed requirements of clause 6 of this Technical Regulation, prior to introducing the products, the authorized person should ensure that cosmetic products undergo a safety assessment based on relevant information, and availability of Cosmetic Product Safety Report prepared according to Annex 1 to this Technical Regulation.

Notification

Prior to introducing cosmetic products, the authorized person should use electronic means to notify (provide) information on these products, providing the following information:

• category of cosmetic products and their name or names that will facilitate their identification;
• name and location of the authorized person who provides free access to the documentation for cosmetic products;
• country of origin of cosmetic products;
• contact details of an individual who may be contacted if necessary;
• presence of nanomaterials and:
  • their identifying characteristics, including chemical name (IUPAC) and other information according to Annexes 2-6;
  • reasonably foreseeable exposure conditions;
• name and unique identifier of chemical substances (CAS) or EU number of substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) of category 1A or 1B according to the classification adopted by legislation of the European Union.
• prescription framework that is taken into account when providing prompt and appropriate medical care in case of complications.

The procedure for notifying (providing) information on cosmetic products is established by the Ministry of Health.

Restrictions for substances listed in Annexes to this Technical Regulation

Without violating the requirements of clause 6 of this Technical Regulation, cosmetic products should not contain:

• prohibited substances listed in Annex 2 to this Technical Regulation;
• substances listed in Annex 3 to this Technical Regulation, without complying with restrictions set out in this Annex;
• dyes other than those listed in Annex 4 to this Technical Regulation and dyes listed in Annex 4 to this Technical Regulation, without observing relevant terms set out in this Annex.
• preservatives other than those listed in Annex 5 to this Technical Regulation and preservatives listed in Annex 5, without observing relevant terms set out in this Annex;
• UV filters other than those listed in Annex 6 to this Technical Regulation and UV filters listed in Annex 6, without observing relevant terms set out in this Annex.

State market surveillance

The state market surveillance of the introduced cosmetic products is carried out under the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products” taking into account the requirements of this Technical Regulation.