Regulations UA REACH and UA CLP

Cosmetic products in Ukraine are regulated by a large number of legislative acts, and since they are substances or mixtures, they are also subject to chemical legislation. The Responsible Person (national manufacturer, importer of foreign cosmetic products, or another party designated as the Responsible Person) must ensure compliance with all applicable requirements.

The main legislative acts in the field of chemical regulation are the Technical Regulation on Classification, Labeling, and Packaging of Chemical Products (UA CLP) and the Technical Regulation on the Safety of Chemical Products (UA REACH), as well as related legislation.

The central executive authority responsible for regulating chemical products is the Ministry of Environmental Protection and Natural Resources of Ukraine (hereinafter – Ministry of Environmental Protection). 

Technical Regulation on Classification, Labeling, and Packaging of chemical products

Resolution No. 539 of the Cabinet of Ministers of Ukraine, dated May 10, 2024, approved the Technical Regulation on the Classification, Labeling, and Packaging of Chemical Products (hereinafter – UA CLP Technical Regulation), which comes into effect on January 26, 2025. The regulation is based on Regulation (EC) No 1272/2008 on the classification, labeling, and packaging of substances and mixtures (CLP or EU CLP).

The regulation applies to chemical products that are placed on the market in Ukraine or produced on the territory of Ukraine.

Manufacturers, importers, and downstream users, before placing chemical products on the market, must gather all available information regarding the hazardous properties of the product, assess the validity of such information, and classify the hazards of the chemical product for all classes and categories, in accordance with the rules and criteria set out in the UA CLP Technical Regulation.

If the chemical product is classified as hazardous in one or more hazard classes, it must be appropriately packaged.

Identified hazards must be communicated to all participants in the supply chain and to consumers by providing the appropriate hazard information on the packaging and in the safety data sheet for the chemical product. The labeling of hazardous chemical products must include the following information:

• Supplier – name, address, and phone number;
• The nominal quantity of the chemical product in the packaging;
• Chemical product identifiers;
• Hazard pictograms;
• Signal word;
• Type of hazardous impact;
• Hazard statements;
• Additional information according to the Technical Regulation (if applicable).

Manufacturers and importers who place chemical substances on the market, including those within chemical products, must submit a notification to the Ministry of Environmental Protection about the hazard classification and information on the hazard of the respective chemical substance within 1 month from the date the chemical substance is placed on the market.

However, such notification may not be required if the chemical substance has undergone the state registration procedure for chemical substances.

Technical Regulation on the Safety of Chemical Products

Resolution No. 847 of the Cabinet of Ministers of Ukraine, dated July 23, 2024, approved the Technical Regulation on the Safety of Chemical Products (hereinafter – UA REACH Technical Regulation), which will come into effect on January 26, 2025. The regulation is based on Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorization, and restriction of chemicals (REACH or EU REACH).

The regulation applies to chemical products that are imported, placed on the market, or produced in Ukraine.

Chemical products cannot be placed on the Ukrainian market if they do not comply with the requirements of the UA REACH Regulation.

According to the regulation, chemical substances, including those contained in other chemical products, are subject to mandatory state registration before being placed on the Ukrainian market if the annual volume of production or import of the substance exceeds 1 ton.

State registration is carried out by the Ministry of Environmental Protection based on an application, a technical dossier, and a chemical safety report. If the decision is positive, the chemical substance is entered into the State Register of Chemical Substances.

Furthermore, the state registration of chemical substances that have been registered in the European Union is carried out through a simplified procedure based on the relevant application, technical dossier, a copy of the chemical safety report obtained through the registration procedure according to Regulation (EC) No 1907/2006, and a document confirming the registration of the substance through the REACH-IT system of the European Chemicals Agency.

For chemical substances that are subject to state registration and are placed on the Ukrainian market in quantities of at least 10 tons per year per applicant for state registration, a chemical safety assessment must be carried out, and a chemical safety report must be prepared.

Hazardous chemical products must be accompanied by a chemical safety data sheet developed in accordance with Annex 2 to the UA REACH Technical Regulation, which must be passed through the entire supply chain of the product.

Impact of UA REACH and UA CLP Technical Regulations on cosmetic products

Although the requirements of the UA CLP Technical Regulation do not apply to finished cosmetic products, they do apply to the chemical raw materials used in the production of cosmetics. The UA CLP Technical Regulation has a significant impact on the Technical Regulation on Cosmetic Products, which includes a ban on the use of category 1A or 1B CMR substances (carcinogenic, mutagenic, or toxic for reproduction). Thus, the UA CLP Technical Regulation serves as a source of information for the prohibition of such substances.

The provisions of the UA REACH Technical Regulation apply to the substances and mixtures used in cosmetic products. Therefore, each chemical substance used in a cosmetic product must be pre-registered if the annual production or import volume exceeds 1 ton.

However, as an exception, the safety report for a chemical substance used in cosmetics should not assess the risks to human health to avoid duplicating the requirements of the Technical Regulation on Cosmetic Products, which already mandates a compulsory safety assessment of cosmetic products for human health.

The section of the regulation requiring the provision of a chemical safety data sheet does not apply to cosmetic products.

UA REACH can directly restrict the use of certain substances in cosmetics to mitigate risks not covered by the Technical Regulation on Cosmetic Products. For example, from January 1, 2025, the regulation will prohibit placing on the market rinse-off cosmetic products containing silicones nonylphenol (D4) and nonylphenol ethoxylate (D5) at concentrations ≥ 0.1% by weight, due to their environmental hazards.

Additionally, the sale of cosmetic products containing intentionally added microplastics at concentrations ≥ 0.01% by weight will be banned. Microplastics are often added to cosmetic products for various purposes, such as exfoliation or achieving a specific texture, fragrance, or color.

Intentionally added microplastics must be removed from cosmetic products according to specific timelines:

• From August 17, 2027, for “rinse-off” products,
• From August 17, 2035, for “lip products,” “nail products,” and “makeup products,”
• From August 17, 2029, for “leave-on” products.

The UA REACH Technical Regulation may also impose requirements on product information and labeling. For instance, it will introduce a mandatory statement “This product contains microplastic” for lip products, nail products, and makeup products that contain synthetic polymer micro-particles.

Our services 

Cratia offers comprehensive regulatory support and assistance throughout all stages of placing cosmetic products on the Ukrainian market:

• Regulatory intelligence, consulting and feasibility study;
• Outsourcing of the Responsible person in Ukraine;
• Filling of the Product Information File (PIF);
• Filling of the Cosmetic Product Safety Report (CPSR) and Ukrainian safety assessor; 
• Review and/or development of labeling, instructions, and advertising materials;
• Notification (registration) of the cosmetic product on the portal; 
• Development of GMP according to ISO 22716; 
• Compliance with UA CLP and UA REACH regulations;
• Compliance with the Technical regulation on aerosol dispensers;
• Legal and consulting support for manufacturers, responsible persons, or distributors (importers).

We possess the necessary knowledge and experience to conduct these tasks, and we are fluent in spoken and written English. We will manage and organize the process, help compile the necessary set of documents, and carry out the procedure within a short timeframe.