Technical regulation on the safety of chemical products (UA REACH)

By the Resolution of the Cabinet of Ministers of Ukraine No. 847 dated July 23, 2024, the “Technical Regulation on the Safety of Chemical Products” was approved, which will come into effect on January 26, 2025. The regulation is based on Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH).

The regulation applies to chemical products that are imported, placed on the market, or manufactured in Ukraine. Chemical products cannot be placed on the Ukrainian market if they do not comply with the requirements of the regulation.

Moreover, the resolution provides for a transitional period during which chemical products that were placed on the market before the entry into force of this resolution and do not meet the requirements of the Technical Regulation may remain on the market for one year from the date the resolution comes into effect, i.e., until January 26, 2026.

The regulation applies to chemical substances both individually and in mixtures, as well as in products.

According to the regulation, companies that produce or import a chemical substance, including as part of other chemical products, in quantities exceeding 1 ton per year, must register this substance.

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

In addition, for chemical substances subject to state registration and 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 conducted, and a chemical safety report must be compiled.

State registration of a chemical substance 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 under EU Regulation No 1907/2006, and a document confirming the registration of the substance through the REACH-IT system of the European Chemicals Agency.

For hazardous chemical products, according to the classification of the “Technical Regulation on the Classification, Labeling, and Packaging of Chemical Products,” the supplier must provide the consumer with a chemical product safety data sheet.

Impact of the regulation on cosmetic products

Since most cosmetic products belong to chemical substances (mixtures), the provisions of this regulation also apply to substances and mixtures used in cosmetic products. Accordingly, each chemical substance (ingredient) in a cosmetic product must be pre-registered if the annual production or import volume of the substance exceeds 1 ton.

Chemical substances with an annual volume exceeding 10 tons must also have a chemical safety report. However, as an exception for substances used in cosmetic products, the report should not assess the risks to human health to avoid duplicating requirements with the Technical Regulation on Cosmetic Products, which already mandates a mandatory safety assessment for human health.

At the same time, Section 4 of the regulation, which requires the provision of a chemical product safety data sheet, does not apply to cosmetic products.

The regulation may also directly limit the use of certain substances in cosmetic products to mitigate risks not covered by the “Technical Regulation on Cosmetic Products.” For instance, from January 1, 2025, the placement on the market of cosmetic products that are rinsed off with water after application and contain silicones nonylphenol (D4) and nonylphenol ethoxylate (D5) in concentrations ≥ 0.1% by mass will be prohibited due to their environmental hazards.

This restriction on nonylphenol (D4) will not affect cosmetic regulation, as it is already prohibited by the “Technical Regulation on Cosmetic Products” in all cosmetic products, not just those that are rinsed off, as it has been classified as a CMR substance.

The regulation will also ban the placement on the market of cosmetic products with intentionally added microplastic (synthetic polymer microparticles) according to the following schedules:

• From August 17, 2027: “rinse-off” cosmetic products containing synthetic polymer microparticles to impart desired characteristics in concentrations ≥ 0.01% by mass or containing synthetic polymer microparticles used as abrasives, i.e., for exfoliating, polishing, or cleansing (“microbeads”).
• From August 17, 2035: “lip products,” “nail products,” “makeup products” containing synthetic polymer microparticles to impart desired characteristics in concentrations ≥ 0.01% by mass or containing microbeads.
• From August 17, 2029: “leave-on” cosmetic products containing synthetic polymer microparticles to impart desired characteristics in concentrations ≥ 0.01% by mass.

The regulation also sets requirements for the information and labeling of such products: from August 17, 2031, to August 16, 2035, suppliers of “lip products,” “nail products,” “makeup products” containing synthetic polymer microparticles must include the statement: “This product contains microplastic.”

Moreover, the regulation may indirectly impact cosmetic products: its prohibitions may make certain chemical substances used in cosmetics unavailable in the supply chain.

Thus, suppliers of cosmetic products (manufacturers, importers) will need to verify the product composition for compliance with the regulation’s requirements and ensure that all chemical substances included in the product and whose supply volume exceeds 1 ton have state registration.

Our services

Cratia provides comprehensive regulatory support and accompanies at all stages of regulatory compliance of cosmetic products in Ukraine:

• outsourcing of a Responsible Person (RP) in Ukraine;
• assessment of the composition of the product;
• filling of the Product Information File;
• Cosmetic Product Safety Report (CPSR);
• verification/development of labeling, instructions, and advertising materials;
• product notification;
• development and implementation of Good Manufacturing Practice in accordance with ISO 22716 (GMP);
• legal and consulting support of the manufacturer, Responsible person or distributor (importer).

We possess deep knowledge and experience, speak and write fluent English. We will take over the organization of the process, assist in filling of the set of documents and perform the required procedures in a short time.

We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.