Technical regulation on cosmetic products and its requirements

On August 3, 2024, the Technical Regulation on Cosmetic Products (hereinafter referred to as the Regulation), approved by the Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021 (hereinafter referred to as CMU Resolution No. 65), came into force.

This is a regulatory legal act whose requirements are mandatory for all market operators. At the same time, the resolution provides for a two-year transition period until August 3, 2026, during which the provision of cosmetic products introduced into the market before August 3, 2024, cannot be prohibited or restricted due to non-compliance with the Regulation’s requirements.

From August 3, 2026, all cosmetic products sold in stores, pharmacies, online, used in clinics, beauty salons, or available in hotels, must comply with the requirements of this Regulation.

The necessity of adopting the new regulatory act was driven not only by the need to harmonize technical regulation in Ukraine with the EU legislation on cosmetics, specifically Regulation (EC) No. 1223/2009, and to eliminate trade barriers with EU countries but also by the obsolescence of existing regulatory norms in the cosmetic industry and the need to improve the quality and safety of cosmetic products.

The adoption of this Regulation strengthens the safety of cosmetic products and organizes the duties and responsibilities of all market participants (manufacturers, importers, distributors, consumers, and the competent authority).
 

What is new in this document?

The Regulation completely changes the procedure for bringing cosmetic products to market. Market entry is significantly simplified: obtaining permits is not required; it is only necessary to notify the competent authority about the product’s introduction to the market by providing relevant information on a special portal (product notification).

However, supervision and control over the product once it is on the market will be intensified. Cosmetic products become an object of state market surveillance: CMU Resolution No. 65 includes them in the list of products subject to state market surveillance, as approved by CMU Resolution No. 1069 dated December 28, 2016.

Market surveillance will be conducted in accordance with the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products” at all stages of product circulation: during customs clearance, in trading and warehouse premises, at fairs or exhibitions.

The State Service of Ukraine on Medicines and Drugs Control (SSUMDC) is designated as the market surveillance authority, which will conduct both scheduled inspections according to an approved sectoral plan and unscheduled ones based on consumer, executive authority, or law enforcement agency requests.

For SSUMDC, this task is not new, as it already conducts similar surveillance for medical devices, and thus is familiar with both the legislation and surveillance procedures.

New responsibilities and penalties

Regarding cosmetic products deemed unsafe or posing risks and/or non-compliant with the established requirements, the market surveillance authority may decide to impose restrictive (corrective) measures, such as restrictions or prohibitions on sales, product withdrawal from circulation, or recall, and market operators may face fines. For instance, the fine for first-time introduction of non-compliant products will be about 51,000 UAH (app. 1200 Euro), and for repeated violations – around 102,000 UAH (app. 2400 Euro). Introducing products posing serious risks will result in fines of 102,000 UAH (app. 2400 Euro) for the first offense and 340,000 UAH (app. 7600 Euro) for repeat offenses.

Fines apply to each type, article, or batch of unsafe, risky, and/or non-compliant products, regardless of the number of units or sales locations.

Mandatory appointment of Responsible person

Another new requirement is the mandatory appointment of a responsible person for each cosmetic product, without whom the product cannot be placed on the market. The responsible person may be a Ukrainian manufacturer or importer, or a third party authorized in writing. The responsible person ensures compliance with the Regulation. Although this person may not directly perform all requirements, such as product safety assessment, they bear full responsibility for ensuring all Regulation requirements are met.

If the responsible person believes that a cosmetic product does not comply with the requirements, they must take corrective actions to bring it into compliance, withdraw it from the market, or recall it. If the product poses a health risk, the responsible person must immediately notify and cooperate with the competent authority, providing all necessary information.

Stringent requirements for product composition and safety

The Regulation also establishes new requirements for the cosmetic product’s composition, labeling, safety, and documentation. It introduces the term “cosmetic product” instead of “cosmetic means” as per State Sanitary Rules and Norms for the safety of perfume and cosmetic products (DSanPin) and sets clear criteria for categorizing products as cosmetic.

Products intended for ingestion, inhalation, injection, or implantation in the human body are not considered cosmetic. Some products currently positioned as cosmetics will no longer fall into this category.

Despite the Regulation’s definition of “cosmetic product,” there are instances of uncertainty regarding the classification of certain products, such as whether they are cosmetics or fall under other categories like medicines, medical devices, or disinfectants, and thus are regulated by other legislation. Such products, known as “borderline products,” may be regulated by multiple legal acts within their application scope.

Methodological Recommendations and Increased Prohibition Lists

To facilitate understanding of whether a borderline product falls under the Technical Regulation on Cosmetic Products, the Ministry of Health of Ukraine issued “Methodological Recommendations for the Application of the Technical Regulation on Cosmetic Products, approved by CMU Resolution No. 65 dated January 20, 2021, regarding borderline groups of cosmetic products,” approved by MOH Order No. 1247 dated July 17, 2024.

The requirements for the composition of cosmetic products become stricter: the list of prohibited substances increases almost fourfold compared to SSR&N, and lists of restricted substances, permitted colorants, preservatives, and UV filters are introduced, along with requirements for CMR substances, nanomaterials, and traces of prohibited substances.

Enhanced safety and documentation

Safety requirements for cosmetic products are strengthened, with a two-level safety assessment system: safety assessment of each ingredient and the final product, conducted by a qualified expert with appropriate medical or pharmaceutical education. The Regulation requires all cosmetic products to undergo a safety assessment and obtain a safety report before being marketed.

This safety assessment includes mandatory studies to confirm the product’s safety in its final packaged form, proper storage throughout its shelf life, stability under certain conditions, and effective preservatives.

The resulting safety report, signed by a qualified expert, should conclude on the product’s safety based on the analysis of all ingredients, the final product, manufacturing methods, research results, labeling, claims, and necessary calculations. Each cosmetic product must have this report, which is a crucial part of the product’s information file.

Product Information File (PIF) and surveillance

The information file must also contain details about the final product, all ingredients, packaging, manufacturing process, labeling, research results, evidence of claimed efficacy, and justification of all product claims. This file must be stored by the responsible person at the address indicated on the product packaging for at least 10 years from the last batch’s market entry and be available to the market surveillance authority.

Despite the mandatory pre-market safety assessment, some consumers may still experience adverse effects when using the product. The Regulation mandates the responsible person to conduct “cosmetovigilance,” collecting and recording information about undesirable and serious undesirable effects, which must be reported to SSUMDC.

Mandatory GMP and labeling requirements

The Regulation also establishes special labeling requirements, listing mandatory information for consumers. Some information can be indicated using symbols understood internationally, reducing the need for translation for other markets.

To protect consumers from misleading claims about a product’s efficacy or other characteristics, the Regulation sets requirements for voluntary information in texts, names, trademarks, images, photographs, or other signs used in labeling, marketing, and advertising of cosmetic products. Claims must be substantiated by reliable evidence based on product research, scientific articles, literature reviews, etc., and stored by the responsible person as part of the product’s information file.

For the first time, the state sets requirements not only for the cosmetic product but also for manufacturing conditions. The Regulation mandates Good Manufacturing Practice (GMP) to ensure products are made in a clean environment and are not contaminated during production. Certification of GMP is not required to avoid additional financial burden on the manufacturer; a compliance statement is sufficient. Compliance with national standard DSTU ISO EN 22716 presumes GMP compliance.

Obligations for distributors and conclusion

The Regulation imposes obligations not only on the responsible person (manufacturer, importer) but also on distributors. They must verify product compliance, check expiration dates, adhere to storage conditions, report serious undesirable effects to SSUMDC, and, in some cases, notify the product, keep, and provide information about the responsible person or distributors who supplied or received the product.

These substantial changes in cosmetic regulation require all market operators to thoroughly study and comply with numerous regulatory acts: the Technical Regulation on Cosmetic Products, the Law of Ukraine “On Technical Regulations and Conformity Assessment,” the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products,” and others, including additional acts for some products – the Technical Regulation on Aerosols and the Technical Regulation on Toy Safety.

Moreover, since most cosmetic products are chemical substances/mixtures, each chemical ingredient with an annual production or import volume of 1 ton or more must be registered under the new Technical Regulation on Chemical Product Safety, effective January 26, 2025, applicable to both raw materials (ingredients) and finished cosmetic products.

Such new technical regulation ensures that cosmetic products are maximally safe for consumers, being made from verified and permitted raw materials in a safe production environment, having undergone a safety assessment, not tested on animals, and with a responsible person guaranteeing problem resolution if issues arise.

Oksana Oliynichuk, Head of FMCG Department of Cratia 

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.