CMS Expert Guide on Beauty in Ukraine

Technical Regulation on Cosmetic Products (Technical Regulation), was adopted by the Cabinet of Ministers Resolution No. 65 as of 2021, and entered into force on August 3, 2024. Technical Regulation is generally based on Regulation (EC) No 1223/2009 on Cosmetic Products. Under the transition provisions of the Technical Regulation marketing of cosmetic products put into circulation before August 3, 2026 is permitted if such products comply with the previous standards effective before entering of the Technical Regulations into force. Previously, the State sanitary regulations and product safety standards of the perfumery and cosmetic industry, approved back in 1999, regulated the circulation of cosmetic products.

Technical Regulation defines the term cosmetic product as any substance or mixture intended to be applied to the external parts of the human body (epidermis, hair, nails, lips, external genitals), teeth, or the mucous membranes of the oral cavity, exclusively or mainly for the purpose of cleaning, perfuming, changing their appearance, protecting, keeping them in good condition, or correcting body odours.

The current version of the Law on Medicines (1996) in contrast defines medicinal product as any substance or combination of substances (one or more active pharmaceutical ingredients and excipients) that possesses properties intended for the treatment or prevention of diseases in humans, or any substance or combination of substances (one or more active pharmaceutical ingredients and excipients) that may be intended to prevent pregnancy, restore, correct, or modify physiological functions in humans by exerting a pharmacological, immunological, or metabolic action, or for establishing a medical diagnosis.

The newly adopted Law on Medicines (2022) which shall be fully enacted within 30 months following termination of martial law in Ukraine, defines medicinal product as any substance or combination of substances that exerts a pharmacological, immunological, or metabolic action and is applied to or administered to a human in an appropriate pharmaceutical form for the treatment or prevention of human diseases, or for the purpose of restoring, improving, or altering physiological functions of the body, or for establishing a medical diagnosis. Medicinal products include: active pharmaceutical ingredients, “in bulk” products; homeopathic remedies; products used for detecting disease pathogens, as well as for combating disease pathogens or parasites; medicinal cosmetic products and medicinal additives to food products; finished medicinal products and medicinal products compounded / produced under pharmacy conditions.

Although the Technical Regulation defines "cosmetic products", there are cases where it is unclear whether certain products are cosmetics or fall under other categories, such as medicinal products, medical device, food product etc., which are regulated differently. These are called "borderline products" and may be subject to multiple regulatory requirements. To clarify whether a borderline product is covered by the Cosmetic Products Technical Regulation, the Ministry of Health of Ukraine (MOH) issued "Guidelines on the Application of the Technical Regulation on Cosmetic Products for borderline product groups." This document was approved by Order No. 1247 of the Ministry of Health of Ukraine on July 17, 2024.

Yes, the Technical Regulation places specific restrictions on substances used in cosmetic products, including the following:

• Prohibited substances: Listed in Annex 2 of the Technical Regulation.
• Restricted substances: Listed in Annex 3, which may only be used if they meet specified conditions.
• Colorants: Only those listed in Annex 4 are permitted, and they must comply with the conditions outlined therein.
• Preservatives: Only preservatives listed in Annex 5 are allowed, provided they meet applicable conditions.
• UV filters: Permissible only if included in Annex 6 and used according to its conditions.

In addition, Technical Regulation prohibits the sale of cosmetic products if the final product or any ingredients have undergone animal testing, with exceptions if:

• The ingredient or combination of ingredients is widely used and has no practical substitute; or
• Animal testing is necessary to draw substantiated conclusions on human health safety, where significant uncertainty exists without such testing.

Substances categorized as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) are regulated as follows:

• The use of Category 1A or 1B CMR substances is entirely prohibited in cosmetics.
• Category 2 CMR substances, as classified by the EU’s Regulation (EC) No 1272/2008, are likewise prohibited in cosmetic products.

Regarding “active” ingredients like acids or retinoids, the Technical Regulation does not include specific provisions. However, all cosmetic ingredients must meet general safety standards, which require a safety assessment prior to market placement. This safety assessment evaluates the toxicological profile of ingredients, including potential toxicity, skin and eye irritation, and other safety factors. Restrictions or prohibitions specified in the annexes apply to active ingredients as relevant.

Lastly, the law distinguishes between products for home use and professional use. Cosmetic products for professional use must carry specific warnings and usage instructions, with detailed precautionary information clearly provided on the label.

Only cosmetic products for which legal entities or natural persons (residents of Ukraine) are designated as responsible persons may be placed on the market. For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations defined by this Technical Regulation. The responsible person is considered to be the manufacturer based in Ukraine, the importer, or a third party authorized by them in writing. Although this person may not directly carry out certain requirements, such as the safety assessment of the product, they are fully responsible for ensuring that all regulatory requirements are met.

Distributors are the responsible persons if they distribute cosmetic products on the market under their own name or trademark, or modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected. Translation of information on the labelling of cosmetic products already made available on the market is not considered a modification of the product.

Yes, the safety assessment for cosmetic products is required in accordance with paragraph 6 of the Technical Regulation. The safety assessment of cosmetic products is conducted by an expert—an individual who has obtained a higher education degree in the specialties "Medicine" or "Pharmacy, Industrial Pharmacy" at the master's level or other higher education recognized as equivalent by the Ministry of Education and Science of Ukraine.

A two-tier assessment system is introduced: checking each ingredient and the final product, conducted by a qualified expert. The regulation requires that all products undergo a safety assessment before being introduced to the market, receiving a safety report. The report, signed by the expert, includes an analysis of the ingredients, the final product, labelling, research, and product claims. It is a key part of the information file, which must be kept by the responsible person for at least 10 years and should be available to regulatory authorities. The regulation obliges the responsible person to conduct "cosmetic surveillance" by collecting and recording data on undesirable and serious side effects, with mandatory reporting of serious cases to the State Service of Medicines and Drug Control (Quality Inspectorate).

Each individual cosmetic product must have labelling that complies with the requirements of the Technical Regulation and other legislative acts. The labelling of cosmetic products must be provided in Ukrainian; additional information in other languages is permitted. The information must be visible, legible, and indelible. It can be applied using a sticker, leaflet, tag, or card.

The labelling must include the following information:

• Name and address of the responsible person;
• Country of origin for imported products;
• Package content in units of weight or volume, or the number of product units;
• Expiry date and symbol, or the phrase "use by";
• Storage conditions;
• Period of use after opening the package;
• Warnings and precautions;
• Special information for professional use;
• Batch (lot) number or identification details;
• Purpose, if not obvious;
• List of ingredients (composition) in descending order, using INCI identifiers;
• Name and address of the manufacturer;
• Date of manufacture.

If the product may pose a risk to health, property, or the environment—information about such properties and potential consequences. Packaging layouts (graphic file and/or photograph) are subject to registration with the competent authority.

The main act regulating advertising in Ukraine is the Law On Advertising. This law sets general rules for advertising, including prohibitions on false or misleading claims. It does not provide for specific requirements or restrictions applicable to cosmetic products (unlike, e.g. medicines, medical devices etc.).

Under the Technical Regulation cosmetic products are subject to state market surveillance. The Quality Inspectorate is the market surveillance body for cosmetic products.

Market surveillance is conducted in accordance with the Law of Ukraine On State Market Surveillance and Control of Non-Food Products at all stages of product circulation: customs clearance, trading and storage facilities, and at fairs and exhibitions.

The Quality Inspectorate conducts scheduled and unscheduled inspections based on consumer complaints and requests from government agencies.

If cosmetic products are found to be dangerous or non-compliant with the Technical Regulation, market surveillance authority may impose restrictive measures such as banning sales, withdrawing from circulation, or recalling the product. Fines may also be imposed on market operators: up to UAH 51,000 for the first violation and up to UAH 102,000 for repeat violations (approximately EUR 1,100 and 2,200). For products posing a serious risk, fines are UAH 102,000 for the first violation and UAH 340,000 for repeat violations (approximately EUR 2,200 and 7,700). Fines are applied per product type, article, or batch, regardless of the number of units or sales locations.

Advertisers of cosmetic products may be liable for misleading or otherwise non-compliant advertising under the Law on Advertising (enforced by the State Service of Ukraine on Food Safety and Consumer Protection – Consumer Protection authority), and misleading information in advertising or promotion under the Law on Unfair Competition (enforced by the Anti-Monopoly Committee of Ukraine).

New regulatory and market surveillance body for cosmetic products will be established in the upcoming years. It shall replace the Quality Inspectorate and partially the MOH functions.

The key regulation regarding supplements is the Law On Basic Principles and Requirements for the Safety and Quality of Food Products. A dietary supplement is a product consisting of vitamins, vitamin-mineral complexes, or herbal supplements, either alone or in combination, in the form of pills, tablets, powders, that are taken orally with food or added to food within physiological norms to provide additional intake of these substances compared to normal diet. Dietary supplements may also contain or include various substances or mixtures of substances, including proteins, carbohydrates, amino acids, edible oils, and extracts from plant and animal materials, which are considered necessary or beneficial for nutrition and overall well-being.

Dietary supplements are intended to complement the diet, enhance physiological functions, and support overall health. They are not designed for the treatment, diagnosis, or prevention of diseases. In Ukraine, dietary supplements are regulated through state registration, focusing on their composition, safety, and labelling requirements. The registration process ensures that these products meet food safety standards, but does not involve rigorous clinical testing. On the other hand, medicinal products are specifically aimed at treating, diagnosing, or preventing diseases. They act on particular physiological processes, with their effectiveness supported by clinical research. Medicinal products in Ukraine are subject to much stricter regulations, including mandatory registration, clinical trials, and comprehensive control by competent authorities. The registration process for medicinal products involves extensive verification of efficacy, safety, and quality, resulting in the issuance of marketing authorisations.

The MOH is responsible for registration of novel foods, food supplements, flavourings, enzymes. This means that certain new ingredients must undergo registration, which includes a safety assessment before they can be used in food supplements.

There are stringent requirements for the composition of infant formulas, grain-based foods, foods for special medical purposes, and weight control products. For example, the use of certain pesticides during the primary production of these products is restricted, and pesticide residue levels in finished products must comply with established standards.

Yes, market operators, including companies or individuals involved in the production, importation, or sale of dietary supplements, bear the responsibility for ensuring compliance with food safety regulations throughout all stages of production and distribution. This responsibility includes making sure that all products meet established quality and safety standards. If a market operator becomes aware that the dietary supplements they produce or sell do not meet safety requirements, they are obligated to take immediate action to withdraw such products from the market. Additionally, they must inform the relevant authorities and, if necessary, consumers about potential risks.

Yes, the MOH is responsible for the state registration of dietary supplements, dietary flavourings, and dietary enzymes, as well as maintaining the state register of these products. Regarding exceptions, the law provides for a simplified approach to the evaluation and registration of certain supplements, provided that these products do not significantly impact food safety. There are also specific requirements for certain categories of products, such as infant nutrition, where legislation defines special standards regarding their composition and use.

Traceability is mandatory, requiring market operators to ensure that dietary supplements can be traced throughout all stages of production and distribution. This means that market operators must be able to identify both their suppliers and buyers, which facilitates a swift response to any safety issues. Documentation is also crucial, because operators must maintain records related to the production, processing, storage, and sale of dietary supplements. This documentation should be available for inspection by competent authorities if needed, providing an additional layer of oversight for product safety.

Dietary supplements must have labeling that includes all necessary information for the safe consumption of the product. Moreover, packaging must comply with safety requirements and protect the product from contamination.

Mandatory information which must be include on packaging:

• Product Name: Clearly stated name of the food supplement.
• Ingredients: Complete list of ingredients, including active components and additives.
• Usage Instructions: Recommendations on dosage and method of consumption.
• Nutritional Claims: Any health benefit claims must be scientifically substantiated and legally permitted.
• Manufacturer Information: Name, location, and contact information of the manufacturer or importer.
• Expiry Date: Manufacturing date and final expiry date of the product. Storage Information: Conditions for storing the product.

Yes, the advertising and promotion of food supplements are allowed within the jurisdiction, provided certain conditions are met.

Main Advertising Requirements:

• Accuracy of Information: Advertising must be truthful and not mislead consumers. All health benefit claims must be scientifically substantiated and verified.
• Prohibition of Medical Claims: Advertising must not claim that food supplements can treat, prevent, or diagnose diseases unless such claims are confirmed by relevant authorities.
• Clear Product Identification: The advertisement must clearly state that the product is a food supplement, not a medicine.
• Infant Nutrition and Special Products: Advertising of infant nutrition and food products for special medical purposes is subject to additional regulation and must comply with specific requirements, including information on nutritional value and usage conditions.

The regulation and compliance enforcement for dietary supplements is governed by several legal documents. The primary document is the Law On the Basic Principles and Requirements for Food Safety and Quality. This law outlines the procedures for the market entry of dietary supplements, requiring market operators to either register their facilities or obtain an operational permit, particularly for those involved in the production and/or storage of animal-based food products. There are exceptions specified in the Law where an operational permit is not required.

The Consumer Protection authority is responsible for regulating the circulation and sale of dietary supplements. Its responsibilities include overseeing food safety and quality, issuing permit documents, and approving export facilities.

When importing dietary supplements into Ukraine, operators must comply with legislation regarding food products.

Yes, significant developments are anticipated in Ukraine's regulatory framework for medical products and cosmetics. A new regulatory body, the Ukraine Medical Agency, is expected to replace the current Quality Inspectorate starting in early 2026. However, this transition is contingent upon final approval by the parliament and the establishment of the Agency by the Cabinet of Ministers, which are still pending. 

In Ukraine, cosmetic devices are not regulated separately from medical devices if they meet certain criteria. Currently, three key technical regulations govern medical devices: (a) Technical Regulation on Medical Devices (Resolution of the Cabinet of Ministers of Ukraine No. 753, 2013), (b) Technical Regulation on In Vitro Diagnostic Devices (Resolution No. 754, 2013) and (c) Technical Regulation on Active Implantable Medical Devices (Resolution No. 755, 2013). These regulations are based on the Law on Technical Regulations and Conformity Assessment and mirror outdated EU directives (Directive 93/42/EEC and Directive 90/385/EEC). The current Ukrainian regulations have not yet been aligned with the EU's Medical Device Regulation (MDR). 

Under the Technical Regulation on Medical Devices, a medical device is defined as any instrument, apparatus, appliance, device, software, material, or other product used alone or in combination for diagnostic or therapeutic purposes that does not primarily achieve its intended effect through pharmacological, immunological, or metabolic means. Several beauty devices, such as laser hair removal devices, microneedling tools, microdermabrasion tools, and radiofrequency devices, may fall under medical device regulation if intended for diagnostic, therapeutic, or rehabilitative purposes. For example, devices that penetrate the skin or use lasers can be considered medical devices. 

All medical devices must undergo conformity assessment in Ukraine, which includes product testing and certification to ensure compliance with technical regulations. The MOH is responsible for technical regulation, while the Quality inspectorate oversees market supervision and compliance for medical devices. Cosmetic devices not classified as medical devices must adhere to general product safety rules under the Law on General Product Safety.

Yes, if a beauty device falls under the medical devices regulation, the manufacturer or authorised representative must ensure the safety and compliance of the device, following the conformity assessment procedures set out in the technical regulations. The person or entity responsible for placing a medical device on the market must ensure it meets the relevant safety, quality, and performance standards before it can be marketed in Ukraine. For non-medical devices, general product safety rules apply.

Yes, cosmetic devices classified as medical devices must undergo a conformity assessment to ensure compliance with the relevant technical regulations. The current Ukrainian regulations are outdated and based on previous EU legislation (Directive 93/42/EEC and Directive 90/385/EEC) and have not been fully aligned with the EU Medical Device Regulation (MDR). However, devices must still meet the safety and performance requirements outlined in the technical regulations. For non-medical cosmetic devices, the Law on General Product Safety mandates that all products be safe for consumers and may require safety assessments to demonstrate compliance.

Yes, the Law on Advertising regulates the advertising of cosmetic and medical devices in Ukraine. It provides general requirements for advertising various goods and includes specific provisions for medical devices (including medical equipment, as well as prophylaxis, diagnostics, treatment, and rehabilitation techniques). According to the Law on Advertising, advertisements for medical devices must contain objective information and clearly indicate that the product is a medical device. For advertisements targeting the general public, restrictions apply to prevent misleading claims about health benefits or safety. Advertisements must also include a warning to consult a doctor before use and refrain from suggesting that medical consultation is unnecessary. There are additional restrictions on advertising to healthcare professionals, with more lenient rules when the advertising appears in specialised publications or during medical events like conferences or seminars. Non-medical cosmetic devices must adhere to the general advertising requirements under the Law on Advertising, ensuring that the information presented is not misleading.

Enforcement is handled by various regulatory bodies. For medical devices, the MOH and the Quality Inspectorate oversee compliance with safety and marketing rules. Non-compliance with medical device regulations can result in fines, product recalls, and, in severe cases, criminal liability, especially if the violation leads to significant harm. For general cosmetic devices, non-compliance with product safety or advertising rules can lead to administrative fines and product removal from the market. Criminal liability may apply if non-compliance causes significant harm.

The Ukrainian parliament is currently considering a draft Law on Medical Devices. If adopted, the law will not dramatically affect the regulation of beauty devices falling under the medical devices category. However, the draft law provides for gradual alignment of the technical regulations on medical devices with the new EU Medical Device Regulation (MDR). This alignment would update the conformity assessment procedures and strengthen safety and performance requirements, but the full implementation of these changes is expected to take place over time.

Yes, the administration of many cosmetic (non-surgical) services is regulated in Ukraine. Services involving injections (such as Botulinum toxins, fillers, mesotherapy, vitamin drips, and weight loss injections) or treatments using medical-grade equipment (e.g., microneedling, laser, IPL) are considered medical procedures and fall under medical regulation. These procedures are regulated by the Fundamentals of Legislation of Ukraine on Healthcare and related regulations issued by the MOH. Medical personnel who administer these treatments must have appropriate medical qualifications, and training is required for certain procedures, especially invasive ones. There is no distinct category for "certified aesthetic practitioners" in Ukraine; only licensed medical professionals (e.g., dermatologists, plastic surgeons) can administer such treatments.

Yes, individuals under the age of 18 cannot undergo most medical procedures, including non-surgical cosmetic treatments such as Botulinum toxins, fillers, or other injection-based therapies, without parental consent. This is regulated under the Civil Code of Ukraine and the Fundamentals of Legislation of Ukraine on Healthcare. Non-invasive cosmetic services may have different rules, depending on the provider’s internal policy, but no specific age restrictions apply to non-medical treatments.

Yes, Botulinum toxin (BT) is a prescription-only drug in Ukraine. Only licensed medical professionals, such as dermatologists or plastic surgeons, can prescribe and administer BT. These professionals must have the appropriate medical qualifications and work under the license of a healthcare institution that is licensed to provide medical services, or individual license as individual healthcare provider. Complaints related to medical malpractice or service provision are handled by the MOH, which is responsible for the licensing of medical service providers. The Quality Inspectorate oversees the circulation of medicines and medical devices, but not medical services.

There is no individual registration with the MOH for businesses; instead, healthcare institutions must be licensed for medical services.

Non-compliance with medical regulations can result in fines, suspension of the healthcare institution’s or individual license, and disciplinary actions against medical personnel. In severe cases, if malpractice results in patient harm, there could be criminal liability. Enforcement is overseen by the MOH, which has the authority to revoke medical service licenses. Non-compliance with non-medical cosmetic services (e.g., dermaplaning, chemical peels) can result in fines under consumer protection laws, but does not typically involve the MOH unless medical services are involved.

Yes, advertising for non-surgical cosmetic services, particularly those involving medical treatments like Botulinum toxins, fillers, and laser treatments, is regulated under the Law on Advertising. The law requires that all advertising for medical services be factual, objective, and include appropriate disclaimers, such as recommending consultations with healthcare professionals. Misleading claims about guaranteed results are prohibited. Third-party booking platforms that promote or allow the booking of such services are subject to the same advertising rules and must ensure that the medical services advertised comply with the law.

There are ongoing discussions about further regulating the aesthetic and cosmetic services sector in Ukraine, particularly with regard to the use of new technologies like cryotherapy, laser treatments, and injectables. The draft Law on Medical Devices, currently under consideration by the Ukrainian parliament, could impact the regulation of equipment used in non-surgical cosmetic services by aligning Ukraine’s technical regulations with the EU Medical Device Regulation (MDR). This could introduce stricter oversight on equipment standards and safety.