Dietary Supplements, Baby Food, and Special-Purpose Food Products

In recent years, the regulation of food products in Ukraine has undergone significant changes toward alignment with European legislation. This shift ensures improved quality and safety of food products in accordance with international standards. Ukrainian legislation is gradually being harmonized with the norms of the European Union, enabling Ukrainian manufacturers to enter EU markets and comply with modern regulatory systems.

The main legislative acts governing food products that are manufactured, placed on the market, or imported (shipped) into the customs territory of Ukraine include:

• the Law of Ukraine “On the Basic Principles and Requirements for Food Safety and Quality”;
• the Law of Ukraine “On State Control of Compliance with Legislation on Food Products, Feed, By-products of Animal Origin, Animal Health and Welfare”;
• and the Law of Ukraine “On Information for Consumers on Food Products”.

Additional requirements for baby food are established in Order No. 1084 “On Approval of Safety Requirements and Certain Quality Indicators for Baby Food”.

Food safety legislation also includes the Law of Ukraine “On Materials and Articles Intended to Come into Contact with Food Products”, which will enter into force on November 19, 2025.

Since 2023, dietary supplements have come under the spotlight of the Antimonopoly Committee of Ukraine (AMCU), and in early 2025, significant regulatory changes were adopted. Read more in our article “Regulation of Dietary Supplements: Analysis of AMCU Cases, Current Legislative Requirements, and the New Law on Dietary Supplements”.

We professionally provide regulatory and legalization services for dietary supplements, baby food, food for special medical purposes, and weight control products. We possess in-depth knowledge of applicable legislation and the practices of regulatory authorities. We offer: comprehensive consultations; evaluation of product eligibility for placement on the market (composition, labeling, etc.); development of labeling under legislative requirements; notification (registration); development and implementation of HACCP systems; voluntary services: obtaining reports, preparing declarations.

As of today, Ukrainian legislation defines the following types of “special” food products:

Dietary supplement – a food product that:

• is a concentrated source of nutrients (including proteins, fats, carbohydrates, vitamins, minerals) or other substances with nutritional or physiological effects;

• is produced in the form of capsules, lozenges, tablets and sachets, ampoules with liquids, dropper bottles, or in other forms of liquids and/or powders;

• is intended for consumption in small, measured quantities;
• is consumed as a supplement to the normal diet, either separately or in combination with other food products.

Food for Special Medical Purposes – a food product specifically developed and manufactured for feeding patients (including infants and young children) that must be consumed under medical supervision, either within a healthcare facility or outside of it. This type of food product is intended to partially or fully replace the normal diet of patients (including infants and young children) who have a limited, impaired, or disturbed ability to ingest, digest, absorb, metabolize, and/or excrete ordinary food or certain nutrients contained therein and/or their metabolites. Such a food product may also be prescribed for the full or partial feeding of patients (including infants and young children) with other physician-defined needs that cannot be met by modifying the normal diet.

Weight-Control Food Product – a specially developed and manufactured food product intended for use during a low-calorie diet to support weight reduction, which, when used according to the instructions provided by the market operator, replaces the daily diet.

Baby Food – a food product intended to meet the nutritional and energy needs of infants and young children, including water for baby food.

Baby food is further subdivided into the following categories:

• Infant formula;
• Follow-on formula;
• Cereal-based baby food;
• Water for baby food;
• Complementary feeding products.

 

State Registration and Notification

The Law of Ukraine “On the Basic Principles and Requirements for Food Safety and Quality” defines a list of sanitary measures subject to mandatory state registration:

• Novel foods;
• Food additives;
• Food flavorings;
• Food enzymes;
• Health claims.

Thus, the circulation of dietary supplements, baby food, food for special medical purposes, and weight-control products is not subject to state registration.

Instead, the Law “On the Basic Principles and Requirements for Food Safety and Quality” obliges food business operators to notify the competent authority of their intention to place baby food, food for special medical purposes, and weight-control food products on the market (notification). From 27.09.2025, the notification becomes mandatory for dietary supplements. 

The procedure for submitting such notifications is approved by Order No. 244 of the Ministry of Agrarian Policy “On Approval of the Procedure for Submitting Notification of Intention to Place Baby Food, Food for Special Medical Purposes, and Weight-Control Food Products on the Market, as well as for Maintaining and Publishing the List of Such Notifications.”

According to this Procedure, food business operators must submit a separate notification for each food product to the competent authority at least 10 working days before placing the food product on the market.

Given that dietary supplements were not previously included in the list of products subject to notification of the intention to place on the market, and that regulation of this category of food products differed significantly from the European approach, the Law of Ukraine “On Amendments to Certain Laws of Ukraine to Improve the Regulation of the Production and Circulation of Dietary Supplements and to Address Other Issues in the Field of Healthcare” was adopted in December 2024.

This new Law introduces the mandatory notification of the intention to place dietary supplements on the market starting from September 27, 2025, following the same approach as that established for baby food, food for special medical purposes, and weight-control food products. In addition, the Law provides for liability of market operators that produce unsafe dietary supplements or distribute dietary supplements with labeling that does not comply with legal requirements.

The competent authority to which the notification must be submitted is the State Service of Ukraine on Food Safety and Consumer Protection (SSUFSCP).

The responsibilities of the SSUFSCP also include:

• maintaining the Notification List;
• entering relevant data into the List;
• ensuring continuous and free public access to the List on the official website of the competent authority.

Along with notifying the intention to place baby food, food for special medical purposes, weight-control food products, and dietary supplements on the market, the market operator must submit a sample of the product label or sticker in Ukrainian.

Food products must be accompanied by product information in accordance with the requirements of the Law of Ukraine “On Information for Consumers on Food Products” and a number of other legislative acts that establish information requirements for food products.

Market operators responsible for food product information (manufacturer or importer) are obliged to ensure the presence and accuracy of such information.

Violation of legal requirements for food labeling (providing inaccurate, false, or unclear information to the consumer) results in the imposition of fines on the market operator. Circulation of incorrectly labeled products is prohibited; such products are subject to withdrawal and/or recall.

Incorrectly labeled food products may be returned to the market only after the labeling is corrected.

To ensure the guaranteed safety of food products (including dietary supplements, food for special medical purposes, weight-control products, and baby food), the Law “On the Basic Principles and Requirements for Food Safety and Quality” obliges market operators to develop, implement, and apply permanently operating procedures based on the principles of Hazard Analysis and Critical Control Points (HACCP).

They must also ensure proper training in the application of such HACCP-based procedures.

 

Dietary Supplements

Starting from September 27, 2025, a new law will enter into force, significantly changing the approach to the production, circulation, and control of dietary supplements. The new definition of the term “dietary supplement” will be harmonized with European legislation.

The law introduces mandatory notification—the submission of a notice to the competent authority regarding the intention to place a dietary supplement on the market for the first time. Without such notification, the sale of dietary supplements is prohibited. The notification must include key product details, such as composition, dosage form, labeling, and information about the manufacturer or importer.

Registration or certification of dietary supplements is not mandatory. However, for imported products, an international safety certificate is required. Strict requirements apply to the composition of products, including permitted ingredients, their forms, dosages, and compliance with regulatory limits. The use of prohibited or restricted substances in dietary supplements is forbidden.

Labeling of dietary supplements must comply with national legislation: it must be in Ukrainian, include mandatory warnings, and must not contain any references to medicinal properties. The law also sets specific advertising rules: it must not include references to treatment, symptom relief, or any misleading health claims.

Special attention is given to verifying the accuracy of health benefit claims. The Antimonopoly Committee of Ukraine has repeatedly fined companies for using statements that attribute medicinal properties to dietary supplements.

The law provides for a transitional period to bring products into compliance: one year for the manufacture and import of non-compliant products, and up to three years for their continued presence on the market. The Ministry of Health is obliged to approve a list of permitted substances and their maximum levels.

 

Baby Food

Baby food in Ukraine is regulated by several laws, particularly the Law of Ukraine “On the Basic Principles and Requirements for Food Safety and Quality”. Requirements for composition, quality, and labeling are further specified in Order No. 1084 of the Ministry of Health, which contains standards specifically for products intended for infants and young children. Baby food includes products intended for consumption by children up to the age of three.

The categories of baby food include:

• Infant formula;
• Follow-on formula;
• Complementary feeding products;
• Cereal-based baby food;
• Specially prepared water.

Each of these categories is clearly defined in legislation, which influences the requirements for composition, dosage, and labeling. Products for children over three years old do not fall under the “baby food” category and are regulated under general food product standards.

Importation of baby food into Ukraine requires an international certificate confirming product safety. Before placing the product on the market, the food business operator must ensure that the composition, intended use, and target age group meet national requirements. Legislation establishes clear limits on permissible ingredients, levels of vitamins and minerals, use of food additives, pesticides, and other substances.

Labeling of baby food is strictly regulated. In addition to the general labeling requirements for all food products, the law prohibits idealization of the product through images, photos, or wording. The label must clearly indicate the age group for which the product is intended and must include warnings regarding its consumption. There are also requirements for font size, language, presentation of nutritional value, and permitted health claims.

Responsibility for compliance lies with the market operators—manufacturers or importers. Since May 2022, state registration and sanitary-epidemiological examination of baby food have been abolished. Instead, a mandatory notification procedure has been introduced, requiring submission of a notice of intent to place baby food on the market.

Notification must be submitted at least 10 working days prior to the product’s market launch, in either electronic or paper form. The notification must include product information, composition, labeling, a sample label, and other documentation. If the mandatory information on the label of an already marketed product is modified, a new notification must be submitted.

Once the notification is submitted and the product is included in the official list, the market operator is allowed to sell the baby food. The entire procedure is free of charge. This approach enhances transparency, ensures the quality and safety of baby food in Ukraine, and brings local regulations closer to European practices.

 

Food for Special Medical Purposes and Weight-Control Products

Food for special medical purposes (FSMP) is intended for patients who have difficulty ingesting or absorbing regular food, as well as for other medical conditions defined by a physician. These products may be used for either partial or full nutritional support in healthcare settings or at home. This category includes products for oral consumption, tube (enteral) feeding, and specialized formulas for infants and young children diagnosed with medical conditions.

Weight-control food products are specially formulated to replace complete meals during weight-loss diets. They are intended for healthy individuals seeking to reduce weight and are designed to provide essential nutrients in accordance with the manufacturer’s instructions.

The legal regulation of these product categories is based on general food legislation, including laws on food safety, state control, consumer information, and materials that come into contact with food. The importation of such products into Ukraine is allowed only if accompanied by an international safety certificate issued by the competent authority of the exporting country.

These products are not subject to mandatory registration, but prior notification is required — a notice to the competent authority of the intention to place the product on the market. This notification must be submitted at least 10 working days before the product is introduced.

The market operator must ensure that the product’s composition and intended use comply with current legislation. Requirements cover permitted additives, substance restrictions, novel ingredients, and scientific justification of effectiveness. Specific composition requirements for FSMPs are still to be approved by the Ministry of Health.

Labeling of such products must comply with general food labeling requirements: it must include mandatory information, indicate specific consumption instructions, use appropriate measurement units, be in Ukrainian, and not mislead the consumer. While there are no additional national labeling rules for these products at this time, the use of stickers is permitted.

The notification of the intention to place such products on the market must follow the format approved by Order No. 244 of the Ministry of Agrarian Policy. It must be accompanied by a sample label, labeling text, and other documents at the operator’s discretion. If mandatory information on the packaging of an already marketed product is changed, a new notification must be submitted.

Notification is free of charge. The right to sell the product arises once the notification is added to the public registry. Manufacturers or importers bear full responsibility for compliance with safety and quality requirements.

 

Food Safety Management System (HACCP)

Each market operator is required to develop and implement an effective Hazard Analysis and Critical Control Points (HACCP) food safety management system to control all potential hazards in food products.

The requirements for the development, implementation, and use of continuous procedures based on HACCP principles are approved by Order No. 590 of the Ministry of Agrarian Policy and Food of Ukraine dated October 1, 2012.

 

Our Services

We professionally provide regulatory and legalization services for dietary supplements, baby food, food for special medical purposes, and weight control products. Our team possesses the required knowledge, experience, and skills, and our specialists are fluent in English.

We offer:

• Evaluation of product composition with in-depth analysis of its formulation and assessment of compliance with legislation and relevant category;
• Review or development of labeling and instructions for use (leaflet);
• Arrangement of laboratory testing to verify compliance with safety requirements and obtain a product safety report;
• Preparation and submission of notification for placing on the market dietary supplements, baby food, food for special medical purposes, and weight-control products;
• Development and implementation of HACCP / ISO 22000 systems;
• Legal and consulting support for manufacturers and importers.