Dietary Supplements: Requirements for Legalization, Composition, and Labeling

The primary legislative acts governing food products that are manufactured, marketed, 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 Regarding Food Products.”

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.

Additional requirements for dietary supplements are established by Order of the Ministry of Health No. 1114 dated December 19, 2013.

Significant changes to the legalization of dietary supplements have been introduced by 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,” which enters into force on September 27, 2025. This Law establishes a new definition of dietary supplements, a new notification procedure (submission of a notice), and significantly increases liability for violations.

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.

According to the Law of Ukraine “On the Basic Principles and Requirements for Food Safety and Quality” (version dated December 18, 2024), the definition of a dietary supplement is as follows:

Dietary supplement – a food product that:

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

• is manufactured in the form of capsules, lozenges, tablets, 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.

The new 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,” which comes into force on September 27, 2025, introduces a revised definition that aligns with European regulations:

Dietary supplement – a food product that:

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

• is a concentrated source of vitamins, minerals, or other substances with a nutritional or physiological effect;

• is marketed in a measured form as a pre-packaged food product in the form of capsules, lozenges, tablets, sachets, ampoules with liquids, dropper bottles, or in other similar forms of liquids and/or powders.

 

Registration and Authorization of Dietary Supplements

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.

Dietary supplements are not included in this list and therefore are not subject to mandatory state registration.

Certification of food products, including dietary supplements, is not mandatory under the same law.

However, when imported into the customs territory of Ukraine, dietary supplements must be accompanied by an international certificate or other document issued by the competent authority of the country of origin or exporting country.

An international certificate may include:

• a health certificate,
• an international veterinary certificate,
• or another document issued by the competent authority of the country of origin or exporting country that certifies the animal’s health and/or the safety of the food product, feed, hay, straw, or by-product of animal origin (Source: Law of Ukraine “On State Control of Compliance with Legislation on Food Products, Feed, By-products of Animal Origin, Animal Health and Welfare”). 

The new Law of Ukraine “On Amendments to Certain Laws…” introduces a mandatory notification procedure for dietary supplements. The market operator (manufacturer or importer) must submit a notification to the competent authority in paper or electronic form about the intention to place a dietary supplement on the market for the first time.

This notification becomes mandatory for all dietary supplements that are already on the market or will be introduced after September 27, 2025.

The market operator gains the right to place the product on the market from the date the notification is entered into the public list of notifications.

The circulation of dietary supplements is prohibited if no notification regarding the first placement on the market has been submitted.

 

Requirements for the Composition of Dietary Supplements

Before making a decision to place a dietary supplement on the market, it is necessary to ensure that its composition, intended use, and daily intake of substances with nutritional or physiological effects comply with the requirements of national legislation.

These requirements include:

• the use of vitamins and minerals, including their forms and minimum/maximum levels;
• the use of food additives and their maximum concentrations in dietary supplements;
• the use of substances prohibited or restricted in food products;
• the inclusion of novel food ingredients in dietary supplements;
• the intended purpose of the dietary supplement;
• the defined age group of consumers.

The list of permitted substances is established by relevant orders of the Ministry of Health of Ukraine and other legislative acts.

 

Labeling and Advertising Requirements for Dietary Supplements

National legislation also sets requirements for the labeling of dietary supplements, which include:

• the list of mandatory information;
• voluntary information;
• language of labeling;
• minimum font size for required information;
• rules for information placement on the packaging;
• mandatory warnings that must appear on dietary supplement labels;
• requirements for nutrition and health claims;
• use of measurement units, rounding rules, and numerical presentation;
• and other provisions.

Information provided to consumers must be accurate, truthful, and clear, and must not mislead.

The legislation also regulates the advertising of dietary supplements. As these products are classified as food, their advertising and labeling must not include:

• claims of possible therapeutic effects or pain relief;
• testimonials, endorsements, or advice related to treatment or alleviation of disease symptoms;
• references to such claims;
• phrases that cause or reinforce a negative emotional state.

The Law of Ukraine “On Advertising” explicitly prohibits any reference to medicinal properties of dietary supplements.

Market operators bear full responsibility for compliance with safety and specific quality indicators, including the correct labeling of dietary supplements, within the scope of their operations.

Since late 2023, the Antimonopoly Committee of Ukraine (AMCU) has paid special attention to dietary supplements, particularly their labeling and advertising claims. The AMCU has imposed several fines—some up to UAH 9 million (~220 000 Euro) — for violations of the law. 

These violations were qualified under Article 151 of the Law of Ukraine “On Protection Against Unfair Competition” as dissemination of misleading information by attributing medicinal properties to dietary supplements.

Most cases analyzed by the AMCU involved claims that equated dietary supplements with medicinal products, such as:

• “For cough”;
• “Expectorant action”;
• “Helps lower cholesterol”;
• “Reduces risk of thrombosis”;
• “Normalizes blood glucose levels”;
• “Supports vascular elasticity,” etc.

The AMCU treats such statements as health claims, which must comply with legislative requirements.

 

Food Safety Management System (HACCP)

Market operators of dietary supplements must develop and implement an effective Hazard Analysis and Critical Control Points (HACCP) food safety management system to control all potential hazards in the product.

The requirements for the development, implementation, and application 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.