New Requirements for Dietary Supplements Effective from September 27, 2025

On December 5, 2024, 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. The law defines clear mechanisms for placing dietary supplements on the market, establishes specific requirements for such products, and strengthens liability for violations of food safety legislation.

The Law introduces a transitional period:

• The Law enters into force six months after its adoption, i.e., on September 27, 2025.
• Market operators must, before the Law takes effect, submit a notification to the competent authority regarding the first placement on the market of dietary supplements that are already on the market and are planned to be marketed after September 27, 2025.
• Dietary supplements that do not meet the new legal requirements may still be imported into the customs territory of Ukraine, manufactured, and placed on the market for one year after the Law became effective — provided that they comply with existing legislation concerning consumer information and food safety and quality indicators. Such dietary supplements may remain on the market until the end of their minimum shelf life or “use by” date, but no longer than three years from the date the Law comes into force.

The Law also strengthens the liability of market operators for non-compliance with legislative requirements regarding dietary supplements and introduces additional fines.

The new Law introduces a revised definition of dietary supplement that is fully aligned with European legislation:

Dietary supplement – a food product that:

• is intended to be consumed in small, measured quantities as a supplement to the normal diet, either alone 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.

Additionally, the Law requires the Ministry of Health of Ukraine (MoH) to approve:

• the procedure and methodology for assessing the impact of vitamins, minerals, and other substances on human health, as well as the maximum allowable levels in food products intended to be marketed as dietary supplements;
• the list of vitamins, minerals, and other substances along with their maximum permitted levels approved for use in dietary supplements.

Notification (Registraiton) Procedure 

The Law establishes specific requirements for dietary supplements, obligating all market operators to submit a notification of the intention to place a dietary supplement on the market at least 10 working days in advance, following the procedure established by the central executive authority responsible for food safety and quality.

The notification may be submitted in paper or electronic form and must include the following information:

• Name of the dietary supplement;
• Information about the market operator (manufacturer or importer);
• Personal registration number of the production facility;
• Form of the dietary supplement;
• List of ingredients and the quantity of each ingredient (the competent authority must ensure protection of confidential information);
• Contact details of the person responsible for submitting the notification.

A sample label or sticker in the official state language (Ukrainian) must be submitted along with the notification.

Within 10 working days of receiving the notification, the competent authority shall enter the relevant information (excluding confidential data) into the public register of notifications of intention to place a dietary supplement on the market.

Submission of the notification and its inclusion in the register are free of charge.

The market operator obtains the right to place the dietary supplement on the market from the date the notification is entered into the register of first-intention notifications.

Under the new Law, dietary supplements may only be placed on the market and sold to end consumers as pre-packaged food products.

The circulation of dietary supplements without notification of first market placement is prohibited.

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.