On March 27, 2025, the Law of Ukraine "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Dietary Supplements, and Regulating Other Issues in the Field of Health Care" dated December 5, 2024 No. 4122-IX came into force - what additional powers do state bodies now have, when does the law come into effect, what amount of fines are possible and for what?
On March 27, 2025, the Law of Ukraine dated 05.12.2024 No. 4122-IX "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Dietary Supplements, and on Regulating Other Issues in the Field of Health Care" came into force. Due to the wide circulation of such products in Ukraine and growing consumer demand, the legislator tightened the requirements for their production, labeling, and sale.
This Law amends, in particular, the laws of Ukraine "On Basic Principles and Requirements for the Safety and Quality of Food Products" and "On State Control over Compliance with Legislation on Food Products, Feed, Animal By-Products, Animal Health and Welfare."
Powers of state authorities regarding the circulation of dietary supplements
- Amendments have been made to Article 6 of the Law of Ukraine "On Basic Principles and Requirements for the Safety and Quality of Food Products. The Ministry of Health approves, in particular:
- the procedure and methodology for assessing the impact on human health of vitamins, minerals and other substances and their maximum permissible doses in food products offered for sale as dietary supplements;
- a list of vitamins, minerals and other substances and their maximum permissible doses permitted for use in dietary supplements.
The Ministry of Health is also authorized to make changes to:
- list of permitted substances (vitamins, minerals and other substances);
- maximum permissible doses permitted for use in dietary supplements.
Such changes are made on the basis of a positive assessment of the effects on human health of vitamins, minerals or other substances and their maximum permissible doses in foodstuffs offered for marketing as a dietary supplement.
- Business entities that intend to place a dietary supplement on the market for the first time are required to notify the State Service for Food and Consumer Protection (hereinafter also referred to as the competent authority) of their intention to place the dietary supplement on the market by sending a notification in paper or electronic form no later than 10 working days prior to placing it on the market. The procedure for such notification will be approved by the State Service for Food and Consumer Protection.
If violations are detected (for example, if the company did not indicate the name or form of the dietary supplement in the notification), the competent authority leaves the notification without action, informing the business entity in accordance with the established procedureIf the deficiencies are eliminated within the deadline, the notification shall be deemed to have been submitted from the date of initial submission. The competent authority shall, within 10 working days from the date of receipt of the notification, enters information about a dietary supplement, except for confidential information, to the list of notifications of the intention to first place on the market of baby food, dietary supplements, foods for special medical purposes and foods for weight control.
If the deficiencies are not eliminated within the period established in the written notification of leaving the application without action, the notification of the intention to place the dietary supplement on the market shall not be included in the list of notifications of the intention to place baby food, dietary supplements, foods for special medical purposes and foods for weight control on the market, as stated in The State Service for Food and Consumer Protection informs the business entity within five working days..
The State Food and Consumer Protection Service will have the authority to maintain and publish on its official website, free of charge, a list of notifications of the intention to first place baby food, dietary supplements, foods for special medical purposes, and foods for weight control.
Liability for violations in the field of dietary supplements and food additives
If violations are detected, penalties may be applied to business entities.
Entrepreneurs will be liable, in particular, for the following offenses:
1) violation by a market operator engaged in the production of dietary supplements of the requirements established by law regarding the provision of information to consumers regarding dietary supplements is punishable by a fine: 440,000 UAH – for legal entities, 360,000 UAH – for sole proprietors.
2) offering for sale or sale of dietary supplements, the notification of the intention to first introduce of which is not included in the list of notifications of the intention to first introduce into circulation of baby food, dietary supplements, foods for special medical purposes and foods for weight control published by the competent authority, is punishable by a fine: 360,000 UAH – for legal entities, 320,000 UAH – for sole proprietors.
3) violation of the requirements for sending a notification of the intention to place food supplements on the market, provided for in clause 5-1 Part 2 of Article 20 of the Law of Ukraine “On Basic Principles and Requirements for the Safety and Quality of Food Products” is punishable by a fine: 160,000 UAH – for legal entities, 120,500 UAH – for sole proprietors
4) failure to comply with the obligation to recall or withdraw from circulation dietary supplements prohibited for sale by the competent authority and/or recalled by the market operator who placed them on the market is punishable by a fine: 400,000 UAH – for legal entities, 360,000 UAH – for sole proprietors
5) violation by a market operator producing dietary supplements of the requirements established by law regarding the content and/or quantity of ingredients and/or substances in dietary supplements is punishable by a fine: 360,000 UAH – for legal entities, 320,000 UAH – for sole proprietors
6) the production of dietary supplements containing substances and/or ingredients not included in the list of vitamins, minerals and other substances and their maximum permissible doses permitted for use in dietary supplements is punishable by a fine: 800,000 UAH – for legal entities, 760,000 UAH – for sole proprietors
7) offering for sale or sale of dietary supplements, upon visual inspection of which the content of the labeling does not correspond to the notification published by the competent authority in the list of notifications of the intention to first place on the market of baby food, dietary supplements, foods for special medical purposes and foods for weight control, is punishable by a fine: 640,000 UAH – for legal entities, 600,000 UAH – for sole proprietors.
Law No. 4122-IX of December 5, 2024 will enter into force on September 27, 2025.
Importantly! Dietary supplements that met the old requirements for providing consumers with information about food products, as well as regarding safety and certain quality indicators, but do not meet the new rules regarding the requirements for dietary supplements, may, within a year after the new law enters into force (after March 27, 2025):
- be imported into the customs territory of Ukraine,
- to be produced,
- to be put into circulation.
Such dietary supplements may be in circulation until the minimum shelf life or "use by" date, but not longer than three years from March 27, 2025.
In addition, market operators are required to submit to the State Service for Food Safety and Consumer Protection a notification of the intention to first place a dietary supplement on the market that was in circulation on the territory of Ukraine before the entry into force of Law No. 4122-IX and is planned to be put into circulation after the entry into force of this Law within six months from March 27, 2025.
So, The Law of Ukraine "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Dietary Supplements, and on Regulating Other Issues in the Sphere of Health Care" dated 05.12.2024 No. 4122-IX, which entered into force on March 27, 2025, significantly strengthens control over the circulation of dietary supplements in Ukraine and expands the powers of state bodies in this area.
In addition, the innovations determine the amount of fines for legal entities and individual entrepreneurs for violating labeling requirements, providing information to consumers, violating requirements for the composition of dietary supplements, etc. Such changes are aimed at ensuring greater safety for consumers and increasing the efficiency of control by competent authorities over products on the market.
Source: Quality management.
