Placing dietary supplements on the market: the regulatory framework, notification and safety requirements in Ukraine

The dietary supplement market in Ukraine has finally moved away from outdated authorisation mechanisms towards the European model of notification and supervision of market operators. The fundamental regulatory principle is that a dietary supplement is a food product, rather than a medicinal product or a substance subject to separate authorisation.

This means that it is fully subject to the basic requirements of food legislation regarding safety, traceability, the HACCP system and registered facilities — in conjunction with specific rules on dosage, laboratory validation and prior notification to the competent authority.

Status of the transitional period: The deadline for submitting notifications regarding dietary supplements that were already in circulation prior to 27 September 2025, as set out in paragraph 2 of Part 1 of Article 32-2 of the Law of Ukraine No. 771/97-VR, ended on 27 September 2026. At present, the lawful marketing of any dietary supplement is possible only provided that the current notification procedure is followed and the relevant information is included in the public Register for sale to consumers.

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1. Regulatory map: current requirements and their impact on business

Requirement / Scope	A rule in force (a provision of the law)	Implications for business
Market authorisation for the market (notification)	Submission of a notice of intent regarding the first placing on the market to the State Service of Ukraine for Food Safety and Consumer Protection at least 10 working days prior to the placing on the market (Article 32-2 of Act No. 771/97-VR ).	This procedure does not constitute registration of the medicinal product. Its placing on the market is not subject to a separate decision, but sale to the end user is permitted only after a notice has been published in the List.
Power registration	The notification must include the personal registration number of the facility registered under Article 25 of Law No. 771/97-VR ( clause 3, part 2, Article 32-2).	Market operator power (production, storage, distribution) must be entered in the State register of capacities by the time of submission of the notification notification.
Formulation (vitamins and minerals)	Only substances and forms included in the positive lists are permitted; the minimum content in a daily ration is at least 15 per cent of the reference value; maximum doses are determined in accordance with the following hierarchy: EFSA UL → EFSA Safe Level → annexes to the order (Ministry of Health Order No. 1114).	Formulations require a mandatory nutrient audit. It is prohibited to declare ingredients in trace amounts (
Restricted and prohibited substances	Clear limits and specific warnings regarding EGCG in green tea and red yeast rice; a ban on ephedra, yohimbe and certain aloe compounds (Ministry of Health Order No. 1613). A ban on substances found in prescription medicines ( Clause 2.2 of Order No. 1114 ).	A mandatory inspection of complex and plant-based preparations is required prior to import or manufacture. Any breach will result in a direct fine of up to 100 minimum monthly wages.
Labeling	Mandatory disclaimers, name ‘dietary supplement’ (Order of the Ministry of Health No. 1114, Law No. 2639-VIII); prohibition of therapeutic properties (Act No. 270/96-Verkhovna Rada); use of health claims exclusively in accordance with the rules of the Order of the Ministry of Health No. 1145.	Labelling must be approved in the final layout before the notification is submitted. Any visual discrepancies between the packaging on the shelf and the published layout will result in a separate fine.
Laboratory justification	The declared nutrient levels must be based on the manufacturer’s laboratory analyses (paragraph 3.8 of Order No. 1114 ); compliance with standards for pollutants (Order No. 368) and microbiology (Order No. 548).	Tests must be carried out to confirm the actual content of active ingredients and the relevant safety parameters within the framework of HACCP.
Liability	Graduated fines under Article 65 of Law No. 2042-VIII, ranging from 15 to 100 times the minimum wage (MW).	The regulatory body makes a clear distinction between procedural breaches (where a notice is issued for the first time without a report) and safety breaches at the facility (a fine without a notice).

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2. The legal status of dietary supplements and regulatory limits

According to Article 1 of Law of Ukraine No. 771/97-VR, a dietary supplement is defined as a food product that meets all of the following criteria:

1. Intended for consumption in small, specified quantities as a supplement to the normal diet;
2. It is a concentrated source of vitamins, minerals or other substances with nutritional or physiological effects;
3. It is sold in measured doses as pre-packaged food product in forms such as capsules, lozenges, tablets, pills, ampoules containing liquids, vials with drop-type dispensers, sachets or dry/liquid mixtures for measured consumption (Article 32-2(9) of Law No. 771/97-VR ).

⚖️ The boundary with medicinal products: legal classification

• Direct provision: A dietary supplement is not a medicinal product and must not be prescribed for the treatment or prevention of diseases. It is prohibited to include in its composition any substances that are active ingredients in registered prescription medicines (except in cases expressly permitted by the current lists set out in Ministry of Health Order No. 1114).
• Legal opinion: Exceeding the established maximum dose of the active substance does not automatically mean that the product is reclassified as a medicinal product. The direct consequence is a finding that the product does not comply with the requirements for the category of dietary supplements (unlawful marketing of a food product). Any other status of the product is determined separately under the legislation on medicinal products.

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3. The notification procedure and monitoring of the List

The notification procedure is governed by Article 32-2 of Law No. 771/97-VR and Ministry of Agrarian Policy Order No. 244.

Key procedural aspects:

1. Notification period: An operator intending to place a food supplement on the market for the first time must submit a notification to the State Service of Ukraine for Food Safety and Consumer Protection at least 10 working days before placing it on the market (Article 32-2(1) of Law No. 771/97-VR ).
2. The relationship between placing on the market and sale to the end consumer: When placing a dietary supplement on the market for the first time, the operator must duly notify the State Service for Food Safety and Consumer Protection at least 10 working days in advance. Current legislation does not make the placing on the market itself contingent upon a specific decision by the State Service for Food Safety and Consumer Protection or the inclusion of a notification in the List. However, offering a dietary supplement for sale and selling it to end consumers prior to the publication of a notification in the List constitutes a separate administrative offence ( paragraph 5-2 of Part 1 of Article 65 of Law No. 2042-VIII ). Therefore, to ensure a safe commercial launch, the market operator must verify that the product entry has actually appeared in the published register.
3. Contents of the notification package:
   • Identification and contact details of the market operator;
   • The personal registration number of the facility registered in accordance with Article 25 of Law No. 771/97-VR;
   • The name of the dietary supplement and its form;
   • A list of ingredients and the quantity of each ingredient (if the law does not require the quantity of an individual ingredient to be stated on the consumer label, this information is treated as confidential in the notification);
   • A sample of labelling (labels, stickers) in the official language;
   • For certain products from EU/EEA countries where legislation requires registration, authorisation or notification: details of the competent authority and a copy of the relevant document (Article 4, para. 32-2).
4. Pending action: The competent authority checks that the information is complete. If the notification is not correctly completed, it remains pending. If the operator rectifies the deficiencies within the specified time limit, the notification is deemed to have been submitted on the date of its initial submission; however, the time limit for consideration is extended by the time taken to rectify the deficiencies.

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4. Requirements for composition and laboratory control

Formulations are developed exclusively in accordance with the principle of positive regulation:

• Minimum threshold: In accordance with clause 2.4 of Ministry of Health Order No. 1114, the content of each vitamin and/or mineral in the recommended daily amount (portion) must be at least 15 per cent of the reference daily intake. If a component is added in a smaller quantity, it cannot be listed as an active ingredient.
• Maximum level scale: The maximum daily intake of vitamins and minerals is determined according to the priority rule:
  1. The Tolerable Upper Intake Level (Tolerable Upper Intake Level, UL), as approved by the EFSA;
  2. In the absence of a UL — safe level (EFSA Safe Level);
  3. In the absence of both parameters, the limit values set out in the table in the Annex to Ministry of Health Order No. 1114 shall apply.
     For other nutrients or physiological substances, the levels set out in the relevant annexes to Order No. 1114 shall apply.
• Laboratory safety validation: The legislation does not prescribe a single standardised list of laboratory tests (‘four fixed protocols for each SKU’). The scope of analytical control is based on an assessment of hazard factors within the framework of the HACCP system and sector-specific hygiene regulations:
  • Maximum levels of contaminants (lead, cadmium, mercury, mycotoxins, etc.) — as set out in Ministry of Health Order No. 368;
  • Microbiological safety standards — in accordance with Ministry of Health Order No. 548;
  • Mandatory requirement of Ministry of Health Order No. 1114 (sub-clauses 3.5–3.8): The quantitative values of nutrients and other active substances stated on the label must be average values based on the manufacturer’s laboratory tests.

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5. Labelling: what is mandatory and what is a myth

The requirements for labelling are set out in the General Law on Consumer Information (Law No. 2639-VIII) and the specific provisions of Ministry of Health Order No. 1114.

Mandatory specific elements (Ministry of Health Order No. 1114):

• The product name must include the words ‘dietary supplement’;
• The names of categories of nutrients or other substances that characterise the product, or an indication of the nature of such substances;
• Recommended daily intake (portion);
• A warning not to exceed the recommended daily intake;
• A warning that the product should not be used as a substitute for a balanced diet;
• A warning to keep the product out of the reach of children;
• General mandatory information under Law No. 2639-VIII: ingredients, allergen labelling, minimum shelf life (‘best before’) or ‘use by’ date, name and address of the market operator, storage conditions.

🚫 What is NOT compulsory (debunking common misconceptions):

• Myth 1: The phrase ‘Not a medicinal product’ is a universal, mandatory legal requirement.
  Regulatory reality: The current Section III of Ministry of Health Order No. 1114 does not include this phrase in the list of mandatory labelling requirements. Its inclusion is established practice to distinguish the product from the pharmaceutical market, but it is not a direct legal requirement.
• Myth 2: All dietary supplements must carry the warning ‘Not suitable for pregnant women or children’.
  Regulatory reality: There is no universal requirement applicable to all categories. Additional specific warnings regarding pregnancy or age restrictions are only included where this is expressly provided for in the regulations for specific restricted substances (for example, Ministry of Health Order No. 1613) or in the results of a toxicological safety assessment.
• Myth 3: ISO 22000 certification is a mandatory requirement for market access.
  Regulatory reality: It is the market operator’s duty to comply with the hygiene requirements of food legislation, to register the facility in accordance with Article 25 of Law No. 771/97-VR, and to consistently apply procedures based on HACCP principles ( Articles 20 and 21 of Law No. 771/97-VR ). The ISO 22000 standard is a voluntary certification and a commercial advantage, not a requirement for notification.

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6. State supervision and the table of sanctions

Supervision of the distribution sector is carried out by the State Service for Food Safety and Consumer Protection in accordance with the provisions of Law of Ukraine No. 2042-VIII. The current Article 65 provides for targeted fines, the amount of which is calculated on the basis of the established minimum wage (MW).

Paragraph of Article 65 of Law No. 2042-VIII	Elements of an offence	Fine: Legal entities	Fine: Sole trader	Procedure for enforcement (order or fine)
p. 5-1	Breach by the manufacturer of the requirements regarding the provision of information to consumers about dietary supplements	55 minimum wage	45 minimum wage	In the event of a first offence, a notice without a report must be issued. A fine is imposed for failure to comply with the notice.
p. 5-2	Offering for sale or selling to end consumers food supplements that are not included in the published List	45 minimum wage	40 minimum wage	In the event of a first offence, a notice without a report is issued. A fine is imposed only if the offence is not rectified in accordance with the notice.
p. 6-2	Breach of the established requirements regarding the submission of a notification of intent to place a product on the market for the first time	20 minimum wage	15 minimum wage	In the event of a first offence, a notice without a report must be issued.
p. 7-1	Failure to fulfil the obligation to recall or withdraw from circulation dangerous or prohibited additives	50 minimum wage	45 minimum wage	A direct fine for failure to implement response measures in relation to hazardous products.
p. 9-2	Failure by the manufacturer to comply with the specified requirements regarding the content and/or quantity of ingredients/substances	45 minimum wage	40 minimum wage	A straight red card straight away. This clause does NOT provide for exemption from the protocol upon first detection.
p. 10-2	The manufacture of dietary supplements using substances/ingredients not included in the authorised lists	100 minimum wage	95 minimum wage	A straight red card straight away. The maximum financial penalty for using unauthorised raw materials.
p. 10-3	Offering for sale/sale of a food supplement whose labelling, upon visual inspection, does not correspond to the published notice	80 minimum wage	75 minimum wage	A straight red card straight away. Carefully check that the product labelling on the mock-up matches that in the List.

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7. A practical checklist for market operators

Steps for new players (launching an SKU onto the market):

• Check the product’s classification: dosage form, food status, absence of medicinal properties.
• To ensure that a market operator’s capacity (production, distribution, storage) is registered with the State Service of Ukraine for Food Safety and Consumer Protection in accordance with Article 25 of Law No. 771/97-VR.
• Check all ingredients and their chemical compounds against the positive lists set out in Ministry of Health Order No. 1114.
• Check the quantitative parameters: the vitamin and mineral content must be at least 15 per cent of the daily reference intake and within the limits set by the EFSA UL / Safe Level / annexes to Order No. 1114.
• Check that the product does not contain any prohibited plant-based ingredients (Ministry of Health Order No. 1613) or substances included in prescription medicines.
• Design a label layout in accordance with the provisions of Law No. 2639-VIII and Ministry of Health Order No. 1114, and verify the admissibility of health claims in accordance with Ministry of Health Order No. 1145.
• Obtain test reports: confirmation of safety (contaminants as per Order No. 368, microbiology as per Order No. 548) and the quantitative content of active ingredients.
• Submit a notification to the State Service for Food Safety and Consumer Protection at least 10 working days before the product is due to be placed on the market.
• Ensure that the notification has been submitted and published in the public Register of Dietary Supplements before the product is sold to the end consumer.

Actions for existing players (to maintain engagement):

• Check that all items in the active product range are included in the State Service for Food Safety and Consumer Protection’s public list.
• Check that the labelling on the actual packaging matches the design included in the public Register (to avoid penalties under Article 65(10-3) of Law No. 2042-VIII).
• Conduct an audit of online sales (online shops, pharmacy chains, marketplaces): mandatory information must be provided to the consumer before the purchase is made (distance selling under Law No. 2639-VIII), and completely remove any claims regarding therapeutic properties or pain relief.
• Ensure that internal traceability and withdrawal/recall procedures are maintained in accordance with the HACCP system.

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8. How the Alden Group can help

The Alden Group provides professional consultancy and regulatory support to dietary supplement market operators in strict accordance with its official catalogue of services:

• Registration of products with the relevant authorities: audit of the dossier, legal support for the submission of a notification regarding the first placing of a dietary supplement on the market to the State Service of Ukraine for Food Safety and Consumer Protection in accordance with Order No. 244 of the Ministry of Agrarian Policy, and monitoring of the inclusion of information in the public Register.
• Product labelling: assessment and development of consumer labelling in accordance with the requirements of Ministry of Health Order No. 1114 and Law No. 2639-VIII; evaluation of the admissibility of nutritional and health claims in accordance with Ministry of Health Order No. 1145.
• Test report: coordination of studies at accredited testing laboratories to quantitatively confirm the content of active substances and verify safety parameters (toxicants in accordance with Order No. 368, microbiology in accordance with Order No. 548).
• Business licences: assistance with the state registration of a market operator’s facilities (production, storage, distribution) in accordance with Article 25 of Law No. 771/97-VR.
• Quality management system: the design and implementation of mandatory HACCP and traceability procedures for the activities of manufacturers and distributors in accordance with the requirements of Articles 20–22 of Law No. 771/97-VR.
• Technical documentation: the development of technical specifications (TS), technical instructions and product specifications for Ukrainian enterprises.

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Official regulatory sources:

1. Law of Ukraine No. 771/97-VR ‘On the Basic Principles and Requirements for the Safety and Quality of Foodstuffs’ — zakon.rada.gov.ua/go/771/97-вр
2. Order No. 1114 of the Ministry of Health of Ukraine ‘On the Approval of Hygiene Requirements for Dietary Supplements’ — zakon.rada.gov.ua/go/z2231-13
3. Order No. 244 of the Ministry of Agrarian Policy of Ukraine ‘Procedure for submitting a notification of intent to place dietary supplements on the market for the first time’ — zakon.rada.gov.ua/go/z0516-22
4. Law of Ukraine No. 2042-VIII ‘On State Control over Compliance with Food Legislation…’ — zakon.rada.gov.ua/go/2042-19
5. Law of Ukraine No. 2639-VIII ‘On Consumer Information on Foodstuffs’ — zakon.rada.gov.ua/go/2639-19
6. Order No. 1613 of the Ministry of Health of Ukraine ‘Rules on the addition of vitamins, minerals and certain other substances to foodstuffs’ — zakon.rada.gov.ua/go/z0891-20
7. Order No. 1145 of the Ministry of Health of Ukraine ‘Requirements for claims regarding nutritional value and health benefits’ — zakon.rada.gov.ua/go/z0745-20