Ukraine has proposed amendments to food and feed labelling regulations and revised food and dietary supplement standards, including updated health impact assessment procedures for supplements.
Ukraine Updates Food Labelling and Supplement Safety Rules
New rules require clearer labels and set safety limits for supplements.
What changed
Food labelling requirements updated for better product disclosure and ingredient transparency.
Product classification revised for food and dietary supplements, affecting compliance obligations.
Health impact assessment introduced for vitamins, minerals, and other substances in dietary supplements.
Maximum permissible doses established for dietary supplements to ensure consumer safety.
Who it affects
Food producers and importers must update product labels to meet new disclosure standards.
Dietary supplement manufacturers must comply with new safety thresholds and health impact assessments.
Retailers must ensure products on shelves meet the updated labelling and safety requirements.
Consumers will benefit from clearer product information and safer dietary supplements.
Compliance Analysis: Ukraine’s Proposed Amendments to Food and Feed Labelling Regulations and Dietary Supplement Standards
Direct Answer
Ukraine is introducing a health impact assessment procedure for vitamins, minerals, and other substances in dietary supplements, alongside revisions to labelling requirements and permitted substance lists. These changes aim to align terminology with EU scientific standards, establish maximum permissible doses, and clarify safety assessments under the Hygienic Requirements for Dietary Supplements (Order No. 1114)1. The amendments will enter into force upon adoption or by 27 September 2025, contingent on the enactment of Law No. 4122-IX2.
Regulation Analysis
1. Health Impact Assessment Procedure for Dietary Supplements
Ukraine currently lacks a formalized process to evaluate the safety of vitamins, minerals, and other substances in dietary supplements. The proposed Draft Order of the Ministry of Health introduces:
- A methodology for assessing human health impacts, including maximum permissible doses2.
- A List of permitted substances (vitamins, minerals, and other compounds) with defined thresholds2.
- Key requirements:
- Substances must undergo hazard analysis based on scientific evidence (e.g., EFSA conclusions)1.
- Maximum permissible daily levels will be set for hesperidin (70 mg), flavonoids (1 g, except Glycyrrhiza glabra-derived flavonoids, classified as novel foods), and other compounds1.
- Proanthocyanidins are redefined as oligo-proanthocyanidins without a separate daily intake limit1.
Authority: Ministry of Health of Ukraine2. Timeline: Entry into force on 27 September 2025 (or upon official publication if delayed)2.
2. Revisions to Dietary Supplement Standards
A. Updated Substance Lists
The amendments revise Annex 3 of Order No. 1114 (Hygienic Requirements for Dietary Supplements) to:
- List I (Plants, Algae, Fungi):
- List IV (Substances with Nutritional/Physiological Effects):
B. Terminology Alignment
- Replace "daily intake" with "acceptable daily intake" and "maximum permissible levels" to align with Ukrainian legislation1.
- Adopt EFSA scientific conclusions for substance classifications (e.g., oligo-proanthocyanidins)1.
3. Labelling and Consumer Information
The revisions address:
- Nutrition and health claims: Governed by Order No. 1145 (2020), which remains in force but may be updated to reflect new substance lists1.
- Risk minimization: Amendments aim to prevent dietary supplements from being misperceived as medicines1.
- Warnings: Mandatory for certain plants (e.g., Glycyrrhiza glabra)1.
4. Compliance Timeline and Stakeholder Engagement
| Milestone | Details | Authority | Citation |
|---|---|---|---|
| Public Consultation | 60-day comment period ending 16 November 2025 (SPS) or 15 March 2026 (TBT) | Ministry of Economy / Cabinet of Ministers | 2,1 |
| Adoption | To be determined; draft Order pending finalization | Ministry of Health | 2 |
| Entry into Force | 27 September 2025 (if aligned with Law No. 4122-IX) or upon publication | Ministry of Health | 2 |
Stakeholder Submissions: Comments may be submitted to:
Summary Answer
Ukraine’s proposed amendments introduce a health impact assessment procedure for dietary supplements, including maximum permissible doses for vitamins, minerals, and other substances2. Key changes include:
- Updated substance lists (e.g., hesperidin: 70 mg/day, flavonoids: 1 g/day) and terminology alignment with EU scientific standards1.
- Revised labelling requirements to prevent misclassification as medicines1.
- Entry into force by 27 September 2025, contingent on Law No. 4122-IX2.
Stakeholders may submit comments until 16 November 2025 (SPS) or 15 March 2026 (TBT)1,2. The Ministry of Health retains authority over implementation1,2.
Sources
- ↩ Committee on Technical Barriers to Trade – Notification – Ukraine – Food and dietary supplements – Revision https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/UKR349R2.pdf&Open=True
- ↩ Committee on Sanitary and Phytosanitary Measures – Notification – Ukraine – Dietary supplements https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/SPS/NUKR254.pdf&Open=True