Ministry of Health of Ukraine issued Order No. 203 introducing extensive amendments to dietary supplement, nutrition claim, health claim, and food fortification regulations.
The changes aim to harmonize Ukrainian food legislation with European Union requirements, particularly for dietary supplements, novel foods, food additives, and health claims.
Key updates include:
1.Clarification that dietary supplement regulations do not apply to medicinal products.
2.Only vitamins, minerals, and other substances specifically permitted under the updated annexes may be used in dietary supplements.
3.Novel foods authorized in the EU may be used in supplements if they comply with Ukrainian legal requirements and EU registration conditions.
4.Food additives, flavorings, and food enzymes used in supplements must comply with Ukraine’s updated food legislation and corresponding EU-aligned standards.
5.Introduction of maximum daily limits for certain vitamins, including:
Vitamin B1: 100 mg
Vitamin B2: 40 mg
Vitamin B12: 100 μg
Vitamin C: 1000 mg
Vitamin K: 200 μg
6.Maximum vitamin and mineral levels in supplements must not exceed EFSA-established Tolerable Upper Intake Levels (ULs) or safe intake levels.
7.New permitted ingredient forms added, including:
Calcifediol monohydrate
Nicotinamide riboside chloride
Magnesium L-threonate
Chromium-enriched yeast
Organic silicon (monomethylsilanetriol)
8.Certain ingredients were recognized as novel foods.
9.Introduction of a new annex listing other substances with nutritional or physiological effects permitted for supplement use.
10.Updated labeling and advertising rules prohibit disease treatment, prevention, or cure claims for dietary supplements.
11.Health claims may only be used if compliant with Ukrainian legislation and corresponding EU-authorized claims.
12.New authorized health claim introduced for carbohydrate solutions supporting endurance performance during high-intensity exercise in trained adults.
Updated claims for EPA/DHA, magnesium, zinc, and protein.
13.Revised “No Added Sugar” claim requirements.
14.New restrictions introduced for:
Green tea extracts containing EGCG
Red yeast rice monacolins
15.Certain substances are now prohibited in foods, including:
Aloe-emodin
Emodin
Danthron
Ephedra preparations
Yohimbe bark preparations
16.Updated definitions and classification requirements for dietary supplement dosage forms, including tablets, gummies, chewables, powders, effervescent tablets, capsules, and soft gels.
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