," Ukrainian Ministry of Health proposed amendments to the national health requirements for dietary supplements and opened the draft regulation for public feedback for a period of 15 days. The proposed revisions aim to align Ukraine’s dietary supplement framework more closely with European Unionan Union scientific standards and strengthen consumer protection.
Under the proposal, the maximum content of vitamins and minerals in the recommended daily intake of dietary supplements must not exceed the tolerable upper intake levels (ULs) established by the European Unionan Food Safety Authority (EFSA). Where EFSA has not set a UL, products must comply with EFSA-recommended safe intake levels.
The draft amendments also introduce stricter rules on labelling and advertising. Dietary supplement labels and promotional materials must not include claims related to therapeutic effects, pain relief, or the prevention, treatment, or cure of diseases. In addition, testimonials, recommendations, or expressions of gratitude associated with disease treatment are prohibited, as is language that may cause fear of health deterioration if the product is not consumed.
A significant component of the proposal is the introduction of a new list of 874 permitted plants, algae, and fungi for use in dietary supplements, along with specific conditions of use and warnings. For example, products containing Ural licorice must not exceed 100 mg of glycyrrhizic acid per recommended daily intake and must carry a warning stating that continuous use beyond six weeks requires medical supervision and that use is prohibited for individuals under 18 years of age.
The proposal further adds six new sources of substances with nutritional or physiological effects. For substances derived from oyster meat and shells, labels must include an allergen warning indicating that the product may cause allergic reactions.
In addition, the draft regulation establishes maximum daily intake levels for 47 amino acids, such as L-alanine, which would be capped at 3.2 grams per day. It also sets intake limits for 249 substances with nutritional or physiological effects, including a restriction that 2’-fucosyllactose in dietary supplements intended for children aged 1 to 3 years must not exceed 120 grams per day.
Finally, new usage regulations for three restricted substances are proposed. In particular, dietary supplements containing red yeast rice must have a monacolin content below 3 mg per daily serving. Labels must specify the number of servings corresponding to the maximum daily intake, include a warning that daily monacolin intake must not exceed 3 mg, and state the monacolin content per serving.
If adopted, these amendments would introduce comprehensive changes affecting formulation, labelling, advertising, and market access for dietary supplements in Ukraine."
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