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February 4, 2016

Hygienic requirements for dietary supplements

On 24 January 2016, the Order of the Ministry of Health of Ukraine No. 1114 dated 19 December 2013 «On approval of Hygienic requirements for dietary supplements» became effective. This Order establishes requirements for dietary supplements, their labelling and advertising, and also provides for the lists of vitamins and minerals and their forms, which are allowed for use in dietary supplements.

Thus, in particular, it is established that dietary supplements shall contain a wide range of nutrients and other ingredients, including vitamins, minerals, amino acids, essential fatty acids, fibre, various plants and herbal extracts. The minimal amount of each vitamin and/or mineral in the recommended daily amount of dietary supplement shall be not less than 15% of the recommended daily amount of consumption (daily need) of the vitamin and/or mineral.

Dietary supplements shall be delivered to the final consumer exclusively in the dosage form and packed with the label, which specifies: the name of a food product; the name of the individual categories of nutrients or other substances that characterize the product or indicate the origin of individual nutrients or other substances; quantity (portion) of dietary supplement recommended for daily consumption; warning not to exceed the recommended amount (portion) for daily consumption; indication that dietary supplements should not be a substitute for balanced diet; warning that the product should be stored out of reach of children.

In addition, it is prohibited to use statements about the possible healing effect or those which cause or contribute to the occurrence of negative psychological state of feeling, publish information about letters of gratitude, recognition, tips, if they are related to treatment or relief of disease conditions, as well as any direct or indirect (veiled) statements on impossibility to ensure the necessary amount of nutrients by following the balanced diet on the label or in any other advert of dietary supplements.

The operators of the market shall have the means to identify a person, who is responsible for delivering dietary supplement, and also have systems and procedures in place for identifying other operators of the market, to which they supply their products. It should be possible to trace dietary supplements and any substances therein at all stages of production and circulation of dietary supplements.

Dietary supplements that do not comply with the Hygienic requirements and are produced and/or circulated within 12 months following the effective date of the Order shall remain in circulation in Ukraine until their expiration date.

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