The draft Order has been developed to improve the regulatory framework governing the production and circulation of dietary supplements and food products containing added vitamins and minerals with a view to ensuring alignment with European Union legislation and harmonizing the terminology used therein with the legislation on food safety and certain quality indicators.
The draft Order proposes amendments to:
Hygiene Requirements for dietary supplements, approved by the Order of the Ministry of Health of Ukraine No. 1114 of 19 December 2013;
Requirements for nutrition and health claims made on food products, approved by the Order of the Ministry of Health of Ukraine No. 1145 of 15 May 2020;
Rules on the addition of vitamins, minerals and certain other substances to foods, approved by the Order of the Ministry of Health of Ukraine No. 1613 of 16 July 2020 (notified in documents G/SPS/N/UKR/147, G/SPS/N/UKR/147/Add.1);
Requirements for Food Flavours, Requirements for Food Additives and Requirements for Food Enzymes, approved by the Order of the Ministry of Health of Ukraine No. 45 of 8 January 2024 (notified in document G/SPS/N/UKR/200/Rev.1/Add.1).
The latter has been added compared to the previous version of the draft Order, notified in document G/SPS/N/UKR/246.
It is also established that dietary supplements, which complied with the requirements in force prior to the entry into effect of this Order, but do not comply with the requirements of the Law of Ukraine No. 4122-IX of 5 December 2024 "On Amendments to Certain Laws of Ukraine on Improving the Regulation of Production and Circulation of Food Supplements, and the Regulation of Other Issues in the Healthcare Sphere" (notified in documents G/SPS/N/UKR/224 and G/SPS/N/UKR/224/Add.1), may be imported into the customs territory of Ukraine, manufactured and/or placed and remain on the market for one year after the entry into force of this Law. Such dietary supplements may remain on the market until the date of minimum shelf life or use-by date, but no longer than three years from the date of entry into force of this Law.
The Law of Ukraine No. 4122-IX of 5 December 2024 came into force on 27 March 2025.
The draft Order is also notified under the TBT Agreement.
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