The draft Law of Ukraine "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Food Supplements" (hereinafter - the Draft Law/Law) introduces new definition of the term "food supplements", establishes the procedure for providing notices on introduction of food supplements into circulation, provides for the authority of the Ministry of Health of Ukraine to approve the list of vitamins and mineral substances, as well as other substances and their maximum permissible doses, which are allowed for use in food supplements, imposes responsibility for the production and sale of food supplements that do not meet the requirements.
The draft Law establishes special requirements for food supplements, in particular the following:
• a market operator who intends to introduce a food supplement into circulation for the first time shall notify the competent authority about such intention by sending a notifice at least ten working days before circulation of the food supplement in question;
• food supplements can be introduced into circulation, offered for sale and sold to the final consumer exclusively as a pre-packaged food products;
• only substances included in the list of vitamins, mineral substances and other substances and their maximum permissible doses allowed for use in food supplements can be used for the production of food supplements, in compliance with the maximum permissible doses established by the specified list to be approved by the Ministry of Health of Ukraine.
It should be noted that food supplements that met the requirements of the legislation prior to the entry into force of the Law may be imported into the customs territory of Ukraine within one year from the date of entry into force of the Law. Such food supplements can be in circulation before the expiry date.
Within six months from the date of entry into force of the Law, the following acts shall be developed or amended to implement the provisions of the Law:
• Order of the Ministry of Health of Ukraine on the approval of the procedure and methodology for assessing the impact of vitamins, minerals or other substances and their maximum permissible doses in food products, which are offered for introduction into circulation as food supplements, on human health;
• Order of the Ministry of Health No. 1114 "On the approval of Hygienic Requirements for Dietary Supplements" of 19 December 2013;
• Order of the Ministry of Agrarian Policy No. 244 "On the approval of the Procedure for sending a notice of the intention to introduce baby food, food products for special medical purposes and food products for weight control into circulation, as well as maintaining and publishing a list of such notifices" of 25 April 2022. Within six months from the date of entry into force of the Law market operators shall submit to the competent authority a notice of the intention to introduce into circulation for the first time a food supplement that was in circulation on the territory of Ukraine as a dietary supplement before the entry into force of the Law and is planned to be put into circulation after its entry into force.
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