Hygiene requirements for dietary supplements , approved by the Ministry of Health of Ukraine on the 19.12.2013 with Decree No 1114 (hereinafter “hygiene requirements” and “Decree” respectively) entered into force on the 24th January.
Hygiene requirements exclusively concern dietary suppements and do not apply to medicinal products, functional foods and special dietary foods.
Therefore, the Order defines the basic requirements , requirements for labeling and advertising of dietary supplements , as well as a list of vitamins and minerals approved for use in the manufacture of dietary supplements
Hygienic requirements set requirements for the content of dietary supplements, in particular, the latter indicate that for the production of dietary supplements vitamins and minerals listed in Annex 1 of the hygiene requirements may be used, in the form specified in Annex 2 to the hygienic requirements. Quality criteria for nutrients used for the production of dietary supplements must comply with the requirements of Ukrainian legislation and in their absence - standards established by the Codex Alimentarius Commission. It is interestingto note that the Codex Alimentarus Comission itself was abolishe in September 2015 , in accordance with the Cabinet of Ministers' Resolution No 692 dating 08.09.2015.
In addition to the basic requirements for the content of dietary supplements , the Order provides that market operators whose activities are related to dietary supplements should be able to identify the person who has supplied the dietary supplement , or any substance intended to enter into the dietary supplements , and have systems and procedures for the establishment of other market operators , to whom they supply their products .Therefore dietary supplements introduced into circulation must be properly labeled in order to facilitate the possibility of their tracking with the appropriate documentation . The opportunity to track dietary supplements and any substance intended to be administered in dietary supplements should be ensured at all stages of production and circulation.
The marking, as well as advertising of dietary supplements should not contain statements on the possible beneficial effects, pain relief; letters of appreciation, recognition, tips, if they are related to treatment or alleviation of the conditions of the disease, as well as links to such information; statements that cause or contribute to the emergence of negative feelings of psychological state; any direct or veiled form that allegations that a full diet can not provide the necessary for the human body of nutrients.
Despite the fact that the Hygiene requirements have already taken effect , the Decree provides that the dietary supplements , which do not meet hygiene requirements and are manufactured and / or put into circulation not later than 12 months from the date of the Decree's entry into force , remain on the market of Ukraine until the expiry of their validity.
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