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Ministry of Justice of Ukraine

December 27, 2013

No. 2231/24763

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of December 19, 2013 No. 1114

About approval of Hygienic requirements to dietary additives

According to subitem 7.1 of the subitem 7 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, subitem 89.1.16 of subitem 89.1 of Item 89 of the Section VI of the National plan of action for 2013 concerning the implementation of the Program of economic reforms for 2010-2014 "Rich society, competitive economy, the effective state" approved by the Presidential decree of Ukraine of March 12, 2013 No. 128, taking into account the Directive of the European Parliament and the EU Council 2002/46/EU of June 10, 2002 PRIKAZYVAYU:

1. Approve Hygienic requirements to dietary additives which are applied.

2. To provide to management of public health (A. Grigorenko) submission of this order in the procedure established by the legislation on state registration in the Ministry of Justice of Ukraine.

3. This order becomes effective in two years from the date of its official publication.

4. The dietary additives which are not meeting the requirements of the Hygienic requirements to dietary additives approved by Item 1 of this order, and made and/or introduced into circulation not later than in 12 months from the date of entry into force remain in market circulation of Ukraine before the termination of term of their validity.

5. To impose control of execution of this order on the First Deputy Minister A. Kachur.

Minister 
G. Bogatyreva

It is approved:

President of National academy of medical sciences of Ukraine 

 

A. Serdyuk

Approved by the Order of the Ministry of Health of Ukraine of December 19, 2013 No. 1114

Hygienic requirements to dietary additives

I. General provisions

1.1. These Hygienic requirements are applied to dietary additives.

1.2. Dietary additives may contain wide range of nutrients and other ingredients, including vitamins, minerals, amino acids, irreplaceable fatty acids, cellulose, various plants and extracts of herbs.

1.3. These Hygienic requirements are not applied to medicines, functional foodstuff and foodstuff to special dietary consumption.

1.4. In these Hygienic requirements the term "separate nutrients" means set of vitamins and/or mineral substances.

Other terms in these Hygienic requirements are used in the values given in the Law of Ukraine "About safety and quality of foodstuff".

II. Requirements to dietary additives

2.1. Dietary additives shall be implemented (to be offered) the final consumer only in dosage form and in packed form.

2.2. For production of dietary additives the vitamins and minerals given in appendix 1 to these Hygienic requirements in the forms determined in appendix 2 to these Hygienic requirements can be used.

Changes and amendments    are brought in appendices 1 and 2 according to the recommendation of the National commission of Ukraine about the Code Alimentarius which considers the specified questions on the basis:

1) the provided information on introduction of corresponding changes and amendments to the European Union law;

2) scientific reasons and the prepared report (file) according to recommendations (methodical documents) of relevant international organizations.

Other substances which characterize product or are specified their origin, can be used for production of dietary additives by modification of these Hygienic requirements according to the recommendation of the National commission of Ukraine about the Code Alimentarius.

2.3. Criteria of quality for the nutrients used for production of the dietary additives including determined by appendix 2 to these Hygienic requirements shall conform to requirements of the legislation of Ukraine, and in case of their absence - according to the standard rates established by the Commission of the Code Alimentarius.

2.4. Minimum content of each vitamin and/or mineral substance in recommended daily amount (portion) of dietary additive shall make at least 15% of the recommended (referensny) daily number of consumption (daily requirement) of vitamin and/or mineral substance.

2.5. The maximum content of separate nutritious or other substances which characterize product or which specify their origin shall be evidence-based and be established, proceeding from:

1) the safest levels established by scientific risk assessment based on scientific data taking into account if it is necessary, different degree of sensitivity at different customer groups;

2) intake of nutrients from other power supplies;

3) regulations of physiological needs of the population for the main feedstuffs.

Any excess of content of each nutrient in recommended daily amount of dietary additive shall be proved by the operator of the market whose activities are connected with dietary additives, in the course of registration of such dietary additive, but cannot reach therapeutic dose and/or triple value of regulation.

2.6. If the legislation of Ukraine, the Commission of the Code Alimentarius do not establish requirements to criteria of quality, the minimum and maximum content of nutrient, such substance can be added to dietary additive only after its approval in the procedure established by the legislation.

2.7. Operators of the market whose activities are connected with dietary additives on all production stages and addresses shall provide compliance of dietary additives to requirements of the legislation of Ukraine on foodstuff.

2.8. The possibility of tracing of the dietary additives and any substances intended for introduction in dietary additives shall be provided at all production phases and addresses.

Operators of the market whose activities are connected with dietary additives shall have opportunity to identify person who delivered dietary additive or any substance intended for introduction in dietary additives and to have systems and procedures for establishment of other operators of the market to whom they deliver the products.

The dietary additives introduced into circulation shall be properly labeled for simplification of possibility of their tracing through the corresponding documentation or information in the procedure established by the legislation.

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