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Registered by the

in the Ministry of Justice

Ukraine

On December 16, 1996 No. 715/1740

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 23, 1996 No. 222

About approval of Health regulations and regulations on use of nutritional supplements

(as amended of the Order of the Ministry of Health of Ukraine of 23.07.1998 No. 218)

According to item 4 of the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of August 12, 1992 N 469, I ORDER:

1. Approve Health regulations and regulations on use of nutritional supplements (are applied).

2. To deputy chief state health officers of Ukraine, the Chief state health officers of the Autonomous Republic of Crimea, areas, cities of Kiev and Sevastopol, on water, rail, air transport, the Ministries of Defence of Ukraine, the Ministry of Internal Affairs of Ukraine, the State committee on cases of protection of frontier of Ukraine, National guard of Ukraine, the Security Service of Ukraine to accept the specified Health regulations to management and application when implementing the state sanitary and epidemiological surveillance.

2. Consider N 1922-78 which are not operating in the territory of Ukraine Health regulations on use of nutritional supplements of 29.09.78.

3. I reserve control of execution of the order.

 

The main state

health officer of Ukraine,

First Deputy Minister V. MARIYEVSKY

Approved by the order of the Ministry of Health of Ukraine of July 23, 1996 No. 222

Health regulations and regulations on use of nutritional supplements

I. General part

1. Nutritional supplements - natural or synthesized substance which are intentionally entered into food for the purpose of provision of necessary properties by it (for example, organoleptic, technological) and are not used independently in the form of foodstuff or regular components of food. Nutritional supplements can remain in foodstuff in full or in the form of substances which are formed after chemical interaction of additives with components of food.

2. These Health regulations and regulations on use of nutritional supplements (further - the SanPiN) do not extend to the polluting third-party substances (contaminants) which unintentionally get to food on time of cultivation of plants and animal or agrotechnical and veterinary actions in case of production, conversion, preparation, packing, storage, transportation and realization of foodstuff owing to contact with the equipment, container, external environment; and also on live microorganisms, their toxins, mechanical additives.

3. According to the sanitary legislation of Ukraine production, application and the realization of nutritional supplements in the territory of the state shall be enabled with the permission of MZO of Ukraine.

Import and sales of products of food which do not meet the requirements of the sanitary legislation of Ukraine, including the substances made with use which are not resolved as nutritional supplements is forbidden.

4. Use of nutritional supplements shall not increase risk degree of possible adverse influence of product on health of the consumer, and also change consumer properties of foodstuff (except for some products of special and dietary purpose).

Use of nutritional supplements for the purpose of concealment of spoil or poor quality of raw materials or ready-made product is not allowed.

5. Introduction of new nutritional supplements in products or change of conditions of their application is considered justified only when it is directed to achievements of the purposes provided below and when those cannot be reached other technologically reasonable means:

a) preserving natural property and nutrition value of product; decrease in nutrition value is possible in the cases provided by the production technology of special and dietary products;

6) increase in storage duration, quality and stability of product or improvement of its organoleptic properties, under condition if it does not change foodstuff essence, does not mislead the consumer and does not increase risk of adverse effect of product on health, in comparison with means which are applied;

c) improvement of conditions of preparation, processing, packing and other production processes, and also packing, transportation and storage of food. But at the same time use of nutritional supplements shall not promote concealment of shortcomings of raw materials or the changes in product arising owing to non-compliance with the established production schedules and sanitary standards and rules at each production phase.

6. Nutritional supplements shall be applied in case of production of foodstuff in quantity, minimum necessary for achievement of technological effect, but it is no more than established most admissible levels (MAL) specified in this document.

The most admissible levels for the nutritional supplements given in these Health regulations and regulations mean the most admissible amount of nutritional supplements which can be added or be in foodstuff irrespective of whether she is added to it directly or as a part of other product (semifinished product) which is entered according to compounding in case of production of ready-made product.

The most admissible levels of nutritional supplements in product are calculated as certain chemical compounds or elements, or otherwise the designated substances, are given in mg on 1 kg of ready-made product or semifinished product (if it is specially caused).

For the nutritional supplements which are not creating threat for health of the person, even in high doses, limiting content of additive is determined by the technological instructions (TI) and does not require ad hoc methods of instrumental control of its content in ready-made product of food.

7. The structure and degree of purity of the substances used as nutritional supplements are determined by specially technical documentation to each type of nutritional supplements in coordination with MZO of Ukraine.

8. Use of nutritional supplements is allowed by the Chief state health officer of Ukraine based on the positive conclusion of the state sanitary and hygienic examination.

Implementation in production of the permitted nutritional supplements at the separate companies is performed under control of organizations of the public sanitary and epidemiologic service on places.

Receipt of the conclusion of the state sanitary and hygienic examination is performed according to the order MZO of Ukraine of 20.10.95 N190.

9. Departmental control of proper use of nutritional supplements at the company, is assigned by their quality, content in foodstuff to technological service of the company and production laboratory.

10. The state sanitary and epidemiological surveillance and selective control behind use of nutritional supplements and their content in foodstuff is performed by the public sanitary and epidemiologic service on places according to Art. 33 of the Law of Ukraine "About ensuring sanitary and epidemiological wellbeing of the population".

11. Methods on identification and determination of nutritional supplements in food are regulated by special documents of general go departmental nature.

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