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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of December 2, 2004 No. 1537

About approval of the Regulations on procedure for production and turnover of dietary supplements to food

(as amended on 16-11-2018)

According to article 11 of the Law of the Republic of Belarus of June 29, 2003 "About quality and safety of food staples and foodstuff for life and health of the person" the Council of Ministers of the Republic of Belarus DECIDES:

1. Approve the enclosed Regulations on procedure for production and turnover of dietary supplements to food.

2. This resolution becomes effective since January 1, 2005.

Prime Minister of the Republic of Belarus

S. Sidorsky

Approved by the Resolution of Council of Ministers of the Republic of Belarus of December 2, 2004 No. 1537

Regulations on procedure for production and turnover of dietary supplements to food

1. This Provision governs the relations in the field of quality assurance of dietary supplements to food and their safety for life and health of the person and extends to the legal entities and individual entrepreneurs performing production and (or) turnover of dietary supplements to food.

2. For the purposes of this provision terms and their determinations in the values established by the legislation on sanitary and epidemiologic wellbeing of the population and the Law of the Republic of Belarus of June 29, 2003 "About quality and safety of food staples and foodstuff for life and health of the person" are used (The national register of legal acts of the Republic of Belarus, 2003, No. 79, 2/966; National legal Internet portal of the Republic of Belarus, 28.07.2018, 2/2565), and also following term and its determination:

specialized departments of shopping facilities - departments (shopping facilities) selling food products.

3. Quality and safety of the dietary supplements to food made, delivered and realized in the Republic of Belarus is provided in the way:

3.1. state registration of dietary supplements to food;

3.2. state, including state sanitary, supervision of safety of dietary supplements to food in case of statement on production, production, in the course of their turnover;

3.3. production supervision in the course of production and (or) turnover of dietary supplements to food;

3.4. carrying out by legal entities and individual entrepreneurs of quality control and safety of the dietary supplements made and (or) imported into the Republic of Belarus to food.

4. For the purposes of this provision the following classification of dietary supplements to food is used:

the dietary supplements to food applied to maintenance in physiological limits of functional activity of organism (contain in the structure biologically active agents, vitamins, minerals, mineral substances, amino acids, live microorganisms and (or) their metabolites making the normalizing impact on structure and biological activity of microflora of digestive tract);

the dietary supplements to food applied to enrichment of food of the person (contain additional sources of proteins, fats, carbohydrates, food fibers in the structure).

5. Turnover of dietary supplements is allowed to food in the presence of their state registration. The legal entities and individual entrepreneurs performing industrial production and (or) wholesale of dietary supplements to food accompany each batch of dietary supplements to food with copies of the documents confirming their quality and safety.

Reference of specific names of dietary supplements to food to this or that classification group is performed by the commission on determination of order of registration and realization of dietary supplements to food of the Ministry of Health.

For the state hygienic registration of the dietary supplements to food intended for food of athletes, the compulsory provision is availability of coordination of the Ministry of Sport and tourism of feasibility of their use in food of athletes.

6. Production of dietary supplements to food will be organized according to sanitary standards and rules of quality assurance and safety of products.

7. Production of dietary supplements to food is performed after carrying out in accordance with the established procedure their state registration according to the technical regulatory legal acts and technological instructions developed and approved in accordance with the established procedure.

The technological instruction shall contain:

characteristic of end products of production;

compounding (if the compounding is not developed in the form of the independent document);

the list of the used equipment;

the description and the graphical scheme of engineering procedure, including preparation of raw materials, the equipment;

necessary actions for conversion of products;

production control with indication of critical control points and controlled parameters;

material balance;

consumption rates of raw materials, materials.

8. All transactions of engineering procedure of production of dietary supplements to food shall be carried out in rooms and on the equipment, specially intended for these purposes, to be controlled with use of the corresponding devices.

9. Quality of dietary supplements to food in the course of their production is controlled and registered at all stages of production process in the amount provided by technical regulatory legal acts and the technological instruction.

10. All raw materials used for production of dietary supplements to food and auxiliary materials are controlled in the amount established by technical regulatory legal acts and shall meet their requirements, and also requirements of sanitary standards and rules, hygienic standard rates.

11. The personnel participating in production of dietary supplements to food shall have medical examination, receive hygienic preparation, follow rules of personal hygiene.

12. In the territory of the Republic of Belarus production and (or) turnover of the dietary supplements to food which are not conforming to the requirements established in Item 14 of this provision are not allowed.

In case of detection of discrepancy to the requirements established in Item 14 of this provision, dietary supplements to food are subject to withdrawal, return, destruction, utilization.

Withdrawal, return, destruction, utilization of dietary supplements to food are made according to the procedure, established by acts of the legislation, and their industrial conversion - according to the procedure, established by the technological instruction.

13. In case of storage of dietary supplements to food, the raw materials used in their production, auxiliary materials the temperature moisture conditions and expiration date determined by technical regulatory legal acts shall be observed.

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