of June 28, 2016 No. 287
About approval of Rules of work on evidence-based confirmation of safety of dietary supplements to food
According to the subitem 14) Item 2 of article 6 of the Law of the Republic of Kazakhstan of July 21, 2007 "About safety of food products", PRIKAZYVAYU:
1. Approve the enclosed Rules of work on evidence-based confirmation of safety of dietary supplements to food.
2. To provide to committee on consumer protection of the Ministry of national economy of the Republic of Kazakhstan in the procedure established by the legislation:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) the direction of the copy of this order in printing and electronic type on official publication in periodic printing editions and information system of law of Ad_let within ten calendar days after its state registration in the Ministry of Justice of the Republic of Kazakhstan, and also in the Republican center of legal information within five working days from the date of receipt of the registered order for inclusion in reference control bank of regulatory legal acts of the Republic of Kazakhstan;
3) placement of this order on official Internet resource of the Ministry of national economy of the Republic of Kazakhstan;
4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of national economy of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.
3. To impose control of execution of this order on the supervising vice-minister of national economy of the Republic of Kazakhstan.
Minister of national economy of the Republic of Kazakhstan
Approved by the Order of the Minister of national economy of the Republic of Kazakhstan of June 28, 2016 No. 287
1. These rules of work on evidence-based confirmation of safety of dietary supplements to food (further - Rules) determine procedure for work by evidence-based confirmation of safety of dietary supplements to food (further - dietary supplement).
2. Confirmation of safety of dietary supplement are their state registration and entering into the Register of certificates on state registration performed according to the procedure, No. 299 established by the decision of the commission of the Customs union of May 28, 2010 "About application of sanitary measures in the Eurasian Economic Union" (further - the Solution No. 299).
3. Requirements according to technical regulations of the Eurasian Economic Union are imposed to dietary supplement.
4. The purpose of scientific reasons is scientific confirmation of harmlessness of dietary supplement, lack of negative impact on health of the population and efficiency of its application.
5. Scientific reasons for safety of dietary supplement consist of the scientific report and the expert opinion.
6. The scientific report is developed and drawn up by dietary supplement producer with involvement of the profile research institutions or profile scientific centers performing practical activities in this sphere.
7. The scientific report is drawn up according to requirements of GOST 7.32-2001 the "Report on research work" approved by Interstate council on standardization, metrology and certification of May 22, 2001 No. 19.
8. In the scientific report is reflected:
1) scientific reasons for the composite structure corresponding to purpose of dietary supplement;
2) reasons for efficiency of application in the declared area;
3) reasons for efficiency of application (dosage);
4) safety of food products in the course of its production (production), storage, transportation (transportation), realization (compliance with the national or international requirements regulating its safety);
5) the comparative analysis of literary data on use of the declared raw materials in clinical and experimental practice;
6) recommendations about application, use, in need of contraindication to use of dietary supplement;
7) reasons for toksikologo-hygienic and biological safety of dietary supplement;
8) for the authorized bodies of the country manufacturer imported by dietary supplement documents, confirmatory that these products are carried to dietary supplement (foodstuff) or is not medicine, and also confirmatory that it is resolved to production and sale;
9) the conclusion and recommendations to registration;
10) the list of the used literature.
9. The expert opinion is submitted the advisory council on dietary supplement registration created under the profile research institution or profile scientific centers which are performing practical activities in this sphere and having accreditation on this type of activity.
10. Advisory council on dietary supplement registration:
1) the analysis of the submitted documentation, according to the list approved according to the Decision No. 299 is performed;
2) the analysis of composition of dietary supplement on compliance to requirements of technical regulations of the Eurasian Economic Union is performed;
3) the analysis of method and dosage of use of dietary supplement, contraindication to application is performed;
4) the analysis of results of research of safety of dietary supplement (protocols of accredited laboratory) is performed;
5) the conclusion and recommendations to registration are drawn up.
11. Laboratory researches dietary supplements for the purposes of execution of the scientific report and the expert opinion are conducted by laboratories, accredited (certified) in national accreditation systems (certification) of state members and entered in the Unified register of certification bodies and test laboratories (centers) of custom union, for the purpose of establishment of safety of dietary supplement according to the Single sanitary and epidemiologic and hygienic requirements to products (goods) which are subject to the state sanitary and epidemiological surveillance (control) approved by the Decision No. 299.
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