Biologically active food supplements (BAFS) to food are compositions of natural or identical to natural biologically active substances intended for direct taking with food, or introduction into food products in order to enrich the diet with individual food or biologically active substances and their complexes;
Turnover of BAFS and raw materials for BAFS production is regulated by the Federal Law of the Russian Federation of March 30, 1999 N 52-FZ “On the sanitary-epidemiological welfare of population”, and the Technical Regulation of the Customs Union of Eurasian Economic Community of Customs Union CU TR 021/2011 “On safety of food products” according to which the BAFS and raw materials for BAFS production are subject to obligatory state registration.
State registration of BAFS is carried out by the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor) on the basis of expertise of documents submitted by the applicant. The registration certificate is issued for the entire period of the industrial production of Russia's production and supply of imports.
Basis for the registration dossier is a study of the samples safety, including an assessment of physico-chemical composition, microbiological purity, organoleptic and radiological studies, toxicological and hygienic assessment, the effectiveness of BAFS, etc., as well as a number of administrative documents of the organization-manufacturer.
The package of documents submitted for BAFS registration in the Federal Service for the Supervision of Public Health and Social Development includs:
- Application for registration of biologically active additive;
- Certificate of the organization-applicant and the manufacturer of BAFS on tax registration;
- Regulatory or technical documentation, agreed in accordance with established procedure;
- Sanitary-epidemiological conclusion for production of BAFS, issued by the Centre of State Sanitary Inspection in the subject of the Russian Federation;
- Consumer label or its draft approved by the manufacturer;
- Explanatory note containing the scientific basis of the BAFS composition, the scientifically based recommendations for use, contraindications, restrictions on the use of dietary supplements, if any;
- Declaration on the use or absence in the biologically active additive composition of components derived from genetically modified organisms;
- Declaration on the absence of biologically active additive composition of ingredients and substances with a narcotic and psychotropic effect, superpotent substances;
- For registeration of BAFS containing:
- live microorganisms, genus and species of microorganism is specified in Latin, strain designation, the availability of patent, information on deposit (passport, certificate), a method of production of the used culture must be indicated (technical specifications number. .. or the Pharmacopoeia article);
- parts of plants, the botanical name is specified in Latin, the form and method of preparation (example: extract - 1:4, infusion - 1-10, etc.);
- designed for athletes, to build muscle mass, for people with high physical activity, it is required to submit from the BAFS manufacturer of the document confirming the absence in its composition of substances and components that are attributable to the doping.
- Protocols of research studies, trials (if any);
- Samples of biologically active food supplements, in amounts necessary to carry out sanitary - epidemiological examination;
- The act of sampling of the specified form;
- For BAFS of foreign production the documents issued by the competent authorities of the country of origin certifying that the products are classified as biologically active food food supplements (food products) or are not a medicinal product, as well as confirming its safety for humans.
After submitting the registration dossier, the Rospotrebnadzor experts conduct an examination of the documents submitted upon which the conclusion is given on a certificate issue of state registration or refusal of state registration.
RusClinic CRO provides the following services for BAFS registration:
- Preliminary analysis of the ingredient composition of BAFS to meet the existing requirements;
- Preparation of registration dossier;
- Organization and monitoring of the pre-trials (toxico-hygienic, organoleptic, physico-chemical, microbiological, radiological, assessment of efficasy);
- Organization and maintenance of the expertise at the Research Institute of Nutrition of RAMS;
- Submission of a registration dossier to the Rospotrebnadzor, the monitoring of registration process;
- Obtaining a certificate of BAFS state registration.