Registration of food supplements (FS).
The turnover of FS and raw materials for FS production shall be governed by the Federal Law of the Russian Federation dated March 30, 1999 No.52-FL “On Sanitary and Epidemiologic Welfare of the population” and Technical Regulation of Customs Union EurAsEc TRCU 021/2011 “On Food Safety”, according to which FS and raw materials for the production are subject to state registration.
Based upon expertise of documents submitted by the applicant, the Federal Service for Consumer Rights and Human Welfare Protection (Rospotrebnadzor) shall conduct state registration of FS. The registration certificate shall be issued for the entire lifecycle of industrial production of the Russian products and supplies of import products.
The basics for compilation of a registration dossier are the samples’ safety studies including the assessment of physicochemical composition, microbiological purity, organoleptic and radiological studies, toxic & hygienic assessment, efficacy of FS and others, as well as a set of administrative documents for a manufacturing organization.
A documentation package submitted to Roszdravnadzor for FS registration includes:
- Application for registration of a food supplement;
- Certificate of an applicant organization and manufacturer of FS on registration with tax authorities;
- Regulatory and technical documentation agreed in due course;
- Sanitary & epidemiological inspection report for FS production issued by the Center of the State Sanitary & Epidemiological Surveillance Agency (GosSanEpidemNadzor) in the constituent entity of the Russian Federation;
- Consumer label or its design approved by the manufacturer;
- Explanatory note containing scientific rationale of FS composition, evidence-based guidelines on application, contraindications, limitations on application of the food supplement, if available;
- Declaration on the use or absence of components derived from genetically modified organisms (GMOs) within the food supplement;
- Declaration on the absence of components and substances with narcotic and psychotropic properties and drastic substances within the food supplement;
- For FS registration containing:
- living microorganisms, stated in Latin: gender and type of a microorganism, strain identification, availability of patent, information on sequestration (passport, certificate), the manufacturing method of the used cultures (Technical specifications No.____or Pharmacopoeial article);
- parts of plants, stated in Latin: botanic name, form and preparation method (example: extract – 1:4, infusion – 1-10 etc.);
- meant for sportsmen, for building up muscle mass, for persons with increased physical activity, FS manufacturer is required to submit a document confirming the absence of substances and components attributed to dopes within its composition;
- Research, test protocols (if available);
- Samples of food supplements in the number sufficient for conducting a sanitary & epidemiological expertise;
- Sampling act in the prescribed form;
- For foreign-made FS documents issued by the authorized authorities of the product country of origin verifying that the said products are attributed to food supplements (food products) or are not considered as medicines as well as documents evidencing its human safety.
Following the delivery of a registration dossier, the experts from Rospotrebnadzor shall conduct expertise of the submitted documents. Based upon the expertise results they will produce an inspection report on issuing a certificate of state registration or denial of state registration.
The company “Medcertificate” provides the following services of FS registration:
- Preliminary analysis of FS ingredient composition for compliance with the applicable requirements;
- Preparation of a registration dossier;
- Organization and monitoring of preliminary tests (toxic & hygienic, organoleptic, physicochemical, microbiological, radiological and assessment of efficacy);
- Organization and support of expertise at the Academic Research Institute of Nutrition;
- Submission of a registration dossier to Rospotrebnadzor, monitoring of registration progress;
- Receipt of the certificate on state registration of food supplements.