Dietary Supplement (BAA) Registration

Biologically active food additives (BAAs) are compositions of natural or identical-to-natural biologically active substances intended for direct consumption with food or for incorporation into food products in order to enrich the diet with certain nutrients or biologically active substances and their complexes.

The circulation of BAAs and of raw materials for BAA production is regulated by Federal Law No. 52-FZ of 30 March 1999, “On Sanitary and Epidemiological Welfare of the Population,” and by Technical Regulation of the EurAsEC Customs Union TR CU 021/2011, “On Food Safety,” which require BAAs and their raw materials to undergo mandatory state registration.

State registration of BAAs is carried out by the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor) based on an expert review of the documents submitted by the applicant. The registration certificate is issued for the entire period of industrial manufacture of a Russian product or the period of supply for an imported one.

The registration dossier is based on sample-safety studies — including physico-chemical composition, microbiological cleanliness, organoleptic and radiological studies, toxicological-hygienic assessment, BAA efficacy, etc. — and on a number of administrative documents on the manufacturing organization.

The document package submitted to Roszdravnadzor to register a BAA includes:

1. Application for BAA registration;
2. Tax-registration certificates of the applicant organization and the BAA manufacturer;
3. Regulatory or technical documentation agreed upon in the prescribed manner;
4. Sanitary-epidemiological conclusion for BAA manufacturing issued by the State Sanitary and Epidemiological Surveillance Centre of the Russian Federation subject;
5. Consumer label or its project approved by the manufacturer;
6. Explanatory note with a scientific justification of the BAA composition, scientifically grounded recommendations for use and contraindications or usage limitations, if any;
7. Declaration on the presence or absence in the BAA of components derived from genetically modified organisms;
8. Declaration on the absence in the BAA of components and substances with narcotic or psychotropic effects, or of potent substances;
9. For registration of BAAs containing:
   • live microorganisms — specify the microorganism’s genus and species in Latin, the strain designation, patent status, depositing information (passport, certificate), and the production method of the used culture (TU No… or Pharmacopoeia article);
   • parts of plants — specify the botanical name in Latin, the form and method of preparation (e.g. extract 1:4, infusion 1:10, etc.);
   • intended for athletes — for building muscle mass, for people under heavy physical load — a document from the BAA manufacturer confirming the absence of doping substances and components;
10. Research and testing reports (if available);
11. BAA samples in the quantity required for the sanitary-epidemiological expert review;
12. A sampling act of the established form;
13. For foreign-made BAAs — documents issued by the competent authorities of the country of origin confirming that the product is classified as a BAA (food product) or is not a drug and confirming its safety for humans.

After the registration dossier is submitted, Rospotrebnadzor specialists conduct an expert review of the documents and, based on that review, issue a conclusion on granting or refusing the state-registration certificate.

Granconsult provides the following BAA registration services:

• Preliminary analysis of the BAA’s ingredient composition against current requirements;
• Preparation of the registration dossier;
• Organization and monitoring of preliminary tests (toxicological-hygienic, organoleptic, physico-chemical, microbiological, radiological, efficacy);
• Organization and support of the expert review at the Research Institute of Nutrition of the Russian Academy of Medical Sciences;
• Submission of the registration dossier to Rospotrebnadzor and monitoring of the registration process;
• Obtaining the BAA state-registration certificate.