Biologically active supplements
In addition to medical devices, biomedical cell products and medicines, many biologically active additives enter Russian market every year. According to DSM Group, in 2017 340.7 million packs of dietary supplements worth 51.2 billion rubles in retail prices were sold through the pharmacy network. Access of these products to the market is carried out in accordance with the legislation of the Customs Union (CU). The main document regulating safety indicators, conditions and processes of production, as well as the procedure of state registration is technical regulation 021/2011 (TR CU 021/2011).
1 – Introduction – see below
2 – Requirements for efficiency and safety of dietary supplements – by link
3 – Technical specifications and technological instruction for the dietary supplement – by link
4 – Classification – by link
5 – About mandatory labeling, when it will be started?
- What are biologically active supplements?
Biologically active food supplements (BAS) – natural and (or) identical to natural biologically active substances, as well as probiotic microorganisms intended for consumption simultaneously with food or introduction into the composition of food products (TR CU 021/2011).
Dietary supplements are used for the purpose of enriching the diet by biologically active substances and their complexes.
According to the regulations, dietary supplements belong to specialized food products and are subject to state registration.
- The procedure of state registration.
State registration of BASs is carried out by the Federal Service for Supervision in the Field of Consumer Rights Protection and Human Welfare (Rospotrebnadzor).
Within 5 working days the registration body considers the application and the package of documents provided by the applicant.
According to the results, the applicant receives a certificate of state registration on the approved form.
Within three working days after positive conclusion, BAS is included to the register of specialized food products
- Required documents
– Test results
– Information about intended use of the product
- State duties
– for the state registration of a new food product, material, products – 5000 rubles
– for the state registration of a single type of product that represents a potential danger to human beings, as well as a type of product imported into the territory of the Russian Federation for the first time – 5000 rubles
- Gammel Irina, Suvorova Olesya, Zaporozhye Larisa Ivanovna Analysis of trends in the Russian market of biologically active food additives// Medical almanac. 2016. No 6 (1). URL: https://cyberleninka.ru/article/n/analiz-tendentsiy-rossiyskogo-rynka-biologicheski-aktivnyh-dobavok-k-pische (Repetition date: 08.11.2018).
- TR CU 021/2011
©Beawire – Nov 2018 with updates March 2019.