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Food Supplement Registration in Russia

Regulatory Authority:

Roszdravnadzor

Registration Timeline:

1.5-3 Months

License validity:

Permanant

Registration Fee:

5,000 rubles

Food supplements are subject to EAEU Unified Sanitary Requirements and Technical Regulation of the Customs Union TR CU 021/2011 “On safety of food products” in Russia. Furthermore, national law of the Russian Federation complements the control of dietary supplements.

Food supplements are meant to complement a diet and contain bioactive substances that are either naturally occurring or the same as those found in nature. Supplements from food cannot be medical.

Registration Process:

Before being sold in Russia, food supplements must receive pre-market approval in the form of a governmental registration. The provisions of state registration are established by TR CU 021/2011.

A dossier for state registration needs to contain:

(i) Proclamation of preliminary assessment

(ii) Documentation of studies and assessments guaranteeing hygienic and epidemiological analysis

(iii) Documentation specific to the product

(iv) Samples of products

(v) The cover page of the submitted application

The registration dossier needs to be completed and sent to the authorized state body (Roszdravnadzor).

Labelling:

The Technical Regulation of the Customs Union TR CU 022/2011 “On food products in terms of labelling” governs the labeling of food supplements. It lays out broad labeling criteria for all food items, including food supplements. To guarantee the free movement of food products released into circulation in the single customs territory of the European Union, the regulation establishes unified mandatory customs duties for the application and fulfillment of food labelling requirements. This is done to prevent misleading practices and ensure consumers’ rights to reliable information about food products.

Claims :

TR CU 022/2011 governs the use of statements regarding nutrition and health (also known as “information about distinctive properties”). The Technical Regulation lays down the broad guidelines for the use of nutrition and health claims on food product labels, including those for food supplements.

The “БОСТ P 55577-2013” National Standard of the Russian Federation offers both general and guidelines for the use of nutrition and health claims, which is a complement to TR CU 022/2011. The national standard is specifically applicable to the assessment of claims (also known as “information about distinctive properties”) regarding the efficacy and nutritional value of specialty and functional food items, including functional food ingredients.