Chapter 68 – Regulatory Aspects of Nutraceuticals: Russian Perspective

This chapter describes regulatory aspects of circulating dietary supplements in the Russian Federation. Since the creation of the Customs Union of the Republic of Belarus, the Republic of Kazakhstan, and the Russian Federation in 2007, the member states have been aiming at merging their food markets with food safety regulations being harmonized across the union territory. At present, foods including those for special use, dietary supplements, and (broadly) nutraceuticals (i.e., vitamin and mineral preparations and herbal extracts) have all been regulated by the Customs Union legislation (e.g., technical regulation TR CU 021/2011 on Food Safety and technical regulation TR CU 022/2011 on Labeling of Foods). In this respect, the authors present a detailed analysis of the product classification adopted in the Customs Union as well as the interpretation of ingredients and labeling requirements. Separate sections of the chapter are dedicated to the issue of product claims and advertising as well as state product registration. With the Customs Union integration becoming a driving force for further evolution of the national regulatory system, the Russian Federation has recently adopted a number of fundamental documents in relation to food safety and public health to ensure that the Russian food safety regulations are in line with the recommendations of the leading international organizations, including the World Health Organization (WHO), the Commission of Codex Alimentarius, and the World Trade Organization (WTO). These documents include Russian Federation Food Security Doctrine, Russian Federation Policy Framework on Healthy Public Nutrition for the period through 2020, and a number of national standards that define requirements for quality and safety of foods for special use. Key aspects of these documents are discussed in detail.