In Russia, food supplements are regulated under Technical Regulation of the Customs Union TR CU 021/2011 “On safety of food products” and the EAEU Unified Sanitary Requirements.Additionally, the regulation of food supplements iscomplemented by national law of the Russian Federation, namely:
· Federal Law of 2 January 2000 No. 29-FZ "On quality and safety of food products" as amended on 13 July 2015;
· SanPiN 184.108.40.2068-01 Hygienic requirements for safety and nutritional value of food products, the Resolution of the Chief State Sanitary Doctor of the Russian Federation of 14 November 2001 No. 36.;
· SanPiN 220.127.116.110-03 Hygienic requirements for the organization of production and sales of biologically active food supplements («БАД»), , the Resolution of the Chief State Sanitary Doctor of the Russian Federation of 17 April 2003 No.50.;
· «МУК» 18.104.22.1681-98 Determination of the safety and efficacy of biologically active food supplements;
· «МР» 22.214.171.1245-04 "Methodological Recommendations. Recommendedconsumption levels of food and biologically active substances»;
· Resolution of the Chief State Sanitary Doctor of the Russian Federation of 15 August 2003 No.146 “On sanitary-epidemiological examination of biologically active additives”.
TR CU 021/2011 and the EAEU Unified Sanitary Requirements list the vitamins, minerals, plant raw materials and the forms of these substances that may be used in production of food supplements for adults and children, including microbiological safety standards and hygienic safety requirements (permissible levels of substances). The Russian Sanitary Requirements SanPiN 126.96.36.1998-01lists plants and other biologically active substances that are permitted and prohibited in manufacture of food supplements.
Food supplement registration
Food supplements fall into the category of specialized food products. All specialized food products are subject to pre-market approval in the form of state registration.TR CU 021/2011esablsihes the provisions on state registration. The state registration of specialized food products is carried out by the national Member State (in Russia, the responsible authority is the Federal Agency “Rospotrebnadzor”).
Before placing a food supplement on the market, the sanitary-epidemiological examination, state registration of a food supplement and labelling compliance should be ensured. The sanitary-epidemiological examination is carried out by the Department of State Sanitary Epidemiological Control of the Ministry of Health and the Federal Center of the State Sanitary and Epidemiological Service of the Russian Federation. Further,based on the results of sanitary-epidemiological examination, the Federal Agency “Rospotrebnadzor” issues a certificate of state registration for a food supplement.
Sanitary Requirements of the Russian Federation, SanPiN 188.8.131.520-03 Hygienic requirements for the organization of production and sales of biologically active food supplements («БАД») and («МУК» 184.108.40.2061-98) establish the procedure and the list of documents to be submitted for sanitary-epidemiological (hygienic) examination and registration of food supplements.
The timeline for the sanitary-epidemiological examination (expert conclusion) arranged by a Certification Company is 2 months depending on the complexity of food supplements. Upon receipt of the expert conclusion a food supplement can be registered. State registration of a food supplement can be done by a Certification Company or directly by the Federal Agency “Rospotrebandzor”.
The timeline procedure of state registration by “Rospotrebnadzor” includes the following steps: 1) consideration of an application and required documents – no more than 5 (five) working days upon receipt of an application; 2) in case of approval, registration of a food supplement in the Single Register of specialized food products - within 3 (three) days; 3) issuance of the Certificate of State Registration - within 3 (three) working days.
Labelling of food supplements is subject to Technical Regulation of the Customs Union TR CU 022/2011 “On food products in terms of labelling”, which provides general labelling requirements for all food products including food supplements. TR CU 022/2011 establishesunified mandatory customs duties for application and fulfillment of food labelling requirements to ensure the free movement of food products released into circulation in the single customs territory of the EAEU with the aim to prevent misleading practices and to ensure consumers' rights to reliable information about food products.
When applying TR CU 022/2011, additional specific framework applicable to food supplementson the level of Russian legislation should be taken into account. These specific requirements are stipulated in:
· SanPiN 220.127.116.110-03,
· SanPiN 18.104.22.1688-01,
· Letter 0100/11727-05-32
Labelling of packaged food supplementsshould be in Russian language and should not contain a statement “ecologically clean product" («экологическичистыйпродукт») in the name and in labelling information of food supplements, as well as the use of other statement that do not have legislative and scientific justification. Furthermore, labelling of a food supplement should state that “it is not a medicine”(«неявляетсялекарством»).
The use of health and nutrition claims (“information about distinctive properties”) is regulated under TR CU 022/2011. The Technical Regulation establishes general requirements for the use of health and nutrition claims in labelling of food products including food supplements.
National Standard of the Russian Federation “ГОСТР 55577-2013”complements TR CU 022/2011 by providing general and specific conditions for the use of health and nutrition claims.In particular, the national standard applies to the evaluation of claims (“information about distinctive properties”) about nutritional value and effectiveness of specialized and functional food products, including functional food ingredients.
Both TR CU 022/2011 and “ГОСТР 55577-2013” represent a legal framework in Russia used by food producers when they want to declarebeneficial effects of their products in the form of health and nutrition claims inlabelling and /or advertising,in graphic text, symbolic or other form. The rules of TR CU 022/2011 and “ГОСТР 55577-2013” apply to nutrition claims such as “low sodium/salt”(«снизкимсодержаниянатрия/пищевойсоли»),“high protein”(«свысокимсодержаниябелка») and to health claims such as “Vitamin A (retinol) contributes to the maintenance of normal skin and normal vision” («ВитаминА (ретинол)способствуетподдержаниюнормальногосостояниякожныхпокрововислизистыхоболочек»).
No provisions are available in officially published legal documents related to new ingredients in food supplement, except for new food supplements.
Pre-market authorisation of new food supplements in the form of state registration on the basis of sanitary and epidemiological examination is necessary. The procedure for state registration of specialized food products and novel food is establishedin TR CU 021/2011 “On safety of food products”.
Sanitary Requirements of the Russian Federation, SanPiN 22.214.171.1240-03 Hygienic requirements for the organization of production and sales of biologically active food supplements («БАД») and («МУК» 126.96.36.1991-98) establish the procedure and the lists of documents to be submitted for sanitary-epidemiological (hygienic) examination and registration of food supplements.
The list of authorized food additives approved for use in all food products including food supplements can be found in the Annex 2 ofTechnical Regulation of the Customs Union TR CU 029/2012 and in the Annex 1 of Russian Sanitary Requirements SanPiN 188.8.131.528-09. Hygienic requirements for the use of food additives.
Technical Regulation TR CU 021/2011, http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/tr/Documents/TR%20TS%20PishevayaProd.pdf
Unified Sanitary Requirements, http://www.eurasiancommission.org/ru/act/texnreg/depsanmer/sanmeri/Pages/P2_299.aspx
Resolution of the Chief State Sanitary Doctor of the Russian Federation of 15 August 2003 No.146 “On sanitary-epidemiological examination of biologically active additives”, http://docs.cntd.ru/document/901871487
Letter of the Federal Agency on Supervision of Consumers’ Rights Protection and Human Wellbeing of 22 December 2005 No. 0100/11727-05-32 “On information in the labelling of food supplements”, http://docs.cntd.ru/document/901962989
National Standard of the Russian Federation “ГОСТР 55577-2013” Specialized and functional food products. Claims about distinctive properties and effectiveness, as amended No. 1, http://docs.cntd.ru/document/1200107585
SanPiN 184.108.40.2068-09. Hygienic requirements for the use of food additives. Additions and changes No. 2 to SanPiN 220.127.116.113-03, Resolution of the Chief State Sanitary Doctor of the Russian Federation of 27 April 2009 No.24, http://docs.cntd.ru/document/902157793