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Registered with the Ministry of Justice of the RF, March 22, 2002 No. N 3326 MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
CHIEF STATE SANITARY INSPECTOR OF THE RUSSIAN FEDERATION
RESOLUTION No. 36
November 14, 2001
ON IMPLEMENTING SANITARY RULES
(as in force of Attachment No. 1 approved by Resolution No. 27 of Chief State Sanitary Inspector of the RF dated 20.08.2002, Attachment No. 2, approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated 15.04.2003, of Chief State Sanitary Inspector of the RF dated 31.05.2002) In pursuance of Federal Law No. 52-FL “On Sanitary and Epidemiologic Well-being of People” dated March 30, 1999 and Regulation on “State sanitary and epidemiologic control” approved by Resolution of the Government of the Russian Federation No. 554 dated July 24, 2000 <*>, hereby order: -------------------------------- <*> Collection of laws and regulations of the Russian Federation No. 31, Article 3295, dated The term of implementation of sanitary and epidemiologic rules and regulations “Hygienic requirements for safety and nutrition value of foodstuff. Sanitary Rules and Regulations (SanPin) 2.3.2.1078-01” was postponed from July 1 to September 1, 2002 (Resolution of Chief State Sanitary Inspector of the RF No. 18 dated 31.05.2002). 1. Put into force, from July 1, 2002, sanitary and epidemiologic rules and regulations “Hygienic requirements for safety and nutrition value of foodstuff. Sanitary Rules and Regulations (SanPin) 2.3.2.1078-01” approved by Chief State Sanitary Inspector of the Russian Federation on 06.11.2001. 2.3.2. FOOD RAW MATERIAL AND FOODSTUFF
HYGIENIC REQUIREMENTS FOR SAFETY AND NUTRITION VALUE OF FOODSTUFF
SANITARY AND EPIDEMIOLOGIC RULES AND REGULATIONS
SanPiN 2.3.2.1078-01
(as in force of Attachment No. 1 approved by Resolution No. 27 of Chief State Sanitary Inspector of the RF dated 20.08.2002) 1.1. Sanitary and epidemiologic rules and regulations “Hygienic requirements for safety and nutrition value of foodstuff (hereinafter – the Sanitary Rules) set forth hygienic requirements for safety and nutrition value of foodstuff for an individual as well as compliance requirements for the said regulations under manufacturing, importing and turnover of foodstuff. 1.2. These Sanitary Rules have been developed on the basis of Federal Laws “On Sanitary and Epidemiologic Well-being of People” (Collection of laws and regulations of the Russian Federation No. 14, Article 1650, dated 1999), “On quality and food safety” (Collection of laws and regulations of the Russian Federation No. 2, Article 150 dated 2000), “On radiation safety of people” (Russian Gazette dated January 17, 1996), “On protection of consumers” (Collection of laws and regulations of the Russian Federation No. 3, Article 140 dated 1996), “On fundamental principles of legislation of the Russian Federation on health care” (Bulletin of the Congress of People’s Deputies of the Russian Federation and the Supreme Council of the Russian Federation No. 33, Article 1318 dated 1993), Resolution of the Government of the Russian Federation No. 554 “On approving the Regulation on State sanitary and epidemiologic service of the Russian Federation and Regulation on state sanitary and epidemiologic control” dated July 24, 2000 (Collection of laws and regulations of the Russian Federation No. 31, Article 3295 dated 2000). 1.3. Sanitary rules are designed for individuals, entrepreneurs and legal entities which activity is carried out in the field of manufacturing, importing and turnover of foodstuff, provision of services in food retail business and public catering as well as for agencies and organizations of the State sanitary and epidemiologic service of the Russian Federation (hereinafter - GosSanEpidemNadzor of Russia), which carry out sanitary and epidemiologic supervision and control. 1.4. Hygienic requirements for materials and items coming in contact with foodstuff shall be established by special sanitary and epidemiologic rules and regulations. 2.1. Foodstuff shall satisfy physiological needs of human beings in required substances and energy, meet demands generally placed to foodstuff with respect to organoleptic and physicochemical parameters and comply with requirements of regulatory documents as per permissible content of chemically, radiologically, biologically active substances and their compounds, microorganisms and other biological organisms endangering the well-being of current and future generations. (as in force of Attachment No. 2 approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated 15.04.2003) 2.2. Foodstuff produced, imported and placed in turnover in the territory of the Russian Federation shall comply with sanitary rules as per their safety and nutrition value. 2.3. Manufacturing, importing and turnover of foodstuff which fails to comply with the appropriate requirements foreseen by these Sanitary Rules shall be not permitted. 2.4. These Sanitary Rules requirements must be complied with when working out regulatory and technical documentation governing the issues of manufacturing, importing and turnover of foodstuff. 2.5. When developing new types of foodstuff, new manufacturing technology, packaging, storage, and transportation individual entrepreneurs and legal entities should justify quality and safety requirements, requirements for maintaining quality and safety, develop programs of quality and safety in-process control, procedures of their testing, and set shelf expiry date of such foodstuff. 2.6. Drafts of technical documents shall be subject to sanitary and epidemiologic examination 2.7. Manufacturing of new foodstuffs in the territory of the Russian Federation and import of foodstuffs to the territory of the Russian Federation which are carried out for the first time shall be allowed only after their state registration in accordance with the established procedure. 2.8. Imported foodstuffs shall be subject to state registration prior to their import to the territory 2.9. Manufacturing of foodstuff shall be carried out in compliance with regulatory and technical documents and be proved by foodstuff quality and safety certificates provided by the manufacturer (hereinafter – quality and safety certificate). 2.10. Food products for public catering shall not require execution of a quality and safety 2.11. Foodstuffs and drafts of technical documents compliance with sanitary rules shall be proved during sanitary and epidemiologic compliance examination to be carried out according to the established procedure. 2.12. When the sanitary rules lack safety and nutrition value requirements for a specific type of new or foodstuff imported for the first time the requirements shall be set during sanitary and epidemiologic examination subject to the following parameters: - established by a vendor of a new type of product in the draft of the regulatory and/or technical - established by applicable sanitary rules for a product similar in its composition and properties; - produced fro the product in the country of its origin; - recommended by international organizations. 2.13. Foodstuff safety and nutrition value requirements shall be recorded in the sanitary and epidemiologic opinion executed according to the established form which shall be issued by authorities and departments of GosSanEpidemNadzor of Russia on the basis of results of sanitary and epidemiologic examination. 2.14. Food raw material of plant origin compulsory requires information on pesticides used during cultivation of crop plants, fumigation of premises and packaging for their storage, pest control of food raw material as well as data on the latest treatment. Food raw material of animal origin compulsory requires information on usage (if any) of pesticides for control of ectoparasites or diseases of animals and fowl, for treating cattle-breading and poultry facilities, fish farming and water basing for fish reproduction as well as specification of pesticide and end date of its use. 2.15. Import, use and turnover of food raw material of animal and plant origin which lacks information on pesticides for its production shall not be tolerated. 2.16. Foodstuffs shall be packed so that to ensure maintaining of quality and safety at all stages 2.17. Individual entrepreneurs and legal entities engaged in manufacturing and turnover of foodstuffs, provision of services in the field of foodstuff retail and public catering shall be obliged to provide customers and consumers as well as state authorities for control and supervision with complete and credible information on quality and safety of foodstuffs, compliance with requirements of regulatory documents under manufacturing and turnover of foodstuff and provision of services in the field of retail trade and public catering. 2.18. Certain kinds of food products (baby food, dietary and specialized food products, probiotic product, food additives, bioactive food additives, foodstuffs from genetically modified sources, etc.) shall specify: (as in force of Attachment No. 2 approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated 15.04.2003) - scope of application (for baby food, dietary and specialized food products, food additives, - name of ingredients comprising food product, food additives, microbic cultures, starter cultures and substances used for enriching foodstuffs; bioactive food additives and enriched products for bioactive agents shall specify percentage of the daily physiological need, if such a need is foreseen; - recommendations for use, application, and, if required, counterindications for their use; - bioactive additives compulsory require information: “Not a medicine”; - food products from genetically modified sources compulsory require information: “Genetically modified product” or “product received from genetically modified sources” or “product contains components from genetically modified sources” (for foodstuffs containing over 5% of components of GMS); - information on state registration. Foodstuffs produced from GMS and not containing deoxyribonucleic acid (DNA) and protein will not require additional labeling in case of compete equivalence of nutrition value of a GMS product to its traditional counterpart (Attachment 4). ConsultantPlus: notes. For references related to marking foodstuffs produced from genetically modified sources see also Resolution of Chief State Sanitary Inspector of the RF No. 12 dated 26.09.1999. 2.19. Terms “dietary”, “medical”, “preventive” “baby”, probiotic product” or their equivalent in designation of foodstuffs, in consumer package information and package inserts for the product shall be used and applied in accordance with the established procedure. (as in force of Attachment No. 2 approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated 15.04.2003) 2.20. When manufacturing food raw material of animal origin the use of feed additives, animal growth-promoting substances, pharmaceuticals, drugs for treating animals and fowl as well as preparations for treating premises for their keeping which have not undergone sanitary and epidemiologic examination and state registration according to the established procedure shall be prohibited. (as in force of Attachment No. 2 approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated 15.04.2003) 2.21. Foodstuffs containing feed additives, animal growth-promoting substances (including hormonal agents), drugs, pesticides, agrochemicals which have not undergone sanitary and epidemiologic examination and state registration according to the established procedure shall not be liable to import, manufacturing and turnover in the territory of the Russian Federation. Their recycling or destruction shall be carried out according to the established procedure. 2.22. In-process control and sanitary and epidemiologic surveillance and monitoring shall be exercised over compliance with requirements for foodstuff safety and nutrition value. 2.23. Individual entrepreneurs and legal entities engaged in production, import and turnover of food products must carry out in-process control including laboratory analysis and testing of safety and nutrition value indexes as per compliance with requirements of these Sanitary Rules according to sanitary rules of a company and carrying out of in-process control. 2.24. Individual entrepreneurs and legal entities engaged in manufacturing and turnover of food products upon the results of carrying out of measures aimed at ensuring quality and safety of foodstuffs, compliance with requirements of regulatory and technical documents including in-process control shall receive quality and safety certificate for every batch of food products. 2.25. Individual entrepreneurs and legal entities engaged in manufacturing and turnover of food products shall carry out laboratory analysis and testing independently or with engagement of laboratories accredited according to the established procedure. 2.26. For conducting laboratory analysis and testing of quality and safety parameters of food products only those techniques and methods will be allowed which are metrology certified and comply with requirements of providing uniformity of measurements and measuring accuracy characteristics, with methods of testing product samples and control of their parameters as well as those methods which comply with the said requirements and approved according to the established procedures. 2.27. Regulatory and technical documents for culture medium intended for control over microbiological factors of safety and nutrition value of foodstuffs shall be subject to sanitary and epidemiologic examination according to the established procedure. 2.28. In case of unacceptable results of analysis even for one of the safety parameters, this parameter is subject to recurrent examination under double volume of sample capture taken from the same batch. The results of the second examination shall apply to the whole batch. 2.29. State sanitary and epidemiologic surveillance and control over compliance of foodstuffs with Sanitary Rules shall be carried out by agencies and departments of GosSanEpidemNadzor of Russia according to the established procedure. III. Foodstuff Hygienic Safety and Nutritional Value Requirements 3.1. These Sanitary Rules shall establish hygienic requirements for safety of foodstuffs and their ability to satisfy physiological need of man in major nutrient materials and energy. 3.2. Organoleptic properties of food products shall be defined by factors of flavor, color, smell and consistency, specific for each type of product and must meet traditionally established tastes and habits of people. Organoleptic properties of food products shall not be changed during storage, transportation and distribution. 3.3. Foodstuffs shall not have foreign odors, after-tastes, inclusions, differences in color and consistency incidental to the given type of product. 3.4. Safety of foodstuffs as per their microbiological and radiological safety as well as with respect to content of chemical contaminants shall be determined by their compliance with hygienic standards provided for these Sanitary Rules (Attachment 1). 3.5. Determination of parameters of safety and nutrition value of food products including bioactive food additives, blend composition shall be carried out for basic type(s) of raw materials both by the mass fraction and permissible levels of controlled contaminants. 3.6. Determination of parameters of safety of dry, concentrated or diluted food products shall be carried out in terms of original product subject to content of dry substances in the raw and final product. 3.7. Hygienic standards shall apply to potentially hazardous chemical compounds and biological subjects which presence in the foodstuffs must not exceed permissible levels of their content in the weight specified (volume) of product under examination. 3.8. The content of major chemical contaminants endangering human health shall be monitored Hygienic requirements for permissible level of content of toxic elements shall apply to all types 3.9. Content of mycotoxins - aflatoxin B1, desoxynivalenol (vomitoxin), zearalenon, Т-2 toxin, penicidin – is controlled in food raw material and food products of plant origin, aflatoxin M1 – in milk and dairy products. Most dangerous contaminants are: for cereal products - desoxynivalenol; for nuts and oil seeds - aflatoxin B1; for fruit and vegetable derivatives - penicidin. 3.10. Occurrence of mycotoxins in baby food and dietary products shall be excluded. 3.11. Pesticides are controlled in all types of food raw material and food products: hexachlorocyclohexane (alpha-, beta-, gamma isomers), DDT and its metabolites. Organomercury pesticides, 2, 4-D acid, its salts and esters are controlled in grain and its derivatives. 2, 4-D acid, its salts and esters are also controlled in fish and fish products. 3.12. Control of food raw material and food products as per the content of residual quantity of pesticides and agrochemicals including fumigants is based on information provided by the product manufacture (vendor) on use of pesticides and agrochemicals under manufacturing and storage of food products. 3.13. Sanitary and epidemiologic examination of food raw material and foodstuffs containing pesticides shall be carried out in compliance with applicable hygienic standards of pesticide content in the objects of environment. 3.14. Residual quantities of animal growth-promoting substances (including hormonal agents), pharmaceuticals (including antibiotics) applied in cattle breeding for fatting, cure and preventive treatment shall be controlled in livestock and fowl. Both admitted for use in agriculture feed antibiotics (grizin, bacitracin) and therapeutic antibiotics most often used in veterinary - antibiotics of tetracycline group, chloramphenicol are controlled in meat, meat food, by-products of beef cattle and poultry. Penicillin, streptomycin, antibiotics of tetracycline group, chloramphenicol are controlled in milk and diary products; in eggs and egg products - bacitracin, antibiotics of tetracycline group, streptomycin, chloramphenicol. 3.15. Control over the content of animal growth-promoting substances (including hormonal agents), pharmaceuticals (including antibiotics) applied in cattle breeding for fatting, cure and preventive treatment of livestock and fowl not specified in clause 3.14 shall be based on information provided by the product manufacture (vendor) on used animal growth-promoting substances and pharmaceuticals during manufacturing and storage of such products. 3.16. Polychlorinated biphenyls are controlled in fish, fish products; benzpyrene – in grain, in 3.17. Occurrence of benzpyrene in baby food and dietary products shall be excluded. 3.18. The following is controlled in isolated products: content of nitrogen compounds: histamine – in salmonids and scombrids (including tuna group); nitrates – in horticulture product; N- nitrosamines – in fish and fish products, meat products and brewer's malt. 3.19. Indications of oxidative deterioration are controlled in fatty products: acid and peroxide 3.20. Content of radionuclides is controlled in food products. (as in force of Attachment No. 2 approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated 15.04.2003) Radiological safety of foodstuffs for Caesium-137 and Strontium-90 shall be determined by their permissible levels of specific activity of radionuclides provided for these Sanitary Rules. Compliance factor – B, which value is calculated using results of measuring specific activity of Caesium-137 and Strontium-90 in a sample, shall be used for determining compliance of foodstuffs with criteria of radiological safety: В = (А/Н) 90Sr + (A/H) 137Cs, where А – specific activity value of 90Sr and 137Cs if food product (Bq/kg), Н – permissible level of specific activity for 90Sr and 137Cs in the same product (Bq/kg). (as in force of Attachment No. 2 approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated 15.04.2003) Radiological safety of foodstuffs contaminated with other radionuclides shall be determined by sanitary rules that specify radiological safety standards. 3.21. Presence of pathogenic microorganisms and causative organisms of parasitic diseases, their toxins inducing contagious and parasitic diseases or endangering human and animal health shall be excluded in food products. 3.22. Sanitary and epidemiologic examination of meat, meat products, fish, shellfish, molluscs, amphibians, reptiles and products of their processing for the presence of causative organisms of parasitic diseases shall be carried out in accordance with sanitary rules for conducting parasitologic control and parasitologic parameters of safety (Attachment 6). 3.23. Presence of causative organisms of parasitic diseases in meat and meat products shall not be tolerated: i.e. bladder worms (cysticercus), larva of trichina and echinococci, cysts of sarcocyst and toxoplasm. 3.24. Presence of live larva of parasites threatening human health shall not be tolerated in fish, shellfish, molluscs, amphibians, reptiles and products of their processing. When finding live tapeworm (helmint) larva one should be governed by sanitary rules for 3.25. Presence of helmint eggs and cysts of enteric pathogens shall not be tolerated in fresh and quick-frozen table greenery, vegetables, fruits and berries. 3.26. Hygienic standards for parasitologic safety parameters of drinking water shall be determined in accordance with hygienic standards specified for quality of centralized drinking water supply systems. 3.27. Hygienic standards for microbiologic parameters of safety and nutrition value of foodstuff shall include the following groups of microorganisms: - sanitary-indicative ones, which include: number of mesophilic aerobian and facultative- anaerobic microorganisms (NMAFAnM), coliforms, Enterobacteriaceae family, enterococcus; - opportunistic pathogens, which include: Е. coli, S. aureus, Proteus class bacteria, В. cereus and sulfite-reducing clostridia, Vibrio parahaemolyticus; - pathogenic microorganisms, including salmonella and Listeria monocytogenes, Yersinia class - spoilage microorganisms – yeasts and mold fungi, lactic-acid microorganisms; - starter flora microorganisms and probiotic microorganisms (lactic-acid microorganisms, propionate microorganisms, yeasts, bifidobacteria, acidophilic bacteria and etc.) – in products with controlled level of biotechnological flora and probiotic products. 3.28. Controlling of microbiologic parameters of safety of foodstuff shall be carried out for majority groups of microorganisms under the alternative principle, i.e. controlled is a mass of product where coliforms, majority of opportunistic pathogens, as well as pathogenic microorganisms including Salmonella and Listeria monocytogenes shall be excluded. In other cases the standard reflects the number of colony-forming units in 1 gr (ml) of the product (CFU/gr, ml). 3.29. Criteria of safety of preserved food products (manufacturing sterility) is the absence of microorganisms capable of growing under temperature of storage specified for certain type of canned food and microorganisms and bacterial toxins endangering human health life in preserved food products (Attachment 8). 3.30. Bioactive food additives are the source of food, minor, pro- and prebiotic natural (identical with natural) bioactive food substances (components), which provide their intake into a human body while eating or introducing into the composition of food products. Bioactive substances, food components and products being their sources and used during manufacturing of bioactive food additives must ensure their efficiency and must not negatively affect human health (Attachment 5a). Bioactive substances, food components and products being their sources that pose - according to current research data – a hazard to human life and health when using them as a component of bioactive food additives shall not be allowed for use when manufacturing bioactive food additives (Attachment 5b). 3.31. The parameters of nutrition value shall be determined in food products. Parameters of nutrition value of food products shall be grounded by a manufacture (developer of technical documents) on the basis of analytic methods of research and/or with use of calculating method subject to composition of a food product and data on composition of raw materials. 3.32. Specific foodstuffs under parameters of nutrition value must comply with requirements of 3.33. Baby food must comply with functional status of a child with account of his/her age and 3.34. Baby food and its components, foodstuff for pregnant women and nursing mothers (hereinafter – specialized products) must comply with hygienic standards of safety and nutrition value provided for these Sanitary Rules (Attachment 3). 3.35. Foodstuffs shall allow the use of food additives which according to the data of current research do not negatively affect human life and health of future generations (Attachments 7). Foodstuffs containing food additives not specified in Attachment 7 shall not be liable to manufacturing, import and distribution in the territory of the Russian Federation. Their recycling or destruction shall be carried out according to the established procedure. 3.36. Food additives application and permissible levels of their content in food products are governed by sanitary rules for application of food additives.

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