Registered with the Ministry of Justice of the RF, March 22, 2002 No. N 3326 MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

Transcription

1 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 , Attachment No. 2, approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated , N 5, ratified. Resolution of the Chief Sanitary Inspector of Russia from N 42, N 6, ratified. Resolution of the Chief Sanitary Inspector of Russia from N 13 N 7, ratified. Resolution of the Chief Sanitary Inspector of Russia from N 17 N 8, ratified. Resolution of the Chief Sanitary Inspector of Russia from N 26 N 10, ratified. Resolution of the Chief Sanitary Inspector of Russia from N 43, Gach N 11, ratified. Resolution of the Chief state health officer of Russia N 56, N 12, ratified. Resolution of the Chief Sanitary Inspector of Russia from N 58, Change in N 13, ratified. Resolution of the Chief state health officer of Russia N 69, Extras N 14, ratified. Resolution of the Chief state health officer of Russia N 28, as amended., as amended by Decree of the Chief State Sanitary Inspector of Russia from N 18) In pursuance of Federal Law No. 52FL On Sanitary and Epidemiologic Wellbeing 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) was postponed from July 1 to September 1, 2002 (Resolution of Chief State Sanitary Inspector of the RF No. 18 dated ). 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) approved by Chief State Sanitary Inspector of the Russian Federation on

2 G. G. ONISHCHENKO

3 FOOD RAW MATERIAL AND FOODSTUFF Approved by: Chief State Sanitary Inspector of the Russian Federation First Deputy Minister of Health of the Russian Federation G. G. ONISHCHENKO HYGIENIC REQUIREMENTS FOR SAFETY AND NUTRITION VALUE OF FOODSTUFF SANITARY AND EPIDEMIOLOGIC RULES AND REGULATIONS SanPiN (as in force of Attachment No. 1 approved by Resolution No. 27 of Chief State Sanitary Inspector of the RF dated ) I. Scope 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 These Sanitary Rules have been developed on the basis of Federal Laws On Sanitary and Epidemiologic Wellbeing of People (Collection of laws and regulations of the Russian Federation No. 14, Article 16, dated 1999), On quality and food safety (Collection of laws and regulations of the Russian Federation No. 2, Article 1 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) 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 Hygienic requirements for materials and items coming in contact with foodstuff shall be established by special sanitary and epidemiologic rules and regulations. II. General 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 wellbeing of current and future generations.

4 (as in force of Attachment No. 2 approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated ) 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 Manufacturing, importing and turnover of foodstuff which fails to comply with the appropriate requirements foreseen by these Sanitary Rules shall be not permitted 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 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 inprocess control, procedures of their testing, and set shelf expiry date of such foodstuff Drafts of technical documents shall be subject to sanitary and epidemiologic examination according to the established procedure 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 Imported foodstuffs shall be subject to state registration prior to their import to the territory of the Russian Federation 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) Food products for public catering shall not require execution of a quality and safety certificate 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 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 document; 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 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 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 cattlebreading and poultry facilities, fish farming and water basing for fish reproduction as well as specification of pesticide and end date of its use 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.

5 2.16. Foodstuffs shall be packed so that to ensure maintaining of quality and safety at all stages of their turnover 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 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 ) scope of application (for baby food, dietary and specialized food products, food additives, bioactive 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 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 ) When manufacturing food raw material of animal origin the use of feed additives, animal growthpromoting 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 ) Foodstuffs containing feed additives, animal growthpromoting 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 Inprocess control and sanitary and epidemiologic surveillance and monitoring shall be exercised over compliance with requirements for foodstuff safety and nutrition value.

6 2.23. Individual entrepreneurs and legal entities engaged in production, import and turnover of food products must carry out inprocess 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 inprocess control 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 inprocess control shall receive quality and safety certificate for every batch of food products. 2.. 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 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 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 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 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 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 Foodstuffs shall not have foreign odors, aftertastes, inclusions, differences in color and consistency incidental to the given type of product 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 by these Sanitary Rules (Attachment 1) 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 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 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.

7 3.8. The content of major chemical contaminants endangering human health shall be monitored in food products. Hygienic requirements for permissible level of content of toxic elements shall apply to all types of food raw material and foodstuffs Content of mycotoxins aflatoxin B1, desoxynivalenol (vomitoxin), zearalenon, Т2 toxin, patuline 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 patuline Occurrence of mycotoxins in baby food and dietary products shall be excluded 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, 4D acid, its salts and esters are controlled in grain and its derivatives. 2, 4D acid, its salts and esters are also controlled in fish and fish products 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 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 Residual quantities of animal growthpromoting substances (including hormonal agents), pharmaceuticals (including antibiotics) applied in cattle breeding for fattening, curative 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, byproducts of beef cattle and poultry. Penicillin, streptomycin, antibiotics of tetracycline group, chloramphenicol are controlled in milk and dairy products; in eggs and egg products bacitracin, antibiotics of tetracycline group, streptomycin, chloramphenicol Control over the content of animal growthpromoting substances (including hormonal agents), pharmaceuticals (including antibiotics) applied in cattle breeding for fattening, curative 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 growthpromoting substances and pharmaceuticals during manufacturing and storage of such products Polychlorinated biphenyls are controlled in fish, fish products; benzopyrene in grain, in smoked meat and fish products Occurrence of benzopyrene in baby food and dietary products shall be excluded 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 Indications of oxidative deterioration are controlled in fatty products: acid and peroxide value 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 ) Radiological safety of foodstuffs for Caesium137 and Strontium90 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 Caesium137 and Strontium90 in a sample, shall be used for determining compliance of foodstuffs with criteria of radiological safety:

8 В = (А/Н) 90Sr + (A/H) 137Cs, where А specific activity value of 90Sr and 137Cs in 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 ) Radiological safety of foodstuffs contaminated with other radionuclides shall be determined by sanitary rules that specify radiological safety standards 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 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) 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 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 parasitic diseases preventive measures. 3.. Presence of helmint eggs and cysts of enteric pathogens shall not be tolerated in fresh and quickfrozen table greenery, vegetables, fruits and berries 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 Hygienic standards for microbiologic parameters of safety and nutrition value of foodstuff shall include the following groups of microorganisms: sanitaryindicative ones, which include: number of mesophilic aerobian and facultativeanaerobic microorganisms (NMAFAnM), coliforms, Enterobacteriaceae family, enterococcus; opportunistic pathogens, which include: Е. coli, S. aureus, Proteus class bacteria, В. cereus and sulfitereducing clostridia, Vibrio parahaemolyticus; pathogenic microorganisms, including salmonella and Listeria monocytogenes, Yersinia class bacteria; spoilage microorganisms yeasts and mold fungi, lacticacid microorganisms; starter flora microorganisms and probiotic microorganisms (lacticacid microorganisms, propionate microorganisms, yeasts, bifidobacteria, acidophilic bacteria and etc.) in products with controlled level of biotechnological flora and probiotic products 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 colonyforming units in 1 gr (ml) of the product (CFU/gr, ml) 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) 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).

9 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) The parameters of nutrition value shall be established in food products. Parameters of nutrition value of food products shall be established by a manufacturer (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 Specific foodstuffs under parameters of nutrition value must comply with requirements of these Sanitary Rules (Attachment 2) Baby food must comply with physiological conditions of a child with account of his/her age and must be safe for baby health Baby food and its components, foodstuff for pregnant women and breast feeding (hereinafter specialized products) must comply with hygienic standards of safety and nutrition value provided for by these Sanitary Rules (Attachment 3) 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 allowed for manufacturing, import and distribution in the territory of the Russian Federation. Their recycling or destruction shall be carried out according to the established procedure Food additives application and permissible levels of their content in food products are governed by sanitary rules for application of food additives In accordance with the Resolution of the Chief Medical Officer of the RF N 30 from January 1, 2010, section III will be supplemented by a new paragraph 3.37: "It is not allowed to use poultry meat, except chilled, mechanically separated poultry meat, raw poultry collagen for the production of child food (for all age groups, including organized children's groups), dietary food (treatment and prevention), special foods for the nutrition of pregnant and breastfeeding women." 3.38 In accordance with the Resolution of the Chief Medical Officer of the RF N 30 from January 1, 2011, section III will be supplemented by a new paragraph 3.38: "It is not allowed to use poultry meat, except chilled, for the production of all kinds of poultry products." 3.39 Control over the content of melamine in milk and milk products is made if there are reasonable assumptions about the possibility of its presence in the food raw materials. Food safety of melamine is determined by its conformity hygienic standards set by these Regulations (Annex 1 and Annex 3).It is not allowed the presence of melamine in food products. (Section 3.39 entered Supplement N 11, ratified. Resolution of the Chief State Sanitary Doctor RF from N 56) Control over the content of dioxins in foods is carried out in cases of environmental degradation associated with manmade and natural accidents, which lead to the formation and penetration of dioxins in the environment; if there are reasonable assumptions about the possibility of their presence in food raw materials. Food safety on the content of dioxins is determined by compliance with hygienic standards set by these Regulations (Annex 1 and Annex 3) Food should not contain melamine (detection limit of less than 1 mg / kg). The content of dioxin should not exceed the permissible levels from 0, to in the respective food groups, according to the requirements of Annex 1. In all baby food dioxins are not allowed. ( 3.41 Amendments introduced N 13, ratified. Resolution of the Chief State Sanitary Doctor RF from N 69)

10 IV. Organization of the Federal Service Supervision of Consumers Protection and Welfare Rights to implement the State registration and safety assessment of foods derived of genetically modified vegetable organisms (Approved according to the addendum and changes N 6, Resolution of the Chief Sanitary Inspector of Russia from N 13) 4.1. New food products derived from GMOs of vegetable origine produced in Russia, as well as food products derived from GMOs of plant origin, imported into the Russian territory for the first time, shall be subject to State registration Federal Supervision of Consumer Rights Protection and Human Wellbeing (hereinafter Rospotrebnadzor) provides the state registration of foods derived from GMOs of plant origin (hereinafter the state registration of GMOs), 4.3. The state registration of GMOs is carried out in accordance with Federal law of N 29FZ "On the quality and food safety" (Collected Legislation Russia, 2000, N 2, Art. 1, 2002, N 1 (Part I), Art. 2, 2003, N 2, Art. 167, 2003, N 27 (am I), Art. 2700; 2004, N 35, Art. 3607, 2005, N 19, Art. 1752; 2005, N, Art. 5242, 2006, N 1, Art. 10, 2006, N 14, art. 1458; 2007, N 1 (am I), Art. 29) and Government Regulation Russia from N 988 "On state registration of new food products, materials and products "(Collected Laws of Russia, 2001, N 1 (Part II), Art. 124, 2001, N 18, Art. 1863; 2002, N 3, Art. 222; 2003, N 7, Art. 653, 2007, N 6, Art. 760, 2007, N 10, art. 1244; 2007, N 12, Art. 1414) For state registration of GMOs individual entrepreneur or organization involved in development and (or) the preparation for the production or importation of imported goods (hereinafter the applicant) shall submit documents to the Federal Service in accordance with the RF Government Decree of N 988 "On state registration of new foods, materials and products" The state registration of GMOs includes, in particular, examination results medicobiological safety assessment carried out in authorized institutions, carrying out sanitaryepidemiological examination, toxicological, hygienic and other types of assessments for the purposes of state registration Biomedical Safety assessment of foods derived from GMOs of plant origin, including: Expert analysis and evaluation of data submitted by the applicant; Expert analysis methods for detection, identification and quantification of GMOs in food; Medicogenetic evaluation; Evaluation of functional and technological properties; Medical and biological research The list and the amount of biomedical research needed to assess safety of foods derived from GMOs of plant origin, determined by the expert (scientists) Boards of the respective authorized organizations based on an analysis of submitted documents by the applicant that contain: 1) Identifying information on GMOs (type, variety, transformational event); 2) Information about the source of the parental organism (taxonomic characterization, the method of reproduction and distribution, data on toxic, allergenic and other unfavorable properties);

11 3) Information on the donor organisms introduced genes (taxonomic characterization history of use); 4) Information about the method of genetic modification (description of the method of modification structure of the vector, the structure insertion); 5) For information about GMOs (description of the properties acquired by the plant as a result of modification, structure of the genetic construction (introduced or removed) and place of its localization, characterization of expression of embedded genes (expression during ontogeny plants, the intensity of expression of the structural components of plants, etc.), characterization of differences with the parental body (the method of reproduction, the ability of cross pollination, resistance to stresses, etc.), the characterization of genetic and phenotypic stability (submitted to be data from Studies of several generations of GMOs), the characterization of the ability to transfer genes to other organisms (plants, microorganisms); 6) The results of the safety assessment of foods derived from GMOs of plant origin: The analysis of compositional equivalence (compare the chemical composition of GMOs with the chemical composition of its traditional counterpart by the following parameters: the protein content, amino acid composition, fat content, fatty acid composition, carbohydrate composition, vitamin content, the content of macroand micronutrient content of biologically active substances, the allergen content, the content of anthropogenic and natural contaminants, the content antinutrients and other substances that are characteristic of plant organisms of this type). The list of indicators varies depending on the properties of the studied plant organism; The results of toxicological research (safety assessment of one or more proteins that determine the manifestation of the given characters in GMOs (molecular and biochemical characterization of the protein, the presence or absence of homology with the toxin protein nature, as well as with proteins with pharmacological or other biological activity, the study of stability of the protein in the processing, storage, processing technology, the impact of temperature and ph, possible modification and / or formation of stable protein fragments resulting from various influences, stability of the protein to proteolytic processing enzymes in experiments in vitro; study of acute oral toxicity of protein in the experiments with rodents; additional research); The results of the safety assessment of the native product (the results of studies on rodents, young rapidly growing animals, if such studies succeeded, additional research will be done); The results of allergy research (evaluation of allergenic properties of one or several proteins that determine the manifestation of the given characters in GMOs (comparison with known allergens, using databases containing information on the threedimensional structure and function of known allergens and related proteins), the definition of potential allergenicity of proteins in immunochemical studies in vitro using IgE, isolated from the serum of patients suffering from allergies, the definition of resistance to proteolytic enzymes; screening study with the use of blood serum of patients suffering from allergies, additional research (including in vivo); An evaluation of the allergenic properties of the native product (comparison of a set of GMO allergens investigated with a set of allergens of its traditional counterpart, etc.), if any information is available on the allergenic properties of the donor organism The results of other studies (determination of food and biological value; use of sophisticated analytical techniques such as profiling technology, etc.), in case these studies were conducted; The results of control carried out in countries using GMOs in the production food; 7) The information necessary for the implementation of state control (supervision) for foods derived from GMOs of plant origin: identification and quantification methods of one or more transformation events, testing protocols, a description of primers, standard samples of composition and properties; 8) Materials for registration of food products derived from GMOs of plant origin in other countries Information constituting a state, commercial and (or) official secrets obtained from Rospotrebnadzor in the exercise of its powers, shall not be subjected to disclosure, except in cases established by a Russian Federation law 4.9. During medical and biological evaluation of the safety of food products, derived from GMOs of plant origin, it is used samples of these food products and their conventional counterparts, provided by the applicant.

12 4.10. Authorized organizations prepare and submit to Rospotrebnadzor reports (expert opinion) about the results of biomedical safety assessment of GMOs Rospotrebnadzor, on the basis of the results, takes a decision on State registration according to the established plan and delivers to the applicant a certificate about the State registration Information about GMOs that have passed the state registration shall be made public in a State Register of food materials and products, authorized for production in Russia or importation into the territory of the Russian Federation and traded (hereinafter the State Register). V. Organization of the Federal Service Supervision of Consumers Protection and Wellbeing Rights under the supervision (control) over the circulation of food products derived from / or using Genetically modified microorganisms (innovations and changes in N 6, Approved. Resolution of the Chief Sanitary Inspector of Russia from N 13) 5.1. Food products derived from / or using genetic engineering modified organisms (hereinafter GMO), as well as products derived from / or use of natural microorganisms biotechnology, traditionally used in the food industry and having a geneticallymodified analogues (hereinafter GMA), should be taken on the state registration in the prescribed manner and inserted in the State or Sanitaryepidemiological Register of conformity certifications and entered in the Register of sanitaryepidemiological certificates (nonconformity) in every activity (works, services), production of project documentation requirements of state sanitary epidemiological rules and regulations (hereinafter the Register sanepidzaklyucheny), which are monitored by a compliance of sanitary rules and norms about the examination of juridical persons andindividual entrepreneurs in the following stages: Imported from abroad; Production Storage and transportation; Implementation As regard the choice of food which are subjected to a sanitaryepidemiological examination about the presence of GMO (GMA), it is necessary to proceed from its belonging to one of three groups of products, production technology which foresees the use of microorganisms of technological microflora or microorganismsproducers (Table 1). Table 1 Group of products depending on the condition of their technological microflora or microorganisms producers Group of raw food products,food and food components containing viable technological microflora The field of application and the main types of products Milk, fat oil industry and cheese production ferments, yeast and biomass on the basis of pure cultures and natural symbiosis of lactic acid, probiotic, propionic acid (bifidobacteria, lactobacilli), acetic acid, leuconostoc, thermophilic streptococci and other microorganisms, yeasts and molds for production

13 Sour milk and yogurt products, including infant and dietetic foods, probiotic, cottage cheese, sour cream, etc. Сheeses (all kinds) Acid butter and products based on it Children's dried milk mixture, dried milk products of mass consumption and dietary food. Margarine, mayonnaise Production of biologically active additives to food Supplements to the food on the basis of probiotic microorganisms, biomass and yeast for their production Biologically active plantbased diet with the addition of microorganisms probiotics Meat and Poultry Processing Industry A Starting level ( growing, cultivation) for meat fermentation on the basis of lactic acid, propionovokislyh microorganisms micrococci, nonpathogenic Staphylococcus, Pediococcus, mold, yeast, etc. Smoked and dried meat and poultry products Fish industry Fermented fish products and preserves Bakery Industry, production of fermented beverages, brewing, alcohol and starch industry, sugar production. Beer Kvass, drinks based on tea fungus, etc. Yeast Ferments for bakery products based on lactic acid and other microorganisms for the production of baked products Standard level( cultivation) of microorganisms and yeast,technological aids for directed fermentation of feedstock in the production of alcohol, sugar, vinegar, etc. Fruit & vegetable processing industry and vegetable products Salted and pickled vegetables, mushrooms and cereals products and starter cultures for production Pickled, salted, pickled vegetables and fruits Fermented products based on vegetable soybean milk Fermented soy and grain products (sauces, national dishes, etc.) others Cultures of microorganisms for use as technological aids. II Group of products containing unviable technological microflora Producer strains for the production of enzymes vitamins and biopreservatives etc. Baking industry Bread made by yeast and sour dough Dairy Industry Heat treated dairy products

14 Canned milk and products containing milk based on fermented components or with addition of them,including also baby food Production of juices and juice drinks, wine: purified fruit and citrus juices, wine and fruit wine III Group of food components and substances supplements and micronutrients made with parts of strain producers, but exempt from them in the technological process Production of biologically active additives to food, production of food concentrates, rich and specialized products Extracts, lysates, proteins, protein products, nucleotide mixture on the basis of yeast and other inactivated microbial biomass Starch industry Modified Starches obtained through microbial fermentation Enzyme preparations for the food industry Vitamins (betacarotene, riboflavin), fatty acids, amino flavors, sweeteners Preservatives (lowlands, lactic acid, etc.) Technological aids for production of alcohol Vinegar Edible organic acids (citric, tartaric, apple, etc.) Prebiotics (fructooligosaccharides), dextrin and other products of Starch Industry Protein hydrolysates on the basis of milk production, meat and poultry raw materials, raw fish and the cacthing of nofish products, plant material, including soybean Glucose syrupgalactogene 5.3 The control of food products for authorized GMO for the use in the population and in the food industry in Russia should be guided by information regarding the food products obtained from or with the use of GMO and introduced in the State Register and the Sanitary Epidemological Register in the prescribed manner As regard the control of food products from GMA implemented by the public and used in the food industry should take into account information about the availability of permits for the use of the GMO in the food industry (Table 2), as well as information about the cultures of microorganisms used in the food industry and aware of their genetic engineeringmodified analogues, potentially suitable for food products (Table 3). TABLE 2 GMO and food on the basis of the GMO, which can be used in the world food industry N Type of food commodities or food Product Organisms (groups, genera, species), used to obtain them traditional natural strains GM strains Область применения в производстве: 1 Ferments, бакконцентраты, first, beginning cultures for fermented products and fermentation products Cultivation of yeast Saccharomyces cerevisiae Штаммы, содержащие ген амилазы из Saccharomyces diastaticus пива

15 2 Enzyme preparations for the food industry, food additives Hemi cellulose Aspergillus oryzae Aspergillus niger Xylanase Lipase monoatsilglitserol Bacillus subtilis Humicola insolens Trichoderma reesei Aspergillus niger Aspergillus oryzae B. amyloliqueefaciens или subtilis В. licheniformis Trichoderma reesei или longibrachiatum Bacillus subtilis Penicillium camembertii Aspergillus oryzae, containing gene gemitsellyulazy and endo1, 4 axylanase from Aspergillus aculeatus Aspergillus oryzae, containing the gene hemi cellulose and endo1,4axylanase from Thermomyces lanuginosus Fusarium venetatum with genome Thermomyces lanuginosum Aspergillus oryzae dthermomyces lanuginosus Bacillus subtilis with gene encoding xylanase from Bacillus subtilis Trichoderma reesei dtrichoderma reesei Aspergillus niger var. awamori daspergillus var. Aspergillus niger with a gene encode products endo1,4 xylanase from Aspergillus niger хлебобулочных изделий

16 Lipase triatsilglitserol Aspergillus oryzae Aspergillus niger Rhizopus arrhizus Rhizomucor miehei Rhizophus niveus Rhizophus oryzae Aspergillus oryzae, containing the lipase gene triatsilglitserola of Humicola lanuginose Aspergillus oryzae d Aspergillus oryzae Aspergillus oryzae d Thermomyces lanuginosus Lactase (Ugalactosidase) Aspergillus niger Aspergillus oryzae Saccharomyces fragilis Saccharomyces lactis Invertase Saccharomyces cerevisiae Крахмалов, Gemitsellyulaza (multi enzyme) Inulinaza Maltogenaza (maltogennaya amylase) Aspergillus niger Bacillus subtilis Trichoderma reesei Aspergillus niger B. subtilis B. subtilis with genome B. stearothermophilu s, B. subtilis with genome the B. brevis сиропов

17 Alphaamylase 1. B. subtilis pc. F 2. Aspergillus oryzae var. 3. B. stearothermophilus 4. Bacillus licheniformis 5. Aspergillus niger 6. Bacillus amyloliquefaciens 7. Microbacterium imperiale 8. Rhizopus oryzae 9. Thermococcales 10. Pseudomonas fluorescens 1. B. subtilis with genome the alpha amylase from B. megaterium, builtin plasmid rsrs B. subtilis with the genome alpha amylase from B. stearothermophilu s, builtin plasmid rsrs720 Bacillus licheniformis d Bacillus licheniformis Aspergillus niger d Aspergillus niger Bacillus licheniformis with gene encoding the alpha amylase from B. stearothermophilu s Bacillus amyloliquefaciens with a gene encoding alphaamylase from Bacillus amyloliquefaciens Bacillus amyloliquefaciens / Bacillus subtilis Pseudomonas fluorescens with a gene encoding alphaamylase from Thermococcales хлебобулочных изделий, напитков, крахмалов Dextronase Chaetomium erraticum Chaetomium gracile Fructose Aspergillus japonicus transferase Glucogenase B. stearothermophilus хлебобулочных изделий Аminoglucosidas e Aspergillus niger хлебобулочных изделий Aspergillus niger, carrying gene encoding amiloglyukozidaz u

18 Carbohydrases Aspergillus niger, var. Aspergillus awamori, var. Bacillus licheniformis Rhizopus oryzae, var. Saccharomyces spp. Catalase Micrococcus lysodeikticus Aspergillus niger Cellulose Chimosin A (Rennet) for cheesemaking Chimosin A for cheesemaking Chimosin B for cheesemaking Chimosin B for cheesemaking Penicillium funiculosum Trichoderma reesei Trichoderma viride Aspergillus niger Aspergillus aculeatus Kluyveromyces lactis B glucanase Aspergillus niger var. Trichoderma harzianum Trichoderma reesei or longibrachiatum Talaromyces emersonii B. subtilis or amyloliquefaciences Aspergillus aculeatus Disporotrichum dimorimorphosporum Aspergillus niger organism donor Trichoderma reeseid Trichoderma reesei E. coli K12 IA 198, containing synthesized chemical coding DNA sequence identical to the bovine gene prohimozina A, builtin vector PPFZ87A Aspergillus niger var. awamori, содерж. ген бычьего прохимозина (NRRZ3112) Вектор pgampr Kluyveromyces lactis (Dombr. Van del Walt) with the bovine genome prochimosin, Amplified on plasmid PUC18 Trichoderma reesei, containing the gene of bovine chimosin B Organismdonor Trichoderma sp. Bacillus sp. B. amyloliquefacienc is d B. amyloliquefacienc is сыров сыров сыров сыров сыров

19 Xylose B. coagulans, Streptomyces olivaceous, Streptomyces rubiginosus, Streptomyces violaceoniger Glucosidase and Aspergillus niger catalase Hemi cellulose Aspergillus niger Lipase Mixture carboaminhydras e and protease Aspergillus oryzae Rhizopus oryzae Rhizopus niveus Penicillium roquefortii Penicillium camembertii Mucor javanicus Rhizomucor miehei Fusarium oxysporum Termomyces lanuginosus B. subtilis var. Aspergillus niger d Aspergillus niger Donor organism Candida antarctica Rhizomucor spp. and Thermomyces spp. Aspergillus niger with the gene lipase from Candida antarctica Aspergillus oryzae with the gene lipase from Rhizomucor miehei Aspergillus oryzae with the gene lipase from Fusarium oxysporum Aspergillus oryzae with a gene encoding lipase from Termomyces lanuginosus масложировой продукции, триглециридов алкогольной продукции, хлебобулочных изделий Pectinase Aspergillus niger Rhizopus oryzae Aspergillus aculeatus Aspergillus oryzae Aspergillus oryzae d Aspergillus aculeatus Aspergillus niger d Aspergillus niger

20 Protease Pullulanase chymesin (Rennet) for cheesemaking Alpha glucoamylase + amylase Aspergillus niger Aspergillus oryzae. Aspergillus melleus Streptomyces fradias Bacillus licheniformis. B. amyloliquefaciens Bacillus subtilis Bacillus thermoprotyolyticus Bacillus stearothermophilus Rhizopus niveus Rhizopus oryzae Klebsiella alrogenes Bacillus acidopullulyticus Bacillus naganoensis Bacillus circulans Klebsiella planticola B. cereus, Mucor miehei, Mucor pysillus, Rhizomucor miehei, Rhizomucor susillus B. mesentericus. Cryphonectria parasitica Aspergillus oryzae Donor organism Rhizomucor Bacillus subtilis d B. amyloliquefaciens Bacillus amyloliquefaciens db. amyloliquefaciens Aspergillus oryzae d Rhizomucor miehei Bacillus amyloliquefaciens plasmid pubnpr2, carrying a gene neutral protease of vector DNA pub110 from Bacillus amyloliquefaciens Bacillus licheniformis d Bacillus deramificans Bacillus subtilis d Bacillus naganoensis Klebsiella planticola d Klebsiella planticola Cryphonectria parasitica d Cryphonectria parasitica Aspergillus oryzae d Rhizomucor miehei аспартама сыров Aspergillus oryzae продуктов крахмалопаточн ой промышленност и Beta Glucanase Aspergillus niger Acetolactathydroc arboxylase B. subtilus UW 193 with the gene alphadecarboxylase from B. brevis on plasmid PUW 235