Customs Union Technical Regulation on Food Safety

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Posted on: 27 May 2012

The Technical Regulation of the Russia-Kazakhstan-Belarus Customs Union (CU) on Food Safety (TR TS 021/2011) is a key CU umbrella regulation covering standards and requirements for all food products

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Voluntary Public - Date: 05.23.2012 GAIN Report Number: RS1233 Russian Federation Post: Moscow Customs Union Technical Regulation on Food Safety Report Categories: FAIRS Subject Report Sanitary/Phytosanitary/Food Safety Policy and Program Announcements Approved By: Morgan Haas Prepared By: Staff Report Highlights: The Technical Regulation of the Russia-Kazakhstan-Belarus Customs Union (CU) on Food Safety (TR TS 021/2011) is a key CU umbrella regulation covering standards and requirements for all food products and processes of their production. It was adopted by the CU Commission decision No. 880 of December 9, 2011, and will come into effect as of July 1, 2013. Table of Contents General Information .................................................................................................................................................... 4 Decision No. 880 On Adoption of Technical regulation of the Customs Union ―On Food Safety‖.............................. 4 TECHNICAL REGULATION On Food Safety ......................................................................................................... 9 CHAPTER 1. GENERAL PROVISIONS ................................................................................................................ 9 Article 1. Scope .................................................................................................................................................... 9 Article 2. Purposes of Adoption ........................................................................................................................... 9 Article 3. Subjects of Technical Regulation ....................................................................................................... 10 Article 4. Definitions .......................................................................................................................................... 10 Article 5. Rules of Circulation on the Market .................................................................................................... 14 Article 6. Identification of Food Products (Processes) for the Purpose of their Referral to the Subjects of Technical Regulation of the Present Technical regulation .................................................................................................. 14 CHAPTER 2. FOOD SAFETY REQUIREMENTS .............................................................................................. 15 Article 7. General Food Safety Requirements .................................................................................................... 15 Article 8. Safety Requirements for Specialized Food Products ......................................................................... 16 Article 9. Requirements for Tonic Beverages .................................................................................................... 19 CHAPTER 3. REQUIREMENTS FOR PROCESSES OF PRODUCTION (MANUFACTURING), STORAGE SHIPMENT (TRANSPORT), SALES, AND DISPOSAL OF FOOD PRODUCTS .............................................. 19 Article 10. Ensuring Safety of Food Products during the Processes of their Production (Manufacturing), Storage, Shipment (Transport), Sales, and Disposal ......................................................................................................... 19 Article 11. Requirements for Ensuring of Food Products Safety in the Process of their Production (Manufacturing) ............................................................................................................................................................................ 20 Article 12. Requirements for Provision of Processes of Food Products Production (Manufacturing) with Water ............................................................................................................................................................................ 21 Article 13. Requirements for Safety of Food Raw Materials that are Used in Production of Food Products .... 22 Article 14. Requirements for Management of Operational Premises where Process of Food Products Production (Manufacturing) is Carried out ........................................................................................................................... 22 Article 15. Requirements for Use of Technological Equipment and Utensils in the Process of Food Products Production (Manufacturing) .................................................................................................................................................. 24 Article 16. Requirements for Storage Conditions and Waste Disposal of Food Products Production (Manufacturing) ............................................................................................................................................................................ 24 Article 17. Requirements for Processes of Storage, Shipment (Transport), and Sales of Food Products .......... 25 Article 18. Requirements for Processes of Food Disposal ................................................................................. 26 Article 19. Requirements for Processes of Obtaining of Non-Processed Food Products of Animal Origin ...... 26 Article 20. Ensuring Conformity of Food Products to Safety Requirements ..................................................... 27 CHAPTER 4. ASSESSMENT (CONFIRMATION) OF CONFORMITY ............................................................ 27 Article 21. Forms of Assessment (Confirmation) of Conformity of Food Products and Processes of Production (Manufacturing), Storage, Shipment (Transport), Sale, and Disposal ................................................................ 27 Article 22. Applicant for Assessment (Confirmation) of Conformity of Food Products ................................... 28 Article 23. Declaration of Conformity ............................................................................................................... 28 Article 24. State Registration of Specialized Food Products .............................................................................. 31 Article 25. Procedure of State Registration of Specialized Food Products ........................................................ 32 Article 26. Unified Register of Specialized Food Products ................................................................................ 33 Article 27. State Registration of Novel Food Products ...................................................................................... 33 Article 28. Procedure of State Registration of Novel Food Products ................................................................. 34 Article 29. Unified Register of Novel Food Products ........................................................................................ 35 Article 30. Veterinary-Sanitary Inspection ......................................................................................................... 35 Article 31. State Registration of Production Facilities ....................................................................................... 36 Article 32. Food Products Production Facilities that are subject to State Registration ...................................... 37 Article 33. Application for State Registration of Production Facilities .............................................................. 37 Article 34. Documents Confirming State Registration of Production Facilities ................................................ 38 Article 35. Procedure of Notification about Changes of Actual Information about Applicant and Food Products Production Facilities that are subject to State Registration ................................................................................. 38 Article 36. Register of Food Products Production Facilities that are subject to State Registration .................... 39 CHAPTER 5. STATE CONTROL (SURVEILLANCE) ....................................................................................... 40 Article 37. Keeping Record of Food Products Production Facilities ................................................................. 40 Article 38. State Control (Surveillance) over Compliance with Requirements of the Present Technical regulation ............................................................................................................................................................................ 40 CHAPTER 6. FOOD PRODUCTS LABELING ................................................................................................... 40 Article 39. Requirements for Food Products Labeling ....................................................................................... 40 CHAPTER 7. SAREGUARD CLAUSE ................................................................................................................ 41 Article 40. Safeguard Clause .............................................................................................................................. 41 Annex No. 1 Microbiological Food Safety Standards (Pathogenic) ....................................................................... 42 Annex No. 2 Microbiological Food Safety Standards ............................................................................................ 45 Annex No. 3 Hygienic safety requirements for food products ................................................................................ 75 Annex No. 4 Maximum Allowable Levels of Radionuclides Cesium-137 and Strontium-90 .............................. 108 Annex No. 5 Requirements for Unprocessed Food (Eatable) Raw Materials of Animal Origin .......................... 110 Annex No. 6 Parasitologicalal Safety Indicators of Fish, Crustaceans, Shellfish, Amphibians, Reptilians, and Products of their Processing ..................................................................................................................................................... 115 Annex No. 7 List of Plants and Products of their Processing, Species of Animal Origin, Microorganisms, Mushrooms, and Biologically Active Substances, Prohibited for Use as Part of Biologically Active Food Additives .................... 120 Annex No. 8 Species of Plant Raw Materials for Manufacturing of Biologically Active Food Additives for Children from 3 to 14 Years Old and Baby Herbal Teas (Herbal Drinks) for Infants .................................................................. 132 Annex No. 9 Vitamins and Mineral Salts Used in Manufacturing of Food Products for Baby Food ................... 134 Annex No. 10 Pesticides prohibited for use in production of food (edible) raw materials intended for manufacturing food products for baby food ........................................................................................................................................... 135 List of standards, voluntary application of which ensures compliance with the requirements of the Technical regulation of the Customs Union “On Food Safety” (TR TS 021/2011) .............................................................. 136 List of Standards containing the rules and methods of examination (testing) and measurement, including the rules for selection of samples required for application and meeting of the requirements of the Technical regulation “On Food Safety” (TR TS 021/2011) and carrying out of assessment (confirmation) of products’ conformity. .............. 146 General Information The Technical regulation of the Russia-Kazakhstan-Belarus Customs Union (CU) on Food Safety (TR TS 021/2011) is a key CU umbrella regulation covering standards and requirements for all food products and processes of their production. It was adopted by the CU Commission decision No. 880 of December 9, 2011, and will come into effect as of July 1, 2013. Below is an unofficial translation of the following: - CU Commission decision No. 880 of December 9, 2011; - CU Technical regulation on Food Safety (TR TS 021/2011) with ten annexes; - List of standards, voluntary application of which ensures compliance with the requirements of the Technical regulation of the Customs Union ―On Food Safety‖ (TR TS 021/2011); - List of Standards containing the rules and methods of examination (testing) and measurement, including the rules for selection of samples required for application and meeting of the requirements of the Technical regulation ―On Food Safety‖ (TR TS 021/2011) and carrying out of assessment (confirmation) of products’ conformity. Decision December 9, 2011 No. 880 Moscow On Adoption of Technical regulation of the Customs Union “On Food Safety” In accordance with Article 13 of the Agreement on common principles and rules of technical regulation in the Republic of Belarus, Kazakhstan and the Russian Federation of November 18, 2010 Customs Union (hereinafter – the Commission) has decided to: 1. Adopt technical regulation of the Customs Union, "On Food Safety" (TR TS 021/2011) (attached). 2. To approve: 2.1. The list of standards voluntary application of which ensures compliance with the requirements of the Technical regulation of the Customs Union ―On Food Safety‖ (TR TS 021/2011) (attached); 2.2. List of Standards containing the rules and methods of examination (testing) and measurement, including the rules for selection of samples required for application and meeting of the requirements of the Technical regulation ―On Food Safety‖ (TR TS 021/2011) and carrying out of assessment (confirmation) of products’ conformity (attached). 3. Establish: 3.1. Technical regulation of the Customs Union ―On Food Safety‖ (hereinafter – the Technical regulation) shall come into force on 1 July 2013; 3.2. Documents on the assessment (confirmation) of compliance with the statutory requirements established by the regulations of the Customs Union or the laws of the Customs Union member-state, issued or adopted in relation to goods which are subjects of the technical regulation of the Technical regulation (hereinafter – the products), before coming into force of the Technical regulation are valid until the expiration of their validity, but no later than February 15, 2015. The stated documents, issued or adopted before the official publication of this Decision, are valid until the expiry of their validity; From the date of entry into force of the Technical regulation issuance or adoption of documents for assessment (confirmation) of conformity to the mandatory requirements previously established by the regulations of the Customs Union or the laws of the Customs Union member-states, is not allowed; 3.3. Until February 15, 2015, the production and release into circulation of products in accordance with the mandatory requirements previously established by the regulations of the Customs Union or the laws of the Customs Union member-states, is allowed if documents on assessment (confirmation) of conformity to the specified regulatory requirements, issued or adopted before the effective date of the Technical regulation, are available. The above products are marked with a national mark of conformity (a mark of circulation on the market) in accordance with the laws of the Customs Union member-state or the Commission Decision No. 386 of 20 September 2010; Marking a product with a unified mark of circulation on the market of the Customs Union member- states is not allowed. 3.4. Circulation of products released into circulation during the period of validity of documents on assessment (confirmation) of conformity, stated in subparagraph 3.2 of this Decision, shall be permitted during the period of shelf life of the products, established in accordance with the laws of the Customs Union member-state. 3.5. The following products shall be subject to state registration in the manner provided in Article 24 of the Technical regulation, until February 15, 2015: 1) natural table mineral water; 2) bottled potable water, packaged in containers; 3) tonic drinks; 4) food additives, complex food additives, flavorings, plant extracts as flavoring substances and raw materials, starter cultures of microorganisms and bacterial starter cultures, processing aids, including enzymes; 5) food products received with the use of genetically modified (transgenic) organisms, including genetically modified organisms; 3.6. Data on industrial facilities, which have been carrying out the activity on production (manufacturing) of food products in accordance with the laws of a Customs Union member-state, shall be entered into the State Register without carrying out state registration procedures for industrial facilities in accordance with the Technical regulation; 3.7. The provisions of Article 29 of the Technical regulation shall come into force with the introduction of the Integrated Information System of external and mutual trade of the Customs Union. 3.8. As of the date of entry into force of technical regulations of the Customs Union on certain types of food products, the Technical regulation shall be amended to clarify the names of food products in accordance with the definitions set forth by such technical regulations, and to exclude safety requirements for the products, which are regulated by such technical regulations (except for the requirements for the content of pathogenic microorganisms and their toxins, mycotoxins, toxic elements, nitrates, global pesticides, as well as acceptable levels of radionuclides), and microbiological safety standards (opportunistic pathogens). 4. Secretariat of the Commission in cooperation with the Parties: 4.1. Prior to the date of entry into force of technical regulations of the Customs Union on certain types of food products to ensure introduction of amendments to the Technical regulation in accordance with paragraph 3.8 of this Decision. 4.2. To prepare a draft action plan needed to implement the Technical regulation, and within three months from the date of entry into force of this Decision, to ensure it submission for the Commission’s approval in the prescribed manner providing for the following: 4.2.1. Preparation and submission for approval by the Commission in the prescribed manner by March 15, 2013, of a draft decision on amendments to the Unified sanitary-epidemiological and hygienic requirements for the goods subject to sanitary surveillance (control), approved by the Customs Union Commission decision No. 299 of May 28, 2010, on exclusion of requirements for the products, which are regulated by the Technical regulation; 4.2.2. Preparation and submission for approval by the Commission in the prescribed manner by March 15, 2013, of a draft decision on amendments to the Uniform list of products subject to mandatory assessment (confirmation) of compliance in the Customs Union with the issuance of unified documents, approved by the Customs Union Commission Decision No. 620 of April 7, 2011, on exclusion of the products, which are regulated by the Technical regulation; 4.2.3. Preparation and submission for approval by the Commission in the prescribed manner by March 15, 2013, of a draft decision on amendments to the Unified list of goods subject to sanitary- epidemiological supervision (control) at the customs border and the customs territory of the Customs Union, approved by the Customs Union Commission decision No. 299 of May 28, 2010, on exclusion of the products, which are regulated by the Technical regulation; 4.2.4. Preparation and submission for approval by the Commission in the prescribed manner of the draft amendments to the procedures of renewal of documents on assessment (confirmation) of conformity to the mandatory requirements that were previously established by the regulations of the Customs Union or the legislation of the Customs Union member-state, issued or adopted before the entry into force of the Technical regulation, for the documents on assessment (confirmation) of conformity to the mandatory requirements of the Technical regulation, except in cases where indicators and (or) their permissible levels do not match the indicators and (or) their permissible levels specified in the Technical regulation; 4.2.5. Preparation and submission for approval by the Commission in the prescribed manner by March 15, 2013, of a draft program for development (amendments, revision) and introduction of interstate standards, the application of which on a voluntary basis ensures compliance with the requirements of the Technical regulation, as well as interstate standards containing rules and methods of examination (tests) and measurements, including the rules of sampling, necessary for the implementation and enforcement of the Technical regulation and the implementation of assessment (confirmation) of the products’ compliance. 4.2.6. Preparation and submission for approval by the Commission in the prescribed manner by March 15, 2013, of a draft decision on amendments to the Unified list of goods subject to veterinary control (supervision), approved by the Customs Union Commission decision No. 317 of June 18, 2010, on exclusion of the products, which are referred to processed food products of animal origin according to the Technical regulation; 4.2.7. Preparation and submission for approval by the Commission in the prescribed manner by March 15, 2013, of a draft decision on amendments to the Regulation on the unified procedure for joint inspections of facilities and sampling of goods (products), subject to veterinary control (supervision), approved by the Customs Union Commission decision No. 834 of October 18, 2011, with regard to bringing it in compliance with the provisions of the Technical regulation; 4.2.8. Preparation and submission for approval by the Commission in the prescribed manner by March 15, 2013, of a draft Regulation "On the establishment of inspection criteria for registration of industrial facilities, carrying out the activities of receiving, processing (reprocessing) of raw unprocessed food products of animal origin." 5. The Russian Party, with the participation of the Parties, on the basis of the results of monitoring of the standards’ application to ensure the preparation of proposals to update the list of standards referred to in paragraph 2 of this Decision and their submission to Secretariat of the Commission for approval in due course at least once a year from the date of entry into force of the Technical regulation. 6. The parties shall: 6.1. By July 1, 2013, ensure adoption of the appropriate decision on the non-application of the regulations of their countries in respect of products, which are regulated by the Technical regulation; 6.2. By July 1, 2013, ensure the readiness of certification bodies, test laboratories (centers) engaged in work on assessment (confirmation) of compliance, for registration of declarations of compliance with the requirements of the Technical regulation; 6.3. Prior to the date of entry into force of the Technical regulation, determine the bodies of state control (supervision), responsible for the implementation of state control (supervision) over compliance with the requirements of the Technical regulation, and inform the Commission thereof; 6.4. From the date of entry into force of the Technical regulation, ensure carrying-out of state control (supervision) over compliance with the requirements of the Technical regulation, taking into account sub-paragraphs 3.2 - 3.4 of this Decision. 7. This Decision shall take effect from the date of its official publication. The Commissioners of the Customs Union: From the Republic of From the Republic of from the Russian Belarus Kazakhstan Federation S. Rumas U. Shukeyev I. Shuvalov TECHNICAL REGULATION On Food Safety CHAPTER 1. GENERAL PROVISIONS Article 1. Scope 1. The Technical regulation of the Customs Union ―On Food Safety‖ (hereinafter – the present Technical regulation) shall establish the following: 1) subjects of technical regulation; 2) safety requirements (including sanitary and epidemiological, hygienic and veterinary) for the subjects of technical regulation; 3) rules of identification of the subjects of technical regulation; 4) forms and procedures of assessment (confirmation) of conformity of the subjects of technical regulation to the present Technical regulation. 2. In application of the present Technical regulation, the requirements established by the relevant technical regulations of the Customs Union, for food products in terms of their labeling, packaging materials, items and equipment for food products production that come into contact with food products, shall be taken into account. 3. In application of the present Technical regulation, the requirements of technical regulations of the Customs Union establishing mandatory requirements for certain types of food products and for the processes of production (manufacturing), storage, shipment (transport), sales, and disposal that are related to the requirements for such food products (hereinafter - technical regulations of the Customs Union for certain types of food products), supplementing and (or) clarifying the requirements of the present Technical regulation, shall be taken into account. Requirements for certain types of food products and for the processes of production (manufacturing), storage, shipment (transport), sales, and disposal that are related to the requirements for such food products, which are established by the other technical regulations of the Customs Union, shall not modify the requirements of the present Technical regulation. 4. Technical regulation of the Customs Union for certain types of food products shall establish the following: 1) subjects of technical regulation; 2) safety requirements for the subjects of technical regulation; 3) rules of identification of the subjects of technical regulation. Technical regulation of the Customs Union for certain types of food products may contain requirements for labeling and contain procedures of conformity confirmation, which do not contradict the requirements of the present Technical regulation. Article 2. Purposes of Adoption The purposes of adoption of the present Technical regulation are: 1) protection of human life and (or) health; 2) prevention of actions that can mislead purchasers (consumers); 3) protection of the environment. Article 3. Subjects of Technical Regulation 1. The subjects of technical regulation of the present Technical regulation shall be the following: 1) food products; 2) processes of production (manufacturing), storage, shipment (transport), sales, and disposal that are related to the requirements for food products. 2. The present Technical regulation shall not cover food products produced by individuals at home, in private household farms or by individuals who engage in horticulture, gardening, and cattle raising; and the processes of production (manufacturing), storage, shipment (transport), and disposal of food products designed for personal consumption only, but not for release into circulation on the customs territory of the Customs Union; cultivation of crops and raising of producing animals in the wild. Article 4. Definitions For the purposes of the present Technical regulation the following terms are used: adapted milk mixtures (breast milk substitute) – baby food products for infants produced in liquid or powdered form on the basis of cow milk or milk of other producing animals and chemically close to the maximum to breast milk for the purposes of satisfying physiological needs of infants for required elements and energy; food flavoring (flavoring) – flavoring substance, or flavoring preparation, or thermal technological flavoring, or smoked flavoring, or flavoring precursors, or their mixture (flavoring part) that are not taken in directly as food and are used for flavoring of food products (with the exception of sweet, sour and salty flavor) with or without adding of other ingredients; safety of food products – condition of food products indicating the absence of inadmissible risk connected with adverse health effects on humans and future generations; biologically active food additives (BAA) – natural and (or) identical to natural biologically active substances, as well as probiotic microorganisms, intended for consumption together with food or mixing into food products; potable water for baby food – potable water intended for baby drinking, cooking and recovering of dry products for feeding of children at home; aquatic biological resources – fishes, aquatic invertebrates, aquatic mammals, algae, other aquatic animals and plants in natural habitat (in natural free-ranging state); adverse health effects of food products on humans – influence of adverse factors connected with presence in food products of contaminants and pollutants that create a threat to human life and health or a threat to life and health of future generations; release of food products into circulation – act of sale and purchase or other terms of food products transfer on the customs territory of the Customs Union starting from manufacturer or importer; genetically modified (genetically engineered, transgenic) organisms (hereinafter - GMO) – an organism or several organisms, any noncellular, unicellular or multicellular formations able for reproduction or transfer of genetic material differing from natural organisms obtained with the use of genetic engineering methods and (or) containing genetically engineered material including genes, their fragments or gene combinations; state registration of production facilities that carry out activities of obtaining, processing (reprocessing) of non-processed food raw materials of animal origin (hereinafter - state registration of production facilities) – provision of access for legal bodies or individual entrepreneurs to the activities of obtaining and processing (reprocessing) of non- processed food raw materials of animal origin; baby herbal beverage (herbal tea) – food products for baby food produced on the basis of herbs and herb extracts; food products identification – procedure of referring food products to the subjects of technical regulation targeted by technical regulations; food manufacturer – an organization regardless of its type of business or an individual entrepreneur including foreign ones that produce (manufacture) food products in their own name for sale to purchasers (consumers) and that are responsible for the conformity of these products to requirements of technical regulations; importer – a resident of a Member State of the Customs Union, which releases food products delivered by a non- resident of a Member State of the Customs Union into circulation on the customs territory of the Customs Union and which is responsible for the conformity of these products to the present Technical regulation; food product component (food ingredient) (hereinafter - component) – a product or a substance (including food additives, flavorings), which in accordance with the recipe are used in the production (manufacturing) of food products and are an integral part thereof; contamination of food products – penetration of items, particles, substances, and organisms (contaminants, pollutants) into food products and their presence in amounts abnormal to these food products or exceeding approved levels, so that they acquire characteristics that are hazardous for humans; initial milk mixtures – adapted (as close chemically as possible to breast milk) or partially adapted (chemically partially close to breast milk) mixtures produced on the base of cow milk or milk of other producing animals and intended for feeding of infants from the first days of life to the age of six months; non-processed food products of animal origin – carcasses (whole rounds) of producing animals of all types that have not been processed (reprocessed), their parts (including blood and offal), raw milk, raw skim milk, raw cream, beekeeping products, eggs and egg products, aquatic biological resources catch, aquaculture products; norms of physiological need for energy and feedstuffs – daily consumption level for feedstuffs that is sufficient for satisfaction of physiological needs of not less than 97.5 percent of population taking into account age, sex, physiological state and physical activity; nutrients (feedstuffs) – substances being components of food products, which are used by human organism as energy sources, sources or precursors of substrates for building, growth, and regeneration of organs and tissues, formation of physiologically active substances that take part in regulation of vital processes, and defining food products’ nutritional value; enriched food products – food products, to which one or more feedstuffs and (or) biologically active substances and (or) probiotic microorganisms that were not originally present therein or that were present in insufficient quantity or lost during the process of production (manufacturing), have been added; herewith the content, which was guaranteed by the manufacturer, of each feedstuff or biologically active substance used for enrichment has been brought to a level meeting the criteria for food products that are the source of the feedstuff or for other distinguishing characteristics of food products; and maximum levels of feedstuffs and (or) biologically active substances in such products shall not exceed the upper level of safe consumption of such substances with their intake from all possible sources (if such levels are available); aquaculture animals – fishes, aquatic invertebrates, aquatic mammals, algae, other aquatic animals and plants contained and raised and planted, and also cultured in semi-free conditions or in artificially created habitat; food products lot – a certain quantity of food products of single line, identically packaged, produced (manufactured) by one manufacturer in accordance with the same regional (interstate) or national standard, and (or) standard of organization, and (or) other manufacturer’s documents, within a certain period of time accompanied by supporting documents that ensure traceability of food products. food additive – any substance (or mixture of substances), with or without its own nutritional value that is usually not consumed directly by humans as food, which is deliberately added to food products for technological purposes (functions) during their production (manufacturing), shipment (transport), and storage that results or may result in the fact that this substance or products of its transformation become components of food products; food additive may perform one or several technological functions; food products – products of animal, plant, microbiological, mineral, artificial, or biotechnological origin, that are natural, processed or reprocessed and are intended for human consumption, including specialized food products, packaged potable water, potable mineral water, alcoholic products (including beer and beer-based drinks), non-alcoholic beverages, biologically active additives (BAA), chewing gum, ferments and starter cultures of microorganisms, yeast, food additives and flavorings, as well as food raw material; food aquaculture products – aquaculture animals hauled (caught) from semi-free conditions of their raising, farming or from an artificially created habitat; food products of dietary therapeutic nutrition – specialized food products with predetermined nutritional and energy value, physical and organoleptical properties, and intended for use as part of therapeutic diets; food products of dietary prophylactic nutrition – specialized food products intended for correction of carbohydrate, lipid, protein, vitamin, and other types of metabolism, where the content and (or) proportion of separate substances was changed as compared to their natural content and (or) which include substances and components that were not initially present, as well as food products that are intended to mitigate risks of development of diseases; food products for baby food – specialized food products intended for baby food for children (for infants from 0 to 3 years old, pre-school-age children from 3 to 6, school-age children from 6 years old and older) that meet respective physiological needs of the child’s organism and are not harmful to health of a respectively aged child; food products for sportsmen nutrition – specialized food products of predetermined chemical composition with increased nutritional value and (or) directed efficiency consisting of a complex of products or represented by their certain types that is targeted specifically at raising adaptive capabilities of humans to physical and psycho-emotional stresses; food products of noncommercial manufacture – food products obtained by individuals at home and (or) in private household farms or by individuals who engage in horticulture, gardening, cattle raising, and other types of activities; novel food products – food products (including food additives and flavorings) that were not previously used for human consumption on the customs territory of the Customs Union, namely: with new or deliberately modified primary molecular structure; consisting of or being isolated from microorganisms, fungi or algae; from plants; isolated from animals, obtained from GMO or with their use; nanomaterials and nanotechnology products except for food products obtained by traditional methods, being in circulation and considered safe by virtue of experience; dehydrated food products – food products, from which originally present water was removed entirely or partially; supplemental feeding products – food products for baby food, which are introduced into the infants’ diet as a supplement to breast milk, substitutes of breast milk or subsequent milk mixtures, and is produced (manufactured) on the basis of ingredients of animal and (or) plant origin; food products of mixed composition – food products, consisting of two or more components except for food additives or flavorings; processing (reprocessing) – heat treatment (except for freezing or cooling), fuming, canning, ageing, ripening, souring, salting, drying, pickling, concentration, extraction, extrusion or a combination of these processes; subsequent milk mixtures – adapted (as close chemically as possible to breast milk) or partially adapted (chemically partially close to breast milk) mixtures produced on the base of cow milk or milk of other producing animals and intended for feeding of infants from the age of six months in combination with supplemental feeding products; prebiotics – food substances that selectively stimulate the growth and (or) biological activity of the protective human intestinal microflora, and facilitate its normal composition and biological activity when systematically consumed as part of food products; probiotic microorganisms – live nonpathogenic and non-toxigenic microorganisms – organisms of protective groups of normal intestinal microbiocenosis of a healthy human and of natural symbiotic aggregations incoming as part of food products for improvement (optimization) of the composition and biological activity of the protective human intestinal microflora; food raw materials – products of animal, plant, microbiological, mineral, artificial, and biotechnological origin, and potable water used for production (manufacturing) of food products; producing animals – animals, except for fishes, aquatic invertebrates, aquatic mammals, and other aquatic animals, intentionally used for obtaining food products from them; production facility where the activities of obtaining, processing (reprocessing) of non-processed food raw materials of animal origin are carried out – facility (building, construction, premises, structure, and other facility) intended for carrying out of activities of obtaining, processing (reprocessing) of non-processed food raw materials of animal origin and used during carrying out of the specified activities; belonging to a legal entity or a natural person as an individual entrepreneur, executing the specified activities as the owner or on other lawful grounds; traceability of food products – possibility to determine through documents (in hard copy or electronic form) the manufacturer and following owners of the food products in circulation except for end user, and also the place of origin (production, manufacturing) of food products and (or) food raw materials; process of food products production (manufacturing) – the whole of or a combination of successively executed various technological operations of food products production (manufacturing); cage fish – fish, raised and (or) stored in a fixture, placed in a water body to keep it alive; perishable food products – food products with a shelf life not exceeding 5 days, unless otherwise established by technical regulations of the Customs Union for certain types of food products, that require special storage and shipment (transport) temperature regimes to keep their safety and prevent cultivation of pathogenic microorganisms, spoilage microorganisms and (or) creation of toxins levels harmful for human health; specialized food products – food products which are regulated by the requirements for their content and (or) proportion of separate substances or all substances and components; and (or) the content and (or) proportion of separate substances with respect to their natural content in such food products has been changed; and (or) the contents includes substances or components initially not present in the products (except for food additives and flavorings); and (or) the manufacturer claims their medical and (or) preventive properties; and which are intended for safe consumption of such food products by certain categories of people; food products shelf life – period of time, during which food products should fully conform to the safety requirements established for them by the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products, as well as keep its consumer properties specified on the label, and upon expiry of which food products are unfit for their intended use; processing aids – substance or materials or their derivatives (except for equipment, packing materials, articles, and utensils) that are not food components and are purposely used during processing of food raw materials and (or) during manufacturing of food products for fulfillment of certain technological purposes and upon achievement thereof are removed from such raw materials, such food products, or residual quantities of which have no technological effect in the final food products; tonic beverages – nonalcoholic and low alcohol beverages containing tonic agents (components), including of plant origin, in the amount sufficient to have a tonic effect on the human organism, except for tea, coffee, and beverages on their basis; catch of aquatic biological resources – aquatic biological resources hauled (caught) in natural habitat; food products disposal – use of food products that do not conform to the requirements of technical regulations of the Customs Union for the purposes that vary from the purposes, for which the food products were intended and are usually used; or bringing of food products that do not conform to the requirements of technical regulations of the Customs Union into the state unfit for any of their use or application as well as excluding its negative effect on humans, animals, and the environment. Article 5. Rules of Circulation on the Market 1. Food products shall be released into circulation on the market provided that they conform to the present Technical regulation as well as other technical regulations of the Customs Union, to which they are subject. 2. Food products that conform to the present Technical regulation as well as other technical regulations of the Customs Union, to which they are subject, and that have passed the procedures of assessment (confirmation) of conformity shall be marked with the unified mark of circulation on the market of the Customs Union member-states. 3. Food products released into circulation, including food raw materials shall be accompanied by supporting documents ensuring traceability of these products. 4. A participant of economic activity (owner of food products) shall withdraw food products from the circulation by himself or upon instruction of the authorized state control (surveillance) bodies of a Customs Union member-state in case the food products do not comply with the requirements of the present Technical regulation and (or) other technical regulations of the Customs Union, to which they are subject, including food products with expired shelf life. Article 6. Identification of Food Products (Processes) for the Purpose of their Referral to the Subjects of Technical Regulation of the Present Technical regulation 1. Interested persons shall carry out identification of food products for the purpose of referring food products to the subjects of technical regulation, to which the present Technical regulation shall apply. 2. Identification of food products is carried out according to their name and (or) features specified in the definition of such products in the present Technical regulation or in technical regulations of the Customs Union for certain types of food products, and (or) using visual, and (or) organoleptical, and (or) analytical methods. 3. Identification of food products is carried out by the following methods: 1) by their name – by way of comparing the name and the purpose of the food products stated on the label on the consumer package and (or) in the accompanying supporting documents with the name specified in the definition of the type of food products in the present Technical regulation or other technical regulations of the Customs Union for certain types of food products; 2) by a visual method – by way of comparing the visual appearance of food products with the features specified in the definition of such food products in the present Technical regulation and (or) in technical regulations of the Customs Union for certain types of food products; 3) by an organoleptical method – by way of comparing the organoleptic characteristics of food products with the features specified in the definition of such food products in the present Technical regulation or in technical regulations of the Customs Union for certain types of food products. The organoleptical method shall be applied if it is impossible to identify food products by their name or by the visual method; 4) by an analytical method – by way of checking of conformity of the food products’ physical-chemical and (or) microbiological characteristics with the ones specified in the definition of such food products in the present Technical regulation or in technical regulations of the Customs Union for certain types of food products. The analytical method shall be applied if it is impossible to identify food products by their name, by the visual or organoleptical methods. CHAPTER 2. FOOD SAFETY REQUIREMENTS Article 7. General Food Safety Requirements 1. Food products in circulation in the customs area of the Customs Union should be safe within the established shelf life during their intended use. 2. Food products’ safety indicators are established in Annexes 1, 2, 3, 4, and 5 of the present Technical regulation. 3. Safety indicators (besides microbiological ones) for food products of mixed composition are defined according to the contribution of separate components taking into account weight ratios and safety indicators for those components established by the present Technical regulation unless otherwise established by Annexes 1, 2, 3, 4, and 6 of the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products. 4. Safety indicators (besides microbiological ones) for dehydrated food products are calculated on the base of initial raw food products taking into account dry substances therein and in dehydrated food products unless otherwise established by Annexes 1, 2, 3, 4, 5, and 6 of the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products. 5. Presence of agents of infectious and parasitic diseases, and their toxins that pose a health risk to humans and animals is not allowed in food products in circulation. 6. Shelf life and storage conditions of food products shall be established by the manufacturer. 7. Materials used for manufacturing of packaging and articles that are in contact with food products shall conform to the requirements established by the relevant technical regulations of the Customs Union. 8. Requirements for food additives, flavorings, and processing aids used during manufacturing of food products are established by the relevant technical regulations of the Customs Union. 9. During production (manufacturing) of food products from food raw materials obtained from GMO of plant, animal, and microbial origin, GMO lines that underwent state registration shall be used. If the manufacturer did not use GMO during production of food products, presence in food products of 0.9 percent or less of GMO is considered an adventitious or technically intractable impurity, and such products do not belong to food products containing GMO. 10. Production (manufacturing) of food products for baby food for infants shall be carried out at specialized production facilities or in specialized rooms or on specialized technological lines. 11. Presence of helminth eggs and cysts of enteric pathogen protozoa in fresh or fresh frozen greens, vegetables, fruits, and berries is not allowed. 12. Content of each foodstuff or biologically active substance used for enrichment in enriched food products shall be brought to the level of consumption in 100 ml or 100 g or a single serving of such products of at least 5 percent of the daily intake’s level. Content of probiotic microorganisms in enriched food products shall amount to at least 109 colony-forming units (microbial cells) in 1 g or in 1 ml of such products. Article 8. Safety Requirements for Specialized Food Products 1. During production (manufacturing) of food products for baby food, food products for pregnant and nursing women, use of food raw materials containing GMO is not allowed. During production of food products for baby food, use of food raw materials produced with the application of pesticides according to Annex No. 10, is not allowed. 2. Food products for pregnant and nursing women shall conform to the requirements established by Annexes No. 1, 2, and 3 of the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products. 3. Food products for infants with respect to their texture should correspond to age specific physiological characteristics of infants’ digestive system for the specific age. 4. Food products for baby food should conform to the following requirements: biscuits for baby food should not contain more than 25 percent of supplemented sugar; bakery products for baby food should not contain more than 0.5 percent of salt; 5. Food products for baby food should not contain: more than 0.2 percent of ethanol; natural coffee; apricot pit nuts; vinegar; sweeteners, except for specialized food products for dietary therapeutic and dietary prophylactic nutrition. 6. Food products for baby food for infants shall not contain trans-isomers of fatty acids in breast milk substitutes in the amount exceeding 4 percent of the total content of fatty acids. 7. It is not allowed to use benzoic, sorbic acid, and their salts for production (manufacturing) of food products for baby food. 8. During production (manufacturing) of food products for baby food for infants it is not allowed to use the following types of food raw materials: 1) curd with acidity of more than 150 Turner degree; 2) soybean meal (except for isolate and concentrate of soy protein); 3) grain and products of its processing infected by pests and contaminated with foreign impurities and pests; 4) products of slaughter of producing animals and poultry that were subjected to refreezing; 5) raw materials of fish and non-finfish that were subjected to refreezing; 6) meat of mechanically deboned producing animals and poultry; 7) collagen containing raw material from poultry meat; 8) offal of producing animals and poultry except for liver, tongue, heart, and blood; 9) veined beef with fat and connective tissue weight ratio above 12 percent; 10) veined pork with fat tissue weight ratio above 32 percent; 11) veined meat of sheep with fat tissue weight ratio above 9 percent; 12) carcasses of spring chicken and broiler chicken of 2nd category; 13) frozen blocks from various types of veined animal meat as well as offal (liver, tongue, heart) with shelf life of more than 6 months; 14) bull meat, boar meat, lean-type animal meat; 15) raw fish materials obtained from caged fish and demersal fish species; 16) waterfowl eggs and meat; 17) spreads; 18) salted butter; 19) vegetable oils – cotton-seed, sesame oil; 20) vegetable oils with peroxide value exceeding 2 mmole of active oxygen/kg of fat (except for olive oil); olive oil with peroxide value exceeding 2 mmole of active oxygen/kg of fat; 21) concentrated diffusion juices; 22) spices (except dill, parsley, celery, caraway, basil, sweet and white pepper, allspice, oregano, cinnamon, vanilla, coriander, cloves, laurel leaf as well as onion, garlic the content of which is defined by the manufacturer); 23) egg powder (for perishable food products); 24) hydrogenated oils and fats, fats with high content of saturated fatty acids, 25) hot spices (pepper, horseradish, mustard); 26) mayonnaise, mayonnaise sauces, sauces on the basis of vegetable oils, creams on the basis of vegetable oils, specialty fats, deep fat. 9. During production (manufacturing) of food products for baby food for pre-school and school aged children it is not allowed to use the following types of food raw materials: 1) products of slaughter of producing animals and poultry that were subjected to refreezing;; 2) raw materials of fish and non-finfish that were subjected to refreezing; 3) meat of mechanically deboned producing animals and poultry; 4) collagen containing raw material from poultry meat; 5) frozen blocks from various types of veined animal meat as well as offal (liver, tongue, heart) with shelf life of more than 6 months; 6) veined beef with fat and connective tissue weight ratio above 20 percent; 7) veined pork with fat tissue weight ratio above 70 percent; 8) veined meat of sheep with fat tissue weight ratio above 9 percent; 9) bull meat, boar meat, lean-type animal meat; 10) offal of producing animals and poultry except for liver, tongue, heart, and blood; 11) waterfowl eggs and meat; 12) concentrated diffusion juices; 13) vegetable oils with peroxide value exceeding 2 mmole of active oxygen/kg of fat (except for olive oil); olive oil with peroxide value exceeding 2 mmole of active oxygen/kg of fat; 14) vegetable oils – cotton-seed oil; 15) hydrogenated oils and fats; 16) hot spices (pepper, horseradish, mustard). 10. During production (manufacturing) of biologically active additives for food for children aged between 3 and 14 and baby herbal beverage (herbal teas) for infants it is only allowed to use plant raw materials specified in Annex 8 of the present Technical regulation. 11. During production (manufacturing) of food products for baby food for infants it is allowed to use vitamins and mineral salts specified in Annex 9 of the present Technical regulation. 12. During production (manufacturing) of food products for baby food for children of all ages in order to add specific aroma and taste it is only allowed to use natural food flavorings (flavoring substances) and for children older than 4 months – also vanillin. 13. During production (manufacturing) of biologically active food additives (BAA) it is not allowed to use plants or products of their processing, species of animal origin, microorganisms, fungi, or biologically active substances that pose a health risk to humans and animals, and are established in Annex No. 7 of the present Technical regulation. 14. Biologically active food additives (BAA) should conform to hygiene requirement of food safety established in Annexes No. 1, 2, and 3 of the present Technical regulation. The content of biologically active substances derived from plants and (or) their extracts in a daily dose of biologically active additives (BAA) should range from 10 to 50 percent of the amount of their single therapeutic dose defined for the use of these substances as medicines. Article 9. Requirements for Tonic Beverages Tonic beverages (including energy ones) are produced (manufactured) in the form of nonalcoholic and low-alcohol beverages. It is allowed to use caffeine and caffeine containing plants (plant extracts), tea, coffee, guarana, matte as well as medicinal plants and their extracts having a tonic effect (ginseng, leuzea, rhodiola rosea, magnolia vine, eleuterococcus) as sources of tonic substances (components). It is allowed to introduce no more than two tonic substances (components) in the content of tonic nonalcoholic beverages, and for tonic low-alcohol beverages – no more than one. During production (manufacturing) of tonic beverages it is allowed to use mineral substances, digestible carbohydrates, vitamins, and vitamin-like substances, substrates, and stimulators of energy metabolism. Caffeine content in tonic beverages shall not exceed 400 mg/dm3. CHAPTER 3. REQUIREMENTS FOR PROCESSES OF PRODUCTION (MANUFACTURING), STORAGE SHIPMENT (TRANSPORT), SALES, AND DISPOSAL OF FOOD PRODUCTS Article 10. Ensuring Safety of Food Products during the Processes of their Production (Manufacturing), Storage, Shipment (Transport), Sales, and Disposal 1. Manufacturers, retailers, and entities performing the functions of foreign manufacturers of food products shall carry out the processes of their production (manufacturing), storage, shipment (transport), sales, and disposal in such a manner so that these products conform to the requirements established for such products by the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products. 2. During carrying out of the food products production (manufacturing) processes, connected with the safety requirements for such products, the manufacturer shall develop, implement, and maintain the procedures based on the HACCP (in English transcription HACCP – Hazard Analysis and Critical Control Points) principles specified in part 3 of the present Article. 3. To ensure safety of food products during the process of their production (manufacturing) the following procedures shall be developed, implemented, and maintained: 1) determination of the technological processes of the food products production (manufacturing) required for ensuring food products safety; 2) determination of the subsequence and route of the technological operations of the food products production (manufacturing) in order to preclude contamination of the food raw materials and food products; 3) determination of the controlled stages of the technological operations and food products at the stages of their production (manufacturing) in production control programs; 4) control of food raw materials, processing aids, packaging materials, and articles used during food products production (manufacturing), as well as control of food products by the means ensuring the required accuracy and completeness of the control; 5) control of the functioning of the technological equipment in such manner as to ensure the production (manufacturing) of the food products that conform to the requirements of the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products; 6) ensuring that information about the controlled stages of technological operations and results of food products control are documented; 7) observation of conditions of the food products’ storage and shipment (transport); 8) maintenance of production premises, technological equipment, and utensils that are used in the process of food products production (manufacturing) in such manner as to preclude contamination of food products; 9) determination of methods and ensuring implementation of personal hygienic rules by employees to ensure food products safety. 10) determination of methods that ensure food products safety, determination of frequency and carrying-out of cleaning, washing, disinfection, disinsectization, and deratization of production premises, technological equipment, and utensils that are used in the process of food products production (manufacturing); 11) maintenance and keeping on paper and (or) in electronic form of the documents confirming the conformity of the produced food products to the requirements established by the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products; 12) traceability of food products. Article 11. Requirements for Ensuring of Food Products Safety in the Process of their Production (Manufacturing) 1. The manufacturer of food products shall implement procedures for ensuring safety in the process of production (manufacturing) of such products in order to ensure that food products released into circulation conform to the requirements of the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products. 2. Organization of ensuring safety in the process of food products production (manufacturing) and control is performed by the manufacturer either individually and (or) with participation of a third party. 3. In order to ensure safety in the process of food products production (manufacturing) the manufacturer shall establish the following: 1) a list of hazardous factors that may lead during the process of production (manufacturing) to release into circulation of food products that do not conform to the requirements of the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products; 2) a list of critical control points in the process of production (manufacturing) – parameters of technological operations of the food products production (manufacturing) process (its part); and safety parameters (indicators) of food raw materials and packaging materials that should be controlled in order to prevent or eliminate hazardous factors specified in paragraph 1 of the present part; 3) parameters limits that are controlled in critical control points; 4) monitoring procedure of critical control points in the process of production (manufacturing); 5) setting of operational procedures in case values of the indicators specified in paragraph 3 of the present part deviate from the established limits; 6) frequency of inspection for conformity of products, which are released into circulation, to the requirements of the present Technical regulation and (or) technical regulations of the Customs Union for certain types of food products; 7) frequency of cleaning, washing, disinfection, deratization, and disinsectization of production premises; cleaning, washing, and disinfection of technological equipment and utensils that are used i
Posted: 27 May 2012

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