Technical Regulations TR EEU 040/2016

Technical Regulation

of the Eurasian Economic Union

"On Safety of Fish and Fish Products"

(TR EAEU 040/2016)

This Technical Regulation has been developed in accordance with Article 52 of the Treaty on the Eurasian Economic Union of 29 May 2014.

This Technical Regulation establishes safety requirements for fish food products placed on the market in the territory of the Eurasian Economic Union (hereinafter, the Union), which are mandatory for application and compliance in the territory of the Union. It also establishes related requirements for the processes of production, storage, transportation, sale and disposal, as well as requirements for the labelling and packaging of fish food products to ensure their free movement.

If other Technical Regulations of the Union (Technical Regulations of the Customs Union) have been adopted in respect of fish food products that establish safety requirements for fish food products and related requirements for the processes of production, storage, transportation, sale and disposal, as well as requirements for the labelling and packaging of fish food products, then fish food products and the related processes of production, storage, transportation, sale and disposal, as well as the labelling and packaging of fish food products, shall comply with the requirements of all Technical Regulations of the Union (Technical Regulations of the Customs Union) that apply to them.

I. Scope

1.This Technical Regulation has been developed to protect human life and health, animal and plant life and health, property and the environment, and to prevent actions that mislead consumers of fish food products regarding their purpose and safety.

2.This Technical Regulation applies to fish food products placed on the market in the territory of the Union.

The objects of technical regulation of this Technical Regulation are:

a) fish food products of plant and animal origin obtained from catches of aquatic biological resources and from aquaculture organisms, in processed or unprocessed form, including the following types:

live fish and live aquatic invertebrates;

raw (fresh) fish, fresh aquatic invertebrates, fresh aquatic mammals, raw (fresh) algae and fresh aquatic plants;

cooked-frozen aquatic invertebrates, algae and other aquatic plants;

chilled fish food products;

superchilled fish food products;

frozen fish food products;

pasteurised fish food products;

air-cured fish food products;

dried fish food products;

dry-air-cured fish food products;

marinated fish food products;

salted fish food products;

hot-smoked fish food products;

cold-smoked fish food products;

lightly smoked fish food products;

lightly air-cured fish food products;

fish food products for children's nutrition, including vegetable-and-fish-based complementary food products, fish-and-vegetable-based complementary food products and fish-based complementary food products;

fish culinary product;

semi-finished fish culinary product;

minced fish food product;

canned fish;

natural canned fish;

natural canned fish with added oil;

semi-canned fish;

semi-preserves;

granular caviar;

roe in ovary sacs;

roe grains;

pasteurised fish roe;

pressed caviar;

salted screened roe;

roe-based fish product;

edible fat from fish, aquatic invertebrates and aquatic mammals;

fish food product hydrolysate;

imitation fish food products;

b) processes of production, storage, transportation, sale and disposal of fish food products.

This Technical Regulation establishes requirements for the labelling and packaging of fish food products that are mandatory for application and compliance in the territory of the Union. These requirements supplement and do not contradict the requirements of the Technical Regulation of the Customs Union "Food Products Regarding Their Labelling" (TR CU 022/2011), adopted by Decision of the Customs Union Commission No. 881 of 9 December 2011 (hereinafter, Technical Regulation of the Customs Union "Food Products Regarding Their Labelling" (TR CU 022/2011)), and of the Technical Regulation of the Customs Union "On Safety of Packaging" (TR CU 005/2011), adopted by Decision of the Customs Union Commission No. 769 of 16 August 2011 (hereinafter, Technical Regulation of the Customs Union "On Safety of Packaging" (TR CU 005/2011)).

3. This Technical Regulation does not apply to:

a) processes of breeding and rearing (grow-out) of fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants;

b) specialised fish food products (except for fish food products for children's nutrition);

c) biologically active food supplements and Food Additives made on the basis of fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants;

d) processes of production, storage, transportation and disposal of non-industrially manufactured fish food products intended for placing on the market in the territory of the Union;

e) fish food products produced by citizens at home and (or) on private household plots, as well as processes of production, storage, transportation and disposal of such products intended solely for personal consumption and not intended for placing on the market in the territory of the Union;

f) products from amphibians and reptiles;

g) non-food fish products.

II. Basic Concepts

4. For the purposes of applying this Technical Regulation, the concepts established by the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011), adopted by Decision of the Customs Union Commission No. 880 of 9 December 2011 (hereinafter – the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011)), and by the Technical Regulation of the Customs Union "Food Products Regarding Their Labelling" (TR CU 022/2011) are used, as well as concepts with the following meanings:

"cooked-frozen aquatic invertebrates" – aquatic invertebrates pre-cooked until complete coagulation of protein and frozen to a temperature not higher than minus 18ºС;

"cooked-frozen algae and other aquatic plants" – algae and other aquatic plants cooked to an elastic, firm consistency and frozen to a temperature not higher than minus 18 ºС;

"raw (fresh) algae and fresh aquatic plants" – algae and other aquatic plants removed from the water that retain their inherent colour, odour, tissue elasticity and a film of water on the surface;

"air-cured fish food products" – fish food products made from pre-salted fish, aquatic invertebrates, aquatic mammals and other aquatic animals by air-curing, with a mass fraction of moisture of not less than 30 percent, having a firm consistency and the properties of a matured product;

"fish food product hydrolysate" – fish food products made from tissues of fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, by hydrolysis;

"glazing" – the process of forming a protective layer of ice on the surface of frozen fish food products by spraying them with or immersing them in drinking or clean water, with or without dissolved food additives;

"deep dehydration (freezer burn) of fish food products" – loss of tissue fluid on the surface of products made from fish, aquatic invertebrates, aquatic mammals and other aquatic animals, manifested by dulling of the surface of frozen products and by the presence of white and (or) yellow spots that have penetrated into the depth of the muscle tissue and cannot be removed mechanically without impairing the appearance;

"live fish" – fish swimming in a natural or near-natural habitat, with natural movements of the body, jaws and gill covers;

"live aquatic invertebrates" – echinoderms, molluscs and crustaceans that show the reactions characteristic of each species to mechanical stimuli and are kept under conditions that sustain their vital activity;

"edible fat from fish, aquatic invertebrates and aquatic mammals" – fish food products made from fat-containing raw materials of fish, aquatic invertebrates and aquatic mammals, with or without the addition of food additives and (or) flavourings;

"granular caviar" – fish food products made from roe grains of fish of the Salmonidae family or the Acipenseridae family, treated with table salt or a mixture of table salt and food additives, with or without the addition of vegetable oil;

"manufacturer" – a legal entity or a natural person registered as an individual entrepreneur, including a foreign manufacturer, that carries out, in its own name, the production or the production and sale of fish food products and is responsible for their conformity with the requirements of the Technical Regulations of the Union (Technical Regulations of the Customs Union);

"roe-based fish product" – ready-to-eat fish food products made from whole or cut ovary sacs of roe or from roe grains of fish, molluscs and echinoderms, with the addition of food product components (food ingredients);

"roe grains" – eggs of fish, molluscs and echinoderms separated from the connective tissue of the ovary sac;

"roe in ovary sacs" – fish food products made from whole or cut ovary sacs of fish, molluscs and echinoderms, in chilled, frozen, salted, smoked or air-cured form;

"imitation fish food products" – fish food products that reproduce the organoleptic characteristics of a given imitated product (for example, "roe analogues", "structured products", "crab sticks");

"marinated fish food products" – fish food products made from fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, treated with a mixture of table salt, sugar, spices and food acid;

"frozen fish food products" – fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, including products made from them, subjected to freezing to a temperature not higher than minus 18ºС in the core of the product;

"presence of parasites (parasitic infestation)" – the presence in fish food products of parasites, clusters of parasites or their remains whose appearance, colour and size make it possible to distinguish them from the muscle tissue of fish, aquatic invertebrates, aquatic mammals and other aquatic animals during visual inspection and (or) by other inspection methods;

"natural canned fish" – fish food products made from fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, with or without the addition of spices to the main components, in hermetically sealed packaging, without prior heat treatment of the components, subjected to sterilisation;

"natural canned fish with added oil" – fish food products made from fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, without prior heat treatment, with the addition of vegetable oil, pork fat or liver fat, in which the mass fraction of sediment in the oil is not regulated, in hermetically sealed packaging, subjected to sterilisation;

"unprocessed fish food products" – fish food products made from fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, that have not undergone processing (treatment);

"unprocessed fish food products of animal origin" fish food products made from fish, aquatic invertebrates, aquatic mammals and other aquatic animals that have not undergone processing (treatment);

"chilled fish food products" – fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, subjected to chilling without reaching the freezing temperature of the tissue fluid, as well as products made from them subjected to chilling to a temperature not higher than 5 ºС in the core of the product;

"pasteurisation" – heat treatment of products at a temperature from 60 ºС to 100 ºС that ensures their safety and microbiological stability at a specified storage temperature during a limited shelf life;

"pasteurised fish roe" – fish food products made from fish roe grains, treated with table salt or a mixture of table salt and food additives, in hermetically sealed packaging, subjected to pasteurisation;

"pasteurised fish food products" – fish food products made with or without the addition of garnishes, sauces or fillings, in hermetically sealed packaging, subjected to pasteurisation;

"pressed caviar" – fish food products made from roe grains salted in a heated saturated table salt solution and subsequently pressed into a homogeneous mass;

"processed fish food products" – fish food products made from fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, that have undergone processing (treatment);

"processed fish food products of animal origin" fish food products made from catches of aquatic biological resources of animal origin and aquaculture food products of animal origin that have undergone processing (treatment);

"processing (treatment)" – heat treatment (except freezing and chilling), smoking, canning, maturing, salting, drying, marinating, concentration, extraction, extrusion or a combination of these processes;

"aquaculture food products of animal origin" fish, aquatic invertebrates, aquatic mammals and other aquatic animals removed (caught) from semi-free conditions of keeping or breeding or from an artificially created habitat;

"aquaculture food products of plant origin" algae and other aquatic plants removed (caught) from semi-free conditions of keeping or breeding or from an artificially created habitat;

"vegetable-and-fish-based complementary food products" – fish food products for children's nutrition intended for the nutrition of infants and young children, made from plant components (fruits, vegetables, cereals, flour) and from fish of various species, containing from 8 to 18 percent fish muscle tissue of the total weight of the product;

"fish-based complementary food products" – fish food products for children's nutrition intended for the nutrition of infants and young children, made from fish of various species, containing more than 40 percent fish muscle tissue of the total weight of the product;

"fish-and-vegetable-based complementary food products" – fish food products for children's nutrition intended for the nutrition of infants and young children, made from fish of various species with the addition of plant components (fruits, vegetables, cereals, flour), containing more than 18 up to 40 percent fish muscle tissue of the total weight of the product;

"fish food products" – fish (including live fish and raw (fresh) fish), aquatic invertebrates (including live and fresh aquatic invertebrates), aquatic mammals (including fresh aquatic mammals) and other aquatic animals, as well as algae (including raw (fresh) algae) and other aquatic plants (including fresh aquatic plants), including products made from them, in unprocessed or processed (treated) form, intended for human consumption;

"hot-smoked fish food products" – fish food products made from pre-salted fish, aquatic invertebrates, aquatic mammals and other aquatic animals by hot smoking, having the colour, odour and taste of smoked products, and fully cooked;

"fish food products for children's nutrition" – fish food products intended for children's nutrition (for young children aged 8 months to 3 years, preschool children aged 3 to 6 years, school-age children aged 6 years and older) that meet the corresponding physiological needs of the child's body and do not harm the health of a child of the corresponding age;

"fish food products of plant origin" fish food products made from catches of aquatic biological resources of plant origin and aquaculture food products of plant origin;

"cold-smoked fish food products" – fish food products made from pre-salted fish, aquatic invertebrates, aquatic mammals and other aquatic animals by smoke, smokeless or mixed cold-smoking methods, having the colour, odour and taste of smoked products;

"lightly smoked fish food products" – fish food products manufactured from pre-salted fish, aquatic invertebrates, aquatic mammals and other aquatic animals by smoke, smokeless or combined cold-smoking methods, and having a light odour and taste of smoked products;

"superchilled fish food products" – fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, subjected to freezing to a temperature 1 ºС or 2 ºС below the freezing point of the tissue fluid inside them;

"semi-canned fish" – fish food products in hermetically sealed packaging, subjected to heat treatment that destroys non-heat-resistant, non-spore-forming microflora, reduces the amount of spore-forming microflora and guarantees the microbiological stability and safety of the product at a storage temperature not exceeding 6 ºС during the shelf life established by the manufacturer;

"semi-preserves" – salted fish food products in which the content of fish is not less than 65 percent of the net weight, and the content of aquatic invertebrates, roe, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, is not less than 55 percent of the net weight, with a mass fraction of table salt not exceeding 8 percent, with or without the addition of food additives, garnishes, sauces or fillings, in tightly and (or) hermetically sealed consumer packaging, and subject to storage under the conditions established by the manufacturer;

"salted screened roe" – fish food products manufactured from roe grains of fish (except fish of the Acipenseridae family and the Salmonidae family), molluscs and echinoderms, treated with table salt or a mixture of table salt and food additives;

"lightly air-cured fish food products" – fish food products manufactured from pre-salted fish, aquatic invertebrates, aquatic mammals and other aquatic animals by drying and air-curing to an established mass fraction of moisture, and having a slightly firm, succulent texture and the properties of a matured product;

"purification and dispatch centre" – a facility with clean running water or drinking water in which live bivalve molluscs are placed for the time necessary for their biological purification, sorting and packing;

"raw (fresh) fish" – fish showing no signs of life, kept at a temperature not exceeding the temperature of its habitat, or chilled;

"fish culinary product" – fish food products manufactured with or without the addition of food ingredients and (or) food additives, ready for consumption with or without heat treatment;

"canned fish" – fish food products manufactured from fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, the mass fraction of which is not less than 50 percent of the net weight, with or without the addition of food additives and flavourings, sauces, garnishes or fillings, in hermetically sealed packaging, and subjected to sterilisation;

"fish waste" – food raw materials unsuitable for the production of fish food products, or unused residues of such products generated during the production of fish food products;

"semi-finished fish culinary product" – fish food products, with or without the addition of food ingredients and (or) food additives, that have undergone one or more stages of culinary processing without being brought to readiness;

"fresh aquatic invertebrates" – crustaceans, molluscs and echinoderms removed from water, retaining signs of life and kept at a temperature close to the temperature of their habitat;

"fresh aquatic mammals" – aquatic mammals showing no signs of life, kept at a temperature not exceeding the temperature of their habitat, or chilled;

"owner of fish food products" – an individual or legal entity that holds the right of ownership and acts as the owner, disposer or user of fish food products;

"salted fish food products" – fish food products treated with table salt or sea salt, with or without the addition of spices, their extracts, sugar or food additives, and ready for consumption;

"sterilisation of canned products" – heat treatment of products at a temperature above 100 ºС that ensures the commercial sterility of canned products under the storage, transport and sale conditions established by the manufacturer during their limited shelf life;

"dried fish food products" – fish food products manufactured from pre-salted fish, aquatic invertebrates, aquatic mammals and other aquatic animals, as well as algae and other aquatic plants, by drying to a mass fraction of moisture not exceeding 20 percent;

"dry-air-cured fish food products" – fish food products manufactured from pre-salted fish, aquatic invertebrates, aquatic mammals and other aquatic animals by drying and air-curing to a mass fraction of moisture of more than 20 and up to 30 percent;

"catches of aquatic biological resources of animal origin" – fish, aquatic invertebrates, aquatic mammals and other aquatic animals extracted (caught) from their natural habitat;

"catches of aquatic biological resources of plant origin" – algae and other aquatic plants extracted (caught) from their natural habitat;

"person authorised by the manufacturer" – a legal entity or an individual registered as an individual entrepreneur in the territory of a Member State of the Union in accordance with the procedure established by the legislation of that Member State, which, on the basis of a contract with the manufacturer, including a foreign manufacturer, acts on behalf of that manufacturer in the conformity assessment and placing on the market of fish food products in the territory of the Union, and bears responsibility for the non-conformity of fish food products with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them;

"minced fish food product" – fish food products manufactured from fish, aquatic invertebrates, aquatic mammals and other aquatic animals by grinding to a homogeneous mass;

"phycotoxins" – natural toxic substances produced by certain species of algae and microalgae and capable of accumulating in molluscs (except cephalopods) and in the internal organs of crabs;

"clean water" – sea water or fresh water, including disinfected (purified) water, that does not contain microorganisms, harmful or radioactive substances or toxic plankton in quantities capable of impairing the safety of fish food products.

III. Identification of Fish Food Products

5. Fish food products shall be identified using one or more of the following methods:

a) name-based method – by comparing the name of the fish food product indicated in the labelling on the consumer packaging, transport packaging and (or) accompanying document with the name specified in the definition of the type of fish food product established by this Technical Regulation;

b) visual method – by comparing the appearance of the fish food product with the characteristics specified in the definition of such fish food product in this Technical Regulation and (or) in the document in accordance with which the product was manufactured;

c) organoleptic method – by comparing the organoleptic characteristics of the fish food product with the characteristics specified in the definition of such fish food product in this Technical Regulation and (or) in the document in accordance with which the product was manufactured;

d) analytical method – by verifying that the morphological, physical, chemical, biochemical and microbiological indicators of the fish food product conform to the characteristics specified in the definition of such fish food product in this Technical Regulation and (or) in the document in accordance with which the product was manufactured, and by establishing the identity of these indicators with authentic natural samples, including by using species identification methods for fish, aquatic invertebrates and other aquatic animals, as well as algae and other aquatic plants.

6. The organoleptic method is applied if fish food products cannot be identified by the name-based method and the visual method.

7. The analytical method is applied if fish food products cannot be identified by the name-based, visual or organoleptic methods.

IV. Rules for the Circulation of Fish Food Products in the Territory of the Union

8. Fish food products shall be placed on the market in the territory of the Union if they conform to the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, and provided that they have undergone conformity assessment in accordance with Section XI of this Technical Regulation.

9. During circulation in the territory of the Union, unprocessed fish food products of animal origin shall be accompanied by a veterinary certificate issued by the authorised body of a Member State of the Union (hereinafter – Member State) and by shipping documentation.

Processed fish food products of animal origin that are subject to veterinary control (supervision) and moved between Member States, whether imported from third countries or produced in the territory of the Union, shall be accompanied by a veterinary certificate confirming epizootic freedom, issued by the authorised body of the Member State without a veterinary and sanitary examination.

Fish food products of plant origin in circulation shall be accompanied by shipping documentation ensuring the traceability of such products.

Each consignment of fish food products of animal origin subject to veterinary control (supervision) shall be imported into the territory of the Union only if accompanied by a veterinary certificate issued by the competent authority of the country of dispatch.

10. Fish food products that conform to the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, and that have undergone conformity assessment, shall be marked with the single mark of product circulation on the market of the Union.

11. The circulation in the territory of the Union of fish food products that do not conform to the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, including fish food products with an expired shelf life, is not permitted.

12. Fish food products that do not conform to the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, including fish food products with an expired shelf life, as well as fish food products whose owner cannot confirm their origin to ensure their traceability, shall be withdrawn from circulation by the owner of fish food products, either on the owner's own initiative or by order of the authorised state control (supervision) bodies of the Member State.

V. Safety Requirements for Fish Food Products

13. Fish food products shall comply with the safety requirements established by this Section, with the safety requirements set out in Annexes No. 1, 3 – 6, and with the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011).

14. Fish food products shall be manufactured from aquatic biological resources extracted (caught) in safe harvesting (fishing) areas, as determined by the data of the scheduled safety monitoring of aquatic biological resources carried out by the authorised bodies of the Member States, and from aquaculture organisms originating from farms (enterprises) that are veterinary-safe. The monitoring data shall be published on the Internet on the official websites of the authorised bodies of the Member States.

15. Aquaculture food products shall not contain natural or synthetic hormonal substances or genetically modified organisms (GMOs).

Maximum permissible levels of residues of veterinary medicinal products (pharmacologically active substances and their metabolites) in aquaculture food products of animal origin shall comply with the requirements established by Article 9¹ of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011).

16. The following fish food products are not permitted for circulation within the territory of the Union:

a) products made from poisonous fish of the families Diodontidae (porcupinefishes), Molidae (sunfishes), Tetraodontidae (pufferfishes) and Canthigasteridae (sharpnose puffers);

b) products whose organoleptic characteristics do not correspond to their consumer properties;

c) frozen products with a temperature in the core of the product above minus 18 ºС;

d) products that have been thawed during storage;

e) products containing biotoxins (phycotoxins) hazardous to human health.

17. Live fish showing signs of dying shall be sold as raw (fresh) fish or sent for processing. Live fish of the Acipenseridae family shall be sent for gutting immediately at the first signs of dying.

The sale of the following is not permitted: low-activity crustaceans, molluscs and echinoderms that retain only some signs of life; injured specimens; specimens contaminated with silt, sand, petroleum products, algae or shells; crustaceans in the moulting stage or with a soft shell; and incomplete molluscs and echinoderms.

Low-activity crustaceans that retain some signs of life shall be sent immediately for chilling, cutting, cooking and (or) freezing.

Sea urchins, crustaceans, gastropod molluscs and bivalve molluscs shall be sent for sale and processing only when alive.

Live sea cucumbers shall be cut immediately after catching.

Live oysters shall be packed with the concave shell valve facing down. Live scallops shall be packed with the convex shell valve facing down.

The shell valves of live bivalve molluscs shall be tightly closed, or slightly open but closing when tapped.

Live crustaceans, echinoderms and molluscs shall respond to mechanical stimulation.

Before placing on the market, live bivalve molluscs shall undergo the necessary holding period at a purification and dispatch centre.

After being packed for sale, live bivalve molluscs shall not be re-immersed in water or sprayed with water.

18. Fish containing objects hazardous to human health in certain of its parts shall be dressed. Such parts shall be removed and subsequently disposed of.

19. Catches of aquatic biological resources and aquaculture food products of animal origin shall be examined for the presence of parasites (parasitic infestation). Parasitological safety indicators for fish, crustaceans, molluscs and their processed products are established in Annex No. 3 to this Technical Regulation.

If live parasites or their larvae hazardous to human health are detected, catches of aquatic biological resources of animal origin and aquaculture food products of animal origin shall be decontaminated by appropriate methods.

If live parasites or their larvae hazardous to human health are detected in live fish, live aquatic invertebrates, raw (fresh) fish, fresh aquatic mammals, fresh aquatic invertebrates, or chilled and superchilled fish food products of animal origin, such products shall, before placing on the market, be frozen to a temperature in all parts of the product not exceeding minus 20 ºС for at least 24 hours, or not exceeding minus 35 ºС for at least 15 hours, or be subjected to other decontamination methods that guarantee the safety of the fish food products.

20. The sale of fish food products whose edible parts are infested with visible parasites is not permitted.

21. In the event of disagreement in the assessment of the organoleptic characteristics of unprocessed fish food products of animal origin, the total volatile basic nitrogen (TVB-N) indicator shall be determined.

Fish food products are considered unfit for industrial processing and human consumption if the following limits of total volatile basic nitrogen (TVB-N) are exceeded:

25 mg of nitrogen per 100 g of flesh for species of the family Scorpaenidae (scorpionfishes);

30 mg of nitrogen per 100 g of flesh for species of the family Pleuronectidae (righteye flounders), except for Hippoglossus spp. (halibut);

35 mg of nitrogen per 100 g of flesh for other fish species.

VI. Requirements for the Production Processes of Fish Food Products

22. The production processes of fish food products shall comply with the requirements of this Technical Regulation and with the relevant requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011).

23. The requirements for the organisation of production premises in which fish food products are produced are established by Article 14 of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011).

24. Special requirements for the organisation of production processes carried out on processing vessels, reception and transport vessels, fishing vessels (hereinafter referred to as vessels) are established by Section VII of this Technical Regulation.

25. The safety of fish food products during their production shall be ensured by:

а) process operations and their operating modes at all stages (sections) of the production of fish food products;

б) an optimal sequence of process operations that prevents contamination of the fish food products being produced;

в) monitoring of the operation of process equipment;

г) compliance with the storage conditions for food raw materials used for the production of fish food products, and for packaging and packaging materials;

д) maintaining the production premises, process equipment and implements used in the production of fish food products in a condition that prevents contamination of fish food products;

е) the selection of methods and the frequency of sanitary treatment, disinfection, disinsection and deratisation of production premises, and of sanitary treatment and disinfection of process equipment and implements used in the production of fish food products. Sanitary treatment, disinfection, disinsection and deratisation shall be carried out at a frequency sufficient to eliminate the risk of contamination of fish food products. The frequency of sanitary treatment, disinfection, disinsection and deratisation is established by the manufacturer of the products;

ж) keeping and retaining documentation and records that confirm compliance with the requirements of this Technical Regulation;

з) the operation of a safety assurance system during the production of fish food products (production control);

и) traceability of fish food products.

26. The equipment used in the production of frozen fish food products shall ensure:

а) reduction of the temperature of fish food products to a temperature not higher than minus 18 ºС;

б) maintenance of the temperature of frozen fish food products at the core of the muscle tissue at not higher than minus 18 ºС during storage in holds, tanks or containers.

27. The area for dressing unprocessed fish food products shall be supplied with drinking water or clean water.

28. Drinking water and clean water are used for chilling and for making ice. Ice shall be protected from contamination.

29. In the production of raw (fresh) fish, fresh aquatic mammals, raw (fresh) algae, fresh aquatic plants and fresh aquatic invertebrates, the following requirements shall be met:

а) during production, contamination of fish, echinoderms, molluscs, crustaceans, aquatic mammals and other aquatic animals, as well as of algae and other aquatic plants, shall be prevented; they shall be protected from exposure to sunlight and weather; and appropriate temperature conditions shall be ensured for the storage of fish food products;

б) where live parasites and their larvae hazardous to human health, by-catch of poisonous fish, or contamination of the catch with bottom sediment or petroleum products are detected, measures shall be taken to prevent the placing on the market of fish food products that do not comply with the requirements of this Technical Regulation and of other Technical Regulations of the Union (Technical Regulations of the Customs Union) that apply to them.

30. In the production of chilled and superchilled fish food products, the following requirements shall be met:

а) tuna, sailfish, mackerel, marlin, swordfish and cartilaginous fish shall be bled immediately after harvesting (catching);

б) fish of the Acipenseridae family (except sterlet) shall be bled and dressed, and the viscera and sphincter shall be removed;

в) marinka, hilsa, osmans and khramulya shall be gutted (the viscera, roe, milt and black membrane shall be thoroughly removed and destroyed); the heads of jumbo flying squid (Dosidicus gigas), hilsa and khramulya shall be removed and destroyed;

г) catfish longer than 53 cm shall be gutted (the viscera, roe, milt and black membrane shall be thoroughly removed);

д) pike longer than 30 cm shall be gutted (the viscera, roe, milt and black membrane shall be thoroughly removed).

31. In the production of frozen fish food products, the following requirements shall be met:

jumbo flying squid (Dosidicus gigas) and octopuses shall be dressed; the heads of jumbo flying squid (Dosidicus gigas) shall not be used for food purposes;

when the cephalothorax of spiny lobsters is removed, the anal opening shall be removed;

in dressed cucumaria, the tentacle crown and the anal opening shall be removed;

freezing shall be carried out until a temperature not higher than minus 18 ºС is reached at the core of the product.

Freezing under natural conditions at the places of harvesting (catching) is permitted at an air temperature not higher than minus 10 ºС, on well-ventilated ice platforms or in a draught, under conditions that ensure the safety of the frozen fish food products. If the temperature reached during natural freezing is higher than minus 18 ºС, the fish shall be further frozen to a temperature not higher than minus 18 ºС.

Cold rooms used for the refrigeration treatment of fish food products shall be equipped with thermometers and (or) devices for automatic monitoring of the air temperature in the room, as well as temperature recording devices.

For separating individual pieces when packing frozen fish food products, an increase in their temperature to not higher than minus 2 ºС is permitted.

Deep dehydration (freezer burn) of frozen fish food products shall not exceed 10 percent of the weight or surface area of the product.

32. The mass fraction of moisture in the muscle tissue of frozen fish food products made from the main commercial fish species and aquatic invertebrates shall not exceed the permissible moisture content limits specified in Annex No. 7.

33. In the production of frozen fish food products from fish, the weight of the glaze applied to these products shall not exceed 5 percent of the weight of the glazed product (taking into account the uncertainty of the determination method).

In the production of frozen fish food products from dressed or peeled crustaceans and their processed products, the weight of the glaze applied to these products shall not exceed 7 percent of the weight of the glazed product (taking into account the uncertainty of the determination method).

In the production of frozen fish food products from whole (undressed) crustaceans, the weight of the glaze applied to these products shall not exceed 14 percent of the weight of the glazed product (taking into account the uncertainty of the determination method).

In the production of frozen fish food products from other fish food products, the weight of the glaze applied to these products shall not exceed 8 percent of the weight of the glazed product (taking into account the uncertainty of the determination method).

Water used for glazing fish food products or for preparing glazing solutions shall meet the requirements for drinking water established by the legislation of the Member State, or the requirements for clean water that meets the same microbiological standards and hygienic requirements as drinking water.

34. In the production of salted and marinated fish food products, unprocessed fish food products that comply with the requirements of this Technical Regulation and with the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011) shall be used.

In the production of salted and marinated fish food products, pond fish weighing more than 1 kg shall be dressed before salting.

In the production of fish food products from Pacific (Far Eastern) fish of the Salmonidae family with a mass fraction of table salt of less than 5 percent, and of fish food products from fish of the Coregonidae family with a mass fraction of table salt of less than 8 percent, only frozen fish food products shall be used.

35. In the production of hot-smoked and cold-smoked fish food products, as well as lightly smoked fish food products, unprocessed fish food products of animal origin that comply with the requirements of this Technical Regulation and with the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011) shall be used.

Hot-smoked and cold-smoked fish food products, as well as lightly smoked fish food products, from grass carp, carp, catfish and silver carp shall be produced only after these fish have been dressed.

Finished hot-smoked and cold-smoked fish food products, as well as lightly smoked fish food products, shall be cooled to a temperature not higher than 20 ºС, packaged and sent to a cold room.

36. In the production of roe, the following requirements shall be met:

а) scallop roe and sea urchin roe shall be produced only from roe obtained from live scallops and live sea urchins;

б) fish roe shall be collected in clean containers and delivered to the processing shop in a chilled state;

в) the time from the start of packing the roe into containers until its pasteurisation shall not exceed 2 hours;

г) roe of fish of the Acipenseridae family shall be produced only from roe obtained from live fish showing no signs of dying;

д) packing of roe from a container or transport packaging into consumer packaging shall be carried out under conditions that ensure its safety;

е) repacking of roe from consumer packaging is not permitted.

37. In the production of dried, dry-air-cured, air-cured and lightly air-cured fish food products, unprocessed fish food products that comply with the requirements of this Technical Regulation and with the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011) shall be used.

Dried, dry-air-cured, air-cured and lightly air-cured fish food products from grass carp and silver carp shall be produced only after these fish have been dressed.

38. In the production of canned fish and semi-preserves, fish food products that comply with the requirements of this Technical Regulation and with the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011) shall be used.

Components (food ingredients) used in the production of canned fish and semi-preserves shall comply with the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011) and of other Technical Regulations of the Union (Technical Regulations of the Customs Union) that apply to them. The use of components (food ingredients) showing signs of spoilage, decomposition or contamination is not permitted.

In the production of canned fish, the following requirements shall be met:

The heat treatment regime for canned fish shall ensure compliance with the microbiological requirements specified in Table 5 of Annex No. 1 to this Technical Regulation;

The time from filling fish food products into packaging to sealing shall not exceed 30 minutes, and the time from filling into packaging to sterilisation shall not exceed 60 minutes;

During sealing, the packaging shall achieve a degree of tightness sufficient to prevent secondary contamination of the product during and after heat treatment;

After heat treatment, canned fish shall be cooled to the storage temperature set by the manufacturer in the technical documentation for the specific type of canned fish;

Canned fish shall be placed on the market only after a positive result of the thermostatic incubation test has been obtained and defective cans have been rejected.

To ensure the safety of canned fish during production, the following is required:

vessels producing natural canned fish from fish liver shall have laboratory equipment and personnel that allow production control to be carried out;

sterilisation equipment shall be fitted with measuring and control instruments and automatic control and recording instruments;

the recorded parameters of the sterilisation process shall be kept, stating the name of the canned product, the packaging size type, the sterilisation equipment number, the batch (cooking) number, the shift number and the sterilisation date, for a period exceeding the shelf life of the canned fish produced by 6 months.

39. Fish food products for the nutrition of children in their first year of life shall be produced at specialised production facilities, in specialised workshops or on specialised production lines.

Fish food products for the nutrition of children aged from 1 to 3 years, preschool and school-age children may be produced at specialised production facilities, in specialised workshops, on specialised production lines, or on process equipment for the production of general-purpose fish food products. In the last case, production shall take place at the start of a shift or in a separate shift, after the equipment has been washed and disinfected.

In the production of canned fish food products for children of all age groups, the products shall be held in the manufacturer's warehouse for at least 21 days to establish their microbiological stability and safety.

40. In the production of fish food products for the nutrition of infants and young children, the use of unprocessed fish food products of animal origin obtained from cage-farmed fish and bottom-dwelling fish species is not permitted.

In the production of fish food products for the nutrition of infants and young children, preschool and school-age children, the use of unprocessed fish food products that have been refrozen is not permitted.

In the production of fish food products for children's nutrition, the following are not permitted: phosphates, flavour (aroma) enhancers, benzoic acid, sorbic acid and their salts; complex food additives containing phosphates, flavour (aroma) enhancers, benzoic acid, sorbic acid, or their salts and esters; and colourants.

In the production of fish food products for children's nutrition, the use of food raw materials is not permitted if they:

contain genetically modified organisms (GMOs);

were produced using animal growth stimulants, including hormonal preparations;

contain residues of antimicrobial agents (taking into account the error of the determination method).

41. Canned fish food products for infants and young children shall be filled into hermetically sealed consumer packaging with a capacity not exceeding:

a) 0,13 kg for fish-based complementary food products;

b) 0,25 kg for fish-and-vegetable-based and vegetable-and-fish-based complementary food products.

42. Fish waste generated during the production of fish food products shall be collected in watertight, labelled containers. It shall be removed from the production premises as it accumulates.

Fish waste shall be stored in containers in refrigerated chambers, separately from raw materials and finished products. Waste may be stored without refrigeration in closed containers for no more than 2 hours.

VII. Special Requirements for Production Processes Carried Out on Vessels

43. Vessels shall have:

a reception area reserved for taking catches of aquatic biological resources on board. It shall protect the products from sunlight, weather, heating elements and any source of contamination, and shall be easy to wash and disinfect;

a system for transferring fish from the reception area to the working areas. The working areas shall be large enough for the production process, easy to wash and disinfect, and arranged so as to prevent any contamination of the products;

an area for storing finished products;

a place for storing packaging materials;

special equipment for the disposal of fish waste and (or) a chamber for storing fish waste;

a water intake device located so as to exclude contact with the water supply system;

hand-washing facilities for personnel involved in the production process.

Vessels on which raw (fresh) fish and fresh aquatic mammals are stored for more than 8 hours shall be equipped with refrigerated holds, tanks or containers. Where necessary, these shall be cooled with ice or with chilled drinking water or chilled clean water for the time specified in the technical documentation for the fish food products.

44. On vessels, fish food products shall not come into contact with bilge water, waste water, smoke, fuel, petroleum products or lubricants, and effective water drainage shall be ensured.

45. Working surfaces and equipment in contact with fish food products on board shall be made of suitable corrosion-resistant material that is smooth and easy to wash and disinfect. Surface coatings shall be durable and non-toxic, and shall be made of materials intended for contact with food products.

46. Vessels intended for storing catches of aquatic biological resources for more than 24 hours shall be equipped with appropriate holds, tanks or containers.

47. Holds shall be separated from engine rooms and crew quarters by bulkheads that prevent contamination of the stored catches of aquatic biological resources. Holds, tanks and containers shall allow catches of aquatic biological resources to be stored under proper conditions. These conditions shall ensure the safety of the catches and, where necessary, prevent their contact with meltwater.

48. On vessels equipped to cool catches of aquatic biological resources with chilled clean seawater, the tanks shall be fitted with devices that achieve and maintain a uniform temperature throughout the tank.

49.Catches of aquatic biological resources shall be cooled with ice or chilled water no later than 1 hour after harvesting (catching).

If the design of the vessel does not allow catches of aquatic biological resources to be cooled with ice or chilled water within 1 hour after harvesting (catching), the catches may be unloaded without ice (under appropriate temperature conditions). Such products shall be unloaded no later than 12 hours after harvesting (catching), and their temperature shall be kept between minus 1 ºC and 4 ºC.

When aquatic biological resources are cooled with water, they shall be kept in clean chilled water on board the vessel for no more than 3 days.

50. Vessels shall have conditions that prevent contact of birds, insects and other animals with the products and prevent contamination of the products by them.

51. Vessels producing frozen fish food products shall have:

a) freezing equipment with enough capacity to lower the temperature rapidly to minus 18 ºC;

b) refrigeration equipment with enough capacity to store frozen fish food products in the holds at a temperature not higher than minus 18 ºC. Holds shall be fitted with thermometers and (or) devices for automatic monitoring of the air temperature in the hold, and with temperature recording devices.

52.The internal walls and ceilings of the holds shall be sanitised before catches of aquatic biological resources are loaded into them.

VIII. Requirements for the Processes of Storage, Transportation, Sale and Disposal of Fish Food Products

53. Manufacturers shall carry out the processes of storage, transportation and sale of fish food products in such a way that these products comply with the requirements of this Technical Regulation and of other Technical Regulations of the Union (Technical Regulations of the Customs Union) that apply to them.

54. The processes of storage, transportation, sale and disposal of fish food products shall comply with the requirements of this Technical Regulation and with the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011).

55. Materials in contact with fish food products during their storage, transportation and sale shall comply with the safety requirements for materials in contact with food products.

56. Thawing of frozen fish food products is not permitted during the storage, transportation and sale of fish food products.

57. During the storage of fish food products, the storage conditions established by the manufacturer shall be observed, taking into account the following requirements:

а) chilled fish food products shall be stored at a temperature not higher than 5 ºС, but above the freezing point of the tissue fluid;

б) frozen fish food products shall be stored at a temperature not higher than minus 18 ºС;

в) superchilled fish food products shall be stored at a temperature from minus 3 ºС to minus 5 ºС;

г) live fish and live aquatic invertebrates shall be kept under conditions that ensure their vital activity, without limitation of shelf life. Containers intended for keeping them shall be made of materials that do not change the quality of the water.

58. In cold storage chambers, fish food products are placed in stacks on racks or pallets with a height of not less than 8 – 10 cm above the floor. The products are placed at a distance of not less than 30 cm from walls and cooling devices. There shall be aisles between the stacks that ensure unobstructed access to the products.

59. Cold storage chambers for the storage of fish food products are equipped with thermometers and (or) devices for automatic control of the air temperature in the chamber, as well as devices for recording the temperature.

60. During storage, fish food products are grouped by species, intended use (sale or processing (treatment)) and thermal state (chilled, superchilled, frozen).

61. An increase in the air temperature in cold storage chambers during the loading or unloading of fish food products is permitted by not more than 5 ºС. Fluctuations of the air temperature during the storage, transportation and sale of fish food products shall not exceed 2 ºС.

62. Storage of chilled, superchilled and frozen fish food products in non-refrigerated premises before loading into a vehicle and (or) container is not permitted.

63. Vehicles and containers intended for the transportation of fish food products are equipped with devices that make it possible to maintain and record the established temperature conditions.

64. Transportation of fish food products in bulk without the use of transport packaging and (or) consumer packaging is not permitted.

65. Cargo compartments of vehicles and containers shall be regularly washed and disinfected at the frequency necessary to ensure that the cargo compartments of vehicles and containers cannot become sources of contamination of the products.

66. The internal surfaces of a vehicle shall be smooth and easy to wash and disinfect.

67. At retail and wholesale trade enterprises, repackaging under vacuum or in a modified atmosphere of fish food products previously packaged under vacuum or in a modified atmosphere is not permitted.

IX. Requirements for Packaging and Labelling of Fish Food Products

68. Packaging for fish food products shall comply with the requirements of this Technical Regulation and with the requirements of the Technical Regulation of the Customs Union "On Safety of Packaging" (TR CU 005/2011).

69. Fish food products shall be packaged under conditions that prevent contamination of the products.

70. Packaging of fish food products shall:

a) ensure the safety of fish food products and the stability of their organoleptic characteristics throughout the shelf life of such products;

b) be made from materials that comply with the requirements for materials in contact with food products;

c) be stored in a separate room under conditions that ensure the safety of fish food products. On vessels, packaging may be stored in the hold under conditions that ensure its safety.

71. Packaging used for storing ice-chilled fish food products shall allow meltwater to drain.

72. Labelling of fish food products shall comply with the requirements of the Technical Regulation of the Customs Union "Food Products Regarding Their Labelling" (TR CU 022/2011).

Information contained in the labelling of fish food products shall be provided in Russian and, where the legislation of the Member States so requires, in the state language(s) of the Member State in whose territory the fish food products are sold – except in the cases specified in subparagraph 3 of part 4.8 of Article 4 of the Technical Regulation of the Customs Union "Food Products Regarding Their Labelling" (TR CU 022/2011).

For fish food products that are packed in the presence of the consumer, the information provided for in paragraph 73 of this Technical Regulation and in subparagraph 13 of part 4.4 of Article 4 of the Technical Regulation of the Customs Union "Food Products Regarding Their Labelling" (TR CU 022/2011) shall be communicated to the consumer by any means that allows an informed choice of these products.

73. Labelling of packaged fish food products shall contain the following information:

a) the name of the fish food product, which includes:

the name of the type of fish food product (for example, "semi-finished fish culinary product", "canned fish");

the zoological name of the species of the aquatic biological resource or aquaculture species (for example, "Greenland halibut");

the type of cut of the fish food product (for example, "cod fillet", "pollock back", "herring carcass");

the type of processing (for example, "pasteurised", "marinated", "reconstituted").

For imitation fish food products, information on the imitation shall be stated in the name or after a dash following the name, in a font that does not differ from the font used for the product name, including its size;

b) for unprocessed fish food products – information on the area of harvesting, extraction (catch) or on the aquaculture origin;

c) information on the composition of the fish food product;

d) the name and location of the manufacturer, or the surname, first name, patronymic and location of the individual entrepreneur acting as manufacturer; the name and location of the person authorised by the manufacturer (if any); the name and location of the importer;

e) the date of production of the fish food product (for products packaged at a place other than the place of manufacture, the date of packaging shall also be stated).

Labelling of fish food products packaged at a place other than the place of their manufacture (except where fish food products are packaged into consumer packaging by retail trade organisations) shall contain information on the manufacturer and on the legal entity or individual entrepreneur that packages the fish food products at a place other than the place of their manufacture, either for subsequent sale or on the order of another legal entity or individual entrepreneur;

f) the shelf life of the fish food product (except for live fish and live aquatic invertebrates);

g) the storage conditions of the fish food product;

h) net weight (for frozen glazed fish food products – the net weight of the frozen fish food product without glaze);

i) information on the use of ionising radiation (if used);

j) the composition of the modified atmosphere in the consumer packaging of the fish food product (if used);

k) the presence of a vacuum, except for canned fish (if used);

l) recommendations for the use (including preparation) of the fish food product, where its use without such recommendations is difficult or may harm consumer health or lead to a reduction or loss of the taste properties of this fish food product;

m) the use of fish with spawning changes in the production of the fish food product (in the production of canned fish);

n) information on the freezing (chilling) of the fish food product;

o) the mass fraction of glaze in percent (for frozen glazed fish food products);

p) nutritional value indicators (for processed fish food products);

q) information on the presence in the fish food product of components obtained using genetically modified organisms (GMOs);

r) the single mark of product circulation on the market of the Union.

74. The name, date of manufacture, shelf life and storage conditions of the fish food product, as well as information on the presence of allergens in its composition, shall be applied to the consumer packaging and/or to a label that is difficult to remove from the consumer packaging. The remaining information shall be applied to the consumer packaging, and/or to a label, and/or to a package insert placed in or attached to each packaging unit.

75. Labelling of fish food products for children's nutrition applied to the packaging shall contain information that the product belongs to food products for young children or to food products for preschool and school-age children.

Labelling of vegetable-and-fish-based, fish-based and fish-and-vegetable-based complementary food products shall additionally contain the recommended age for introducing these products into the diet of young children:

vegetable-and-fish-based, fish-based and fish-and-vegetable-based complementary food products made from cod, hake, pike-perch, fish of the Salmonidae family, pollock, haddock, so-iuy mullet and other species of oceanic, marine and freshwater fish – over 8 months of age;

puréed canned fish (particle size up to 1,5 mm; up to 20 percent of particles up to 3 mm in size are permitted) – over 8 months of age;

coarsely ground canned fish (particle size up to 3 mm; up to 20 percent of particles up to 5 mm in size are permitted) – over 9 months of age.

76. For the following product groups of fish food products, the labelling shall contain the following additional information:

a) live fish: fish of the Acipenseridae family – the words "if the fish dies, gut it immediately and remove the sphincter";

b) frozen fish food products:

grade (if any) or category (for frozen fish fillets);

net weight of the fish food product without glaze (for frozen glazed fish food products);

c) fish food products produced from frozen fish food products – the words "produced from frozen raw material";

d) hot-smoked and cold-smoked fish food products, as well as lightly smoked fish food products, in whose production smoke flavourings are used – information on the use of smoke flavourings;

e) fish culinary products – the words "ready-to-eat product";

f) imitation fish food products – information on the imitation;

g) semi-finished fish culinary products – the words "semi-finished culinary product";

h) canned fish – the following code marks shall be applied to the outer surface of the cans by embossing or with indelible ink:

date of production: day – two digits (for numbers up to and including "9", the digit "0" is placed in front), month – two digits (for numbers up to and including "9", the digit "0" is placed in front), year – the last two digits;

assortment code (one to three characters – digits or letters, except the letter "Р") and the number of the manufacturing enterprise (one to three characters – digits and letters) (if any);

shift number (one digit) and fishing industry index (the letter "Р").

When applying the date of production, assortment code, number of the manufacturing enterprise, shift number and fishing industry index, a space of one or two characters shall be left between them.

When labelling lithographed cans, the details not present on the lithograph shall be applied to the lid (bottom) of the can, provided that the date of production is stated before the other details. The fishing industry index may be omitted;

i) roe:

the species of fish from which the roe was obtained;

granular caviar produced from frozen roe of fish of the Salmonidae family – the words "produced from frozen raw material";

roe obtained from hybrids of fish of the Acipenseridae family – the name of the hybrid or the combination of species of aquatic biological resources (for example, the words "granular caviar of Russian-Lena sturgeon").

77. Labelling of fish food products placed in transport packaging shall be carried out in accordance with the requirements of the Technical Regulation of the Customs Union "Food Products Regarding Their Labelling" (TR CU 022/2011).

X. Ensuring Compliance of Fish Food Products with Safety Requirements

78. Compliance of fish food products with this Technical Regulation is ensured by meeting its requirements, the requirements of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011) and other Technical Regulations of the Union (Technical Regulations of the Customs Union) that apply to these products.

79. Methods of research (testing) and measurement are established in the standards included in the list of standards containing rules and methods of research (testing) and measurement, including sampling rules, necessary for the application and fulfilment of the requirements of this Technical Regulation and for conformity assessment of products.

XI. Conformity assessment of fish food products

80. Fish food products are subject to conformity assessment before placing on the market in the territory of the Union.

81. Conformity assessment of fish food products, except for the products specified in paragraph 84 of this Technical Regulation, for compliance with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, is carried out in the following forms:

a) conformity confirmation of fish food products, except for fish food products for children's nutrition, novel fish food products, and unprocessed fish food products of animal origin (including live fish and live aquatic invertebrates);

b) state registration of novel fish food products and fish food products for children's nutrition, except for unprocessed fish food products of animal origin intended for children's nutrition, in accordance with the provisions of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011);

c) veterinary and sanitary examination of unprocessed fish food products of animal origin, live fish and live aquatic invertebrates.

82. Conformity assessment of the processes of production, storage, transportation, sale and disposal of fish food products for compliance with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them is carried out in the form of state control (supervision) of compliance with the requirements established by this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, except for the production processes of fish food products specified in paragraph 83 of this Technical Regulation.

83. Conformity assessment of the processes of production and processing of aquaculture food products of animal origin and catches of aquatic biological resources of animal origin is carried out in the form of state registration of production facilities in accordance with the provisions of the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011).

84. Conformity assessment of non-industrially manufactured fish food products and fish food products of catering establishments (public catering) intended for sale in the provision of services, as well as of the processes of sale of such fish food products, is carried out in the form of state supervision (control) of compliance with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them.

85. Conformity assessment of non-industrially manufactured fish food products of animal origin for compliance with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them may be carried out in the form of veterinary and sanitary examination.

86. Veterinary and sanitary examination of unprocessed fish food products of animal origin, live fish and live aquatic invertebrates, and the documentation of its results, are carried out in accordance with the Technical Regulation of the Customs Union "On Food Safety" (TR CU 021/2011) with regard to veterinary and sanitary examination.

87. Conformity confirmation of fish food products is carried out in the form of a conformity declaration procedure under declaration scheme 3d, 4d or 6d.

88. In the conformity declaration procedure for fish food products, the applicant may be a legal entity or a natural person registered as an individual entrepreneur in the territory of a Member State in accordance with its legislation, acting as the manufacturer, the seller or the person authorised by the manufacturer.

89. The conformity declaration procedure for serially manufactured fish food products is carried out under schemes 3d and 6d; for a batch of fish food products, under scheme 4d.

90. In the conformity declaration procedure for fish food products, the applicant may be:

a) for schemes 3d and 6d – the manufacturer (the person authorised by the manufacturer);

b) for scheme 4d – the manufacturer (the person authorised by the manufacturer) or the seller.

91. The applicant selects the declaration scheme for fish food products.

92. The conformity declaration procedure for fish food products under schemes 3d, 4d and 6d is carried out by the applicant on the basis of its own evidence and evidence obtained with the participation of an accredited testing laboratory (centre) included in the Unified Register of Conformity Assessment Bodies of the Union.

93. In the conformity declaration procedure for fish food products, the applicant:

a) compiles and analyses the documents confirming the compliance of the fish food products with the requirements of this Technical Regulation, including:

copies of documents confirming state registration as a legal entity or an individual entrepreneur;

the document in accordance with which the fish food products were manufactured (if available);

test reports of the fish food products confirming compliance with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them;

the contract (supply agreement) or shipping documentation (for scheme 4d) (if available);

a document confirming the safety of unprocessed fish food products of animal origin based on the results of veterinary and sanitary examination;

a certificate for the quality and safety management system (a copy of the certificate) (for scheme 6d);

other documents, at the applicant's choice, that served as the basis for conformity confirmation of the fish food products with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them (if available);

b) carries out product identification of the fish food products in accordance with Section III of this Technical Regulation;

c) ensures production control and takes all necessary measures to ensure that the production process of the fish food products ensures their compliance with the requirements of this Technical Regulation (for schemes 3d and 6d);

d) takes all necessary measures to ensure the stable operation of the quality and safety management system (for scheme 6d);

e) adopts the declaration of conformity, which is drawn up in accordance with the uniform form and rules approved by Decision of the Board of the Eurasian Economic Commission No. 293 of 25 December 2012;

f) applies the single mark of product circulation on the market of the Union.

94. After completion of the conformity confirmation procedures, the applicant compiles a set of documents that includes:

a) the documents provided for in subparagraph "a" of paragraph 93 of this Technical Regulation;

b) the test report (test reports) issued by an accredited testing laboratory (centre) included in the Unified Register of Conformity Assessment Bodies of the Union;

c) the registered declaration of conformity.

95. The declaration of conformity is subject to registration in accordance with the procedure established by Decision of the Board of the Eurasian Economic Commission No. 76 of 9 April 2013.

96. The validity period of the declaration of conformity for fish food products is not more than 3 years under scheme 3d and not more than 5 years under scheme 6d. The validity period of the declaration of conformity for a batch of fish food products (scheme 4d) is set by the applicant but may not exceed the shelf life of the fish food products.

97. The certification body for management systems carries out surveillance of the stable operation of the quality and safety management system (for scheme 6d).

98. The applicant keeps the set of documents specified in paragraph 94 of this Technical Regulation for the following periods:

a) for serially manufactured products – at least 5 years from the date on which the declaration ceases to be valid;

b) for a batch of products – at least 5 years from the date on which the sale of the batch of fish food products is completed.

XII. Marking of fish food products with the single mark of product circulation on the market of the Union

99. Fish food products that comply with the safety requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, and that have passed the conformity assessment procedure in accordance with the provisions of this Technical Regulation, are marked with the single mark of product circulation on the market of the Union.

100. Marking with the single mark of product circulation on the market of the Union is carried out before the fish food products are placed on the market in the territory of the Union.

101. The single mark of product circulation on the market of the Union is applied to each unit of fish food products (consumer packaging and transport packaging, or the tag, or the label) by any method that ensures a clear and legible image throughout the entire shelf life of such products.

If it is not possible to apply the single mark of product circulation on the market of the Union to the consumer packaging and transport packaging, or the tag, or the label, it may be applied to the accompanying documents.

102. Marking of fish food products with the single mark of product circulation on the market of the Union certifies that the fish food products comply with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them.

XIII. State control (supervision) of compliance with the requirements of this Technical Regulation

103. State control (supervision) of compliance with the requirements of this Technical Regulation with respect to fish food products and the related processes of production, storage, transportation, sale and disposal is carried out in accordance with the legislation of the Member State.

XIV. Safeguard clause

104. The authorised bodies of the Member States are obliged to take all measures to restrict and prohibit the placing on the market in the territory of the Union of fish food products that do not comply with the requirements of this Technical Regulation and other Technical Regulations of the Union (Technical Regulations of the Customs Union) applicable to them, and to withdraw such products from circulation.

In this case, the authorised body of the Member State is obliged to notify the authorised bodies of the other Member States of the relevant decision, stating the reason for the decision and providing evidence that explains the need for the relevant measures.

ANNEX No. 1
to the Technical Regulation
of the Eurasian Economic
Union "On Safety of Fish and
Fish Products" (TR EAEU
040/2016)

Microbiological safety criteria

Table 1

Microbiological safety criteria for fish food products

Table 2

Microbiological safety criteria for other fish food products

Table 3

Microbiological safety criteria for fish food products for children's nutrition

(for preschool and school‑age children)

Table 4

Microbiological safety criteria for the main types of food raw materials and components used in the production of fish food products for children's nutrition

Table 5

Microbiological safety indicators of canned fish food products

ANNEX No. 2
to the Technical Regulation
of the Eurasian Economic
Union "On Safety of Fish and
Fish Products" (TR EAEU
040/2016)

Maximum permissible levels of residues of veterinary drugs, animal growth promoters (including hormonal preparations) and medicinal products (including antimicrobial agents) in aquaculture food products of animal origin*

Footnote. Annex 2 was repealed by Decision of the Council of the Eurasian Economic Commission No. 70 of 23.06.2023 (enters into force upon expiry of 12 months from the date of its official publication).

ANNEX No. 3
to the Technical Regulation
of the Eurasian Economic
Union "On Safety of Fish and
Fish Products" (TR EAEU
040/2016)

Parasitological safety indicators of fish, crustaceans, molluscs and their processed products

Table 1

Freshwater fish and its processed products

Table 2

Anadromous fish and its processed products

Table 3

Marine fish and its processed products

Table 4

Freshwater crustaceans, marine molluscs and their processed products

ANNEX No. 4
to the Technical Regulation
of the Eurasian Economic
Union "On Safety of Fish and
Fish Products" (TR EAEU
040/2016)

Hygienic safety requirements for fish food products

* Calculated on the basis of the raw material, taking into account the dry matter content in it and in the final product.

ANNEX No. 5
to the Technical Regulation
of the Eurasian Economic
Union "On Safety of Fish and
Fish Products" (TR EAEU
040/2016)

Nutritional value and safety indicators of fish food products for the nutrition of infants and young children

Table 1

Nutritional value of canned fish (per 100 g of product)

Table 2

Safety indicators of canned fish

* Calculated on the basis of the raw material, taking into account the dry matter content in it and in the final product.

** Dioxins are determined where there is a reasonable assumption of their possible presence in the raw material, taking into account the following:

a) the maximum level of dioxin does not apply to products containing less than 1 % fat;

b) dioxins are the sum of polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) and are expressed as the sum of toxic equivalents (TEQ) according to the World Health Organization (WHO) scale:

Toxic equivalents (WHO scale)

Table 3

Nutritional value of fish‑and‑vegetable‑based canned products (per 100 g of product)

Table 4

Safety indicators of fish‑and‑vegetable‑based canned products

* Calculated on the basis of the raw material, taking into account the dry matter content in the raw material and in the final product.

** Dioxins are determined where there is a reasonable assumption that they may be present in the raw material, taking into account the following:

a) the maximum dioxin level does not apply to products containing less than 1 % fat;

b) dioxins are the sum of polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) and are expressed as the sum of toxic equivalents (TEQ) on the World Health Organization (WHO) scale:

Toxic equivalents (WHO scale)

ANNEX No. 6
to the Technical Regulation
of the Eurasian Economic
Union "On Safety of Fish and
Fish Products" (TR EAEU
040/2016)

Nutritional value and safety indicators of fish food products for the nutrition of preschool and school‑age children

Table 1

Nutritional value of semi‑finished products made from fish food products (per 100 g of product)

Table 2

Safety indicators of semi‑finished products made from fish food products

* Calculated on the basis of the raw material, taking into account the dry matter content in the raw material and in the final product.

** Dioxins are determined where there is a reasonable assumption that they may be present in the raw material, taking into account the following:

a) the maximum dioxin level does not apply to products containing less than 1 % fat;

b) dioxins are the sum of polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) and are expressed as the sum of toxic equivalents (TEQ) on the World Health Organization (WHO) scale:

Toxic equivalents (WHO scale)

Table 3

Nutritional value of culinary products made from fish food products (per 100 g of product)

Table 4

Safety indicators of culinary products made from fish food products

* Residues of those antibiotics that were used in the production of the raw material must be controlled. Control of the chloramphenicol content in ready-to-eat processed products of animal origin is carried out when a method of research (testing) and measurement is available that is included in the list of standards containing rules and methods of research (testing) and measurement, including sampling rules, necessary for the application and fulfilment of the requirements of the Technical Regulation of the Eurasian Economic Union "On Safety of Fish and Fish Products" (TR EAEU 040/2016) and for conformity assessment of objects of technical regulation. Until such a method is approved, control is carried out based on the raw material. Control of the content of tetracycline-group antibiotics in fish, aquatic invertebrates, aquatic mammals, other aquatic animals and products made from them is carried out when a method of research (testing) and measurement is available that is included in the list of standards containing rules and methods of research (testing) and measurement, including sampling rules, necessary for the application and fulfilment of the requirements of the Technical Regulation of the Eurasian Economic Union "On Safety of Fish and Fish Products" (TR EAEU 040/2016) and for conformity assessment of objects of technical regulation.

** Calculated on the basis of the raw material, taking into account the dry matter content in the raw material and in the final product.

*** Dioxins are determined where there is a reasonable assumption that they may be present in the raw material, taking into account the following:

a) the maximum level of dioxin does not apply to products containing less than 1 % fat;

b) dioxins are the sum of polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) and are expressed as the sum of toxic equivalents (TEQ) according to the World Health Organization (WHO) scale:

Toxic equivalents (WHO scale)

ANNEX No. 7
to the Technical Regulation
of the Eurasian Economic
Union "On Safety of Fish and
Fish Products" (TR EAEU
040/2016)

Permissible moisture content limits in the muscle tissue of frozen fish food products from the main commercial fish species and aquatic invertebrates