TECHNICAL REGULATIONS OF THE CUSTOMS UNION

TR CU 027/2012

On the safety of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition

1. This technical regulation of the Customs Union "On the safety of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition" (hereinafter referred to as the Technical Regulation) has been developed in accordance with the Agreement on Common Principles and Rules of Technical Regulation in the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation dated November 18, 2010.

2. This Technical Regulation has been developed in order to establish in the single customs territory of the Customs Union uniform mandatory requirements for the application and execution of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, ensuring the free movement of products put into circulation in the single customs territory of the Customs Union.

3. If other technical regulations of the Customs Union establishing requirements for certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, are adopted with respect to certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, then certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, must comply with the requirements of all technical regulations of the Customs Union, which apply to them.

1. This Technical Regulation establishes:

1) objects of technical regulation;

2) safety requirements (including sanitary-epidemiological and hygienic requirements) for the objects of technical regulation;

3) rules of identification of objects of technical regulation;

4) forms and rules for assessing compliance of technical regulation objects with the requirements of this Technical Regulation.

2. The objectives of the adoption of this Technical Regulation are:

protection of human life and (or) health;

prevention of actions misleading purchasers (consumers).

3. When applying this Technical Regulation, the requirements for food products in terms of their labeling, materials in contact with food products, including packaging, and food raw materials used, established by the relevant technical regulations of the Customs Union, must be taken into account.

4. When applying these Technical Regulations, the requirements of the technical regulations of the Customs Union, which establish mandatory requirements for food products and its individual types, must be taken into account.

1. The objects of technical regulation of this Technical Regulation are issued into circulation and in circulation in the single customs territory of the member states of the Customs Union:

specialized food products for athletes, pregnant and lactating women;

food products of dietary therapeutic and dietary preventive nutrition, including for baby food.

2. The requirements of this Technical Regulation do not apply to:

food products for baby food, with the exception of food products for dietary therapeutic and dietary preventive nutrition for baby food;

food products manufactured by catering enterprises (catering, in organized collectives);

natural mineral, therapeutic table, therapeutic mineral water with a mineralization of more than 1 mg / dm or with less mineralization, containing biologically active components in an amount not lower than balneological norms;

biologically active food additives.

1. For the purposes of attribution of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, to the objects of technical regulation, in respect of which this Technical Regulation applies, interested persons shall identify food products.

2. Identification of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, is carried out in accordance with the procedure established by the technical regulations of the Customs Union "On Food Safety".

This Technical Regulation uses the definitions established by the technical regulations of the Customs Union "On Food Safety", as well as the following terms and definitions:

1) dietary therapeutic food products - specialized food products with a given nutritional and energy value, physical and organoleptic properties, and intended for use as part of therapeutic diets;

2) dietary preventive nutrition food products - specialized food products intended for the correction of carbohydrate, fat, protein, vitamin and other types of metabolism, in which the content and (or) the ratio of individual substances relative to their natural content has been changed, and (or) the composition of which includes substances or components not initially present, as well as food products intended to reduce the risk of developing diseases;

3) food products for athletes' nutrition - specialized food products of a given chemical composition, increased nutritional value and (or) directed effectiveness, consisting of a complex of products or represented by their separate types, which has a specific effect on increasing a person's adaptive capabilities to physical and neuropsychiatric stress;

4) food products for the nutrition of pregnant and lactating women - specialized food products in which the content and (or) the ratio of individual substances relative to their natural content has been changed, and (or) the composition of which includes substances or components not initially present, intended to meet the physiological needs of the body of a pregnant and lactating woman;

5) enteral nutrition food products - liquid or dry (restored to ready-to-use) dietary therapeutic or dietary preventive nutrition food products intended for oral consumption directly or administration through a probe if it is impossible to provide the body with nutrients and energy in the usual way;

6) food products of diabetic nutrition - food products of dietary therapeutic or dietary preventive nutrition, in which the content of easily digestible carbohydrates (monosaccharides - glucose, fructose, galactose, and disaccharides - sucrose, lactose) is absent or reduced relative to their content in similar food products and (or) the carbohydrate composition is changed;

7) antireflux mixtures - mixtures containing a thickener (thickeners) and designed to prevent regurgitation of food in young children;

8) mixtures for feeding premature and (or) underweight children - food products for baby food produced on the basis of cow's milk or milk of other productive animals and (or) milk processing products and intended to meet the physiological needs of premature and (or) underweight children;

9) low-lactose (lactose-free) food products - food products of dietary therapeutic or dietary preventive nutrition produced on the basis of cow's milk or milk of other productive animals and (or) milk processing products in which the lactose content is reduced compared to similar food products;

10) food products without (or with a low content of) individual amino acids - food products of dietary therapeutic or dietary preventive nutrition obtained on the basis of hydrolysates of proteins released (or with a low content) from individual amino acids and (or) from a mixture of amino acids without phenylalanine, and (or) using components with a reduced content of phenylalanine.

1. Specialized food products, including dietary therapeutic and dietary preventive nutrition, specified in paragraph 1 of Article 2 of this Technical Regulation, are put into circulation on the market if they comply with this Technical Regulation, as well as other technical regulations of the Customs Union, the effect of which extends to it.

2. Specialized food products, including dietary therapeutic and dietary preventive nutrition, specified in paragraph 1 of Article 2 of this Technical Regulation, complying with the requirements of this Technical Regulation, other technical regulations of the Customs Union, the effect of which applies to it, and having passed the assessment (confirmation) of conformity, are marked with a single product circulation mark on the market of the member states of the Customs Union.

1. Food raw materials, food additives used in the production of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition must comply with the safety requirements established by the technical regulations of the Customs Union "On food safety".

In the production of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, it is allowed to use food additives that meet the requirements of this Technical Regulation and the technical regulations of the Customs Union "Safety requirements for food additives, flavorings and technological aids".

2. Food products of dietary therapeutic and dietary preventive nutrition must meet the physiological needs of the human body for the necessary nutrients and energy, taking into account risk factors and pathogenesis of diseases, meet the established hygienic requirements for the permissible content of contaminants and biologically active substances and compounds, microorganisms and other biological organisms that pose a danger to the health of current and future generations.

3. Not allowed:

1) the use of dietary therapeutic and dietary preventive nutrition for the production of food products, food products for the nutrition of pregnant and lactating women of poultry meat, except chilled, mechanically deboned poultry meat and collagen-containing raw materials from poultry meat;

2) the use of food raw materials containing GMOs and (or) components derived from GMOs for the production of food products for pregnant and lactating women, dietary therapeutic and dietary preventive nutrition for baby food.

4. Food products for the nutrition of pregnant and lactating women must comply with the requirements set out in Annexes 1 and 2 to this Technical Regulation.

5. Certain types of products of children's dietary therapeutic and children's dietary preventive nutrition for young children must comply with the requirements set out in Annex 3 to this Technical Regulation.

6. The composition of salt substitutes must comply with the requirements set out in Annex 2 to this Technical Regulation.

The sodium content in salt substitutes should not exceed 120 mg / 100 g of the mass of the mixture of salt substitutes.

7. The addition of iodine-containing compounds to salt and salt substitutes must comply with the norms of the national legislation of the member state of the Customs Union in which the products are sold.

8. Certain types of specialized food products, including for athletes' nutrition, must not contain psychotropic, narcotic, poisonous, potent, doping agents and/or their metabolites, other prohibited substances included in the WADA (World Anti-Doping Agency) list.

9. Certain types of specialized gluten-free food products must consist or be made from one or more components that do not contain wheat, rye, barley, oats or their crossbred variants (obtained by crossing them) and (or) must consist or be made in a special way (to reduce gluten levels) from one or more components that are derived from wheat, rye, barley, oats or their crossbred variants, and in which the gluten level in ready-to-eat products is no more than 20 mg/kg.

10. Certain types of specialized food products with a low gluten content must consist or be manufactured in a special way (to reduce gluten levels) from one or more components that are obtained from wheat, rye, barley, oats or their cross-bred variants, and in which the gluten level in ready-to-eat products is more than 20 mg/kg, but not more than 100 mg/kg.

1. Packaging and labeling of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, must comply with the requirements of the technical regulations of the Customs Union "Technical Regulations for food products in terms of its labeling" and "On packaging safety".

2. Certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, must be packaged and packaged in a way that ensures their safety and consumer properties declared in the labeling during the shelf life, subject to the conditions of their transportation and storage.

3. When packing certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, materials and products that meet the safety requirements for materials and products in contact with food products established by the relevant technical regulations of the Customs Union must be used.

4. Perishable food products of dietary therapeutic and dietary preventive nutrition should be produced only in packaged form in small-piece packaging for single consumption.

5. Labeling of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, must contain information about the purpose of products in accordance with the definitions established in Article 4 of this Technical Regulation, the categories of persons for whom they are intended and (or) information about changes in the composition of such products, recommendations for their use.

6. Instructions for the storage of dietary therapeutic and dietary preventive nutrition after opening the package should be given in the labeling, if necessary to ensure the completeness of the properties and nutritional value of the products. If the products cannot be stored after opening the package, or cannot be stored in the package after opening, an appropriate warning should be contained about this.

7. In addition to all labeling instructions concerning dietary products with a low sodium content (with the exception of salt substitutes as such), the following special labeling instructions must be followed:

1) in the presence of substitutes, the presence of salt substitutes listed in Annex 4* of this Technical Regulation must be indicated;

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* The text of the application on the official website of the Customs Union Commission www.tsouz.ru

2) when adding a salt substitute consisting entirely or partially of potassium salt, it is necessary to indicate on the label the total potassium content expressed in milligrams of cation per 100 grams of products.

8. Salt substitutes should be called "low sodium salt substitute" or "low sodium dietary salt". The labeling of salt substitutes should contain a complete list of ingredients, as well as the content of cations (sodium, potassium, calcium, magnesium, ammonium and choline) per 100 grams of the mass of the mixture of substitutes.

9. Labeling of food products for athletes' nutrition should include the following additional information:

- for products having a given nutritional and energy value and directional efficiency, consisting of a set of nutrients or represented by their separate types, the information is indicated: "specialized food products for athletes' nutrition";

- additional information is provided on consumer packaging: information on the nutritional and energy value of products, the proportion of physiological needs; recommended dosages, cooking methods (if necessary), conditions and duration of use.

1. The processes of production (manufacture), storage, transportation, sale and disposal of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, ensuring their safety, must comply with the requirements established by this Technical Regulation and the technical regulations of the Customs Union "On food safety".

2. All bulk components must be passed through magnetic traps before use.

3. Separate rooms are allocated for working with living microorganisms.

1. Compliance of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition with this Technical Regulation is ensured by the fulfillment of its safety requirements.

2. Methods of research (testing) and measurements of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, are established in the standards included in the List of Standards containing rules and methods of research (testing) and measurements, including sampling rules necessary for the application and fulfillment of the requirements of this Technical Regulation and the assessment (confirmation) of conformity of products.

1. Assessment of compliance of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition with the requirements of this Technical Regulation is carried out in the form of state registration in accordance with the procedure established by the technical regulations of the Customs Union "On food Safety".

2. At the state registration of products of dietary therapeutic and dietary preventive nutrition, a document (s) confirming the declared therapeutic and (or) preventive properties is provided.

3. Conformity assessment of the processes of production, storage, sale, transportation, disposal of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, is carried out in the form of state supervision (control) over compliance with the requirements for food products established by this Technical Regulation and other technical regulations in the field of food safety.*10.3)

1. Certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, that meet the safety requirements of this Technical Regulation and have passed the conformity assessment procedure must be marked with a single product circulation mark on the market of the member states of the Customs Union.

2. Marking with a single sign of circulation of products on the market of the member states of the Customs Union is carried out before the release of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition into circulation on the market.

3. A single product circulation mark on the market of the member states of the Customs Union is applied to each product unit (consumer packaging, and (or) label, and (or) label) and (or) shipping documentation. A single product circulation mark on the market of the member states of the Customs Union is applied in any way that provides a clear and clear image throughout the shelf life of the products.

1. The member States of the Customs Union are obliged to take measures to prevent the release into circulation in the single customs territory of the Customs Union, as well as the withdrawal from circulation of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, that do not meet the requirements of this Technical Regulation.

2. The authorized body of a member state of the Customs Union is obliged to notify the Eurasian Economic Commission and the authorized bodies of other member states of the Customs Union of the decision, indicating the reasons for this decision and providing evidence explaining the need for this measure.*12.2)

3. The following cases may be the basis for the application of this article:

failure to comply with the requirements of this Technical Regulation;

incorrect application of standards related to this Technical Regulation, if these standards have been applied.

In certain types of specialized food products produced using technological and/or probiotic microflora, the content and species composition of lactic acid and probiotic microorganisms are normalized - Table 1.

In certain types of specialized non-canned food products processed before sale, conditionally pathogenic microorganisms, sanitary-indicative microorganisms and microorganisms that cause spoilage are normalized, characterizing the safety, sanitary and hygienic state of production and the stability of products in storage - Table 2.

Compliance with these indicators is assessed at the stage of circulation of certain types of specialized food products throughout their shelf life.

Salt substitutes may also contain:

1) colloidal silicon or calcium silicate not more than 1% by weight of the mixture of substitutes, individually or in combination;

2) fillers: safe and suitable food products for general use (for example, sugar, grain flour).

Laboratory control of casein is carried out in the presence of a control method approved in accordance with the established procedure.

Electronic text of the document

prepared by CJSC "Codex" and verified by:

official website

Customs Union Commissions

www.tsouz.ru

as of 06/19/2012