In accordance with Article 3 of the Treaty on the Eurasian Economic Commission dated 18 November 2011, the Council of the Eurasian Economic Commission decided:
1. To adopt the Customs Union Technical Regulation “On the Safety of Certain Types of Specialized Food Products, Including Dietary Therapeutic and Dietary Preventive Nutrition” (TR CU 027/2012) (attached).
2. To establish that the Customs Union Technical Regulation specified in Clause 1 of this Decision shall enter into force on 1 July 2013.
3. This Decision shall enter into force upon the expiry of 30 calendar days from the date of its official publication.
Members of the Council of the Eurasian Economic Commission:
For the Republic of |
For the Republic of |
For the Russian |
S. Rumas |
K. Kelimbetov |
I. Shuvalov |
ADOPTED
by the Decision of the Council of the Eurasian
Economic Commission
dated 15 June 2012 No. 34
TECHNICAL REGULATION
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
Contents
Foreword
Article 1 Scope of Application
Article 2 Objects of Technical Regulation
Article 3 Identification Rules
Article 4 Definitions
Article 5 Rules for Placing on the Market
Article 6 Safety Requirements for Certain Types of Specialized Food Products, Including Dietary Therapeutic and Dietary Preventive Nutrition
Article 7 Requirements for the Packaging and Marking of Certain Types of Specialized Food Products, Including Dietary Therapeutic and Dietary Preventive Nutrition
Article 8 Safety Requirements for the Processes of Production, Storage, Conveyance (Transportation), Sale and Disposal of Certain Types of Specialized Food Products, Including Dietary Therapeutic and Dietary Preventive Nutrition
Article 9 Ensuring Compliance with Safety Requirements
Article 10 Conformity Assessment
Article 11 Marking with the Single Mark of Product Circulation on the Market of the Member States of the Customs Union
Article 12 Safeguard Clause
Appendix 1
Appendix 2
Appendix 3
Chapter 1. GENERAL PROVISIONS
FOREWORD
1. This Customs Union Technical Regulation “On the Safety of Certain Types of Specialized Food Products, Including Dietary Therapeutic and Dietary Preventive Nutrition” (hereinafter referred to as the Technical Regulation) was 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 18 November 2010.
2. This Technical Regulation was developed for the purpose of establishing, within the single customs territory of the Customs Union, uniform mandatory requirements for application and compliance to certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, and ensuring the free movement of products placed on the market within the single customs territory of the Customs Union.
3. If other Customs Union Technical Regulations establishing requirements for certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, are adopted, such certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, shall comply with the requirements of all Customs Union Technical Regulations applicable to them.
Article 1
SCOPE OF APPLICATION
1. This Technical Regulation establishes:
1) objects of technical regulation;
2) safety requirements (including sanitary and epidemiological and hygienic requirements) for objects of technical regulation;
3) identification rules for objects of technical regulation;
4) forms and rules for conformity assessment of objects of technical regulation against the requirements of this Technical Regulation.
2. The purposes of adopting this Technical Regulation are:
protection of human life and/or health;
prevention of actions that mislead purchasers (consumers).
3. When applying this Technical Regulation, the requirements for food products concerning their marking, materials in contact with food products, including packaging, and the food raw materials used, established by the relevant Customs Union Technical Regulations, shall be taken into account.
4. When applying this Technical Regulation, the requirements of the Customs Union Technical Regulations establishing mandatory requirements for food products and certain types thereof shall be taken into account.
Article 2
OBJECTS OF TECHNICAL REGULATION
1. The objects of technical regulation under this Technical Regulation are specialized food products placed on the market and in circulation within the single customs territory of the Member States of the Customs Union:
specialized food products for sports nutrition and for pregnant and breastfeeding women;
food products for dietary therapeutic and dietary preventive nutrition, including food products for infants and children.
2. The requirements of this Technical Regulation do not apply to:
food products for infants and children, except for food products for dietary therapeutic and dietary preventive nutrition for infants and children;
food products manufactured by catering establishments (public catering establishments, organized groups);
natural mineral water, medicinal table water, medicinal mineral water with a mineral content exceeding 1 mg/dm3 or, at a lower mineral content, containing biologically active components in quantities not lower than the balneological standards;
food supplements.
Article 3
IDENTIFICATION RULES
1. For the purposes of classifying certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, as objects of technical regulation to which this Technical Regulation applies, interested parties shall carry out identification of the food products.
2. Identification of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, shall be carried out in accordance with the procedure established by the Customs Union Technical Regulation “On the Safety of Food Products”.
Article 4
DEFINITIONS
This Technical Regulation uses the definitions established by the Customs Union Technical Regulation “On the Safety of Food Products”, as well as the following terms and definitions:
1) food products for dietary therapeutic nutrition – specialized food products with specified nutritional and energy value and physical and organoleptic properties, intended for use as part of therapeutic diets;
2) food products for dietary preventive nutrition – specialized food products intended to correct carbohydrate, fat, protein, vitamin and other types of metabolism, in which the content and/or ratio of certain substances has been changed relative to their natural content, and/or which contain substances or components not originally present, as well as food products intended to reduce the risk of disease development;
3) food products for sports nutrition – specialized food products of a specified chemical composition, increased nutritional value and/or targeted effectiveness, consisting of a complex of products or represented by individual types thereof, which have a specific effect on increasing the human body's adaptive capacity to physical and neuro-emotional loads;
4) food products for pregnant and breastfeeding women – specialized food products in which the content and/or ratio of certain substances has been changed relative to their natural content, and/or which contain substances or components not originally present, intended to satisfy the physiological needs of the body of a pregnant or breastfeeding woman;
5) food products for enteral nutrition – liquid or dry food products for dietary therapeutic or dietary preventive nutrition (reconstituted to a ready-to-use form), intended for oral consumption directly or administration through a tube when it is impossible to provide the body with nutrients and energy by conventional means;
6) food products for diabetic nutrition – food products for dietary therapeutic or dietary preventive nutrition in which easily digestible carbohydrates (monosaccharides – glucose, fructose, galactose, and disaccharides – sucrose, lactose) are absent or present in reduced amounts relative to their content in similar food products and/or whose carbohydrate composition has been changed;
7) anti-reflux formulas – formulas containing a thickener (thickeners) and intended to prevent regurgitation of food in infants;
8) formulas for preterm and/or low-birth-weight infants – food products for infants and children produced on the basis of cow's milk or the milk of other productive animals and/or milk-processing products and intended to satisfy the physiological needs of preterm and/or low-birth-weight infants;
9) low-lactose (lactose-free) food products – food products for dietary therapeutic or dietary preventive nutrition produced on the basis of cow's milk or the milk of other productive animals and/or milk-processing products, in which the lactose content is reduced compared with similar food products;
10) food products free from specific amino acids (or with a low content thereof) – food products for dietary therapeutic or dietary preventive nutrition obtained on the basis of protein hydrolysates free from specific amino acids (or with a low content thereof) and/or from a mixture of amino acids free from phenylalanine, and/or using components with a reduced phenylalanine content.
Article 5
RULES FOR PLACING ON THE MARKET
1. Specialized food products, including dietary therapeutic and dietary preventive nutrition, specified in Clause 1 of Article 2 of this Technical Regulation, shall be placed on the market if they comply with this Technical Regulation and with other Customs Union Technical Regulations applicable to them.
2. Specialized food products, including dietary therapeutic and dietary preventive nutrition, specified in Clause 1 of Article 2 of this Technical Regulation, which comply with the requirements of this Technical Regulation and other Customs Union Technical Regulations applicable to them and have undergone conformity assessment (confirmation), shall bear the single mark of product circulation on the market of the Member States of the Customs Union.
Chapter 2
SAFETY REQUIREMENTS FOR FOOD PRODUCTS
Article 6
SAFETY REQUIREMENTS FOR CERTAIN TYPES OF SPECIALIZED
FOOD PRODUCTS, INCLUDING DIETARY THERAPEUTIC AND
DIETARY PREVENTIVE NUTRITION
1. Food raw materials and Food Additives used in the production of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, shall comply with the safety requirements established by the Technical Regulation of the Customs Union "On Safety of Food Products".
In the production of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, it is permitted to use Food Additives that comply with the requirements of this Technical Regulation and of the Technical Regulation of the Customs Union "Safety Requirements for Food Additives, Flavourings and Processing Aids".
2. Food products for dietary therapeutic and dietary preventive nutrition shall meet the physiological needs of the human body for essential nutrients and energy, taking into account the risk factors and pathogenesis of diseases. They shall comply with the established hygienic requirements for the permissible content of contaminants, biologically active substances and compounds, microorganisms and other biological organisms that pose a danger to the health of present and future generations.
3. The following is not permitted:
1) the use of poultry meat, except chilled poultry meat, as well as mechanically deboned poultry meat and collagen-containing raw materials from poultry meat, for the production of food products for dietary therapeutic and dietary preventive nutrition and of food products for pregnant and breastfeeding women;
2) the use of food raw materials containing GMOs and (or) components derived from GMOs for the production of food products for pregnant and breastfeeding women and of food products for dietary therapeutic and dietary preventive nutrition intended for infants and children.
4. Food products for pregnant and breastfeeding women shall comply with the requirements established in Annexes 1 and 2 to this Technical Regulation.
5. Certain types of products for children's dietary therapeutic and children's dietary preventive nutrition for young children shall comply with the requirements established in Annex 3 to this Technical Regulation.
6. The composition of salt substitutes shall comply with the requirements established in Annex 2 to this Technical Regulation.
The sodium content of salt substitutes shall not exceed 120 mg/100 g of the weight of the salt substitute mixture.
7. The addition of iodine-containing compounds to salt and salt substitutes shall comply with 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 products for sports nutrition, shall not contain psychotropic substances, narcotic drugs, poisonous or potent substances, doping agents and/or their metabolites, or other prohibited substances included in the WADA list (World Anti-Doping Agency).
9. Certain types of gluten-free specialized food products shall consist of, or be made from, one or more ingredients that do not contain wheat, rye, barley, oats or their crossbred varieties (obtained by crossing them), and (or) shall consist of, or be specially processed (to reduce the gluten level) from, one or more ingredients obtained from wheat, rye, barley, oats or their crossbred varieties, in which the gluten level in the ready-to-eat product does not exceed 20 mg/kg.
10. Certain types of specialized food products with a low gluten content shall consist of, or be specially processed (to reduce the gluten level) from, one or more ingredients obtained from wheat, rye, barley, oats or their crossbred varieties, in which the gluten level in the ready-to-eat product is more than 20 mg/kg but not more than 100 mg/kg.
Chapter 3. LABELLING OF FOOD PRODUCTS
Article 7
REQUIREMENTS FOR PACKAGING AND LABELLING OF CERTAIN TYPES OF SPECIALIZED FOOD PRODUCTS, INCLUDING DIETARY THERAPEUTIC AND DIETARY PREVENTIVE NUTRITION
1. The packaging and labelling of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, shall comply with the requirements of the Technical Regulations of the Customs Union "Food Products in Terms of Their Labelling" and "On Safety of Packaging".
2. Certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, shall be portioned and packaged in a manner that ensures their safety and the consumer properties declared in the labelling throughout the shelf life, provided that the conditions of their transportation and storage are observed.
3. Materials and articles used for packaging certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, shall comply with the safety requirements for materials and articles in contact with food products established by the relevant Technical Regulation of the Customs Union.
4. Perishable food products for dietary therapeutic and dietary preventive nutrition shall be released only in pre-packaged form, in small single-serving packages.
5. The labelling of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, shall contain information on the intended purpose of the products in accordance with the definitions established in Article 4 of this Technical Regulation, the category of persons for whom they are intended and (or) information on changes in the composition of such products, and recommendations for their use.
6. Instructions for storing food products for dietary therapeutic and dietary preventive nutrition after opening the package shall be given in the labelling if this is necessary to preserve the full 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 shall be provided.
7. In addition to all labelling indications relating to low-sodium dietary products (except salt substitutes as such), the following special labelling indications shall be complied with:
1) where salt substitutes are present, the presence of the salt substitutes listed in Annex 4 to this Technical Regulation shall be indicated;
2) where a salt substitute consisting wholly or partly of a potassium salt is added, the total potassium content, expressed in milligrams of cation per 100 grams of product, shall be indicated in the labelling.
8. Salt substitutes shall be designated as "low-sodium salt substitute" or "low-sodium dietary salt". The labelling of salt substitutes shall 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 weight of the substitute mixture.
9. The labelling of food products for sports nutrition shall include the following additional information:
- for products with a specified nutritional and energy value and targeted effectiveness, consisting of a set of nutrients or represented by individual types of nutrients, the following information shall be indicated: "specialized food product for sports nutrition";
- the following information shall additionally be placed on the consumer packaging: information on the nutritional and energy value of the product and the proportion of the physiological requirement; recommended dosages, methods of preparation (where necessary), and conditions and duration of use.
Chapter 4. REQUIREMENTS FOR THE PROCESSES OF PRODUCTION
(MANUFACTURE), STORAGE, CARRIAGE (TRANSPORTATION),
SALE AND DISPOSAL OF CERTAIN TYPES OF SPECIALIZED
FOOD PRODUCTS, INCLUDING DIETARY THERAPEUTIC AND
DIETARY PREVENTIVE NUTRITION
Article 8
SAFETY REQUIREMENTS FOR THE PROCESSES OF PRODUCTION, STORAGE,
CARRIAGE (TRANSPORTATION), SALE AND DISPOSAL
OF CERTAIN TYPES OF SPECIALIZED FOOD PRODUCTS,
INCLUDING DIETARY THERAPEUTIC AND DIETARY PREVENTIVE
NUTRITION
1. The processes of production (manufacture), storage, carriage, sale and disposal of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, that ensure their safety shall comply with the requirements established by this Technical Regulation and by the Technical Regulation of the Customs Union "On Safety of Food Products".
2. All free-flowing ingredients shall be passed through magnetic separators before use.
3. Separate premises shall be allocated for work with live microorganisms.
Chapter 5. CONFORMITY ASSESSMENT (CONFIRMATION)
Article 9
ENSURING COMPLIANCE WITH SAFETY REQUIREMENTS
1. The conformity of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, with this Technical Regulation is ensured by fulfilling its safety requirements.
2. The methods for research (testing) and measurement 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 for research (testing) and measurement, including sampling rules, necessary for the application and fulfilment of the requirements of this Technical Regulation and for the conformity assessment (confirmation) of products.
Article 10
CONFORMITY ASSESSMENT
1. The conformity assessment of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition, for compliance 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 Regulation of the Customs Union "On Safety of Food Products".
2. For the State Registration of products for dietary therapeutic and dietary preventive nutrition, a document (documents) confirming the declared therapeutic and (or) preventive properties shall be submitted.
3. The conformity assessment of the processes of production, storage, sale, carriage and 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) of compliance with the requirements for food products established by this Technical Regulation and by other Technical Regulations in the field of food product safety.
Article 11
MARKING WITH THE SINGLE MARK OF PRODUCT CIRCULATION ON THE MARKET
OF THE MEMBER STATES OF THE CUSTOMS UNION
1. Certain types of specialized food products, including dietary therapeutic nutrition and dietary preventive nutrition, that comply with the safety requirements of this Technical Regulation and have undergone the conformity assessment procedure must be marked with the single mark of product circulation on the market of the Member States of the Customs Union.
2. Marking with the single mark of product circulation on the market of the Member States of the Customs Union is performed before certain types of specialized food products, including dietary therapeutic nutrition and dietary preventive nutrition, are placed on the market.
3. The single mark of product circulation on the market of the Member States of the Customs Union is applied to each unit of product (consumer container and/or tag and/or label) and/or to the shipping documentation. The single mark of product circulation on the market of the Member States of the Customs Union is applied by any method that ensures a clear and legible image throughout the entire shelf life of the product.
Chapter 6. SAFEGUARD CLAUSE
Article 12
SAFEGUARD CLAUSE
1. The Member States of the Customs Union shall take measures to prevent the placing on the market within the single customs territory of the Customs Union of certain types of specialized food products, including dietary therapeutic nutrition and dietary preventive nutrition, that do not comply with the requirements of this Technical Regulation, and to withdraw such products from circulation.
2. The authorized body of a Member State of the Customs Union shall notify the Eurasian Economic Commission and the authorized bodies of the other Member States of the Customs Union of the decision taken. The notification shall state the reasons for the decision and provide evidence explaining the need for this measure.
3. The following cases may constitute grounds for applying this Article:
non-compliance with the requirements of this Technical Regulation;
incorrect application of standards interrelated with this Technical Regulation, if these standards were applied.
Annex 1
to the Technical Regulation of the Customs Union
“On the Safety of Certain Types
of Specialized Food Products,
Including Dietary Therapeutic and Dietary
Preventive Nutrition”
Microbiological safety standards (opportunistic pathogens)
In certain types of specialized food products manufactured using technological and/or probiotic microflora, the content and species composition of lactic acid and probiotic microorganisms are regulated - Table 1.
In certain types of specialized non-preserved food products that are processed before sale, the following are regulated: opportunistic pathogens, sanitary indicator microorganisms and spoilage microorganisms. These characterize the safety, the sanitary and hygienic condition of production and the storage stability of the products - Table 2.
Compliance with these indicators is assessed at the circulation stage of certain types of specialized food products throughout their entire shelf life.
Table 1
Requirements for the content of biotechnological and
probiotic microorganisms in certain types
of specialized food products
Indicators Bifidobacteria and/or | Permissible 1х106 | Product groups Milk-based products |
Table 2
Requirements for opportunistic pathogens and sanitary indicator
microorganisms in food products
2.1 Meat and meat products, poultry, and products of their processing
Indicators |
Permissible |
Product groups |
Number of mesophilic |
1х103 |
Meat (all animal species): |
Coliform group bacteria |
0,1 |
Meat (all animal species): |
Bacteria of the genus Proteus, |
1,0 |
Meat (all animal species): |
2.2. Other products
Indicators | Permissible levels | Product groups |
Number of | 5х102 | Pectin for dietary |
5х103 | Dry products for | |
1х104 | Edible gelatin for | |
Coliform group bacteria | 0,1 | Dry products for |
1,0 | Pectin for dietary | |
S.aureus, not permitted | 1 | Dry products for |
B.sereus, CFU/g, not more than | 10 | Dry products for |
Yeasts, CFU/g, not more than | 10 | Dry products for |
50 | Pectin (for dietary | |
Moulds, CFU/g, not more than | 50 | Pectin (for dietary |
100 | Dry products for |
2.3. Products for the Nutrition of Pregnant and Breastfeeding Women
Indicators | Permissible levels | Product groups |
Count of mesophilic | 5x103 | Herbal instant |
2,5x104 | Milk-based | |
5x104 | Porridges | |
Coliform bacteria | 3,0 g | Milk-based |
1,0 g | Milk-based | |
0,1 g | Porridges based on milk and cereals | |
E.coli are not permitted in a product | 10 g | Milk-based |
S.aureus are not permitted in a product | 10 g | Milk-based |
1,0 g | Milk-based | |
Moulds, CFU/g, not more than | 10 | Milk-based |
50 | Herbal instant teas | |
100 | Milk-based | |
200 | Porridges based on milk and cereals | |
Yeasts, CFU/g, not more than | 10 | Milk-based |
50 | Milk-based | |
100 | Porridges based on milk and cereals | |
B.cereus are not permitted in a product volume of, cm3 | 1,0 | Milk-based |
B.cereus, CFU/g, not more than | Not permitted in 1,0 g | Milk-based |
100 | Herbal instant teas | |
2x102 | Milk-based |
2.4. Specialized products for therapeutic nutrition of children,
for preterm and (or) low‑birth‑weight infants
Count of mesophilic aerobic | 1х102 | Sterilized adapted |
2х102 | Pasteurized meat-based sausages | |
5х102 | Reconstituted pasteurized | |
2х103 | Products based on | |
3х103 | Low-protein products | |
1х104 | Freeze-dried meat-based | |
1,5х104 | Freeze-dried meat-based | |
2,5х104 | Low-lactose and | |
Coliform bacteria (coliforms are not permitted in the product mass, g) | 1,0 | Low-lactose and |
0,3 | Dry dairy | |
E.coli are not permitted in the product mass, g | 10 | Products for |
S.aureus are not permitted in the product mass, g | 10 | Products for |
1,0 | Low-lactose and | |
0,1 | Low-protein products | |
Sulphite-reducing clostridia | 0,1 | Freeze-dried products |
Moulds, CFU/g | 10 | Low-protein products (starches, cereals and pasta). |
50 | Products based on soy protein isolate. Freeze-dried meat-based products for children under 2 years. Products for preterm and (or) low-birth-weight infants. Products based on full or partial protein hydrolysates. Products free from phenylalanine or with a low phenylalanine content. Low-protein products (except starches, cereals and pasta) | |
100 | Low-lactose and lactose-free products. Dry dairy high-protein products. Freeze-dried meat-based products for children over 2 years. Freeze-dried milk-based products (cottage cheese, etc.) | |
Yeasts, CFU/g | 10 | Products based on soy protein isolate. Products for preterm and (or) low-birth-weight infants. Products based on full or partial protein hydrolysates. Products free from phenylalanine or with a low phenylalanine content. |
50 | Low-lactose and lactose-free products. Dry dairy high-protein products. Low-protein products (starches, cereals and pasta and other products). Freeze-dried products based on meat and milk (cottage cheese, etc.). Freeze-dried products based on meat | |
100 | Freeze-dried meat-based products for children over 2 years | |
B.cereus, CFU/g | 100 | Products based on soy protein isolate. Low-protein products (starches, cereals and pasta and other products). Products based on full or partial protein hydrolysates. Products free from phenylalanine or with a low phenylalanine content. Freeze-dried meat-based products for children under 2 years. Products for preterm and (or) low-birth-weight infants |
2х102 | Low-lactose and lactose-free products. Freeze-dried meat-based products for children over 2 years |
Annex 2
to the Technical Regulation of the Customs Union
“On the Safety of Certain Types
of Specialized Food Products,
Including Dietary Therapeutic and Dietary
Preventive Nutrition”
Composition of Salt Substitutes
Composition of salt substitutes |
Conditions of use |
1 |
2 |
a) potassium sulphate; potassium, |
Not limited; however, the content |
b) magnesium salts of adipic, |
The content of Mg++ shall not exceed |
c) choline salts of acetic, |
The content of choline shall not |
d) free adipic, |
Salt substitutes may also contain:
1) colloidal silicon dioxide or calcium silicate, not more than 1% of the mass of the mixture of substitutes, individually or in combination;
2) fillers: safe and suitable food products for general consumption (for example, sugar, cereal flour).
Annex 3
to the Technical Regulation of the Customs Union
"On safety of certain types
of specialized food products,
including dietary therapeutic and dietary
preventive nutrition"
Requirements for the nutritional value of certain types
of specialized food products, including dietary
therapeutic and dietary preventive nutrition
for young children
Product name | Nutritional | Units | Permissible | Notes |
Low-lactose (lactose-free) food products | LOW-LACTOSE AND LACTOSE-FREE PRODUCTS FOR INFANTS IN THE 1ST YEAR OF LIFE | |||
Protein | g/l | 12-21 | ||
Taurine | mg/l, max. | 80 | ||
L-carnitine | Same | 20 ( if added) | ||
Fat | g/l | 30-40 | ||
Linoleic acid | % of total fatty acids | 14-20 | ||
mg/l, max. | 4000-8000 | |||
Carbohydrates | g/l | 65-80 | ||
Lactose | g/l, max. | 10 | In low-lactose products | |
same | 0,1 | In lactose-free products | ||
Minerals: | ||||
calcium | mg/l | 330-700 | ||
phosphorus | Same | 150-400 | ||
potassium | Same | 400-800 | ||
sodium | Same | 150 - 300 | ||
magnesium | Same | 30-90 | ||
copper | Same | 0,3-1,0 | ||
manganese | µg/l | 10-300 | ||
iron | mg/l | 3-14 | ||
zinc | Same | 3-10 | ||
chlorides | Same | 400-800 | ||
iodine | µg/l | 50-150 | ||
ash | g/l | 3-5 | ||
Vitamins: | ||||
retinol (A) | µg-eq/l | 400-1000 | ||
tocopherol (E) | mg/l | 4-12 | ||
calciferol (D) | µg/l | 7,5-12,5 | ||
vitamin K | Same | 25-60 | ||
thiamine (B1) | Same | 400-1000 | ||
riboflavin (B2) | Same | 500-1500 | ||
pyridoxine (B6) | Same | 300-1000 | ||
Pantothenic | Same | 2700-5000 | ||
folic | Same | 60-150 | ||
cyanocobalamin (B12) | µg/l | 1,0-3,0 | ||
niacin (PP) | mg/l | 2-10 | ||
Ascorbic acid (C) | mg/l | 60-150 | ||
biotin | µg/l | 10-40 | ||
carnitine | mg/l | 10-20 | ||
inositol | mg/l | 20-60 | ||
choline | Same | 50-150 | ||
Low-lactose (lactose-free) food products | Osmolality | mOsm/kg, | 300 | |
LOW-LACTOSE PROCESSED MILK PRODUCTS FOR YOUNG CHILDREN | ||||
Protein | g/l | 40-47 | ||
Casein/ | - | 80:20 | ||
Fat | g/l | 20-38 | ||
Linoleic acid | % of total fatty | 15 | ||
mg/l | 5000-6000 | |||
Carbohydrates | g/l | 60-65 | ||
Glucose | Same | 25-28 | ||
Galactose | Same | 6-7 | ||
Lactose | g/l, max. | 16 | ||
Energy | kcal/l | 600-680 | ||
Soy protein | Protein | g/l | 15-20 | |
Methionine | same | 0,25-0,35 | ||
Fat | g/l | 30-38 | ||
Linoleic acid | % of | 14 | ||
mg/l, | 4000 | |||
Carbohydrates | g/l | 65-80 | ||
Energy value | kcal/l | 650-720 | ||
Minerals: | ||||
calcium | mg/l | 450-750 | ||
phosphorus | Same | 250-500 | ||
potassium | Same | 500-800 | ||
sodium | Same | 200-320 | ||
magnesium | Same | 40-80 | ||
copper | Same | 0,4-1,0 | ||
iron | mg/l | 6-14 | ||
zinc | Same | 4-10 | ||
ash | g/l | 3-5 | ||
Vitamins: | ||||
retinol (A) | µg-eq/l | 500-800 | ||
tocopherol (E) | mg/l | 5-15 | ||
calciferol (D) | µg/l | 8-12 | ||
vitamin K | Same | 25-100 | ||
thiamine (B1) | Same | 300-600 | ||
riboflavin (B2) | Same | 600-1000 | ||
pyridoxine (B6) | Same | 300-700 | ||
folic acid (Bc) | Same | 60-150 | ||
cyanocobalamin (B12) | µg/l | 1,5-3,0 | ||
niacin (PP) | mg/l | 4-8 | ||
Ascorbic acid (C) | mg/l | 60-150 | ||
Taurine | mg/l | 45-55 | ||
L-carnitine | Same | 10-20 | ||
Osmolality | mOsm/kg, | 300 | ||
Formulas based on | Protein (equiv.) | g/l | 12-22 | |
Taurine | mg/l | 40-55 | ||
L-carnitine | Same | 10-25 | ||
Fat | g/l | 25-35 | ||
Linoleic acid | % of total | 14 | ||
mg/l, | 4000 | |||
Carbohydrates | g/l | 70-95 | ||
Energy | kcal/l | 650-720 | ||
Minerals: | ||||
calcium | mg/l | 330-980 | ||
phosphorus | Same | 150-600 | ||
potassium | Same | 400-1000 | ||
sodium | Same | 150-350 | ||
magnesium | Same | 50-100 | ||
copper | Same | 0,3-1,0 | ||
iron | mg/l | 6-14 | ||
zinc | Same | 3-10 | ||
ash | g/l | 4-5 | ||
Vitamins: | ||||
retinol (A) | µg-eq/l | 500-800 | ||
tocopherol (E) | mg/l | 6-14 | ||
calciferol (D) | µg/l | 5-15 | ||
thiamine (B1) | Same | 400-600 | ||
riboflavin (B2) | Same | 600-1000 | ||
pyridoxine (B6) | Same | 500-700 | ||
folic acid (Bc) | Same | 50-100 | ||
cyanocobalamin (B12) | µg/l | 1,5-3,0 | ||
niacin (PP) | mg/l | 3-8 | ||
Ascorbic acid (C) | mg/l | 50-150 | ||
Osmolality | mOsm/kg, | 320 | ||
Phenylalanine-free formulas (low-phenylalanine formulas) for infants | Protein (equiv.) | g/l | 16-20 | |
Phenylalanine | mg/l, not more than | 500 | In products | |
Taurine | mg/l | 40-55 | ||
L-carnitine | Same | 10-25 | ||
Fat | g/l | 30-38 | ||
Linoleic acid | % of | 14 | ||
mg/l, | 5000 | |||
Carbohydrates | g/l | 65-80 | ||
Energy | kcal/l | 570-720 | ||
Minerals: | ||||
calcium | mg/l | 300-700 | ||
phosphorus | Same | 300-500 | ||
potassium | Same | 500-800 | ||
sodium | Same | 150-300 | ||
magnesium | Same | 40-60 | ||
copper | Same | 0,3-1,0 | ||
iron | mg/l | 3-14 | ||
zinc | Same | 4-10 | ||
ash | g/l | 4-5 | ||
iodine | µg/l | 50-120 | ||
Vitamins: | ||||
retinol (A) | µg-eq/l | 500-800 | ||
tocopherol (E) | mg/l | 4-12 | ||
calciferol (D) | µg/l | 8-12 | ||
thiamine (B1) | Same | 350-700 | ||
riboflavin (B2) | Same | 500-1000 | ||
pyridoxine (B6) | Same | 300-700 | ||
folic acid (Bc) | Same | 50-100 | ||
cyanocobalamin (B12) | µg/l | 1,5-3,0 | ||
niacin (PP) | mg/l | 3-8 | ||
Ascorbic acid (C) | mg/l | 20-100 | ||
Osmolality | mOsm/kg, not more than | 320 | ||
Formulas | Protein | g/l | 19 - 31 | |
Taurine | mg/l | Not more than 90 | ||
Fat | g/l | 33 - 45 | ||
Linoleic acid | g/l | 2,6 – 10,5 | ||
Alpha-linolenic | mg/l | Not less than | ||
Docosahexaenoic | mg/l | 80 – 205 | ||
Arachidonic | mg/l | 120 – 295 | ||
Eicosapentaenoic acid | % | Not more than 30 | ||
Carbohydrates | g/l | 72 - 94 | ||
Energy | kcal/l | 660 - 890 | ||
Minerals: | ||||
calcium | mg/l | 800 - 1400 | ||
phosphorus | Same | 400 - 700 | ||
potassium | Same | 450 - 1200 | ||
sodium | Same | 300 - 800 | ||
magnesium | Same | 50 - 130 | ||
copper | Same | 0,6 – 1,6 | ||
iron | mg/l | 13 - 20 | ||
zinc | Same | 7 - 13 | ||
chlorides | Same | 400 - 1200 | ||
manganese | µg/l | 45 - 200 | ||
iodine | Same | 75 - 325 | ||
selenium | Same | 13 - 70 | ||
Vitamins: | ||||
retinol (A) | µg-eq/l | 1500 - 3000 | ||
tocopherol(E) | mg/l | 15 - 60 | ||
calciferol (D) | µg/l | 15 - 60 | ||
Vitamin K | Same | 30 - 200 | ||
thiamine (B1) | Same | 750 - 2000 | ||
riboflavin (B2) | Same | 600 - 4000 | ||
pantothenic | mg/l | 2,3 – 14,0 | ||
pyridoxine (B6) | Same | 200 - 2000 | ||
folic acid (Bc) | Same | 225 - 600 | ||
cyanocobalamin (B12) | µg/l | 0,6 – 5,3 | ||
niacin(PP) | mg/l | 2,5 - 38 | ||
ascorbic acid (C) | mg/l | 60 - 300 | ||
inositol | Same | 30 - 350 | ||
biotin | µg/l | 10 - 300 | ||
choline | mg/l | 50 - 350 | ||
L-carnitine | mg/l | 15 – 45 | ||
Formulas | nucleotides | mg/l | Not more than 35 | |
Osmolality | mOsm/kg, | 310 | ||
Laboratory control of casein is carried out where a control method approved in accordance with the established procedure is available.
