Aptauja ilgs līdz 23. oktobrim.
The translation of this document is outdated.
Translation validity: 30.05.2008.–27.06.2009. Amendments not included: 17.06.2009., 03.11.2009., 14.12.2010., 04.06.2013., 30.07.2013., 14.01.2014.
Regulations Regarding Infant Formulae and Follow-on Formulae for InfantsIssued pursuant to I. General Provisions1. These Regulations prescribe the composition, labelling and advertising requirements for food products intended for infants from birth to 12 months of age (hereinafter - infants) - infant formulae and follow-on formulae for infants (hereinafter - formulae). 2. Due to the specific composition or special manufacturing process thereof, formulae shall be clearly separated from other types of food and shall be suitable for feeding healthy infants if it is not possible to feed them with breast milk. 3. In accordance with the purpose of use, formulae shall be divided into the following groups: 3.1. infant formulae, intended for the special diet of infants during the first few months of life and satisfying the nutritional requirements of such infants until commencement of the appropriate complementary feeding; 3.2. follow-on formulae for infants, intended for the nutritional diet of infants, upon introduction of the appropriate complementary feeding, and constituting the principal liquid element in a progressively diversified diet for these infants and children aged from one to three years (hereinafter - small children). 4. The appropriate formulae shall be allowed to be distributed in the European Economic Zone and exported to third countries in accordance to the requirements of these Regulations. 5. Formulae shall only be distributed in retail trade in pre-packaged form. II. Requirements for the Composition of a Formula6. Formulae shall not contain any substances in such quantity as to endanger the health of infants and small children. 7. The manufacturer shall ensure that the composition of the product referred to in Sub-paragraph 3.1 of these Regulations shall comply with the requirements specified in Annex 1 of these Regulations. Infant formulae shall be manufactured from protein sources defined in Paragraph 2 of Annex 1 of these Regulations and other food ingredients, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data. Such suitability may be substantiated by systematically reviewing data regarding foreseeable benefits and safety considerations, as well as with appropriate studies, which shall be carried out according to expert guidance on the design and conduct of such studies. 8. The manufacturer shall ensure that the composition of the product referred to in Sub-paragraph 3.2 of these Regulations shall comply with the requirements specified in Annex 2 of these Regulations. Infant formulae shall be manufactured from the protein sources defined in Paragraph 2 of Annex 1 of these Regulations and other food ingredients, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data. Such suitability may be substantiated by systematically reviewing data regarding foreseeable benefits and safety considerations, as well as with appropriate studies which shall be carried out according to expert guidance on the design and conduct of such studies. 9. Only the substances referred to in Annex 3 to these Regulations shall be permitted to be added to formulae, in order to ensure that infants receive the necessary vitamins, mineral substances, amino acids and other nitrogen-containing substances and nutrients. Purity criteria shall be adopted for the substances referred to in Annex 3 to these Regulations, which are provided for by the regulatory enactments regarding the utilisation thereof in foodstuffs. 10. The levels for pesticide residues, specified in regulatory enactments regarding pesticide residues in products of plant and animal origin, in formulae shall not exceed 0.01 mg/kg, except the pesticides, the maximum permissible levels for residues of which have been specified in Annex 4 to these Regulations. 11. It is prohibited to use the pesticides specified in Annex 5 of these Regulations in the acquisition of agricultural products if these products are used in the production of formulae. It shall be considered that the pesticides referred to in Annex 5 to these Regulations have not been used, if: 11.1. the levels of residues of pesticides referred to in Annex 5, Table 1 of these Regulations do not exceed the analytical method quantitative determination limit of 0.003 mg/kg; or 11.2. the levels of residues of pesticides referred to in Annex 5, Table 2 of these Regulations do not exceed 0.003 mg/kg. 12. The permissible maximum levels of residues of pesticides in formulae, which have been produced for the feeding of infants, have been specified in Paragraph 10 and 11 of these Regulations. 13. When preparing formulae for use, only potable water shall be added thereto. 14. The utilisation of food additives in formulae shall be prescribed by the regulatory enactments regarding the use of food additives. III. Requirements for the Labelling of Formula15. If the formula is produced from various proteins, the product label shall indicate the relevant formula trade name - "Infant Formula" or "Follow-on Formula for Infants". 16. If the formula is only produced from cows' milk proteins, the product label shall indicate the relevant formula trade name - "Infant Milk" or "Follow-on Milk for Infants". 17. When the formula is imported from another Member State of the European Union, the trade name of the product in Latvian shall correspond to the trade name of the product in one of the European Union Member State languages (Annex 6). 18. In addition to the information specified in the regulatory enactments regarding labelling of food products, the labelling of the formula shall specify: 18.1. the energy value of the product in kilojoules (kJ) and kilocalories (kcal), the content of proteins, carbohydrates and fats (expressed in numerical form) per 100 millilitres of the product ready for use; 18.2. the average quantity (expressed in numerical form) of each vitamin and each mineral substance referred to in Annexes 1 or 2 of these Regulations, and also the quantity of choline, inositol and carnitine (expressed in numerical form), if they have been added, per 100 millilitres of the product ready for use; 18.3. product preparation, directions for storage and use and a warning regarding hazards to health, which may arise due to inappropriate preparation or storage of the product. 19. Labelling of a formula may include the average quantity of nutrients mentioned in Annex 3 (expressed in numerical form) per 100 ml of the product ready for use, which are not referred to in Annexes 1 or 2 to these Regulations. 20. The information provided in the labelling of a formula regarding the use of the product may not contain a recommendation to refuse breast-feeding. It is prohibited to use the words "humanised", "maternalised", "adjusted", "adapted" or other words in the labelling, which equate formulae to breast milk. 21.The product labelling referred to in Sub-paragraph 3.1 of these Regulations shall include the following: 21.1. information regarding the suitability of the product for feeding of infants from birth, if it is not possible to breast feed an infant. 21.2. the statement "Būtiska informācija" (Relevant Information), "Svarīga norāde" (Important Notice) or equivalent specification in bold print, followed by a statement: 21.2.1. regarding the superiority of breast feeding and breast milk as the best infant nutrition which protects infants from health impairments; and 21.2.2. that the product should be used only in accordance with the recommendation of a medical practitioner. 22. The labelling of the product referred to in Sub-paragraph 3.1 may not include pictures of children or other pictures or text idealising the use of the product. The label may include graphic representations which facilitate preparation of the product. 23. The product labelling referred to in Sub-paragraph 3.1 of these Regulations shall bear nutrition and health value annotations in accordance with the requirements referred to in Annex 7 to these Regulations. 24. The product labelling referred to in Sub-paragraph 3.2 of these Regulations shall specify that the product is only suitable for the nutrition of infants who are older than six months, that it is only part of a diversified diet and that is not to be utilised as an infant formula during the first six months of life, and that the decision to begin complementary feeding (including any exception in connection with nutrition up to six months of age), should only be made based on the advice of an independent person who has qualifications in medicine, nutrition or pharmacy, or the opinion of a specialist responsible for maternal and child care. 25. The additional labelling information referred to in Sub-paragraph 3.2 of these regulations, which is expressed in numerical form, may indicate information regarding the vitamin and mineral substances (expressed in terms of percentage of the reference value indicated therein) per 100 ml of the product prepared for use, set out in Annex 8 to these Regulations. 26. The products referred to in Sub-paragraph 3.1 of these Regulations and the products referred to in Sub-paragraph 3.2 of these Regulations shall be labelled in the language of the state, in which they shall be distributed, and in such a way that it would enable consumers to make a clear distinction between such products so as to avoid any risk of confusion between an infant formula and a follow-on formula for infants. IV. Requirements for Advertising a Formula and Informative Materials27. The requirements for labelling a formula, which are referred to by Paragraph 20, Sub-paragraph 21.2, Paragraphs 22, 23 and 26 of these Regulations, shall also apply to: 27.1. the presentation of the formula, packaging and the packaging materials utilised, as well as the way in which they are arranged and the setting in which they are displayed; 27.2. advertising of a formula. 28. Advertising of infant formulae shall be restricted to publications specialising in baby care and scientific publications in accordance with the requirements referred to in Paragraph 20, Sub-paragraph 21.2., Paragraphs 22, 23, 26 and Sub-paragraph 27.2 of these Regulations. Advertising may contain only scientifically valid information. The advertising shall not directly indicate or imply that bottle-feeding is equivalent or superior to breast feeding. 29. Formulae may not be advertised at the point of sale by giving out samples of the product directly to the consumers or in any other way promoting sales in retail trade (for example, with special show-cases, discount coupons, premiums, special sales, selling goods at reduced prices, selling in a package with other goods). 30. It is prohibited to distribute (either directly or indirectly) infant formulae or samples thereof for free or low-priced via the health care system, or to give them as gifts to pregnant women, mothers of infants and small children or members of their families. 31.The State agency "Public Health Agency" (hereinafter - Public Health Agency) shall provide those, for whom the referred to information is necessary, with objective and consistent written or audiovisual information regarding infant feeding. Public Health Agency shall ensure planning, presentation and dissemination of the referred to information, as well as control thereof. The information referred to shall cover the following issues: 31.1. the benefits and superiority of breast feeding over feeding with formulae; 31.2. maternal nutrition, preparing for breast-feeding and prolongation of breast feeding; 31.3. the possible negative effect on breast feeding, which may be caused by partial formula feeding; 31.4. the difficulty of resuming breast feeding after a pause; and 31.5. where necessary - information regarding the proper use of infant formulae shall contain information about their use, social and financial implications, regarding the health hazards of inappropriate foods or feeding methods, as well as of the improper use of a formula, that such formulae are only intended for infants for which formulae are necessary, and only for as long as that is necessary. It is prohibited to include in information any pictures which idealise the use of the referred to product. 32. The information regarding formulae, which the manufacturers and distributors provide to health care workers, shall be scientifically based. 33. Manufacturers and distributors may donate informative and educational supplementary aids or materials only on request, which the receiver of the donation shall submit to the Public Health Agency. The Public Health Agency shall evaluate the conformity of the respective supplementary aids or materials to the requirements referred to in Paragraph 35 of these Regulations and shall provide a written approval. 34. In order to coordinate donation of the informative and educational supplementary aids or materials, the manufacturer or distributor shall submit an application to the Public Health Agency, to which a description of the supplementary aids or materials or a copy thereof is attached. 35. The informative and educational supplementary aids or materials may bear the donating company's name or logo, but not its trademark, which has been patented for infant formula. Informative and educational supplementary aids or materials shall be distributed only through the mediation of the health care institutions. 36. Infant formulae may be supplied by donations or low-price sales to social care institutions for feeding infants, for whom these products are necessary, and only for as long as it is necessary. 37. For the implementation of the supervision of the principles and objectives of the International Code of Marketing of Breast-milk in relation to marketing, information and the responsibility of health care institutions, the Public Health Agency shall, once in every two years, perform monitoring of the code. The report on the monitoring results shall be submitted by the Public Health Agency to the Ministry of Health and the Ministry of Agriculture. 38. It shall be permissible to import and distribute an infant formula in Latvia, if the manufacturer, distributor or packer has previously submitted a written notification to the Food and Veterinary Service regarding its importation and distribution in the Republic of Latvia (Annex 9) and a sample of the relevant product's label. 39. The Food and Veterinary Service shall publish the list on the Internet home page thereof, where the infant formulae are indicated, for which the notification referred to in Paragraph 38 of these Regulations has been received. The following information shall be indicated in the list: 39.1. name, address and registration number of the manufacturer; 39.2. the name of the distributor, importer or packer, address and registration number; 39.3. the relevant name of the product. 40. If the Food and Veterinary Service determines that the infant formula does not meet the requirements of these Regulations, the relevant product shall be recognised as unfit for distribution and information regarding it shall be removed from the list referred to in Paragraph 39 of these Regulations. V. Closing Provisions41. Cabinet Regulation No. 368 of 31 May 2005, Regulations Regarding the Mandatory Harmlessness Requirements for the Composition of Breast Milk Substitutes, as well as the Procedures for Labelling and Evaluation of Advertising Thereof (Latvijas Vēstnesis [the Official Gazette of the Government of Latvia], 2005, Nos. 88, 210; 2007, No. 104), is repealed. 42. It shall be permissible to distribute until 31 December 2009 formulae, the composition and labelling of which do not comply with the requirements of these Regulations, if the requirements referred to in Cabinet Regulation No. 368 of 31 May 2005, Regulations Regarding the Mandatory Harmlessness Requirements for the Composition of Breast Milk Substitutes, as well as the Procedures for Labelling and Evaluation of Advertising thereof that were in force until the day of coming into force of these Regulations have been complied with. From 1 January 2010, it shall be prohibited to distribute formulae that do not comply with the requirements of these Regulations. 43. A distributor shall, until 1 July 2008, submit a written notification regarding infant formulae which have been manufactured or imported into Latvia up to the day of coming into force of these Regulations, together with a labelling sample for the relevant product. Informative Reference to European Union DirectivesThese Regulations contain legal norms arising from: 1) Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses; 2) Council Directive 92/52/ECC of 18 June 1992 on infant formulae and follow-on formulae intended for export to third countries; 3) Directive 96/84/EC of the European Parliament and Council of 19 December 1996 amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses; 4) Directive 1999/41/EC of the European Parliament and Council of 7 June 1999 amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses; 5) Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC. Prime Minister I. Godmanis Acting for the Minister for Agriculture
-
Annex 1 Infant Formulae
|
No. |
Energy value and ingredients of formula, units of measurement |
Minimum quantity |
Maximum quantity |
1 |
2 |
3 |
4 |
1. | Energy value, kJ/100 ml (kcal/100 ml) |
250 (60) |
295 (70) |
2. | Protein2, 3,4: | ||
2.1. | in formula manufactured from cows' milk proteins, g/100 kJ (g/100 kcal) |
0.45 (1.8)5 |
0,7 (3) |
2.2. | in formula manufactured from protein hydrolysates, g/100 kJ (g/100 kcal) |
0.45 (1.8)6, 7 |
0,7 (3) |
2.3. | in formula manufactured from soy protein isolates, alone or in a mixture with cows' milk proteins, g/100 kJ (g/100 kcal) |
0.56 (2.25)7 |
0.7 (3) |
3. | Taurine, if added, mg/100 kJ (mg/100 kcal) |
- |
2.9 (12) |
4. | Choline, mg/100 kJ (mg/100 kcal) |
1.7 (7) |
12 (50) |
5. | Lipids, g/100 kJ (g/100 kcal)8: |
1.05 (4.4) |
1.4 (6.0) |
5.1. | lauric acid and myristic acid |
- |
separately or as a whole 20% of the total fat content |
5.2. | linoleic acid (in the form of glycerides (linoleates)), mg/100 kJ (mg/100 kcal) |
70 (300) |
285 (1200) |
5.3. | alpha-linolenic acid, mg/100 kJ (mg/100 kcal) |
12 (50) |
- |
5.4. | linoleic acid and alpha-linolenic acid ratio |
5 |
15 |
5.5. | trans fatty acids |
- |
3 % of the total fat content |
5.6. | erucic acid |
- |
1% of the total fat content |
5.7. | long-chain polyunsaturated acids (LCP)) (C20, C22) may be added: | ||
5.7.1. | n-3 fatty acids |
- |
1% of the total fat content |
5.7.2. | n-6 fatty acids |
- |
2% of the total fat content, arachidonic acid 1% of the total fat content |
5.7.3. | eicosapentaenoic acid (20:5, n-3) content shall not exceed docosahexaenoic acid (22:6, n-3) content the docosahexaenoic acid (22:6, n-3) content shall not exceed the n-6 fatty acid content | ||
6. | Phospholipids, g/l |
2 |
|
7. | Inositol, mg/100 kJ (mg/100 kcal) |
1 (4) |
10 (40) |
8. | Carbohydrates, g/100 kJ (g/100 kcal)10: |
2.2 (9) |
3.4 (14) |
8.1. | only lactose, maltose, sucrose, malto-dextrins, glucose syrup, dried glucose syrup, uncooked starch naturally free of gluten, gelatinised starch naturally free of gluten | ||
8.2. | lactose |
1.1 (4.5)9 |
- |
8.3. | sucrose, only for products which are produced from protein hydrolysates |
- |
20 % of the total carbohydrate content |
8.4. | glucose, only for products which are produced from protein hydrolysates |
0.5 (2) |
|
8.5. | uncooked starch and/or gelatinised starch |
- |
2 g/100 ml and 30 % of the total carbohydrate content |
9. | Fructo-oligosaccharides and galacto-oligosaccharides10, g/100 ml |
0.8 |
|
10. | Minerals: | ||
10.1. | from cows' milk proteins or from protein hydrolysates in manufactured infant formula | ||
10.1.1. | sodium, mg/100 kJ (mg/100 kcal) |
5 (20) |
14 (60) |
10.1.2. | potassium, mg/100 kJ (mg/100 kcal) |
15 (60) |
38 (160) |
10.1.3. | chlorides, mg/100 kJ (mg/100 kcal) |
12 (50) |
38 (160) |
10.1.4. | calcium, mg/100 kJ (mg/100 kcal) |
12 (50) |
33 (140) |
10.1.5. | phosphorus, mg/100 kJ (mg/100 kcal) |
6 (25) |
22 (90) |
10.1.6. | magnesium, mg/100 kJ (mg/100 kcal) |
1.2 (5) |
3.6 (15) |
10.1.7. | iron, mg/100 kJ (mg/100 kcal) |
0.07 (0.3) |
0.3 (1.3) |
10.1.8. | zinc, mg/100 kJ (mg/100 kcal) |
0.12 (0.5) |
0.36 (1.5) |
10.1.9. | copper, µg /100 kJ (µg /100 kcal) |
8.4 (35) |
25 (100) |
10.1.10. | iodine, μg/100 kJ (μg/100 kcal) |
2.5 (10) |
12 (50) |
10.1.11. | selenium, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
2.2 (9) |
10.1.12. | manganese, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
25 (100) |
10.1.13. | fluoride, µg /100 kJ (µg /100 kcal) |
- |
25 (100) |
10.1.14. | calcium and phosphorus ratio |
1 |
2 |
10.2. | in a formula manufactured from soy protein isolates, alone or in a mixture with cows' milk proteins, mg/100 kJ (mg/100 kcal): | ||
10.2.1. | sodium, mg/100 kJ (mg/100 kcal) |
5 (20) |
14 (60) |
10.2.2. | potassium, mg/100 kJ (mg/100 kcal) |
15 (60) |
38 (160) |
10.2.3. | chlorides, mg/100 kJ (mg/100 kcal) |
12 (50) |
38 (160) |
10.2.4. | calcium, mg/100 kJ (mg/100 kcal) |
12 (50) |
33 (140) |
10.2.5. | phosphorus, mg/100 kJ (mg/100 kcal) |
7.5 (30) |
25(100) |
10.2.6. | magnesium, mg/100 kJ (mg/100 kcal) |
1.2 (5) |
3.6 (15) |
10.2.7. | iron, mg/100 kJ (mg/100 kcal) |
0.12(0.45) |
0.5 (2) |
10.2.8. | zinc, mg/100 kJ (mg/100 kcal) |
0.12 (0,5) |
0.36 (1.5) |
10.2.9. | copper, µg /100 kJ (µg /100 kcal) |
8.4 (35) |
25 (100) |
10.2.10. | iodine, μg/100 kJ (μg/100 kcal) |
2.5 (10) |
12 (50) |
10.2.11. | selenium, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
2.2 (9) |
10.2.12. | manganese, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
25 (100) |
10.2.13. | fluorides, µg /100 kJ (µg /100 kcal) |
- |
25 (100) |
10.2.14. | calcium and phosphorus ratio |
1.2 |
2.0 |
11. | Vitamins: | ||
11.1. | vitamin A, μg RE/100 kJ (μg RE/100 kcal)11 |
14 (60) |
43 (180) |
11.2. | vitamin D, μg/100 kJ (μg/100 kcal)12 |
0.25 (1) |
0.65 (2.5) |
11.3. | thiamin, μg/100 kJ (μg/100 kcal) |
14 (60) |
72 (300) |
11.4. | riboflavin, μg/100 kJ (μg/100 kcal) |
19 (80) |
95 (400) |
11.5. | niacin, µg /100 kJ (µg /100 kcal)13 |
72 (300) |
375 (1500) |
11.6. | pantothenic acid, μg/100 kJ (μg/100 kcal) |
95 (400) |
475 (2000) |
11.7. | vitamin B6, μg/100 kJ (μg/100 kcal) |
9 (35) |
42 (175) |
11.8. | biotin, μg/100 kJ (μg/100 kcal) |
0.4 (1.5) |
1.8 (7.5) |
11.9. | folic acid, μg/100 kJ (μg/100 kcal) |
2.5 (10) |
12 (50) |
11.10. | vitamin B12, μg/100 kJ (μg/100 kcal) |
0.025 (0,1) |
0.12 (0.5) |
11.11. | vitamin C, μg/100 kJ (μg/100 kcal) |
2.5 (10) |
7.5 (30) |
11.12. | vitamin K, μg/100 kJ (μg/100 kcal) |
1 (4) |
6 (25) |
11.13. | Vitamin E (mg α-TE)14 |
0.5/g polyunsaturated acids expressed as linoleic acid, as corrected for the double bonds15, but not less than 0.1 mg/100 kJ (0.5 mg/100 kcal) |
1.2 mg/100 kJ (5 mg/100 kcal) |
12. | Nucleotides, total quantity, mg/100 kJ (mg/100 kcal), including: |
- |
1.2 (5) |
12.1. | cytidine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.60 (2.50) |
12.2. | uridine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.42 (1.75) |
12.3. | adenosine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.36 (1.50) |
12.4. | guanosine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.12 (0.50) |
12.5. | inosine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.24 (1,00) |
1 The formula is set out for usage in a finished
product prepared according to the instructions of the
manufacturer.
2 Protein content = nitrogen content x 6.25.
3 The addition of amino acids to the formula is
permitted solely for the purpose of improving the nutritional
value of the proteins, and only in the proportions necessary for
this purpose.
4 For a formula to have the energy value equal to
breast milk, it shall contain an available quantity of each
essential and non-essential amino acid which is not less than
that contained in breast milk.
The content of essential and semi-essential amino acids in breast milk
No. |
Amino acids |
mg/100 kJ (1 kJ = 0,239 kcal) |
mg/100 kcal |
1 |
2 |
3 |
4 |
1. | Cystine |
9 |
38 |
2. | Histidine |
10 |
40 |
3. | Isoleucine |
22 |
90 |
4. | Leucine |
40 |
166 |
5. | Lysine |
27 |
113 |
6. | Methionine |
5 |
23 |
7. | Phenylalanine |
20 |
83 |
8. | Threonine |
18 |
77 |
9. | Tryptophan |
8 |
32 |
10. | Tyrosine |
18 |
76 |
11. | Valine |
21 |
88 |
For calculation purposes, the concentration of cystine and
methionine may be added together, if the cystine/methionine ratio
is not greater than 2, and the phenylalanine and tyrozine
concentration can be added together, if the
tyrosine/phenylalanine ratio is not greater than 2. The ratio of
methionine/cystine may be greater than 2 but shall not be greater
than 3 provided that the suitability for the particular
nutritional use by infants is demonstrated through appropriate
studies following generally accepted expert guidance on the
design and conduct of such studies.
5 If the infant formula is produced from cows' milk
protein and its content is from 0.45 to 0.5 g/100 kJ (2 g/100
kcal), the suitability of the infant formula to nutritional use
by infants shall be demonstrated through appropriate studies that
are conducted, based on generally accepted guidance on the design
and conduct of such studies.
6 If the infant formula is produced from protein
hydrolysates and its content is from 0.45 to 0.56 g/100 kJ (2.25
g/100 kcal), the suitability of the infant formula to nutritional
use by infants shall be demonstrated through appropriate studies
that shall be conducted, based on generally accepted guidance on
the design and conduct of such studies, and the protein
hydrolysates conform to these specifications.
1. Protein content (nitrogen content x 6.25):
minimum - 0.44 g/100 kJ (1.86 g/100 kcal), maximum - 0.7 g/100 kJ
(3 g/100 kcal).
2. Protein source - demineralised sweet whey protein, derived
from cows' milk after the enzymatic precipitation of caseins,
utilising chymosin, consisting of:
a) 63% caseino-glycomacropeptide free whey protein isolate with a
minimum protein content of 95% of dry matter and protein
denaturation of less than 70% and an ash content of 3%; and
b) 37% sweet whey protein concentrate with a minimum protein
content of 87% of dry matter and protein denaturation of less
than 70% and a maximum ash content of 3.5%.
3. Protein processing - a two-stage hydrolysis process, in which
trypsination is utilised with a heat-treatment stage (for 3 to 10
minutes at a temperature of 80-100°C) between two hydrolysis
stages.
7 The L-carnitine content shall be at least equal to
0.3 mg/100 kJ (1.2 mg/100 kcal).
8 The use of sesame seed oil and cotton seed oil is
prohibited.
9 Shall not apply to a formula in which the content of
soya proteins exceeds 50% of the total protein content.
10 If the content contains 90% oligogalactosyl-lactose
and 10% high molecular weight oligofructosyl sacchrose. Other
combinations and maximum levels of fructo-oligosaccharides and
galacto-oligosaccharides may be used in accordance with Paragraph
7 of these Regulations.
11 RE - equivalent of all trans-retinols.
12 In the form of cholecalciferol, of which 10 μg =
400 i.u. of vitamin D.
13 Preformed niacin.
14 į-TE = d- ά-tocopherol equivalent.
15 0.5 mg α-TE/1 g linoleic acid (18:2 n-6); 0.75 mg
α-TE/1 g α-linoleic acid (18:3 n-3); 1.0 mg α-TE/1 g arahidonic
acid (20:4 n-6); 1.25 mg α-TE/1 g eicosapentaenoic acid (20:5
n-3); 1.5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 2
Cabinet Regulation No. 370
of 26 May 2008
No. |
Energy value and ingredients of formula, units of measurement |
Minimum quantity |
Maximum quantity |
1 |
2 |
3 |
4 |
1. | Energy value, kJ/100 ml (kcal/100 ml) |
250 (60) |
295 (70) |
2. | Proteins2, 3, 4, g/100 kJ (g/100 kcal): | ||
2.1. | in a formula manufactured from cows' milk proteins, g/100 kJ (g/100 kcal) |
0.45 (1.8) |
0.8 (3.5) |
2.2. | in a formula manufactured from protein hydrolysates, g/100 kJ (g/100 kcal): |
0.56 (2.25) |
0.8 (3.5) |
2.3. | in a formula manufactured from soy protein isolates, alone or in a mixture with cows' milk proteins, g/100 kJ (g/100 kcal) |
0.56 (2.25) |
0.8 (3.5) |
3. | calcium, mg/100 kJ (mg/100 kcal) |
2.9 (12) |
|
4. | Lipids, g/100 kJ (g/100 kcal)6: |
0.96 (4.0) |
1.4 (6.0) |
4.1. | lauric acid and myristic acid |
- |
separately or as a whole 20% of the total fat content |
4.2. | linoleic acid (in the form of glycerides, i.e. linoleates) |
70 (300)9 |
285 (1200) |
4.3. | alpha-linolenic acid, mg/100 kJ (mg/100 kcal) |
12 (50) |
|
4.4. | linoleic/alpha-linolenic acid ratio |
5 |
15 |
4.5. | trans fatty acids |
- |
3 % of the total fat content |
4.6. | erucic acid |
- |
1% of the total fat content |
4.7. | long-chain polyunsaturated fatty acids (LCP) (C20, C22) may be added: | ||
4.7.1. | n-3 fatty acids |
- |
1% of the total fat content |
4.7.2. | n-6 fatty acids |
- |
2% of the total fat content, arachidonic acid 1% of the total fat content |
4.7.3. | the eicosapentaenoic acid (20:5 n-3) content shall not exceed the docosahexaenoic acid (22:6 n-3) content; the docosahexaenoic acid (22:6 n-3) content shall not exceed the n-6 fatty acid content | ||
5. | Phospholipids, g/l |
2 |
|
6. | Carbohydrates, g/100 kJ (g/100 kcal)7: |
2.2 (9) |
3.4 (14) |
6.1. | lactose |
1.1 (4.5)8 |
- |
6.2. | sucrose, fructose, honey9 |
- |
separately or as a whole 20% of the total carbohydrate content |
6.3. | glucose, only for a product which has been produced from protein hydrolysates |
0.5 (2) |
|
7. | Fructo-oligosaccharides and galacto-oligosaccharides10, g/100 ml |
0.8 |
|
8. | Minerals: | ||
8.1. | from cows' milk proteins or from protein hydrolysates in manufactured formula | ||
8.1.1. | sodium, mg/100 kJ (mg/100 kcal) |
5 (20) |
14 (60) |
8.1.2. | potassium, mg/100 kJ (mg/100 kcal) |
15 (60) |
38 (160) |
8.1.3. | chlorides, mg/100 kJ (mg/100 kcal) |
12 (50) |
38 (160) |
8.1.4. | calcium, mg/100 kJ (mg/100 kcal) |
12 (50) |
33 (140) |
8.1.5. | phosphorus, mg/100 kJ (mg/100 kcal) |
6 (25) |
22 (90) |
8.1.6. | magnesium, mg/100 kJ (mg/100 kcal) |
1.2 (5) |
3.6 (15) |
8.1.7. | iron, mg/100 kJ (mg/100 kcal) |
0.14 (0.6) |
0.5 (2) |
8.1.8. | zinc, mg/100 kJ (mg/100 kcal) |
0.12 (0.5) |
0.36 (1.5) |
8.1.9. | copper, µg /100 kJ (µg /100 kcal) |
8.4 (35) |
25 (100) |
8.1.10. | iodine, μg/100 kJ (μg/100 kcal) |
2.5 (10) |
12 (50) |
8.1.11. | selenium, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
2.2 (9) |
8.1.12. | manganese, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
25 (100) |
8.1.13. | fluorides, µg /100 kJ (µg /100 kcal) |
- |
25 (100) |
8.1.14. | Calcium/phosphorus ratio |
1 |
2 |
8.2. | in a formula manufactured only from soy protein isolates or mixed with cows' milk proteins | ||
8.2.1. | sodium, mg/100 kJ (mg/100 kcal) |
5 (20) |
14 (60) |
8.2.2. | potassium, mg/100 kJ (mg/100 kcal) |
15 (60) |
38 (160) |
8.2.3. | chlorides, mg/100 kJ (mg/100 kcal) |
12 (50) |
38 (160) |
8.2.4. | calcium, mg/100 kJ (mg/100 kcal) |
12 (50) |
33 (140) |
8.2.5. | phosphorus, mg/100 kJ (mg/100 kcal) |
7.5 (30) |
25 (100) |
8.2.6. | magnesium, mg/100 kJ (mg/100 kcal) |
1.2 (5) |
3.6 (15) |
8.2.7. | iron, mg/100 kJ (mg/100 kcal) |
0.22 (0.9) |
0.65 (2.5) |
8.2.8. | zinc, mg/100 kJ (mg/100 kcal) |
0.12 (0.5) |
0.36 (1.5) |
8.2.9. | copper, μg/100 kJ (μg/100 kcal) |
8.4 (35) |
25 (100) |
8.2.10. | iodine, μg/100 kJ (μg/100 kcal) |
2.5 (10) |
12 (50) |
8.2.11. | selenium, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
2.2 (9) |
8.2.12. | manganese, µg /100 kJ (µg /100 kcal) |
0.25 (1) |
25 (100) |
8.2.13. | fluorides, µg /100 kJ (µg /100 kcal) |
- |
25 (100) |
8.2.14. | calcium/phosphorus ratio |
1 |
2 |
9. | Vitamins: | ||
9.1. | vitamin A, μg RE/100 kJ (μg RE/100 kcal)11 |
14 (60) |
43 (180) |
9.2. | vitamin D, μg/100 kJ (μg/100 kcal)12 |
0.25 (1) |
0.75 (3) |
9.3. | thiamin, μg/100 kJ (μg/100 kcal) |
14 (60) |
72 (300) |
9.4. | riboflavin, μg/100 kJ (μg/100 kcal) |
19 (80) |
95 (400) |
9.5. | niacin, μg /100 kJ (μg /100 kcal)13 |
72 (300) |
375 (1500) |
9.6. | pantothenic acid, μg/100 kJ (μg/100 kcal) |
95 (400) |
475 (2000) |
9.7. | vitamin B6, μg/100 kJ (μg/100 kcal) |
9 (35) |
42 (175) |
9.8. | biotin, μg/100 kJ (μg/100 kcal) |
0.4 (1.5) |
1.8 (7.5) |
9.9. | folic acid, µg /100 kJ (µg /100 kcal) |
2.5 (10) |
12 (50) |
9.10. | vitamin B12, μg/100 kJ (μg/100 kcal) |
0.025 (0.1) |
0.12 (0.5) |
9.11. | vitamin C, μg/100 kJ (μg/100 kcal) |
2.5 (10) |
7.5 (30) |
9.12. | vitamin K, μg/100 kJ (μg/100 kcal) |
1 (4) |
6 (25) |
9.13. | vitamin E, mg α-TE14 |
0.5/g polyunsaturated acids expressed as linoleic acid as corrected for the double bonds15, but not less than 0.1 mg/100 kJ (0.5 mg/100 kcal) |
1.2 mg/100 kJ (5 mg/100 kcal) |
10. | Nucleotides, total quantity that may be added, mg/100 kJ (mg/100 kcal), including: |
- |
1.2 (5) |
10.1. | cytidine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.60 (2.50) |
10.2. | uridine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.42 (1.75) |
10.3. | adenosine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.36 (1.50) |
10.4. | guanosine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.12 (0.50) |
10.5. | inosine 5'-monophosphate, mg/100 kJ (mg/100 kcal) |
- |
0.24 (1.00) |
Notes.
1The formulae is set out for usage in a finished
product prepared according to the instructions of the
manufacturer.
2 Protein content = nitrogen content x 6.25.
3 The addition of amino acids to the formula is
permitted solely for the purpose of improving the nutritional
value of the proteins, and only in the proportions necessary for
this purpose.
4 If the formula is made of soy proteins alone or
together with cows' milk proteins, other proteins are not
permitted to be added.
5 For a formula to have the energy value equal to
breast milk, it shall contain an available quantity of each
essential and non-essential amino acid which is not less than
that contained in breast milk proteins.
The content of essential and semi-essential amino acids in breast milk:
No. |
Amino acids |
mg/100 kJ (1 kJ = 0.239 kcal) |
mg/100 kcal |
1 |
2 |
3 |
4 |
1. | Cystine |
9 |
38 |
2. | Histidine |
10 |
40 |
3. | Isoleucine |
22 |
90 |
4. | Leucine |
40 |
166 |
5. | Lysine |
27 |
113 |
6. | Methionine |
5 |
23 |
7. | Phenylalanine |
20 |
83 |
8. | Threonine |
18 |
77 |
9. | Tryptophan |
8 |
32 |
10. | Tyrosine |
18 |
76 |
11. | Valine |
21 |
88 |
For calculation purposes, the concentration of cystine and
methionine may be added together, if the cystine/methionine ratio
is not greater than 2, and the phenylalanine and tyrozine
concentration can be added together, if the
tyrosine/phenylalanine ratio is not greater than 2. The ratio of
methionine/cystine may be greater than 2 but shall not be greater
than 3, provided that the suitability for the particular
nutritional use by infants is demonstrated through appropriate
studies following generally accepted expert guidance on the
design and conduct of such studies.
6 The use of sesame seed oil and cotton seed oil is
prohibited.
7 It is not permitted to use ingredients containing
gluten.
8 Shall not apply to a formula in which the content of
soy protein isolates exceeds 50% of the total protein
content.
9 The honey is processed in order to destroy
Clostridium botulinum spores.
10 If the content contains 90% oligogalactosyl-lactose
and 10% high molecular weight oligofructosyl saccharose. Other
combinations and maximum levels of fructo-oligosaccharides and
galacto-oligosaccharides may be used in accordance with Paragraph
8 of these Regulations.
11 RE = equivalent of all trans-retinols.
12 In the form of cholecalciferol, of which 10 μg =
400 i.u. of vitamin D.
13 Previously prepared niacin.
14 α-TE = d- α-tocopherol equivalent.
15 0.5 mg α-TE/1 g linoleic acid (18:2 n-6); 0.75 mg
α-TE/1 g α-linoleic acid (18:3 n-3); 1.0 mg α-TE/1 g arachidonic
acid (20:4 n-6); 1.25 mg α-TE/1 g eicosapentaenoic acid (20:5
n-3); 1.5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 3
Cabinet Regulation No. 370
of 26 May 2008
No. |
Substance |
Permitted forms of the substance |
1 |
2 |
3 |
1. | Vitamins: | |
1.1. | vitamin A |
retinyl acetate
retinyl palmitate retinol |
1.2. | vitamin D |
vitamin D2 (ergocalciferol)
vitamin D3 (cholecalciferol) |
1.3. | vitamin B1 |
thiamin hydrochloride
thiamin mononitrate |
1.4. | vitamin B2 |
riboflavin
sodium riboflavin-5'-phosphate |
1.5. | niacin |
nicotinamide
nicotinic acid |
1.6. | vitamin B6 |
pyridoxine hydrochloride
pyridoxine- 5΄-phosphate |
1.7. | pantothenic acid |
calcium D-pantothenate
sodium D-pantothenate dexpanthenol |
1.8. | folate | folic acid |
1.9. | vitamin B12 |
cyanocobalamin
hydroxocobalamin |
1.10. | biotin | D-biotin |
1.11. | vitamin C |
L-ascorbic acid
sodium L-ascorbate calcium L-ascorbate 6-palmityl-L-ascorbic acid (ascorbyl palmitate) potassium ascorbate |
1.12. | vitamin K | phylloquinone (phytomenadione) |
1.13. | vitamin E |
D-alpha-tocopherol
DL-alpha-tocopherol D-alpha-tocopherol acetate DL-alpha-tocopherol acetate |
2. | Minerals: | |
2.1. | calcium (Ca) |
calcium carbonate
calcium chloride calcium citrates calcium gluconate calcium glycerophosphate calcium lactate calcium hydroxide calcium phosphates |
2.2. | magnesium (Mg) |
magnesium carbonate
magnesium chloride magnesium oxide magnesium phosphates magnesium sulphate magnesium gluconate magnesium hydroxide magnesium citrates |
2.3. | iron (Fe) |
ferrous citrate
ferrous gluconate ferrous lactate ferrous sulphate ferric ammonium citrate ferrous fumarate ferric diphosphate (ferric pyrophosphate) ferrous bisglycinate |
2.4. | Copper (Cu) |
cupric citrate
cupric gluconate cupric sulphate copper lysine complex cupric carbonate |
2.5. | iodine (J) |
potassium iodide
sodium iodide potassium iodate |
2.6. | zinc (Zn) |
zinc acetate
zinc chloride zinc lactate zinc sulphate zinc citrate zinc gluconate zinc oxide |
2.7. | manganese (Mn) |
manganese carbonate
manganese chloride manganese citrate manganese gluconate manganese sulphate |
2.8. | sodium (Na) |
sodium bicarbonate
sodium chloride sodium citrate sodium gluconate sodium carbonate sodium lactate sodium phosphates sodium hydroxide |
2.9. | potassium (K) |
potassium bicarbonate
potassium carbonate potassium chloride potassium citrates potassium gluconate potassium lactate potassium phosphates potassium hydroxide |
2.10. | selenium (Se) |
sodium selenate
sodium selenite |
3. | Amino acids and other nitrogen compounds: | |
3.1. | L-arginine and its hydrochloride | |
3.2. | L-cystine and its hydrohloride | |
3.3. | L-histidine and its hydrochloride | |
3.4. | L-isoleucine and its hydrochloride | |
3.5. | L-leucine and its hydrochloride | |
3.6. | L-lysine and its hydrochloride | |
3.7. | L-cysteine and its hydrochloride | |
3.8. | L-methionine | |
3.9. | L-phenylalanine | |
3.10. | L-threonine | |
3.11. | L-tryptophan | |
3.12. | L-tyrosine | |
3.13. | L-valine | |
3.14. | L-carnitine and its hydrochloride | |
3.15. | L-carnitine-L-tartrate | |
3.16. | taurine | |
3.17. | cytidine -5'-monophosphate and its sodium salt | |
3.18. | uridine -5'-monophosphate and its sodium salt | |
3.19. | adenosine -5'-monophosphate and its sodium salt | |
3.20. | guanosine -5'-monophosphate and its sodium salt | |
3.21. | inosine -5'-monophosphate and its sodium salt | |
4. | Other nutrients: | |
4.1. | choline | |
4.2. | choline chloride | |
4.3. | choline citrate | |
4.4. | choline bitartrate | |
4.5. | inositol |
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 4
Cabinet Regulation No. 370
of 26 May 2008
No. |
Name of pesticide (pesticide metabolite) |
Maximum permissible residue limit (mg/kg) |
1. | Cadusafos |
0.006 |
2. | Demeton-S-methyl/demeton-S-methylsulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl) |
0.006 |
3. | Ethoprophos |
0.008 |
4. | Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) |
0.004 |
5. | Propineb/propylenethiourea (sum of propineb and propylenethiourea |
0.006 |
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 5
Cabinet Regulation No. 370
of 26 May 2008
Table 1
No. |
Name of pesticide (name of pesticide residue) |
1. | Disulfoton (sum of disulfoton, disulfoton sulphoxide and disulfoton sulfone, expressed as disulfoton)) |
2. | Fensulfothion (sum of fensulfothion, fensulfothion oxygen analogue and fensulfothion sulphones, expressed as fensulfothion) |
3. | Fentin, expressed as triphenyltin cation |
4. | Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop) |
5. | Heptachlor and trans-heptachlor epoxide, expressed as heptachlor |
6. | Hexachlorobenzene |
7. | Nitrofen |
8. | Omethoate |
9. | Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos) |
Table 2
No. |
Name of pesticide |
1. | Aldrin and dieldrin, expressed as dieldrin |
2. | Endrin |
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 6
Cabinet Regulation No. 370
of 26 May 2008
Trade names of formulae substitutes made of various proteins in Latvian and European Union languages:
No. |
Language |
Trade name |
|
1.1. | Latvian | Mākslīgais maisījums zīdaiņiem | Mākslīgais papildu ēdināšanas maisījums zīdaiņiem |
1.2. | English | Infant formula | Follow-on formula |
1.3. | Danish | Modermælkserstatning | Tilskudsblanding |
1.4. | German | Säuglingsanfangsnahrung | Folgenahrung |
1.5. | Greek | Παρασκεύασμα για βρέφη | Παρασκεύασμα δεύτερης βρεφικής ηλικίας |
1.6. | Spanish | Preparado para lactantes | Preparado de continuación |
1.7. | French | Préparation pour nourrissons | Préparation de suite |
1.8. | Italian | Alimento per lattanti | Alimento di proseguimento |
1.9. | Dutch | Volledige zuigelingenvoeding | Opvolgzuigelingenvoeding |
1.10. | Portuguese | Fórmula para lactentes | Fórmula de transição |
1.11. | Finnish | Äidinmaidonkorvike | Vieroitusvalmiste |
1.12. | Swedish | Modersmjölksersättning | Tillskottsnäring |
1.13. | Czech | Počáteční kojenecká výživa | Pokračovací kojenecká výživa |
1.14. | Estonian | Imiku piimasegu | Jätkupiimasegu |
1.15. | Lithuanian | Mišinys kūdikiams iki papildomo maitinimo įvedimo | Mišinys kūdikiams, įvedus papildomą maitinimą |
1.16. | Hungarian | Anyatej-helyettesítő tápszer | Anyatej-kiegészítő tápszer |
1.17. | Maltese | Formula tat-trabi | Formula tal-prosegwiment |
1.18. | Polish | Preparat do początkowego żywienia niemowląt | Preparat do dalszego żywienia niemowląt |
1.19. | Slovenian | Začetna formula za dojenčke | Nadaljevalna formula za dojenčke |
1.20. | Slovak | Počiatočná dojčenská výživa | Následná dojčenská výživa |
1.21. | Bulgarian | Храни за кърмачета | Преходни храни |
1.22. | Romanian | Preparate pentru sugari | Preparate pentru copii de vâarstă mică |
Trade names of formulae made of cows' milk proteins in Latvian and European Union languages:
No. |
Language |
Trade name |
|
2.1. | Latvian | Mākslīgais piena maisījums zīdaiņiem | Mākslīgais papildu ēdināšanas piena maisījums zīdaiņiem |
2.2. | English | Infant milk | Follow-on milk |
2.3. | Danish | Modermælkserstatning udelukkende baseret på mælk | Tilskudsblanding udelukkende baseret på mælk |
2.4. | German | Säuglingsmilchnahrung | Folgemilch |
2.5. | Greek | Γάλα για βρέφη | Γάλα δεύτερης βρεφικής ηλικίας |
2.6. | Spanish | Leche para lactantes | Leche de continuación |
2.7. | French | Lait pour nourrissons | Lait de suite |
2.8. | Italian | Latte per lattanti | Latte di proseguimento |
2.9. | Dutch | Volledige zuigelingenvoeding op basis van melk/Zuigelingenmelk | Opvolgmelk |
2.10. | Portuguese | Leite para lactentes | Leite de transição |
2.11. | Finnish | Maitopohjainen äidinmaidonkorvike | Maitopohjainen vieroitusvalmiste |
2.12. | Swedish | Modersmjölksersättning uteslutande baserad på mjölk | Tillskottsnäring uteslutande baserad på mjölk |
2.13. | Czech | Počáteční mléčná kojenecká výživa | Pokračovací mléčná kojenecká výživa |
2.14. | Estonian | Piimal põhinev imiku piimasegu | Piimal põhinev jätkupiimasegu |
2.15. | Lithuanian | Pieno mišinys kūdikiams iki papildomo maitinimo įvedimo | Pieno mišinys kūdikiams, įvedus papildomą maitinimą |
2.16. | Hungarian | Tejalapú anyatej-helyettesítő tápszer | Tejalapú anyatej-kiegészítő tápszer |
2.17. | Maltese | Ħalib tat-trabi | Ħalib tal-prosegwiment |
2.18. | Polish | Mleko początkowe | Mleko następne |
2.19. | Slovenian | Začetno mleko za dojenčke | Nadaljevalno mleko za dojenčke |
2.20. | Slovak | Počiatočná dojčenská mliečna výživa | Následná dojčenská mliečna výživa |
2.21. | Bulgarian | Млека за кърмачета | Преходни млека |
2.22. | Romanian | Lapte pentru sugari | Lapte pentru copii de varsta mica |
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 7
Cabinet Regulation No.370
of 26 May 2008
No. |
References |
Conditions of utilisation |
1 |
2 |
3 |
1. | References which are related to nutritional value: | |
1.1. | only contains lactose | Lactose shall be the only carbohydrate present in the composition |
1.2. | does not contain lactose | The lactose content shall not be greater than 2.5 mg/100 kJ (10 mg/100 kcal) |
1.3. | long chain polyunsaturated fatty acid (LCP) has been added or an equivalent reference as regards the addition of docosahexaenoic acid | The docosahexaenoic acid content shall not be less than 0.2% of the total fatty acid content |
1.4. | a reference to the option of the addition of such ingredients: | |
1.4.1. | taurine | By choice added in such amount, that would be in conformity with the particular intended utilisation for infants and in accordance with the conditions prescribed in Annex 1 |
1.4.2. | fructo-oligosaccharides and galacto-oligosaccharides | |
1.4.3. | nucleotides | |
2. | References, relating to the health of the product, including the reduction of disease risk references: | |
2.1. | reduced allergy risk to cows' milk proteins. The labelling may contain a reference regarding a reduced allergen content and regarding a reduced allergen antigen properties | a) objective and scientifically verified data must be available, attesting to the referred to properties |
b) the formula meets the requirements of Annex 1, Sub-paragraph 2.2 and the amount of immunoreactive protein that has been determined by generally accepted methods is less than 1% of nitrogen-containing substances in the formula | ||
c) the labelling shall indicate that the product must not be consumed by infants allergic to the intact proteins from which the product is made, unless generally accepted clinical tests provide proof of the product's tolerance in more than 90% of infants (confidence interval 95%), hypersensitive to proteins from which the formula is made | ||
d) infant formula, which is administered orally to experimental animals, should not induce sensitisation to the intact proteins from which the formula has been derived. |
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 8
Cabinet Regulation No. 370
of 26 May 2008
No. |
Nutrient |
Reference value |
1. | vitamin A |
400 μg |
2. | vitamin D |
7 μg |
3. | vitamin E |
5 mg TE |
4. | vitamin K |
12 μg |
5. | vitamin C |
45 mg |
6. | Thiamin |
0.5 mg |
7. | Riboflavin |
0.7 mg |
8. | Niacin |
7 mg |
9. | vitamin B6 |
0.7 mg |
10. | Folate |
125 μg |
11. | vitamin B12 |
0.8 μg |
12. | Pantothenic acid |
3 mg |
13. | Biotin |
10 μg |
14. | Calcium |
550 mg |
15. | Phosphorus |
550 mg |
16. | Potassium |
1,000 mg |
17. | Sodium |
400 mg |
18. | Chlorine |
500 mg |
19. | Iron |
8 mg |
20. | Zinc |
5 mg |
21. | Iodine |
80 μg |
22. | Selenium |
20 μg |
23. | Copper |
0.5 mg |
24. | Magnesium |
80 mg |
25. | Manganese |
1.2 mg |
Acting for the Minister for Agriculture
-
Minister for Education and Science T. Koķe
Annex 9
Cabinet Regulation No.370
of 26 May 2008
I. Information Regarding the Submitter
Name of product | ||
Producer | firm (name) | |
state | ||
address | ||
registration number |
II. Information Regarding the Submitter of the Notice
Mark the appropriate square
Producer
Packer
Importer
Company (name) | |
State | |
Legal address | |
Registration number in the Commercial Register | |
Registration (recognition) certificate number of the food undertaking issued by the Food and Veterinary Service | |
Contact person | |
Contact telephone | |
E-mail address |
III. Certification by the Submitter
I have got acquainted with the regulatory enactments prescribing the requirements for importing, distribution, composition and labelling of infant formulae in the Republic of Latvia. I certify that the provided information is true. | ||||
(position, telephone number) |
(signature and full name)* |
|||
(date) | ||||
Place for a seal |
* The referred to details "signature", "date", and "place for a seal" of the document shall not be filled in if the document is prepared in accordance with the regulatory enactments regarding drawing up of electronic documents.
Acting for the Minister for Agriculture
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Minister for Education and Science T. Koķe
Translation © 2009 Valsts valodas centrs (State Language Centre)