Executive Order On Infant Formulae And Follow-On Formulae For Infants And Young Children

Original Language Title: Bekendtgørelse om modermælkserstatninger og tilskudsblandinger til spædbørn og småbørn

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Overview (table of contents)



Chapter 1



Definitions





Chapter 2



Marketing





Chapter 3



Requirements for the composition of the





Chapter 4



Product indications and labelling





Chapter 5



Marketing and advertising





Chapter 6



Notification of infant formulae





Chapter 7



Exports to countries outside the EU





Chapter 8



Punishment and the entry into force of





Annex 1



Essential composition of infant formulae





Annex 2



Essential composition of follow-on formulae





Annex 3



Nutrients





Annex 4



Nutrition and health claims for infant formulae and conditions for making thereof





Annex 5



Essential and semi essential amino acids in breast milk





Annex 6



Specification for protein content and source, as well as protein processing





Annex 7



Reference values for use in the nutrition labelling of foods for infants and young children



The full text of the ordonnance on infant formulae and follow-on formulae for infants and småbørn1)

Under section 5, paragraph 1, § 7, § 8, paragraph 2, article 11, § 15, § 16, section 17, paragraph 1, article 19, § 37, § 39, paragraph 1, article 49, paragraph 1, and section 60, paragraph 3, of the law on food, see. lovbekendtgørelse nr. 820 of 1. July 2011, fixed: Chapter 1 Definitions article 1. For the purposes of this order: 1) infants: children under the age of 12 months.

2) Toddlers: Children between 1 and 3 years.

3) infant formulae: foods that are intended to provide special infant diets in their first months of life, and which in itself covers these babies ' nutritional needs until there is supplemented by other appropriate diet.

4) follow-on formulae: foodstuffs which are intended to provide special infant diets, when supplementing with other appropriate diet is begun, and which constitute the main liquid ingredient of these infants gradually more varied diet.

§ 2. In this order, see the definitions of ' claim ', ' nutrition claim ', ' health claim ' and ' claim of a reduced risk of disease ' in article 2, paragraph 2, no. 1), 4), 5) and (6)), in European Parliament and Council Regulation (EC) No 1782/2003. 1924/2006 of 20. December 2006 on nutrition and health claims made on foods, use.

Chapter 2 marketing section 3. Infant formulae and follow-on formulae must be placed on the market only if they comply with the provisions of this Ordinance.

§ 4. Only infant formulae may be marketed or otherwise is published in order to be suitable for use as the only product to cover the normal, healthy babies ' nutritional needs during the first months of life before there is supplemented by other appropriate diet.

Chapter 3 Requirements to the composition section 5. Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children.

§ 6. Infant formulae shall be manufactured from proteins, as defined in annex 1, point 2, and other food ingredients, about which it by generally accepted scientific data has shown that they are suitable for babies ' special diet from birth.

(2). This suitability shall be documented in a systematic review of the available data on the expected benefits and for security reasons, as well as, where appropriate, relevant studies that are conducted in accordance with generally accepted expert guidance on the design and implementation of such studies.

§ 7. Follow-on formulae shall be manufactured from proteins, as defined in annex 2, paragraph 2, and other food ingredients, about which it by generally accepted scientific data has shown that they are suitable for the special diet for infants over 6 months.

(2). This suitability shall be documented in a systematic review of the available data on the expected benefits and for security reasons, as well as, where appropriate, relevant studies that are conducted in accordance with generally accepted expert guidance on the design and implementation of such studies.

§ 8. Infant formulae shall comply with the compositional requirements set out in annex 1 to this regulation, taking account of the specifications given in annex 5.

(2). For infant formulae manufactured from cows ' milk proteins defined on the basis of annex 1, section 2.1, with a protein content between the minimum and 0.5 g/100 kJ (2 g/100 kcal), the infant when determining the suitability of infant special diet documented by appropriate tests carried out in accordance with generally accepted expert guidance on the design and implementation of such studies.

(3). For infant formulae, which are manufactured on the basis of hydrolysed protein defined in annex 1, point 2.2, with a protein content between the minimum and 0.56 g/100 kJ (2.25 g/100 kcal), the infant when determining the suitability of infant special diet documented by appropriate tests carried out in accordance with generally accepted expert guidance on the design and implementation of such studies, and products must be in accordance with the specifications laid down in annex 6.

§ 9. Follow-on formulae shall comply with the compositional requirements set out in annex II, taking account of the specifications set forth in annex 5.

§ 10. Infant formulae and follow-on formulae must, where appropriate, require only the addition of water to be ready for use.

§ 11. In annex 1 and 2 prohibition and restrictions must be observed for the use of food ingredients in infant formulae and follow-on formulae.

§ 12. In the manufacture of infant formulae and follow-on formulae may be used only in the annex 3 listed nutrients in order to comply with the requirements for the content of: 1) vitamins, minerals), 2 3) amino acids and other nitrogen compounds, and 4) other substances with specific nutritional purposes.

§ 13. The person responsible for first placing on the market of the product in Denmark, must ensure that it analyzed the content of nutrients laid down maximum limits in the legislation, are not exceeded, exclusive analysis uncertainty.

§ 14. If in EU legislation, including on food additives set out purity criteria for the use of the substances referred to in annex 3, the Executive order applies to these regardless of the purpose of the addition.

(2). For substances for which purity criteria have not yet been laid down in EU legislation applies the purity criteria set out in the notice of the addition of nutrients to foods.

(3). For substances for which purity criteria have not yet been laid down in Community law or in the Ordinance on the addition of nutrients to foods, find commonly acceptable purity criteria recommended by international bodies shall apply pending the adoption of purity criteria on EU level.

§ 15. The sections 6-12 mentioned requirements can be waived in the case of products for which the European Commission in accordance with article 4, paragraph 2, of the European Parliament and of the Council directive 2009/39/EC of 6 May 2003. May 2009 on foodstuffs intended for particular nutritional uses has granted temporary permission for marketing.

Chapter 4 sales descriptions and labelling section 16. The name of the products referred to in paragraph 1, no. 3 and 4 are respectively» infant formula ' and ' tilskudsblanding '.

§ 17. The name of the products referred to in paragraph 1, no. 3 and 4, and produced completely based on cows ' milk proteins, are respectively» infant formula based entirely on milk ' and ' tilskudsblanding based entirely on milk '.

§ 18. Infant formulae and follow-on formulae shall in addition to meeting the General labelling provisions be labeled with the following information regarding the product suitability: 1) For infant formulae: An indication that the product is suitable as a special diet for infants from birth when they are not being breastfed.

2) For follow-on formulae: an indication that the product is only suitable as a special diet for infants over 6 months that it only should be included in a balanced diet, that it should not be used as a substitute for breast milk during the first 6 months of life, and that the decision to start giving different diet than breast milk, including in seksmånedersalderen, should only be taken after recommendation from independent persons with training in the field of medicine , nutrition or pharmacy, or other persons who are professionally competent with regard to child care, on the basis of the individual infant specific growth and development needs.

§ 19. Infant formulae and follow-on formulae shall in addition be labelled with the following information about the product's content and proper use: 1) a numerical indication of the energy value expressed in kilojoules (kJ) and kilocalories (kcal) and the content of protein, carbohydrate and fat per 100 ml of the product ready.

2) a numerical indication of the average quantity of each mineral substance and vitamin listed in annex 1 and annex 2 respectively, and where applicable of choline, inositol and carnitine, per 100 ml of the product ready.

3) instructions on how the product is prepared, stored and disposed of properly, and a warning against the health hazards of inappropriate preparation and storage.

§ 20. The labelling may bear the following information:


1) For infant formulae and follow-on formulae: a numerical indication of the average quantity of the nutrients set out in annex 3, per 100 ml of the product ready for when such declaration is not covered by section 19, no. 2.2) For follow-on formulae in addition to numerical information, information: on vitamins and minerals listed in annex 7, expressed as a percentage of the specified reference value per 100 ml of the product ready.

§ 21. The labelling of infant formulae and follow-on formulae shall be designed in such a way that it contains the necessary information about the product's proper use, and to not be encouraged to give up breast-feeding.

(2). The use of expressions such as ' humanized ', ' maternalized ', ' adapted ' or similar terms shall be prohibited.

§ 22. The labelling of infant formulae shall in addition include the following compulsory particulars to be entered after the word ' Important ' or an equivalent expression: 1) an indication of breastfeeding for unbeatable value, and 2) A recommendation on the use of the product only after recommendation from independent persons with training in medicine, nutrition or pharmacy, or other persons who are professionally competent with regard to child care.

§ 23. The labelling of infant formulae shall not be provided with pictures of babies or other pictures or text which may idealize the use of the product. They may, however, be provided with graphic illustrations, which make it possible to identify the product as infant formula, and as showing cooking methods.

§ 24. The labelling of infant formulae shall contain only nutrition and health claims as referred to in annex 4 of the Executive order, and only in compliance with the conditions laid down in annex 4.

§ 25. Infant formulae and follow-on formulae shall be labelled in such a way that it puts consumers able to clearly distinguish between the products, so as to avoid the risk of confusion between infant formulae and follow-on formulae.

Chapter 5 marketing and promotion section 26. In sections 21-25 requirements, prohibitions and restrictions shall also apply: 1) presentation of the products referred to in (a)) in particular their shape, appearance and packaging and the used packaging material, (b)) the way in which they are placed, and (c)) the setting in which they are presented, 2) reklame.

§ 27. Advertising for infant formula are allowed only in scientific publications and special literature addressed to health professionals.

(2). Advertising as referred to in paragraph 1 must comply with the requirements of sections 21-25 and section 26, no. 2, and may only contain scientific and factual information.

(3). Scientific and factual information must not imply or give the impression that the use of infant formula is just as good as or better than breastfeeding.

section 28. On retail sites, there must be no advertised, distributed samples or other promotional methods to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, promotional campaigns, loss-making deals and lure deals.

section 29. Manufacturers and distributors of infant formula must not distribute free or reduced price products, samples or any other promotional gifts to the public, pregnant women, mothers or their family either directly or indirectly through the public health sector or the employees in this sector.

section 30. Infant formulae, which are distributed free or sold at low cost to institutions or organizations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be nourished by infant formula, and only so long as it is necessary for these infants.

section 31. The distribution of free information and educational equipment or materials by manufacturers and dealers may only take place upon request.

(2). Producers and distributors will inform the ongoing Food Agency concerning the allocation of the equipment referred to in paragraph 1 and the material by sending 1) copies of it doled out equipment and material, 2) information about the beneficiary group, and 3) amount of distributed material per beneficiary group.

(3). It referred to in paragraph 1, the equipment and material 1) can be supplied with the relevant manufacturer or distributor's name or logo, 2) must not refer to a proprietary product, and breast-3) may be distributed only through the public health sector.

section 32. In writing or audio visual information and educational materials on infant nutrition, which is aimed at pregnant women and parents, should contain clear information about: 1) benefits and the unsurpassed value of breastfeeding, see. However, paragraph 3, 2) the mother's nutrition and how she can best prepare and maintain lactation, 3) the possible negative effect on breast-feeding by starting with additional bottles, 4) the difficulty of reversing the decision not to breast-feed, and 5) the proper use of infant formulae, if its use would prove necessary.

(2). When the material referred to in paragraph 1 be provided on the use of infant formula, to be there at the same time, draws attention to the social and economic consequences, the health hazards associated with inadequate food or nutrition methods and, in particular, the health hazards associated with improper use of infant formulae.

(3). The material referred to in paragraph 2, shall not contain images that idealize the use of infant formula.

Chapter 6 section 33 Notification of infant formulae. EU-EUROPEAN UNION-producer, the importer or the person responsible for first placing on the market in Denmark of an infant formula, must submit an example of the markings applied to the Food Agency, before the product is marketed in Denmark.

Chapter 7 exports to countries outside the EUROPEAN UNION § 34. Infant formulae and follow-on formulae intended for use in countries outside the European Union must either comply with the provisions of §§ 5-13, § 15, § § 18-25 and section 26, paragraph 1, point (a)), or be in accordance with international standards developed by Codex Alimentarius, unless the importing country or its legislation imposes other requirements.

(2). These products have to be labelled on a for the importing country suitable language, so any risk of confusion between infant formulae with follow-on formulae is obviated.

Chapter 8 Penalty and the entry into force of section 35. Violation of §§ 4-33 or section 34 is punishable by a fine.

(2). The penalty can rise to imprisonment for up to 2 years if the offence is committed with intent or gross negligence, and there in the infringement is 1) caused damage to the health or caused danger for doing so, or 2) achieved or intentional obtained a financial benefit for the person himself or others.

(3). That can be imposed on companies, etc. (legal persons) criminal liability according to the rules laid down in the Penal Code chapter. 5. § 36. The notice shall enter into force on the 1. December 2012.

(2). At the same time repealed Executive Order No. 1504 by 13. December 2007 on infant formulae and follow-on formulae for infants and young children.

Food Agency, 26. November 2012 P.D.V. Hanne L/Anette Flensburg



Annex 1 Essential composition of infant formulae

The values listed in this annex, apply to the finished product ready for use, marketed as such or reconstituted in accordance with manufacturer's instructions.

1. ENERGI









Mindst





A maximum of







250 kJ/100 ml

(60 kcal/100 ml)





295 kJ/100 ml

(70 kcal/100 ml)











2. PROTEIN

Protein content = nitrogen content x 6.25.

2.1. the infant formulae manufactured from cows ' milk proteins Mindst1) up to a maximum of







0.45 g/100kJ

(1.8 g/100 kcal)





0.7 g/100 kJ

(3 g/100 kcal)









1) infant formulae manufactured from cows ' milk protein with a protein content between the minimum and 0.5 g/100 kJ (2 g/100 kcal) shall comply with section 8, paragraph 2.











By the same energy content must contain an infant formula at least as much available quantity of each essential and semi-essential amino acid as the reference protein (breast milk, as defined in annex 5).

To calculate the content of methionine and cystine may be added together if the methionine: cystine, however, the ratio is not greater than 2, and the content of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. Methionine: cystinforholdet can be larger than 2 but not greater than 3, provided that the product's suitability as a special diet for infants has been documented by appropriate tests carried out in accordance with generally accepted expert guidance on the design and implementation of such studies.

2.2. the infant formulae manufactured from protein hydrolysates.










Mindst1)





Højst







0.45 g/100kJ

(1.8 g/100 kcal)





0.7 g/100 kJ

(3 g/100 kcal)









1) infant formulae manufactured from protein hydrolysates with a protein content between the minimum and 0.56 g/100 kJ (2.25 g/100 kcal) shall comply with § 8, paragraph 3.











By the same energy content must contain an infant formula at least as much available quantity of each essential and semi-essential amino acid as the reference protein (breast milk, as defined in annex 5).

To calculate the content of methionine and cystine may be added together if the methionine: cystine, however, the ratio is not greater than 2, and the content of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. Methionine: cystinforholdet can be larger than 2 but not greater than 3, provided that the product's suitability as a special diet for infants-children is demonstrated by appropriate investigations carried out in accordance with generally accepted expert guidance on the design and implementation of such studies.

L-carnitine content shall not be less than 0.3 mg/100 kJ (1.2 mg/100 kcal).

2.3 infant formulae manufactured from soya protein isolates alone or mixed with cows ' milk Minimum





A maximum of







0.56 g/100kJ

(2.25 g/100 kcal)





0.7 g/100 kJ

(3 g/100 kcal)











Only proteinisolater from soya may be used for the production of these infant formulae.

By the same energy content must contain an infant formula at least as much available quantity of each essential and semi-essential amino acid as the reference protein (breast milk, as defined in annex 5).

To calculate the content of methionine and cystine may be added together if the methionine: cystine, however, the ratio is not greater than 2, and the content of phenylalanine and tyrosine may be added together if the tyrosine: phenylalaninforholdet is not greater than 2. Methionine: cystine ratio may be greater than 2 but not greater than 3, provided that the product's suitability as a special diet for infants has been documented by appropriate tests carried out in accordance with generally accepted expert guidance on the design and implementation of such studies.

L-carnitine content shall be at least equal to 0.3 mg/100 kJ (1.2 mg/100 kcal).

2.4. In all cases, only added to the amino acids to infant formulae in order to improve the nutritional value of the protein, and only to the extent necessary for the purpose.

3. TAURINE

If taurine added to infant formulae must not exceed equal 2.9 mg/100 kJ (12 mg/100 kcal).

4. CHOLIN









Mindst





A maximum of







1.7 mg/100 kJ

(7 mg/100 kcal)





12 mg/100 kJ

(50 g/100 kcal)











5. FEDT









Mindst





A maximum of







1.05 g/100 kJ

(4.4 g/100 kcal)





1.4 g/100 kJ

(6 g/100 kcal)











5.1. It shall be prohibited to use:

-sesame seed oil

-cotton-seed oil.

5.2 Lauric acid and myristic acid Minimum.





A maximum of







-





Alone or in combination:

20% of the total fat content











5.3. The content of trans fatty acids may not exceed 3% of the total fat content.

5.4. The erucic acid content shall not exceed 1% of the total fat content.

5.5. the linoleic acid (in the form of glycerides = linoleater) at least





A maximum of







70 mg/100 kJ

(300 mg/100 kcal)





285 mg/100 kJ

(1200 mg/100 kcal)











5.6. the alpha-linolenic acid Content shall not be less than 12 mg/100 kJ (50 mg/100 kcal).

The relationship between/Alpha: alpha-linolenic acid must not be less than 5 and not exceed 15.

5.7. Polyunsaturated fatty acids (LCP) with long chains (20 and 22 carbon atoms) may be added. In this case, the content must not exceed:

-1% of the total fat content for n-3 LCP, and

-2% of the total fat content for n-6 LCP (1% of the total fat content of arachidonic acid

(20:4 n-6)).

The content of Eicosapentaenoic Acid (20:5 n-3) content shall not exceed of Docosahexaenoic acid (22:6 n-3).

Contents of Docosahexaenoic acid (22:6 n-3) must not exceed the content of n-6 LCP.

6. PHOSPHOLIPIDS

The content of phospholipids in infant formulae must not exceed 2 grams per litre.

7. INOSITOL









Mindst





A maximum of







1 mg/100 kJ

(4 mg/100 kcal)





10 mg/100 kJ

(40 mg/100 kcal)











8. CARBOHYDRATES Minimum





A maximum of







2.2 g/100 kJ

(9 g/100 kcal)





3.4 g/100 kJ

(14 g/100 kcal)











8.1. Use only the following carbohydrates:

-lactose

-maltose

-sucrose

-glucose

-wheat

-glucose syrup or dried glucose syrup

-pre-cooked starch (naturally free of gluten)

-starch gel (naturally free of gluten) 8.2. Lactose









Mindst





A maximum of







1.1 g/100 kJ

(4.5 g/100 kcal)





-

-











This provision shall not apply to infant formulae in which soya protein isolates represent more than 50% of the total protein content.

8.3. Sucrose

Sucrose may only be added to infant formulae manufactured from protein hydrolysates. The sucrose content shall not exceed 20% of the total carbohydrate content.

8.4. Glucose

Glucose may only be added to infant formulae manufactured from protein hydrolysates. If add glucose, its contents must not exceed 0.5 g/100 kJ (2 g/100 kcal).

8.5 Pre-cooked starch and/or gelatiniseret. At least





A maximum of







-





2 g/100 ml, and 30% of the total carbohydrate content











9. FRUCTO-OLIGOSACCHARIDES and GALACTO-OLIGOSACCHARIDES

Fructo-oligosaccharides may be added and galacto-oligosaccharides for infant formulae. In this case, the content shall not exceed 0.8 g/100 ml with a combination of 90% oligogalactosyl-lactose and 10% oligofructosyl-sucrose with high molecular weight.

Other combinations and maximum levels for fructo-oligosaccharides and galacto-oligosaccharides may be used in accordance with § 6.

10. MINERALS 10.1. Infant formulae manufactured from cows ' milk proteins or protein hydrolysates per 100 kJ





Per 100 kcal





 



At least





A maximum of





At least






A maximum of







Sodium (mg)





5





14





20





60







Potassium (mg)





15





38





60





160







Chloride (mg)





12





38





50





160







Calcium (mg)





12





33





50





140







Phosphorus (mg)





6





22





25





90







Magnesium (mg)





1.2





3.6





5





15







Iron (mg)





0.07





0.3





0.3





1.3







Zinc (mg)





0.12





0.36





0.5





1.5







Copper (µ g)





8.4





25





35





100







Iodine (µ g)





2.5





12





10





50







Selenium (µ g)





0.25





2.2





1





9







Manganese (µ g)





0.25





25





1





100











Calcium: phosphorus ratio shall not be less than 1.0% and not more than 2.0.

10.2. the infant formulae manufactured from soya protein isolates alone or mixed with cows ' milk proteins

All requirements of point 10.1 shall apply except in the case of iron and phosphorus, where values are as follows: per 100 kJ





Per 100 kcal





 



At least





A maximum of





At least





A maximum of







Iron (mg)





0.12





0.5





0.45





2







Phosphorus (mg)





7.5





25





30





100











11. VITAMINER







 



Pr. 100 kJ





Per 100 kcal





 



At least





A maximum of





At least





A maximum of







Vitamin A (µg-RE)1)





14





43





60





180







Vitamin D (µg)2)





0,25





0.65





1





2.5







Thiamin (µg)





14





72





60





300







Riboflavin (µg)





19





95





80





400







Niacin(µg)3)





72





375





300





1500







Pantothenic acid (µ g)





95





475





400





2000







Vitamin B6 (µ g)





9





42





35





175







Biotin (µ g)





0.4





1.8





1.5





7.5







Folic acid (µ g)






2.5





12





10





50







Vitamin B12 (µ g)





0.025





0.12





0.1





0.5







Vitamin C (mg)





2.5





7.5





10





30







Vitamin K (µ g)





1





6





4





25







Vitamin E (mg α-TE) 4) 0,5/g polyunsaturated fatty acids expressed as linoleic acid corrected for dobbeltbindinger5), but never less than 0.1 mg per 100 available kJ





1.2





0,5/g polyunsaturated fatty acids expressed as linoleic acid corrected for dobbeltbindinger5), but never less than 0.5 mg per 100 available kcal





5









1) RE = all trans-retinolækvivalenter.



2) in the form of cholecalciferol, of which 10 µ g = 400 international units of vitamin d.



3) Finished formed niacin.



4) α-TE = d-α-tocopherolækvivalent.



5) 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).











12. NUCLEOTIDES

Følgende nukleotider må tilsættes:







 



Højst1)





 



(mg/100 kJ)





(mg/100 kcal)







Cytidin 5 '-monophosphat





0.60





2.50







Uridin 5 '-monophosphat





0.42





1.75







Adenosine 5 '-monophosphat





0.36





1.50







Guanosin 5 '-monophosphat





0.12





0.50







Inosin 5 '-monophosphat





0.24





1.00









1) the total concentration of nucleotides shall not exceed 1.2 mg/100 kJ (5 mg/100 kcal).













Annex 2 Essential composition of follow-on formulae

The values listed in this annex, apply to the finished product ready for use, marketed as such or reconstituted in accordance with manufacturer's instructions.

1. ENERGI









Mindst





A maximum of







250 kJ/100 ml

(60 kcal/100 ml)





295 kJ/100 ml

(70 kcal/100 ml)











2. PROTEIN 2.1. Follow-on formulae manufactured from cows ' milk proteins Minimum





A maximum of







0.45 g/100 kJ

(1.8 g/100 kcal)





0.8 g/100 kJ

(3.5 g/100 kcal)











By the same energy content should contain a mixture of grants at least as much available quantity of each essential and semi-essential amino acid as the reference protein (breast milk, as defined in annex 5).

To calculate the content of methionine and cystine may be added together if the methionine: cystine, however, the ratio is not greater than 3, and the content of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2.

2.2. Follow-on formulae manufactured from protein hydrolysates Minimum





A maximum of







0.56 g/100 kJ

(2.25 g/100 kcal)





0.8 g/100 kJ

(3.5 g/100 kcal)











By the same energy content should contain a mixture of grants at least as much available quantity of each essential and semi-essential amino acid as the reference protein (breast milk, as defined in annex 5).

To calculate the content of methionine and cystine may be added together if the methionine: cystine, however, the ratio is not greater than 3, and the content of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine, however, the ratio is not greater than 2.

2.3 follow-on formulae manufactured from soya protein isolates alone or mixed with cows ' milk proteins Minimum





A maximum of







0.56 g/100 kJ

(2.25 g/100 kcal)





0.8 g/100 kJ

(3.5 g/100 kcal)











Only proteinisolater from soya may be used for the production of these follow-on formulae.

By the same energy content must grant the mixture contain at least as much available quantity of each essential and semi-essential amino acid as the reference protein (breast milk, as defined in annex 5).

To calculate the content of methionine and cystine may be added together if the methionine: cystine, however, the ratio is not greater than 3, and the content of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2.

2.4. In all cases, only added to amino acids for follow-on formulae in order to improve the nutritional value of the protein, and only insofar as is necessary for that purpose.

3. TAURINE

If taurine added to follow-on formulae must not exceed content 2.9 mg/100 kJ (12 mg/100 kcal).

4. FEDT









Mindst





A maximum of







0.96 g/100 kJ

(4.0 g/100 kcal)





1.4 g/100 kJ

(6.0 g/100 kcal)











4.1. It shall be prohibited to use:

-sesame seed oil

-cotton-seed oil.

4.2 Lauric acid and myristic acid Minimum.





A maximum of







-





alone or in combination:

20% of the total fat content











4.3. content of trans-fatty acids must not exceed 3% of the total fat content.

4.4. The erucic acid content shall not exceed 1% of the total fat content.


4.5. the linoleic acid (in the form of glycerides = linoleater) at least





A maximum of







70 mg/100 kJ

(300 mg/100 kcal)





285 mg/100 kJ

(1200 mg/100 kcal)











4.6. the alpha-linolenic acid Content shall not be less than 12 mg/100 kJ (50 mg/100 kcal).

The relationship between/Alpha: alpha-linolenic acid must not be less than 5 and not exceed 15.

4.7. Polyunsaturated fatty acids (LCP) with long chains (20 and 22 carbon atoms) can be added. In this case, the content must not exceed:

-1% of the total fat content for n-3 LCP, and

-2% of the total fat content for n-6 LCP (1% of the total fat content from arachidonic acid (20:4 n-6)).

The content of Eicosapentaenoic Acid (20:5 n-3) content shall not exceed of Docosahexaenoic acid (22:6 n-3).

Contents of Docosahexaenoic acid (22:6 n-3) must not exceed the content of n-6 LCP.

5. PHOSPHOLIPIDS

The content of phospholipids in follow-on formulae must not exceed 2 grams per litre.

6. CARBOHYDRATES Minimum





A maximum of







2.2 g/100 kJ

(9 g/100 kcal)





3.4 g/100 kJ

(14 g/100 kcal)











6.1. It is prohibited to use ingredients that contain gluten.

6.2. Lactose









Mindst





A maximum of







1.1 g/100 kJ

(4.5 g/100 kcal)





-











This provision shall not apply to products, in which soya protein isolates represent more than 50% of the total protein content.

6.3. Sucrose, fructose, honey Minimum





A maximum of







-





Alone or in combination:

20% of the total carbohydrate content











Honey shall be treated so the spores of Clostridium botulinum is killed.

6.4. Glucose

Glucose may only be added to follow-on formulae manufactured from protein hydrolysates. If add glucose, its contents must not exceed 0.5 g/100 kJ (2 g/100 kcal).

7. FRUCTO-OLIGOSACCHARIDES and GALACTO-OLIGOSACCHARIDES

Fructo-oligosaccharides may be added and galacto-oligosaccharides to follow-on formulae. In this case, the content shall not exceed 0.8 g/100 ml with a combination of 90% oligogalactosyl-lactose and 10% oligofructosyl-sucrose with high molecular weight.

Other combinations and maximum levels for fructo-oligosaccharides and galacto-oligosaccharides may be used in accordance with section 7.

8. MINERALS 8.1. Follow-on formulae manufactured from cows ' milk proteins or protein hydrolysates per 100 kJ





Per 100 kcal





 



At least





A maximum of





At least





A maximum of







Sodium (mg)





5





14





20





60







Potassium (mg)





15





38





60





160







Chloride (mg)





12





38





50





160







Calcium (mg)





12





33





50





140







Phosphorus (mg)





6





22





25





90







Magnesium (mg)





1.2





3.6





5





15







Iron (mg)





0.14





0.5





0.6





2







Zinc (mg)





0.12





0.36





0.5





1.5







Copper (µ g)





8.4





25





35





100







Iodine (µ g)





2.5





12





10





50







Selenium (µ g)





0.25





2.2





1





9







Manganese (µ g)





0.25





25





1





100







Fluoride (µ g)





-





25





-





100











Calcium: phosphorus ratio shall not be less than 1.0% and not more than 2.0.

8.2. Follow-on formulae manufactured from soya protein isolates alone or mixed with cows ' milk proteins

All requirements of point 8.1 shall apply except in the case of iron and phosphorus, where requirements are as follows: per 100 kJ





Per 100 kcal





 



At least





A maximum of





At least





A maximum of








Iron (mg)





0.22





0.65





0.9





2.5







Phosphorus (mg)





7.5





25





30





100











9. VITAMINER







 



Pr. 100 kJ





Per 100 kcal





 



At least





A maximum of





At least





A maximum of







Vitamin A (µg-RE)1)





14





43





60





180







Vitamin D (µg)2)





0,25





0.65





1





2.5







Thiamin (µg)





14





72





60





300







Riboflavin (µg)





19





95





80





400







Niacin(µg)3)





72





375





300





1500







Pantothenic acid (µ g)





95





475





400





2000







Vitamin B6 (µ g)





9





42





35





175







Biotin (µ g)





0.4





1.8





1.5





7.5







Folic acid (µ g)





2.5





12





10





50







Vitamin B12 (µ g)





0.025





0.12





0.1





0.5







Vitamin C (mg)





2.5





7.5





10





30







Vitamin K (µ g)





1





6





4





25







Vitamin E (mg α-TE) 4) 0,5/g polyunsaturated fatty acids expressed as linoleic acid corrected for dobbeltbindinger5), but never less than 0.1 mg per 100 available kJ





1.2





0,5/g polyunsaturated fatty acids expressed as linoleic acid corrected for dobbeltbindinger5), but never less than 0.5 mg per 100 available kcal





5









1) RE = all trans-retinolækvivalenter.



2) in the form of cholecalciferol, of which 10 µ g = 400 international units of vitamin d.



3) Finished formed niacin.



4) α-TE = d-α-tocopherolækvivalent.



5) 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).











10. NUCLEOTIDES

Følgende nukleotider må tilsættes:







 



Højst1)





 



(mg/100 kJ)





(mg/100 kcal)







Cytidin 5 '-monophosphat





0.60





2.50







Uridin 5 '-monophosphat





0.42





1.75







Adenosine 5 '-monophosphat





0.36





1.50







Guanosin 5 '-monophosphat





0.12





0.50







Inosin 5 '-monophosphat





0.24





1.00









1) the total concentration of nucleotides shall not exceed 1.2 mg/100 kJ (5 mg/100 kcal).













Annex 3 nutrients 1. Vitaminer











Vitamin









Vitamin designation









Vitamin A





Retinylacetat





 



Retinylpalmitat





 



Retinol








Vitamin D





Vitamin D2 (ergocalciferol)





 



Vitamin D3 (cholecalciferol)







Vitamin B1 Thiamine-hydrochloride





 



Thiaminmononitrat







Vitamin B2 Riboflavin





 



Riboflavin-5'phosphat, sodium







Niacin





Nicotinic Acid amide





 



Nicotinic Acid







Vitamin B6 Pyridoxine hydrochloride





 



Pyridoxal-5 '-phosphate







Folate





Folic acid







Pantothenic acid





Calcium-D-pantothenate





 



Sodium-D-pantothenate





 



Dexpanthenol







Vitamin B12 Cyanocobalamin





 



Hydroxocobalamin







Biotin





D-biotin







Vitamin C





L-Ascorbic acid





 



Sodium-L-ascorbate





 



Calcium-L-ascorbate





 



L-Ascorbyl-6-palmitate





 



Kaliumascorbat







Vitamin E





D-alpha-tocopherol





 



DL-alpha-tocopherol





 



D-alpha-tocopherol acetate





 



DL-alpha-tocopherol acetate







Vitamin K





Phylloquinon (Phytomenadione)











2. Mineraler











Mineraler









Mineral description









Calcium (Ca)





Calcium carbonate





 



Calcium chloride





 



Calcium citrate





 



Calciumgluconat





 



Calciumglycerophosphat





 



Calciumlactat





 



Calcium salts of orthophosphoric acid





 



Calcium hydroxide







Magnesium (Mg)





Magnesium carbonate





 



Magnesium chloride





 



Magnesium oxide





 



Magnesium salts of orthophosphoric acid





 



Magnesium sulphate





 



Magnesium gluconate





 



Magnesium hydroxide





 



Magnesium salts of citric acid







Iron (Fe)





Ferrocitrat





 



Ferrogluconate





 



Ferrolactat





 



Ferrous sulphate





 



Ferric ammonium citrate





 



Ferrofumarat





 



Ferridiphosphat





 



Ferrous bisglycinate







Copper (Cu)





Cupricitrat





 



Cuprigluconat





 



Copper sulphate





 



Copper-lysine complex





 



Kobbercarbonat







Iodine (I)





Potassium iodide





 



Sodium iodide





 



Potassium iodate







Zinc (Zn)





Zinc acetate





 



Zinc chloride





 



Zinklactat





 



Zinc sulphate





 



Zinc citrate





 



Zinc





 



Zinc oxide







Manganese (Mn)





Manganese carbonate





 



Manganese





 



Manganese citrate





 



Manganese sulphate





 



Manganese







Sodium (Na)





Sodium bicarbonate





 



Sodium chloride





 



Sodium citrate





 



Natriumgluconat





 



Sodium carbonate






 



Natriumlactat





 



Sodium salts of orthophosphoric acid





 



Sodium hydroxide







Potassium (K)





Potassium bicarbonate





 



Potassium carbonate





 



Potash





 



Potassium citrate





 



Kaliumgluconat





 



Kaliumlactat





 



Potassium salts of orthophosphoric acid





 



Potassium hydroxide







Selenium (Se)





Sodium selenium





 



Sodium selenite











3. Amino acids and other nitrogen compounds L-cystine and hydrochloridet thereof







L-Histidine and hydrochloridet thereof







L-isoleucine and hydrochloridet thereof







L-Leucine and hydrochloridet thereof







L-lysine and hydrochloridet thereof







L-cysteine and hydrochloridet thereof







L-methionine







L-phenylalanine







L-threonine







L-tryptophan







L-tyrosine







L-valine







L-carnitine and hydrochloridet thereof







L-carnitine L-tartrate







Taurine







Cytidin 5 '-monophosphat and its sodium salts







Uridin 5 '-monophosphat and its sodium salts







Adenosine 5 '-monophosphat and its sodium salts







Guanosin 5 '-monophosphat and its sodium salts







Inosin 5 '-monophosphat and its sodium salts











4. Other nutrients Choline







Choline chloride







Cholincitrat







Cholinbitartrat







Inositol













Annex 4 nutrition and health claims for infant formulae and conditions for the submission thereof 1. NUTRITION CLAIMS nutrition claim



 





1.1. Lactose only





Lactose is the only carbohydrate present.







1.2. Lactosefri





Analysing lactose content does not exceed 2.5 mg/100 kJ (10 mg/100 kcal).







1.3. added LCP or equivalent nutrition claim, relating to the addition of Docosahexaenoic acid





Contents of Docosahexaenoic acid is at least 0.2% of the total fatty acid content.







1.4. Nutrition claims relating to the addition of the following optional ingredients:



 













1.4.1. taurine







1.4.2 fructo-oligosaccharides and galacto.-oligosaccharides







1.4.3 nucleotides













Added on a voluntary basis, in an amount that is appropriate for the intended particular use for infants, and in accordance with the conditions set out in annex 1.











2. HEALTH CLAIMS (INCLUDING CLAIMS of a REDUCED RISK of disease)









Health claim





Conditions for health claim







2.1. Reduced risk of allergy to milk proteins. This health claim may include terms referring to reduced allergen or antigen a content.





a) there must be objective and scientifically verified data as proof of the claimed properties.





 



b) infant formulae shall comply with the provisions of paragraph 2.2 of annex 1, and the amount of immunoreaktivt protein measured with generally acceptable methods must be less than 1% of nitrogenous substances in infant formulae.





 



(c)) it has to be on the label that the product may not be used for infants who are allergic to the intact proteins from which it is manufactured unless generally accepted clinical tests provide evidence that infant substitutions are tolerated by more than 90% confidence interval (95%) of infants who are hypersensitive to the proteins, the hydrolysed product is obtained from.





 



d) Infant compensation lodged by mouth should not induce sensitization in animals to the intact proteins, such as infant formula is made from.













Annex 5 Essential and semi essential amino acids in breast milk

For purposes of this notice are the essential and semi essential amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal following: per 100 kJ1) per 100 kcal







Cystine





9





38







Histidine





10





40







Isoleucine





22





90







Leucine





40





166







Lysine





27





113







Methionine





5





23







Phenylalanine






20





83







Threonine





18





77







Tryptophan





8





32







Tyrosine





18





76







Valine





21





88









1 kJ = 0.239 kcal) 1.













Annex 6 specification for protein content and source, as well as protein processing

This specification applies to the protein content and source, as well as protein processing, which are used in the manufacture of infant formulae with a protein content less than 0.56 g/100 kJ (2.25 g/100 kcal) manufactured based on hydrolysates of whey protein derived from cows ' milk protein.

1. Protein content

Protein content = nitrogen content x 6.25.









At least





A maximum of







0.44 g/100 kJ





0.7 g/100 kJ







(1.86 g/100 kcal)





(3 g/100 kcal)











2. Protein source

Demineralised sweet whey protein derived from cows ' milk after enzymatic precipitation of caseins using chymosin, consisting of: (a) 63% casein-glycomacropeptide)-freely-filtered with a protein content of not less than 95% of dry matter and protein denaturation of less than 70% and an ash content more than 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 an ash content not exceeding 3.5%.



3. Protein processing

Hydrolysis in two steps by the use of a trypsinpræparat with a heat treatment step (3-10 min at 80-100 ° C) between the two hydrolysis steps.



Annex 7 Reference values for use in the nutrition labelling of foods for infants and young children nutrient









The reference value for nutrition labelling









Vitamin A (µ g)





400







Vitamin D (µ g)





7







Vitamin E (mg TE)





5







Vitamin K (µ g)





12







Vitamin C (mg)





45







Thiamin (mg)





0.5







Riboflavin (mg)





0.7







Niacin (mg)





7







Vitamin B6 (mg)





0.7







Folic acid (µ g)





125







Vitamin B12 (µ g)





0.8







Pantothenic acid (mg)





3







Biotin (µ g)





10







Calcium (mg)





550







Phosphorus (mg)





550







Potassium (mg)





1000







Sodium (mg)





400







Chloride (mg)





500







Iron (mg)





8







Zinc (mg)





5







Iodine (µ g)





80







Selenium (µ g)





20







Copper (mg)





0.5







Magnesium (mg)





80







Manganese (mg)





1.2









Official notes 1) Decree transposing Commission Directive 2006/141/EC of 22. December 2006, the official journal of the European Union 2006, L 401, page 1, and Council Directive 92/52/EEC of 18. June 1992 on export to third countries of infant formulae and follow-on formulae for infants and young children, the Official Journal 1992 L 179, page 129. In the notice are included certain provisions of Commission Regulation (EC) No. 1243/2008, L 335, page 25. According to article 288 of the Treaty where a regulation is directly applicable in each Member State. The reproduction of these provisions in the Ordinance is thus entirely justified in practical terms and shall not affect the validity of the regulation's immediate in Denmark.