Key Benefits:
Chapter 1 | Definitions |
Chapter 2 | Marketing |
Chapter 3 | Composition requirements |
Chapter 4 | Labels and labelling |
Chapter 5 | Marketing and advertising |
Chapter 6 | Notification of breast-milk substitutes |
Chapter 7 | Export to countries outside the EU |
Chapter 8 | Penalty and entry into force |
Appendix 1 | Tissue of formula for breast milk |
Appendix 2 | Mixture of mixtures of mixtures |
Appendix 3 | Nuxients |
Appendix 4 | Nutrition and health claims for breast-milk substitutes and conditions for the submission of such information |
Appendix 5 | Essential and semiessential amino acids in breast milk |
Appendix 6 | Specification of the protein content and source and the protein processing used in the manufacture of formula milk substitutes and for mixtures with a protein content of less than 0,56 g/100 kJ (2,25 g/100 kcal) obtained from the hydrolysates based on the protein content of the sample. in the choice of valleys derived from cow-milk proteins. |
Appendix 7 | Reference values for the nutritional provision of food for infants and small children |
Publication of breast-milk substitutes and mixtures for infants and small children 1)
In accordance with paragraph 5 (2), One, section 7, section 8, paragraph 8. 2, section 11, section 15, section 16, section 17, paragraph 17, 1, section 19, section 37, section 39, paragraph Paragraph 1, section 49, paragraph. Paragraph 60 (1) and 60 (2). 3, in the law of foodstuffs, cf. Law Order no. 250 of 8. March 2013 :
Chapter 1
Definitions
§ 1. For the purposes of this notice :
1) Children under 12 months of age.
2) Small children : children aged between 1 and 3 years.
3) Milk substitutes : food, which is intended to be the special diet of the infant in their first living months and which in itself covers these infant nutrients ' needs until a second appropriate diet is supplemented.
4) Offer mixtures : food, which is intended to constitute the special diet of the infant, when supplementing with other appropriate diet, which constitutes the most essential liquid component of these infant foods, which is the more varied diet of these babies.
§ 2. In this notice, the definitions of 'claim', 'nutritional claim', 'health claims' and ' award a reduced risk of disease ` in Article 2 (2) shall be considered. 2, no. Regulation (1), (4), (5) and (6) of the Regulation (EC) No (EC) No, 1924/2006 of 20. In December 2006 on the nutritional and health claims of food, use.
Chapter 2
Marketing
§ 3. Milk substitutes and mixtures may be placed on the market only if they comply with the provisions of this notice.
§ 4. Only breast-milk substitutes may be placed on the market or otherwise provided to be suitable for the sole product to cover the nutritional needs of normal, healthy infant nutritional needs in the first living months before complementing with other appropriate diet.
Chapter 3
Composition requirements
§ 5. Milk-milk substitutes and mixtures must not contain any substance in such a quantity that it involves a health hazard for babies and children.
§ 6. Milk substitutes shall meet the composition requirements set out in Annex 1, taking into account the specifications set out in Annex 5.
Paragraph 2. Milk substitutes must be prepared by protein, as defined in Annex 1 (2) and other food ingredients which, in general scientific data, have shown that they are suitable for the special diet of the infants of the infant.
Paragraph 3. This fitness shall be documented in a systematic review of the anticipated benefits and safety considerations, as well as, where necessary, appropriate studies carried out in accordance with generally accepted, expert guidance on the design and implementation of such investigations.
Paragraph 4. In the case of breast-milk substitutes produced on the basis of the milk or goat-milk proteins defined in Annex 1, point 2.1, with a protein content between the minimum limit and 0,5 g/100 kJ (2 g/100 kcal), the suitability of the formula for milk shall be suitability for the milk the special diet of the infant shall be documented by appropriate examinations carried out in accordance with generally accepted expert guidance on the design and execution of such investigations.
Paragraph 5. In the case of breast-milk substitutes produced from hydrolysed protein as defined in Annex 1 (2.2) with a protein content between the minimum limit and 0,56 g/100 kJ (2,25 g/100 kcal), the fitness for the milk is to be the suitability of the infant formula, special diet shall be documented by appropriate examinations carried out in accordance with generally accepted expert guidance on the design and implementation of such investigations, and the products must be in accordance with the specifications in : Annex 6.
§ 7. Offer mixtures must satisfy the composition requirements set out in Annex 2, taking into account the specifications set out in Annex 5.
Paragraph 2. Offer mixtures must be prepared by protein, as defined in Annex 2 (2) and other food ingredients which, in general scientific data, have shown that they are suitable for the special diet for infants of more than 6 months.
Paragraph 3. This fitness shall be documented in a systematic review of the anticipated benefits and safety considerations, as well as, where necessary, appropriate studies carried out in accordance with generally accepted, expert guidance on the design and implementation of such investigations.
Paragraph 4. In the case of fortified mixtures obtained from hydrolysed protein defined in Annex 2, section 2.2, with a protein content between the minimum limit and 0,56 g/100 kJ (2,25 g/100 kcal), the suitability of the subsidy to the special diet of the infant must be added to the special diet of the infants. shall be documented by appropriate examinations carried out in accordance with generally accepted expert guidance on the design and implementation of such investigations, and the products must comply with the specifications set out in Annex 6.
§ 8. The formula for the formula of the formula for the formula of a formula for the use of a formula for the use of a formula for the use of a formula for the use of a formula for the use of
§ 9. The prohibition and restrictions contained in Annexes 1 and 2 must be observed in the use of food ingredients in breast-milk substitutes and the mixtures of the subsidy.
§ 10. For the production of placenta and forceps, the nutrients referred to in Annex 3 may be used only in order to comply with the requirements for :
1) vitamins,
2) minerals,
3) amino acids and other nitrogen compounds ; and
4) other substances with particular nutritional purposes.
§ 11. The person responsible for the first marketing of the product in Denmark shall ensure that the analyzed content of nutrient limits laid down for the maximum limits laid down in the legislation shall not be exceeded, excluding the analytical uncertainty.
§ 12. If, in EU legislation, including food additives, the level of purity criteria for the use of the substances referred to in Annex 3 of the notice shall apply, regardless of the purpose of the condition.
Paragraph 2. For substances which have not yet been laid down for purity criteria in EU legislation, the purity criteria set out in the notification concerning the addition of nutrients to food are subject to the provisions of the purity of the Community legislation.
Paragraph 3. In the case of substances which have not yet been laid down for the purity criteria of EU law or in the notification on the addition of nutrients to food, the generally acceptable criteria for purity shall be deemed to be recommended by international bodies, until the level of purity criteria is adopted at EU level.
§ 13. The requirements referred to in section 6 to 12 may be waisted for products for which the European Commission, in accordance with Article 4 (2), is granted. 2, in Directive 2009 /39/EC of the European Parliament and of the Council of 6. May 2009 on foods intended for particular nutrition has granted temporary authorisation to be placed on the market.
Chapter 4
Labels and labelling
§ 14. The sales designation for breast-milk substitutes and mixtures are, respectively, ' Milk-milk substitutes ` and ' subsidy mixture ` respectively.
§ 15. The sales description of breast-milk substitutes and forging mixtures produced entirely on the basis of the milk or goat-milk proteins, respectively, are ' Mother-milk substitutes based exclusively on milk ' and ' subsidy mixture only based on milk '.
§ 16. Milk-milk substitutes and forging mixtures must, in addition to the general labelling provisions, be labelled with the following information on the suitability of the product :
1) In the case of breast-milk substitutes, an indication that the product is suitable for the special diet for infants from birth when they are not breastfed.
2) in the case of fortification : an indication that the product is only suitable for the special diet for infants of more than 6 months, that the product should not be used as a substitute for milk in the first six habitats, and the decision to start giving other diet other than breast milk, including before the age of six months, should only be taken in accordance with the recommendation of independent persons with training in medicine, nutrition or pharmaci or any other person who is professionally ; responsible for child care, starting with the specific growth of the individual infant, developmental needs.
§ 17. In addition, milk-milk substitutes and subsidy mixtures must also be marked with the following information on the product's content and proper use :
1) A numerical indication of the energy content expressed in kilojoule (kJ) and kiolocalories (kcal) as well as the content of protein, carbohydrate and fats per fats. 100 ml of use of use of the product.
2) A numerical indication of the average quantity of each mineral and vitamin listed in Annexes 1 and Annex 2, as well as, where appropriate, of choline, inositol and carnitin per litre, respectively ; 100 ml of use of use of the product.
3) A guide in how the product is prepared, stored and disposed of properly, and a warning against the health hazard of an un-correct preparation and storage.
§ 18. Labelling may include the following information :
1) In the case of breast-milk substitutes and for mixtures, a numerical indication of the average quantity of nutrient substances listed in Annex 3, 100 ml of the use of the use of a product, where such a declaration is not covered by Section 17 (s). 2.
2) For mixtures : in addition to numerical information, information on vitamins and minerals listed in Annex 7, expressed as a percentage of the reference value specified in each of the above. 100 ml of use of use of the product.
§ 19. The labelling of breast-milk substitutes and mixtures must be designed in such a way that it contains the necessary information on the proper use of the product and shall not be encouraged to give up the amusing.
Paragraph 2. The use of terms as "humanised", "moderated", "custom" or similar terms is prohibited.
20. The labelling of formula milk substitutes shall also include the following mandatory particulars, which are entered after the word "Important" or a corresponding expression :
1) An indication of the unmatched value of the amps, and
2) A recommendation to use the product only after a recommendation of independent persons with training in medicine, nutrition or pharmaci, or by other people who are professionally responsible in the field of childcare.
§ 21. The labelling of breast-milk substitutes shall not be provided with pictures of infants or other images or a text that may idealize the use of the product. However, they may be provided with graphic illustrations that enable the product to be identified as a formula for formula and which shows the preparation methods.
§ 22. The labelling of breast-milk substitutes shall contain only nutritional and health claims referred to in Annex 4 of the notice and only in compliance with the conditions laid down in Annex 4.
-23. Milk substitutes and mixtures must be labelled in such a way that it enables consumers to clearly distinguish between the products to avoid the risk of confusion between breast-milk substitutes and the mixtures of the subsidy.
Chapter 5
Marketing and advertising
§ 24. The requirements, bans and restrictions shall also apply in section 19 to 23 :
1) in the case of presentation of the products concerned,
a) in particular their shape, appearance and packaging, and the packaging material used,
b) the manner in which they are located ; and
c) the surroundings in which they appear, and
2) for publicity.
§ 25. Advertising for breast-milk substituting is only permitted in scientific publications and specialised in specialised health professionals.
Paragraph 2. Advertising as referred to in paragraph 1. 1 shall comply with the conditions in section 19-23 and section 24, nr. 2, and may contain only scientific and factual information. The information must not imply or give the impression that the use of formula formula is as good as or better than suave.
SECTION 26. In the outlets on outlets, no advertising shall be adversated, samples or used other promotional methods to direct the sale of formula directly to the consumer in the retail stage, such as special exhibits, coupons, premiums, promotional campaigns, loss-making offerings and decoys ;
§ 27. Producers and distributors of milk-milk substituts may not distribute free or priced products, samples or other sales promotions to the public, pregnant women, mothers or their families directly or indirectly through it ; public health services or the employees of this sector.
§ 28. Milk substitutes which are distributed free or sold at low cost to institutions or organisations, either for use in the institutions or for distribution outside these, may be used only by or distributed to infants which have to stay ; the nutrient of formula, and only as long as it is necessary for these babies.
§ 29. The distribution of free information and training equipment or material from manufacturers and distributors may only take place at the request of the information.
Paragraph 2. Producers and retailers shall inform the FDA continuously on the distribution of the information referred to in paragraph 1. 1 mentioned equipment and material on the transmission of :
1) copies of the equipment and equipment,
2) Recipient Group information ; and
3) the quantity of distributed material per year ; recipient group.
Paragraph 3. The one in paragraph 1. 1 mentioned equipment and material
1) may be prejudicial to the name or the name of the manufacturer or the manufacturer of the distributor,
2) not refer to a name-protected formula produced by a name-protected product ; and
3) must be distributed only through the public health sector.
-$30. Written or audio-visual information on infant nutrients intended for pregnant women and peddling parents must provide clear information on :
1) the benefits and unripened value of the amning, cf. however, paragraph 1 3,
2) the mother's nutrition, as well as the way in which she prepares and sustaining the feeding,
3) the possible negative effects on the amusing by starting with supplementary bottles,
4) the difficulty of remaking the decision not to breast-feed, and
5) the correct use of formula formula for formula, where its use should prove necessary.
Paragraph 2. In the matter referred to in paragraph 1. 1 information on the use of formula for formula, bearing in mind the social and economic consequences, health risks associated with unsuitable food or nutritional methods, and in particular the health risks associated with incorrect use ; of breast milk substitutes.
Paragraph 3. The material referred to in paragraph 1. 2 may not contain images that are idealizing the use of formula formula.
Chapter 6
Notification of breast-milk substitutes
§ 31. The EU producer, the EU importer or the person responsible for the first marketing in Denmark of a formula of formula shall send an example of the labelling used for the Food Authority before the product is marketed in Denmark.
Chapter 7
Export to countries outside the EU
§ 32. Milk-milk substitutes and subsidy mixtures intended for use in non-EU countries must either comply with the provisions of section 5-11, section 12, paragraph 12. Paragraph 1 or 3, section 16-23 and section 24 (4). Paragraph 1, or in accordance with international standards, drawn up by the Codex Alimentarius, unless the importing country or its legislation makes other requirements.
Paragraph 2. These products must be labelled in an import country suitable language, so that any risk of mixing formula with subsidy mixtures is avoided.
Chapter 8
Penalty and entry into force
§ 33. Heading 4-11, section 12, paragraph 12. 1 or 3 or sections 13 to 32 shall be punished by fine.
Paragraph 2. The sentence may rise to a maximum sentence for two years if the infringement has been committed with a set of negligence or gross negligence, and there is a breach in the infringement proceedings ;
1) damage to health or to the detriment of such risks ; or
2) obtained or intended to benefit from the economic advantage of the person concerned himself or others.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code cap. 5.
§ 34. The announcement shall enter into force on the sixth. February 2014.
Paragraph 2. At the same time, notice No 1198 of 9. October 2013, in the case of breast-milk substitutes and forceps for infants and small children.
The FDA, the 31. January 2014
P.D.V.
Hanne Larsen.
/ Marianne Øhlenschläger Larsen
Appendix 1
Tissue of formula for breast milk
The values set out in this Annex shall apply to the finished use of the products placed on the market as such or are reconstituted in accordance with the manufacturer ' s instructions.
1. ENERGY
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2. PROTEIN
Protein content = nitrogencontent x 6.25.
2.1. Milk-milk substitutes made by cow ' s milk or goat-milk proteins
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In the case of the same energy content, the formula contains a minimum quantity of each essential and semi-essential amino acid, as the reference protein (mother milk as defined in Annex 5).
However, in the calculation, the content of methionine and cystin may be adjacent if the methion-in:cys ratio is not greater than 2, and the content of phenylalanine and the contents of phenylalanine may be obediene if the thiand:phenylalanine ratio is not greater than 2. Methionin : The information unit may be greater than 2, but no greater than 3, provided that the suitability of the product for infants is documented in the relevant studies carried out in accordance with generally accepted ; expert guidance on the design and implementation of such investigations.
2.2. Milk-milk substitutes obtained from hydrolysed protein
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In the case of the same energy content, the formula contains a minimum quantity of each essential and semi-essential amino acid, as the reference protein (mother milk as defined in Annex 5).
However, in the calculation, the content of methionine and cystin may be adjacent if the methion-in:cys ratio is not greater than 2, and the content of phenylalanine and the contents of phenylalanine may be obediene if the thiand:phenylalanine ratio is not greater than 2. Methionin : The information unit may be greater than 2, but no greater than 3, provided that the suitability of the product for infants is documented in the relevant studies carried out in accordance with generally accepted ; expert guidance on the design and implementation of such investigations.
The L-carnitincontent content must be at least 0,3 mg/100 kJ (1,2 mg/100 kcal).
2.3. Milk substitutes derived from soya protein isolates alone or mixed with milk or goat-milk proteins ;
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Only protein isolates from soya may be used for the production of these formula.
In the case of the same energy content, the formula contains a minimum quantity of each essential and semi-essential amino acid, as the reference protein (mother milk as defined in Annex 5).
However, in the calculation, the content of methionine and cystin may be adjacent if the methion-in:bicycle ratio is not greater than 2, and the content of phenylalanine and the contents of phenylalanine and of its may be obedience : the phenylalanine ratio is not greater than 2. The methionine ratio may be greater than 2, but no greater than 3, provided that the suitability of the product for infants is documented by relevant studies carried out in accordance with generally accepted, expert guidance on the design and implementation of such investigations.
The L-carnitinine content must be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).
2.4. In all cases, only amino acids are added to formula for formula to improve the nutritional value of the protein, and only to the extent necessary for the purpose of the protein.
3. TAURIN
If taurine is added to formula formula, the taureine content shall not exceed 2,9 mg/100 kJ (12 mg/100 kcal).
4. CHOLIN
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5. COOL.
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5.1. It shall be prohibited to use :
Sesame seed oil.
-cotton seed oil
5.2. Laurinc acid and myristinic acid
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5.3. The content of trans-fatty acids shall not exceed 3% of the total fat content.
5.4. The content of erucaic acid must not exceed 1% of the total fat content.
5.5. Linoic acid (in the form of glycerides = linoleates)
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5.6. The content of alpha-linol acid must not be less than 12 mg/100 kJ (50 mg/100 kcal).
The ratio between linol:alpha linoleic acid must not be less than 5 and not exceed 15.
5.7. A polyunsaturated fatty acids (LCP) with long chains (20 and 22 carbon atoms) can be added. In such cases, the content shall 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 eicosapentaenc acid (20: 5 n-3) may not exceed the levels of docosahexaenoic acid (22: 6 n 3).
The content of docosahexaenoic acid (22: 6 n-3) must not exceed the content of n-6 LCP.
6. PHOSPHOLIPIDER
The content of phospholipides in breast-milk substitutes shall not exceed 2 grams per litre.
7. INOSITOL
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8. CARBOHYDRATES
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8.1. The following carbs shall be used only :
-lactose
-Pathtose
-sucrose
-glucose
-Maltodextriner
-glucose syrup or dried glucose syrup,
-Adecoy starch (naturally free of gluten)
-gelatinated starch (naturally free of gluten)
8.2. Lactose
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This provision shall not apply to breast-milk substitutes in which soyprotein isolates represent more than 50% of the total protein content.
8.3. Saccharose
Saccharose may be added only to formula formula obtained from hydrolysed protein. The contents of sucrose shall not exceed 20% of the total carbohydrate content.
8.4. Glucose
Glucose may only be added to formula formula obtained from hydrolysed protein. If glucose is added, the content of this content shall not exceed 0,5 g/100 kJ (2 g/100 kcal).
8.5. Proboil and / or gelatinised starch
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9. FRUCTO OLIGOSACCHARIDES AND GALACTO OLIGOSACCHARIDES
Fructo oil saccharides and galacto oil saccharides are added to formula for breast-milk substitutes. In this case, the content shall not exceed 0,8 g/100 ml with a combination of 90% oil bile bile lactose and 10% oligofructosyl saccharose with a high molecular weight.
Other combinations of and maximum limits for fructo oil saccharides and galacosaccharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharitable Two and three.
10. MINERALS
10.1. Milk-milk substitutes made by milk or goat-milk proteins or hydrolysed proteins
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The calcium :phosphorst ratio must be at least 1,0 and not more than 2,0.
10.2. Milk substitutes derived from soya protein isolates alone or mixed with milk or goat-milk proteins ;
All requirements of point 10.1 apply, except as regards iron and phosphorus, where the values are as follows :
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11. VITAMINS
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12. NUCLEODES
The following nucleodes can be added :
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Appendix 2
Mixture of mixtures of mixtures
The values set out in this Annex shall apply to the finished use of the products placed on the market as such or are reconstituted in accordance with the manufacturer ' s instructions.
1. ENERGY
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2. PROTEIN
(Protein content = nitrogencontent x 6,25)
2.1. Copious mixtures obtained from the composition of the cow or goat-milk proteins
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In the case of the same energy content, the grant mixture must contain at least equal quantities of each essential and semi-essential aminoic acid as the reference protein (first parent milk as defined in Annex 5).
However, in the calculation, the content of methionine and cystin may be adjacent if the methion-in:cys ratio is not greater than 3 and the content of phenylalanine and the contents of phenylalanine may be obediene if the thibisine :phenylalanine ratio is not greater than 2.
2.2. Sperture mixtures obtained from hydrolysed protein
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In the case of the same energy content, the grant mixture must contain at least equal quantities of each essential and semi-essential aminoic acid as the reference protein (first parent milk as defined in Annex 5).
However, if the methion-in:cys ratio is not greater than 3 and the content of phenylalanine and the contents of phenylalanine ratio, the contents of methionine and cystin may be adjacent to the contents of the contents of methionine and the content of phenylalanine and the contents of phenylalanine and the contents of the contents of phenylalanine and its contents may
2.3. Offer mixture based on soya protein isolates alone or mixed with milk or goat-milk proteins
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Only protein isolates from soya may be used in the manufacture of these for-exchange mixtures.
In the case of the same energy content, the grant mixture must contain at least equal quantities of each essential and semi-essential aminoic acid as the reference protein (first parent milk as defined in Annex 5).
However, in the calculation, the content of methionine and cystin may be adjacent if the methion-in:cys ratio is not greater than 3 and the content of phenylalanine and the contents of phenylalanine may be obediene if the thibisine :phenylalanine ratio is not greater than 2.
2.4. In all cases, only amino acids are added to fortified mixtures in order to improve the nutritional value of the protein, and only to the extent necessary for that purpose.
3. TAURIN
If taurin is added to fortified mixtures, the content may not exceed 2,9 mg/100 kJ (12 mg/100 kcal).
4. COOL.
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4.1. It shall be prohibited to use :
Sesame seed oil.
-cotton seed oil.
4.2. Laurinc acid and myristinic acid
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4.3. The content of trans-fatty acids shall not exceed 3% of the total fat content.
4.4. The content of erucaic acid must not exceed 1% of the total fat content.
4.5. Linoic acid (in the form of glycerides = linoleates)
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4.6. The content of alpha-linol acid must not be less than 12 mg/100 kJ (50 mg/100 kcal).
The ratio between linol:alpha linoleic acid must not be less than 5 and not exceed 15.
4.7. A polyunsaturated fatty acids (LCP) with long chains (20 and 22 carbon atoms) can be added. In such cases, the content shall 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 eicosapentaenc acid (20: 5 n-3) may not exceed the levels of docosahexaenoic acid (22: 6 n 3).
The content of docosahexaenoic acid (22: 6 n-3) must not exceed the content of n-6 LCP.
5. PHOSPHOLIPIDER
The content of phospholipides in the subsidy mixtures may not exceed 2 g/l.
6. CARBOHYDRATES
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6.1. The use of ingredients containing gluten shall be prohibited.
6.2. Lactose
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This provision shall not apply to products which represent more than 50% of the total protein content in which soya protein isolates represent more than 50% of the total protein content.
6.3. Saccharose, fructose, honey
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Honey needs to be treated, so trace of Clostridium botulinum has been killed.
6.4. Glucose
Glucose must only be added to mixtures made of hydrolysed protein. If glucose is added, the content of this content shall not exceed 0,5 g/100 kJ (2 g/100 kcal).
7. FRUCTO OLIGOSACCHARIDES AND GALACTO OLIGOSACCHARIDES
Fructo oil saccharides and galacosaccharides are added to the mixtures of mixtures. In this case, the content shall not exceed 0,8 g/100 ml with a combination of 90% oil bile bile lactose and 10% oligofructosyl saccharose with a high molecular weight.
Other combinations of and maximum limits for fructo oil saccharides and galacosaccharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharicharides are applicable in accordance with section 7 (4). Two and three.
8. MINERALS
8.1. Persiblings manufactured on the basis of milk or goat-milk proteins or hydrolysed proteins
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The calcium :phosphorst ratio must be at least 1,0 and not more than 2,0.
8.2. Offer mixture based on soya protein isolates alone or mixed with milk or goat-milk proteins
All requirements of paragraph 8.1 shall apply, except as regards iron and phosphorus, where the requirements are as follows :
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9. VITAMINS
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10. NUCLEODES
The following nucleotides are to be added :
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Appendix 3
Nuxients
1. Vitamins
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2. Minerals
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3. Amino acids and other nitrogen compounds
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4. Other nutrients
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Appendix 4
Nutrition and health claims for breast-milk substitutes and conditions for the submission of such information
1. NUTRIANGES
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2. HEALTH CLAIMS (INCLUDING CLAIMS OF A REDUCED RISK OF DISEASE)
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Appendix 5
Essential and semiessential amino acids in breast milk
For the purposes of this notice, the essential and semi-essential amino acids in breast milk are expressed in mg per mg. 100 kJ and 100 kcal :
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Appendix 6
Specification of the protein content and source and the protein processing used in the manufacture of formula milk substitutes and for mixtures with a protein content of less than 0,56 g/100 kJ (2,25 g/100 kcal) obtained from the hydrolysates based on the protein content of the sample. in the choice of valleys derived from cow-milk proteins.
1. Protein content
Protein content = nitrogencontent x 6.25.
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2. Protein Source
Deminalizing protein of sweet valle derived from cow ' s milk after enzymatic extraction of caseins by use of the chymosine and consisting of :
a) 63% casein-glycomacropeptid-free valleprotein isolate with a protein content of not less than 95% in the dry matter and a protein content of less than 70% and an ash content of not more than 3%, and
b) 37% of the protein concentration of sweet valle with a protein content of not less than 87% in the dry matter and a protein content of less than 70% and an ash content of not more than 3,5%.
3. Protein Processing
Hydrolysis in two steps, using a pressure preparation with a heat treatment stage (3-10 min. at 80 to 100 ° C) between the two hydrolysesteps.
4. Protein quality
The essentials and semi-essential amino acids in breast milk expressed in mg per mg. 100 kJ and 100 kcal is the following :
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Appendix 7
Reference values for the nutritional provision of food for infants and small children
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1) The announcement shall implement the Commission Directive 2006 /141/EC of 22. In December 2006, on breast-milk substitutes and subsidy mixtures for infants and children, the EU Official Journal, L 401, page 1, as amended by Commission Directive 2013 /46/EU of 28. August 2013, the EU-2013, L 230, page 16, and Council Directive 92/52/EEC of 18. June 1992 on exports to third countries of milk-milk substitutes and forceps for infants and small children, the Community Official Journal, L 179, page 129. The publication shall include certain provisions of Commission Regulation (EC) No 2 ; 1243/2008, L 335, page 25. According to Article 288 of the EDF Treaty, a Regulation shall apply immediately in each Member State. The rendition of these provisions in the notice is therefore based solely on practical considerations and is without prejudice to the immediate validity of the regulation in Denmark.