Regulations on infant formula and the grant date of the mixtures-2008-08-13-936 Ministry health and Human Services Department published in 2008 clips 9 (Appendix) FOR the entry into force last modified 13.08.2008-2014-02-18-191 Change FOR-2001-10-11-1163 applies to Norway Pursuant law-2003-12-19-124-§ 9, law-2003-12-19-124-section 10, FOR-2003-12-19-1790, FOR-2004-05-05-884 Announced 22.08.2008 at. 14.35 short title regulations on infant formula mv Chapter overview: chapter I, scope and purpose definitions (§ § 1-3) chapter II. Composition (sections 4-8) chapter III. Tagging (sections 9-15) chapter IV. Presentation, marketing and advertising (§ § 16-20) chapter V. Information and educational materials (§ § 21-24) Chapter VII. Administrative provisions (§ § 25-27) Appendix 1. Requirements for the composition of infant formula after preparation according to manufacturer's instructions Appendix 2. Requirements for the composition of the mixtures in the grant for the preparation according to manufacturer's instructions Appendix 3. Nutrients Appendix 4. Allowable nutritional and wellness claims on formula milk-composition requirements Appendix 5. Essential and conditional essential amino acids in breast milk Attachment 6. Specification for the protein content, the protein source and processing of protein used in the manufacture of infant formula and tilskuddsblandi ...
Attachment 7. Reference values for nutrient Declaration to products marketed to infants and young children Attachment 8. Pesticides which shall not be used in agricultural products for use in the manufacture of infant formula and grant mixtures Attachment 9. Special maximum limits for residues of pesticides or metabolites in breast milk substitute and grant legal authority established by the mixtures: health and Human Services Department 13. August 2008 with authorization in law 19. December 2003 No. 124 on food production and food safety, etc. (matloven) the first paragraph of section 9 and section 10 the second paragraph, cf.. the delegation decision 19. December 2003 No. 1790. Added title: the delegation decision 5. May 2004 No. 884. the EEA Joint referrals: the EEA Agreement-annex II, chap. XII Nr. 54zzzv (Directive 2006/141/EC, as amended by Regulation (EC) No 1243/2008 and Directive 2013/46/EU).
Changes: modified by regulations July 13, 2009 # 1007, 18 Feb. 2014 Nr. 191. Chapter I, scope and purpose definitions section 1. Scope this regulation provides provisions on the composition, selection, marketing, advertising and sales of infant formula and the grant to healthy cereals intended infants.
The provisions of this Regulation apply in addition to the provisions given in the current regulations on foodstuffs for use on special nutritional behov1 and replace these in those cases where the provisions of this regulation is more complete.

§ 2. Purpose the purpose of these regulations is to ensure that infant formula and the grant is safe and that the mixtures they satisfy infant special nutritional needs. The provisions of the regulations will help to promote and protect breastfeeding, at the same time as they are to ensure a proper use of the products.

§ 3. Definitions in this regulation be understood with;

1. infants: children under 12 months 2.

young children: children from one up to three years 3.

infant formula: food which alone covers infant nutritional needs in their first months of living up to the introduction of solid food 4.

the grant mix: the food that is intended for infants from the introduction of other appropriate cost, and that can make the most essential liquid constituent of it eventually more varied the diet of these children 5.

residues of pesticides: residues of pesticides, etc. in mother's milk and cereals, and grant their any poisonous omdannelses or down wrapping products, as defined in regulation 21. December 1993 No. 1388 about residues of pesticides, etc. in food processing and livestock feed.

Chapter II. The composition section 4. In General, infant formula and the grant to be traded on the mixes, the Norwegian market, must be in accordance with the provisions given in this regulation.
Infant formula and grant mixtures must not contain substances in such quantities that it can cause danger for sped and small children's health.
No products other than infant formula may be marketed as suitable for travellers to be able to cover the healthy infant special nutritional needs in their first months up until the introduction of solid food.
It can only required the addition of water at preparation of infant formula and grant that the products to be mixtures be ready.
Only those substances that are set out in Appendix 3 can be added to infant formula and the grant to meet the requirements the mixtures in section 5 and section 6 of the content;

1. mineral substances 2.
vitamins 3.
amino acids and other nitrogen compounds 4.
other substances with special nutritional function.

Restrictions and ban on the use of special ingredients in infant formula and the grant, which is dealt with by the mixtures in attachments 1 and 2, shall be met.

§ 5. Mother's milk infant formula to meet the requirements of the composition and the use of ingredients that are set out in Appendix 1, taking into account the specifications given in annex 5.
Other food ingredients can be used if the general scientific data by reputable is determined to be suitable to be included in the infant fare from birth. The suitability should be demonstrated through a systematic review of the available data and relevant studies where there is added importance on safety and expected benefits. Such studies should be based on generally accepted scientific design and implementation.
In cases where infant formula is based on cow's milk or goat's milk protein, as defined in annex 1, point 2.1, with a protein content between the minimum and 0.5 g/100 kJ (2 g/100 kcal), the suitability of the product should be demonstrated through appropriate studies. These studies should be based on generally accepted scientific design and implementation.
In cases where infant formula is based on partial hydrolysates of proteins, as 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 suitability of the product should be demonstrated through appropriate studies. These studies should be based on generally accepted scientific design and implementation, as well as to comply with the specifications given in annex 6.
In cases where the grant is based on partial mixtures hydrolysates of proteins, as 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 suitability of the product should be demonstrated through appropriate studies. These studies should be based on generally accepted scientific design and implementation, as well as to comply with the specifications given in annex 6.

section 6. The grant the grant to meet mixtures mixtures the requirements to the composition and use of ingredients that are set out in Appendix 2, taking into account the specifications given in annex 5.
Other food ingredients can be used if the general scientific data by reputable is determined to be suitable to be included in the diet of infants older than six months. The suitability should be demonstrated through a systematic review of the available data and relevant studies where there is added importance on safety and expected benefits. Such studies should be based on generally accepted scientific design and implementation.

section 7. Purity criteria if it is in the EU are stipulated for purity criteria the substances listed in Appendix 3, applies to these as well for the substances included in this annex and which are included in the manufacture of products covered by this regulation.
For substances where it in the European Union is not prepared to purity criteria, generally accepted international criteria and purity apply until the European Union has prepared its own purity criteria. National purity criteria should still be used if they are stricter than the international purity criteria.

section 8. Residues of pesticides, etc. Infant formula and grant mixtures such as are done for consumption, shall not contain residues of the pesticides that exceed a limit value of 0.01 mg/kg. Limit value applies for each pesticide.
Methods of analysis used to determine the contents of the residues of pesticides, should be methods that are based on generally accepted and standardized methods.
Pesticides listed in annex 8 should not be used in the production of ingredients to be included in infant formula and grant mixtures. For supervisory purposes does the following: 1. It is believed that the pesticides listed in table 1 in annex 8 is not used if the analysis result for residues of pesticides does not exceed 0.003 mg/kg. This level, which is the method's limit, analysis kvantifiserings should be reconsidered if it is considered necessary in the light of new technology.

2. It is believed that the pesticides listed in table 2 in annex 8 is not used if the analysis result for residues of pesticides does not exceed 0.003 mg/kg. This level should be reconsidered in the light of new data on environmental pollution.

For pesticides listed in annex 9 concerns the limit values stated in this appendix.
The provisions given in this paragraph apply to infant formula and grant blend that is done for consumption, regardless if it is traded as a drink ready or to be mixed with water.

Chapter III. Marking section 9. General requirements in addition to the special provisions in this select the given regulation, to infant formula and the grant will be selected after the current regulations mixtures about labeling of food products. 1 in cases where the provisions of this regulation are more complete than in the General note the regulations, apply the provisions of this regulation.

No other food than breast milk substitute can be marked with that they alone can cover the nutritional needs of healthy infants in their first four to six months to live.

§ 10. Item designation Item designation for the products defined in § 3 No. 3 and Nr. 4, to be respectively "infant formula" and "Grant mix". When the protein source in the products exclusively based on cow's milk or goat's milk protein, to last the term be respectively "infant formula based on milk" and "the grant mix based on milk".

section 11. Declaration of the nutrient content-mandatory declaration, infant formula and the grant should be labeled mixtures: a) the energy content expressed in kilojoules (kJ) and kilocalories (kcal), as well as the content of protein, carbohydrate and fat, expressed in numbers per 100 ml fresh for the product.

b) the average content of each mineral and vitamin specified in Appendix 1, respectively, and Appendix 2, as well as, where appropriate, the content of choline, inositol and karnitin, expressed in numbers per 100 ml fresh for the product.

c) Selection will contain a guidance on preparation and storage of breast milk substitute and grant mixtures, as well as what the consumer will do with any residue of the products. The marking should contain a warning against hazardous consequences of improper food preparation and storage.

§ 12. Declaration of the nutrient-voluntary additional declaration, infant formula and the grant can be marked in addition blends with the average content of the nutrients that are specified in annex 3, expressed in numbers per 100 ml fresh for the product, if the Declaration is not covered by the provisions of section 11, letter b. Grant mixtures can, in addition to a numeric specification, also be selected with the content of the vitamins and minerals specified in annex 7. The values shall be expressed as a percentage of the reference values set in the annex per 100 ml fresh for the product.

section 13. Design and content in the selection the selection of infant formula and the grant shall be made to the mixes, it provides the necessary information about the correct use of the products and not against breast feeding work.
It is not allowed to use expressions like "humanisert", "mother's custom," "specially adapted for" or similar.
Infant formula and the grant to be marked so that the cereals it is easy for the consumer to see the difference in these two product groups in order to avoid the risk of confusion between infant formula and grant mixtures.

section 14. Special provisions for infant formula the following information will be included in the selection marked as "important information" or equivalent: (a) information about the ammingens unmatched value (b) a request that the product be used only on the recommendation of the independent health care professionals who have knowledge in medicine, nutrition or pharmacy, or who have a professional responsibility for infant nutrition.

The marking should contain information that the product is suitable for infants from birth when the child is not being breastfed.
The selection shall not include pictures of infants. It should also not contain other pictures or text which may idealize the use of the product. However, it is allowed to use graphical illustrations to identify the product and to view the tilberedelses methods.
The selection of infant formula can contain nutrition and health claims, but only in the cases and under the conditions mentioned in Appendix 4.

section 15. Special provisions for the grant should provide information mixtures the selection of that product;

1. only suitable to the nutrition of infants from six months 2.
just have to be used as part of a more diverse cost 3.
cannot be used as a substitute for breast milk or infant formula in the infant's first six months living 4.
information about that if the parent would like to introduce solid food before the child is six months old, they should consult with independent health care professionals who have knowledge in medicine, nutrition or pharmacy, or who have a professional responsibility for infant nutrition. The advice given, should be based on the infant's individual needs.

Chapter IV. Presentation, marketing and advertising section 16. Presentation the provisions of section 13 and section 14 also apply to the presentation, marketing and advertising for infant formula and grant mixtures. With the presentation refer especially to the form, appearance, wrapping and packaging, as well as the way the næringsmiddelet is placed on and the surroundings it be presented in.

§ 17. Advertising advertising for infant formula and the grant should be restricted to mixtures scientific publications and only contain information of scientific and actual character.
The provisions of section 13, section 14 and section 16 also apply to advertising for infant formula and grant mixtures.
The information must not give the impression that the infant formula and is equal with the grant, mixtures or better than breastfeeding.

§ 18. The ban on marketing in the retail sector it is not allowed to promote infant formula and grant mixtures at the outlet, hand out samples or other promotional methods such as exhibitions, discount coupons, prizes, promotions, rewarding and lure loss offer offers to affect the sale to the consumer.

§ 19. The ban on the distribution of samples and more manufacturers and retailers of infant formula and the grant may not share mixes out free products, offer prisnedsatte products, provide samples or other promotional gifts to the general public or to pregnant women, mothers or their families, either directly or indirectly through the public health sector.

section 20. Limitations in the supply of infant formula with the partially hydrolyzed protein infant formula that meets the requirements in annex 4 pt 2.1, allowed only traded through pharmacies. It is to be given guidance on the use of the product.

Chapter v. information and educational materials to section 21. Information and educational materials-General provisions information about infant formula and the grant aimed at cereals sped and small children's parents and others with responsibility for sped and small children's nutrition should be relevant, objective and unambiguous.
It will be in the information and educational material not used images or text that idealize the use of infant formula and grant mixtures.
The provisions of section 21-section 23 applies both to written materials and audio-visual materials.

§ 22. Information and educational materials to the consumer information and educational material that deals with food for infants, and that is made for pregnant women and mothers, should contain clear information about the following points;

1. ammingens unobtainable value 2.
mother's nutritional situation, how the mother best preparing to breastfeed, as well as helpful advice about how the mother can make it easier to maintain breastfeeding 3.
the possible negative effects an introduction of bottle feeding can inflict breastfeeding 4.
the difficulties of taking up again breastfeeding 5.
when needed-the proper use of infant formula.

When such materials contain information about the use of infant formula and the grant, it also blends should be given information about;

1. the social and financial consequences of the use of these products involves 2.
health danger of improper use of the products, including the preparation, use and matemetoder.

§ 23. Requirements for the manufacturer and importer information materials, equipment, and material intended to be used in teaching, prepared by the manufacturer or distributor, should only be handed out on request.
Such materials or equipment can contain name and logo's, but it should not be referred to a special infant formula or the grant mixture. Such materials should only be distributed through the public health system.

section 24. Gifts and offers to institutions and organizations gifts and deals on infant formula to institutions and organizations, regardless of whether they are intended to be used on the institutions or distributed, should only be given to the infant that must ernæres with infant formula, and only as long as it is necessary for these babies.

Chapter VII. Administrative provisions § 25. Report for the sake of an effective monitoring of the market to be infant formula and the grant be reported to FDA cereals when they are traded or marketed on the Norwegian market. The message is done by the producer/importer sends the following information: a) the name and address of the manufacturer and the importer, if any, b) a copy of the næringsmidlets labeling and any marketing materials and c) information about the næringsmidlets composition to the extent not emerges from the information under letter b).

Norwegian food safety authority may request additional information and documentation.

§ 26. Transitional arrangements it's from 31. December 2009 prohibited selling products that are not in accordance with this regulation.

§ 27. Entry into force these regulations shall enter into force immediately. At the same time repealed regulations 11. October 2001 No. 1163 on infant formula and grant mixtures.

Appendix 1. Requirements for the composition of infant formula after preparation according to manufacturer's instructions the stated values apply to products that are ready for use. 
1. Energy Minimum Maximum 250 kJ/100 ml 100 ml 295/kJ (60 kcal/100 ml) (70 kcal/100 ml) 2. Proteins Protein content = nitrogen content x 6.25. 
2.1. Infant formula manufactured on the basis of cow's milk or goat's milk proteins Minimum1 Maximum 0.45 g/100 kJ 0.7 g/100 kJ (1.8 g/100 kcal) (3 g/100 kcal) the product shall contain an available quantity of each essential and conditionally essential amino acid that is at least equal to the contents of the reference protein (breast milk, as defined in Appendix 5), calculated per unit of energy. When calculating the contents of methionine and cysteine can be added if the methionine: cysteine-ratioen is not greater than two. The concentration of phenylalanine and tyrosine may be added if the tyrosine: phenylalanine-ratioen is not greater than two.

Methionine: cysteine-ratioen can be greater than two but not more than three, provided that the product is suitable and adapted infant special nutritional needs. The suitability must be able to be documented through formålstjenelige studies based on generally accepted scientific design and implementation. 
2.2. Infant formula manufactured on the basis of partial hydrolysates of proteins Minimum1 Maximum 0.45 g/100 kJ 0.7 g/100 kJ (1.8 g/100 kcal) (3 g/100 kcal) the product shall contain an available quantity of each essential and conditionally essential amino acid that is at least equal to the contents of the reference protein (breast milk, as defined in Appendix 5), calculated per unit of energy. When calculating the contents of methionine and cysteine can be added if the methionine: cysteine-ratioen is not greater than two. The concentration of phenylalanine and tyrosine may be added if the tyrosine: phenylalanine-ratioen is not greater than two.
Methionine: cysteine-ratioen can be greater than two but not more than three, provided that the product is suitable and adapted infant special nutritional needs. The suitability must be able to be documented through formålstjenelige studies based on generally accepted scientific design and implementation.
The contents of the L-karnitin should be at least 0.3 mg/100 kJ (1.2 mg/100 kcal). 
2.3. Infant formula manufactured on the basis of soy protein isolates, alone or in mixture with cow's milk or goat's milk proteins Minimum Maximum 0.56 g/100 kJ 0.7 g/100 kJ (2.25 g/100 kcal) (3 g/100 kcal) only protein isolates from soya may be used.
The product should contain an available quantity of each essential and conditionally essential amino acid that is at least equal to the contents of the reference protein (breast milk, as defined in Appendix 5), calculated per unit of energy. When calculating the contents of methionine and cysteine can be added if the methionine: cysteine-ratioen is not greater than two. The concentration of phenylalanine and tyrosine may be added if the tyrosine: phenylalanine-ratioen is not greater than two.
Methionine: cysteine-ratioen can be greater than two but not more than three, provided that the product is suitable and adapted infant special nutritional needs. The suitability must be able to be documented through formålstjenelige studies based on generally accepted scientific design and implementation.
The contents of the L-karnitin should be at least 0.3 mg/100 kJ (1.2 mg/100 kcal). 
2.4. The addition of amino acids the addition of amino acids is permitted only for the purpose of improving the nutritional value proteinenes, and only in the amounts that are required for this purpose. 
2.5. Taurine If taurine added infant formula, the amount of taurine shall not exceed 2.9 mg/100 kJ (12 mg/100 kcal). 
2.6. Choline Minimum Maximum 1.7 mg/100 kJ 12 mg/100 kJ (7 mg/100 kcal) (50 mg/100 kcal) 3. Fat Minimum Maximum 1.05 g/100 kJ 1.4 g/100 kJ (4.4 g/100 kcal) (6.0 g/100 kcal) 3.1. It is prohibited to use the following ingredients:-sesamfrøolje-cotton seed oil. 

3.2. Lauric acid and myristinsyre Minimum Maximum-Separately or together: 20% of the total fat content 3.3. Trans fats Content of trans fats should not exceed 3% of the total fat content. 
3.4. The content of erucic acid, erucic acid shall not exceed 1% of the total fat content. 
3.5. Linoleic acid (in the form of glycerides = linoleater) Minimum Maximum 70 mg/100 kJ 285 mg/100 kJ (300 mg/100 kcal) (1200 mg/100 kcal) 3.6. Linoleic (alpha-linolenic) Content of Alpha-linoleic shall not be less than 12 mg/100 kJ (50 mg/100 kcal).
The ratio of linoleic acid/alpha-linolenic should be a minimum of 5 and a maximum of 15. 
3.7. Long-chain polyunsaturated fatty acids, polyunsaturated fatty acids with long carbon chains (20 and 22 carbon atoms) can be added. If these kinds of fatty acids are added to the content does not exceed;

-1% of the total fat content when it comes to long-chain n-3 fatty acids-2% of the total fat content when it comes to long-chain n-6 fatty acids (1% of the total fat content in the case of arachidonic acid (20:4 n-6)).

The content of Eicosapentaenoic Acid (20:5 n-3) shall not exceed the content of Docosahexaenoic acid (22:6 n-3).
The contents of Docosahexaenoic acid (22:6 n-3) shall not exceed the content of long-chain n-6 fatty acids. 
4. Phospholipids content of phospholipids in infant formula should not be greater than 2 g/L. 
5. Minimum 1 mg Inositol Maximum/100 kJ 10 mg/100 kJ (5 mg/100 kcal) (40 mg/100 kcal) 6. Carbohydrates Minimum Maximum 2.2 g/100 kJ 3.4 g/100 kJ (7 g/100 kcal) (14 g/100 kcal) 6.1. Only the following carbohydrates may be used:-lactose,-maltose-sucrose-glucose-maltodekstriner-glukosesirup or dried glukosesirup-prekokt starch naturally free of gluten-gelatinisert starch naturally free of gluten. 

6.2. Lactose Minimum Maximum 1.1 g/100 kJ-(4.5 g/100 kcal) this provision does not apply to infant formula how soy proteins make up more than 50% of the total protein content. 
6.3. Sucrose Sucrose may only be added to infant formula based on partial hydrolysates of proteins. If sucrose is added to the content does not exceed 20% of the total carbohydrate content. 
6.4. Glucose Glucose may only be added to infant formula based on partial hydrolysates of proteins. If glucose is added to the content does not exceed 0.5 g/100 kJ (2 g/100 kcal). 
6.5. Prekokt starch and/or gelatinisert starch Minimum Maximum-2 g/100 ml, and a maximum of 30% of the total carbohydrate content 7. Fruktooligosakkarider and galaktooligosakkarider Fruktooligosakkarider and galaktooligosakkarider can be added to infant formula. The content shall not exceed 0.8 g/100 ml in a combination of 90% oligogalactosyllaktose and 10% oligofruktosylsakkarose with high molecular weight.
Other combinations and maximum levels of fruktooligosakkarider and galaktooligosakkarider can be used in accordance with § 5 the second paragraph. 
8. Minerals 8.1. Infant formula based on cow's milk or goat's milk proteins and partially hydrolyzed protein per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum sodium (mg) 5 14 20 60 potassium (mg) 15 38 60 160 Chlorine (mg) Calcium (mg) 12 38 50 160 * 12 33 50 140 phosphorus (mg) 6 22 25 90 * Magnesium (mg) 1.2 3.6 5 15 iron (mg) 0.3 1.3 0.3 0.07 zinc (mg) 0.12 0.36 0.5 1.5 copper (μg) 25 35 100 8.4 iodine (μg) 2.5 12 10 50

Selenium (μg) 0.25 2.2 1 9 Manganese (μg) 0.25 25 1 100 Fluoride (μg)-25-100 5.1. Infant formula manufactured on the basis of soy protein isolates, alone or in mixture with cow's milk or goat's milk proteins All requirements in section 8.1. comes apart from the requirements of the content of iron and phosphorus, which are these: per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum iron (mg) 0.12 0.45 0.5 2 phosphorus (mg) 25 30 100 9 7.5. Vitamins per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (μg-RE) 1 14 43 60 180 Vitamin D (μg) 0.25 0.65 1 2.5 2 Thiamine (μg) 14 72 60 300 Riboflavin (μg) 19 95 80 400 Niacin (μg) 3 72 375 300 1500 Pantothenic acid (μg) 95 475 400 2000 Vitamin B6 (μg) 9 42 35 175 Biotin (μg) 0.4 1.8 1.5 7.5 folic acid (μg) 2.5 12 10 50 Vitamin B12 (μg) 0.025 0.12 Vitamin C (0.5 0.1 mg) Vitamin K 2.5 10 30 7.5 (μg) 1 6 4 25 Vitamin E (mg Alpha-TEA) 4 0.5/g of polyunsaturated fatty acids expressed as linoleic acid, corrected for the content of the standard bindings, 5 but no matter not less than 0.1 mg per 100 available kJ 1.2 0.5/g of polyunsaturated fatty acids expressed as linoleic acid, corrected for the content of the standard bindings, 5 but no matter no less than 0.5 mg per 100 available kJ 5 10. Nucleotides the following nucleotides may added: Maksimum1 mg/100 kJ mg/100 kcal Cytidin 5 '-monophosphate 0.60 2.50 Uridin 5 '-monophosphate 0.42 1.75 Adenosine 5 '-monophosphate 0.36 1.50 Guanosin 5 '-monophosphate 0.12 0.50 Inosin 5 '-monophosphate 0.24 1.00 Attachment 2. Requirements for the composition of the mixtures in the grant for the preparation according to manufacturer's instructions the stated values apply to products that are ready for use. 
1. Energy Minimum Maximum 250 kJ/100 ml 100 ml 295/kJ (60 kcal/100 ml) (70 kcal/100 ml) 2. Proteins Protein content = nitrogen content x 6.25. 
2.1. The grant mix based on cow's milk or goat's milk proteins Minimum Maximum 0.45 g/100 kJ 0.8 g/100 kJ (1.8 g/100 kcal) (3.5 g/100 kcal) the product shall contain an available quantity of each essential and conditionally essential amino acid that is at least equal to the contents of the reference protein (breast milk, as defined in Appendix 5), calculated per unit of energy. When calculating the contents of methionine and cysteine can be added if the methionine: cysteine-ratioen is not greater than three. The concentration of phenylalanine and tyrosine may be added if the tyrosine: phenylalanine-ratioen is not greater than two. 
2.2. The grant based on the partially hydrolyzed blend protein Minimum Maximum 0.45 g/100 kJ 0.8 g/100 kJ (1.8 g/100 kcal) (3.5 g/100 kcal) the product shall contain an available quantity of each essential and conditionally essential amino acid that is at least equal to the contents of the reference protein (breast milk, as defined in Appendix 5), calculated per unit of energy. When calculating the contents of methionine and cysteine can be added if the methionine: cysteine-ratioen is not greater than three. The concentration of phenylalanine and tyrosine may be added if the tyrosine: phenylalanine-ratioen is not greater than two. 
2.3. The grant mixtures based on soy protein isolates, alone or in mixture with cow's milk or goat's milk proteins Minimum Maximum 0.56 g/100 kJ 0.8 g/100 kJ (2.25 g/100 kcal) (3.5 g/100 kcal) only protein isolates from soya may be used at the production of these grant blends.

The product should contain an available quantity of each essential and conditionally essential amino acid that is at least equal to the contents of the reference protein (breast milk, as defined in Appendix 5), calculated per unit of energy. When calculating the contents of methionine and cysteine can be added if the methionine: cysteine-ratioen is not greater than three. The concentration of phenylalanine and tyrosine may be added if the tyrosine: phenylalanine-ratioen is not greater than two. 
2.4. The addition of amino acids the addition of amino acids is permitted only for the purpose of improving the nutritional value proteinenes, and only in the amounts that are required for this purpose. 
2.5. Taurine If taurine is added to the grant the amount of cereals, taurine not exceed 2.9 mg/100 kJ (12 mg/100 kcal). 
3. Fat Minimum Maximum 0.96 g/100 kJ 1.4 g/100 kJ (4.0 g/100 kcal) (6.0 g/100 kcal) 3.1. It is prohibited to use the following substances:-sesamfrøolje-cotton seed oil. 

3.2. Lauric acid and myristinsyre Minimum Maximum-Separately or together: 20% of the total fat content 3.3. Trans fats Content of trans fats should not exceed 3% of the total fat content. 
3.4. The content of erucic acid, erucic acid shall not exceed 1% of the total fat content. 
3.5. Linoleic acid (in the form of glycerides = linoleater) Minimum Maximum 70 mg/100 kJ 285 mg/100 kJ (300 mg/100 kcal) (1200 mg/100 kcal) 3.6. Linoleic (alpha-linolenic) Content of Alpha-linoleic shall not be less than 12 mg/100 kJ (50 mg/100 kcal).
The ratio of linoleic acid/alpha-linolenic should be a minimum of 5 and a maximum of 15. 
3.7. Long-chain polyunsaturated fatty acids, polyunsaturated fatty acids with long carbon chains (20 and 22 carbon atoms) can be added. If these kinds of fatty acids are added to the content does not exceed;

-1% of the total fat content when it comes to long-chain n-3 fatty acids-2% of the total fat content when it comes to long-chain n-6 fettsyerer (1% of the total fat content in the case of arachidonic acid (20:4 n-6)).

The content of Eicosapentaenoic Acid (20:5 n-3) shall not exceed the content of Docosahexaenoic acid (22:6 n-3).
The contents of Docosahexaenoic acid (22:6 n-3) shall not exceed the content of long-chain n-6 fatty acids. 
4. Phospholipids content of phospholipids in the grant mixtures shall not be greater than 2 g/L. 
5. Carbohydrates Minimum Maximum 2.2 g/100 kJ 3.4 g/100 kJ (7 g/100 kcal) (14 g/100 kcal) It is prohibited to use ingredients that contain gluten. 
5.1. Lactose Minimum Maximum 1.1 g/100 kJ-(4.5 g/100 kcal) this provision does not apply to the grant mixtures where soy protein isolates make up more than 50% of the total protein content. 
5.2. Sucrose, fructose, honey Minimum maximum (alone or combined)-20% of the total carbohydrate content by use of honey, this is treated so any spores of Clostridium botulinum are destroyed. 
5.3. Glucose Glucose may only be added to the grant mix based on partial hydrolysates of proteins. If glucose is added to the content does not exceed 0.5 g/100 kJ (2 g/100 kcal). 
6. Fruktooligosakkarider and galaktooligosakkarider Fruktooligosakkarider and galaktooligosakkarider can be added to the grant mixture. The content shall not exceed 0.8 g/100 ml in a combination of 90% oligogalactosyllaktose and 10% oligofruktosylsakkarose of high molecular weight.
Other combinations and maximum levels of fruktooligosakkarider and galaktooligosakkarider can be used in accordance with section 6. 
7. Minerals 7.1. The grant mixtures based on cow's milk or goat's milk proteins or hydrolyzed protein per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum sodium (mg) 5 14 20 60 potassium (mg) 15 38 60 160 Chlorine (mg) Calcium (mg) 12 38 50 160 * 12 33 50 140 phosphorus (mg) 6 22 25 90 * Magnesium (mg) 1.2 3.6 5 15 iron (mg) 0.6 0.5 0.14 2 zinc (mg) 0.12 0.36 0.5 1.5 copper (μg) 25 35 100 8.4 iodine (μg) Selenium (2.5 12 10 50 0.25 μg) 2.2 1 9 Manganese (μg) 0.25 25 1 100 Fluoride (μg)-25-100 7.2. The grant mix produced on the basis of soy protein isolates, alone or in mixture with cow's milk or goat's milk proteins All requirements in section 7.1. comes apart from the requirements of the content of iron and phosphorus, which are these: per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum iron (mg) 0.65 2.5 0.22 0.9 phosphorus (mg) 7.5 25 30 100 8. Vitamins per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (μg-RE) 1 14 43 60 180 Vitamin D (μg) 0.25 0.75 1 3 2 Thiamine (μg) 14 72 60 300 Riboflavin (μg) 19 95 80 400 Niacin (μg) 3 72 375 300 1500 Pantothenic acid (μg) 95 475 400 2000 Vitamin B6 (μg) 9 42 35 175 Biotin (μg) 0.4 1.8 1.5 7.5 folic acid (μg) 2.5 12 10 50 Vitamin B12 (μg) 0.025 0.12 Vitamin C (0.5 0.1 mg) Vitamin K 2.5 10 30 7.5 (μg) 1 6 4 25 Vitamin E (mg Alpha-TEA) 4 0.5/g of polyunsaturated fatty acids expressed as linoleic acid, corrected for the content of the standard bindings, 5 but no matter not less than 0.1 mg/100 kJ available 1.2 0.5/g of polyunsaturated fatty acids expressed as linoleic acid, corrected for the content of the standard bindings, 5 but no matter no less than 0.5 mg/100 kJ 5 9 available. Nucleotides the following nucleotides may added: Maksimum1 mg/100 kJ mg/100 kcal Cytidin 5 '-monophosphate 0.60 2.50 Uridin 5 '-monophosphate 0.42 1.75 Adenosine 5 '-monophosphate 0.36 1.50 Guanosin 5 '-monophosphate 0.12 0.50 Inosin 5 '-monophosphate 0.24 1.00 Appendix 3. Nutrients 1. Vitamins Vitamin A Vitamin Vitamin connection Retinylacetat Retinylpalmitat Retinol Vitamin D Vitamin D ₂ (ergokalsiferol) Vitamin D ₃ (kolekalsiferol) Thiamine (vitamin B ₁) Tiaminhydroklorid Tiaminmononitrat Riboflavin (vitamin B ₂) Riboflavin Riboflavin-5 '-phosphate, sodium Niacin Nicotinamide Nicotinic Acid Vitamin B6 Pyridoksinhydroklorid Pyridoksal-5 '-phosphate Folate folic acid Pantothenic acid D-pantotenat calcium-Sodium-D-pantotenat Dexpantenol Vitamin B12-Cyanokobalamin Biotin D Hydroksykobalamin biotin Vitamin C L-Ascorbic acid Sodium L-ascorbate-calcium-L-ascorbate 6-palmityl-L-Ascorbic acid (askorbylpalmitat) Kaliumaskorbat Vitamin E D-alpha-tocopherol DL-alpha tocopherol-D-Alpha-tokoferylacetat DL-Alpha-tokoferylacetat Vitamin K Fyllokinon (Fytomenadion) 2. Minerals Minerals Permitted salts calcium (Ca) calcium carbonate Calcium chloride Kalsiumsitrater Kalsiumglukonat Kalsiumglyserofosfat Kalsiumlaktat Kalsiums shrine of ortofosforsyre calcium hydroxide Magnesium (Mg) magnesium carbonate Magnesium chloride Magnesium oxide Magnesium salts of Magnesium sulphate Magnesiumhydroksid ortofosforsyre Magnesiumglukonat Magnesiumsitrater iron (Fe) ferrous sulphate Jernsitrat Jernlaktat Jernammoniumsitrat Jernglukonat Jernfumarat Jerndifosfat (jernpyrofosfat) Jernglycinat copper (Cu) Kobbersitrat Kobberglukonat copper sulphate Copper-lysine complex Kobberkarbonat Iodine (I) potassium iodide Natriumjodid Kaliumjodat zinc (Zn) Zinc Sinkacetat chloride Sinklaktat Zinc sulphate Sinksitrat Sinkglukonat zinc oxide Manganese (Mn) Mangankarbonat Manganklorid Mangansitrat Mangansulfat Manganglukonat sodium (Na) sodium bicarbonate sodium chloride sodium citrate Natriumglukonat
Sodium carbonate Natriumlaktat Natriums shrine of ortofosforsyre sodium hydroxide potassium (K) Kaliumbikarbonat Kaliumkarbonat Kaliumklorid Kaliumsitrater Kaliumglukonat Kaliumlaktat Kaliums shrine of ortofosforsyre potassium hydroxide Selenium Natriums the nat Natriumselenitt 3. Amino acids and other nitrogen compounds L-arginine and its hydroklorid1 L-cysteine and its hydrochloride L-Histidine and its hydrochloride L-isoleucine and its hydrochloride L-Moldovan and its hydrochloride L-lysine and its hydrochloride L-cysteine and its hydrochloride L-methionine L-phenylalanine L-treonin L-tryptophan L-tyrosine L-valine and L-karnitin its hydroklorider L-karnitin-L-Taurine tartrat Cytidin 5 '-monophosphate and its sodium salt Uridin 5 '-monophosphate and its sodium salt Adenosine 5 '-monophosphate and its sodium salt Guanosin 5 '-monophosphate and its sodium salt Inosin 5 '-monophosphate and its sodium salt.
  4. Other substances Choline Kolinsitrat Inositol Kolinklorid Kolinbitatrat.

Appendix 4. Allowable nutritional and wellness claims on formula milk-composition requirements 1. Nutrition claims Claim related to the Subject of the claim 1.1 lactose Only Lactose is the only karbohydratet that are present.

1.2 the content of lactose lactose free is not greater than 2.5 mg/100 kJ (10 mg/100 kcal).

1.3 Added long-chain polyunsaturated fatty acids or a similar claim related to Docosahexaenoic acid docosahexaenoic acid added to the contents of the must be a minimum of 0.2% of the total fatty acid content.

1.4 Claims relating to the use of the following optional ingredients: 1.4.1 taurine 1.4.2 and 1.4.3 fruktooligosakkarider galaktooligosakkarider nucleotides Added, on a voluntary basis, in amounts that will be appropriate for products intended for infants, and that is in accordance with the requirements given in annex 1.

  2. Health claims (including claims of reduced risk of disease) Claim related to the Subject of the claim 2.1 reduced risk of allergy to milk proteins. The claim may include referrals to reduced allergenic or no antigenic experiences occurring properties.
a) it should be objective and scientifically verified evidence on the alleged properties.
b) mother's milk replacement to meet the requirements of annex 1 section 2.2, and the amount of immunoreaktivt protein, measured with the generally recognized methods shall constitute less than 1% of the total amount of nitrogenous substances.

c) the marking shall clearly disclose that mother's milk the replacement does not have to be taken of infants who are allergic to the intact proteins it is made of, with less widely acclaimed clinical research documenting that mother's milk replacement is tolerated by more than 90% of infants (confidence interval 95%) that are overfølsomme to the proteins that hydrolysatet is portrayed by.
d) mother's milk replacement, when it should be taken orally, not evoke sensitization in animals to the intact proteins that breast milk substitute is portrayed by.

Appendix 5. Essential and conditional essential amino acids in breast milk for use in these regulations are reference values for the content of essential and conditional essential amino acids in breast milk, expressed in mg per 100 kJ and 100 mg per kcal, the following: per 100 kcal per 100 kJ1 Cysteine Histidine Isoleucine 22 90 9 38 10 40 40 166 27 113 Moldovan Lysine Methionine Phenylalanine Treonin 5 23 20 83 18 77 Tryptophan Tyrosine Valine 8 32 21 88 18 76 Attachment 6. Specification for the protein content, the protein source and processing of protein used in the manufacture of infant formula and grant mixtures with a protein content under 0.56 g/100 kJ (2.25 g/100 kcal) based on myseproteinhydrolysat from the cow's milk protein 1. Protein content Protein content = nitrogen content x 6.25. 

Minimum Maximum 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 of based on cow's milk, processed by enzymatic precipitation of kaseiner where it is used, consisting of chymosin: (a) 63% kaseinglykomakropeptid-free myseproteinisolat with a protein content of minimum 95% solids, proteindenaturering of less than 70% and a maximum ash content of 3% and (b) 37% sweet myseporoteinkonsentrat with a minimum protein content of 87% solids, proteindenatuering of less than 70% and a maximum ash content of 3.5%. 

3. Protein processing Hydrolysis in two steps by the use of trypsinpreparat with a heat treatment step (from 3 to 10 minutes at 80 to 100 ° C) between the two hydrolysetrinnene. 
4. Protein quality reference values for essential and conditional essential amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following: Per 100 k/J1 Per 100 kcal Arginine 16 69 6 24 Histidine 11 45 Isoleucine Cysteine 17 72 37 156 Lysine 29 122 Methionine Moldovan 7 29 Phenylalanine 15 62 19 80 Tryptophan 7 30 Tyrosine Treonin 14 59 Valine 19 80 Attachment 7. Reference values for nutrient Declaration to products marketed to infants and young children nutrient reference value for declaration, Vitamin A (μg) 400 Vitamin D (μg) 7 Vitamin E (mg TE) 5 Vitamin K (μg) 12 Vitamin C (mg) 45 Thiamine (mg) Riboflavin (mg) 0.5 0.7 Niacin (mg) 7 Vitamin B6 (mg) folic acid 0.7 (μg) 125 Vitamin B12 (μg) 0.8 Pantothenic acid (mg) 3 Biotin (μg) 10 calcium (mg) Phosphorus (mg) 550 550 potassium (mg) Sodium (mg) 1000 400 Chlorine (mg) 500 Iron (mg) zinc (8 5 mg) iodine (μg) Selenium (μg) 80 20 copper (mg) Magnesium (mg) 0.5 80 Manganese (mg) 1.2 Attachment 8. Pesticides which shall not be used in agricultural products for use in the manufacture of infant formula and grant mixtures table 1 Chemical name of the substance (residue definition) Disulfoton (sum of disulfoton, disulfotonsulfoksid and disulfotonsulfon, expressed as disulfoton) Fensulfotion (sum of fensulfotion, its oxygen analogue and their sulfoner, expressed as fensulfotion) Fentin, expressed as trifenyltinkation Haloksyfop (by haloksyfop, its salts and esters, including konjungater, expressed as haloksyfop) Heptaklor and trans-heptaklorepoxid , expressed by heptaklor Hexachlorobenzene Nitrofen Ometoat Terbufos (sum of terbufos, its sulfoxid and sulfon, expressed as terbufos) table 2 Chemical name of the substance Aldrin and dieldrin, expressed as dieldrin Endrin Attachment 9. Special maximum limits for residues of pesticides or metabolites in breast milk substitute and grant mixtures Chemical name of substance Maximum restnivå (mg/kg) Cadusafos 0.006 Demeton-S-methyl/demeton-S-methyl-Sulfon/oksydemeton (individually or combined, expressed as demeton-S-methyl) Etoprofos 0.006 0.008 Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) 0.004 Propineb/propylentiourea (sum of propineb and propylentiourea) 0.006