The regulation on foodstuffs for special medical purposes Date-2001-11-08-1279 Ministry Ministry of health and human services published in 2001 booklet 14 (attachment) entry into force 08.11.2001 Last changed-2008-08-13-937 Change applies to Norway Pursuant law-2003-12-19-124-§ 9, law-2003-12-19-124-section 10, law-2003-12-19-124-section 33, law-2003-12-19-124-section 36, FOR-2003-12-19-1790 Announced 20.11.2001 Directed 11.01.2002 (Appendix 2 table 2 Niacin) short title regulations on medical foods Chapter overview: chapter I. Scope and definitions (sections 1-4) chapter II. Composition (§ § 5-8) chapter III. Tagging and turnover (§ § 9-17) chapter IV. Administrative provisions (§ § 18-23) Appendix 1. Content of vitamins and minerals in foods for special medical purposes that are specific to the infant Attachment 2. Content of vitamins and minerals in foods for special medical purposes that are specific to children from 1 year and adults: the legal authority established by the Ministry of health and social (now health and Human Services Department) 8. November 2001 under the legal authority of the law of 19. December 2003 No. 124 on food production and food safety, etc. (matloven) the first paragraph of section 9, section 10 the second paragraph, section 33 the first paragraph, cf.. section 36 the second paragraph, cf.. the delegation decision of 19. December 2003 No. 1790. the EEA Joint referrals: the EEA Agreement-annex II, chap. XII (Directive 1999/21/EC, Directive 96/84/EC, Nr. 54w (Directive 2006/141/EC)).
Changes: modified by regulations 15 jan 2004 Nr. 270 (including title), 13 Aug. 2008 Nr. 937. Chapter I. Scope and definitions section 1. Scope this regulation provides provisions on the composition, labelling and marketing of food products that are specific to the use of special medical needs.
The provisions of this Regulation apply in addition to the provisions in the regulation of 21. December 1993 No. 1382 of foodstuffs for use on special nutritional needs and replace these in the cases where the provisions of this regulation is more complete.

§ 2. Purpose the purpose of these regulations is to ensure that foods that are intended for people with a need for special customized cost because of a specific disease, functional disorder or other medical condition have an appropriate composition and labelling as well as that they are traded via suitable sales channels.

§ 3. Definitions in this regulation be understood by 1.

infants: children under 12 months.

2. food for special medical purposes: a category foodstuffs for special nutritional needs, described in section 4, which is especially produced or composed with a view to be included in the kostbehandling of patients and to be used under medical supervision. The compostion is specific to pose only or complementary food source for patients as a) has limited, impaired or disturbed capacity to ingest, Digest, absorb, conversion or excrete ordinary foodstuffs, either single nutrients or certain metabolism products, or b) have other medical dietary needs not diagnosed as can be covered by the change of the patient's normal diet, by other foods for special nutritional needs , or by a combination of these.

§ 4. Categories of foods for special medical purposes Foodstuffs for special medical purposes are grouped into the following three categories: 1. Nutritionally complete foods with a standard nutrient composition, which, when used in accordance with the manufacturer's instructions, may constitute the only food source for the people they are intended for.

2. Nutritional complete foods with a nutrient composition that is tailored to the needs of a specific disease, functional disorder or other medical condition, which, when used in accordance with the manufacturer's instructions, may constitute the only food source for the people they are intended for.

3. Nutritional set not complete food products, either with a standard composition or with a composition that is tailored to the needs of a specific disease, functional disorder or other medical condition, which is not suitable to be the only food source.

Food described in section 1 and 2 can also be used to replace parts of the patient's dietary or as supplements to the diet.

Chapter II. The composition section 5. In General, the composition of the foodstuffs for special medical purposes shall be based on recognized medical and nutritional principles.
Used in accordance with the manufacturer's instructions to be safe and appropriate food and effectively meet the special nutritional needs of the people they are intended for. This should be able to be documented by reference to generally accepted scientific data.

section 6. Content of nutrients in products destined to the infant Foods for special medical purposes that are specific to infants to meet the requirements of the content of vitamins and minerals that are set out in annex 1.
Food should meet the requirements of other nutrients that are set out in the current regulations on infant formula and the grant for infants and young children, apart from the discrepancies, if any, are necessary in the interests of the product's purpose.
Requirements in regulation 13. August 2008 No. 936 about infant formula and grant mixtures section 5 first, third and fourth paragraph and section 6 the first paragraph applies from 1. January 2012.

section 7. Content of vitamins and minerals in specific products to children from 1 year and adults Foodstuffs for special medical purposes that are specific to children from 1 year and adults to meet the requirements of the content of vitamins and minerals that are set out in Appendix 2.

section 8. Deviations from the mix requirements-temporary permission to turnover Food Authority can give a temporary permission for the sales of products that do not meet the requirements of the composition set out in section 6 and section 7 if the European Commission in accordance with Directive 89/398/EEC art. 4 PT 1a (cf. Directive 96/84/EC art. 1) has given such a temporary permission.
If necessary it can be associated with special requirements about the marking of the changed composition of the permit.

Chapter III. Tagging and revenue section 9. General selection requirements Foodstuffs for special medical purposes shall be marked according to the current regulations on the labelling of foodstuffs. 1 § 10. Item designation Item designation for the products defined in § 3 No. 2 to be "Food for special medical purposes".

section 11. Declaration of nutritional Foods for special medical purposes should be tagged with: 1. Energy content expressed in kilojoules (kJ) and kilocalories (kcal) and the content of protein, carbohydrate and fat.

2. The average amount of the minerals and vitamins that emerges from the attachments 1 and 2 if they are found in the product.

3. If the information is necessary for the correct use of the product, the content of the various constituents of protein, carbohydrate and/or fat as well as, where appropriate, the contents of other nutrients and their constituents.

Information in accordance with the first paragraph shall be entered in the number per 100 g or per 100 ml of the product as it frambys and, when appropriate, per 100 g or per 100 ml of the ready product, prepared according to the manufacturer's instructions.
Information in accordance with the first paragraph can also be set a) per serving, according to the amount of the designation on the label, or b) per serving, provided that the number of servings in the package.

§ 12. Special information about the species of origin of the selection/protein should include information on the origin of and the nature of the proteins and/or the proteinhydrolysater product contains.

section 13. Osmolalitet/when it is appropriate to include information about the product's labeling osmolalitet or tearlab osmolarity test cards.

section 14. Information about the application as well as contraindications the marking should contain the following information: 1. "to the kostbehandling of ..." where the open field to be filled in with the diseases, functional disorders or medical conditions the product is intended for, 2. a description of the properties and/or characteristics that make the product suitable as well as the basis for the product to be used. Especially to changes in content of nutrients is indicated if the content is increased or decreased, nutrients are removed or changed in other ways, 3.
If necessary, information about the relevant precautions and contraindications and 4.
If the necessary information about that product does not have to be given parenteralt.

section 15. Information emphasizes that "important" in the selection the following information will be included in the selection marked as "important information" or equivalent: 1. Information about the product to be used under medical supervision, 2. information on whether the product is suitable for use as the sole food source, 3. if applicable, information about the product is intended for a specific age group and 4.
If necessary, information about the product can pose a health hazard if consumed by people who do not suffer from the diseases, functional disorders, or other medical conditions the product is intended for.

section 16. Information about food preparation and storage Selection shall give instructions for the correct preparation and use of the product as well as about the storage of the product after the seal is opened if necessary.

§ 17. Constraints in revenue for special purpose Foods medical traded to the consumer is allowed only through hospitals and other health institutions led by the doctor as well as via pharmacies or other companies that have affiliated doctor, dietitian, pharmacist or nurse.

Chapter IV. Administrative provisions § 18. Supervision and decision the FSA supervises and don't understand the decision to carry out the provisions given in and in pursuance of this regulation.


§ 19. Report food products covered by this Regulation shall be reported to the FDA before 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 c) information about the næringsmidlets composition to the extent this is not emerges from the information under letter b.

Norwegian food safety authority may request additional information and documentation.

section 20. Exemption the FSA can in special cases, the provisions of this dispense from these regulations, provided that it will not run counter to Norway's international obligations, including the EEA Agreement.

§ 21. Punishment intentionally or negligent violation of this regulation or the regulations and decisions given in pursuance of it, are punishable according to matloven § 28.

§ 22. Transitional provisions From 1. November 2001, it is forbidden to trade in products that are not in accordance with this regulation.

§ 23. Entry into force this Regulation shall enter into force immediately.

Appendix 1. Content of vitamins and minerals in foods for special medical purposes that are specific to infants the stated values apply to products that are ready for use, either prepared according to the manufacturer's instructions or traded as ready products.

1. Nutritional complete foods for special medical purposes as described in section 4 subsection 1, and which is specific to infants, to contain the vitamins and minerals that emerges from table 1, in amounts that are within the specified limit values.

2. Nutritional complete foods for special medical purposes as described in section 4 pt 2, and that is specific to infants, to contain the vitamins and minerals that emerges from table 1, in amounts that are within the specified limit values, but changes in the content of one or more of these nutrients, if any, are necessary in the interests of the product's purpose.

3. the content of vitamins and minerals in nutritionally speaking not complete foods for special medical purposes as described in section 4 subsection 3, and that are specific to the infant, shall not exceed the maximum values in table 1, but changes in the content of one or more of these nutrients, if any, are necessary in the interests of the product's purpose.

Table 1. Requirements to the content of vitamins and minerals in nutritionally complete foods particular to the infant Vitamins Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (μg RE) 14 43 60 180 Vitamin D (μg) 0.25 0.75 1 3 Vitamin K (μg) 1 5 4 20 Vitamin C (mg) 1.9 6 8 25 Thiamine (mg) 0.01 0.075 0.04 0.3 Riboflavin (mg) 0.1 0.45 0.014 0.06 Vitamin B6 (mg) 0.009 0.075 0.035 0.3 Niacin (mg NE) 0.75 0.8 0.2 3

Folic acid (μg) 1 6 4 25 Vitamin B12 (μg) 0.025 0.12 0.5 0.1 Pantothenic acid (mg) 0.5 0.3 0.07 2 Biotin (μg) 0.4 5 1.5 20 Vitamin E (mg α-TE) 0,5/g polyunsaturated fatty acids expressed as linoleic acid, but not less than 0.1 mg per 100 kJ 0.75 0.5/g polyunsaturated fatty acids expressed as linoleic acid, but not less than 0.5 mg per 100 kcal 3 Minerals Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum sodium (mg) 5 14 20 60

Chloride (mg) 12 29 50 125 potassium (mg) 15 35 60 145 calcium (mg) Phosphorus (mg) 12 60 50 250 1 6 22 25 90 Magnesium (mg) 1.2 3.6 5 15 iron (mg) 0.12 0.5 0.5 2 zinc (mg) 0.12 0.5 0.6 2.4 copper (μg) 4.8 29 20 120 iodine (μg) 1.2 8.4 5 35 Selenium (μg) 0.25 0.7 1 3 Manganese (μg) 0.25 25 1 100 Chromium (μg)-2.5-10 Molybdenum (μg)-2.5-10 Fluoride (mg)-0.05-0.2 Attachments 2. Content of vitamins and minerals in foods for special medical purposes that are specific to children from 1 year and adults the stated values apply to products that are ready for use, either prepared according to the manufacturer's instructions or traded as ready products.

1. Nutritional complete foods for special medical purposes as described in section 4 subsection 1, and which are specific to children from 1 year and adults, will contain the vitamins and minerals that emerges from table 2, in amounts that are within the specified limit values.

2. Nutritional complete foods for special medical purposes as described in section 4 pt 2, and which are specific to children from 1 year and adults, will contain the vitamins and minerals that emerges from table 2, in amounts that are within the specified limit values, but changes in the content of one or more of these nutrients, if any, are necessary in the interests of the product's purpose.

3. the content of vitamins and minerals in nutritionally speaking not complete foods for special medical purposes as described in section 4 subsection 3, and that are specific to children from 1 year and adults, shall not exceed the maximum values in table 2, except for the changes in the content of one or more of these nutrients, if any, are necessary in the interests of the product's purpose.

Table 2. Requirements to the content of vitamins and minerals in nutritionally complete foods specific to children from 1 year and adults Vitamins Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (μg RE) 8.4 43 35 180 Vitamin D (μg) 0.12/0.5 0.65 0,751 2.5/31 Vitamin K (μg) 0.85 5 3.5 20 Vitamin C (mg) 0.54 5.25 2.25 22 Thiamine (mg) 0.12 0.5 0.015 0.06 Riboflavin (mg) 0.5 0.02 0.12 0.08 Vitamin B6 (mg) 0.5 0.02 0.12 0.08

Niacin (mg NE) 0.22 0.9 0.75 3 folic acid (μg) Vitamin B12 2.5 12.5 10 50 (μg) 0.017 0.07 0.17 0.7 Pantothenic acid (mg) 0.035 0.35 0.15 1.5 Biotin (μg) 1.8 7.5 0.18 0.75 Vitamin E (mg α-TE) 0,5/g polyunsaturated fatty acids expressed as linoleic acid, but not less than 0.1 mg per 100 kJ 0.75 0.5/g polyunsaturated fatty acids expressed as linoleic acid, but not less than 0.5 mg per 100 kcal 3 Minerals Per 100 kJ Per 100 kcal Minimum Maximum Minimum
Maximum sodium (mg) 7.2 42 30 175 Chloride (mg) 7.2 42 30 175 potassium (mg) Calcium (mg) 19 70 80 295 8.4/121/35/42 592 501 175/2501 phosphorus (mg) 19 30 80 7.2 Magnesium (mg) 1.8 6 7.5 25 iron (mg) 0.12 0.5 0.5 2 zinc (mg) 0.12 0.36 0.5 1.5 copper (μg) iodine (μg) 15 125 60 500 1.55 8.4 6.5 35 Selenium (μg) 0.6 2.5 2.5 10 Manganese (mg) 0.12 0.012 0.5 0.05 Chromium (μg) 0.3
3.6 1.25 15 Molybdenum (μg) 0.72 4.3 3.5 18 Fluoride (mg)-0.05-0.2