Regulation on dietetic foods (Dietary Regulation)
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DiätV
Date of completion: 20.06.1963
Full quote:
" Diätverordnung in the version of the notice dated 28 April 2005 (BGBl. 1161), as last amended by Article 1 of the Regulation of 25 February 2014 (BGBl I). 218) has been amended "
| Status: |
New by Bek. v. 28.4.2005 I 1161; |
| |
Last amended by Art. 1 V v. 25.2.2014 I 218 |
For more details, please refer to the menu under
Notes
Footnote
(+ + + Text certificate: 12.9.1981 + + +)
(+ + + For application in the accession area cf. for the period from 3.10.1990 to
31.12.1990 V v. 28.9.1990 I 2117 (EGRÜblV) u. for the period from 1 January 1991
V v. 18.12.1990 I 2915 (EGÜblV) + + +)
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Content Summary
| First section |
§ § § |
| |
General provisions |
1 to 4a |
| Second section |
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| |
Additives and other substances for use in dietetic foods |
5 to 10 |
| Third Section |
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Special provisions for certain foodstuffs |
11 to 14d |
| Fourth Section |
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| |
Information and labelling requirements |
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| |
Identification of additives |
15 to 18 |
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General labelling |
19 |
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Special markings |
21 to 24 |
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Form of information and labelling |
25 |
| Fifth Section |
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| |
Offences and regularties |
26 |
| Sixth Section |
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| |
Final provisions |
27 to 29 |
| 23 installations |
First section
General provisions
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§ 1
(1) Dietetic foods are foods intended for particular nutritional uses. (2) Food is intended for a particular diet if it is intended for use in the food industry.
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1.
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meet the specific nutritional requirements of the following consumer groups:
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a)
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of certain groups of persons whose digestive or resorting process or metabolism is disturbed; or
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b)
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of certain categories of persons who are in particular physiological conditions and can therefore benefit from the controlled intake of certain substances contained in the diet, or
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c)
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Healthy infants or toddlers,
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2.
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are suitable for the specified nutritional purpose and are placed on the market with the indication that they are suitable for this purpose; and
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3.
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differ significantly from the food of general consumption due to their particular composition or the specific process of their preparation.
(3) For the purposes of this Regulation:
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1.
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Food: food other than milk which meets the specific nutritional requirements of healthy infants and young children, and which is intended to feed infants during the period of deforestation and for the feeding of infants and young children during the period of Gradual conversion to normal food.
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2.
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Cereal-based foods: Beikost
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a)
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simple cereal products which have to be prepared or prepared with milk or other appropriate nutritiy liquids,
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b)
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Cereal products containing an added protein which is or must be prepared with water or other protein-free liquids,
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c)
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Pasta which is consumed after boiling in boiling water or other suitable liquids, or
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d)
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Onions or biscuits which are consumed either as such or after comminution with the addition of water, milk or other suitable liquids.
(4) For the purposes of this Regulation, foods intended for use in low-calorie diets for weight reduction shall be products intended for use as a substitute for an entire daily ration or as a substitute for one or more meals in the context of the daily ration, and (4a) For the purposes of this Regulation, dietary foods for special medical purposes (balance-based diets) are products which are processed or formulated in a special way and which are for the dietetic treatment of patients. They shall be used for the exclusive or partial diet of patients with reduced, disabled or impaired capacity to take up, digestion, resorption, metabolism or excretion of ordinary foods or certain other foods nutrients or their metabolites or the diet of patients with other medically-related nutritional requirements, for their dietary treatment, a modification of the normal diet, other foods for a particular diet, Diet or a combination of both are not sufficient. Balance-sheet diets are divided into
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1.
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Full balance-sheet diets
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a)
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with a standard nutrient formulation, or
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b)
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with a nutrient formulation specific to certain complaints or adapted to a particular disease or disorder,
which, in the case of use according to the manufacturer ' s instructions, may be the only source of food for persons for which they are intended; and
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2.
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Supplementary balanced diets
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a)
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with a standard nutrient formulation, or
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b)
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with a nutrient formulation specific to certain complaints or adapted to a particular disease or disorder,
that are not suitable for use as a single source of food.
(5) Dietetic food is also a saline substitute. (6) For the purposes of this Regulation:
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1.
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Infants: children under 12 months of age;
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2.
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Infants: children between one year and three years;
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3.
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Infant formula: food intended for the particular diet of infants during the first months of life and which, in their own right, corresponds to the nutritional requirements of these infants until the introduction of appropriate food supplements;
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4.
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Follow-up: Food intended for the particular nutrition of infants from the introduction of adequate food and the largest liquid part of a diet that is more and more diversified for these infants.
(7) Additives within the meaning of this Regulation are substances within the meaning of § 2 (3) sentence 1 and 2 of the Food and Feed Code. (8) For "nutrition claim", "health claim" and "indication of the reduction of a food and feed code" For the purposes of this Regulation, the definitions in Article 2 (2) (4), (5) and (6) shall apply in each case in conjunction with Article 2 (2) (1) of Regulation (EC) No 1924/2006 of 20 December 2006 on nourishment and health and health claims made on foods (OJ L 327, 22. EU No L 12 p. 3).
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§ 2
(1) In the field of transport with or in the advertising of other than dietary foods (food of general consumption) may
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1.
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the word "dietetic" alone or in combination with other words,
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2.
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the names, other information and arrangements which might give the impression that it is a dietetic food;
not to be used. (2) By way of derogation from paragraph 1 (2), foods of the general consumption, which
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1.
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are intended to be issued in hospitals and comparable facilities under medical supervision, with references to the suitability for a particular nutritional purpose within the meaning of § 1, in the traffic is brought,
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2.
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are suitable for infants or young children, with a reference to it being placed on the market.
Foodstuffs of general consumption which are placed on the market by reference to the first sentence of the first sentence of paragraph 2 shall be:
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1.
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§ § 4, 14, 19 and 22 as well as
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2.
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Section 2 (1) (2) of the contaminant regulation
As an indication within the meaning of paragraph 1 (2), it shall not apply if:
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1.
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the chemical analysis, the individual analytical values or the physiological calorific value of food; or
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2.
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Special features in the qualitative and quantitative composition of a food
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3.
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(dropped)
(4) spirit drinks and beverages produced in accordance with an alcohol content of less than 15 per cent may not be marketed as dietary foods or with a reference to a specific nutritional purpose; be brought.
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§ 3
(1) By way of derogation from the second sentence of Article 12 (2) of the Food and Feed Code, the prohibitions of Section 12 (1) (1) and (7) of the Food and Feed Code shall also apply to dietetic foods, to the extent that they are not permitted under paragraph 2. (2) Permitted in the case of
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1.
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(dropped)
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2.
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Foods suitable for the treatment of disorders of intestinal motility and intestinal flora and their sequellations in infants, the statement " Dietetic foods suitable for the treatment of infant dyspepsia (diarratic disease) in the case of infants) only within the framework of the medical prescription "; provided that they are suitable for curing, they may additionally be referred to as medicinal foods,
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3.
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a)
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Food for the treatment of hepatic cell or renal insufficiency, which is adapted in the protein, amino acid and electrolyte levels,
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b)
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food suitable for the treatment of congenital metabolic disorders,
the statement "Dietetic food suitable for the treatment of ... use only under constant medical control",
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4.
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Foods intended for particular nutritional uses
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a)
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Maldigestion or malabsorption,
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b)
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Disorders of food intake,
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c)
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Chronic inflammatory bowel disease or pre- or post-operative treatment in the intestine's operations,
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d)
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chronic pancreatitis, or
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e)
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Gout
, the statement "on the special diet at ... within the framework of a diet plan".
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§ 4
(1) Dietetic foods intended for delivery to the consumer may be placed on the market only in pre-packed packaging, except for sweeteners, provided that dietary foods are used for human consumption; and Place to be delivered. The consumer shall be entitled to the same places as restaurants, communal catering facilities and tradesmen to the extent that they relate to the consumption of food within their premises. (2) By way of derogation from paragraph 1, half-sentence 1 may include dietary requirements. Meat products and dietetic cheeses are released to the consumer, even when cut.
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Section 4a
(1) Anyone who has a dietary balance within the meaning of Article 1 (4a), an infant formula within the meaning of Article 1 (6) (3) or a dietetic food which does not belong to any of the groups of dietetic food listed in Appendix 8 shall be deemed to be If the manufacturer or importer wishes to place on the market, this shall be indicated by the Federal Office for Consumer Protection and Food Safety at the latest when placing the product on the market, by presenting a sample of the label used for the product. (2) If the dietary food has already been used in another Member State of the European Union, (3) The Federal Office for Consumer Protection and Food Safety shall transmit the following information to the competent authority of the Member State of the European Union. (3) The Federal Office for Consumer Protection and Food Safety shall forward the The Federal Office for Consumer Protection and Food Safety (Bundesamt für Consumer Protection and Food Safety) examines whether the Federal Office for Consumer Protection and Food Safety (Bundesamt für Consumer Protection and Food Safety) is responsible for monitoring and monitoring the food safety of the food industry dietetic foods not associated with any of the groups listed in Appendix 8 of dietetic foodstuffs shall be in accordance with the requirements of section 1 (2) and shall inform the authorities referred to in paragraph 3 of the test result. (5) As far as this is necessary for the examination referred to in paragraph 4, the Federal Office of Consumer protection and food safety from the manufacturer or importer require the submission of the scientific work and data resulting from the fact that the declared product complies with the requirements of § 1 (2). If the work in question has been published in an easily accessible publication, a reference to this publication is sufficient. (6) Has the Federal Office for Consumer Protection and Food Safety found that the product indicated The Federal Office of Consumer Protection and Food Safety may provisionally prohibit the placing on the market of the product as a dietary foodstuff or provide it with conditions, in accordance with the requirements of Section 1 (2).
Second section
Additives and other substances for use in dietetic foods
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§ 5
(1) In the production, production and preparation of dietetic foods, additives may be added only in accordance with this Regulation. (2) The use of drinking water prepared in accordance with the Drinking Water Preparation Regulation, shall not be deemed to be the addition of additives within the meaning of this Regulation.
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§ 6
For the use of additives in dietetic foods for technological purposes, the additional substance authorisation regulation applies. In addition to the additives authorised there, dietetic foods, other than dietetic foods intended for infants or young children, are the substances listed in Annex 5 (2) of the Flavourings Regulation as flavouring substances for flavourings, provided that they are intended to serve a technological purpose. The content of these additives shall not exceed the quantitative limits laid down in Annex 5 (2) of the flavouring regulation.
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§ 7
(1) It shall
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1.
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for dietetic foods, other than infant formulae and follow-on formulae according to § 14c and the apprentice according to § 14d, which are listed in Appendix 2,
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2.
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for infant formulae and follow-on formulae in accordance with § 14c and in accordance with § 14d, the restrictions laid down in Annex 9 in compliance with the restrictions laid down therein
shall be authorised provided that they are intended to serve a nutritional or dietary purpose. The authorisation shall apply if, in Annex 2, column 2, the use of a substance is restricted to certain dietary foods only for those dietetic foods. The maximum quantities specified in Appendix 2 may not be exceeded. (2) Where minimum quantities are indicated in Appendix 2 for additives listed there, dietary foods may be added to the additives for those uses. authorised additives shall be placed on the market only if the specified minimum quantities are not lower than the minimum quantities specified.
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§ 7a
It is prohibited in the manufacture of dietetic foods, other than infant formulae and follow-on formulae in accordance with § 14c and by-products according to § 14d, other substances which do not contain any additives within the meaning of Article 2 (3) of the Food and Agriculture Committee. The feed codes are to be used for nutritional or dietary purposes as the substances referred to in Appendix 2, category 1 to 6, and marked with an asterisk. Where, in Annex 2, column 2, the use of a substance is restricted to certain dietetic foods, this substance may only be used in these dietary foodstuffs.
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§ 7b
All substances listed in Annexes 2 and 9 may be added to dietetic foods in the manner and quantity only in such a way that they meet the particular nutritional requirements of the person group for which they are intended. Section 7 (1) sentence 3 and (2) shall remain unaffected. At the request of the authority referred to in Article 4a (1), the manufacturer or importer shall submit the scientific work and data which, in accordance with the state of the scientific knowledge, shall be suitable for the purposes of nutritional or dietary use. Added substances for the corresponding group of persons. If the corresponding work is available in an easily accessible publication, it is sufficient to make an indication.
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§ 8 (omitted)
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§ 8a (omitted)
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§ 9
(1) The additives listed in Appendix 3 shall be approved as saline salesmen. The content of adipic acid and adipic acid, calculated as adipic acid, must not exceed 60 grams in one kilogram of saline salesset. Saline salcers may be used for the production of dietetic foods intended for sodium-sensitive foods, including in jodiated form. (2) The magnesium compounds referred to in point 1 of Appendix 3 are only permitted if they are: at least one of the non-magnesium-containing compounds mentioned in Appendix 3. The mixture may not contain more than 20 hundred parts of the total potassium and calcium cations of magnesium compounds, calculated as magnesium cations. (3) The salts of cholins referred to in point 3 of Appendix 3 are only permitted if: they are mixed with at least one of the non-cholinhale compounds mentioned in Appendix 3. The mixture shall not contain more than 3 hundredths of choline.
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§ 10 (omitted)
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Third Section
Special provisions for certain foodstuffs
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§ 11
(1) Those who wish to produce jointed salesmen, other dietetic foods with the addition of iodine compounds or dietary foods intended for use as a balanced diet, shall require the approval. Authorisation shall be granted for a particular establishment. (2) The authorisation shall be granted only if the person under whose management the food referred to in paragraph 1 is to be produced shall be subject to the necessary expertise and reliability. , and if the operation is equipped with the equipment necessary for the proper production of these foodstuffs, in particular for correct dosing and uniform mixing.
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§ 11a
(1) The foodstuffs referred to in Article 11 (1) may be brought within the scope of this Regulation only if, for the consignment, the consignment is active for free circulation, for customs purposes in an open customs warehouses, for the active purpose of the goods, Processing, conversion or the date of use shall be accompanied by a certificate issued in accordance with the model of Appendix 4. The consignment shall be the quantity of the goods to which the official certificate relates. The certificate must be issued in triplicate by the competent authority of the country of origin and drawn up in the German language; the original as well as the multi-copies must be marked as such. A multi-copy of the certificate shall be sent by the customs office at the expense of the person entitled to dispose of the office responsible for the place of customs clearance of the official control of foodstuffs. (2) A presentation of the certificate shall be submitted by the customs office. Paragraph 1 shall not be required if the relevant foodstuffs of the same manufacturer have already been brought into the scope of this Regulation by means of a certificate referred to in paragraph 1 and the consignment is accompanied by a written declaration by the manufacturer is attached. This declaration must result in the conformity of foodstuffs with the foodstuffs already in place and the place of the official food surveillance competent for the place of the first customs clearance. (3) Paragraph 1 shall not apply to: Common salesmen and other dietary foods, with the addition of iodine compounds, which are lawful in another Member State of the European Union or of another Contracting State of the Agreement on the European Economic Area and lawfully placed on the market or from a third country and are lawfully placed on the market in a Member State of the European Union or of another State Party to the Agreement on the European Economic Area.
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§ 12 (omitted)
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§ 13
(1) Dietetic foods for sodium-sensitive products may only be manufactured and placed on the market for commercial purposes if they meet the following requirements:
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1.
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In the case of food, other than beverages, the sodium content shall not exceed the amount of 120 milligrams per 100 grams of the food-ready food,
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2.
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in the case of beverages, other than natural mineral water, the sodium content may not exceed the quantity of 2 milligrams per 100 millilitres of the ready-to-eat foodstuff.
With the indication "strictly low sodium", also supplemented by the indication "strictly cochless", dietary dietary foods, excluding beverages, may be labelled only if the sodium content is 40 milligrams per 100 grams of the (2) Substances which are not additives may be unmixed or, after mixing with other foodstuffs, only labelled as saline, if they contain no sodium. (3) Products which: prepared on the basis of sodium chloride, sodium salt or sea salt, , dietetic foods may be placed on the market only if they are labelled "no saline substitute" in combination with the name of the product.
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§ 14
(1) Dietetic foods intended for infants or young children must comply with the following requirements:
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1.
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they may, in so far as other food law provisions do not apply more stringent rules,
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a)
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contain no more than 0.01 milligrams per kilogram, subject to the provisions of points (b) and (c), of plant protection products, pest control and protection products,
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b)
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in respect of the substances listed in Appendix 22, do not contain any residues exceeding the maximum levels referred to in that Annex,
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c)
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shall not be made from products whose production has been applied to the plant protection, pest control and protection products listed in Appendix 23; these products shall be deemed not to have been applied when the products listed in Annex 23 to this Regulation are not applied in Annex 23. have not been exceeded;
the value referred to in point (a) and the values referred to in point (b) in the case of cereal-based foods and other co-foods for infants and young children, and in the case of infant formulae and follow-on formulae, refer to the ready-to-eat or after- the product prepared by the manufacturer;
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(dropped)
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the use of milk, milk products or milk constituents shall not be allowed to detect bacterial inhibitors with biological examination procedures.
(2) Dietetic foods intended for infants or young children must also meet the following requirements:
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1.
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the amount of cereals or cereal products contained in them must be free from residues of grinding and polishing and free from coarse spelt splinters;
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2.
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their content of mineral components which are insoluble in hydrochloric acid shall not exceed 0.1 part by weight;
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3.
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After the baking process, the content of water-soluble carbohydrates resulting from the degradation of the starch in the baking and roasting process and by enzymatic degradation must not be less than 12 hundredths after the baking process;
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4.
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they are manufactured using milk, milk products or milk components,
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a)
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Not more than 10 000 germs, in 1.0 millilitre of a food ready for consumption, not more than 50,000 germs in 1.0 grams of a food placed on the market, dry or dipped into circulation, with acid in acid milk products which are not to be taken into account for these types of bacterial species,
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b)
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No more than 150 aerobic spore-forming or other protein-dissolving bacteria (caseolytes) may be cultivated in 1.0 millilitre of the food ready for human consumption or in 0.1 gram of the food placed on the market in dry or dicked form;
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if they are placed on the market for use as children's sugar, nutrient sugar or sugar cane sugar, they must consist of a mixture of monosaccharides, disaccharides, higher oligosaccharides and polysaccharides, the content of which must be Monosaccharides shall not be more than 15 hundredths of which, by way of derogation, products which are not exclusively intended for healthy infants or young children must consist of starch degradation products, the content of maltose not less than may be as 20 hundredths and not more than 50 hundred parts; these provisions do not apply to malt extract.
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(dropped)
(3) (omitted)
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§ 14a
(1) Food for low-calorie diets for weight reduction may only be produced and marketed commercially, if the addition of additives and other substances to nutritional or dietetic purposes (2) Food for low-calorie diets for weight reduction may only be manufactured and placed on the market if it is in its composition as set out in Annex 17 to the Directive. (3) foods for low calorie content The weight reduction diet intended to replace a daily ration may be placed on the market for commercial purposes only in a pre-filled package containing all the ingredients. (4) The provisions of paragraphs 2 and 3 shall not apply to dietetic products. use, as a daily ration or meal, of certain foods which, according to a medical instruction, are produced on a case-by-case basis and which are administered under medical supervision in the context of catering in hospitals or similar establishments; if the different composition is based on medical indication is available.
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Section 14b
(1) The production of balanced diets must be based on reasonable medical and dietetic principles. Balanced diets must be used safely and usefully in accordance with the manufacturer's instructions and shall be effective in the sense that they meet the specific nutritional requirements of the persons for whom they are intended. They may only be used under medical supervision. (2) Full accounting diets within the meaning of section 1 (4a) sentence 3 (1) may be manufactured and marketed only if they are subject to the substances listed in Appendix 6. (3) Supplementary balanced diets within the meaning of § 1 (4a) sentence 3 no. 2 may only be manufactured and placed on the market for commercial purposes if the content of the substances is Appendix 6 does not exceed the maximum quantities listed in Annex 6, and the (4) The quantitative limits laid down in Appendix 6 shall also apply to the addition of additives and other substances authorised by paragraph 7 in conjunction with Appendix 2 to nutritional or physiological nutritional or nutritional requirements. For dietary purposes in accordance with § 7a in conjunction with Appendix 2. (5) If a need adjustment is necessary for special dietary requirements on balance sheets, the maximum quantities and minimum quantities to be observed in accordance with Appendix 6 may be dismissed. The labelling of the food must contain an indication of these deviations and the justification for this. (6) Accounting diets intended for infants must be included in their composition, with the exception of those referred to in Appendix 6. Nutrients which comply with the requirements for infant and follow-on formulae in Annex 10 and 11, provided that the special purpose is not preclude.
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§ 14c
(1) Infant formulae and follow-on formulae may only be manufactured and marketed in the commercial sector if:
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1.
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have not been used for the manufacture of substances and compounds other than those listed in Appendix 9, having regard to the restrictions laid down therein, in order to meet the requirements for vitamins, minerals, amino acids and other substances to meet nitrogen compounds and other substances for particular nutritional uses, and
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2.
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necessary for the preparation of the ready-to-eat foodstuff, if necessary, the addition of water.
(2) The infant formula may also be manufactured and marketed only commercially, subject to paragraph 3, if:
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For their production as protein sources, no other protein sources other than those specified in Annex 10, point 2, and also only those ingredients which are suitable for the particular nutritional use of infants from birth to by general recognised scientific evidence, and
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in their composition, the minimum quantities and quantitative limits laid down in Appendix 10, in relation to the ready-to-eat product, and the other restrictions on the use of ingredients and the other ingredients listed in that Annex, The minimum and maximum quantities of the constituents shall be calculated on the basis of the values of amino acids in breast milk laid down in Appendix 12.
The suitability referred to in the first sentence of sentence 1 shall be demonstrated by a systematic evaluation of the available data in relation to the expected benefits and in terms of safety considerations and, where appropriate, by appropriate studies, which shall be carried out under On the basis of generally accepted recommendations for the design and implementation of such studies in professional circles. (3) Insofar as the infant formula within the meaning of paragraph 2 is taken from the
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Cow ' s milk proteins or goat milk proteins described in Appendix 10, point 2.1, with a protein content between the minimum value and 0.5 g/100 kJ (2 g/100 kcal), or
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2.
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the protein hydrolysates described in Appendix 10, point 2.2, with a protein content between the minimum value and 0.56 g/100 kJ (2.25 g/100 kcal)
, it may only be placed on the market if its suitability for the particular nutritional use of infants has been demonstrated by studies which, on the basis of generally accepted recommendations in the field of design, are designed to: and carrying out such studies. Products referred to in the first sentence of paragraph 2 shall comply with the specifications laid down in Annex 24. (4) The following shall also be manufactured and placed on the market only if the following conditions are met:
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1.
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For their production as protein sources, no other protein sources other than those specified in Annex 11 (2) and, furthermore, only those ingredients which are suitable for the particular nutritional use of infants older than six months have been used, has been demonstrated by generally accepted scientific evidence, and
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in their composition, the minimum quantities and maximum quantities referred to in Appendix 11, in relation to the ready-to-eat product, as well as the other restrictions on use laid down therein, and the other additional requirements laid down therein; the composition is in accordance with the minimum and maximum quantities of the constituents, the values of amino acids in breast milk laid down in Appendix 12 must be used.
The suitability referred to in the first sentence of sentence 1 shall be demonstrated by a systematic evaluation of the available data in relation to the expected benefits and in terms of safety considerations and, where appropriate, by appropriate studies, which shall be carried out under On the basis of generally accepted recommendations for the design and implementation of such studies in professional circles. (5) Insofar as follow-on formulae within the meaning of paragraph 4 are derived from the protein hydrolysates described in Appendix 11, point 2.2. with a protein content between the minimum value and 0.56 g/100 kJ (2.25 g/100 kcal) , it may only be placed on the market if its suitability for the particular nutritional use of infants has been demonstrated by studies which, on the basis of generally accepted recommendations in the field of Design and implementation of such studies have been carried out. The specifications of Appendix 24 shall be taken into account.
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§ 14d
(1) Beikost may only be produced on a commercial basis from ingredients suitable for the particular nutritional use of infants and young children according to generally accepted scientific knowledge. (2) Beikost may only be manufactured commercially. and shall be placed on the market if, for their manufacture, no substances and compounds other than those listed in Appendix 9 have been used, having regard to the restrictions laid down there, in order to meet the requirements for vitamins, Mineral substances, amino acids and other nitrogen compounds and other (3) Foods may only be manufactured and placed on the market if the vitamins, minerals and trace elements added are the maximum values set out in Annex 18, and in the case of potassium and Calcium in relation to the product placed on the market, in other respects relative to the ready-to-eat product, not exceeding. (4) Cereals may only be produced and marketed on a commercial basis if, in addition, it is in its composition comply with the requirements and limits laid down in Annex 19. (5) In Annex 20, it may be manufactured and marketed only if it complies with the requirements and restrictions laid down in that Annex.
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§ 14e (omitted)
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§ 14f (omitted)
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Fourth Section
Information, labelling and advertising
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Identification of additives
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§ 15
(dropped)
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§ 16 (omitted)
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§ 17
(1) In the case of dietetic food in pre-packed prepackages to be labelled in accordance with the Food Labelling Regulation and those authorised in accordance with Article 7 of this Regulation, additives and other substances for nutritional or dietary purposes as defined in § 7a , the added amount of these substances, based on 100 grams, must be given in the case of liquids to 100 millilitres of the food. For the purposes of the identification of added vitamins, § 8 (4), second sentence, of the food labelling regulation applies accordingly. (2) In the case of dietetic foods, which are in pre-packed packaging within the meaning of Article 1 (2) of the Food Labelling Regulation, or in the case of additives and other substances which have been authorised in accordance with Article 7 for nutritional or dietary purposes in accordance with Article 7a, the content of these substances shall be given by the indication of the Transport name and the quantity of the substance, based on 100 grams, of liquids on 100 milliliters of the food, to be identified. The consumer shall be equal to restaurants, catering facilities and tradesmen to the extent that they relate to the consumption of food within their premises. (3) Paragraphs 1 and 2 shall not apply to the dietetic Foods which are covered by § § 21, 21a, 22a or 22b.
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§ 18
In the case of dietetic foodstuffs, the following information shall also be provided:
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(dropped)
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2.
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in the case of dietetic foods to which additives authorised as saline salesmen have been added, the indication "with saline salt replacement",
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(dropped)
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in the case of dietetic foods to which iodinated saline salesmen have been added, the indication "with iodinated saline salesset".
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General labelling
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§ 19
(1) Dietetic foods, other than those covered by § § 21, 21a, 22a or 22b, may only be placed on the market for commercial purposes only if the marking is indicated on the label:
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1.
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the special nutritional properties belonging to the name or subject to § 3 of the particular nutritional purpose;
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2.
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the characteristics of the qualitative and quantitative composition or of the specific production process by which the product acquires its particular nutritional properties;
-
3.
-
the average content of usable carbohydrates, fats and proteins, either in grams, in relation to 100 grams, in the case of liquids per 100 millilitres of food, or in hundredparts of the weight; the indication shall not be required with a content of less than one hundredth;
-
4.
-
The average physiological calorific value in kilojoules and kilocalories, based on 100 grams, in liquids per 100 milliliters of food, with the words " ... Kilojoule (... Kilocalories) "or" ... kJ (... kcal) "; in the case of products which are ready for consumption only after the addition of other foodstuffs, the product is in addition to 100 grams, in the case of liquids to 100 millilitres of ready-to-eat products. Indicate the calorific value; if the calorific value is less than 50 kilojoules (12 kilocalories) in 100 grams or 100 millilitres, the information may be given by the indications "calorific value less than 50 kJ (12 kcal) in 100 g" or "calorific value below 50 kJ (12 kcal) in 100 ml" shall be replaced.
In the case of portions of a portion or a portion of portions, the information referred to in the first sentence of 1 (3) and (4) shall be taken into account in addition to a portion. (2) The physiological calorific value shall be calculated in accordance with Section 2 (3) of the Nutrition Labelling Regulation.
-
Special markings
Unofficial table of contents
§ § 20 and 20a (omitted)
-
Unofficial table of contents
Section 21
(1) For balance-sheet diets, the term "Dietetic food for special medical purposes (balance-based diet)" is the name of the sales name within the meaning of the food labelling regulation. (2) Accounting diets may only be used in transport if they contain the following information in accordance with sentence 2:
-
1.
-
the indication "for the dietary treatment of ..." supplemented by the disease, disorder or discomfort to which the food is intended;
-
2.
-
a description of the properties and characteristics to which the food has its intended purpose;
-
3.
-
an indication when nutrients have been increased, decreased, removed or otherwise altered,
-
4.
-
the fact that it is a diet intended solely for the purpose of nutrition or a supplementary balance sheet,
-
5.
-
an indication of the age group, provided that the food is intended for a particular age group,
-
6.
-
an indication where the balance sheet may endanger the health of persons who are not suffering from the diseases, disorders or ailments for which this balanced diet is intended,
-
7.
-
an indication that the food must be used under medical supervision,
-
8.
-
an indication of certain precautions or contraindications provided that interactions with other substances, in particular with medicinal products, may occur,
-
9.
-
an indication that the food may not be used parenterally if that product is suitable for special nutritional uses.
The words "important hint" or an equivalent formulation must be preceded by the words in points 4 to 7. Furthermore, the following information may be placed on the market only with the following information in accordance with the rates 2 to 4 shall be:
-
1.
-
the calorific value in kilojoules (KJ) and kilocalories (kcal), as well as the content of proteins, carbohydrates and fats,
-
2.
-
the average quantity of all the minerals and vitamins contained in the food and listed in Appendix 6,
-
3.
-
the content of constituents of proteins, carbohydrates and fats or other nutrients and their constituents, provided that such information is necessary for the appropriate use of the product,
-
4.
-
Data on osmolality or osmolarity on balanced diets in liquid form and
-
5.
-
Information on the origin and nature of the proteins and protein hydrolysates contained in the product.
In the cases referred to in points 1 to 3, the data shall be expressed as a numerical statement of 100 grams or 100 millilitres of the food product when placed on the market and in the case of a product which is still ready for use in accordance with the manufacturer ' s instructions. requires 100 grams or 100 millilitres of the ready-to-use product. In the case of portions of a portion or a portion of portions, the data according to numbers 1 to 3 may also be given in addition to a meal or a portion of a portion of the material. In the case of supplementary balanced diets within the meaning of section 1 (4a) sentence 3 (b), the particulars referred to in points 1 to 3 relate to the product when placed on the market when the preparation is not standardised but with a variety of different products. (4) Accounting diets may be placed on the market only with a use instruction, provided that they are necessary for the proper preparation, use and storage of the food after opening of the pre-filled package. is.
Unofficial table of contents
Section 21a
(1) Food for low-calorie diets for weight reduction, intended to replace a whole daily ration, may only be used with the sales designation "Daily ration for weight-controlling nutrition" in accordance with § 25 (1) (1) (1). (2) Food for low-calorie diets intended to reduce weight, intended to replace one or more meals in the course of a daily ration, may only be used with the name 'meal' for a weight-controlling diet " in accordance with § 25 (1) No. 1 (3) foods intended for low-calorie diets for weight reduction may only be placed on the market for commercial purposes only if the labelling also provides the following information in accordance with section 25 (1) (1) contains
-
1.
-
the necessary information on the correct preparation of the product, accompanied by the reference to the requirement of compliance;
-
2.
-
information on the potential effect of the product if it comes to a daily income of more than 20 g of polyalcohols, according to the manufacturer's instructions, and
-
3.
-
an indication of the need for sufficient daily liquid uptake.
(4) Foods for low-calorie diets for weight reduction may only be placed on the market for commercial purposes if the labelling contains the following information in accordance with section 25 (1) (1)
-
1.
-
the calorific value in kilojoules and kilocalories, as well as the protein, carbohydrate and fat content of each specified quantity of the ready-to-use product; and
-
2.
-
the average quantity of the mineral substances and vitamins listed in Annex 17, point 7, of the quantity of the ready-to-use product specified.
(5) Food for low-calorie diets for weight reduction, intended to replace a whole daily ration, may only be placed on the market in commercial terms if the labelling is in accordance with § 25 (1) (1) (1) (1) (1) (1)).
-
1.
-
an indication that the product contains all the nutrients required for one day in an appropriate quantity; and
-
2.
-
the warning that the product may not be used for more than three weeks without a medical advice;
(6) Food for low-calorie diets intended to reduce weight, intended to replace one or more meals in the context of the daily ration, may only be placed on the market if the labelling is carried out in accordance with In accordance with § 25 (1) no. 1
-
1.
-
information on the percentage of the daily dose of the minerals and vitamins listed in Annex 17, point 7, to the extent that Annex 1 to the Nutritional Labelling Ordinance is called daily doses, and
-
2.
-
the fact that the product only fulfils the intended purpose in the context of a low-calorie diet and that other foods must be part of this diet,
(7) Food intended for low-calorie diets for weight reduction should not be placed on the market on a commercial basis with:
-
1.
-
Information on the time required for a possible weight loss or
-
2.
-
Information on the amount of possible weight loss.
In the case of foodstuffs as defined in the first sentence, the information referred to therein shall not be allowed to apply. (8) § 14a (4) shall apply accordingly.
Unofficial table of contents
Section 22
(1) In the case of dietetic foods intended for infants or young children, the quantity of food required for a meal must be indicated. If the food contains d-lactic acid or dl-lactic acid, the reference "do not use for infants in the first three months of life" is also required. (2) In the case of products according to § 14 (2) no. 5, except malt extract, indicate:
-
1.
-
the content of monosaccharides and disaccharides in hundredparts,
-
2.
-
"Do not use in addition to pre-filled foods for infants and young children" in combination with the name,
-
3.
-
the further indication "only for healthy infants and young children", provided that the content of monosaccharides is more than 5 hundredths.
(3) In the case of delivery in the mail order trade, the information referred to in the second sentence of paragraph 1 and 2 (2) and (3) must also be clearly visible and easily legible in the offer lists, in the case of delivery in the travel industry, also on the order forms.
Unofficial table of contents
Section 22a
(1) Dietetic foods intended as infant formulae may be placed on the market only with the name of "infant formulae"; if their protein content is exclusively derived from cow ' s milk protein or In the case of a goat ' s milk protein, they may be placed on the market only with the name 'Infant milk food'. Dietary foods intended as follow-on formulae may be placed on the market only with the name "follow-on formula"; if their protein content consists exclusively of cow ' s milk protein or goat ' s milk protein, they may only be placed on the market. (2) products referred to in paragraph 1 may also be placed on the market only if the marking is marked by
-
1.
-
in the case of infant formulae and follow-on formulae
-
a)
-
the necessary information on the intended use of the product,
-
b)
-
Guidance on the correct preparation and disposal of the product,
-
c)
-
a guide to correct storage,
-
d)
-
a warning against the adverse health effects of improper preparation and storage,
-
e)
-
an indication of the physiological calorific value expressed in kilojoules and kilocalories, the content of protein, carbohydrates and fat per 100 millilitres of the ready-to-eat product in numbers and
-
f)
-
an indication of the average quantity of all the minerals and vitamins listed in Annexes 10 and 11, and, where appropriate, the quantity of choline, inositol and carnitine per 100 millilitres of the finished product in numbers,
-
2.
-
in the case of infant formulae,
-
a)
-
an indication that the product is suitable for the particular nutritional use of infants from birth if they are not breastfed, and
-
b)
-
a clearly visible and "important" reference to the superiority of breast-feeding in conjunction with the recommendation that the product should only be referred to the Council of independent experts in the field of medicine, nutrition or medicinal products, or other persons responsible for infant and child care,
-
3.
-
for follow-on formulae
-
a)
-
the warning that the product is suitable only for the particular nutritional use of infants aged at least six months, should only be part of a mixed diet and not as a substitute for breast milk during the first six months of the year to use life months, and
-
b)
-
an indication that the decision to begin the use of co-foods in general or in exceptional cases in the first six months only applies to the advice of independent experts in the field of medicine, nutrition or medicinal products; or other persons responsible for infant and child care, and taking into account the growth and development requirements of the individual infant,
.
(3) Products referred to in paragraph 1 may not be placed on the market where the marking is marked
-
1.
-
in the case of infant formulae and follow-on formulae
-
a)
-
The terms "humanized", "maternised", "adapted", or similar terms,
-
b)
-
Information that discourage breastfeeding,
-
2.
-
in the case of infant formulae
-
a)
-
Illustrations of infants or the use of the product idealising other illustrations or words, other than drawings, for the easier identification of the product or for the presentation of methods of preparation,
-
b)
-
Other than the nutrition and health claims other than those used in Annex 15, or
-
c)
-
the information provided for in Annex 15, if the product does not meet the requirements laid down therein for the use of this information,
are included.
(4) If, in addition to the numerical data, further information on the vitamins and minerals listed in Appendix 16 is included in the follow-on formula, this information shall be expressed as a percentage of the reference values referred to in Annex 16; based on 100 milliliters of the ready-to-eat product.
Unofficial table of contents
§ 22b
(1) Beikost may only be placed on the market in commercial terms if the marking is in accordance with § 25 (1) (1) (1) (1) (1) (1))
-
1.
-
information from which, after the completion of the fourth month of life, the co-food may be used,
-
2.
-
details of gluten content or gluten-free food for use in the case of infants aged under six months, and
-
3.
-
the necessary information on the preparation of the product, accompanied by a reference to the importance of its compliance;
(2) Beikost may also be placed on the market only if, in accordance with § 25 (1) (1) (1) (1) (1) (1) (1) (1) (1)
-
1.
-
the physiological calorific value expressed in kilojoules and kilocalories, the content of protein, carbohydrates and fat per 100 g or 100 ml of the product to be delivered to the consumer, and with the prescribed consumption per unit of consumption,
-
2.
-
the average content of the minerals and vitamins listed in Annexes 19 or 20 for the product in question per 100 g or 100 ml of the product to be delivered to the consumer, and at the prescribed consumption per unit of consumption
(3) In the case of nutrients listed in Appendix 9 which are not included in the labelling in accordance with paragraph 2 (2), it may only be placed on the market if it is used in the labelling of the average of the nutrients listed in Annex 9. (4) In the case of a percentage of the reference value of the product to be delivered to the consumer, the percentage of the reference value of the product to be delivered to the consumer shall be expressed in the case of a percentage of the reference value of the product to be delivered to the consumer and the percentage of the product to be delivered to the Vitamins and minerals may be placed on the market only for commercial purposes, if the content of the vitamins and minerals indicated is at least 15 per cent of the reference values specified therein and the content of the product to be delivered to the consumer is 100 grams or 100 millilitres per 100 millilitres of the product to be delivered to the consumer, and In the case of each of the components, there is provided a process for the production of
Unofficial table of contents
Section 23
(1) (omitted) (2) (omitted) (3) Cooking salt substitute is to be marked as "saline salty substitute", jodized saline substitute as "jodized saline substitute". In the case of potassium-containing saline salesmen, the following shall be stated:
-
1.
-
the content of potassium in hundredths of the weight,
-
2.
-
the warning "in the event of disturbances of the potassium balance, in particular in the case of renal insufficiency, only use after medical consultation".
Unofficial table of contents
§ 24
For dietetic foods for sodium-sensitive foods, the use of potassium-containing saline should be used to indicate:
-
1.
-
the content of potassium in milligrams, based on 100 grams, in the case of liquids per 100 millilitres of food,
-
2.
-
the warning "in the event of disturbances of the potassium balance, in particular in the case of renal insufficiency, only use after medical consultation".
-
Form of information and labelling
Unofficial table of contents
Section 25
(1) In the case of food in pre-packed packaging to be labelled in accordance with the Food labelling Regulation,
-
1.
-
the information in accordance with § 13 (3), § 14b (5) sentence 2, § 19 (1), § 21 (2), § 22 (1) and (2), § 22a (1) and 2 (1) and 2 (2) and § § 23 and 24 in a clearly visible position,
-
2.
-
the information referred to in section 17 (1) and (21) (3) sentence 1 (5) in connection with the indication of the substance in the list of ingredients prescribed in accordance with section 3 (1) (3) of the food labelling regulation;
-
3.
-
the information in accordance with § 18, § 21 (2) sentence 1, no. 1, 3 and 4 in conjunction with the sales designation prescribed in accordance with § 3 (1) No. 1 of the Food-labelling Regulation
be appropriate. The indication in accordance with section 22 (1) sentence 1 may take place at another place of the pre-filled package, if it is particularly pointed out. In addition, § 3 (3) sentence 1 of the Food-Labelling Regulation applies accordingly. (2) The information given in section 21 (3), first sentence, No. 1 to 4, and sentences 2 to 4, as well as (4), can be made in a recording attached to the pre-filled package. (3) In the case of food delivered in pre-packed packaging within the meaning of Article 1 (2) of the Foodstuffs Labelling Regulation or loosely to the consumer, the following shall be: Information pursuant to § 13 (3), § 17 (2), § § 18, and 19 (1) and § 24 are made on signs that are to be found on the or, in addition to the goods, to be clearly visible or to be drawn up for the consumer. The consumer is the same as a restaurant, a community catering facility, and a trader where they refer to food for consumption within their premises. (4) In the case of food not consumed in pre-packed products for human consumption given on the spot, the information according to § 17 (2) as well as § § 18 and 19 (1) suffixed. With regard to the manner of information, § 9 of the Additive Authorisation Regulation applies accordingly.
Unofficial table of contents
Section 25a
(1) In the case of advertising, Section 22a (2) (1) (a) and (2) (b) and (2) (2) (2) (2) (2) (2) (2) In addition, it is prohibited to advertise infant formulae, which:
-
1.
-
published in other publications devoted to the use of scientific or infant care,
-
2.
-
other than substantive and scientific information; these may not give the impression or suggest that bottling of breast milk is equivalent or superior to that of breast milk; or
-
3.
-
consumers are encouraged to buy, by distributing samples, by providing free or cheap products, or by other additional incentives, whether directly or indirectly via institutions or persons acting in health care.
(3) A written or audiovisual material on the nutrition of infants, directed at pregnant women and mothers of infants and young children for information and training purposes, and indirectly for advertising purposes for Infant formulae or follow-on formulae may only be distributed if there is clear information on:
-
1.
-
the benefits and benefits of breastfeeding,
-
2.
-
the diet of the mother, as well as the preparation for breastfeeding and possibilities for continuing breastfeeding,
-
3.
-
the possible negative effect of the additional bottle feed on breastfeeding,
-
4.
-
the difficulty of unclosing, not being silent,
-
5.
-
if necessary, the proper use of the infant formula.
(4) Where the material referred to in paragraph 3 contains information on the use of infant formulae, it may also be distributed only if it provides information on the social and financial implications of such use and on the the risk to health arising from the use of food not suitable as an infant formula, by inappropriate dietary methods and by improper use of infant formula (5) It is prohibited to use material in the the purpose of paragraph 3 is to be distributed, in or on the images, with (6) Manufacturers and distributors of infant formulae and follow-on formulae shall be prohibited, free of charge, for information and training purposes, which may be indirect to the advertising of Infant formulae or follow-on formulae shall be distributed. This does not apply if these items are made available on request via institutions operating in the health care system. In this case, these items may not be marked with trade marks for infant formulae or follow-on formulae. The further requirements for distribution are governed by national law.
Fifth Section
Offences and regularties
Unofficial table of contents
Section 26
(1) According to § 58 (1) (18), (4) to (6) of the Food and Feed Code, it shall be punished who intentionally or negligently
-
1.
-
, contrary to § 7a or § 7b (1) sentence 1, a substance shall be used or added,
-
2.
-
-
a)
-
(dropped)
-
b)
-
(dropped)
-
c)
-
Contrary to § 13 (1) sentence 1, dietetic foods for sodium-sensitive
-
d)
-
dietetic foods for infants or young children who do not comply with the requirements referred to in Article 14 (2),
-
e)
-
Contrary to § 14a (1) or (2), foods for low-calorie diets for weight reduction,
-
f)
-
Diets accounted for in accordance with section 14b (2) or (3),
-
g)
-
contrary to § 14c (1), (2) sentence 1 or (3) sentence 1 infant formula,
-
h)
-
contrary to Article 14c (1), (4) sentence 1 or paragraph 5, sentence 1, follow-on formulae, or
-
i)
-
Contrary to § 14d para. 2, 3, 4 or 5 Beikost
manufacturing or placing on the market in commercial terms
-
3.
-
Foods of general consumption which do not comply with the requirements of section 14 (2) in conjunction with § 2 (2) sentence 2, with an indication that they are suitable for infants or young children, are marketed or marketed in a commercial or commercial manner.
-
3a.
-
(dropped)
-
4.
-
In breach of § 22b para. 1 no. 2, confiscably placed on the market.
(2) According to Article 59 (1) (21) (a) of the Food and Feed Code, it shall be punished who:
-
1.
-
an indication in accordance with Section 4a (1) sentence 1 is not reimbursed, not correct or not reimbursed in good time,
-
2.
-
an enforceable arrangement in accordance with Section 4a (6) of this Directive,
-
3.
-
(i) jodded salesmen, other dietetic foods, with the addition of iodine compounds or dietary foods intended for use as a balanced diet, without authorization pursuant to section 11 (1) sentence 1, or
-
4.
-
Food without the following
-
a)
-
(dropped)
-
b)
-
(dropped)
-
c)
-
(dropped)
-
d)
-
(dropped)
-
e)
-
Section 21a (3) (3) or (5) (2),
-
f)
-
Section 22 (1) sentence 2, subsection 2 (2) or (3) or (3), also in conjunction with § 2 para. 2 sentence 2,
-
g)
-
Section 22a (2) (1) (d) or (3) (a),
-
h)
-
Section 23 (3) sentence 2, no. 2, or
-
i)
-
Section 24 No. 2
must be placed on the market on a commercial basis.
(3) In accordance with Article 59 (1) (21) (a) of the Food and Feed Code, it shall be punished who, in the commercial production of foodstuffs intended to be placed on the market, shall be punished by means of the additives referred to in Article 6, sentence 3, § 7 (1) sentence 3 in conjunction with Annex 2 or § 9 (1) sentence 2, subsection 2 sentence 2 or para. 3 sentence 2 stipulated maximum quantities. (4) According to § 59 (1) No. 21 (a) of the Food and Feed Code, it shall be punished who for commercial purposes, placing dietary products on the market for which a content of additives or other substances for nutritional or dietary purposes, contrary to § 17 (1) sentence 1 or (2), § 18 sentence 1 or § 25, are not or are not identified in the prescribed manner. (5) According to § 59 (1) (21) (a) of the Food and Feed Code shall be punished
-
1.
-
Contrary to the provisions of Article 2 (1), the use of names, particulars or arrangements for the advertising of foodstuffs of general consumption is used in the advertising of foodstuffs of general consumption,
-
2.
-
-
a)
-
Alcoholic beverages referred to in paragraph 2 (4) as dietary foods or having a reference to a specific nutritional purpose,
-
b)
-
Contrary to Section 7 (2) of the Food and Agriculture Committee, food containing an additive to the additives of Appendix 2 below the minimum quantities indicated therein,
-
c)
-
(dropped)
-
d)
-
Foodstuffs which do not comply with the requirements of section 13 (1), second sentence, or para. 2, with the marking referred to therein,
-
e)
-
Foodstuffs which are not marked in the prescribed manner in accordance with Section 13 (3) or § 14b (5) sentence 2, in each case also in connection with Section 25, not or not in the prescribed manner,
-
f)
-
, contrary to Article 21 (2), diets are placed on the market without the required information,
-
g)
-
contrary to § 21a (1), (2) or (6) (2) or (7) sentence 1, foods for low-calorie diets for weight reduction, or
-
h)
-
contrary to Article 22a (1), (2) (2), (3) (b) or (3), a dietary food
shall be placed on the market for commercial purposes, or
-
3.
-
contrary to § 21a (7) sentence 2 advertising.
(6) Anyone who is negligent in committing an act referred to in paragraphs 2 to 5 shall act in accordance with Section 60 (1) of the Food and Feed Code. (7) Contrary to the order of law within the meaning of Section 60 (2) (26) (a) of the Food and Feed Code. Animal feed code, who intentionally or negligently
-
1.
-
against
-
a)
-
Section 19 (1),
-
b)
-
Section 21 (3) sentence 1 or (4),
-
c)
-
Article 21a (3) Nos. 1 or 2, para. 4, 5 (1) or (6) no. 1,
-
d)
-
Section 22a (2) (1) (a), (b), (e) or (f)
-
e)
-
Section 22b (1) (1) or (3) or (2)
a dietetic food is marketed on a commercial basis, or
-
2.
-
in accordance with Article 22b (3) or (4), it shall be placed on the market for commercial purposes,
-
3.
-
Contrary to Article 25a, paragraph 2, no. 1 or 2, advertising,
-
4.
-
Article 25a, para. 2 no. 3, para. 3, 4, 5 or 6, sentence 1, which distributes an object or material.
(8) An administrative offence within the meaning of Section 60 (2) (26) (b) of the Food and Feed Code acts as a result of intentional or negligent conduct contrary to § 4 (1), § 14a (3) or § 22a (2) (1) (c) of a Food and Feed Code ("foodstuff"). commercially available on the market.
Sixth Section
Final provisions
Unofficial table of contents
§ 27
The provisions of the Butterfly Regulation and the Honey Ordinance remain unaffected. The provisions of other legal regulations relating to the production and placing on the market of foodstuffs shall remain unaffected in so far as the provisions of this Regulation are not contrary to the provisions of this Regulation.
Unofficial table of contents
§ 27a (omitted)
-
Unofficial table of contents
§ 28 (omitted)
-
Unofficial table of contents
§ 28
(1) Products which comply with this Regulation in the version in force until 31 December 2007 may be placed on the market until 31 December 2009. (2) By way of derogation from paragraph 1, products within the meaning of section 14b (6) shall be allowed to: of this Regulation, which shall be in force until 31 December 2007, shall be placed on the market until 31 December 2011. (3) Until the end of 14 August 2008, products may be placed on the market after the end of the period of 14 August 2008. Regulations for the first time put on the market and then continue to be placed on the market until the stocks are dismantled (4) Dietetic foods for diabetics, which are covered by this Regulation in the up to 8. The new version of the Directive, which is in force in October 2010, may still be October 2012. After the expiry of the transitional period, the dietary foods not covered by this Regulation may be sold for diabetics up to the date of their minimum durability.
Unofficial table of contents
§ 29
(dropped)
Unofficial table of contents
Appendix 1 (omitted)
-
Unofficial table of contents
Appendix 1a (omitted)
-
Unofficial table of contents
Appendix 2 (to § 7 para. 1, § § 7a and 7b)
Additives and other substances which may be added to dietetic foods for nutritional or dietetic purposes
(Fundstelle: BGBl. I 2005, 1177-1183;
with regard to of the individual amendments. Footnote)
| Fabric |
Usage |
Maximum quantities (except for balance-sheet diets 1)) |
Minimum quantities (except for balance-sheet diets 1)) |
| Category 1 |
|
|
|
| Vitamins |
|
|
|
Vitamin A
-Retinol
-Retinyl acetate
-Retinylpalmitate |
|
-
a)
-
in the case of dietetic foods intended for use as a meal or in place of a meal or as a daily ration for low-calorie diets for weight reduction, a total of up to 0.9 milligrams per meal per meal and up to 1.8 milligrams per daily ration, calculated as retinol
|
|
-
b)
-
in the case of margarine and mixed fat products, up to 10 milligrams per kilogram, calculated as retinol
|
|
-
c)
-
in the case of additional food intended for pregnant women and breast-feeding, not more than 1.1 milligrams in relation to the daily consumption, calculated as retinol
|
-
c)
-
in the case of additional food intended for pregnant women and breast-feeding, at least 0.3 milligrams in relation to the daily consumption, calculated as retinol
|
-
d)
-
(dropped)
|
|
-
e)
-
(dropped)
|
|
| -beta-carotene *) |
|
|
|
Vitamin D
-Vitamin D3
(Cholecalciferol)
-Vitamin D2
(Ergocalciferol) |
|
-
a)
-
in the case of dietetic foods intended for use as a meal or in place of a meal or as a daily ration for a low-calorie diet for weight reduction, a total of up to 1.6 micrograms per meal per meal and up to 5 micrograms per meal per meal Daily ration, calculated as Calciferol
-
b)
-
in the case of margarine and mixed fat products, a total of up to 25 micrograms per kilogram, calculated as calciferol
-
c)
-
(dropped)
|
|
| Vitamin E |
|
|
|
-D-alpha-Tocopherol *)
-DL-alpha-Tocopherol *)
-D-alpha-tocopheryl acetate
-DL-alpha-tocopheryl acetate |
|
|
|
| D-alpha-tocopheryl acid succinate |
|
|
|
| Vitamin K |
|
|
|
| -Phylloquinon *) |
|
|
|
| (Phytomenadione *)) |
|
|
|
| Vitamin B1 |
|
|
|
| -Thiamine hydrochloride |
|
|
|
| -thiamine mononitrate |
|
|
|
| Vitamin B2 |
|
|
|
| -Riboflavin *) |
|
|
|
| -Riboflavin-5 '-phosphate, sodium |
|
|
|
| Niacin |
|
|
|
| -nicotinic acid |
|
|
|
| -Nicotinamide |
|
|
|
| Pantothenic acid |
|
|
|
| -Calcium-Dpantothenate |
|
|
|
| -Sodium-Dpantothenate |
|
|
|
| -D-Panthenol *) |
|
|
|
| Vitamin B6 |
|
|
|
| -pyridoxine hydrochloride |
|
|
|
| -pyridoxin-5 '-phosphate-pyridoxine dipalmitate |
|
|
|
| Folate |
|
|
|
| -Calcium-L-methylfolate |
|
|
|
| -vitamin B9 *) (pteroylglutamic acid *)) |
|
|
|
| Vitamin B12 |
|
|
|
| -cyanocobalamin *) |
|
|
|
| -Hydroxocobalamin |
|
|
|
| Biotin |
|
|
|
| -D-biotin *) |
|
|
|
| Vitamin C |
|
|
|
| -L-ascorbic acid *) |
|
|
|
| -Sodium-L-ascorbate |
|
|
|
| -Calcium-L-ascorbate |
|
|
|
| -Potassium-L-ascorbate |
|
|
|
| -L-Ascorbyl-6-palmitate |
|
|
|
| Category 2 |
|
|
|
| Mineral substances |
|
|
|
| Calcium |
|
|
|
| -Calcium carbonate |
|
|
|
| -calcium chloride |
|
|
|
| -calcium salts of |
|
|
|
| Citric acid |
|
|
|
| -Calcium gluconate |
|
|
|
| -calcium glycerophosphate |
|
|
|
| -calcium lactate |
|
|
|
| -calcium salts of |
|
|
|
| Orthophosphoric acid |
|
|
|
| -calcium hydroxide |
|
|
|
| -Calcium oxide |
|
|
|
| -Calcium sulphate |
|
|
|
| Magnesium |
|
|
|
| magnesium acetate |
|
|
|
| -Magnesium-Laspartat |
only for balance-sheet diets |
|
|
| -magnesium carbonate |
|
|
|
| -magnesium chloride |
|
|
|
| -magnesium salts of |
|
|
|
| Citric acid |
|
|
|
| -magnesium gluconate |
|
|
|
| -Magnesium- |
|
|
|
| glycerophosphate |
|
|
|
| -magnesium salts of |
|
|
|
| Orthophosphoric acid |
|
|
|
| -magnesium lactate |
|
|
|
| -magnesium hydroxide I |
|
|
|
| -magnesium oxide |
|
|
|
| -magnesium sulphate |
|
|
|
| Iron |
|
|
|
| -Iron carbonate |
|
|
|
| -Iron citrate |
|
|
|
| -Iron ammonium citrate |
|
|
|
| -Iron fumarate |
|
|
|
| -Iron lactate |
|
|
|
| -Eisengluconat |
|
|
|
| -Iron bisglycinate |
|
|
|
| -ice-sodium diphosphate |
|
|
|
| -iron diphosphate |
|
|
|
| (Iron pyrophosphate) |
|
|
|
| -Iron accharate |
|
|
|
| -Iron sulphate |
|
|
|
| Elemental iron |
|
|
|
| (Carbonyl + electrolytically + hydrogen reduced) |
|
|
|
| Copper |
|
|
|
| -Copper carbonate |
|
|
|
| -Copper citrate |
|
|
|
| -Copper gluconate |
|
|
|
| -Copper sulphate |
|
|
|
| -Copper lysine complex |
|
|
|
| Iodine |
|
|
|
| -potassium iodide-potassium iodate-sodium iodide-sodium iodate |
Only the potassium compounds may be used in jodised saline salesday. |
-
a)
-
in the case of dietetic foods intended for use as a meal or in place
|
-
a)
-
(dropped)
|
| as |
| |
|
of a meal or as a day -- |
Meal or in place |
| one |
| |
|
In the form of powders, granules or ready-to-drink products, at most 300 micrograms, based on the amount of daily consumption, calculated as iodine, for overweight |
Meal or daily ration intended for overweight and offered in formulated form as powder, granules or ready-to-drink, at least 130 micrograms, based on the daily consumption, calculated as iodine |
| |
|
-
b)
-
(dropped)
|
-
b)
-
(dropped)
|
| |
|
-
c)
-
(dropped)
|
-
c)
-
for cereal-based foods for infants or young children in total at least 100 micrograms per kilogram of ready-to-eat product, calculated as iodine
|
| |
|
-
d)
-
for iodinated saline substitute maximum 25 milligrams of iodine per kilogram of yodized saline salesset
|
-
d)
-
at least 15 milligrams of iodine per kilogram of yodiated saline substitute for joted saline salesset
|
| Zinc |
|
|
|
| -Zinc acetate |
|
|
|
| -Zinc carbonate |
|
|
|
| -Zinc chloride |
|
|
|
| -Zinc Citrate |
|
|
|
| -zinc gluconate |
|
|
|
| -Zinklactat |
|
|
|
| -Zinc oxide |
|
|
|
| -Zinc sulphate |
|
|
|
| Manganese |
|
|
|
| -Manganese Carbonate |
|
|
|
| -Manganese chloride |
|
|
|
| -Manganese Citrate |
|
|
|
| -Mangangluconat |
|
|
|
| -Manganese glycerophosphate |
|
|
|
| -Manganese Sulphate |
|
|
|
| Sodium |
|
|
|
| -sodium bicarbonate |
|
|
|
| -Sodium carbonate |
|
|
|
| -sodium chloride *) |
|
|
|
| -sodium citrate |
|
|
|
| -sodium gluconate |
|
|
|
| -sodium lactate |
|
|
|
| -Sodium hydroxide |
|
|
|
| -Sodium salts of the |
|
|
|
| Orthophosphoric acid |
|
|
|
| Potassium |
|
|
|
| -potassium bicarbonate |
|
|
|
| -Potassium Carbonate |
|
|
|
| -Potassium chloride |
|
|
|
| -potassium citrate |
|
|
|
| -potassium gluconate |
|
|
|
| -potassium glycerophosphate |
|
|
|
| -Potassium hydroxide |
|
|
|
| -potassium lactate |
|
|
|
| -Potassium salts of the |
|
|
|
| Orthophosphoric acid |
|
|
|
| Selenium |
|
|
|
| -sodium selenate |
|
|
|
| -sodium hydrogen selenite |
|
|
|
| -sodium selenite |
|
|
|
| Chromium (III) and |
|
|
|
| Hexahydrate |
|
|
|
| -chromium (III) chloride |
|
|
|
| -chromium (III) sulphate |
|
|
|
| Molybdenum (VI) |
|
|
|
| -ammonium molybdate |
|
|
|
| -sodium molybdate |
|
|
|
| Fluorine |
|
|
|
| -Potassium fluoride |
|
|
|
| -Sodium fluoride |
|
|
|
| Category 3 |
|
|
|
| Amino acids |
|
|
|
| -L-Alanin |
|
|
|
| -L-Arginine |
|
|
|
| -L-aspartic acid |
only for balance-sheet diets |
|
|
| -L-Citrullin |
only for balance-sheet diets |
|
|
| -L-Cysteine |
|
|
|
| -L-Cystin |
|
|
|
| -L-Histidine |
|
|
|
| -L-glutamic acid |
|
|
|
| -L-glutamine |
|
|
|
| -Glycine |
only for balance-sheet diets |
|
|
| -L-Isoleucine |
|
|
|
| -L-Leucine |
|
|
|
| -L-Lysine |
|
|
|
| -L-lysine acetate |
|
|
|
| -L-methionine |
|
|
|
| -L-Ornithine |
|
|
|
| -L-phenylalanine |
|
|
|
| -L-Proline |
only for balance-sheet diets |
|
|
| -L-Serine |
only for balance-sheet diets |
|
|
| -L-Threonine |
|
|
|
| -L-tryptophan |
|
|
|
| -L-Tyrosin |
|
|
|
| -L-Valine |
|
|
|
| -L-Arginine-L-Aspartat |
only for balance-sheet diets |
|
|
| -L-Lysine-L-Aspartat |
only for balance-sheet diets |
|
|
| -L-Lysine-L-Glutamate |
only for balance-sheet diets |
|
|
| -N-Acetyl-L-Cysteine |
only for balance-sheet diets |
|
|
| -N-Acetyl-L-methionine |
only for balance-sheet diets intended for persons older than 1 year |
|
|
| In the case of authorised amino acids, the sodium, potassium, calcium and magnesium salts and their hydrochlorides can also be used. |
|
|
|
| Category 4 |
|
|
|
| Carnitine and taurine |
|
|
|
| -L-carnitine *) |
|
|
|
| -L-carnitine hydrochloride |
|
|
|
| -L-Carnitin-L-Tartrate |
|
|
|
| -Taurine |
|
|
|
| Category 5 |
|
|
|
| Nucleotides |
|
|
|
| -Adenosine-5 '-phosphoric acid (AMP) |
|
|
|
| -Sodium salts |
|
|
|
| of AMP |
|
|
|
| -Cytidine-5 '-monophosphoric acid (CMP) |
|
|
|
| -Sodium salts |
|
|
|
| of CMP |
|
|
|
| -Guanosine-5 ' phosphoric acid (GMP) |
|
|
|
| -Sodium salts of GMP |
|
|
|
| -Inosine-5 '-phosphoric acid (IMP) |
|
|
|
| -Sodium salts of IMP |
|
|
|
| -Uridin-5 '-phosphoric acid (UMP) |
|
|
|
| -Sodium salts of UMP |
|
|
|
| Category 6 |
|
|
|
| Choline and Inosit |
|
|
|
| -Choline *) |
|
|
|
| -Choline Chloride |
|
|
|
| -Choline citrate |
|
|
|
| -Cholintartrate |
|
|
|
| -Inosit |
|
|
|
Other substances
-Agar-Agar
-St John's breadcrumbs
-Guarker flour |
for dietetic foods intended for use as a meal or in place of a meal or as a daily ration for low-calorie diets for weight reduction |
a total of up to 30 grams per kilogram of the ready-to-eat product, including the quantities added for technological purposes |
|
-pectin
-amidated pectin |
for dietetic foods intended for use as a meal or in place of a meal or as a daily ration for low-calorie diets for weight reduction |
a total of up to 50 grams per kilogram of the ready-to-eat product, including the quantities added for technological purposes |
|
-St John's breadcrumbs
-Guarker flour
-pectin
amidated pectin
-lecithin |
for food, suitable for the treatment of infant dyspepsia |
a total of up to 10 grams per kilogram of ready-to-eat product |
|
| 1) The maximum and minimum quantities of substances used for balance-sheet diets shall be determined in accordance with the quantitative limits laid down in paragraph 14b in conjunction with Appendix 6. |
-
*)
-
The substances marked in this way are not additives.
|
Unofficial table of contents
Appendix 3 (to § 9)
Additives authorised for dietetic foods as saline salesset
Source of the original text: BGBl. I 2005, 1184
-
1.
-
The compounds of potassium, calcium and magnesium with adipic acid, succinic acid, glutamic acid, carbonic acid, lactic acid, hydrochloric acid, tartaric acid and citric acid; monopotassium phosphate; adipic acid; glutamic acid;
-
2.
-
potassium sulphate;
-
3.
-
the choline salts of acetic acid, carbonic acid, lactic acid, hydrochloric acid, tartaric acid and citric acid;
-
4.
-
Potassium guanylate and potassium aluminate.
Unofficial table of contents
Appendix 4 (to § 11a)
Official certificate for the movement of iodinated saline, of other dietetic foods, with the addition of iodine compounds or of dietetic foods intended for use as a balance-sheet diet
(Fundstelle des Originaltextes: BGBl. I 2005, 1185)
Country of origin: ................................................................
Issuing Authority: .........................................................
I. Information on the identification of the goods:
Type of goods: ............................................................
Transport name of the goods: ............................................
Number of packages of consignment: .......................................................
Quantity of goods by weight: ..............................................................
Labelling of the consignment: .......................................................
II. Origin of the goods:
Name and address of manufacturing plant: ............................
Name and address of the sender: ........................................
III. Determination of the goods:
Name and address of consignee: .......................................................
The goods are dispatched by: ............................................................
(place of dispatch)
to: ............................................................
(place of destination)
IV. Certificate
The signatory authority shall certify *):
(a) that the above-mentioned common saline rate shall be:
Use of potassium or Sodium iodate was produced and
at least 15 milligrams, but not more than 25 milligrams
Iodine per kilogram of iodinated feed salt, including
of a natural iodine content,
(b) that the food referred to above shall be:
Addition of the provisions of Annex 2 of the Dietary Regulation
Iodine compounds have been produced and the
not below the minimum quantities laid down in Annex 2
and maximum levels shall not be exceeded,
(c) that the food referred to above, which is the
Use as a balance-sheet diet is intended to
Regulations of § 14b of the Diätverordnung (Diätverordnung)
.......................... ....................
(Place and date) (service seal) (competent authority)
-----
*) Please delete as appropriate.
Unofficial table of contents
Appendix 5 (omitted)
-
Unofficial table of contents
Appendix 6 (to § 14b) Minimum and maximum quantities of minerals, trace elements and vitamins of balanced diets, related to the ready-to-eat product
(Fundstelle des Originaltextes: BGBl. I 2005, 1186;
with regard to of the individual amendments. Footnote)
| Infants |
Other than infants |
| |
Minimum quantity based on 100 KJ |
Maximum quantity based on 100 KJ |
Minimum quantity based on 100 kcal |
Maximum quantity based on 100 kcal |
Minimum quantity based on 100 KJ |
Maximum quantity based on 100 KJ |
Minimum quantity based on 100 Kcal |
Maximum quantity based on 100 kcal |
| Vitamins |
|
|
|
|
|
|
|
|
| Vitamin A (myg RE) |
14 |
43 |
60 |
180 |
8.4 |
43 |
35 |
180 |
| Vitamin D (myg) |
0.25 |
0.75 |
1 |
3 |
0.12 |
0.65/ |
0.5 |
2 ,5/3 |
| |
|
|
|
|
|
|
0.75 1) |
1) |
| Vitamin K (myg) |
1 |
5 |
4 |
20 |
0.85 |
5 |
3.5 |
20 |
| Vitamin C (mg) |
1.9 |
6 |
8 |
25 |
0.54 |
5.25 |
2.25 |
22 |
| Thiamine (mg) |
0.01 |
0.075 |
0.04 |
0.3 |
0.015 |
0.12 |
0.06 |
0.5 |
| Riboflavin (mg) |
0.014 |
0.1 |
0.06 |
0.45 |
0.02 |
0.12 |
0.08 |
0.5 |
| Vitamin B6 (mg) |
0.009 |
0.075 |
0.035 |
0.3 |
0.02 |
0.12 |
0.08 |
0.5 |
| Niacin (mg NE) |
0.2 |
0.75 |
0.8 |
3 |
0.22 |
0.75 |
0.9 |
3 |
| Folic acid (myg) |
1 |
6 |
4 |
25 |
2.5 |
12.5 |
10 |
50 |
| Vitamin B12 (myg) |
0.025 |
0.12 |
0.1 |
0.5 |
0.017 |
0.17 |
0.07 |
0.7 |
| Panthothenic acid |
|
|
|
|
|
|
|
|
| (mg) |
0.07 |
0.5 |
0.3 |
2 |
0.35 |
0.35 |
0.15 |
1.5 |
| Biotin (myg) |
0.4 |
5 |
1.5 |
20 |
0.18 |
1.8 |
0.75 |
7.5 |
| Vitamin E (mg alpha-TE) |
0 ,5/g |
0.75 |
0 ,5/g |
3 |
0 ,5/g |
0.75 |
0 ,5/g |
3 |
| |
polyunsaturated fatty acid, expressed as linoleic acid, re, not less than 0.1 mg per 100 usable |
|
polyunsaturated fatty acid, expressed as linoleic acid, re, not less than 0.1 mg per 100 usable |
|
polyunsaturated fatty acid, expressed as linoleic acid, re, not less than 0.1 mg per 100 usable |
|
polyunsaturated fatty acid, expressed as linoleic acid, re, not less than 0.1 mg per 100 usable |
|
| |
KJ |
|
Kcal |
|
KJ |
|
Kcal |
|
| Mineral substances |
|
|
|
|
|
|
|
|
| Sodium (mg) |
5 |
14 |
20 |
60 |
7.2 |
42 |
30 |
175 |
| Chloride (mg) |
12 |
29 |
50 |
125 |
7.2 |
42 |
30 |
175 |
| Potassium (mg) |
15 |
35 |
60 |
145 |
19 |
70 |
80 |
295 |
| Calcium (mg) |
12 |
60 |
50 |
250 |
8.4/ |
42/ |
35/ |
175/ |
| |
|
|
|
|
12 1) |
60 1) |
50 1) 250 1) |
|
| Phosphorus (mg) |
6 2) |
22 2) |
25 2) 90 2) |
7.2 |
19 |
30 |
80 |
|
| Magnesium (mg) |
1.2 |
3.6 |
5 |
15 |
1.8 |
6 |
7.5 |
25 |
| Iron (mg) |
0.12 |
0.5 |
0.5 |
2 |
0.12 |
0.5 |
0.5 |
2 |
| Zinc (mg) |
0.12 |
0.6 |
0.5 |
2.4 |
0.12 |
0.36 |
0.5 |
1.5 |
| Copper (myg) |
4.8 |
29 |
20 |
120 |
15 |
125 |
60 |
500 |
| Jod (myg) |
1.2 |
8.4 |
5 |
35 |
1.55 |
8.4 |
6.5 |
35 |
| Selenium (myg) |
0.25 |
0.7 |
1 |
3 |
0.6 |
2.5 |
2.5 |
10 |
| Manganese (myg) |
0.25 |
25 |
1 |
100 |
12 |
120 |
50 |
500 |
| Chrome (myg) |
|
2.5 |
|
10 |
0.3 |
3.6 |
1.25 |
5 |
| Molybdenum (myg) |
|
2.5 |
|
10 |
0.72 |
4.3 |
3.5 |
18 |
| Fluoride (mg) |
|
0.05 |
|
0.2 |
|
0.05 |
|
0.2 |
-
1)
-
For products intended for children from 1 to 10 years of age.
|
-
2)
-
The calcium/phosphorus ratio shall not be less than 1.2 and not more than 2.0.
|
Unofficial table of contents
Appendix 7 (omitted)
-
Unofficial table of contents
Annex 8 (to § 4a (1))
(Fundstelle: BGBl. I 2005, 1187;
with regard to of the individual amendments. Footnote)
| Groups of food products for which individual regulations are to be met |
| 1. |
Infant formulae and follow-on formulae |
| 2. |
Cereal-based foods and other supplements for infants and young children |
| 3. |
Food with low or reduced calorific value for weight monitoring |
| 4. |
Foods for special medical purposes (balance-sheet diets) |
| 5. |
Low-sodium foods, including dietary salts, which have a low sodium content or are sodium-free |
| 6. |
Gluten-free food |
| 7. |
Food for intensive muscular effort, especially for sportsmen |
| 8. |
Food for persons suffering from a change in glucose metabolism (diabetic) |
Unofficial table of contents
Annex 9 (to § 7 para. 1 no. 2, § 7b, § 14c para. 1, § 14d para. 2, § 22b para. 3)
(Fundstelle: BGBl. I 2005, 1188-1190;
with regard to of the individual amendments. Footnote)
| 1. Vitamins |
| Vitamin |
Vitamin compound |
not approved for use in |
| Vitamin A |
Retinyl acetate |
|
| |
Retinyl palmitate |
|
| Beta-carotene |
Infant formulae and follow-on formulae |
| Retinol |
|
| Vitamin D |
Vitamin D2 (Ergocalciferol) |
|
| |
Vitamin D3 (Cholecalciferol) |
|
| Vitamin B1 |
Thiamine hydrochloride |
|
| |
Thiamine nitrate |
|
| Vitamin B2 |
Riboflavin |
|
| |
Riboflavin-5 '-phosphate |
|
| Sodium |
|
| Niacin |
Nicotinic acid amide |
|
| |
Nicotinic acid |
|
| Vitamin B6 |
Pyridoxine hydrochloride |
|
| |
Pyridoxin-5 '-phosphate |
|
| Pyridoxine palmitate |
Infant formulae and follow-on formulae |
| Folic acid |
Folate |
|
| Pantothenic acid |
Calcium-D-pantothenate |
|
| |
Sodium D-pantothenate |
|
| Dexpanthenol |
|
| Vitamin B12 |
Cyanocobalamin |
|
| |
Hydroxocobalamin |
|
| Biotin |
D-Biotin |
|
| Vitamin C |
L-Ascorbinic acid |
|
| |
Sodium L-ascorbate |
|
| Calcium-L-ascorbate |
|
| 6-Palmitoyl-L-ascorbic acid |
|
| (L-Ascorbyl palmitate) |
|
| Potassium ascorbate |
|
| Vitamin E |
D-alpha-tocopherol |
|
| |
DL-Alpha-tocopherol |
|
| D-alpha-tocopheryl acetate |
|
| DL-alpha-tocopheryl acetate |
|
| Vitamin K |
Phylloquinone (Phytomenadione) |
|
| 2. Mineral substances |
| Mineral |
Mineral compounds |
not approved for use in |
| Calcium (Ca) |
Calcium carbonate |
|
| |
Calcium chloride |
|
| Calcium citrate |
|
| Calcium gluconate |
|
| Calcium glycerophosphate |
|
| Calcium lactate |
|
| Calcium orthophosphate |
|
| Calcium oxide |
Infant formulae and follow-on formulae |
| Calcium hydroxide |
|
| Magnesium (Mg) |
magnesium carbonate |
|
| |
magnesium chloride |
|
| magnesium lactate |
Infant formulae and follow-on formulae |
| Magnesium oxide |
|
| Magnesium orthophosphates |
|
| magnesium sulphate |
|
| Magnesium gluconate |
|
| magnesium glycerophosphate |
Infant formulae and follow-on formulae |
| magnesium hydroxide |
|
| magnesium citrate |
|
| Iron (Fe) |
elemental iron |
Infant formulae and follow-on formulae |
| |
Iron-II-bisglycinate |
Beikost |
| Iron (II) carbonate |
Infant formulae and follow-on formulae |
| Iron-II citrate |
|
| Iron-II-gluconate |
|
| Iron-II-lactate |
|
| Iron (II) sulphate |
|
| Iron-II-ammonium citrate |
|
| Iron-II fumarate |
|
| Iron (III) diphosphate |
|
| Iron-III-saccharate |
Infant formulae and follow-on formulae |
| Ferric sodium diphosphate |
Infant formulae and follow-on formulae |
| Copper (Cu) |
Copper citrate |
|
| |
Copper gluconate |
|
| Copper sulphate |
|
| Copper lysine complex |
|
| Copper carbonate |
|
| Iodine (I) |
Potassium iodide |
|
| |
Sodium iodide |
|
| Potassium iodate |
|
| Sodium iodate |
Infant formulae and follow-on formulae |
| Zinc (Zn) |
Zinc acetate |
|
| |
Zinc Chloride |
|
| Zinc actate |
|
| Zinc sulphate |
|
| zinc citrate |
|
| Zinc gluconate |
|
| Zinc oxide |
|
| Manganese (Mn) |
Manganese II carbonate |
|
| |
Manganese (II) chloride |
|
| Manganese II citrate |
|
| Manganese (II) sulphate |
|
| Manganese-II-gluconate |
|
| Manganese II glycerophosphate |
Infant formulae and follow-on formulae |
| Sodium (Na) |
Sodium bicarbonate |
Beikost |
| |
Sodium chloride |
| Sodium citrate |
| Sodium gluconate |
| Sodium carbonate |
| Sodium lactate |
| Sodium orthophosphates |
| Sodium hydroxide |
| Potassium (K) |
Potassium bicarbonate |
Beikost |
| |
Potassium carbonate |
Beikost |
| Potassium chloride |
|
| Potassium citrate |
|
| Potassium gluconate |
|
| Potassium glycerophosphate |
Infant formulae and follow-on formulae |
| Potassium lactate |
|
| Potassium orthophosphates |
Beikost |
| Potassium hydroxide |
Beikost |
| Selenium (Se) |
Sodium selenate |
Beikost |
| |
Sodium selenite |
| 3. Amino acids and their compounds as well as other nitrogen-containing compounds |
| Fabric |
Not approved for use in |
| L-Arginine and its hydrochloride |
Infant formulae and follow-on formulae 1) |
| L-Cystin and its Hydrochloride |
|
| L-Histidine and its hydrochloride |
|
| L-Isoleucine and its hydrochloride |
|
| L-Leucine and its hydrochloride |
|
| L-Lysine and its hydrochloride |
|
| L-Cysteine and its hydrochloride |
|
| L-Methionine |
|
| L-phenylalanine |
|
| L-Threonine |
|
| L-Tryptophan |
|
| L-Tyrosin |
|
| L-Valine |
|
| L-carnitine and its hydrochloride |
|
| L-Carnitin-L-Tartrate |
Beikost |
| Taurine |
Beikost |
| Cytidine 5 '-monophosphate and its sodium salt |
Beikost |
| Uridin-5 '-monophosphate and its sodium salt |
Beikost |
| Adenosine-5 '-monophosphate and its sodium salt |
Beikost |
| Guanosin-5 '-monophosphate and its sodium salt |
Beikost |
| Inosin-5 '-monophosphate and its sodium salt |
Beikost |
| 4. Other substances |
| Choline |
| Choline chloride |
| Choline citrate |
| Choline tartrate |
| Inositol |
Unofficial table of contents
Annex 10 (to § 14c (2) and (3) and (22a) (2) (1) (f))
Basic composition of infant formula after preparation as indicated by the manufacturer
(Fundstelle: BGBl. I 2007, 3267-3271;
with regard to of the individual amendments. (footnote) The given values refer to the product either ready for consumption or prepared in accordance with the manufacturer ' s instructions.
-
1.
-
Burn Value
at least
250 kJ/100 ml
(60 kcal/100 ml) |
295 kJ/100 ml
(70 kcal/100 ml) |
-
2.
-
Protein sources may only be used for the following protein sources
(protein content = nitrogen content x 6.25).
-
2.1
-
Infant formula on the basis of cow's milk proteins or goat milk proteins 1)
at least Maximum
0.45 g/100 kJ
(1.8 g/100 kcal) |
0.7 g/100 kJ
(3 g/100 kcal) |
-
2.2
-
Infant formula on the basis of protein hydrolysates 2)
at least Maximum
0.45 g/100 kJ
(1.8 g/100 kcal) |
0.7 g/100 kJ
(3 g/100 kcal) |
The L-carnitine content must be at least 0.3 mg/100 kJ (1.2 mg/100 kcal).
-
2.3
-
Infant formulae from soy protein isolates, pure or in a mixture with cow ' s milk proteins or goat ' s milk proteins
at least
0.56 g/100 kJ
(2.25 g/100 kcal) |
0.7 g/100 kJ
(3 g/100 kcal) |
Only protein isolates from soya are to be used in the preparation of this infant formula. The L-carnitine content must be at least 0.3 mg/100 kJ (1.2 mg/100 kcal). Infant formulae contain any indispensable and conditionally indispensable amino acid at least in the same quantity available as the reference protein (breast milk according to Appendix 12). However, in this calculation, the methionine and cystine content may be combined, provided that the ratio of methionine to cystine is not greater than 2: 1; the phenylalanine and tyrosine content may be combined, provided that: The tyrosine ratio to phenylalanine is not greater than 2: 1. The ratio of methionine to cystine may be greater than 2: 1, but not more than 3: 1, provided that the suitability of the product for the particular nutritional needs of infants has been demonstrated by appropriate studies, which, according to general terms, are: recognised recommendations by professional circles for the design and implementation of such studies.
-
2.4
-
Amino acids In all cases, the addition of amino acids is only permitted in order to improve the nutritional value of the proteins and only in the quantities necessary for this purpose.
-
3.
-
If taurine is added to infant formula, the taurine content must not be greater than 2.9 mg/100 kJ (12 mg/100 kcal).
-
4.
-
Choline
at least
1.7 mg/100 kJ
(7 mg/100 kcal) |
12 mg/100 kJ
(50 mg/100 kcal) |
-
5.
-
Bold
at least
1.05 g/100 kJ
(4.4 g/100 kcal) |
1.4 g/100 kJ
(6,0 g/100 kcal) |
-
5.1
-
The use of the following ingredients is prohibited:
-
-
-
Sesame oil
-
-
-
Cottonseed oil.
-
5.2
-
Lauric acid and myristic acid
at least
| - |
individually or in total:
20% of the total fat content |
-
5.3
-
The content of trans fatty acids must not exceed 3% of the total fat content.
-
5.4
-
The erucic acid content must not exceed 1% of the total fat content.
-
5.5
-
Linoleic acid (in the form of glycerides = linoleates)
at least
70 mg/100 kJ
(300 mg/100 kcal) |
285 mg/100 kJ
(1 200 mg/100 kcal) |
-
5.6
-
The α-linolenic acid content must be at least 12 mg/100 kJ (50 mg/100 kcal). The ratio of linoleic acid to α-linolenic acid must be at least 5: 1 and must not exceed 15: 1.
-
5.7
-
Long-chain (20 and 22 carbon atoms), polyunsaturated fatty acids can be added. In this case, their share of the total fat content shall be:
-
-
-
in the case of long-chain, polyunsaturated n-3 fatty acids, at most 1%, and
-
-
-
in the case of long-chain, polyunsaturated n-6 fatty acids, at most 2% (at most 1% for arachidonic acid (20: 4 n-6))
The content of eicosapentaenoic acid (20: 5 n-3) must not be higher than the content of docosahexaenoic acid (22: 6 n-3). The docosahexaenoic acid content (22: 6 n-3) must not exceed the content of long-chain, polyunsaturated n-6-fatty acids.
-
6.
-
PhospholipideThe content of phospholipids in infant formulae may not be higher than 2 g/l.
-
7.
-
Inositol
at least
1 mg/100 kJ
(4 mg/100 kcal) |
10 mg/100 kJ
(40 mg/100 kcal) |
-
8.
-
Carbohydate
at least
2.2 g/100 kJ
(9 g/100 kcal) |
3.4 g/100 kJ
(14 g/100 kcal) |
-
8.1
-
Only the following carbohydrates may be used:
-
-
-
Lactose,
-
-
-
Maltose,
-
-
-
sucrose,
-
-
-
glucose,
-
-
-
maltodextrins,
-
-
-
glucose syrup or dried glucose syrup,
-
-
-
pre-cooked starch, by nature gluten-free,
-
-
-
gelatinized starch, by nature gluten-free.
-
8.2
-
Lactose
at least
1.1 g/100 kJ
(4.5 g/100 kcal) |
- |
The provision does not apply to infant formulae, in which the proportion of soya protein isolates is more than 50% of the total protein content.
-
8.3
-
Saccharose sucrose may only be added to infant formulae produced from protein hydrolysates. If sucrose is added, its content may not exceed 20% of the total carbohydrate content.
-
8.4
-
Glucose glucose may only be added to infant formulae produced from protein hydrolysates. If glucose is added, its content may not exceed 0.5 g/100 kJ (2 g/100 kcal).
-
8.5
-
Pre-cooked starch and/or gelatinized starch
at least
| - |
2 g/100 ml and 30%
of the total carbohydrate content |
-
9.
-
Fructo-oligosaccharides and galacto oligosaccharideFructo oligosaccharides and galacto-oligosaccharides may be added to infant formulae. In this case, their share may not exceed 0.8 g/100 ml in a combination of 90% oligogalactosyl lactose and 10% oligofructosyl sucrose with a high molecular weight. Other combinations and maximum levels of fructo-oligosaccharides and Galacto-Oligosaccharides can be used in accordance with § 14c (2) (a).
-
10.
-
Mineral substances
-
10.1
-
Infant formulae from cow's milk proteins or goat milk proteins or protein hydrolysates
per 100 kJje 100 kcal
minimum maximum at least
| Sodium (mg) |
5 |
14 |
20 |
60 |
| Potassium (mg) |
15 |
38 |
60 |
160 |
| Chlorine (mg) |
12 |
38 |
50 |
160 |
| Calcium (mg) |
12 |
33 |
50 |
140 |
| Phosphorus (mg) |
6 |
22 |
25 |
90 |
| Magnesium (mg) |
1.2 |
3.6 |
5 |
15 |
| Iron (mg) |
0.07 |
0.3 |
0.3 |
1.3 |
| Zinc (mg) |
0.12 |
0.36 |
0.5 |
1.5 |
| Copper (µ g) |
8.4 |
25 |
35 |
100 |
| Iodine (µ g) |
2.5 |
12 |
10 |
50 |
| Selenium (µ g) |
0.25 |
2.2 |
1 |
9 |
| Manganese (µ g) |
0.25 |
25 |
1 |
100 |
| Fluorine (µ g) |
- |
25 |
- |
100 |
The ratio of calcium to phosphorus in infant formula is at least 1: 1 and not more than 2: 1.
-
10.2
-
Infant formulae from soy protein isolates, pure or in a mixture with cow ' s milk proteins or goat ' s milk protein. All the requirements set out in point 10.1 shall apply, with the exception of iron and phosphorus requirements, which are as follows:
per 100 kJje 100 kcal
minimum maximum at least
| Iron (mg) |
0.12 |
0.5 |
0.45 |
2 |
| Phosphorus (mg) |
7.5 |
25 |
30 |
100 |
-
11.
-
Vitamins
per 100 kJje 100 kcal
minimum maximum at least
| Vitamin A (µ g-RE) 1) |
14 |
43 |
60 |
180 |
| Vitamin D (µ g) 2) |
0.25 |
0.65 |
1 |
2.5 |
| Thiamine (µ g) |
14 |
72 |
60 |
300 |
| Riboflavin (µ g) |
19 |
95 |
80 |
400 |
| Niacin (µ g) 3) |
72 |
375 |
300 |
1 500 |
| Pantothenic acid (µ g) |
95 |
475 |
400 |
2 000 |
| Vitamin B6 (µ g) |
9 |
42 |
35 |
175 |
| Biotin (µ g) |
0.4 |
1.8 |
1.5 |
7.5 |
| Folic acid (µ g) |
2.5 |
12 |
10 |
50 |
| Vitamin B12 (µ g) |
0.025 |
0.12 |
0.1 |
0.5 |
| Vitamin C (mg) |
2.5 |
7.5 |
10 |
30 |
| Vitamin K (µ g) |
1 |
6 |
4 |
25 |
| Vitamin E (mg α-TE) 4) |
0 ,5/g polyunsaturated
Fatty acids, expressed as linoleic acid, corrected by the number of double-
The 5) , on
no case
, however, less than 0,1 mg/100 kJ |
1.2 |
0 ,5/g polyunsaturated
Fatty acids, expressed as linoleic acid, corrected by the number of double-
The 5) , on
no case
but less than 0,5 mg/100
available kcal |
5 |
-
-
RE = Retinol equivalent, all trans.
-
-
In the form of cholecalciferol, of which 10 µ g = 400 IU of vitamin D.
-
-
Pre-formed niacin.
-
-
α-TE = d-α-Tocopherol equivalent.
-
-
0.5 mg α-TE/1 g linoleic acid (18: 2 n-6); 0.75 mg α-TE/1 g α-linolenic acid (18: 3 n-3); 1.0 mg α-TE/1 g arachidonic acid (20: 4 n-6); 1.25 mg α-TE/1 g eicosapentaenoic acid (20: 5 n-3); 1.5 mg α-TE/1 g docosahexaenoic acid (22: 6 n-3).
-
12.
-
Nucleotides The following nucleotides can be used: 1)
Maximum
(mg/100 kJ) (mg/100 kcal)
| Cytidine 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 |
-
-
The total concentration of nucleotides must not exceed 1.2 mg/100 kJ (5 mg/100 kcal).
Footnote
Appendix 10 No. 8 Surr. Italic print: Should be really loud "carbohydrates"
Unofficial table of contents
Annex 11 (to § 14c (4) and (5) and (22a) (2) (1) (f))
Basic composition of follow-on formulae after preparation according to manufacturer's instructions
(Fundstelle: BGBl. I 2007, 3271-3274;
with regard to of the individual amendments. Footnote)
The values indicated shall relate to the product which is either ready for consumption or prepared in accordance with the manufacturer ' s instructions.
-
1.
-
Burn Value
at least
250 kJ/100 ml
(60 kcal/100 ml) |
295 kJ/100 ml
(70 kcal/100 ml) |
-
2.
-
Protein sources may only be used for the following protein sources
(protein content = nitrogen content x 6.25).
-
2.1
-
Follow-up on the basis of cow ' s milk proteins or goat milk proteins
at least
0.45 g/100 kJ
(1.8 g/100 kcal) |
0.8 g/100 kJ
(3.5 g/100 kcal) |
-
2.2
-
Follow-up on the basis of protein hydrolysates 1
at least Maximum
0.45 g/100 kJ
(1.8 g/100 kcal) |
0.8 g/100 kJ
(3.5 g/100 kcal) |
-
2.3
-
Follow-up from soy protein isolates, pure or in a mixture with cow's milk proteins or goat milk proteins
at least
0.56 g/100 kJ
(2.25 g/100 kcal) |
0.8 g/100 kJ
(3.5 g/100 kcal) |
In the case of the same calorific value, the follow-on formula shall contain any indispensable and conditionally indispensable amino acid at least in the same quantity available as the reference protein (breast milk according to Appendix 12). However, in this calculation, the methionine and cystine content may be combined, provided that the ratio of methionine to cystine is not greater than 3: 1; the phenylalanine and tyrosine content may be combined, provided that: The ratio of tyrosine to phenylalanine is not greater than 2: 1.
-
2.4
-
Amino acids In all cases, the addition of amino acids is only permitted in order to improve the nutritional value of the proteins and only in the quantities necessary for this purpose.
-
3.
-
When taurine is added, the taurine content must not be greater than 2.9 mg/100 kJ (12 mg/100 kcal).
-
4.
-
Bold
at least
0.96 g/100 kJ
(4.0 g/100 kcal) |
1.4 g/100 kJ
(6,0 g/100 kcal) |
-
4.1
-
The use of the following ingredients is prohibited:
-
-
-
Sesame oil
-
-
-
Cottonseed oil.
-
4.2
-
Lauric acid and myristic acid
at least
| - |
Single or total:
20% of the total fat content |
-
4.3
-
The content of trans fatty acids must not exceed 3% of the total fat content.
-
4.4
-
The erucic acid content must not exceed 1% of the total fat content.
-
4.5
-
Linoleic acid (in the form of glycerides = linoleates)
at least
70 mg/100 kJ
(300 mg/100 kcal) |
285 mg/100 kJ
(1 200 mg/100 kcal) |
-
4.6
-
The α-linolenic acid content must be at least 12 mg/100 kJ (50 mg/100 kcal). The ratio of linoleic acid to α-linolenic acid must be at least 5: 1 and must not exceed 15: 1.
-
4.7
-
Long-chain (20 and 22 carbon atoms), polyunsaturated fatty acids can be added. In this case, their share of the total fat content shall be:
-
-
-
in the case of long-chain, polyunsaturated n-3 fatty acids, at most 1%, and
-
-
-
in the case of long-chain, polyunsaturated n-6 fatty acids, at most 2% (at most 1% for arachidonic acid (20: 4 n-6))
The content of eicosapentaenoic acid (20: 5 n-3) must not be higher than the content of docosahexaenoic acid (22: 6 n-3). The docosahexaenoic acid content (22: 6 n-3) must not exceed the content of long-chain, polyunsaturated n-6-fatty acids.
-
5.
-
PhospholipideThe content of phospholipids in follow-on formulae may not be higher than 2g/l.
-
6.
-
Carbohydrates
at least
2.2 g/100 kJ
(9 g/100 kcal) |
3.4 g/100 kJ
(14 g/100 kcal) |
-
6.1
-
The use of gluten-containing ingredients is prohibited.
-
6.2
-
Lactose
at least
1.1 g/100 kJ
(4.5 g/100 kcal) |
- |
The provision shall not apply to follow-on formulae, in which the proportion of soya protein isolates is more than 50% of the total protein content.
-
6.3
-
Sucrose, Fructose, Honey
at least
| - |
individually or in total 20%
of the total carbohydrate content |
Honey is to be subjected to a treatment for the destruction of Clostridium botulinum-Sporen.
-
6.4
-
Glucose glucose may only be added to the follow-on formula produced from protein hydrolysates. If glucose is added, its content may not exceed 0.5 g/100 kJ (2 g/100 kcal).
-
7.
-
Fructo-oligosaccharides and galacto-oligosaccharideFructo-oligosaccharides and galacto-oligosaccharides may be added to the following formula. In this case, their share may not exceed 0.8 g/100 ml in a combination of 90% oligogalactosyl lactose and 10% oligofructosyl sucrose with a high molecular weight. Other combinations and maximum levels of fructo-oligosaccharides and Galacto-Oligosaccharides may be used in accordance with § 14c (4) (a).
-
8.
-
Mineral substances
-
8.1
-
Follow-up from cow's milk proteins or goat milk proteins or protein hydrolysates
per 100 kJje 100 kcal
minimum maximum at least
| Sodium (mg) |
5 |
14 |
20 |
60 |
| Potassium (mg) |
15 |
38 |
60 |
160 |
| Chlorine (mg) |
12 |
38 |
50 |
160 |
| Calcium (mg) |
12 |
33 |
50 |
140 |
| Phosphorus (mg) |
6 |
22 |
25 |
90 |
| Magnesium (mg) |
1.2 |
3.6 |
5 |
15 |
| Iron (mg) |
0.14 |
0.5 |
0.6 |
2 |
| Zinc (mg) |
0.12 |
0.36 |
0.5 |
1.5 |
| Copper (µ g) |
8.4 |
25 |
35 |
100 |
| Iodine (µ g) |
2.5 |
12 |
10 |
50 |
| Selenium (µ g) |
0.25 |
2.2 |
1 |
9 |
| Manganese (µ g) |
0.25 |
25 |
1 |
100 |
| Fluorine (µ g) |
- |
25 |
- |
100 |
The ratio of calcium to phosphorus in follow-on formulae shall be at least 1: 1 and not more than 2: 1.
-
8.2
-
Follow-up from soy protein isolates, or in a mixture with cow ' s milk proteins or goat ' s milk protein, all the requirements set out in point 8.1 shall apply, with the exception of iron and phosphorus requirements, which shall read as follows:
per 100 kJje 100 kcal
minimum maximum at least
| Iron (mg) |
0.22 |
0.65 |
0.9 |
2.5 |
| Phosphorus (mg) |
7.5 |
25 |
30 |
100 |
-
9.
-
Vitamins
per 100 kJje 100 kcal
minimum maximum at least
| Vitamin A (µ g-RE) 1) |
14 |
43 |
60 |
180 |
| Vitamin D (µ g) 2) |
0.25 |
0.75 |
1 |
3 |
| Thiamine (µ g) |
14 |
72 |
60 |
300 |
| Riboflavin (µ g) |
19 |
95 |
80 |
400 |
| Niacin (µ g) 3) |
72 |
375 |
300 |
1 500 |
| Pantothenic acid (µ g) |
95 |
475 |
400 |
2 000 |
| Vitamin B6 (µ g) |
9 |
42 |
35 |
175 |
| Biotin (µ g) |
0.4 |
1.8 |
1.5 |
7.5 |
| Folic acid (µ g) |
2.5 |
12 |
10 |
50 |
| Vitamin B12 (µ g) |
0.025 |
0.12 |
0.1 |
0.5 |
| Vitamin C (mg) |
2.5 |
7.5 |
10 |
30 |
| Vitamin K (µ g) |
1 |
6 |
4 |
25 |
| Vitamin E (mg α-TE) 4) |
0 ,5/g polyunsaturated fatty acids, expressed as linoleic acid, corrected by the number of double bonds 5) , in no case, however,
less than
0.1 mg/100
available kJ |
1.2 |
0 ,5/g polyunsaturated fatty acids, expressed as linoleic acid, corrected by the number of double bonds 5) , in no case, however,
less than
0.5 mg/100
available kcal |
5 |
-
-
RE = Retinol equivalent, all trans.
-
-
In the form of cholecalciferol, of which 10 µ g = 400 IU of vitamin D.
-
-
Pre-formed niacin.
-
-
α-TE = d-α-Tocopherol equivalent.
-
-
0.5 mg α-TE/1 g linoleic acid (18: 2 n-6); 0.75 mg α-TE/1 g α-linolenic acid (18: 3 n-3); 1.0 mg α-TE/1 g arachidonic acid (20: 4 n-6); 1.25 mg α-TE/1 g eicosapentaenoic acid (20: 5 n-3); 1.5 mg α-TE/1 g docosahexaenoic acid (22: 6 n-3).
-
10.
-
Nucleotides The following nucleotides can be used: 1)
Maximum
(mg/100 kJ) (mg/100 kcal)
| Cytidine 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 |
-
-
The total concentration of nucleotides must not exceed 1.2 mg/100 kJ (5 mg/100 kcal).
Unofficial table of contents
Appendix 12 (to § 14c (2) and (4); Appendixes 10 and 11, respectively Nos. 2.1, 2.2 and 2.3)
Indispensable and conditionally indispensable
Amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal
(Fundstelle des Originaltextes: BGBl. I 2007, 3274)
1)
Amino acid per 100 kJ per 100 kcal
| Cystin |
9 |
38 |
| Histidine |
10 |
40 |
| Isoleucine |
22 |
90 |
| Leucine |
40 |
166 |
| Lysine |
27 |
113 |
| Methionine |
5 |
23 |
| Phenylalanine |
20 |
83 |
| Threonine |
18 |
77 |
| Tryptophan |
8 |
32 |
| Tyrosine |
18 |
76 |
| Valine |
21 |
88 |
-
-
1 kJ = 0,239 kcal
Unofficial table of contents
Appendix 13 (omitted)
-
Unofficial table of contents
Appendix 14 (omitted)
-
Unofficial table of contents
Annex 15 (to section 22a (3) (2) (b) and (c))
Nutrition and health claims for
Infant formulae and conditions justifying a claim
(Fundstelle des Originaltextes: BGBl. I 2007, 3275)
-
1.
-
Nutrition claims
Nutrition-related disclosure requirement for nutrition claims
| 1.1 |
Only lactose included |
Lactose is the only existing
Carbohydrate. |
| 1.2 |
Lactose-free |
The lactose content is at most 2.5 mg/100 kJ (10 mg/100 kcal). |
| 1.3 |
Addition of long-chain, polyunsaturated fatty acids or an equivalent nutrition claim with respect to the addition of docosahexaenoic acid |
The content of docosahexaenoic acid is at least 0.2% of the total fatty acid content. |
| 1.4 |
Nutrition claim with regard to the
Addition of the following optional ingredients: |
Voluntarily added in a concentration appropriate for the intended special use by infants and corresponding to the conditions set out in Appendix 10. |
| 1.4.1 |
Taurine |
| 1.4.2 |
Fructo-Oligosaccharides and Galacto
oligosaccharides |
| 1.4.3 |
Nucleotides |
-
2.
-
Health claims (including information on the reduction of disease risks)
Health claim requirements for health claims
| 2.1 |
Reducing the risk of allergies to milk proteins. In this health claim terms may be used which refer to reduced allergen or reduced antigen content. |
a) |
Objective and scientifically proven data must be available for the detection of the claimed properties. |
| b) |
Infant formulae must comply with the requirements set out in Annex 10, point 2.2, the quantity of proteins causing the immune response must be demonstrated by means of generally accepted measurement methods, and must not exceed 1% of the nitrogen containing substances of the initial food. |
| c) |
The labelling shall indicate that infants who are allergic to intact proteins from which the food is produced may not consume them unless evidence of the presence of the presence of the human body is required to be used in a generally accepted clinical test. The compatibility of infant formula in more than 90% (95% of confidence) has been performed in cases where infants suffer from hypersensitivity to the proteins from which the hydrolyzate is produced. |
| d) |
The orally administered infant formula should not raise sensitisation in animals against the intact proteins from which the infant formula is produced. |
Unofficial table of contents
Annex 16 (to section 22a (4))
Reference values for nutrition labelling
of foods intended for infants and young children
(Fundstelle: BGBl. I 2007, 3276;
with regard to of the individual amendments. Footnote)
Nutrient reference value
| Vitamin A |
(μg) |
400 |
| Vitamin D |
(μg) |
7 |
| Vitamin E |
(mg TE) |
5 |
| Vitamin K |
(μg) |
12 |
| Vitamin C |
(mg) |
45 |
| Thiamine |
(mg) |
0.5 |
| Riboflavin |
(mg) |
0.7 |
| Niacin |
(mg) |
7 |
| Vitamin B6 |
(mg) |
0.7 |
| Folate |
(μg) |
125 |
| Vitamin B12 |
(μg) |
0.8 |
| Pantothenic acid |
(mg) |
3 |
| Biotin |
(μg) |
10 |
| Calcium |
(mg) |
550 |
| Phosphorus |
(mg) |
550 |
| Potassium |
(mg) |
1.000 |
| Sodium |
(mg) |
400 |
| Chlorine |
(mg) |
500 |
| Iron |
(mg) |
8 |
| Zinc |
(mg) |
5 |
| Iodine |
(μg) |
80 |
| Selenium |
(μg) |
20 |
| Copper |
(mg) |
0.5 |
| Magnesium |
(mg) |
80 |
| Manganese |
(mg) |
1.2 |
Unofficial table of contents
Annex 17 (to § 14a (2), § 21a (4) No. 2, § 21a (6) no. 1)
Essential ingredients of foods for low calorie diets
Source of the original text: BGBl. I 2005, 1203-1204
The information refers to ready-to-use products sold as such or made ready for use in accordance with the manufacturer ' s instructions.
-
1.
-
Burn Value
-
1.1
-
The calorific value of a product intended to replace a daily ration shall be at least 3,360 kilojoules (800 kilocalories) and no more than 5,040 kilojoules (1,200 kilocalories) per daily ration.
-
1.2
-
The calorific value of a product intended to replace a meal must be at least 840 kilojoules (200 kilocalories) and a maximum of 1,680 kilojoules (400 kilocalories) per meal.
-
2.
-
Proteins
-
2.1
-
The calorific value of food for low-calorie diets must be at least 25% and no more than 50% proteins. In no case shall any product intended to replace a daily ration contain more than 125g of proteins.
-
2.2
-
The rules for proteins refer to the reference protein described in paragraph 6. If the chemical index is less than 100% of the index of the reference protein, the minimum protein content should be increased accordingly. In this case, the chemical index of the protein added must be at least 80% of the index of the reference protein.
-
2.3
-
The chemical index is the lowest ratio between the amount of each single essential amino acid of the protein to be tested and the amount of the corresponding amino acid of the reference protein in each case.
-
2.4
-
The addition of amino acids is only permitted in order to improve the nutritional value of the proteins and only to the extent necessary for this purpose.
-
3.
-
Fat
-
3.1
-
The calorific value of the fats shall not exceed 30% of the total calorific value of the product.
-
3.2
-
Products intended to replace a daily ration must contain at least 4.5 g of linoleic acid.
-
3.3
-
Products which are intended to replace a meal must contain at least 1 g of linoleic acid.
-
4.
-
BallaststoffeThe products intended for the replacement of a daily ration must contain at least 10 g and not more than 30 g of fibre per day ration.
-
5.
-
Vitamins and minerals
-
5.1
-
The products intended to replace a daily ration must supply at least the vitamin and mineral contents listed in paragraph 7 above.
-
5.2
-
The products which are offered as a substitute for one or more meals as part of the daily ration must provide at least 30% of the amounts of vitamins and minerals listed in paragraph 7 per meal and at least 500 mg of potassium per meal .
| 6. |
Request scheme for amino acids |
|
| |
|
g/100 g protein |
| Cystin + methionine |
1.7 |
| Histidine |
1.6 |
| Isoleucine |
1.3 |
| Leucine |
1.9 |
| Lysine |
1.6 |
| Phenylalanine + Thyrosin |
1.9 |
| Threonine |
0.9 |
| Tryptophan |
0.5 |
| Valine |
1.3 |
| 7. |
Nutrient contents per day |
|
| |
Vitamin A |
700 myg retinol equivalent |
| Vitamin D |
5 myg |
| Vitamin E |
10 mg Tocopherol equivalent |
| Vitamin C |
45 mg |
| Thiamine |
1.1 mg |
| Riboflavin |
1.6 mg |
| Niacin |
18 mg nicotinic acid amide equivalent |
| Vitamin B6 |
1.5 mg |
| Folate |
200 myg |
| Vitamin B12 |
1.4 myg |
| Biotin |
15 myg |
| Pantothenic acid |
3 mg |
| Calcium |
700 mg |
| Phosphorus |
550 mg |
| Potassium |
3.100 mg |
| Iron |
16 mg |
| Zinc |
9.5 mg |
| Copper |
1.1 mg |
| Iodine |
130 myg |
| Selenium |
55 myg |
| Sodium |
575 mg |
| Magnesium |
150 mg |
| Manganese |
1 mg |
Unofficial table of contents
Annex 18 (to § 14d (3))
Maximum amounts of vitamins, minerals and trace elements, if they are added to the food
Source of the original text: BGBl. I 2005, 1205
Maximum nutritional value per 100 kcal
| Vitamin A |
180 myg RE |
| Vitamins E |
3 mg alpha-TE |
| Vitamins C |
12 ,5/25 11) /125 22) mg |
| Thiamine |
0 ,25/0, 5 33) mg |
| Riboflavin |
0.4 mg |
| Niacin |
4.5 mg NE |
| Vitamin B6 |
0.35 mg |
| Folic acid |
50 myg |
| Vitamin B12 |
0.35 myg |
| Pantothenic acid |
1.5 mg |
| Biotin |
10 myg |
| Potassium |
160 mg |
| Calcium |
80/180 44) /100 55) mg |
| Magnesium |
40 mg |
| Iron |
3 mg |
| Zinc |
2 mg |
| Copper |
40 myg |
| Iodine |
35 myg |
| Manganese |
0.6 mg |
-
-
This limit shall apply to the products referred to in Article 1 (3) (2) (d).
-
-
This limit shall apply to the products referred to in Article 1 (3) (2) (a) and (b).
-
-
This limit shall apply to cereal-based products.
-
-
This limit shall apply to fruit-based products, fruit juices, fruit nectars and vegetable juices.
-
-
This limit shall apply to products enriched with iron.
Unofficial table of contents
Annex 19 (to § 14d para. 4, § 22b para. 2 no. 2)
Basic composition of cereal beige
(Fundstelle: BGBl. I 2005, 1206-1207;
with regard to of the individual amendments. Footnote) The nutritional requirements refer to the prepared product as ready for consumption or prepared for consumption according to the manufacturer ' s instructions.
-
-
1.
-
Cereals The proportion of cereal or tuber products or a mixture of the two must be at least 25% of the weight of the final mixture (dry weight).
-
2.
-
Protein
-
2.1
-
In the case of the products referred to in Article 1 (3) (2) (b) and (d), the protein content may not exceed 1.3 g/100 kJ (5.5 g/100 kcal).
-
2.2
-
In the case of the products referred to in Article 1 (3) (2) (b), the content of the protein added must be at least 0.48 g/100 kJ (2 g/100 kcal).
-
2.3
-
The biscuits referred to in Article 1 (3) (2) (d), which are produced with the addition of a high protein food and are offered as such, must have a protein content of at least 0.36 g/100 kJ (1.5 g/100 kcal). .
-
2.4
-
The chemical index of the protein added must be at least 80% of the reference protein Casein, as described in Appendix 13, or the protein efficiency (PER) of the protein in the mixture must be at least 70% of the reference protein. In all cases, the addition of amino acids is only permitted in order to improve the nutritional value of the protein mixture and only in the ratio necessary for this purpose.
-
3.
-
Carbohydrates
-
3.1
-
Where the products are added to the products referred to in Article 1 (3) (2) (a) and (d) of sucrose, fructose, glucose, glucose syrup or honey, the following may be added:
-
-
-
the proportion of carbohydrates derived from these additives is not more than 1.8 g per 100 kJ (7.5 g/100 kcal),
-
-
-
the addition of fructose to a maximum of 0.9 g/100 kJ (3.75 g/100 kcal)
.
-
3.2
-
If, according to Article 1 (3) (2) (b), sucrose, fructose, glucose, glucose syrup or honey are added to the products, the products may be added to the products.
-
-
-
the proportion of carbohydrates derived from these additives is not more than 1.2 g per 100 kJ (5 g/100 kcal),
-
-
-
the addition of fructose to a maximum of 0.6 g/100 kJ (2.5 g/100 kcal)
.
-
4.
-
Fat
-
4.1
-
In the case of the products referred to in Article 1 (3) (2) (a) and (d), the fat content may not exceed 0.8 g/100 kJ (3.3 g/100 kcal).
-
4.2
-
The products referred to in Article 1 (3) (2) (b) may have a fat content of not more than 1.1 g/100 kJ (4.5 g/100 kcal). If the fat content exceeds 0.8 g/100 kJ (3.3 g/100 kcal),
-
-
-
the lauric acid content may not exceed 15% of the total fat content,
-
-
-
the myristic acid content shall not exceed 15% of the total fat content,
-
-
-
the linoleic acid content (in the form of glycerides = linoleates) must reach a value of at least 70 mg/100 kJ (300 mg/100 kcal) and not more than 285 mg/100 kJ (1,200 mg/100 kcal).
-
5.
-
Mineral substances
-
5.1
-
Sodium
-
-
-
Sodium salts may only be added to cereals, if necessary for technical reasons.
-
-
-
The sodium content of cereal-based foods may not exceed 25 mg/100 kJ (100 mg/100 kcal).
-
5.2
-
Calcium
-
5.2.1
-
The products referred to in Article 1 (3) (2) (b) must have a calcium content of at least 20 mg/100 kJ (80 mg/100 kcal).
-
5.2.2
-
The products referred to in Article 1 (3) (2) (d), manufactured using milk, (milk cookies), which are offered as such, must have a calcium content of at least 12 mg/100 kJ (50 mg/100 kcal).
-
6.
-
Vitamins
-
6.1
-
Cereal beige must have a thiamine content of at least 25 myg/100 kJ (100 myg/100 kcal).
6.2 For the products referred to in Article 1 (3) (2) (b)
the following contents:
-----------------------------------------------------------------------
per 100 kJ per 100 kcal
Min max. Min max.
-----------------------------------------------------------------------
Vitamin A (myg RE) 1) 14 43 60 180
Vitamin D (myg) 2) 0.25 0.75 1 3
-----
1) RE = all-trans retinol equivalent.
2) In the form of cholecalciferol, of which 10 myg=400 IU of vitamin D.
These limit values also apply in the case of vitamin A and D other
Added as referred to in Article 1 (3) (2) (b) of the cereal aid
.
Unofficial table of contents
Appendix 20 (to § 14d para. 5, § 22b para. 2 no. 2)
Basic composition of other co-foods as cereal-based foods
(Fundstelle des Originaltextes: BGBl. I 2005, 1208-1209;
with regard to of the individual amendments. Footnote)
The nutritional requirements refer to the product prepared as ready-to-eat or ready-to-eat according to the manufacturer's instructions.
-
-
1.
-
Protein
-
1.1
-
Where meat, poultry, fish, offal or other conventional sources of protein are the only ingredients mentioned in the transport name, it shall be necessary to:
-
-
-
whereas the percentage of meat, poultry, fish, offal or other conventional sources of protein as a whole is at least 40% of the total weight of the product and at least 25% of the total weight of the protein sources;
-
-
-
the content of protein from said sources is at least 1.7 g/100 kJ (7 g/100 kcal).
-
1.2
-
Where meat, poultry, fish, offal or other conventional sources of protein are, individually or in combination, in the first place, whether or not the product has been established as a meal, must be:
-
-
-
the percentage of meat, poultry, fish, offal or other conventional sources of protein as a whole is at least 10% of the total weight of the product and at least 25% of the weight of the protein sources;
-
-
-
the content of protein from the sources mentioned is at least 1 g/100 kJ (4.2 g/100 kcal).
-
1.3
-
Where meat, poultry, fish, offal or other conventional sources of protein are mentioned in the name of the transport name individually or in combination, but not in the first place, whether the product has been served as a meal, or not, must be: not
-
-
-
the percentage of meat, poultry, fish, offal or other conventional sources of protein as a whole is at least 8% of the total weight of the product and at least 25% of the weight of the protein sources;
-
-
-
the content of protein from said sources is at least 0.5 g/100 kJ (2.2 g/100 kcal),
-
-
-
the total content of any protein of any kind is at least 0.7 g/100 kJ (3 g/100 kcal).
-
1.3a
-
If cheese is mentioned together with other ingredients in the name of a non-sweet product, whether or not the product has been made up as a meal,
-
-
-
the protein content of milk products must be at least 0.5 g/100 kJ (2.2 g/100 kcal) and protein from all sources in total at least 0.7 g/100 kJ (3 g/100 kcal).
-
1.4
-
However, if the product is referred to as a meal on the label, meat, poultry, fish, offal or other conventional sources of protein are not mentioned in the sales description, the total protein content of the product must be taken from all sources. at least 0.7 g/100 kJ (3 g/100 kcal).
-
1.4a
-
Sauces intended to be served as a supplement to a meal shall not be subject to the requirements of points 1.1 to 1.4.
-
1.4b
-
Desserts in which milk products are the first or only ingredient in the sales designation must contain at least 2.2 g of milk protein/100 kcal. All other desserts are excluded from the requirements in 1.1 to 1.4.
-
1.5
-
The addition of amino acids is only permitted in order to improve the nutritional value of the existing proteins and only in the amount required for this purpose.
-
2.
-
Carbohydrates The carbohydrate content of juices and nectars from fruit and vegetables, pure fruit dishes, desserts or puddings may at most reach the following values:
-
-
-
10 g/100 ml of vegetable juice and drinks based on vegetable juice;
-
-
-
15 g/100 ml in the case of fruit juice or Fruit nectar and beverages produced on the basis of the fruit nectar;
-
-
-
20 g/100 g for pure fruit dishes;
-
-
-
25 g/100 g for desserts and puddings;
-
-
-
5 g/100 g for other beverages not prepared from milk.
-
3.
-
Bold
-
3.1
-
For products referred to in 1.1 of this Appendix: where meat or cheese is the only ingredient listed in the name of the transport name, or if it is in the first place, the total fat content of all sources shall not exceed 1,4 g/100 kJ (6 g/100 kcal) .
-
3.2
-
For all other products, the total content of fat from all sources may not exceed 1.1 g/100 kJ (4.5 g/100 kcal).
-
4.
-
Sodium
-
4.1
-
The sodium content of the finished product shall not exceed 48 mg/100 kJ (200 mg/100 kcal) or not more than 200 mg/100 g. However, where cheese is the only ingredient referred to in the transport name, the sodium content may not exceed 70 mg/kJ (300 mg/100 kcal).
-
4.2
-
Fruit foods, desserts and puddings must not be added to sodium salts, except for technological purposes.
-
5.
-
VitamineIn the case of fruit juice, fruit nectar or vegetable juice, the vitamin C content of the finished product must be at least 6 mg/100 kJ (25 mg/100 kcal) or 25 mg/100 g. In the case of vegetable juice, the content of vitamin A of the finished product must be at least 25 myg RE/100 kJ (100 myg RE/100 kcal) 1) . Otherwise, the addition of vitamin A to other co-foods is not permitted as a cereal supplement. Other food supplements as cereal supplements must not be added to vitamin D.
-
-
RE = all-trans retinol equivalent.
Unofficial table of contents
Appendix 21 (to § 22b (4))
Reference values for the nutrition labelling of nurses for infants and young children
Source of the original text: BGBl. I 2005, 1210
Nutrient reference value for labelling
| Vitamin A |
400 myg |
| Vitamin D |
10 myg |
| Vitamin C |
25 mg |
| Thiamine |
0.5 mg |
| Riboflavin |
0.8 mg |
| Niacin equivalent |
9 mg |
| Vitamin B6 |
0.7 mg |
| Folate |
100 myg |
| Vitamin B12 |
0.7 myg |
| Calcium |
400 mg |
| Iron |
6 mg |
| Zinc |
4 mg |
| Iodine |
70 myg |
| Selenium |
10 myg |
| Copper |
0.4 mg |
Unofficial table of contents
Annex 22 (to section 14 (1) (1) (b))
Specific maximum residue levels for pesticides or their metabolites in infant formulae, follow-on formulae, cereal-based foods and other co-foods for infants and young children
Source of the original text: BGBl. I 2005, 1211
Chemical name of the maximum substance residue content (mg/kg)
| Cadusafos |
0.006 |
| Demeton-S-methyl/Demeton-S-methyl-sulphon/oxydemeton-methyl (singly or combined, expressed as Demeton-S-methyl) |
0.006 |
| Ethoprophos |
0.008 |
| Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) |
0.004 |
| Propineb/propylene-thiourea (sum of propineb and propylene-thiourea) |
0.006 |
Unofficial table of contents
Annex 23 (to section 14 (1) (1) (c))
Pesticides used in agricultural products intended for the manufacture of infant formulae, follow-on formulae, cereal-based foods and other co-foods for infants and young children shall be deemed not to be used if the specific maximum residue levels shall not be exceeded
(Fundstelle: BGBl. I 2005, 1212)
List A
Chemical name of the substance (residue definition) Maximum residue level (mg/kg)
| Disulfoton (Sum of Disulfoton, Disulfoton-Sulfoxide and Disulfoton-Sulfon, expressed as Disulfoton) |
0.003 |
| Fensulphothion (sum of fensulphothion, its oxygen analogue and its sulphones, expressed as fensulphothion) |
0.003 |
| Fentin, expressed as triphenyl tin cation |
0.003 |
| Haloxyfop (sum of halxyfop, its salts and esters, including conjugates, expressed as haloxyfop) |
0.003 |
| Heptachlor and trans-heptachlor-epoxide, expressed as heptachlor |
0.003 |
| Hexachlorobenzene |
0.003 |
| Nitrofen |
0.003 |
| Omethoate |
0.003 |
| Terbufos (Sum of Terbufos, whose sulphoxide and its sulphone, expressed as terbufos) |
0.003 |
List B
Chemical name of the maximum substance residue content (mg/kg)
| Aldrin and Dieldrin, expressed as dieldrin |
0.003 |
| Endrin |
0.003 |
Unofficial table of contents
Annex 24 (to § 14c (3) and (5))
Specification of protein content and source as well as protein processing and quality in the manufacture of infant formula and follow-on formula with a protein content of less than 0.56 g/100 kJ (2.25 g/100 kcal) based on Whey protein hydrolysates from cow ' s milk protein
(Fundstelle: BGBl. I 2007, 3276-3277;
with regard to of the individual amendments. Footnote)
-
1.
-
Protein content (protein content) = nitrogen content × 6,25
at least
0.44 g/100 kJ
(1.86 g/100 kcal) |
0.7 g/100 kJ
(3 g/100 kcal) |
-
2.
-
Protein quelledemineralized sweet whey protein from cow's milk after enzymatic precipitation of casein using chymosin, consisting of:
-
a)
-
63% Casein-Glycomacropeptide-free whey protein isolate with a minimum protein content of 95% dry mass and a protein denaturation of less than 70% and a maximum ash content of 3%; and
-
b)
-
37% sweet whey protein concentrate with a minimum protein content of 87% dry matter and protein denaturation of less than 70% and a maximum ash content of 3.5%.
-
3.
-
Protein-processing two-stage hydrolysis process using a trypsin preparation with a heat treatment step (3 to 10 minutes at 80 to 100 ° C) between the two hydrolysis steps.
-
4.
-
Protein quality within the meaning of Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006 /141/EC as regards the requirements for the composition of certain infant formulae (OJ L 327, 30.12.2008, p. 25) The following values, expressed in mg per 100 kJ and 100 kcal, shall apply to the essential amino acids in breast milk which are essential and essential:
1)
Per 100 kJ Per 100 kcal
| Arginine |
16 |
69 |
| Cystin |
6 |
24 |
| Histidine |
11 |
45 |
| Isoleucine |
17 |
72 |
| Leucine |
37 |
156 |
| Lysine |
29 |
122 |
| Methionine |
7 |
29 |
| Phenylalanine |
15 |
62 |
| Threonine |
19 |
80 |
| Tryptophan |
7 |
30 |
| Tyrosine |
14 |
59 |
| Valine |
19 |
80 |
-
-
1 kJ = 0,239 kcal.
