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RS 817.022.32 Order of the DFI of 23 November 2005 on the addition of essential or physiologically relevant substances to foodstuffs

Original Language Title: RS 817.022.32 Ordonnance du DFI du 23 novembre 2005 sur l’addition de substances essentielles ou physiologiquement utiles aux denrées alimentaires

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817.022.32

DFI Ordinance on the addition of essential or physiologically relevant substances to foodstuffs

On 23 November 2005 (State 1 Er January 2014)

The Federal Department of the Interior (DFI),

See art. 18, para. 2, of the Ordinance of 23 November 2005 on foodstuffs and common objects (ODAlOUs) 1 ,

Stops:

Art. 1 Purpose and scope

1 This order sets out the conditions applying to the addition of essential or physiologically useful substances such as vitamins, mineral salts and other substances to foodstuffs, as well as the labelling and Related advertising. 1

2 The use of essential or physiologically useful substances as additives is governed by the provisions of the Ordinance of 23 November 2005 on additives 2 .


1 New content according to the c. I of the DFI O of 7 March 2008, in force since 1 Er April 2008 ( RO 2008 1049 ).
2 [ RO 2005 6191 . RO 2007 2997 art. 7]. See currently O of June 22, 2007 (RS 817.022.31 ).

Art. 2 1 Adjunctions allowed and not allowed

1 Vitamins, minerals and other substances listed in Schedule 1 may be added to foods for the purpose of maintaining or improving their nutritional value or for reasons of public health.

2 The associations of vitamins, minerals and other substances listed in Annex 2 shall be allowed.

3 Vitamins, minerals and other substances may not be added to the foodstuffs listed in Annex 4.

4 The specific provisions applying to the various categories of foodstuffs are reserved.


1 New content according to the c. I of the DFI O of 7 March 2008, in force since 1 Er April 2008 ( RO 2008 1049 ).

Art. 3 Maximum Allowed Quantities

The addition of substances shall be calculated in such a way that the daily ration set out in Annex 3 does not exceed the daily intake recommended for adults according to Annex 1.

Art. 3 A 1 New Edible Oil

For new edible oils defined in s. 5 B To 5 J The DFI order of 23 November 2005 on edible oils and fats and their derivatives 2 Which are used to enrich foodstuffs in fatty acids, the specifications, the uses and the maximum levels mentioned in art. 5 C , 5 D , 5 E And 5 H Of the aforementioned order shall apply.


1 Introduced by ch. I of the O of the DFI of 25 Nov 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).
2 RS 817.022.105

Art. 4 1 Overdosage

In order to offset the loss of vitamins during storage, the initial intake of a daily ration can be increased, for each vitamin, up to 300 % of the recommended daily intake. For vitamin A the maximum overdose allowed is 200 % of the recommended daily intake.


1 New content according to the c. I of the O of the DFI of 25 Nov 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).

Art. 5 Addition of substances to edible salt and drinking water

1 The addition of fluoride, iodide or iodate to edible salt is allowed as long as it is justified in terms of public health.

2 The edible salt containing fluoride, iodide or iodate must contain, per kg, 250 mg fluoride calculated in fluorine or 20 to 30 mg iodine or iodate calculated in iodine.

3 The addition of fluoride to drinking water is permitted as long as it is justified in terms of public health.

4 Potable water containing fluoride must contain, per litre, a maximum of 1 mg of fluoride calculated in fluorine.

Art. 6 Labeling

1 Any addition of essential or physiologically relevant substances to a foodstuff must be reported in the list of ingredients in the food.

1bis The foods to which vitamins, minerals or other substances have been added must be labelled according to the meaning of the art. 22-29 of the Ordinance of the DFI of 23 November 2005 on the labelling and advertising of foodstuffs 1 An exception is the use of edible salt/cooking salt/iodized salt or edible salt/cooking salt/fluorinated salt. 2

2 The declared vitamin content may not exceed the daily intake recommended in the daily ration, even in the case of overdose within the meaning of s. 4. 3

3 In the case of adjunctive foods and food supplements, the labelling must indicate the vitamin content at the end of the retention period. 4

4 The iodized or fluorinated edible salt should be referred to as "Edible Sel/Kitchen Sel/Iodized Salt" or "Edible Sel/Kitchen Sel". 5

5 For edible salt, the following shall be allowed:

A.
For iodized salt: "Adequate iodine intake prevents the formation of a goitre";
B.
For fluorinated salt: "Fluoride is effective against cavities".

3 The labelling must indicate the vitamin content at the time the foodstuff is delivered to the consumer. 6


1 RS 817.022.21
2 Introduced by ch. I of the DFI O of 7 March 2008, in force since 1 Er April 2008 ( RO 2008 1049 ).
3 New content according to the c. I of the DFI O of 7 March 2008, in force since 1 Er April 2008 ( RO 2008 1049 ).
4 New content according to the c. I of the DFI O of 7 March 2008, in force since 1 Er April 2008 ( RO 2008 1049 ).
5 New content according to the c. I of the DFI O of 7 March 2008, in force since 1 Er April 2008 ( RO 2008 1049 ).
6 Introduced by ch. I of the O of the DFI of 25 Nov 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).

Art. 7 Authorisation of substances on a case-by-case basis

1 The Federal Office for Food Safety and Veterinary Affairs (FVO) may, on request, authorise the addition of other essential or physiologically useful substances not included in Annex 1. 1

2 It examines the safety of the added substance, the appropriateness of adding, the labelling and the corresponding advertising.

3 The authorisation procedure, the duration of the authorisation and its revocation shall be governed by Art. 5, para. 3 and 4, and art. 6, para. 1, 2 and 4, ODAlOUs.


1 New content according to the c. I of the O of the DFI of 25 Nov 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).

Art. 8 1 Amendment of Annexes

The OSAV regularly adapts the annexes to this order according to the scientific and technical knowledge and the laws of Switzerland's main trading partners. It takes into account the decisions of the European Food Safety Authority (EFSA).


1 New content according to the c. I of the O of the DFI of 25 Nov 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).

Art. Entry into force

This order shall enter into force on 1 Er January 2006.

Transitional Provision of the Amendment of 7 March 2008 2

Transitional provision of the amendment of 27 April 2009 3

Transitional Provision of the Amendment of 12 October 2010 4

Transitional provisions relating to the amendment of 25 November 2013 5

1 Foodstuffs not in accordance with the amended version of 25 November 2013 of this Ordinance may still be manufactured, imported and labelled under the old right until 31 December 2015.

2 They may be handed over to the consumer in accordance with the old right until stocks are exhausted.


Annex 1 1

(art. 2, para. 1, and art. 3)

Vitamins, mineral salts and other permitted substances, daily intakes recommended for adults

Substance

Recommended Daily Intake for Adults

1 Vitamins

Vitamin A

800

M G

â-carotene (provitamin A)

4.8

Mg

Vitamin D

5

M G

Vitamin E

12

Mg

Vitamin C

80

Mg

Vitamin K

75

M G

Vitamin B 1 (Thiamin)

1.1

Mg

Vitamin B 2 (Riboflavin)

1.4

Mg

Niacin (vitamin PP)

16

Mg

Vitamin B 6

1.4

Mg

Folic acid/folacin

200

M G

Vitamin B 12

2.5

M G

Biotin

50

M G

Pantothenic acid

6

Mg

2 Mineral salts

Calcium

800

Mg

Phosphorus

700

Mg

Iron

14

Mg

Magnesium

375

Mg

Zinc

10

Mg

Iodine

150

M G

Selenium

55

M G

Copper

1

Mg

Manganese

2

Mg

Chromium

40

M G

Molybdenum

50

M G

Fluoride

3.5

Mg

Potassium

2000

Mg

Chloride

800

Mg

3 Other Substances

Choline

550

Mg

Livestock

1.5

G

Lycopene

15

Mg

Fatty acids:

Polyunsaturated fatty acids (n-6)

10

G

Alpha-linolenic acid (n-3)

2

G

Eicosapentaenoic acid and docosahexaenoic acid combined (EPA + DHA) (n-3)

500

Mg


1 New content according to the c. II of the O of the DFI of 25 November 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).


State 1 Er January 2014

Annex 2 1

(art. 2, para. 2)

Acceptable associations of vitamins, minerals and other substances

Category 1: Vitamins

Vitamin A

Retinol

Retinyl acetate

Retinyl Palmitate

Beta-carotene

Vitamin D

Vitamin D 3 (cholecalciferol)

Vitamin D 2 (ergocalciferol)

Vitamin E

D-alpha-tocopherol

DL-alpha-tocopherol

D-alpha-tocopherol acetate

DL-alpha-tocopherol acetate

D-alpha-tocopherol acid sugar

Vitamin K

Phylloquinone (phytomenadione)

Menaquinone 2

Vitamin B 1

Thiamine Hydrochloride

Thiamine Nitrate

Vitamin B 2

Riboflavin

Riboflavin-5-sodium phosphate

Niacin

Nicotinic acid

Nicotinamide

Pantothenic acid

D-Calcium pantothenate

D-Sodium pantothenate

D-panthenol

Vitamin B 6

Pyridoxine Hydrochloride

Pyridoxine-5-phosphate

Pyridoxine Dipalmitate

Folic acid

Pterylglutamic acid

L-methylfolate of calcium

Vitamin B 12

Cyanocobalamin

Hydroxocobalamin

Biotin

D-biotin

Vitamin C

L-ascorbic acid

Sodium ascorbate

Calcium ascorbate

Potassium ascorbate

L-ascorbyl 6-palmitate

Category 2: mineral salts

Bore

Boric acid

Sodium Borate

Calcium

Calcium Carbonate

Calcium Chloride

Calcium citrate malate

Calcium salts of citric acid

Calcium Gluconate

Calcium glycerophosphate

Calcium lactate

Calcium salts of orthophosphoric acid

Calcium hydroxide

Calcium malate

Calcium oxide

Calcium sulfate

Chromium

Chromium (III) chloride and its hexahydrate form

Chromium (III) sulfate and its hexahydrate form

Chromium Picolinate

Fluorine

Sodium Fluoride

Potassium Fluoride

Potassium

Potassium icarbonate

Potassium carbonate

Potassium chloride

Potassium Citrate

Potassium luconate

Potassium glycerophosphate

Potassium Lactate

Potassium hydroxide

Potassium salts of orthophosphoric acid

Magnesium

Magnesium acetate

Magnesium Carbonate

Magnesium chloride

Citric Acid Magnesium Salts

Magnesium gluconate

Magnesium Glycerophosphate

Orthophosphoric Acid Magnesium Salts

Magnesium Lactate

Magnesium Hydroxide

Magnesium oxide

Potassium-magnesium Citrate

Magnesium sulfate

Molybdenum

Ammonium Molybdate (molybdenum [VI])

Sodium Molybdate (molybdenum [VI])

Iron

Ferrous Bisglycinate

Iron Carbonate

Iron Citrate

Ammonium iron Citrate

Iron Gluconate

Iron Fumarate

Iron sodium phosphate

Iron Lactate

Iron sulfate

Ferrous ammonium phosphate

Iron removal sodium salt (III)

Iron phosphate (iron pyrophosphate)

Iron Saccharate

Iron elemental (sum of iron carbonyl, electrolyte iron, and iron reduced to hydrogen)

Iodine

Potassium iodide

Iodate of potassium

Sodium Iodure

Sodium Iodate

Copper

Copper Carbonate

Copper Citrate

Copper Gluconate

Copper sulfate

Copper-lysine complex

Manganese

Manganese Carbonate

Manganese chloride

Manganese Citrate

Manganese Gluconate

Manganese glycerophosphate

Manganese sulfate

Sodium

Sodium Bicarbonate

Sodium Carbonate

Sodium Citrate

Sodium Gluconate

Sodium Lactate

Sodium Hydroxide

Sodium salts of orthophosphoric acid

Selenium

Selenium enriched yeast 3

Sodium Selenate

Sodium hydrogenoselenite

Sodium selenite

Zinc

Zinc acetate

Zinc bisglycinate

Zinc chloride

Zinc Citrate

Zinc carbonate

Zinc gluconate

Zinc Lactate

Zinc oxide

Zinc sulfate

Category 3: Other substances

Livestock

Betaine HCl

Choline

Choline

Choline chloride

Choline Tartrate

Citrat of choline

Fatty acids

Fatty acids derived from edible oils and oils according to the DFI Ordinance of 23 November 2005 on edible oils and fats and their derivatives 4 .

Lycopene

Specifications as per Decisions 2009 /355/EC 5 , 2009 /362/THIS 6 And 2009 /365/EC 7 .


1 New content according to the c. II of the O of the DFI of 25 November 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).
2 Menaquinone primarily in the form of menaquinone-7 and, to a lesser extent, menaquinone-6.
3 Enriched selenium-enriched Levures in the presence of sodium selenite as a source of selenium and of which the selenium content, in the dehydrated form as marketed, is at most 2.5 mg/g. The predominant species of organic selenium present in yeast is selenomethionine, which constitutes between 60 and 85 % of the total selenium extracted in the product. Other compounds containing organic selenium, including selenocysteine, may not exceed 10 % of the total selenium extracted. Inorganic selenium levels normally do not exceed 1 % of the total selenium extracted.
4 RS 817.022.105
5 Commission D 2009 /355/EC of 28 April 2009 authorising the placing on the market of lycopene oleoresin extracted from tomato as a new food ingredient in application of R (EC) n O 258/97 of the European Parliament and of the Council, OJ L 109, 30.4.2009 p. 47.
6 Commission D 2009 /362/EC of 30 April 2009 authorising the placing on the market of lycopene as a new food ingredient under R (EC) n O 258/97 of the European Parliament and of the Council, OJ L 110, 1.5.2009 p. 54.
7 Commission D 2009 /365/EC of 28 April 2009 authorising the placing on the market of lycopene from Blakeslea trispora as a new food ingredient under R (EC) n O 258/97 of the European Parliament and of the Council, OJ L 111, 5.5.2009 p. 31.


State 1 Er January 2014

Annex 3 1

(art. 3)

Daily Rations

Foodstuffs

Daily Ration in g

Laits, regardless of the fat content

500

Acid Laits, All Categories

250

Cheese, cheese-based products

100

Butter, margarine, minarine

50

Edible oils and fats

30

Yeast extract, dry yeast

10

Grains, milling products

-
Dry consumption such as wheat germ

30

-
For hydrated preparations

100

Breakfast beverages (dehydrated preparations)

40

Breakfast Cereals

50

Bread, bakery items

100

Articles of biscuit and biscottery

100

Pasta (dehydrated)

100

Processed fruits and vegetables

200

Processed Potatoes

150

Fruit juices, nectars

300

Lemon juice

30

Limonads, cold tea, table drinks, beverages containing caffeine, etc.

500

Vegetable juice

200

Jams, jellies, spreads

50

Meat-based products

150

Confectionery Items

25

Tea, infusions of plants or fruit and similar hot beverages

300


1 New content according to the c. II of the O of the DFI of 25 November 2013, in force since 1 Er Jan 2014 ( RO 2013 5285 ).


State 1 Er January 2014

Annex 4 1

(art. 2, para. 3)

List of foodstuffs which cannot be added to vitamins, mineral salts or other substances

The following foodstuffs may not be added of vitamins, minerals or other substances:

1.
Fruits, vegetables, meat, including poultry, and fish;
2.
Beverages exceeding 1.2 % by volume of alcohol.

1 Introduced by c. III al. 2 of the DFI O of 7 March 2008, with effect from 1 Er April 2008 ( RO 2008 1049 ).


State 1 Er January 2014