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RS 817.022.14 DFI Ordinance of 16 December 2016 on Food Supplements (OCAl)

Original Language Title: RS 817.022.14 Ordonnance du DFI du 16 décembre 2016 sur les compléments alimentaires (OCAl)

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817.022.14

DFI Guidelines on Food Supplements

(OCAl)

On 16 December 2016 (State 1 Er May 2017)

The Federal Department of the Interior (DFI),

Having regard to art. 10, para. 4, let. A, 12, para. 3, 14, para. 1, 25, para. 2, 26, para. 3, and 36, para. 3 and 4, of the Ordinance of 16 December 2016 on foodstuffs and common objects (ODAlOUs) 1 ,

Stops:

Art. 1 Food supplements

Food supplements are foodstuffs intended to supplement the normal diet. They are a concentrated source of vitamins, mineral salts or other substances having a nutritional or physiological effect alone or in combination, marketed in the form of doses.

Art. 2 Requirements

1 Food supplements may only be marketed in a pre-packaged form unless they are given to the consumer for direct consumption.

2 They must be proposed in the form of doses such as capsules, pellets, tablets, pills or other similar forms, as well as sachets of powder, liquid light bulbs, flasks with a dropper or other Similar forms of liquid or powdered preparations intended to be taken in measured units of small quantity.

3 They may contain:

A.
The vitamins and minerals listed in Schedule 1, Part A, to the conditions contained therein;
B.
Other substances, in accordance with the restrictions set out in Annex 1, Part B;
C.
Substances that meet any of the following conditions:
1.
They are authorised under the DFI order of 16 December 2016 on new kinds of foodstuffs 1 And can be used in food supplements,
2.
They have been authorized by the FVO as new kinds of foodstuffs;
D.
Other foodstuffs; the let. A to c are reserved.

4 The substances listed in Annex 4 of the Ordinance of the DFI of 16 December 2016 on the addition of vitamins, minerals and certain other substances to foodstuffs (OASM) 2 Are forbidden.

5 The maximum amounts of vitamins, minerals and other substances defined in Annex 1 shall not be exceeded per recommended daily dose.

6 The accepted nutrient complexes of vitamins, minerals and other substances are set out in Schedule 2.

7 The requirements for the cultivation of live bacteria are defined in Annex 3.

8 The basic salts (bicarbonate, carbonate and citrate) of magnesium, potassium and calcium are allowed in dietary supplements based on basic mineral salts.


Art. 3 Labelling

1 The specific name of a food supplement is " Food supplement ", supplemented by the names of the categories of vitamins, mineral salts or other substances characterizing the product or by a reference to the nature of the vitamins, minerals or other substances.

2 The content of vitamins, minerals or other substances and their percentage in relation to the reference intake referred to in Annex 10, Part A of the Ordinance of the DFI of 16 December 2016 concerning information on foodstuffs (OIDAl) 1 Must be expressed in numerical form per recommended daily dose. The percentage can also be expressed in graphical form.

3 Labelling must include the content of vitamins, minerals and other substances at the time of delivery to the consumer. The values specified must be based on the average values referred to in s. 26, para. 4, OIDAl.

4 In the case of a reference to a vitamin, a mineral salt or other substance, must be understood by the recommended daily dose:

A.
For vitamins and minerals: at least 15 % of the reference amount set out in Annex 10, Part A, OIDAl;
B.
For other substances: at least 15 % of the maximum quantity set out in Schedule 1.

5 In the event of a reference to cultures of live bacteria or lactase, should be understood per recommended daily dose:

A.
For live bacterial cultures: at least 10 8 UFC 2 ;
B.
For lactase: 4500 FCC units 3 .
6 The addition of live bacterial cultures must be included in the list of ingredients and in the specific name in one of the following forms:
A.
Under the specific scientific nomenclature according to the requirements of the International Committee on Systematics of Prokaryotes 4 ;
B.
With the statement " With lactic ferments."

7 The indications referred to in Art. 3, para. 1, let. A to i, k, m and o to q, OIDAl must be completed by the following information:

A.
The recommended daily intake expressed in portions of the product;
B.
A warning that the recommended daily dose should not be exceeded;
C.
A statement that food supplements should not be used as substitutes for a varied diet;
D.
A statement that the products must be kept out of the reach of young children;
E.
Warnings or references to the specific target group or conditions of use set out in Schedule 1.

1 RS 817.022.16
2 UFC = colony-forming units
3 FCC = Food Chemicals Codex
4 CPSI; www.the-icsp.org

Art. 4 Prohibited Mentions

The labelling, presentation and advertising of dietary supplements may not indicate or suggest that a balanced and varied diet is not a sufficient source of nutrients in general.

Art. 5 Purity criteria

1 For substances listed in Annex 2, the specific purity criteria for additives as defined in the Annex to Regulation (EU) No 231/2012 1 , are applicable.

2 For substances listed in Annex 2 for which purity criteria have not been defined, the generally accepted purity criteria, recommended by international bodies such as FAO and WHO and European pharmacopoeias, Are applicable.


1 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down the specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council, OJ L 83, 22.3.2012, p. 1; last amended by Regulation (EU) No 2015/1739, OJ L 253, 30.09.2015, p. 3

Art. 6 Refreshing Annexes

1 The OSAV adapts the annexes according to the evolution of scientific and technical knowledge and the laws of Switzerland's main trading partners.

2 It may issue transitional provisions.

Art. 7 Entry into force

This order shall enter into force on 1 Er May 2017.

(art. 2, para. 3, let. A, b, and 5, 3, al. 4, let. B, and 7, let. (e)

Vitamins, mineral salts and other substances: maximum allowable quantities for adults

Part A: vitamins and mineral salts allowed

Part B: other substances with restrictions of use

1 Amino acid

L-arginine

2500 mg

L-citrulline

1000 mg

L-glutamine

10 g

Glycine

5 g

L-histidine

600 mg

L-isoleucine

1200 mg

L-leucine

2400 mg

L-lysine

1800 mg

L-methionine + L-cysteine (total)

900 mg

L-ornithine

2000 mg

L-phenylalanine + L-tyrosine (total)

1500 mg

L-threonine

900 mg

L-tryptophan

240 mg

L-valine

1600 mg

2 Other substances, amino acids not included

Alpha-linolenic acid (n-3)

2000 mg

Docosahexaenoic acid (DHA)

250 mg

450 mg

For pregnant or breastfeeding women

Eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) (total) (long chain n-3)

3000 mg

Not suitable for pregnant or nursing women.

450 mg

For pregnant or breastfeeding women

Conjugated linoleic acid (CLA)

3 g

Not suitable for people with diabetes, adolescents and pregnant or lactating women.

Astaxanthine

4 mg

Beta-alanine

3.2 g

Do not consume more than 8 to 10 weeks.

-The substance is delivered only as tablets, formulated as long-release tablets with the help of appropriate products (additives).

-The outlet shall be divided into at least two doses per day, preferably during a meal.

Livestock

1500 mg

Caffeine

3 mg/kg body weight

Lutein Carotenoid

10 mg

Lycopine Carotenoid

15 mg

Zeaxanthin carotenoid

2 mg

Catechins, epigallocatechin gallate (EGCG)

90 mg (calculated as EGCG)

Do not take jeun, in case of a strict hypocaloric diet or at the same time as other green tea products.

Choline

550 mg

Coenzyme NADH

10 mg

Coenzyme Q 10

50 mg

Water-soluble Tomato Concentrate (WSTC I)

3 g

Water-soluble Tomato Concentrate (WSTC II)

150 mg

Creatine

3 g

Living bacterial cultures

None

Glucosamine

750 mg

Hesperidin

430 mg

It is advisable for people taking medication to consult their doctor before taking these products.

Inositol

1000 mg

Isoflavones

50 mg

L-carnitine

1000 mg

Lactase

None

The target group should be informed that there are differences in lactose tolerance and that the persons concerned should take advice from a specialist concerning the function assumed by the substance in their diet.

Methylsulfonylmethane (MSM)

1000 mg

Proanthocyanidin Oligomeres (OPC)

150 mg

A product with OPC does not replace a fresh fruit and vegetable diet.

Chondroitin sulfate

500 mg

Not suitable for pregnant or lactating women, children, adolescents and people with anticoagulant treatment.

Taurine

1000 mg


Annex 2

(art. 2, para. 6, and 5, para. 1 and 2)

Permitted nutritional supplements of vitamins, minerals and other substances

1. Vitamins

Pantothenic acid

D-Calcium pantothenate

D-Sodium pantothenate

Dexpantothenol

Pantethine

Biotin

D-biotin

Folates

Pterylglutamic acid

L-methylfolate of calcium

(6S) - 5-methyltetrahydrofolic acid, glucosamine salt

Niacin

Nicotinic acid

Nicotinamide

Inositol hexanicotinate or inositol hexaniacinate

Riboflavin

Riboflavin

Riboflavin-5 ' - sodium phosphate

Thiamin

Thiamine Hydrochloride

Thiamine Mononitrate

Monophosphate thiamine chloride

Thiamine pyrophosphate chloride

Vitamin A

Retinol

Retinol acetate

Retinol Palmitate

Beta-carotene

Vitamin B6

Pyridoxine Hydrochloride

Pyridoxin-5 ' - phosphate

Pyridoxal 5 ' - phosphate

Vitamin B12

Cyanocobalamin

Hydroxocobalamin

5 ' - desoxyadenosylcobalamin

Methylcobalamin

Vitamin C

L-ascorbic acid

Sodium ascorbate

Calcium ascorbate (threonate content must be less than or equal to 2 %)

Potassium ascorbate

L-ascorbyl 6-palmitate

Magnesium ascorbate

Zinc ascorbate

Vitamin D

Vitamin D3 or cholecalciferol

Vitamin D2 or ergocalciferol

Vitamin E

D-alpha-tocopherol

DL-alpha-tocopherol

D-alpha-tocopherol acetate

DL-alpha-tocopherol acetate

D-alpha-tocopherol acid sugar

Mixtures of tocopherols 1

Tocotrienol-tocopherol 2

Vitamin K

Phylloquinone or phytomenadione

Menaquinone 3

2. Mineral salts

Calcium

Calcium acetate

Calcium ascorbate

Calcium bisglycinate

Calcium Carbonate

Calcium Chloride

Calcium citrate malate

Calcium salts of citric acid

Calcium Gluconate

Calcium glycerophosphate

Calcium lactate

Calcium Pyruvate

Calcium salts of orthophosphoric acid

Calcium Succinate

Calcium hydroxide

Calcium lysinate

Calcium malate

Calcium oxide

Calcium pidolate

L-Calcium Threonate

Calcium sulfate

Limestone or maërl red algae 4

Calcium-magnesium mixtures

Dolomite Powder

Fossil Coral Powder or Scleractinia

Chromium

Chromium chloride (III)

Chromium-enriched Levue 5

Chromium (III) Lactate trihydrate

Chromium nitrate

Chromium Picolinate

Chromium sulfate (III)

Copper

Copper Carbonate

Copper Citrate

Copper Gluconate

Copper sulfate

Copper L-aspartate

Copper bisglycinate

Copper-lysine complex

Copper (II) oxide

Iron

Ferrous Carbonate

Ferrous Citrate

Ferric ammonium Citrate

Ferrous Gluconate

Ferrous fumarate

Ferric sodium phosphate

Ferrous Lactate

Ferrous sulfate

Ferric phosphate or ferric pyrophosphate

Ferric Saccharate

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

Ferrous Bisglycinate

Ferrous pidolate

Ferrous phosphate (II)

Ferrous ammonium phosphate (II)

Iron Detach Sodium Salt (III)

Iron Taurate (II)

Iodine

Sodium Iodure

Sodium Iodate

Potassium iodide

Iodate of potassium

Magnesium

Magnesium acetate

Magnesium ascorbate

Magnesium Bisglycinate

Magnesium Carbonate

Magnesium chloride

Citric Acid Magnesium Salts

Magnesium gluconate

Magnesium Glycerophosphate

Orthophosphoric Acid Magnesium Salts

Magnesium Lactate

Magnesium lysinate

Magnesium Hydroxide

Magnesium malate

Magnesium oxide

Magnesium pidolate

Potassium-magnesium Citrate

Magnesium Pyruvate

Magnesium Succinate

Magnesium sulfate

Magnesium Taurate

Magnesium Acetyl-taurinate

Manganese

Manganese Ascorbate

Manganese L-aspartate

Manganese bisglycinate

Manganese Carbonate

Manganese chloride

Manganese Citrate

Manganese Gluconate

Manganese glycerophosphate

Manganese Pidolate

Manganese sulfate

Molybdenum (VI)

Ammonium Molybdate

Potassium Molybdate

Sodium Molybdate

Potassium

Potassium sulphate

Potassium icarbonate

Potassium carbonate

Potassium chloride

Potassium Citrate

Potassium luconate

Potassium glycerophosphate

Potassium Lactate

Potassium hydroxide

Potassium pidolate

Potassium malate

Potassium salts of orthophosphoric acid

Selenium

L-selenomethionine

Selenium enriched yeast 6

Selyneous acid

Sodium Selenate

Sodium hydrogenoselenite

Sodium selenite

Silicium

Choline-stabilized orthosilicic acid

Silicon dioxide

Silicic acid (in gel form)

Zinc

Zinc acetate

Zinc ascorbate

Zinc L-aspartate

Zinc bisglycinate

Zinc chloride

Zinc Citrate

Zinc gluconate

Zinc Lactate

Zinc lysinate

Zinc malate

Zinc mono-L-methionine sulfate

Zinc oxide

Zinc carbonate

Zinc pidolate

Zinc Picolinate

Zinc sulfate

3. Other substances

3.1 Amino acids

Note: for valid amino acids, sodium, potassium, calcium and magnesium salts and their chlorhydrates may also be used.

L-arginine

L-citrulline, citrulline malate

L-cysteine

L-glutamine

Glycine

L-histidine

L-isoleucine

L-leucine

L-lysine

L-methionine

L-ornithine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

3.2 Other substances, amino acids not included

Omega-3 Fatty Acids

Vegetable oils, fish oils and seaweed

Conjugated linoleic acid (CLA)

Conjugated linoleic acid (CLA) extract of safflower oil

Linoleic acid extracted from edible oils

Astaxanthine

Oiloresin high in astaxanthin extracted from Haematococcus Pluvialis

Beta-alanine

Beta-alanine, CAS No. 107-95-9, purity 98-101 %; heavy metals 10 ppm; Pb ≤ 3 ppm; As ≤ 1 ppm; Hg ≤0.1 ppm; Cd ≤ 1 ppm

Livestock

Betaic hydrochloride

Caffeine

Caffeine

Catechins, epigallocatechin gallate (EGCG)

Catechins, epigallocatechin gallate (EGCG) of green tea

Choline

Choline

Choline chloride

Ccholine Citrate

Choline Tartrates

Coenzyme NADH

NADH

Disodium NADH

Coenzyme Q10

Ubiquinone

Ubiquinol

Water Soluble Tomato Concentrates WSTC I and II

Hydrosoluble tomato concentrates WSTC I and II according to EFSA Journal 2010; 8 (7): 1689

Creatine

Creatine monohydrate

Creatine Pyruvate

DHA and its esters of fish oil or seaweed

EPA and its fish oil or algal oil esters

Glucosamine

Glucosamine chloride

Glucosamine sulfate

Hesperidin

Hesperidine from unripe oranges

Inositol

Inositol

Isoflavones

Isoflavones (soy or clover extracts from meadows)

L-carnitine

L-carnitine

L-carnitine hydrochloride

L-carnitine-L-tartrate

Lactase

FCC Lactase 7

Lutein

Lutein and its tageta esters

Lycopene

Lycopene from Tomatoes

Methylsulfonylmethane (MSM)

Methylsulfonylmethane (MSM)

Proanthocyanidin Oligomeres (OPC)

Proanthocyanidin (OPC) Oligomere of Grape or Pine Bark

Chondroitin sulfate

Chondroitin sulfate

Taurine

Taurine

Zaiaxanthin

Zéaxanthin (garden extract)


1 Alpha-tocopherol < 20 %, beta-tocopherol < 10 %, gamma-tocopherol 50-70 % and delta-tocopherol 10-30 %
2 Typical levels of certain tocopherols and tocotrienols: - 115 mg/g alpha-tocopherol (101 mg/g minimum); - 5 mg/g beta-tocopherol (< 1 mg/g minimum); - 45 mg/g gamma-tocopherol (25 mg/g minimum); - 12 mg/g delta-tocopherol (3 mg/g Minimum); - 67 mg/g alpha-tocotrienol (30 mg/g minimum);-< 1 mg/g beta-tocotrienol (< 1 mg/g minimum); - 82 mg/g gamma-tocotrienol (45 mg/g minimum); - 5 mg/g delta-tocotrienol (1 mg/g minimum).
3 Menaquinone is primarily in the form of menaquinone-7 and, to a lesser extent, menaquinone-6.
4 Calcium Algae of the genera Lithothamnium corallioides And Phymatolithon calcareum Or mixtures of these genera
5 Chromium-enriched Levures produced by culture of Saccharomyces cerevisiae In the presence of chromium (III) chloride as a source of chromium and whose chromium content, in the dehydrated form as marketed, is 230 to 300 mg/kg. Chromium (VI) levels must not exceed 0.2 % of the total chromium content.
6 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.
7 FCC = Food Chemicals Codex


State 1 Er May 2017

Annex 3

(art. 2, para. 7)

Requirements for the cultivation of live bacteria for use in food supplements

1
The cultures of live bacteria used in food supplements must be specific to human consumption and pose no health hazard.
2
Live cells from strains of one or more bacterial species ( Species ) Can be used.
3
They must meet the following criteria:
3.1
They must, preferably, be of human origin and not present pathogenic properties for human beings, nor resistance to antibiotics.
3.2
They must be included in an internationally recognized collection of strains.
3.3
The species and strain must be characterized by molecular biology methods. In other words:
A.
Species: DNA-DNA hybridization or 16S rRNA gene sequence analysis;
B.
Strain: Internationally recognized molecular biology method such as fingerprint techniques (PFGE or RAPD).

State 1 Er May 2017