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1. ------IND- 2015 9509 CH- EN- ------ 20151023--- --- PROJET
FDHA Ordinance
on Food Supplements
(VNem)
of …
The Federal Department of Home Affairs (FDHA),
having regard to Articles 5(4), 7(3), 9(1), 21(2) and 31(4) and 31(5) of the
Foodstuffs and Utility Articles Ordinance dated ...1 (LGV),
decrees the following:
Article 1
Subject matter and scope
This Ordinance describes the food additives, sets the requirements pertaining to
them and regulates their special labelling.
Article 2
Definitions
1
Food supplements are foods intended to supplement the normal diet and made
from simple or multiple concentrates of nutrients or other substances with a
nutritional or physiological effect and are brought on to the market in particular
dosages.
2
Nutrients as defined in this Ordinance are vitamins and minerals, including trace
elements.
Article 3
1
Requirements
Food supplements may only be supplied to consumers in pre-packaged form.
2
Food supplements must be offered to be taken in measured small quantities in
administrative forms such as capsules, lozenges, tablets, pills, sachets of powder,
liquid ampoules or droplet-dispensing bottles.
3
They may also contain:
a.
the nutrients listed in Annex 1 and other substances including substances
permitted under Regulation (EU) No ...2 (new Novel Food Regulation of the
EU), provided they meet its requirements;
SR ...
SR 817.02
OJ ...
1
2
2014......
1
Ordinance on Food Supplements
b.
AS 2013
foods except the plants, plant parts or preparations thereof listed in Annex 2.
4
The maximum concentrations of the nutrients and other substances determined in
Annex 1 are not permitted to be exceed for each recommended daily intake.
5Annex
3 regulates the permissible forms of the nutrients and other substances.
6
The requirements for live bacteria cultures are governed in accordance with
Annex 4.
7
For food additives with alkaline mineral substances suitable alkaline salts
(bicarbonate, carbonate and citrate) of the minerals magnesium, potassium or
calcium are permissible.
Article 4
Labelling
The designation used for the aforementioned products is “food supplements”,
supplemented by the names of the categories of nutrients or other substances
characteristic of the product, or with details specifying the nature of the nutrients or
other substances.
1
2
Where reference is made to a nutrient or other substance, then per recommended
daily ration the following must be included:
a.
for nutrients: at least 15 % of the reference quantity in accordance with
Annex 10 Part A of the FDHA Ordinance dated ...3 concerning information
on food (LIV);
b.
in the case of other substances: at least 15 % of the maximum concentration
in accordance with Annex 1.
3
Where reference is made to live bacteria cultures or lactase, then per recommended
daily ration the following must be included:
a.
in the case of live bacteria cultures at least 108 CFU (colony-forming units);
b.
in the case of lactase 4500 FCC (Food Chemicals Codex) units.
4
Reference to the addition of live bacteria cultures in the list of ingredients and the
specific designation must be made as follows:
a.
under the specific scientific nomenclature in accordance with the
requirements of the ICSP (International Committee on Systematics of
Prokaryotes4); or
b.
with the note “with lactic acid bacteria”.
5
The following must be included in addition to the details as set out in Article 3(1)ak and n-q LIV:
3
4
2
a.
the recommended daily intake in portions of the product;
b.
a warning message not to exceed the stated recommended daily intake;
SR ...
www.the-icsp.org/
Ordinance on Food Supplements
AS 2013
c.
a note of the fact that food supplements are not to be used as a replacement
for a varied diet;
d.
a note that the products must be stored out of the reach of small children;
e.
for the other substances the warning messages in accordance with Annex 1.
6
The nutrients or other substances contained in food supplements and their
respective percentage of the reference quantities in accordance with Annex 10 Part
A LIV are to be stated in numeric form per daily ration.
7
The percentages in accordance with paragraph 6 may also be shown in graphic
form.
8
The values stated in paragraph 6 must be based on averages obtained from food
analysis carried out by the producer.
9
The nutrient and other substances contained at the time of delivery to consumers
must be shown on the labelling.
10
If a voluntary declaration of the nutrients is made, this has to comply with
Article 20 (1)–(5) LIV.
Article 5
Restriction on promotion
The labelling and make-up of food additives and its advertising must not contain any
indication to assert or arouse the impression that in general it is not possible to ingest
reasonable quantities of nutrients with a balanced, varied diet.
Article 6
Reporting obligation
1
An entity being either a producer or importer which intends placing food
supplements on the market must notify the Federal Food Safety and Veterinary
Office (FSVO) of this prior to the first placing on the market.
2
This notification must be accompanied by a specimen of the label to be used for
the food supplement.
Article 7
Purity requirements
1
The specific purity criteria apply to the substances listed in Annex 3 as specified
for food additives in the annex to Commission Regulation (EU) No 231/20125.
2
For the substances listed in Annex 3 for which no purity criteria have been
determined the generally recognised purity criteria recommended by international
panels shall apply.
5
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down 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 of 22 March 2012, p. 1; last amended in
Regulation (EU) No 1274/2013, OJ L 328 of 7 December 2013, p. 79.
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Ordinance on Food Supplements
Article 8
AS 2013
Adaptation of the annexes
The FSVO shall regularly adapt the annexes in this Ordinance to the state of the art
in science and technology as well as to the laws of the most important trading
partners of Switzerland.
Article 9
1 The
Transitional provisions
transitional provisions are commensurate with Article 84 LGV.
2
Foodstuffs which are subject to reporting obligations in accordance with
Article 6(1) and have already been placed on the market and registered under the
legislation to date shall also be deemed to have been registered under the new law.
Article 10
Entry into force
This Order shall enter into force on …………. .
...
Federal Department of Home Affairs:
Alain Berset
4
Annex 1
(Articles 3(3)(a) and (4), and 4(2)(b))
Nutrients and other substances in the maximum concentrations permissible for adults
Nutrients and other substances
Maximum concentrations permissible
for adults
Restrictions/warnings (italics)
1 Nutrients
1.1 Vitamins
Vitamin A
Vitamin D
Vitamin E
Vitamin C
Vitamin K
Thiamine (vitamin B1)
Riboflavin (vitamin B2)
Niacin
Vitamin B6
Folic acid/folacin
Vitamin B12
Biotin
Pantothenic acid
1.2 Minerals and trace elements
Calcium
Phosphorus
Iron
2014......
1 600 g
15 g
20 g
36 mg
240 mg
225 μg
3.3 mg
4.2 mg
48 mg
4.2 mg
600 g
800 g
7.5 g
450 g
18 mg
800 mg
700 mg
14 mg
30 mg
For persons of 60 and older
For pregnant women up to the 12th week of pregnancy
For women during pregnancy and while breastfeeding
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Ordinance on Food Supplements
Nutrients and other substances
Magnesium
Zinc
Iodine
Selenium
Copper
Manganese
Chromium
Molybdenum
Potassium
Chloride
Silicon
AS 2013
Maximum concentrations permissible
for adults
375 mg
15 mg
150 g
55 g
1 mg
2 mg
40 g
50 g
2 000 mg
800 mg
200 mg
2 Other substances
2.1 Amino acids
L-histidine
L-isoleucine
L-leucine
L-lysine
L-methionine + L-cysteine
L-phenylalanine + L-tyrosine
L-threonine
L-valine
2.2 Other substances
Alpha linolenic acid (n-3)
Astaxanthin
Betaine
Carotenoid lutein
Carotenoid lycopene
Carotenoid zeaxanthin
6
600 mg
700 mg
1 100 mg
700 mg
900 mg
1 500 mg
500 mg
800 mg
2g
4 mg
1.5 g
10 mg
15 mg
2 mg
Restrictions/warnings (italics)
Ordinance on Food Supplements
Nutrients and other substances
AS 2013
Maximum concentrations permissible
for adults
Choline
Chondroitin sulfate
550 mg
500 mg
Coenzyme Q10
Eicosapentaenoic acid (EPA) + docosahexaenoic acid
(DHA) (combined) (long-chain n-3)
Glucosamine
Isoflavone
Catechin, epigallocatechin gallate (EGCG)
30 mg
500 mg
Conjugated linoleic acid (CLA)
Creatine
L-carnitine
Lactase
Live bacteria cultures
Linoleic acid (n-6)
Oligomeric proanthocyanidins (OPC)
Taurine
750 mg
50 mg
90 mg
(counted as EGCG)
3g
3g
1g
none
none
10 g
150 mg
Restrictions/warnings (italics)
“Unsuitable for women while pregnant or breastfeeding, children,
young people and persons taking anticoagulant medication.”
“Do not take on an empty stomach, during a strict, low-calorie diet
and not together with other products based on green tea.”
“Unsuitable for diabetics, young people, women during pregnancy
or while breastfeeding.”
The target group must be notified that lactose tolerance varies and
that those affected by intolerance should consult a skilled person
concerning the function of this substance in their nutrition.
“A product with OPC does not replace a diet with fresh fruit and
vegetables.”
1 000 mg
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Ordinance on Food Supplements
AS 2013
Annex 2
(Article 3(3)(b))
List of plants, plant parts and derivative preparations whose use in food supplements is not permitted
Scientific, botanical designation
English name
Acorus calamus L.
Arctostaphylos uva-ursi (L.) Spreng.
Arnica montana L.
Azadirachta indica A.Juss.
Catha edulis (Vahl) Forssk. ex Endl.
Ephedra spp.
Harpagophytum procumbens (Burch.) DC.
Hypericum perforatum L.
Laricifomes officinales (Villars: Fries)
Kotl. et Pouz oder Fomes officinalis
Pausinystalia yohimbe (K.Schum.) Pierre
ex Beille
Quassia amara L. und Picrasma excelsa
(Sw)
Teucrium chamaedrys L.
Sweet flag
Bearberry
Arnica
Indian lilac
Khat
Ephedra
Devil’s claw
Common Saint John’s wort
Laricifomes officinalis
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Yohimbe
Quassia
Germander speedwell
Plant parts
Comments
Annex 3
(Article 3(5))
Permissible forms of nutrients and other substances
1. Nutrients
1.1 Vitamins
Vitamin A
Retinol
Retinyl acetate
Retinyl palmitate
Beta carotene
Vitamin D
Vitamin D3 (cholecalciferol)
Vitamin D2 (ergocalciferol)
Vitamin E
D-alpha-tocopherol
Dl-alpha-tocopherol
D-alpha-tocopheryl acetate
Dl-alpha-tocopheryl acetate
D-alpha-tocopheryl acid succinate
Mixed tocopherols6
Tocotrienol tocopherol7
Vitamin K
Phylloquinone (phytomenadione)
Menaquinone8
Thiamine
Thiamine hydrochloride
Thiamine mononitrate
Thiamine monophosphate chloride
Thiamine pyrophosphate chloride
Riboflavin
Riboflavin
Riboflavin-5'-phosphate, sodium
Niacin
Nicotinic acid
Nicotine amide
Inositol hexanicotinate (inositol niacinate)
6
7
8
α-tocopherol < 20 %, β-tocopherol < 10 %, γ-tocopherol 50–70 %, and δ-tocopherol 10–
30 %.
Typical quantities of individual tocopherols and tocotrienols are:
– 115 mg/g α-tocopherol (101 mg/g min. content);
– 5 mg/g β-tocopherol (< 1 mg/g min. content);
– 45 mg/g γ-tocopherol (25 mg/g min. content);
– 12 mg/g δ-tocopherol (3 mg/g min. content);
– 67 mg/g α-tocotrienol (30 mg/g min. content);
– < 1 mg/g β-tocotrienol (< 1 mg/g min. content);
– 82 mg/g γ-tocotrienol (45 mg/g min. content);
– 5 mg/g δ-tocotrienol (1 mg/g min. content).
Menaquinone is primarily found as menaquinone-7 and to a lesser extent as
menaquinone-6.
2014......
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Ordinance on Food Supplements
Pantothenic acid
Calcium D-pantothenate
Sodium D-pantothenate
D-panthenol
Pantethine
Vitamin B6
Pyridoxine hydrochloride
Pyridoxine-5'-phosphate
Pyridoxal-5'-phosphate
Folate
Pteroylglutamic acid
Calcium-l-methylfolate
Vitamin B12
Cyanocobalamin
Hydroxocobalamin
5'-deoxyadenosylcobalamin
Methylcobalamin
Biotin
D-biotin
Vitamin C
L-ascorbic acid
Sodium l-ascorbate
Calcium l-ascorbat (may contain up to 2 % threonate)
Potassium l-ascorbate
L-ascorbyl 6-palmitate
Magnesium l-ascorbate
Zinc l-ascorbate
1.2 Minerals
Calcium
Calcium acetate
Calcium l-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 l-lysinate
Calcium malate
Calcium oxide
Calcium l-pidolate
Calcium l-threonate
Calcium sulfate
Calcium-containing red algae (maerl)9
9
10
The calcified algae of the genera Lithothamnium corallioides and Phymatolithon
calcareum or mixtures thereof
AS 2013
Ordinance on Food Supplements
AS 2013
Magnesium
Magnesium acetate
Magnesium l-ascorbate
Magnesium bisglycinate
Magnesium carbonate
Magnesium chloride
Magnesium salts of citric acid
Magnesium gluconate
Magnesium glycerophosphate
Magnesium salts of orthophosphoric acid
Magnesium lactate
Magnesium l-lysinate
Magnesium hydroxide
Magnesium malate
Magnesium oxide
Magnesium l-pidolate
Magnesium potassium citrate
Magnesium pyruvate
Magnesium succinate
Magnesium sulfate
Magnesium taurate
Magnesium acetyl taurate
Calcium-magnesium mixtures
Dolomite powder
Fossilised coral powder (scleractinia)
Iron
Iron carbonate
Iron citrate
Iron ammonium citrate
Iron gluconate
Iron fumarate
Iron sodium diphosphate
Iron lactate
Iron sulfate
Iron diphosphate (iron pyrophosphate)
Iron saccharate
elemental iron (carbonyl + electrolytic + hydrogen reduced)
Iron bisglycinate
Iron l-pidolate
Iron(II) phosphate
Iron(II) taurate
Iron(II) ammonium phosphate
Iron(III) sodium EDTA
Copper
Copper carbonate
Copper citrate
Copper gluconate
Copper sulfate
Copper l-aspartate
Copper bisglycinate
Copper lysine complex
Copper(II) oxide
Iodine
Sodium iodide
Sodium iodate
Potassium iodide
Potassium iodate
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Ordinance on Food Supplements
AS 2013
Zinc
Zinc acetate
Zinc l-ascorbate
Zinc l-aspartate
Zinc bisglycinate
Zinc chloride
Zinc citrate
Zinc gluconate
Zinc lactate
Zinc l-lysinate
Zinc malate
Zinc mono-l-methionine sulfate
Zinc oxide
Zinc carbonate
Zinc l-pidolate
Zinc picolinate
Zinc sulfate
Manganese
Manganese ascorbate
Manganese l-aspartate
Manganese bisglycinate
Manganese carbonate
Manganese chloride
Manganese citrate
Manganese gluconate
Manganese glycerophosphate
Manganese pidolate
Manganese sulfate
Potassium
Potassium sulfate
Potassium bicarbonate
Potassium carbonate
Potassium chloride
Potassium citrate
Potassium gluconate
Potassium glycerophosphate
Potassium lactate
Potassium hydroxide
Potassium l-pidolate
Potassium malate
Potassium salts of orthophosphoric acid
Selenium
L-selenomethionine
Selenium yeast10
Selenous acid
Sodium selanate
Sodium hydrogen selenite
Sodium selenite
10
12
In the presence of sodium selenite as the selenium source types of selenium yeast
obtained in culture, which in the dried form normally marketed contain no more than
2.5 mg Se/g. The organic selenium type predominant in the yeast is selenium methionine
(between 60 and 85 % of the selenium contained in the product). The content of other
organic selenium compounds including selenium cysteine is not permitted to exceed 10 %
of the entire selenium extract. The content of inorganic selenium is normally not
permitted to exceed 1 % of the entire selenium extract.
Ordinance on Food Supplements
AS 2013
Chromium
Chromium(III) chloride
Chromium-enriched yeast11
Chromium(III) lactate trihydrate
Chromium nitrate
Chromium picolinate
Chromium(III) sulfate
Molybdenum (VI)
Ammonium molybdate
Potassium molybdate
Sodium molybdate
Silicon
Choline-stabilised orthosilicic acid
Silicon dioxide
Silicic acid (in gel form)
2. Other substances
2.1 Amino acids
Note: In the case of permitted amino acids, the sodium, potassium, calcium and magnesium
salts as well as their hydrochlorides can be used.
L-cysteine
L-histidine
L-isoleucine
L-leucine
L-lysine
L-methionine
L-phenylalanine
L-threonine
L-tyrosine
L-valine
2.2 Other substances
Astaxanthin
Astaxanthin-rich oleoresin extracted from Haematococcus pluvialis
Betaine
Betaine hydrochloride
L-carnitine
L-carnitine
L-carnitine hydrochloride
L-carnitine L-tartrate
Choline
Choline
Choline chloride
Choline tartrate
Choline citrate
11
In the presence of chromium(III) chloride as chromium source in a culture of
Saccharomyces cerevisiae obtained with chromium-enriched yeast which in the ordinary
dried form marketed contains 230–300 mg chromium/kg. The content of chromium(VI)
is not permitted to exceed 0.2 % of the entire chromium content.
13
Ordinance on Food Supplements
Chondroitin sulfate
Chondroitin sulfate (Ph. Eur.)
Coenzyme Q10
Coenzyme Q10 (ubiquinone, ubiquinol)
DHA and its esters from fish oil or algae oil
EPA and its esters from fish oil or algae oil
Glucosamine
Glucosamine chloride
Glucosamine sulfate
Isoflavone
Isoflavone from soya or red clover extracts
Catechin, epigallocatechin gallate (EGCG)
Catechin, epigallocatechin gallate (EGCG) from green tea
Conjugated linoleic acid (CLA)
Conjugated linoleic acid (CLA) from thistle oil
Creatine
Creatine monohydrate
Creatine pyruvate
L-carnitine
L-carnitine
L-carnitine hydrochloride
L-carnitine L-tartrate
Lactase
Lactase FCC (Food Chemicals Codex)
Linoleic acid
Lutein
Lutein from Tagetes
Lycopene
Lycopene from tomatoes
Oligomeric proanthocyanidins (OPC)
Oligomeric proanthocyanidins (OPC) from grapes or pine bark
Omega-3 fatty acids from plant oils, fish oils and algae oils
Taurine
Taurine
Zeaxanthin
Zeaxanthin from Tagetes
14
AS 2013
Ordinance on Food Supplements
AS 2013
Annex 4
(Article 3(5))
Requirements of live bacteria cultures for use in food
supplements
1
Live bacteria cultures found in food supplements must be suitable for food
purposes and harmless to health.
2
Living cells from strains of one or more types of bacteria (species) may be
used.
3
These must meet the following criteria:
3.1
They must preferably be of human origin and not have human-pathogenic
properties or any transferable antibiotic resistance.
3.2
They must be stored in an internationally recognised strain collection.
3.3
Species and strains must be characterised with molecular-biological
methods. This means:
a. Species: DNA-DNA hybridisation or 16SrRNA sequence analysis;
b. Strain: Internationally accepted molecular-biological method such as
the PFGE or RAPD molecular-biological fingerprinting process.
15