Food supplements
A webinar presented by:
Dr Andy Bowles
Attendee Notes 12/06/2018
Food Supplements
Dr Andy Bowles
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This webinar will consider
What are food supplements?
Legal framework
Permitted ingredients
Labelling of food supplements
Common non-compliances
This webinar will consider
What are food supplements?
Legal framework
Permitted ingredients
Labelling of food supplements
Common non-compliances
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What are food supplements?
Vitamin tablets Protein powders Mineral capsules Body building mixes
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What are food supplements?
Defined as - Any food the purpose of which is to supplement the normal diet and which – a) Is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; AND b) Is sold in dose form
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What are food supplements?
“Dose Form” A form such as capsules, pastilles, tablets, pills, and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids or powders designed to be taken in measured small unit quantities.
“Nutritional or Physiological Effect” Not defined
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What are food supplements?
Food Supplements must be sold prepacked
Prepacked – Ready for sale to the ultimate consumer or a catering establishment, AND It is put into packaging before being offered for sale in such a way that the food supplement cannot be altered without opening or changing the packaging.
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Medicinal products
Any substance or combination of substances presented as having properties of preventing or treating disease in human beings that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis
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Medicinal products
Medicines and Healthcare products Regulatory Agency (MHRA) Further information https://www.gov.uk/guidance/decide-if-your- product-is-a-medicine-or-a-medical-device
What is a Medicinal Product Guidance (https://www.gov.uk/government/uploads/system/uploads/attachment_dat a/file/398998/A_guide_to_what_is_a_medicinal_product.pdf)
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Borderline medicinal products
Agnus castus Phenibut Amygdalin Picamilon Benzocaine Pygeum Africanum Black cohosh DMAA Rhubarb root GABA Synephrine Hoodia Yohimbine Hydroxycitric Acid Lidocaine Melatonin
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This webinar will consider
What are food supplements?
Legal framework
Permitted ingredients
Labelling of food supplements
Common non-compliances
Legal framework
Directive 2002/46/EC Food Supplements (E, W, S & NI) Regulations 2003 As amended
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Food Supplements (E) Regulation 2003
Regulation 5 Regulation 6 Regulation 2 Prohibition on sale Regulation 8 Labelling Definitions relating to Enforcement requirements composition
Schedule 1 Regulation 3 Regulation 7 Regulation 9 Permitted vitamins & Scope Manner of marking Offences minerals
Schedule 2 Regulation 4 Form of vitamins & Restriction on sale minerals
Guidance
Non-statutory guidance produced by DoH Summary information on legislation relating to the sale of food supplements Label advisory statements and suggested reformulations Summary information on the labelling of food supplements Guidance notes on legislation implementing Directive 2002/46/EC on food supplements List of Vitamins and Minerals which may be used in the manufacture of food supplements in the EU
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This webinar will consider
What are food supplements?
Legal framework
Permitted ingredients
Labelling of food supplements
Common non-compliances
Permitted vitamins and minerals
Permitted List Schedule 1 Food Supplements Regs Annex 1 of Directive 2002/46/EC Form of vitamins and minerals to be used Schedule 2 Food Supplements Regs Annex 2 of directive 2002/46/EC
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Permitted list
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Permitted form
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EFSA Register of questions
http://registerofquestions.efsa.europa.eu/roqFrontend/login?0
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This webinar will consider
What are food supplements?
Legal framework
Permitted ingredients
Labelling of food supplements
Common non-compliances
Labelling of food supplements
Labelling requirements set out: Regulation (EU)1169/2011 Mandatory requirements Food Supplements Regulations Additional requirements Regulation (EC) 1924/2006 Nutrition and health claims
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Regulation 1169/2011
Art 9 Mandatory Food Information Information must be: Easily visible and Clearly Legible Exempt from nutritional labelling requirement Minimum font size applies to mandatory requirements only
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Labelling Requirements Regulation 6 Must be marked with: Name “Food Supplement” Name of the category of any Vitamin, Mineral or Other Substance with a nutritional or physiological effect which characterises the product or an indication of the nature of the vitamin or mineral or other substance.
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Labelling Requirements Regulation 6
The portion of product recommended for daily consumption. Statement to the effect that food supplements should not be used as a substitute for a varied diet.
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Labelling Requirements Regulation 6
Statement to the effect that the product should be stored out of the reach of young children.
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Labelling Requirements Regulation 6
Amount of Vitamin, Mineral or Other Substance providing nutritional or physiological effect In numerical form with relevant unit of measurement Average amount based on analysis Vitamins and Minerals listed in Annex 1 also state percentage of RDA
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Source: Guidance Note No. 21: Food Supplements Regulations and Notifications (Revision 2) FSAI
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This webinar will consider
What are food supplements?
Legal framework
Permitted ingredients
Labelling of food supplements
Common non-compliances
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Common non-compliances
Nutrition claims Health claims Claims generally not substantiated Novel ingredients General labelling issues Non-permitted additives Failure to include food supplement label info.
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This webinar will consider
What are food supplements?
Legal framework
Permitted ingredients
Labelling of food supplements
Common non-compliances
Dr Andy Bowles Specialist Food Law Solicitor
www.abcfoodlaw.co.uk @abcfoodlaw 01603 274486
11 Page11 Page12 Page13 Page14 Source: Guidance Note No. 21: Food Supplements Regulations and Notifications (Revision 2) FSAI
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▼M3 ANNEX I
Vitamins and minerals which may be used in the manufacture of food supplements
1. Vitamins Vitamin A (μg RE)
Vitamin D (μg)
Vitamin E (mg a-TE)
Vitamin K (μg)
Vitamin B1 (mg)
Vitamin B2 (mg)
Niacin (mg NE)
Pantothenic acid (mg)
Vitamin B6 (mg)
Folic acid (μg) (1 )
Vitamin B12 (μg)
Biotin (μg)
Vitamin C (mg)
2. Minerals Calcium (mg)
Magnesium (mg)
Iron (mg)
Copper (μg)
Iodine (μg)
Zinc (mg)
Manganese (mg)
Sodium (mg)
Potassium (mg)
Selenium (μg)
Chromium (μg)
Molybdenum (μg)
Fluoride (mg)
Chloride (mg)
Phosphorus (mg)
Boron (mg)
Silicon (mg)
(1 ) Folic acid is the term included in Annex I of Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions for nutrition labelling purposes and covers all forms of folates.
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▼M3 ANNEX II
Vitamin and mineral substances which may be used in the manufacture of food supplements
A. Vitamins 1. VITAMIN A (a) retinol (b) retinyl acetate (c) retinyl palmitate (d) beta-carotene 2. VITAMIN D (a) cholecalciferol (b) ergocalciferol 3. VITAMIN E (a) D-alpha-tocopherol (b) DL-alpha-tocopherol (c) D-alpha-tocopheryl acetate (d) DL-alpha-tocopheryl acetate (e) D-alpha-tocopheryl acid succinate
(f) mixed tocopherols (1 )
(g) tocotrienol tocopherol (2 ) 4. VITAMIN K (a) phylloquinone (phytomenadione)
(b) menaquinone (3 ) 5. VITAMIN B1 (a) thiamin hydrochloride (b) thiamin mononitrate (c) thiamine monophosphate chloride (d) thiamine pyrophosphate chloride 6. VITAMIN B2 (a) riboflavin (b) riboflavin 5′-phosphate, sodium 7. NIACIN (a) nicotinic acid (b) nicotinamide
(c) inositol hexanicotinate (inositol hexaniacinate)
(1 ) alpha-tocopherol < 20 %, beta-tocopherol < 10 %, gamma-tocopherol 50-70 % and delta- tocopherol 10-30 % (2 ) Typical levels of individual 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 occurring principally as menaquinone-7 and, to a minor extent, mena quinone-6.
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▼M3 8. PANTOTHENIC ACID (a) D-pantothenate, calcium (b) D-pantothenate, sodium (c) dexpanthenol (d) pantethine 9. VITAMIN B6 (a) pyridoxine hydrochloride (b) pyridoxine 5′-phosphate (c) pyridoxal 5′-phosphate 10. FOLATE (a) pteroylmonoglutamic acid (b) calcium-L-methylfolate ▼M6 (c) (6S)-5-methyltetrahydrofolic acid, glucosamine salt ▼M3 11. VITAMIN B12 (a) cyanocobalamin (b) hydroxocobalamin (c) 5′-deoxyadenosylcobalamin (d) methylcobalamin 12. BIOTIN (a) D-biotin 13. VITAMIN C (a) L-ascorbic acid (b) sodium-L-ascorbate
(c) calcium-L-ascorbate (1 ) (d) potassium-L-ascorbate (e) L-ascorbyl 6-palmitate (f) magnesium L-ascorbate (g) zinc L-ascorbate B. Minerals 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
(1 ) May contain up to 2 % of threonate.
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▼M3 calcium L-lysinate calcium malate calcium oxide calcium L-pidolate calcium L-threonate calcium sulphate ▼M7 calcium phosphoryl oligosaccharides ▼M3 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 sulphate magnesium taurate magnesium acetyl taurate ferrous carbonate ferrous citrate ferric ammonium citrate ferrous gluconate ferrous fumarate ferric sodium diphosphate ferrous lactate ferrous sulphate ferric diphosphate (ferric pyrophosphate) ferric saccharate elemental iron (carbonyl + electrolytic + hydrogen reduced) ferrous bisglycinate ferrous L-pidolate ferrous phosphate
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▼M4 ferrous ammonium phosphate
ferric sodium EDTA
▼M3 iron (II) taurate
cupric carbonate
cupric citrate
cupric gluconate
cupric sulphate
copper L-aspartate
copper bisglycinate
copper lysine complex
copper (II) oxide
sodium iodate
potassium iodate
zinc L-ascorbate
zinc L-aspartate
zinc bisglycinate
zinc chloride
zinc citrate
zinc lactate
zinc L-lysinate
zinc malate
zinc mono-L-methionine sulphate
zinc carbonate
zinc L-pidolate
zinc picolinate
zinc sulphate
manganese ascorbate
manganese L-aspartate
manganese bisglycinate
manganese carbonate
manganese chloride
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▼M3 manganese citrate manganese gluconate manganese glycerophosphate manganese pidolate manganese sulphate sodium bicarbonate sodium carbonate sodium chloride sodium citrate sodium gluconate sodium lactate sodium hydroxide sodium salts of orthophosphoric acid ▼M4 sodium sulphate potassium sulphate ▼M3 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 L-selenomethionine
selenium enriched yeast (1 ) selenious acid sodium selenate sodium hydrogen selenite sodium selenite chromium (III) chloride ▼M5 chromium enriched yeast (2 ) ▼M3 chromium (III) lactate trihydrate chromium nitrate chromium picolinate chromium (III) sulphate ammonium molybdate (molybdenum (VI)) potassium molybdate (molybdenum (VI)) sodium molybdate (molybdenum (VI))
(1 ) Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dried form as marketed, not more than 2,5 mg Se/g. The predominant organic selenium species present in the yeast is selenomethionine (between 60 and 85 % of the total extracted selenium in the product). The content of other organic selenium compounds including selenocysteine shall not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally shall not exceed 1 % of total extracted selenium. (2 ) Chromium-enriched yeast produced by culture of Saccharomyces cerevisiae in the presence of chromium(III) chloride as a source of chromium and containing, in the dried form as marketed, 230-300 mg of chromium/kg. The content of chromium(VI) shall not exceed 0,2 % of total chromium.
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▼M3 calcium fluoride potassium fluoride sodium fluoride sodium monofluorophosphate boric acid sodium borate choline-stabilised orthosilicic acid silicon dioxide
silicic acid (1 ) ▼M7 organic silicon (monomethylsilanetriol)
(1 ) In the form of gel.
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