SevenEasyStepsToAssessNon-ComplianceOfAFoodSupplement
Threeeasyimmediatechecksofthelabel
1. Ifaproductislabelledas‘DietarySupplement’,itisnon-compliant.
Allfoodsupplementsmustbelabelledwith‘FoodSupplement’.
2. Iftheproductliststhevitamins,mineralsandotheractivesubstancesunder‘SupplementFacts’ora
similarheading,andfollowsthisby‘Otheringredients’listingthecarriersandotheradditivesetc.,itis
non-compliant.
ALL ingredients (including the active ingredients) must be listed under the heading ‘Ingredients’ in descending
orderbyweightofinput.Activeingredientsmustbequantifiedeitherseparatelyunderanappropriateheading
orwithintheingredientslistitself.
3. IfthequantityofvitaminsA,DorEisgivensolelyorprincipallyas‘IU’,itisnon-compliant.
Thequantityofthesevitaminsmustbestatedonfoodsupplementlabelsusingtheapplicableunits:
vitaminA‘µgRE’;vitaminD‘µg’;vitaminE‘mgα-TE’.
AlthoughthevoluntarilydeclarationofquantityinIUmaysometimesbeprovided,thismustnottakepriority.
Foureasychecksrequiringtheuseoflists
4. The only permitted vitamins and minerals for use in food supplements are listed in Annex I of
Directive2002/46/EConfoodsupplements,asamended.Iftheproductcontainsvitaminsorminerals
otherthanthoselisted(e.g.vanadium),itisnon-compliant.
Thepermittedvitaminsandminerals,asofNovember2016,arelistedinAppendixIofthisdocument.
5. TheonlypermittedvitaminandmineralsourcesforuseinfoodsupplementsarelistedinAnnexIIof
Directive 2002/46/EC on food supplements, as amended. If the product contains vitamin or mineral
sourcesotherthanthoselisted(e.g.potassiumglycinatecomplex),itisnon-compliant.
Thepermittedvitaminandmineralsources,asofNovember2016,arelistedinAppendixIIofthisdocument.
6. CertainingredientshavebeendeterminedbytheUKFoodStandardsAgency(FSA)tobenovelfoods
requiringauthorisationbeforetheycanbepermittedforuse(e.g.Acaciarigidula).Theseingredients
arelistedontheFSAwebsite.CertainotheringredientsareincludedintheEUnovelfoodscatalogue.
Neither of these lists are exhaustive, but if any of the ingredients stated as novel are present in a
product, it is non-compliant, unless proof can be provided by the company that the ingredient falls
underoneofthefewexceptions(asprovidedbytheFSA).
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FSAlistofunauthorisednovelfoods
EUnovelfoodcatalogue
7. If the product bears health claims, these should relate only to those authorised via Regulation
1924/2006onnutritionandhealthclaims(includingdiseaseriskreductionclaims)andpresentonthe
EU Register on nutrition and health claims. Certain on-hold claims are also permitted. Claims which
refertopreventing,treatingorcuringadisease/illnessarenotpermitted.
Thiscanbeacomplicatedissue.UKguidanceonclaimscanbefoundfromtheDepartmentofHealth
(DH), the Committee of Advertising Practice (CAP) and the Medicines and Healthcare products
RegulatoryAgency(MHRA).
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EURegisterofnutritionandhealthclaims
DHGuidetocompliancewithRegulation(EC)1924/2006onnutritionandhealthclaimsmadeonfoods
DHguidancerelatingto‘onhold’healthclaims
CAPHelpNotes
MHRAGuidetowhatisamedicinalproduct
(ThelinksarecurrentasofNovember2016.However,wehavenocontroloverotheragenciesrelocatingtheirwebpages.
Therefore,ifanyofthelinksdonotwork,searchinyourwebbrowserforthedocumentname)
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Leading the Food Supplement Industry
APPENDIXI
Listofpermittedvitaminsandmineralsforuseinfoodsupplements
andtheunitsbywhichtheyshouldbequantified
(asofNovember2016)
TakenfromAnnexIofDirective2002/46/ECasamended
Vitamins
VitaminA(μgRE)
VitaminD(μg)
VitaminE(mga-TE)
VitaminK(μg)
VitaminB1(thiamin)(mg)
VitaminB2(riboflavin)(mg)
Niacin(mgNE)
Pantothenicacid(mg)
VitaminB6(mg)
Folicacid(μg)
VitaminB12(μg)
Biotin(μg)
VitaminC(mg)
Minerals
B
Boron(mg)
C
Calcium(mg)
Chloride(mg)
Chromium(μg)
Copper(μg)
F
Fluoride(mg)
I
Iodine(μg)
Iron(mg)
M
Magnesium(mg)
Manganese(mg)
Molybdenum(μg)
P
Phosphorus(mg)
Potassium(mg)
S
Selenium(μg)
Silicon(mg)
Sodium(mg)
Z
Zinc(mg)
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Leading the Food Supplement Industry
APPENDIXII
Listofpermittedvitaminsandmineralsourcesforuseinfoodsupplements
(asofNovember2016)
TakenfromAnnexIIofDirective2002/46/ECasamended
VITAMINS
Pantothenicacid
D-pantothenate,calcium
D-pantothenate,sodium
Dexpanthenol
Pantethine
VitaminB6
Pyridoxinehydrochloride
Pyridoxine5′-phosphate
Pyridoxal5′-phosphate
Folate(folicacid)
Pteroylmonoglutamicacid
Calcium-L-methylfolate
(6S)-5-methyltetrahydrofolicacid,
glucosaminesalt
VitaminB12
Cyanocobalamin
Hydroxocobalamin
5′-deoxyadenosylcobalamin
Methylcobalamin
Biotin
D-biotin
VitaminC
L-ascorbicacid
Sodium-L-ascorbate
Calcium-L-ascorbate(1)
Potassium-L-ascorbate
L-ascorbyl6-palmitate
MagnesiumL-ascorbate
ZincL-ascorbate
VitaminA
Retinol
Retinylacetate
Retinylpalmitate
Beta-carotene
VitaminD
Cholecalciferol
Ergocalciferol
VitaminE
D-alpha-tocopherol
DL-alpha-tocopherol
D-alpha-tocopherylacetate
DL-alpha-tocopherylacetate
D-alpha-tocopherylacidsuccinate
Mixedtocopherols(1)
Tocotrienoltocopherol(1)
VitaminK
Phylloquinone(phytomenadione)
Menaquinone(1)
VitaminB1(Thiamin)
Thiaminhydrochloride
Thiaminmononitrate
Thiaminemonophosphatechloride
Thiaminepyrophosphatechloride
VitaminB2(Riboflavin)
Riboflavin
Riboflavin5′-phosphate,sodium
Niacin
Nicotinicacid
Nicotinamide
Inositolhexanicotinate(inositol
hexaniacinate)
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MINERALS
Copper
Cupriccarbonate
Cupriccitrate
Cupricgluconate
Cupricsulphate
Copperl-aspartate
Copperbisglycinate
Copperlysinecomplex
Copper(ii)oxide
Boron
Boricacid
Sodiumborate
Calcium
Calciumacetate
CalciumL-ascorbate
Calciumbisglycinate
Calciumcarbonate
Calciumchloride
Calciumcitratemalate
Calciumsaltsofcitricacid
Calciumgluconate
Calciumglycerophosphate
Calciumlactate
Calciumpyruvate
Calciumsaltsoforthophosphoric
acid
Calciumsuccinate
Calciumhydroxide
CalciumL-lysinate
Calciummalate
Calciumoxide
CalciumL-pidolate
CalciumL-threonate
Calciumsulphate
Chloride
Anyofthelistedchloridesalts
Chromium
Chromium(III)chloride
Chromiumenrichedyeast1
Chromium(III)lactatetrihydrate
Chromiumnitrate
Chromiumpicolinate
Chromium(III)sulphate
Note:theingredientmaybelistedas‘copper...’,in
whichcasethecompanyshouldbeabletoconfirm
thesourceusediscupric(whererelevant)
Fluoride
Calciumfluoride
Potassiumfluoride
Sodiumfluoride
Sodiummonofluorophosphate
Iodine
Potassiumiodide
Potassiumiodate
Sodiumiodide
Sodiumiodate
Iron
Ferrouscarbonate
Ferrouscitrate
Ferricammoniumcitrate
Ferrousgluconate
Ferrousfumarate
Ferricsodiumdiphosphate
Ferrouslactate
Ferroussulphate
Ferricdiphosphate(ferric
pyrophosphate)
Ferricsaccharate
Elementaliron(carbonyl+
electrolytic+hydrogen
reduced)
Ferrousbisglycinate
Ferrousl-pidolate
Ferrousphosphate
Ferrousammoniumphosphate
Ferricsodiumedta
Iron(ii)taurate
Note:theingredientmaybelistedas‘iron...’,in
whichcasethecompanyshouldbeabletoconfirm
thesourceusedisferrousorferric(whererelevant)
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Magnesium
Magnesiumacetate
Magnesiuml-ascorbate
Magnesiumbisglycinate
Magnesiumcarbonate
Magnesiumchloride
Magnesiumsaltsofcitricacid
Magnesiumgluconate
Magnesiumglycerophosphate
Magnesiumsaltsof
orthophosphoricacid
Magnesiumlactate
Magnesiuml-lysinate
Magnesiumhydroxide
Magnesiummalate
Magnesiumoxide
Magnesiuml-pidolate
Magnesiumpotassiumcitrate
Magnesiumpyruvate
Magnesiumsuccinate
Magnesiumsulphate
Magnesiumtaurate
Magnesiumacetyltaurate
Manganese
Manganeseascorbate
Manganesel-aspartate
Manganesebisglycinate
Manganesecarbonate
Manganesechloride
Manganesecitrate
Manganesegluconate
Manganeseglycerophosphate
Manganesepidolate
Manganesesulphate
Molybdenum
Ammoniummolybdate
(molybdenum(VI))
Potassiummolybdate
(molybdenum(VI))
Sodiummolybdate(molybdenum
(VI))
Phosphorus
Anyofthelistedphosphatesthat
provideasufficientquantity
Potassium
Potassiumbicarbonate
Potassiumcarbonate
Potassiumchloride
Potassiumcitrate
Potassiumgluconate
Potassiumglycerophosphate
Potassiumlactate
Potassiumhydroxide
Potassiuml-pidolate
Potassiummalate
Potassiumsaltsoforthophosphoric
acid
Selenium
L-selenomethionine
Seleniumenrichedyeast1
Seleniousacid
Sodiumselenate
Sodiumhydrogenselenite
Sodiumselenite
Silicon
Choline-stabilisedorthosilicicacid
Silicondioxide
Silicicacid1
Sodium
Sodiumbicarbonate
Sodiumcarbonate
Sodiumchloride
Sodiumcitrate
Sodiumgluconate
Sodiumlactate
Sodiumhydroxide
Sodiumsaltsoforthophosphoric
acid
Sodiumsulphate
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Zinc
zincacetate
Zincl-ascorbate
Zincl-aspartate
Zincbisglycinate
Zincchloride
Zinccitrate
Zincgluconate
Zinclactate
Zincl-lysinate
Zincmalate
Zincmono-l-methioninesulphate
Zincoxide
Zinccarbonate
Zincl-pidolate
Zincpicolinate
Zincsulphate
1
TheingredientmustbeintheformspecifiedinAnnexIIofDirective2002/46/ECasamended
NOTE:Synonymsmightbeusedintheingredientslistforsomeofthesesubstances.
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© CRN UK 2016
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