2001L0015—EN—10.02.2004—001.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONDIRECTIVE2001/15/EC
of15February2001
on substances that may be added for specific nutritional purposes in foods for particular nutri-
tionaluses
(TextwithEEArelevance)
(OJL52,22.2.2001,p.19)
Amendedby:
OfficialJournal
No page date
►M1CommissionDirective2004/5/ECof20January2004 L14 19 21.1.2004
Correctedby:
►C1Corrigendum,OJL253,21.9.2001,p.34(2001/15/EC)
▼B
COMMISSIONDIRECTIVE2001/15/EC
of15February2001
on substances that may be added for specific nutritional purposes
infoodsforparticular nutritionaluses
(TextwithEEArelevance)
THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,
HavingregardtoCouncilDirective89/398/EECof3May1989onthe
approximation ofthelawsofthe MemberStatesrelating tofoodstuffsintendedforparticularnutritionaluses(
1),aslastamendedbyEuropean
Parliament and Council Directive 1999/41/EC(2), and in particular
Article4(2)thereof,
AfterconsultingtheScientificCommitteeforFood,Whereas:
(1)A number of nutritional substances such as vitamins, minerals,
amino acids and others may be added to foods for particularnutritional uses in order to ensure that the particular nutritionalrequirements of the persons for whom those foods are intended
are fulfilled and/or in order to satisfy legal requirements laid
down in specific directives adopted pursuant to Article 4(1) ofDirective89/398/EEC.
(2)It is not possible to define nutritional substances as a distinct
group for the purpose of this Directive nor to draw up at this
stageanexhaustivelistofallcategoriesofnutritionalsubstancesthatmaybeaddedinfoodsforparticularnutritionaluses.
(3)The range of foods for particular nutritional uses is very wideand diversified and the technological processes used for theirmanufacture are varied. For this reason, the widest possiblechoice ofsubstancesthat can besafely usedinthemanufactureoffoodsforparticularnutritionalusesshouldbeavailableforthecategoriesofnutritionalsubstancestobelistedinthisDirective.
(4)The choice of substances should be based primarily on theirsafety and subsequently on their availability for use by humansand their organoleptic and technological properties. The inclu-sion of substances in the list of those that may be used in the
manufacture of foods for particular nutritional uses does not
meanthattheiradditiontothosefoodsisnecessaryordesirable.
(5)Where the addition of a nutritional substance has been judged
necessary, this has been stipulated by specific rules in the rele-
vant specific directives together with the appropriatequantitativeconditions,asthecasemaybe.
(6)In the absence of any specific rules or in the case of foods for
particular nutritional uses not covered by specific directives,
nutritional substances should be used in order to manufactureproducts that are in conformity with the definition of suchproducts and fulfil the particular nutritional requirements of thepersons for whomthey are intended. The products in question
mustalsobesafewhenusedasinstructedbythemanufacturer.
(7)The provisions concerning the list of the nutritional substances
that may be used in the manufacture of infant formulae andfollow-on formulae and of processed cereal-based foods and
baby foods for infants and young children are laid down in
Commission Directive 91/321/EEC of 14 May 1991 on infantformulae and follow-on formulae(
3), as last amended by Direc-2001L0015—EN—10.02.2004—001.001—2
(1) OJL186,30.6.1989,p.27.
(2) OJL172,8.7.1999,p.38.
(3) OJL175,4.7.1991,p.35.
▼B
tive 1999/50/EC(1), and Commission Directive 96/5/EC of 16
February 1996 on processed cereal-based foods and baby foodsforinfants and young children(
2),as last amended byDirective
1999/39/EC(3).Therefore thoseprovisionsneednotberepeated
inthisDirective.
(8)A number of the nutritional substances may also be used infoodstuffs as food additives. In this context purity criteria havebeenoraretobeadoptedforthematCommunitylevelinaccor-
dancewithCouncilDirective89/107/EECof21December1988
on the approximation of the laws of the Member Statesconcerning food additives authorised for use in foodstuffsintended for human consumption(
4), as amended by European
Parliament and Council Directive 94/34/EC(5). Those purity
criteria should be applicable for those substances whatever the
purposeoftheiruseinfoodstuffs.
(9)Pending the adoption of purity criteria for the rest of the
substances at Community Ievel, and in order to ensure a highlevel ofprotection forpublic health, generally acceptable puritycriteria recommended by international organisations or agencies
including but not limited to the Joint FAO/WHO Expert
Committee on Food Additives (JECFA), EUP (European Phar-macopoeia) should apply. Member States should be permittedto maintain national rules setting stricter purity criteria, withoutprejudicetotherulessetoutintheTreaty.
(10)Somespecificnutrients ortheirderivatives havebeenidentified
as specifically necessary for the manufacture of some foods
belonging to the group of foods for special medical purposesandtheirpotentialuseshouldbereservedtothemanufacture oftheseproducts.
(11)The measures provided in this Directive are in accordance with
theopinionoftheStandingCommitteeonFoodstuffs,
HASADOPTEDTHISDIRECTIVE:
Article 1
1. For the categories of substances added for specific nutritional
purposesinfoodsforparticular nutritional useslisted in the Annexto
thisDirectiveonlythechemicalsubstancesmentionedundereachcate-gory may be used in the manufacture of foodstuffs for particularnutritionalusescoveredbyDirective89/398/EEC.
The use of those substances shall be in conformity with any specific
provisions concerning those substances that may be laid down inspecific directives provided for in Article 4(1) of Directive 89/398/EEC.
2. Without prejudice to European Parliament and Council Regula-
tion(EC)No258/97(
6),othersubstancesaddedforspecificnutritional
purposes,notbelongingtooneofthecategorieslistedintheAnnexto
this Directive, may be usedin the manufacture of foodsfor particular
nutritionaluses.
3. The use of nutritional substances in foods for particular nutri-
tional uses shall result in the manufacture of safe products that fulfilthe particular nutritional requirements of the persons for whom theyareintendedasestablishedbygenerallyacceptedscientificdata.
4. The competent authorities of Member States, referred to in
Article 9of Directive 89/398/EEC, shall be empowered to require the2001L0015—EN—10.02.2004—001.001—3
(1) OJL139,2.6.1999,p.29.
(2) OJL49,28.2.1996,p.17.
(3) OJL124,18.5.1999,p.8.
(4) OJL40,11.2.1989,p.27.
(5) OJL237,10.9.1994,p.1.
(6) OJL43,14.2.1997,p.1.
▼B
manufacturer or,whereappropriate,theimportertoproducethescien-
tific work and the data establishing the use of substances added forspecific nutritional purposes in compliance with paragraph 3. If such
work is contained in a readily available publication, a mere reference
tothispublicationshallsuffice.
Article 2
1. Purity criteria for substances listed in the Annex, specified by
Community legislation for their use in the manufacture of foodstuffsforpurposesotherthanthosecoveredbythisDirective,shallapply.
2. ForthosesubstanceslistedintheAnnexforwhichpuritycriteria
are not specified by Community legislation, and until the adoption ofsuch specifications, generally acceptable purity criteria recommended
byinternationalbodiesshallapply.Nationalrulessettingstricterpurity
criteriamaybemaintained.
Article 3
Member States shall adopt and publish the provisions necessary to
complywiththisDirectiveby31March2002atthelatest.TheyshallforthwithinformtheCommissionthereof.
Theyshallapplythoseprovisionsinsuchawayasto:
(a) permit trade in products complying with this Directive with effect
from1April2002;
(b) prohibittradeinproductswhichdonotcomplywiththisDirective
witheffectfrom1April2004.
WhenMemberStatesadoptthoseprovisions,theyshallcontainarefer-
ence to this Directive or be accompanied by such a reference on theoccasion of their official publication. Member States shall determinehowsuchreferenceistobemade.
Article 4
This Directive shall enter into force on the 20th day following its
publicationinthe Official Journal of the European Communities .
Article 5
ThisDirectiveisaddressedtotheMemberStates.2001L0015—EN—10.02.2004—001.001—4
▼B
ANNEX
SUBSTANCES THAT MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN
FOODSFORPARTICULARNUTRITIONALUSES
Forthepurposeofthistable:
— ‘FSMP’meansfoodsforparticularnutritionalusesintendedforspecialmedicalpurposes,
— ‘All FPNU’ means dietary foods for particular nutritional uses including FSMPs but excluding
infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for
infantsandyoungchildren.
SubstanceConditionofuse
AllFPNU FSMP
Category1.Vitamins
VITAMINA
—retinol x
—retinylacetate x
—retinylpalmitate x
—beta-carotene x
VITAMIND
—cholecalciferol x—ergocalciferol x
VITAMINE
—D-alpha-tocopherol x
—DL-alpha-tocopherol x
—D-alpha-tocopherylacetate x
—DL-alpha-tocopherylacetate x
—D-alpha-tocopherylacidsuccinate x
VITAMINK
—phylloquinone(phytomenadione) x
VITAMINB1
—thiaminhydrochloride x
—thiaminmononitrate x
VITAMINB2
—riboflavin x
—riboflavin5'-phosphate,sodiumx
NIACIN
—nicotinicacid x
—nicotinamide x
PANTOTHENICACID
—D-pantothenate,calciumx
—D-pantothenate,sodiumx—dexpanthenol x
VITAMINB6
—pyridoxinehydrochloride x
—pyridoxine5'-phosphate x
—pyridoxinedipalmitate x
FOLICACID
—pteroylmonoglutamicacid x
VITAMINB12
—cyanocobalamin x
—hydroxocobalamin x2001L0015—EN—10.02.2004—001.001—5
▼B
SubstanceConditionofuse
AllFPNU FSMP
BIOTIN
—D-biotin xVITAMINC
—L-ascorbicacid x
—sodium-L-ascorbate x—calcium-L-ascorbate x—potassium-L-ascorbate x—L-ascorbyl6-palmitate xCategory2. Minerals
CALCIUM
—carbonate x—chloride x—saltsofcitricacid x—gluconate x—glycerophosphate x—lactate x
—saltsoforthophosphoricacid x
—hydroxide x—oxide x
—sulphate x
MAGNESIUM
—acetate x—carbonate x
—chloride x
—saltsofcitricacid x—gluconate x—glycerophosphate x—saltsoforthophosphoricacid x—lactate x
—hydroxide x
—oxide x—sulphate xIRON—ferrouscarbonate x—ferrouscitrate x—ferricammoniumcitrate x
—ferrousgluconate x
—ferrousfumarate x—ferricsodiumdiphosphate x—ferrouslactate x—ferroussulphate x—ferricdiphosphate(ferricpyrophosphate) x—ferricsaccharate x
— elemental iron (carbonyl + electrolytic + hydrogen
reduced)x2001L0015—EN—10.02.2004—001.001—6
▼M1
▼B
▼B
SubstanceConditionofuse
AllFPNU FSMP
COPPER
—cupriccarbonate x
—cupriccitrate x—cupricgluconate x
—cupricsulphate x
—copperlysinecomplex x
IODINE
—potassiumiodide x—potassiumiodate x
—sodiumiodide x
—sodiumiodate xZINC
—acetate x
—chloride x
—citrate x
—gluconate x—lactate x
—oxide x
—carbonate x—sulphate x
MANGANESE
—carbonate x
—chloride x
—citrate x—gluconate x
—glycerophosphate x
—sulphate xSODIUM
—bicarbonate x
—carbonate x—chloride x
—citrate x
—gluconate x
—lactate x
—hydroxide x—saltsoforthophosphoricacid x
POTASSIUM
—bicarbonate x—carbonate x
—chloride x
—citrate x
—gluconate x
—glycerophosphate x—lactate x
—hydroxide x
—saltsoforthophosphoricacid x2001L0015—EN—10.02.2004—001.001—7
▼B
SubstanceConditionofuse
AllFPNU FSMP
SELENIUM
—sodiumselenate x—sodiumhydrogenselentine x—sodiumselenite xCHROMIUM(III)andtheirhexahydrates—chloride x—sulphate xMOLYBDENUM(VI)—ammoniummolybdate x—sodiummolybdate xFLUORINE—potassiumfluoride x—sodiumfluoride xCategory3. Aminoacids—L-alanine x—L-arginine x—L-asparticacid x—L-citrulline x
—L-cysteine x—Cystine x—L-histidine x—L-glutamicacid x—L-glutamine x
—glycine x
—L-isoleucine x
—L-leucine x
—L-lysine x—L-lysineacetate x—L-methionine x—L-ornithine x—L-phenylalanine x—L-proline x
—L-threonine x—L-tryptophan x—L-tyrosine x—L-valine x
—L-serine x
—L-arginine-L-aspartate x—L-lysine-L-aspartate x—L-lysine-L-glutamate x—N-acetyl-L-cysteine x—N-acetyl-L-methionine xinproducts
intendedfor
personsover1
yearofage2001L0015—EN—10.02.2004—001.001—8
▼C1
▼B
▼M1
▼B
SubstanceConditionofuse
AllFPNU FSMP
For animo acids, as far as applicable, also the sodium,
potassiumcalciumandmagnesiumsaltsaswellastheir
hydrochloridesmaybeused
Category4. Carnitineandtaurine
—L-carnitine x
—L-carnitinehydrochloride x
—taurine x
—L-carnitine-L-tartrate xCategory5. Nucleotides
—adenosine5'-phosphoricacid(AMP) x
—sodiumsaltsofAMP x
—cytidine5'-monophosphoricacid(CMP) x
—sodiumsaltsofCMP x
—guanosine5'-phosphoricacid(GMP) x
—sodiumsaltsofGMP x
—insosine5'-phosphoricacid(IMP) x
—sodimsaltsofIMP x
—uridine5'-phosphoricacid(UMP) x
—sodiumsaltsofUMP x
Category6. Cholineandinositol
—choline x
—cholinechloride x
—cholinebitartrate x—cholinecitrate x
—inositol x2001L0015—EN—10.02.2004—001.001—9
▼M1
▼B