NoC116/6 OfficialJournaloftheEuropeanCommunities 27.4.93
II
(PreparatoryActs)
COMMISSION
ProposalforaCouncilDecisionconcerningtheuseandmarketingofenzymesmicro-organisms
andtheirpreparationsinanimalnutrition
(93/C116/07)
COM(93)119final
(SubmittedbytheCommissionon29March1993)
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity ,andinparticularArticle43
thereof,
HavingregardtotheproposalfromtheCommission ,
HavingregardtotheopinionoftheEuropean
Parliament ,
HavingregardtotheopinionoftheEconomicand
SocialCommittee ;
WhereasCouncilDirective70/524/EECconcerning
additivesinfeedingstuffs('),aslastamendedby
Directive92/113/EEC(2)laysdowntheprinciples
relatingtotheauthorizationandtheuseofadditives;
WhereasCouncilDirective87/153/EECfixing
guidelinesfortheassessmentofadditivesinfeeding­
stuffs(})constitutesaguidefordefiningthescientific
informationnecessarytoidentifyandcharacterizethe
productsconcerned,aswellasthestudiesnecessaryto
evaluate,inparticular,theirefficacyandinnocuousness
forhumans,animalsandtheenvironment ;
Whereasadvancesinscientificandtechnological
knowledgepermittheuseofcertainenzymes,micro­
organismsandtheirpreparationsinanimalnutritionin
ordertoimprovethedigestibilityofnutrients,orto
stabilizethefloraofthedigestivesystemofanimals,and
toreducethecontentofcertainsubstancesdangerousto
theenvironment ,whereasatthemomentnocriteriaexist
fortheexaminationofrequestsforauthorizationforuse
asadditivesofthisnewgenerationofproducts;Whereasitisessential,intheexpectationofan
amendmenttotheguidelinesandinordertoallowthe
submissionofdossiersfortheseproducts,toallow
provisionallytheuseandmarketingofenzymes,micro­
organismsandtheirpreparationsatnationallevel,
providedtheydonotpresentanydangertohumanor
animalhealth;
Whereastheauthorizationoftheseproductsrequiresan
inventoryofthematthelevelofMemberStates,andthe
transmission totheCommission ofcertaininformation
justifyingtheirinclusioninnationallists;
WhereasMemberStatesmaynotrestrictthemarketing
oflivestockproductsobtainedfromfeedscontaining
enzymes,micro-organisms ortheirpreparationswhen
theseareincludedonanationallistestablished
accordingtotheprovisionsofthisDecision;
WhereastheprovisionsofthisDecisiondonotapplyto
enzymes,micro-organisms ,ortotheirpreparationswhen
usedassilageagents;
WhereasthisDecisionapplieswithoutprejudiceto
Directive70/524/EECsubjecttotheamendmentswhich
shouldstillbemadetothisDirectiveinordertoallow
thecoexistenceofthetemporaryregime;
Whereasitisadvisableasaconsequencetoamend
Directive87/153/EEC,andquickly,withaviewto
havingavailablethenecessaryrulesforthespecific
examinationofadditivesbelongingtothenewgroupof
enzymesandmicro-organisms ,whereasinthemeantime,
thedossierswhichwillbesubmittedwithaviewto
assessingproductsincludedinthenationallistshouldbe
preparedaccordingtotheguidelinesestablishedfor
additivesingeneral;
(1)OJNoL270,14.12.1970,p.1.
(2)OJNoL16,25.1.1993,p.2.
(')OJNoL64,7.3.1987,p.19.Whereasitisadvisablethatindustryisgivensufficient
timetoapplythenewprovisionsprovidedforenzymes,

27.4.93 OfficialJournaloftheEuropeanCommunities NoC116/7
Article5
Before1January1988,arulingwillbegivenin
accordancewiththeprocedureprovidedbyDirective
70/524/EEConthedossiersreferredtointhesecond
indentofArticle3concerningtheauthorizationof
additivesinanimalnutrition .
Article6
WhereMemberStatesfinditimpossibletosatisfyoneof
theconditionsreferredtoinArticle3,foranenzyme,
micro-organism ,orapreparationusedontheirterritory,
theyshalltakeallthenecessarymeasurestoensurethat
theenzyme,micro-organism orpreparationobtained
fromthemisnolongerused.
Article7
1.Enzymes,micro-organisms andtheirpreparations ,
aswellaspre-mixturesandcompoundfeedingstuffsin
whichtheyhavebeenincorporated ,mayonlybe
marketediftheparticularslistedbelow,whichshouldbe
clearlyvisible,legibleandindelibleandforwhichthe
producer,packer,importer,sellerordistributorestab­
lishedwithintheCommunityshallbeheldresponsible
areshownonthepackaging,containeroronalabel
attachedthereto:
A.forenzymes:
(a)thespecificnameoftheactiveconstituent(s)
accordingtotheirenzymaticactivity(ies)andthe
identificationnumber(s)accordingtotheInterna­
tionalUnionofBiochemistry ;
(b)theactivityunits(activityunits(')pergor
activityunitsperml);
(c)thenameorbusinessnameandtheaddressor
registeredplaceofbusinessoftheperson
responsiblefortheparticularsinthisparagraph;
(d)thenameorbusinessnameandaddressor
registeredplaceofbusinessofthemanufacturer is
heisnotresponsiblefortheparticularsonthe
label;
(e)theexpirydateoftheguaranteeorthestorage
lifefromthedateofmanufacture ;
(f)thebatchreferencenumberandthedateof
manufacture ;
(g)directionsforuseandwhereappropriate,asafety
recommendation ;
(h)thenetweightandforliquidadditiveseitherthe
netvolumeorthenetweight;
(i)theindication'tobeusedexclusivelyforthe
manufactureoffeedingstuffs';micro-organisms andtheirpreparationsaswellaspre­
mixturesandfeedingstuffscontainingthem,
HASADOPTEDTHISDECISION :
Article1
1.ThisDecisionshallapplytotheuseandmarketing
ofenzymes,micro-organisms andtheirpreparationsin
animalnutrition .
2.ThisDecisonapplieswithoutprejudicetothe
provisionsofDirective70/524/EECandparticularlyto
theprovisionsconcerningtheauthorizationofenzymes,
micro-organisms andtheirpreparationsforuseas
additives .
Article2
BywayofderogationfromArticle3ofDirective
70/524/EECMemberStatesshallallowtheuseand
marketingofenzymes,micro-organisms andtheirprepa­
rationsinfeedingstuffsontheirterritory,providedthat,
onthebasisoftheavailableinformation ,theproductsdo
notpresentadangertohumanoranimalhealth,and
thattheyareincludedinthelistwhichhasbeenestab­
lishedbyvirtueofArticle3.
Article3
OnthebasisoftheinformationtheyreceiveMember
Statesshallforward :
—totheCommissionbefore1January1994alistof
enzymesandmicro-organisms andtheirpreparations
usedontheirterritories,accompaniedbyanidentifi­
cationnoteestablishedforeachproductaccordingto
themodelgivenintheAnnex,
—totheCommission andtootherMemberStates
before1January1996,thedossiersjustifyingthese
authorizations bythemanufacturer(s )having
requestedinclusionoftheirproductsinthelist
referredtointhefirstindentabove.
Article4
1.TheCommission shallcommunicate toMember
Statesthelistsofenzymes,micro-organisms andtheir
preparations ,whichhavebeensenttothemin
accordancewiththeprovisionsofArticle3.
2.Where,eitheranenzyme,micro-organism ora
preparationmanufactured fromthemareincludedin
severalnationallists,itmaybeagreedbetweenthe
MemberStatesconcernedthatonlyonedossieris
presentedbyoneofthem.
3.TheCommissionshallpublishintheOfficial
JournaloftheEuropeanCommunities ,PartC,before31
March1996,onthebasisofthedossierswhichhave
beenpresentedtotheminaccordancewithArticle3,a
listofenzymes,micro-organisms andtheirpreparations
permittedindifferentMemberStates.(')Unitsofactivityexpressedasnmoleproductreleasedper
minutepergramofenzymaticpreparation .

NoC116/8 OfficialJournaloftheEuropeanCommunities 27.4.93
B.formicro-organisms :
(a)theidentificationofthestrain(s)accordingtothe
recognizedinternationalcodeofnomenclature
andthedepositingnumberofthestrain(s);
(b)thenumberofcolony-forming units(CFU/g);
(c)thenameorbusinessnameandaddressor
registeredplaceofbusinessoftheperson
responsiblefortheparticularsreferredtointhis
paragraph;
(d)thenameorbusinessnameandaddressor
registeredplaceofbusinessofthemanufacturerif
heisnotresponsiblefortheparticularsonthe
label;
(e)theexpirydateoftheguarantee,orthestorage
lifefromthedateofmanufacturer ;
(f)thebatchreferencenumberandthedateof
manufacturer ;
(g)thedirectionsforuseandwhereappropriate,a
safetyrecommendation ;
(h)thenetweight,andforliquidadditiveseitherthe
netvolumeorthenetweight;
(i)theindication'tobeusedexclusivelyforthe
manufactureoffeedingstuffs';
C.forpre-mixturescontainingenzymes:
(a)thedescription'pre-mixture';
(b)theindication'tobeusedexclusivelyinthe
manufactureoffeedingstuffs';
(c)thedirectionsforuseandanysafetyrecommen­
dationsregardingtheuseofpre-mixtures ;
(d)theanimalspeciesorcategoryofanimalsfor
whichthepre-mixtureisintended;
(e)thenameorbusinessnameandtheaddressor
registeredplaceofbusinessoftheperson
responsiblefortheparticularsreferredtointhis
paragraph;
(f)thenetweightand,inthecaseofliquids,either
thevolumeornetweight;
(g)thespecificnameoftheactiveconstituent(s)
accordingtotheirenzymaticactivity(ies)andthe
identificationnumber(s)accordingtotheInterna­
tionalUnionofBiochemistry ;
(h)theactivityunits(activityunitspergoractivity
unitsperml);
(i)theexpirydateoftheguaranteeorthestorage
lifefromthedateofmanufacturer ;
(j)thenameorbusinessnameandaddressor
registeredplaceofbusinessofthemanufacturerif
heisnotresponsiblefortheparticularsonthe
label;
D.forpre-mixturescontainingmicro-organisms :
(a)thedescription'pre-mixture';
(b)theindication'tobeusedexclusivelyinthe
manufactureoffeedingstuffs';(c)thedirectionsforuseandanysafetyrecommen­
dationsregardingtheuseofpre-mixtures ;
(d)theanimalspeciesorcategoryofanimalsfor
whichthepre-mixtureisintended;
(e)thenameorbusinessnameandtheaddressor
registeredplaceofbusinessoftheperson
responsiblefortheparticularsreferredtointhis
paragraph;
(f)thenetweightand,inthecaseofliquids,either
thevolumeornetweight;
(g)theidentificationofthestrain(s)accordingtothe
recognizedinternationalcodeofnomenclature
andthedepositingnumberofthestrain(s);
(h)thenumberofcolony-formingunits(CFU/g);
(i)thenameorbusinessnameandaddressor
registeredplaceofbusinessoftheperson
responsiblefortheparticularsreferredtointhis
paragraph;
(j)thenameorbusinessnameandaddressor
registeredplaceofbusinessofthemanufacturer if
heisnotresponsiblefortheparticularsonthe
label;
E.forcompoundfeedsinwhichenzymeshavebeenincor­
porated:
(a)thespecificnameoftheactiveconstituent(s )
accordingtotheirenzymaticactivity(ies)
conformingwithAnnexesIorIIandtheidentifi­
cationnumberaccordingtotheInternational
UnionofBiochemistry ;
(b)theactivityunits(activityunitsperg)oractivity
unitsperml;
(c)theexpirydateoftheguaranteeorthestorage
lifefromthedateofmanufacture ;
F.forcompoundfeedsinwhichmicro-organisms havebeen
incorporated:
(a)theidentificationofthestrain(s)accordingtothe
recognizedinternationalcodeofnomenclature
andthedepositingnumberofthestrain(s);
(b)thenumberofcolony-forming units(CFU/g);
(c)theexpiry,dateoftheguaranteeorthestorage
lifefromthedateofmanufacture .
2.Informationotherthanthatprescribedinparagraph
1,subparagraphs A,B,CandDsuchasthecommercial
name,maybeincludedonthepackaging,containersor
onalabelattachedtheretoprovidedthatitisclearly
separatedfromtheindicationsmentionedabove.
Article8
ThisDecisionisapplicablefrom1July1993.However
Article7isonlyapplicablefrom1January1994.
Article9
ThisDecisionisaddressedtotheMemberStates.

27.4.93 OfficialJournaloftheEuropeanCommunities NoC116/9
ANNEX
MODELOFIDENTIFICATION NOTE
1.Identityoftheproduct
—tradename
—qualitativeandquantitativecomposition
—activesubstance(s)
—othercomponents
—impurities
—undesirablesubstances
—nameorbusinessnameandtheaddressorregisteredplaceofbusinessofthemanufacturer
—placeofmanufacture
—nameorbusinessnameandtheaddressorregisteredplaceofbusinessofthemanufacturer
2.Specificationsconcerningtheactivesubstance
2.1.Formicro-organisms
—nameandtaxonomicdescriptionaccordingtotheinternationalcodesofnomenclature(')
—nameandplaceofculturecollectionwherethestrainisregisteredanddepositedandthenumber
ofregistrationanddeposit
—possiblegeneticmanipulation
—thenumberofcolony-forming units(CFU/g)foreachspecies
2.2.Forenzymes
—nameaccordingtomainenzymaticactivitiesandECnumber(2)
—biologicalorigin
—relevantactivitieswithregardtoappropriatetypesofsubstrates,chemicallypure(expressedin
activityunits(3)perg)
NB:Iftheactivesubstanceisamixtureofactivecomponents ,allthecomponentsmustbedescribed
separatelywithanindicationoftheirproportioninthemixture
3.Qualitiesoftheproduct
—mainsought-aftereffect
—informationconcerningefficiency
—justificationforthepresenceofeachcomponentifthesubstanceisamixtureofeffective
components
—othereffects
(')SuchasBergey's'ManualofSystematicBacteriology -,'TheYeasts,ataxonomicstudybyLodderandKregervanRij;
'AinsworthsandBishy'sdictionaryoftheFungibyHawksworth ;'SuttonandAinsworthon"ThegenusAspergillus"'by
RaperandFennell.
(')EnzymeNomenclature ,Recommendations (1984)oftheNomenclatureCommitteeoftheInternationalUnionof
Biochemistry ,AcademicPress1984.
(')Activityunitsexpressedasµmoleofproductreleasedperminutepergramoftheenzymaticpreparations .

NoC116/10 OfficialJournaloftheEuropeanCommunities 27.4.93
4.Conditionsfortheuseofproduct
—usesprovidedforinanimalnutrition(speciesorcategoriesofanimal,typeoffeedingstuffsfor
animal,periodofuse,etc.)
—proposeddosageinpre-mixesandfeedingstuffs (appropriateunitsofbiologicalactivitysuchas
CFUpergramofproductformicro-organisms oractivityunitspergramforenzymepreparations )
—otherknownusesoftheactivesubstanceorthepreparation (infoodstuffs,humanorveterinary
medicine,industryetc.)
—recommendations concerningsafetyofuseoftheproductinrelationtotargetspecies,the
consumerandtheenvironment
—ifnecessay,measuresforthepreventionofrisksandmeansofprotectionduringmanufactureand
handling
5.Technologicalinformation
—stabilityofproduct
—withregardtoatmosphericagents
—duringthepreparationofpre-mixturesandfeedingstuffs
—inthecaseofpresentationofpre-mixturesandfeedingstuffs
—detaileddescriptionofprocessofmanufactureandmethodsusedconcerningthecontrolofthe
qualityoftheproductduringitsmanufacture
6.Control
—methodsofanalysisforthedeterminationoftheproduct
—inpre-mixtures
—infeedingstuffs
Wherepossibleinformationprovidedintheidentificationnotemustbeaccompaniedbyexistingscientific
data.