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"B "C1 COUNCIL REGULATION (EC) No 1139/98
of 26 May 1998
concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically
modified organisms, of particulars other than those provided for in Directive 79/112/EEC 3
(OJL159,3.6.1998,p.4)
Amendedby:
OfficialJournal
No page date
"M1CommissionRegulation(EC)No49/2000of10January2000 L6 13 11.1.2000
Correctedby:
"C1Corrigendum,OJL190,4.7.1998,p.86(1139/98)
"C2Corrigendum,OJL94,9.4.1999,p.27(1139/98)1998R1139—EN—10.04.2000—001.001—1
COUNCIL REGULATION (EC) No 1139/98
of 26 May 1998
concerning the compulsory indication, on the labelling of certain
foodstuffs produced from genetically modified organisms, of particulars
other than those provided for in Directive 79/112/EEC
THECOUNCILOFTHEEUROPEANUNION,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,
HavingregardtoCouncilDirective79/112/EECof18December1978onthe
approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs(1), and in particular Article 4(2)
thereof,
HavingregardtotheproposalfromtheCommission,(1) Whereas, in accordance with the provisions of Part C of Council
Directive 90/220/EEC of 23 April 1990 on the deliberate release into
the environment of genetically modified organisms(
2), consents have
beengivenfortheplacingonthemarketofcertaingeneticallymodified
products by Commission Decision 96/281/EC of 3 April 1996
concerning the placing on the market of genetically modified soyabeans ( Glycine max L.) with increased tolerance to the herbicide
glyphosate, pursuant to Council Directive 90/220/EEC(
3), and by
Commission Decision 97/98/EC of 23 January 1997 concerning the
placingonthemarketofgeneticallymodifiedmaize( Zea maysL.)with
thecombinedmodificationforinsecticidalpropertiesconferredbytheBt-endotoxingeneandincreasedtolerancetotheherbicideglufosinate
ammoniumpursuanttoCouncilDirective90/220/EEC(
4);
(2) WhereasinaccordancewithDirective90/220/EECtherewerenosafety
groundsformentioningonthelabelofgeneticallymodifiedsoyabeans
(Glycine max L.)orofgeneticallymodifiedmaize( Zea maysL).that
theywereobtainedbygeneticmodificationtechniques;
(3) Whereas Directive 90/220/EEC does not cover non-viable products
derivedfromgeneticallymodifiedorganisms(hereinafterreferredtoas
‘GMOs’);
(4) WhereascertainMemberStateshavetakenmeasuresinrespectofthe
labelling of foods and food ingredients produced from the products
concerned; whereas differences between those measures are liable to
impede the free movement of those foods and food ingredients andtherebyadverselyaffectthefunctioningoftheinternalmarket;whereasitisthereforenecessarytoadoptuniformCommunitylabellingrulesfor
theproductsconcerned;
(5) WhereasRegulation(EC)No258/97oftheEuropeanParliamentandof
theCouncilof27January1997concerningnovelfoodsandnovelfood
ingredients(
5), lays down, in Article 8, additional specific labelling
requirements in order to ensure proper information for the finalconsumer;whereasthoseadditionalspecificlabellingrequirementsdonot apply to foods or food ingredients which were used for human
consumptiontoasignificantdegreewithinthe Communitybeforethe
entry into force of Regulation (EC) 258/97 and are for that reasonconsiderednottobenovel;
(6) Whereas,inordertopreventdistortionsofcompetition,labellingrules
fortheinformationofthefinalconsumerbasedonthesameprinciplesshouldapplytofoodsandfoodingredientsconsistingoforderivedfromGMOswhichwereplacedonthemarketbeforetheentryintoforceof
Regulation(EC)No258/97pursuanttoaconsentgivenunderDirective
90/220/EEC,andtofoodsandfoodingredientswhichareplacedonthemarketthereafter;!B
(1) OJL33,8.2.1979,p.1.DirectiveaslastamendedbyDirective97/4/ECofthe
EuropeanParliamentandoftheCouncil(OJL43,14.2.1997,p.21).
(2) OJL117,8.5.1990,p.15.DirectiveaslastamendedbyDirective97/35/EC(OJL
169,27.6.1997,p.72).
(3) OJL107,30.4.1996,p.10.
(4) OJL31,1.2.1997,p.69.
(5) OJL43,14.2.1997,p.1.!C1
!B1998R1139—EN—10.04.2000—001.001—2
(7) Whereas, therefore, Commission Regulation (EC) No 1813/97 of 19
September1997concerningthecompulsoryindicationonthelabellingofcertainfoodstuffsproducedfromgeneticallymodifiedorganismsofparticulars other than those provided for in Directive 79/112/EEC(
1)
laiddowngenerallabellingrulesfortheabovementionedproducts;
(8) WhereasitisnowurgenttolaydowndetaileduniformCommunityrules
forthelabellingofthefoodstuffscoveredbyRegulation(EC)No1813/97;
(9) Whereas, in particular, drawing on the approach taken in Article 8 of
Regulation (EC) No 258/97, it is necessary to ensure that the final
consumer is informed of any characteristic or food property, such ascomposition,nutritionalvalueornutritionaleffectsortheintendeduseof the food, which renders a food or food ingredient no longer
equivalent to an existing food or food ingredient; whereas, for that
purpose, foods and food ingredients produced from geneticallymodified soya beans or from genetically modified maize which arenot equivalent to conventional counterparts should be subject to
labellingrequirements;
(10) Whereas,drawingontheapproachtakeninArticle8ofRegulation(EC)
No 258/97, it is necessary that labelling requirements are based onscientificevaluation;
(11) Whereas it is necessary to establish clear labelling rules for the
abovementionedproducts,allowingofficialcontrolonareliable,readily
repeatable and practicable basis; whereas common scientificallyvalidatedtestingmethodsshouldbedeveloped;
(12) Whereas it is also necessary to ensure that the labelling requirements
are no more burdensome than necessary but sufficiently detailed to
supplyconsumerswiththeinformationtheyrequire;
(13) Whereas at this stage the presence in foods and food ingredients of
protein or DNA resulting from genetic modification constitutes thecriterion best complying with the abovementioned requirements;
whereassuchanapproachcouldbereconsideredinthelightoffuture
developmentsinscientificknowledge;
(14) WhereasadventitiouscontaminationoffoodstuffswithDNAorprotein
resulting from genetic modification cannot be excluded; whereas
labellingasaresultofsuchcontaminationcouldbeavoidedbysettinga
thresholdforthedetectionofDNAandprotein;
(15) Whereasurgentconsiderationmustbegiven,inthelightofanyrelevant
scientificadvice,tothequestionofwhetherademinimisthresholdforthepresenceofDNAorproteinresultingfromgeneticmodificationcan
besetand,ifso,atwhatlevel;
(16) Whereas f oods and food ingredients produced from genetically
modified soya beans ( Glycine max L.) or from genetically modified
maize ( Zea maysL.), in which DNA resulting from genetic
modification is present, are not equivalent and should therefore be
subjecttolabellingrequirements;
(17) Whereas it is possible that protein or DNA resulting from genetic
modification has been destroyed by successive stages of processing;whereas,inthatcase,foodsandfoodingredientsshouldbeconsidered
equivalentforlabellingpurposes;whereastheyshouldthereforenotbe
subjecttolabellingrequirements;whereasalistofsuchproductsshouldbedrawnup;
(18) Whereas, nevertheless, some processing methods may eliminate DNA
butnotproteins;whereasthepossibilitycannot beexcludedthatsuch
methodsmaybecapableofbeingappliedtofooduses;whereasfoodsandfoodingredientsinwhichDNAresultingfromgeneticmodificationisnotpresentbutinwhichproteinsresultingfromgeneticmodification
are present, cannot beconsidered tobeequivalent;whereas therefore,
theyshouldbesubjecttolabellingrequirements;
(19) Whereas the necessary information should be provided in the list of
ingredientsexceptinthecaseofproductsforwhichnosuchlistexists,
inwhichcaseitshouldappearclearlyonthelabellingoftheproduct;!B
(1) OJL257,20.9.1997,p.7.1998R1139—EN—10.04.2000—001.001—3
(20) WhereasthisRegulationiswithoutprejudicetotheoperators’rightto
includevoluntaryclaimsinthelabelsoftheirproductsastoparticularsother than those laid down in this Regulation (such as the absence offoods and food ingredients produced from genetically modified soya
beansandmaize,orthepresenceofsuchfoodsandfoodingredientsin
cases where it is not scientifically verifiable but evidence of it isavailablethroughothermeans),providedthatsuchclaimsaremadeincompliancewiththeprovisionsofDirective79/112/EEC;
(21) Whereas, having regard to their scope and effects, the Community
measures introduced by this Regulation are not only necessary but
essential if the objectives set are to be attained; whereas those
objectivescannotbeattainedbytheMemberStatesactingindividually;
(22) Whereas this Regulation replaces Commission Regulation (EC) No
1813/97,whichshouldthereforeberepealed;
(23) Whereas in pursuance of the procedure laid down in Article 17 of
Directive79/112/EEC,adraftofthistextwassubmittedtotheStanding
CommitteeonFoodstuffs,whichwasunabletodeliveranopinion,andwhereas in accordance with the same procedure the Commission
addressed a proposal to the Council, concerning the measures to be
adopted,
HASADOPTEDTHISREGULATION:
Article 1
1. ThisRegulationshallapplytofoodsandfoodingredientswhicharetobe
delivered as such
"M1to the final consumer or mass caterers 3
(hereinafter referred to as ‘the specified foodstuffs’) produced, in whole or
inpart,from:
— geneticallymodifiedsoyabeanscoveredbyDecision96/281/EC,
— geneticallymodifiedmaizecoveredbyDecision97/98/EC.
2. ThisRegulationshallnotapplytofoodadditives,flavouringsforusein
foodstuffs or extraction solvents used in the production of foodstuffs asreferredtoinArticle2(1)ofRegulation(EC)No258/97.
Article 2
1. The specified foodstuffs shall be subject to the additional specific
labellingrequirementslaiddowninparagraph3.
2. The specified foodstuffs shall not be subject to the additional specific
labellingrequirementswhere:
(a) neitherproteinnorDNAresultingfromgeneticmodificationasspecified
inArticle1(1)ispresentintheirfoodingredientsindividuallyconsideredorthefoodcomprisingasingleingredient;
or
(b) materialderivedfromthegeneticallymodifiedorganismsreferredtoin
Article1(1),togetherwithanymaterialplacedonthemarketpursuanttoRegulation (EC) No 258/97 derived from other genetically modified
organisms,ispresentintheirfoodingredientsor thefoodcomprisinga
single ingredient in a proportion no higher than 1 % of the foodingredients individually considered or food comprising a singleingredient,providedthispresenceisadventitious;
In order to establish that the presence of this material is adventitious,
operators must be in a position to supply evidence to satisfy the
competent authorities that they have taken appropriate steps to avoid
usingthegeneticallymodifiedorganisms(orproducethereof)referredtointhepreviousparagraphasasource.!M11998R1139—EN—10.04.2000—001.001—4
2a. Inordertofacilitatetheapplicationofparagraph2(a),anon-exhaustive
list of food ingredients or foods comprising a single ingredient in whichneitherproteinnorDNAresultingfromthegeneticmodificationasspecifiedinArticle1(1)ispresent,shallbedrawnupundertheprocedurelaiddownin
Article 17 of Directive 79/112/EEC, taking account of technical develop-
ments, the opinion of the Scientific Committee for food and any otherrelevantscientificadvice.
3. Theadditionalspecificlabellingrequirementsshallbethefollowing:(a) wherethefoodconsistsofmorethanoneingredient,thewords‘produced
fromgeneticallymodifiedsoya’or‘producedfromgeneticallymodifiedmaize’,asappropriate,shallappearinthelistofingredientsprovidedfor
by Article 6 of Directive 79/112/EEC in parentheses immediately after
the name of the ingredient concerned. Alternatively, these words mayappear in a prominently displayed footnote to the list of ingredients,
relatedbymeansofanasterisk(*)totheingredientconcerned.Wherean
ingredient is already listed as being produced from soya or maize thewords ‘produced from genetically modified’ may be abbreviated to‘genetically modified’; if the abbreviated form of words is used as a
footnote, the asterisk shall be directly attached to the word ‘soya’ or
‘maize’.Whereeitherformofwordsisusedasafootnote,itshallhaveatypefaceofatleastthesamesizeasthelistof ingredientsitself;
(b) inthecaseofproductsforwhichnolistof ingredientsexists,thewords
‘producedfromgeneticallymodifiedsoya’or‘producedfromgenetically
modifiedmaize’,asappropriate,shallappearclearlyonthelabellingof
thefood;
(c) where in accordance with the provisions of the first indent of Article
6(5)(b)ofDirective79/112/EECaningredientisdesignatedbythenameofacategory,thatdesignationshallbecompletedbythewords‘contains
…(*) produced from genetically modified soya/genetically modified
maize’,asappropriate;
(d) where an ingredient of a compound ingredient is derived from the
specified foodstuffs, it shall be mentioned on the labelling of the finalproduct,withtheadditionofthewordingsetoutinpoint(b).
4. This Article shall be without prejudice to the other requirements of
Communitylawconcerningthelabellingoffoodstuffs.
Article 3
CommissionRegulation(EC)No1813/97isherebyrepealed.
Article 4
1. ThelabellingrequirementsofthisRegulationshallnotapplytoproducts
which have been lawfully manufactured and labelled in the Community, or
which have been lawfully imported into the Community and put into freecirculation,beforetheentryintoforceofthisRegulation.
2. The application of Article 2 to products placed on the market with
labellingcomplyingwithCommissionRegulation(EC)No1813/97soasto
indicatethepresenceofgeneticallymodifiedmaterialmaybepostponeduntil
sixmonthsaftertheentryintoforceofthisRegulation.
Article 5
This Regulation shall enter into force 90 days after its publication in the
Official Journal of the European Communities.
ThisRegulationshallbebindinginitsentiretyanddirectlyapplicableinall
MemberStates.!M1
(*) Ingredient(s)tobespecified.!B1998R1139—EN—10.04.2000—001.001—5