REGULATION (EC) No 1332/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 December 2008
on food enzymes and amending Council Directive 83/417/EEC, Council Regul ation (EC)
No1493/1999,Directive2000/13/EC,CouncilDirective2001/112/ECandR egulation(EC)No258/97
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and
Social Committee (
1),
ActinginaccordancewiththeprocedurelaiddowninArticle251
of the Treaty (2),
Whereas:
(1)The free movement of safe and wholesome food is an
essentialaspectoftheinternalmarketandcontributessig-nificantly to the health and well-being of citizens, and totheir social and economic interests.
(2)Ahighlevelofprotectionofhumanlifeandhealthshould
be assured in the pursuit of Community policies.
(3)Food enzymes other than those used as food additives are
not currently regulated or are regulated as processing aidsunder the legislation of the Member States. Differencesbetweennationallaws,regulationsandadministrativepro-visions concerning the assessment and authorisation offood enzymes may hinder their free movement, creatingconditions for unequal and unfair competition. It is there-fore necessary to adopt Community rules harmonisingnationalprovisionsrelatingtotheuseofenzymesinfoods.(4)ThisRegulationshouldonlycoverenzymesthatareadded
to food to perform a technological function in the manu-facture, processing, preparation, treatment, packaging,transportorstorageofsuchfood,includingenzymesusedasprocessingaids(hereinafterreferredtoasfoodenzymes).
The scope of this Regulation should therefore not extendto enzymes that are not added to food to perform a tech-nological function but are intended for human consump-tion,suchasenzymesfornutritionalordigestivepurposes.Microbial cultures traditionally used in the production offoodsuchascheeseandwine,andwhichmayincidentallyproduce enzymes but are not specifically used to producethem, should not be considered food enzymes.
(5)Food enzymes used exclusively in the production of food
additives falling within the scope of Regulation (EC)No 1333/2008 of the European Parliament and of theCouncilof16December2008onfoodadditives(
3)should
be excluded from the scope of this Regulation, since thesafety of these foods is already assessed and regulated.However, when these food enzymes are used as such infood, they are covered by this Regulation.
(6)Food enzymes should be approved and used only if they
fulfil the criteria laid down in this Regulation. Foodenzymes must be safe when used, there must be a techno-logical need for their use and their use must not misleadthe consumer. Misleading the consumer includes, but isnotlimitedto,issuesrelatedtothenature,freshness,qual-ity of ingredients used, the naturalness of a product or ofthe production process, or the nutritional quality of theproduct. The approval of food enzymes should also takeinto account other factors relevant to the matter underconsideration including societal, economic, traditional,ethical and environmental factors, the precautionary prin-ciple and the feasibility of controls.
(7)Somefoodenzymesarepermittedforspecificuses,suchas
in fruit juices and certain similar products and certain lac-toproteins intended for human consumption, and for cer-tain authorised oenological practices and processes. Theuse of such food enzymes should comply with this
(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (OJ C 175 E,
10.7.2008, p. 162), Council Common Position of 10 March 2008(OJC111E,6.5.2008,p.32),PositionoftheEuropeanParliamentof8 July 2008 (not yet published in the Official Journal) and CouncilDecision of 18 November 2008.
(3) See page 16 of this Official Journal.31.12.2008 EN Official Journal of the European Union L 354/7Regulation and with the specific provisions laid down in
the relevant Community legislation. Council Directive2001/112/ECof20December2001relatingtofruitjuicesand certain similar products intended for human con-sumption (
1), Council Directive 83/417/EEC of 25 July
1983 on the approximation of the laws of the MemberStates relating to certain lactoproteins (caseins and casein-ates) intended for human consumption (
2) and Council
Regulation (EC) No 1493/1999 of 17 May 1999 on thecommon organisation of the market in wine (
3) should
thereforebeamendedaccordingly.Sinceallfoodenzymesshould be covered by this Regulation, Regulation (EC)No258/97oftheEuropeanParliamentandoftheCouncilof27January1997concerningnovelfoodsandnovelfoodingredients (
4) should be amended accordingly.
(8)Food enzymes the use of which is permitted within the
CommunityshouldappearinaCommunitylistthatshouldclearly describe the enzymes and specify any conditionsgoverning their use, including where necessary informa-tion on their function in the final food. This list should besupplemented by specifications, in particular on their ori-gin,includingwhererelevantinformationaboutallergenicproperties, and purity criteria.
(9)In order to ensure harmonisation, the risk assessment of
food enzymes and their inclusion in the Community listshould be carried out in accordance with the procedurelaid down in Regulation (EC) No 1331/2008 of the Euro-peanParliamentandoftheCouncilof16December2008establishing a common authorisation procedure for foodadditives, food enzymes and food flavourings (
5).
(10)UnderRegulation(EC)No178/2002oftheEuropeanPar-
liament and of the Council of 28 January 2002 layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishing the European Food Safety Authority and lay-ing down procedures in matters of food safety (
6), the
EuropeanFoodSafetyAuthority(hereinafterreferredtoastheAuthority)istobeconsultedonmatterslikelytoaffectpublic health.
(11)AfoodenzymewhichfallswithinthescopeofRegulation
(EC)No1829/2003oftheEuropeanParliamentandoftheCouncil of 22 September 2003 on genetically modifiedfood and feed (
7) should be authorised in accordance with
that Regulation as well as under this Regulation.(12)A food enzyme already included in the Community list
under this Regulation which is prepared by productionmethods or using starting materials significantly differentfrom those included in the risk assessment of the Author-ity, or different from those covered by the authorisationand the specifications under this Regulation, should besubmitted for evaluation by the Authority. ‘Significantlydifferent’ could mean inter aliaa change of the production
methodfromextractionfromaplanttoproductionbyfer-mentation using a micro-organism or a genetic modifica-tion of the original micro-organism, a change in startingmaterials, or a change in particle size.
(13)Since many food enzymes are already on the Community
market, provision should be made to ensure that theswitchover to a Community list of food enzymes takesplace smoothly and does not disturb the existing foodenzyme market. Sufficient time should be allowed forapplicantstomakeavailabletheinformationnecessaryforthe risk assessment of these products. An initial two-yearperiod should therefore be allowed following the date ofapplicationoftheimplementingmeasurestobelaiddowninaccordancewithRegulation(EC)No1331/2008[estab-lishing a common authorisation procedure for food addi-tives,foodenzymesandfoodflavourings],inordertogiveapplicants sufficient time to submit the information onexisting enzymes which may be included in the Commu-nity list to be drawn up under this Regulation. It should
also be possible to submit applications for the authorisa-tion of new enzymes during the initial two-year period.The Authority should evaluate without delay all applica-tions for food enzymes for which sufficient informationhas been submitted during that period.
(14)In order to ensure fair and equal conditions for all appli-
cants, the Community list should be drawn up in a singlestep.Thatlistshouldbeestablishedaftercompletionoftherisk assessment of all food enzymes for which sufficientinformationhasbeensubmittedduringtheinitialtwo-yearperiod.However,theriskassessmentsoftheAuthorityforindividual enzymes should be published as soon as theyare completed.
(15)Asignificantnumberofapplicationsisexpectedtobesub-
mittedduringtheinitialtwo-yearperiod.Alengthyperiodmay therefore be needed before the risk assessment ofthesehasbeencompletedandtheCommunitylistisdrawnup. In order to ensure equal access to the market for newfood enzymes after the initial two-year period, a transi-tional period should be provided for during which foodenzymes and food using food enzymes may be placed onthe market and used, in accordance with the existingnational rules in the Member States, until the Communitylist has been drawn up.
(1) OJ L 10, 12.1.2002, p. 58.
(2) OJ L 237, 26.8.1983, p. 25.
(3) OJ L 179, 14.7.1999, p. 1.
(4) OJ L 43, 14.2.1997, p. 1.
(5) See page 1 of this Official Journal.
(6) OJ L 31, 1.2.2002, p. 1.
(7) OJ L 268, 18.10.2003, p. 1.L 354/8 EN Official Journal of the European Union 31.12.2008(16)ThefoodenzymesE1103InvertaseandE1105Lysozyme,
that have been authorised as food additives under Direc-tive95/2/ECoftheEuropeanParliamentandoftheCoun-cil of 20 February 1995 on food additives other thancolours and sweeteners (
1), and the conditions governing
theiruseshouldbecarriedoverfromDirective95/2/ECtotheCommunitylistwhenitisdrawnupbythisRegulation.Inaddition,CouncilRegulation(EC)No1493/1999autho-rises the use of urease, beta-glucanase and lysozyme inwine subject to the conditions laid down in CommissionRegulation (EC) No 423/2008 of 8 May 2008 on layingdown certain detailed rules for implementing Council
Regulation (EC) No 1493/1999 and establishing a Com-munity code of oenological practices and processes (
2).
Those substances are food enzymes and they should fallwithinthescopeofthisRegulation.Theyshouldthereforealso be added to the Community list when it is drawn upfor their use in wine in accordance with Regulation (EC)No 1493/1999 and Regulation (EC) No 423/2008.
(17)Foodenzymesremainsubjecttothegenerallabellingobli-
gationsprovidedforinDirective2000/13/ECoftheEuro-pean Parliament and of the Council of 20 March 2000 onthe approximation of the laws of the Member States relat-ing to the labelling, presentation and advertising of food-stuffs (
3) and, as the case may be, in Regulation (EC)
No 1829/2003 and in Regulation (EC) No 1830/2003 oftheEuropeanParliamentandoftheCouncilof22Septem-ber 2003 concerning the traceability and labelling ofgeneticallymodifiedorganismsandthetraceabilityoffoodand feed products produced from genetically modifiedorganisms (
4).Inaddition,specificprovisionsonthelabel-
ling of food enzymes sold as such to the manufacturer orto the consumer should be contained in this Regulation.
(18)Food enzymes are covered by the definition of food in
Regulation (EC) No 178/2002 and are therefore, whenused in food, required to be indicated as ingredients in thelabelling of the food in compliance with Directive2000/13/EC. Food enzymes should be designated by theirtechnological function in food, followed by the specificname of the food enzyme. However, provision should bemade for a derogation from the provisions on labelling incases where the enzyme performs no technological func-tioninthefinalproductbutispresentinthefoodstuffonlyas a result of carry-over from one or more of the ingredi-entsofthefoodstufforwhereitisusedasaprocessingaid.Directive 2000/13/EC should be amended accordingly.(19)Food enzymes should be kept under continuous observa-
tionandshouldbere-evaluatedwhenevernecessaryinthe
light of changing conditions governing their use and newscientific information.
(20)The measures necessary for the implementation of this
Regulation should be adopted in accordance with CouncilDecision 1999/468/EC of 28 June 1999 laying down theprocedures for the exercise of implementing powers con-ferred on the Commission (
5).
(21)In particular the Commission should be empowered to
adopt appropriate transitional measures. Since those mea-suresareofgeneralscopeandaredesignedtoamendnon-essential elements of this Regulation, inter alia,b y
supplementing it with new non-essential elements, theymust be adopted in accordance with the regulatory proce-dure with scrutiny provided for in Article 5a of Decision1999/468/EC.
(22)In order to develop and update Community law on food
enzymes in a proportionate and effective way, it is neces-sarytocollectdata,shareinformationandcoordinateworkbetweenMemberStates.Forthatpurpose,itmaybeusefulto undertake studies to address specific issues with a viewto facilitating the decision-making process. It is appropri-ate that the Community finance such studies as part of itsbudgetary procedure. The financing of such measures iscoveredbyRegulation(EC)No882/2004oftheEuropeanParliamentandoftheCouncilof29April2004onofficialcontrols performed to ensure the verification of compli-ance with feed and food law, animal health and animalwelfare rules (
6).
(23)MemberStatesaretocarryoutofficialcontrolsinorderto
enforce compliance with this Regulation in accordancewith Regulation (EC) No 882/2004.
(24)SincetheobjectiveofthisRegulation,namelytolaydown
Communityrulesonfoodenzymes,cannotbesufficientlyachieved by the Member States and can therefore, in theinterestsofmarketunityandahighlevelofconsumerpro-tection, be better achieved at Community level, the Com-munity may adopt measures, in accordance with theprincipleofsubsidiarityassetoutinArticle5oftheTreaty.In accordance with the principle of proportionality, as setout in that Article, this Regulation does not go beyondwhat is necessary in order to achieve that objective,
(1) OJ L 61, 18.3.1995, p. 1.
(2) OJ L 127, 15.5.2008, p. 13.
(3) OJ L 109, 6.5.2000, p. 29.
(4) OJ L 268, 18.10.2003, p. 24.(5) OJ L 184, 17.7.1999, p. 23.
(6) OJL165,30.4.2004,p.1.CorrectedversioninOJL191,28.5.2004,
p. 1.31.12.2008 EN Official Journal of the European Union L 354/9HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down rules on food enzymes used in foods,
including such enzymes used as processing aids, with a view toensuring the effective functioning of the internal market whilstensuring a high level of protection of human health and a highlevel of consumer protection, including the protection of con-sumer interests and fair practices in food trade, taking intoaccount, where appropriate, the protection of the environment.
For those purposes, this Regulation provides for:(a) a Community list of approved food enzymes;(b) conditions of use of food enzymes in foods;(c) rules on the labelling of food enzymes sold as such.
Article 2
Scope
1. This Regulation shall apply to food enzymes as defined in
Article 3.
2. This Regulation shall not apply to food enzymes when and
insofar as they are used in the production of:
(a) food additives falling within the scope of Regulation (EC)
No 1333/2008 [on food additives];
(b) processing aids.3. This Regulation shall apply without prejudice to any spe-
cific Community rules concerning the use of food enzymes:
(a) in specific foods;(b) for purposes other than those covered by this Regulation.4. This Regulation shall not apply to microbial cultures that
are traditionally used in the production of food and which mayincidentallyproduceenzymes,butwhicharenotspecificallyusedto produce them.Article 3
Definitions
1. For the purposes of this Regulation, the definitions laid
down in Regulation (EC) No 178/2002, Regulation (EC)No 1829/2003 and Regulation (EC) No 1333/2008 [on foodadditives] shall apply.
2. The following definitions shall also apply:(a) ‘food enzyme’ means a product obtained from plants, ani-
mals or micro-organisms or products thereof includinga product obtained by a fermentation process usingmicro-organisms:
(i) containing one or more enzymes capable of catalyzing
a specific biochemical reaction; and
(ii) added to food for a technological purpose at any stage
of the manufacturing, processing, preparation, treat-ment, packaging, transport or storage of foods;
(b) ‘foodenzymepreparation’meansaformulationconsistingof
oneormorefoodenzymesinwhichsubstancessuchasfoodadditives and/or other food ingredients are incorporated tofacilitate their storage, sale, standardisation, dilution ordissolution.
CHAPTER II
COMMUNITY LIST OF APPROVED FOOD ENZYMES
Article 4
Community list of food enzymes
OnlyfoodenzymesincludedintheCommunitylistmaybeplaced
on the market as such and used in foods, in accordance with thespecifications and conditions of use provided for in Article 7(2).
Article 5
Prohibition of non-compliant food enzymes and/or
non-compliant food
No person shall place on the market a food enzyme or any food
inwhichsuchafoodenzymehasbeenusediftheuseofthefoodenzymedoesnotcomplywiththisRegulationanditsimplement-ing measures.L 354/10
EN Official Journal of the European Union 31.12.2008Article 6
General conditions for inclusion of food enzymes in the
Community list
A food enzyme may be included in the Community list only if it
meets the following conditions and, where relevant, other legiti-mate factors:
(a) it does not, on the basis of the scientific evidence available,
pose a safety concern to the health of the consumer at thelevel of use proposed;
(b) there is a reasonable technological need, and(c) its use does not mislead the consumer. Misleading the con-
sumer includes, but is not limited to, issues related to thenature, freshness and quality of the ingredients used, thenaturalnessofaproductoroftheproductionprocess,orthenutritional quality of the product.
Article 7
The content of the Community list of food enzymes
1. Afoodenzymewhichcomplieswiththeconditionssetout
in Article 6 may, in accordance with the procedure referred to inRegulation (EC) No 1331/2008 [establishing a common authori-sation procedure for food additives, food enzymes and food fla-vourings], be included in the Community list.
2. The entry of a food enzyme in the Community list shall
specify:
(a) the name of the food enzyme;(b) the specifications of the food enzyme, including its origin,
purity criteria and any other necessary information;
(c) the foods to which the food enzyme may be added;(d) the conditions under which the food enzyme may be used;
where appropriate, no maximum level shall be fixed for afood enzyme. In that case, the food enzyme shall be used inaccordance with the quantum satis principle;
(e) if appropriate, whether there are any restrictions on the sale
of the food enzyme directly to the final consumer;
(f) wherenecessary,specificrequirementsinrespectofthelabel-
ling of food in which the food enzymes have been used inorder to ensure that the final consumer is informed of thephysicalconditionofthefoodorthespecifictreatmentithasundergone.3. The Community list shall be amended in accordance with
the procedure referred to in Regulation (EC) No 1331/2008[establishing a common authorisation procedure for food addi-tives, food enzymes and food flavourings].
Article 8
Food enzyme falling within the scope of Regulation (EC)
No 1829/2003
1. A food enzyme falling within the scope of Regulation (EC)
No 1829/2003 may be included in the Community list in accor-dance with this Regulation only when it is covered by an autho-risation in accordance with Regulation (EC) No 1829/2003.
2. When a food enzyme already included in the Community
listisproducedfromadifferentsourcefallingwithinthescopeofRegulation (EC) No 1829/2003, it will not require a new autho-
risation under this Regulation, as long as the new source is cov-ered by an authorisation in accordance with Regulation (EC)No 1829/2003 and the food enzyme complies with the specifi-cations established under this Regulation.
Article 9
Interpretation decisions
Where necessary, it may be decided in accordance with the regu-
latory procedure referred to in Article 15(2) whether or not:
(a) a given substance meets the definition of food enzyme in
Article 3;
(b) a particular food belongs to a category of food in the Com-
munity list of food enzymes.
CHAPTER III
LABELLING
Article 10
Labelling of food enzymes and food enzyme preparations
not intended for sale to the final consumer
1. Food enzymes and food enzyme preparations not intended
for sale to the final consumer, whether sold singly or mixed witheachotherand/orotherfoodingredients,asdefinedinArticle6(4)of Directive 2000/13/EC, may only be marketed with the label-ling provided for in Article 11 of this Regulation, which must beeasily visible, clearly legible and indelible. The information pro-vided for in Article 11 shall be in a language easily understand-able to purchasers.31.12.2008
EN Official Journal of the European Union L 354/112. Within its own territory, the Member State in which the
productismarketedmay,inaccordancewiththeTreaty,stipulatethat the information provided for in Article 11 shall be given inone or more of the official languages of the Community, to bedetermined by that Member State. This shall not preclude suchinformation from being indicated in several languages.
Article 11
General labelling requirements for food enzymes and food
enzyme preparations not intended for sale to the final
consumer
1. Where food enzymes and food enzyme preparations not
intended for sale to the final consumer are sold singly or mixedwitheachotherand/orotherfoodingredients,theirpackagingorcontainers shall bear the following information:
(a) the name laid down under this Regulation in respect of each
food enzyme or a sales description which includes the nameof each food enzyme or in the absence of such a name, theaccepted name laid down in the nomenclature of the Inter-national Union of Biochemistry and Molecular Biology(IUBMB);
(b) the statement ‘for food’ or the statement ‘restricted use in
food’ or a more specific reference to its intended food use;
(c) if necessary, the special conditions of storage and/or use;(d) a mark identifying the batch or lot;(e) instructions for use, if the omission thereof would preclude
appropriate use of the food enzyme;
(f) thenameorbusinessnameandaddressofthemanufacturer,
packager or seller;
(g) an indication of the maximum quantity of each component
orgroupofcomponentssubjecttoquantitativelimitationinfood and/or appropriate information in clear and easilyunderstandabletermsenablingthepurchasertocomplywiththisRegulationorotherrelevantCommunitylaw;wherethesame limit on quantity applies to a group of componentsusedsinglyorincombination,thecombinedpercentagemaybe given as a single figure; the limit on quantity shall beexpressedeithernumericallyorbythe quantumsatis principle;(h) the net quantity;
(i) the activity of the food enzyme(s);(j) the date of minimum durability or use-by-date;(k) whererelevant,informationonafoodenzymeorothersub-
stances as referred to in this Article and listed in Annex IIIato Directive 2000/13/EC.
2. Wherefoodenzymesand/orfoodenzymepreparationsare
sold mixed with each other and/or with other food ingredients,their packaging or containers shall bear a list of all ingredients indescending order of their percentage by weight of the total.
3. The packaging or containers of food enzyme preparations
shall bear a list of all components in descending order of theirpercentage by weight of the total.
4. Bywayofderogationfromparagraphs1,2and3,theinfor-
mation required in paragraph 1 points (e) to (g) and in para-graphs 2 and 3 may appear merely on the documents relating tothe consignment which are to be supplied with or prior to thedelivery, provided that the indication ‘not for retail sale’ appearsonaneasilyvisiblepartofthepackagingorcontaineroftheprod-uct in question.
5. By way of derogation from paragraphs 1, 2 and 3, where
food enzymes and food enzyme preparations are supplied intankers all of the information may appear merely on the accom-panying documents relating to the consignment which are to besupplied with the delivery.
Article 12
Labelling of food enzymes and food enzyme preparations
intended for sale to the final consumer
1. WithoutprejudicetoDirective2000/13/EC,CouncilDirec-
tive 89/396/EEC of 14 June 1989 on indications or marks iden-tifyingthelottowhichafoodstuffbelongs(
1)andRegulation(EC)
No 1829/2003, food enzymes and food enzyme preparationssold singly or mixed with each other and/or other food ingredi-entsintendedforsaletothefinalconsumermaybemarketedonlyif their packaging contains the following information:
(a) the name laid down under this Regulation in respect of each
food enzyme or a sales description which includes the nameof each food enzyme or in the absence of such a name, theacceptednamelaiddowninthenomenclatureoftheIUBMB;
(1) OJ L 186, 30.6.1989, p. 21.L 354/12 EN Official Journal of the European Union 31.12.2008(b) the statement ‘for food’ or the statement ‘restricted use in
food’ or a more specific reference to its intended food use.
2. For the information provided for in paragraph 1 of this
Article, Article 13(2) of Directive 2000/13/EC shall applyaccordingly.
Article 13
Other labelling requirements
Articles 10 to 12 shall be without prejudice to more detailed or
more extensive laws, regulations or administrative provisionsregarding weights and measures or applying to the presentation,classification, packaging and labelling of dangerous substancesand preparations or applying to the transport of such substancesand preparations.
CHAPTER IV
PROCEDURAL PROVISIONS AND IMPLEMENTATION
Article 14
Information obligation
1. AproduceroruserofafoodenzymeshallinformtheCom-
mission immediately of any new scientific or technical informa-tion which might affect the assessment of the safety of the foodenzyme.
2. For a food enzyme already approved under this Regulation
whichispreparedbyproductionmethodsorusingstartingmate-rials significantly different from those included in the risk assess-mentoftheEuropeanFoodSafetyAuthority(hereinafterreferredto as the Authority), a producer or user shall, before marketingthe food enzyme, submit to the Commission the necessary datato allow an evaluation of the food enzyme with regard to themodified production method or characteristics to be undertakenby the Authority.
3. Aproduceroruserofafoodenzymeshall,attherequestof
the Commission, inform it of the actual use of the food enzyme.SuchinformationshallbemadeavailabletoMemberStatesbytheCommission.
Article 15
Committee
1. TheCommissionshallbeassistedbytheStandingCommit-
tee on the Food Chain and Animal Health.
2. Wherereferenceismadetothisparagraph,Articles5and7
of Decision 1999/468/EC shall apply, having regard to the pro-visions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.
3. Where reference is made to this paragraph, Article 5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply, havingregard to the provisions of Article 8 thereof.Article 16
Community financing of harmonised policies
The legal basis for the financing of measures resulting from
this Regulation shall be Article 66(1)(c) of Regulation (EC)No 882/2004.
CHAPTER V
TRANSITIONAL AND FINAL PROVISIONS
Article 17
Establishment of the Community list of food enzymes
1. TheCommunitylistoffoodenzymesshallbedrawnupon
the basis of applications made pursuant to paragraph 2.
2. Interestedpartiesmaysubmitapplicationsfortheinclusion
of a food enzyme in the Community list.
Thedeadlineforsubmittingsuchapplicationsshallbe24months
after the date of application of the implementing measures to belaid down in accordance with Article 9(1) of Regulation (EC)No 1331/2008 [establishing a common authorisation procedurefor food additives, food enzymes and food flavourings].
3. The Commission shall establish a Register of all food
enzymes to be considered for inclusion in the Community list inrespect of which an application complying with the validity cri-teria to be laid down in accordance with Article 9(1) of Regula-tion (EC) No 1331/2008 [establishing a common authorisationprocedureforfoodadditives,foodenzymesandfoodflavourings]hasbeensubmittedinaccordancewithparagraph2ofthisArticle(hereinafterreferredtoastheRegister).TheRegistershallbemadeavailable to the public.
The Commission shall submit the applications to the Authority
for its opinion.
4. TheCommunitylistshallbeadoptedbytheCommissionin
accordance with the procedure laid down in Regulation (EC)No 1331/2008 [establishing a common authorisation procedurefor food additives, food enzymes and food flavourings], once theAuthority has issued an opinion on each food enzyme includedin the Register.
However, by way of derogation from that procedure:(a) Article 5(1) of Regulation (EC) No 1331/2008 [establishing
a common authorisation procedure for food additives, foodenzymesandfoodflavourings]shallnotapplytotheAuthori-ty’s adoption of its opinion;
(b) the Commission shall adopt the Community list for the first
time after the Authority has delivered its opinion on all thefood enzymes listed in the Register.
5. If necessary, any appropriate transitional measures for the
purposes of this Article which are designed to amend non-essential elements of this Regulation, inter alia, by supplementing
it, shall be adopted in accordance with the regulatory procedurewith scrutiny referred to in Article 15(3).31.12.2008
EN Official Journal of the European Union L 354/13Article 18
Transitional measures
1. Notwithstanding Articles 7 and 17 of this Regulation, the
Communitylistshall,whendrawnup,includethefollowingfoodenzymes:
(a) E 1103 Invertase and E 1105 Lysozyme, stating the condi-
tions governing their use as specified in Annex I and Part Cof Annex III to Directive 95/2/EC;
(b) Urease,beta-glucanaseandlysozymeforuseinwineinaccor-
dance with Regulation (EC) No 1493/1999 and the imple-menting rules for that Regulation.
2. Food enzymes, food enzyme preparations and food con-
taining food enzymes placed on the market or labelled before20 January 2010 which do not comply with the provisions ofArticles 10 to 12 may be marketed until their date of minimumdurability or use-by-date.
Article 19
Amendments to Directive 83/417/EEC
In Directive 83/417/EEC, in Annex I, Section III(d), the indents
shall be replaced by the following:
‘— rennet meeting the requirements of Regulation (EC)
No1332/2008oftheEuropeanParliamentandoftheCoun-cil of 16 December 2008 on food enzymes (
*);
— othermilk-coagulatingenzymesmeetingtherequirementsof
Regulation (EC) No 1332/2008.
(*) OJ L 354, 31.12.2008, p. 7.’
Article 20
Amendment to Regulation (EC) No 1493/1999
In Regulation (EC) No 1493/1999, the following paragraph shall
be added to Article 43:
‘3. Enzymes and enzymatic preparations used in the autho-
rised oenological practices and processes listed in Annex IV shallmeet the requirements of Regulation (EC) No 1332/2008 of theEuropeanParliamentandoftheCouncilof16December2008on
food enzymes (
*).
(*) OJ L 354, 31.12.2008, p. 7.’Article 21
Amendments to Directive 2000/13/EC
Directive 2000/13/EC is hereby amended as follows:1. Article 6(4) shall be amended as follows:
(a) point (a) shall be replaced by the following:
‘(a) “Ingredient” shall mean any substance, including
additives and enzymes, used in the manufacture orpreparation of a foodstuff and still present in thefinished product, even if in altered form.’;
(b) in point (c)(ii), the introductory word ‘additives’ shall be
replaced by ‘additives and enzymes’;
(c) in point (c)(iii), the words ‘additives or flavouring’ shall
be replaced by ‘additives or enzymes or flavourings’;
2. the following indent shall be added to Article 6(6):
‘— enzymes other than as referred to in paragraph 4(c)(ii)
shallbedesignatedbythenameofoneofthecategoriesof ingredients listed in Annex II, followed by their spe-cific name,’.
Article 22
Amendments to Directive 2001/112/EC
In Directive 2001/112/EC, in Annex I, Section II(2), the fourth,
fifth and sixth indents shall be replaced by the following:
‘— Pectolytic enzymes meeting the requirements of Regulation
(EC) No 1332/2008 of the European Parliament and of theCouncil of 16 December 2008 on food enzymes (
*);
— ProteolyticenzymesmeetingtherequirementsofRegulation
(EC) No 1332/2008;
— AmylolyticenzymesmeetingtherequirementsofRegulation
(EC) No 1332/2008.
(*) OJ L 354, 31.12.2008, p. 7.’L 354/14 EN Official Journal of the European Union 31.12.2008Article 23
Amendment to Regulation (EC) No 258/97
InRegulation(EC)No258/97,thefollowingpointshallbeadded
to Article 2(1):
‘(d) food enzymes falling within the scope of Regulation (EC)
No1332/2008oftheEuropeanParliamentandoftheCoun-cil of 16 December 2008 on food enzymes (
*).
(*) OJ L 354, 31.12.2008, p. 7.’Article 24
Entry into force
This Regulation shall enter into force on the 20th day following
that of its publication in the Official Journal of the European Union .
Article 4 shall apply from the date of application of the Commu-
nity list. Until that date, national provisions in force concerningtheplacingonthemarketanduseoffoodenzymesandfoodpro-duced with food enzymes shall continue to apply in the MemberStates.
Articles 10 to 13 shall apply from 20 January 2010.
This Regulation shall be binding in its entirety and directly applicable i n all Member States.
Done at Strasbourg, 16 December 2008.
For the European Parliament
The President
H.-G. PÖTTERINGFor the Council
The President
B. LE MAIRE31.12.2008 EN Official Journal of the European Union L 354/15