REGULATION (EC) No 1333/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 December 2008
on food additives
(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)ThisRegulationreplacespreviousDirectivesandDecisions
concerning food additives permitted for use in foods withaviewtoensuringtheeffectivefunctioningoftheinternalmarketwhilstensuringahighlevelofprotectionofhumanhealth and a high level of consumer protection, includingthe protection of consumer interests, via comprehensiveand streamlined procedures.(4)This Regulation harmonises the use of food additives in
foods in the Community. This includes the use of foodadditives in foods covered by Council Directive89/398/EEC of 3 May 1989 on the approximation of thelaws of the Member States relating to foodstuffs intendedfor particular nutritional uses (
3) and the use of certain
foodcoloursforthehealthmarkingofmeatandthedeco-ration and stamping of eggs. It also harmonises the use offood additives in food additives and food enzymes thusensuringtheirsafetyandqualityandfacilitatingtheirstor-age and use. This has not previously been regulated atCommunity level.
(5)Food additives are substances that are not normally con-
sumedasfooditselfbutareaddedtofoodintentionallyfora technological purpose described in this Regulation, suchas the preservation of food. All food additives should becoveredbythisRegulation,andthereforeinthelightofsci-entific progress and technological development the list offunctionalclassesshouldbeupdated.However,substancesshould not be considered as food additives when they areused for the purpose of imparting flavour and/or taste orfor nutritional purposes, such as salt replacers, vitaminsand minerals. Moreover, substances considered as foodswhich may be used for a technological function, such assodiumchlorideorsaffronforcolouringandfoodenzymesshould also not fall within the scope of this Regulation.However, preparations obtained from foods and othernaturalsourcematerialthatareintendedtohaveatechno-logical effect in the final food and which are obtained byselective extraction of constituents (e.g. pigments) relativeto the nutritive or aromatic constituents, should be con-sidered additives within the meaning of this Regulation.Finally, food enzymes are covered by Regulation (EC)No 1332/2008 of the European Parliament and of theCouncilof16December2008onfoodenzymes(
4),which
excludes the application of this Regulation.
(6)Substancesnotconsumedasfooditselfbutusedintention-
ally in the processing of foods, which only remain as resi-dues in the final food and do not have a technologicaleffect in the final product (processing aids), should not becovered by this Regulation.
(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. 142), Council Common Position of 10 March 2008(OJC111E,6.5.2008,p.10),PositionoftheEuropeanParliamentof8 July 2008 (not yet published in the Official Journal) and CouncilDecision of 18 November 2008.
(3) OJ L 186, 30.6.1989, p. 27.
(4) See page 7 of this Official Journal.L 354/16 EN Official Journal of the European Union 31.12.2008(7)Food additives should be approved and used only if they
fulfil the criteria laid down in this Regulation. Food addi-tives must be safe when used, there must be a technologi-cal need for their use, and their use must not mislead theconsumer and must be of benefit to the consumer. Mis-leadingtheconsumerincludes,butisnotlimitedto,issuesrelatedtothenature,freshness,qualityofingredientsused,the naturalness of a product or of the production process,orthenutritionalqualityoftheproduct,includingitsfruitand vegetable content. The approval of food additivesshould also take into account other factors relevant to thematter under consideration including societal, economic,traditional, ethical and environmental factors, the precau-tionary principle and the feasibility of controls. The useand maximum levels of a food additive should take intoaccounttheintakeofthefoodadditivefromothersourcesandtheexposuretothefoodadditivebyspecialgroupsofconsumers (e.g. allergic consumers).
(8)Food additives must comply with the approved specifica-
tions, which should include information to adequatelyidentifythefoodadditive,includingorigin,andtodescribethe acceptable criteria of purity. The specifications previ-ously developed for food additives included in Commis-sion Directive 95/31/EC of 5 July 1995 laying downspecific criteria of purity concerning sweeteners for use infoodstuffs (
1), Commission Directive 95/45/EC of 26 July
1995 laying down specific purity criteria concerningcoloursforuseinfoodstuffs (
2)andCommissionDirective
96/77/ECof2December1996layingdownspecificpuritycriteria on food additives other than colours and sweeten-ers (
3) should be maintained until the corresponding addi-
tivesareenteredintheAnnexestothisRegulation.Atthattime, the specifications related to such additives should beset out in a Regulation. Those specifications should relatedirectlytotheadditivesincludedintheCommunitylistsinthe Annexes to this Regulation. However, considering thecomplexcharacterandsubstanceofsuchspecifications,forthesakeofclaritytheyshouldnotbeintegratedassuchinthe Community lists but should be set out in one or moreseparate Regulations.
(9)Somefoodadditivesarepermittedforspecificusesforcer-
tain authorised oenological practices and processes. Theuse of such food additives should comply with this Regu-lationandwiththespecificprovisionslaiddownintherel-evant Community legislation.
(10)In order to ensure harmonisation, the risk assessment and
approval of food additives should be carried out in accor-dance with the procedure laid down in Regulation (EC)No 1331/2008 of the European Parliament and of theCouncil of 16 December 2008 establishing a common
authorisation procedure for food additives, food enzymesand food flavourings (
4)
(11)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 (
5), the
EuropeanFoodSafetyAuthority(hereinafterreferredtoastheAuthority)istobeconsultedonmatterslikelytoaffectpublic health.
(12)AfoodadditivewhichfallswithinthescopeofRegulation
(EC)No1829/2003oftheEuropeanParliamentandoftheCouncil of 22 September 2003 on genetically modifiedfood and feed (
6) should be authorised in accordance with
that Regulation as well as under this Regulation.
(13)A food additive already approved under this Regulation
which is prepared by production methods or using start-ing materials significantly different from those included inthe risk assessment of the Authority, or different fromthose covered by the specifications laid down, should besubmitted for evaluation by the Authority. ‘Significantlydifferent’couldmean, interalia,achangeoftheproduction
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, including the use ofnanotechnology.
(14)Food additives should be kept under continuous observa-
tion and must be re-evaluated whenever necessary in thelight of changing conditions of use and new scientificinformation. Where necessary, the Commission togetherwith the Member States should consider appropriateaction.
(15)Member States which maintained on 1 January 1992 pro-
hibitions on the use of certain additives in certain specificfoods which are considered traditional and are producedontheirterritoryshouldbepermittedtocontinuetoapply
those prohibitions. Moreover, as regard products such as‘Feta’or‘Salamecacciatore’,thisRegulationshouldbewith-out prejudice to more restrictive rules linked to the use ofcertain denominations under Council Regulation (EC)No510/2006of20March2006ontheprotectionofgeo-graphical indications and designations of origin for agri-culturalproductsandfoodstuffs(
7)andCouncilRegulation
(EC)No509/2006of20March2006onagriculturalprod-uctsandfoodstuffsastraditionalspecialitiesguaranteed(
8).
(1) OJ L 178, 28.7.1995, p. 1.
(2) OJ L 226, 22.9.1995, p. 1.
(3) OJ L 339, 30.12.1996, p. 1.(4) See page 1 of this Official Journal.
(5) OJ L 31, 1.2.2002, p. 1.
(6) OJ L 268, 18.10.2003, p. 1.
(7) OJ L 93, 31.3.2006, p. 12.
(8) OJ L 93, 31.3.2006, p. 1.31.12.2008 EN Official Journal of the European Union L 354/17(16)Unless subject to further restrictions, an additive may be
presentinfood,otherthanbydirectaddition,asaresultofcarry-over from an ingredient in which the additive waspermitted, provided that the level of the additive in thefinal food is no greater than would be introduced by theuse of the ingredient under proper technological condi-tions and good manufacturing practice.
(17)Foodadditivesremainsubjecttothegenerallabellingobli-
gations as provided for in Directive 2000/13/EC of theEuropeanParliamentandoftheCouncilof20March2000on the approximation of the laws of the Member Statesrelating to the labelling, presentation and advertising offoodstuffs (
1) 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 (
2).Inaddition,specificprovisionsonthelabel-
ling of food additives sold as such to the manufacturer orto the final consumer should be contained in thisRegulation.
(18)Sweeteners authorised under this Regulation may be used
in table-top sweeteners sold directly to consumers. Manu-facturersofsuchproductsshouldmakeinformationavail-abletotheconsumerbyappropriatemeanstoallowthemto use the product in a safe manner. Such informationcouldbemadeavailableinanumberofwaysincludingonproduct labels, Internet websites, consumer informationlines or at the point of sale. In order to adopt a uniformapproachtotheimplementationofthisrequirement,guid-ance drawn up at Community level may be necessary.
(19)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 (
3).
(20)In particular the Commission should be empowered to
amendtheAnnexesofthisRegulationandtoadoptappro-priate transitional measures. Since those measures are ofgeneralscopeandaredesignedtoamendnon-essentialele-ments of this Regulation, inter alia, by supplementing it
with new non-essential elements, they must be adopted in
accordance with the regulatory procedure with scrutinyprovided for in Article 5a of Decision 1999/468/EC.
(21)On grounds of efficiency, the normal time-limits for the
regulatory procedure with scrutiny should be curtailed forthe adoption of certain amendments to Annexes II and IIIrelatingtosubstancesalreadyauthorisedunderotherCom-
munity law as well as any appropriate transitional mea-sures related to these substances.
(22)In order to develop and update Community law on food
additives 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 (
4).
(23)MemberStatesaretocarryoutofficialcontrolsinorderto
enforce compliance with this Regulation in accordancewith Regulation (EC) No 882/2004.
(24)SincetheobjectiveofthisRegulation,namelytolaydown
Communityrulesonfoodadditives,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.
(25)Following the adoption of this Regulation the Commis-
sion, assisted by the Standing Committee on the FoodChain and Animal Health, should review all the existingauthorisationsforcriteria,otherthansafety,suchasintake,technological need and the potential to mislead the con-sumer.Allfoodadditivesthataretocontinuetobeautho-rised in the Community should be transferred to theCommunity lists in Annexes II and III to this Regulation.AnnexIIItothisRegulationshouldbecompletedwiththe
other food additives used in food additives and foodenzymes as well as carriers for nutrients and their condi-tions of use in accordance with Regulation (EC)No1331/2008[establishingacommonauthorisationpro-cedureforfoodadditives,foodenzymesandfoodflavour-ings]. To allow a suitable transition period, the provisionsinAnnexIII,otherthantheprovisionsconcerningcarriersforfoodadditivesandfoodadditivesinflavourings,shouldnot apply until 1 January 2011.
(26)Until the future Community lists of food additives are
established, it is necessary to provide for a simplified pro-cedure allowing the current lists of food additives con-tained in the existing Directives to be updated.
(1) OJ L 109, 6.5.2000, p. 29.
(2) OJ L 268, 18.10.2003, p. 24.
(3) OJ L 184, 17.7.1999, p. 23. (4) OJ L 165, 30.4.2004, p. 1. Corrected by OJ L 191, 28.5.2004, p. 1.L 354/18 EN Official Journal of the European Union 31.12.2008(27)Withoutprejudicetotheoutcomeofthereviewreferredto
inrecital25,withinoneyearfollowingtheadoptionofthisRegulation the Commission should set up an evaluationprogramme for the Authority to re-evaluate the safety ofthefoodadditivesthatwerealreadyapprovedintheCom-munity. That programme should define the needs and theorder of priorities according to which the approved foodadditives are to be examined.
(28)This Regulation repeals and replaces the following acts:
Council Directive of 23 October 1962 on the approxima-tion of the rules of the Member States concerning thecolouringmattersauthorisedforuseinfoodstuffsintendedfor human consumption (
1), Council Directive 65/66/EEC
of 26 January 1965 laying down specific criteria of purityfor preservatives authorised for use in foodstuffs intendedforhumanconsumption(
2),CouncilDirective78/663/EEC
of 25 July 1978 laying down specific criteria of purity foremulsifiers, stabilizers, thickeners and gelling agents foruse in foodstuffs (
3), Council Directive 78/664/EEC of
25 July 1978 laying down specific criteria of purity forantioxidantswhichmaybeusedinfoodstuffsintendedforhuman consumption (
4), First Commission Directive
81/712/EEC of 28 July 1981 laying down Communitymethodsofanalysisforverifyingthatcertainadditivesusedin foodstuffs satisfy criteria of purity (
5), Council Directive
89/107/EEC of 21 December 1988 on the approximationofthelawsoftheMemberStatesconcerningfoodadditives
authorised for use in foodstuffs intended for human con-sumption (
6), Directive 94/35/EC of the European Parlia-
ment and of the Council of 30 June 1994 on sweetenersfor use in foodstuffs (
7), Directive 94/36/EC of the Euro-
pean Parliament and of the Council of 30 June 1994 oncolours for use in foodstuffs (
8), Directive 95/2/EC of the
European Parliament and of the Council of 20 February1995 on food additives other than colours and sweeten-ers(
9),DecisionNo292/97/ECoftheEuropeanParliament
and of the Council of 19 December 1996 on the mainte-nance of national laws prohibiting the use of certain addi-tives in the production of certain specific foodstuffs (
10)
and Commission Decision 2002/247/EC of 27 March2002suspendingtheplacingonthemarketandimportofjellyconfectionarycontainingthefoodadditiveE425kon-jac (
11). However, it is appropriate that certain provisions
of those acts remain in force during a transitional periodto allow time for the preparation of the Community listsin the Annexes to this Regulation,HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down rules on food additives used in foods
with a view to ensuring the effective functioning of the internalmarketwhilstensuringahighlevelofprotectionofhumanhealthandahighlevelofconsumerprotection,includingtheprotectionof consumer interests and fair practices in food trade, taking intoaccount, where appropriate, the protection of the environment.
For those purposes, this Regulation provides for:(a) Community lists of approved food additives as set out in
Annexes II and III;
(b) conditionsofuseoffoodadditivesinfoods,includinginfood
additivesandinfoodenzymesascoveredbyRegulation(EC)No 1332/2008 [on food enzymes], and in food flavouringsas covered by Regulation (EC) No 1334/2008 of the Euro-peanParliamentandoftheCouncilof16December2008onflavourings and certain food ingredients with flavouringproperties for use in and on foods (
12);
(c) rules on the labelling of food additives sold as such.
Article 2
Scope
1. This Regulation shall apply to food additives.2. This Regulation shall not apply to the following substances
unless they are used as food additives:
(a) processing aids;(b) substances used for the protection of plants and plant prod-
ucts in accordance with Community rules relating to planthealth;
(c) substances added to foods as nutrients;(d) substances used for the treatment of water for human con-
sumption falling within the scope of Council Directive98/83/EC of 3 November 1998 on the quality of waterintended for human consumption (
13);(1) OJ 115, 11.11.1962, p. 2645/62.
(2) OJ 22, 9.2.1965, p. 373.
(3) OJ L 223, 14.8.1978, p. 7.
(4) OJ L 223, 14.8.1978, p. 30.
(5) OJ L 257, 10.9.1981, p. 1.
(6) OJ L 40, 11.2.1989, p. 27.
(7) OJ L 237, 10.9.1994, p. 3.
(8) OJ L 237, 10.9.1994, p. 13.
(9) OJ L 61, 18.3.1995, p. 1.
(10) OJ L 48, 19.2.1997, p. 13.
(11) OJ L 84, 28.3.2002, p. 69.(12) See page 34 of this Official Journal.
(13) OJ L 330, 5.12.1998, p. 32.31.12.2008 EN Official Journal of the European Union L 354/19(e) flavourings falling within the scope of Regulation (EC)
No 1334/2008 [on flavourings and certain food ingredientswith flavouring properties for use in and on foods].
3. This Regulation shall not apply to food enzymes falling
within the scope of Regulation (EC) No 1332/2008 [on foodenzymes], with effect from the date of adoption of the Commu-nity list of food enzymes in accordance with Article 17 of thatRegulation.
4. This Regulation shall apply without prejudice to any spe-
cific Community rules concerning the use of food additives:
(a) in specific foods;(b) for purposes other than those covered by this Regulation.
Article 3
Definitions
1. For the purposes of this Regulation, the definitions laid
down in Regulations (EC) No 178/2002 and (EC) No1829/2003shall apply.
2. ForthepurposesofthisRegulationthefollowingdefinitions
shall also apply:
(a) ‘food additive’ shall mean any substance not normally con-
sumed as a food in itself and not normally used as a charac-teristic ingredient of food, whether or not it has nutritivevalue, the intentional addition of which to food for a tech-nological purpose in the manufacture, processing, prepara-tion,treatment,packaging,transportorstorageofsuchfoodresults, or may be reasonably expected to result, in it or itsby-products becoming directly or indirectly a component ofsuch foods;
The following are not considered to be food additives:(i) monosaccharides,disaccharidesoroligosaccharidesand
foodscontainingthesesubstancesusedfortheirsweet-ening properties;
(ii) foods, whether dried or in concentrated form, includ-
ingflavouringsincorporatedduringthemanufacturingofcompoundfoods,becauseoftheiraromatic,sapidornutritive properties together with a secondary colour-ing effect;
(iii) substancesusedincoveringorcoatingmaterials,which
do not form part of foods and are not intended to beconsumed together with those foods;
(iv) products containing pectin and derived from dried
applepomaceorpeelofcitrusfruitsorquinces,orfromamixtureofthem,bytheactionofdiluteacidfollowedbypartialneutralisationwithsodiumorpotassiumsalts(liquid pectin);(v) chewing gum bases;
(vi) white or yellow dextrin, roasted or dextrinated starch,
starch modified by acid or alkali treatment, bleachedstarch,physicallymodifiedstarchandstarchtreatedbyamylolitic enzymes;
(vii) ammonium chloride;(viii) blood plasma, edible gelatin, protein hydrolysates and
their salts, milk protein and gluten;
(ix) amino acids and their salts other than glutamic acid,
glycine, cysteine and cystine and their salts having notechnological function;
(x) caseinates and casein;(xi) inulin;
(b) ‘processing aid’ shall mean any substance which:
(i) is not consumed as a food by itself;(ii) is intentionally used in the processing of raw materials,
foods or their ingredients, to fulfil a certain technologi-cal purpose during treatment or processing; and
(iii) mayresultintheunintentionalbuttechnicallyunavoid-
ablepresenceinthefinalproductofresiduesofthesub-stance or its derivatives provided they do not presentanyhealthriskanddonothaveanytechnologicaleffecton the final product;
(c) ‘functional class’ shall mean one of the categories set out in
Annex I based on the technological function a food additiveexerts in the foodstuff;
(d) ‘unprocessed food’ shall mean a food which has not under-
gone any treatment resulting in a substantial change in theoriginalstateofthefood,forwhichpurposethefollowinginparticulararenotregardedasresultinginsubstantialchange:dividing, parting, severing, boning, mincing, skinning, par-ing, peeling, grinding, cutting, cleaning, trimming, deep-freezing, freezing, chilling, milling, husking, packing orunpacking;
(e) ‘food with no added sugars’ shall mean a food without the
following:
(i) any added monosaccharides or disaccharides;(ii) any added food containing monosaccharides or disac-
charides which is used for its sweetening properties;L 354/20
EN Official Journal of the European Union 31.12.2008(f) ‘energy-reducedfood’shallmeanafoodwithanenergyvalue
reduced by at least 30 % compared with the original food ora similar product;
(g) ‘table-top sweeteners’ shall mean preparations of permitted
sweeteners, which may contain other food additives and/orfood ingredients and which are intended for sale to the finalconsumer as a substitute for sugars;
(h) ‘quantumsatis’shallmeanthatnomaximumnumericallevel
is specified and substances shall be used in accordance withgood manufacturing practice, at a level not higher than isnecessary to achieve the intended purpose and provided theconsumer is not misled.
CHAPTER II
COMMUNITY LISTS OF APPROVED FOOD ADDITIVES
Article 4
Community lists of food additives
1. Only food additives included in the Community list in
Annex II may be placed on the market as such and used in foodsunder the conditions of use specified therein.
2. Only food additives included in the Community list in
Annex III may be used in food additives, in food enzymes and infood flavourings under the conditions of use specified therein.
3. FoodadditivesinAnnexIIshallbelistedonthebasisofthe
categories of food to which they may be added.
4. FoodadditivesinAnnexIIIshallbelistedonthebasisofthe
food additives, food enzymes, food flavourings and nutrients orcategories thereof to which they may be added.
5. Food additives shall comply with the specifications as
referred to in Article 14.
Article 5
Prohibition of non-compliant food additives and/or
non-compliant food
No person shall place on the market a food additive or any food
inwhichsuchafoodadditiveispresentiftheuseofthefoodaddi-tive does not comply with this Regulation.Article 6
General conditions for inclusion and use of food additives
in Community lists
1. A food additive may be included in the Community lists in
Annexes II and III only if it meets the following conditions and,where relevant, other legitimate factors, including environmentalfactors:
(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 that cannot be
achieved by other economically and technologically practi-cable means; and
(c) its use does not mislead the consumer.2. TobeincludedintheCommunitylistsinAnnexesIIandIII
a food additive must have advantages and benefits for the con-sumerandthereforeserveoneormoreofthefollowingpurposes:
(a) preserving the nutritional quality of the food;(b) providing necessary ingredients or constituents for foods
manufactured for groups of consumers with special dietary
needs;
(c) enhancing the keeping quality or stability of a food or
improving its organoleptic properties, provided that thenature, substance or quality of the food is not changed insuch a way as to mislead the consumer;
(d) aiding in the manufacture, processing, preparation, treat-
ment, packing, transport or storage of food, including foodadditives, food enzymes and food flavourings, provided thatthefoodadditiveisnotusedtodisguisetheeffectsoftheuseof faulty raw materials or of any undesirable practices ortechniques, including unhygienic practices or techniques,during the course of any such activities.
3. By way of derogation from paragraph 2(a), a food additive
which reduces the nutritional quality of a food may be includedin the Community list in Annex II provided that:
(a) the food does not constitute a significant component of a
normal diet; or
(b) thefoodadditiveisnecessaryfortheproductionoffoodsfor
groups of consumers with special dietary needs.31.12.2008
EN Official Journal of the European Union L 354/21Article 7
Specific conditions for sweeteners
AfoodadditivemaybeincludedintheCommunitylistinAnnexII
forthefunctionalclassofsweeteneronlyif,inadditiontoservingone or more of the purposes set out in Article 6(2), it serves oneor more of the following purposes:
(a) replacing sugars for the production of energy-reduced food,
non-cariogenic food or food with no added sugars; or
(b) replacing sugars where this permits an increase in the shelf-
life of the food; or
(c) producing food intended for particular nutritional uses as
defined in Article 1(2)(a) of Directive 89/398/EEC.
Article 8
Specific conditions for colours
AfoodadditivemaybeincludedintheCommunitylistinAnnexII
for the functional class of colour only if, in addition to servingone or more of the purposes set out in Article 6(2), it serves oneof the following purposes:
(a) restoringtheoriginalappearanceoffoodofwhichthecolour
has been affected by processing, storage, packaging and dis-tribution, whereby visual acceptability may have beenimpaired;
(b) making food more visually appealing;(c) giving colour to food otherwise colourless.
Article 9
Functional classes of food additives
1. FoodadditivesmaybeassignedinAnnexesIIandIIItoone
of the functional classes in Annex I on the basis of the principaltechnological function of the food additive.
Allocating a food additive to a functional class shall not preclude
it from being used for several functions.
2. Where necessary, as a result of scientific progress or tech-
nological development, the measures, designed to amend non-essential elements of this Regulation, relating to additionalfunctional classes which may be added to Annex I shall beadopted in accordance with the regulatory procedure with scru-tiny referred to in Article 28(3).Article 10
The content of the Community lists of food additives
1. Afoodadditivewhichcomplieswiththeconditionssetout
in Articles 6, 7 and 8 may, in accordance with the procedurereferredtoinRegulation(EC)No1331/2008[establishingacom-mon authorisation procedure for food additives, food enzymesand food flavourings] be included in:
(a) the Community list in Annex II to this Regulation; and/or(b) the Community list in Annex III to this Regulation.2. The entry for a food additive in the Community lists in
Annexes II and III shall specify:
(a) the name of the food additive and its E number;(b) the foods to which the food additive may be added;(c) the conditions under which the food additive may be used;(d) if appropriate, whether there are any restrictions on the sale
of the food additive directly to the final consumer.
3. TheCommunitylistsinAnnexesIIandIIIshallbeamended
in accordance with the procedure referred to in Regulation (EC)No 1331/2008 [establishing a common authorisation procedurefor food additives, food enzymes and food flavourings].
Article 11
Levels of use of food additives
1. When establishing the conditions of use referred to in
Article 10(2)(c):
(a) the level of use shall be set at the lowest level necessary to
achieve the desired effect;
(b) the levels shall take into account:
(i) any acceptable daily intake, or equivalent assessment,
established for the food additive and the probable dailyintake of it from all sources;
(ii) where the food additive is to be used in foods eaten by
specialgroupsofconsumers,thepossibledailyintakeofthe food additive by consumers in those groups.
2. Where appropriate, no maximum numerical level shall be
fixed for a food additive (quantum satis). In that case, the foodadditive shall be used in accordance with the principle of quan-tum satis.L 354/22
EN Official Journal of the European Union 31.12.20083. The maximum levels of food additives set out in Annex II
shall apply to the food as marketed, unless otherwise stated. Byway of derogation from this principle, for dried and/or concen-trated foods which need to be reconstituted the maximum levelsshall apply to the food as reconstituted according to the instruc-tions on the label taking into account the minimum dilutionfactor.
4. The maximum levels for colours set out in Annex II shall
apply to the quantities of colouring principle contained in thecolouring preparation unless otherwise stated.
Article 12
Changes in the production process or starting materials of
a food additive already included in a Community list
WhenafoodadditiveisalreadyincludedinaCommunitylistand
there is a significant change in its production methods or in thestarting materials used, or there is a change in particle size, forexample through nanotechnology, the food additive prepared bythosenewmethodsormaterialsshallbeconsideredasadifferentadditive and a new entry in the Community lists or a change inthe specifications shall be required before it can be placed on themarket.
Article 13
Food additives falling within the scope of Regulation (EC)
No 1829/2003
1. A food additive falling within the scope of Regulation (EC)
No 1829/2003 may be included in the Community lists inAnnexes II and III in accordance with this Regulation only whenit is covered by an authorisation in accordance with Regulation(EC) No 1829/2003.
2. When a food additive 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 additive complies with the specifi-cations established under this Regulation.
Article 14
Specifications of food additives
The specifications of food additives relating, in particular, to ori-
gin, purity criteria and any other necessary information, shall beadopted when the food additive is included in the CommunitylistsinAnnexesIIandIIIforthefirsttime,inaccordancewiththeprocedure referred to in Regulation (EC) No 1331/2008 [estab-lishing a common authorisation procedure for food additives,food enzymes and food flavourings].CHAPTER III
USE OF FOOD ADDITIVES IN FOODS
Article 15
Use of food additives in unprocessed foods
Food additives shall not be used in unprocessed foods, except
where such use is specifically provided for in Annex II.
Article 16
Use of food additives in foods for infants and young
children
Food additives shall not be used in foods for infants and young
childrenasreferredtoinDirective89/398/EEC,includingdietaryfoodsforinfantsandyoungchildrenforspecialmedicalpurposes,except where specifically provided for in Annex II to thisRegulation.
Article 17
Use of colours for markings
Only food colours listed in Annex II to this Regulation may be
used for the purpose of health marking as provided for in Coun-cilDirective91/497/EECof29July1991amendingandconsoli-dating Directive 64/433/EEC on health problems affecting intra-Communitytradeinfreshmeattoextendittotheproductionandmarketingoffreshmeat (
1)andothermarkingsrequiredonmeat
products, for the decorative colouring of eggshells and for thestamping of eggshells as provided for in Regulation (EC)No 853/2004 of the European Parliament and of the Council of29April2004layingdownspecifichygienerulesforfoodofani-mal origin (
2).
Article 18
Carry-over principle
1. The presence of a food additive shall be permitted:(a) in a compound food other than as referred to in Annex II,
where the food additive is permitted in one of the ingredi-ents of the compound food;
(b) in a food to which a food additive, food enzyme or food fla-
vouring has been added, where the food additive:
(i) is permitted in the food additive, food enzyme or food
flavouring in accordance with this Regulation; and
(1) OJ L 268, 24.9.1991, p. 69.
(2) OJL139,30.4.2004,p.55.CorrectedbyOJL226,25.6.2004,p.22.31.12.2008 EN Official Journal of the European Union L 354/23(ii) has been carried over to the food via the food additive,
food enzyme or food flavouring; and
(iii) has no technological function in the final food;
(c) in a food which is to be used solely in the preparation of a
compoundfoodandprovidedthatthecompoundfoodcom-plies with this Regulation.
2. Paragraph 1 shall not apply to infant formulae, follow-on
formulae, processed cereal-based foods and baby foods anddietary foods for special medical purposes intended for infantsandyoungchildrenasreferredtoinDirective89/398/EEC,exceptwhere specifically provided for.
3. Whereafoodadditiveinafoodflavouring,foodadditiveor
food enzyme is added to a food and has a technological functioninthatfood,itshallbeconsideredafoodadditiveofthatfoodandnotafoodadditiveoftheaddedflavouring,foodadditiveorfoodenzyme, and must then comply with the conditions of use forthat food as provided for.
4. Without prejudice to paragraph 1, the presence of a food
additive used as a sweetener shall be permitted in a compoundfoodwithnoaddedsugars,inanenergy-reducedcompoundfood,incompounddietaryfoodsintendedforlow-caloriediets,innon-cariogenic compound foods, and in a compound food with anincreased shelf-life, provided that the sweetener is permitted inone of the ingredients of the compound food.
Article 19
Interpretation decisions
Where necessary, it may be decided in accordance with the regu-
latory procedure referred to in Article 28(2) whether or not:
(a) a particular food belongs to a category of food referred to in
Annex II; or
(b) a food additive listed in Annexes II and III and permitted at
‘quantumsatis’isusedinaccordancewiththecriteriareferredto in Article 11(2); or
(c) a given substance meets the definition of food additive in
Article 3.
Article 20
Traditional foods
The Member States listed in Annex IV may continue to prohibit
the use of certain categories of food additives in the traditionalfoods produced on their territory as listed in that Annex.CHAPTER IV
LABELLING
Article 21
Labelling of food additives not intended for sale to the
final consumer
1. Food additives not intended for sale to the final consumer,
whether sold singly or mixed with each other and/or with foodingredients, as defined in Article 6(4) of Directive 2000/13/EC,mayonlybemarketedwiththelabellingprovidedforinArticle22ofthisRegulation,whichmustbeeasilyvisible,clearlylegibleandindelible. The information shall be in a language easily under-standable to purchasers.
2. Within its own territory, the Member State in which the
productismarketedmay,inaccordancewiththeTreaty,stipulatethat the information provided for in Article 22 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 22
General labelling requirements for food additives not
intended for sale to the final consumer
1. Wherefoodadditivesnotintendedforsaletothefinalcon-
sumeraresoldsinglyormixedwitheachotherand/orotherfoodingredients and/or with other substances added to them, theirpackaging or containers shall bear the following information:
(a) the name and/or E-number laid down in this Regulation in
respect of each food additive or a sales description whichincludes the name and/or E-number of each food additive;
(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 additive;
(f) thenameorbusinessnameandaddressofthemanufacturer,
packager or seller;L 354/24
EN Official Journal of the European Union 31.12.2008(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 beexpressed either numerically or by the quantum satisprinciple;
(h) the net quantity;(i) the date of minimum durability or use-by-date;(j) whererelevant,informationonafoodadditiveorothersub-
stances referred to in this Article and listed in Annex IIIa toDirective 2000/13/EC as regards the indication of the ingre-dients present in foodstuffs.
2. Wherefoodadditivesaresoldmixedwitheachotherand/or
with other food ingredients, their packaging or containers shallbear a list of all ingredients in descending order of their percent-age by weight of the total.
3. Where substances (including food additives or other food
ingredients) are added to food additives to facilitate their storage,sale, standardisation, dilution or dissolution, their packaging orcontainers shall bear a list of all such substances in descendingorder of their percentage 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
foodadditivesaresuppliedintankers,alloftheinformationmayappear merely on the accompanying documents relating to theconsignment which are to be supplied with the delivery.
Article 23
Labelling of food additives 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 additives sold singly or mixed with eachother and/or other food ingredients intended for sale to the final
consumer may be marketed only if their packaging contains thefollowing information:
(a) the name and E-number laid down in this Regulation in
respect of each food additive or a sales description whichincludes the name and E-number of each food additive;
(b) the statement ‘for food’ or the statement ‘restricted use in
food’ or a more specific reference to its intended food use.
2. Bywayofderogationfromparagraph1(a),thesalesdescrip-
tion of a table-top sweetener shall include the term ‘… -basedtable-topsweetener’,usingthename(s)ofthesweetener(s)usedinits composition.
3. The labelling of a table-top sweetener containing polyols
and/oraspartameand/oraspartame-acesulfamesaltshallbearthefollowing warnings:
(a) polyols:‘excessiveconsumptionmayinducelaxativeeffects’;(b) aspartame/aspartame-acesulfame salt: ‘contains a source of
phenylalanine’.
4. Manufacturers of table-top sweeteners shall make available
by appropriate means the necessary information to allow theirsafe use by consumers. Guidance for the implementation of thisparagraphmaybeadoptedinaccordancewiththeregulatorypro-cedure with scrutiny referred to in Article 28(3).
5. For the information provided for in paragraphs 1 to 3 of
this Article, Article 13(2) of Directive 2000/13/EC shall applyaccordingly.
Article 24
Labelling requirement for foods containing certain food
colours
1. WithoutprejudicetoDirective2000/13/EC,thelabellingof
food containing the food colours listed in Annex V to this Regu-lation shall include the additional information set out in thatAnnex.
2. In relation to the information provided in paragraph 1 of
this Article, Article 13(2) of Directive 2000/13/EC shall applyaccordingly.
3. Where necessary as a result of scientific progress or techni-
cal development, Annex V shall be amended by measures,designed to amend non-essential elements of this Regulation, inaccordance with the regulatory procedure with scrutiny referredto in Article 28(4).
(1) OJ L 186, 30.6.1989, p. 21.31.12.2008 EN Official Journal of the European Union L 354/25Article 25
Other labelling requirements
Articles 21, 22, 23 and 24 shall be without prejudice to more
detailedormoreextensivelaws,regulationsoradministrativepro-visions regarding weights and measures or applying to the pre-sentation, classification, packaging and labelling of dangeroussubstances and preparations or applying to the transport of suchsubstances and preparations.
CHAPTER V
PROCEDURAL PROVISIONS AND IMPLEMENTATION
Article 26
Information obligation
1. AproduceroruserofafoodadditiveshallinformtheCom-
mission immediately of any new scientific or technical informa-tion which might affect the assessment of the safety of the foodadditive.
2. Aproduceroruserofafoodadditiveshall,attherequestof
the Commission, inform it of the actual use of the food additive.SuchinformationshallbemadeavailabletoMemberStatesbytheCommission.
Article 27
Monitoring of food additive intake
1. Member States shall maintain systems to monitor the con-
sumptionanduseoffoodadditivesonarisk-basedapproachandreport their findings with appropriate frequency to the Commis-sion and the Authority.
2. After the Authority has been consulted, a common meth-
odology for the gathering of information by the Member Stateson dietary intake of food additives in the Community shall beadopted in accordance with the regulatory procedure referred toin Article 28(2).
Article 28
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.
4. Where reference is made to this paragraph, Article 5a(1)
to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shallapply, having regard to the provisions of Article 8 thereof.
The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e) of
Decision 1999/468/EC shall be 2 months, 2 months and 4months respectively.
Article 29
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 VI
TRANSITIONAL AND FINAL PROVISIONS
Article 30
Establishment of Community lists of food additives
1. Food additives which are permitted for use in foods under
Directives 94/35/EC, 94/36/EC and 95/2/EC, as amended on thebasis of Article 31 of this Regulation, and their conditions of useshall be entered in Annex II to this Regulation after a review oftheir compliance with Articles 6, 7 and 8 thereof. The measuresrelating to the entry of such additives in Annex II, which aredesignedtoamendnon-essentialelementsofthisRegulation,shallbe adopted in accordance with the regulatory procedure withscrutiny referred to in Article 28(4). The review shall not includeanewriskassessmentbytheAuthority.Thereviewshallbecom-pleted by 20 January 2011.
Food additives and uses which are no longer needed shall not be
entered in Annex II.
2. FoodadditivesauthorisedforuseinfoodadditivesinDirec-
tive95/2/ECandtheirconditionsofuseshallbeenteredinPart1of Annex III to this Regulation after a review of their compliancewith Article 6 thereof. The measures relating to the entry of suchadditivesinAnnexIII,whicharedesignedtoamendnon-essentialelements of this Regulation, shall be adopted in accordance withtheregulatoryprocedurewithscrutinyreferredtoinArticle28(4).ThereviewshallnotincludeanewriskassessmentbytheAuthor-ity. The review shall be completed by 20 January 2011.
Food additives and uses which are no longer needed shall not be
entered in Annex III.L 354/26
EN Official Journal of the European Union 31.12.20083. Food additives authorised for use in food flavourings in
Directive 95/2/EC and their conditions of use shall be entered inPart4ofAnnexIIItothisRegulationafterareviewoftheircom-pliance with Article 6 thereof. The measures relating to the entryofsuchadditivesinAnnexIII,whicharedesignedtoamendnon-essential elements of this Regulation, shall be adopted in accor-dance with the regulatory procedure with scrutiny referred to inArticle 28(4). The review shall not include a new risk assessmentby the Authority. The review shall be completed by 20 January2011.
Food additives and uses which are no longer needed shall not be
entered in Annex III.
4. Specifications of the food additives covered under para-
graphs 1 to 3 of this Article shall be adopted, in accordance withRegulation (EC) No 1331/2008 [establishing a common authori-sation procedure for food additives, food enzymes and food fla-vourings], at the moment those food additives are entered in theAnnexes in accordance with those paragraphs.
5. The measures relating to any appropriate transitional mea-
sures,whicharedesignedtoamendnon-essentialelementsofthisRegulation, inter alia, by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referredto in Article 28(3).
Article 31
Transitional measures
Until the establishment of the Community lists of food additives
as provided for in Article 30 is completed, the Annexes to Direc-tives 94/35/EC, 94/36/EC and 95/2/EC shall be amended, wherenecessary, by measures, designed to amend non-essential ele-ments of those Directives, adopted by the Commission in accor-dance with the regulatory procedure with scrutiny referred to inArticle 28(4).
Foods placed on the market or labelled before 20 January 2010
which do not comply with Article 22(1)(i) and (4) may be mar-keted until their date of minimum durability or use-by-date.
Foodsplacedonthemarketorlabelledbefore20July2010which
do not comply with Article 24 may be marketed until their dateof minimum durability or use-by-date.
Article 32
Re-evaluation of approved food additives
1. Food additives which were permitted before 20 January
2009 shall be subject to a new risk assessment carried out by theAuthority.
2. After consultation of the Authority, an evaluation pro-
grammeforthoseadditivesshallbeadoptedby20January2010,in accordance with the regulatory procedure referred to inArticle28(2).TheevaluationprogrammeshallbepublishedintheOfficial Journal of the European Union .Article 33
Repeals
1. The following acts shall be repealed:(a) CouncilDirectiveof23October1962ontheapproximation
of the rules of the Member States concerning the colouringmatters authorised for use in foodstuffs intended for humanconsumption;
(b) Directive 65/66/EEC;(c) Directive 78/663/EEC;(d) Directive 78/664/EEC;(e) Directive 81/712/EEC;(f) Directive 89/107/EEC;(g) Directive 94/35/EC;
(h) Directive 94/36/EC;(i) Directive 95/2/EC;(j) Decision No 292/97/EC;(k) Decision 2002/247/EC.2. References to the repealed acts shall be construed as refer-
ences to this Regulation.
Article 34
Transitional provisions
By way of derogation from Article 33, the following provisions
shall continue to apply until the transfer under Article 30(1), (2)and (3) of this Regulation of food additives already permitted inDirectives94/35/EC,94/36/ECand95/2/EChasbeencompleted:
(a) Article2(1),(2)and(4)ofDirective94/35/ECandtheAnnex
thereto;
(b) Article2(1)to(6),(8),(9)and(10)ofDirective94/36/ECand
Annexes I to V thereto;
(c) Articles 2 and 4 of Directive 95/2/EC and Annexes I to VI
thereto.
Notwithstanding point (c), the authorisations for E 1103 Inver-
tase and E 1105 Lysozyme laid down in Directive 95/2/EC shallbe repealed with effect from the date of application of the Com-munity list on food enzymes in accordance with Article 17 ofRegulation (EC) No 1332/2008 [on food enzymes].31.12.2008
EN Official Journal of the European Union L 354/27Article 35
Entry into force
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union .It shall apply from 20 January 2010.
However, Article 4(2) shall apply to Parts 2, 3 and 5 of Annex III
from1January2011andArticle23(4)shallapplyfrom20Janu-ary 2011. Article 24 shall apply from 20 July 2010. Article 31shall apply from 20 January 2009.
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 MAIREL 354/28 EN Official Journal of the European Union 31.12.2008ANNEX I
Functional classes of food additives in foods and of food additives in food additives and food enzymes
1. ‘sweeteners’ are substances used to impart a sweet taste to foods or in ta ble-top sweeteners;
2. ‘colours’ are substances which add or restore colour in a food, and inclu de natural constituents of foods and natural
sourceswhicharenormallynotconsumedasfoodsassuchandnotnormallyus edascharacteristicingredientsoffood.
Preparations obtained from foods and other edible natural source materia ls obtained by physical and/or chemical
extractionresultinginaselectiveextractionofthepigmentsrelativet othenutritiveoraromaticconstituentsarecolours
within the meaning of this Regulation;
3. ‘preservatives’ are substances which prolong the shelf-life of foods b y protecting them against deterioration caused by
micro-organisms and/or which protect against growth of pathogenic micro -organisms;
4. ‘antioxidants’ are substances which prolong the shelf-life of foods by protecting them against deterioration caused by
oxidation, such as fat rancidity and colour changes;
5. ‘carriers’aresubstancesusedtodissolve,dilute,disperseorotherw isephysicallymodifyafoodadditiveoraflavouring,
food enzyme, nutrient and/or other substance added for nutritional or phy siological purposes to a food without alter-
ing its function (and without exerting any technological effect themselv es) in order to facilitate its handling, applica-
tion or use;
6. ‘acids’ are substances which increase the acidity of a foodstuff and/or impart a sour taste to it;
7. ‘acidity regulators’ are substances which alter or control the acidity or alkalinity of a foodstuff;
8. ‘anti-caking agents’ are substances which reduce the tendency of indiv idual particles of a foodstuff to adhere to one
another;
9. ‘anti-foaming agents’ are substances which prevent or reduce foaming;10. ‘bulking agents’ are substances which contribute to the volume of a foo dstuff without contributing significantly to its
available energy value;
11. ‘emulsifiers’aresubstanceswhichmakeitpossibletoformormaintai nahomogenousmixtureoftwoormoreimmis-
cible phases such as oil and water in a foodstuff;
12. ‘emulsifying salts’ are substances which convert proteins contained in cheese into a dispersed form and thereby bring
about homogenous distribution of fat and other components;
13. ‘firming agents’ are substances which make or keep tissues of fruit or v egetables firm or crisp, or interact with gelling
agents to produce or strengthen a gel;
14. ‘flavour enhancers’ are substances which enhance the existing taste a nd/or odour of a foodstuff;
15. ‘foamingagents’aresubstanceswhichmakeitpossibletoformahomoge nousdispersionofagaseousphaseinaliquid
or solid foodstuff;
16. ‘gelling agents’ are substances which give a foodstuff texture throug h formation of a gel;
17. ‘glazingagents’(includinglubricants)aresubstanceswhich,whena ppliedtotheexternalsurfaceofafoodstuff,impart
a shiny appearance or provide a protective coating;
18. ‘humectants’aresubstanceswhichpreventfoodsfromdryingoutbycou nteractingtheeffectofanatmospherehaving
a low degree of humidity, or promote the dissolution of a powder in an aqueou s medium;31.12.2008 EN Official Journal of the European Union L 354/2919. ‘modified starches’ are substances obtained by one or more chemical tr eatments of edible starches, which may have
undergone a physical or enzymatic treatment, and may be acid or alkali thin ned or bleached;
20. ‘packaging gases’ are gases other than air, introduced into a containe r before, during or after the placing of a foodstuff
in that container;
21. ‘propellants’ are gases other than air which expel a foodstuff from a co ntainer;
22. ‘raising agents’ are substances or combinations of substances which l iberate gas and thereby increase the volume of a
dough or a batter;
23. ‘sequestrants’ are substances which form chemical complexes with met allic ions;
24. ‘stabilisers’ are substances which make it possible to maintain the ph ysico-chemical state of a foodstuff; stabilisers
include substances which enable the maintenance of a homogenous dispersi on of two or more immiscible substances
in a foodstuff, substances which stabilise, retain or intensify an existi ng colour of a foodstuff and substances which
increasethebindingcapacityofthefood,includingtheformationofcros s-linksbetweenproteinsenablingthebinding
of food pieces into re-constituted food;
25. ‘thickeners’ are substances which increase the viscosity of a foodstu ff;
26. ‘flourtreatmentagents’aresubstances,otherthanemulsifiers,whi chareaddedtoflourordoughtoimproveitsbaking
quality.L 354/30 EN Official Journal of the European Union 31.12.2008ANNEX II
Community list of food additives approved for use in foods and conditions o f use.
ANNEX III
Community list of food additives approved for use in food additives, food e nzymes and food flavourings, and their condi-
tions of use.
Community list of carriers in nutrients and their conditions of use.
Part 1 Carriers in food additives
Part 2 Food additives other than carriers in food additivesPart 3 Food additives including carriers in food enzymesPart 4 Food additives including carriers in food flavouringsPart 5 Carriers in nutrients and other substances added for nutritional an d/or for other physiological purposes31.12.2008 EN Official Journal of the European Union L 354/31ANNEX IV
Traditional foods for which certain Member States may continue to prohibi t the use of certain categories
of food additives
Member State FoodsCategories of additives which may continue
to be banned
Germany TraditionalGermanbeer(Biernachdeutschem
Reinheitsgebot gebraut)All except propellant gases
France Traditional French bread All
France Traditional French preserved truffles AllFrance Traditional French preserved snails AllFrance Traditional French goose and duck preserves
(confit)All
Austria Traditional Austrian ‘Bergkäse’ All except preservatives
Finland Traditional Finnish ‘Mämmi’ All except preservativesSweden
FinlandTraditional Swedish and Finnish fruit syrups Colours
Denmark Traditional Danish ‘Kødboller’ Preservatives and colours
Denmark Traditional Danish ‘Leverpostej’ Preservatives (other than sor bic acid) and
colours
Spain Traditional Spanish ‘Lomo embuchado’ All except preservatives and antioxidants
Italy Traditional Italian ‘Mortadella’ All except preservatives, antio xidants,
pH-adjusting agents, flavour enhancers, stabilis-ers and packaging gas
Italy Traditional Italian ‘Cotechino e zampone’ All except preservative s, antioxidants,
pH-adjusting agents, flavour enhancers, stabilis-ers and packaging gasL 354/32 EN Official Journal of the European Union 31.12.2008ANNEX V
List of the food colours referred to in Article 24 for which the labelling of foods shall include
additional information
Foods containing one or more of the following food colours Information
Sunset yellow (E 110) (*) ‘name or E number of the colour(s)’: may have an adverse
effect on activity and attention in children.
Quinoline yellow (E 104) (*)
Carmoisine (E 122) (*)
Allura red (E 129) (*)
Tartrazine (E 102) (*)
Ponceau 4R (E 124) (*)
(*) Withtheexceptionoffoodswherethecolour(s)hasbeenusedforthepurpo sesofhealthorothermarkingonmeatproductsorforstamp-
ing or decorative colouring on eggshells.31.12.2008 EN Official Journal of the European Union L 354/33