I
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obl igatory)
REGULATIONS
REGULATION (EC) No 1331/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 December 2008
establishingacommonauthorisationprocedureforfoodadditives,foode nzymesandfoodflavourings
(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)In order to protect human health, the safety of additives,
enzymes and flavourings for use in foodstuffs for humanconsumption must be assessed before they are placed onthe Community market.(4)Regulation (EC) No 1333/2008 of the European Parlia-
ment and of the Council of 16 December 2008 on foodadditives (
3), Regulation (EC) No 1332/2008 of the Euro-
peanParliamentandoftheCouncilof16December2008on food enzymes (
4) and Regulation (EC) No 1334/2008
of the European Parliament and of the Council of16December2008onflavouringsandcertainfoodingre-dientswithflavouringpropertiesforuseinandonfoods (
5)
(hereinafterreferredtoasthesectoralfoodlaws)laydownharmonised criteria and requirements concerning theassessment and authorisation of these substances.
(5)It is envisaged, in particular, that food additives, food
enzymesandfoodflavourings,totheextentthatthesafetyof food flavourings must be assessed in accordance withRegulation(EC)No1334/2008[onflavouringsandcertainfood ingredients with flavouring properties for use in andon foods], must not be placed on the market or used infoodstuffsforhumanconsumption,inaccordancewiththeconditionslaiddownineachsectoralfoodlaw,unlesstheyareincludedonaCommunitylistofauthorisedsubstances.
(6)Ensuring transparency in the production and handling of
food is absolutely crucial in order to maintain consumerconfidence.
(7)Inthiscontext,itappearsappropriatetoestablishforthese
three categories of substances a common Communityassessment and authorisation procedure that is effective,time-limited and transparent, so as to facilitate their freemovement within the Community market.
(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. 134), Council Common Position of 10 March 2008(OJ C 111 E, 6.5.2008, p. 1), Position of the European Parliament of8 July 2008 (not yet published in the Official Journal) and CouncilDecision of 18 November 2008.(3) See page 16 of this Official Journal.
(4) See page 7 of this Official Journal.
(5) See page 34 of this Official Journal.31.12.2008 EN Official Journal of the European Union L 354/1(8)This common procedure must be founded on the prin-
ciplesofgoodadministrationandlegalcertaintyandmustbe implemented in compliance with those principles.
(9)This Regulation will thus complete the regulatory frame-
work concerning the authorisation of the substances bylayingdownthevariousstagesoftheprocedure,thedead-lines for those stages, the role of the parties involved andtheprinciplesthatapply.Nevertheless,forsomeaspectsoftheprocedure,itisnecessarytotakethespecificcharacter-istics of each sectoral food law into consideration.
(10)Thedeadlineslaiddownintheproceduretakeintoaccount
thetimeneededtoconsiderthedifferentcriteriasetineachsectoral food law, as well as allowing adequate time forconsultation when preparing the draft measures. In par-ticular, the nine-months deadline for the Commission topresent a draft regulation updating the Community listshould not preclude the possibility of this being donewithin a shorter period.
(11)UponreceiptofanapplicationtheCommissionshouldini-
tiate the procedure and where necessary seek the opinionoftheEuropeanFoodSafetyAuthority(hereinafterreferredto as the Authority) established by Regulation (EC)No178/2002oftheEuropeanParliamentandoftheCoun-cil of 28 January 2002 laying down the general principlesand requirements of food law, establishing the EuropeanFoodSafetyAuthorityandlayingdownproceduresinmat-ters of food safety (
1) as soon as possible after the validity
and applicability of the application have been assessed.
(12)In accordance with the framework for risk assessment in
matters of food safety established by Regulation (EC)No178/2002,theauthorisationtoplacesubstancesonthemarket must be preceded by an independent scientificassessment, of the highest possible standard, of the risksthat they pose to human health. This assessment, whichmustbecarriedoutundertheresponsibilityoftheAuthor-ity,mustbefollowedbyariskmanagementdecisiontakenby the Commission under a regulatory procedure thatensures close cooperation between the Commission andthe Member States.
(13)Theauthorisationtoplacesubstancesonthemarketshould
be granted pursuant to this Regulation provided that thecriteriaforauthorisationlaiddownunderthesectoralfoodlaws are satisfied.(14)It is recognised that, in some cases, scientific risk assess-
mentalonecannotprovidealltheinformationonwhichariskmanagementdecisionshouldbebased,andthatotherlegitimate factors relevant to the matter under consider-ation may be taken into account, including societal, eco-nomic, traditional, ethical and environmental factors andthe feasibility of controls.
(15)In order to ensure that both business operators in the sec-
tors concerned and the public are kept informed of theauthorisations in force, the authorised substances shouldbe included on a Community list created, maintained andpublished by the Commission.
(16)Where appropriate and under certain circumstances, the
specific sectoral food law may provide for protection ofscientific data and other information submitted by theapplicant for a certain period of time. In this case, the sec-toralfoodlawshouldlaydowntheconditionsunderwhichthese data may not be used for the benefit of anotherapplicant.
(17)NetworkingbetweentheAuthorityandtheMemberStates’
organisationsoperatinginthefieldswithintheAuthority’smission is one of the basic principles of the Authority’soperation. In consequence, in preparing its opinion, theAuthority may use the network made available to it byArticle 36 of Regulation (EC) No 178/2002 and by Com-mission Regulation (EC) No 2230/2004 (
2).
(18)The common authorisation procedure for the substances
must fulfil transparency and public information require-ments while guaranteeing the right of applicants to pre-serve the confidentiality of certain information.
(19)Protectingtheconfidentialityofcertainaspectsofanappli-
cationshouldbemaintainedasaconsiderationinordertoprotectthecompetitivepositionofanapplicant.However,information relating to the safety of a substance, includ-ing, but not limited to, toxicological studies, other safetystudies and raw data as such, should under no circum-stances be confidential.
(20)PursuanttoRegulation(EC)No178/2002,Regulation(EC)
No 1049/2001 of the European Parliament and of theCouncil of 30 May 2001 regarding public access to Euro-pean Parliament, Council and Commission documents (
3)
applies to documents held by the Authority.
(1) OJ L 31, 1.2.2002, p. 1.(2) Regulation (EC) No 2230/2004 of 23 December 2004 laying down
detailed rules for the implementation of European Parliament andCouncil Regulation (EC) No 178/2002 with regard to the network oforganisations operating in the fields within the European Food SafetyAuthority’s mission (OJ L 379, 24.12.2004, p. 64).
(
3) OJ L 145, 31.5.2001, p. 43.L 354/2 EN Official Journal of the European Union 31.12.2008(21)Regulation (EC) No 178/2002 establishes procedures for
taking emergency measures in relation to foodstuffs ofCommunity origin or imported from third countries. ItauthorisestheCommissiontoadoptsuchmeasuresinsitu-ations where foodstuffs are likely to constitute a seriousrisk to human health, animal health or the environmentand where such risk cannot be contained satisfactorily bymeasures taken by the Member State(s) concerned.
(22)In the interests of efficiency and legislative simplification,
there should be a medium-term examination of the ques-tion whether to extend the scope of the common proce-dure to other legislation in the area of food.
(23)Since the objectives of this Regulation cannot be suffi-
ciently achieved by the Member States on account of dif-ferences between national laws and provisions and canthereforebebetterachievedatCommunitylevel,theCom-munity may adopt measures, in accordance with the prin-cipleofsubsidiarityassetoutinArticle5oftheTreaty.Inaccordancewiththeprincipleofproportionality,assetoutinthatArticle,thisRegulationdoesnotgobeyondwhatisnecessary in order to achieve those objectives.
(24)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 (
1).
(25)In particular the Commission should be empowered to
update the Community lists. Since those measures are ofgeneralscopeandaredesignedtoamendnon-essentialele-ments of each sectoral food law, inter alia, by supplement-
ing it with new non-essential elements, they must beadopted in accordance with the regulatory procedurewith scrutiny provided for in Article 5a of Decision1999/468/EC.
(26)On grounds of efficiency, the normal time-limits for the
regulatory procedure with scrutiny should be curtailed forthe addition of substances to the Community lists and foradding,removingorchangingconditions,specificationsorrestrictionsassociatedwiththepresenceofasubstanceonthe Community lists.
(27)When,onimperativegroundsofurgency,thenormaltime-
limitsfortheregulatoryprocedurewithscrutinycannotbecomplied with, the Commission should be able to applythe urgency procedure provided for in Article 5a(6) ofDecision 1999/468/EC for the removal of a substancefrom the Community lists and for adding, removing orchanging conditions, specifications or restrictions associ-ated with the presence of a substance on the Communitylists,HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PRINCIPLES
Article 1
Subject matter and scope
1. This Regulation lays down a common procedure for the
assessment and authorisation (hereinafter referred to as the com-mon procedure) of food additives, food enzymes, food flavour-ings and source materials of food flavourings and of foodingredientswithflavouringpropertiesusedorintendedforuseinoronfoodstuffs(hereinafterreferredtoasthesubstances),whichcontributestothefreemovementoffoodwithintheCommunityand to a high level of protection of human health and to a highlevel of consumer protection, including the protection of con-sumerinterests.ThisRegulationshallnotapplytosmokeflavour-ingsfallingwithinthescopeofRegulation(EC)No2065/2003ofthe European Parliament and of the Council of 10 November2003 on smoke flavourings used or intended for use in or onfoods (
2).
2. The common procedure shall lay down the procedural
arrangements for updating the lists of substances the marketingofwhichisauthorisedintheCommunitypursuanttoRegulation(EC) No 1333/2008 [on food additives], Regulation (EC)No 1332/2008 [on food enzymes] and Regulation (EC)No1334/2008[onflavouringsandcertainfoodingredientswithflavouringpropertiesforuseinandonfoods](hereinafterreferredto as the sectoral food laws).
3. The criteria according to which substances can be included
on the Community list provided for in Article 2, the content ofthe regulation referred to in Article 7 and, where applicable, thetransitional provisions concerning ongoing procedures are laiddown in each sectoral food law.
Article 2
Community list of substances
1. Under each sectoral food law, substances that have been
authorised to be placed on the Community market shall beincluded on a list the content of which is determined by the saidlaw (hereinafter referred to as the Community list). The Commu-nitylistshallbeupdatedbytheCommission.Itshallbepublishedin theOfficial Journal of the European Union .
2. ‘Updating the Community list’ means:(a) adding a substance to the Community list;
(1) OJ L 184, 17.7.1999, p. 23. (2) OJ L 309, 26.11.2003, p. 1.31.12.2008 EN Official Journal of the European Union L 354/3(b) removing a substance from the Community list;
(c) adding, removing or changing conditions, specifications or
restrictions associated with the presence of a substance onthe Community list.
CHAPTER II
COMMON PROCEDURE
Article 3
Main stages of the common procedure
1. The common procedure for updating the Community list
may be started either on the initiative of the Commission or fol-lowing an application. Applications may be made by a MemberState or by an interested party, who may represent several inter-ested parties, in accordance with the conditions provided for bythe implementing measures referred to in Article 9(1)(a) (herein-afterreferredtoastheapplicant).ApplicationsshallbesenttotheCommission.
2. The Commission shall seek the opinion of the European
FoodSafetyAuthority(hereinafterreferredtoastheAuthority),tobe given in accordance with Article 5.
However,fortheupdatesreferredtoinArticle2(2)(b)and(c),the
Commission shall not be required to seek the opinion of theAuthorityiftheupdatesinquestionarenotliabletohaveaneffecton human health.
3. Thecommonprocedureshallendwiththeadoptionbythe
Commission of a regulation implementing the update, in accor-dance with Article 7.
4. By way of derogation from paragraph 3, the Commission
may end the common procedure and decide not to proceed witha planned update, at any stage of the procedure, if it judges thatsuch an update is not justified. Where applicable, it shall takeaccount of the opinion of the Authority, the views of MemberStates, any relevant provisions of Community law and any otherlegitimate factors relevant to the matter under consideration.
Insuchcases,whereapplicable,theCommissionshallinformthe
applicant and the Member States directly, indicating in its letterthe reasons for not considering the update justified.
Article 4
Initiating the procedure
1. On receipt of an application to update the Community list,
the Commission:
(a) shallacknowledgereceiptoftheapplicationinwritingtothe
applicant within 14 working days of receiving it;
(b) whereapplicable,shallassoonaspossiblenotifytheAuthor-
ity of the application and request its opinion in accordancewith Article 3(2).The application shall be made available to the Member States by
the Commission.
2. Whereitstartstheprocedureonitsowninitiative,theCom-
mission shall inform the Member States and, where applicable,request the opinion of the Authority.
Article 5
Opinion of the Authority
1. The Authority shall give its opinion within nine months of
receipt of a valid application.
2. TheAuthorityshallforwarditsopiniontotheCommission,
the Member States and, where applicable, the applicant.
Article 6
Additional information concerning risk assessment
1. In duly justified cases where the Authority requests addi-
tional information from applicants, the period referred to inArticle 5(1) may be extended. After consulting the applicant, theAuthority shall lay down a period within which this informationcan be provided and shall inform the Commission of the addi-tional period needed. If the Commission does not object withineightworkingdaysofbeinginformedbytheAuthority,theperiodreferred to in Article 5(1) shall be automatically extended by theadditional period. The Commission shall inform the MemberStates of the extension.
2. If the additional information is not sent to the Authority
within the additional period referred to in paragraph 1, theAuthority shall finalise its opinion on the basis of the informa-tion already provided.
3. Where applicants submit additional information on their
owninitiative,theyshallsendittotheAuthorityandtotheCom-mission.Insuchcases,theAuthorityshallgiveitsopinionwithinthe original period without prejudice to Article 10.
4. The additional information shall be made available to the
Member States and the Commission by the Authority.
Article 7
Updating the Community list
1. WithinninemonthsoftheAuthoritygivingitsopinion,the
Commission shall submit to the Committee referred to inArticle14(1)adraftregulationupdatingtheCommunitylist,tak-ing account of the opinion of the Authority, any relevant provi-sionsofCommunitylawandanyotherlegitimatefactorsrelevantto the matter under consideration.
In those cases where an opinion of the Authority has not been
requested, the nine-month period shall start from the date theCommission receives a valid application.
2. IntheRegulationupdatingtheCommunitylist,theconsid-
erations on which it is based shall be explained.L 354/4
EN Official Journal of the European Union 31.12.20083. Where the draft regulation is not in accordance with the
opinion of the Authority, the Commission shall explain the rea-sons for its decision.
4. Themeasures,designedtoamendnon-essentialelementsof
each sectoral food law, relating to the removal of a substancefromtheCommunitylist,shallbeadoptedinaccordancewiththeregulatory procedure with scrutiny referred to in Article 14(3).
5. On grounds of efficiency, the measures designed to amend
non-essential elements of each sectoral food law, inter alia,b y
supplementing it, relating to the addition of a substance to theCommunitylistandforadding,removingorchangingconditions,specifications or restrictions associated with the presence of thesubstanceontheCommunitylist,shallbeadoptedinaccordancewith the regulatory procedure with scrutiny referred to inArticle 14(4).
6. On imperative grounds of urgency, the Commission may
use the urgency procedure referred to in Article 14(5) for theremoval of a substance from the Community list and for adding,removing or changing conditions, specifications or restrictionsassociated with the presence of a substance on the Communitylist.
Article 8
Additional information concerning risk management
1. Where the Commission requests additional information
from applicants on matters concerning risk management, it shalldetermine,togetherwiththeapplicant,aperiodwithinwhichthatinformationcanbeprovided.Insuchcases,theperiodreferredtoin Article 7 may be extended accordingly. The Commission shallinform the Member States of the extension and shall make theadditionalinformationavailabletotheMemberStatesonceithasbeen provided.
2. If the additional information is not sent within the addi-
tionalperiodreferredtoinparagraph1,theCommissionshallacton the basis of the information already provided.
CHAPTER III
MISCELLANEOUS PROVISIONS
Article 9
Implementing measures
1. In accordance with the regulatory procedure referred to in
Article 14(2), within a period of no longer than 24 months fromthe adoption of each sectoral food law, the implementing mea-suresforthisRegulationshallbeadoptedbytheCommission,andshall concern in particular:
(a) the content, drafting and presentation of the application
referred to in Article 4(1);(b) the arrangements for checking the validity of applications;
(c) thetypeofinformationthatmustbeincludedintheopinion
of the Authority referred to in Article 5.
2. Withaviewtotheadoptionoftheimplementingmeasures
referred to in paragraph 1(a), the Commission shall consult theAuthority, which, within six months of the date of entry intoforce of each sectoral food law, shall present it with a proposalconcerningthedatarequiredforriskassessmentofthesubstancesconcerned.
Article 10
Extension of time periods
In exceptional circumstances, the periods referred to in
Article5(1)andArticle7maybeextendedbytheCommissiononits own initiative or, where applicable, at the Authority’s request,if the nature of the matter in question so justifies, without preju-dice to Article 6(1) and Article 8(1). In such cases the Commis-sion shall, where appropriate, inform the applicant and theMember States of the extension and the reasons for it.
Article 11
Transparency
The Authority shall ensure the transparency of its activities in
accordance with Article 38 of Regulation (EC) No 178/2002. Inparticular,itshallmakeitsopinionspublicwithoutdelay.Itshallalsomakepublicanyrequestforitsopinionaswellasanyexten-sion of period pursuant to Article 6(1).
Article 12
Confidentiality
1. Among the information provided by applicants, confiden-
tialtreatmentmaybegiventoinformationthedisclosureofwhichmight significantly harm their competitive position.
Information relating to the following shall not, in any circum-
stances, be regarded as confidential:
(a) the name and address of the applicant;(b) the name and a clear description of the substance;(c) thejustificationfortheuseofthesubstanceinoronspecific
foodstuffs or food categories;
(d) informationthatisrelevanttotheassessmentofthesafetyof
the substance;
(e) where applicable, the analysis method(s).2. For the purposes of implementing paragraph 1, applicants
shall indicate which of the information provided they wish to betreated as confidential. Verifiable justification must be given insuch cases.31.12.2008
EN Official Journal of the European Union L 354/53. The Commission shall decide after consulting with the
applicants which information can remain confidential and shallnotify applicants and the Member States accordingly.
4. After being made aware of the Commission’s position,
applicants shall have three weeks in which to withdraw theirapplication so as to preserve the confidentiality of the informa-tion provided. Confidentiality shall be preserved until this periodexpires.
5. The Commission, the Authority and the Member States
shall,inaccordancewithRegulation(EC)No1049/2001,takethenecessary measures to ensure appropriate confidentiality of theinformation received by them under this Regulation, except forinformation which must be made public if circumstances sorequire in order to protect human health, animal health or theenvironment.
6. Ifanapplicantwithdraws,orhaswithdrawn,itsapplication,
the Commission, the Authority and the Member States shall notdiscloseconfidentialinformation,includinginformationthecon-fidentiality of which is the subject of disagreement between theCommission and the applicant.
7. The implementation of paragraphs 1 to 6 shall not affect
the circulation of information between the Commission, theAuthority and the Member States.
Article 13
Emergencies
IntheeventofanemergencyconcerningasubstanceontheCom-
munity list, particularly in the light of an opinion of the Author-ity,measuresshallbeadoptedinaccordancewiththeproceduresreferredtoinArticles53and54ofRegulation(EC)No178/2002.
Article 14
Committee
1. TheCommissionshallbeassistedbytheStandingCommit-
teeontheFoodChainandAnimalHealthestablishedbyArticle58of Regulation (EC) No 178/2002.2. 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 two months, two months andfour months respectively.
5. Wherereferenceismadetothisparagraph,Article5a(1),(2),
(4) and (6) and Article 7 of Decision 1999/468/EC shall apply,having regard to the provisions of Article 8 thereof.
Article 15
Competent authorities of the Member States
Not later than six months after the entry into force of each sec-
toral food law, Member States shall forward to the Commissionand to the Authority, in relation to each sectoral food law, thename and address of the national competent authority for thepurposes of the common procedure, as well as a contact pointtherein.
CHAPTER IV
FINAL PROVISION
Article 16
Entry into force
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union .
For each sectoral food law, it shall apply from the date of appli-
cation of the measures referred to in Article 9(1).
Article 9 shall 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 354/6 EN Official Journal of the European Union 31.12.2008