欧盟食品添加剂标准法规(食品添加、食品酶制剂和食品用.pdf

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1、I(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)REGULATIONSREGULATION(EC)No 1331/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 16 December 2008establishingacommonauthorisationprocedureforfoodadditives,foodenzymesandfoodflavourings(Text with EEA relevance)THE

2、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 andSocial Committee(1),Acting in ac

3、cordance with the procedure laid down in Article 251of the Treaty(2),Whereas:(1)The free movement of safe and wholesome food is anessential aspect of the internal market and contributes sig-nificantly to the health and well-being of citizens,and totheir social and economic interests.(2)A high level

4、of protection of human life and health shouldbe 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)

5、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-pean Parliament and of the Council of 16 December 2008on food enzymes(4)and Regulation(EC)No 1334/2008of the European Parliament and of the Council of16 December

6、 2008 on flavourings and certain food ingre-dientswithflavouringpropertiesforuseinandonfoods(5)(hereinafter referred to as the sectoral food laws)lay downharmonised criteria and requirements concerning theassessment and authorisation of these substances.(5)It is envisaged,in particular,that food add

7、itives,foodenzymes and food flavourings,to the extent that the safetyof food flavourings must be assessed in accordance withRegulation(EC)No 1334/2008 on flavourings and certainfood ingredients with flavouring properties for use in andon foods,must not be placed on the market or used infoodstuffs fo

8、r human consumption,in accordance with theconditions laid down in each sectoral food law,unless theyare included on a Community list of authorised substances.(6)Ensuring transparency in the production and handling offood is absolutely crucial in order to maintain consumerconfidence.(7)In this contex

9、t,it appears appropriate to establish for thesethree 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 Europe

10、an 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)S

11、ee page 7 of this Official Journal.(5)See page 34 of this Official Journal.31.12.2008ENOfficial Journal of the European UnionL 354/1(8)This common procedure must be founded on the prin-ciples of good administration and legal certainty and mustbe implemented in compliance with those principles.(9)Thi

12、s Regulation will thus complete the regulatory frame-work concerning the authorisation of the substances bylaying down the various stages of the procedure,the dead-lines for those stages,the role of the parties involved andthe principles that apply.Nevertheless,for some aspects ofthe procedure,it is

13、 necessary to take the specific character-istics of each sectoral food law into consideration.(10)The deadlines laid down in the procedure take into accountthe time needed to consider the different criteria set in eachsectoral food law,as well as allowing adequate time forconsultation when preparing

14、 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)Upon receipt of an application the Commission should ini-tiate the procedure and wh

15、ere necessary seek the opinionof the European Food Safety Authority(hereinafter referredto 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 EuropeanFood S

16、afety Authority and laying down procedures in mat-ters of food safety(1)as soon as possible after the validityand applicability of the application have been assessed.(12)In accordance with the framework for risk assessment inmatters of food safety established by Regulation(EC)No 178/2002,the authori

17、sation to place substances on themarket must be preceded by an independent scientificassessment,of the highest possible standard,of the risksthat they pose to human health.This assessment,whichmust be carried out under the responsibility of the Author-ity,must be followed by a risk management decisi

18、on takenby the Commission under a regulatory procedure thatensures close cooperation between the Commission andthe Member States.(13)Theauthorisationtoplacesubstancesonthemarketshouldbe granted pursuant to this Regulation provided that thecriteria for authorisation laid down under the sectoral foodl

19、aws are satisfied.(14)It is recognised that,in some cases,scientific risk assess-ment alone cannot provide all the information on which arisk management decision should be based,and that otherlegitimate factors relevant to the matter under consider-ation may be taken into account,including societal,

20、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,

21、maintained andpublished by the Commission.(16)Where appropriate and under certain circumstances,thespecific 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-toralfoodlawshouldlaydownthecon

22、ditionsunderwhichthese data may not be used for the benefit of anotherapplicant.(17)Networking between the Authority and the Member Statesorganisations operating in the fields within the Authoritysmission is one of the basic principles of the Authoritysoperation.In consequence,in preparing its opini

23、on,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 substancesmust fulfil transparency and public information require-ments while guaranteeing the right of a

24、pplicants to pre-serve the confidentiality of certain information.(19)Protecting the confidentiality of certain aspects of an appli-cation should be maintained as a consideration in order toprotect the competitive position of an applicant.However,information relating to the safety of a substance,inc

25、lud-ing,but not limited to,toxicological studies,other safetystudies and raw data as such,should under no circum-stances be confidential.(20)Pursuant to Regulation(EC)No 178/2002,Regulation(EC)No 1049/2001 of the European Parliament and of theCouncil of 30 May 2001 regarding public access to Euro-pe

26、an 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 downdetailed rules for the implementation of European Parliament andCouncil Regulation(EC)No 178/2002 with regard to the networ

27、k oforganisations operating in the fields within the European Food SafetyAuthoritys mission(OJ L 379,24.12.2004,p.64).(3)OJ L 145,31.5.2001,p.43.L 354/2ENOfficial Journal of the European Union31.12.2008(21)Regulation(EC)No 178/2002 establishes procedures fortaking emergency measures in relation to f

28、oodstuffs ofCommunity origin or imported from third countries.Itauthorises the Commission to adopt such measures in situ-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 ta

29、ken 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 c

30、annot be suffi-ciently achieved by the Member States on account of dif-ferences between national laws and provisions and cantherefore be better achieved at Community level,the Com-munity may adopt measures,in accordance with the prin-ciple of subsidiarity as set out in Article 5 of the Treaty.Inacco

31、rdance with the principle of proportionality,as set outin that Article,this Regulation does not go beyond what isnecessary in order to achieve those objectives.(24)The measures necessary for the implementation of thisRegulation should be adopted in accordance with CouncilDecision 1999/468/EC of 28 J

32、une 1999 laying down theprocedures for the exercise of implementing powers con-ferred on the Commission(1).(25)In particular the Commission should be empowered toupdate the Community lists.Since those measures are ofgeneral scope and are designed to amend non-essential ele-ments of each sectoral foo

33、d 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 theregulatory procedure with scrutiny should be

34、 curtailed forthe addition of substances to the Community lists and foradding,removing or changing conditions,specifications orrestrictions associated with the presence of a substance onthe Community lists.(27)When,onimperativegroundsofurgency,thenormaltime-limits for the regulatory procedure with s

35、crutiny cannot becomplied 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 pres

36、ence of a substance on the Communitylists,HAVE ADOPTED THIS REGULATION:CHAPTER IGENERAL PRINCIPLESArticle 1Subject matter and scope1.This Regulation lays down a common procedure for theassessment and authorisation(hereinafter referred to as the com-mon procedure)of food additives,food enzymes,food f

37、lavour-ings and source materials of food flavourings and of foodingredients with flavouring properties used or intended for use inor on foodstuffs(hereinafter referred to as the substances),whichcontributes to the free movement of food within the Communityand to a high level of protection of human h

38、ealth and to a highlevel of consumer protection,including the protection of con-sumer interests.This Regulation shall not apply to smoke flavour-ings falling within the scope of Regulation(EC)No 2065/2003 ofthe European Parliament and of the Council of 10 November2003 on smoke flavourings used or in

39、tended for use in or onfoods(2).2.The common procedure shall lay down the proceduralarrangements for updating the lists of substances the marketingof which is authorised in the Community pursuant to Regulation(EC)No 1333/2008 on food additives,Regulation(EC)No 1332/2008 on food enzymes and Regulatio

40、n(EC)No 1334/2008 on flavourings and certain food ingredients withflavouring properties for use in and on foods(hereinafter referredto as the sectoral food laws).3.The criteria according to which substances can be includedon the Community list provided for in Article 2,the content ofthe regulation r

41、eferred to in Article 7 and,where applicable,thetransitional provisions concerning ongoing procedures are laiddown in each sectoral food law.Article 2Community list of substances1.Under each sectoral food law,substances that have beenauthorised to be placed on the Community market shall beincluded o

42、n a list the content of which is determined by the saidlaw(hereinafter referred to as the Community list).The Commu-nity list shall be updated by the Commission.It shall be publishedin the Official Journal of the European Union.2.Updating the Community list means:(a)adding a substance to the Communi

43、ty list;(1)OJ L 184,17.7.1999,p.23.(2)OJ L 309,26.11.2003,p.1.31.12.2008ENOfficial Journal of the European UnionL 354/3(b)removing a substance from the Community list;(c)adding,removing or changing conditions,specifications orrestrictions associated with the presence of a substance onthe Community l

44、ist.CHAPTER IICOMMON PROCEDUREArticle 3Main stages of the common procedure1.The common procedure for updating the Community listmay 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

45、 several inter-ested parties,in accordance with the conditions provided for bythe implementing measures referred to in Article 9(1)(a)(herein-after referred to as the applicant).Applications shall be sent to theCommission.2.The Commission shall seek the opinion of the EuropeanFood Safety Authority(h

46、ereinafter referred to as the Authority),tobe given in accordance with Article 5.However,for the updates referred to in Article 2(2)(b)and(c),theCommission shall not be required to seek the opinion of theAuthority if the updates in question are not liable to have an effecton human health.3.The commo

47、n procedure shall end with the adoption by theCommission of a regulation implementing the update,in accor-dance with Article 7.4.By way of derogation from paragraph 3,the Commissionmay end the common procedure and decide not to proceed witha planned update,at any stage of the procedure,if it judges

48、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.In such cases,where applicable,the Commission shall

49、inform theapplicant and the Member States directly,indicating in its letterthe reasons for not considering the update justified.Article 4Initiating the procedure1.On receipt of an application to update the Community list,the Commission:(a)shall acknowledge receipt of the application in writing to th

50、eapplicant within 14 working days of receiving it;(b)where applicable,shall as soon as possible notify the Author-ity of the application and request its opinion in accordancewith Article 3(2).The application shall be made available to the Member States bythe Commission.2.Where it starts the procedur