200768EC欧盟过敏原规定.pdf.pdf

DIRECTIVESCOMMISSION DIRECTIVE 2007/68/ECof 27 November 2007amending Annex IIIa to Directive 2000/13/EC of the European Parliament and of the Council asregards certain food ingredients(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,Having regard to Directive 2000/13/EC of the EuropeanParliament and of the Council of 20 March 2000 on theapproximation of the laws of the Member States relating tothe labelling,presentation and advertising of foodstuffs(1),andin particular third subparagraph of Article 6(11)and Article 21thereof,Whereas:(1)Annex IIIa to Directive 2000/13/EC establishes a list offood ingredients which must be indicated on the label offoodstuffs as they are likely to cause adverse reactions insusceptible individuals.(2)Directive 2000/13/EC provides for the possibility ofexcluding from the labelling requirement ingredients orsubstances derived from ingredients listed in Annex IIIafor which it has been scientifically established that theyare not likely,under specific circumstances,to triggeradverse reactions.(3)Commission Directive 2005/26/EC(2)establishes the listof food ingredients or substances provisionally excludedfrom the labelling requirement until the 25 November2007.(4)A number of applications for permanent exemption fromthe labelling requirement have been submitted to theEuropean Food Safety Authority(EFSA).Those appli-cationsconcernsubstancesforwhichprovisionalexemptions were granted by Directive 2005/26/EC.Onthe basis of the EFSA opinions and other available infor-mation,it can be concluded that certain ingredients orsubstances derived from those ingredients listed in AnnexIIIa to Directive 2000/13/EC are not likely,under specificcircumstances,to cause adverse reactions in susceptibleindividuals.(5)Those ingredients or substances derived from thoseingredients should therefore be permanently excludedfrom Annex IIIa to Directive 2000/13/EC.(6)Annex IIIa of Directive 2000/13/EC should be amendedaccordingly.(7)Directive2005/26/ECshouldberepealedon26 November 2007 in view of the deadline set byArticle6(11),secondsubparagraphofDirective2000/13/EC.(8)In order to avoid disruption of the market,it is necessaryfor this Directive to apply from the 26 November 2007.(9)It was expected that this Directive could be adopted andpublished well in advance of the date of 26 November2007 in order to give time to the industry to adapt tothe new rules.Since this has not been possible inpractice,temporary measures appear therefore necessaryto facilitate the application of the new rules.Indeedchanges in labelling rules will affect industry,mainlysmall and medium enterprises,which need an adaptationperiod to smooth the transition towards new labellingrequirements.(10)The measures provided for in this Directive are inaccordancewiththeopinionoftheStandingCommittee on the Food Chain and Animal Health,EN28.11.2007Official Journal of the European UnionL 310/11(1)OJL109,6.5.2000,p.29.DirectiveaslastamendedbyCommissionDirective2006/142/EC(OJL368,23.12.2006,p.110).(2)OJ L 75,22.3.2005,p.33.Directive as amended by Directive2005/63/EC(OJ L 258,4.10.2005,p.3).HAS ADOPTED THIS DIRECTIVE:Article 1Annex IIIa to Directive 2000/13/EC is replaced by the text inthe Annex to this Directive as from 26 November 2007.Article 21.Member States shall bring into force the laws,regulationsand administrative provisions necessary to comply with thisDirective by 31 May 2008 at the latest.They shall forthwithcommunicate to the Commission the text of those provisionsand a correlation table between those provisions and thisDirective.When Member States adopt those provisions,they shall containa reference to this Directive or be accompanied by such areference on the occasion of their official publication.MemberStates shall determine how such reference is to be made.2.Member States shall communicate to the Commission thetext of the main provisions of national law which they adopt inthe field covered by this Directive.Article 3Directive 2005/26/EC shall be repealed on 26 November 2007.Member States shall allow foodstuffs placed on the market orlabelled before 31 May 2009 that comply with the provisionsof Directive 2005/26/EC to be marketed until stocks areexhausted.Article 4This Directive shall enter into force on the day following that ofits publication in the Official Journal of the European Union.Article 5This Directive is addressed to the Member States.Done at Brussels,27 November 2007.For the CommissionMarkos KYPRIANOUMember of the CommissionENL 310/12Official Journal of the European Union28.11.2007ANNEXANNEX IIIaIngredients referred to in Article 6(3a),(10)and(11)1.Cereals containing gluten(i.e.wheat,rye,barley,oats,spelt,kamut or their hybridised strains)and products thereof,except:(a)wheat-based glucose syrups including dextrose(1);(b)wheat-based maltodextrins(1);(c)glucose syrups based on barley;(d)cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholicbeverages.2.Crustaceans and products thereof.3.Eggs and products thereof.4.Fish and products thereof,except:(a)fish gelatine used as carrier for vitamin or carotenoid preparations;(b)fish gelatine or Isinglass used as fining agent in beer and wine.5.Peanuts and products thereof.6.Soybeans and products thereof,except:(a)fully refined soybean oil and fat(1);(b)natural mixed tocopherols(E306),natural D-alpha tocopherol,natural D-alpha tocopherol acetate,naturalD-alpha tocopherol succinate from soybean sources;(c)vegetable oils derived phytosterols and phytosterol esters from soybean sources;(d)plant stanol ester produced from vegetable oil sterols from soybean sources.7.Milk and products thereof(including lactose),except:(a)whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholicbeverages;(b)lactitol.8.Nuts,i.e.almonds(Amygdalus communis L.),hazelnuts(Corylus avellana),walnuts(Juglans regia),cashews(Anacardiumoccidentale),pecan nuts(Carya illinoiesis(Wangenh.)K.Koch),Brazil nuts(Bertholletia excelsa),pistachio nuts(Pistaciavera),macadamia nuts and Queensland nuts(Macadamia ternifolia),and products thereof,except:(a)nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholicbeverages.EN28.11.2007Official Journal of the European UnionL 310/13(1)And products thereof,insofar as the process that they have undergone is not likely to increase the level of allergenicity assessed by theEFSA for the relevant product from which they originated.9.Celery and products thereof.10.Mustard and products thereof.11.Sesame seeds and products thereof.12.Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.13.Lupin and products thereof.14.Molluscs and products thereof.ENL 310/14Official Journal of the European Union28.11.2007