2006-13-EC-欧盟对饲料产品中二恶英的要求标准.pdf

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1、COMMISSION DIRECTIVE 2006/13/ECof 3 February 2006amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Councilon undesirable substances in animal feed as regards dioxins and dioxin-like PCBs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Havingre

2、gardtotheTreatyestablishingtheEuropeanCommunity,Having regard to Directive 2002/32/EC of the EuropeanParliament and of the Council of 7 May 2002 on undesirablesubstances in animal feed(1),and in particular Article 8(1)thereof,Whereas:(1)Directive 2002/32/EC provides that the putting intocirculation

3、and the use of products intended for animalfeedthatcontainlevelsofundesirablesubstancesexceeding the maximum levels laid down in Annex Ithereto is prohibited.(2)The term dioxins as referred to in this Directive covers agroup of 75 polychlorinated dibenzo-p-dioxin congeners(PCDD)and 135 polychlorinat

4、ed dibenzofuran(PCDF)congeners,of which 17 are of toxicological concern.Polychlorinated biphenyls(PCBs)are a group of 209different congeners which can be divided into twogroups according to their toxicological properties:12congeners exhibit similar toxicological properties todioxinsand aretherefore

5、often termed dioxin-likePCBs.TheotherPCBsdonotexhibitdioxin-liketoxicity but they have a different toxicological profile.(3)Each congener of dioxins or dioxin-like PCBs exhibits adifferent level of toxicity.In order to be able to sum upthe toxicity of these different congeners,the concept oftoxic eq

6、uivalency factors(TEFs)has been introduced tofacilitate risk assessment and regulatory control.Thismeans that the analytical results relating to all 17 indi-vidual dioxin congeners and to the 12 dioxin-like PCBcongeners are expressed in terms of a quantifiable unit,namely the TCDD toxic equivalent c

7、oncentration(TEQ).(4)On 30 May 2001 the Scientific Committee for Food(SCF)adopted an opinion on the Risk Assessment ofDioxins and Dioxin-like PCBs in Food,updating itsopinion of 22 November 2000 on this subject on thebasis of new scientific information that had becomeavailable since the latters adop

8、tion(2).The SCF fixed atolerable weekly intake(TWI)of 14 pg WHO-TEQ/kgbody weight for dioxins and dioxin-like PCBs.Exposureestimates indicate that a considerable proportion of theCommunity population have a dietary intake in excess ofthe TWI.Certain population groups in some countriescould be at hig

9、her risk owing to particular dietary habits.(5)More than 90%of human dioxin and dioxin-like PCBexposure derives from foodstuffs.Foodstuffs of animaloriginnormallycontributeapproximately80%ofoverallexposure.Thedioxinanddioxin-likePCBburden in animals stems mainly from feedingstuffs.Therefore feedings

10、tuffs,and in some cases soil,are ofconcern as potential sources of dioxins and dioxin-likePCBs.(6)The Scientific Committee for Animal Nutrition(SCAN)has been asked to advise on the sources of contami-nationoffeedingstuffswithdioxinsandPCBs,includingdioxin-likePCBs,theexposureoffood-producing animals

11、 to dioxins and PCBs,the carry-overof these compounds to food products of animal origin,and any impact on animal health of dioxins and PCBspresent in feedingstuffs.The SCAN adopted an opinionon 6 November 2000.It identified fish meal and fish oilas the most heavily contaminated feed materials.Animal

12、fatwasidentifiedasthenextmostseriouslycontaminatedmaterial.Allotherfeedmaterialsofanimal and plant origin had relatively low levels ofdioxincontamination.Roughagespresentedawiderange of dioxin contamination depending on location,degree of contamination with soil and exposure tosources of aerial poll

13、ution.The SCAN recommended,inter alia,that emphasis should be placed on reducingthe impact of the most contaminated feed materials onoverall diet contamination.ENL 32/44Official Journal of the European Union4.2.2006(1)OJ L 140,30.5.2002,p.10.Directive as last amended by Directive2005/87/EC(OJ L 318,

14、6.12.2005,p.19).(2)OpinionoftheScientificCommitteeon FoodontheRiskAssessment of Dioxins and Dioxin-like PCBs in Food adopted on30 May 2001 Update based on new scientific informationavailable since the adoption of the SCF opinion of 22 November2000(http:/europa.eu.int/comm/food/fs/sc/scf/out90_en.pdf

15、).(7)Although,from a toxicological point of view,themaximum level should apply to dioxins and dioxin-likePCBs,maximum levels were set for dioxins only and notfor dioxin-like PCBs,given the very limited data availableat that time on the prevalence of dioxin-like PCBs.However,in the meantime more data

16、 on the presenceof dioxin-like PCBs have become available.(8)According to Directive 2002/32/EC,the Commissionshould review the provisions as regards dioxins by theend of 2004 for the first time,in the light of new dataon the presence of dioxins and dioxin-like PCBs,inparticular with a view to the in

17、clusion of dioxin-likePCBs in the levels to be set.(9)All operators in the food and feed chain must continueto make all possible efforts to do all that is necessary tolimit the presence of dioxins and PCBs present in feedand food.Directive 2002/32/EC accordingly providesthat the maximum levels appli

18、cable should be furtherreviewed by 31 December 2006 at the latest with theaim of significantly reducing the maximum levels.Giventhe time necessary to obtain sufficient monitoring data todetermine such significantly lower levels,that time-limitshould be extended.(10)It is proposed to set maximum leve

19、ls for the sum ofdioxins and dioxin-like PCBs expressed in World HealthOrganisation(WHO)toxic equivalents,using the WHO-TEFs as this is the most appropriate approach from atoxicological point of view.In order to ensure asmoothswitchover,foratransitionalperiodtheexisting levels for dioxins should con

20、tinue to apply,inaddition to the newly set levels for the sum of dioxinsand dioxin-like PCBs.The separate maximum level fordioxins(PCDD/F)remains applicable for a temporaryperiod.Theproductsintendedforanimalfeedmentioned in point 27a have to comply during thatperiod with the maximum levels for dioxi

21、ns and withthe maximum levels for the sum of dioxins and dioxin-like PCBs.Consideration will be given by 31 December2008 to dispensing with the separate maximum level fordioxins.(11)It is of major importance that analytical results arereported and interpreted in a uniform way in order toensure a har

22、monised enforcement approach throughoutthe Community.Commission Directive 2002/70/EC of26 July 2002 establishing requirements for the determi-nation of levels of dioxins and dioxin-like PCBs infeedingstuffs(1)provides that a product intended foranimal feeding shall be considered as non-compliantwith

23、 the established maximum level if the analyticalresult confirmed by duplicate analysis and calculated asthe mean of at least two separate determinations exceedsthe maximum level beyond reasonable doubt taking intoaccount the measurement uncertainty.There are differentpossibilities to estimate the ex

24、panded uncertainty(2).(12)The scope of Directive 2002/32/EC covers the possibilityof establishing maximum levels of undesirable substancesin feed additives.Since high levels of dioxins have beenfound in trace elements,a maximum level should beestablished for dioxins and the sum of dioxins anddioxin-

25、like PCBs for all additives belonging to the func-tional group of compounds of trace elements and themaximum levels should be extended to all additivesbelonging to the functional group of binders and anti-caking agents and to premixtures.(13)In order to encourage a proactive approach to reducingthe

26、dioxins and dioxin-like PCBs present in food andfeed,action levels were set by Commission Recommend-ation 2002/201/EC of 4 March 2002 on the reduction ofthe presence of dioxins,furans and PCBs in feedingstuffsand foodstuffs(3).Those action levels are a tool forcompetent authorities and operators to

27、highlight thosecases where it is appropriate to identify a source ofcontamination and to take measures to reduce oreliminate it.Since the sources of dioxins and dioxin-like PCBs are different,separate action levels should bedetermined for dioxins on the one hand and for dioxin-like PCBs on the other

28、 hand.(14)Directive 2002/32/EC provides for the possibility ofsetting action levels.The action levels should thereforebe transferred from Recommendation 2002/201/EC toAnnex II to Directive 2002/32/EC.(15)The reduction of human exposure to dioxins and dioxin-like PCBs through food consumption is impo

29、rtant andnecessarytoensureconsumerprotection.Asfoodcontamination is directly related to feed contamination,an integrated approach must be adopted to reduce dioxinand dioxin-like PCB incidence throughout the food chain,i.e.from products intended for animal feed throughfood-producinganimalstohumans.Ap

30、roactiveapproach is followed to actively reduce the dioxins anddioxin-like PCBs in feed and food and consequently themaximum levels applicable should be reviewed within adefined period of time with the objective to set lowerlevels.Therefore consideration will be given by 31December 2008 at the lates

31、t to significantly reducingthe maximum levels for the sum of dioxins and dioxin-like PCBs.EN4.2.2006Official Journal of the European UnionL 32/45(1)OJ L 209,6.8.2002,p.15.Directive as amended by Directive2005/7/EC(OJ L 27,29.1.2005,p.41).(2)Information on different ways for the estimation of the exp

32、andeduncertainty and on the value of the measurement uncertainty can befound in the report Report on the relationship between analyticalresults,measurement uncertainty,recovery factors and the provisionsof EU food and feed legislation http:/europa.eu.int/comm/food/food/chemicalsafety/contaminants/re

33、port-sampling_analysis_2004_en.pdf(3)OJ L 67,9.3.2002,p.69.(16)Operators need to make efforts to step up their decon-tamination capacity to remove effectively dioxins anddioxin-like PCBs from fish oil.Further efforts have todone by the operators to investigate the different possi-bilities to remove

34、dioxins and dioxin-like PCBs from fishmeal and fish protein-hydrolysates.Once the decontami-nation technology is also available for fish meal and fishprotein hydrolysates,operators will have to do efforts toprovide for sufficient decontamination capacity.Thesignificant lower maximum level for the su

35、m of dioxinsand dioxin-like PCBs,to which consideration shall begiven by 31 December 2008,shall be for fish oil,fishmeal and fish protein hydrolysates based on the technicalpossibilities of the most effective,economically viable,decontamination procedure.As regards fish feed,thissignificant lower le

36、vel shall be determined based on thetechnical possibilities of the most effective,economicallyviable,decontamination procedure for fish oil and fishmeal.(17)The extraction procedure used for the analysis of dioxinsand dioxin-like PCBs has a large influence on theanalytical result in particular on pr

37、oducts intended foranimal feed of mineral origin and it is therefore appro-priate to determine before the date of application theextraction procedure to be used for the analysis ofdioxins and dioxin-like PCBs.(18)Directive 2002/32/EC should therefore be amendedaccordingly.(19)The measures provided f

38、or in this Directive are inaccordancewiththeopinionoftheStandingCommittee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annexes I and II to Directive 2002/32/EC are amended inaccordance with the Annex to this Directive.Article 21.Member States shall bring into force the law

39、s,regulationsand administrative provisions necessary to comply with thisDirective by 4 November 2006 at the latest.They shallforthwith communicate to the Commission the text of thoseprovisions and a correlation table between those provisions andthis Directive.When Member States adopt those provision

40、s,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 thetexts of the provisions of national law which they

41、 adopt in thefield covered by this Directive.Article 3This Directive shall enter into force on the 20th day followingits publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels,3 February 2006.For the CommissionMarkos KYPRI

42、ANOUMember of the CommissionENL 32/46Official Journal of the European Union4.2.2006ANNEX(a)Point 27 in Annex I to Directive 2002/32/EC is replaced by the following:Undesirable substancesProducts intended for animal feedMaximum content relative to a feedingstuff with amoisture content of 12%(1)(2)(3)

43、27a.Dioxins(sum of polychlorinated dibenzo-para-dioxins(PCDDs)and polychlorinateddibenzofurans(PCDFs)expressedinWorld Health Organisation(WHO)toxicequivalents,using the WHO-TEFs(toxicequivalency factors,1997(*)(a)Feed materials of plant origin with theexception of vegetable oils and their by-product

44、s0,75 ng WHO-PCDD/F-TEQ/kg(*)(*)(b)Vegetable oils and their by-products0,75 ng WHO-PCDD/F-TEQ/kg(*)(*)(c)Feed materials of mineral origin1,0 ng WHO-PCDD/F-TEQ/kg(*)(*)(d)Animal fat,including milk fat and egg fat2,0 ng WHO-PCDD/F-TEQ/kg(*)(*)(e)Other land animal products includingmilk and milk produc

45、ts and eggs andegg products0,75 ng WHO-PCDD/F-TEQ/kg(*)(*)(f)Fish oil6,0 ng WHO-PCDD/F-TEQ/kg(*)(*)(g)Fish,other aquatic animals,their productsand by-products with the exception offish oil and fish protein hydrolysatescontaining more than 20%fat(*)1,25 ng WHO-PCDD/F-TEQ/kg(*)(*)(h)Fish protein hydro

46、lysates containing morethan 20%fat2,25 ng WHO-PCDD/F-TEQ/kg(*)(*)(i)Theadditiveskaoliniticclay,calciumsulphate dihydrate,vermiculite,natrolite-phonolite,synthetic calcium aluminatesand clinoptilolite of sedimentary originbelonging to the functional groups ofbinders and anti-caking agents0,75 ng WHO-

47、PCDD/F-TEQ/kg(*)(*)(j)Additivesbelongingtothefunctionalgroup of compounds of trace elements1,0 ng WHO-PCDD/F-TEQ/kg(*)(*)(k)Premixtures1,0 ng WHO-PCDD/F-TEQ/kg(*)(*)(l)Compoundfeedingstuffs,withtheexception of feed for fur animals,petfoods and feed for fish0,75 ng WHO-PCDD/F-TEQ/kg(*)(*)(m)Feed for

48、fish.Pet foods2,25 ng WHO-PCDD/F-TEQ/kg(*)(*)27b.Sum of dioxins and dioxin-like PCBs(sumofpolychlorinateddibenzo-para-dioxins(PCDDs),polychlorinated dibenzofurans(PCDFs)and polychlorinated biphenyls(PCBs)expressed in World Health Organi-sation(WHO)toxic equivalents,using theWHO-TEFs(toxicequivalency

49、factors,1997(*)(a)Feed materials of plant origin with theexception of vegetable oils and their by-products1,25 ng WHO-PCDD/F-PCB-TEQ/kg(*)(b)Vegetable oils and their by-products1,5 ng WHO-PCDD/F-PCB-TEQ/kg(*)(c)Feed materials of mineral origin1,5 ng WHO-PCDD/F-PCB-TEQ/kg(*)(d)Animal fat,including mi

50、lk fat and egg fat3,0 ng WHO-PCDD/F-PCB-TEQ/kg(*)EN4.2.2006Official Journal of the European UnionL 32/47(1)(2)(3)(e)Other land animal products includingmilk and milk products and eggs andegg products1,25 ng WHO-PCDD/F-PCB-TEQ/kg(*)(f)Fish oil24,0 ng WHO-PCDD/F-PCB-TEQ/kg(*)(g)Fish,other aquatic anim