COUNCIL DIRECTIVE of 15July1975 on waste
MDD指令93_42_EEC(中英文对照版最终版)
第 1 页 共 72页 Edited By Stephen Ling. Any question, please contact with me Via Email: ibat@
Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products; whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products; 鉴于部分医疗器械是符合 1965 年 1 月 26 日理事会第 65/65/EEC 号指令, 与专卖医药产品有关的法律, 法规或管理行 为所订的实施规定, 鉴于医疗器械的上市基本上由本指令规范, 但医疗产品的上市则受 65/65/EEC 号指令规范; 鉴于若 有某种器械须与其他医疗产品组成一完整的产品而上市销售, 使用, 且无法二次使用时, 则该组合产品应受 65/65/EEC 号指令规范; 鉴于前述的医疗器械和包含医疗物质且该物质单独使用时符合 65/65/EEC 号指令规定的医疗器械应加以 区别; 鉴于前述包含于医疗器械的医疗物质若对人体产生作用以辅助医疗器械的作用时, 则该医疗器械的上市应由本指 令规范; 鉴于 1975 年 5 月 20 日 75/318/EEC 号理事会指令[制定各会员国在测试专利医疗产品方面有关分析药物毒性 和临床的标准及调查书的法律调和], 医疗物质的安全, 品质及效用在前述情况下则须依该指令明定的适当方法加以证 实;
电子产品三防设计培训资料 (1)
防湿热、防霉菌、防盐雾腐蚀。 （简称：防潮、防霉、防盐雾或三防）
2。对三防定义的理解
1）国外通称为 防腐蚀 技术 2）“三防”的真实含义：
凡是由大气（候）环境或设备的平台环境而引起 的设备所有故障都属于“三防”防护的范畴。而不仅 限于防潮、防霉、防盐雾。
铝合金盖板与镀银件接触导致铝合金腐蚀。 镀银模块于铝合金底座接触，导致铝底座腐蚀。 镀银器件安装在铝合金面板上，湿热试验后导致铝面
板腐蚀，器件外壳改为镀镍后，通过试验。 SMA高频连接器，用镀锌螺钉，在湿热环境6个月后，
彩锌螺钉生锈，应选用不锈钢紧固件。
腐蚀案例
三防失效案例三：应力腐蚀
海军某舰，天线采用钢管焊接涂漆，二年后焊 接处锈蚀而断裂。
不受控的环境,偶尔会R.H 100%如 仓库,地下室,户外简单遮蔽等.
恶劣环境如：海上舰船,岛屿或距离海岸,盐碱
地3.7Km；冶炼，化工，皮革 厂1~3Km 受有害物质（酸，碱，盐。 SO2 H2S 等）侵蚀。
暴露在高真空和高辐射下.(高冲击、振动）
4.6.3 结构件分类-----按所处环境划分
1) “Ⅰ” 型表面和 “Ⅱ” 型表面
镉及其化合物
75
六价铬及其化合物
900
多溴联苯（PBB）及其衍生物如多溴联苯醚（PBDE）
多溴联苯氧化物（PBDO）
多氯联苯及其衍生物（PCTS）
900 5
6. 三防的主要案例
6.1 三防设计的重要性及典型案例分析.
根据多年的统计分析：
事故中属设计不当或设计错误占 80 % 由加工或工艺问题占20 %
4）环境适应性（Environmental adaptability）
英文ELV指令
DIRECTIVE 2000/53/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 18September2000on end-of life vehiclesTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community,and in particular Article 175(1)thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Having consulted the Committee of the Regions,Acting in accordance with the procedure referred to in Article 251of the Treaty in the light of the joint text approved by the Conciliation Committee on 23May 2000(3),Whereas(1)The different national measures concerning end-of life vehicles should be harmonised in order,first,to mini-mise the impact of end-of life vehicles on the environ-ment,thus contributing to the protection,preservation and improvement of the quality of the environment and energy conservation,and,second,to ensure the smooth operation of the internal market and avoid distortions of competition in the Community.(2)A Community-wide framework is necessary in order to ensure coherence between national approaches in attaining the objectives stated above,particularly with a view to the design of vehicles for recycling and recovery,to the requirements for collection and treatment facili-ties,and to the attainment of the targets for reuse,recycling and recovery,taking into account the principle of subsidiarity and the polluter-pays principle.(3)Every year end-of life vehicles in the Community generate between 8and 9million tonnes of waste,which must be managed correctly.(4)In order to implement the precautionary and preventive principles and in line with the Community strategy for waste management,the generation of waste must be avoided as much as possible.(5)It is a further fundamental principle that waste should be reused and recovered,and that preference be given to reuse and recycling.(6)Member States should take measures to ensure that economic operators set up systems for the collection,treatment and recovery of end-of life vehicles.(7)Member States should ensure that the last holder and/or owner can deliver the end-of life vehicle to an authorised treatment facility without any cost as a result of the vehicle having no or a negative,market value.Member States should ensure that producers meet all,or a signifi-cant part of,the costs of the implementation of these measures;the normal functioning of market forces should not be hindered.(8)This Directive should cover vehicles and end-of life vehicles,including their components and materials,as well as spare and replacement parts,without prejudice to safety standards,air emissions and noise control.(9)This Directive should be understood as having borrowed,where appropriate,the terminology used by several existing directives,namely Council Directive 67/548/EEC of 27June 1967on the approximation of laws,regulations and administrative provisions relating to the classification,packaging and labelling of dangerous substances (4),Council Directive 70/156/EEC of 6February 1970on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (5),and Council Directive 75/442/EEC of 15July 1975on waste (6).(10)Vintage vehicles,meaning historic vehicles or vehicles of value to collectors or intended for museums,kept in a proper and environmentally sound manner,either ready for use or stripped into parts,are not covered by the definition of waste laid down by Directive 75/442/EEC and do not fall within the scope of this Directive.(11)It is important that preventive measures be applied from the conception phase of the vehicle onwards and take the form,in particular,of reduction and control of hazardous substances in vehicles,in order to prevent their release into the environment,to facilitate recycling and to avoid the disposal of hazardous waste.In partic-ular the use of lead,mercury,cadmium and hexavalent(1)OJ C 337,7.11.1997,p.3,andOJ C 156,3.6.1999,p.5.(2)OJ C 129,27.4.1998,p.44.(4)OJ 196,16.8.1967,p.1.Directive as last amended by Commission Directive 98/98/EC (OJ L 355,30.12.1998,p.1).(3)Opinion of the European Parliament of 11February 1999(OJ C 150,28.5.1999,p.420),Council Common Position of 29July 1999(OJ C 317,4.11.1999,p.19)and Decision of the European Parliament of 3February 2000(not yet published in the Official Journal).Council Decision of 20July 2000and Decision of the European Parliament of 7September 2000.(5)OJ L 42,23.2.1970,p.1.Directive as last amended by Directive 98/91/EC of the European Parliament and of the Council (OJ L 11,16.1.1999,p.25).(6)OJ L 194,25.7.1975,p.39.Directive as last amended by Commis-sion Decision 96/350/EC (OJ L 135,6.6.1996,p.32).chromium should be prohibited.These heavy metalsshould only be used in certain applications according toa list which will be regularly reviewed.This will help toensure that certain materials and components do notbecome shredder residues,and are not incinerated ordisposed of in landfills.(12)The recycling of all plastics from end-of life vehiclesshould be continuously improved.The Commission iscurrently examining the environmental impacts of PVC.The Commission will,on the basis of this work,makeproposals as appropriate as to the use of PVC includingconsiderations for vehicles.(13)The requirements for dismantling,reuse and recycling ofend-of life vehicles and their components should beintegrated in the design and production of new vehicles.(14)The development of markets for recycled materialsshould be encouraged.(15)In order to ensure that end-of life vehicles are discardedwithout endangering the environment,appropriatecollection systems should be set up.(16)A certificate of destruction,to be used as a condition forthe de-registration of end-of life vehicles,should beintroduced.Member States without a de-registrationsystem should set up a system according to which acertificate of destruction is notified to the relevantcompetent authority when the end-of life vehicle istransferred to a treatment facility.(17)This Directive does not prevent Member States fromgranting,where appropriate,temporary deregistrationsof vehicles.(18)Collection and treatment operators should be allowed tooperate only when they have received a permit or,incase a registration is used instead of a permit,specificconditions have been complied with.(19)The recyclability and recoverability of vehicles should bepromoted.(20)It is important to lay down requirements for storage andtreatment operations in order to prevent negativeimpacts on the environment and to avoid the emergenceof distortions in trade and competition.(21)In order to achieve results in the short term and to giveoperators,consumers and public authorities the neces-sary perspective for the longer term,quantified targetsfor reuse,recycling and recovery to be achieved byeconomic operators should be set.(22)Producers should ensure that vehicles are designed andmanufactured in such a way as to allow the quantifiedtargets for reuse,recycling and recovery to be achieved.To this end the Commission will promote the prepara-tion of European standards and will take the othernecessary measures in order to amend the pertinentEuropean vehicle type-approval legislation.(23)Member States should ensure that in implementing theprovisions of this Directive competition is preserved,inparticular as regards the access of small and medium-sized enterprises to the collection,dismantling,treat-ment and recycling market.(24)In order to facilitate the dismantling and recovery,inparticular recycling of end-of life vehicles,vehicle manu-facturers should provide authorised treatment facilitieswith all requisite dismantling information,in particularfor hazardous materials.(25)The preparation of European standards,where appro-priate,should be promoted.Vehicle manufacturers andmaterial producers should use component and materialcoding standards,to be established by the Commissionassisted by the relevant committee.In the preparation ofthese standards the Commission will take account,asappropriate,of the work going on in this area in therelevant international forums.(26)Community-wide data on end-of life vehicles are neededin order to monitor the implementation of the objectivesof this Directive.(27)Consumers have to be adequately informed in order toadjust their behaviour and attitudes;to this end informa-tion should be made available by the relevant economicoperators.(28)Member States may choose to implement certain provi-sions by means of agreements with the economic sectorconcerned,provided that certain conditions are met.(29)The adaptation to scientific and technical progress of therequirements for treatment facilities and for the use ofhazardous substances and,as well as the adoption ofminimum standards for the certificate of destruction,theformats for the database and the implementation meas-ures necessary to control compliance with the quantifiedtargets should be effected by the Commission under aCommittee procedure.(30)The measures to be taken for the implementation of thisDirective should be adopted in accordance with CouncilDecision1999/468/EC of28June1999laying downthe procedures for the exercise of implementing powersconferred on the Commission(1).(31)Member States may apply the provisions of thisDirective in advance of the date set out therein,providedsuch measures are compatible with the Treaty, (1)OJ L184,17.7.1999,p.23.HAVE ADOPTED THIS DIRECTIVE:Article1ObjectivesThis Directive lays down measures which aim,as a first priority,at the prevention of waste from vehicles and,in addition,at the reuse,recycling and other forms of recovery of end-of life vehicles and their components so as to reduce the disposal of waste,as well as at the improvement in the envir-onmental performance of all of the economic operators involved in the life cycle of vehicles and especially the opera-tors directly involved in the treatment of end-of life vehicles.Article2DefinitionsFor the purposes of this Directive:1.‘vehicle’means any vehicle designated as category M1or N1defined in Annex IIA to Directive70/156/EEC,and three wheel motor vehicles as defined in Directive92/61/EEC, but excluding motor tricycles;2.‘end-of life vehicle’means a vehicle which is waste withinthe meaning of Article1(a)of Directive75/442/EEC;3.‘producer’means the vehicle manufacturer or the profes-sional importer of a vehicle into a Member State;4.‘prevention’means measures aiming at the reduction of thequantity and the harmfulness for the environment of end-of life vehicles,their materials and substances;5.‘treatment’means any activity after the end-of life vehiclehas been handed over to a facility for depollution,disman-tling,shearing,shredding,recovery or preparation for disposal of the shredder wastes,and any other operation carried out for the recovery and/or disposal of the end-of life vehicle and its components;6.‘reuse’means any operation by which components ofend-of life vehicles are used for the same purpose for which they were conceived;7.‘recycling’means the reprocessing in a production processof the waste materials for the original purpose or for other purposes but excluding energy recovery.Energy recovery means the use of combustible waste as a means to generate energy through direct incineration with or without other waste but with recovery of the heat;8.‘recovery’means any of the applicable operations providedfor in Annex IIB to Directive75/442/EEC;9.‘disposal’means any of the applicable operations providedfor in Annex IIA to Directive75/442/EEC;10.‘economic operators’means producers,distributors,collec-tors,motor vehicle insurance companies,dismantlers, shredders,recoverers,recyclers and other treatment opera-tors of end-of life vehicles,including their components and materials;11.‘hazardous substance’means any substance which isconsidered to be dangerous under Directive67/548/EEC;12.‘shredder’means any device used for tearing into pieces orfragmenting end-of life vehicles,including for the purpose of obtaining directly reusable metal scrap;13.‘dismantling information’means all information requiredfor the correct and environmentally sound treatment of end-of life vehicles.It shall be made available to authorised treatment facilities by vehicle manufacturers and compo-nent producers in the form of manuals or by means of electronic media(e.g.CD-ROM,on-line services).Article3Scope1.This Directive shall cover vehicles and end-of life vehicles, including their components and materials.Without prejudice to Article5(4),third subparagraph,this shall apply irrespective of how the vehicle has been serviced or repaired during use and irrespective of whether it is equipped with components supplied by the producer or with other components whose fitting as spare or replacement parts accords with the appro-priate Community provisions or domestic provisions.2.This Directive shall apply without prejudice to existing Community legislation and relevant national legislation,in particular as regards safety standards,air emissions and noise controls and the protection of soil and water.3.Where a producer only makes or imports vehicles that are exempt from Directive70/156/EEC by virtue of Article 8(2)(a)thereof,Member States may exempt that producer and his vehicles from Articles7(4),8and9of this Directive.4.Special-purpose vehicles as defined in the second indent of Article4(1)(a)of Directive70/156/EEC shall be excluded from the provisions of Article7of this Directive.5.For three-wheel motor vehicles only Articles5(1),5(2) and6of this Directive shall apply.Article4Prevention1.In order to promote the prevention of waste Member States shall encourage,in particular:(a)vehicle manufacturers,in liaison with material and equip-ment manufacturers,to limit the use of hazardous substances in vehicles and to reduce them as far as possible from the conception of the vehicle onwards,so as in particular to prevent their release into the environment, make recycling easier,and avoid the need to dispose of hazardous waste;(b)the design and production of new vehicles which take intofull account and facilitate the dismantling,reuse and recovery,in particular the recycling,of end-of life vehicles, their components and materials;(c)vehicle manufacturers,in liaison with material and equip-ment manufacturers,to integrate an increasing quantity of recycled material in vehicles and other products,in order to develop the markets for recycled materials.2.(a)Member States shall ensure that materials and compo-nents of vehicles put on the market after1July2003donot contain lead,mercury,cadmium or hexavalent chro-mium other than in cases listed in Annex II under theconditions specified therein;(b)in accordance with the procedure laid down in Article11the Commission shall on a regular basis,accordingto technical and scientific progress,amend Annex II,inorder to:(i)as necessary,establish maximum concentrationvalues up to which the existence of the substancesreferred to in subparagraph(a)in specific materialsand components of vehicles shall be tolerated;(ii)exempt certain materials and components of vehicles from the provisions of subparagraph(a)ifthe use of these substances is unavoidable;(iii)delete materials and components of vehicles from Annex II if the use of these substances is avoidable;(iv)under points(i)and(ii)designate those materials and components of vehicles that can be strippedbefore further treatment;they shall be labelled ormade identifiable by other appropriate means; (c)the Commission shall amend Annex II for the first timenot later than21October2001.In any case none of theexemptions listed therein shall be deleted from theAnnex before1January2003.Article5Collection1.Member States shall take the necessary measures to ensure:—that economic operators set up systems for the collection of all end-of life vehicles and,as far as technically feasible, of waste used parts removed when passenger cars are repaired,—the adequate availability of collection facilities within their territory.2.Member States shall also take the necessary measures to ensure that all end-of life vehicles are transferred to authorised treatment facilities.3.Member States shall set up a system according to which the presentation of a certificate of destruction is a condition for deregistration of the end-of life vehicle.This certificate shall be issued to the holder and/or owner when the end-of life vehicle is transferred to a treatment facility.Treatment facilities,which have obtained a permit in accordance with Article6,shall be permitted to issue a certificate of destruction.Member States may permit producers,dealers and collectors on behalf of an authorised treatment facility to issue certificates of destruction provided that they guarantee that the end-of life vehicle is transferred to an authorised treatment facility and provided that they are registered with public authorities.Issuing the certificate of destruction by treatment facilities or dealers or collectors on behalf of an authorised treatment facility does not entitle them to claim any financial reimburse-ment,except in cases where this has been explicitly arranged by Member States.Member States which do not have a deregistration system at the date of entry into force of this Directive shall set up a system according to which a certificate of destruction is noti-fied to the relevant competent authority when the end-of life vehicle is transferred to a treatment facility and shall otherwise comply with the terms of this paragraph.Member States making use of this subparagraph shall inform the Commission of the reasons thereof.4.Member States shall take the necessary measures to ensure that the delivery of the vehicle to an authorised treat-ment facility in accordance with paragraph3occurs without any cost for the last holder and/or owner as a result of the vehicle's having no or a negative market value.Member States shall take the necessary measures to ensure that producers meet all,or a significant part of,the costs of the implementation of this measure and/or take back end-of life vehicles under the same conditions as referred to in the first subparagraph.Member States may provide that the delivery of end-of life vehicles is not fully free of charge if the end-of life vehicle does not contain the essential components of a vehicle,in particular the engine and the coachwork,or contains waste which has been added to the end-of life vehicle.The Commission shall regularly monitor the implementation of the first subparagraph to ensure that it does not result in market distortions,and if necessary shall propose to the Euro-pean Parliament and the Council an amendment thereto.5.Member States shall take the necessary measures to ensure that competent authorities mutually recognise and accept the certificates of destruction issued in other Member States in accordance with paragraph 3.To this end,the Commission shall draw up,not later than21October2001 the minimum requirements for the certificate of destruction.Article6Treatment1.Member States shall take the necessary measures to ensure that all end-of life vehicles are stored(even temporarily) and treated in accordance with the general requirements laid down in Article4of Directive75/442/EEC,and in compliance with the minimum technical requirements set out in Annex I to this Directive,without prejudice to national regulations on health and environment.2.Member States shall take the necessary measures to ensure that any establishment or undertaking carrying out treatment operations obtains a permit from or be registered with the competent authorities,in compliance with Articles9, 10and11of Directive75/442/EEC.The derogation from the permit requirement referred to in Article11(1)(b)of Directive75/442/EEC may apply to recovery operations concerning waste of end-of life vehicles after they have been treated according to Annex1(3)to this Directive if there is an inspection by the competent authorities before the registration.This inspection shall verify:(a)type and quantities of waste to be treated;(b)general technical requirements to be complied with;(c)safety precautions to be taken,in order to achieve the objectives referred to in Article4of Directive75/442/EEC.This inspection shall take place once a year.Member States using the derogation shall send the results to the Commission.3.Member States shall take the necessary measures to ensure that any establishment or undertaking carrying out treatment operations fulfils at least the following obligations in accordance with Annex I:(a)end-of life vehicles shall be stripped before further treat-ment or other equivalent arrangements are made in order to reduce any adverse impact on the po-nents or materials labelled or otherwise made identifiable in accordance with Article4(2)shall be stripped before further treatment;(b)hazardous materials and components shall be removed andsegregated in a selective way so as not to contaminate subsequent shredder waste from end-of life vehicles; (c)stripping operations and storage shall be carried out insuch a way as to ensure the suitability of vehicle compo-nents for reuse and recovery,and in particular for recy-cling.Treatment operations for depollution of end-of life vehicles as referred to in Annex I(3)shall be carried out as soon as possible.4.Member States shall take the necessary measures to ensure that the permit or registration referred to in paragraph 2includes all conditions necessary for compliance with the requirements of paragraphs1,2and3.5.Member States shall encourage establishments or under-takings,which carry out treatment operations to introduce, certified environmental management systems.Article7Reuse and recovery1.Member States shall take the necessary measures to encourage the reuse of components which are suitable for reuse,the recovery of components which cannot be reused and the giving of preference to recycling when environmentally viable,without prejudice to requirements regarding the safety of vehicles and environmental requirements such as air emis-sions and noise control.2.Member States shall take the necessary measures to ensure that the following targets are attained by economic operators:(a)no later than1January2006,for all end-of life vehicles,the reuse and recovery shall be increased to a minimum of 85%by an average weight per vehicle and year.Within the same time limit the reuse and recycling shall be increased to a minimum of80%by an average weight per vehicle and year;for vehicles produced before1January1980,Member States may lay down lower targets,but not lower than 75%for reuse and recovery and not lower than70%for reuse and recycling.Member States making use of this subparagraph shall inform the Commission and the other Member States of the reasons therefor;(b)no later than1January2015,for all end-of life vehicles,the reuse and recovery shall be increased to a minimum of 95%by an average weight per vehicle and year.Within the same time limit,the re-use and recycling shall be increased to a minimum of85%by an average weight per vehicle and year.By31December2005at the latest the European Parliament and the Council shall re-examine the targets referred to in paragraph(b)on the basis of a report of the Commission, accompanied by a proposal.In its report the Commission shall take into account the development of the material composition of vehicles and any other relevant environmental aspects related to vehicles.The Commission shall,in accordance with the procedure laid down in Article11,establish the detailed rules necessary to control compliance of Member States with the targets set out in this paragraph.In doing so the Commission shall take into account all relevant factors,inter alia the availability of data and the issue of exports and imports of end-of life vehicles.The Commission shall take this measure not later than21October 2002.3.On the basis of a proposal from the Commission,the European Parliament and the Council shall establish targets for reuse and recovery and for reuse and recycling for the years beyond2015.4.In order to prepare an amendment to Directive70/ 156/EEC,the Commission shall promote the preparation of European standards relating to the dismantlability,recover-ability and recyclability of vehicles.Once the standards are agreed,but in any case no later than by the end of2001,the European Parliament and the Council,on the basis of a proposal from the Commission,shall amend Directive70/ 156/EEC so that vehicles type-approved in accordance with that Directive and put on the market after three years after the amendment of the Directive70/156/EEC are re-usable and/or recyclable to a minimum of85%by weight per vehicle and are re-usable and/or recoverable to a minimum of95%by weight per vehicle.5.In proposing the amendment to Directive70/156/EEC relating to the ability to be dismantled,recoverability and recyclability of vehicles,the Commission shall take into account as appropriate the need to ensure that the reuse of components does not give rise to safety or environmental hazards.Article8Coding standards/dismantling information1.Member States shall take the necessary measures to ensure that producers,in concert with material and equipment manufacturers,use component and material coding standards, in particular to facilitate the identification of those components and materials which are suitable for reuse and recovery.2.Not later than21October2001the Commission shall,in accordance with the procedure laid down in Article11estab-lish the standards referred to in paragraph1of this Article.In so doing,the Commission shall take account of the work going on in this area in the relevant international forums and contri-bute to this work as appropriate.3.Member States shall take the necessary measures to ensure that producers provide dismantling information for each type of new vehicle put on the market within six months after the vehicle is put on the market.This information shall identify,as far as it is needed by treatment facilities in order to comply with the provisions of this Directive,the different vehicle components and materials,and the location of all hazardous substances in the vehicles,in particular with a view to the achievement of the objectives laid down in Article7.4.Without prejudice to commercial and industrial confiden-tiality,Member States shall take the necessary measures to ensure that manufacturers of components used in vehicles make available to authorised treatment facilities,as far as it is requested by these facilities,appropriate information concerning dismantling,storage and testing of components which can be reused.Article9Reporting and information1.At three-year intervals Member States shall send a report to the Commission on the implementation of this Directive. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article6of Directive91/692/EEC(1) with a view to establishing databases on end-of life vehicles and their treatment.The report shall contain relevant information on possible changes in the structure of motor vehicle dealing and of the collection,dismantling,shredding,recovery and recycling industries,leading to any distortion of competition between or within Member States.The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report.The report shall be made to the Commission within nine months of the end of the three-year period covered by it.The first report shall cover the period of three years from21 April2002.Based on the above information,the Commission shall publish a report on the implementation of this Directive within nine months of receiving the reports from the Member States.2.Member States shall require in each case the relevant economic operators to publish information on:—the design of vehicles and their components with a view to their recoverability and recyclability,—the environmentally sound treatment of end-of life vehicles, in particular the removal of all fluids and dismantling,—the development and optimisation of ways to reuse,recycle and recover end-of life vehicles and their components,—the progress achieved with regard to recovery and recycling to reduce the waste to be disposed of and to increase the recovery and recycling rates.The producer must make this information accessible to the prospective buyers of vehicles.It shall be included in promo-tional literature used in the marketing of the new vehicle.Article10Implementation1.Member States shall bring into force the laws,regulations and administrative provisions necessary to comply with this Directive by21April2002.They shall immediately inform the Commission thereof.When Member States adopt these measures,these shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication.The methods of making such a reference shall be laid down by Member States.2.Member States shall communicate to the Commission the text of the main provisions of domestic law,which they adopt in the field governed by this Directive.3.Provided that the objectives set out in this Directive are achieved,Member States may transpose the provisions set out in Articles4(1),5(1),7(1),8(1),8(3)and9(2)and specify the detailed rules of implementation of Article5(4)by means of agreements between the competent authorities and the economic sectors concerned.Such agreements shall meet the following requirements(a)agreements shall be enforceable;(b)agreements need to specify objectives with the corre-sponding deadlines;(c)agreements shall be published in the national officialjournal or an official document equally accessible to the public and transmitted to the Commission;(d)the results achieved under an agreement shall be monitoredregularly,reported to the competent authorities and to the Commission and made available to the public under the conditions set out in the agreement;(e)the competent authorities shall make provisions to examinethe progress reached under an agreement;(1)OJ L377,31.12.1991,p.48.。
[机械仪表]欧盟环保法规介绍
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1. On waste electrical and electronic equipment (WEEE) 2002/96/EC 2. On the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) 2002/95/EC
國大會中通過）
1993年12月29日
禁止有害廢棄物越境移動及規範在 國內處理的原則
生物多樣性的保育與其成分的永續 利用
減少溫室效應氣體排放 (管制氣體包括：CO2、CH4、N2O
、HFCS、PFCS、SF6 )
鹿特丹公約
斯德哥爾摩公約
Feb. 23, 2005
1998年9月 2001年5月
2003年
Feb. 23, 2005
16
8
Feb 23, 2005
第二條：適用範圍
大型家電用品 小型家電用品 資訊及電訊設備 消費性設備 照明設備 電動工具 玩具、娛樂運動器材 自動販賣機
Feb. 23, 2005
17
第四條：防止
從 2006 年 7 月 1 日起，所有進入歐洲市場的電 子和電器產品不能含有下列六大類的危害物質 並要展示相應的證明文件。
Feb. 23, 2005
6
3
Feb 23, 2005
歐盟含鎘量指令
指令要求：91/338/EEC 限值: 100 ppm 公告之測試方法:
• X-Ray Fluorescence ( NITON 700 XRF ) • EN 1122 (塑膠中鎘含量測定之方法) • 中子活化法
EC1935-2004食品接触类原料和制品[欧盟]1935-2004指令-中英文整理版
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REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 27 October 2004on materials and articles intended to come into contact with food and repealing Directives80/590/EECand 89/109/EEC2004年10月27日发布关于食品接触类原料和物料的欧盟1935/2004指令，同时撤销原欧洲共同体80/590和89/109指令THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEANUNION,欧洲议会与理事会Having regard to the Treaty establishing the European Community,and in particular Article 95 thereof,注意到建立欧洲共同体的《条约》，特别是第95条Having regard to the proposal from the Commission, 注意到委员会的提案Having regard to the opinion of the European Economic andSocial Committee (1),注意到欧洲经济和社会委员会的意见（1）Acting in accordance with the procedure laid down in Article 251of the Treaty (2),按照《条约》第251条规定的程序（2）Whereas:鉴于(1) Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (3) established general principles for eliminating the differences between the laws of the Member States as regards those materials and articles and provided for the adoption of implementing directives concerning specific groups of materials and articles (specific directives). This approach was successful and should be continued.理事会1988年12月21日的指令89 /109 /EEC关于统一各成员国材料和制品用于接触食品的法律，为消除各成员国关于这些原料和物料制定的差异，以及为特定材料和物品（具体指令）提供通过执行的指令而建立的一般原则。
2005[1].747.EC 中英文
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COMMISSION DECISIONof 21 October 2005amending for the purposes of adapting to technical progress the Annex to Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment(notified under document number C(2005) 4054)(Text with EEA relevance)(2005/747/EC)欧盟委员会于2005年10月21日为了适应技术发展，针对指令2002/95/EC附录关于欧盟议会和欧盟理事会在电气电子设备中限制使用某些有害物质进行修改的决定。
THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(b) thereof, Whereas:欧洲共同体委员会，注意到成立欧洲共同体的条约，注意到欧洲议会和欧盟理事会2003年1月27日第2002/95/EC 号关于在电气电子设备（1）中限制使用某些有害物质指令，特别是其中第5(1)(b)条，鉴于：(1) In accordance with Directive 2002/95/EC the Commission is required to evaluate certain hazardous substances prohibited pursuant to Article 4(1) of that Directive.(1)遵照第2002/95/EC号指令，欧盟委员会需要对指令第4（1）条所禁令的某些有害物质进行评估。
EC_882_2004 确保所执行的官方控制符合饲料和食品法规以及动物卫生和动物福利规则
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents ►B ►C1 REGULATION (EC) No 882/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 29 April 2004on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules ◄ (OJ L 165, 30.4.2004, p. 1)Amended by:Official Journal No page date ►M1 Commission Regulation (EC) No 776/2006 of 23 May 2006 L136 3 24.5.2006 ►M2 Council Regulation (EC) No 1791/2006 of 20 November 2006 L363 1 20.12.2006 ►M3 Commission Regulation (EC) No 180/2008 of 28 February 2008 L56 4 29.2.2008 ►M4 Council Regulation (EC) No 301/2008 of 17 March 2008 L97 85 9.4.2008 ►M5 Commission Regulation (EC) No 737/2008 of 28 July 2008 L201 29 30.7.2008 ►M6 Commission Regulation (EC) No 1029/2008 of 20 October 2008 L278 6 21.10.2008 ►M7 Regulation (EC) No 596/2009 of the European Parliament and of theCouncil of 18 June 2009 L 188 14 18.7.2009 ►M8 Commission Regulation (EU) No 87/2011 of 2 February 2011 L29 1 3.2.2011 ►M9 Commission Regulation (EU) No 208/2011 of 2 March 2011 L58 29 3.3.2011 ►M10 amended by Commission Regulation (EU) No 880/2011 of 2September 2011 L 228 8 3.9.2011 ►M11 Commission Regulation (EU) No 563/2012 of 27 June 2012 L 168 24 28.6.2012Corrected by: ►C1 Corrigendum, OJ L 191, 28.5.2004, p. 1 (882/2004)▼C1REGULATION (EC) No 882/2004 OF THE EUROPEANPARLIAMENT AND OF THE COUNCILof 29 April 2004on official controls performed to ensure the verification of compliance with feed and food law, animal health and animalwelfare rulesTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and 152(4)(b) thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and SocialCommittee ( 1), Having regard to the opinion of the Committee of the Regions ( 2), Acting in accordance with the procedure laid down in Article 251 of theTreaty ( 3), Whereas:(1) Feed and food should be safe and wholesome. Community legis lation comprises a set of rules to ensure that this objective is attained. These rules extend to the production and the placing on the market of both feed and food.(2) Thebasic rules with regard to feed and food law are laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general prin ciples and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters offood safety ( 4). (3) Inaddition to those basic rules, more specific feed and food law covers different areas such as animal nutrition including medicated feedingstuffs, feed and food hygiene, zoonoses, animal by-products, residues and contaminants, control and eradi cation of animal diseases with a public health impact, feed and food labelling, pesticides, feed and food additives, vitamins, mineral salts, trace elements and other additives, materials in contact with food, quality and compositional requirements, drinking water, ionisation, novel foods and genetically modified organisms (GMOs). ( 1 ) OJ C 234, 30.9.2003, p. 25. (2 ) OJ C 23, 27.1.2004, p. 14.(4) Communityfeed and food law is based on the principle that feed and food business operators at all stages of production, processing and distribution within the businesses under their control are responsible for ensuring that feed and food satisfy the requirements of feed and food law which are relevant to their activities.(5) Animalhealth and animal welfare are important factors that contribute to the quality and safety of food, to the prevention of the spreading of animal diseases and to a humane treatment of animals. The rules covering these matters are laid down in several acts. These acts specify the obligations of natural and legal persons with regard to animal health and animal welfare as well as the duties of the competent authorities.(6) TheMember States should enforce feed and food law, animal heath and animal welfare rules and monitor and verify that the relevant requirements thereof are fulfilled by business operators at all stages of production, processing and distribution. Official controls should be organised for that purpose.(7) Itis therefore appropriate to establish at Community level a harmonised framework of general rules for the organisation of such controls. It is appropriate to assess in the light of experience whether such a general framework functions properly, in particular in the area of animal health and welfare. It is therefore appropriate for the Commission to present a report together with any necessary proposal.(8) As a general rule this Community framework should not includeofficial controls with regard to organisms harmful to plants and plant products since these controls are already adequately covered by Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against theirspread within the Community ( 1). Certain aspects of this Regu lation should however also apply to the plant health sector and in particular those concerning the establishment of multiannual national control plans and Community inspections within the Member States and in third countries. It is therefore appropriate to amend Directive 2000/29/EC accordingly.(9) Council Regulations (EEC) No 2092/91 of 24 June 1991 onorganic production of agricultural products and indications referring thereto on agricultural products andfoodstuffs ( 2), (EEC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations oforigin for agricultural products and foodstuffs (1), and (EEC)No 2082/92 of 14 July 1992 on certificates of specific character for agricultural products and foodstuffs (2) containspecific measures for the verification of compliance with therequirements contained therein. The requirements of this Regulation should be flexible enough so as to take account of thespecificity of these areas.(10)For the verification of compliance with the rules on the commonorganisation of the markets of agricultural products (arable crops,wine, olive oil, fruit and vegetables, hops, milk and milkproducts, beef and veal, sheepmeat and goatmeat and honey) awell established and specific control system is already in place.This Regulation should therefore not apply to these areas, all themore since the objectives of this Regulation differ from theobjectives pursued by the control mechanisms for the commonorganisation of the markets of agricultural products.(11) The competent authorities for performing official controls shouldmeet a number of operational criteria so as to ensure their impartiality and effectiveness. They should have a sufficient number ofsuitably qualified and experienced staff and possess adequatefacilities and equipment to carry out their duties properly.(12) The official controls should be carried out using appropriate techniques developed for that purpose, including routine surveillancechecks and more intensive controls such as inspections, verifications, audits, sampling and the testing of samples. The correctimplementation of those techniques requires appropriate trainingof the staff performing official controls. Training is also requiredin order to ensure that the competent authorities take decisions ina uniform way, in particular with regard to the implementation ofthe hazard analysis and critical control points (HACCP) principles.(13) The frequency of official controls should be regular and proportionate to the risk, taking into account the results of the checkscarried out by feed and food business operators under HACCPbased control programmes or quality assurance programmes,where such programmes are designed to meet requirements offeed and food law, animal health and animal welfare rules. Adhoc controls should be carried out in case of suspicion ofnon-compliance. Additionally ad hoc controls could be carriedout at any time, even where there is no suspicion of non-compliance.(14) Official controls should take place on the basis of documentedprocedures so as to ensure that these controls are carried outuniformly and are of a consistently high quality.(15) The competent authorities should ensure that where differentcontrol units are involved in carrying out official controls, appropriate coordination procedures are in place and effectively implemented.(16) The competent authorities should also ensure that, where thecompetence to carry out official controls has been delegatedfrom the central level to a regional or local level, there iseffective and efficient coordination between the central leveland that regional or local level.(17)Laboratories involved in the analysis of official samples shouldwork in accordance with internationally approved procedures orcriteria-based performance standards and use methods of analysisthat have, as far as possible, been validated. Such laboratoriesshould in particular have equipment that enables the correct determination of standards such as maximum residue levels fixed byCommunity law.(18) The designation of Community and national reference laboratories should contribute to a high quality and uniformity ofanalytical results. This objective can be achieved by activitiessuch as the application of validated analytical methods, ensuring that reference materials are available, the organisationof comparative testing and the training of staff from laboratories.(19) The activities of reference laboratories should cover all the areasof feed and food law and animal health, in particular those areaswhere there is a need for precise analytical and diagnostic results.(20) For a number of activities related to official controls, theEuropean Committee for Standardisation (CEN) has developedEuropean standards (EN standards) appropriate for the purposeof this Regulation. These EN standards relate in particular to theoperation and assessment of testing laboratories and to theoperation and accreditation of control bodies. International standards have also been drawn up by the International Organisation for Standardisation (ISO) and the International Union ofPure and Applied Chemistry (IUPAC). These standards might, incertain well defined cases, be appropriate for the purposes of thisRegulation, taking into account that performance criteria are laiddown in feed and food law in order to ensure flexibility and costeffectiveness.(21)Provision should be made for delegating competence forperforming specific control tasks from the competent authorityto a control body, and for the conditions under which such delegation can take place.(22) Appropriate procedures should be available for the cooperation ofthe competent authorities in and between the Member States, inparticular when official controls reveal that feed and foodproblems extend to more than one Member State. In order tofacilitate such cooperation, Member States should designate oneor more liaison bodies with the role of coordinating the transmission and reception of requests for assistance.(23)In accordance with Article 50 of Regulation (EC) No 178/2002,(24) It is important to create uniform procedures for the control offeed and food from third countries introduced into the territory ofthe Community, taking into account that harmonised importprocedures have already been established for food of animalorigin by virtue of Council Directive 97/78/EC (1), and for liveanimals by virtue of Council Directive 91/496/EEC (2).These existing procedures function properly and should be maintained.(25) The checks on feed and food from third countries referred to inDirective 97/78/EC are limited to veterinary aspects. It isnecessary to supplement these checks with official controls onaspects that are not covered by veterinary checks, such as thoseon additives, labelling, traceability, irradiation of food andmaterials in contact with food.(26)Community legislation also provides for procedures for thecontrol of imported feed by virtue of Council Directive 95/53/EC of 25 October 1995 fixing the principles governingthe organisation of official inspections in the field of animalnutrition (3). That Directive contains principles and proceduresthat must be applied by the Member States when releasingimported feed for free circulation.(27)It is appropriate to establish Community rules in order to ensurethat feed and food from third countries is submitted to officialcontrols before release for free circulation in the Community.Special attention should be paid to import controls of feed andfood for which there may be an increased risk of contamination.(28) Provision should also be made for the organisation of officialcontrols of feed and food that is introduced into the territory ofthe Community under customs procedures other than free circulation, and in particular those introduced under the customsprocedures referred to in points (b) to (f) of Article 4(16) ofCouncil Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (4), as well as their entryinto a free zone or free warehouse. This includes the introductionof feed and food from third countries by passengers of international means of transport and through parcels sent by mail.(1) Council Directive 97/78/EC of 18 December 1997 laying down the principlesgoverning the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).(2) Council Directive 91/496/EEC of 15 July 1991 laying down the principlesgoverning the organisation of veterinary checks on animals entering the Community from third countries (OJ L 268, 24.9.1991, p. 56). Directive as last amended by Directive 96/43/EC (OJ L 162, 1.7.1996, p. 1).(3) OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive2001/46/EC of the European Parliament and of the Council (OJ L 234,(29) For the purpose of official controls on feed and food, it isnecessary to define the territory of the Community in whichthe rules apply in order to ensure that feed and food that isintroduced into this territory is submitted to the controls laiddown by this Regulation. This territory is not necessarily thesame as provided for in Article 299 of the Treaty, or asdefined in Article 3 of Regulation (EEC) No 2913/92.(30)In order to ensure a more efficient organisation of the officialcontrols on feed and food from third countries and in order tofacilitate commercial flows, it may be necessary to designatespecific points of entry for feed and food from third countriesinto the territory of the Community. Likewise, it may benecessary to require prior notification of the arrival of goods atthe territory of the Community. It should be ensured that eachdesignated point of entry has access to the appropriate facilities tooperate controls within reasonable time limits.(31)In establishing rules on the official controls of feed and foodfrom third countries, it should be ensured that the competentauthorities and the customs services work together, taking intoaccount the fact that rules to that effect already exist in CouncilRegulation (EEC) No 339/93 of 8 February 1993 on checks forconformity with the rules on product safety in the case ofproducts imported from third countries (1).(32) Adequate financial resources should be available for organisingofficial controls. Hence, the competent authorities of the MemberStates should be able to levy the fees or charges to cover thecosts incurred through official controls. In the process, thecompetent authorities of the Member States will be at liberty toestablish the fees and charges as flat-rate amounts based on thecosts incurred and taking the specific situation of the establishments into account. Where fees are imposed on operators,common principles should apply. It is appropriate therefore tolay down the criteria for setting the level of inspection fees.With regard to fees applicable for import controls, it is appropriate to establish directly the rates for main import items with aview to ensuring their uniform application and to avoiding tradedistortions.(33) Community feed and food law provides for the registration orapproval of certain feed and food businesses by the competentauthority. This is particularly the case in Regulation (EC)No 852/2004 of the European Parliament and of the Council of29 April 2004 on the hygiene of foodstuffs (2), Regulation (EC)No 853/2004 of the European Parliament and of the Council of29 April 2004 laying down specific hygiene rules for food ofanimal origin (2), Council Directive 95/69/EC of 22 December1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (3) and the futureregulation on feed hygiene.(1) OJ L 40, 17.2.1993, p. 1. Regulation as last amended by Regulation (EC)Procedures should be put in place in order to ensure that registration and approval of feed and food businesses are carried outin an effective and transparent way.(34) In order to have a global and uniform approach with regard toofficial controls, Member States should establish and implementmultiannual national control plans in accordance with broadguidelines drawn up at Community level. These guidelinesshould promote coherent national strategies, and identify risk-based priorities and the most effective control procedures.A Community strategy should take a comprehensive, integratedapproach to the operation of controls. In view of the non-bindingcharacter of certain technical guidelines to be established it isappropriate to establish them by means of a consultative Committee procedure.(35) The multiannual national control plans should cover feed andfood law, and the legislation on animal health and animalwelfare.(36) The multiannual national control plans should establish a solidbasis for the Commission inspection services to carry out controlsin the Member States. The control plans should enable theCommission inspection services to verify whether the officialcontrols in the Member States are organised in accordance withthe criteria laid down in this Regulation. Where appropriate and,in particular, where the audit of the Member States against themultiannual national control plans shows weaknesses or failures,detailed inspections and audits should be carried out.(37)Member States should be required to present an annual report tothe Commission with information on the implementation of themultiannual national control plans. This report should provide theresults of the official controls and audits carried out during theprevious year and, where necessary, an update of the initialcontrol plan in response to these results.(38) Community controls in the Member States should allow theCommission control services to verify whether feed and foodlaw and the legislation on animal health and animal welfare areimplemented in a uniform and correct way throughout theCommunity.(39)Community controls in third countries are required in order toverify compliance or equivalence with Community feed and foodlaw as well as with the legislation on animal health and, whereappropriate, welfare. Third countries may also be requested toprovide information on their control systems. This information,which should be established on the basis of Community guidelines, should form the basis for subsequent Commissioncontrols, which should be carried out within a multidisciplinary(40) In order to ensure that imported goods comply with or areequivalent to Community feed and food law, it is necessary toestablish procedures that allow the definition of import conditionsand certification requirements as appropriate.(41)Breaches of feed and food law and of animal health and animalwelfare rules may constitute a threat to human health, animalhealth, and animal welfare. Such breaches should therefore besubject to effective, dissuasive and proportionate measures atnational level throughout the Community.(42) Such measures should include administrative action by thecompetent authorities in the Member States who should haveprocedures in place for that purpose. The advantage of suchprocedures is that quick action can be undertaken in order torestore the situation.(43) Operators should have a right to appeal against the decisionstaken by the competent authority as a result of the officialcontrols, and be informed of such a right.(44) It is appropriate to take account of the special needs ofdeveloping countries, and in particular of the least-developedcountries, and to introduce measures to that effect. TheCommission should be committed to support developingcountries with regard to feed and food safety, which is animportant element of human health and trade development.Such support should be organised in the context of theCommunity's development cooperation policy.(45) The rules contained in this Regulation underpin the integratedand horizontal approach necessary to implement a coherentcontrol policy on feed and food safety, animal health andanimal welfare. There should be room however to developspecific control rules where required, for example with regardto the setting of maximum residue levels for certain contaminantsat Community level. Likewise, more specific rules existing in thearea of feed and food and animal health and animal welfarecontrols should be kept in place.These include in particular the following acts: Directive 96/22/EC Council Directive 96/22/EC of 29 April1996 concerning the prohibition on the use in (1),Directive 96/23/EC (2), Regulation (EC) No 854/2004 (3),(4), Regulation (EC)Regulation (EC) No 999/2001(1) stockfarming of certain substances having a hormonal or thyrostatic actionand of beta-agonists, (OJ L 125, 23.5.1996, p. 3). Directive as last amended by Directive 2003/74/EC of the European Parliament and of the Council (OJ L 262, 14.10.2003, p. 17).(2) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certainsubstances and residues thereof in live animals and animal products (OJ L 125, 23.5.1996, p. 10). Directive as last amended by Regulation (EC) No 806/2003.(3) Regulation (EC) No 854/2004 of the European Parliament and of the Councilof 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206).(4) Regulation (EC) No 999/2001 of the European Parliament and of the CouncilNo 2160/2003(1), Directive 86/362/EEC(2), Directive90/642/EEC (3) and the implementing rules resulting therefrom,Directive 92/1/EEC (4), Directive 92/2/EEC (5), and acts on thecontrol of animal diseases such as foot-and-mouth disease, swinefever etc., as well as requirements on the official controls on thewelfare of animals.(46) This Regulation covers areas that are already covered in certainacts in force at present. It is appropriate therefore to repeal inparticular the following acts on feed and food controls and toreplace them by the rules of this Regulation: Directive(7); Directive70/373/EEC (6); Directive 85/591/EEC(9); Decision89/397/EEC (8); Directive 93/99/EEC93/383/EEC (10); Directive 95/53/EC; Directive 96/43/EC (11);Decision 98/728/EC (12); and Decision 1999/313/EC (13).(1) Regulation (EC) No 2160/2003 of the European Parliament and of theCouncil of 17 November 2003 on the control of salmonella and otherfood-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1).(2) Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximumlevels for pesticide residues in and on cereals (OJ L 221, 7.8.1986, p. 37).Directive as last amended by Commission Directive 2004/2/EC (OJ L 14,21.1.2004, p. 10).(3) Council Directive 90/642/EEC of 27 November 1990 on the fixing ofmaximum levels for pesticide residues in and on certain products of plantorigin, including fruit and vegetables (OJ L 350, 14.12.1990, p. 71).Directive as last amended by Commission Directive 2004/2/EC.(4) Commission Directive 92/1/EEC of 13 January 1992 on the monitoring oftemperatures in the means of transport, warehousing and storage ofquick-frozen foodstuffs intended for human consumption (OJ L 34,11.2.1992, p. 28).(5) Commission Directive 92/2/EEC of 13 January 1992 laying down thesampling procedure and the Community method of analysis for the officialcontrol of the temperatures of quick-frozen foods intended for humanconsumption (OJ L 34, 11.2.1992, p. 30).(6) Council Directive 70/373/EEC of 20 July 1970 on the introduction ofCommunity methods of sampling and analysis for the official control offeedingstuffs (OJ L 170, 3.8.1970, p. 2). Directive as last amended byRegulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).(7) Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoringof foodstuffs intended for human consumption (OJ L 372, 31.12.1985,p. 50). Directive as last amended by Regulation (EC) No 1882/2003 ofthe European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) (8) Council Directive 89/397/EEC of 14 June 1989 on the official control offoodstuffs (OJ L 186, 30.6.1989, p. 23)(9) Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (OJ L 290,24.11.1993, p. 14). Directive as amended by Regulation (EC) No 1882/2003. (10) Council Decision 93/383/EEC of 14 June 1993 of reference laboratories forthe monitoring of marine biotoxins (OJ L 166, 8.7.1993, p. 31). Decision asamended by Decision 1999/312/EC (OJ L 120, 8.5.1999, p. 37).(11) Council Directive 96/43/EC of 26 June 1996 amending and consolidatingDirective 85/73/EEC in order to ensure financing of veterinary inspectionsand controls on live animals and certain animal products (OJ L 162,1.7.1996, p. 1).(12) Council Decision 98/728/EC of 14 December 1998 concerning a Community(47)In the light of this Regulation, Directives 96/23/EC, 97/78/ECand 2000/29/EC should be amended.(48) Since the objective of this Regulation, namely to ensure aharmonised approach with regard to official controls, cannot besufficiently achieved by the Member States and can therefore, byreason of its complexity, its trans-border character and, withregard to feed and food imports, its international character, bebetter achieved at Community level, the Community may adoptmeasures, in accordance with the principle of subsidiarity as setout in Article 5 of the Treaty. In accordance with the principle ofproportionality, as set out in that Article, this Regulation does notgo beyond what is necessary in order to achieve that objective.(49) The measures necessary for the implementation of this Regulationshould be adopted in accordance with Council Decision1999/468/EC of 28 June 1999 laying down the procedures forthe exercise of implementing powers conferred on theCommission (1),HAVE ADOPTED THIS REGULATION:TITLE ISUBJECT MATTER, SCOPE AND DEFINITIONSArticle 1Subject matter and scope1. This Regulation lays down general rules for the performance of official controls to verify compliance with rules aiming, in particular, at:(a) preventing, eliminating or reducing to acceptable levels risks tohumans and animals, either directly or through the environment;and(b) guaranteeing fair practices in feed and food trade and protectingconsumer interests, including feed and food labelling and other forms of consumer information.controlstheverifi2. ThisofficialforshallnotRegulationapplytocation of compliance with the rules on common market organisations of agricultural products.tospecificprejudiceCommunity Regulation3. Thiswithoutshallbeprovisions concerning official controls.4. The performance of official controls pursuant to this Regulation shall be without prejudice to feed and food business operators' primary legal responsibility for ensuring feed and food safety, as laid down in Regulation (EC) No 178/2002, and any civil or criminal liability arising from the breach of their obligations.(1) OJ L 184, 17.7.1999, p. 23.。
95_2_EC 食品添加剂的指令
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents ►B EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No 95/2/ECof 20 February 1995on food additives other than colours and sweeteners (OJ L 61, 18.3.1995, p. 1)Amended by:Official Journal No page date ►M1 Directive 96/85/EC of the European Parliament and of the Council of19 December 1996 L 86 4 28.3.1997 ►M2 Directive 98/72/EC of the European Parliament and of the Council of15 October 1998 L 295 18 4.11.1998 ►M3 Directive 2001/5/EC of the European Parliament and of the Council of12 February 2001 L 55 59 24.2.2001 ►M4 Directive 2003/52/EC of the European Parliament and of the Council of 18 June 2003L 178 23 17.7.2003 ►M5 Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003L 284 1 31.10.2003 ►M6 Directive 2003/114/EC of the European Parliament and of the Council of 22 December 2003L 24 58 29.1.2004 ►M7 Directive 2006/52/EC of the European Parliament and of the Council of 5 July 2006L 204 10 26.7.2006 ►M8 Commission Directive 2010/69/EU of 22 October 2010 L 279 22 23.10.2010Corrected by: ►C1 Corrigendum, OJ L 248, 14.10.1995, p. 60 (95/2/EC) ►C2 Corrigendum, OJ L 78, 17.3.2007, p. 32 (2006/52/EC)EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVENo 95/2/ECof 20 February 1995on food additives other than colours and sweetenersTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),Having regard to the Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (4), and in particular Article 3 (2) thereof,Whereas differences between national laws relating to preservatives, antioxidants and other additives and their conditions of use hinder the free movement of foodstuffs; whereas this may create conditions of unfair competition;Whereas the prime consideration for any rules on these food additives and their conditions of use should be the need to protect the consumer;Whereas it is generally recognized that unprocessed foodstuffs and certain other foodstuffs should be free from food additives;Whereas, having regard to the most recent scientific and toxicological information on these substances, some of them are to be permitted only for certain foodstuffs and under certain conditions of use;Whereas it is necessary to lay down strict rules for the use of food additives in infant formulae, follow-on formulae and weaning foods, as referred to in Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (5), and in particular Article 4 (1)(e) thereof;(1) OJ No C 206, 13. 8. 1992, p. 12, and OJ No C 189, 13. 7. 1993, p. 11.(2) OJ No C 108, 19. 4. 1993, p. 26.(3) Opinion of the European Parliament of 26 May 1993 (OJ No C 176, 28. 6.1993, p. 117), confirmed on 2 December 1993 (OJ No C 342, 20. 12. 1993), common position of the Council of 10 March 1994 (OJ No C 172, 24. 6.1994, p. 4) and decision of the European Parliament of 16 November 1994Whereas this Directive is not intended to affect rules relating tosweeteners and colours;Whereas, pending specific provisions pursuant to Council Directive91/414/EEC of 15 July 1991 concerning the placing of plant protectionproducts on the market (1), and pursuant to Council Directive90/642/EEC of 27 November 1990 on the fixing of maximum levelsfor pesticide residues in and on certain products of plant origin,including fruit and vegetables (2), certain substances belonging to thiscategory are provisionally covered by this Directive;Whereas the Commission is to adapt Community provisions to accordwith the rules laid down in this Directive;Whereas the Scientific Committee for Food has been consulted for thosesubstances which are not yet the subject of a Community provision;Whereas it is necessary to include in this Directive specific provisionsconcerning additives referred to in other Community provisions;Whereas it is desirable that when a decision is taken on whether aparticular foodstuff belongs to a certain category of foods, the consultation of the Standing Committee for Foodstuffs procedure is followed;Whereas modifications of existing purity criteria for food additives otherthan colours and sweeteners and new specifications for those where nopurity criteria exist will be adopted in accordance with the procedurelaid down in Article 11 of Directive 89/107/EEC;Whereas the Scientific Committee for Food has not yet given anopinion on flour treatment agents; whereas those agents will be thesubject of a separate Directive;(3),Whereas this Directive replaces Directives 64/54/EEC70/357/EEC (4), 74/329/EEC (5) and 83/463/EEC (6); whereas thoseDirectives are hereby repealed,HAVE ADOPTED THIS DIRECTIVE:Article 1▼M21. This Directive is a specific Directive forming a part of the comprehensive Directive, within the meaning of Article 3 of Directive89/107/EEC, and applies to additives other than colours and sweeteners.It does not apply to enzymes other than those mentioned in theAnnexes,(1) OJ No L 230, 19. 8. 1991, p. 1. Directive as last amended by CommissionRegulation (EEC) No 3600/92 (OJ No L 366, 15. 12. 1992, p. 10).(2) OJ No L 350, 14. 12. 1990, p. 71.(3) OJ No 12, 27. 1. 1964, p. 161/64.42. Only additives which satisfy the requirements laid down by theScientific Committee for Food may be used in foodstuffs.thisDirective:ofpurposethe3. For(a) ‘preservatives’ are substances which prolong the shelf-life offoodstuffs by protecting them against deterioration caused bymicro-organisms;(b) ‘antioxidants’ are substances which prolong the shelf-life offoodstuffs by protecting them against deterioration caused byoxidation, such as fat rancidity and colour changes;▼M7(c) ‘carriers’, including carrier solvents, are substances used todissolve, dilute, disperse or otherwise physically modify a foodadditive or flavouring without altering its function (and withoutexerting any technological effect themselves) in order to facilitateits handling, application or use;▼B(d) ‘acids’ are substances which increase the acidity of a foodstuffand/or impart a sour taste to it;(e) ‘acidity regulators’ are substances which alter or control the acidityor alkalinity of a foodstuff;(f) ‘anti-caking agents’ are substances which reduce the tendency ofindividual particles of a foodstuff to adhere to one another;(g) ‘anti-foaming agents’ are substances which prevent or reducefoaming;(h) ‘bulking agents’ are substances which contribute to the volume of afoodstuff without contributing significantly to its available energyvalue;(i) ‘emulsifiers’ are substances which make it possible to form ormaintain a homogenous mixture of two or more immisciblephases such as oil and water in a foodstuff;(j) ‘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;(k) ‘firming agents’ are substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling agents toproduce or strengthen a gel;(l) ‘flavour enhancers’ are substances which enhance the existing taste and/or odour of a foodstuff;(m) ‘foaming agents’ are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solidfoodstuff;(o) ‘glazing agents’ (including lubricants) are substances which, when applied to the external surface of a foodstuff, impart a shinyappearance or provide a protective coating;(p) ‘humectants’ are substances which prevent foodstuffs from drying out by counteracting the effect of an atmosphere having a lowdegree of humidity, or promote the dissolution of a powder in anaqueous medium;(q) ‘modified starches’ are substances obtained by one or more chemical treatments of edible starches, which may haveundergone a physical or enzymatic treatment, and may be acid oralkali thinned or bleached;(r) ‘packaging gases’ are gases other than air, introduced into a container before, during or after the placing of a foodstuff in thatcontainer;(s) ‘propellants’ are gases other than air which expel a foodstuff froma container;(t) ‘raising agents’ are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter;(u) ‘sequestrants’ are substances which form chemical complexes with metallic ions;▼M6(v) ‘stabilisers’ are substances which make it possible to maintain the physico-chemical state of a foodstuff; stabilisers include substanceswhich enable the maintenance of a homogenous dispersion of twoor more immiscible substances in a foodstuff, substances whichstabilise, retain or intensify an existing colour of a foodstuff andsubstances which increase the binding capacity of the food,including the formation of cross-links between proteins enablingthe binding of food pieces into re-constituted food;▼B(w) ‘thickeners’ are substances which increase the viscosity of a foodstuff.thanaresubstanceswhichemulsifiers4. Flourothertreatmentagentsare added to flour or dough to improve its baking quality.5. For the purposes of this Directive the following are not consideredas food additives:(a) substances used for treatment of drinking water as provided for inDirective 80/778/EEC (1);(b) products containing pectin and derived from dried apple pomace orpeel of citrus fruits, or from a mixture of both, by the action ofdilute acid followed by partial neutralization with sodium orpotassium salts (‘liquid pectin’);(c) chewing gum bases;(d) white or yellow dextrin, roasted or dextrinated starch, starchmodified by acid or alkali treatment, bleached starch, physicallymodified starch and starch treated by amylolitic enzymes;(e) ammonium chloride;(f) blood plasma, edible gelatin, protein hydrolysates and their salts,milk protein and gluten;(g) amino acids and their salts other than glutamic acid, glycine,cysteine and cystine and their salts and having no additive function;(h) caseinates and casein;(i) inulin.Article 2▼M21. Only substances listed in Annexes I, III, IV and V may be used infoodstuffs for the purposes mentioned in Article 1(3) and Article 1(4),2. Food additives listed in Annex I are permitted in foodstuffs, forthe purposes mentioned in Article 1(3) and Article 1(4), with theexception of those foodstuffs listed in Annex II, following the‘quantum satis’ principle,▼B3. Except where specifically provided for, paragraph 2 does notapply to:(a) — unprocessed foodstuffs,— honey as defined in Directive 74/409/EEC (1)— non-emulsified oils and fats of animal or vegetable origin,— butter,▼M2— pasteurised and sterilised (including UHT) milk (including plain, skimmed and semi-skimmed) and plain pasteurised cream,▼B— unflavoured, live fermented milk products,— natural mineral water as defined in Directive 80/777/EEC (2) and spring water,— coffee (excluding flavoured instant coffee) and coffee extracts,— unflavoured leaf tea,— sugars as defined in Directive 73/437/EEC (1),▼M2— dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets, in accordance with Directive 89/398/EEC,▼B— natural unflavoured buttermilk (excluding sterilized buttermilk).Within the meaning of this Directive, the term ‘unprocessed’ meansnot having undergone any treatment resulting in a substantialchange in the original state of the foodstuffs; however, thefoodstuffs may have been, for example, divided, parted, severed,boned, minced, skinned, pared, peeled, ground, cut, cleaned,trimmed, deep-frozen or frozen, chilled, milled or husked, packedor unpacked;(b) foods for infants and young children as referred to in Directive89/398/EEC, including foods for infants and young children notin good health; these foodstuffs are subject to the provisions ofAnnex VI;(c) the foodstuffs listed in Annex II, which may contain only thoseadditives referred to in that Annex and those additives referred toin Annexes III and IV under the conditions specified therein.4. Additives listed in Annexes III and IV may only be used in thefoodstuffs referred to in those Annexes and under the conditionsspecified therein.5. Only those additives listed in Annex V may be used as carriers orcarrier solvents for food additives and must be used under theconditions specified therein.6. The provisions of this Directive shall also apply to the corresponding foodstuffs intended for particular nutritional uses inaccordance with Directive 89/398/EEC.7. Maximum levels indicated in the Annexes refer to foodstuffs asmarketed, unless otherwise stated.8. In the Annexes to this Directive, ‘quantum satis’ means that nomaximum level is specified. However, additives shall be used inaccordance with good manufacturing practice, at a level not higherthan is necessary to achieve the intended purpose and provided thatthey do not mislead the consumer.Article 3▼M6additivepermissible:isfoodapresence1. Theof(a) in a compound foodstuff other than one mentioned in Article 2(3),to the extent to which the food additive is permitted in one of theingredients of the compound foodstuff;(b) in a foodstuff where a flavouring has been added, to the extent towhich the food additive is permitted in the flavouring in compliancewith this Directive and has been carried over to the foodstuff via theflavouring, provided the food additive has no technological functionin the final foodstuff; or(c) if the foodstuff is destined to be used solely in the preparation of acompound foodstuff and to an extent such that the compoundfoodstuff conforms to the provisions of this Directive.▼Binfantformulae,formulaefollow-onto2. Paragraphapply1doesnotand►M7 processed cereal-based foods and baby foods ◄, as referred▼M63. The level of additives in flavourings shall be limited to theminimum necessary to guarantee the safety and quality of flavouringsand to facilitate their storage. Furthermore, the presence of additives inflavourings must not mislead consumers or present a hazard to theirhealth. If the presence of an additive in a foodstuff, as a consequence ofadding flavourings, has a technological function in the foodstuff, it shallbe considered as an additive of the foodstuff and not as an additive ofthe flavouring.▼BArticle 4This Directive shall apply without prejudice to specific Directivespermitting additives listed in the Annexes to be used as sweeteners orcolours.Article 5Where necessary, it may be decided by the procedure laid down inArticle 6 of this Directive:— whether a particular foodstuff not categorized at the moment this Directive was adopted belongs to a category of foodstuffs referred toin Article 2 or in one of the Annexes, or— whether a food additive listed in the Annexes and authorized at ‘quantum satis’ is used in accordance with the criteria referred toin Article 2, or— whether a substance is a food additive within the meaning of Article 1.▼M5Article 6theStandingCommitteeonbyassisted1. ThebeCommissionshallthe Food Chain and Animal Health, set up by Article 58 of Regulation(EC) No 178/2002 (1), hereinafter referred to as ‘the Committee’.2. Where reference is made to this Article, Articles 5 and 7 ofDecision 1999/468/EC (1) shall apply, having regard to the provisionsof Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall beset at three months.rulesprocedure.itsofadoptCommittee3. Theshall▼BArticle 7Member States shall, within three years of the entry into force of thisDirective, establish systems to monitor the consumption and use of foodadditives and report their findings to the Commission.The Commission shall report to the European Parliament and theCouncil within five years of the entry into force of this Directive onthe changes which have taken place in the food additives market, thelevels of use and consumption.In accordance with the general criteria in point 4 of Annex II toDirective 89/107/EEC, within five years of the entry into force of thisDirective, the Commission shall review the conditions of use referred toin this Directive, and propose amendments where necessary.Article 8and83/463/EEC74/329/EEC70/357/EEC,1. Directives64/54/EEC,are hereby repealed.2. References to these repealed Directives and to the purity criteriafor certain food additives referred to in them shall henceforth beconstrued as references to this Directive.Article 9Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than25 September 1996 in order to:— allow, by 25 September 1996 at the latest, trade in and use of products conforming to this Directive,— prohibit by 25 March 1997 at the latest, trade in and use of products not conforming to this Directive; products put on the market orlabelled before that date which do not comply with this Directivemay, however, be marketed until stocks are exhausted.They shall forthwith inform the Commission thereof.1When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.Article 10This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities.Article 11This Directive is addressed to the Member States.ANNEX IFOOD ADDITIVES GENERALLY PERMITTED FOR USE IN FOODSTUFFS NOT REFERRED TO IN ARTICLE 2 (3) Note1. Substances on this list may be added to all foodstuffs with the exception ofthose referred to in Article 2 (3) following the quantum satis principle.▼M62. The substances listed under numbers E 407, E 407a and E 440 may bestandardised with sugars, on condition that this is stated in addition to thenumber and designation.▼B3. Explanation of symbols used:* The substances E 290, E 938, E 939, E 941, E 942, E 948 and►M3 E949 ◄ may also be used in the foodstuffs referred to in Article 2 (3).# The substances E 410, E 412, E 415 and E 417 may not be used toproduce dehydrated foodstuffs intended to rehydrate on ingestion.▼M74. The substances listed under numbers E 400, E 401, E 402, E 403, E 404, E406, E 407, E 407a, E 410, E 412, E 413, E 414, E 415, E 417, E 418 and E440 may not be used in jelly mini-cups, defined, for the purpose of thisDirective, as jelly confectionery of a firm consistence, contained in semi-rigid mini-cups or mini-capsules, intended to be ingested in a single bite byexerting pressure on the mini-cups or mini-capsule to project the confectionery into the mouth.▼B▼M6▼B▼M1▼M7▼B▼M6▼M2▼M6▼B▼M2▼M3▼M2▼B▼M2(1) May be used only as a flour treatment agent.ANNEX IIFOODSTUFFS IN WHICH A LIMITED NUMBER OF ADDITIVES OF ANNEX I MAY BEUSED▼M6▼B▼M2▼B▼B▼B▼B ▼M6▼B▼M2▼B▼B▼M2▼M8▼B(1) OJ No L 228, 16. 8. 1973, p. 23.Cocoa and chocolate products energy-reduced or with no added sugars are not covered by Annex II.(2) OJ No L 244, 30. 9. 1993, p. 23.(3) OJ No L 205, 13. 8. 1979, p. 5.(4) OJ No L 24, 30. 1. 1976, p. 49.(5) OJ No L 84, 27. 3. 1987, p. 1.(6) OJ No L 373, 31. 12. 1988, p. 59.(7) OJ No L 231, 13. 8. 1992, p. 1.(8) OJ No L 176, 3. 7. 1984, p. 6.ANNEX IIICONDITIONALLY PERMITTED PRESERVATIVES ANDANTIOXIDANTSPART ASorbates, benzoates and p-hydroxybenzoates▼M7▼B(1) Benzoic acid may be present in certain fermented products resulting from the fermentation process following good manufacturing practice.Note1. The levels of all substances mentioned above are expressed as the free acid.2. The abbreviations used in the table mean the following:— Sa + Ba: Sa and Ba used singly or in combination— Sa + PHB: Sa and PHB used singly or in combination— Sa + Ba + PHB: Sa, Ba and PHB used singly or in combination.3. The maximum levels of use indicated refer to foodstuffs ready forconsumption prepared following manufacturers' instructions.▼M2▼B▼M7▼B▼B▼M2▼M7▼M6▼M7▼M8▼B( 1 ) This entry does not include dairy-based drinks. ( 2 ) OJ No L 84, 27. 3. 1987, p. 1. ( 3) OJ No L 186, 30. 6. 1989, p. 27. ►M7 ( 4 ) Directive 2002/46/EC of the European Parliament and of the Council (OJ L 183, 12.7.2002, p. 51). ◄ ►M7 ( 5) Commission Directive 1999/21/EC (OJ L 91, 7.4.1999, p. 29). ◄ PART BSulphur dioxide and sulphitesNote1. Maximum levels are expressed as SO 2 in mg/kg or mg/l as appropriate andrelate to the total quantity, available from all sources. 2. An SO 2 content of not more than 10 mg/kg or 10 mg/l is not considered tobe present.▼B▼B▼M7▼M8▼B(1) In edible parts.PART COther preservatives▼M2▼M8▼B▼M8▼B►M8(1) This substance may be present in certain cheeses as a result of fermentation process. ◄(a) When labelled ‘for food use’, nitrite may be sold only in a mixture with salt or a salt substitute.(b) Fo-value 3 is equivalent to 3 minutes heating at 121o C (reduction of the bacterial load of one billion spores in each 1 000 cans toone spore in a thousand cans).(c) Nitrates may be present in some heat-treated meat products resulting from natural conversion of nitrites to nitrates in a low-acidenvironment.1 Meat products are immersed in curing solution containing nitrites and/or nitrates, salt and other components. The meat products mayundergo further treatments e.g. smoking.1.1 Meat is injected with curing solution followed by immersion curing for 3 to 10 days. The immersion brine solution also includesmicrobiological starter cultures.1.2 Immersion cured for 3 to 5 days. Product is not heat-treated and has a high water activity.1.3 Immersion cured for at least4 days and pre-cooked.1.4 Meat is injected with curing solution followed by immersion curing. Curing time is 14 to 21 days followed by maturation in cold-smoke for 4 to 5 weeks.1.5 Immersion cured for 4 to 5 days at 5 to 7o C, matured for typically 24 to 40 hours at 22o C, possibly smoked for 24 hrs at 20 to 25o Cand stored for 3 to 6 weeks at 12 to 14o C.1.6 Curing time depending on the shape and weight of meat pieces for approximately 2 days/kg followed by stabilisation/maturation.2 Dry curing process involves dry application of curing mixture containing nitrites and/or nitrates, salt and other components to thesurface of the meat followed by a period of stabilisation/maturation. The meat products may undergo further treatments e.g. smoking.2.1 Dry curing followed by maturation for at least 4 days.2.2 Dry curing with a stabilisation period of at least 10 days and a maturation period of more than 45 days.2.3 Dry cured for 10 to 15 days followed by a 30 to 45 day stabilisation period and a maturation period of at least 2 months.2.4 Dry cured for 3 days + 1 day/kg followed by a 1 week post-salting period and an ageing/ripening period of 45 days to 18 months.2.5 Curing time depending on the shape and weight of meat pieces for approximately 10 to 14 days followed by stabilisation/maturation.3 Immersion and dry cured processes used in combination or where nitrite and/or nitrate is included in a compound product or wherethe curing solution is injected into the product prior to cooking. The products may undergo further treatments e.g. smoking.3.1 Dry curing and immersion curing used in combination (without injection of curing solution). Curing time depending on the shape andweight of meat pieces for approximately 14 to 35 days followed by stabilisation/maturation.3.2 Injection of curing solution followed, after a minimum of 2 days, by cooking in boiling water for up to 3 hours.3.3 Product has a minimum 4-week maturation period and a water/protein ratio of less than 1,7.3.4 Maturation period of at least 30 days.3.5 Dried product cooked to 70o C followed by 8 to 12 day drying and smoking process. Fermented product subject to 14 to 30 daythree-stage fermentation process followed by smoking.3.6 Raw fermented dried sausage without added nitrites. Product is fermented at temperatures in the range of 18 to 22o C or lower (10 to12o C) and then has a minimum ageing/ripening period of 3 weeks. Product has a water/protein ratio of less than 1,7.▼M2▼B▼M6▼B(1) Propionic acid and its salts may be present in certain fermented products resulting from the fermentation process following goodmanufacturing practice.►M6(2) Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (OJ L 179,14.7.1999, p.1). Regulation as last amended by Commission Regulation (EC) No 1795/2003 (OJ L 262, 14.10.2003, p. 1).(3) Commission Regulation (EC) No 1622/2000 of 24 July 2000 laying down certain detailed rules for implementing Regulation (EC) No1493/1999 on the common organisation of the market in wine and establishing a Community code of oenological practices andprocesses (OJ L 194, 31.7.2000, p.1). Regulation as last amended by Regulation (EC) No 1410/2003 (OJ L 201, 8.8.2003, p. 9). ◄PART DOther antioxidantsNote►M7The * in the table refers to the proportionality rule: when combinations of gallates, TBHQ, BHA and BHT are used, the individual levels must be reduced proportionally. ◄▼M7▼C2▼B▼M7ANNEX IVOTHER PERMITTED ADDITIVESThe maximum levels of use indicated refer to foodstuffs ready for consumption prepared following manufacturers' instructions.▼M2▼B▼M2▼M2▼M6▼M2▼B▼M7▼B▼M7▼M8。
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Thisdocumentismeantpurelyasdocumentationtoolandtheinstitutionsdonotassumeanyliabilityforitscontents"B
COUNCILDIRECTIVE
of15July1975onwaste
(75/442/EEC)(OJL194,25.7.1975,p.39)
Amendedby:OfficialJournalNopagedate
"M1
CouncilDirective91/156/EECof18March1991L783226.3.1991
"M2
CouncilDirective91/692/EECof23December1991L3774831.12.1991
"M3
CommissionDecision96/350/ECof24May1996L135326.6.1996
1975L0442—EN—28.05.1996—003.001—1COUNCILDIRECTIVEof15July1975onwaste
(75/442/EEC)
THECOUNCILOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanEconomicCommunity,andinparticularArticles100and235thereof;
HavingregardtotheproposalfromtheCommission;HavingregardtotheOpinionoftheEuropeanParliament(1);
HavingregardtotheOpinionoftheEconomicandSocialCommittee(2);WhereasanydisparitybetweentheprovisionsonwastedisposalalreadyapplicableorinpreparationinthevariousMemberStatesmaycreateunequalconditionsofcompetitionandthusdirectlyaffectthefunctioningofthecommonmarket;whereasitisthereforenecessarytoapproximatelawsinthisfield,asprovidedforinArticle100oftheTreaty;
WhereasitseemsnecessaryforthisapproximationoflawstobeaccompaniedbyCommunityactionsothatoneoftheaimsoftheCommunityinthesphereofprotectionoftheenvironmentandimprovementofthequalityoflifecanbeachievedbymoreextensiverules;whereascertainspecificprovisionstothiseffectshouldthereforebelaiddown;whereasArticle235oftheTreatyshouldbeinvokedasthepowersrequiredforthispurposehavenotbeenprovidedforbytheTreaty;
Whereastheessentialobjectiveofallprovisionsrelatingtowastedisposalmustbetheprotectionofhumanhealthandtheenvironmentagainstharmfuleffectscausedbythecollection,transport,treatment,storageandtippingofwaste;
Whereastherecoveryofwasteandtheuseofrecoveredmaterialsshouldbeencouragedinordertoconservenaturalresources;
WhereastheprogrammeofactionoftheEuropeanCommunitiesontheenvironment(3),stressestheneedforCommunityaction,includingthe
harmonizationoflegislation;
Whereaseffectiveandconsistentregulationsonwastedisposalwhichneitherobstructintra-Communitytradenoraffectconditionsofcompetitionshouldbeappliedtomovablepropertywhichtheownerdisposesoforisrequiredtodisposeofundertheprovisionsofnationallawinforce,withtheexceptionofradioactive,miningandagriculturalwaste,animalcarcases,wastewaters,gaseouseffluentsandwastecoveredbyspecificCommunityrules;
Whereas,inordertoensuretheprotectionoftheenvironment,provisionshouldbemadeforasystemofpermitsforundertakingswhichtreat,storeortipwasteonbehalfofthirdparties,forasupervisorysystemforundertakingswhichdisposeoftheirownwasteandforthosewhichcollectthewasteofothers,andforaplanembracingtheessentialfactorstobetakenintoconsiderationinrespectofthevariouswastedisposaloperations;
Whereasthatproportionofthecostsnotcoveredbytheproceedsoftreatingthewastemustbedefrayedinaccordancewiththe‘polluterpays’principle,
!B
(1)OJNoC32,11.2.1975,p.36.(2)OJNoC16,23.1.1975,p.12.(3)OJNoC112,20.12.1973,p.3.
1975L0442—EN—28.05.1996—003.001—2HASADOPTEDTHISDIRECTIVE:Article1ForthepurposesofthisDirective:(a)‘waste’shallmeananysubstanceorobjectinthecategoriessetoutinAnnexIwhichtheholderdiscardsorintendsorisrequiredtodiscard.
TheCommission,actinginaccordancewiththeprocedurelaiddowninArticle18,willdrawup,notlaterthan1April1993,alistofwastesbelongingtothecategorieslistedinAnnexI.Thislistwillbeperiodicallyreviewedand,ifnecessary,revisedbythesameprocedure;
(b)‘producer’shallmeananyonewhoseactivitiesproducewaste(‘originalproducer’)and/oranyonewhocarriesoutpre-processing,mixingorotheroperationsresultinginachangeinthenatureorcompositionofthiswaste;
(c)‘holder’shallmeantheproducerofthewasteorthenaturalorlegalpersonwhoisinpossessionofit;
(d)‘management’shallmeanthecollection,transport,recoveryanddisposalofwaste,includingthesupervisionofsuchoperationsandafter-careofdisposalsites;
(e)‘disposal’shallmeananyoftheoperationsprovidedforinAnnexII,A;
(f)‘recovery’shallmeananyoftheoperationsprovidedforinAnnexII,B;
(g)‘collection’shallmeanthegathering,sortingand/ormixingofwasteforthepurposeoftransport.
Article21.ThefollowingshallbeexcludedfromthescopeofthisDirective:(a)gaseouseffluentsemittedintotheatmosphere;(b)wheretheyarealreadycoveredbyotherlegislation:(i)radioactivewaste;(ii)wasteresultingfromprospecting,extraction,treatmentandstorageofmineralresourcesandtheworkingofquarries;
(iii)animalcarcasesandthefollowingagriculturalwaste:faecalmatterandothernatural,non-dangeroussubstancesusedinfarming;
(iv)wastewaters,withtheexceptionofwasteinliquidform;(v)decommissionedexplosives.2.SpecificrulesforparticularinstancesorsupplementingthoseofthisDirectiveonthemanagementofparticularcategoriesofwastemaybelaiddownbymeansofindividualDirectives.