EC19352004食品接触类原料和制品欧盟19352004指令中英文整理版

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1、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 Directives 80/590/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

2、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),

3、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

4、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 a

5、pproach 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。这种做法是成功的并会延续下去。(2) The specific directives adopted under Directive 89/109/EEC in general contain provisions which leave little room for the exerc

6、ise of discretion by the MemberStates in their transposition besides being subject to frequent amendments required to adapt them rapidly to technological progress. It should therefore be possible for such measures to take the form of regulations or decisions. At the same time it is appropriate to in

7、clude a number of additional subjects. Directive 89/109/EEC should therefore be replaced.具体通过89 /109 /EEC的指令一般来说囊括的规定都没有空间让成员国在法律移植上斟酌运用，除了遇到要求快速适应技术上进步的常见修正。因此，这应当可以采用相关方法决定规章或决议的形式。同时，添加额外的项目是可取的。89/109/EEC指令因此被取代。(3) The principle underlying this Regulation is that any material or article intende

8、d to come into contact directly or indirectly with food must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic

9、properties.此规章的基本原则是任何用于直接或间接接触食物原料或物件对于在传输一定数量食物过程中危害人类健康或者给食物结构带来不可接受的改变或者恶化其感官作用的物质呈现充分的惰性反应。(4) New types of materials and articles designed to actively maintain or improve the condition of the food (active food contact materials and articles) are not inert by their design, unlike traditional ma

10、terials and articles intended to come into contact with food. Other types of new materials and articles are designed to monitor the condition of the food (intelligent food contact materials and articles). Both these types of materials and articles may be brought into contact with food. It is therefo

11、re necessary, for reasons of clarity and legal certainty, for active and intelligent food contact materials and articles to be included in the scope of this Regulation and the main requirements for their use to be established. Further requirements should be stated in specific measures, to include po

12、sitive lists of authorized substances and/or materials and articles, which should be adopted as soon as possible.所有旨在积极保持或提高食品（活性食品接触的原料或物件）状况的新款式的原料或物件在设计过程中必须呈现惰性，不同于以往新原料或物件会接触到食物。其他新原料或物件需用于监测食品（智能型食品接触的原料或物件）状况。这两种原料或物件可能会接触到食物。所以，出于明确原因和合法性，对于活性食品和智能型食品的接触原料或物件都在此规章范围内，以及它们使用的主要要求也有明确规定。那些尽快被采

13、用的进一步要求包括授权物质和原料或物件的准许进口货单将规定在具体措施中。(5) Active food contact materials and articles are designed to deliberately incorporate active components intended to be released into the food or to absorb substances from the food. They should be distinguished from materials and articles which are traditionally

14、used to release their natural ingredients into specific types of food during the process of their manufacture, such as wooden barrels.活性食品接触的原料或物件旨在有意的吸收释放到食物中的“活性”成分或者从食物中吸收物质。它们在生产过程中，如木桶的生产，必须区分那些传统用于释放天然配料到具体食物中的原料与物件。(6) Active food contact materials and articles may change the composition or t

15、he organoleptic properties of the food only if the changes comply with the Community provisions applicable to food, such as the provisions of Directive 89/107/EEC (4) on food additives. In particular, substances such as food additives deliberately incorporated into certain active food contact materi

16、als and articles for release into packaged foods or the environment surrounding such foods, should be authorised under the relevant Community provisions applicable to food and also be subject to other rules which will be established in a specific measure.活性食品接触的原料或物件当且只有符合食品的社区规定，如89/107/EEC (4)指令中的

17、食品规定，才可以改变其成分或感官特性。特别是某些特定的活性食品的食品添加剂所接触的原料和物件释放到包装上或周围的环境等，应当授权于相应的食品社区规定同时要遵循即将成立的具体措施规定。(1) OJ C 117, 30.4.2004, p. 1.(2) Opinion of the European Parliament of 31 March 2004 (not yet published in the Official Journal) and Council Decision of 14 October 2004.2004年3月31日的欧盟议会意见（还没在官方期刊出版）和2004年10月14

18、日理事会决议(3) OJ L 40, 11.2.1989, p. 38. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council(OJ L 284, 31.10.2003, p. 1)指令由欧盟议会和理事会的1882/2003规章修改.(4) Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States conc

19、erning food additives authorised for use in foodstuffs intended for human consumption(OJ L 40, 11.2.1989, p. 27). Directive as last amended by Regulation (EC) No 1882/2003.L 338/4 EN Official Journal of the European Union 13.11.2004理事会1988年12月21日的指令89 /109 /EEC关于统一各成员国授权使用添加剂的法律(OJ L 40, 11.2.1989,

20、p. 27)。指令最后由13.11.2004官方期刊的No 1882/2003.L 338/4规章修正In addition, adequate labelling or information should support users in the safe and correct use of active materials and articles in compliance with the food legislation, including the provisions on food labelling.除此以外，提供充足的满足食品法规的标签或者信息支持用户处于安全和活性原料

21、和物件的正确使用(7) Active and intelligent food contact materials and articles should not change the composition or the organoleptic properties of food or give information about the condition of the food that could mislead consumers. For example,active food contact materials and articles should not release

22、or absorb substances such as aldehydes or amines in order to mask an incipient spoilage of the food. Such changes which could manipulate signs of spoilage could mislead the consumer and they should therefore not be allowed.活跃性和智能型的食品触点原料和物件不应该改变其组成或者食品的感官特性或者给关于能误导消费者食品状态的信息。例如，活跃性食品触点原料和物件不应该释放或者吸收

23、像乙醛或者胺那样的物质从而为了掩饰食品的开始变化。这样能操纵变质迹象的变化能误导消费者，因此不被允许。Similarly, active food contact materials and articles which produce colour changes to the food that give the wrong information concerning the condition of the food could mislead the consumer and therefore should not be allowed either.与此类似，活性食品触点原料和物

24、件换乘错了信息关于食品的状态可能误导消费者的给的食品， 因此也不被允许。(8) Any material or article intended to come into contact with food which is placed on the market should comply with the requirements of this Regulation. Nevertheless, materials and articles supplied as antiques should be excluded as they are available in restrict

25、ed quantities and their contact with food is therefore limited.所有要接触食品的原料或物件在投入市场前需要符合这条规章的要求。 虽然如此， 视为古董的原料或物件排除在一定限制数量内是被允许的情况，因此接触食品也是被限制的。(9) Covering or coating materials forming part of the food and possibly being consumed with it should not fall within the scope of this Regulation. On the oth

26、er hand, this Regulation should apply to covering or coating materials which cover cheese rinds, prepared meat products or fruit but which do not form part of food and are not intended to be consumed together with such food.可能和食物一起使用的组成部分覆盖原料或涂料表层不适合这条规章的范围。另一方面，这条规章应该适用于那些非组成部分的且不一起消费使用的涂层原料如盖住乳酪皮、

27、预加工肉产品或者水果的涂料表层。(10) It is necessary to lay down various types of restrictions and conditions for the use of the materials and articles covered by this Regulation and the substances used in their manufacture. It is appropriate to establish those restrictions and conditions in specific measures havin

28、g regard to the technological characteristics specific to each group of materials and articles.对此规章覆盖的原料和物件的使用情况和其生产过程中使用的材料，制定不同类型限制和制约是非常必要的。对各组原料和物件的具体关于技术性质细节的措施建立限制条件是合适的。(11) Pursuant to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down th

29、e general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), the European Food Safety Authority (the Authority) should be consulted before provisions liable to affect public health are adopted under speci

30、fic measures.(11) 按照欧盟议会的(EC) No.178/2002规章和2002年1月28日委员会拟定总则和食品法律的要求，建立欧洲食品安全局并且对有关食品安全拟定程序 ( 1 ) ,在具体措施下影响公众健康的规定采用前，需要咨询欧洲食品安全局的意见。(12) When specific measures include a list of substances authorized within the Community for use in the manufacture of materials and articles intended to come into co

31、ntact with food, those substances should undergo a safety assessment prior to their authorisation. The safety assessment and authorisation of those substances should be without prejudice to the relevant requirements of the Community legislation concerning the registration, evaluation, authorization

32、and restriction of chemicals.当具体措施包括用于生产接触食品类的原料和物件的一系列社区授权物质，这些物质必须经过安全评估阶段才能获得授权。这些物质的安全评估和授权必须不影响共同体就注册、评估、授权和化学限制的相关立法要求。(13) Differences between national laws, regulations and administrative provisions concerning the safety assessment and authorisation of substances used in the manufacture of m

33、aterials and articles intended to come into contact with food may hinder the free movement of those materials and articles, creating conditions of unequal and unfair competition. An authorisation procedure should therefore be established at Community level. In order to ensure harmonized safety asses

34、sment of those substances, the Authority should carry out such assessments.国家法律、规章和管理条例对在接触食品的原料和物质生产过程中所用的物质的安全评估和授权的规定差别，会阻碍这些原料和物件的自由活动，产生不平等和不公平的竞争。因此审定程序须在社区水平上建立。为了保证这些物质安全评估协调，食品安全局须执行这样的评估。(14) The safety assessment of substances should be followed by a risk management decision as to whether

35、 those substances should be entered on a Community list of authorized substances.物质的安全评估必须遵循风险管理决定，不管这些物质是否列入社区授权目录(15) It is appropriate to provide for the possibility of an administrative review of specific acts or omissions on the part of the Authority under this Regulation. This review should be

36、 without prejudice to the role of the Authority as an independent scientific point of reference in risk assessment.就此规章下的安全局而言，为具体作为或不作为的，提供可能性管理检阅是合适的。这种检阅在风险评估中作为独立的科学参考点，对于安全局的角色不能有任何偏倚。(16) Labelling supports users in the correct use of the materials and articles. Methods used for such labelling

37、 may vary according to the user.标签支持用户正确使用原料和物件。标签的使用方法可以根据用户做相应的改变。(17) Commission Directive 80/590/EEC (2) introduced a symbol that may accompany materials and articles intended to come into contact with foodstuffs. This symbol should, for reasons of simplicity, be incorporated in this Regulation.

38、委托指令的80/590 /EEC( 2 ) 采用一种符号可以伴随接触食品的原料和物件。这各符号出于简化的原因，应该被并入这条规章里。(18) The traceability of materials and articles intended to come into contact with food should be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of resp

39、onsibility. Business operators should at least be able to identify the businesses from which, and to which, the materials and articles are supplied.(1) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No1642/2003 (OJ L 245, 29.9.2003, p. 4).(2) Commission Directive 80/590/EEC of 9 J

40、une 1980 determining the symbol that may accompany materials and articles intended to come into contact with foodstuffs (OJ L 151, 19.6.1980, p. 21). Directive as last amended by the 2003 Act of Accession13.11.2004 EN Official Journal of the European Union L 338/5接触食品类的原料和物件保证在任何阶段都可以追溯，为了便于控制，瑕疵品的回

41、收，客户信息和责任归因。交易运营商最低限度必须做到识别出原料和物件是从哪里来，运到哪里去。(1)根据规章(EC)NO.1642/2003(OJ L 245，29.9.2003， 页 4). 修改的规章OJ L 31，1.2.2002， 页 1.(2)欧盟委员会1980年6月9日关于确定接触食品类原料和物件的80/590/EEC指令。此法规以2003指令添加到2004年11月13日的欧盟L L 338/5联合公报为最后修正。(19) In the control of the compliance of the materials and articles with this Regulatio

42、n, it is appropriate to take into account the special needs of developing countries, and in particular of the least developed countries. The Commission has been committed by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to e

43、nsure the verification of compliance with feed and food law, animal health and animal welfare rules (1) to support developing countries with regard to food safety, including the safety of the materials and articles in contact with food. Special provisions have therefore been established in that Regu

44、lation which should be applicable also to the food contact materials and articles.(19)对受控于此规则的原料和物件，应该考虑发展中国家，特别是不发达国家的特殊需求。委员会遵循欧盟议会No 882/2004和2004年4月29号的理事会，关于执行确定饲料和食品法、动物的健康和动物福利法规（1）受控事实的官方管理手段，以确保发展中国家的食品，包括接触食品原料和物件的安全。具体条例因此成立，同时适用于接触食品的原料和物件。 (20) It is necessary to establish procedures fo

45、r the adoption of safeguard measures in situations where a material or article is likely to constitute a serious risk to human health.(20)当原料或物件对人类有一系列持续的危害，需要建立保卫措施的程序 (21) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European

46、Parliament, Council and Commission documents (2) applies to documents held by the Authority.2001年3月30日欧盟议会和理事会关于公众参与欧盟议会、理事会和共同体文献的(EC) No 1049/2001规章，适用于安全局执行文献。(22) It is appropriate to protect the investment made by innovators in gathering the information and data supporting an application made u

47、nder this Regulation. In order to avoid unnecessary repetition of studies and in particular animal testing, however, sharing of data should be permitted provided there is agreement between the interested parties.保护搜集支持此规章下实际应用的信息和数据的改革人的投资是合理的。为了避免不必要的重复实验，特别是动物测试，然而，在利益关系的双方同意下，分享数据时允许的。(23) Commun

48、ity and national reference laboratories should be designated to contribute to a high quality and uniformity of analytical results. This objective will be achieved within the framework of Regulation (EC) No 882/2004.(23) 欧共体和国家参数实验室必须致力于高品质和一致性的分析结果。这个目标将在在(EC) No 882/2004规章框架下得到实现。(24) The use of re

49、cycled materials and articles should be favoured in the Community for environmental reasons, provided that strict requirements are established to ensure food safety and consumer protection. Such requirements should be established taking also into account the technological characteristics of the diff

50、erent groups of materials and articles mentioned in Annex I. Priority should be given to the harmonisation of rules on recycled plastic material and articles as their use is increasing and national laws and provisions are lacking or are divergent. Therefore, a draft of a specific measure on recycled

51、 plastic materials and articles should be made available to the public as soon as possible in order to clarify the legal situation in the Community.对于回收原料和物件的使用需符合共同体出于环境因素为了保证食品安全和消费者的保护而制定严格要求。这些要求也要考虑附件一提及的各类原料和物件的技术特征。再循环的塑料原料和物件使用量增加，当国家法律和规章有分歧时，优先考虑和谐持续的规则。因此，需要尽快起草有关回收利用的原料和物件的具体措施，从而明确共同体的合

52、法性。(25) The measures necessary for the implementation of this Regulation and amendments to Annexes I and II hereto should be adopted in accordance with CouncilDecision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (3).此规则的必

53、要执行措施和附件1,2的修正必须与理事会1999年6月28日的1999/468/EC决定规定的执行权力程序相符。(26) Member States should lay down rules on sanctions applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Such sanctions must be effective, proportionate and dissuasive.会员国应该制定评定违反这条规章条款的制裁并保证其

54、有效性。这些制裁必须是有效的，均衡的和有劝诫作用。(27) It is necessary for business operators to have sufficient time to adapt to some of the requirements established by this Regulation.应该给运营商足够的时间适应此规章的要求。(28) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States because of the differ

55、ences between the national laws and provisions and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Ar

56、ticle, this Regulation does not go beyond what is necessary in order to achieve those objectives.基于国家间的法律和条约有差异，各国不能保证达到此规章的目标，因此，在共同体的基础上会达到更好的效果，共同体也许会根据条约第五章辅助原则采用一系列措施。依照条款的均衡性原则，为了达到这些目标，此规章超出其范围。(29) Directives 80/590/EEC and 89/109/EEC should therefore be repealed,HAVE ADOPTED THIS REGULATION

57、:指令80/590 /EEC和89/109 /EEC因此应该被废止，已经采用这条规章： 第1条 Article 1Purpose and subject matter1. The purpose of this Regulation is to ensure the effective functioning of the internal market in relation to the placing on the market in the Community of materials and articles intended to come into contact directl

58、y or indirectly with food, whilst providing the basis for securing a high level of protection of human health and the interests of consumers.(1) OJ L 165, 30.4.2004, p. 1. Regulation as corrected in OJ L 191,28.5.2004, p. 1.(2) OJ L 145, 31.5.2001, p. 43. (3) OJ L 184, 17.7.1999, p. 23L 338/6 EN Off

59、icial Journal of the European Union 13.11.2004目的和主要内容 1. 这条规章的目的是为了保证直接或间接接触食品类的原料和物件国际市场的高效运作，时时为人类健康和客户利益提供固定的高水准保护(1) OJ L 165，30.4.2004，页1.作为 OJ L 191 28.5.2004 , 页1.修正版 (2) OJ L 145，31.5.2001，页43.(3) OJ L 184，17.7.1999，页23 ，13.11.2004的政府公关 L 338/6 2. This Regulation shall apply to materials and

60、 articles, including active and intelligent food contact materials and articles, (hereinafter referred to as materials and articles) which in their finished state:(a) are intended to be brought into contact with food;or(b) are already in contact with food and were intended for that purpose;or(c) can

61、 reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.2. 这条规章将适用于接触活性食品和智能型食品的原料和物件，(在下文称为的原料和物件) (a) 计划与食品接触；或者 (b) 已经与食品接触，并且已打算倾向于那目的； 或者 (c) 在平常或者可预见的情况下能购买到与食品接触或者转移成分到食品的3. This Regulation shall not

62、apply to:(a) materials and articles which are supplied as antiques;(b) covering or coating materials, such as the materials covering cheese rinds, prepared meat products or fruits, which form part of the food and may be consumed together with this food;(c) fixed public or private water supply equipm

63、ent.3. 这规章将不适用于： (a) 作为古董的原料和物件； (b) 涂层材料，例如包装乳酪皮，预加工肉产品或者水果，组成食品的部分和可能和食品一起食用的； (c) 修理公众或私人用水设备。 Article 2Definitions1. For the purposes of this Regulation, the relevant definitions laid down in Regulation (EC) No 178/2002 shall apply, with the exception of the definitions of traceability and placi

64、ng on the market, which shall have the following meanings:(a) traceability: the ability to trace and follow a material or article through all stages of manufacture, processing and distribution;(b) placing on the market: the holding of materials and articles for the purpose of sale, including offerin

65、g for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves.第2条 定义 1. 为了这条规章的目的，指令(EC)No. 178/2002制定的相应定义，“可追溯的”和“在市场配售”的定义例外，需要有以下的定义：(a) 可追溯性： 在生产，整合和运输的所有阶段都能追溯和跟踪原料或物件(b) 可在市场配售'： 为了销售而持有的那些原料和物件，包括供应商或其他形式的经销商，是否免费，以及销售，分配和其他形式经销。2. The following definitions shall also apply:(a) active food contact materials and articles (hereinafter referred to as active materials and articles) means materials and articles th