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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) Opi
