EC193食品接触类原料和制品欧盟193指令中英文整理版.docx

1、EC193食品接触类原料和制品欧盟193指令中英文整理版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

2、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 Econo

3、mic 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 in

4、tended 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 (

5、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。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 lea

6、ve little room for the exercise 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

7、time it is appropriate to include 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

8、 material or article intended 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 deteri

9、oration in its organoleptic 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 d

10、esign, unlike traditional materials 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 cont

11、act with food. It is therefore 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 spec

12、ific measures, to include positive 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

13、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 artic

14、les which are traditionally 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

15、 change the composition or the 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 certai

16、n active food contact materials 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

17、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) 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

18、欧盟议会意见（还没在官方期刊出版）和2004年10月14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 la

19、ws of the Member States concerning 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

20、用添加剂的法律(OJ L 40, 11.2.1989, 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

21、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

22、articles should not release 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

23、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 al

24、lowed either.与此类似，活性食品触点原料和物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 th

25、ey are available in restricted 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

26、 this Regulation. On the other 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

27、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、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 condition

28、s in specific measures having 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

29、 January 2002 laying down the 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 he

30、alth are adopted under specific 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 artic

31、les intended to come into contact 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

32、, evaluation, authorization 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 materials 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 lev