1、1 REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EECand 89/109/EEC 2004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 PARLIAM
2、ENT AND THE COUNCIL OF THE EUROPEAN UNION,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 and Socia
3、l 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 251 of 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 intende
4、d 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 (speci
5、fic 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
6、which leave little room for the exercise of discretion by the Member States 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
7、 the same 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 Re
8、gulation is that any 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
9、the food or a deterioration 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)
10、 are not inert by their design, 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
11、 may be brought into contact 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
12、 should be stated in specific 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
13、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， 2 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
14、distinguished from materials and articles 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) Act
15、ive food contact materials and articles may 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 addi
16、tives deliberately incorporated into certain 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 establis
17、hed 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) Opinion of the European Parliament of 31 March 2004 (not yet published in the Official Journal)
18、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 89/10
19、7/EEC of 21 December 1988 on the approximation of the laws 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
20、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, 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 th
21、e 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 th
22、at could mislead consumers. For example,active food contact materials and 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
23、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
24、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 Regula
25、tion. Nevertheless, materials and articles supplied as antiques should be excluded as they 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 for
26、ming part of the food and possibly being consumed with it should not fall within the scope of 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 3 are not i
27、ntended 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、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 s
28、ubstances used in their manufacture. It is appropriate to establish those restrictions and conditions 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
29、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 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 Europe
30、an Food Safety Authority (the Authority) should be consulted before provisions liable to affect public health 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
31、 include a list of substances authorized within the Community for use in the manufacture of materials and articles 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 sh
32、ould be without prejudice to the relevant requirements of the Community legislation concerning the registration, 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 natio
33、nal 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
34、and unfair competition. An authorisation procedure should therefore be established at Community level. In order to ensure harmonized safety assessment 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
35、。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 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 prov
36、ide 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 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
37、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 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
38、 accompany materials and articles intended to come into contact with foodstuffs. This symbol should, for reasons of simplicity, be incorporated in this Regulation. 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 i
39、nto 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 responsibility. Business operators should at least be able to identify the businesses from which, and to which, the materials and articl
40、es are supplied. (1) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4). (2) Commission Directive 80/590/EEC of 9 June 1980 determining the symbol that may accompany materials 4 and articles intended to come into contact with foodstuffs (OJ L 1
41、51, 19.6.1980, p. 21). Directive as last amended by the 2003 Act of Accession 13.11.2004 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
42、. (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 Regulation, it is appropriate to take into account the special needs of developing countries, and in particular of the least d
43、eveloped 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 ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1) to support de
44、veloping 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 Regulation 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
45、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 for the adoption of safeguard measures in situations where a material or article is likely to constitut
46、e 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 Parliament, Council and Commission documents (2) applies to documents held by the Authority. 2001年3
47、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 under this Regulation. In order to avoid unnecessary repetition of studies and in particular ani
48、mal 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) Community and national reference laboratories should be designated to contribute to a high quali
49、ty 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 recycled 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 different groups of materials and articles mentioned in Annex I. Priority should be
