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EC1935_2004食品接触类原料和制品(欧盟)1935_2004指令_中英文整理版

EC1935_2004食品接触类原料和制品(欧盟)1935_2004指令_中英文整理版
EC1935_2004食品接触类原料和制品(欧盟)1935_2004指令_中英文整理版

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 PARLIAMENT 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

Social 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 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。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 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 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 Regulation 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 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) 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 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 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 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 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 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 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) 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 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 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 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 Regulation. 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 forming 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 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、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 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 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 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 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 should 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 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 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。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 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 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 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.

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 responsibility. 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) 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 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 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.

(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 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 ensure 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 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 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 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 under 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) Community 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 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 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 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 Council

Decision 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 differences 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 Article, 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:

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 1

Purpose and subject matter

1. 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 directly 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. 23

L 338/6 EN Official 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 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 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 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 equipment.

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 2

Definitions

1. 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 ‘placing 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 offering 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 that are intended to extend the

shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food;

2. 下列定义也将适用:

(a) 接触活性食品的原料和物件(在下文称为的活性原料和物件)意思是为了延长保质期或保持或提高包装

食品的状态。它们含有那些可以从包装食品或食品周边环境释放或吸收物质。

(b) ‘intelligent food contact materials and articles’ (hereinafter referred to as intelligent materials and articles) means materials and articles which monitor the condition of packaged food or the environment surrounding the food;

(b) 接触智能型食品的原料和物件(在下文称为智能型原料和物件)意思是能监察包装食品或食品周围环境

的情况。

(c) ‘business’ means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing and distribution of materials and articles;

(c) 商业单位意思为那些从事这些原料和物件在生产,加工和分销的任何阶段的任何活动,无论是公众事业还是私人事业。

(d) ‘business operator’ means the natural or legal persons responsible for ensuring that the requirements of this Regulation are met within the business under their control.

(d)“商业运营商”意为自然人或法人有责任在其控制范围内保证达到此规章规定的要求。

Article 3

General requirements

1. Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:

(a) endanger human health; or

(b) bring about an unacceptable change in the composition of the food; or

(c) bring about a deterioration in the organoleptic characteristics thereof.

第3条

一般规格

1. 原料和物件,包括活性的和智能型的,需保证良好的生产惯例能保证在正常或可预见的情况下的使用都不会在数量上传递组成要素到食物上致:

(a) 危害人健康;或者

(b) 给食品组成带来不利的改变;或者

(c) 恶化感官的特性

2. The labelling, advertising and presentation of a material or article shall not mislead the consumers.

2. 产品标签、广告及外观不能误导消费者

Article 4

Special requirements for active and intelligent materials

and articles

1. In the application of Article 3(1)(b) and 3(1)(c), active materials and articles may bring about changes in the composition or organoleptic characteristics of food on condition that the changes comply with the Community provisions applicable to food, such as the provisions of Directive 89/107/EEC on food additives and related implementing measures, or, if no Community provisions exist, with the national provisions applicable to food. 13.11.2004 EN Official Journal of the European Union L 338/7

第4条

活性和智能化原料和物件的特别的要求

1. 在第三条(1)(b) 和(1)(c)所列,活性原料和物件也许会给食品的组成或感官性质带来变化,这些变化必须服从89/107/EEC关于食物的指令和相关执行措施,或者,如果没有共同体的指令存在,则参考2004年11月13日欧盟政府公告

2. Pending the adoption of additional rules in a specific measure on active and intelligent materials and articles, substances deliberately incorporated into active materials and articles to be released into the food or the environment surrounding the food shall be authorised and used in accordance with the relevant Community provisions applicable to food, and shall comply with the provisions of this Regulation and its implementing measures. These substances shall be considered as ingredients within the meaning of Article 6(4)(a) of Directive 2000/13/EC (1).

2. 在对于活性和智能型材料采用额外规则期间,活性材料包含的会释放到食品或其环境的物质需符合共同体关于食品的相应条例,还有此规章的规定及其执行措施。这些物质即为2000/13/EC (1)指令的第6条(4)(a)所定义的配料。

3. Active materials and articles shall not bring about changes in the composition or organoleptic characteristics of food, for instance by masking the spoilage of food, which could mislead consumers.

3. 活性的原料和物件不能改变食品的组成或感官特性,如掩饰食品腐化来误导消费者。

4. Intelligent materials and articles shall not give information about the condition of the food which could mislead consumers.

智能型的原料和物件不能提供误导消费者的产品信息。

5. Active and intelligent materials and articles already brought into contact with food shall be adequately labelled to allow identification by the consumer of

non-edible parts.

活性和智能型接触食品的原料和物件必须提供可分辨的标签,提醒消费者不可食用。

6. Active and intelligent materials and articles shall be adequately labelled to indicate that the materials or articles are active and/or intelligent.

活性和智能原料和物件必须标上活性和/或智能型Article 5

Specific measures for groups of materials and articles

1. For the groups of materials and articles listed in Annex

I and, where appropriate, combinations of those materials and articles or recycled materials and articles used in the manufacture of those materials and articles, specific measures may be adopted or amended in accordance with the procedure referred to in Article 23(2). Those specific measures may include:

第5条

归类原料和物件具体的措施

1. 在附件1所列的原料物件的归类以及这些材料的组合物或生产过程中的回收利用,将会在23条(2)提及的程序里采用或修正具体措施。这些具体措施包括:

(a) a list of substances authorised for use in the manufacturing of materials and articles;

列出生产过程中所用的授权物质

(b) list(s) of authorised substances incorporated in active or intelligent food contact materials and articles, or list(s) of active or intelligent materials and articles and, when necessary, special conditions of use for these substances and/or the materials and articles in which they are incorporated;

列出活性或智能型接触食品的原料和物件所包含的授权物质,或活性(智能型)材料,当有必要时,还要提供这些包含物质的具体使用情况。

(c) purity standards for substances referred to in (a);

(a)提及的物质有纯度指标。

(d) special conditions of use for substances referred to in (a) and/or the materials and articles in which they are used;

(a)提及物质的具体使用情况

(e) specific limits on the migration of certain constituents or groups of constituents into or on to food, taking due account of other possible sources of exposure to those constituents;

关于某些要素的转移或在食物里边或表面的要素群的具体限制,对于这些要素暴露的其他资料都要有适当的数据记录

(f) an overall limit on the migration of constituents into or on to food;

食品内或表明的转移要素的整体限制。

(g) provisions aimed at protecting human health against hazards arising from oral contact with materials and articles;

保护人类健康免受口服接触材料产生危害的条例

(h) other rules to ensure compliance with Articles 3 and 4;

其他符合第三条和第四条的规则。

(i) basic rules for checking compliance with points (a) to (h);

符合(a)到(h)要点的基本检测规则

(j) rules concerning the collection of samples and the methods of analysis to check compliance with points (a) to (h);

符合(a)到(h)要点检测样品和分析方法的规则

(k) specific provisions for ensuring the traceability of materials and articles including provisions regarding the duration for retention of records or provisions to allow, if necessary, for derogations from the requirements of Article 17;

确保材料的可追溯性的具体条例,如果有必要,根据第17条的损毁要求保存记录的时间或许可的条例。(l) additional provisions of labelling for active and intelligent materials and articles;

活性和智能型材料要有额外的标签规则。

(m) provisions requiring the Commission to establish and maintain a publicly available Community Register (Register) of authorised substances, processes, or materials or articles;

委员会需要建立和保持一个公开的关于授权物质、进程或材料的注册簿

(1) Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L 109,

6.5.2000, p. 29). Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15). L 338/8 EN Official Journal of the European Union 13.11.2004 2000年3月20日欧洲议会和委员会2000/13/EC指令综合各成员国关于食品标签、外观和广告的法律(OJ L 109, 6.5.2000, p. 29)。指令于欧洲政府公告2003/89/EC (OJ L 308, 25.11.2003, 页. 15). L 338/8最后修订。

(n) specific procedural rules adapting, as necessary, the procedure referred to in Articles 8 to 12, or making it appropriate for the authorisation of certain types of materials and articles and/or processes used in their manufacture, including, where necessary, a procedure for an individual authorization of a substance, process, or material or article through a decision addressed to an applicant.

具体程序上的规则根据需要适应第8到12条涉及的内容,或者使其适用于某些类型的材料或其在生产过程包括个人授权的物质、制作法或者送样材料。

2. Existing specific directives on materials and articles shall be amended in accordance with the procedure laid down in Article 23(2).

2.现存关于原料和物件的具体指令需根据第23条( 2 ) 作修正。Article 6

National specific measures

In the absence of specific measures referred to in Article 5, this Regulation shall not prevent Member States from maintaining or adopting national provisions provided they comply with the rules of the Treaty.

第6条

国家具体的措施

在缺乏第5条提及的具体措施时,此规章不得阻止会员国主张或采用条约规定的国际规则

Article 7

Role of the European Food Safety Authority

Provisions liable to affect public health shall be adopted after consulting the European Food Safety Authority, hereinafter referred to as ‘the Authority’.

第7条

欧洲食品安全局的角色

可能影响公众健康安全的规则需在咨询欧盟食品安全局后方可采用,以下简称安全局。

Article 8

General requirements for the authorisation of substances

1. When a list of substances as referred to in points (a) and (b) of the second subparagraph of Article 5(1) is adopted, anyone seeking an authorisation for a substance not yet included in that list shall submit an application in accordance with Article 9(1).

第8条

物质的审定的一般规格

当需采用第5条(1)的第二段中a点和b点提及的一栏物质,所有人对没有包含在内的物质需按照第9条(1)提交申请书以获得授权书。

2. No substance shall be authorised unless it has been adequately and sufficiently demonstrated that, when used under the conditions to be set in the specific measures, the final material or article satisfies the requirements of Article 3 and, where they apply, Article 4.

当在具体措施设立的情况下使用的物质需提供合适的充足的说明才能授权,当申请时(第4条),最后的原料和物件需满足第三条的要求。

Article 9

Application for authorisation of a new substance

1. To obtain the authorisation referred to in Article 8(1),

the following procedure shall apply:

第9条

一种新物质的授权申请

1. 根据第8(1)条的规定,要取得授权的物质需按照以下程序申请:

(a) an application shall be submitted to the competent authority of a Member State accompanied by the following:

(a)申请表按以下要求交到合资格的成员国:

(i) the name and address of the applicant;

申请者的名称和地址

(ii) a technical dossier containing the information specified in the guidelines for the safety assessment of a substance to be published by the Authority;

包含安全局公布的物质安全评估准则确定内容的技术文档

(iii) a summary of the technical dossier;

技术文档的摘要

(b) the competent authority referred to in (a) shall:

(a)提及的胜任当局机构应该:

(i) acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

在收到申请书后14天内,需开具收到确认书给申请人。确认书需说明申请书的收到日期。

(ii) inform the Authority without delay; and

及时通知安全局,并且

(iii) make the application and any supplementary information supplied by the applicant available to the Authority;

制定申请表和提供申请人的任何补充信息给安全局

(c) the Authority shall without delay inform the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them.

安全局需及时通知会员国和委员会,以及制定申请表及提供申请人的任何补充信息。

2. The Authority shall publish detailed guidelines concerning the preparation and the submission of the application (1).

安全局需出版关于申请书(1)准备工作和依据详细指导方针。Article 10

Opinion of the Authority

1. The Authority shall give an opinion within six months of the receipt of a valid application, as to whether, under the intended conditions of use of the material or article in which it is used, the substance complies with the safety criteria laid down in Article 3 and, where they apply, Article 4.

第10条

安全局的意见

安全局需在6个月内为有效的申请书提供意见,原材料或物料的使用是否符合预定的条件,按照第4条规定,物质需符合第3条制定的安全准则。

The Authority may extend the said period by a maximum period of a further six months. In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States.

安全局可以延长最多6个月的规定期限。在这种情况下需向申请者、委员会和成语国提供延期的原因。(1) Pending such publication, applicants may consult the ‘Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation’. –

http://europa.eu.int/comm/food/fs/sc/scf/out82_en.pdf. 13.11.2004 EN Official Journal of the European Union L 338/9

在公布期间,申请人可咨询“安全食品科学委员会关于接触食品的物质安全评估及其授权的申请说明报告的指导方针”——

http://europa.eu.int/comm/food/fs/sc/scf/out82_en.pdf 2004年11月13日欧洲政府公告L 338/9

2. The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Authority. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided. Similarly, the time limit shall be suspended for the time allowed the applicant to prepare oral or written explanations.

安全局,在适当的时候,请求申请人在安全局规定的时间内补充申请表的细则。当安全局请求补充信息时,第1段落规定的时间期限需终止,直至拿到相应的信息。同样,时间限制需终止来让申请人有足够时间准备口头或者书面解释。

3. In order to prepare its opinion, the Authority shall:

(a) verify that the information and documents submitted by the applicant are in accordance with Article 9(1)(a), in

which case the application shall be regarded as valid, and examine whether the substance complies with the safety criteria laid down in Article 3 and, where they apply, Article 4;

为了准备其专业性的鉴定,安全局需:

(a)当申请视为有效的情况下,核实申请人递交的信息和文档符合第9(1)条,和根据第4条规定,审查物质是否符合第3条规定的安全准则。

(b) inform the applicant, the Commission and the Member States if an application is not valid.

(b)如果申请无效要通知申请人、委员会和成员国

4. In the event of an opinion in favour of authorising the evaluated substance, the opinion shall include:

在赞成授权的物质鉴定中,需包括:

(a) the designation of the substance including its specifications; and

物质的名称包括说明书;以及

(b) where appropriate, recommendations for any conditions or restrictions of use for the evaluated substance and/or the material or article in which it is used; and

当在适当的时候,待评估物质在任何使用情况或使用限定的建议书

(c) an assessment as to whether the analytical method proposed is appropriate for the intended control purposes. 一份关于分析方法是否适用于预定的控制目的的评估报告

5. The Authority shall forward its opinion to the Commission, the Member States and the applicant.

安全局需把鉴定结果发送给委员会、成员国和申请人

6. The Authority shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 20.

安全局根据第20条规定,在删除机密信息后把结果公布。

Article 11

Community authorisation

1. The Community authorisation of a substance or substances shall take place in the form of the adoption of a specific measure. The Commission shall, where appropriate, prepare a draft of a specific measure, as referred to in Article 5, to authorise the substance or substances evaluated by the Authority and specify or change the conditions of its or their use.

第11条委员会审定

1. 委员会的审定需在采用具体措施的形势下产生。委员会需,当合适的时候,按照第5条提及的要求准备具体措施的起草,来批准由安全局评估的物质、详述或其使用环境改变。

2. The draft specific measure shall take into account the opinion of the Authority, relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft specific measure is not in accordance with the opinion of the Authority, the Commission shall provide without delay an explanation for the reasons for the differences. If the Commission does not intend to prepare a draft specific measure after a favourable opinion by the Authority, it shall inform the applicant without delay and provide the applicant with an explanation.

具体措施的草案需考虑安全局的鉴定结果、相应的委员会法律规定和其他合理考虑范围内的合法因素。当具体措施草案与安全局的决议不符,委员会需及时提供差异的原因说明。当安全局发布通过决议后,如果委员会不打算准备具体措施草案需及时通知申请人并提供说明。

3. Community authorisation in the form of a specific measure, as referred to in paragraph 1, shall be adopted in accordance with the procedure referred to in Article

23(2).

委员会具体措施形式下的审定,如第1段提及的,必须按第23(2)规定采用。

4. After the authorisation of a substance in accordance with this Regulation, any business operator using the authorised substance or materials or articles containing the authorised substance shall comply with any condition or restriction attached to such authorisation.

物质根据此规章授权后,任何商业运营者使用授权原料或物质包括授权实体需遵循授权证书附上的任何使用情况或限制条件。

5. The applicant or any business operator using the authorized substance or materials or articles containing the authorised substance shall immediately inform the Commission of any new scientific or technical information, which might affect the safety assessment of the authorised substance in relation to human health. If necessary, the Authority shall then review the assessment. 申请人或商业运营商使用授权原料或物质包括授权实体需马上把可能影响授权物质关于人类健康的安全评估结果的科学或技术上的新信息通知委员会。如有必要,安全局需重新审核评估。

6. The granting of an authorisation shall not affect the general civil and criminal liability of any business operator in respect of the authorised substance, the material or article containing the authorised substance,

and the food that is in contact with such

material or article.

授权不能影响商业运营商关于授权原料或物质包括授权实体和接触这些材料的食品的一般民事和刑事责任Article 12

Modification, suspension and revocation of authorisation

1. The applicant or any business operator using the authorized substance or materials or articles containing the authorised substance may, in accordance with the procedure laid down in Article 9(1), apply for modification of the existing authorisation.

第12条

审定的修改,暂停和撤消

1.使用授权原料或物质包括授权实体的申请人或商业运营商需依照第9条( 1 )规定的程序进行申请对现有审定结果的修正

2. The application shall be accompanied by the following:

(a) a reference to the original application;

(b) a technical dossier containing the new information in accordance with the guidelines referred to in Article 9(2);

(c) a new complete summary of the technical dossier in a standardized form. L 338/10 EN Official Journal of the European Union 13.11.2004

2,申请书需附上以下资料:

(a)关于申请书原件的证明书

(b)依照第9条(2)提及的准则,包含新信息的技术文档材料

(c)按照2004年11月13日欧洲政府公告L 338/10关于技术文档材料标准规格,提供方一份新的完整的技术文档摘要

3. On its own initiative or following a request from a Member State or the Commission, the Authority shall evaluate whether the opinion or the authorisation is still in accordance with this Regulation, in accordance with the procedure laid down in Article 10, where applicable. The Authority may, where necessary, consult the applicant.

根据其自有的主动权或以下成员国或委员会的要求,根据第10条规定的程序,无论鉴定结果或授权是否依然符合这项规章安全局都需评估。在适当的时候,还要要咨询申请人。

4. The Commission shall examine the opinion of the Authority without delay and prepare a draft specific measure to be taken. 委员会需及时检验安全局审定结果并准备具体措施的草案。

5. A draft specific measure modifying an authorisation shall specify any necessary changes in the conditions of use and, if any, in the restrictions attached to that authorisation.

修改审定决议的草案需对使用情况,还有审定附录的限制情况(如果有的话)

的任何必要改变作出详述。

6. A final specific measure on the modification, suspension or revocation of the authorisation shall be adopted in accordance with the procedure referred to in Article 23(2).

关于审定决议修改、暂停或废止的最后确切措施需根据第23(2)条规定的程序来采用。

Article 13

Competent authorities of Member States

Each Member State shall notify to the Commission and to the Authority the name and address, as well as a contact point, of the national competent authority or authorities designated to be responsible in its territory for receiving the application for authorization referred to in Articles 9 to 12. The Commission shall publish the name and address of the national competent authorities as well as the contact points notified in accordance with this Article. 第13条

成员国的主管当局

每个成员国需将名称和地址告知委员会和安全局,还有根据第9到12条规定指派在其范围内承担责任的国家主管当局的联系要点。委员会需公布国家主管当局名称和地址以及联系要点。

Article 14

Administrative review

Any act adopted under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.To this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question. The Commission shall take a decision within two months requiring, if appropriate, the Authority to undo its act or to remedy its failure to act.

第14条

行政复审

任何被采用的或者失效的法令,此规章赋予安全局的

权利将由委员会重新审视自己的主动权或负责成员国或任何人直接和各自关心的要求。为了使以上审议有效,需在两个月内,从组织担心的事变成行动事实或疏忽问题之日记起,向委员会递交。委员会需在要求的两个月内做决定,如果合适的话,安全局停止其行动或从新补救失效的行动。

Article 15

Labelling

1. Without prejudice to the specific measures referred to in Article 5, materials and articles, which are not yet in contact with food when placed on the market, shall be accompanied by:

(a) the words ‘for food contact’, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the symbol reproduced in Annex II; and

第15条

标签

1. 不违背第5条规定的具体措施,原料和物件投放到市场时还未接触食品,需要遵循:

(a) “用于接触食品”的字样,或具体使用指示,如咖啡机、酒杯、汤勺,或附件II出现的符号;并且

(b) if necessary, special instructions to be observed for safe and appropriate use; and

如果有必要的话,关于安全和使用方法的特殊说明书;并且

(c) the name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for placing on the market established within the Community; and

名称或交易名称,在任何情况下,在共同体成立的负责投放市场工作的生产商、加工方或销售的地址或注册办公。

(d) adequate labelling or identification to ensure traceability of the material or article, as described in Article 17; and

足够的标签或证明保证第17条描述的材料或物品的可追溯性

(e) in the case of active materials and articles, information on the permitted use or uses and other relevant information such as the name and quantity of the substances released by the active component so as to enable food business operators who use these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food, including the provisions on food labelling.

对于活性材料和物件,许可使用的信息和其他相关信息,如活性因子释放的物质名称和数量,这是为了让这些使用这些材料的食品运营商遵循其他共合体的规定或,如果没有这些规定,则遵循国家对食品的规定包括食品标签的规定。

2. The information referred to in paragraph 1(a) shall not, however, be obligatory for any articles which, because of their characteristics, are clearly intended to come into contact with food.

第1段(a)提及的信息,由于它们的规格参数,不能强制性的符合关于接触食品的条款

3. The information required by paragraph 1 shall be conspicuous,clearly legible and indelible.

根据第1段的规定,信息需显眼,清晰易读且不能擦拭的

4. Retail trade in materials and articles shall be prohibited if the information required under paragraph (1)(a), (b) and (e) is not given in a language easily understood by purchasers. 13.11.2004 EN Official Journal of the European Union L 338/11

2004年11月13日欧洲政府公告L 338/11,若不能提供第1段(a), (b) 和(e)规定易于买方了解的信息,原料和物件的零售交易需禁止。

5. Within its own territory, the Member State in which the material or article is marketed may, in accordance with the rules of the Treaty, stipulate that those labelling particulars shall be given in one or more languages which it shall determine from among the official languages of the Community.

在其自行管理区域内,成员国在销售原料或物件需遵循条约规定的原则,规定提供那些共合体官方语言中的一种或更多语言的标签。

6. Paragraphs 4 and 5 shall not preclude the labelling particulars from being indicated in several languages.

第4、5段不能限制由几种语言表示的标签详情

7. At the retail stage, the information required under paragraph 1 shall be displayed on:

(a) the materials and articles or on their packaging; or

(b) labels affixed to the materials and articles or to their packaging; or

在销售阶段,按照第1段要求的信息需显示在:

(a)原料和物件上或者包装上;或者

(b)附在原料和物件上或包装上的标签;或者

(c) a notice in the immediate vicinity of the materials and articles and clearly visible to purchasers; for the information referred to in paragraph 1(c), however, this option shall be open only if, for technical reasons, that information or a label bearing it cannot be affixed to the

materials and articles at either the manufacturing or the marketing stage.

最接近原料和物件处的注意标识需清晰可见;第1段(c)提及的信息在出于技术上原因才能公开,那信息或标签在生产或销售时都不能附在原料和物件上

8. At the marketing stages other than the retail stage, the information required by paragraph 1 shall be displayed on:

(a) the accompanying documents; or

(b) the labels or packaging; or

(c) the materials and articles themselves.

在经销过程中,除了零售,第1段要求的信息需显示在:

(a)随附的文件;或

(b)标签或包装;或

(c)销售的原料和物件上

9. The information provided for in paragraph 1(a), (b) and

(e) shall be confined to materials and articles which comply with:

(a) the criteria laid down in Article 3 and, where they apply, Article 4; and

(b) the specific measures referred to in Article 5 or, in their absence, with any national provisions applicable to these materials and articles.

对于遵循以下条件的原料和物件禁闭第1段(a), (b) 和(e)所提供的信息:

(a) 根据第4条规定,审查要符合第3条规定

(b)第5条制定的具体措施或若没有,则遵循国家对它们的制定的条款

Article 16

Declaration of compliance

1. The specific measures referred to in Article 5 shall require that materials and articles covered by those measures be accompanied by a written declaration stating that they comply with the rules applicable to them. Appropriate documentation shall be available to demonstrate such compliance. That documentation shall be made available to the competent authorities on demand.

第16条

守法声明

1.第5条规定的具体措施要求那些原料和物件需附上书面声明它们符合所要求的规则。在有需求时,有适当的文件说明它们符合要求提供给主管当局。

2. In the absence of specific measures, this Regulation shall not prevent Member States from retaining or adopting national provisions for declarations of compliance for materials and articles.

2. 缺乏具体的措施的情况下,此规章应阻止成员国保留或采用国家规则去申明原料和物件符合要求。Article 17

Traceability

1. The traceability of materials and articles shall be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility.

第17条

可追溯性

1. 原料和物件的可追溯性需保证在所有阶段,使得控制,瑕疵品的回收,客户信息及责任归属便利实现

2. With due regard to technological feasibility, business operators shall have in place systems and procedures to allow identification of the businesses from which and to which materials or articles and, where appropriate, substances or products covered by this Regulation and its implementing measures used in their manufacture are supplied. That information shall be made available to the competent authorities on demand.

2,由于技术上的可行性,商业运营商需有适当的系统和程序使原料和物件的来源和去处可识别,还有此规章涵盖的物质或产品以及生产过程中使用的执行措施。在需要的情况下,这些信息需提供给主管当局。

3. The materials and articles which are placed on the market in the Community shall be identifiable by an appropriate system which allows their traceability by means of labelling or relevant documentation or information.

投放到共同体市场的原料和物件由一定的系统提供标签追溯或相关文件或资料确认信息。

Article 18

Safeguard measures

1. When a Member State, as a result of new information or a reassessment of existing information has detailed grounds for concluding that the use of a material or article endangers human health, although it complies with the relevant specific measures, it may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission and give reasons for the suspension or restriction. L 338/12 EN Official Journal of the European Union 13.11.2004

第18条

保护测量

1. 新信息或现有信息的重新评估有详细的理由认为使用某原料或物件将会危害人类健康,即使它符合相关具体措施,都可能暂时中止使用或考虑其领域范围限制使用。这需马上通知其他成员国和共同体并给出中止或限制的理由,2004年11月13日欧洲政府公告L 338/12

2. The Commission shall examine as soon as possible, where appropriate after obtaining an opinion from the Authority, within the Committee referred to in Article

23(1) the grounds adduced by the Member State referred to in paragraph 1 and shall deliver its opinion without delay and take appropriate measures.

当收到安全局的决议时,委员会应尽快审查。第23(1)条规定,由委员会委员,成员国按照第1段的要求列举理由,并及时发表决议和采用适当的措施。

3. If the Commission considers that amendments to the relevant specific measures are necessary in order to remedy the difficulties referred to in paragraph 1 and to ensure the protection of human health, those amendments shall be adopted in accordance with the procedure referred to in Article 23(2).

如果委员会认为相应具体措施的修正对于缓解第1段

所述的困境有必要,且能保证人类健康。则在符合第23(2)条提及的程序下采用这些修正。

4. The Member State referred to in paragraph 1 may retain the suspension or restriction until the amendments referred to in paragraph 3 have been adopted or the Commission has declined to adopt such amendments.

第1段里,成员国可能会保留中止或限制决议直到第3段所提的修正被采用或委员会拒绝采用这样的修正决定。

Article 19

Public access

1. Applications for authorisation, supplementary information from applicants and opinions from the Authority, excluding confidential information, shall be made accessible to the public in accordance with Articles 38, 39 and 41 of Regulation (EC) No 178/200

2.

2. Member States shall process applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.

第19条

公众访问

1. 申请人和安全局决议的授权申请书,补充信息不包括机密信息,根据178/2002号指令的第38,39和41条规定要方便公众查看。

审定,附加的信息的申请2. 根据1049/2001号指令的第5条规定,成员国需把进入申请书归档。

Article 20

Confidentiality

1. The applicant may indicate which information submitted under Articles 9(1), 10(2) and 12(2) is to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.

第20条

机密性

1. 申请人需指明在第9(1), 10(2) 和12(2)条下递交的资料,由于披露会损害其竞争优势而视为机密资料。在这种情况下要提供正当的可论证的理由。

2. Information relating to the following shall not be considered confidential:

(a) the name and address of the applicant and the chemical name of the substance;

(b) information of direct relevance to the assessment of the safety of the substance;

(c) the analytical method or methods.

以下情况的信息不能视为机密:

(a)申请人的名称和地址,物质的化学名称

(b)关于物质的安全评估的资料

(c)分析方法

3. The Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant and the Authority of its decision.

与申请人磋商后委员会要确定需保密的资料并把决议通知给申请者和安全局。

4. The Authority shall supply the Commission and the Member States with all information in its possession on request.

安全局需给委员会和成员国提供所要求的一切信息

5. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health.

委员会、安全局和成员国需采取必要措施确保这些信息的保密性,除了那些为了保证人类健康而必须公布的信息

6. If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information provided, including research and development information as well as information on which the Commission and the applicant disagree as to its confidentiality.

如果申请人撤销或已经撤销申请书,安全局、委员会和成员国需尊重商业和行业信息的机密性,包括研究和开发信息还用委员会和申请人关于机密性的差异信息。

Article 21

Sharing of existing data

Information given in an application submitted in accordance with Articles 9(1), 10(2) and 12(2) may be used for the benefit of another applicant, provided that the Authority considered that the substance is the same as the one for which the original application was submitted, including the degree of purity and the nature of impurities, and that the other applicant has agreed with the original applicant that such information may be used.

第21条

现有的数据的分享

由申请人递交的符合第9(1), 10(2)和12(2)规定的资料

可能用于造福其他申请人,对于安全局认为物质与原递交申请是一致的,包括纯度及天然杂质,而且其他申请人同意原申请人,则规定可以使用这样的资料。Article 22

Amendments to Annexes I and II

Amendments to Annexes I and II shall be adopted in accordance with the procedure referred to in Article

23(2).

第22条

对附件I和II的修改

参考第23 ( 2 ) 条采用对附件I 和II的修改

Article 23

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58(1) of Regulation (EC) No

178/2002.

第23条

委员会程序

1. 178/2002号指令第58(1)条设立食物链及动物健康的常务委员将帮助委员会

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

关于1999/468/EC决议的第5条和第7条的申请需考虑

第8条的规定方法。1999/468/EC决议的第5(6)设立的期限为3个月。

3. The Committee shall adopt its rules of procedure.

委员会需采纳程序的规则

Article 24

Inspection and control measures

1. Member States shall carry out official controls in order to enforce compliance with this Regulation in accordance with relevant provisions of Community law relating to official food and feed controls. 13.11.2004 EN Official Journal of the European Union L 338/13

第24条

检查和控制措施

1. 各成员国应实施官方控制以便执行遵守本条例依照有关规定共同体关于食品和饲料控制,2004年11月13日欧洲政府公告L 338/ 13。

2. Where necessary and on the request of the Commission, the Authority shall assist in developing technical guidance on sampling and testing to facilitate a coordinated approach for the application of paragraph 1.

在必要时,应委员会要求,安全局应当协助第1段的申请人对协调样品收集和测试上发展技术方面的指导.

3. The Community reference laboratory for materials and articles intended to come into contact with food and national reference laboratories established as laid down in Regulation (EC) No 882/2004 shall assist Member States in the application of paragraph 1 by contributing to a high quality and uniformity of analytical results.

882/2004号指令规定成立接触食品的原料和物件的共同体参考实验室和国家参考实验室,需提供高质量和均匀性的分析结果来协助第1段申请情况的成员国Article 25

Sanctions

Member States shall lay down the rules on sanctions applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The sanctions provided for must be effective, proportionate and dissuasive. Member States shall communicate the relevant provisions to the Commission by 13 May 2005 and shall communicate to it without delay any subsequent

amendment affecting them.

第25条

制裁

各成员国应制定适用于违反本条例规定的制裁,并应采取一切必要措施,确保其执行。制裁规定必须是有效的,适度和有劝阻效果的。各成员国应在2005年5月13日向委员会传递有关规定,传递应及时且不影响他们以后的任何修正案。

Article 26

Repeals

Directives 80/590/EEC and 89/109/EEC are repealed. References to the repealed Directives shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III.

第26条

废止

80/590 和89/109 指令被废止。引用该废除指示应被解释为对本规定参考,和应阅读附件3的相关表

Article 27

Transitional arrangements

Materials and articles that have been lawfully placed on the market before 3 December 2004 may be marketed until the stocks are exhausted.

第27条

过渡安排

在2004年12月3日前合法投入市场的原料和物件可能直至库存耗尽才停止流通市场。

Article 28

Entry into force

This Regulation shall enter into force on the 20 th day following that of its publication in the Official Journal of the European Union. Article 17 shall apply from 27 October 2006. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 27 October 2004.

For the European Parliament

J. BORRELL FONTELLES

For the Council

The President

A. NICOLAI The President

L 338/14 EN Official Journal of the European Union 13.11.2004

第28条

生效

本规定在自2006年10月27日欧洲政府公告第17条公布后20天内生效。这一规定具有约束力,并直接适用于所有成员国。

于2004年10月27日斯特拉斯堡(法国东北部城市)最终确定

欧洲议会

J. BORRELL FONTELLES

委员会主席

A.尼古拉

总统

2004年11月13日欧洲政府公告L 338/14

ANNEX I附件I

List of groups of materials and articles which may be covered by specific measures

具体措施涉及的原料与物件的名单

1. Active and intelligent materials and articles活性和智能型的原料和物件

2. Adhesives粘合剂

3. Ceramics陶瓷制品

4. Cork软木

5. Rubbers合成橡胶

6. Glass玻璃

7. Ion-exchange resins离子交换树脂

8. Metals and alloys金属合金

9. Paper and board纸张和纸板

10. Plastics塑料

11. Printing inks印刷油墨

12. Regenerated cellulose再生细胞膜质

13. Silicones硅胶

14. Textiles纺织品

15. Varnishes and coatings油漆和涂层

16. Waxes蜡

17. Wood木材

13.11.2004 EN Official Journal of the European Union L 338/15

2004年11月13日欧洲政府公告L 338/15

ANNEX II附件II

Symbol标志

L 338/16 EN Official Journal of the European Union 13.11.2004

2004年11月13日欧洲政府公告L 338/16

ANNEX III附件III

Correlation table关系表

Directive 89/109/EEC This Regulation 89/109/EEC指令

Article 1 Article 1

— Article 2第2条(以此类推)

Article 2 Article 3

— Article 4

Article 3 Article 5

— Article 7

— Article 8

— Article 9

— Article 10

— Article 11

— Article 12

— Article 13

— Article 14

Article 4 —

Article 6 Article 15

— Article 16

— Article 17

Article 5 Article 18

Article 7 Article 6

— Article 19

— Article 20

— Article 21

— Article 22

Article 8 —Article 9 Article 23

— Article 24

— Article 25

Article 10 Article 26

— Article 27

Article 11 —

Article 12 —

Article 13 Article 28

Annex I Annex I

Annex II —

Annex III Annex III

Directive 80/590/EEC This Regulation Annex Annex II

欧盟食品安全法规与应对

欧盟最新食品安全法规与应 对 -标准化文件发布号:(9456-EUATWK-MWUB-WUNN-INNUL-DDQTY-KII

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