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

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 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 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 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 3 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 4 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 5 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 6 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