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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日發(fā)布關(guān)于食品接觸類原料和物料的歐 盟1935 2004指令 同時撤銷原歐洲共同體80 590和 89 109指令 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION 歐洲議會與理事會 Having regard to the Treaty establishing the European Community and in particular Article 95 thereof 注意到建立歐洲共同體的 條約 特別是第95條 Having regard to the proposal from the Commission 注意到委員會的提案 Having regard to the opinion of the European Economic and Social Committee 1 注意到歐洲經(jīng)濟和社會委員會的意見 1 Acting in accordance with the procedure laid down in Article 251 of the Treaty 2 按照 條約 第251條規(guī)定的程序 2 Whereas 鑒于 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 理事會 1988 年 12 月 21 日的指令 89 109 EEC 關(guān) 于統(tǒng)一各成員國材料和制品用于接觸食品的法律 為 消除各成員國關(guān)于這些原料和物料制定的差異 以及 為特定材料和物品 具體指令 提供通過執(zhí)行的指令 而建立的一般原則 這種做法是成功的并會延續(xù)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 具體通過 89 109 EEC 的指令一般來說囊括的規(guī)定 都沒有空間讓成員國在法律移植上斟酌運用 除了遇 到要求快速適應(yīng)技術(shù)上進步的常見修正 因此 這應(yīng) 當可以采用相關(guān)方法決定規(guī)章或決議的形式 同時 添加額外的項目是可取的 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 此規(guī)章的基本原則是任何用于直接或間接接觸食物原 料或物件對于在傳輸一定數(shù)量食物過程中危害人類健 康或者給食物結(jié)構(gòu)帶來不可接受的改變或者惡化其感 官作用的物質(zhì)呈現(xiàn)充分的惰性反應(yīng) 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 所有旨在積極保持或提高食品 活性食品接觸的原料 或物件 狀況的新款式的原料或物件在設(shè)計過程中必 須呈現(xiàn)惰性 不同于以往新原料或物件會接觸到食物 其他新原料或物件需用于監(jiān)測食品 智能型食品接觸 的原料或物件 狀況 這兩種原料或物件可能會接觸 到食物 所以 出于明確原因和合法性 對于活性食 品和智能型食品的接觸原料或物件都在此規(guī)章范圍內(nèi) 2 以及它們使用的主要要求也有明確規(guī)定 那些盡快被 采用的進一步要求包括授權(quán)物質(zhì)和原料或物件的準許 進口貨單將規(guī)定在具體措施中 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 活性食品接觸的原料或物件旨在有意的吸收釋放到食 物中的 活性 成分或者從食物中吸收物質(zhì) 它們在 生產(chǎn)過程中 如木桶的生產(chǎn) 必須區(qū)分那些傳統(tǒng)用于 釋放天然配料到具體食物中的原料與物件 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 活性食品接觸的原料或物件當且只有符合食品的社區(qū) 規(guī)定 如89 107 EEC 4 指令中的食品規(guī)定 才可以 改變其成分或感官特性 特別是某些特定的活性食品 的食品添加劑所接觸的原料和物件釋放到包裝上或周 圍的環(huán)境等 應(yīng)當授權(quán)于相應(yīng)的食品社區(qū)規(guī)定同時要 遵循即將成立的具體措施規(guī)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日的歐盟議會意見 還沒在官方期刊出 版 和2004年10月14日理事會決議 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 指令由歐盟議會和理事會的1882 2003規(guī)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 理事會 1988 年 12 月 21 日的指令 89 109 EEC 關(guān) 于統(tǒng)一各成員國授權(quán)使用添加劑的法律 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 規(guī)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 提供充足的滿足食品法規(guī)的標簽或者信息 支持用戶處于安全和活性原料和物件的正確使用 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 活躍性和智能型的食品觸點原料和物件不應(yīng)該改變其 組成或者食品的感官特性或者給關(guān)于能誤導(dǎo)消費者食 品狀態(tài)的信息 例如 活躍性食品觸點 原料和物件不 應(yīng)該釋放或者吸收像乙醛或者胺那樣的物質(zhì)從而為了 掩飾食品的開始變化 這樣能操 縱變質(zhì)跡象的變化能 誤導(dǎo)消費者 因此不被允許 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 與此類似 活性食品觸點原料和物件 換乘錯了信息關(guān) 于食品的狀態(tài)可能誤導(dǎo)消費者的給的食品 因此也不 被允許 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 所有要接觸食品的原料或物件在投入市場前需要符合 這條規(guī)章的要求 雖然如此 視為古董的原料或物 件排除在一定限制數(shù)量內(nèi)是被允許的情況 因此接觸 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組成部分覆蓋原料或涂料表層 不適合這條規(guī)章的范圍 另一方面 這條規(guī)章應(yīng)該適 用于那些非組成部分的且不一起消費使用的涂層原料 如蓋住乳酪皮 預(yù)加工肉產(chǎn)品或者水果的涂料表層 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 對此規(guī)章覆蓋的原料和物件的使用情況和其生產(chǎn)過程 中使用的材料 制定不同類型限制和制約是非常必要 的 對各組原料和物件的具體關(guān)于技術(shù)性質(zhì)細節(jié)的措 施建立限制條件是合適的 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 按照歐盟議會的 EC No 178 2002規(guī)章和2002年1 月28日委員會擬定總則和食品法律的要求 建立歐洲 食品安全局并且對有關(guān)食品安全擬定程序 1 在具 體措施下影響公眾健康的規(guī)定采用前 需要咨詢歐洲 食品安全局的意見 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 當具體措施包括用于生產(chǎn)接觸食品類的原料和物件的 一系列社區(qū)授權(quán)物質(zhì) 這些物質(zhì)必須經(jīng)過安全評估階 段才能獲得授權(quán) 這些物質(zhì)的安全評估和授權(quán)必須不 影響共同體就注冊 評估 授權(quán)和化學(xué)限制的相關(guān)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 國家法律 規(guī)章和管理條例對在接觸食品的原料和物 質(zhì)生產(chǎn)過程中所用的物質(zhì)的安全評估和授權(quán)的規(guī)定差 別 會阻礙這些原料和物件的自由活動 產(chǎn)生不平等 和不公平的競爭 因此審定程序須在社區(qū)水平上建立 為了保證這些物質(zhì)安全評估協(xié)調(diào) 食品安全局須執(zhí)行 這樣的評估 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 物質(zhì)的安全評估必須遵循風險管理決定 不管這些物 質(zhì)是否列入社區(qū)授權(quán)目錄 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 就此規(guī)章下的安全局而言 為具體作為或不作為的 提供可能性管理檢閱是合適的 這種檢閱在風險評估 中作為獨立的科學(xué)參考點 對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 標簽支持用戶正確使用原料和物件 標簽的使用方法 可以根據(jù)用戶做相應(yīng)的改變 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 采用一種符號可以伴隨 接觸食品的原料和物件 這各符號 出于簡化的原因 應(yīng)該被并入這條規(guī)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 接觸食品類的原料和物件保證在任何階段都可以追溯 為了便于控制 瑕疵品的回收 客戶信息和責任歸因 交易運營商最低限度必須做到識別出原料和物件是從 哪里來 運到哪里去 1 根據(jù)規(guī)章 EC NO 1642 2003 OJ L 245 29 9 2003 頁 4 修改的規(guī)章OJ L 31 1 2 2002 頁 1 2 歐盟委員會1980年6月9日關(guān)于確定接觸食品類原料 和物件的80 590 EEC指令 此法規(guī)以2003指令添加到 2004年11月13日的歐盟L L 338 5聯(lián)合公報為最后修正 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 對受控于此規(guī)則的原料和物件 應(yīng)該考慮發(fā)展中 國家 特別是不發(fā)達國家的特殊需求 委員會遵循歐 盟議會 No 882 2004 和 2004 年 4 月 29 號的理事會 關(guān)于執(zhí)行確定飼料和食品法 動物的健康和動物福利法規(guī) 1 受控事實的官方管理手段 以確保發(fā)展中國家的食 品 包括接觸食品原料和物件的安全 具體條例因此 成立 同時適用于接觸食品的原料和物件 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 當原料或物件對人類有一系列持續(xù)的危害 需要 建立保衛(wèi)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日歐盟議會和理事會關(guān)于公眾參與歐盟 議會 理事會和共同體文獻的 EC No 1049 2001規(guī)章 適用于安全局執(zhí)行文獻 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 保護搜集支持此規(guī)章下實際應(yīng)用的信息和數(shù)據(jù)的改革 人的投資是合理的 為了避免不必要的重復(fù)實驗 特 別是動物測試 然而 在利益關(guān)系的雙方同意下 分 享數(shù)據(jù)時允許的 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 歐共體和國家參數(shù)實驗室必須致力于高品質(zhì)和一 致性的分析結(jié)果 這個目標將在在 EC No 882 2004 規(guī)章框架下得到實現(xiàn) 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 對于回收原料和物件的使用需符合共同體出于環(huán)境因 素為了保證食品安全和消費者的保護而制定嚴格要求 這些要求也要考慮附件一提及的各類原料和物件的技 術(shù)特征 再循環(huán)的塑料原料和物件使用量增加 當國 家法律和規(guī)章有分歧時 優(yōu)先考慮和諧持續(xù)的規(guī)則 因此 需要盡快起草有關(guān)回收利用的原料和物件的具 體措施 從而明確共同體的合法性 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 此規(guī)則的必要執(zhí)行措施和附件1 2的修正必須與理事會 1999年6月28日的 1999 468 EC決定 規(guī)定的執(zhí)行權(quán)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 會員國應(yīng)該制定評定違反這條規(guī)章條款的制裁并保證 其有效性 這些制裁必須是有效的 均衡的和有勸誡 作用 27 It is necessary for business operators to have sufficient time to adapt to some of the requirements established by this Regulation 應(yīng)該給運營商足夠的時間適應(yīng)此規(guī)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 基于國家間的法律和條約有差異 各國不能保證達到 此規(guī)章的目標 因此 在共同體的基礎(chǔ)上會達到更好 的效果 共同體也許會根據(jù)條約第五章輔助原則采用 一系列措施 依照條款的均衡性原則 為了達到這些 目標 此規(guī)章超出其范圍 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因此應(yīng)該被廢止 已經(jīng)采用這條規(guī)章 第 1條 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 目的和主要內(nèi)容 1 這條規(guī)章的目的是為了保證直接或間接接觸食品類 的原料和物件國際市場的高效運作 時時為人類健康 和客戶利益提供固定的高水準保護 1 OJ L 165 30 4 2004 頁1 作為 OJ L 191 28 5 2004 頁1 修正版 2 OJ L 145 31 5 2001 頁43 3 OJ L 184 17 7 1999 頁23 13 11 2004的政府公 關(guān) 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 這條規(guī)章將適用于接觸活性食品和智能型食品的原 料和物件 在下文稱為的原料和物件 a 計劃與食品接觸 或者 b 已經(jīng)與食品接觸 并且 已打算傾向于那目的 或 者 c 在平?；蛘呖深A(yù)見的情況下能購買到與食品接觸 或者轉(zhuǎn)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 這規(guī)章將不適用于 a 作為古董的原料和物件 b 涂層材料 例如包裝乳酪皮 預(yù)加工肉產(chǎn)品或者水 果 組成食品的部分和可能和食品一起食用的 c 修理公眾或私人用水設(shè)備 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條 定義 1 為了這條規(guī)章的目的 指令 EC No 178 2002制定 的相應(yīng)定義 可追溯的 和 在市場配售 的定義 例外 需要有以下的定義 a 可追溯性 在生產(chǎn) 整合和運輸?shù)乃须A段都能 追溯和跟蹤原料或物件 b 可在市場配售 為了銷售而持有的那些原料和物 件 包括供應(yīng)商或其他形式的經(jīng)銷商 是否免 費 以及 銷售 分配和其他形式經(jīng)銷 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 下列定義也將適用 a 接觸活性食品的原料和物件 在下文稱為的活性原 料和物件 意思是為了延長保質(zhì)期或保持或提高包裝 食品的狀態(tài) 它們含有那些可以從包裝食品或食品周 邊環(huán)境釋放或吸收物質(zhì) b intelligent food contact materials and articles hereinafter referred to as intelligent materials and articles means