EC1935_2004食品接觸類原料和制品(歐盟)1935_2004指令_中英文整理版

1、REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 27 October 2004on materials and articles intended to come into contact with food and repealing Directives 80/590/EECand 89/109/EEC2004年10月27日發(fā)布關(guān)于食品接觸類原料和物料的歐盟1935/2004指令，同時(shí)撤銷原歐洲共同體80/590和89/109指令THE EUROPEAN PARLIAMENT AND

2、THE COUNCIL OF THE EUROPEANUNION,歐洲議會(huì)與理事會(huì)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(huì)的提案Having regard to the opinion of the European Economic andSocial Committee (1),

3、注意到歐洲經(jīng)濟(jì)和社會(huì)委員會(huì)的意見（1）Acting in accordance with the procedure laid down in Article 251of 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

4、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 a

5、pproach was successful and should be continued.理事會(huì)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(huì)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 exerc

6、ise of discretion by the MemberStates in their transposition besides being subject to frequent amendments required to adapt them rapidly to technological progress. It should therefore be possible for such measures to take the form of regulations or decisions. At the same time it is appropriate to in

7、clude 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(yùn)用，除了遇到要求快速適應(yīng)技術(shù)上進(jìn)步的常見修正。因此，這應(yīng)當(dāng)可以采用相關(guān)方法決定規(guī)章或決議的形式。同時(shí)，添加額外的項(xiàng)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 intende

8、d 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

9、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(duì)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 ma

10、terials 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 therefo

11、re 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 po

12、sitive 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(jì)過程中必須呈現(xiàn)惰性，不同于以往新原料或物件會(huì)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(huì)接觸到食物。所以，出于明確原因和合法性，對(duì)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)，以及它們使用的主要要求也有明確規(guī)定。那些盡快被采

13、用的進(jìn)一步要求包括授權(quán)物質(zhì)和原料或物件的準(zhǔn)許進(jìn)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

14、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?cè)谏a(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 t

15、he 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 materi

16、als 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(dāng)且只有符合食品的社區(qū)規(guī)定，如89/107/EEC (4)指令中的

17、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(dāng)授權(quán)于相應(yīng)的食品社區(qū)規(guī)定同時(shí)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(huì)意見（還沒在官方期刊出版）和2004年10月14

18、日理事會(huì)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(huì)和理事會(huì)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 conc

19、erning 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(huì)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,

20、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(biāo)簽或者信息支持用戶處于安全和活性原料

21、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

22、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(diǎn)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(fèi)者食品狀態(tài)的信息。例如，活躍性食品觸點(diǎn)原料和物件不應(yīng)該釋放或者吸收

23、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(fèi)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(diǎn)原料和物

24、件換乘錯(cuò)了信息關(guān)于食品的狀態(tài)可能誤導(dǎo)消費(fèi)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 restrict

25、ed 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 oth

26、er 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(fèi)使用的涂層原料如蓋住乳酪皮、

27、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 havin

28、g regard to the technological characteristics specific to each group of materials and articles.對(duì)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(duì)各組原料和物件的具體關(guān)于技術(shù)性質(zhì)細(xì)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 th

29、e 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 speci

30、fic measures.(11) 按照歐盟議會(huì)的(EC) No.178/2002規(guī)章和2002年1月28日委員會(huì)擬定總則和食品法律的要求，建立歐洲食品安全局并且對(duì)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 co

31、ntact 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

32、and restriction of chemicals.當(dāng)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(píng)估階段才能獲得授權(quán)。這些物質(zhì)的安全評(píng)估和授權(quán)必須不影響共同體就注冊(cè)、評(píng)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 m

33、aterials 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 asses

34、sment of those substances, the Authority should carry out such assessments.國家法律、規(guī)章和管理?xiàng)l例對(duì)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(píng)估和授權(quán)的規(guī)定差別，會(huì)阻礙這些原料和物件的自由活動(dòng)，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(píng)估協(xié)調(diào)，食品安全局須執(zhí)行這樣的評(píng)估。(14) The safety assessment of substances should be followed by a risk management decision as to whether

35、 those substances should be entered on a Community list of authorized substances.物質(zhì)的安全評(píng)估必須遵循風(fēng)險(xiǎn)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

36、 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(fēng)險(xiǎn)評(píng)估中作為獨(dú)立的科學(xué)參考點(diǎn)，對(duì)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

37、 may vary according to the user.標(biāo)簽支持用戶正確使用原料和物件。標(biāo)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.

38、委托指令的80/590 /EEC( 2 ) 采用一種符號(hào)可以伴隨接觸食品的原料和物件。這各符號(hào)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 resp

39、onsibility. 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) No1642/2003 (OJ L 245, 29.9.2003, p. 4).(2) Commission Directive 80/590/EEC of 9 J

40、une 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 Accession13.11.2004 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

41、收，客戶信息和責(zé)任歸因。交易運(yùn)營商最低限度必須做到識(shí)別出原料和物件是從哪里來，運(yùn)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(huì)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(bào)為最后修正。(19) In the control of the compliance of the materials and articles with this Regulatio

42、n, 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 e

43、nsure 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 Regu

44、lation which should be applicable also to the food contact materials and articles.(19)對(duì)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(dá)國家的特殊需求。委員會(huì)遵循歐盟議會(huì)No 882/2004和2004年4月29號(hào)的理事會(huì)，關(guān)于執(zhí)行確定飼料和食品法、動(dòng)物的健康和動(dòng)物福利法規(guī)（1）受控事實(shí)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(shí)適用于接觸食品的原料和物件。 (20) It is necessary to establish procedures fo

45、r the adoption of safeguard measures in situations where a material or article is likely to constitute a serious risk to human health.(20)當(dāng)原料或物件對(duì)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

46、Parliament, Council and Commission documents (2) applies to documents held by the Authority.2001年3月30日歐盟議會(huì)和理事會(huì)關(guān)于公眾參與歐盟議會(huì)、理事會(huì)和共同體文獻(xiàn)的(EC) No 1049/2001規(guī)章，適用于安全局執(zhí)行文獻(xiàn)。(22) It is appropriate to protect the investment made by innovators in gathering the information and data supporting an application made u

47、nder 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(hù)搜集支持此規(guī)章下實(shí)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(shí)驗(yàn)，特別是動(dòng)物測試，然而，在利益關(guān)系的雙方同意下，分享數(shù)據(jù)時(shí)允許的。(23) Commun

48、ity 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(shí)驗(yàn)室必須致力于高品質(zhì)和一致性的分析結(jié)果。這個(gè)目標(biāo)將在在(EC) No 882/2004規(guī)章框架下得到實(shí)現(xiàn)。(24) The use of re

49、cycled 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 diff

50、erent 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

51、 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(duì)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(fèi)者的保護(hù)而制定嚴(yán)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(dāng)國家法律和規(guī)章有分歧時(shí)，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

52、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 CouncilDecision 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

53、要執(zhí)行措施和附件1,2的修正必須與理事會(huì)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.會(huì)員國應(yīng)該制定評(píng)定違反這條規(guī)章條款的制裁并保證其

54、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(yùn)營商足夠的時(shí)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 differ

55、ences 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 Ar

56、ticle, 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(dá)到此規(guī)章的目標(biāo)，因此，在共同體的基礎(chǔ)上會(huì)達(dá)到更好的效果，共同體也許會(huì)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(dá)到這些目標(biāo)，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

57、: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 1Purpose and subject matter1. 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 directl

58、y 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. 23L 338/6 EN Off

59、icial 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(yùn)作，時(shí)時(shí)為人類健康和客戶利益提供固定的高水準(zhǔn)保護(hù)(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