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EC NO 20232006:關(guān)于食品接觸材料和制品的良好操作規(guī)范

英文原文：

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

?B ??????????COMMISSION REGULATION (EC) No 2023/2006

of 22 December 2006

on good manufacturing practice for materials and articles intended to come into contact with food

(Text with EEA relevance)

(OJ L 384, 29.12.2006, p. 75)

Amended by: Official Journal

No: L 86 page 9 date 28.3.2008

?M1

Commission Regulation (EC) No 282/2008 of 27 March 2008

?

COMMISSION REGULATION (EC) No 2023/2006

of 22 December 2006

on good manufacturing practice for materials and articles intended to come into contact with food

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1935/2004 of the European Parliament and the Council of 27 October 2004 on materials and articles intended to come into contact with food (1), and in particular Article 5(1) thereof,

Whereas:

(1)?? Groups of materials and articles listed in Annex I to Regulation (EC) No 1935/2004 and combinations of those materials and articles or recycled materials and articles used in those materials and articles should be manufactured in compliance with general and detailed rules on good manufacturing practice (GMP).

(2)?? Some sectors of industry have established GMP guidelines, while others have not. Consequently, it appears necessary to ensure uniformity among Member States as regards GMP for materials and articles intended to come into contact with food.

(3)?? In order to ensure such conformity, it is appropriate to lay down certain obligations on business operators.

(4)?? All business operators should operate an effective quality management of their manufacturing operations which should be adapted to their position in the supply chain.

(5)?? The rules should apply to materials and articles intended to be brought into contact with food, or already in contact with food and were intended for this purpose, or those which 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.

(6)?? The rules on GMP should be applied proportionately to avoid undue burdens for small businesses.

(7)?? Detailed rules should now be set for processes involving printing inks and should be established for other processes as necessary. For printing inks applied to the non-food contact side of a material or article GMP should in particular ensure that substances are not transferred into food by set-off or transfer through the substrate.

(8)?? The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.

(1) OJ L 338, 13.11.2004, p. 4.

?

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down the rules on good manufacturing practice (GMP) for the groups of materials and articles intended to come into contact with food (hereafter referred to as materials and articles) listed in Annex I to Regulation (EC) No 1935/2004 and combinations of those materials and articles or recycled materials and articles used in those materials and articles.

Article 2

Scope

This Regulation shall apply to all sectors and to all stages of manufacture, processing and distribution of materials and articles, up to but excluding the production of starting substances. The detailed rules set out in the Annex shall apply to the relevant individually mentioned processes, as appropriate.

Article 3

Definitions

For the purpose of this Regulation, the following definitions shall apply:

(a)?? ‘good manufacturing practice (GMP)’ means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof;

(b)?? ‘quality assurance system’ means the total sum of the organised and documented arrangements made with the purpose of ensuring that materials and articles are of the quality required to ensure conformity with the rules applicable to them and the quality standards necessary for their intended use;

(c)?? ‘quality control system’ means the systematic application of measures established within the quality assurance system that ensure compliance of starting materials and intermediate and finished materials and articles with the specification determined in the quality assurance system;

(d)?? ‘non-food-contact side’ means the surface of the material or article that is not directly in contact with food;

(e)?? ‘food-contact side’ means the surface of a material or article that is directly in contact with the food.

Article 4

Conformity with good manufacturing practice

The business operator shall ensure that manufacturing operations are carried out in accordance with:

(a)?? the general rules on GMP as provided for in Article 5, 6, and 7,

(b)?? the detailed rules on GMP as set out in the Annex.

Article 5

Quality assurance system

1.????? The business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system. That system shall:

(a)?? take account of the adequacy of personnel, their knowledge and skills, and the organisation of the premises and equipment such as is necessary to ensure that finished materials and articles comply with the rules applicable to them;

(b)?? be applied taking into account the size of the business run by the operator, so as not to be an excessive burden on the business.

2.????? Starting materials shall be selected and comply with pre-established specifications that shall ensure compliance of the material or article with the rules applicable to it.

3.????? The different operations shall be carried out in accordance with pre-established instructions and procedures.

Article 6

Quality control system

1.????? The business operator shall establish and maintain an effective quality control system.

2.????? The quality control system shall include monitoring of the implementation and achievement of GMP and identify measures to correct any failure to achieve GMP. Such corrective measures shall be implemented without delay and made available to the competent authorities for inspections.

Article 7

Documentation

1.????? The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to specifications, manufacturing formulae and processing which are relevant to compliance and safety of the finished material or article.

2.????? The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to records covering the various manufacturing operations performed which are relevant to compliance and safety of the finished material or article and with respect to the results of the quality control system.

3.????? The documentation shall be made available by the business operator to the competent authorities at their request.

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Article 8

Entry into force

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 August 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

Detailed rules on good manufacturing practice

▼M1

A. Printing inks

▼B

Processes involving the application of printing inks to the non-food contact side of a material or article

1.??????? Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food-contact side:

(a)?? through the substrate or;

(b)?? by set-off in the stack or the reel,

in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.

2.??????? Printed materials and articles shall be handled and stored in their finished and semi-finished states in such a manner that substances from the printed surface are not transferred to the food-contact side:

(a)?? through the substrate or;

(b)?? by set-off in the stack or reel,

in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.

3.??????? The printed surfaces shall not come into direct contact with food.

▼M1

B. Quality assurance system for plastic recycling processes covered by Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006

1.????? The quality assurance system implemented by the recycler must give adequate confidence in the capability of the recycling process to ensure the recycled plastic meets the requirements in the authorisation.

2.????? All the elements, requirements and provisions adopted by the recycler for his quality assurance system must be documented in a systematic and orderly manner in the form of written policy statements and procedures.

That quality system documentation must permit uniform interpretation of the quality policy and procedures, such as quality programmes, plans, manuals, records and measures taken to ensure traceability.

It must include, in particular:

(a)?? a quality policy manual, containing a clear definition of the recycler’s quality objectives, the organisation of the business and in particular the organisational structures, the responsibilities of the managerial staff and their organisational authority where manufacture of the recycled plastic is concerned;

(b)?? the quality control plans, including those for input and recycled plastic characterisation, suppliers’ qualification, sorting processes, washing processes, deep cleansing processes, heating processes, or any other part of the process relevant for the quality of the recycled plastic including the choice of points which are critical for the quality control of the recycled plastics;

(c)?? the managing and operative procedures implemented to monitor and control the whole recycling process, including the inspection and quality assurance techniques at all the manufacturing stages, especially the establishment of critical limits at the points which are critical for the quality of the recycled plastics;

(d)?? the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired recycled plastic quality, including control of products which fail to conform;

(e)?? the tests and analytical protocols or any other scientific evidence applied before, during and after recycled plastic production, the frequency with which they will take place, and the test equipment used; it must be adequately possible to trace back the calibration of the test equipment;

(f)??? the recording documents adopted.

譯文：

本文件僅作為文件工具，機(jī)構(gòu)不對其內(nèi)容承擔(dān)任何責(zé)任

歐盟委員會第2023/2006號法規(guī)

2006年12月22日

與食品接觸的材料和物品的良好制造規(guī)范

（與歐洲經(jīng)濟(jì)區(qū)相關(guān)的文本）

（OJ L 3842006年12月29日，第75頁）

修訂人：官方公報

No: L 86 page 9 date 28.3.2008

?

2008年3月27日第282/2008號委員會條例（EC）

歐盟委員會第2023/2006號法規(guī)

2006年12月22日

與食品接觸的材料和物品的良好制造規(guī)范

（與歐洲經(jīng)濟(jì)區(qū)相關(guān)的文本）

歐洲共同體委員會，

關(guān)于建立歐洲共同體的條約，

考慮到2004年10月27日歐洲議會和理事會關(guān)于與食品接觸的材料和物品的第1935/2004號法規(guī)（EC），特別是其中的第5（1）條，

鑒于：

（1）??? 第1935/2004號法規(guī)（EC）附件一中列出的材料和物品組，以及這些材料和物品或回收材料和物品的組合，應(yīng)按照良好制造規(guī)范（GMP）的一般和詳細(xì)規(guī)則制造。

（2）??? 一些行業(yè)部門制定了GMP指南，而其他行業(yè)則沒有。因此，似乎有必要確保成員國在與食品接觸的材料和物品的GMP方面的一致性。

（3）??? 為了確保這種一致性，應(yīng)當(dāng)對經(jīng)營者規(guī)定某些義務(wù)。

（4）??? 所有企業(yè)經(jīng)營者都應(yīng)該對其生產(chǎn)經(jīng)營活動進(jìn)行有效的質(zhì)量管理，并根據(jù)其在供應(yīng)鏈中的地位進(jìn)行調(diào)整。

（5）??? 這些規(guī)則應(yīng)適用于擬與食品接觸的材料和物品，或已與食品接觸并用于此目的的材料和制品，或可合理預(yù)期與食品接觸或在正?；蚩深A(yù)見的使用條件下將其成分轉(zhuǎn)移到食品中的材料和物品。

（6）??? GMP規(guī)則應(yīng)按比例適用，以避免給小企業(yè)帶來不適當(dāng)?shù)呢?fù)擔(dān)。

（7）??? 現(xiàn)在應(yīng)為涉及印刷油墨的工藝制定詳細(xì)規(guī)則，并在必要時為其他工藝制定細(xì)則。對于應(yīng)用于材料或物品非食品接觸側(cè)的印刷油墨，GMP應(yīng)特別確保物質(zhì)不會通過接觸或滲透而轉(zhuǎn)移到食品中。

（8）??? 本條例規(guī)定的措施符合食品鏈和動物健康常務(wù)委員會（SCFCAH）的意見。

?

已通過本條例：

?

第 1 條

主題

該法規(guī)規(guī)定了第1935/2004號法規(guī)（EC）附件一中列出的擬與食品接觸的材料和物品（以下簡稱材料和物品）組的良好生產(chǎn)規(guī)范（GMP）規(guī)則，以及這些材料和物品或回收材料和物品的組合以及這些材料和物品中使用的物品。

第二條

范圍

本條例應(yīng)適用于材料和物品的所有部門和制造、加工和分銷的所有階段，但不包括起始物質(zhì)的生產(chǎn)。附件中規(guī)定的詳細(xì)規(guī)則應(yīng)酌情適用于單獨提及的相關(guān)進(jìn)程。

第3條

定義

在本法規(guī)中，以下定義適用：

(a)?? “良好生產(chǎn)規(guī)范（GMP）”是指質(zhì)量保證的各個方面，這些方面確保材料和物品的生產(chǎn)和控制是一致的，以確保符合適用于它們的規(guī)則和適合其預(yù)期用途的質(zhì)量標(biāo)準(zhǔn)，不會危害人類健康或?qū)е率称烦煞职l(fā)生不可接受的變化或?qū)е缕涓泄偬匦詯夯?/span>

(b)?? “質(zhì)量保證體系”是指為確保材料和物品的質(zhì)量符合適用規(guī)則和預(yù)期用途所需的質(zhì)量標(biāo)準(zhǔn)而作出的有組織和有文件記錄的安排的總和；

(c)?? “質(zhì)量控制體系”是指在質(zhì)量保證體系內(nèi)建立的系統(tǒng)應(yīng)用措施，以確保起始材料、中間材料和成品符合質(zhì)量保證體系中確定的規(guī)范；

(d)?? “非食品接觸面”是指不直接接觸食品的材料或物品的表面；

(e)?? “食品接觸面”是指與食品直接接觸的材料或物品的表面。

第4條

符合良好制造規(guī)范

企業(yè)經(jīng)營者應(yīng)確保按照以下要求進(jìn)行生產(chǎn)操作：

（a） 第5、6和7條規(guī)定的GMP一般規(guī)則，

（b） 附錄中規(guī)定的GMP細(xì)則。

第5條

質(zhì)量保證體系

1.經(jīng)營者應(yīng)建立、實施并確保遵守有效且有文件記錄的質(zhì)量保證體系。該系統(tǒng)應(yīng)：

（a） 考慮人員的充足性、他們的知識和技能以及場所和設(shè)備的組織，如確保成品材料和物品符合適用規(guī)則所必需的；

（b） 應(yīng)用時應(yīng)考慮到運(yùn)營商經(jīng)營的業(yè)務(wù)規(guī)模，以免對業(yè)務(wù)造成過度負(fù)擔(dān)。

2.起始材料的選擇應(yīng)符合預(yù)先制定的規(guī)范，該規(guī)范應(yīng)確保材料或物品符合適用的規(guī)則。

3.不同的操作應(yīng)按照預(yù)先制定的指示和程序進(jìn)行。

第6條

質(zhì)量控制體系

1.經(jīng)營者應(yīng)建立并保持有效的質(zhì)量控制體系。

2.質(zhì)量控制體系應(yīng)包括監(jiān)督GMP的實施和實現(xiàn)，并確定糾正任何未能實現(xiàn)GMP的措施。此類糾正措施應(yīng)立即實施，并提供給主管當(dāng)局檢查。

第7條

文檔

1.經(jīng)營者應(yīng)建立并維護(hù)與成品材料或物品的合規(guī)性和安全相關(guān)的規(guī)范、生產(chǎn)配方和加工相關(guān)的紙質(zhì)或電子格式的適當(dāng)文件。

2.企業(yè)經(jīng)營者應(yīng)建立并保存適當(dāng)?shù)募堎|(zhì)或電子文件，記錄所執(zhí)行的與成品材料或物品的合規(guī)性和安全相關(guān)的各種生產(chǎn)操作，以及質(zhì)量控制體系的結(jié)果。

第8條

生效

本法規(guī)應(yīng)自其在《歐盟官方公報》上發(fā)布后的第20天起生效。

自2008年8月1日起適用。

本法規(guī)整體上具有約束力，并直接適用于所有成員國。

附件

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良好制造規(guī)范的詳細(xì)規(guī)則

▼M1

A、 打印墨水

▼B

在材料或物品的非食品接觸面上使用印刷油墨的工藝

1.應(yīng)用于材料和物品非食品接觸側(cè)的印刷油墨的配方和/或應(yīng)用方式應(yīng)確保印刷表面的物質(zhì)不會轉(zhuǎn)移到食品接觸側(cè)：

（a） 通過滲透或；

（b） 通過在堆疊或卷軸狀態(tài)下接觸，

導(dǎo)致食品中物質(zhì)含量不符合第1935/2004號法規(guī)（EC）第3條要求的濃度。

2.印刷材料和物品應(yīng)在成品和半成品狀態(tài)下搬運(yùn)和儲存，以確保印刷表面的物質(zhì)不會轉(zhuǎn)移到食品接觸側(cè)：

（a） 通過滲透或；

（b） 通過在堆疊或卷軸狀態(tài)下接觸，

導(dǎo)致食品中物質(zhì)含量不符合第1935/2004號法規(guī)（EC）第3條要求的濃度。

3.????? 印刷表面不得直接接觸食物。

▼M1

B、 第282/2008號法規(guī)（EC）所涵蓋的塑料回收過程的質(zhì)量保證體系，該法規(guī)涉及與食品接觸的回收塑料材料和物品，并修訂了第2023/2006號法規(guī)（歐盟）

1.回收商實施的質(zhì)量保證體系必須對回收過程的能力有足夠的信心，以確?；厥账芰戏鲜跈?quán)要求。

2.必須以書面政策聲明和程序的形式，系統(tǒng)有序地記錄回收者為其質(zhì)量保證體系所采用的所有要素、要求和規(guī)定。

質(zhì)量體系文件必須允許對質(zhì)量政策和程序進(jìn)行統(tǒng)一解釋，例如質(zhì)量計劃、計劃、手冊、記錄和為確?？勺匪菪远扇〉拇胧?。

它必須特別包括：

（a） 質(zhì)量政策手冊，其中明確定義了回收商的質(zhì)量目標(biāo)、業(yè)務(wù)組織，尤其是組織結(jié)構(gòu)、管理人員的職責(zé)及其組織機(jī)構(gòu)（涉及再生塑料的制造）；

（b） 質(zhì)量控制計劃，包括輸入和回收塑料特性、供應(yīng)商資質(zhì)、分類過程、清洗過程、深度清洗過程、加熱過程或與回收塑料質(zhì)量相關(guān)的任何其他過程部分的計劃，包括對回收塑料質(zhì)量控制至關(guān)重要的點的選擇；

（c） 為監(jiān)測和控制整個回收過程而實施的管理和操作程序，包括所有制造階段的檢查和質(zhì)量保證技術(shù)，特別是在對回收塑料質(zhì)量至關(guān)重要的點上建立關(guān)鍵限值；

（d） 監(jiān)測質(zhì)量體系有效運(yùn)行的方法，特別是其實現(xiàn)預(yù)期回收塑料質(zhì)量的能力，包括對不合格產(chǎn)品的控制；

（e） 在回收塑料生產(chǎn)之前、期間和之后應(yīng)用的測試和分析協(xié)議或任何其他科學(xué)證據(jù)，測試和分析的頻率，以及使用的測試設(shè)備；必須能夠充分追溯試驗設(shè)備的校準(zhǔn)；

（f） 相關(guān)被采用的記錄文件。