(EC) No 2023/2006：关于食品接触材料和制品的良好操作规范 原文与翻译 中文版
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EC NO 20232006:关于食品接触材料和制品的良好操作规范
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.
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.
译文：
本文件仅作为文件工具，机构不对其内容承担任何责任
欧盟委员会第2023/2006号法规
2006年12月22日
与食品接触的材料和物品的良好制造规范
（与欧洲经济区相关的文本）
（OJ L 3842006年12月29日，第75页）
修订人：官方公报
No: L 86 page 9 date 28.3.2008
2008年3月27日第282/2008号委员会条例（EC）
欧盟委员会第2023/2006号法规
2006年12月22日
与食品接触的材料和物品的良好制造规范
（与欧洲经济区相关的文本）
欧洲共同体委员会，
关于建立欧洲共同体的条约，
考虑到2004年10月27日欧洲议会和理事会关于与食品接触的材料和物品的第1935/2004号法规（EC），特别是其中的第5（1）条，
鉴于：
（1） 第1935/2004号法规（EC）附件一中列出的材料和物品组，以及这些材料和物品或回收材料和物品的组合，应按照良好制造规范（GMP）的一般和详细规则制造。
（2） 一些行业部门制定了GMP指南，而其他行业则没有。因此，似乎有必要确保成员国在与食品接触的材料和物品的GMP方面的一致性。
（3） 为了确保这种一致性，应当对经营者规定某些义务。
（4） 所有企业经营者都应该对其生产经营活动进行有效的质量管理，并根据其在供应链中的地位进行调整。
（5） 这些规则应适用于拟与食品接触的材料和物品，或已与食品接触并用于此目的的材料和制品，或可合理预期与食品接触或在正常或可预见的使用条件下将其成分转移到食品中的材料和物品。
（6） GMP规则应按比例适用，以避免给小企业带来不适当的负担。
（7） 现在应为涉及印刷油墨的工艺制定详细规则，并在必要时为其他工艺制定细则。对于应用于材料或物品非食品接触侧的印刷油墨，GMP应特别确保物质不会通过接触或渗透而转移到食品中。
（8） 本条例规定的措施符合食品链和动物健康常务委员会（SCFCAH）的意见。
已通过本条例：
第 1 条
主题
该法规规定了第1935/2004号法规（EC）附件一中列出的拟与食品接触的材料和物品（以下简称材料和物品）组的良好生产规范（GMP）规则，以及这些材料和物品或回收材料和物品的组合以及这些材料和物品中使用的物品。
第二条
范围
本条例应适用于材料和物品的所有部门和制造、加工和分销的所有阶段，但不包括起始物质的生产。附件中规定的详细规则应酌情适用于单独提及的相关进程。
第3条
定义
在本法规中，以下定义适用：
(a) “良好生产规范（GMP）”是指质量保证的各个方面，这些方面确保材料和物品的生产和控制是一致的，以确保符合适用于它们的规则和适合其预期用途的质量标准，不会危害人类健康或导致食品成分发生不可接受的变化或导致其感官特性恶化；
(b) “质量保证体系”是指为确保材料和物品的质量符合适用规则和预期用途所需的质量标准而作出的有组织和有文件记录的安排的总和；
(c) “质量控制体系”是指在质量保证体系内建立的系统应用措施，以确保起始材料、中间材料和成品符合质量保证体系中确定的规范；
(d) “非食品接触面”是指不直接接触食品的材料或物品的表面；
(e) “食品接触面”是指与食品直接接触的材料或物品的表面。
第4条
符合良好制造规范
企业经营者应确保按照以下要求进行生产操作：
（a） 第5、6和7条规定的GMP一般规则，
（b） 附录中规定的GMP细则。
第5条
质量保证体系
1.经营者应建立、实施并确保遵守有效且有文件记录的质量保证体系。该系统应：
（a） 考虑人员的充足性、他们的知识和技能以及场所和设备的组织，如确保成品材料和物品符合适用规则所必需的；
（b） 应用时应考虑到运营商经营的业务规模，以免对业务造成过度负担。
2.起始材料的选择应符合预先制定的规范，该规范应确保材料或物品符合适用的规则。
3.不同的操作应按照预先制定的指示和程序进行。
第6条
质量控制体系
1.经营者应建立并保持有效的质量控制体系。
2.质量控制体系应包括监督GMP的实施和实现，并确定纠正任何未能实现GMP的措施。此类纠正措施应立即实施，并提供给主管当局检查。
第7条
文档
1.经营者应建立并维护与成品材料或物品的合规性和安全相关的规范、生产配方和加工相关的纸质或电子格式的适当文件。
2.企业经营者应建立并保存适当的纸质或电子文件，记录所执行的与成品材料或物品的合规性和安全相关的各种生产操作，以及质量控制体系的结果。
第8条
生效
本法规应自其在《欧盟官方公报》上发布后的第20天起生效。
自2008年8月1日起适用。
本法规整体上具有约束力，并直接适用于所有成员国。
附件
良好制造规范的详细规则
▼M1
A、 打印墨水
▼B
在材料或物品的非食品接触面上使用印刷油墨的工艺
1.应用于材料和物品非食品接触侧的印刷油墨的配方和/或应用方式应确保印刷表面的物质不会转移到食品接触侧：
（a） 通过渗透或；
（b） 通过在堆叠或卷轴状态下接触，
导致食品中物质含量不符合第1935/2004号法规（EC）第3条要求的浓度。
2.印刷材料和物品应在成品和半成品状态下搬运和储存，以确保印刷表面的物质不会转移到食品接触侧：
（a） 通过渗透或；
（b） 通过在堆叠或卷轴状态下接触，
导致食品中物质含量不符合第1935/2004号法规（EC）第3条要求的浓度。
3. 印刷表面不得直接接触食物。
▼M1
B、 第282/2008号法规（EC）所涵盖的塑料回收过程的质量保证体系，该法规涉及与食品接触的回收塑料材料和物品，并修订了第2023/2006号法规（欧盟）
1.回收商实施的质量保证体系必须对回收过程的能力有足够的信心，以确保回收塑料符合授权要求。
2.必须以书面政策声明和程序的形式，系统有序地记录回收者为其质量保证体系所采用的所有要素、要求和规定。
质量体系文件必须允许对质量政策和程序进行统一解释，例如质量计划、计划、手册、记录和为确保可追溯性而采取的措施。
它必须特别包括：
（a） 质量政策手册，其中明确定义了回收商的质量目标、业务组织，尤其是组织结构、管理人员的职责及其组织机构（涉及再生塑料的制造）；
（b） 质量控制计划，包括输入和回收塑料特性、供应商资质、分类过程、清洗过程、深度清洗过程、加热过程或与回收塑料质量相关的任何其他过程部分的计划，包括对回收塑料质量控制至关重要的点的选择；
（c） 为监测和控制整个回收过程而实施的管理和操作程序，包括所有制造阶段的检查和质量保证技术，特别是在对回收塑料质量至关重要的点上建立关键限值；
（d） 监测质量体系有效运行的方法，特别是其实现预期回收塑料质量的能力，包括对不合格产品的控制；
（e） 在回收塑料生产之前、期间和之后应用的测试和分析协议或任何其他科学证据，测试和分析的频率，以及使用的测试设备；必须能够充分追溯试验设备的校准；
（f） 相关被采用的记录文件。
