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食品安全国家标准 食品接触材料及制品生产通用卫生规范
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GB 31603-2015
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标准编号: GB 31603-2015 (GB31603-2015)
中文名称: 食品安全国家标准 食品接触材料及制品生产通用卫生规范
英文名称: National Food Safety Standard -- General Health Code for Production of Food-contacted Materials and Products
行业: 国家标准
中标分类: X09
字数估计: 7,763
发布日期: 2015-09-21
实施日期: 2016-03-21
标准依据: 食品安全国家标准的公告（2015年 第7号）
发布机构: 中华人民共和国国家卫生和计划生育委员会
GB 31603-2015: 食品安全国家标准 食品接触材料及制品生产通用卫生规范
GB 31603-2015 英文名称: National Food Safety Standard -- General Health Code for Production of Food-contacted Materials and Products
1 范围
本标准规定了食品接触材料及制品的生产,从原辅料采购、加工、包装、贮存和运输等各个环节的场
所、设施、人员的基本卫生要求和管理准则。
本标准适用于各类食品接触材料及制品的生产,如确有必要制定某类食品接触材料及制品的专项
卫生规范,应当以本标准作为基础。
2 基本要求
2.1 生产全过程及最终产品不应危害人体健康和造成食品特性的改变。
2.2 生产全过程应符合国家相关法律法规及标准的要求,并在可以达到预期目的前提下尽可能降低原
辅料的使用量。为达到以上目的企业应制定相应的具体要求。
2.3 企业应建立、实施并遵守有效的安全控制体系,以确保原辅料、半成品和成品符合相应的食品安全
要求。
2.4 产品的标识应符合国家相关法律法规及标准的要求。
3 厂区环境
3.1 厂区应与有毒有害污染源保持相应的距离。
3.2 厂区道路应硬化,内外环境应整洁、卫生,生产区的空气、水质、场地应符合相应生产要求。
3.3 企业的生产、行政、生活和辅助区的总体布局应合理,避免交叉污染。
3.4 企业应根据情况制定和执行虫害控制措施,防止虫害的孳生。
4 厂房
4.1 厂房应按生产工艺流程及卫生要求进行合理布局,并根据不同生产区域的洁净度要求合理划分作
业区,对厂区内的生产车间和公共场所实行分级卫生管理。
4.2 厂房面积应与生产能力相匹配,有足够的空间和场地放置设备、物料和产品,并满足生产操作
需要。
4.3 生产车间与库房的墙壁、地面表面应平整光滑,以减少灰尘积聚且便于清洁;对于不经清洁直接接
触食品的在制品和最终产品,其生产车间顶棚应易于清洁、消毒,在结构上不利于冷凝水垂直滴下。
4.4 同一生产车间内以及相邻生产车间之间的生产操作不应造成交叉污染。不同卫生要求的产品在
同一生产区域内生产时,应保证各产品自身的卫生性能。生产车间内设备与设备间、设备与墙壁间,应
有适当的空间,便于相关操作。
4.5 生产车间应按需建立人员通道、参观通道和物流通道,并保持通道畅通,无杂物堆积。
5 设施和设备
5.1 设施
5.1.1 应具备与生产能力和卫生要求相匹配的卫生、通风、搬运、输送等设施,并维护完好。
5.1.2 应按需配备适当的供水设施和排水设施。
5.1.3 生产场所设置的水池、地漏等不应对产品造成污染。
5.1.4 应配备足够的清洁设施,有特殊卫生要求的车间应配备适宜的消毒设施并定期消毒。对于不经
清洁直接接触食品的在制品和最终产品,其生产车间、库房应设置消毒、防尘、防虫害等设施,且不应对
产品造成污染。
5.1.5 应配备废弃物处理设施,防止对产品造成污染。废水、废气、废料的排放,噪声污染及卫生要求
等应符合国家有关规定。
5.1.6 对于不经清洁直接接触食品的在制品和最终产品,应符合以下要求:
---应在生产车间入口处设置更衣室,更衣室大小应与生产人员数量相适应,并保证工作服与个人
服装及其他物品分开放置。
---应在生产车间入口处按需设置换鞋(穿戴鞋套)设施或工作鞋靴消毒设施。如设置工作鞋靴消
毒设施,其规格尺寸应能满足消毒需要。
---应在生产车间入口处设置洗手、消毒、除尘设施。
5.1.7 鼓励其他产品的生产车间采取5.1.6中规定的措施。
5.1.8 生产车间内的更衣室和换鞋、洗手、消毒、除尘等设施应由专人管理,并及时清洗和消毒,保持清
洁状态,避免给产品带来污染。
5.1.9 应为员工提供适当、方便的卫生间和洗手设施,卫生间应与生产车间分隔并保持清洁。
5.1.10 厂房内应有充足的自然采光或人工照明,对照明度有特殊要求的生产区域可设置局部照明。
5.1.11 生产工艺对温度、湿度有要求的生产车间,应配备温湿度调节及监控设施。
5.2 设备
5.2.1 应配备与生产能力相适应的生产设备和必要的检验设备。
5.2.2 生产设备的设计、选型、布局、安装应符合生产要求,便于使用和保养、维修,并易于清洁。
5.2.3 应正确使用和维护生产设备及工具,避免生产过程中对产品造成污染,并定期进行保养和维修。
5.2.4 用于生产和检验的仪器、仪表、量具、衡器等的适用范围和精度应符合生产和检验的要求,应有
明显的状态标识,并定期校验和记录。
5.2.5 影响产品安全的生产和检验设备(包括备品、备件)应建立设备档案,记录其使用、保养、维修的
实际情况,并由专人管理。
6 人员
6.1 应建立产品安全相关岗位的培训制度,对相关岗位的从业人员进行相应的食品安全知识培训。
6.2 企业负责人应了解其在食品安全管理中的职责与作用,以及相关的专业技术知识等。
6.3 企业应有专人负责与食品安全相关的工作,相关人员应具有产品安全管理的知识和经验,有能力
对产品生产过程中出现的食品安全问题做出正确处理。
6.4 生产操作人员应熟悉自己的岗位职责,具有与其职责相适应的基础理论知识和实际操作技能,能
熟练地按工艺文件进行生产操作。
6.5 检验人员应熟悉产品检验规定,具有与工作相适应的食品安全知识、技能和相应的资格。
6.6 生产车间人员应严格遵守有关卫生制度,保持个人清洁、卫生,按规定穿戴工作衣帽、鞋,不应佩戴
饰物,不应将与生产无关的物品带入车间;来访者进入车间时应遵循同等的卫生要求。
7 原辅料要求
7.1 原辅料应符合国家相关法律法规和标准的要求,其使用应保证生产的产品符合食品安全要求。
7.2 应建立原辅料的采购、验收、运输和贮存管理制度。
7.3 应建立原辅料供应商管理制度,规定供应商的选择、审核、评估程序。应对供应商进行评价,选择
合格供应商。
7.4 原辅料运输应符合规定的运输条件,不应与有毒有害物料混装、混运,避免变质和污染。
7.5 应按规定对采购的原辅料进行验收,查验合格证明文件。无法提供有效文件的,应按照相应的食
品安全标准或企业验收标准进行检验或验证,并保存相关记录。
7.6 应将待验、合格、不合格原辅料分区、按批次存放,并有明显标识。
7.7 原辅料贮存应根据原辅料的物理特性和化学特性,选择合适的贮存条件分别储存。有毒有害物
进行操作。
7.8 设备使用的清洁材料、润滑剂、粘合剂、脱模剂、清洗剂和消毒剂等化学物品应按用途分类、标识,安全存放使用,避免对产品造成污染。
7.9 原辅料的使用应遵循“先进先出”的原则。不应使用不合格的原辅料,应及时处理并记录在案。
7.10 应建立完善的出入库记录制度,保存相应的采购、验收、贮存、使用及运输记录。
8 生产过程的产品安全控制
8.1 生产加工卫生要求
8.1.1 生产工艺应保证最终产品不危害人体健康,不造成食品特性的改变;应避免使用或产生有毒有
害物质,如无法避免应采取有效措施消除或降低其危害,确保产品符合国家相关法律法规和标准的
要求。
制指标并记录。试制品经检测合格后,方可投入批量生产。如原辅料及工艺等发生变更,应重新进行评
估并记录。
8.1.3 应通过危害分析方法明确生产过程中影响产品安全的关键环节,并建立相应的控制措施。应对
关键控制环节实施严格监控,落实控制措施的相关文件,如配料(投料)表、岗位操作规程等,并建立可追
溯性记录。
8.1.4 对有特殊生产要求的区域(如无菌包装产品、无菌消毒控制区域),应设置环境控制的整体范围,
监测区域内的空气质量,避免受到化学品和微生物的污染,并将监测结果记录存档。
8.1.5 生产过程中应采取措施识别、防止和消除外来异物的污染风险并防止交叉污染,外来异物包括
但不限于刀片、非生产性玻璃、易碎塑料、木头及其他易与包装材料相混淆的材料等。
8.2.1 用于食品接触材料及制品的印刷油墨应符合国家相关法律法规和标准的要求。
8.2.2 用于食品接触材料及制品非食品接触面的印刷油墨层不应与食品直接接触。
8.2.3 在印刷油墨的配方设计、涂覆过程以及印刷半成品或成品的处理、贮存过程中,应确保印刷油墨
不易从食品接触材料及制品上脱落。
8.2.4 在印刷油墨的配方设计、涂覆过程以及印刷半成品或成品的处理、贮存过程中,应严格控制通过
渗透过基材、因堆叠或卷绕引起的黏粘等方式造成的从印刷面转移到食品接触面的物质,确保其最终迁
移到食品中的物质浓度符合食品安全要求,即不应危害人体健康和造成食品特性的改变。
GB 31603-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard – General Health Code for
Production of Food-contacted Materials and Products
ISSUED ON. SEPTEMBER 21, 2015
IMPLEMENTED ON. SEPTEMBER 21, 2016
Issued by. National Health and Family Planning Commission of the
People’s Republic of China
Table of Contents
1 Application Scope ... 3
2 Basic Requirements ... 3
3 Factory Environment ... 3
4 Plant ... 4
5 Facilities and Equipment ... 4
6 Personnel ... 6
7 Requirements for Raw and Auxiliary Materials ... 7
8 Product Safety Control During Production Process ... 8
9 Management Organization ... 9
10 Inspection ... 10
11 Product Tracing and Recall ... 10
12 Document Management and Record ... 11
National Food Safety Standard – General Health Code for
Production of Food-contacted Materials and Products
1 Application Scope
This Standard specifies the basic health requirements and management guidelines for
the sites, facilities and personnel of all links of the production of all kinds of food-
contacted materials and products, including purchase of raw and auxiliary materials,
processing, packaging and transportation.
This Standard applies to the production of all kinds of food-contacted materials and
products. This Standard shall be used as the basis if it is necessary to make a special
health specification for a certain food-contacted material or product.
2 Basic Requirements
2.1 The whole production process and final products shall not be harmful to human
health and cause any change in the characteristics of food.
2.2 The whole production process shall be as specified in relevant national laws,
regulations and standards. The use of raw and auxiliary materials shall be reduced as
much as possible, provided that the intended purpose can be achieved.
2.3 The enterprise shall establish, implement and comply with an effective safety
control system to ensure the raw and auxiliary materials, semi-finished products and
finished products meet the corresponding food safety requirements.
2.4 The product marking shall be as specified in relevant national laws, regulations
and standards.
3 Factory Environment
3.1 The factory shall be kept an appropriate distance from toxic, hazardous pollution
sources.
3.2 The roads in the factory shall be hardened. The environment inside and outside
shall be clean and tidy. The air, water and site in the manufacturing area shall meet the
production requirements.
3.3 The overall layout of production, administrative, domestic and supplementary
areas of the enterprise shall be reasonable to prevent cross contamination.
3.4 The enterprise shall make and implement pest control measures as appropriate
5.2.2 The design, type, layout and installation of production equipment shall meet the
production requirements, which shall be convenient for use, maintenance, servicing
and cleaning.
5.2.3 Production equipment and tools shall be used and maintained correctly to
prevent causing pollution to products during the production process. Maintenance and
servicing shall be carried out periodically.
5.2.4 The application ranges and accuracies of the instruments, meters, measures
and weighing apparatus and others for production and inspection shall meet the
requirements for production and inspection. Obvious state identification shall be
provided for them. They shall be calibrated periodically and the results shall be
recorded.
5.2.5 Equipment archives shall be established for the equipment of production and
inspection related to product safety. The details of use, maintenance and servicing
shall be recorded and managed by special personnel.
6 Personnel
6.1 The training system for product safety-related posts shall be established. The
employees for relevant posts shall receive corresponding food safety knowledge
6.2 The person in charge of enterprise shall understand his/her responsibilities and
roles in food safety management, as well as related special technical knowledge.
6.3 The enterprise shall designate special personnel to be in charge of the food
safety related work. The personnel shall have the knowledge and experiences related
to product safety management who are capable of solving the food safety problems
correctly during the product manufacturing process.
6.4 The personnel of production and operation shall be familiar with their own post
responsibilities, possess the basic theoretical knowledge and actual operation skills
related to their responsibilities and be able to carry out production and operation
6.5 The inspection personnel shall be familiar with product inspection rules and
possess the food safety knowledge and skills and corresponding qualifications which
match with their work.
6.6 The personnel of manufacturing workshops shall observe strictly relevant health
system to keep individual hygiene. They shall wear work clothes, cap and shoes as
specified. They shall not bring articles irrelevant to production into the workshops. The
visitors shall comply with the equal health requirements when they come to the
workshops.
8 Product Safety Control During Production Process
8.1.1 The production process shall ensure that the finished products are not harmful
to human health and do not cause the change of food characteristics. The use or
production of toxic, hazardous substances shall be avoided; if it is impossible to avoid,
effective measures shall be taken to eliminate or reduce harm to ensure that products
are as specified in relevant national laws, regulations and standards.
8.1.2 The enterprise shall carry out as required safety assessment and verification of
the raw and auxiliary materials, formulas and production processes which are used for
the first time, test the main control indexes and keep records. Mass production can
only be started after the products produced for trial are accepted. If there is any change
out once again and the records kept.
8.1.3 The key links related to product safety during the production process shall be
defined with the hazard analysis method and the corresponding control measures
established. The key control links shall be monitored intensively; relevant documents
of control measures shall be implemented, such as batching (feeding) tables and post
operating instructions; traceable records shall be kept.
8.1.4 For the areas with special production requirements (such as aseptic packaging
products and aseptic control areas), the whole range of environmental control shall be
specified to monitor the air quality within the area and prevent the pollution of
8.1.5 During the production process, measures shall be taken to identify, prevent and
eliminate the pollution risks of foreign objects and to prevent cross contamination. The
foreign objects include but not limited to blades, nonproductive glass, brittle plastic,
wood and other materials which are liable to mix with packaging materials.
8.2 Health requirements for printing
8.2.1 The printing ink for food-contacted materials and products shall be as specified
in relevant national laws, regulations and standards.
8.2.2 The printing ink for the non-food-contacted surface of food-contacted materials
and products shall not be in direct contact with food.
treatment and storage process of semi-finished printing products or finished products,
it shall be ensured that printing ink is not easy to peel off the food-contacted materials
and products.
products. A competent third-party organization can be entrusted to carry out verification
or inspection, if necessary. When it is decided whether products are as specified in
standard, it shall be ensured that the product type matches with the application scope
of relevant standards. In case of any noncompliance of raw and auxiliary materials and
products, the specific reasons shall be reviewed and the corrective measures taken.
10 Inspection
body with corresponding qualifications to ensure products meet relevant standards.
Inspection site and inspection capability shall be ready for self-inspection with regard
to the inspection items; inspection shall be carried out by the inspection personnel with
corresponding qualifications in accordance with the inspection method; the
instruments and equipment used for inspection shall be calibrated periodically; all
inspection records and test reports shall be kept intact.
10.2 Process inspection shall be carried ...
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