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食品安全国家标准 食品辐照加工卫生规范
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GB 18524-2016
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标准编号: GB 18524-2016 (GB18524-2016)
中文名称: 食品安全国家标准 食品辐照加工卫生规范
英文名称: Codex general technical requirement for food irradiation
行业: 国家标准
中标分类: X09
字数估计: 8,810
发布日期: 2016-12-23
实施日期: 2017-06-23
旧标准 (被替代): GB/T 18524-2001
标准依据: National Health and Family Planning Commission Notice No.17 of 2016
GB 18524-2016: 食品安全国家标准 食品辐照加工卫生规范
GB 18524-2016 英文名称: Codex general technical requirement for food irradiation
1 范围
本标准规定了食品辐照加工的辐照装置、辐照加工过程、人员和记录等基本卫生要求和管理准则。
本标准适用于食品的辐照加工。
2 术语和定义
GB 14881-2013中的术语和定义适用于本标准。
2.1 食品辐照
利用电离辐射在食品中产生的辐射化学与辐射微生物学效应而达到抑制发芽、延迟或促进成熟、杀
虫、杀菌、灭菌和防腐等目的的辐照过程。
2.2 吸收剂量D
任何电离辐射,授予质量为 dm 的物质的平均能量 dε 除以 dm 的商值,即 D =dε/dm。
2.3 剂量不均匀度
加工负荷内最大吸收剂量和最小吸收剂量之比。
2.4 最低有效剂量
在食品辐照时,为达到某种辐照目的所需的最低剂量,即工艺剂量的下限值。
2.5 最高耐受剂量
在食品辐照时,不会对食品的品质和功能特性产生负面影响的最大剂量,即工艺剂量的上限值。
2.6 辐照工艺剂量
在食品辐照中为了达到预期的工艺目的所需的吸收剂量范围,其下限值应大于最低有效剂量,上限
值应小于最高耐受剂量。
2.7 食品装载模式
辐照容器内食品箱的放置方式。
2.8 安装鉴定
获得证据并用文件证明设备已经按照说明的要求予以提供并安装了的过程。
2.9 运行鉴定
当设备按程序运行时,获得证据并用文件来证明所安装的设备在预期的范围内运行。
2.10 性能鉴定
当所安装和运行的设备按照程序运行时,获得证据并以文件证明设备按照规定标准运行生产出符
合要求的食品。
3 食品辐照的基本原则
3.1 用于辐照处理的食品应按照GB 14881和相关食品安全国家标准进行处理、加工和运输。
3.2 食品辐照不能代替食品生产加工过程中的卫生控制或良好生产规范,仅可在合理的工艺需求或对
消费者健康有利的情况下才能使用。不得用辐照加工手段处理劣质不合格的食品。
3.3 辐照剂量应准确可靠,尽量采用该工艺所需的最低剂量,剂量不均匀度不应超过2.0。
3.4 辐照处理不应对食品结构完整性、功能性质、感官属性等产生不利影响。辐照后的食品应符合相
应的食品安全国家标准产品标准中相应条款的规定。
3.5 辐照食品种类应在GB 14891规定的范围内,不允许对其他食品进行辐照处理。
3.6 除5.2.5中规定可重复辐照的特例外,其他情况下不得进行重复辐照。
4 辐照装置的通用技术要求
4.1 辐射源
食品辐照可用的电离辐射源为 60Co或137Cs放射性核素产生的γ射线、电子加速器产生的能量不
高于5MeV的X射线、电子加速器产生的能量不高于10MeV的电子束。
4.2 辐照装置
辐照装置的选址、设计及建造应符合相关国家标准,满足食品辐照加工的卫生要求。
4.3 辐照装置的安装鉴定、运行鉴定和性能鉴定
4.3.1 辐照装置在设备安装之后,必须进行安装鉴定,以保证设备的性能能够达到设计要求;安装鉴定
完成之后应进行运行鉴定,以确定设备能够按照设定程序进行运行。
4.3.2 食品在接受辐照前必须完成性能鉴定,确认其在正常操作情况下所接受的吸收剂量及其分布和
辐照的重复性。
4.3.2.1 在与待辐照食品密度相近的模拟物装填后的辐照容器内,以三维立体的(便于区别最大和最小
吸收剂量位置)方式布放剂量计进行吸收剂量分布图测定,确定最大吸收剂量、最小吸收剂量和参考点
吸收剂量的位置。
4.3.2.2 建立不同堆积密度和堆积方式的产品中剂量分布与辐照运行参数的关系,确保产品获得规定
限值内的吸收剂量。
4.3.2.3 辐射源活度增加或运行参数改变时必须重新进行鉴定,以确定初始的鉴定是否有效;否则,必
须重新测量剂量分布图。
4.3.2.4 当设备维修可能影响辐射源结构、食品装载模式或辐照装置运行参数时,必须重新进行性能
鉴定。
4.3.3 辐照装置的电子机械系统必须运行可靠,并符合GB 17568或GB/T 25306的要求。
4.4 使用和维护
4.4.1 辐照装置建成后,必须按国家有关规定,经验收合格并取得辐射安全许可证后方可使用。
4.4.2 辐照装置使用单位应制定辐照装置使用规范,并按照规范使用辐照装置。
4.4.3 辐照装置应进行定期检查和维护,以确保安全使用。
5 辐照加工过程控制
5.1 辐照前准备
5.1.1 辐照前要求
5.1.1.1 辐照前食品的包装
应根据食品类型和辐照加工过程选择合适的包装方式,包装应方便辐照加工的进行。包装应能有
效地避免辐照加工后的再污染。包装应符合相应标准和有关规定。
5.1.1.2 辐照前食品的贮藏
不同类型的辐照食品应分开存放,并有明显标识。有特殊贮藏要求如低温等的食品应满足其贮藏
要求。
5.1.2 辐照设备的选择
应根据辐照食品的种类、辐照目的和产品状态(如散装或定型包装)及其特性以及辐照设备处理能
力选择辐照设备。
5.1.3 辐照工艺剂量与常规剂量的测量
5.1.3.1 工艺剂量应设定在最低有效剂量与最高耐受剂量之间。
5.1.3.2 启用剂量测量应包括辐照源到辐照位置的重复性、辐照场(产品中)剂量分布、不同堆积密度和堆积方式的产品中辐照运行参数与产品吸收剂量的关系。
5.1.3.3 日常剂量监测应包括抽样监测产品吸收剂量、定期标定辐照场、核对产品剂量不均匀度、检验装置运行参数及与产品吸收剂量的关系。
执行。
5.2 辐照加工过程
5.2.1 工艺规范的制定和食品安全要求
辐照工艺规范应保证辐照食品与未辐照食品分开、辐照处理能够达到既定的工艺目的和卫生质量
要求。
5.2.2 辐照工艺剂量的确定
5.2.2.1 应根据辐照食品种类和辐照目的确定辐照工艺剂量,被辐照食品的吸收剂量应符合GB 14891
的要求。
5.2.2.2 工艺剂量应在最低有效剂量与最高耐受剂量之间。
5.2.3.1 每类食品的不同包装都应单独建立装载模式。装载模式说明中应写明辐照容器内食品单元的
数量和位置。
5.2.3.2 装载模式的设计应在辐照容器容许重量范围内最大限度地充满容器空间,并尽可能均匀分布,
以使剂量不均匀度最小。
5.2.4 对剂量的测量
5.2.4.1 食品装载模式建立后,应使用实际产品或近似密度的模拟物装载,以测量其剂量分布,进行装
载模式验证。
5.2.4.2 测量剂量分布时应有足够数量的剂量计布放于辐照产品负载中,以确定最小和最大剂量区域,
进而选定常规剂量监测位置,并计算出常规剂量点的剂量与最大剂量和最小剂量之间的关系。剂量测
关系。
5.2.4.3 常规辐照加工中,剂量计应布放在辐照容器内的最小剂量或与最小剂量区有已知定量关系的
容易放置的位置上。此外,还应在最大剂量区布放剂量计以监测食品接受的最大剂量。并做好记录、
存档。
5.2.4.4 当辐照参数发生变化时,应重新进行剂量分布的测量。应根据装置预期的辐射加工应用和剂
量测量系统的性能及测量不确定度等方面的要求,按GB/T 16640的规定选择适用的剂量测量用工作剂
量计,并应定期溯源至国家吸收剂量标准。
5.2.5 重复辐照
5.2.5.1 除为控制虫害再次侵袭,低含水量食品(如谷物、豆类、脱水食品及类似产品)可以进行重复辐
5.2.5.2 对下列食品进行辐照时,不属于重复辐照:
---用小于1kGy剂量辐照过的原料制成的食品;
---含5%以下辐照配料的食品;
---为实现特殊工艺目的,将所需的全部吸收剂量分多次进行照射的食品。
5.2.5.3 重复辐照食品的累积剂量不应超过10kGy。
5.3 辐照后处理
5.3.1 储存
辐照产品和未辐照产品应分别存放在辐照区和未辐照区。产品放行前的储存应符合
GB 14881-2013中第10章的规定。
应制定产品的辐照放行程序。程序应定义指定的辐照过程的要求,并应考虑测量系统的不确定度。
如果这些要求不能满足,辐照产品被认为不合格产品。
应规定控制和处理辐照不合格产品的相关职责和权利。
此外,不合格产品的管理应得到辐照运营商和客户的一致同意,并应规定在技术协议中。应保存文
件化的程序和记录以寻找引起不合格的原因和问题。
GB 18524-2016
GB
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
National food safety standard – Hygienic
specification for food irradiation processing
ISSUED ON. DECEMBER 23, 2016
IMPLEMENTED ON. DECEMBER 23, 2017
Issued by. National Health and Family Planning Commission of the PRC;
State Food and Drug Administration.
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Terms and definitions ... 4
3 Basic principles of food irradiation ... 5
4 General technical requirements for irradiation devices ... 6
5 Radiation processing process control ... 7
6 Personnel management ... 10
7 Radiation safety management ... 10
8 Marking ... 11
9 Records and document management ... 11
Foreword
This standard replaces GB/T 18524-2001 “General technical requirements for
food irradiation”.
As compared with GB/T 18524-2001, the main changes of this standard are as
follows.
- CHANGE the standard name into “National food safety standard –
Hygienic specification for food irradiation processing”;
- MODIFY the standard structure;
- ADD the terms and definitions;
- ADD the basic hygienic requirements and management guidelines for
radiation processing, personnel and records;
- ADD the relevant requirements for the radiation processing process control
and radiation safety control;
- ADD the management requirements for records and documents;
- DELETE the Appendix A from the original standard, the content of which is
moved into the irradiation processing control part. DELETE the Appendix B
from the original standard which relates to the packaging materials, the
content of which is moved into the packaging part.
National food safety standard – Hygienic
specification for food irradiation processing
1 Scope
This standard specifies the basic hygienic requirements and management
guidelines for irradiation device, irradiation processing, personnel and records
for food irradiation processing.
This standard applies to food irradiation processing.
2 Terms and definitions
The terms and definitions in GB 14881-2013 apply to this standard.
2.1 Food irradiation
It refers to the irradiation process in which the radiation chemistry and radiation
microbiological effects produced by ionizing radiation in foodstuffs are used to
inhibit the germination, delay or promote ripening, and realize the insecticide,
disinfection, sterilization, and antisepsis.
2.2 Absorption dosage D
It refers to the quotient obtained through dividing the average energy which
is given by any ionizing radiation onto the substance having a mass of dm by
the dm, that is, , in the unit of J • kg-1 (joules/kg), in the name Gray,
and in the symbol of Gy, 1 Gy = 1 J • kg-1.
2.3 Dosage nonuniformity
The ratio of the maximum absorption dosage to the minimum absorption
dosage within the processing load.
2.4 Minimum effective dosage
The minimum dosage required to achieve a radiation purpose, i.e., the lower
limit of the process dosage, when the food is irradiated.
2.5 Maximum tolerated dosage
The maximum dosage, i.e., the upper limit of the process dosage, that does
not adversely affect the food quality and functional characteristics when the
food is irradiated.
5.2.4.1 After the food loading mode is established, it shall load with the actual
product or the simulant of similar density to measure its dosage distribution, so
as to perform the loading mode verification.
5.2.4.2 When measuring the dosage distribution, a sufficient number of
dosimeters shall be placed in the irradiated product load to determine the
minimum and maximum dosage areas, then select the conventional dosage
monitoring location, AND calculate the relationship between the dosage at the
conventional dosage point and the maximum dosage and minimum dosage.
The dosage measurement shall include the sampling monitoring product
inspection of the relationship between the device operation parameters and
product absorption dosage.
5.2.4.3 In conventional irradiation processing, the dosimeter shall be placed at
the location of the minimum dosage in the irradiation container OR the position
easy to be placed having the known quantitative relationship with the minimum
dosage. Meanwhile, it shall also install a dosimeter at the maximum dosage
area to monitor the maximum acceptable dosage of the food. AND it shall
make record AND archive it.
5.2.4.4 When the irradiation parameters change, the dosage distribution shall
processing application of the device, the dosage measurement system
performance, and the measurement uncertainty, etc., select the appropriate
dosage measurement dosimeter in accordance with the provisions of GB/T
16640, AND it shall trace back to the national absorption dosage standards.
5.2.5 Repeated Irradiation
5.2.5.1 In addition to the repeated irradiations of the low moisture foods (such
as cereals, beans, dehydrated food, and similar products), the repeated
irradiation shall not be performed under other conditions.
5.2.5.2 Irradiation of the following foods is not considered as repeated
- Food made from raw materials irradiated by less than 1 kGy dosage;
- Food containing 5% or less of radiation;
- Food irradiated for many times by all the dosage to be absorbed to realize
the special process purposes.
5.2.5.3 The cumulative dose of repeated irradiated food shall not exceed 10
kGy.
5.3 Post-irradiation treatment
5.3.1 Storage
8 Marking
4.1.11.1 of GB 14891 and GB 7718.
9 Records and document management
9.1 Irradiation records
9.1.1 Irradiation device records
It shall record all data relating to the construction, acceptance, licensing
registration, and maintenance of the irradiation device.
9.1.2 Recording of irradiation processing parameters
It shall record the parameters on the irradiation processing control, dosage
detection, and irradiation device during startup and daily operation.
It shall record the product type, irradiation purpose, irradiation dosage,
irradiation date, and post-irradiation product quality inspection (including
post-irradiation sampling, retention and inventory management).
It shall record the irradiation processing requirements and conditions, which
shall be kept by special person AND archived for reference. The records of the
irradiation processing and conditions shall include but not limited to the
following.
a) The name, code, lot number and quantity, exit-factory date, receiving
date of the irradiated food, AND the name, address and contact of the
b) The purpose of irradiation;
c) The name and activity of the radionuclide, OR the irradiation device
energy, beam, scan width, transmission speed and processing
parameters that affect the absorption dosage of the food;
d) The density of the irradiated food, AND the loading pattern of the food in
the irradiation container or within the irradiation device;
e) Irradiation dosage;
f) The operating parameters set by the irradiation device;
g) The date of irradiation;
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