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食品安全国家标准 饮料生产卫生规范
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GB 12695-2016
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标准编号: GB 12695-2016 (GB12695-2016)
中文名称: 食品安全国家标准 饮料生产卫生规范
英文名称: Good manufacturing practice for drink factory
行业: 国家标准
中标分类: C53
国际标准分类: 67.040
字数估计: 9,915
发布日期: 2016-12-23
实施日期: 2017-06-23
旧标准 (被替代): GB 12695-2003
标准依据: National Health and Family Planning Commission Notice No.17 of 2016
发布机构: 中华人民共和国国家卫生和计划生育委员会、国家食品药品监督管理总局
范围: 本标准规定了饮料生产过程中原料采购、加工、包装、贮存和运输等环节的场所、设施、人员的基本要求和管理准则。本标准适用于除包装饮用水外的饮料生产，不适用于现制现售的饮料。
GB 12695-2016: 食品安全国家标准 饮料生产卫生规范
GB 12695-2016 英文名称: Good manufacturing practice for drink factory
1 范围
本标准规定了饮料生产过程中原料采购、加工、包装、贮存和运输等环节的场所、设施、人员的基本要求和管理准则。
本标准适用于除包装饮用水外的饮料生产,不适用于现制现售的饮料。
2 术语和定义
GB 14881-2013中的术语和定义适用于本标准。
3 选址及厂区环境
应符合GB 14881-2013中第3章的相关规定。
4 厂房和车间
4.1 应符合GB 14881-2013中第4章的相关规定。
4.2 厂房和车间的设计通常划分为一般作业区、准清洁作业区、清洁作业区。各区之间应有效隔离,防止交叉污染。一般作业区通常包括原料处理区、仓库、外包装区等;准清洁作业区通常包括杀菌区、配料区、包装容器清洗消毒区等;清洁作业区通常包括液体饮料的灌装防护区或固体饮料的内包装区等。具体划分时根据产品特点、生产工艺及生产过程对清洁程度的要求设定。
4.3 液体饮料企业一般应设置水处理区、配料区、灌装防护区、包装区、原辅材料及包装材料仓库、成品仓库、检测实验室等,生产食品工业用浓缩液(汁、浆)的企业还应设置原料清洗区(与后续工序有效隔离)。固体饮料企业一般应设置配料区、干燥脱水区/混合区、包装区、原辅材料及包装材料仓库、成品仓库、检测实验室等。如使用周转的容器生产,还应单独设立周转容器检查、预洗间。
4.4 清洁作业区应根据不同种类的饮料特点和工艺要求分别制定不同的空气洁净度要求。
4.5 出入清洁作业区的原料、包装容器或材料、废弃物、设备等,应有防止交叉污染的措施,如设置专用物流通道等。
4.6 作业中有排水或废水流经的地面,以及作业环境经常潮湿或以水洗方式清洁等区域的地面应耐酸
耐碱。
5 设施与设备
5.1 一般要求
应符合GB 14881-2013中第5章的相关规定。
5.2 设施
5.2.1 供水设施
5.2.1.1 必要时应配备储水设备(如储水槽、储水塔、储水池等),储水设备应符合国家相关标准或规定,
以无毒、无异味、不导致水质污染的材料构筑,有防污染设施,并定期清洗消毒。
5.2.1.2 供水设施出入口应增设安全卫生设施,防止异物进入。
5.2.2 排水设施
5.2.2.1 排水系统内及其下方不应有食品加工用水的供水管路。
5.2.2.2 排水口应设置在易于清洁的区域,并配有相应大小的滤网等装置,防止产生异味及固体废弃物
堵塞排水管道。
5.2.2.3 所有废水排放管道(包括下水道)必须能适应废水排放高峰的需要,建造方式应避免污染食品
加工用水。
5.2.3 清洁消毒设施
5.2.3.1 应根据工艺需要配备包装容器清洁消毒设施,如使用周转容器生产,应配备周转容器的清洗消
毒设施。
5.2.3.2 与产品接触的设备及管道的清洗消毒应配备清洗系统,鼓励使用原位清洗系统(CIP),并定期
对清洗系统的清洗效果进行评估。
5.2.4 个人卫生设施
5.2.4.1 生产场所或生产车间入口处应设置更衣室,洗手、干手和消毒设施,换鞋(穿戴鞋套)设施或工
作鞋靴消毒设施,必要时应设置风淋设施。
5.2.4.2 出入清洁作业区的人员应有防止交叉污染的措施,如要求更换工作服、工作鞋靴或鞋套。若采
用吹瓶、灌装、封盖(封口)一体设备的灌装防护区入口可依据实际需求调整。
5.2.4.3 液体饮料清洁作业区内的灌装防护区如对空气洁净度有更高要求时,入口应设置二次更衣室,
洗手和(或)消毒设施,换鞋(穿戴鞋套)设施或工作鞋靴消毒设施,必要时应设置风淋设施。符合下列条
件之一的可不设置上述设施:
a) 使用自带洁净室及洁净环境自动恢复功能的灌装设备;
b) 使用灌装和封盖(封口)都在无菌密闭环境下进行的灌装设备;
c) 非直接饮用产品[如食品工业用浓缩液(汁、浆)、食品工业用饮料浓浆等]的灌装防护区入口。
5.2.4.4 固体饮料的配料区、干燥脱水区/混合区、内包装区入口处应设置洗手和(或)消毒设施,换鞋
(穿戴鞋套)设施或工作鞋靴消毒设施。
5.2.4.5 如设置风淋设施,应定期对其进行清洁和维护。
5.2.5 仓储设施
5.2.5.1 应具有与所生产产品的数量、贮存要求、周转容器周转期及产品检验周期相适应的仓储设施,
仓储设施包括自有仓库或外租仓库。
5.2.5.2 同一仓库贮存性质不同的物品时,应适当分离或分隔(如分类、分架、分区存放等),并有明显的
标识。
5.2.5.3 必要时应具有冷藏(冻)库,冷藏(冻)库应配备可正确显示库内温、湿度的设施。
5.3 设备
5.3.1 生产设备
应配备与生产能力和实际工艺相适应的设备,液体饮料生产一般包括:水处理设备、配料设施、过滤
设备(需过滤的产品)、杀菌设备(需杀菌的产品)、自动灌装封盖(封口)设备、生产日期标注设备、工器具的清洗消毒设施等,固体饮料生产一般包括:混合配料设备、焙烤设备(有焙烤工艺的)、干燥脱水设备(有湿法生产工艺的)、包装设备、生产日期标注设备等。
5.3.2 设备要求
5.3.2.1 灌装、封盖(封口)设备鼓励采用全自动设备,避免交叉污染和人员直接接触待包装食品。
5.3.2.2 生产设备应有明显的运行状态标识,并定期维护、保养和验证。设备安装、维修、保养的操作不应影响产品的质量。设备应进行验证或确认,确保各项性能满足工艺要求。无法正常使用的设备应有明显标识。
5.3.2.3 每次生产前应检查设备是否处于正常状态,防止影响产品安全的情形发生;出现故障应及时排
除并记录故障发生时间、原因及可能受影响的产品批次。
5.3.2.4 设备备件应贮存在专门的区域,以便设备维修时能及时获得,并应保持备件贮存区域清洁
干燥。
6 卫生管理
6.1 应符合GB 14881-2013中第6章的相关规定。
6.2 清洁作业区的空调机和净化空气口应定期维护。
7 食品原料、食品添加剂和食品相关产品
7.1 一般要求
7.1.1 应符合GB 14881-2013中第7章的相关规定。
7.1.2 企业应建立原料、食品添加剂和食品相关产品供应商管理制度,规定供应商的选择、审核、评估程序,并在与其签订的合同中明确双方应承担的安全责任。
7.1.3 应对供应商采用的工艺流程和安全措施进行评估,必要时应进行定期现场评审或对流程进行
监控。
7.1.4 启封后的原料未用尽时必须密封,存放于适当场所,防止污染,在确保产品质量的前提下,在保
质期内尽快使用。固体原料在进入投料间时,应先除去外包装或采用有效措施防止交叉污染。
7.1.5 应保存食品原料、食品添加剂和食品相关产品采购、验收、贮存和运输的相关记录,保存期限不得少于产品保质期满后6个月;没有明确保质期的,保存期限不得少于2年。
7.1.6 需要清洗的原料,清洗原水应符合GB 5749中的相关规定。再利用的清洗用水应符合工艺和卫
7.1.7 具有吸附性的原料应避免与有强烈气味的原料或其他物品共同运输、贮存。
7.2 食品添加剂
包装用气体应符合相关标准或规定,并且在特定贮存和使用条件下不影响食品的安全和产品特性。
7.3 食品相关产品
7.3.1 非连线生产(外购)的包装容器、材料在运输和贮存过程中应使用清洁卫生、防水的材料包装,运
输车厢和贮存库必须保持清洁,不得与有毒有害物品混合运输贮存,应有防尘、防污染措施。
7.3.2 包装容器、材料应符合相关标准或规定,并且在特定贮存和使用条件下不影响食品的安全和产
品特性。食品接触的包装容器、材料用添加剂应符合GB 9685及相关法规要求。
7.4 菌种
保其活性,防止其他杂菌污染。发酵用菌种应根据菌种的特性在适宜温度下贮存,以保持菌种的活力。
8 生产过程的食品安全控制
8.1 一般要求
应符合GB 14881-2013中第8章的相关规定。
8.2 产品污染风险控制
8.2.1 应定期检测食品加工用水水质。饮料用水需脱氯时,应定期检验,确保游离余氯去除充分。
8.2.2 有水处理工艺的,应规定水处理过滤装置的清洗更换要求,制定处理后水的控制指标并监测
记录。
8.2.3 有调配工艺的,需复核确认,防止投料种类和数量有误。
8.2.5 溶解后的糖浆应过滤去除杂质,调好的糖浆应尽快使用。
8.2.6 半成品的贮存应严格控制温度和时间,配制好的半成品应尽快使用。因故延缓生产时,应对已
调配好的半成品及时作有效处理,防止污染或腐败变质,恢复生产时应对其进行检验,不符合标准的应
予以废弃。
8.2.7 杀菌工序应有相应的杀菌参数(如温度、时间、压力等)的记录或图表,并定时检查是否达到规定
要求。
8.2.8 生产时应确保产品封口的密闭性。
8.3 生物污染的控制
8.3.1 清洁和消毒
8.3.1.2 清洁作业区生产前应启动空气净化系统,对车间内空气进行净化。
8.3.1.3 应保证清洁人员的数量并根据需要明确每个人的责任,所有的清洁人员均应接受良好的培训,
认识污染的危害性和防止污染的重要性,确保生产车间达到卫生要求。
8.3.1.4 用于不同清洁区内的清洁工具应有明确标识,不得混用。
8.3.1.5 包装容器、材料在使用前应清洁或消毒,如果采用吹瓶、灌装、封盖(封口)一体设备,且设备自
带空瓶或瓶胚除尘和瓶盖消毒功能,可不再进行空瓶和瓶盖清洗消毒。
8.3.2 食品加工过程的微生物监控
饮料加工过程的微生物监控应包括:微生物监控指标、取样点、监控频率、取样和检测方法、评判原
则以及不符合情况的处理等,具体可参照附录A的要求,并结合生产工艺及产品特点制定监控内容。
GB 12695-2016
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard -
Specifications for Production Sanitation of Drinks
ISSUED ON. DECEMBER 23, 2016
IMPLEMENTED ON. DECEMBER 23, 2017
Issued by. National Health and Family Planning Commission of the
People’s Republic of China;
China 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 Application Scope ... 4
2 Terms and Definitions ... 4
3 Site Selection and Factory Environment ... 4
4 Plant and Workshop ... 4
5 Facilities and Equipment ... 5
6 Hygienic Management ... 8
7 Food Materials, Food Additives and Food Related Products ... 8
8 Food Safety Control for Production Process ... 9
9 Inspection ... 11
10 Storage and Transportation of Products ... 11
11 Product Recall Management ... 12
12 Training ... 12
13 Management System and Personnel ... 12
14 Record Keeping and File Management ... 12
Appendix A ... 13
Foreword
This Standard replaces GB 12695-2003, Good Manufacturing Practice of Drink
Factory.
Compared with GB 12695-2003, the major changes of this Standard are as follows.
-- the standard name is changed into “National Food Safety Standard –
Specifications for Production Sanitation of Drinks”;
-- the framework of the standard is modified;
-- the terms and definitions are modified;
-- the requirements for plant and workshop are modified;
-- the requirements for facilities and equipment are modified;
-- the requirements for food materials, food additives and food related products;
-- the requirements for the food safety control of the production process are
emphasized and the major measures for controlling biological, chemical and
physical contamination are made;
-- the inspection requirements are modified;
-- the requirements for product recall, personnel and training are added;
-- the requirements for record keeping and file management;
-- Annex A “Microbiological Monitoring Procedure Guide for the Production Process
of Drinks” is added.
National Food Safety Standard -
Specifications for Production Sanitation of Drinks
1 Application Scope
This Standard specifies the basic requirements and management guidelines for sites,
facilities and personnel during material purchase, processing, packaging, storage and
transportation and others in the production process of drinks.
This Standard applies to the production of drinks except packaged drinking water; it
does not apply to drinks which are made and sold on site.
2 Terms and Definitions
For the purposes of this document, the terms and definitions defined in GB 14881-
2013 apply.
3 Site Selection and Factory Environment
As specified in Article 3 of GB 14881-2013.
4 Plant and Workshop
4.1 As specified in Article 4 of GB 14881-2013.
4.2 Plant and workshop are usually designed including general work zones, quasi-
clean work zones and clean work zones. All zones shall be segregated by effective
means to prevent cross contamination. General work zones include raw material
handling zones, warehouses, outer packing zones and so on; quasi-clean work zones
usually include sterilization zones, batching zones, packaging container cleaning and
sterilization zones and so on; clean work zones include filling protective zones of liquid
the product characteristics, production process and the requirements of production
process for cleanliness.
4.3 Generally, the enterprise of liquid drinks shall provide water treatment zones,
batching zones, filling protective zones, packing zones, warehouses of raw and
auxiliary materials and packing materials, warehouses of finished products, testing
laboratories and so on, and the enterprise producing concentrates (juices and pulps)
for the food industry shall provide raw material cleaning zone (which shall be
segregated from the subsequent procedures by effective means). Generally, the
sterilization facilities.
a regular basis.
5.2.5 Storage facilities
5.2.5.1 Storage facilities shall be provided in accordance with the quantity of products
produced, storage requirements, circulating period of circulating containers and
product testing period; storage facilities include owned warehouses and rented
warehouses.
5.2.5.2 When materials of different natures are stored in the same warehouse, they
shall be separated or segregated from each other (e.g. they are stored by sorts,
shelves and zones) and marked with visible signs.
(freezing) warehouses shall be provided with devices for correct display of temperature
and humidity in warehouses.
5.3 Equipment
5.3.1 Provide equipment in accordance with the production capacity and actual
process. The equipment for the production of liquid drinks generally includes water
treatment equipment, batching equipment, filter equipment (for products needing to be
filtered), sterilization equipment (for products needing to be sterilized), automatic filling
and capping (sealing) equipment, manufacturing date marking equipment, cleaning
and sterilization equipment of tools and instruments; the equipment for the production
there is a baking process), drying and dehydration equipment (if there is a wet
manufacturing process), packing equipment, manufacturing date marking equipment
and so on.
5.3.2 Equipment requirements
5.3.2.1 The use of fully automatic equipment is encouraged as filling and capping
(sealing) equipment to prevent cross contamination and operators directly contacting
food to be packed.
5.3.2.2 Production equipment shall be marked clearly with the operating status and
maintained and verified on a regular basis. The handling of installation, maintenance
be verified or confirmed to ensure all properties can meet the technological
requirements. The equipment which is out of normal use shall be marked
conspicuously.
5.3.2.3 Examine whether the equipment is in the normal status before production
each time to prevent the occurrences which influences the safety of products; in case
liquids, water and other ingredients and food additives which are used in proportioning,
their characteristics shall be verified before use to ensure there are no abnormalities.
8.2.5 Syrup shall be filtered to remove impurities after dissolving; the syrup prepared
shall be used immediately after preparation.
finished products; the semi-finished products shall be used immediately after
preparation. When production is delayed for some reason, the semi-finished products
prepared shall be treated in time by effective means to prevent contamination or
deterioration; when production is recovered, they shall be tested and discarded if they
fail to meet the standard.
8.2.7 The sterilization procedures shall be provided with records or charts of
sterilization parameters (such as temperature, time, pressure and so on) and it shall
be examined on a regular basis whether the requirements specified are met.
8.2.8 During production, the impermeability of product sealing shall be ensured.
8.3.1 Cleaning and sterilization
8.3.1.1 The methods for cleaning and sterilization shall be safe, hygienic and
effective.
8.3.1.2 Air purification systems shall be started before the production in clean work
zones to purify the air in the workshops.
8.3.1.3 The number of cleaners shall be ensured; all cleaners shall be well trained in
accordance with the defined responsibilities of each person, to be aware of the hazards
of contamination and the significance of contamination prevention and ensure the
production workshops achieve the hygienic requirements.
which shall not be mixed up.
8.3.1.5 Packing containers and materials shall be cleaned or sterilized before use; if
integrated equipment of bottle blowing, filling and capping (sealing) is used and if
equipment has a dedusting function for empty bottles or preforms and the...
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