GB 31603-2015 PDF English
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National food safety standard - General Health Code for Production of Food-contacted Materials and Products
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GB 31603-2015: National food safety standard - General Health Code for Production of Food-contacted Materials and Products
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB31603-2015
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
to prevent propagation of insect pests.
4 Plant
4.1 The plant shall be well arranged in accordance with the production process and
health requirements. The operating areas shall be divided appropriately in accordance
with the cleanliness requirements for different production areas. Hierarchical health
management shall be carried out for the manufacturing workshops and public places
within the plant.
4.2 The plant area shall be compatible with the production capacity. There shall be
sufficient space and site for the storage of equipment, materials and products in order
to meet the requirements of production and operation.
4.3 The wall and floor surfaces of the manufacturing workshops and storerooms shall
be smooth to reduce dust accumulation for the convenience of cleaning; for the
products being processed and final products which are in direct contact with food
without cleaning, the ceiling of the manufacturing workshops shall be convenient for
cleaning and disinfection, whose structure prevents condensate water dripping directly.
4.4 The production and operation in the same manufacturing workshop or adjacent
manufacturing workshops shall not cause cross contamination. When products of
different health requirements are produced within a common production area, the
health properties of all products shall be ensured. Appropriate space shall be provided
between equipment and equipment or equipment and wall, for the convenience of
operation.
5 Facilities and Equipment
5.1 Facilities
5.1.1 The facilities for health, ventilation, transportation and conveying shall be
provided which match with the production capacity and health requirements. They shall
be well maintained.
5.1.2 The facilities for water supply and drainage shall be provided as appropriate.
5.1.3 The water tanks, floor drains and other devices provided for the production area
shall not cause pollution to products.
5.1.4 Sufficient cleaning facilities shall be provided. The workshops with special
health requirements shall be provided with appropriate disinfection facilities and
disinfected periodically. For the products being processed and final products which are
in direct contact with food without cleaning, the manufacturing workshops and
storerooms shall be provided with facilities including disinfection, dust prevention and
insect prevention and shall not cause pollution to products.
5.1.5 The facilities for waste disposal shall be provided to prevent causing pollution
to products. The requirements for the discharge of waste water, waste gas and waste
materials, noise pollution and health and other aspects shall meet the relevant national
regulations.
5.1.6 The products being processed and final products which are in direct contact
with food without cleaning shall meet the following requirements.
-- Changing rooms shall be provided at the entrance of the manufacturing
workshops. The size of changing rooms shall match with the number of
production personnel. Work clothes shall be separated from individual clothes
and other articles.
-- The facilities for changing shoes (or wearing shoe cover) or disinfecting work
shoes shall be provided at the entrance of the manufacturing workshops. If the
disinfection facilities for work shoes are provided, their specifications and
dimensions shall meet the disinfection requirements.
-- The facilities for handwashing, disinfection and dust extraction shall be provided
at the entrance of the manufacturing workshops.
5.1.7 It is recommended that the measures specified in 5.1.6 should be taken for the
manufacturing workshops of other products.
5.1.8 The changing rooms and facilities in the manufacturing workshops for changing
shoes, handwashing, disinfection and dust extraction shall be managed by special
personnel, which shall be cleaned and disinfected in time and kept in clean condition
to prevent causing pollution to products.
5.1.9 Appropriate, convenient toilets and handwashing facilities shall be provided for
staff. Toilets shall be partitioned from the manufacturing workshops and kept clean.
5.1.10 Adequate natural lighting or artificial lighting shall be provided in the plant. The
production areas with special requirements for the intensity of illumination can be
provided with local lighting.
5.1.11 The manufacturing workshops whose production process is subjected to
temperature and humidity shall be provided with temperature-humidity regulating and
monitoring facilities.
5.2 Equipment
5.2.1 Production equipment matching with production capacity and necessary
inspection equipment shall be provided.
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.
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
training.
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
expertly in accordance with the process files.
7 Requirements for Raw and Auxiliary Materials
7.1 The raw and auxiliary materials shall be as specified in relevant national laws,
regulations and standards. Their use shall ensure the products manufactured meet
food safety requirements.
7.2 The management system for purchase, acceptance, transportation and storage
of raw and auxiliary materials shall be established.
7.3 The management system for suppliers of raw and auxiliary, which specifies the
procedures for selection, verification and assessment of suppliers. The suppliers shall
be evaluated for the selection of qualified suppliers.
7.4 The transportation of raw and auxiliary materials shall meet the specified
transportation conditions, which shall not be mixed with toxic, hazardous materials to
prevent contamination and deterioration.
7.5 Raw and auxiliary materials purchased shall be accepted as specified. Their
conformity certification documents shall be examined. For those without effective
documents, they shall be inspected or verified in accordance with corresponding food
safety standards or enterprise acceptance standards and relevant records shall be
kept.
7.6 The materials to be tested and the accepted and rejected materials shall be
stored in different areas and by batch. Obvious identification shall be provided.
7.7 In accordance with the physical and chemical characteristics of raw and auxiliary
materials, the conditions for storage of them shall be selected as appropriate. Toxic,
hazardous materials and inflammable, explosive materials shall be stored separately,
marked clearly and kept by special personnel; they shall be used by trained personnel
in accordance with the method for use.
7.8 The cleaning materials, lubricating agents, adhesion agents, release agents,
washing agents, disinfectant and other chemicals used by equipment shall be
classified and marked in accordance with their application, and stored and used safely
to prevent causing pollution to products.
8 Product Safety Control During Production Process
8.1 Health requirements for production and processing
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
in raw and auxiliary materials, processes or other aspects, assessment shall be carried
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
chemicals and microorganisms. The monitoring results shall be recorded.
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.
8.2.3 During the formula design and applying process of printing ink as well as the
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.
8.2.4 During the formula design and applying process of printing ink as well as the
treatment and storage process of semi-finished printing products or finished products,
the substance, which is transferred from printing surface to food-contacted surface as
a result of penetration through base material or adhesion caused by folding or winding,
shall be controlled intensively, to ensure that the concentration of the substance
transferred to food is as required by food safety, i.e. not harmful to human health or
causing the change of food characteristics.
8.3 Health requirements for packaging, storage and transportation
8.3.1 The containers, tools and equipment used for packaging, storage and handling
shall be kept clean, not causing pollution to products; the packaging method shall be
capable of preventing secondary pollution.
8.3.2 Appropriate conditions for storage and transportation shall be selected in
accordance with the physical and chemical characteristics of products; effective
measures shall be taken to prevent the pollution of toxic, hazardous substances.
Protection shall be strengthened during the process of storage and transportation to
prevent damages and pollution of finished products.
8.3.3 The guarantee period of products shall be made in accordance with the
characteristics of products and as specified in relevant national laws, regulations and
standards.
8.3.4 Inspection status shall be indicated for finished products; rejected products
shall be stored separately and marked clearly.
8.3.5 The products stored in warehouse shall be inspected periodically; temperature-
humidity records shall be kept if necessary; in case of any exceptional situation, it shall
be dealt with in time.
8.3.6 Transportation means (such as vehicles and containers) shall be kept clean
and dry and provided with rain-proof measures.
9 Management Organization
9.1 The enterprise shall establish a health management department to be
responsible for the general management of the health-related work of the enterprise.
The department shall be responsible for publicizing and implementing relevant laws
and rules and supervising and checking the implementation of the enterprise;
preparing and revising all health management system and plan of the enterprise;
organizing the health publicity and education work and training personnel concerned.
10 Inspection
10.1 Products shall be inspected by self-inspection or by entrusting an 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 out for products as specified in accordance
with relevant parameters and requirements of the process instructions, and the records
kept.
10.3 Each batch of products shall be sampled randomly for ex-factory inspection as
specified in relevant standards, and the records kept.
10.4 Type inspection shall be carried out as specified in relevant standards.
10.5 The management system of rejected products shall be established; the rejected
products shall be handled accordingly.
10.6 The sample preservation system for finished products shall be established as
required; the time of preservation shall not be less than the guarantee period marked
on finished products; the enterprise shall specify guarantee period for those having no
guarantee period requirements.
11 Product Tracing and Recall
11.1 The product tracing system shall be established to ensure the traceability of all
links from the purchase of raw and auxiliary materials to the distribution of products.
11.2 The product recall system shall be established. When it is found that some batch
or type of products contains or may contain elements which may cause hazards to the
health of consumers, the product recall procedure shall be initiated in accordance with
relevant national regulations; related departments shall be notified in time; relevant
records shall be kept.
11.3 The recalled products shall be handled accordingly. For the products recalled
because their labelling, marking or instruction does not comply with the food safety
standards, their distribution can be continued, provided that corrective measures are
taken and food safety can be ensured; the corrective measures shall be indicated
expressly to consumers during distribution.
11.4 The consumer compliant settling mechanism shall be established. For the
suggestions and complaints in written or unwritten form made by clients, relevant
department of the enterprise shall keep unified records, find out causes and deal with
them properly.
12 Document Management and Record
12.1 The systematic, effective document management procedure shall be
established and implemented to carry out control management for all documents to
ensure the documents are kept intact and convenient for searching and tracing.
12.2 The procedures and responsibilities related to the preparation and revision of
all documents shall be specified and implemented; they shall be revised and confirmed
by the authorized officer with regard to the applicability.
12.3 The compliance documents of raw and auxiliary materials and the production
records shall be kept and archived; the method for archiving shall be convenient for
retrieval.
12.4 Product information shall be recorded faithfully, including but not limited to
product name, specification, quantity, manufacturing date, manufacturing batch,
inspection result, purchaser name and contact information and sale date.
12.5 The invalid documents preserved as required by the laws and information
preservation shall be marked.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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