GB 23790-201 0FRYE(SEICH) - RVR - BARES Page 11 of 23

HCE BE 7 \f35

GB 23790-—2010

Table 1 Requirements for air cleanliness control of cleaning and quasi-cleaning work areas

Area Total bacterial count (cfu/dish)| Test method

Cleaning work area

0 Determination according to natural prec
Quasi-cleaning work area =50 1 method in GB/T 18204.1

5.1.9 The cleaning work area shall be kept dry, and the water supply facilities and systems
shall be minimized, otherwise protective measures shall be taken, and the upper space of
main production work surface shall not be traversed to avoid the secondary
contamination.

§.1.10 Plants, workshops and warehouses shall be provided with facilities preventing entrance of
animals such as insects and rats.

5.2 Interior architectural structure
Relevant requirements of GB 12693 shall be met.
53 Facilities

5.3.1 Water supply facilities
Relevant requirements of GB 12693 shall be met.
5.3.2 Drainage system

Relevant requirements of GB 12693 shall be met. Within the cleaning work area,
appropriate facilities shall be provided or appropriate measures shall be taken to keep dry
so as to avoid the growth and spread of relevant microbes caused by production of water
residue.

$33 Cleaning facilities

5.3.3.1 Relevant requirements of GB 12693 shall be met.

5.3.3.2 For cleaning work area requiring to keep dry, the following measures shall be taken:
a) Dry cleaning process applicable to the plate and equipment shall be used; or

b) Ifthe dry cleaning means are unavailable, wet cleaning may be used under controlled
condition, but the equipment and environment shall be restored to dry completely in
time to protect the area from contamination.

5.3.4 Personal hygiene facilities
5.3.4.1 Relevant requirements of GB 12693 shall be met.

5.3.4.2 The dressing room and hand-washing disinfection room shall be arranged near the
entrance to the processing workshop or at an appropriate place. Adequate non-manual
faucets, disinfecting facilities and automation inductive hand drying facilities shall be
provided in the hand-washing disinfection room.

5.3.4.3 Cleaning means shall be provided at the entrances of the workshops to avoid the
contamination of footwear to workshops.

5.3.4.4 A second dressing room shall be provided at the entrance of the cleaning work area, and
the hand disinfection facilities shall be provided before entry of the cleaning work area.

5.3.5 Ventilation facilities
Relevant requirements of GB 12693 shall be met.

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GB 23790-201 0Fx (FE SCA - HINER - HEEB Page 18 of 24

9.6.6.5

9.6.7

9.7
9.7.1

9.7.2

10
10.1
10.2

11

12

13

14

15
15.1

15.2

16

cee QE AA 55

GB 23790---2010

foreign matters, and process monitoring or effectiveness verification shall be performed
for these measures.

When products of various types are produced in the same production line, the production
line shall be effectively cleaned and site clearance records shall be kept to ensure that
products switching will not affect products of the next batch.

Production water control

The production water and equipment cleaning water in direct contact with food shall
conform to the relevant requirements of GB 5749. Circulating water, ice, steam and water
for other purpose shall conform to the relevant requirements of GB 12693.

Product information and labels

Product labels shall conform to GB 13432, national standards for corresponding products
and other relevant national regulations.

The labels shall indicate reconstitution method, reconstitution water, storage method of
the products and other information, and shall guide customers to prevent the practice that
may cause foodborne diseases due to improper use of the products when preparing and
handling the products and feeding.

Inspection
Relevant requirements of GB 12693 shall be met.

Representative samples of finished products shall be taken batch by batch, including the
first finished product after packing every day and other sampled finished products, and
inspected according to provisions of relevant national regulations and standards.

Storage and transport of products
Relevant requirements of GB 12693 shall be met.
Product tracing and recall

Relevant requirements of GB 12693 shall be met.
Training

Relevant requirements of GB 12693 shall be met.
Management institution and personnel
Relevant requirements of GB 12693 shall be met.
Record and document management
Record management

Relevant requirements of GB 12693 shall be met.
Document management

Relevant requirements of GB 12693 shall be met.

Monitoring and evaluation of effectiveness of food safety control
measures

The monitoring and evaluation measures in Annex A shall be used to ensure the
effectiveness of food safety control measures

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GB 23790-20107 (FE ICMK) - HUNGER: - HABE Page 14 of 23

7.34

7.35

14
7.41
7.4.2

1S

716

7.7

78

19

8.1

8.2
8.2.1
8.2.2

USC BE 8 7/15

GB 23790--2010

televant provisions and standard requirements, especially to ensure the applicability of
cleaning and infecting plan, appropriate concentration of cleaning agents and
disinfectants, and to ensure that the CIP system conforms to the relevant temperature and
time requirements. The equipment shall be washed properly when necessary.

Cleaning and disinfection schedule shall be formulated for all production workshops to
ensure that all areas are cleaned, and special cleaning shall be made for important area,
equipment and instrument.

The number of the cleaners shall be guaranteed and the responsibilities of each person
shall be clarified as required; all the cleaners shall be well trained, and understand the
hazard of contamination and importance of preventing contamination; and record shall be
made for cleaning and disinfection.

Personal health and hygiene requirement
Relevant requirements of GB 12693 shall be met.

The employees at the cleaning work area shall wear work clothes (or disposable work
clothes) conforming to hygiene requirements of the area, and wear hats, masks and
footwear. The employees at the quasi-cleaning work area and commonly work area shall
wear the work clothes conforming to hygiene requirements of the corresponding area, and
hats and footwear. The work clothes and footwear used in the quasi-cleaning work area
and commonly work area can not be worn outside the specified areas.

Insect control

Relevant requirements of GB 12693 shall be met.
Waste disposal

Relevant requirements of GB 12693 shall be met.
Management of toxic and hazardous substances
Relevant requirements of GB 12693 shall be met.
Sewage and dirt management

Relevant requirements of GB 12693 shall be met.
Work clothes management

Relevant requirements of GB 12693 shall be met.

Requirements for raw materials and packing materials
General requirements

Relevant requirements of GB 12693 shall be met. Raw materials to be used shall conform
to the requirements of national standards and (or) related regulations, shall ensure the
safety of infants and young children, and satisfy nutritional requirements, and substances
harmful to nutrition and health of infants and young children and non-food substances
shall not be used or added.

Purchase and acceptance requirements for raw materials and packing materials
Relevant requirements of GB 12693 shall be met.

For the raw materials entering the dry-mix process directly, enterprises shall take
measures to ensure that the microbial indexes of the raw materials conforms to the

raniivamante AP mendnet ctandacd and ance that tha wranca an

+ Af onvihann te

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GB 23790-2010niE(GE SCHR) - HUBER - HEE Page 12 of 23

5.3.7

6.1
6.1.1

6.1.2

6.1.3

6.1.3.1
6.1.3.2

6.1.3.3

6.1.3.4

6.2

6.3

7.2

13
7.31
7.3.2

WCE Se 8 /15

GB 23790—2010
Warehousing facilities
Relevant requirements of GB 12693 shall be met.
Equipment
Production equipment
General requirements
Relevant requirements of GB 12693 shall be met.
Materials
Relevant requirements of GB 12693 shall be met.
Design
The production equipment shall conform to the relevant requirements of GB 12693.

The production of the powdered formulae for infants and young children is classified into
the dry-mix process and the wet-mix process (including the combined process), and the
corresponding production equipment shall be equipped according to the process demand.

The production equipment shall be marked with obvious running status and being
repaired, maintained and verified regularly. The installation, repair and maintenance of
the equipment shall not affect the quality of products. The repaired equipment shall be
verified or confirmed to ensure that all performances meet the process requirements.
Non-conforming equipment shall be removed from the production area, and shall be
marked with obvious sign before removal.

Compressed air or other inert gases for food and cleaning food contact surfaces or
equipment shall be subject to filtration and purification treatment to prevent any indirect
contamination.

Monitoring equipment

Relevant requirements of GB 12693 shall be met.
Maintenance and repair of equipment
Relevant requirements of GB 12693 shall be met.
Hygiene management

Hygiene management system

Relevant requirements of GB 12693 shall be met.
Hygiene management for plant and facilities
Relevant requirements of GB 12693 shall be met.
Cleaning and disinfection

Relevant requirements of GB 12693 shall be met.

For the cleaning work area involving dry process (such as dry mix, filling and packaging),
dry cleaning process for the production equipment and processing environment is the
most effective measure to avoid the microbial reproduction, and the wet cleaning shall be
avoided as much as possible. The wet cleaning shall be only available for the equipment
components that can be handled to a special room or the circumstance that dry measures
can be taken immediately after wet cleaning.

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GB 23790-2010tR#E(RICM - HUA - RFCS Page 16 of 24

9.6.2

9.6.3

9.6.4

9.6.5

9.6.5.1

9.6.5.2
9.6.5.3

9.6.5.4

9.6.5.5

9.6.5.6

9.6.6

9.6.6.1
9.6.6.2

9.6.6.3

WE QE 11/15
GB 23790—2010

Intermediate storage

During the wet-mix process and combined process, corresponding measures shall be
taken for the intermediate storage of liquid semi-finished products to prevent the
microbial growth. The bare raw material powder in the dry-mix production or the bare
powdered semi-finished products in the wet-mix production shall be kept in the cleaning
work area.

Process procedure from heat treatment to drying

From heat treatment to drying, all transport pipes and equipment shall be kept enclosed
and be thoroughly cleaned and disinfected regularly.

Cooling

During the wet-mix process and the combined process production, the dried bare semi-
finished powder shall be cooled in the cleaning work area.

Dry mixing
During the dry-mix process and the combined process, the following key factors shall be
controlled in dry mixing:

The bare powder process (e.g. premixing, filling, batching and feeding) in contact with
air environment shall be made in the cleaning work area. The temperature and relative
humidity in the cleaning work area’ shall be compatible with the production process of the
powdered formulae for infants and young children. If there is no special requirement, the
temperature shall be not higher than 25 °C, and the relative humidity shall be below 65%.

Ingredients shall be weighed accurately.

The key process parameters (e.g. mixing time) related to mixing uniformity shall be
verified; the mixing uniformity shall be confirmed.

The inner wall of equipment in contact with materials shall be smooth, flat, free of dead
space, easy to clean and corrosion resistant, and its inner surface layer shall be made of
materials which will not react with the materials, release particles or absorb materials.

Compressed air required by transporting materials at positive pressure can be used only
after degreasing, dehydration, cleaning, filtering and sterilization treatment.

For raw materials, packing materials and personnel, strict hygienic control requirements
shall be formulated. The raw materials shall enter the work area through the material
channel after necessary cleaning procedures and shall subject to the procedures of
removing outer package or experiencing outer package disinfection. Operating personnel
shall enter the cleaning work area after the procedures of secondary dressing and hand

cleaning and disinfection to ensure hand hygiene of the related personnel, and they shall
wear work clothes, hoods, change shoes or wear shoe covers.

Inner packing procedure
The following key factors shall be controlled:
The inner packing procedure shall be carried out in the cleaning work area.

Only the related personnel shall be allowed to enter the packing room, and please refer to
9.6.5.6 for the requirements for raw materials, packing materials and personnel.

Before use, the outer package of the packing material shall be checked for intactness to
ensure that the packing materials are uncontaminated.

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GB 23790-201 0bsHE(3E CHD) - HINER - HABE Page 2 of 24

National Standard of the People's Republic of China

GB 23790—2010

National Food Safety Standard
Good Manufacturing Practice for Powdered
Formulae for Infants and Young Children

Issued on 2010-03-26 Implemented on 2010-12-01
Issued by Ministry of Health of the People’s Republic of China

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GB 23790-2010bRHE(GE ICR) - HVE - ERE Page 20 of 24

A.2.2.1

A.2.2.2

A.2.3

A2.4

A25

A.2.6

ed QE 15 /15

GB 23790-2010

The monitoring plan shall contain the following two samples:

Samples shall be taken from the surfaces which do not contact food, e.g. ground, pipes
and platform outside the equipment and around the production line. Under these
conditions, degree of contamination risk and contaminant content will depend on the
location and design of the production line and equipment.

Samples shall be taken from the surface in direct contact with food, such as the
equipment that may contaminate products directly from powder spray tower to package,
and microbes generate easily for the clots at tail of the screen absorb water. If there are
indicator bacteria, enterobacter sakazakii or salmonella on food contact surface, the
product contamination risk is high.

Target microbes

Salmonella and enterobacter sakazakii are the main target microbes, and
enterobacteriaece can act as the hygiene indicator. The enterobacteriaece content shows
the possibility of the existence of salmonella, and the growth conditions of salmonella
and enterobacter sakazakii.

Sampling points and sample size
The sample size changes with the complexity of the process and the production line.

The sampling points shall be the places where microbes may hide or enter to cause
contamination. The sampling points can be determined according to related
documentations, and also can be determined according to experience and professional
knowledge or historical date collected by factory contamination survey. The sampling
points shall be evaluated regularly, and necessary sampling points shall be added in the
monitoring plan according to special conditions, such as important maintenance and
construction activities or worsening of the hygiene condition.

The sampling plan shall be comprehensive and representative, and scientific and
reasonable sampling shall be performed at the production shifts of different types and
different periods of these shifts. In order to verify the effectiveness of cleaning measures,
sampling shall be made before startup for production.

Sampling frequency

The sampling frequency shall be decided according to factors in A.2.1, and be determined
according to the data about existence of microbes in all current areas covered by the
monitoring plan. If such data is unavailable, sufficient data shall be collected to determine
reasonable sampling frequency, including collecting the occurrence of salmonella or
enterobacter sakazakii for a long time.

The frequency of implementing the monitoring plan shall be adjusted according to the
detection results and degree of contamination risk. When the quantity of pathogenic
bacteria or indicator bacteria detected in finished product increases, environmental
sampling and survey sampling shall be enhanced to determine the contamination sources.
When the risk of contamination increases (e.g. after maintenance, construction or wet
cleaning), the sampling frequency shall be increased properly.

Sampling tools and methods

The sampling tools and methods shall be chosen according to surface type and sampling
location, for example, scraping the residue on the surface or powder in vacuum cleaner as
samples directly, for bigger surface, wiping and sampling by sponge (or cotton swab)

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GB 23790-201 0s #2 (SE 5ChR) - HVE - HEEB Page 20 of 24

ed RE 11/15
GB 237902010

Annex A
(Normative)

Environmental Monitoring Guide for Salmonella, Enterobacter
Sakazakii and Other Enterobacteriaece in Cleaning Work Area of

Al

AAA

A.1.2

A113

A2
A221

Powdered Formulae for Infants and Young Children

For a few enterobacteriaece (EB for short) may exist in the production environment with
good hygiene condition, including enterobacter sakazakii (Cronobacter), the pasteurized
products may be contaminated by the environment, causing trace amount of
enterobacteriaece in the finished products. Therefore, the enterobacteriaece in the
production environment shall be monitored to confirm effectiveness of hygiene control
procedure, and the manufacturers shall take corrective measures in time when there is any
deviation. The basic data of the hygiene conditions is obtained by continuous monitoring
and trend change shall be tracked. Practices of some manufacturers indicate that
decreasing the amount of enterobacteriaece in environment can reduce the amount of
enterobacteriaece (including enterobacter sakazakii and salmonella) in the finished
products.

In order to prevent contamination and limitation of microbes in finished products for
sampling inspection, environmental monitoring plan shall be formulated. The monitoring
plan may act as a food safety management tool to evaluate the hygiene condition in the
cleaning work area (dry area) and as a basic procedure of HACCP.

When formulating the monitoring plan, the following ecological characters of salmonella,
enterobacter sakazakii and other enterobacteriaece shall be considered:

Although salmonella is seldom found in dry environment, a monitoring plan shall be
formulated to prevent entry of salmonella, evaluate the effectiveness of the hygiene
control measures in the production environment, and guide the related personnel to
prevent further spread in case of salmonella detection.

Enterobacter sakazakii is more often to be found than salmonella in the dry environment.
Enterobacter sakazakii are easily detected if proper sampling and test methods are used.
A monitoring plan shall be formulated to evaluate whether the amount of enterobacter
sakazakii increase, and effective measures shall be taken to prevent growth.

Enterobacteriaece is widely distributed, are a kind of common coliform in dry
environment, and easily detected. Enterobacteriaece may act as indicator bacteria for
production process and environmental hygiene condition.

Factors to be considered while designing sampling plan
Product varieties and process

The requirements and scope of the sampling plan shall be determined according to
product characters, customer ages and hygiene conditions. For all kinds of products in
this Standard, salmonella is specified as a pathogenic bacterium; while for some products,
enterobacter sakazakii are specified as a kind of pathogenic bacteria.

Monitoring shall focus on the area where microbes can conceal and generate easily, e.g.
the cleaning work area in dry environment. Special attention shall be paid to the boundary
between this area and its neighbor area with lower hygiene level and the place that is
close to production line and equipment is contaminated easily, for example, the opening
in enclosed equipment for occasional inspection. The known or possible contaminated

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GB 23790-2010#RvE( ICM) - HUE - HES Page 9 of 24

8.3
8.3.1
8.3.2

8.3.3

9.1.1
9.1.2

9.2

9.3

9.4

9.5

9.6

9.6.1

WE SE 5 /15
GB 23790-2010

Transport and storage requirements for raw materials and packing materials
Relevant requirements of GB 12693 shall be met.

Food additives and food nutritional fortification substances shall be managed by special
persons, and stored in special warehouse or area, and special register (or warehouse
management software) shall be used to record the names, purchasing dates, purchasing
volumes and use amount of the additives and nutritional fortification substances, and
their terms of validity shall be kept in mind.

Vitamins, microelements and other nutritional fortification substances susceptible to
quality change during storage shall be subject to raw material qualification, and shall be
inspected when necessary to ensure that they meet the raw material requirements.

The purchase, acceptance, storage and transport records of raw materials and
packing materials shall be kept.

Food safety control in production
Control of microbial contamination
Relevant requirements of GB 12693 shall be met.

When there is any deviation in the monitoring results of control measures, appropriate
corrective measures shall be taken.

Control of chemical contamination

Relevant requirements of GB 12693 shall be met.
Control of physical contamination

Relevant requirements of GB 12693 shall be met.

Food additives and nutritional fortification substances
Relevant requirements of GB 12693 shall be met.
Packing materials

Relevant requirements of GB 12693 shall be met.
Specific processing procedures

All processing procedures in production process of the powdered formulae for infants and
young children shall conform to the requirements of the specific processing procedures of
dry-mix process or wet-mix process, and shall conform to the following requirements:

Heat treatment (wet-mix process and combined process)

The heat treatment procedure shall be considered as a critical control point for ensuring
the safety of powdered formulae for infants and young children. For temperature and time
of the heat treatment, the impact of product attributes and other factors (e.g. fat content,
total solid content) on thermal resistance of targeted microbes shall be taken into account.
So relevant processes shall be formulated to check whether the temperature and time are
deviated, and appropriate corrective measures shall be taken.

If the soybean purchased is not heated for enzyme inactivation (or experiences
incomplete enzyme inactivation), such soybean-based products shall achieve the effect of
killing pathogenic bacteria and complete enzyme inactivation simultaneously by heat
treatment (urease is negative), and be monitored as the critical control point.

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GB 23790-2010FxHE (GE SCAR) - HUBER - HEEB Page 12 of 24

5.1
5.1.1
5.1.2

5.1.2.1

5.1.2.2

5.1.2.3

5.1.2.4

5.1.2.5

5.1.3

5.1.4

5:15

5.1.6

5.1.8

WCE QE 1 (48
GB 23790—2010

Design and layout
Relevant requirements of GB 12693 shall be met.

Plant and workshop shall be reasonable designed, and relevant facilities and equipment
suitable for production shall be constructed and planned to avoid microbial generation
and contamination especially contamination caused by salmonella and enterobacter
sakazakii (Cronobacter) and avoid or reduce existence or reproduction of these bacteria
in concealed places. The following factors shall be taken into consideration in design to
avoid the microbial generation:

In design, the wet area shall be isolated and separated from dry area; contamination
caused by employees, equipment and material movement shall be controlled effectively
to prevent salmonella and enterobacter sakazakii from entering the cleaning work area.

Reasonable drainage facilities shall be designed; ground shall be flat and have proper
slope to avoid water accumulation; and condensation water shall be avoided in cleaning
work area.

The processing materials shall be stored properly so as to avoid the generation of the
place unfavorable for cleaning.

The wet cleaning process shall be designed properly to avoid the generation and
transmission of salmonella and enterobacter sakazakii due to improper wet cleaning
process in dry area.

Clearance among various pipes, cables and holes through building floors, ceilings and
walls shall be enclosed and sealed well.

The interior design and layout of production place of the powdered formulae for infants
and young children shall be arranged properly according to production process and
hygiene requirements.

The operations in dry processing area without subsequent sterilization shall be made in
cleaning work area, such as the operation from drying (or post-drying) process to filling
and packaging.

Work areas shall be graded by cleanliness according to production process, hygiene and
quality requirements. As a general rule, there are commonly work area, quasi-cleaning
work area and cleaning work area. A separate air purification system with filter unit shall
be installed in cleaning work area and shall remain under positive pressure.

Effective physical isolation shall be provided among work areas of different cleanliness
levels. The positive pressure from cleaning work area to other areas shall be kept to
prevent unpurified air entering cleaning work area to cause cross contamination.

Access to cleaning work area shall be reasonably restricted to avoid or reduce pathogenic
bacterial contamination. Measures for preventing cross contamination shall be taken for
personnel, raw materials, packing materials, waste, equipment, etc. entering and leaving
the cleaning work area, such as establishment of personnel dressing room for changing
work clothes, footwear or shoe covers, special material corridor, waste corridor, etc. For
the raw materials or products entering the cleaning work area through pipes, proper air
filtration system shall be designed and installed.

The purification level of each work area shall meet the requirements of processing the
powdered formulae for infants and young children for air purification. The air cleanliness
of cleaning work area and quasi-cleaning work area shall conform to the requirements of

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GB 23790-201 0fn HE (BE 5C AX) - HVIGER - HAE Page 10 of 24

De SE 1 71s

GB 23790-—2010

National Food Safety Standard

Good Manufacturing Practice for Powdered Formulae for Infants and

3.2

3.3

3.4

3.5

3.6

Young Children
Scope

This Standard is applicable to manufacturers of powdered formulae for infants and young
children (including powdered formulae for infants, powdered formulae for older infants
and young children) with milk or soybean and its processed products as main materials.

Normative references

Documents referenced in this Standard are essential for application of this Standard. For
dated references, only the dated edition is applicable to this Standard. For undated
references, the latest edition (including all amendments) is applicable to this Standard.

Terms and Definitions
Cleaning work area

Work areas with high cleanliness requirement, such as workshops for storage, fillimg and
inner packing of bare semi-products to be packed.

Quasi-cleaning work area

Work areas with cleanliness requirement lower than that of cleaning work area, such as
Taw material preprocessing workshop.

Commonly work area

Work areas with cleanliness requirement lower than that of quasi-cleaning work area,
such as milk collecting workshop, raw material warehouse, packing material warehouse,
outer packing workshop and finished products warehouse.

Wet-mix process

Production process processing and mixing ingredients of powdered formulae for infants
and young children in liquid state, usually including blending, heat treatment,
concentration, drying and other procedures.

Dry-mix process

Production process processing and mixing ingredients of powdered formulae for infants
and young children in dry state to make finished products.

Combined process

Production process processing and mixing some ingredients of powdered formulae for
infants and young children in liquid state, and adding the rest dry ingredients by the dry-
mix process to make finished products after drying.

Site selection and factory environment

Relevant requirements of GB 12693 shall be met. Factories shall be away from livestock
farms, and animals shall not be kept in the factories.

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GB 23790-20107 (SEICHR) - HVE - HAE Page 6 of 24

Kee SE 1 7/15
GB 23790—-2010

Foreword

This Standard replaces GB/T 23790-2009 Good Manufacturing Practice for Infant formula Factory.

This Standard refers to international standard CAC/RCP 66-2008 Code of Hygienic Practice for
Powdered Formulae for Infants and Young Children.

The main changes in this Standard over GB/T 23790-2009 are as follows:

changing the name of this Standard into Good Manufacturing Practice for Powdered
Formulae for Infants and Young Children.

changing voluntary standard to mandatory standard;
modifying provision framework of this Standard;
adding relevant requirements for raw material purchase, acceptance, transport and storage;

modifying food safety control measures for manufacturing process, adding specific
treatment procedures for safety control, and formulating control requirements for important
procedures such as heat treatment, intermediate storage, cooling, dry mixing and inner
packaging; and referring to provisions of GB 12693-2010 for critical control measures for
microbial, chemical and physical contamination;

adding requirements for safety control of raw material soybean;

adding monitoring and evaluation method for effectiveness of food safety control measures;
and

adding Annex A and specifying the requirements for monitoring main contamination
sources in the environment of cleaning work area — salmonella, enterobacter sakazakii and
other enterobacteriaece.

Annex A of this Standard is normative.
The previous edition(s) replaced by this Standard is (are) as follows:

GB/T 23790-2009.

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GB 23790-201 0h HE (SE 5ChR) - RVR - HEEB Page 22 of 24

A2.8

A.29

WCE RE 15: [7/18

GB 23790-2010

The analysis methods shall be capable of detecting the target microbes effectively, have
acceptable sensitivity and related records. On the premise of ensuring the sensitivity,
several samples may be mixed for detection. If positive result is detected, location of the
positive sample shall be further determined. If necessary, gene technology can be used to
analyze enterobacter sakazakii sources and the related information of contamination route
of powdered formulae for infants and children.

Data management

The monitoring plan shall contain data record and evaluation system, e.g. trend analysis.
The data must be subject to continuous evaluation so as to modify and adjust the
monitoring plan properly. Effective management shall be performed on the data of
enterobacteriaece and enterobacter sakazakii, and the neglected mild or intermittent
contamination may be found.

Corrective measures of positive results

The monitoring plan aims to find whether the target microbe exists in environment.
Before formulating the monitoring plan, acceptance standard and corresponding measures
shall be prepared. The monitoring plan shall specify specific measures and clarify the
corresponding reasons. The relevant measures include being actionless (no risk of
contamination), enhancing cleaning, tracing contamination sources (adding
environmental test), evaluating hygiene measures, detaining and testing products.

The manufacturers shall formulate the measures after detecting enterobacteriaece and
enterobacter sakazakii so as to response accurately in case of exceeding standard. The
hygiene procedures and control measures shall be evaluated. When salmonella is detected,
corrective actions shall be taken immediately, the trend of enterobacter sakazakii and the
change in quantity of enterobacteriaece shall be evaluated, and the action to be taken shall
depend on the possibility that the products are contaminated by salmonella and
enterobacter sakazakii.

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