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Global Standard
FOOD SAFETY
ISSUE 9
GUIDE TO
KEY CHANGES
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Food
Safety
Global Standard
FOOD SAFETY
ISSUE 9
GUIDE TO
KEY CHANGES
August 2022
FOOD SAFETY
ISSUE 9
GUIDE TO KEY CHANGES
Copyright and liability

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The Global Standard Food Safety: Guide to Key Changes and the terms of the disclaimer set out above shall be
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Copyright
© BRCGS August 2022
ISBN 978-1-78490-462-3
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FOOD SAFETY
ISSUE 9
Contents
Introduction 4
Background and objectives of Issue 9 4
Summary of key changes to the requirements 4
Changes to the audit protocol 6
Detailed changes to the requirements 7

1 Senior management commitment 8
2 The food safety plan - HACCP 14
3 Food safety and quality management system 22
4 Site standards 37
5 Product control 62
6 Process control 75
7 Personnel 79
8 Production risk zones – high risk, high care and ambient high care 83
9 Requirements for traded products 90
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ISSUE 9
Introduction
BRCGS published Issue 9 of the Global Standard Food Safety (hereafter referred to as the Standard) in August 2022
and this issue will be used for all audits conducted from 1 February 2023. Certificates issued against Issue 8 remain
valid for the duration indicated on the certificate.
This document is intended to introduce Issue 9 and act as a guide for all users to the changes and the reasons for
the changes since Issue 8. The document provides a full list of all the changes to the requirements and will be a
useful reference for companies needing to update their quality systems in preparation for an audit against Issue 9.
There is also an interpretation guideline which provides guidance on all the clauses. These documents are available
to all certificated sites on BRCGS Participate as part of the service package or separately via the BRCGS Store.
Background and objectives of Issue 9

Development process
A review of the emerging product safety concerns since the publication of Issue 8 identified a number of
opportunities for further development. The key objectives identified for the working group was to:
• encourage understanding and further development of product safety culture

• ensure global applicability, maintaining compatibility with the updated Codex General Principles of Food Hygiene,
and benchmarking to the Global Food Safety Initiative (GFSI) benchmarking requirements
• expand the audit options to include the use of information and communication technology (ICT)
• update the requirements associated with core product safety activities, such as internal audits, root cause analysis,
preventive actions and incident management
• provide greater clarity for sites completing animal primary conversion and producing animal feed.
The detail of the Standard was developed by a working group made up of international stakeholders representing
food manufacturers, retailers, food service companies, certification bodies, accreditation bodies and independent
technical experts.
The draft requirements were published in December 2021 for industry consultation. All of the comments received
on the draft were reviewed before the final version was produced.
Summary of key changes to the requirements

Issue 8 of the Standard was well received, and we acknowledge that it is a growing standard, with a number of new
sites entering the programme on a monthly basis. The requirements of Issue 9 represent an evolution from previous
issues, with a continued emphasis on management commitment, a food safety programme (based on hazard analysis
and critical control points (HACCP)), and a supporting quality management system. The continuing objective has
been to direct the focus of the audit towards the implementation of good manufacturing practices.
The vast majority of the requirements are largely unchanged, receiving only minor edits to the wording to aid clarity.
This means that the key changes are easy to identify, enabling sites to concentrate on those areas which need to be
addressed for certification to Issue 9.
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ISSUE 9
Consistency with other BRCGS Standards

We have amended some clauses to reflect the good practice learnt from other BRCGS Standards. For example, the
term ‘integrity’ has been replaced by ‘authenticity’ to ensure consistent terminology throughout our Standards.
Product safety culture

The importance of product safety culture has gained renewed understanding since it was first incorporated into the
Standard. To this end, and following feedback from the food industry, the working group reviewed the requirement
and auditing of food safety culture. This resulted in a major revision of the requirement 1.1.2.
HACCP/Food Safety Plan

The working group felt that it was appropriate to update the wording for section 2 concerning the HACCP food
safety plan to align the requirements with the 2020 revision of the General Principles of Food Hygiene.
Outsourced processing
An analysis indicated that a significant number of enquiries have related to the definition of outsourced processing.
To focus on the issue, the Standard has updated the definition and some of the requirements.
Equipment
Since the publication of Issue 8 of the Standard, GFSI has published a new benchmark on the hygienic design of
food buildings and equipment.
The working group completed a full review of the existing requirements for equipment and this resulted in a major
revision of the requirements in section 4.6.
Animal primary conversion

In May 2021 BRCGS published a position statement on the additional requirements for sites which undertake animal
primary conversion. The working group agreed that the content of the position statement should be incorporated
into the Standard.
Additional modules
The following additional modules have been reviewed and updated for Issue 9.
Module 10 – Global G.A.P. Chain of Custody
Module 11 – Meat Supply Chain Assurance.
Module 13 – Meeting FSMA Requirements for Food (Previously known as Module 13: FSMA Preventive controls
preparedness)
These modules are voluntary; however, where the company applies for certification to a module, all relevant
requirements from the Standard (sections 1–9) must be fulfilled in addition to all the requirements outlined in the
module, unless there are any justifiable exceptions (e.g. Section 9: Requirements for traded products only applies to
sites that handles traded products).
Colour-coding of requirements
The audit process gives specific emphasis to the practical implementation of food safety procedures within the
factory and general good manufacturing practices. Auditing these areas therefore forms a significant proportion of
the audit.
As an aid to this process, the requirements within the Standard have been colour-coded. This colour-coding shows
the activities that would usually be audited as part of the assessment of the production areas and facilities, and
those that would form part of an audit of records, systems and documentation.
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The colour-coding also highlights which requirements may be audited remotely, as part of a blended audit, and
which must be audited when the auditor is on site.
The colour-coding is as follows:
Audit of records, systems and documentation
Audit of production facilities and good manufacturing practice
Requirements assessed in both
Changes to the audit protocol

Announced audits to include a mandatory unannounced audit every 3 years
Due to the added confidence provided by unannounced audits, the GFSI benchmark 2020 introduced a requirement
for all certificated sites to have at least one unannounced audit within every 3-year period, even where the site has
opted to be part of an announced audit programme.
Therefore, every 3 years, the audit will be unannounced; the certification body will notify the site and agree which
year this will be, to ensure that the site is aware that an unannounced audit will take place in the coming year.
However, the actual date of the unannounced audit will not be communicated to the site in advance.
The protocol for an unannounced audit at least once every 3 years was initially introduced into the BRCGS
Standards via position statement BRCGS079, but is now fully incorporated into the Standard audit protocol to
remove the need for sites to refer to a separate audit protocol.
All other aspects of the announced audit protocol remain unchanged. More details on the announced audit
programme can be found in Part III, section 2 of the Standard.
Blended announced audit programme

BRCGS has introduced a blended announced audit option that utilises the evolving role of information,
communication technology (ICT) to incorporate remote assessment into the audit process. With this audit option
the audit is split into two separate parts: a remote audit, followed by an on-site audit. The first part (the remote
audit) looks predominantly at the documented systems and records using ICT, while the second part (the announced
on-site audit) focuses mainly on production, storage and other on-site areas.
The significance of this audit option resides in the flexibility provided to the audit scheduling. More details on the
blended announced audit protocol can be found in Part III, section 3 of the Standard.
Unannounced audits
The unannounced audit protocol has remained largely unchanged from Issue 8 to Issue 9.
START!
The START! Programme will undergo a full review to ensure that it remains applicable and relevant for smaller sites
and those who are developing their product safety and quality systems.
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ISSUE 9
Detailed changes to the requirements

The following tables highlight the key changes to the requirements between Issues 8 and 9 and provide a brief
commentary on the reasons for each change, where applicable.
Changes from Issue 8 have been highlighted in red text.
Where text has been removed this is shown by using strikethrough text.
Please note, however, that it is the responsibility of the site to study all the requirements of the Standard to ensure
that these are understood and that suitable processes are in place to achieve compliance.
It is a requirement that all sites undergoing a BRCGS audit to the Global Standard Food Safety (Issue 9) have access
to an official copy of the Standard. Companies must comply with all requirements to achieve certification.
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1 Senior management commitment

1.1 Senior management commitment and continual improvement
Fundamental
Statement of intent Comments

The site’s senior management shall demonstrate they are fully committed Several clauses in section 1 have
to the implementation of the requirements of the Global Standard Food been updated to reflect the
Safety and to processes which facilitate continual improvement of food importance of product safety culture
safety, quality management and the site’s food safety and quality culture. and management commitment to
the processes for effective product
safety, authenticity, legality and
quality.
Clause Requirements Comments

1.1.1 The site shall have a documented policy which A site must state its intention for the
states the site’s intention to meet its obligation continuous improvement of product
to produce safe, legal and authentic products to safety and quality culture.
the specified quality, and its responsibility to its
customers. This shall:
• be signed by the person with overall responsibility
for the site
• be communicated to all staff
• include commitment to continuously improve the
site’s food safety and quality culture.
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1.1.2 The site’s senior management shall define and The importance of the effect of
maintain a clear plan for the development and the site’s product safety on the
continuing improvement of a food safety and quality implementation of robust food
culture. The plan shall include measures needed to safety management systems has
achieve a positive culture change. gained understanding since it was
first incorporated into the Standard.
This shall include:
The updated clause is designed
• defined activities involving all sections of the
to provide sites with a clear
site that have an impact on product safety. As
indication of the topics that need
a minimum, these activities shall be designed
to be considered as part of a robust
around:
continual improvement plan.
• clear and open communication on product
safety
• training
• feedback from employees
• the behaviours required to maintain and
improve product safety processes
• performance measurement on activities related
to the safety, authenticity, legality and quality of
products
• an action plan indicating how the activities will
be undertaken and measured, and the intended
timescales
• a review of the effectiveness of completed
activities.
The plan shall be reviewed and updated at least
annually, at a minimum.
1.1.3 The site’s senior management shall ensure that The term ‘authenticity’ has been
clear objectives are defined to maintain and improve added to several clauses to
the safety, authenticity, legality and quality of highlight the importance of senior
products manufactured, in accordance with the food management commitment in
safety and quality policy and this Standard. These preventing food fraud and therefore
objectives shall be: ensuring products are authentic.
• documented and include targets or clear measures The objectives are relevant to the
of success entire workforce, therefore should
• clearly communicated to all staff be communicated to all staff. This
• monitored and results reported at least quarterly clause was amended to clarify the
to site senior management and all staff. requirement and encourage best
practice.
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1.1.4 Management review meetings attended by the The review of food safety and
site’s senior management shall be undertaken quality culture plan is important for
at appropriate planned intervals, annually at a continual improvement. The clause
minimum, to review the site performance against the has been amended to clarify the
Standard and objectives set in clause 1.1.3. requirement to ensure the food
safety culture plan remains up-to-
The review process shall include the evaluation of:
date and effective.
• previous management review action plans and
timeframes
• the results of internal, second-party and/or third-
party audits
• any objectives that have not been met, to
understand the underlying reasons. This
information shall be used when setting future
objectives and to facilitate continual improvement
• any customer complaints and the results of any
customer feedback
• any incidents (including both recalls and
withdrawals), corrective actions, out-of-
specification results and non-conforming
materials
• the effectiveness of the systems for HACCP, food
defence and authenticity, and the food safety and
quality culture plan
• resource requirements.
Records of the meeting shall be documented and
used to revise the objectives thereby encouraging
continual improvement. The decisions and actions
agreed within the review process shall be effectively
communicated to appropriate staff, and actions
implemented within agreed timescales.
1.1.5 The site shall have a demonstrable meeting The term ‘integrity’ has been
programme which enables food safety, authenticity, replaced by ‘authenticity’ to ensure
legality, integrity and quality issues to be brought consistent terminology throughout
to the attention of senior management. These the Standard.
meetings shall occur at least monthly.
The requirement for staff to report
Employees shall be aware of the need to report any any evidence of out of specification
evidence of unsafe or out-of-specification product products or raw materials has been
or raw materials, to a designated manager to enable moved to a new clause (clause 1.2.3)
the resolution of issues requiring immediate action. to emphasise that this is everyone’s
responsibility.
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1.1.6 The company shall have a confidential reporting To ensure consistent terminology
system to enable staff to report concerns relating the Standard uses the term ‘shall’ for
to product safety, authenticity, integrity legality and requirements that a site must meet.
quality.
The mechanism (e.g. the relevant telephone
number) for reporting concerns must shall be clearly
communicated to staff.
The company’s senior management shall have a
process for assessing any concerns raised. Records
of the assessment and, where appropriate, actions
taken, shall be documented.
1.1.7 The company’s senior management shall provide This clause was updated to reflect
the human and financial resources required to the Standard’s full scope – product
produce safely safe, authentic, legal products to safety, authenticity, legality and
the specified quality and in compliance with the quality.
requirements of this Standard.
1.1.8 No significant changes to this clause.
1.1.10 Where the site is certificated to the Standard, it This clause was updated to reflect
shall ensure that announced or blended announced the new blended audit option.
recertification audits occur on or before the audit
due date indicated on the certificate.
1.1.11 The most senior production or operations manager Several different auditing techniques
on site shall participate in the opening and closing are used by an auditor to confirm
meetings of the audit for certification to the the site’s compliance with the
Standard. Standard. One technique is holding
discussions with the senior
Relevant departmental managers or their deputies
management and members of staff
shall be available as required during the audit.
because they are responsible for
A member of the senior management team on site developing plans and implementing
shall be available during the audit for a discussion identified activities.
on effective implementation of the food safety
quality culture plan.
1.1.13 The BRCGS logo and references to certification

status shall only be used in accordance with the
conditions of use detailed in the audit protocol
section (Part III, section 5.6 6.7) of the Standard.
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1.1.14 Where required by legislation, the site shall This was clause 4.2.4 in Issue 8. It
maintain appropriate registrations with the relevant has been added to this section to
authorities. provide greater clarity. The previous
location implied that the clause only
related to food defence, whereas
it is the responsibility of senior
management to ensure all legally
required registrations are completed.
1.2 Organisational structure, responsibilities and management authority
Statement of Intent Comments

The company shall have a clear organisational structure and lines of The term ‘authenticity’ has been
communication to enable the effective management of services ensuring added to several clauses to highlight
product safety, authenticity, legality and quality. the importance of preventing
food fraud and therefore ensuring
products are authentic.

1.2.1 The company shall have an organisation chart ‘Integrity’ has been changed to
demonstrating the management structure of the ‘authenticity’ to ensure consistency
company. The responsibilities for the management with section 1.1.
of activities which ensure food safety, integrity
authenticity, legality and quality shall be clearly
allocated and understood by the managers
responsible. It shall be clearly documented who
deputises in the absence of the responsible person.
1.2.2 The site’s senior management shall ensure that This clause has been amended to aid
all employees are aware of their responsibilities. further clarity on the requirement on
Where documented work instructions exist for ensuring staff are aware of their roles
activities undertaken, the relevant employees shall and responsibilities.
have access to these and be able to demonstrate
that work is carried out in accordance with the
instructions.
The site’s senior management shall ensure that
all staff are aware of their responsibilities and
demonstrate that work is carried out in accordance
with documented site policies, procedures, work
instructions and existing practices for activities
undertaken. All staff shall have access to relevant
documentation.
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1.2.3 Staff shall be aware of the need to report any risks NEW CLAUSE
or any evidence of unsafe or out-of-specification
Previously part of clause 1.1.5, this
product, equipment, packaging or raw materials, to
has become a separate clause.
a designated manager to enable the resolution of
It highlights the importance of
issues requiring immediate action.
everyone being involved in food
safety, and that the site needs a
mechanism to deal with any issues
raised.
Colour-coding of the requirement
has been changed from green to
yellow colouring in Issue 9 (i.e.
the requirement shall be an audit
of production facilities and good
manufacturing practices.
1.2.4 If the site does not have the appropriate in-house NEW CLAUSE
knowledge of food safety, authenticity, legality
This concept was previously
or quality, external expertise (e.g. food safety
restricted to the HACCP plan
consultants) may be used; however, the day-to-day
(section 2) but wherever external
management of the food safety systems shall remain
expertise is used, it is vital the
the responsibility of the company.
management of food safety remains
the responsibility of the site.
has been changed from green to
yellow colouring in Issue 9 (i.e.
the requirement shall be an audit
manufacturing practices.
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2 The food safety plan - HACCP

Fundamental
2.1 The HACCP food safety team (equivalent to Codex Alimentarius Step 1)

The company shall have a fully implemented and effective food safety
plan incorporating the Codex Alimentarius HACCP principles.
Clause Requirement Comments

2.1.1 The HACCP or food safety plan shall be developed Last paragraph was deleted because
and managed by a multi-disciplinary food safety it has been added to a new clause
team that includes those responsible for quality 1.2.4.
assurance, technical management, production
operations engineering and other relevant functions
(e.g. engineering, hygiene).
The team leader shall have an in-depth knowledge
of Codex HACCP principles (or equivalent) and
be able to demonstrate competence, experience
and training. Where there is a legal requirement for
specific training, this shall be in place.
The team members shall have specific knowledge
of HACCP and relevant knowledge of products,
processes and associated hazards.
In the event of the site not having the appropriate
in-house knowledge, external expertise may be
used, but day-to-day management of the food
safety system shall remain the responsibility of the
company.
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2.2 Prerequisite programmes

2.2.1 The site shall establish and maintain environmental The BRCGS Technical Working
and operational programmes necessary to create Group discussed the wording and
an environment suitable to produce safe and legal concluded that the term disinfection
food products (prerequisite programmes). As a guide should replace sanitising. Examples
these may include the following, although this is not of prerequisite programmes are
an exhaustive list: provided in the Interpretation
Guideline.
• cleaning and sanitising disinfection (e.g. See
section 4.11) ‘Shall’ is used for requirements that a
• pest management (e.g. See section 4.14) site must meet.
• maintenance programmes for equipment and
buildings (e.g. See sections 4.4 and 4.6)
• personal hygiene requirements (e.g. section 7.2)
• staff training (e.g. section 7.1)
• supplier approval and purchasing (e.g. section 3.5.1)
• transportation arrangements (e.g. section 4.16)
• processes to prevent cross-contamination (e.g.
sections 4.9 and 4.10)
• allergen controls management (e.g. section 5.3).
The prerequisite programmes for the particular areas
of the site shall take into account the production
risk zoning (see clause 4.3.1).
The control measures and monitoring procedures
for the prerequisite programmes must shall be
clearly documented and shall be included within
the development and reviews of the HACCP or food
safety plan.
2.3 Describe the product (equivalent to Codex Alimentarius Step 2)

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2.3.2 All relevant information needed to conduct the This clause has been amended
hazard analysis shall be collected, maintained, to include further examples of
documented and updated. The company shall information sources.
ensure that the HACCP or food safety plan is based
on comprehensive information sources, which are
referenced and available on request. As a guide, this
may include the following, although this is not an
exhaustive list:
• the latest scientific literature
• historical and known hazards associated with
specific food products
• relevant codes of practice
• recognised guidelines
• food safety legislation relevant for the production
and sale of products
• customer requirements
• a copy of any existing site HACCP plans (e.g. for
products already in production at the site)
• a map of the premises and equipment layout (see
clause 4.3.2)
• a water distribution diagram for the site (see
clause 4.5.2)
• indication of any areas (zones) where high-risk,
high-care or ambient high-care production
facilities are required (see clause 4.3.1).
2.4 Identify intended use (equivalent to Codex Alimentarius Step 3)

2.5 Construct a process flow diagram (equivalent to Codex Alimentarius Step 4)

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2.6 Verify process flow diagram (equivalent to Codex Alimentarius Step 5)

2.6.1 The HACCP food safety team shall verify the Verification of changes to the
accuracy of the flow diagrams by on-site audit process flow diagram is vital to
and challenge at least annually at least annually, ensure any changes to operations
and whenever there are changes to the process, are assessed in a timely manner and
to ensure any changes have been considered as incorporated into the HACCP or
a part of the HACCP or food safety plan. Daily food safety plan. This ensures any
and seasonal variations shall be considered and potential hazards are effectively
evaluated. Records of verified flow diagrams shall be managed.
maintained.
The clause has been amended to
encourage best practice.
2.7 List all potential hazards associated with each process step, conduct a hazard
analysis and consider any measures to control identified hazards (equivalent to
Codex Alimentarius Step 6, Principle 1)

2.7.1 The HACCP food safety team shall identify and Clause updated to include section
record all the potential hazards that are reasonably numbers.
expected to occur at each step in relation to
product, process and facilities. This shall include
hazards present in raw materials, those introduced
during the process, or surviving the process steps,
and consideration of the following types of hazard:
• microbiological
• physical contamination
• chemical and radiological contamination
• fraud (e.g. substitution or deliberate/intentional
adulteration) (see section 5.4)
• malicious contamination of products (see section
4.2)
• allergen risks (see section 5.3).
It shall also take account of the preceding and
following steps in the process chain.
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2.7.2 The HACCP food safety team shall conduct a hazard This clause has been amended
analysis to identify the significant hazards (i.e. those to reflect best practice in the
hazards that are reasonably likely to occur at an identification of significant hazards
unacceptable level), which need to be prevented, in the hazard analysis.
eliminated or reduced to acceptable levels.
Consideration shall be given to the following:
• likely occurrence of hazard
• severity of the effects on consumer safety
• vulnerability of those exposed
• survival and multiplication of micro-organisms of
specific concern to the product
• presence or production of toxins, chemicals or
foreign bodies
• contamination of raw materials, intermediate/
semi-processed product, or finished product.
Where elimination of the hazard is not practical,
justification for acceptable levels of the hazard
in the finished product shall be determined and
documented.
2.7.3 The HACCP food safety team shall consider the This clause was amended because
control measures necessary to prevent or eliminate the requirement for validation of
a food safety hazard or reduce it to an acceptable prerequisite programmes is covered
level. Where the control is achieved through existing in a new clause (2.7.4).
prerequisite programmes, this shall be stated and
the adequacy of the programme to control the
specific hazard validated.
Consideration may be given to using more than one
control measure.
2.7.4 Where the control of a specific food safety hazard NEW CLAUSE
is achieved through prerequisite programmes
To emphasise that the control
(see section 2.2) or control measures other than
of specific hazards needs to be
CCPs (see clause 2.8.1), this shall be stated and the
validated where the control is
adequacy of the programme to control the specific
achieved via a prerequisite or a
hazard validated.
control measure other than a critical
control point (CCP).
It is important they are documented,
and the adequacy is validated by the
site.
It is not a requirement for all
prerequisite programmes to be
validated, only those designed to
control a specific hazard.
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2.8 Determine the CCPs (equivalent to Codex Alimentarius Step 7, Principle 2)

2.9 Establish validated critical limits for each CCP (equivalent to Codex Alimentarius
Step 8, Principle 3)

2.10 Establish a monitoring system for each CCP (equivalent to Codex Alimentarius

2.10.2 Colour-coding of the requirement

has been changed to dual colouring
(i.e. the requirement shall be an audit
manufacturing practises and records,
systems and documentation).
2.11 Establish a corrective action plan (equivalent to Codex Alimentarius Step 10,
Principle 5)

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2.12 Validate the HACCP plan and establish verification procedures (equivalent to
Codex Alimentarius Step 11, Principle 6)

2.12.1 Procedures of verification shall be established NEW CLAUSE
to confirm that the HACCP or food safety plan,
Clause 2.12.1 in Issue 8 has become
including controls managed by prerequisite
clause 2.12.2 to facilitate greater
programmes, continues to be effective. Examples of
clarity on the requirement to verify
verification activities include:
existing HACCP or food safety plans.
• internal audits
This new requirement reflects
• review of records where acceptable limits have
the recommendation from Codex
been exceeded
Alimentarius General Principles of
• review of complaints by enforcement authorities
Food Safety for the validation of
or customers
food safety controls.
• review of incidents of product withdrawal or
recall. Changes to the HACCP or food
safety plans which may affect
Results of verification shall be recorded and
product safety, must be checked
communicated to the HACCP food safety team.
to ensure they effectively control
HACCP or food safety plans shall be validated prior the identified hazard before
to any changes which may affect product safety, implementation.
to ensure that the plan will effectively control the
identified hazards before implementation.
For existing HACCP or food safety plans, this may be
achieved using the established processes detailed in
clauses 2.12.2 and 2.12.3.
2.12.2 Procedures of verification shall be established NEW CLAUSE

to confirm that the HACCP or food safety plan,
This clause was clause 2.12.1 in Issue
including controls managed by prerequisite
8.
programmes, continues to be effective. Examples of
verification activities include:
• internal audits
• review of records where acceptable limits have
been exceeded
• review of complaints by enforcement authorities
or customers
• review of incidents of product withdrawal or
recall.
Results of verification shall be recorded and
communicated to the HACCP food safety team.
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2.12.3 The HACCP food safety team shall review the NEW CLAUSE
HACCP or food safety plan and prerequisite
Clause 2.14.1 in Issue 8 has been
programmes at least annually and prior to any
become clause 2.12.3. as the review
changes which may affect food safety. As a guide,
process is closely linked to validation
these may include the following, although this is not
and verification processes (clauses
an exhaustive list:
2.12.1 and 2.12.2).
• change in raw materials or supplier of raw
materials
• change in ingredients/recipe
(i.e. the requirement shall be an audit
• change in processing conditions, cleaning
and disinfection procedures, process flow or
equipment
• change in packaging, storage or distribution
conditions
• change in consumer use
• emergence of a new risk (e.g. known adulteration
of an ingredient or other relevant, published
information, such as the recall of a similar product)
• review following a significant product safety
incident (e.g. a product recall)
• new developments in scientific information
associated with ingredients, process, packaging or
product.
Appropriate changes resulting from the review shall
be incorporated into the HACCP or food safety
plan and/or prerequisite programmes. Changes shall
be fully documented, and the validation shall be
recorded.
Where appropriate, the changes shall also be
reflected in the company’s product safety policy
and food safety objectives.
2.13 HACCP documentation and record-keeping (equivalent to Codex Alimentarius


2.14 Review the HACCP plan

2.14.1 The HACCP food safety team shall review the Section 2.14 and clause 2.14.1 moved
HACCP or food safety plan … . to section 2.12. See clause 2.12.3.
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3 Food safety and quality management system

3.1 Food safety and quality manual

The company’s processes and procedures to meet the requirements
of this Standard shall be documented to allow consistent application,
facilitate training, and support due diligence in the production of a safe
product.

3.1.3 All procedures and work instructions shall be clearly Consistent terminology is used here.
legible, unambiguous, in appropriate languages ‘Should’ is used for requirements
and sufficiently detailed to enable their correct where compliance is expected or
application by appropriate staff. This shall should desired.
include the use of photographs, diagrams or other
This is explained further in the
pictorial instructions where written communication
Interpretation Guideline.
alone is not sufficient (e.g. there are issues of
literacy or foreign language).
3.2 Document control

The company shall operate an effective document control system to No significant changes to statement
ensure that only the correct versions of documents, including recording of intent or requirements in this
forms, are available and in use. section.
3.3 Record completion and maintenance

The site shall maintain genuine records to demonstrate the effective No significant changes to statement
control of product safety, legality and quality. of intent or requirements in this
section.
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3.4 Internal audits
Fundamental

The company shall be able to demonstrate that it verifies the effective An effective internal audit
application of the food safety plan, and the implementation of the programme is a vital tool for the
requirements of the Global Standard Food Safety and the site’s food management and maintenance of
safety and quality management system. product safety. A robust internal
audit programme will consider all
of the site’s food safety and quality
management systems. The statement
of intent has been amended
to clarify the requirement and
encourage best practice.

3.4.1 There shall be a scheduled programme of internal In accordance with the statement of
audits. intent, the clause has been amended
to include the site’s food safety and
At a minimum, the programme shall include at
quality systems in the internal audit
least four different audit dates spread throughout
programme.
the year. The frequency at which each activity is
audited shall be established in relation to the risks
associated with the activity and previous audit
performance. All activities that form a part of site’s
food safety and quality systems, including those
relevant to food safety, authenticity, legality and
quality, shall be covered at least once each year.
At a minimum, the scope of the internal audit
programme shall include the:
The scope of the internal audit programme shall
include, although this is not an exhaustive list:
• HACCP or food safety plan, including the
activities to implement it (e.g. supplier approval,
corrective actions and verification)
• prerequisite programmes (e.g. hygiene, pest
management)
• food defence and food fraud prevention plans
• procedures implemented to achieve the Standard.
Each internal audit within the programme shall have
a defined scope and consider a specific activity or a
section of the HACCP or food safety plan.
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3.4.3 The internal audit programme shall be fully It is important that the site handles
implemented. Internal audit reports shall identify any non-conformities identified in its
conformity as well as non-conformity and include internal audits as detailed in section
objective evidence of the findings. 3.7 to ensure consistency. The clause
has been amended to encourage
The results shall be reported to the personnel
best practice.
responsible for the activity audited.
Further guidance is provided in the
Corrective and preventive actions, and timescales
Interpretation Guideline.
for their implementation, shall be agreed and their
completion verified. All non-conformities shall be
handled as detailed in section 3.7. A summary of the
results shall be reviewed in the management review
meetings (see clause 1.1.4).
3.4.4 In addition to the internal audit programme, there This clause has been updated to
shall be a separate programme of documented provide further clarification on
inspections to ensure that the factory environment the requirements for fabrication
and processing equipment are maintained in inspections. Fabrication inspection
a suitable condition for food production. At a scope, results, corrective actions,
minimum, these inspections shall include: (including timescales for completion
and verification) and the review of
• hygiene inspections to assess cleaning and
the results were added.
housekeeping performance
• fabrication inspections to identify risks to
the product from the building or equipment.
(e.g. doors, walls, facilities and equipment) to
identify risks to the product from the building or
equipment.
The frequency of these inspections shall be based
on risk but will be no less than once per month in
open product areas and on any changes that may
affect food safety but shall be no less than once per
month in open product areas.
The results shall be reported to the personnel
responsible for the activity or area audited.
Corrective actions, and timescales for their
implementation, shall be agreed and their
completion verified.
A summary of the results shall be reviewed in the
management review meetings (see clause 1.1.4).
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3.5 Supplier and raw material approval and performance monitoring

3.5.1 Management of suppliers of raw materials and packaging
Fundamental

The company shall have an effective supplier approval and monitoring Authenticity has been added to this
system to ensure that any potential risks from raw materials (including section to highlight the importance
primary packaging) to the safety, authenticity, legality and quality of the of the supplier approval processes in
final product are understood and managed. maintaining product authenticity and
therefore preventing food fraud.

3.5.1.1 The company shall undertake a documented risk This clause has been amended to
assessment of each raw material or group of raw consider customer requirements in
materials, including primary packaging, to identify raw material/primary packaging risk
potential risks to product safety, authenticity, assessments.
legality and quality. This shall take into account the
potential for:
• allergens (allergen content and potential
contamination)
• foreign-body risks
• microbiological contamination
• chemical contamination
• variety or species cross-contamination
• substitution or fraud (see clause 5.4.2)
• any risks associated with raw materials which
are subject to legislative control or customer
requirements
Consideration shall also be given to the significance
of a raw material to the quality of the final product.
The risk assessment shall form the basis for the raw
material acceptance and testing procedure and for
the processes adopted for supplier approval and
monitoring.
The risk assessment for a raw material shall be
updated:
• when there is a change in a raw material, the
processing of a raw material, or the supplier of a
raw material
• if a new risk emerges
• following a product recall or withdrawal, where a
specific raw material has been implicated
• at least every 3 years.
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3.5.1.2 The company shall have a documented supplier This clause has been updated to
approval procedure to ensure that all suppliers reflect the GFSI benchmark.
of raw materials, including primary packaging,
effectively manage risks to raw material quality
and safety and are operating effective traceability
processes. The approval procedure shall be based on
risk and include either one or a combination of:
• a valid certification to the applicable BRCGS
Standard or GFSI-benchmarked standard. The
scope of the certification shall include the raw
materials purchased
or
• supplier audits, with a scope to include product
safety, traceability, HACCP review, the product
security and food defence plan, the product
authenticity plan and good manufacturing
practices. The audit shall ensure that these
plans form part of the supplier’s product safety
management system and that any resultant actions
are implemented. The supplier audit shall be
undertaken by an experienced and demonstrably
competent product safety auditor. Where the
supplier audit is completed by a second or third
party, the company shall be able to:
• demonstrate the competency of the auditor
• confirm that the scope of the audit includes
product safety, product security and food
defence plan, product authenticity, traceability,
HACCP review and good manufacturing
practices
• obtain and review a copy of the full audit report
or
• where a valid risk-based justification is provided
and the supplier is assessed as low risk only, a
completed supplier questionnaire may be used for
initial approval. At a minimum, the questionnaire
shall have a scope that includes product safety,
product security and food defence, product
authenticity, traceability, HACCP review and
good manufacturing practices. The questionnaire
and it shall have been reviewed and verified by a
demonstrably competent person.
3.5.1.3 No significant changes to this clause.
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3.5.1.6 The company shall ensure that its suppliers of raw Clause amended to reflect additional
materials (including primary packaging) have an requirements to be completed where
effective traceability system. Where a supplier has the approval of the raw material is
been approved based on a questionnaire instead of purchased from an agent, broker
certification or audit, verification of the supplier’s or wholesaler) and is based on a
traceability system shall be carried out on first questionnaire.
approval and then at least every 3 years. This may be
achieved by a traceability test.
Where the supplier is not the manufacturer, packer
or consolidator of the raw material (e.g. purchased
from an agent, broker or wholesaler) and approval is
based on a questionnaire instead of certification or
audit, the verification of the traceability system shall
be carried out on the last manufacturer, packer or
consolidator of the raw material.
Where a raw material is received directly from a
farm or fish farm, further verification of the farm’s
traceability system is not mandatory.
3.5.1.7 The procedures shall define how exceptions to Where exceptions to the supplier
the supplier approval processes in clause 3.5.1.2 approval process places product
are handled (e.g. where raw material suppliers are quality and safety at risk, additional
prescribed by a customer) or where information requirements must be completed.
for effective supplier approval is not available (e.g. The clause has been amended to
bulk agricultural commodity products) and instead clarify these requirements.
product testing is used to verify product quality and
safety.
The procedures shall define the actions required in
either of the following circumstances:
• an exception to the supplier approval processes
in clause 3.5.1.2 occurs (e.g. where raw material
suppliers are prescribed by a customer)
• information for effective supplier approval is
not available (e.g. bulk agricultural commodity
products).
In both the above situations product testing is used
to verify product quality and safety.
When a site produces customer-branded product,
the customer shall be made aware of the relevant
exceptions.
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3.5.2 Raw material and packaging acceptance, monitoring and management procedures

Controls on the acceptance of raw materials (including primary packaging)
shall ensure that these do not compromise the safety, legality or quality
of products and, where appropriate, any claims of authenticity.

3.5.2.3 Where the site is in receipt of live animals, there This clause has become clause 5.9.2
shall be an inspection by a suitably competent because the requirement is relevant
individual at lairage and post mortem to ensure that to section 5.9 Animal primary
the animals are fit for human consumption conversion.
3.5.3 Management of suppliers of services

The company shall be able to demonstrate that where services are
outsourced, the service is appropriate and any risks presented to food
safety, authenticity, legality and quality have been evaluated to ensure
effective controls are in place.
3.5.3.1 There shall be a procedure for the approval and The management of suppliers of
monitoring of suppliers of services. Such services services are not only limited to
shall include, as appropriate: facilities and products services.
Additional examples have been
• pest control
added to the clause to emphasise
• laundry services
the wide scope of services that
• contracted cleaning
should be considered.
• contracted servicing and maintenance of
equipment
• transport and distribution
• off-site storage of ingredients or packaging or
products (other than at the supplier’s facilities)
prior to delivery to the site
• off-site packing of products
• laboratory testing
• catering services
• waste management
• providers of product safety training
• product safety consultants.
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3.5.3.1 continued This approval and monitoring process shall be risk-
based and take into consideration:
• risk to the safety and quality of products
• compliance with any specific legal requirements
• potential risks to the security of the product
(i.e. risks identified in the vulnerability and food
defence assessments).
3.5.3.3 There shall be a documented process for ongoing NEW CLAUSE

performance review of suppliers of services, based
Ongoing monitoring and approval,
on risk and defined performance criteria. The
is important, where suppliers of
process shall be fully implemented.
services are used, to ensure they
Records of the review shall be kept. continue to provide the correct level
of services.
3.5.4 Management of outsourced processing

Where any intermediate process step (including production, processing The BRCGS Technical Working
or storage) in the manufacture of a product is outsourced to a third party Group were in agreement that
or undertaken at another site, and subsequently returned to the site, this further clarity should be provided
shall be managed to ensure it does not compromise the product safety, on the definition for outsourced
authenticity, legality or quality. product. A new definition has
been added to the glossary and
further guidance and explanation
can be found in the Interpretation
Guideline.

3.5.4.1 The company shall be able to demonstrate that, This clause has been amended based
where part of the production process or any part on the new definition of outsourced
of the final packing is outsourced and undertaken processing.
off-site, this has been declared to the brand
owner and, where required, approval granted. (i.e.
any intermediate process step) is outsourced or
undertaken off site, and subsequently returned to
the site, this has been declared to the customer and,
where required, approval granted.
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3.5.4.2 The company shall ensure that outsourced This clause has been updated to
processors are approved and monitored, to ensure reflect the requirements of the GFSI
that they effectively manage risks to product safety Benchmark.
and quality and are operating effective traceability
processes.
The approval and monitoring procedure shall
be based on risk and include either one or a
combination of:
scope of the certification shall include the
activities completed for the site
or
safety, traceability, HACCP review, product
security and food defence plan, product
practices. The audit shall ensure that these
plans form part of the supplier’s product safety
management system and that any resultant actions
are implemented. The supplier audit shall be
undertaken by an experienced and demonstrably
competent product safety auditor. Where this
supplier audit is completed by a second or third
party, the company shall be able to
product safety, traceability, HACCP review,
product security and food defence plan, product
practices
• obtain and review a copy of the full audit report.
There shall be a documented process for ongoing

supplier performance review, based on risk and
defined performance criteria. The process shall be
fully implemented. Records of the review shall be
kept.
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3.5.4.3 Any outsourced processing operations shall: This clause has been amended to
highlight the importance of ensuring
• be undertaken in accordance with established
that any hazards associated with the
contracts which clearly define any processing and/
outsourced operations are identified
or packing requirements and product specification
and controlled.
• maintain product traceability.
Where any processes are outsourced, including
production, manufacture, processing or storage, the
risks to the product safety, authenticity and legality
shall form part of the site’s food safety plan (HACCP
plan).
3.5.4.4 The company shall establish inspection and NEW CLAUSE

test procedures for products where part of the
Clause 3.5.4.4 in Issue 8 has become
processing has been outsourced, including visual,
clause 3.5.4.6 to facilitate greater
chemical and/or microbiological testing.
clarity in section 3.5.
The frequency and methods of inspection or testing
This clause reflects that good
shall depend on risk assessment.
practice when outsourcing
Requirements for outsourced processing shall be activities is to define the service in a
agreed and documented in a service specification specification that aids product safety,
(similar to a finished product specification). This authenticity, legality and quality.
shall include any specific handling requirements for
the products.
3.5.4.5 Any outsourced processing operations shall: NEW CLAUSE

• be undertaken in accordance with established
contracts which clearly define any processing
requirements
• maintain product traceability.
3.5.4.6 The company shall establish inspection and NEW CLAUSE

test procedures for products where part of the
This was clause 3.5.4.4 in Issue 8.
processing has been outsourced, including visual,
chemical and/or microbiological testing.
The frequency and methods of inspection or testing
shall depend on risk assessment.
3.6 Specifications

Specifications shall exist for raw materials (including primary packaging),
finished products and any product or service which could affect the
integrity of the finished product.
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3.6.1 Specifications for raw materials and primary Allergen standards added as another
packaging shall be adequate and accurate and example critical to the safety,
ensure compliance with relevant safety and legality and quality of the product
legislative requirements. The specifications shall and packaging.
include defined limits for relevant attributes of the
material which may affect the quality or safety of
the final products (e.g. chemical, microbiological, or
physical or allergen standards).
3.7 Corrective and preventive actions
Fundamental

The site shall be able to demonstrate that it uses the information from Corrective and preventive actions
identified issues in the food safety and quality management system (e.g. are applicable to a wide range of
non-conforming products, internal audits, complaints, product recalls, non-conforming situations. Examples
product testing, second- and third-party audits and online reviews) to have been added to the statement
make to complete necessary corrective actions and prevent recurrence. to highlight situations where such
actions should be applied.

3.7.1 The site shall have a procedure for handling and Root cause analysis and the
correcting issues identified in the food safety and implementation of preventative
quality management system. action are a vital part in the
management of corrective and
The site procedures shall include the completion
preventive actions.
of root cause analysis and implementation of
preventive action. The clause has therefore been
amended to ensure that site
procedures include the identification
of the underlying cause of the
non-conformity and completion
of suitable action to prevent a
recurrence.
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3.7.2 Where a non-conformity places the safety, In accordance with the Statement
authenticity or legality of a product at risk, or where of Intent, the clause has been
there is an adverse trend in quality, this shall be amended to highlight that root cause
investigated and recorded including: analysis and preventative action are
applicable to all non-conformities
• clear documentation of the non-conformity
within the product safety and quality
• assessment of consequences by a suitably
management system.
competent and authorised person
• the corrective action to address the immediate Colour-coding of the requirement
issue has been changed to dual colouring
• completion of root cause analysis to identify (i.e. the requirement shall be an
the fundamental cause (root cause) of the non- audit of production facilities and
conformity good manufacturing practises
• appropriate timescales for corrective and as well as records, systems and
preventive actions documentation).
• the person(s) responsible for corrective and
preventive actions
• verification that the corrective and preventive
actions has have been implemented and is are
effective.
Root cause analysis shall also be used to prevent
recurrence of non-conformities, and to implement
ongoing improvements when analysis of non-
conformities for trends shows there has been a
significant increase in a type of non-conformity.
3.7.3 The site shall have a procedure for the completion To provide additional clarification
of root cause analysis. At a minimum root cause on the requirements, this clause has
analysis shall be used to implement ongoing been combined with two clauses
improvements and to prevent recurrence of non- (3.7.1 and 3.7.2).
conformities when:
• analysis of non-conformities for trends shows
there has been a significant increase in a type of
non-conformity
• a non-conformity places the safety, legality or
quality of a product at risk.
3.8 Control of non-conforming product

The site shall ensure that any out-of-specification product is effectively
managed to prevent unauthorised release.
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3.8.1 There shall be procedures for managing non- A slight amendment so that the
conforming products. These procedures shall site procedures for managing
include: non-conforming products includes
the management of any product
• the requirement for staff to identify and report a
returned to the site.
potentially non-conforming product
• clear identification of a non-conforming product
(e.g. direct labelling or the use of IT systems)
• secure storage to prevent accidental release (e.g.
physical or computer-based isolation)
• management of any product returned to the site
• referral to the brand owner where required
• defined responsibilities for decision-making on
the use or disposal of products appropriate to the
issue (e.g. destruction, reworking, downgrading to
an alternative label or acceptance by concession)
• records of the decision on the use or disposal of
the product
• records of destruction where a product is
destroyed for food safety reasons.
3.9 Traceability
Fundamental

The site shall be able to trace all raw material product lots (including
primary packaging) from its suppliers through all stages of processing and
dispatch to its customers and vice versa.

3.9.1 The site shall have a documented traceability Some countries have specific
procedure designed to maintain traceability legislative requirements relating to
throughout the site’s processes. At a minimum this traceability. Where these exist in the
shall include: country of sale or intended use, the
site is expected to operate systems
• how the traceability system works
that comply with the legislative
• the labelling and records required.
requirements.
Where applicable, the traceability system shall meet
the legal requirements in the country of sale or
intended use.
3.9.2 No significant changes to this clause
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3.9.3 The site shall test the traceability system across the Clarification added regarding the
range of product groups to ensure traceability can scope of the quantity check/mass
be determined from the supplier of raw material balance test.
(including primary packaging) to the finished
In this context finished product
product and vice versa. including quantity check/
includes any printed packaging or
mass balance For food raw materials and finished
labels that have food safety or legal
products (i.e. including printed packaging and labels
information on it, and therefore
with food safety and legal information), the test
printed labels must be include in the
of the traceability system shall include a quantity
quantity check/mass balance.
check/mass balance.
The traceability test shall include a summary of the
documents that should be referenced during the
test, and clearly show the links between them. The
test shall occur at a predetermined frequency, at a
minimum annually, and results shall be retained for
inspection. Traceability should be achievable within
4 hours.
3.10 Complaint-handling

Customer complaints shall be handled effectively and information used
to reduce recurring complaint levels.

3.11 Management of incidents, product withdrawal and product recall

The company shall have a plan and system in place to manage incidents
effectively and enable the withdrawal and recall of products should this
be required.
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3.11.1 The company shall have procedures designed The term ‘authenticity’ has been
to report and effectively manage incidents and added to ensure consistent use
potential emergency situations that impact food of terminology throughout the
safety, authenticity, legality or quality. This shall Standard.
include consideration of contingency plans to
There are a wide range of incidents,
maintain product safety, authenticity, legality and
product recall and product withdraw
quality. Incidents may include:
situations that may impact food
• disruption to key services such as water, energy, safety, authenticity, legality or
transport, refrigeration processes, staff availability quality; they are not limited
and communications to disruption to key services,
• events such as fire, flood or natural disaster emergency situations, malicious
• malicious contamination or sabotage contamination or sabotage or
• product contamination indicating a product may cybersecurity attacks. Contaminated
be unsafe or illegal product (i.e. unsafe or illegal) was
• failure of, or attacks against, digital cyber-security. added as another example.
Where products which have been released from the
site may be affected by an incident, consideration
shall be given to the need to withdraw or recall
products.
3.11.3 The product recall and withdrawal incident Clause was updated to cover
management procedures (including those for the full scope of the section (i.e.
product recall and withdrawal) shall be tested, at management of incidents, product
least annually, in a way that ensures their effective withdrawal and product recall).
operation. Results of the test shall be retained and
shall include timings of key activities. The results
of the test and of any actual recall shall be used to
review the procedure and implement improvements
as necessary.
3.11.4 In the event of a significant food safety, authenticity ‘Integrity’ and ‘legality’ added to
or legality incident, including a product recall, food safety to ensure significant
regulatory food safety non-conformity (e.g. a incidents that relate to food safety,
regulatory enforcement notice) or food safety- authenticity or legality issues are
related withdrawal, the certification body issuing the correctly reported to the certification
current certificate for the site against this Standard body. The correct information must
shall be notified within 3 working days. be reported in a timely manner
to allow ongoing validity of the
The company shall then provide sufficient
certification to be confirmed.
information to enable the certification body to
assess any effects of the incident on the ongoing Further guidance can be found in the
validity of the current certificate within 21 calendar Interpretation Guideline.
days. As a minimum, this shall include corrective
action, root cause analysis and a preventive action
plan.
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4 Site standards
4.1 External standards and site security

The production site shall be of suitable size, location and construction, In Issue 8 site security was divided
and be maintained to reduce the risk of contamination and facilitate the between sections 4.1 and 4.2.
production of safe and legal finished products.
For Issue 9 site security has been
separated from food defence and is
now full incorporated in this section.

4.1.4 Policies and systems shall be in place to ensure that NEW CLAUSE
access to the site by staff, contractors and visitors
In Issue 8, the first paragraph of this
is controlled. A visitor recording system shall be in
clause was included in clause 4.2.3.
place.
It has been moved to this clause to
Contractors and visitors, including drivers, shall be facilitate greater clarity on the site
made aware of the procedures for access to the site. access procedures.
Only authorised personnel shall have access to
production and storage areas. Contractors working
in product processing or storage areas shall be the
responsibility of a nominated person.
Staff shall be trained in site security procedures.
4.2 Site security and Food defence

Systems shall protect products, premises and brands from malicious Site security has been removed from
actions while under the control of the site. section 4.2 and incorporated into
section 4.1.
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4.2.1 Where personnel are engaged in threat assessments NEW CLAUSE
and food defence plans, the individual or team
Competency of the food defence
responsible shall understand potential food defence
team has been added – this includes
risks at the site. This shall include knowledge of
both the sites knowledge and
both the site and the principles of food defence.
the knowledge of the principles/
Where there is a legal requirement for specific processes of food defence which the
training, this shall be in place. team will use to develop a robust
food defence plan.
Some countries have specific
legislative requirements relating to
food defence training. Where these
exist, the site is expected to operate
systems that comply with the
legislative requirements.
4.2.2 The company shall undertake a documented risk Some countries have specific
assessment (threat assessment) of the potential risks legislative requirements relating
to products from any deliberate attempt to inflict to the food defence plan. Where
contamination or damage. This threat assessment these exist, the site is expected to
shall include both internal and external threats. operate systems that comply with
the legislative requirements.
The output from this assessment shall be a
documented threat assessment plan. This plan
shall be kept under review to reflect changing
circumstances and market intelligence. It shall be
formally reviewed at least annually and whenever:
• a new risk emerges (e.g. a new threat is publicised
or identified)
• an incident occurs, where product security or food
defence is implicated.
Where applicable, the food defence plan shall meet
the legal requirements in the country of sale or
intended use.
4.2.3 Where raw materials or products are identified as Threat assessment plan changed
being at particular risk, the threat assessment plan to food defence plan to ensure
food defence plan shall include controls to mitigate consistent use of terminology in the
these risks. Where prevention is not sufficient or Standard.
possible, systems shall be in place to identify any
tampering.
These controls shall be monitored, the results
documented, and the controls reviewed at least
annually.
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4.2.4 Areas where a significant risk is identified shall be Requirement for site access
defined, monitored and controlled. These shall procedures has been moved to
include external storage and intake points for clause 4.1.4 to reflect change made
products and raw materials (including packaging). to this section to focus on food
defence.
Policies and systems shall be in place to ensure
that only authorised personnel have access to
production and storage areas, and that access to
the site by employees, contractors and visitors is
controlled. A visitor recording system shall be in
place.
Staff shall be trained in site security procedures and
food defence.
4.2.4 Where required by legislation, the site shall Clause 4.2.4 in Issue 8 has become
maintain appropriate registrations with the relevant clause 1.1.14 in Issue 9 to facilitate
authorities. greater clarity on senior management
responsibility.
4.3 Layout, product flow and segregation
Fundamental

The factory layout, flow of processes and movement of personnel shall
be sufficient to prevent the risk of product contamination and to comply
with relevant legislation.

4.3.1 The site shall assess the production risk zones NEW CLAUSE
required for the products manufactured, processed
This clause has been added as sites
or packed at the site, using the definitions in
need to be aware of the relevant
Appendix 2 of the Standard.
production risk zones for the
products they manufacture, process
or pack before determining the
appropriate facilities and process
flows detailed in this section of the
Standard.
Sites should use the definitions in
Appendix 2 of the Standard to assess
the production facilities.
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4.3.2 There shall be a map of the site. At a minimum, this This clause was 4.3.1 in Issue 8.
map shall define:
• production risk zones, where product is has been changed to dual colouring
at different levels of risk from pathogen (i.e. Requirement shall be an audit
contamination – for example, high-risk, high-care, of production facilities, good
ambient high-care, low-risk and enclosed product manufacturing practises, records,
areas (see clause 4.3.1 and Appendix 2) systems and documentation).
• access points for personnel
• access points for raw materials (including
packaging), semi-finished products and open
products
• routes of movement for personnel
• routes of movement for raw materials (including
packaging)
• routes for the removal of waste
• routes for the movement of rework
• location of any staff facilities, including changing
rooms, toilets, canteens and smoking areas
• production process flows
• any areas where time segregation is used to
complete different activities (for example, time
segregation for high-care areas).
4.3.3 Contractors and visitors, including drivers, shall The final sentence was moved to
be made aware of the requirements of the areas clause 4.1.4 to provide further clarity
they are visiting, with special reference to hazards of the requirements for contractors
and potential product contamination. Contractors on site.
working in product processing or storage areas shall
be the responsibility of a nominated person.
4.3.4 The movement of personnel, raw materials,

packaging, rework and/or waste shall not
compromise the safety of products. The process
flow, together with the use of demonstrably
effective procedures, shall be in place to minimise
the risk of the contamination of raw materials,
intermediate/semi-processed products, packaging
and finished products.
4.3.5 Premises shall allow sufficient working space and

storage capacity to enable all operations to be
carried out properly under safe hygienic conditions.
4.3.6 Temporary structures constructed during building

work or refurbishment etc. shall be designed and
located to avoid pest harbourage and ensure the
safety and quality of products.
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4.4 Building fabric, raw material-handling, preparation, processing, packing and storage
areas

The fabrication of the site, buildings and facilities shall be suitable for the
intended purpose.

4.4.6 Where elevated walkways, access steps or Clause updated to provide additional
mezzanine floors are adjacent to or pass over clarification on the requirements, for
production lines which have open products, they access steps and mezzanine floors
shall be: above production lines which have
open products.
• designed to prevent contamination of products
and production lines
• easy to clean
• correctly maintained.
4.4.11 Where plastic strip curtains are present, these NEW CLAUSE
shall be maintained in good condition, clean,
The maintenance of plastic strip
fitted correctly (e.g. to prevent pest ingress or for
curtains has been added to ensure
temperature control), and shall not pose a food
where used, they operate as intended
safety risk.
and do not introduce a risk to food
safety.
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4.5 Utilities – water, ice, air and other gases

Utilities used within the production and storage areas shall be monitored
to effectively control the risk of product contamination.

4.5.1 All water (including ice and steam) used as a raw All water including, water stored
material in the manufacture of processed food, and handled on site, falls within the
the preparation of product, hand-washing or scope of this clause. The clause has
equipment or plant cleaning shall be supplied in therefore been amended to provide
sufficient quantity, be potable at point of use, be clarification of this scope and to
fit for purpose and pose no risk of contamination encourage best practice.
according to applicable legislation.
Where water is stored and handled on site (e.g. in
storage or holding tanks) these shall be managed to
minimise food safety risks.
The microbiological and chemical quality of water
shall be analysed as required by legislation or at
least annually. The sampling points, scope of the
test and frequency of analysis shall be based on risk,
taking into account the source of the water, on-site
storage and distribution facilities, previous sample
history and usage.
4.6 Equipment

All food-processing production and product-handling equipment shall be The statement of intent has been
suitable for the intended purpose and shall be used to minimise the risk updated to provide clarity on the
of contamination of product. scope of this section of the Standard.
The topic of equipment design
and its suitability for use in food
manufacturing, commonly referred
to as hygienic design has developed
considerably since publication of
Issue 8. Therefore, this section has
been expanded to reflect current
good practice.
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4.6.1 All equipment shall be constructed of appropriate Before any new equipment is
materials. The design and placement of equipment purchased, a purchase specification
shall ensure it can be effectively cleaned and should be agreed by the site to
maintained. ensure the new equipment will meet
any relevant legislation, be suitable
There shall be a documented purchase specification
for food contact (where appropriate)
for any new equipment detailing the site
and be suitable for the intended use.
requirements for the equipment. This may, for
example, include: New equipment includes, equipment
purchased from a manufacturer,
• any relevant legislation
refurbished and second hand
• where applicable, requirements for food contact
equipment. It is therefore useful to
surfaces to meet legal requirements
think about these clauses in terms of
• details of intended use of the equipment and the
equipment which is new to the site.
type of materials it will be handling.
The green colour-coding of the
Depending on its intended use, new equipment to
requirement reflects the fact that
site (including second-hand equipment) may require
this is most likely to be audited as
authorisation from a multi-disciplinary team.
an audit of records, systems and
The supplier should provide evidence that documentation and not production
equipment meets these site requirements prior to facilities and good manufacturing
supply. practises.
4.6.2 Equipment that is in direct contact with food The design and construction of
shall be suitable for food contact and meet legal equipment must consider product
requirements where applicable. contamination (i.e. it must be
designed to prevent contamination).
The design and construction of equipment shall be
based on risk, to prevent product contamination. For
example, the use of the correct seals, impervious
surfaces or smooth welds and joints, where they
are exposed to product and could otherwise
result in foreign-body, microbiological or allergen
contamination of the product.
Equipment that is in direct contact with food
shall be suitable for food contact and meet legal
requirements where applicable.
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4.6.3 A documented, risk-based commissioning procedure NEW CLAUSE
shall be in place to ensure that food safety and
New clause added as installation
integrity is maintained during the installation of new
(or commissioning) represents a
equipment to site.
key point in the process where
Installation work shall be followed by a documented food safety could be implicated if
hygiene clearance procedure. processes are not controlled and
specifically designed to prevent
New equipment to site shall be inspected by an
hazards occurring,
authorised member of staff before being accepted
into operation. The amount of installation should
be proportional to the complexity of
The commissioning procedure shall include the
the equipment and the food safety
update of any other site procedures that are affected
risks relevant to the equipment.
by the new equipment, for example, training,
operating procedures, cleaning, environmental
monitoring, maintenance schedules or internal
audits.
The design and placement of equipment shall
ensure that it can be effectively cleaned and
maintained.
4.6.4 A procedure shall be in place to manage the NEW CLAUSE

movement of static equipment in production areas,
Static equipment is rarely moved
to ensure that food safety is managed and the
and therefore it is possible to
integrity of the equipment is maintained.
unintentionally introduce a product
safety risk, or damage equipment
integrity if the equipment is moved
without careful consideration of the
risks. Therefore the clause was added
to ensure that product safety and
equipment integrity is considered
prior to any movement of this type
of equipment.
4.6.5 Equipment that is not used or is taken out of service NEW CLAUSE
shall be cleaned and stored in a manner that does
New clause to ensure that the
not pose a risk to the product.
condition (cleanliness) of equipment
Equipment stored in internal production and storage is managed after it has been stored
areas shall be kept clean. and prior to use; to ensure that any
dust, dirt or other contamination is
Food contact equipment that has been stored
removed.
but is not in daily use shall be cleaned and, where
necessary, disinfected prior to use.
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4.6.6 Mobile equipment (e.g. forklift trucks, pallet trucks, NEW CLAUSE
scissor lifts and ladders) used in open product areas
There is a risk of inadvertently
shall not pose a risk to the product.
moving contaminants from one area
Where the use of mobile equipment in external to another when mobile equipment
areas cannot be avoided and poses a risk to the is used in more than one area. This
product, the equipment shall be cleaned and clause was added to ensure sites
disinfected prior to entering production areas. consider and manage this risk.
4.6.7 Battery-charging equipment shall not be stored in NEW CLAUSE

open product areas (unless the batteries are fully
There are additional requirements
sealed and/or maintenance-free) or where there is a
that must be completed by the site
risk to products.
where battery-charging equipment is
in use.
4.7 Maintenance

An effective maintenance programme shall be in operation for plant
and equipment, to prevent contamination and reduce the potential for
breakdowns.

4.7.1 There shall be a documented planned preventive Colour-coding of requirement has
maintenance schedule or condition monitoring been changed to green reflecting
system which includes all plant, processing that the schedule will mainly be
equipment and mobile equipment. The maintenance an audit of records, systems and
requirements shall be defined when commissioning documentation and not production
new equipment and reviewed after repairing existing facilities and good manufacturing
equipment. practises).
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4.8 Staff facilities

Staff facilities shall be sufficient to accommodate the required number
of personnel, and shall be designed and operated to minimise the risk
of product contamination. The facilities shall be maintained in good and
clean condition.

4.8.8 Where catering facilities (including vending Clause updated to provide clarity on
machines) are provided on the premises, they shall the types of contamination that a
be suitably controlled to prevent contamination site should manage where catering
of products (e.g. as a source of food poisoning, the facilities are provided.
use of allergenic ingredients or introduction of new
allergenic material to the site).
4.9 Chemical and physical product contamination control: raw material-handling,

preparation, processing, packing and storage areas

Appropriate facilities and procedures shall be in place to control the risk
of chemical or physical contamination of product.
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4.9.1 Chemical control

4.9.1.1 Processes shall be in place to manage the use, Additional requirements have been
storage and handling of non-food chemicals to added on designated storage areas
prevent chemical contamination. These shall for chemicals and procedures for
include, at a minimum: managing chemical contamination
spillages and waste disposal to
• an approved list of chemicals for purchase
develop best practices.
• availability of material safety data sheets and
specifications Colour-coding of the requirement
• confirmation of suitability for use in a food- has been changed to dual colouring
processing environment (i.e. requirement shall be an audit
• avoidance of strongly scented products of production facilities and good
• the labelling and/or identification of containers of manufacturing practises and records,
chemicals at all times systems and documentation).
• a designated storage area (separate from
chemicals used as raw materials in products) with
access restricted to authorised personnel
• use by trained personnel only
• procedures to manage any spills
• procedures for the safe, legal disposal or return
of obsolete or out-of-date chemicals and empty
chemical containers.
4.9.2 Metal control

4.9.3 Glass, brittle plastic, ceramics and similar materials

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4.9.4 Products packed into glass or other brittle containers

4.9.5 Wood

4.9.5.1 Wood should not be used in open product areas This clause was amended to provide
except where this is a process requirement (e.g. clarity and to develop best practice
maturation of products in wood). Where the use relating to the use of wood in
of wood cannot be avoided, the condition of wood production areas.
shall be continually monitored its condition shall be
monitored on a risk-based frequency to ensure it is
in good condition and free from damage or splinters
which could contaminate products.
Wood used for food contact purposes shall be fit
for purpose (e.g. free from damage or splinters,
free from taint; and wood treatments, where used,
are used only in accordance with legislation and
approved for food use).
4.9.6 Other physical contaminants

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4.9.6.2 Pens used in open product areas shall be controlled Physical contaminants in open
to minimise the risk of physical contamination (e.g. product areas are not limited to pens.
designed without small parts and detectable by The clause has been amended to
foreign-body detection equipment). include a longer list of examples.
Portable handheld equipment, e.g. stationery items
(pens, pencils etc.), mobile phones, tablets and
similar portable items used in open product areas,
shall be controlled by the site to minimise the risk
of physical contamination. The site may consider, for
example:
• excluding non-approved items
• restricting the use to site-issued equipment
• ensuring stationery items such as pens are
designed without small external parts and
are detectable by foreign-body detection
equipment, or are used in designated areas where
contamination is prevented.
4.9.6.3 Based on risk, procedures shall be implemented to NEW CLAUSE

minimise other types of foreign-body contamination
Procedures should be in-place to
(i.e. types of contamination that are not specifically
minimise all types of potential
covered in section 4.9).
foreign body contamination, not just
those listed in the previous clauses.
The clause has therefore been
added to clarify and encourage best
practice.
4.10 Foreign-body detection and removal equipment

The risk of product contamination shall be reduced or eliminated by the
effective use of equipment to remove or detect foreign bodies.
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4.10.1 Selection and operation of foreign-body detection and removal equipment

4.10.1.1 A documented assessment in association with HACCP study changed to food
the food safety plan (see section 2) HACCP study safety plan to ensure consistent use
shall be carried out on each production process to of terminology in the Standard.
identify the potential use of equipment to detect
Bullet points have been re-worded
or remove foreign-body contamination. Typical
to simplify requirement.
equipment to be considered may include:
• filters and sieves
• sieves
• metal detection and X-ray detection equipment
• magnets
• optical sorting equipment
• X-ray detection equipment
• other physical separation equipment (e.g. gravity
separation, fluid bed technology).
4.10.2 Filters and sieves

4.10.3 Metal detectors and X-ray equipment

4.10.3.1 Metal detection equipment shall be in place unless Where used, metal detection
risk assessment demonstrates that this does not equipment improves food safety. The
improve food safety the protection of final products clause has therefore been amended
from metal contamination. Where metal detectors to clarify the requirement.
are not used, justification shall be documented. The
absence of metal detection would only normally be
based on the use of an alternative, more effective
method of protection (e.g. use of X-ray, fine sieves or
filtration of products).
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4.10.3.4 Metal detector testing procedures shall, at a This clause has been amended to
minimum, include: clarify the position of a test piece on
a conveyor.
• use of test pieces incorporating a sphere of metal
of a known diameter selected on the basis of risk. More guidance can be found in the
The test pieces shall be marked with the size and Interpretation Guideline.
type of test material contained
• tests carried out using separate test pieces
containing ferrous metal, stainless steel and
typically non-ferrous metal, unless the product is
within a foil container where a ferrous-only test
may be applicable
• a test to prove that both the detection and
rejection mechanisms are working effectively
under normal working conditions
• tests of the metal detector by passing successive
test packs through the unit at typical line
operating speed
• checks of failsafe systems fitted to the detection
and rejection systems.
In addition, where metal detectors are incorporated
on conveyors, the test piece shall be passed as close
as possible to the least sensitive area of the metal
detector (usually the centre of the metal detector
aperture). Wherever possible, the test piece shall be
inserted within a clearly identified sample pack of
the food being produced at the time of the test.
Where in-line metal detectors are used, the test
piece shall be placed in the product flow wherever
this is possible, and the correct timing of the
rejection system to remove identified contamination
shall be validated. Testing of in-line metal detectors
shall be completed during both line start-up and at
the end of the production period.
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4.10.3.5 X-ray equipment testing procedures shall, at a NEW CLAUSE
minimum, include:
Where X-ray equipment is in use it
• use of test pieces incorporating a sphere of is important there are procedures to
suitable material (e.g. a typical contaminant) of a ensure its effectiveness is verified.
known diameter selected on the basis of risk. The The requirement for X-ray testing
test pieces shall be marked with the size and type has therefore been added.
of test material contained
• tests carried out using separate test pieces
• a test to prove that both the detection and
rejection mechanisms are working effectively
under normal working conditions
• tests of the X-ray equipment by passing
successive test packs through the unit at typical
line operating speed
• checks of failsafe systems fitted to the detection
and rejection systems.
In addition, where X-ray equipment is incorporated
on conveyors, the test piece shall be passed as
close as possible to the least sensitive area of the
X-ray equipment (e.g. this may be close to the X-ray
source or close to the X-ray equipment). Wherever
possible, the test piece shall be inserted into a
clearly identified sample pack of the food being
produced at the time of the test.
Where in-line X-ray equipment is used, the test
piece shall be placed in the product flow wherever
this is possible, and the correct timing of the
rejection system to remove identified contamination
shall be validated. Testing of in-line equipment shall
be completed both during line start-up and at the
end of the production period.
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4.10.4 Magnets

4.10.4.1 The type, location and strength of magnets shall be To provide additional clarification
fully documented. on the requirements, this clause has
been updated to highlight that it
Procedures shall be in place for the inspection,
relates to food safety (e.g. to remove
cleaning, strength testing and integrity checks of
product contamination) prior to sale
magnets used for food safety purposes, including
to the customer.
final product testing, e.g. to remove product
contamination. Records of all checks shall be Whilst good practice is to confirm
maintained. the correct operation of all magnets,
this clause would not be mandatory
where the magnets are solely used
for other purposes. For example, at
the beginning of a production line
to protect equipment that could be
damaged, rather than for product
safety.
4.10.5 Optical sorting equipment

4.10.5.1 Each unit Optical sorting equipment used Clause amended to clarify that
for final product testing shall be checked in the requirements for checking
accordance with the manufacturer’s instructions or optical sorting equipment relate to
recommendations. Checks shall be documented. equipment used for final product
testing.
4.10.6 Container cleanliness – glass jars, cans and other rigid containers

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4.10.7 Other foreign-body detection and removal equipment

4.10.7.1 Other foreign-body detection and removal NEW CLAUSE
equipment, such as gravity separation, fluid bed
Controls and procedures should
technology or aspirators, shall be checked in
be in place for all foreign body
accordance with the manufacturer’s instructions or
detection and removal equipment,
recommendations.
not just those listed in the previous
Checks shall be documented. clauses. Where other foreign-body
detection removal equipment
is in use it is important that the
effectiveness is verified as per the
manufacturer’s instructions or
recommendations.
4.11 Housekeeping and hygiene
Fundamental

Housekeeping and cleaning systems shall be in place which ensure
appropriate standards of hygiene are maintained at all times and the risk
of product contamination is minimised.

4.11.2 Documented cleaning and disinfection procedures This clause was amended to clarify
shall be in place and maintained for the building, that cleaning records include both
plant and all equipment. Cleaning procedures for those relating to completion of the
the processing equipment and food contact surfaces cleaning and the sign off process.
shall, at a minimum, include:
• responsibility for cleaning
• item/area to be cleaned
• frequency of cleaning
• method of cleaning, including dismantling
equipment for cleaning purposes where required
• cleaning chemicals and concentrations
• cleaning materials to be used
• cleaning records (including records for completion
and sign-off) and responsibility for verification.
The frequency and methods of cleaning shall be
based on risk.
The procedures shall be implemented to ensure
appropriate standards of cleaning are achieved.
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4.11.7 Cleaning in place (CIP)

4.11.7.1 All CIP equipment shall be designed and Clause updated because where
constructed to ensure effective operation. This shall rinse solutions are recovered and
include: reused there should be a specific risk
assessment in place to prevent cross
• validation confirming the correct design and
contamination in CIP equipment (e.g.
operation of the system
due to allergens or the existence
• an up-to-date schematic diagram of the layout of
of different production risk zones
the CIP system
within the site).
• where rinse solutions are recovered and re-used,
an assessment of the risk of cross-contamination
(e.g. due to the re-introduction of an allergen or
the existence of different production risk zones
within the site).
Alterations or additions to the CIP system shall
be authorised by a suitably competent individual
before changes are made. A record of changes shall
be maintained.
The system shall be revalidated at a frequency based
on risk, and following any alteration or addition.
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4.11.7.3 The CIP equipment shall be maintained by suitably This clause has been amended to
trained staff to ensure effective cleaning is carried provide additional clarification on
out. This shall include: the requirements.
• detergent concentrations shall be checked
routinely
• recovered post-rinse solutions shall be monitored
for build-up of carry-over from the detergent
tanks
• filters, where fitted, shall be cleaned and inspected
at a defined frequency
• where used, flexible hoses shall be stored
hygienically when not in use, and inspected at a
defined frequency to ensure that they are in good
condition.
• routine checking of detergent concentrations
• monitoring of recovered post-rinse solutions for
build-up of carry-over from the detergent tanks
• cleaning and inspection of filters, where fitted, at a
defined frequency
• storing flexible hoses (where used) hygienically
when not in use, and inspecting them at a defined
frequency to ensure that they are in good
condition.
4.11.7.4 CIP facilities, where used, shall be monitored at a Spray balls must be monitored to
defined frequency based on risk. This may include: ensure the on-going effectiveness
of the CIP facilities. The clause has
• monitoring of process parameters defined in
therefore been amended to clarify
clause 4.11.7.2
the requirement and encourage best
• ensuring correct connections, piping and settings
practice.
are in place
• confirming the process is operating correctly (e.g.
valves are opening/closing sequentially, spray balls
are operating correctly)
• ensuring effective completion of the cleaning
cycle
• monitoring for effective results, including draining
where required.
Procedures shall define the action to be taken if
monitoring indicates that processing is outside the
defined limits.
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4.11.8 Environmental monitoring

Risk-based environmental monitoring programmes shall be in place for Relevant has been added because
relevant pathogens or spoilage organisms. At a minimum, these shall the risk assessment should focus
include all production areas with open and/or ready-to-eat products. on significant pathogens or spoilage
organisms.

4.11.8.2 Appropriate control or action limits shall be defined Where monitoring results show
for the environmental monitoring programme. an upward trend towards a control
or action limit it is vital that the
The company shall document the corrective action
site investigates the results before
to be taken when monitored results indicate a
the control limit or action limit is
failure to meet a control limit, or when monitored
exceeded.
results indicate an upward trend of positive results
(i.e. a trend towards a control or action limit).
4.11.8.3 The company shall review the environmental It is vital the environmental
monitoring programme at least annually and monitoring plan remains up
whenever there are: to date and relevant, and is
therefore reviewed whenever
• changes in processing conditions, process flow or
there are changes in processing,
equipment which could impact the environmental
new developments in scientific
monitoring programme
information or results indicate
• new developments in scientific information (e.g.
that the plan may not be operating
new pathogens of concern)
effectively.
• failures of the programme to identify a significant
issue (e.g. regulatory authority tests identifying
positive results which the site programme did not)
• product failures (products with positive tests)
• consistently negative results (e.g. a site with a
long history of negative results should review
its programme to consider whether the correct
parts of the factory are being tested, whether the
testing is being conducted correctly, whether the
tests are for the appropriate organisms, etc.).
4.12 Waste and waste disposal

Waste disposal shall be managed in accordance with legal requirements
and to prevent accumulation, risk of contamination and the attraction of
pests.
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4.12.3 Waste removal from open product areas shall be NEW CLAUSE
managed to ensure that it does not compromise
Clause added to minimise the risk
product safety.
of product contamination when
removing waste from open product
areas.
4.13 Management of surplus food and products for animal feed

Effective processes shall be in place to ensure the safety and legality of
by-products of the primary processing activity of the site.

4.13.2 Where customer-branded products which do not This clause has been amended to
meet specifications are sold to staff or passed on to give clarification on products sold to
charities or other organisations, this shall be with staff or donated.
the prior consent of the brand owner.
Traceability has also been added to
Processes shall be in place to ensure that all emphasise the importance of being
products (own-branded and customer-branded) able to trace products even when
which are sold to staff or passed on to charities or they have been donated or sold to
other organisations) are fit for consumption and staff.
meet legal requirements, and that their traceability
is maintained.
4.14 Pest management

The whole site shall have an effective preventive pest management
programme in place to minimise the risk of infestation pest presence, and
resources shall be available to respond rapidly to any issues which occur
to prevent risk to products.
Pest management programmes shall comply with all applicable legislation.
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(i.e. requirement shall be an audit
4.14.10 An in-depth, documented pest management Feedback on Issue 8 indicated that

assessment shall be undertaken at a frequency this clause is not well understood.
based on risk, but at least annually, by a pest The clause has therefore been
management expert to review the pest management updated to aid understanding and
measures in place. The survey assessment shall: application.
• provide include an in-depth inspection of the site,
equipment and facilities for pest activity
• review the existing pest management measures in
place and make any recommendations for change.
The survey assessment shall be timed to allow
access to equipment for inspection where a risk of
stored product insect infestation exists.
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4.15 Storage facilities

All facilities used for the storage of raw materials, packaging, in-process No significant changes to statement
products and finished products shall be suitable for purpose. of intent or requirements in this
section.
4.16 Dispatch and transport

Procedures shall be in place to ensure that the management of dispatch
and of the vehicles and containers used for transporting products from
the site do not present a risk to the safety, security or quality of the
products.

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4.16.6 Where the company employs third-party Clause updated to be consistent
contractors, all the requirements specified in this with the clauses in section 3.5 which
section shall be clearly defined in the contract or also relate to approval of suppliers,
terms and conditions and verified, or the contracted suppliers of services and outsourced
company shall be certificated to the Global Standard processing.
for Storage and Distribution or similar GFSI-
recognised scheme.
Where the company uses contractors, it shall have a
documented supplier approval procedure to ensure
risks to food quality and safety are effectively
managed during dispatch and transport operations.
The approval procedure shall be based on risk and
include either one or a combination of:
Standard (e.g. Global Standard Storage and
Distribution) or GFSI-benchmarked standard
or
• a completed contract or terms and conditions. At
a minimum, this shall include all the requirements
of clauses 4.16.1 to 4.16.5. This shall have been
reviewed and verified by a demonstrably
competent person.
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5 Product control
5.1 Product design/development

Product design and development procedures shall be in place for
new products or processes and any changes to product, packaging or
manufacturing processes to ensure that safe and legal products are
produced.

5.1.1 The company shall provide clear guidelines on This clause aims to formalise
any restrictions to the scope of new product processes for new product
developments to control the introduction of development, (including changes
hazards which would be unacceptable to the site or to existing products, processes
customers (e.g. the introduction of allergens, glass and packaging), to ensure it does
packaging or microbiological risks). not adversely affect the safety
and legality of either the existing
The company shall have a procedure for new
products or the new products
product development and changes to existing
themselves.
product, packaging and manufacturing processes.
Procedures must be in place
This procedure shall include any restrictions
to minimise the risk of product
to the scope of new product development to
contamination.
control the introduction of hazards which would
be unacceptable to the site or customers (e.g. Colour-coding of the requirement
the introduction of allergens, glass packaging, has been changed to dual colouring
microbiological risks or the introduction of (i.e. requirement shall be an audit
ingredients that may affect product claims). of production facilities and good
5.2 Product labelling

Product labelling shall comply with the appropriate legal requirements
and contain information to enable the safe handling, display, storage
and preparation of the product within the food supply chain or by the
customer.
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5.2.1 All products shall be labelled to meet legal The clause has been updated to
requirements for the designated country of use and include artwork.
shall include information to allow the safe handling,
display, storage, preparation and use of the product
within the food supply chain or by the customer.
There shall be a process to verify that ingredient and
allergen labelling is correct based on the product
recipe and ingredient specifications.
The company shall have a procedure for artwork
approval and sign-off.
5.2.3 Where a product is designed to enable a claim to be NEW CLAUSE

made to satisfy a consumer group (e.g. a nutritional
Clause 5.2.3 in Issue 8 clause has
claim, reduced sugar), the company shall ensure that
been included in clause 5.4.7 in Issue
the product formulation and production process are
9 so that the requirements relating
fully validated to meet the stated claim.
to product claims are in the same
Where the label information is the responsibility of section.
a customer or a nominated second or third party, the
Issue 9 clause 5.2.3 was clause 5.2.4
company shall provide information:
in Issue 8.
• to enable the label to be accurately created
• whenever a change occurs which may affect the
label information.
5.2.4 Where the label information is the responsibility of NEW CLAUSE

a customer or a nominated third party, the company
Issue 9 clause 5.2.4 was clause 5.2.5
shall provide information:
in Issue 8.
• to enable the label to be accurately created
• whenever a change occurs which may affect the
label information.
Where cooking instructions are provided to ensure
product safety, they shall be fully validated to
ensure that, when the product is cooked according
to the instructions, a safe, ready-to-eat product is
consistently produced
5.2.5 Where cooking instructions are provided to ensure This clause has been moved to
product safety, they shall be fully validated to clause 5.2.4.
ensure that, when the product is cooked according
to the instructions, a safe, ready-to-eat product is
consistently produced.
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5.3 Management of allergens
Fundamental

The site shall have a system for the management of allergenic materials Cross-contact added to statement of
which minimises the risk of allergen contamination (cross-contact) of intent and several clauses in section
products and meets legal requirements for labelling in the country of sale. to reflect terminology commonly
used in allergen management.

5.3.1 The site shall carry out an assessment of raw Status changed to profile to aid
materials to establish the presence and likelihood further clarity on the requirement to
of contamination (cross-contact) by allergens review raw material specifications.
(see glossary). This shall include a review of the
raw material specifications and, where required,
the acquisition of additional information from
suppliers (e.g. through questionnaires to understand
the allergen status profile of the raw material, its
ingredients and the factory in which it is produced).
5.3.3 A documented risk assessment shall be carried out No significant changes to this clause.
to identify routes of contamination (cross-contact)
and establish documented policies, and procedures
for handling raw materials and intermediate and
finished products, to ensure cross-contamination
(cross-contact) is avoided. This assessment shall
include:
• consideration of the physical state of the
allergenic material (e.g. powder, liquid, particulate)
• identification of potential points of cross-
contamination (cross-contact) through the
process flow
• assessment of the risk of allergen cross-
contamination (cross-contact) at each process
step
• identification of suitable controls to reduce or
eliminate the risk of cross-contamination (cross-
contact).

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5.3.6 Where a justified, risk-based assessment Legislation added because some

demonstrates that the nature of the production countries have specific legislative
process is such that cross-contamination (cross- requirements relating to allergen
contact) from an allergen cannot be prevented, a labelling. Where these exist in the
warning should be included on the label. Legislation, country of sale or intended use, the
national guidelines or codes of practice shall be site is expected to operate systems
used when making such a warning statement. that comply with the legislative
requirements.
5.3.7 Where a claim is made regarding the suitability of Hyper-sensitivity added to provide
a food for individuals with a food allergy or food further clarification.
sensitivity (sometimes referred to as a ‘food hyper-
sensitivity’) for allergy or food sensitivity sufferers,
the site shall ensure that the production process
is fully validated to meet the stated claim and the
effectiveness of the process is routinely verified.
This shall be documented.

5.4 Product authenticity, claims and chain of custody

Systems shall be in place to minimise the risk of purchasing fraudulent or
adulterated food raw materials and to ensure that all product descriptions
and claims are legal, accurate and verified.
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5.4.1 Where personnel are engaged in vulnerability NEW CLAUSE
assessments, the individual or team responsible
It is vital personnel completing the
shall understand potential food fraud risks. This shall
vulnerability assessments for food
include knowledge of raw materials used by the site
fraud are competent– this includes
and the principles of vulnerability assessment.
knowledge of both food fraud
risks, raw materials and knowledge
of the principles/processes of the
vulnerability assessment which the
team will use to develop a robust
vulnerability assessment plan.
5.4.2 The company shall have processes in place to access Clause 1.1.8 requires sites to have
information on historical and developing threats systems to be kept informed and
to the supply chain which may present a risk of review scientific developments,
adulteration or substitution of raw materials (i.e. new risks, codes of practise etc. A
fraudulent raw materials). Such information may robust system of data gathering and
come from, for example: review is likely to provide the site
with a good source of information
• trade associations
that can be used in the vulnerability
• government sources
assessment, hence the last bulletin
• private resource centres
point was added.
• activities completed for clause 1.1.8.
5.4.3 A documented vulnerability assessment shall be This clause was amended to provide
carried out on all food raw materials or groups of raw additional clarification on the
materials to assess the potential risk of adulteration requirements. The update provides
or substitution. This shall take into account: situations for when the vulnerability
assessment should be reviewed by
• historical evidence of substitution or adulteration
the site.
• economic factors which may make adulteration or
substitution more attractive
• ease of access to raw materials through the supply
chain
• sophistication of routine testing to identify
adulterants
• the nature of the raw material.
The output from this assessment shall be a
documented vulnerability assessment plan.
This plan shall be kept under review to reflect
changing economic circumstances and market
intelligence which may alter the potential risks. It
shall be reviewed annually and whenever there is:
• a change in raw materials or a supplier of raw
materials
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5.4.3 continued • emergence of a new risk (e.g. known adulteration
of an ingredient or developments in scientific
information associated with authenticity of the
site’s products or raw materials, for example,
information obtained as part of clause 1.1.8)
• following a significant product safety incident (e.g.
a product recall) where the authenticity of the
site’s products or raw materials is implicated.
5.4.4 Where raw materials are identified as being at

particular risk of adulteration or substitution,
the vulnerability assessment plan shall include
appropriate assurance and/or testing processes to
mitigate the identified risks.
5.4.5 Where products are labelled or claims are made on The clause has been updated to
finished packs which are dependent on the status provide additional clarification and
of a raw material, the status of each batch of the raw with reference to particular scheme
material shall be verified. These claims include: requirements.
• specific provenance or origin
• breed/varietal claims
• assured status (e.g. GLOBALG.A.P.)
• genetically modified organism (GMO) status
• identity preserved
• named specific trademarked ingredients.
The facility shall maintain purchasing records,
traceability of raw material usage and final product
packing records to substantiate claims. The site
shall undertake documented mass balance tests at
a frequency to meet the particular requirements
or at least every 6 months in the absence of a
scheme-specific requirement of any schemes they
are certificated to, or in the absence of a scheme-
specific requirement, at least one mass balance test
every 6 months.
5.4.6 The process flow for the production of products NEW CLAUSE
where claims are made shall be documented and
The first paragraph has been moved
potential areas for contamination or loss of identity
to clause 5.4.7 in Issue 9.
identified. Appropriate controls shall be established
to ensure the integrity of the product claims. This clause was previously clause
5.4.5 in Issue 8.
Where claims are made about the methods of
production (e.g. organic, halal, kosher), the site shall
maintain the necessary certification status in order
to make such a claim.
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5.4.7 Where a product is designed to enable a claim to NEW CLAUSE
be made, the company shall ensure that all claims
Clauses 5.2.3 and 5.4.6 in Issue 8
are substantiated, and product formulation and
have been moved here to group
the production process are fully validated to meet
clauses on claims together.
the stated claim and any legal requirements (in the
country of intended sale) relating to the claim. The site must ensure that production
processes ensure that claims are
The process flow (see clause 2.5.1) for the
consistently met.
production of products where claims are made
shall be documented and potential areas for In addition the site must identify
contamination or loss of identity identified. potential sources of contamination
and loss of identity and ensure
Appropriate controls shall be established to ensure
suitable controls are in place to
the integrity of the product claims.
prevent them from occurring.
5.5 Product packaging

Product packaging and processes for the purchase of product packaging Statement of intent updated to
shall be appropriate for the intended use. and Packaging shall be stored include the purchasing of product
under conditions to prevent contamination and minimise deterioration. packaging to reflect activities in
section 5.5.

5.5.1 When purchasing or specifying primary packaging, To provide additional clarification on
the supplier of packaging materials shall be made the requirements, further examples
aware of any particular characteristics of the food or added to highlight particular
existing packaging (e.g. high fat content, pH, usage characteristics of the packaging.
conditions such as microwaving, other packaging
used on the product, use of recyclable or reusable
packaging materials) which may affect packaging
suitability.
Certificates of conformity or other evidence shall
be available for primary packaging to confirm it
complies with applicable food safety legislation and
is suitable for its intended use.
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5.6 Product inspection, on-site product testing and laboratory testing analysis
5.6.1 Product inspection and testing

The company shall undertake or subcontract inspection and analyses Issue 8 sections 5.6.1 and 5.6.2 have
which are critical to confirm product safety, authenticity, legality, integrity been combined into a single new
and quality, using appropriate procedures, facilities and standards. section covering on-site product
testing and laboratory analysis.
Therefore several clauses in this
section have been updated to
reflect the change. Clause numbers
have also been renumbered in this
section.
The term ‘integrity’ has been
replaced by ‘authenticity’ to ensure
consistent terminology throughout
the Standard.
5.6.1 There shall be a scheduled programme of product In issue 8, this clause was 5.6.1.1.
testing which may include microbiological, chemical,
Processes for obtaining and
physical and organoleptic testing according to risk.
delivering product samples have
The methods, processes for obtaining product
been added to the clause as these
samples (including, where appropriate, their delivery
can be a potential source of product
to a laboratory), frequency and specified limits shall
contamination (e.g. if other products
be documented.
on the production line were
contaminated during sampling) and
to ensure the integrity (and therefore
suitability) of the samples for testing.
5.6.2 Test and inspection results shall be recorded and In Issue 8, this were clauses 5.6.1.2
reviewed regularly to identify trends. and 5.6.2.5.
The significance of external on-site and The clause has been amended
laboratory results shall be understood and acted to highlight the importance of
upon accordingly. Appropriate actions shall be measurement uncertainty associated
implemented promptly to address any unsatisfactory with laboratory test results.
results or trends.
Where legal limits apply, these shall be understood
and appropriate action taken promptly to address
any exceedance of these limits.
Where applicable, the measurement uncertainty
associated with laboratory test results shall be
considered.
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5.6.3 The site shall ensure that a system of validation This clause was 5.6.1.3 in Issue 8.
and ongoing verification of the shelf life is in place.
This shall be based on risk and shall include sensory
analysis and, as applicable, microbiological testing
and relevant chemical factors such as pH and aw.
Records and results from shelf-life tests shall verify
the shelf-life period indicated on the product.
5.6.4 Pathogen testing (including pathogens tested as This clause was 5.6.2.1 in Issue 8.
part of the site's environmental testing monitoring
This clause has been amended
programme) shall be subcontracted to an external
to provide further clarity on the
laboratory or, where conducted internally, the
requirement.
laboratory facility shall be fully segregated
from the production and storage areas and have
operating procedures to prevent any risk of product
contamination. contamination of products or
production areas.
5.6.5 Where routine testing laboratories are present This clause was 5.6.2.2 in Issue 8.
on a manufacturing site, they shall be located,
The clause has been updated to
designed and operated to eliminate potential risks
reflect the range of activities the
to product safety. Controls shall be documented and
sites needs to complete to prevent
implemented, and include consideration of:
contamination.
• operating procedures to contain laboratory
activities, including the design and operation of
drainage and ventilation systems
• access and security of the facility
• movement of laboratory personnel
• hygiene and protective clothing arrangements
• processes for obtaining product samples
• disposal of laboratory waste.
• movement of materials that may pose a risk to
products, raw materials or the production area,
into and out of the laboratory, including the
disposal of laboratory waste
• the management and monitoring of laboratory
equipment.
Where testing activities are performed in
production or storage areas (e.g. at the line tests or
rapid tests), these shall be located, designed and
operated to prevent product contamination.
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5.6.6 Where the company undertakes or subcontracts This clause was 5.6.2.3 in Issue 8.
analyses which are critical to product safety,
authenticity or legality, the laboratory or
subcontractors shall have gained recognised
laboratory accreditation or operate in accordance
with the requirements and principles of ISO/
IEC 17025, including proficiency testing where
applicable. Documented justification shall be
available where accredited methods are not
undertaken
5.6.7 Procedures shall be in place to ensure reliability of This clause was 5.6.2.4 in Issue 8.
laboratory results, other than those critical to safety
and legality specified in clause 5.6.6. 5.6.2.3. These
shall include:
• use of recognised test methods, where available
• documented testing procedures
• ensuring staff are suitably qualified and/or trained
and competent to carry out the analysis required
• use of a system to verify the accuracy of test
results (e.g. ring or proficiency testing where
applicable)
• use of appropriately calibrated and maintained
equipment.
5.6.2 Laboratory testing

5.6.2.1 Pathogen testing (including pathogens tested as part Refer to the statement of intent in
of the environmental testing) shall be subcontracted section 5.6.
to an external laboratory …
Section 5.6.2 and the clauses in the
section have been incorporated into
section 5.6.
5.6.2.2 Where routine testing laboratories are present on a

manufacturing site, they shall be located …
5.6.2.3 Where the company undertakes or subcontracts

analyses which are critical to …
5.6.2.4 Procedures shall be in place to ensure reliability of

laboratory results, other than those critical to …
5.6.2.5 The significance of laboratory results shall be

understood and acted upon accordingly. …
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5.7 Product release

The site shall ensure that finished product is not released unless all No significant changes to statement
agreed procedures have been followed. of intent or requirements in this
section.
5.8 Pet food and animal feed

The site shall ensure that pet food and animal feed products are safe and Animal feed product added to
fit for intended use. statement. Several clauses in this
section have therefore been updated
to reflect the change made to the
statement.

5.8.1 The site shall ensure that pet food and animal feed
is formulated/designed for the intended use (e.g.
where products are designed for complete diet or as
a complementary product).
5.8.2 Where a site’s product range includes pet food or Colour-coding of the requirement
animal feed products for different animal species, has been changed to dual colouring
the site shall have specific procedures for the (i.e. requirement shall be an audit
management of any ingredients, raw materials, of production facilities and good
products or rework that could be harmful to manufacturing practises and records,
unintended recipients. systems and documentation).
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5.8.3 Where the site manufactures, processes or packs The clause, has been updated to
pet food or animal feed products that contain include animal feed products and
medicinal substances, the site shall have specific highlight additional requirements
procedures for the management of the medicated such as supplier approval, staff
raw materials and finished products. At a minimum, training and waste disposal to ensure
these procedures shall include: processes are in place to prevent
contamination.
• identification of medication-containing materials
handled on site. These can be raw materials,
processing aids, intermediate and finished
products, rework or any new product or product
development ingredients
• supplier approval equivalent to section 3.5.1 for all
medicated raw materials
• specific staff training on the correct handling of
medicated materials
• mechanisms to ensure the correct concentrations
of medicinal substances in finished products
• procedures (e.g. cleaning procedures) to prevent
contamination of non-medicated pet food or
animal feed with materials containing medicinal
substances
• specific procedures to ensure the correct labelling
of medicated pet food or animal feed
• waste disposal mechanisms (see section 4.12) that
include the safe and legal disposal of medicated
raw materials and products.
5.8.4 Site procedures shall be designed and implemented NEW CLAUSE

to meet the relevant pet food and animal feed
product safety legislation (both in the country of
legislative requirements relating to
production and in the country of sale).
pet food and animal feed. Where
these exist in the country of sale or
intended use, the site is expected to
operate systems that comply with
the legislative requirements.
5.9 Animal primary conversion

For animal primary conversion, the site shall operate controlled processes NEW STATEMENT
that ensure products are safe and fit for intended use.
The section has been added to
reflect the new GFSI benchmark.
For Issue 8 this information was
contained in a separate position
statement.
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5.9.1 The company shall undertake a risk assessment NEW CLAUSE
for potential prohibited substances (i.e. those
prohibited by legislation in the country of operation
legislative requirements relating
or intended country of sale). Example substances
to prohibited substances. Where
include pharmaceuticals, veterinary medicines (e.g.
these exist in the country of sale or
growth hormones), heavy metals and pesticides.
intended use, the site is expected
The risk assessment may be completed as part of to operate systems that comply
clause 3.5.1.1 or as a separate activity. with the legislative requirements.
Therefore, sites are required to
The results of the risk assessment shall be included
complete a risk assessment to
in raw material acceptance and testing procedures
identify the risks associated with
and in the processes adopted for supplier approval
potential prohibited substances.
and monitoring (see clauses 3.5.1.2–3.5.2.2).
It is vital that the site includes the
results of the risk assessment in the
supplier approval and monitoring
processes, so that any identified risks
are managed within the supply chain.
5.9.2 Where the site is in receipt of live animals, there In Issue 8 this clause was 3.5.2.3.
shall be an inspection by a suitably competent
Clause has been moved to this
individual at lairage and post-mortem to ensure that
section as it refers to animal primary
the animals are fit for human consumption.
conversion.
5.9.3 The site shall operate procedures to ensure that the NEW CLAUSE
traceability of all edible parts of the carcass (i.e. all
Traceability is an important for safety
parts that are intended for the human food supply
and legality requirements for all
chain) is maintained.
food products, ingredients and raw
materials, including all edible parts
of the carcass.
5.9.4 The site shall establish defined time and NEW CLAUSE
temperature requirements for all post-slaughter
Added because site should
processes (for example, post-slaughter cooling,
confirm post-slaughter times and
processing, storage and distribution). These
temperatures to ensure product
requirements shall be defined for all chilled or
safety.
frozen, edible parts of the carcass.
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6 Process control
6.1 Control of operations
Fundamental

The site shall operate to process procedures specifications and/or work Process specifications, work
instructions/procedures that ensure the production of consistently instructions and procedures are all
safe and legal product with the desired quality characteristics, in full valuable ways for site’s to document
compliance with the HACCP or food safety plan. activities and ensure the production
of safe product in accordance with
the site food safety plan.

6.1.1 Documented process specifications and work Colour-coding of the requirement
instructions/procedures shall be available for the has been changed to dual colouring
key processes in the production of products to (i.e. requirement shall be an audit
ensure product safety, legality and quality. The of production facilities and good
process specifications and work instructions manufacturing practises and records,
specifications/procedures (as appropriate) shall systems and documentation).
include:
The clause reflects the importance
• recipes – including identification of any allergens of ensuring process specifications
• mixing instructions, speed, time and work instructions/procedures
• equipment process settings are updated prior to any changes
• cooking times and temperatures to ensure everyone works to the
• cooling times and temperatures correct, and most up to date version.
• labelling instructions
• coding and shelf-life marking
• storage conditions (e.g. storage temperatures)
• any additional critical control points identified in
the HACCP or food safety plan.
Process specifications shall be in accordance with
the agreed finished product specification.
The site shall review the process specifications and
work instructions/procedures prior to any changes
which may affect food safety, legality and quality.
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6.1.7 Where a site handles products or materials (e.g. NEW CLAUSE
by-products from production processes) that
The clause has been added because,
are outside the scope of the audit, these shall
it is important that the site considers
be controlled to ensure that they do not create
the safety, authenticity and legality
a product safety, authenticity or legality risk to
risks associated with products or
products within the scope.
materials handled on site, even when
these are outside the scope of the
audit.
6.2 Labelling and pack control
Fundamental

The management controls of product-labelling activities shall ensure that
products will be correctly labelled and coded.

6.2.1 There shall be a formal process for the allocation A reconciliation check has been
of packaging materials to packing lines and control added to the clause to ensure that
in the packing area which ensures that only the any inconsistencies or unexpected
packaging for immediate use is available to the results can be investigated in a
packing machines. timely manner.
Where offline coding or printing of packaging
materials occurs:
• setting and amendments to the printer parameters
(e.g. the input of, or changes to, date codes) shall
only be completed by an authorised member of
staff
• controls shall be in place to ensure that only
correctly printed material is available at the
packing machines.
Processes shall be in place to check label use is
reconciled with expected use and the cause of any
inconsistencies investigated.
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6.2.2 Documented checks of the production line shall This clause has been amended to
be carried out before commencing production and provide additional clarification on
following changes of product. These shall ensure the requirement. Sites must check to
that lines have been suitably cleared and are ready ensure products, printed-packaging
for production. Documented checks shall be carried and labels from previous productions
out at product changes to ensure that all products have been removed during product
and printed packaging and labels from the previous changeover.
production have been removed from the line before
changing to the next production.
6.2.3 Procedures shall be in place to ensure that all Examples have been added to
products are packed into the correct packaging and the clause to provide additional
correctly labelled. These shall include checks: clarification on the requirements.
• at the start of packing
• during the packing run (e.g. at predefined intervals
and when printed packaging or labels are brought
to the line during the production run)
• when changing batches of packaging materials at
the end of each production run.
The checks shall also include verification of any
printing carried out at the packing stage including, as
appropriate:
• date coding
• batch coding
• quantity indication
• pricing information
• bar coding
• country of origin
• allergen information.
6.3 Quantity – weight, volume and number control

The site shall operate a quantity control system which conforms to legal
requirements in the country where the product is sold and any additional
industry sector codes or specified customer requirements.

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6.3.3 Where used, the site shall establish procedures for “Processes for handling rejected
the operation and testing of online check weighers. packs” have been added because it
At a minimum, this shall include: vital rejected packs do not re-enter
the product-flow.
• consideration of any legal requirements
• responsibilities for testing the equipment
• operating effectiveness and any variations for
particular products
• methods and frequency of testing the check
weighers
• processes for handling rejected packs
• records of the test results.
6.4 Calibration and control of measuring and monitoring devices

The site shall be able to demonstrate that measuring equipment is No significant changes to statement
sufficiently accurate and reliable to provide confidence in measurement of intent or requirements in this
results. section.
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7 Personnel
7.1 Training: raw material-handling, preparation, processing, packing and storage areas
Fundamental

The company shall ensure that all personnel performing work that affects
product safety, legality and quality are demonstrably competent to carry
out their activity, through training, work experience or qualification.

7.1.1 All relevant personnel, including agency-supplied In accordance with the statement of
staff, temporary staff and contractors, shall be intent, the clause has been amended
appropriately trained prior to commencing work to highlight that the requirement
and adequately supervised throughout the working applies to all personnel on site.
period. The clause does not require each
member of staff to be trained in
every activity or to the same level.
However, it is important for the site
to assess the amount, type and level
of training needed for each specific
role.
7.1.2 Where personnel are engaged in activities relating Control measures have been added
to control measures and critical control points, to section 2 of the Standard (e.g.
relevant training and competency assessment shall clause 2.7.4). It is therefore important
be in place. to ensure control measures are
managed correctly and have been
added to this clause to ensure
relevant training and competency
assessments are provided.


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7.2 Personal hygiene: raw material-handling, preparation, processing, packing and

storage areas

The site’s personal hygiene standards shall be developed to minimise
the risk of product contamination from personnel, be appropriate to the
products produced and be adopted by all personnel, including agency-
supplied staff, contractors and visitors to the production facility.

7.2.1 The requirements for personal hygiene shall be This clause has been amended
documented and communicated to all personnel. to provide additional clarification
These shall include, at a minimum, the following: on the requirements for personal
hygiene.
• watches and similar wearable devices shall not be
worn
• jewellery shall not be worn, with the exception of
a single, plain wedding ring, wedding wristband or
medical alert jewellery
• rings and studs in exposed parts of the body, such
as ears, noses and eyebrows, shall not be worn
• fingernails shall be kept short, clean and
unvarnished
• false fingernails and nail art shall not be permitted
• excessive perfume or aftershave shall not be worn.
Compliance with the requirements shall be checked
routinely.
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7.3 Medical screening

The company shall have procedures in place to ensure that employee, The statement has been updated
staff, agency staff, contractors or visitors are not a source of transmission to include procedures for
of infections, diseases (including food-borne diseases) or conditions to communicable diseases, conditions
products. and symptoms that may place
product at risk.

7.3.1 The site shall make staff aware of the symptoms of Clause has been amended to
infection, disease or condition which would prevent highlight that the requirement also
a person working with open food. The site shall applies to contractors and visitors to
have a procedure which enables notification by the site.
employees, staff (including temporary employees),
contractors and visitors to the site, of any relevant
symptoms, infection, disease or condition with
which they may have been in contact with or may be
suffering from.
7.3.3 There shall be procedures for employees, staff Clause has been updated to include
(including temporary employees), contractors and temporary staff because the
visitors relating to action to be taken where they documented procedure applies to all
may be suffering from or have been in contact with personnel.
an infectious disease. Expert medical advice shall be
sought where required.
7.4 Protective clothing: employees, staff or visitors to production areas

Suitable site-issued protective clothing shall be worn by employees, staff,
contractors or visitors working in or entering production areas.

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7.4.3 Laundering of protective clothing shall take place Clause reformatted to clarify how
by an approved contracted Protective clothing shall and when protective clothing shall
be laundered by an approved contracted or in- be laundered.
house laundry using defined criteria to validate the
effectiveness of the laundering process. The laundry
must operate procedures which ensure:
• adequate segregation between dirty and cleaned
clothes
• effective cleaning of the protective clothing
• cleaned clothes are supplied protected from
contamination until use (e.g. by the use of covers
or bags).
Washing of protective clothing by the employee
is exceptional but shall be acceptable where the
protective clothing is to protect the employee from
the products handled and the clothing is worn in
enclosed product or low-risk areas only where:
• the protective clothing is not used for product
safety purposes, for example, it is used to protect
the employee from the products handled
and
• the protective clothing is worn in enclosed
product or low-risk areas only.
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8 Production risk zones – high risk, high care and ambient high care
production risk zones
8.1 Layout, product flow and segregation in high-risk, high-care and ambient high-care
zones

The site shall be able to demonstrate that production facilities and
controls are suitable to prevent pathogen contamination of products.

8.1.1 The map of the site (see clause 4.3.1) shall include Several of the requirements from
areas (zones) where the product is at different levels Issue 8, section 8, have to moved
of risk from contamination. The map shall show: to section 4.3. This clause has been
updated to link with the site map in
• high-risk areas
clause 4.3.2.
• high-care areas
• ambient high-care areas Colour-coding of the requirement
• low-risk areas has been changed to dual colouring
• enclosed product areas (i.e. requirement shall be an audit
• non-product areas. of production facilities and good
See Appendix 2 for guidelines on defining the
production risk zones.
This zoning shall be taken into account when
determining the prerequisite programmes for the
particular areas of the site.
The map of the site (see clause 4.3.2) shall include
the location of the pathogen control step(s).
8.1.2 Where high-risk areas are part of the manufacturing This clause was updated because it
site, there should be physical segregation between is important to consider chemicals
these areas and other parts of the site. Segregation in the segregation between high-risk
shall take into account the flow of product, the areas and other parts of the site.
nature of materials (including packaging), the
equipment, the personnel, the chemicals, the
disposal of waste, the flow of air, the air quality and
the provision of utilities (including drains).
The location of transfer points shall not
compromise the segregation between high-risk
areas and other areas of the factory. Practices
shall be in place to minimise the risk of product
contamination (e.g. the disinfection of materials on
entry).
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8.1.3 Where high-care areas are part of the manufacturing This clause was updated because it
site, there should be physical segregation between is important to consider procedures
these areas and other parts of the site. Segregation for changeover and chemicals in the
shall take into account the flow of product, the segregation between high-care areas
nature of materials (including packaging), the and other parts of the site.
equipment, the personnel, the chemicals, the
disposal of waste, the flow of air, the air quality and
the provision of utilities (including drains).
Where physical barriers are not in place, the of production facilities and good
site shall have undertaken a documented risk manufacturing practises and records,
assessment of the potential for cross-contamination, systems and documentation).
and effective, validated processes shall be in place
to protect products from contamination, including
the procedures for changeover from low-risk to
high-care.
8.2 Building fabric in high-risk and high-care zones

8.2.3 Where sites include removable walls as part of NEW CLAUSE

the design of the high-risk or high-care area (e.g.
Where removable walls are used
to allow occasional movement of large items or
for high-risk or high-care areas
specialist maintenance equipment), procedures shall
it is important that documented
be in place to ensure:
procedures exist to minimise the
• removable walls are tight fitting risk of contamination. The clause
• their use is managed has been added to highlight the
• movement of the walls is authorised and is requirement and encourage best
completed only by trained and authorised staff practice.
• cleaning and reconditioning procedures are in
place and completed prior to production.
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8.3 Equipment and maintenance in high-risk and high-care zones

8.3.1 Maintenance activities undertaken in high-risk Clause reworded to clarify the
and high-care areas shall respect the segregation requirement.
requirements of the area. Wherever possible, tools
and equipment shall be dedicated for use in that
area and retained in the same there.
8.3.3 Where portable equipment (e.g. handheld devices) The use or transportation of battery
and battery-charging equipment is used in high-risk charging equipment has been added
or high-care areas, these items shall either: to the clause.
• be visually distinctive and dedicated for use in
that area, or
• have specific procedures (e.g. a full clean)
to ensure that their use does not result in
contamination.
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8.4 Staff facilities for high-risk and high-care zones

8.4.1 Where an operation includes a high-risk or high- Clause reformatted to provide clarity
care area, personnel shall enter via a specially on hand-washing and disinfection
designated changing facility at the entrance to the facilities requirements.
area. The changing facilities shall incorporate the
following:
• clear instructions for the order of changing into
and out of dedicated protective clothes to prevent
the contamination of clean clothing
• protective clothing that is visually distinct from
that worn in other areas and which shall not be
worn outside the area
• a hand-washing routine during the changing
procedure to prevent contamination of the clean
clothing (i.e. hand-washing after hair covering and
footwear have been put on, but before handling
clean protective clothing)
• provision and use of hand-washing and
disinfection facilities that shall, as . At a minimum
these shall be situated:
• prior to entry for high-risk areas
• on entry for high-care areas
• dedicated site footwear that is provided by the
site and which shall not be worn outside the
factory
• an effective control of footwear to prevent the
introduction of pathogens into the area.
Control may be by segregation and a controlled
change of footwear before entering the area (such
as a barrier or bench system) or by the use of
controlled and managed boot-wash facilities where
these demonstrably provide an effective control of
footwear to prevent the introduction of pathogens
into the area.
A programme of environmental monitoring shall
be used to assess the effectiveness of footwear
controls.
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8.5 Housekeeping and hygiene in high-risk and high-care zones

8.5.1 Environmental cleaning procedures in high-care/ The bullet points removed from this
high-risk areas shall, at a minimum, include: clause are included in clause 4.11.2.
• responsibility for cleaning Colour-coding of the requirement
• item/area to be cleaned has been changed to dual colouring
• frequency of cleaning (i.e. requirement shall be an audit
• method of cleaning, including dismantling of production facilities and good
equipment for cleaning purposes where required manufacturing practises and records,
• cleaning chemicals and concentrations systems and documentation).
• cleaning materials to be used
• cleaning records and responsibility for verification.
The frequency and methods of cleaning shall
be based on risk, and the procedures shall be
implemented to ensure that appropriate standards
of cleaning are achieved.
Environmental cleaning procedures in high-
care/high-risk areas shall consider the different
microbiological risks associated with each
production risk zone.
At a minimum, cleaning procedures in high-risk and
high-care areas shall include all of the requirements
in clause 4.11.2 The frequency and methods of
cleaning shall be based on risk, and the procedures
shall be implemented to ensure that appropriate
standards of cleaning are achieved.
8.5.2 Microbiological limits for acceptable and “Allergen testing” has been removed
unacceptable cleaning performance shall be defined from the clause as section 8 focuses
for high-risk/high-care production risk zones. on pathogen control rather than
allergen management.
These limits shall be based on the potential
hazards relevant to the product or processing Allergen management is covered in
area. Therefore, acceptable levels of cleaning shall sections 5.3 and 4.11.
be defined, for example, by visual appearance,
ATP bioluminescence techniques (see glossary),
microbiological testing, allergen testing or chemical
testing as appropriate. The site shall define the
corrective action to be taken when monitored
results are outside of the acceptable limits.
Where cleaning and disinfection procedures are
part of a defined prerequisite plan to control the risk
of a specific hazard, the cleaning and disinfection
procedures and frequencies shall be validated and
records maintained. This shall include the risk from
cleaning chemical residues on food contact surfaces
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8.5.3 Equipment used for cleaning in high-care and high- It is important for cleaning
risk areas shall be: equipment not to become a source
of contamination. The clause has
• visually distinctive and dedicated for use in that
therefore been amended to include
area
requirements for cleaning equipment
• hygienically designed and fit for purpose
(i.e. to be hygienically designed,
• cleaned and stored in a hygienic manner to
clean and stored appropriately).
prevent contamination (for example, storing
equipment in designated locations, off the floor,
when not in use).
8.5.4 Where the site uses CIP equipment, either this shall NEW CLAUSE
be for a specific area only (i.e. separate equipment
CIP equipment must not transfer
for high-risk, high-care and other production areas)
contamination from the lower risk
or the CIP system shall be designed and controlled
areas to the higher risk areas and
so that it does not present a risk of contamination
either separate systems or robust
to the high-risk/high-care area (i.e. controlling
controls must be in place to prevent
direction of flow from high-risk/high-care to low-
this contamination.
risk areas, preventing the recycling or re-use of rinse
solutions from one area to another).
8.6 Waste/waste disposal in high-risk, high-care zones.

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8.7 Protective clothing in high-risk and high-care zones

8.7.1 Laundering of protective clothing for high-risk Clause reformatted to clarify the
and high-care areas shall be done by an approved requirement for protection of
contracted or in-house laundry using defined criteria cleaned clothes until used.
to validate the effectiveness of the laundering
process. The laundry must operate procedures
which ensure:
• adequate segregation between dirty and cleaned
clothes
• adequate segregation between clothes for high-
risk, high-care and low-risk areas etc.
• effective cleaning of the protective clothing
• commercial sterilisation of the protective clothing
following the washing and drying process
• protection of the cleaned clothes from
contamination until use. (e.g. by the use of covers
or bags).
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9 Requirements for traded products

9.1 The food safety plan – HACCP

The site shall operate a HACCP or food safety plan for the processes for NEW SECTION
which it is responsible.
All operations must be considered as
part of a HACCP or food safety plan
to ensure all hazards are identified
and risks from products and
processes are correctly managed.

9.1.1 The company shall either: NEW CLAUSE
• have a HACCP or food safety plan specifically for Clause added to reflect the
the traded products handled on site, or statement of intent.
• incorporate the traded products into its existing
The site must complete a HACCP or
HACCP or food safety plans (see section 2).
food safety plan which includes the
The scope of traded products HACCP or food safety traded products or ensure the traded
plan shall include the products and the processes products are covered in existing
for which the site is responsible. At a minimum, this HACCP or food safety plans.
shall include goods receipt, storage and dispatch.
9.2 Approval and performance monitoring of manufacturers/packers of traded food

products

The company shall operate procedures for approval of the last Clause numbers have been
manufacturer or packer of food products which are traded to ensure that renumbered in the section to reflect
traded food products are safe, legal and manufactured in accordance with change (i.e. new clause added).
any defined product specifications.
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9.2.1 The company shall have a documented supplier
approval procedure which identifies the process for
initial and ongoing approval of suppliers and the
manufacturer/processor of each product traded. The
requirements shall be based on the results of a risk
assessment which shall include consideration of:
• the nature of the product and associated risks
• customer-specific requirements
• legislative requirements in the country of sale or
importation of the product
• source or country of origin
• potential for adulteration or fraud
• potential risks in the supply chain to the point of
receipt of the goods by the company
• the brand identity of products (i.e. customer own
brand or branded product).
9.2.2 The company shall have a procedure for the initial

and ongoing approval of manufacturers of products.
This approval procedure shall be based on risk and
include either one or a combination of:
scope of the certification shall include the
products purchased
safety, traceability, HACCP review and good
manufacturing practices, undertaken by an
experienced and demonstrably competent
product safety auditor. Where this supplier audit is
completed by a second or third party, the company
shall be able to:
product safety, traceability, HACCP review and
good manufacturing practices
• obtain and review a copy of the full audit report
or
• where a valid risk-based justification is provided
and the supplier is assessed as low risk only, a
completed supplier questionnaire may be used
for initial approval. The questionnaire shall have
a scope that includes product safety, traceability,
HACCP review and good manufacturing practices,
and it shall have been reviewed and verified by a
demonstrably competent person.
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9.2.3 Records shall be maintained of the manufacturer’s/
packer’s approval process, including audit reports
or verified certificates confirming the product safety
status of the manufacturing/packing sites supplying
the products traded. There shall be a process of
review and records of follow-up of any issues
identified at the manufacturing/packing sites with
the potential to affect food products traded by the
company.
9.2.4 There shall be a process for the ongoing review

of manufacturers/packers, based on risk and using
defined performance criteria, which may include
complaints, results of any product tests, regulatory
warnings/alerts, customer rejections or feedback.
The process shall be fully implemented.
Where approval is based on questionnaires, these
shall be reissued at least every 3 years and suppliers
shall be required to notify the site of any significant
changes in the interim, including any change in
certification status.
Records of the review shall be kept.
9.3 Specifications

Specifications or information to meet legal requirements and assist Clause numbers have been
customers in the safe usage of the product shall be maintained and renumbered in the section to reflect
available to customers. change.

9.3.1 Specifications shall be available for all products.
These shall either be in the agreed format
as supplied by the customer or, where this is
not specified, include key data to meet legal
requirements and assist the customer in the safe
usage of the product.
Specifications may be in the form of a printed
or electronic document, or part of an online
specification system.
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9.3.2 The company shall seek formal agreement of
the specifications with relevant parties. Where
specifications are not formally agreed, the company
shall be able to demonstrate that it has taken steps
to ensure formal agreement is in place.
9.3.3 Companies shall operate demonstrable processes

to ensure that any customer-specified requirements
are met. This may be by inclusion of customer
requirements within buying specifications, or by
undertaking further work on the purchased product
to meet the customer’s specification (e.g. sorting or
grading of product).
9.3.4 Specification review shall be sufficiently frequent

to ensure that data is current or at a minimum
every 3 years, taking into account product changes,
suppliers, regulations and other risks.
Reviews and changes shall be documented.
9.4 Product inspection and laboratory testing

The site shall operate processes to ensure that the products received Clause numbers have been
comply with buying specifications and that the supplied product is in renumbered in the section to reflect
accordance with any customer specification. change.

9.4.1 The site shall have a product sampling or assurance
programme to verify that the products are in
accordance with buying specifications and meet
legal and safety requirements.
Where verification is based on sampling, the sample
rate and assessment process shall be risk-based.
Records of the results of assessments or analysis
shall be maintained.
9.4.2 Where verification of conformity is provided by the

supplier (e.g. certificates of conformity or analysis),
the level of confidence in the information provided
shall be supported by commissioning periodic
independent product analysis.
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9.4.3 Where claims are made about the products being
handled, including the provenance, chain of
custody and assured or ‘identity preserved’ status
of a product or raw materials used, supporting
information shall be available from the supplier or
independently to verify the claim.
9.4.4 Where the company undertakes or subcontracts Clause updated to include IEC
analyses which are critical to product safety or (International Electrotechnical
legality, the laboratory or subcontractors shall Commission) principles and
have gained recognised laboratory accreditation requirements.
or operate in accordance with the requirements
and principles of ISO/IEC 17025. Documented
justification shall be available where non-accredited
test methods are used.
9.4.5 Test and inspection results shall be retained and

reviewed to identify trends. Appropriate actions
shall be implemented promptly to address any
unsatisfactory results or trends.
9.5 Product legality

The company shall have processes in place to ensure that the food Clause numbers have been
products traded comply with the legal requirements in the country of sale renumbered in the section to reflect
where known. change.

9.5.1 The company shall have documented processes
to verify the legality of products which are traded.
These processes shall include as appropriate:
• labelling information
• compliance with relevant legal compositional
requirements
• compliance with quantity or volume requirements.
Where such responsibilities are undertaken by the
customer, this shall be clearly stated in contracts.
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9.6 Traceability

The company shall be able to trace all product lots back to the last As per previous comment for reason
manufacturer and forward to the customer of the company. for clause renumbering.

9.6.1 The site shall maintain a traceability system for Clause has been amended to include
all batches of product which identify the last details of the traceability system
manufacturer or, in the case of primary agricultural to ensure affected product can be
products, the packer or place of last significant easily identified in the event of a
change to the product. product recall or withdrawal.
The site’s traceability procedure (see clause 3.9.1)
shall include details of the system used for the
traceability of traded products.
The traceability system shall ensure that, for all
batches of product, the site can identify the last
manufacturer or, in the case of primary agricultural
products, the packer or place of last significant
change to the product.
Records shall also be maintained to identify
the recipient of each batch of product from the
company.
9.6.2 The company shall test the traceability system

at least annually to ensure that traceability can
be determined back to the last manufacturer and
forward to the recipient of the product from the
company. This shall include identification of the
movement of the product through the chain from
the manufacturer to receipt by the company (e.g.
each movement and intermediate place of storage).
9.6.3 The traceability test shall include the reconciliation

of quantities of product received by the company
for the chosen batch or product lot. Traceability
should be achievable within 4 hours (1 day when
information is required from external parties).
brcgs.com 95
Food
Safety
BRCGS
Floor 2
7 Harp Lane
London EC3R 6DP
T: +44 (0)20 3931 8150

E: [email protected]
To learn more about the BRCGS certification programme please visit

brcgs.com
To learn more about the BRCGS online publication service for

certificated sites, please visit brcgsparticipate.com
To purchase printed copies or PDFs from the full range of BRCGS

publications please visit brcgs.com/store

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© BRCGS August 2022

For more information about BRCGS, contact:

BRCGS, Second Floor, 7 Harp Lane, London EC3R 6DP

Tel: +44 (0) 20 3931 8150

Typeset by Williams Lea, London

Detailed changes to the requirements 7

Background and objectives of Issue 9

• encourage understanding and further development of product safety culture

Summary of key changes to the requirements

Consistency with other BRCGS Standards

Product safety culture

HACCP/Food Safety Plan

Animal primary conversion

Module 10 – Global G.A.P. Chain of Custody

Module 11 – Meat Supply Chain Assurance.

The colour-coding is as follows:

Audit of records, systems and documentation

Audit of production facilities and good manufacturing practice

Requirements assessed in both

Changes to the audit protocol

Blended announced audit programme

Detailed changes to the requirements

Changes from Issue 8 have been highlighted in red text.

1 Senior management commitment

Statement of intent Comments

Clause Requirements Comments

Clause Requirements Comments

Clause Requirements Comments

Clause Requirements Comments

1.1.8 No significant changes to this clause.

1.1.9 No significant changes to this clause.

1.1.12 No significant changes to this clause.

1.1.13 The BRCGS logo and references to certification

Clause Requirements Comments

1.2 Organisational structure, responsibilities and management authority

Statement of Intent Comments

Clause Requirements Comments

Clause Requirements Comments

2 The food safety plan - HACCP

Statement of Intent Comments

Clause Requirement Comments

2.1.2 No significant changes to this clause.

2.2 Prerequisite programmes

Clause Requirements Comments

2.3 Describe the product (equivalent to Codex Alimentarius Step 2)

Clause Requirements Comments

Clause Requirements Comments

2.4 Identify intended use (equivalent to Codex Alimentarius Step 3)

Clause Requirements Comments

2.5 Construct a process flow diagram (equivalent to Codex Alimentarius Step 4)

Clause Requirements Comments

2.6 Verify process flow diagram (equivalent to Codex Alimentarius Step 5)

Clause Requirements Comments

Clause Requirements Comments

Clause Requirements Comments

2.8 Determine the CCPs (equivalent to Codex Alimentarius Step 7, Principle 2)

Clause Requirements Comments