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Food

Safety

Global Standard
FOOD SAFETY
ISSUE 9

A S
I T
ER
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A U
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GUIDE TO
KEY CHANGES

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Food
Safety

Global Standard
FOOD SAFETY A S
ISSUE 9 I T
GUIDE TO ER
KEY CHANGES V
August 2022
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FOOD SAFETY
ISSUE 9
GUIDE TO KEY CHANGES

Copyright and liability


BRCGS1 publishes information and expresses opinions in good faith, but accepts no liability for any error or omission
in any such information or opinion including any information or opinion contained in this publication.

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Whilst BRCGS has endeavoured to ensure that the information in this publication is accurate, it shall not be liable
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Nothing excludes or limits the liability of BRCGS for death or personal injury caused by its negligence, for fraud or

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fraudulent misrepresentation or for any matter which it would be illegal for them to exclude or attempt to exclude
liability for.

The Global Standard Food Safety: Guide to Key Changes and the terms of the disclaimer set out above shall be
construed in accordance with English law and shall be subject to the non-exclusive jurisdiction of the English
Courts.

Copyright

© BRCGS August 2022

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ISBN 978-1-78490-462-3

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photocopying or storage in any medium by electronic means) without the written permission of the copyright owner.
Application for permission should be addressed to the Head of Publishing at BRCGS (contact details below). Full

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1
BRCGS is a trading name of BRC Trading Ltd. BRCGS is part of LGC ASSURE

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FOOD SAFETY
ISSUE 9
GUIDE TO KEY CHANGES

Contents
Introduction4
Background and objectives of Issue 9
Summary of key changes to the requirements
Changes to the audit protocol

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4
6

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Detailed changes to the requirements 7
1
2
3
4
5
Senior management commitment
The food safety plan - HACCP
Food safety and quality management system
Site standards 
Product control 
R I 8
14
22
37
62
6
7
8
9
Process control
Personnel 

Requirements for traded products 

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Production risk zones – high risk, high care and ambient high care
75
79
83
90

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Introduction

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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.

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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

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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

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Development process

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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:

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• 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)

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• 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.

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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.

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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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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

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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

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The working group felt that it was appropriate to update the wording for section 2 concerning the HACCP food

Outsourced processing
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safety plan to align the requirements with the 2020 revision of the General Principles of Food Hygiene.

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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

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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

Animal primary conversion

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revision of the requirements in section 4.6.

In May 2021 BRCGS published a position statement on the additional requirements for sites which undertake animal

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primary conversion. The working group agreed that the content of the position statement should be incorporated
into the Standard.

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Additional modules
The following additional modules have been reviewed and updated for Issue 9.

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

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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

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Requirements assessed in both

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Changes to the audit protocol

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Announced audits to include a mandatory unannounced audit every 3 years R
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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.

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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

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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.

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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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Detailed changes to the requirements

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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.

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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.

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It is a requirement that all sites undergoing a BRCGS audit to the Global Standard Food Safety (Issue 9) have access

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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
The site’s senior management shall demonstrate they are fully committed
Comments

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Several clauses in section 1 have

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to the implementation of the requirements of the Global Standard Food been updated to reflect the

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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

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safety, authenticity, legality and
quality.

Clause
1.1.1
Requirements
The site shall have a documented policy which

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states the site’s intention to meet its obligation
to produce safe, legal and authentic products to
the specified quality, and its responsibility to its
Comments
A site must state its intention for the
continuous improvement of product
safety and quality culture.

for the site

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customers. This shall:
• be signed by the person with overall responsibility

• be communicated to all staff

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• include commitment to continuously improve the
site’s food safety and quality culture.

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Clause Requirements Comments


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

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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.

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This shall include:
The updated clause is designed
• defined activities involving all sections of the

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to provide sites with a clear
site that have an impact on product safety. As

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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.

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• clear and open communication on product
safety
• training
• feedback from employees
• the behaviours required to maintain and
improve product safety processes

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• performance measurement on activities related
to the safety, authenticity, legality and quality of
products

timescales

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• an action plan indicating how the activities will
be undertaken and measured, and the intended

• a review of the effectiveness of completed


activities.

1.1.3

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The plan shall be reviewed and updated at least
annually, at a minimum.

The site’s senior management shall ensure that The term ‘authenticity’ has been

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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

B safety and quality policy and this Standard. These


objectives shall be:
• documented and include targets or clear measures
of success
• clearly communicated to all staff
• monitored and results reported at least quarterly
preventing food fraud and therefore
ensuring products are authentic.
The objectives are relevant to the
entire workforce, therefore should
be communicated to all staff. This
clause was amended to clarify the
to site senior management and all staff. requirement and encourage best
practice.

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Clause Requirements Comments


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

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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-

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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

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• any objectives that have not been met, to
understand the underlying reasons. This
information shall be used when setting future

customer feedback
• any incidents (including both recalls and
withdrawals), corrective actions, out-of-
specification results and non-conforming
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objectives and to facilitate continual improvement
• any customer complaints and the results of any

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materials

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• the effectiveness of the systems for HACCP, food
defence and authenticity, and the food safety and
quality culture plan
• resource requirements.

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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

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communicated to appropriate staff, and actions
implemented within agreed timescales.

B 1.1.5 The site shall have a demonstrable meeting


programme which enables food safety, authenticity,
legality, integrity and quality issues to be brought
to the attention of senior management. These
meetings shall occur at least monthly.
Employees shall be aware of the need to report any
The term ‘integrity’ has been
replaced by ‘authenticity’ to ensure
consistent terminology throughout
the Standard.
The requirement for staff to report
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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Clause Requirements Comments


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.

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quality.
The mechanism (e.g. the relevant telephone

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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

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taken, shall be documented.

1.1.7 The company’s senior management shall provide This clause was updated to reflect

1.1.8
requirements of this Standard.

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the human and financial resources required to
produce safely safe, authentic, legal products to
the specified quality and in compliance with the
the Standard’s full scope – product
safety, authenticity, legality and
quality.

No significant changes to this clause.

1.1.9

1.1.10

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Where the site is certificated to the Standard, it
No significant changes to this clause.

This clause was updated to reflect

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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

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The most senior production or operations manager
on site shall participate in the opening and closing
meetings of the audit for certification to the
Standard.
Several different auditing techniques
are used by an auditor to confirm
the site’s compliance with the
Standard. One technique is holding

B Relevant departmental managers or their deputies


shall be available as required during the audit.
A member of the senior management team on site
shall be available during the audit for a discussion
on effective implementation of the food safety
quality culture plan.
discussions with the senior
management and members of staff
because they are responsible for
developing plans and implementing
identified activities.

1.1.12 No significant changes to this clause.

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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Clause Requirements Comments


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

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location implied that the clause only
related to food defence, whereas
it is the responsibility of senior

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management to ensure all legally
required registrations are completed.

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1.2 Organisational structure, responsibilities and management authority

Statement of Intent

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CommentsI
product safety, authenticity, legality and quality.

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

Clause
1.2.1
Requirements

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The company shall have an organisation chart
demonstrating the management structure of the
company. The responsibilities for the management
Comments
‘Integrity’ has been changed to
‘authenticity’ to ensure consistency
with section 1.1.

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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.

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1.2.2 The site’s senior management shall ensure that
all employees are aware of their responsibilities.
Where documented work instructions exist for
activities undertaken, the relevant employees shall
have access to these and be able to demonstrate
that work is carried out in accordance with the
This clause has been amended to aid
further clarity on the requirement on
ensuring staff are aware of their roles
and responsibilities.

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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Clause Requirements Comments


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.

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a designated manager to enable the resolution of
It highlights the importance of
issues requiring immediate action.
everyone being involved in food

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safety, and that the site needs a
mechanism to deal with any issues

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raised.

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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

1.2.4

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If the site does not have the appropriate in-house
knowledge of food safety, authenticity, legality
or quality, external expertise (e.g. food safety
consultants) may be used; however, the day-to-day
manufacturing practices.

NEW CLAUSE
This concept was previously
restricted to the HACCP plan

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(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

E A the responsibility of the site.


Colour-coding of the requirement
has been changed from green to
yellow colouring in Issue 9 (i.e.

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the requirement shall be an audit
of production facilities and good
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)

Statement of Intent
The company shall have a fully implemented and effective food safety
Comments

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T
plan incorporating the Codex Alimentarius HACCP principles.

Clause
2.1.1
Requirement
The HACCP or food safety plan shall be developed
and managed by a multi-disciplinary food safety
team that includes those responsible for quality
Comments

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Last paragraph was deleted because
it has been added to a new clause
1.2.4.
assurance, technical management, production

(e.g. engineering, hygiene).

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operations engineering and other relevant functions

The team leader shall have an in-depth knowledge


of Codex HACCP principles (or equivalent) and

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be able to demonstrate competence, experience
and training. Where there is a legal requirement for
specific training, this shall be in place.

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The team members shall have specific knowledge

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of HACCP and relevant knowledge of products,
processes and associated hazards.
In the event of the site not having the appropriate

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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.

B 2.1.2 No significant changes to this clause.

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2.2 Prerequisite programmes

Clause Requirements Comments


2.2.1 The site shall establish and maintain environmental The BRCGS Technical Working

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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
an exhaustive list:
• cleaning and sanitising disinfection (e.g. See
A
of prerequisite programmes are
provided in the Interpretation

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Guideline.
section 4.11)
• pest management (e.g. See section 4.14)
• maintenance programmes for equipment and
buildings (e.g. See sections 4.4 and 4.6) I
‘Shall’ is used for requirements that a
site must meet.

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• 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)

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• transportation arrangements (e.g. section 4.16)
• processes to prevent cross-contamination (e.g.
sections 4.9 and 4.10)

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• allergen controls management (e.g. section 5.3).
The prerequisite programmes for the particular areas

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of the site shall take into account the production
risk zoning (see clause 4.3.1).

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The control measures and monitoring procedures
for the prerequisite programmes must shall be
clearly documented and shall be included within

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2.3
R the development and reviews of the HACCP or food
safety plan.

Describe the product (equivalent to Codex Alimentarius Step 2)

BClause
2.3.1
Requirements Comments
No significant changes to this clause.

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Clause Requirements Comments


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.

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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:

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• the latest scientific literature
• historical and known hazards associated with
specific food products
• relevant codes of practice
• recognised guidelines

and sale of products


• customer requirements
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• food safety legislation relevant for the production
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• 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

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clause 4.3.2)
• a water distribution diagram for the site (see
clause 4.5.2)

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• indication of any areas (zones) where high-risk,
high-care or ambient high-care production

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facilities are required (see clause 4.3.1).

2.4

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Clause
2.4.1
R
Identify intended use (equivalent to Codex Alimentarius Step 3)

Requirements Comments
No significant changes to this clause.

B
2.5

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

Requirements Comments
2.5.1 No significant changes to this clause.

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

Clause Requirements Comments


2.6.1 The HACCP food safety team shall verify the Verification of changes to the

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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
a part of the HACCP or food safety plan. Daily
and seasonal variations shall be considered and
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incorporated into the HACCP or
food safety plan. This ensures any

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potential hazards are effectively

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evaluated. Records of verified flow diagrams shall be managed.
maintained.
The clause has been amended to

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encourage best practice.

2.7

Clause
Codex Alimentarius Step 6, Principle 1)

Requirements V E
List all potential hazards associated with each process step, conduct a hazard
analysis and consider any measures to control identified hazards (equivalent to

Comments
2.7.1

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The HACCP food safety team shall identify and
record all the potential hazards that are reasonably
expected to occur at each step in relation to
product, process and facilities. This shall include
Clause updated to include section
numbers.

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during the process, or surviving the process steps,
and consideration of the following types of hazard:
• microbiological

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• physical contamination
• chemical and radiological contamination
• fraud (e.g. substitution or deliberate/intentional

B 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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GUIDE TO KEY CHANGES

Clause Requirements Comments


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

S
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

T A
I
• 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

E
• contamination of raw materials, intermediate/
semi-processed product, or finished product. R
V
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

U
The HACCP food safety team shall consider the

A
control measures necessary to prevent or eliminate
a food safety hazard or reduce it to an acceptable
level. Where the control is achieved through existing
This clause was amended because
the requirement for validation of
prerequisite programmes is covered
in a new clause (2.7.4).

R E
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

U
control measure.

2.7.4 Where the control of a specific food safety hazard NEW CLAUSE

B is achieved through prerequisite programmes


(see section 2.2) or control measures other than
CCPs (see clause 2.8.1), this shall be stated and the
adequacy of the programme to control the specific
hazard validated.
To emphasise that the control
of specific hazards needs to be
validated where the control is
achieved via a prerequisite or a
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)

Clause Requirements Comments


2.8.1 No significant changes to this clause.

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

A S
Clause
2.9.1
Requirements

T
Comments

I
No significant changes to this clause.

2.9.2

E R
No significant changes to this clause.

2.10 Establish a monitoring system for each CCP (equivalent to Codex Alimentarius
Step 9, Principle 4)

Clause Requirements
V Comments
2.10.1

2.10.2

A U No significant changes to this clause.

Colour-coding of the requirement


has been changed to dual colouring

R E (i.e. the requirement shall be an audit


of production facilities and good
manufacturing practises and records,
systems and documentation).

B U
2.11

Clause
2.11.1
Establish a corrective action plan (equivalent to Codex Alimentarius Step 10,
Principle 5)

Requirements Comments
No significant changes to this clause.

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

Clause Requirements Comments

S
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

A
clause 2.12.2 to facilitate greater
programmes, continues to be effective. Examples of
clarity on the requirement to verify
verification activities include:

T
existing HACCP or food safety plans.

I
• internal audits
This new requirement reflects
• review of records where acceptable limits have
the recommendation from Codex
been exceeded

R
Alimentarius General Principles of
• review of complaints by enforcement authorities
Food Safety for the validation of
or customers
food safety controls.

E
• review of incidents of product withdrawal or
recall. Changes to the HACCP or food
safety plans which may affect

V
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

U
to any changes which may affect product safety, implementation.
to ensure that the plan will effectively control the
identified hazards before implementation.

A
For existing HACCP or food safety plans, this may be
achieved using the established processes detailed in

E
clauses 2.12.2 and 2.12.3.

R
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

U
8.
programmes, continues to be effective. Examples of
verification activities include:

B • 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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Clause Requirements Comments


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

S
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:

A
2.12.1 and 2.12.2).
• change in raw materials or supplier of raw
Colour-coding of the requirement

T
materials
has been changed to dual colouring

I
• change in ingredients/recipe
(i.e. the requirement shall be an audit
• change in processing conditions, cleaning
of production facilities and good
and disinfection procedures, process flow or

R
manufacturing practises and records,
equipment
systems and documentation).
• change in packaging, storage or distribution

E
conditions
• change in consumer use
• emergence of a new risk (e.g. known adulteration

V
of an ingredient or other relevant, published
information, such as the recall of a similar product)
• review following a significant product safety

U
incident (e.g. a product recall)
• new developments in scientific information
associated with ingredients, process, packaging or

E
product.

A
Appropriate changes resulting from the review shall
be incorporated into the HACCP or food safety
plan and/or prerequisite programmes. Changes shall

R
be fully documented, and the validation shall be
recorded.

U
Where appropriate, the changes shall also be
reflected in the company’s product safety policy
and food safety objectives.

B
2.13 HACCP documentation and record-keeping (equivalent to Codex Alimentarius
Step 12, Principle 7)

Clause Requirements Comments


2.13.1 No significant changes to this clause.

2.14 Review the HACCP plan

Clause Requirements Comments


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

Statement of Intent Comments


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.
A S
Clause
3.1.1
Requirement Comments

I T
R
No significant changes to this clause.

3.1.2 No significant changes to this clause.

3.1.3

V E
All procedures and work instructions shall be clearly
legible, unambiguous, in appropriate languages
and sufficiently detailed to enable their correct
application by appropriate staff. This shall should
include the use of photographs, diagrams or other
Consistent terminology is used here.
‘Should’ is used for requirements
where compliance is expected or
desired.

U
This is explained further in the
pictorial instructions where written communication
Interpretation Guideline.
alone is not sufficient (e.g. there are issues of

A
literacy or foreign language).

3.2

Statement of intent E
Document control

R
The company shall operate an effective document control system to
Comments
No significant changes to statement

B U
ensure that only the correct versions of documents, including recording
forms, are available and in use.

3.3 Record completion and maintenance


of intent or requirements in this
section.

Statement of intent Comments


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

Statement of intent Comments


The company shall be able to demonstrate that it verifies the effective
application of the food safety plan, and the implementation of the
requirements of the Global Standard Food Safety and the site’s food
safety and quality management system.
An effective internal audit

A S
programme is a vital tool for the
management and maintenance of
product safety. A robust internal

I T
audit programme will consider all
of the site’s food safety and quality
management systems. The statement

R
of intent has been amended
to clarify the requirement and
encourage best practice.

Clause
3.4.1
Requirements

V E
There shall be a scheduled programme of internal
audits.
At a minimum, the programme shall include at
Comments
In accordance with the statement of
intent, the clause has been amended
to include the site’s food safety and

U
quality systems in the internal audit
least four different audit dates spread throughout
programme.
the year. The frequency at which each activity is

E A
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

U R 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

B 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.

3.4.2 No significant changes to this clause.

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Clause Requirements Comments


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

S
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.

A
responsible for the activity audited.
Further guidance is provided in the
Corrective and preventive actions, and timescales

T
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).

R I
3.4.4
shall be a separate programme of documented

V E
In addition to the internal audit programme, there

inspections to ensure that the factory environment


and processing equipment are maintained in
a suitable condition for food production. At a
minimum, these inspections shall include:
This clause has been updated to
provide further clarification on
the requirements for fabrication
inspections. Fabrication inspection
scope, results, corrective actions,
(including timescales for completion

U
• hygiene inspections to assess cleaning and
housekeeping performance

A
• fabrication inspections to identify risks to
the product from the building or equipment.
and verification) and the review of
the results were added.

E
(e.g. doors, walls, facilities and equipment) to
identify risks to the product from the building or
equipment.

U R
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

B
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

Statement of Intent
The company shall have an effective supplier approval and monitoring
system to ensure that any potential risks from raw materials (including
Comments

A S
Authenticity has been added to this
section to highlight the importance
primary packaging) to the safety, authenticity, legality and quality of the
final product are understood and managed.

I T
of the supplier approval processes in
maintaining product authenticity and
therefore preventing food fraud.

Clause
3.5.1.1
Requirement

E
The company shall undertake a documented risk
assessment of each raw material or group of raw R
Comments
This clause has been amended to
consider customer requirements in

V
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:

A U
• allergens (allergen content and potential
contamination)
• foreign-body risks
• microbiological contamination

E
• chemical contamination
• variety or species cross-contamination
• substitution or fraud (see clause 5.4.2)

U R • any risks associated with raw materials which


are subject to legislative control or customer
requirements
Consideration shall also be given to the significance

B
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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Clause Requirement Comments


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,

S
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

T A
I
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

E
safety, traceability, HACCP review, the product
security and food defence plan, the product
authenticity plan and good manufacturing
R
V
practices. The audit shall ensure that these
plans form part of the supplier’s product safety
management system and that any resultant actions

U
are implemented. The supplier audit shall be
undertaken by an experienced and demonstrably
competent product safety auditor. Where the

E A
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

R
product safety, product security and food
defence plan, product authenticity, traceability,
HACCP review and good manufacturing

B U or
practices
• obtain and review a copy of the full audit report

• 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.

3.5.1.4 No significant changes to this clause.

3.5.1.5 No significant changes to this clause.

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Clause Requirement Comments


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

S
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.

T A
I
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

E
be carried out on the last manufacturer, packer or
consolidator of the raw material. R
V
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

A U
The procedures shall define how exceptions to
the supplier approval processes in clause 3.5.1.2
are handled (e.g. where raw material suppliers are
prescribed by a customer) or where information
for effective supplier approval is not available (e.g.
Where exceptions to the supplier
approval process places product
quality and safety at risk, additional
requirements must be completed.
The clause has been amended to

E
bulk agricultural commodity products) and instead
product testing is used to verify product quality and

R
safety.
The procedures shall define the actions required in
clarify these requirements.

U
either of the following circumstances:
• an exception to the supplier approval processes

B
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

Statement of Intent Comments


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.

Clause
3.5.2.1
Requirement Comments

A S
T
No significant changes to this clause.

3.5.2.2

3.5.2.3 Where the site is in receipt of live animals, there


shall be an inspection by a suitably competent
I
No significant changes to this clause.

R
This clause has become clause 5.9.2
because the requirement is relevant

E
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

V
U
Statement of Intent Comments
The company shall be able to demonstrate that where services are

effective controls are in place.

3.5.3.1
A
outsourced, the service is appropriate and any risks presented to food
safety, authenticity, legality and quality have been evaluated to ensure

E
There shall be a procedure for the approval and The management of suppliers of

U R
monitoring of suppliers of services. Such services
shall include, as appropriate:


pest control
laundry services
services are not only limited to
facilities and products services.
Additional examples have been
added to the clause to emphasise
the wide scope of services that

B
• 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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Clause Requirement Comments


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).

A S
3.5.3.2

3.5.3.3 There shall be a documented process for ongoing


I T
No significant changes to this clause.

NEW CLAUSE
performance review of suppliers of services, based
on risk and defined performance criteria. The
process shall be fully implemented.
Records of the review shall be kept.

E R
Ongoing monitoring and approval,
is important, where suppliers of
services are used, to ensure they
continue to provide the correct level

V
of services.

3.5.4 Management of outsourced processing

Statement of Intent

A U
Where any intermediate process step (including production, processing
or storage) in the manufacture of a product is outsourced to a third party
Comments
The BRCGS Technical Working
Group were in agreement that

R E
or undertaken at another site, and subsequently returned to the site, this
shall be managed to ensure it does not compromise the product safety,
authenticity, legality or quality.
further clarity should be provided
on the definition for outsourced
product. A new definition has
been added to the glossary and
further guidance and explanation

B U
Clause
3.5.4.1
Requirement
The company shall be able to demonstrate that,
where part of the production process or any part
can be found in the Interpretation
Guideline.

Comments
This clause has been amended based
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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Clause Requirement Comments


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.

S
and quality and are operating effective traceability
processes.

A
The approval and monitoring procedure shall
be based on risk and include either one or a

T
combination of:
• a valid certification to the applicable BRCGS

or
Standard or GFSI-benchmarked standard. The
scope of the certification shall include the
activities completed for the site

R I
safety, traceability, HACCP review, product
security and food defence plan, product
authenticity plan and good manufacturing

V E
• supplier audits, with a scope to include product

practices. The audit shall ensure that these


plans form part of the supplier’s product safety

A U
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

R E
party, the company shall be able to
• demonstrate the competency of the auditor
• confirm that the scope of the audit includes
product safety, traceability, HACCP review,
product security and food defence plan, product

B U authenticity plan and good manufacturing


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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Clause Requirement Comments


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/

S
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

T A
3.5.4.4
shall form part of the site’s food safety plan (HACCP
plan).

The company shall establish inspection and


test procedures for products where part of the
R I
NEW CLAUSE

E
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.

shall depend on risk assessment.

V
The frequency and methods of inspection or testing

Requirements for outsourced processing shall be


This clause reflects that good
practice when outsourcing
activities is to define the service in a

A U
agreed and documented in a service specification
(similar to a finished product specification). This
shall include any specific handling requirements for
the products.
specification that aids product safety,
authenticity, legality and quality.

3.5.4.5

R E Any outsourced processing operations shall:


• be undertaken in accordance with established
contracts which clearly define any processing
requirements
NEW CLAUSE

U
• maintain product traceability.

3.5.4.6 The company shall establish inspection and NEW CLAUSE

B test procedures for products where part of the


processing has been outsourced, including visual,
chemical and/or microbiological testing.
The frequency and methods of inspection or testing
shall depend on risk assessment.
This was clause 3.5.4.4 in Issue 8.

3.6 Specifications

Statement of Intent Comments


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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Clause Requirement Comments


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

S
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).

T A
3.6.2

3.6.3

3.6.4
R I
No significant changes to this clause.

No significant changes to this clause.

No significant changes to this clause.

3.7 Corrective and preventive actions

Fundamental
V E
Statement of Intent

A U
The site shall be able to demonstrate that it uses the information from
identified issues in the food safety and quality management system (e.g.
Comments
Corrective and preventive actions
are applicable to a wide range of

E
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

Clause

U
3.7.1
R
Requirement
The site shall have a procedure for handling and
actions should be applied.

Comments
Root cause analysis and the

B correcting issues identified in the food safety and


quality management system.
The site procedures shall include the completion
of root cause analysis and implementation of
preventive action.
implementation of preventative
action are a vital part in the
management of corrective and
preventive actions.
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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Clause Requirement Comments


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

S
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

A
• assessment of consequences by a suitably
management system.
competent and authorised person

T
• the corrective action to address the immediate Colour-coding of the requirement

I
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
• appropriate timescales for corrective and
preventive actions

E
• the person(s) responsible for corrective and
preventive actions
R
good manufacturing practises
as well as records, systems and
documentation).

V
• verification that the corrective and preventive
actions has have been implemented and is are
effective.

A U
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

R E The site shall have a procedure for the completion


of root cause analysis. At a minimum root cause
analysis shall be used to implement ongoing
improvements and to prevent recurrence of non-
To provide additional clarification
on the requirements, this clause has
been combined with two clauses
(3.7.1 and 3.7.2).

B U 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

Statement of Intent Comments


The site shall ensure that any out-of-specification product is effectively
managed to prevent unauthorised release.

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Clause Requirement Comments


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

S
the management of any product
• the requirement for staff to identify and report a
returned to the site.
potentially non-conforming product

A
• clear identification of a non-conforming product
(e.g. direct labelling or the use of IT systems)

T
• secure storage to prevent accidental release (e.g.

I
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

E
issue (e.g. destruction, reworking, downgrading to
an alternative label or acceptance by concession)
• records of the decision on the use or disposal of
R
the product

V
• records of destruction where a product is
destroyed for food safety reasons.

3.9 Traceability

Fundamental
A U
Statement of Intent

R E
The site shall be able to trace all raw material product lots (including
primary packaging) from its suppliers through all stages of processing and
Comments

U
dispatch to its customers and vice versa.

Clause Requirement Comments

B 3.9.1 The site shall have a documented traceability


procedure designed to maintain traceability
throughout the site’s processes. At a minimum this
shall include:
• how the traceability system works
Some countries have specific
legislative requirements relating to
traceability. Where these exist in the
country of sale or intended use, the
site is expected to operate systems
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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Clause Requirement Comments


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.

S
(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

A
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

T
printed labels must be include in the
of the traceability system shall include a quantity

I
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

E
test shall occur at a predetermined frequency, at a
minimum annually, and results shall be retained for
inspection. Traceability should be achievable within
R
3.9.4
4 hours.

V No significant changes to this clause.

3.10 Complaint-handling

Statement of Intent
A U Comments

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

Requirement Comments

B U
3.10.1

3.10.2

3.11 Management of incidents, product withdrawal and product recall


No significant changes to this clause.

No significant changes to this clause.

Statement of Intent Comments


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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Clause Requirement Comments


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

S
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

A
product recall and product withdraw
quality. Incidents may include:
situations that may impact food

T
• disruption to key services such as water, energy, safety, authenticity, legality or

I
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
• product contamination indicating a product may
be unsafe or illegal

E
• failure of, or attacks against, digital cyber-security. R
contamination or sabotage or
cybersecurity attacks. Contaminated
product (i.e. unsafe or illegal) was
added as another example.

V
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.

3.11.2

3.11.3

A U
The product recall and withdrawal incident
No significant changes to this clause.

Clause was updated to cover

E
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).

R
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

B U
3.11.4
review the procedure and implement improvements
as necessary.

In the event of a significant food safety, authenticity


or legality incident, including a product recall,
regulatory food safety non-conformity (e.g. a
‘Integrity’ and ‘legality’ added to
food safety to ensure significant
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

Statement of Intent Comments


The production site shall be of suitable size, location and construction,
and be maintained to reduce the risk of contamination and facilitate the
production of safe and legal finished products.
between sections 4.1 and 4.2.
S
In Issue 8 site security was divided

A
For Issue 9 site security has been

T
separated from food defence and is

I
now full incorporated in this section.

Clause Requirement Comments


4.1.1

4.1.2

E R
No significant changes to this clause.

No significant changes to this clause.

4.1.3

4.1.4
V
Policies and systems shall be in place to ensure that
No significant changes to this clause.

NEW CLAUSE

U
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.

A
It has been moved to this clause to
Contractors and visitors, including drivers, shall be facilitate greater clarity on the site

E
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

U R in product processing or storage areas shall be the


responsibility of a nominated person.
Staff shall be trained in site security procedures.

B
4.2 Site security and Food defence

Statement of Intent
Systems shall protect products, premises and brands from malicious
actions while under the control of the site.
Comments
Site security has been removed from
section 4.2 and incorporated into
section 4.1.

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Clause Requirement Comments


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

S
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/

A
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

T
food defence plan.

R I
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

4.2.2

V E
The company shall undertake a documented risk
assessment (threat assessment) of the potential risks
to products from any deliberate attempt to inflict
contamination or damage. This threat assessment
legislative requirements.

Some countries have specific


legislative requirements relating
to the food defence plan. Where
these exist, the site is expected to

U
shall include both internal and external threats.
The output from this assessment shall be a

A
documented threat assessment plan. This plan
shall be kept under review to reflect changing
operate systems that comply with
the legislative requirements.

E
circumstances and market intelligence. It shall be
formally reviewed at least annually and whenever:

R
• a new risk emerges (e.g. a new threat is publicised
or identified)
• an incident occurs, where product security or food

B U
4.2.3
defence is implicated.
Where applicable, the food defence plan shall meet
the legal requirements in the country of sale or
intended use.

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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Clause Requirement Comments


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

S
products and raw materials (including packaging). to this section to focus on food
defence.
Policies and systems shall be in place to ensure

A
that only authorised personnel have access to
production and storage areas, and that access to

T
the site by employees, contractors and visitors is

I
controlled. A visitor recording system shall be in
place.

R
Staff shall be trained in site security procedures and
food defence.

4.2.4

authorities.

V E
Where required by legislation, the site shall
maintain appropriate registrations with the relevant
Clause 4.2.4 in Issue 8 has become
clause 1.1.14 in Issue 9 to facilitate
greater clarity on senior management
responsibility.

4.3

U
Layout, product flow and segregation

Fundamental

A
E
Statement of intent Comments
The factory layout, flow of processes and movement of personnel shall

U
Clause R
be sufficient to prevent the risk of product contamination and to comply
with relevant legislation.

Requirements Comments

B
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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Clause Requirements Comments


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:
Colour-coding of the requirement
• production risk zones, where product is has been changed to dual colouring
at different levels of risk from pathogen
contamination – for example, high-risk, high-care,
ambient high-care, low-risk and enclosed product
areas (see clause 4.3.1 and Appendix 2)

A
manufacturing practises, records,
systems and documentation). S
(i.e. Requirement shall be an audit
of production facilities, good

T
• access points for personnel

I
• 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
E R
V
• location of any staff facilities, including changing
rooms, toilets, canteens and smoking areas
• production process flows

U
• any areas where time segregation is used to
complete different activities (for example, time
segregation for high-care areas).

4.3.3

A
Contractors and visitors, including drivers, shall

E
be made aware of the requirements of the areas
they are visiting, with special reference to hazards
and potential product contamination. Contractors
The final sentence was moved to
clause 4.1.4 to provide further clarity
of the requirements for contractors
on site.

U
4.3.4 R
working in product processing or storage areas shall
be the responsibility of a nominated person.

The movement of personnel, raw materials,


packaging, rework and/or waste shall not

B 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

Statement of intent Comments

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

Clause
4.4.1
Requirements Comments

T A
No significant changes to this clause.

4.4.2

4.4.3

R I
No significant changes to this clause.

No significant changes to this clause.

4.4.4

4.4.5

4.4.6 Where elevated walkways, access steps or


V E No significant changes to this clause.

No significant changes to this clause.

Clause updated to provide additional

shall be:

A U
mezzanine floors are adjacent to or pass over
production lines which have open products, they

• designed to prevent contamination of products


clarification on the requirements, for
access steps and mezzanine floors
above production lines which have
open products.

E
and production lines
• easy to clean
• correctly maintained.

4.4.7

U
4.4.8 R No significant changes to this clause.

No significant changes to this clause.

B4.4.9

4.4.10

4.4.11 Where plastic strip curtains are present, these


shall be maintained in good condition, clean,
No significant changes to this clause.

No significant changes to this clause.

NEW CLAUSE
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

Statement of intent Comments


Utilities used within the production and storage areas shall be monitored

S
to effectively control the risk of product contamination.

Clause Requirements Comments


4.5.1 All water (including ice and steam) used as a raw
material in the manufacture of processed food,
A
All water including, water stored

T
and handled on site, falls within the

I
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
according to applicable legislation.

E
Where water is stored and handled on site (e.g. in
storage or holding tanks) these shall be managed to
R
encourage best practice.

V
minimise food safety risks.
The microbiological and chemical quality of water
shall be analysed as required by legislation or at

U
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

4.5.2

E A
storage and distribution facilities, previous sample
history and usage.

No significant changes to this clause.

4.5.3

U
4.6 Equipment R No significant changes to this clause.

B Statement of intent
All food-processing production and product-handling equipment shall be
suitable for the intended purpose and shall be used to minimise the risk
of contamination of product.
Comments
The statement of intent has been
updated to provide clarity on the
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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Clause Requirements Comments


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

S
maintained. ensure the new equipment will meet
any relevant legislation, be suitable
There shall be a documented purchase specification
for food contact (where appropriate)

A
for any new equipment detailing the site
and be suitable for the intended use.
requirements for the equipment. This may, for

T
example, include: New equipment includes, equipment

I
purchased from a manufacturer,
• any relevant legislation
refurbished and second hand
• where applicable, requirements for food contact
equipment. It is therefore useful to

R
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.

E
Depending on its intended use, new equipment to
site (including second-hand equipment) may require

V
authorisation from a multi-disciplinary team.
The supplier should provide evidence that
equipment meets these site requirements prior to
The green colour-coding of the
requirement reflects the fact that
this is most likely to be audited as
an audit of records, systems and
documentation and not production
facilities and good manufacturing

4.6.2
supply.

A U
Equipment that is in direct contact with food
shall be suitable for food contact and meet legal
requirements where applicable.
practises.

The design and construction of


equipment must consider product
contamination (i.e. it must be

E
The design and construction of equipment shall be
based on risk, to prevent product contamination. For

R
example, the use of the correct seals, impervious
surfaces or smooth welds and joints, where they
designed to prevent contamination).

U
are exposed to product and could otherwise
result in foreign-body, microbiological or allergen
contamination of the product.

B Equipment that is in direct contact with food


shall be suitable for food contact and meet legal
requirements where applicable.

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Clause Requirements Comments


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

S
equipment to site.
key point in the process where
Installation work shall be followed by a documented food safety could be implicated if

A
hygiene clearance procedure. processes are not controlled and
specifically designed to prevent
New equipment to site shall be inspected by an

T
hazards occurring,
authorised member of staff before being accepted
into operation.
The commissioning procedure shall include the
update of any other site procedures that are affected
by the new equipment, for example, training,

R I
The amount of installation should
be proportional to the complexity of
the equipment and the food safety
risks relevant to the equipment.

E
operating procedures, cleaning, environmental
monitoring, maintenance schedules or internal
audits.
The design and placement of equipment shall

V
ensure that it can be effectively cleaned and
maintained.

4.6.4

U
A procedure shall be in place to manage the

A
movement of static equipment in production areas,
to ensure that food safety is managed and the
integrity of the equipment is maintained.
NEW CLAUSE
Static equipment is rarely moved
and therefore it is possible to

E
unintentionally introduce a product
safety risk, or damage equipment
integrity if the equipment is moved

U R 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

B 4.6.5 Equipment that is not used or is taken out of service


shall be cleaned and stored in a manner that does
not pose a risk to the product.
Equipment stored in internal production and storage
of equipment.

NEW CLAUSE
New clause to ensure that the
condition (cleanliness) of equipment
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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Clause Requirements Comments


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
areas cannot be avoided and poses a risk to the
product, the equipment shall be cleaned and
disinfected prior to entering production areas.

A S
to another when mobile equipment
is used in more than one area. This
clause was added to ensure sites
consider and manage this risk.

4.6.7 Battery-charging equipment shall not be stored in


open product areas (unless the batteries are fully
sealed and/or maintenance-free) or where there is a
I T
NEW CLAUSE
There are additional requirements

R
that must be completed by the site
risk to products.
where battery-charging equipment is
in use.

4.7 Maintenance

Statement of intent
V E Comments

breakdowns.

Clause Requirements
U
An effective maintenance programme shall be in operation for plant
and equipment, to prevent contamination and reduce the potential for

A Comments
4.7.1

R E There shall be a documented planned preventive


maintenance schedule or condition monitoring
system which includes all plant, processing
equipment and mobile equipment. The maintenance
Colour-coding of requirement has
been changed to green reflecting
that the schedule will mainly be
an audit of records, systems and

B U
4.7.2

4.7.3
requirements shall be defined when commissioning
new equipment and reviewed after repairing existing
equipment.
documentation and not production
facilities and good manufacturing
practises).

No significant changes to this clause.

No significant changes to this clause.

4.7.4 No significant changes to this clause.

4.7.5 No significant changes to this clause.

4.7.6 No significant changes to this clause.

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4.8 Staff facilities

Statement of intent Comments


Staff facilities shall be sufficient to accommodate the required number

S
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.

Clause Requirements Comments

T A
I
4.8.1 No significant changes to this clause.

4.8.2 No significant changes to this clause.

4.8.3

4.8.4

E R
No significant changes to this clause.

No significant changes to this clause.

4.8.5

4.8.6
V No significant changes to this clause.

No significant changes to this clause.

4.8.7

4.8.8

A U
Where catering facilities (including vending
No significant changes to this clause.

Clause updated to provide clarity on

E
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.

R
use of allergenic ingredients or introduction of new
allergenic material to the site).

B U
4.9 Chemical and physical product contamination control: raw material-handling,
preparation, processing, packing and storage areas

Statement of intent Comments


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

Clause Requirements Comments


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
include, at a minimum:
• an approved list of chemicals for purchase
• availability of material safety data sheets and
develop best practices.

A S
for chemicals and procedures for
managing chemical contamination
spillages and waste disposal to

specifications
• confirmation of suitability for use in a food-
processing environment
T
Colour-coding of the requirement

I
has been changed to dual colouring
(i.e. requirement shall be an audit

R
• 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

access restricted to authorised personnel


• use by trained personnel only
• procedures to manage any spills
E
chemicals used as raw materials in products) with

V
• procedures for the safe, legal disposal or return

4.9.1.2

A U
of obsolete or out-of-date chemicals and empty
chemical containers.

No significant changes to this clause.

4.9.2

Clause

R E
Metal control

Requirements Comments

B U
4.9.2.1

4.9.2.2

4.9.3 Glass, brittle plastic, ceramics and similar materials


No significant changes to this clause.

No significant changes to this clause.

Clause Requirements Comments


4.9.3.1 No significant changes to this clause.

4.9.3.2 No significant changes to this clause.

4.9.3.3 No significant changes to this clause.

4.9.3.4 No significant changes to this clause.

4.9.3.5 No significant changes to this clause.

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4.9.4 Products packed into glass or other brittle containers

Clause Requirements Comments


4.9.4.1 No significant changes to this clause.

4.9.4.2

4.9.4.3

A S
No significant changes to this clause.

No significant changes to this clause.

4.9.5

Clause
Wood

Requirements Comments
I T
4.9.5.1 Wood should not be used in open product areas

E
except where this is a process requirement (e.g.
maturation of products in wood). Where the use
of wood cannot be avoided, the condition of wood
R
This clause was amended to provide
clarity and to develop best practice
relating to the use of wood in
production areas.

V
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

U
which could contaminate products.
Wood used for food contact purposes shall be fit

A
for purpose (e.g. free from damage or splinters,
free from taint; and wood treatments, where used,

E
are used only in accordance with legislation and
approved for food use).

4.9.6

U
Clause R
Other physical contaminants

Requirements Comments

B
4.9.6.1 No significant changes to this clause.

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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

S
foreign-body detection equipment). include a longer list of examples.
Portable handheld equipment, e.g. stationery items

A
(pens, pencils etc.), mobile phones, tablets and
similar portable items used in open product areas,

T
shall be controlled by the site to minimise the risk

I
of physical contamination. The site may consider, for
example:

R
• excluding non-approved items
• restricting the use to site-issued equipment
• ensuring stationery items such as pens are

4.9.6.3
E
designed without small external parts and
are detectable by foreign-body detection

V
equipment, or are used in designated areas where
contamination is prevented.

Based on risk, procedures shall be implemented to NEW CLAUSE

A U
minimise other types of foreign-body contamination
(i.e. types of contamination that are not specifically
covered in section 4.9).
Procedures should be in-place to
minimise all types of potential
foreign body contamination, not just
those listed in the previous clauses.

R E The clause has therefore been


added to clarify and encourage best
practice.

U
4.10 Foreign-body detection and removal equipment

BStatement of intent
The risk of product contamination shall be reduced or eliminated by the
effective use of equipment to remove or detect foreign bodies.
Comments

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4.10.1 Selection and operation of foreign-body detection and removal equipment

Clause Requirements Comments


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
identify the potential use of equipment to detect
or remove foreign-body contamination. Typical
equipment to be considered may include:
of terminology in the Standard.

S
Bullet points have been re-worded
to simplify requirement.

A



filters and sieves
sieves
metal detection and X-ray detection equipment

I T
R
• magnets
• optical sorting equipment
• X-ray detection equipment

4.10.1.2

4.10.1.3

V E
other physical separation equipment (e.g. gravity
separation, fluid bed technology).

No significant changes to this clause.

No significant changes to this clause.

4.10.1.4

4.10.2 Filters and sieves


A U No significant changes to this clause.

Clause
4.10.2.1

R E
Requirements Comments
No significant changes to this clause.

B U
4.10.2.2

4.10.3 Metal detectors and X-ray equipment

Clause Requirements
No significant changes to this clause.

Comments
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).

4.10.3.2 No significant changes to this clause.

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4.10.3.3 No significant changes to this clause.

4.10.3.4 Metal detector testing procedures shall, at a This clause has been amended to

S
minimum, include: clarify the position of a test piece on
a conveyor.
• use of test pieces incorporating a sphere of metal

A
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.

T
type of test material contained

I
• 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

E
• a test to prove that both the detection and
rejection mechanisms are working effectively
under normal working conditions
R
V
• tests of the metal detector by passing successive
test packs through the unit at typical line
operating speed

U
• checks of failsafe systems fitted to the detection
and rejection systems.

A
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

R E
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.

U
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

B 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
known diameter selected on the basis of risk. The
test pieces shall be marked with the size and type
of test material contained S
ensure its effectiveness is verified.
The requirement for X-ray testing
has therefore been added.

A
T
• tests carried out using separate test pieces

I
• 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

E
• checks of failsafe systems fitted to the detection
and rejection systems.
R
V
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

A U
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.

R E
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

U
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

Clause Requirements Comments


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
Procedures shall be in place for the inspection,
cleaning, strength testing and integrity checks of
magnets used for food safety purposes, including
final product testing, e.g. to remove product
to the customer.

A S
been updated to highlight that it
relates to food safety (e.g. to remove
product contamination) prior to sale

contamination. Records of all checks shall be


maintained.

I T
Whilst good practice is to confirm
the correct operation of all magnets,
this clause would not be mandatory

R
where the magnets are solely used
for other purposes. For example, at
the beginning of a production line

4.10.5 Optical sorting equipment


V E to protect equipment that could be
damaged, rather than for product
safety.

Clause
4.10.5.1
Requirements

A U
Each unit Optical sorting equipment used
for final product testing shall be checked in
Comments
Clause amended to clarify that
the requirements for checking

R E accordance with the manufacturer’s instructions or


recommendations. Checks shall be documented.
optical sorting equipment relate to
equipment used for final product
testing.

U
4.10.6 Container cleanliness – glass jars, cans and other rigid containers

B
Clause Requirements Comments
4.10.6.1 No significant changes to this clause.

4.10.6.2 No significant changes to this clause.

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4.10.7 Other foreign-body detection and removal equipment

Clause Requirements Comments


4.10.7.1 Other foreign-body detection and removal NEW CLAUSE
equipment, such as gravity separation, fluid bed

S
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,

A
recommendations.
not just those listed in the previous
Checks shall be documented. clauses. Where other foreign-body

I T
detection removal equipment
is in use it is important that the
effectiveness is verified as per the

R
manufacturer’s instructions or
recommendations.

4.11 Housekeeping and hygiene

Fundamental

V E
U
Statement of Intent Comments
Housekeeping and cleaning systems shall be in place which ensure

Clause

E
Requirement A
appropriate standards of hygiene are maintained at all times and the risk
of product contamination is minimised.

Comments

R
4.11.1 No significant changes to this clause.

4.11.2 Documented cleaning and disinfection procedures This clause was amended to clarify

B U shall be in place and maintained for the building,


plant and all equipment. Cleaning procedures for
the processing equipment and food contact surfaces
shall, at a minimum, include:


responsibility for cleaning
item/area to be cleaned
that cleaning records include both
those relating to completion of the
cleaning and the sign off process.

• 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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Clause Requirement Comments


4.11.3 No significant changes to this clause.

4.11.4 No significant changes to this clause.

4.11.5

4.11.6

A S
No significant changes to this clause.

No significant changes to this clause.

4.11.7 Cleaning in place (CIP)

I T
Clause
4.11.7.1
Requirements
All CIP equipment shall be designed and

E
constructed to ensure effective operation. This shall
include:
R
Comments
Clause updated because where
rinse solutions are recovered and
reused there should be a specific risk

operation of the system


V
• validation confirming the correct design and

• an up-to-date schematic diagram of the layout of


assessment in place to prevent cross
contamination in CIP equipment (e.g.
due to allergens or the existence

U
of different production risk zones
the CIP system
within the site).
• where rinse solutions are recovered and re-used,

A
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

R E 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

U
be maintained.
The system shall be revalidated at a frequency based

B
on risk, and following any alteration or addition.

4.11.7.2 No significant changes to this clause.

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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

A S
T
tanks

I
• 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

E
• monitoring of recovered post-rinse solutions for
R
V
build-up of carry-over from the detergent tanks
• cleaning and inspection of filters, where fitted, at a
defined frequency

U
• storing flexible hoses (where used) hygienically
when not in use, and inspecting them at a defined
frequency to ensure that they are in good

4.11.7.4
condition.

E A
CIP facilities, where used, shall be monitored at a
defined frequency based on risk. This may include:
Spray balls must be monitored to
ensure the on-going effectiveness
of the CIP facilities. The clause has

R
• 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

U
practice.
are in place
• confirming the process is operating correctly (e.g.

B
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

Statement of Intent Comments


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.

Clause Requirement Comments

A S
on significant pathogens or spoilage
organisms.

4.11.8.1

4.11.8.2 Appropriate control or action limits shall be defined


I T
No significant changes to this clause.

Where monitoring results show


for the environmental monitoring programme.
The company shall document the corrective action

E
to be taken when monitored results indicate a
failure to meet a control limit, or when monitored R
an upward trend towards a control
or action limit it is vital that the
site investigates the results before
the control limit or action limit is
exceeded.

V
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

A U
monitoring programme at least annually and
whenever there are:
• changes in processing conditions, process flow or
equipment which could impact the environmental
monitoring plan remains up
to date and relevant, and is
therefore reviewed whenever
there are changes in processing,
new developments in scientific

E
monitoring programme
information or results indicate
• new developments in scientific information (e.g.
that the plan may not be operating
new pathogens of concern)

R
effectively.
• failures of the programme to identify a significant
issue (e.g. regulatory authority tests identifying

U
positive results which the site programme did not)
• product failures (products with positive tests)
• consistently negative results (e.g. a site with a

B 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

Statement of Intent Comments


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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Clause Requirements Comments


4.12.1 No significant changes to this clause.

4.12.2 No significant changes to this clause.

4.12.3 Waste removal from open product areas shall be


managed to ensure that it does not compromise
product safety.
NEW CLAUSE

A S
Clause added to minimise the risk
of product contamination when

T
removing waste from open product

I
areas.

4.12.4 No significant changes to this clause.

4.13 Management of surplus food and products for animal feed

E R
V
Statement of Intent Comments
Effective processes shall be in place to ensure the safety and legality of
by-products of the primary processing activity of the site.

Clause
4.13.1
Requirements

A U Comments
No significant changes to this clause.

E
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.

U R
the prior consent of the brand owner.
Processes shall be in place to ensure that all
products (own-branded and customer-branded)
which are sold to staff or passed on to charities or
Traceability has also been added to
emphasise the importance of being
able to trace products even when
they have been donated or sold to

B
other organisations) are fit for consumption and staff.
meet legal requirements, and that their traceability
is maintained.

4.13.3 No significant changes to this clause.

4.14 Pest management

Statement of Intent Comments


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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Clause Requirement Comments


4.14.1 No significant changes to this clause.

4.14.2 No significant changes to this clause.

4.14.3

4.14.4

A S
No significant changes to this clause.

No significant changes to this clause.

4.14.5

4.14.6
I T
No significant changes to this clause.

No significant changes to this clause.

4.14.7

4.14.8

E R
No significant changes to this clause.

No significant changes to this clause.

4.14.9

V Colour-coding of the requirement


has been changed to dual colouring
(i.e. requirement shall be an audit

U
of production facilities and good
manufacturing practises and records,
systems and documentation).

4.14.10

A
An in-depth, documented pest management

E
assessment shall be undertaken at a frequency
based on risk, but at least annually, by a pest
management expert to review the pest management
Feedback on Issue 8 indicated that
this clause is not well understood.
The clause has therefore been
updated to aid understanding and

U R
measures in place. The survey assessment shall:
• provide include an in-depth inspection of the site,
equipment and facilities for pest activity
• review the existing pest management measures in
application.

B
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.

4.14.11 No significant changes to this clause.

4.14.12 No significant changes to this clause.

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4.15 Storage facilities

Statement of intent Comments


All facilities used for the storage of raw materials, packaging, in-process No significant changes to statement

S
products and finished products shall be suitable for purpose. of intent or requirements in this
section.

4.16 Dispatch and transport

T A
Statement of intent
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
Comments

R I
products.

Clause
4.16.1
Requirements

V E Comments
No significant changes to this clause.

U
4.16.2 No significant changes to this clause.

4.16.3

A
No significant changes to this clause.

4.16.4 No significant changes to this clause.

4.16.5

R E No significant changes to this clause.

B U

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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,

S
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

T A
I
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:

E
• a valid certification to the applicable BRCGS
Standard (e.g. Global Standard Storage and R
V
Distribution) or GFSI-benchmarked standard
or
• a completed contract or terms and conditions. At
a minimum, this shall include all the requirements

U
of clauses 4.16.1 to 4.16.5. This shall have been
reviewed and verified by a demonstrably

A
competent person.

R E
B U

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5 Product control
5.1 Product design/development

Statement of intent Comments


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.
A S
Clause
5.1.1
Requirements Comments

I T
R
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

packaging or microbiological risks).


The company shall have a procedure for new
product development and changes to existing
E
hazards which would be unacceptable to the site or
customers (e.g. the introduction of allergens, glass

V
to existing products, processes
and packaging), to ensure it does
not adversely affect the safety
and legality of either the existing
products or the new products
themselves.

U
product, packaging and manufacturing processes.
Procedures must be in place
This procedure shall include any restrictions
to minimise the risk of product

A
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

R E
the introduction of allergens, glass packaging,
microbiological risks or the introduction of
ingredients that may affect product claims).
has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good
manufacturing practises and records,
systems and documentation).

B U 5.1.2

5.1.3

5.1.4
No significant changes to this clause.

No significant changes to this clause.

No significant changes to this clause.

5.2 Product labelling

Statement of intent Comments


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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Clause Requirements Comments


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,

S
display, storage, preparation and use of the product
within the food supply chain or by the customer.

A
There shall be a process to verify that ingredient and
allergen labelling is correct based on the product

T
recipe and ingredient specifications.

5.2.2
The company shall have a procedure for artwork
approval and sign-off.

R I
No significant changes to this clause.

5.2.3

V E
Where a product is designed to enable a claim to be
made to satisfy a consumer group (e.g. a nutritional
claim, reduced sugar), the company shall ensure that
the product formulation and production process are
fully validated to meet the stated claim.
NEW CLAUSE
Clause 5.2.3 in Issue 8 clause has
been included in clause 5.4.7 in Issue
9 so that the requirements relating
to product claims are in the same

U
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:

A
in Issue 8.
• to enable the label to be accurately created
• whenever a change occurs which may affect the

5.2.4

R E
label information.

Where the label information is the responsibility of


a customer or a nominated third party, the company
shall provide information:
NEW CLAUSE
Issue 9 clause 5.2.4 was clause 5.2.5

U
in Issue 8.
• to enable the label to be accurately created
• whenever a change occurs which may affect the

B 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

Statement of intent Comments


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

A
to reflect terminology commonly
used in allergen management.

Clause
5.3.1
Requirements
The site shall carry out an assessment of raw
Comments

I T
Status changed to profile to aid
materials to establish the presence and likelihood
of contamination (cross-contact) by allergens

E
(see glossary). This shall include a review of the
raw material specifications and, where required, R
further clarity on the requirement to
review raw material specifications.

V
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).

5.3.2

5.3.3

A U
A documented risk assessment shall be carried out
to identify routes of contamination (cross-contact)
No significant changes to this clause.

No significant changes to this clause.

R E
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:

B U • 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).

5.3.4 Colour-coding of the requirement


has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good
manufacturing practises and records,
systems and documentation).

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Clause Requirements Comments


5.3.5 Colour-coding of the requirement
has been changed to dual colouring
(i.e. requirement shall be an audit

S
of production facilities and good
manufacturing practises and records,
systems and documentation).

5.3.6 Where a justified, risk-based assessment


demonstrates that the nature of the production
A
Legislation added because some

T
countries have specific legislative
process is such that cross-contamination (cross-
contact) from an allergen cannot be prevented, a
warning should be included on the label. Legislation,
national guidelines or codes of practice shall be
used when making such a warning statement.
I
requirements relating to allergen
labelling. Where these exist in the

R
country of sale or intended use, the
site is expected to operate systems
that comply with the legislative

5.3.7

V E
Where a claim is made regarding the suitability of
a food for individuals with a food allergy or food
sensitivity (sometimes referred to as a ‘food hyper-
sensitivity’) for allergy or food sensitivity sufferers,
requirements.

Hyper-sensitivity added to provide


further clarification.

A U
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.

5.3.8

R E Colour-coding of the requirement


has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good
manufacturing practises and records,

B U
5.4 Product authenticity, claims and chain of custody

Statement of intent
systems and documentation).

Comments
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

S
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

A
risks, raw materials and knowledge
of the principles/processes of the

T
vulnerability assessment which the

I
team will use to develop a robust
vulnerability assessment plan.

R
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

E
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:


trade associations
government sources V review is likely to provide the site
with a good source of information
that can be used in the vulnerability

U
assessment, hence the last bulletin
• private resource centres
point was added.
• activities completed for clause 1.1.8.

5.4.3

A
A documented vulnerability assessment shall be

E
carried out on all food raw materials or groups of raw
materials to assess the potential risk of adulteration
or substitution. This shall take into account:
This clause was amended to provide
additional clarification on the
requirements. The update provides
situations for when the vulnerability

R
assessment should be reviewed by
• historical evidence of substitution or adulteration
the site.
• economic factors which may make adulteration or

U
substitution more attractive
• ease of access to raw materials through the supply
chain

B • 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

S
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.

T A
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.
R I
5.4.5

E
Where products are labelled or claims are made on

V
finished packs which are dependent on the status
of a raw material, the status of each batch of the raw
material shall be verified. These claims include:
The clause has been updated to
provide additional clarification and
with reference to particular scheme
requirements.

U
• specific provenance or origin
• breed/varietal claims
• assured status (e.g. GLOBALG.A.P.)

E



A
genetically modified organism (GMO) status
identity preserved
named specific trademarked ingredients.
The facility shall maintain purchasing records,

R
traceability of raw material usage and final product
packing records to substantiate claims. The site
shall undertake documented mass balance tests at

B U 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

S
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
The process flow (see clause 2.5.1) for the
production of products where claims are made
consistently met.

T A
processes ensure that claims are

I
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

R
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

Statement of intent
V E Comments

U
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

Clause
5.5.1
E
Requirements
A
When purchasing or specifying primary packaging,
section 5.5.

Comments
To provide additional clarification on

U R
the supplier of packaging materials shall be made
aware of any particular characteristics of the food or
existing packaging (e.g. high fat content, pH, usage
conditions such as microwaving, other packaging
used on the product, use of recyclable or reusable
the requirements, further examples
added to highlight particular
characteristics of the packaging.

B 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.

5.5.2 No significant changes to this clause.

5.5.3 No significant changes to this clause.

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5.6 Product inspection, on-site product testing and laboratory testing analysis
5.6.1 Product inspection and testing

Statement of intent Comments


The company shall undertake or subcontract inspection and analyses
which are critical to confirm product safety, authenticity, legality, integrity
and quality, using appropriate procedures, facilities and standards.
been combined into a single new

A S
Issue 8 sections 5.6.1 and 5.6.2 have

section covering on-site product


testing and laboratory analysis.

T
Therefore several clauses in this

I
section have been updated to
reflect the change. Clause numbers
have also been renumbered in this

E R
section.
The term ‘integrity’ has been
replaced by ‘authenticity’ to ensure
consistent terminology throughout

5.6.1
V
There shall be a scheduled programme of product
the Standard.

In issue 8, this clause was 5.6.1.1.

U
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

A
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

E
be documented.
on the production line were
contaminated during sampling) and

R
to ensure the integrity (and therefore
suitability) of the samples for testing.

U
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.

B The significance of external on-site and


laboratory results shall be understood and acted
upon accordingly. Appropriate actions shall be
implemented promptly to address any unsatisfactory
results or trends.
Where legal limits apply, these shall be understood
The clause has been amended
to highlight the importance of
measurement uncertainty associated
with laboratory test results.

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

S
analysis and, as applicable, microbiological testing
and relevant chemical factors such as pH and aw.
Records and results from shelf-life tests shall verify

5.6.4
the shelf-life period indicated on the product.

Pathogen testing (including pathogens tested as

T A
This clause was 5.6.2.1 in Issue 8.
part of the site's environmental testing monitoring
programme) shall be subcontracted to an external
laboratory or, where conducted internally, the
laboratory facility shall be fully segregated
from the production and storage areas and have
R I
This clause has been amended
to provide further clarity on the
requirement.

5.6.5
contamination. contamination of products or
production areas.

V
Where routine testing laboratories are present
E
operating procedures to prevent any risk of product

on a manufacturing site, they shall be located,


This clause was 5.6.2.2 in Issue 8.

U
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

A
implemented, and include consideration of:
contamination.
• operating procedures to contain laboratory

E
activities, including the design and operation of
drainage and ventilation systems
• access and security of the facility

R
• movement of laboratory personnel
• hygiene and protective clothing arrangements

U
• processes for obtaining product samples
• disposal of laboratory waste.
• movement of materials that may pose a risk to

B 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

S
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

T A
5.6.7
undertaken

Procedures shall be in place to ensure reliability of


laboratory results, other than those critical to safety
and legality specified in clause 5.6.6. 5.6.2.3. These
R I
This clause was 5.6.2.4 in Issue 8.

shall include:

• documented testing procedures

V E
• use of recognised test methods, where available

• ensuring staff are suitably qualified and/or trained


and competent to carry out the analysis required

U
• use of a system to verify the accuracy of test
results (e.g. ring or proficiency testing where
applicable)

5.6.2
E
Laboratory testing
A
• use of appropriately calibrated and maintained
equipment.

Clause

U
5.6.2.1 R Requirements
Pathogen testing (including pathogens tested as part
of the environmental testing) shall be subcontracted
Comments
Refer to the statement of intent in
section 5.6.

B 5.6.2.2
to an external laboratory …

Where routine testing laboratories are present on a


manufacturing site, they shall be located …
Section 5.6.2 and the clauses in the
section have been incorporated into
section 5.6.

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

Statement of intent Comments


The site shall ensure that finished product is not released unless all No significant changes to statement

S
agreed procedures have been followed. of intent or requirements in this
section.

5.8 Pet food and animal feed

T A
Statement of intent
The site shall ensure that pet food and animal feed products are safe and
fit for intended use. I
Comments

R
Animal feed product added to
statement. Several clauses in this
section have therefore been updated

Clause
5.8.1
Requirements

V E
The site shall ensure that pet food and animal feed
to reflect the change made to the
statement.

Comments

U
is formulated/designed for the intended use (e.g.
where products are designed for complete diet or as

A
a complementary product).

5.8.2 Where a site’s product range includes pet food or Colour-coding of the requirement

E
animal feed products for different animal species,
the site shall have specific procedures for the

R
management of any ingredients, raw materials,
products or rework that could be harmful to
unintended recipients.
has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good
manufacturing practises and records,
systems and documentation).

B U

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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

S
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
• identification of medication-containing materials
handled on site. These can be raw materials,
contamination.

T A
I
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

medicated materials

E
• specific staff training on the correct handling of

• mechanisms to ensure the correct concentrations


R
V
of medicinal substances in finished products
• procedures (e.g. cleaning procedures) to prevent
contamination of non-medicated pet food or

U
animal feed with materials containing medicinal
substances
• specific procedures to ensure the correct labelling

E A
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

U R Site procedures shall be designed and implemented


to meet the relevant pet food and animal feed
product safety legislation (both in the country of
production and in the country of sale).
NEW CLAUSE
Some countries have specific
legislative requirements relating to
pet food and animal feed. Where

B
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

Statement of intent Comments


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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Clause Requirements Comments
5.9.1 The company shall undertake a risk assessment NEW CLAUSE
for potential prohibited substances (i.e. those

S
Some countries have specific
prohibited by legislation in the country of operation
legislative requirements relating
or intended country of sale). Example substances

A
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
clause 3.5.1.1 or as a separate activity.
The results of the risk assessment shall be included T
to operate systems that comply

I
with the legislative requirements.
Therefore, sites are required to

R
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.

E
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

V supplier approval and monitoring


processes, so that any identified risks
are managed within the supply chain.

5.9.2

U
Where the site is in receipt of live animals, there

A
shall be an inspection by a suitably competent
individual at lairage and post-mortem to ensure that
the animals are fit for human consumption.
In Issue 8 this clause was 3.5.2.3.
Clause has been moved to this
section as it refers to animal primary

E
conversion.

5.9.3 The site shall operate procedures to ensure that the NEW CLAUSE

U R
traceability of all edible parts of the carcass (i.e. all
parts that are intended for the human food supply
chain) is maintained.
Traceability is an important for safety
and legality requirements for all
food products, ingredients and raw
materials, including all edible parts

B
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

Statement of intent
The site shall operate to process procedures specifications and/or work
Comments

A
Process specifications, workS
T
instructions/procedures that ensure the production of consistently instructions and procedures are all

I
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

R
the site food safety plan.

Clause Requirements Comments


6.1.1 Documented process specifications and work

V E
instructions/procedures shall be available for the
key processes in the production of products to
ensure product safety, legality and quality. The
process specifications and work instructions
Colour-coding of the requirement
has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good
manufacturing practises and records,

include:

A U
specifications/procedures (as appropriate) shall

recipes – including identification of any allergens


mixing instructions, speed, time
systems and documentation).
The clause reflects the importance
of ensuring process specifications
and work instructions/procedures

R E •




equipment process settings
cooking times and temperatures
cooling times and temperatures
labelling instructions
coding and shelf-life marking
are updated prior to any changes
to ensure everyone works to the
correct, and most up to date version.

U
• storage conditions (e.g. storage temperatures)
• any additional critical control points identified in

B
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.

6.1.2 No significant changes to this clause.

6.1.3 No significant changes to this clause.

6.1.4 No significant changes to this clause.

6.1.5 No significant changes to this clause.

6.1.6 No significant changes to this clause.

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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

S
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.

A
materials handled on site, even when
these are outside the scope of the

T
audit.

6.2 Labelling and pack control

Fundamental
R I
Statement of intent

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

U
Clause Requirements Comments
6.2.1 There shall be a formal process for the allocation A reconciliation check has been

E A
of packaging materials to packing lines and control
in the packing area which ensures that only the
packaging for immediate use is available to the
packing machines.
added to the clause to ensure that
any inconsistencies or unexpected
results can be investigated in a
timely manner.

R
Where offline coding or printing of packaging
materials occurs:

U
• 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

B 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

S
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
production have been removed from the line before
changing to the next production.
changeover.

T A
6.2.3 Procedures shall be in place to ensure that all
products are packed into the correct packaging and
correctly labelled. These shall include checks:

R I
Examples have been added to
the clause to provide additional
clarification on the requirements.

E
• 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)

V
• when changing batches of packaging materials at
the end of each production run.

appropriate:
• date coding

A U
The checks shall also include verification of any
printing carried out at the packing stage including, as

E
• batch coding
• quantity indication
• pricing information

U
6.2.4
R •


bar coding
country of origin
allergen information.

No significant changes to this clause.

B
6.3 Quantity – weight, volume and number control

Statement of intent Comments


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.

Clause Requirements Comments


6.3.1 No significant changes to this clause.

6.3.2 No significant changes to this clause.

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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

S
the product-flow.
• consideration of any legal requirements
• responsibilities for testing the equipment

A
• operating effectiveness and any variations for
particular products

T
• methods and frequency of testing the check

I
weighers
• processes for handling rejected packs
• records of the test results.

6.4 Calibration and control of measuring and monitoring devices

Statement of intent
E R
Comments

V
The site shall be able to demonstrate that measuring equipment is
sufficiently accurate and reliable to provide confidence in measurement
No significant changes to statement
of intent or requirements in this

U
results. section.

E A
U R
B

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7 Personnel
7.1 Training: raw material-handling, preparation, processing, packing and storage areas

Fundamental

Statement of intent
The company shall ensure that all personnel performing work that affects
Comments

A S
T
product safety, legality and quality are demonstrably competent to carry

I
out their activity, through training, work experience or qualification.

Clause Requirements Comments


7.1.1 All relevant personnel, including agency-supplied
staff, temporary staff and contractors, shall be

E
appropriately trained prior to commencing work
and adequately supervised throughout the working
R
In accordance with the statement of
intent, the clause has been amended
to highlight that the requirement
applies to all personnel on site.

V
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

7.1.2
A U to assess the amount, type and level
of training needed for each specific
role.

E
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

U R 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.

B 7.1.3

7.1.4
No significant changes to this clause.

Colour-coding of the requirement


has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good
manufacturing practises and records,
systems and documentation).

7.1.5 Colour-coding of the requirement


has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good
manufacturing practises and records,
systems and documentation).

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Clause Requirements Comments


7.1.6 No significant changes to this clause.

7.1.7 No significant changes to this clause.

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


storage areas

A S
Statement of intent
The site’s personal hygiene standards shall be developed to minimise
Comments

I T
R
the risk of product contamination from personnel, be appropriate to the
products produced and be adopted by all personnel, including agency-

E
supplied staff, contractors and visitors to the production facility.

Clause Requirements Comments


7.2.1

V
The requirements for personal hygiene shall be
documented and communicated to all personnel.
These shall include, at a minimum, the following:
This clause has been amended
to provide additional clarification
on the requirements for personal

worn

A U
• watches and similar wearable devices shall not be

• jewellery shall not be worn, with the exception of


a single, plain wedding ring, wedding wristband or
hygiene.

R E
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

U
• false fingernails and nail art shall not be permitted
• excessive perfume or aftershave shall not be worn.

B
Compliance with the requirements shall be checked
routinely.

7.2.2 No significant changes to this clause.

7.2.3 No significant changes to this clause.

7.2.4 No significant changes to this clause.

7.2.5 No significant changes to this clause.

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7.3 Medical screening

Statement of intent Comments


The company shall have procedures in place to ensure that employee, The statement has been updated

S
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

Clause Requirements
product at risk.

T
Comments
A
7.3.1 The site shall make staff aware of the symptoms of
infection, disease or condition which would prevent
a person working with open food. The site shall
have a procedure which enables notification by
I
Clause has been amended to
highlight that the requirement also

R
applies to contractors and visitors to
the site.

E
employees, staff (including temporary employees),
contractors and visitors to the site, of any relevant
symptoms, infection, disease or condition with

V
which they may have been in contact with or may be
suffering from.

U
7.3.2 No significant changes to this clause.

7.3.3

A
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

R E may be suffering from or have been in contact with


an infectious disease. Expert medical advice shall be
sought where required.
personnel.

U
7.4 Protective clothing: employees, staff or visitors to production areas

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

Clause Requirements Comments


7.4.1 No significant changes to this clause.

7.4.2 No significant changes to this clause.

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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.

S
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

T A
I
• 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

E
is exceptional but shall be acceptable where the
protective clothing is to protect the employee from R
V
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

U
safety purposes, for example, it is used to protect
the employee from the products handled
and

7.4.4

E A
• the protective clothing is worn in enclosed
product or low-risk areas only.

No significant changes to this clause.

7.4.5

U
7.4.6
R No significant changes to this clause.

No significant changes to this clause.

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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

Statement of intent
The site shall be able to demonstrate that production facilities and
Comments

A S
controls are suitable to prevent pathogen contamination of products.

Clause Requirements

I T
Comments
8.1.1 The map of the site (see clause 4.3.1) shall include
areas (zones) where the product is at different levels

• high-risk areas

E
of risk from contamination. The map shall show:
R
Several of the requirements from
Issue 8, section 8, have to moved
to section 4.3. This clause has been
updated to link with the site map in
clause 4.3.2.

V
• 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

U
non-product areas.
See Appendix 2 for guidelines on defining the

A
production risk zones.
of production facilities and good
manufacturing practises and records,
systems and documentation).

E
This zoning shall be taken into account when
determining the prerequisite programmes for the
particular areas of the site.

U 8.1.2 R The map of the site (see clause 4.3.2) shall include
the location of the pathogen control step(s).

Where high-risk areas are part of the manufacturing This clause was updated because it

B
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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Clause Requirements Comments


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

S
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

A
Colour-coding of the requirement
disposal of waste, the flow of air, the air quality and
has been changed to dual colouring
the provision of utilities (including drains).

T
(i.e. requirement shall be an audit

I
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.

E R
8.1.4

8.2 Building fabric in high-risk and high-care zones V No significant changes to this clause.

Clause
8.2.1
Requirements

A U Comments
No significant changes to this clause.

8.2.2

8.2.3

R E
Where sites include removable walls as part of
the design of the high-risk or high-care area (e.g.
No significant changes to this clause.

NEW CLAUSE
Where removable walls are used

U
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

B
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

Clause Requirements Comments


8.3.1 Maintenance activities undertaken in high-risk Clause reworded to clarify the

S
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

8.3.2
area and retained in the same there.

T A
No significant changes to this clause.

8.3.3 Where portable equipment (e.g. handheld devices)


and battery-charging equipment is used in high-risk
or high-care areas, these items shall either:

R I
The use or transportation of battery
charging equipment has been added
to the clause.

E
• be visually distinctive and dedicated for use in
that area, or
• have specific procedures (e.g. a full clean)

V
to ensure that their use does not result in
contamination.

A U
R E
B U

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8.4 Staff facilities for high-risk and high-care zones

Clause Requirements Comments


8.4.1 Where an operation includes a high-risk or high- Clause reformatted to provide clarity

S
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

T A
I
and out of dedicated protective clothes to prevent
the contamination of clean clothing
• protective clothing that is visually distinct from

R
that worn in other areas and which shall not be
worn outside the area

E
• a hand-washing routine during the changing
procedure to prevent contamination of the clean
clothing (i.e. hand-washing after hair covering and

clean protective clothing)


• provision and use of hand-washing and
V
footwear have been put on, but before handling

U
disinfection facilities that shall, as . At a minimum
these shall be situated:
• prior to entry for high-risk areas

E A
• 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

U R 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

B
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

Clause Requirements Comments


8.5.1 Environmental cleaning procedures in high-care/ The bullet points removed from this

S
high-risk areas shall, at a minimum, include: clause are included in clause 4.11.2.
• responsibility for cleaning Colour-coding of the requirement

A
• 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
• cleaning chemicals and concentrations
• cleaning materials to be used
I T
manufacturing practises and records,
systems and documentation).

R
• cleaning records and responsibility for verification.
The frequency and methods of cleaning shall

E
be based on risk, and the procedures shall be
implemented to ensure that appropriate standards

V
of cleaning are achieved.
Environmental cleaning procedures in high-
care/high-risk areas shall consider the different
microbiological risks associated with each

U
production risk zone.

A
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

8.5.2
R E cleaning shall be based on risk, and the procedures
shall be implemented to ensure that appropriate
standards of cleaning are achieved.

Microbiological limits for acceptable and “Allergen testing” has been removed

B U unacceptable cleaning performance shall be defined


for high-risk/high-care production risk zones.
These limits shall be based on the potential
hazards relevant to the product or processing
area. Therefore, acceptable levels of cleaning shall
be defined, for example, by visual appearance,
from the clause as section 8 focuses
on pathogen control rather than
allergen management.
Allergen management is covered in
sections 5.3 and 4.11.

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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Clause Requirements Comments


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

S
therefore been amended to include
area
requirements for cleaning equipment
• hygienically designed and fit for purpose
(i.e. to be hygienically designed,

A
• cleaned and stored in a hygienic manner to
clean and stored appropriately).
prevent contamination (for example, storing

T
equipment in designated locations, off the floor,

I
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
for high-risk, high-care and other production areas)

E
or the CIP system shall be designed and controlled
so that it does not present a risk of contamination
to the high-risk/high-care area (i.e. controlling
R
CIP equipment must not transfer
contamination from the lower risk
areas to the higher risk areas and
either separate systems or robust

V
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

Clause Requirements
A U
Waste/waste disposal in high-risk, high-care zones.

Comments
8.6.1

R E Colour-coding of the requirement


has been changed to dual colouring
(i.e. requirement shall be an audit
of production facilities and good

U
manufacturing practises and records,
systems and documentation).

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

Clause Requirements Comments


8.7.1 Laundering of protective clothing for high-risk Clause reformatted to clarify the

S
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

T A
clothes
• adequate segregation between clothes for high-
risk, high-care and low-risk areas etc.
• effective cleaning of the protective clothing

R I
E
• commercial sterilisation of the protective clothing
following the washing and drying process
• protection of the cleaned clothes from

8.7.2
or bags).

V
contamination until use. (e.g. by the use of covers

U
No significant changes to this clause.

8.7.3 No significant changes to this clause.

E A
U R
B

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9 Requirements for traded products


9.1 The food safety plan – HACCP

Statement of intent Comments


The site shall operate a HACCP or food safety plan for the processes for
which it is responsible.
NEW SECTION

A S
All operations must be considered as
part of a HACCP or food safety plan

T
to ensure all hazards are identified

I
and risks from products and
processes are correctly managed.

Clause
9.1.1
Requirements
The company shall either:

E
• have a HACCP or food safety plan specifically for R
Comments
NEW CLAUSE
Clause added to reflect the

V
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

U
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.

9.2 A
shall include goods receipt, storage and dispatch.

E
Approval and performance monitoring of manufacturers/packers of traded food
products

U
Statement of intent
R
The company shall operate procedures for approval of the last
Comments
Clause numbers have been

B
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

S
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

T A
I
• 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

E
• the brand identity of products (i.e. customer own
brand or branded product).
R
9.2.2

V
The company shall have a procedure for the initial
and ongoing approval of manufacturers of products.

U
This approval procedure shall be based on risk and
include either one or a combination of:

A
• a valid certification to the applicable BRCGS
Standard or GFSI-benchmarked standard. The
scope of the certification shall include the

R E
products purchased
• supplier audits, with a scope to include product
safety, traceability, HACCP review and good
manufacturing practices, undertaken by an
experienced and demonstrably competent

B U product safety auditor. Where this 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, 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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Clause Requirements Comments


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

S
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.

T A
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
R I
V E
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

U
changes in the interim, including any change in
certification status.

A
Records of the review shall be kept.

9.3 Specifications

Statement of intent

R E
Specifications or information to meet legal requirements and assist
Comments
Clause numbers have been

B U
customers in the safe usage of the product shall be maintained and
available to customers.

Clause
9.3.1
Requirements
Specifications shall be available for all products.
These shall either be in the agreed format
renumbered in the section to reflect
change.

Comments

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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Clause Requirements Comments


9.3.2 The company shall seek formal agreement of
the specifications with relevant parties. Where
specifications are not formally agreed, the company

S
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

T A
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).

R I
9.3.4

suppliers, regulations and other risks.


Reviews and changes shall be documented.
V E
Specification review shall be sufficiently frequent
to ensure that data is current or at a minimum
every 3 years, taking into account product changes,

9.4

Statement of intent
A U
Product inspection and laboratory testing

Comments

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

U
Clause Requirements Comments
9.4.1 The site shall have a product sampling or assurance

B 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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Clause Requirements Comments


9.4.3 Where claims are made about the products being
handled, including the provenance, chain of
custody and assured or ‘identity preserved’ status

S
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


analyses which are critical to product safety or
Clause updated to include IEC

T A
(International Electrotechnical
legality, the laboratory or subcontractors shall
have gained recognised laboratory accreditation
or operate in accordance with the requirements
and principles of ISO/IEC 17025. Documented
justification shall be available where non-accredited
I
Commission) principles and
requirements.

R
9.4.5
test methods are used.

V E
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

A U
E
Statement of intent Comments
The company shall have processes in place to ensure that the food Clause numbers have been

where known.

U
Clause R
products traded comply with the legal requirements in the country of sale

Requirements
renumbered in the section to reflect
change.

Comments

B
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

Statement of intent Comments


The company shall be able to trace all product lots back to the last As per previous comment for reason

S
manufacturer and forward to the customer of the company. for clause renumbering.

Clause Requirements Comments


9.6.1 The site shall maintain a traceability system for
all batches of product which identify the last
A
Clause has been amended to include

T
details of the traceability system

I
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.

E
The traceability system shall ensure that, for all
R
V
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

U
change to the product.
Records shall also be maintained to identify

A
the recipient of each batch of product from the
company.

9.6.2

R E 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

B U
9.6.3
movement of the product through the chain from
the manufacturer to receipt by the company (e.g.
each movement and intermediate place of storage).

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).

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Food
Safety

A S
I T
ER
V
A U
R E
B U
BRCGS
Floor 2
7 Harp Lane
London EC3R 6DP

T: +44 (0)20 3931 8150


E: enquiries@brcgs.com

To learn more about the BRCGS certification programme please visit


brcgs.com

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certificated sites, please visit brcgsparticipate.com

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