December 2020 1
The safety and shelf-life of
vacuum and modified
atmosphere packed
chilled foods with respect
to non-proteolytic
Clostridium botulinum
Published: December 2020
Last reviewed: December 2020
December 2020 2
Purpose
These guidance notes have been produced to provide non-binding recommendations
on how to produce vacuum and modified atmosphere packaged chilled foods safely to
achieve compliance with Article 5 of Regulation (EC) No 852/2004.
Legal status
This guidance provides best practice information on how to produce vacuum and
modified atmosphere packaged chilled foods safely to achieve compliance with Article
5 of Regulation (EC) No 852/2004.
Who is this publication for?
• Manufacturers and retailers of chilled vacuum and modified atmosphere packed
(VP/MAP) foods and to assist in the practical development of HACCP (Hazard
Analysis Critical Control Point) procedures for these foods.
• Food Law Enforcement Officers.
Which UK countries does this guidance apply to?
The whole UK
Review date
We will review this guidance before June 2022.
Key words
• Hygiene and food safety,
• Food law, monitoring and controls
December 2020 3
Revision history
Revision No.
Revision date
Purpose of revision
Revised by
1
July 2008
Guidance – First date of
publication
Kathryn Callaghan
2
January 2017
Clarification and updated
legal references
Nick Laverty, Chris
Rowswell, Kirsten Stone,
Jo Edge & Antonis
Ampatzoglou
3
June 2017
Update to Q and A
Chris Rowswell
4
December 2020
Guidance revised to
exclude VP/MAP chilled
fresh beef, lamb and pork
only from the scope of the
guidance (the section on
‘VP/MAP Chilled fresh
beef, lamb and pork’
refers). Guidance
template also updated for
accessibility.
Alistair Edwards, Mary
McGlinchey
December 2020 4
Contents
Introduction ................................................................................................................... 5
Intended audience ........................................................................................................ 6
Purpose of the guidance ............................................................................................... 6
Legal status of guidance ............................................................................................... 8
VP/MAP Chilled fresh beef, lamb and pork .................................................................. 9
Non-proteolytic C. botulinum and foodborne botulism ................................................ 10
Risks from other pathogens ........................................................................................ 10
Factors controlling growth and toxin production by non-proteolytic C. botulinum in
chilled foods................................................................................................................ 11
Determining the shelf-life of VP/MAP products stored at 3-8°C .................................. 12
Background information on the specific controlling factors for chilled VP/MAP foods in
which a shelf-life of longer than 10 days is indicated .................................................. 14
Heat treatment ............................................................................................................ 17
Acidity of the food ....................................................................................................... 17
Sodium chloride (NaCl) content .................................................................................. 18
Water activity (a
w
) ...................................................................................................... 19
Other controlling factors ............................................................................................. 19
The uses and limitations of predictive growth models ................................................ 20
Challenge Testing ....................................................................................................... 20
Practice of re-wrapping VP/MAP foods ...................................................................... 21
Frequently asked questions ........................................................................................ 22
Further advice ............................................................................................................. 36
Glossary
...................................................................................................................... 37
Review date ................................................................................................................ 39
Contact us .................................................................................................................. 39
December 2020 5
Introduction
1.
This guidance is applicable to all raw and ready-to-eat vacuum packed (VP) or
modified atmosphere packed (MAP) chilled foods, except for fresh beef, lamb and
pork, and provides advice on how to produce these foods safely.
2.
This guidance provides best practice advice on vacuum packed and modified
atmosphere packed (VP/MAP) chilled foods irrespective of the distribution channel, in
relation to microbiological safety and shelf-life limitations associated with control of
non-proteolytic (psychrotrophic) Clostridium botulinum.
3.
The bacterium Clostridium botulinum is able to grow and produce a harmful toxin in
the absence of oxygen. It is important that vacuum-packed chilled foods have the
necessary controlling factors or hurdles in place to minimise the risk of growth and
toxin production by this organism,
throughout the shelf-life of the product.
4.
The guidance explains the 10 day shelf-life rule and the requirement for additional
controlling factors, where the shelf-life is greater than 10 days.
5.
The guidance has been revised in December 2020 to no longer apply to VP/MAP
chilled fresh beef, lamb and pork only, as described in the section Chilled fresh beef,
lamb and pork. The guidance explains that if a food business chooses to apply the
guidance for chilled fresh beef, lamb and pork a 13 day maximum shelf-life may be
applied.
6.
The process of vacuum packaging removes air and prevents its return by an airtight
seal surrounding the food within the packaging material. With modified atmosphere
or “gas” packaging, air is replaced by a strictly controlled mixture of gases usually
chosen from carbon dioxide, oxygen and nitrogen. There are various methods
available which are described in detail in the Industry Code of Practice for the
Manufacture of Vacuum and Modified Atmosphere Packaged Chilled Foods.
7.
Although VP/MAP techniques can increase the shelf-life of chilled foods by limiting
the growth of microorganisms causing food spoilage, under certain circumstances
a bacterium called non-proteolytic C. botulinum may grow in the absence of
oxygen. Non-proteolytic C. botulinum is able to grow and produce a harmful toxin
December 2020 6
at temperatures of 3°C and above. It is important that VP/MAP chilled foods have
appropriate controls in place to minimise the risk of this organism growing and
producing harmful levels of toxin, throughout the shelf-life of the product.
8.
Although non-proteolytic C. botulinum food poisoning is very rare in the UK, its very
serious nature (see below) means that any business engaged in producing
VP/MAP foods must understand the risks associated with it and take steps to
appropriately manage it. It is essential that all critical control points are identified
and controlled at all times.
Intended audience
9.
The guidance is recommended for use by manufacturers and retailers of chilled
VP/MAP foods (raw & ready-to-eat), and to assist in the practical development of
HACCP (hazard analysis and critical control points) for these foods
1
.
10.
The guidance is designed to meet the needs of all levels of expertise, from technical
managers in large enterprises to small businesses and individuals. The guidance is
also designed to help Food Law Enforcement Officers carry out their enforcement
duties.
Purpose of the guidance
11.
These guidance notes have been produced to provide non-binding recommendations
on how to produce VP/MAP chilled foods safely to achieve compliance with Article 5
of Regulation (EC) No 852/2004. Although the UK left the EU on 31 January 2020, EU
food law, including Regulation (EC) No 852/2004, continues to apply in the UK. On 31
December 2020, EU food law, including Regulation (EC) No 852/2004, will become
UK law. These guidance notes are unaffected by the change in the source of food law.
12.
Note: where FBOs use additives as controlling factors to limit the growth of pathogens,
they must comply with Regulation (EC) No 1333/2008. FBOs must also comply with
1
Article 5 of Regulation EC 852/2004 on the hygiene of foodstuffs
December 2020 7
Regulation (EC) No 2073/2005 which sets microbiological criteria for foodstuffs.
13.
Businesses with specific queries may wish to seek the advice of their local
enforcement agency, which will usually be the environmental health department of
the local authority or the Food Standards Agency if the establishment is approved by
the FSA or Food Standards Scotland if the establishment is approved by FSS.
14.
The guidance summarises the advice of the Advisory Committee on the
Microbiological Safety of Food (ACMSF) Report on Vacuum Packaging and
Associated Processes
2
, the Industry Code of Practice for the Manufacture of
Vacuum
and Modified Atmosphere Packaged Chilled Foods
3
and the recommendations
found in the ACMSF 2006 Report
4
. The ACMSF recommended a maximum 10-day
shelf-life for vacuum and modified atmosphere packed foods stored at
temperatures between 3°C and 8°C when other specified controlling factors could
not be identified.
15.
An ACMSF subgroup report on C. botulinum published in February 2020
recommended a maximum 13 day shelf-life for VP/MAP chilled fresh beef, lamb and
pork. Additional considerations have also been taken into account in the guidance.
16.
The microbiological safety concerns summarised here are focussed on the control of
non-proteolytic Clostridium botulinum, which is able to grow and produce toxin at
3°C and above. Foods stored at less than 3°C are outside the scope of this
guidance.
17.
However, food business operators (FBOs) must still take into account other hazards
that may be associated with their products, in particular Listeria monocytogenes,
2
Advisory Committee on the Microbiological Safety of Food. Report on Vacuum
Packaging and Associated Processes; 1992. HMSO, London
3
Campden and Chorleywood Food Research Association. Guideline No 11: A Code
of Practice for the Manufacture of Vacuum and Modified Atmosphere Packaged
Chilled Foods; May 1996
4
ACMSF Annual Report 2006 published by FSA August 2007, FSA/1191/0807
December 2020 8
which is capable of growing at temperatures below 0°C and controls for which should
be included in HACCP based procedures, as well as taken into consideration when
setting shelf-life.
Legal status of guidance
18.
This guidance provides best practice recommendations on how to produce vacuum
and modified atmosphere packaged chilled foods safely. to achieve compliance with
Article 5 of Regulation (EC) No 852/2004.
Important - EU references in FSA/FSS guidance documents are relevant during
the transition period.
19.
The UK exited the EU on 31 January 2020. There is now a transition period until the
end of 2020 while the UK and EU negotiate additional arrangements. EU law
continues to apply in the UK during the transition period, including rules on food and
feed. This means references in this guidance to EU regulations (as amended) and any
related EU guidance material remain relevant.
20.
From 1 January 2021, other than in Northern Ireland, any references to EU
Regulations should be read as meaning retained EU law. You can access retained EU
law via HM Government EU Exit Web Archive. This should be read alongside any EU
Exit legislation that was made to ensure retained EU law operates correctly in a UK
context. EU Exit legislation is on legislation.gov.uk. In Northern Ireland, EU law will
continue to apply in respect to the majority of food and feed hygiene and safety law,
as listed in the Northern Ireland Protocol, and retained EU law will not apply to
Northern Ireland in these circumstances.
21.
When we publish new and amended guidance after the transition period, we will aim to
ensure that cross-references are updated to accurately reflect the law which is then in
force.
December 2020 9
VP/MAP Chilled fresh beef, lamb and pork
22.
This guidance on C. botulinum does not apply to VP/MAP chilled fresh beef, lamb and
pork, which is without added ingredients or further processing beyond cutting, packing,
chilling, freezing and quick-freezing.
23.
However, this guidance does apply to any beef, lamb or pork that is further processed
such as minced, cooked or mixed with any other ingredients such as herbs, spices or
curing salts. The guidance applies to these and to any other VP/MAP chilled foods.
24.
FBOs producing the specific VP/MAP chilled fresh beef, lamb and pork which is
outside the scope of this guidance will be responsible for identifying and applying a
safe shelf-life in relation to non-proteolytic C. botulinum in line with their existing food
safety management systems, in the same way they do for other types of food
5
.
25.
It is recognised that small and medium sized food businesses may not have resources
and expertise for identifying a suitable shelf-life for specific VP/MAP chilled fresh beef,
lamb and pork that are outside the scope of this guidance. Therefore, FBOs, including
small and medium sized food businesses, may choose to apply the guidance to their
VP/MAP chilled fresh beef, lamb and pork that are outside the scope of this guidance.
In these circumstances FBOs which are maintaining good hygiene practice may
choose to apply up to a maximum 13 day shelf-life for their VP/MAP chilled fresh beef,
lamb and pork in relation to C. botulinum, without further verification or validation of
the 13-day shelf-life for C. botulinum. FBOs choosing to rely on this guidance as the
basis for applying a 13-day shelf-life for these products should follow this guidance in
the same manner as it applies to 10 days. The ACMSF on 30 January 2020 endorsed
5
Examples of industry guides that FBOs may use include: the “Guidelines for Setting
Shelf life of Chilled Foods in relation to non-proteolytic Clostridium botulinum” issued
by Chilled Food Association/Quadram Institute/Leatherhead Food Research/Meat &
Livestock Australia/British Retail Consortium in 2018, and “Shelf Life of MAP and VP
Raw Meat Products in Relation to non-proteolytic Clostridium botulinum” issued by
BRC Global Standards in 2018.
December 2020 10
a recommendation of its subgroup’s report on C. botulinum that a 13 day maximum
shelf-life may be applied for VP/MAP chilled fresh beef, lamb and pork. The shelf-life
should not be restarted if the VP/MAP chilled fresh beef, lamb and pork is subject to a
further re-wrapping under vacuum or modified atmosphere, unless appropriate
controls are applied as set out in this guidance.
Non-proteolytic C. botulinum and foodborne
botulism
26.
Non-proteolytic C. botulinum is a spore-forming anaerobic bacterium. This
bacterium produces a very powerful toxin in food that causes the serious illness
botulism, a potentially fatal form of food poisoning. Botulinum toxin is the most potent
biological toxin known. The spores are widely distributed in the environment, and
may also be present in food. In a favourable environment spores may germinate
leading to toxin formation.
27.
Outbreaks of foodborne botulism have been associated with foods sealed in air-tight
containers including VP/MAP foods (e.g. smoked fish). It is important to note that
the presence of air, or a similar oxygen-containing atmosphere, cannot be relied
upon to prevent growth and toxin formation by non-proteolytic C. botulinum. Such
foods can contain oxygen free areas that will allow C. botulinum to grow and form
toxin.
Risks from other pathogens
28.
This guidance is focussed on the risk from non-proteolytic C. botulinum and the
additional controlling factors that can be used to extend the shelf-life to greater than
10 days are specific for this organism. However, FBOs must still take into account all
other relevant hazards that may be associated with their products. This is particularly
important for Listeria monocytogenes, which is also capable of growing under VP/MAP
conditions and at refrigeration temperatures, whilst other hazards might not be able
grow but may survive in the food. Therefore, other hazards, such as L.
monocytogenes, should be included in the HACCP based procedures, as well as
taken into consideration when setting shelf-life.
Links to shelf-life guidance that is available specifically for L. monocytogenes in ready-
December 2020 11
to-eat foods can be found below:
• Guidance document on L. monocytogenes shelf-life studies for ready-to-eat
foods
• FSA’s ‘General guidance for FBOs on Regulation 2073/2005’
• CFA and BRC guidance on ‘Shelf-life of ready-to-eat food in relation to L.
monocytogenes – guidance for food business operators (2010)’:
For advice on avoiding cross contamination when using vacuum packing machinery:
• FSA’s Guidance for food businesses to clarify the steps that they need to take
to control the risk of food becoming contaminated by E. coli O157
Factors controlling growth and toxin production by
non-proteolytic C. botulinum in chilled foods
29.
It is the FBO’s responsibility to ensure that the shelf-life they set is appropriate and
that the safety of the food at the end of shelf-life can be demonstrated. FBOs may
wish to consult experts (e.g. research organisations) on how to establish and validate
the shelf-life and demonstrate the safety of their products with regards to non-
proteolytic C. botulinum, using appropriate methodology (e.g. modelling, challenge
testing and other appropriate means of validation).
30.
The ACMSF recommended that in addition to chill temperatures (3-8°C) which
should be maintained throughout the food chain, the following controlling factors
should be used singly or in combination to prevent growth and toxin production by
non-proteolytic C. botulinum in chilled foods with a shelf-life of
more than 10 days:
• a heat treatment of 90°C for 10 minutes or equivalent lethality at the slowest
heating point in the food
6
• a pH of 5.0 or less throughout the food and throughout all components of
6
shortened at points in this guidance to heat treatment of 90°C for 10 minutes, but this
should always be the slowest heating point of the food.
December 2020 12
complex foods
• a minimum salt level of 3.5% in the aqueous phase throughout the food and
throughout all components of complex foods
• a water activity (a
w)
of 0.97 or less throughout the food and throughout all
components of complex foods
• a combination of heat and preservative factors which can be shown
consistently to prevent growth and toxin production by non-proteolytic C.
botulinum
31.
The following decision tree should be used by the FBO to
determine if the risk of C.
botulinum in the product they produce is effectively controlled where the shelf-life is
greater than 10 days:
Determining the shelf-life of VP/MAP products stored at 3-
8°C
Q. Is the final product given a heat treatment of 90°C for 10 mins or equivalent at
the slowest heating point?
If Yes
Did the product receive this heat treatment in the sealed final pack?
Yes - Can apply shelf-life greater than 10 days at 8°C maximum.
No - Is wrapping done under strict hygienic conditions that effectively address the risk
of cross-contamination with spores of non-proteolytic C. botulinum?
• Yes - Can apply shelf-life greater than 10 days at 8°C maximum.
• No - Restrict shelf-life to 10 days or less at 8°C maximum.
If No
Is control achieved by other controlling factors?
Yes – Does a single controlling factor comply with ACMSF guidance or has the
combination of controlling factors been demonstrated to control non-proteolytic C.
botulinum? (e.g. via modelling, challenge testing and other appropriate means of
December 2020 13
validation)
• Yes – Can apply shelf-life greater than 10 days at 8°C maximum – FBO must
be able to demonstrate that the food is safe until the end of shelf-life allocated
• No - Restrict shelf-life to 10 days or less at 8°C maximum.
No – Restrict shelf-life to 10 days or less at 8°C maximum.
Controlling Factors in Addition to Chilled Storage
• Heat treatment
• Acidity of food
• Sodium chloride (salt content)
• Water activity
• Combination of controlling factors including the above and preservatives e.g.
nitrite (see paragraph 40)
Re-Wrapping
If a VP/MAP product is unwrapped e.g. for slicing or portioning, and then re-wrapped
(in VP/MAP), the shelf-life given to the re-wrapped product must not exceed the shelf-
life given to the original product. Where the (VP/MAP) re-wrapped shelf-life is to be
greater than 10 days then this must be justified with respect to controlling factors to
prevent growth of non-proteolytic C. botulinum and toxin production. (see paragraphs
44 and 45)
VP/MAP Ingredients
Where VP/MAP food or ingredients are used in another product the life of the final
product shall not exceed that of the original lives given to the ingredients. However, if
the VP/MAP food or ingredient is given a further processing treatment to destroy
vegetative cells, e.g. heating 70°C for 2 minutes or equivalent effect, the shelf-lives do
not need to be incorporated into that of the final product providing the HACCP plan
demonstrates that it remains safe for human consumption.
December 2020 14
Background information on the specific controlling
factors for chilled VP/MAP foods in which a shelf-life
of longer than 10 days is indicated
32.
Since spores of non-proteolytic C. botulinum are widely distributed in the
environment, it should be assumed that any ingredient/food might be contaminated.
It is on this basis that specific recommendations for shelf-life of VP/MAP foods are
made.
33.
The controlling factors indicated in paragraph 30, should be used singly or in
combination to prevent growth and toxin production by non-proteolytic C. botulinum in
chilled foods with a shelf-life of greater than 10 days. The shelf-life will begin as
soon as the controlling factor(s) have been first applied.
December 2020 15
Table 1: Equivalent time/temperature combinations for spores of non-
proteolytic C. botulinum 6, 7
Temperature (°C)
Time (mins)
80
129.0
81
100.0
82
77.0
83
60.0
84
46.0
85
36.0
86
28.0
87
22.0
88
17.0
89
13.0
90
10.0
91
7.9
6
Data from ACMSF Report of Vacuum Packaging and Associated Processes, 1992,
ISBN 0-11-321558-4, and Best Practice Guidelines for the Production of Chilled
Foods, Chilled Food Association, 2006, 4th edition, The Stationary Office, ISBN13
978-1- 901798-11-1
7
Z values used for the calculation of the figures in Table 1 are based on ACMSF and
CFA data. ACMSF Z values limited to 80°C to 90°C range. CFA Z values limited to
90°C to 100°C
December 2020 16
Temperature (°C)
Time (mins)
92
6.3
93
5.0
94
4.0
95
3.2
96
2.5
97
2.0
98
1.6
99
1.3
100
1.0
December 2020 17
Heat treatment
34.
If heat treatment is to be used as the single controlling factor, the minimum heat
treatment that should be used to manufacture a chilled VP/MAP product is 90°C for
10 minutes or equivalent achieved at the slowest heating point in the product.
Equivalent times and temperatures are given in Table 1. In
most cases the shelf-life
will apply from the time of cooking.
35.
Ideally heat treatment should be carried out in the final sealed pack as this minimizes
the opportunity for re-contamination with non-proteolytic C. botulinum or other
pathogens
8
of the final product. However, if this is not possible, packing may be
carried out post-heat treatment as long as it is done under strict hygienic conditions
that prevent microbiological cross-contamination. As spores of C. botulinum are
ubiquitous in the environment, this would involve a strict level of control to ensure that
conditions are such that effectively address the risk of cross-contamination following
the heat treatment. If this level of control cannot be applied, then one or more of the
other controlling factors identified in this guidance should be used, if a shelf-life of
greater than 10 days is to be applied. FBOs must be able to demonstrate to the
satisfaction of the Competent Authority how the risk of cross-contamination with
spores of non-proteolytic C botulinum is controlled in products packed post-heat
treatment, as they must verify that the HACCP-based procedures in place are
appropriate
7
9
.
Acidity of the food
36.
The level of acid in a food can be a controlling factor in the growth of
microorganisms. A pH of 5.0 or less throughout a food and all of its components,
stored at chill temperatures of 8°C or lower is sufficient to inhibit the growth of non-
proteolytic C. botulinum. The pH of some multicomponent foods may vary within the
8
E. coli cross-contamination guidance
9
Article 18 of Regulation (EC) No 2017/625
December 2020 18
product due to diffusion and mixing limitations and if pH is the controlling factor for
safety, a pH of 5.0 or below should be achieved throughout all parts and
components of the final product. This should be monitored for every batch of
product. The FBO must define the batch
10
. Batch size is a key point to consider in
any risk management action. Acidified foods containing meat, fats or oils are
notoriously difficult to acidify uniformly and extra care should be taken with these
foods.
Sodium chloride (NaCl) content
37.
A concentration of 3.5% sodium chloride in the aqueous phase of a food stored at
temperatures 8°C or lo we r is sufficient to inhibit the growth of non-proteolytic C.
botulinum. The percentage of sodium chloride (NaCl, salt) in the aqueous phase of
a product can be calculated from the grams of sodium chloride present in 100g
product and the moisture content (grams of water per 100g of product) using the
following calculation:
(NaCl content x 100) / (NaCl content + moisture content)
Key
NaCl content = g NaCl / 100g product
Moisture content = g H
2
O / 100g product
38.
If salt content is the controlling factor for safety, a concentration of 3.5% or above
should be achieved throughout the aqueous phase of a food. This should be
monitored for every production batch.
10
Batch is defined in Article 2 (e) of the Regulation for the microbiological criteria for
foodstuffs (2073/2005/EC) as a group or set of identifiable products obtained from a
given process under practically identical circumstances and produced in a given place
within one defined production period.
December 2020 19
Water activity (a
w
)
39.
By using water-binding chemicals such as sodium chloride or sugars, it is
possible to remove the available water from a food, to a point at which the growth
of microorganisms is inhibited. A water activity (a
w
) of 0.97 or lower should be
achieved throughout the food stored at temperatures between 3 and 8°C to inhibit
the growth of non-proteolytic C. botulinum. The a
w
of some multicomponent foods
may vary within the product and if a
w
is the controlling factor for safety, an a
w
of
0.97 or below should be achieved throughout all components of the food. This
should be monitored for every b a t c h of product. However, there could be
circumstances where reduced monitoring might be appropriate (see question 8). Due
to the nature of the test it may be necessary to approach a specialised
laboratory to take a
w
measurements and to interpret and provide the results.
Other controlling factors
40.
Combinations of a lower level of the specific controlling factors described above
may be able to prevent growth of non-proteolytic C. botulinum and toxin production.
Other
combinations, e.g. addition of nitrite, may also be used to prevent growth of
non-proteolytic C. botulinum, provided that it complies with the additive legislation
Regulation (EC) No 1333/2008. Where a lower level of factors is used, each factor is
not able to inhibit the growth of non-proteolytic C. botulinum on its own but inhibition of
growth and toxin production is reliant on the combined effect of all factors (hurdle
technology). These specific combinations need to be validated for each product
using sound scientific principles; this is a highly specialised field and there is an
expectation that expert advice is needed to produce the necessary data.
Mathematical models such as ComBase Predictor and Pathogen Modelling Program
and challenge testing are examples of approaches that can be used to obtain relevant
information on combinations of controlling factors.
December 2020 20
The uses and limitations of predictive growth
models
41.
Predictive microbiology models are important tools for food safety
management as
they provide a scientific basis to underpin key aspects of
HACCP - based food
safety management procedures. Predictive models available include those that
describe growth limits, growth and thermal inactivation. Predictive models for non-
proteolytic C. botulinum are freely available in ComBase Predictor and the Pathogen
Modelling Program.
These models can be used to predict the effect of conditions in
the food (e.g.
pH, temperature) on the growth of non-proteolytic C. botulinum. It is
important to recognise that models can only provide accurate information when
interpreted by microbiologists with appropriate skills and experience.
Where a
business does not have such skill and expertise it should consult an expert in food
microbiology (see the frequently asked questions section below). The models are
of particular benefit in providing a guide for the need for
challenge testing or to
enable the effective targeting of a challenge test
study.
Challenge Testing
42.
To establish whether a shelf-life of greater than 10 days is safe when VP/MAP chilled
foods do not have any of the single specified controlling factors, challenge testing may
be considered. If this is to be carried out, it is important to ensure that the analysis
takes into account any variability that may occur within a batch and between batches
of product. An appropriate centre of expertise should be consulted both to carry out
challenge testing and interpret the results.
43.
Where results from predictive models and challenge testing may conflict, the results of
challenge testing should always take precedence. Predictive models are useful as a
general guide, however there are limitations that must be taken into account and
challenge testing can therefore be used to back-up these predictions and provide the
evidence to show whether C. botulinum is capable of growing and producing toxin
within a product.
December 2020 21
Practice of re-wrapping VP/MAP foods
44.
Where no other controlling factor can be identified, the maximum shelf-life should be
10 days from when the product is first vacuum packed or modified atmosphere
packed. The shelf-life should not be restarted if the product is subject to a further re-
wrapping under vacuum or modified atmosphere, unless other controlling factors are
first applied.
45.
The practice of giving a “rolling 10 day shelf-life” is of great concern. If a VP/MAP
product is unwrapped, e.g. for slicing or portioning, and then re-wrapped (into VP or
MAP), the shelf-life given to the re-wrapped product should not exceed the shelf-life
given to the original product. Where the re-wrapped shelf-life is intended to be greater
than 10 days then the FBO carrying out the re-wrapping must be able to demonstrate
to their competent authority that it is safe to do so with respect to controlling factors to
prevent the growth of non-proteolytic C. botulinum in the re-wrapped product.
46.
In these cases, consideration should be given to the controlling factors used by the
original manufacturer, as well as any other additional controlling factors the FBO may
introduce to the re-wrapped (VP/MAP) product (see question 24).
December 2020 22
Frequently asked questions
1. Q: Do some foods have a greater risk of C. botulinum than others?
A: Table 2 gives examples of foods that differ in their inherent risk with respect to C.
botulinum e.g. hot smoked fish would have a greater inherent risk relative to a hard
cheese like Cheddar. However, non-proteolytic C. botulinum must still be considered a
potential risk for raw and ready to eat VP/MAP chilled foods, and incorporated into
HACCP based procedures.
Table 2: Risk assessment of non-proteolytic C. botulinum
in chilled foods
adapted from Table 12, page 29, Report on
vacuum packaging and associated
processes, ACMSF,
London: HMSO 1992
Food category
Examples
Usual controlling
factors (in addition to
chill temperature)
Priority for
attention
Hot smoked
mackerel, trout,
shellfish
salt, shelf-life
High
Fresh chilled
pasta (MAP)
cannelloni, ravioli
shelf-life
Medium
Hard Cheese
Cheddar
a
w
, pH, salt
Low
2. Q: Is raw meat included in the scope of this guidance with respect to the
control of non-proteolytic C. botulinum?
A: Yes, this guidance applies to all VP/MAP chilled raw and ready-to-eat food,
including raw meat, with the exception of VP/MAP chilled fresh beef, lamb and pork
(see the answer to question 2.1 below). During a review by the ACMSF on vacuum
packaging and the associated risks, consideration was given to whether VP/MAP
chilled foods, whether raw or ready-to-eat, could present a food safety risk from
anaerobic microorganisms, such as non-proteolytic C. botulinum. This is because
spores of C. botulinum are ubiquitous in the environment, which includes soil, salt and
December 2020 23
fresh water sediments and in the gastrointestinal tracts of animals and fish, and are
therefore likely to be present on food. It is not possible to be certain that an
unprocessed food will not contain spores of C. botulinum. In addition, although VP and
MAP techniques are designed to increase the shelf-life of products, the removal of
oxygen creates the right conditions for anaerobic organisms such as C. botulinum to
grow and produce toxin. With this in mind, VP/MAP chilled foods must therefore have
controls in place, throughout the shelf-life of the product, to minimise the risk of this
bacterium growing and producing toxin or the FBO must provide evidence that growth
of pathogens is not supported. This should be included as part of HACCP-based
procedures in identifying the relevant hazards associated with products, which
includes non-proteolytic C. botulinum for VP/MAP chilled foods.
If controlling factors are not already validated, FBOs should assess and validate each
individual product against the risk from C. botulinum and, where the shelf-life is
greater than 10 days without a sufficient single controlling factor, provide evidence of
the safety of the product throughout its entire shelf-life in respect to non-proteolytic C.
botulinum (e.g. via modelling, challenge testing or other appropriate means of
validation).
2.1 Q: Is VP/MAP fresh beef, lamb and pork included in the scope of this
guidance with respect to the control of non-proteolytic C. botulinum?
No. This guidance does not apply to chilled fresh beef, lamb and pork, without added
ingredients or further processing beyond cutting, packing, chilling, freezing and quick-
freezing.
In 2020 the FSA/FSS undertook a review of available evidence on the shelf-life of
VP/MAP chilled fresh beef, lamb and pork and concluded that it was not proportionate
to continue to specifically reference VP/MAP chilled fresh beef, lamb and pork in the
guidance on non-proteolytic C. botulinum. The research and evidence review did not
identify any report of an outbreak of foodborne botulism linked to VP/MAP chilled fresh
beef, lamb and pork over several decades either in the UK, including before the
guidance was issued, or internationally. It remains the responsibility of FBOs
producing products such as these and applying shelf-lives to appropriately validate the
shelf-life.
December 2020 24
However, this guidance does apply to any beef, lamb or pork that is further processed
such as minced, cooked or mixed with any other ingredients such as herbs, spices or
curing salts. The guidance applies to these and to any other VP/MAP chilled foods.
FBOs producing the specific VP/MAP chilled fresh beef, lamb and pork which is
outside the scope of this guidance will be responsible for identifying and applying a
safe shelf-life in relation to non-proteolytic C. botulinum in line with their existing food
safety management systems, in the same way they do for other types of food
8
.
It is recognised that small and medium sized food businesses may not have resources
and expertise for identifying a suitable shelf-life for specific VP/MAP chilled fresh beef,
lamb and pork that are outside the scope of this guidance. Therefore, FBOs, including
small and medium sized food businesses, that voluntarily want to apply the guidance
to their VP/MAP chilled fresh beef, lamb and pork that are outside the scope of this
guidance may do so. In these circumstances FBOs which are maintaining good
hygiene practice may apply up to a maximum 13 day shelf-life for their VP/MAP chilled
fresh beef, lamb and pork in relation to C. botulinum, should they wish to do so,
without further verification or validation of the 13-day shelf-life for C. botulinum. The
FBO should follow this guidance in the same manner as it applies to 10 days but may
apply 13 days. The ACMSF on 30 January 2020 endorsed a recommendation of its
subgroup’s report on C. botulinum that a 13 day maximum shelf-life may be applied for
VP/MAP chilled fresh beef, lamb and pork. The shelf-life should not be restarted if the
VP/MAP chilled fresh beef, lamb and pork is subject to a further re-wrapping under
vacuum or modified atmosphere, unless appropriate controls are applied as set out in
the guidance.
8
Examples of industry guides that FBOs may use include: the “Guidelines for Setting
Shelf life of Chilled Foods in relation to non-proteolytic Clostridium botulinum” issued
by Chilled Food Association/Quadram Institute/Leatherhead Food Research/Meat &
Livestock Australia/British Retail Consortium in 2018, and “Shelf Life of MAP and VP
Raw Meat Products in Relation to non-proteolytic Clostridium botulinum” issued by
BRC Global Standards in 2018.
December 2020 25
3. Q: What are the key aspects of the guidance?
A: The FSA/FSS guidance recommends that the shelf-life applied to VP and MAP
products be restricted to no greater than 10 days unless the FBO is able to
demonstrate that appropriate key control measures are in place. There are two
recommended ways to ensure the safety of VP and MAP
products. They should
either be heated to a sufficient temperature to inactivate the spores of non-
proteolytic C. botulinum (ideally in the final sealed pack) or subject to a single or a
combination of
preservative control factors to prevent the growth of non-
proteolytic C. botulinum and production of toxin. These are explained in the section
“Background information on the specific controlling factors”.
4. Q: How should FBOs establish the appropriate shelf-life with respect to C.
botulinum for their products?
A: FBOs should look at the decision tree in this document. If the shelf-life is
beyond 10 days the FBO must be able to demonstrate how their HACCP-based
procedures and control measures ensure that the food remains safe within the
allocated shelf-life. Article 3.2, Annex II of Regulation (EC) 2073/2005:
microbiological criteria for foodstuffs
11
, describes the necessary practices and
procedures to be considered for establishing shelf-life. It is noted that this is set
out
specifically for L. monocytogenes and is not a general legal requirement for C.
botulinum; however, this information may assist in determining an appropriate
approach.
5. Q: How should a FBO establish the appropriate shelf-life for VP/MAP
products stored below 3°C?
A: If an FBO labels their product to be stored at <3°C, it is important that they have an
appropriate understanding of the temperatures at which the product will be held during
all stages after it leaves their control. If the product is likely to be stored at between
3°C and 8°C after it leaves the FBO’s control (e.g. during transit or at retail or during
11
Commission Regulation (EC) No 2073/2005
December 2020 26
storage in commercial or domestic kitchens), then if no other adequate controlling
factors for C. botulinum exist, the maximum 10 day shelf-life for the VP/MAP product
should be applied from the point the VP/MAP product reaches or is likely to reach a
temperature of 3°C or above. If the FBO does not know the refrigeration temperatures
at which their product will be held after it leaves their control, then they should
consider that it may be held at temperatures above 3°C and that the label’s
instructions to ensure that the product will be kept <3°C may not ensure the product’s
safety if the shelf life is longer than 10 days.
Establishments not subject to approval under Regulation (EC) 853/2004 (such as
catering businesses and retailers) may lawfully store food at temperatures up to 8°C.
An in-home temperature survey published in 2010 by Waste and Resources Action
Programme (WRAP) found that the majority of domestic refrigerators operate at a
mean air temperature of around 7°C, with only 29 % of the sample operating at mean
air temperatures of 5°C or less. It is therefore likely that food supplied directly to
caterers, retailers and/or final consumers will not be stored at temperatures below
3°C.
6. Q: If the FBO wishes to test their VP/MAP chilled product for the presence
of non-proteolytic C. botulinum spores, will negative results be
considered sufficient evidence to exempt them from applying the controls
specified in this guidance?
A: Spores of non-proteolytic C. botulinum are ubiquitous in the environment and may
be present on food. Testing for the presence of non-proteolytic C. botulinum spores is
unlikely to provide 100% reassurance that spores of C. botulinum are not present, and
should therefore not be relied upon as the only way of verifying the FBO’s methods. In
addition, testing for spores of other Clostridium species, such as Clostridium
perfringens, is not considered a reliable indicator for C. botulinum. The best way to
prevent the risk from growth and toxin production is by ensuring that sufficient controls
are in place.
December 2020 27
7. Q: What can a FBO do if they wish to have a shelf-life of greater than 10
days for their VP/MAP chilled product, but is unable to heat treat in the
final sealed pack and the product does not meet any of the specified
controlling factors?
A: For some products and production practices the product is not able to meet the
controlling factors that would be sufficient to control non-proteolytic C. botulinum and
the product cannot be heat treated in the final sealed pack. In this case, it would be
acceptable for challenge testing or an appropriate alternative approach to be carried
out to determine whether a particular product is unable to support growth of non-
proteolytic C. botulinum and toxin production. If this is to be carried out, it is important
to ensure that the analysis takes into account any variability that may occur within a
batch and between batches of product. As this is a highly specialised area, challenge
testing or any alternative approaches should be carried out by an appropriate centre of
expertise.
8. Q: Can nitrites be used as a controlling factor to prevent growth and toxin
production of non-proteolytic C. botulinum, where a shelf-life greater than
10 days is to be applied?
A: The guidance covers the main controlling factors that a FBO can apply in addition
to chill temperatures to enable a shelf-life of greater than 10 days. In addition to these,
it is also possible to use a lower level of factors (i.e. heat treatment, pH, salt
concentration and a
w
) in a food to achieve a combined preservation effect or use
additional preservatives such as nitrite to comply with additive legislation Regulation
(EC) No 1333/2008. Where a lower level of factors is used, each factor is not able to
inhibit the growth of C. botulinum and production of toxin on its own but the safety of
the food with respect to non-proteolytic C. botulinum relies on the combined effect of
all factors. Where a combination of factors is used, it is necessary to illustrate that the
preservation system chosen can consistently prevent growth of non-proteolytic C.
botulinum and toxin production; this may be done by predictive modelling, challenge
testing or other appropriate means of validation.
In relation to other preservatives, the only controlling factors in addition to heating at
90°C for 10 minutes, which are currently recommended to inhibit the growth of C.
botulinum and production of toxin are salt, pH and a
w
and these are explained in more
December 2020 28
detail in the FSA/FSS guidance. There are other preservatives which will have an
impact on the growth of C. botulinum, such as nitrite, sorbic acid, benzoate and
lactate. Whilst there may not be sufficient data to allow a recommendation for any of
these preservatives to be a controlling factor in their own right, they may contribute to
the overall product safety.
The ACMSF report on vacuum and modified atmosphere packaging and associated
processes states specifically for nitrite that “inhibition of C. botulinum by nitrite in foods
depends heavily upon a number of factors such as acidity and salt content. In addition,
there are pressures to reduce nitrite levels in some foods because of the risk of
formation of carcinogenic N-nitroso compounds in some situations. Taken together
these two limitations mean that the scope for the use of nitrite on its own to control C.
botulinum is limited”. Another issue surrounding the use of nitrite as a controlling factor
is that nitrite depletes readily from the product during storage, thereby reducing the
antimicrobial affect.
In summary, nitrite and other preservatives may have antibotulinal properties in a
number of different food stuffs. However, as the efficacy of these preservatives seems
to be dependent on the heat treatment given, the pH of the product and other
constituents of the food, their use as controlling factors to prevent growth of non-
proteolytic C. botulinum and toxin production needs to be evaluated for each specific
product, for example by challenge testing or other appropriate means of validation. An
FBO’s HACCP-based food safety management procedures should have ongoing
monitoring to ensure that the products are of the right specification, which can control
growth of non-proteolytic C. botulinum and production of toxin. The FBO must be able
to demonstrate to the satisfaction of the Competent Authority both that the controlling
factors are effective and also that the level of monitoring to ensure consistent
adherence to specification is appropriate.
9. Q: Once the appropriate controlling factors for a specific product have
been identified by the FBO, should every production batch be monitored
for these controls?
A: It is important that the controlling factors for chilled VP/MAP products are controlled
for every production batch and achieved consistently and uniformly throughout the
product, to ensure that the required level for safety is maintained. However, sampling
December 2020 29
every production batch may be impractical due to the cost and size of the FBO’s
operation. It is therefore the responsibility of the FBO to demonstrate to the
Competent Authority that the monitoring of the controlling factors is adequate to
guarantee that the specified level is being met for each production batch. Ideally,
monitoring of each production batch initially should be in place to verify that the recipe
and production method used can consistently achieve the levels required throughout
the product to prevent growth of non-proteolytic C. botulinum and production of toxin.
If consistent results are achieved and the FBO can demonstrate to the satisfaction of
the Competent Authority (e.g. through historical data) that there is confidence that the
recipe and the production method (taking into account potential for human error if
appropriate) can reliably produce a safe product, there may be circumstances where
reduced monitoring could then be introduced, if the competent authority is satisfied
that it is justified.
10. Q: What specific food legislation is applicable to a business using
VP/MAP technology?
A: A FBO must be compliant with the general principles and requirements of food law
in Regulation (EC) 178/2002. They must be able to identify the hazards associated
with their operation and the methods to control those hazards. Article 5 of Regulation
(EC) 852/2004 requires FBOs to have in place permanently a procedure based on
HACCP principles. A FBO should be able to provide the local authority with evidence
to demonstrate the way they control the hazards, including that of non-proteolytic C.
botulinum in relation to their VP/MAP products. See Article 5(4) (a) of Regulation (EC)
No 852/2004 on the hygiene of foodstuffs.
11. Q: How much information should be contained in HACCP based food
safety management procedures covering VP/MAP technology?
A: The extent and detail of the information in an FBO’s HACCP documentation will
depend on the shelf- life the FBO applies to their products and the controls required.
The HACCP-based controls must be proportionate to the risk. The product should
display the “ use by” date and the required storage conditions clearly printed on the
December 2020 30
pack.
12
12. Q: Is the FSA’s Safer Food, Better Business (SFBB) pack, or FSS’s
Cooksafe suitable for manufacturers of VP/MAP products?
A: HACCP procedures as set out in the SFBB pack for caterers are unlikely to be
suitable, especially when the business wishes to apply a shelf-life greater than 10
days. In such circumstances the business will need to set out their critical control
points (CCPs) and monitoring procedures in more detail than is generally used in
SFBB and will need to keep appropriate records.
13. Q: What level of process validation might be appropriate for a HACCP
plan?
A: Validation involves confirmation that, if followed, the HACCP plan will result in the
production of safe food. This is to ensure that the control measures and their
associated limits are appropriate and can be applied in practice. The level and
nature of validation required will depend on the products and processes involved.
The most important things to validate are that the control measures at the critical
control points are sufficient to
achieve the objectives. The performance of some
control measures will have already been validated by others or be so well established
in practice that validation can be considered to be achieved (some examples are
provided in this document e.g. heat treatment of 90°C for 10 minutes, pH of 5.0 or
less, minimum salt concentration of
3.5%, a
w
of 0.97 or less). However, when this
is not the case (e.g. when using different time temperature combinations or a
combination of controlling factors that if used singly, would not control growth of non-
proteolytic C. botulinum), validation should be undertaken.
14. Q: Who is responsible for undertaking the validation process?
A: The onus is on the FBO to demonstrate that their food products are safe. Validation
can be undertaken by the FBO themselves, if they have the expertise, or by
12
Regulation (EU) No 1169/2011 – Article 9 - on the provision of food information to
consumers.
December 2020 31
another organisation on their behalf. If
the business is not using already validated
procedures they should be able to
demonstrate how they have validated their
HACCP plan, in particular the critical control measures.
15. Q: What steps should the competent authority take to ensure that
validation is undertaken correctly?
A: The competent authority should ensure, as part of their role in verifying that the
controls in place are appropriate, that validation is undertaken by the business in
meeting their obligation of complying with Article 5 of Regulation (EC) No 852/2004. If
control measures are being used that have not already been validated or are not
accepted practice, then the authority should request evidence of the validation
process, including when it was undertaken and who was undertook it as well as their
level of
expertise.
16. Q: What action can the local authority take if evidence of the validation
process is not provided?
A: Article 5(1) of Regulation (EC) No 852/2004 requires a FBO to
put in place,
implement and maintain permanent procedures based on HACCP principles. Under
Article 5(4) (a), a FBO is also required to provide the Competent Authority with
evidence of their compliance with Article 5(1) in the manner that the Competent
Authority requires. This is monitored by on-going verification checks.
Failure to meet the requirements in the Regulations may mean that an offence under
the Food Safety and Hygiene (England) Regulations 2013 (and equivalent
Regulations in Wales, Northern Ireland and Scotland) has been committed.
A range of enforcement powers are available to competent authorities across the UK
and these include:
The use of a hygiene improvement notice (HIN) to require either (i) that validation is
carried out or (ii) that evidence is provided of the result of the validation process.
Remedial Action or detention notices can also be applied in certain establishments to
prohibit the use of any equipment or any part of the establishment specified in the
notice; or to impose conditions or prohibit the carrying out of any process.
In some cases it may be appropriate to consider detention and/or seizure of non-
December 2020 32
compliant product/withdrawal or recall from your customers (see Q. 20).
The use of enforcement powers is subject to the guidance in the Food Law Code of
Practice and to the local food law enforcement policy, as well as guidance set out in
the Manual of Official Controls for approved meat establishments.
17. Q: A business is applying a shelf-life of greater than 10 days to their
VP/MAP products. How should the local authority satisfy itself that this is
an appropriate shelf- life?
A: Food businesses should be able to provide scientific evidence that supports the
shelf-life determination applied to their products. If a business is unable to provide this
evidence further investigation and action may be required to protect consumer safety.
General advice on enforcement is contained within the Food Law Code of
Practice
and associated Practice Guidance, as well as the Manual of Official Controls.
18. Q: What further investigation or action might be necessary?
A: The first stage is to consider whether the FSA/FSS guidance in respect of VP and
MAP
products is being followed. The decision tree summarises the key questions
that
need to be considered.
19. Q: How concerned should the competent authority be if a FBO continues
to apply a shelf-life of greater than 10 days without the scientific evidence
to support the shelf-life?
A: The view taken by the ACMSF is that businesses producing VP and MAP should
base their controls on the assumption that spores of non-proteolytic C. botulinum
may be present in ingredients/foods. Competent authorities should ensure that
such controls are in place in order to protect consumer safety. Local authorities
should take a risk-based approach when prioritising enforcement activities e.g.
focus on businesses using VP/MAP in respect of food categories falling within the
“ high priority for attention” category, examples of which are shown in Table 2 of this
document.
December 2020 33
20. Q: What further action can be considered if a FBO continues to produce
VP/MAP products and applies a shelf-life greater than 10 days contrary to
the guidance and the advice of the competent authority?
A: Powers exist in the Food Safety and Hygiene (England) Regulations 2013 and
equivalent legislation in Scotland
13
, Wales and Northern Ireland, to issue a
hygiene emergency prohibition notice where there is evidence that there is an
imminent risk to consumers. Before considering such action, the competent
authority should consider the advice contained in this document and other
references therein and seek advice of an appropriate expert who may be able to
provide evidence in court on behalf of the authority if their action is challenged. The
seizure of food and the possibility of
product recall would also need to be
considered. In considering whether enforcement action is appropriate or
necessary it should be recognised that the advice of the ACMSF is based on best
scientific advice and industry practice. There is no specific law across the UK that
covers the use of VP/MAP
technology.
21. Q: Under what circumstances might a local authority consider the use of
a hygiene emergency prohibition notice?
A: If appropriate evidence is found, a hygiene emergency prohibition notice may be
served on the FBO, followed by an application to a Magistrates’ or Sheriff Court for
a hygiene emergency prohibition order. The following provides an example of
circumstances where an authorised officer may consider the use of these
prohibition powers because the health risk condition in Regulation 8(4) of the Food
Safety and Hygiene (England) Regulations 2013 and the other devolved UK
equivalent regulations is likely to be satisfied. That is, there is an imminent risk of
injury to health under Regulation 8(4). This example is in no way prescriptive or
exhaustive and is for illustrative purposes only.
14
A FBO producing a vacuum packed
13
Food Hygiene (Scotland) Regulation 2006 (as amended)
14
Text taken from the Food Law Code of Practice
December 2020 34
product which falls within the category requiring ”high” priority for attention (see
paragraph 40 and Table 2), with a product shelf-life significantly in excess of 10
days and a complete failure to
demonstrate effective control of non-proteolytic C.
botulinum. The FBO is likely to have a general failure to satisfy relevant statutory
obligations and a poor track record of compliance (i.e. a score of 15/20 in Part 2 of the
Food Hygiene Scoring System and a confidence in management score of 20/30 in
Chapter 5 of the Food Law Code of Practice).
Before considering such action the local authority should consider the information
provided in the answer to question 13 particularly the need for expert evidence.
22. Q: A business has been identified using VP and/or MAP technology for
chilled foods. The FBO does not appear to understand the inherent
hazards associated with this form of food packaging. What action should
the local authority take?
A: The FBO should be provided with a copy of this guidance. Officers should
consider whether the FBO’s knowledge gap has resulted, or might result, in the
production of food which is unsafe or otherwise non-compliant with food law. Help
and guidance should be provided to the business using a risk-based and
proportionate enforcement approach in accordance with the advice contained in the
Food Law Code of Practice and equivalent codes elsewhere in the UK.
15
23. Q: If a FBO is repacking VP/MAP products what action should the local
authority take to satisfy itself that the activity is safe and appropriate?
A: An FBO must be able to identify the hazards associated with their business and
the methods to control those hazards and reflect these in the business’s HACCP
based food safety management procedures. Reference to the decision tree will
identify those factors that need to be taken into account when a VP/MAP product is
repacked.
15
https://www.foodstandards.gov.scot/publications-and-research/publications/food-
law-code-of-practice-scotland-2019
December 2020 35
24. Q: If a FBO is opening VP/MAP products with a shelf-life of greater than
10 days and re-wrapping and wishes to continue applying a shelf-life of
greater than 10 days, how can the FBO ensure that this process is safe?
A: For products that were originally given a shelf-life of 10 days by the manufacturer,
the FBO who is re-wrapping the product needs to ensure adequate controlling factors
are in place before applying a re-wrapped shelf-life of greater than 10 days. The FBO
may need to contact the manufacturer to determine what controlling factors they put in
place for their product. Importantly, the shelf-life of the re-wrapped product should not
exceed the shelf-life given to the original product unless additional controls are applied
before it is re-wrapped. FBOs extending the shelf- life of the product will need to be
able to demonstrate that it is safe.
The shelf-life given to the re-wrapped VP/MAP product will depend on the controlling
factors used by the manufacturer when applying the original shelf-life of greater than
10 days. For instance, if the controlling factor used in addition to chilled storage was a
heat treatment of 90°C for 10 minutes or equivalent, due to the potential for re-
contamination with non-proteolytic C. botulinum spores between opening and re-
wrapping, the shelf-life applied to the re-wrapped product should not be greater than
10 days, unless other controlling factors are introduced .
If the controlling factors used in addition to chilled storage are factors other than heat
treatment such as pH, salt or a
w
; these are unlikely to have changed following opening
and re-wrapping, unless for example other ingredients are added to the product. If the
Competent Authority is satisfied that there is evidence that these controlling factors
have not changed and remain sufficient to control non-proteolytic C. botulinum and
any other relevant microorganisms, then the shelf-life applied to the re-wrapped
product may be greater than 10 days, but cannot exceed the shelf-life given to the
original product. If information on the controlling factors used by the original
manufacturer to apply a shelf-life of greater than 10 days cannot be obtained, the FBO
would be best placed to apply a maximum 10 days shelf-life to the re-wrapped product
unless the FBO can identify or introduce additional controlling factors. Again, the shelf-
life of the re-wrapped product should not exceed the shelf-life given to the original
product.
December 2020 36
Further advice
25. Q: If an environmental health officer, Official Veterinarian or an FBO is
concerned about the safety of a process where can they go to seek
technical advice and opinion?
A: There are a number of food research organisations able to provide advice
including:
• Campden BRI +44(0)1386 842 000
• Quadram Institute +44(0)1603 255 000
• Leatherhead Food Research +44(0)1372 376 761
Trade associations may also be able to provide an opinion e.g. Chilled Food
Association 01858 565166.
December 2020 37
Glossary
Batch: a group or set of identifiable products obtained from a given process under
practically identical circumstances and produced in a given place within one defined
production period.
Challenge testing: deliberate inoculation of relevant microorganisms into a food
product to determine the product’s ability to support survival, growth or inactivation of
the organisms during storage at defined temperature(s).
Controlling factor: factors that can be used to prevent the growth and toxin
production by non-proteolytic C. botulinum. In addition to chill temperatures (less
than or equal to 8°C), the following factors should be used singly or in combination to
prevent growth and toxin production by non-proteolytic C. botulinum in prepared
chilled foods with an assigned shelf-life of more than 10 days:
• a heat treatment of 90°C for 10 minutes or equivalent lethality in the slowest
heating point in the food
• a pH of 5.0 or less throughout the food
• a salt level of 3.5% or more (aqueous) throughout the food
• an a
w
of 0.97 or lower throughout the food
• a combination of heat and preservation factors which has been shown to
consistently prevent growth and toxin production by C. botulinum
Hazard Analysis Critical Control Point (HACCP): procedures applied by food
businesses that identify, monitor, evaluate and control hazards which are significant
for food safety.
Modified atmosphere packaging (MAP): atmosphere in a packaged product (gas)
that differs from the ambient atmosphere.
Non-proteolytic C. botulinum: psychrotrophic clostridia that can grow and produce
botulinum neurotoxin at chill temperatures. The terms “non-proteolytic C. botulinum”
and “psychrotrophic C. botulinum” are equivalent and interchangeable.
Psychrotrophic C. botulinum: see Non-proteolytic C. botulinum.
Shelf-life: the period during which the product maintains its microbiological safety
December 2020 38
and organoleptic qualities at a specific storage temperature. It is based on identified
hazards for the product, heat or other preservation treatments, packaging method
and other hurdles or inhibiting factors that may be used.
Vacuum packaging (VP): the removal of all or most of the air within a package,
without deliberate replacement with another gas mixture, and prevention of its
return by an airtight seal around the food within the packaging material.
Validation: obtaining evidence that the elements of the HACCP plan are effective.
December 2020 39
Review date
We aim to keep all guidance up to date and undertake regularly reviews to ensure
guidance remains relevant. The next scheduled review date for this guidance is
before June 2022.
Contact us
We welcome your feedback on this guidance, including reports of any broken links or
out-of-date content.
Contact: [email protected]
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copyright holders concerned.
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