Transcript L monocytogenes - Food Standards Agency

Regulation (EC) 2073/2005 on
Microbiological Criteria for
Foodstuffs, with an Emphasis
on Listeria monocytogenes
Learn more with the Food Standards Agency
© Food Standards Agency 2015
Objectives
Improved understanding of:
• General requirements relating to
Regulation (EC) 2073/2005 on
microbiological criteria for
foodstuffs
• Specific requirements relating to
Listeria monocytogenes (Lm)
• How to interpret and comply with
the requirements of Regulation
(EC) 2073/2005
Programme
0915-0930
0930-1000
1000-1100
1100-1115
11 15-1200
12 00-1300
1300-1315
1315-1415
1415-1430
1430-1530
1530-1630
1630-1700
Registration
Background and Legal Requirements
Sampling and Testing – Microbiological and environmental
Coffee break
Corrective Actions Following Unsatisfactory Results
Lunch
Why Lm is a problem
Legal Requirements for Lm
Tea Break
Breakout Sessions to Consider Case Study Scenarios
Reporting Back on Approach to Manage Case Studies
Summing Up, Questions and Close
Example of real enquiry
From UK restaurateur:
• “I am currently making my own fishcakes in a
restaurant in xxxxx.
• I am selling them to the public at Farmers markets
and also to some other restaurants.
• I am interested in expanding and being able to send
the cakes in the post, but can find no information
regarding how it is possible, can you help?”
Example of real enquiry
From Czech Republic:
• We are interested in R&D services to help us develop a
range of 21 day life, chilled sandwiches.
• As shocking as it seems, short shelf life is the biggest
reason why major retailers have refused my products and I'm at P+12 already. ”
Background and Legal
Requirements
© Food Standards Agency 2015
PURPOSE of EU FOOD LAW
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Protection of public health
Provision of information to consumers
Assure fair trading and competitive conditions
Adequate and necessary official controls
EU Established marketing standards
General Food Hygiene Directive 93/43/EEC
Now implemented by EC and UK Regulations
OFFICIAL CONTROLS
882 and 854/2004
FOOD BUSINESSES
852 and 853/2004;
2073/2005
GENERAL PRINCIPLES
178/2002
INTERESTS OF CONSUMERS
EC Regulation 2073/2005
• “Foodstuffs should not
contain micro organisms or
their toxins or metabolites
in quantities that present
an unacceptable risk to
health”. (Paragraph 2)
• Article 5 EC Regulation
852/2004 HACCP
Procedures
• “Food business operators
shall take measures, as
part of their HACCP...for
raw materials to meet the
process hygiene criteria
and finished product to
meet the food safety
criteria” Article 3.
Commission Regulation (EC) No 2073/2005 (OJ L338, p1, 22/12/05) of 15/11/05 on microbiological criteria for foodstuffs
EC Regulation 2073/2005
FBO must meet;
Food Safety Criteria (Chapter 1); specific foods for
shelf life and Lm, Salmonella, E. coli, Enterobacter
sakazakii, Staphylococcal enterotoxins and histamine.
“Shall conduct studies...shelf life of ready to eat food
and Lm”.
Process Hygiene Criteria (Chapter 2) for supply,
handling and raw materials and foodstuffs.
© Food Standards Agency 2015
PARNUTs Regulation 609/2013
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Food intended for infants and young children,
food for special medical purposes, and total diet
replacement for weight control
Examples:
• infant formula and follow-on formula
• processed cereal-based food (infants and young
children)
• baby food
• food for special medical purposes
• total diet replacement for weight control
© Food Standards Agency 2015
EC Regulation 852/2004
•Article 5 “Put in place a permanent procedure based
on HACCP principles” https://myhaccp.food.gov.uk/
•Food Safety Management System
•Food Law Practice Guidance Annex 11 pg 206
https://www.food.gov.uk/sites/default/files/Food%20Law%20Practice%20Guidance%20-%202012.pdf
•Flexibility; compliance at a high level
•Does the business require 853/2004 approval?
© Food Standards Agency 2015
Validation of HACCP
• To validate the HACCP the Food Business Owner
must verify that;
• All identified control measures are implemented
• All such measures are implemented correctly and
effectively.
• Are suitable to control the relevant hazards.
• Compliant with food safety requirements i.e. Article
14 EC Regulation 178/2002.
© Food Standards Agency 2015
EC Regulation 882/2004
• Official controls performed to ensure the verification
of compliance with food law.
• “Competent authorities shall carry out official
controls in accordance with documented procedures”.
• Procedures to verify the effectiveness of the official
controls.
• Implementation of HACCP principles
• Management systems operate to meet food law.
© Food Standards Agency 2015
ARTICLE 5
852/2004
ARTICLE 4
853/2004
HACCP
ARTICLE 3
882/2004
© Food Standards Agency 2015
ARTICLE 3
2073/2005
EC Regulation 2073/2004 Annex I
Chapter 1. Food safety criteria
Chapter 2. Process hygiene criteria
Chapter 3. Rules for sampling and preparation of test
samples
© Food Standards Agency 2015
Definitions
• Food Safety Criterion
• a criterion defining the acceptability of a
product or a batch of foodstuff applicable to
products placed on the market
• an exceedance during shelf life is a
breach of legislation, requiring action as
specified in the Regulation
© Food Standards Agency 2015
Definitions
• Process Hygiene Criterion
• a criterion indicating the acceptable functioning of
the production process
• applies during the manufacture/processing stage
• ingredients and food products are supplied, handled
and processed so that Process Hygiene Criteria are
met.
• does not apply to products placed on the market
• when exceeded, corrective action must be taken to
maintain process hygiene
• an exceedance does not require withdrawal or
recall
© Food Standards Agency 2015
Annex I Criteria for…
Food Safety Criteria
RTE foods
Minced meat and meat preparations
Fresh poultry meat
MSM
Meat and products thereof
Gelatine and collagen
Milk and dairy products
Infant formula and dried dietary
foods for infants for special medical
purposes
• Egg products
• Fishery products (inc fish sauce),
shellfish, cooked crustaceans
• Produce (seeds for sprouting and
unheated sprouted seeds,
unpasteurised
pre-cut)
© Food Standards Agency juices,
2015
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Process Hygiene Criteria
• Meat and products thereof
• Milk and dairy products
• Infant formula and dried dietary
foods for infants for special medical
purposes
• Egg products
• Fishery products, shellfish and
cooked crustaceans
• Produce (unpasteurised juices, precut)
Flexibility with 2073/2005
•FSA
Guidance
https://www.food.gov.uk/sites/default/files/multimedia/pdfs/ecregguidmicrobiolcriteria.pdf
•Paragraph 3.5 “Allows flexibility for the food business
to decide what should be done to demonstrate
compliance and, where testing is carried out, the
sampling and testing plan should be proportionate to
the risk and to the nature and size of the business”.
© Food Standards Agency 2015
Definitions
Egg Products
• 853/2004/EC: processed products resulting from
the processing of eggs, or of various components
or mixtures of eggs, or from the further
processing of such processed products.
© Food Standards Agency 2015
Definitions
Meat Preparations
• 853/2004/EC: Fresh meat, including meat that
has been reduced to fragments, which has had
foodstuffs, seasonings or additives added to it or
which has undergone processes insufficient to
modify the internal muscle fibre structure of the
meat and thus to eliminate the characteristics of
fresh meat.
© Food Standards Agency 2015
Definitions
Meat Products
• 853/2004/EC: processed products resulting from
the processing of meat or from the further
processing of such processed products, so that
the cut surface shows that the product no longer
has the characteristics of fresh meat.
Minced Meat
• 853/2004/EC: boned meat that has been minced
into fragments and contains <1% salt.
© Food Standards Agency 2015
Definitions
Placing on the Market
• 178/2002/EC: “The holding of food or feed for the
purpose of sale, including offering for sale or any
other form or transfer, whether free of charge or
not, and sale, distribution, and other forms or
transfer themselves”.
• In practice this means food is placed on the
market if it has left the control of the
primary manufacturer.
© Food Standards Agency 2015
Definitions
Ready-to-eat (RTE)
• Intended by the producer or the manufacturer for direct
human consumption without the need for cooking or other
processing effective to reduce to an acceptable level or
eliminate microorganisms of concern.
• In practice this means food intended for direct
human consumption without the need for cooking
or reheating.
• The FBO decides whether or not a food is RTE.
© Food Standards Agency 2015
What makes food RTE?
• Manufacturer’s risk assessment and product design, i.e. HACCP
plan:
• Appropriate controls
• Minimise potential for contamination by zoonotic organisms
• Hygienic preparation and packing
• Prevent re-/cross-contamination
• Process
• Limited shelf life
• Ensure peak quality
• Minimise opportunity for microbial growth
• Chilled distribution, sale and storage
• Minimise potential for microbial growth
• Appropriate usage instructions
• Durability date
Criteria Summary
• Absence of Shigatoxin=producing E coli (STEC) in
sprouts
• 178/2002 implies absence from all foods at point of
consumption
• Absence of pathogens in
• dried infant formulae and food for special medical purposes
• Absence of Salmonella in
• ready to eat food
• minced meat and meat preparations made from poultry meat intended
to be eaten cooked
• gelatine and collagen
• 100/g Lm in RTE food not for infants/PARNUTs
• unless the FBO cannot demonstrate that 100/g will not be exceeded
during the shelf life
© Food Standards Agency 2015
National Control Plan (NCP)
• Regulation (EC) 2160/2003 (control of salmonella
and other specified food-borne zoonotic agents)
• Member States to take effective measures to detect and
control Salmonellas of public health significance in
specified animal species at all relevant stages of production
• NCP required for each specified zoonosis/zoonotic agent
• Targets for reduction of Salmonella agreed
• https://www.gov.uk/government/uploads/system/uploads/attachment_data/file
/183088/salmonella-turkeys.pdf
• /183077/salmonella-layers.pdf
• /183080/salmonella-broilers.pdf
© Food Standards Agency 2015
Sampling and Testing –
Microbiological and Environmental
Article 5 of EC Regulation
2073/2005
Food safety is neither guaranteed nor controlled by
microbiological testing
Sampling Plans
• A systematic way to assess microbiological
quality of food lots (batch of products)
• Take into account each food’s properties,
production processes, storage conditions,
associated risks, targeted consumers and
practical limitations
• Samples must be taken independently and
randomly
© Food Standards Agency 2015
Definitions
• ‘Sample’: a set composed of one or several units
or a portion of matter selected by different means
in a population or in an important quantity of
matter, which is intended to provide information
on a given characteristic of the studied population
or matter and to provide a basis for a decision
concerning the population or matter in question or
concerning the process which has produced it
© Food Standards Agency 2015
Definitions
• 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
© Food Standards Agency 2015
Sampling Plans
• The relevant microorganism
• Number of samples to be tested (n)
• n may be reduced if the FBO can demonstrate by historical
documentation that he has effective HACCP-based procedures
• Test methods
• Annex I - analytical methods (are also reference methods)
• Microbiological limits, m and M
• Acceptable (<m) normally achieved when using HACCP and GMP)
• Marginally acceptable (>m and <M)
• Unacceptable (>M) above which contamination is
hazardous/unacceptable
• Allowed sample numbers per category (>m, <M, >M)
© Food Standards Agency 2015
Sampling Plans
• Two class:
• If the organism is not permitted in a unit-volume
• Pass/fail
• Three class:
• If the organism is permitted in a unit-volume
• Acceptable prevalence and level of contamination
© Food Standards Agency 2015
Two Class Sampling Plan
• Only one microbiological limit (m)
• Two classes of attributes (<m and >m) i.e. pass, fail
• Maximum allowable number of unsatisfactory
samples (c)
© Food Standards Agency 2015
Two Class Sampling
(4) Regular testing against the criterion is not useful in normal circumstances for the following ready-to-eat foods: those which have received heat treatment or other processing effective to
eliminate L. monocytogenes, when recontamination is not possible after this treatment (e.g. products heat treated in their final package), bread, biscuits and similar products, bottled or
packed waters, soft drinks, beer, cider, wine, spirits and similar products, sugar, honey and confectionery, including cocoa and chocolate products, live bivalve molluscs.
(5) This criterion applies if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life.
The operator may fix intermediate limits at the limit of 100 cfu/g is not exceeded at the end of the shelf-life.
(7) This criterion applies to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent
authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life.
(8) Products with pH ≤4.4 or aW ≤ 0.92, products with pH ≤ 5.0 and aW ≤ 0.94, products with a shelf-life of less than five days are automatically considered to belong to this category. Other
categories of products can also belong to this category, subject to scientific justification.
© Food Standards Agency 2015
Three Class Sampling Plan
• Two microbiological limits, m and M:
• m = GMP upper limit
• M = the limit beyond which the contamination level is hazardous
or unacceptable
© Food Standards Agency 2015
Three Class Sampling - Histamine
(17) Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae.
(18) Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of Regulation (EC) No 178/2002, according to which the whole batch
should be deemed unsafe, shall not apply, unless the result is above M.
(19) Ref: 1. Malle P., Valle M., Bouquelet S. Assay of biogenic amines involved in fish decomposition. J. AOAC Internat. 1996, 79, 43-49. 2. Duflos G., Dervin C., Malle P.,
Bouquelet S. Relevance of matrix effect in determination of biogenic amines in plaice (Pleuronectes platessa) and whiting (Merlangus merlangus. J. AOAC Internat. 1999, 82,
1097-1101.
© Food Standards Agency 2015
Histamines
• Satisfactory:
• the mean value is ≤ m or a maximum of c/n values
observed are between m and M or no values observed
exceed M
• Unsatisfactory:
• the mean value is > m or
• more than c/n values are between m and M or
• one or more is >M
• What is the course of action if:
• [Example]
© Food Standards Agency 2015
Testing and 2073/2005
• 2073/2005 requires FBOs to
• Ensure their products comply with microbiological criteria
• Test against microbiological criteria as appropriate “when they are
validating or verifying the correct functioning of their
procedures based on HACCP principles and Good Hygienic
Practice (GHP)”
• 2073/2005 not intended to lead to additional testing
• validating/verification testing is part of HACCP
• 2073/2005 should not lead to an increased reliance on or
use of positive release
© Food Standards Agency 2015
Important – limitations of testing
• Cannot rely on final product microbiological testing
alone to demonstrate product safety
• HACCP, GMP must be in place and functioning properly
• Testing only identifies the status of that sample
• Overlying trend must be considered
• Using an inappropriate method or a poorly-run
laboratory may lead to false results
• Negatives => false sense of security
• Positives => unjustified withdrawal/recall
© Food Standards Agency 2015
Important - limitations of testing
• Foods may not be heat processed
• Foods may be RTE, ready to reheat or ready to cook
• Many foods are not homogeneous – multicomponent
• Attempt a representative sub-sample
• Over time and many numbers of samples this gives an ‘average’
sample with respect to microbiological contamination
• Will still see a degree of heterogeneity
• Gives a good indication of variability over time
• Can give confidence in study results
© Food Standards Agency 2015
Important - limitations of testing
• Short shelf life foods:
• Results will often not be available within the shelf life
• Environmental sampling
• Testing is retrospective and therefore of very limited
value except for historical data and trend analysis
• Not commercially viable to test sufficient products for
positive release to have statistically reliable results
© Food Standards Agency 2015
Sampling and testing frequencies
• 2073/2005 does not specify sampling/testing frequency
except for:
• raw minced meat, meat preparations, certain meat products intended to
be cooked, and MSM
• FBOs otherwise decide appropriate sampling frequencies
in the context of their procedures based on HACCP
principles and GHP, taking into account the instructions
for use of the foodstuff
• Sampling frequency may be adapted to the nature and
size of the food business, provided that food safety is not
endangered
© Food Standards Agency 2015
Sampling Frequency
•Based on risk
•Take account of instructions for use of
foodstuff e.g. ready-to-eat
•Annex 1 sets minimum levels of sampling
•Reduced sampling plan may be appropriate
© Food Standards Agency 2015
Specified sampling frequencies
• Minced meat, meat preparations, MSM or fresh
poultry meat:
• FBOs to take samples at least once a week, changing
the day of sampling each week ‘to ensure that each day
of the week is covered’
• If satisfactory results obtained for six consecutive
weeks can reduce sampling to fortnightly for:
• minced meat and meat preparations - E. coli and aerobic
colony count, and
• carcases - Enterobacteriaceae and aerobic colony count
© Food Standards Agency 2015
Specified sampling frequencies
• Salmonella sampling frequency may be reduced for
minced meat, meat preparations, carcases and fresh
poultry meat to fortnightly if:
• satisfactory results have been obtained for 30
consecutive weeks, or
• there is a national or regional salmonella control
programme in place and if this programme includes
testing that replaces the sampling required by the
Regulation, and further reduced if
• the national or regional salmonella control programme
demonstrates that salmonella prevalence is low in
animals purchased by the slaughterhouse.
© Food Standards Agency 2015
Specified sampling frequencies
• Exemptions from sampling frequencies
• for small slaughterhouses and establishments producing minced meat,
meat preparations and fresh poultry meat in small quantities
• when justified by a risk analysis and consequently authorised by the CA
© Food Standards Agency 2015
Flexibility with 2073/2005
•Food Business Owner is to decide the
frequency of sampling and testing.
•According to risk, nature and size of business.
•If Food Business Owner can evidence that
FSMS in place and functioning correctly and/or
following FSA guidance, Industry Guides may
NOT need to test.
•https://www.food.gov.uk/sites/default/files/multimedia/pdfs/ecregguidmicrobiolcriteria.pdf
© Food Standards Agency 2015
Flexibility with 2073/2005
•Where microbiological testing is appropriate
flexibilities apply for sampling and testing
frequency.
•Do NOT need to test every batch.
•May use alternative indicators e.g.
time/temperature profiles; same end result.
•May use good hygiene practises.
•https://www.food.gov.uk/sites/default/files/multimedia/pdfs/ecregguidmicrobiolcriteria.pdf
© Food Standards Agency 2015
2073/2005 Testing and sampling
• If testing aims to specifically assess acceptability of a certain
batch of foodstuffs or a process, Annex I sampling plans are a
minimum.
• FBOs may use other sampling and testing procedures if they
can demonstrate equivalence to the satisfaction of the
Competent Authority.
• May involve alternative sampling sites and use of trend analyses
• For Process Hygiene Criteria can test against alternative
microorganisms and related microbiological limits as well as
analytes other than microbiological ones.
© Food Standards Agency 2015
2073/2005 Testing and sampling
Production environment sampling required of FBOs:
• producing RTE foods, which may pose a Lm risk for
public health
• Sample for Lm
• Listeria spp sampling accepted by FSA and the EC
• producing dried infant formulae or dried foods for
special medical purposes intended for infants below
6 months which pose an Enterobacter sakazakii risk
• Sample for Enterobacteriaceae
© Food Standards Agency 2015
2073/2005: Testing and sampling
• Reference methods contained in Annex I
• Environmental sampling reference method ISO18593.
• Alternative analytical methods are
acceptable when
• validated against the reference method and,
• if a proprietary method, certified by a third party using
EN/ISO 16140 or other internationally accepted similar
protocols.
© Food Standards Agency 2015
2073/2005: Testing and sampling
• FBOs can use alternative methods if validated
according to internationally accepted protocols
and their use authorised by the Competent
Authority
• EHPs should ask the FBO for evidence of method
validation and verify it
• Discuss with FSA if further advice is needed
ISO 16140: Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods
(ISO 16140:2003 + Amd.1:2011)
© Food Standards Agency 2015
Verification by EHP
• EHP must verify that approach use by food
business is appropriate.
•Record on file that alternative methods have
been assessed and deemed appropriate.
•FVO audits
© Food Standards Agency 2015
Food sampling
• Plastic sample bags - sterile and robust so not to tear
• Samples must be taken using aseptic techniques
• Sample bag must be labelled (sampling date and time,
location, temperature of the food) and be secured with a
tamperproof seal
• Hold samples taken during normal working hours at 2-6°C
• If sample taken outside office hours deliver to laboratory in a
cool box/mobile refrigerator pre-cooled to 2-6°C as soon as
practicable
• Samples must not be frozen before submission to a laboratory
• Final product samples should be taken in pack at the end of
the process
© Food Standards Agency 2015
Environmental sampling
• Required for processing areas for:
• RTE foods which may pose a Lm risk – sampling for Lm specified
but Listeria spp sampling accepted and is industry standard
• Dried infant formulae or dried foods for special medical purposes
intended for infants below six months which pose an Enterobacter
sakazakii risk – sample for Enterobacteriaceae
• EU Lm Reference Lab/ANSES Guidelines on sampling
food processing areas and equipment
• http://ec.europa.eu/food/food/biosafety/salmonella/docs/guidel
ines_sampling_en.pdf
Lm hotspots
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Places that are wet (including screw threads)
Hollow or ball bearing-filled conveyor belt rollers
Equipment controls and door handles
Gaps between joined materials
Equipment support rods
Worn or cracked rubber seals around chiller doors
Drains
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How to sample the environment
• Environmental microbiological tests are not real time
hygiene monitoring, but can be used to:
• verify cleaning and disinfection
• to evaluate trends and
• for investigation purposes.
• Investigation results should not be used to monitor
trends.
• Any additional sampling points highlighted in an
investigation should be included in the routine
sampling plan.
© Food Standards Agency 2015
How to sample the environment
• Rapid Hygiene Monitoring (ATP):
• ATP swabbing and similar rapid hygiene monitoring systems give a
result that can be interpreted before start-up.
• ATP results do not relate directly to microbial levels, but are a good
indicator of hygiene.
• relatively expensive, so best used to monitor specific CCPs, e.g.
food contact critical equipment such as slicing blades, and to train
hygiene staff in cleaning.
© Food Standards Agency 2015
How to sample the environment
• Use swabs appropriate to the size of the surface being tested
• Sterile sponges can be used for larger areas
• Use an appropriate medium or neutraliser for transportation to
the laboratory
• If swabbing after cleaning, ensure that a deactivation agent
has been applied beforehand i.e. swabs must be pre treated
with deactivating agent prior to swabbing
• Swabs should be tested within 24 hours of swabbing
© Food Standards Agency 2015
How to sample the environment
© Food Standards Agency 2015
How to sample the environment
• For cracked surfaces, e.g. drains
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Use sterile waffle sponges and sterile neutralising diluent
Agitate the sponge
Push the sponge to send the diluent out into cracks
Relax pressure for the sponge to suck the diluent back up
Scrub 2 perpendicular directions if surface not too abrasive
Interpreting sample data
• Trend analysis
• Historical data
• Moving average for PHC
© Food Standards Agency 2015
Trending
• Recital 25:
• Trends in test results should be analysed, as they are able to
reveal unwanted developments in the manufacturing process
enabling the FBO to take corrective actions before the process is
out of control.
Trend analysis
• A procedure to detect a change in the patterns of
observations over a period of time
• Can be applied to testing against a microbiological
criterion
• Can detect a gradual loss of control that might not be
detected by a moving window approach, as well as a
more sudden loss of control
• May show changes or patterns in the data that result
from unwanted changes in the manufacturing process
• enables the FBO to take corrective actions before the food safety
management system is out of control
© Food Standards Agency 2015
Trend analysis
• An adverse trend is when levels are frequently at or
near the Report level or when a significant increase
over the level normally observed is seen.
• Adverse trends must be identified, investigated and
appropriate corrective actions taken.
© Food Standards Agency 2015
Is this process under control?
© Food Standards Agency 2015
Moving average for PHCs
Trend Example
180000
0.014
160000
0.012
140000
0.010%
No. samples taken
0.008
0.007%
100000
0.045%
80000
60000
0.006
0.004%
0.004
0.004%
40000
0.002
20000
0
0
1
2
3
4
5
6
Period
© Food Standards Agency 2015
7
8
9
10
% Lm positives
0.01
120000
Historical data
• Article 5.3: "The number of sample units of the
sampling plans set out in Annex I may be reduced, if
the FBO can demonstrate by historical
documentation, that he has effective HACCP-based
procedures."
• The more confidence you have in the FBO’s
procedures and efficacy of controls, the less testing
is required.
© Food Standards Agency 2015
Confidence in
HACCP systems
High

Low
Testing Level
Low
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High
Historical data
• For example, for raw materials FBOs should demonstrate:
• Understanding of the microbiological hazards and risks associated with
the raw material
• Knowledge and confidence in the supplier/ producer of the raw
material
• The risk associated with the volume of the raw material used
• Historical data to support these points
• Confidence can be enhanced by the FBO:
• Auditing their suppliers and their HACCP including their microbiological
checks, and/or
• Increasing the frequency of checks until sufficient historical data is
available
© Food Standards Agency 2015
Retail Surveys
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FSA Campylobacter in whole chickens from retailers
4000 chickens sampled Feb 2014 to Feb 2015
19% positive >1000 cfu/g Campylobacter
73% positive for presence of Campylobacter
0.1% packaging positive >1000 cfu/g Campylobacter
7% packaging positive for presence of Campy.
Variations between retailers but none met target.
© Food Standards Agency 2015
Retail Surveys – Listeria
March–Sept 2007 (FSA Project B18024)
• Cooked sliced meat (CSM) and pâté sold by SMEs & major
retailers, outlets sampled by percentage of market share
• 1691 CSM samples:
• 2.82% Listeria spp, 1.53% Lm
• 1651 pâté samples:
• 0.82% Listeria spp, 0.32% Lm
• S aureus
• 0.18% CSM, 0.12% pâté
• Enterobacteriaceae
• 11.56% CSM: 10-2.9x105 cfu/g
• 6.12% pâté: 10-1.4x105 cfu/g
• No Campylobacter, Salmonella, E coli O157 or E coli found
© Food Standards Agency 2015
Retail Surveys – Listeria
April 2012-March 2013 (FSA Project FS241042)
• Cooked Sliced Meats sold by SMEs
• 1049 samples from ~100 producers:
• 7% +ve Listeria spp
• 3.8% +ve Lm
• Listeria isolated from products of 27% of producers sampled
• Mean Listeria prevalence 25% in product from 23 producers
• Enterobacteriaceae enumerated in 36.2%
• mean 2.96 ± 1.47 log cfu/g
• E. coli enumerated in 0.48%
• Mean sample surface temperature 6.8°C
• 71.3% >5°C, 32.7% >8°C
© Food Standards Agency 2015
Corrective Actions Following
Unsatisfactory Results
Article 7 of 2073/2005
•Where results of testing against criteria are
unsatisfactory Food Business Owners shall...
•Take action necessary to protect the health of
consumers
•Withdraw; Article 19 Regulation (EC) 178/2002
•Recall
•Take corrective actions as specified in their
HACCP
•Find the cause of the unsatisfactory result
© Food Standards Agency 2015
Corrective Action
Art 7.2-7.4 requires appropriate investigation and corrective
action if:
• a trend towards unsatisfactory results is found, or
• Process Hygiene Criteria are exceeded
To include:
• the actions specified in the Annex I for each criterion
• other corrective actions defined in the FBO’s HACCP-based procedures
• other actions necessary to protect the health of consumers
• FBO taking measures to find the cause of the unsatisfactory results to
prevent recurrence of the unacceptable microbiological contamination
and may include modifications to the HACCP-based procedures or
other food hygiene control measures in place.
© Food Standards Agency 2015
Corrective Actions
• Should be based on:
• an assessment of the risk to the consumer where
relevant
• the point in the food chain, and the food specified and
may consider history of conformance
• FBOs must:
• re-evaluate their food safety control systems, including
Good Hygiene Practice and operational procedures,
and/or
• investigate further to determine appropriate
preventative actions to be taken.
© Food Standards Agency 2015
Article 7 of 2073/2005
•Unsatisfactory results against Food Safety Criterion
•If not yet at retail level may be further processed to
eliminate hazard.
•Only by manufacturer not retailer.
•“Manufacturer may use unsatisfactory foods for another
purpose provided does not pose a risk to public or animal
health and provided that this use has been decided within
the procedures based on HACCP principles and good
hygiene practice and authorised by the competent
authority”.
© Food Standards Agency 2015
Corrective Actions
•
For non-conformance with a Food Safety Criterion actions should include:
•
•
•
•
•
•
•
•
appropriate product containment and traceability
potential further processing or diversion to an alternative use
rework or
rejection or
destruction of product
more frequent sampling
withdrawal and/or recall
Investigate common influences:
•
•
Temperature - Storage and thermal process delivery
Plant hygiene control
•
•
•
•
•
•
Raw material quality
Segregation
Delivery and efficacy of hygiene schedules
Environmental sampling
Appropriateness of shelf life (Lm)
Verify that corrective action has been successful - increase sampling?
© Food Standards Agency 2015
Verification of compliance
• “To evaluate whether a foodstuff complies with own
HACCP”.
• Verify withdrawal/recall/corrective actions.
• Audit HACCP
• How can you do this?
• Identify products withdrawn/recalled
• Trace through system
© Food Standards Agency 2015
Traceability
• Article 18 of Regulation (EC) 178/2002
• “The ability to follow the movement of a food through a
specified stage (s) of production, processing and
distribution”. Codex Alimentarius
• One step back
• One step forward
• Escherichia coli (STEC) O104:H4; Germany and France
(2011)... Egyptian seed source
© Food Standards Agency 2015
Reporting Food Incidents/Hazards
• Food Law Code 2015 Chapter 2.
• Incidents = Food Hazards, Food fraud and Non
hazardous.
• Localised/serious/non localised
• CA must risk assess food hazard to determine extent etc
• Primary authority
• Report online
•
https://www.food.gov.uk/enforcement/enforcework/report
© Food Standards Agency 2015
Enforcement
“is reasonable, proportionate, risk-based and consistent
with good practice” - Food Law Code 2015 Chapter 6.
• Except where significant risk...operate a graduated and
educational approach.
• Primary Authority resolution.
• Start at the bottom of the pyramid; education, further
advice and sampling, HINs, HEPNs, RANs, prosecution.
•
© Food Standards Agency 2015
Enforcement
• Primary authority; have they validated the HACCP?
• BDRO website https://www.gov.uk/government/organisations/better-regulation-delivery-office
• Enforcement Policy
• Code for Crown Prosecutors
1. Evidence Test
2. Public Interest
https://www.cps.gov.uk/publications/code_for_crown_prosecutors/codetest.html
© Food Standards Agency 2015
Enforcement
• Non Compliance with
Article 3 of EC
Regulation 2073/2005
• “Shall ensure that”
• Process hygiene and
food safety criteria are
met.
• “Shall conduct shelf life
studies”
© Food Standards Agency 2015
•
•
•
•
Options;
Educate
Advise
Enforce : Remedial
Action Notice/Hygiene
Improvement
Notice/Emergency
Hygiene Prohibition
Notice/Prosecution.
Enforcement
• Non compliance with
Article 4 of EC
Regulation 2073/2005
• “Shall perform testing as
appropriate against the
microbiological criteria
set out in Annex I”.
© Food Standards Agency 2015
•
•
•
•
Options;
Educate
Advise
Enforce : Hygiene
Improvement
Notice/Prosecution.
Enforcement
• Non compliance with
Article 5 of EC
Regulation 2073/2005
• Reference methods in
accordance with Annex I
• Compliance ISO 18953
© Food Standards Agency 2015
•
•
•
•
Options;
Educate
Advise
Enforce : Hygiene
Improvement
Notice/Prosecution.
Enforcement
• Non compliance with
Article 7 of EC
Regulation 2073/2005
• Shall take corrective
actions
• Shall find the cause
© Food Standards Agency 2015
•
•
•
•
Options;
Educate
Advise
Enforce : Remedial
Action Notice/Hygiene
Improvement
Notice/Prosecution.
Enforcement
• Non compliance with
Article 14 of EC
Regulation 178/2002.
• Food unfit for human
consumption or injurious
to health.
© Food Standards Agency 2015
•
•
•
•
Options;
Educate
Advise
Enforce : Remedial
Action Notice/Hygiene
Improvement
Notice/Prosecution.
Enforcement
• Non compliance with
Article 19 of EC
Regulation 178/2002
• Withdrawal, Recall and
notification to competent
authorities.
© Food Standards Agency 2015
•
•
•
•
Options;
Educate
Advise
Enforce : Remedial
Action Notice/Hygiene
Improvement
Notice/Prosecution.
Enforcement
• Non compliance with
Regulation 29 of Food
Safety Food Hygiene
(England) Regulations
2013.
• Food not produced
processed or distributed
in accordance with
hygiene regulations.
© Food Standards Agency 2015
Options;
Educate
Advise
Enforce : Remedial
Action Notice/Hygiene
Improvement
Notice/Prosecution/
• Detention Notice for
examination (reg.10)
•
•
•
•
Enforcement
• Remember
• Remember
• All offences committed
under Regulation 19 of
Food Safety Food
Hygiene (England)
Regulations 2013
• Must fulfil the health
risk condition for
service of Hygiene
Emergency Prohibition
Notice
© Food Standards Agency 2015
Real Life Enforcement
•Routine sampling 4th Aug 2008 revealed ;
•Hot smoked trout 4,500 Lm and Hot smoked
salmon Lm so high uncountable.
•Approved establishment with HACCP
•Three employees
•Production of smoked fish on 22 July+ 18 days
•6th Aug; Notified by laboratory; RDC notified FSA
© Food Standards Agency 2015
Real Life Enforcement
•Notified business immediately
•Instructed to issue Product Recall on affected
batch
•Closed for weekend
•Team briefing; notified neighbouring authorities
•11th Aug; Formal samples of smoked fish on site
and informal environmental samples
© Food Standards Agency 2015
Real Life Enforcement
•13th Aug; Full Inspection of premises revealed
poor standards
•Rat infestation
•Poor structural standards
•Lack of disinfection
•Poor personal hygiene
•Served Remedial Action Notice for physical
conditions not Lm.
© Food Standards Agency 2015
Real Life Enforcement
•13th Aug; CCDC notified of case of listeriosis in
hospital
•Checked business closed (RAN)
• 14 Aug; Served detention notice on 40 remaining
hot smoked salmon and trout fillets from batch
•15th Aug; interviewed patient; had not consumed
smoked fish
•Visited establishment to check compliance
© Food Standards Agency 2015
Real Life Enforcement
•15 Aug Served Prevention of Damage by Pests
Act Notice on land owner
•Business conducted deep clean; results showed
minimal Lm but high levels of Enterobacteriecae
•Further environmental sampling
•One colony of Lm remained
•Advised to install heating
•30 Sept; All physical works complete
© Food Standards Agency 2015
Real Life Enforcement
•
•
•
•
•
•
Revised HACCP submitted for approval
3rd Oct; comments made on HACCP
8th Oct; HACCP further revised and accepted
8th Oct; Service of withdrawal notices
13th Oct; Wrote to FSA to advise incident closed
Business subsequently folded.
© Food Standards Agency 2015
Summary
Before making enforcement decisions consider;
1. HAZARD; what is the causative organism?
2. RISK; with associated food and distribution.
3. FACTS; what evidence do you have to support
the “facts”?
4. PUBLIC HEALTH and INTEREST; how will
these be served?
© Food Standards Agency 2015
1215-1300
Lunch
© Food Standards Agency 2015
Why Lm is a Problem
• The biggest cause of deaths from foodborne illness in the EU
and UK
• Transmission from:
• contaminated food
• the environment
• mother to foetus
• Major transmission route to humans is contaminated food
Listeriosis
The biggest cause of foodborne illness deaths in the UK and EU
Disease
Campylobacteriosis
Salmonellosis
Yersiniosis
VTEC infections
Listeriosis
Hospitalisation
Number of
Rate
confirmed Reported
human hospitalised (%)
cases
cases
214,779
82,694
6,471
6,043
1,763
11,922
7,841
481
922
735
43.6
36.0
48.4
37.1
99.1
Deaths
Reported Casedeaths fatality
rate (%)
56
59
2
13
191
0.05
0.14
0.05
0.36
15.6
13 food-borne outbreaks reported by 7 MS and 1 non-MS. 3 outbreaks implicated seafood
EFSA Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Foodborne Outbreaks in 2013. EFSA Journal; 13 (1): 3991
© Food Standards Agency 2015
Listeriosis
• UK lab-confirmed cases:
• 1990-2000: 114-136 p.a.
• 2000-2009: doubled
• 2008-2013, England and Wales:
• 1017 cases reported
• 129 pregnancy-related
• 54% cases were males
• 64.7% were >60 years of age
• 17 outbreaks/clusters investigated (83 cases)
Epidemiology of listeriosis in England and Wales between 2008 and 2013. ACMSF. ACM/1135, January 2014
Listeriosis
• Invasive:
• similar to meningitis, blood infections, septicaemia, local
infections
• Non-invasive:
• Can sometimes only cause febrile gastroenteritis
• England and Wales (2008-2013):
• bacteraemia in 79% cases
Lm ecology
• One of 6 spp of Listeria:
• monocytogenes, innocua, welshimeri, seeligeri, grayi, ivanovii
•
•
•
•
•
•
•
•
•
Gram-positive rod-shaped bacterium
Widespread in the environment: soil, water, animal faeces, vegetation
Carried by 10% of people
Forms persistent biofilms on surfaces creating reservoir of
contamination resistant to cleaning and disinfection
Grows at refrigerator temperatures
Grows in low oxygen environments, e.g. vacuum packed foods
Can survive freezing
Is highly salt tolerant
Relatively heat resistant (70°C/2 mins for 6-log reduction)
© Food Standards Agency 2015
Lm ecology
Factor
Growth
Survival
Lower Limit
Optimum
Upper Limit
-1.5 to 3.0
30-37
45
-18
pH
4.2-4.3
7
9.4-9.5
3.3-4.2
aW
09.90-0.93
0.99
>0.99
<0.90
<0.5
0.7
12-16
>20
Temperature (°C)
NaCl (%)
Atmosphere
© Food Standards Agency 2015
Facultative anaerobe – survives in presence or absence of oxygen
Lm ecology
• Lm enters a factory from workers, raw materials etc
• Drains are a hotspot unless special measures are taken
• Spreads onto equipment (e.g. screw threads, cable duct,
imperfect joins) and becomes persistent
• Persistent strains are mostly isolated from final products
• Lm can adhere to all equipment materials commonly
used in the food industry, and form biofilms
Biofilms
• Organisms adhere to a surface, produce extracellular
polysaccharides and become embedded
• Persistent Lm strains adhere to surfaces and form
biofilms more readily than sporadic strains
• Once biofilms are established they are difficult to remove
and can be resistant to cleaning and disinfection
• Quaternary ammonium compounds (quats) particularly effective against
Gram positive organisms such as Lm
• Lm significantly more resistant to disinfection in biofilms
than when free-living
• Thick, complex Lm biofilms more difficult to remove than
adherent single cells
•© Food
Can
contaminate food in contact during preparation
Standards Agency 2015
Vulnerable Groups
• People with weakened immune systems are particularly susceptible
to listeriosis, and likely to suffer more severe symptoms
• Vulnerable groups include:
• cancer patients
• patients undergoing immunosuppressive or cytotoxic treatment
• unborn and newly delivered infants
• pregnant women
• people with diabetes
• alcoholics (including those with alcoholic liver disease)
• People using gastric acid inhibitors*
• the elderly
© Food Standards Agency 2015
* Risk factors for sporadic listeriosis in the Netherlands, 2008 to 2013. Euro Surveill. 2015;20(31):pii=21199
Notable Recalls from the UK Market
Ear & Tongue Roll
Lithuanian import - 2.8 x 106 cfu/g
Use by 16/10/08, Recall 22/10/08
Home Black Pudding Sausage
Polish import – 6 x 105 cfu/g
Use by 30/10/10, Recall 20/10/10
http://www.food.gov.uk/news/newsarchive/2008/oct/samsono
www.food.gov.uk/enforcement/alerts/2010/oct/sokolowssaus
age
Prevalence in UK RTE Foods
• Higher prevalence in
• Food sliced to order rather than pre-packed
• Non-prepacked foods without clear storage/usage instructions
• Food from sandwich bars, butchers, convenience shops, bakeries
• ‘Consumer at risk' score inversely proportional to prevalence
HPA/LACORS Survey May 2006-April 2007
Premises type
No. samples
Samples (% Lm)
Sandwich bar
106
6 (5.7)
Supermarket pre-packed
3820
Mar–Sep 2007 (FSA B18024)
55 (1.4)
Apr 2012-Mar 2013 (FSA FS241042)
Cooked sliced meat sold by SMEs &
majors
Cooked sliced meat sold by SMEs
Listeria spp
2.8%
7%
Lm
1.5%
3.8%
11.6%: 10-2.9x105 cfu/g
36.2%: mean 2.96±1.47 log cfu/g
ND
0.48%
Enterobacteriaceae
E. coli
UK Listeriosis cases/clusters
Year
Region
Cases
Vehicle
1999
NE England
4
Hospital sandwiches
2003
NE England
17
Butter
2003
NE England
18
None identified
2003
S Wales
2
Hospital sandwiches
2003
SW England
5
Hospital sandwiches
2004
E Mids
6
None identified
2004
SE England
2
Hospital sandwiches
2005
NW England
1
Sliced meat
2006
London
1
Sliced meat
2007
London
1
Hospital sandwiches
2011
Staffordshire
3
Hospital sandwiches
2012
Northern Ireland
Hospital sandwiches
ACM 847a (ACMSF) 2007, Eurosurveillance 16 (20) May 2011 + supplementary information
Foods of particular risk to vulnerable
groups
Meat
Fish
• Smoked fish
• Cooked shellfish
• Pate
• Cooked (sliced)
meats /poultry
• Pate
• Cured meats
Pasteurised/
unpasteurised cheeses
• Soft blue veined
• Mould ripened soft
Prepared foods
• Pre-packed sandwiches
• Prepared salad
vegetables
• Some cut fruits,
including melon
Generally high risk:
•
•
•
•
Chilled
Ready to eat
Able to support the growth of Lm
Proteinaceous foods - free amino acids required for Lm growth
EFSA Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Foodborne Outbreaks in 2013. EFSA Journal; 13 (1): 3991
© Food Standards Agency 2015
Legal Requirements for
L. monocytogenes
RTE foods classification
• Intended for infants and for special medical purposes
• Foods able to support the growth of Lm during shelf life
(other than those intended for infants and for special
medical purposes)
• Foods unable to support the growth of Lm during shelf
life (other than those intended for infants and for special
medical purposes)
• Foods listed in Annex I Chapter 1 2073/2005 footnotes
© Food Standards Agency 2015
Food Safety Criteria: Lm and RTE foods
Food Category
Microorganisms
1.1 RTE foods
intended for infants
and RTE foods for
special medical
purposes
1.2 RTE foods able to
support the growth of
L. monocytogenes
other than those
intended for infants
and young children
and ready-to eat-foods
for special medical
purposes3
Listeria
monocytogenes
Listeria
monocytogenes
1.3 RTE foods unable Listeria
to support growth of L. monocytogenes
Monocytogenes other
than those intended for
infants and special
medical purposes
Samplin
g plan
Limits
Analytical
Reference
Method
Stage where the
criterion applies
n
10
c
0
m
M
Absence in
25g
EN/ISO
11290-1
Products placed on
the market during
their shelf life
5
0
100 cfu/g
EN/ISO
11290-1
Products placed on
the market during
their shelf-life
5
0
Absence in
25g
EN/ISO
11290-2
0
100 cfu/g
EN/ISO
11290-1
Before the food has
left the immediate
control of the FBO
who has produced
it
Products placed on
the market during
their shelf-life
5
3
n = number of samples
c= number of samples units giving values between m and M.
For food safety criteria only 1 limit is provided so m=M
Footnotes are included to the Annex which assist in the interpretation/appliocation of the criteria.
Annex I, Chapter 1 footnotes
• (4) Regular testing against Lm is not required in normal circumstances for
the following RTE foods:
• those which have received heat treatment or other processing effective to
eliminate Lm when recontamination is not possible after this treatment (for
example, products heat treated in their final package)
• fresh, uncut and unprocessed vegetables and fruits, excluding sprouted
seeds
• bread, biscuits and similar products
• bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar
products
• sugar, honey and confectionery, including cocoa and chocolate products,
• live bivalve molluscs
• food grade salt.
© Food Standards Agency 2015
Annex I, Chapter 1 footnotes
• (5) This criterion shall apply if the manufacturer is able to demonstrate, to
the satisfaction of the CA, that the product will not exceed 100 cfu/g
throughout the shelf-life. The FBO may fix intermediate limits during the
process that must be low enough to guarantee that the limit of 100 cfu/g is
not exceeded at the end of shelf-life.
• 100 cfu/g allowed
• (7) This criterion shall apply to products before they have left the immediate
control of the producing FBO, when he is not able to demonstrate, to the
satisfaction of the competent authority, that the product will not exceed the
limit of 100 cfu/g throughout the shelf-life.
• 0 cfu/g allowed
© Food Standards Agency 2015
Annex I, Chapter 1 footnotes
• (8) Products with pH ≤ 4.4 or aW ≤ 0.92,
products with pH ≤ 5,0 and aW ≤ 0.94, products
with a shelf-life of less than five days shall be
automatically considered to belong to this
category. Other categories of products can also
belong to this category, subject to scientific
justification.
• Does not support growth of Lm
© Food Standards Agency 2015
Food Safety Criteria Annex I
1.1 Ready to eat foods intended for infants and ready to
eat foods for special medical purposes;
• Lm
• Sampling plan; n=10; c=0
• Absence in 25g
• Where? Products placed on the market during their
shelf life.
• Regular testing not required for foods which have been
heat treated when recontamination is not possible.
© Food Standards Agency 2015
Food Safety Criteria...
1.2 Ready to eat foods able to support the growth of Lm,
other than those intended for infants and for special
medical purposes.
• For products placed on the market during their shelf
life, sampling plan n=5; c=0; Lm limit 100 cfu/g
throughout shelf life.
• Before the food has left the immediate control of the
FBO who has produced it, sampling plan n=5; absence
in 25g, when FBO not able to demonstrate that product
will not exceed limit throughout shelf life.
© Food Standards Agency 2015
Food Safety Criteria...
1.3 Ready to eat foods unable to support the growth of
Lm, other than those intended for infants and for special
medical purposes.
• For products placed on the market during their shelf
life, sampling plan n=5; c=0; Lm limit 100 cfu/g when
placed on the market at throughout shelf life.
© Food Standards Agency 2015
Labelling
•Article 6 of EC Regulation 2073/2005
•Minced meat, meat preparations, meat products intended
to be eaten cooked
•Batch clearly labelled to inform consumer of need for
thorough cooking prior to cooking.
© Food Standards Agency 2015
Shelf Life
• Either the period corresponding to the period
preceding the “use by” or the minimum durability
date.
• In practice the period during which the product
maintains its microbiological safety and sensory
qualities at a specific storage temperature.
• Annex II - approach with respect to Lm and RTE
foods
© Food Standards Agency 2015
Shelf Life
• A critical parameter
• A CCP for chilled foods
• Setting appropriate shelf life is part of HACCP and
required by law
• How should it be set in relation to L. monocytogenes?
© Food Standards Agency 2015
Shelf life assessment hierarchy
• Scientific data (e.g. pH, aw, literature)
• Product will not support growth, growth reported to be limited
• Historical or other data are the best data. real
• Levels found in reality
• Safety record of the product
• Model outputs (e.g. http://ComBase.cc)
• Will not support growth, growth limited within given shelf life
under expected storage conditions
• Shared industry data on any of the above
• Trade associations
• If no data available then consider shelf life or challenge test studies
• Note: shelf life assessment is not challenge testing
Shelf life in practice
• Design safety into the product during NPD
• Number of studies determined by HACCP
• Assess before factory trialling:
• Micro safety and stability: indicators + spoilage organisms
• Organoleptic characteristics, e.g. texture, colour
• Pathogens
• Test using a competent laboratory (ISO 17025):
•
•
•
•
Day of production (DOP)
End of life (EOL)
In-between (if shelf life long enough)
Use a different sample for each test point
• Ongoing monitoring
Comparing shelf lives
UK
Other EU
USA
Delicatessen
meat
10-15 d (uncured)
15->30 d (cured)
[major retailers]
14-28 d(uncured)
14-56 d(cured)
28-84 d
Sandwiches
2 d [major retailers]
<14* d
< 23 d
<120 d
<120 d
4 d [airline]
10 d [discounter]
Cold-smoked
salmon
21-24 d
Fundamentally the same food so why such different shelf lives?
Use of preservatives, shelf life protocol variability, lack of shelf
life validation + reacting to commercial demands
* Fillings generally low aw
Answer:
Annex II – Shelf Life Studies
• The studies shall take into account the inherent
variability linked to:
• the product
• the micro-organisms in question and
• the processing and storage conditions.
© Food Standards Agency 2015
Annex II – Shelf Life Studies
• The studies shall include:
• specifications for physico-chemical characteristics of the product,
such as pH, aW, salt content, concentration of preservatives and
the type of packaging system, taking into account the storage
and processing conditions, the possibilities for contamination and
the foreseen shelf-life, and
• consultation of available scientific literature and research data
regarding the growth and survival characteristics of the microorganisms of concern.
© Food Standards Agency 2015
Annex II – Shelf Life Studies
• When necessary… FBO shall conduct additional
studies, which may include:
• predictive mathematical modelling… using critical growth or
survival factors for micro-organisms of concern in the product,
© Food Standards Agency 2015
Annex II – Shelf Life Studies
• When necessary… FBO shall conduct additional
studies, which may include:
• predictive mathematical modelling… using critical growth or
survival factors for micro-organisms of concern in the product,
• tests to investigate the ability of the appropriately inoculated
micro-organism of concern to grow or survive in the product
under different reasonably foreseeable storage conditions
(challenge testing),
© Food Standards Agency 2015
Challenge Testing
• Not required by 2073/2005
• If the FBO has GMP, HACCP, supporting systems and the
shelf life approach is followed it is not expected to challenge
test
• Issues:
• Not quick, inexpensive, or simple
• Does not reflect either actual contamination levels,
competition, nor the physical state of organisms which may
be expected to be present in reality
• Relates only to that specific product formulation/process
combination – need to re-do if change characteristic
The safety/stability of a product should instead be
satisfactorily addressed during NPD
Annex II – Shelf Life Studies
• When necessary… FBO shall conduct additional
studies, which may include:
• predictive mathematical modelling… using critical growth or
survival factors for micro-organisms of concern in the product,
• tests to investigate the ability of the appropriately inoculated
micro-organism of concern to grow or survive in the product
under different reasonably foreseeable storage conditions
(challenge testing),
• studies to evaluate the growth or survival of the micro-organisms
of concern that may be present in the product during the shelflife under reasonably foreseeable conditions of distribution,
storage and use.
© Food Standards Agency 2015
Domestic Fridges
Temperature
reported (°C)
<4°C
4.0-4.9°C
5.0-5.9°C
6.0-6.9°C
7.0-7.9°C
8.0-8.9°C
9.0-9.9°C
≥10°C
Number of
fridges at
specified
temperature
143
1,255
120
24
1,356
68
633
8
% fridges at
specified
temperature
4
34.8
3.3
0.7
37.6
1.9
17.5
0.2
Cumulative
%
4
38.8
42.1
42.8
80.4
82.3
99.8
100
Of 3,607 domestic refrigerators (consolidated surveys) worldwide 39% were <5°C,
80% were <8°C. Mean European and UK temperature 6.6°C
Source: Cl botulinum in vacuum and modified atmosphere packed (MAP) chilled foods (FSA Project B13006)
Temperature protocols
• EC Technical Guidance Document on Shelf-life
Studies for Lm in RTE Foods
• Test 3 batches of product, inoculum <100 cfu/g (cultures preadapted to chill conditions), store 7d @ 8°C then 14d @ 12°C
• UK industry approach
• Single batch of product, inoculum 100-1000 cfu/g (cultures
grown overnight at optimal temperature), store 21d @ 8°C
• EC/UK protocol equivalence*
• Little difference in outcomes re time for 2 log increase in levels
* Evaluation of Listeria challenge testing protocols: A practical study using cooked
sliced ham. (2013) Food Control. http://dx.doi.org/10.1016/j.foodcont.2012.06.010
© Food Standards Agency 2015
Shelf Life: Lm and RTE foods
• Guidance for FBOs – CFA/BRC/FSA (2010)
• http://tinyurl.com/BRCCFALmShelfLife
• EC, for FBOs
• http://ec.Europa.eu/food/biosafety/salmonella/docs/translation_g
uidance_lm_en.pdf
• http://ec.europa.eu/food/food/biosafety/salmonella/docs/shelflife
_listeria_monocytogenes_en.pdf
• EC, for specialised laboratories
• http://ec.europa.eu/food/food/biosafety/salmonella/docs/technic
al_guidance_listeria_en.pdf
© Food Standards Agency 2015
Historical Lm data
• The best indication of an organism’s behaviour in
a foodstuff in reality
• When present, Lm is from the environment
• Stressed and will grow slower than those that have
been grown for use in inoculation studies, i.e. in
predictive models, challenge testing
• 2073/2005
• Data on Lm levels present at DOP and at the end of shelf life
(EOL) can be used to assess growth potential
• Most of the time Lm should be absent
• Manufacturers should have a database for Lm comprising
appropriate DOP and EOL samples for each RTE food
• Manufacturers can share data
Example industry data
• [CFA headline data for RTE foods]
© Food Standards Agency 2015
1415-1430
Tea Break
© Food Standards Agency 2015
Breakout Sessions – Case
Study Scenarios
Case Study Scenarios
• Case Study 1
• Testing of a sample of 2 day shelf life of chilled
sandwich taken at retail contains 20 cfu/g L.
monocytogenes
• Case Study 2
• Official testing of a sample of 28 day shelf life
chilled RTE smoked fish taken at retail (10 days
into shelf life) contains 20 cfu/g L. monocytogenes
• Case Study 3
• Routine testing of brief with herbs, tested prior to
dispatch from the producing dairy contains 20 cfu/g
L. monocytogenes
Case Study 1
• Testing of a sample of 2 day shelf life of chilled
sandwich taken at retail contains 20 cfu/g L.
monocytogenes
• What is the appropriate action?
• Which provisions/criteria apply?
• Does the product comply with Regulation
2073/2005?
• What follow-up action is required?
Case study 1: Sandwiches
• Which criterion applies?
• Criteria for Lm in RTE foods apply.
• Different criteria apply if product supports growth
or not and whether likely to be consumed by a
specific consumer group
• Ingredients could support the growth of Lm either
individually or when combined but footnote 8 to
Annex I Ch I states foods with a shelf life of less
than 5 days are automatically considered a food
which does not support growth
• Therefore Criterion 1.3 applies i.e 100 cfu/g
when on the market
Case study 1: Sandwiches
Conclusion
The sandwiches comply with the Regulation BUT..
• Lm is a pathogen and should not be present in food.
FBOs should be aiming for absence in products but
occasionally low levels will be detected.
• Detection of Lm in a product should always prompt an
investigation by the LA or FBO to identify and
control/eliminate possible sources.
• Environmental monitoring (production environment and
equipment) will help identify potential sources and
indicate whether controls are effective (Art 5(2))
Case Study 2: Smoked fish at retail
• Official testing of a sample of 28 day shelf life
chilled RTE smoked fish taken at retail (10
days into shelf life) contains 20 cfu/g L.
monocytogenes
• Does any action need to be taken?
• Which provisions/criteria apply?
• What is the appropriate response?
• What follow-up action is required?
Case study 2: smoked fish at retail
• Criterion 1.2 applies as Lm would be expected to
grow in this product.
• Follow-up action is needed to determine which
criteria apply and whether the product complies.
• Have shelf life studies been carried out to show
levels will not exceed 100 cfu/g during the shelf life?
• Yes – criterion 1.2a applies (100cfu/g) – product
complies with the Regulation
• No – criterion 1.2b applies (absence of Lm at the
end of manufacture)
Case study 2: smoked fish at retail
Applying Criterion 1.2b
• Can the FBO demonstrate LM is absent in 25g at the
end of manufacture?
• No – product does not comply and should be
removed on the market
• Yes – product complies
Case study 2: smoked fish at retail
• Criterion 1.2b only applies at the end of manufacture
so if a product is at retail it is outside the scope of
Regulation 2073/2005.
• Local risk assessment is needed to determine
appropriate action.
• If enforcement action is needed, then Regulation
178/2005 or food hygiene legislation will provide the
appropriate legal base.
Case study 2: Smoked fish at retail
FBO carried out shelf life studies but there are
concerns about evidence provided. What should
be done?
• FBO cannot demonstrate product complies with the
criteria throughout shelf life.
• Action taken depends on local risk assessment and
evidence/data available.
• Where there are concerns that product will pose a
food safety risk it should be removed from market.
• FBO should be advised that more evidence needed to
support shelf life. In the meantime, they may need to
either shorten shelf life or comply with criterion 1.2b
(absence of Lm in 25g at end of manufacture)
Case Study 3: Brie with herbs
• Routine testing of brie with herbs, tested prior
to dispatch from the producing dairy contains
20 cfu/g L. monocytogenes
• What is the appropriate action?
• Which provisions/criteria apply?
• What is the appropriate response?
• What follow-up action is required?
Case Study 3: Brie with herbs
• Which provisions/criteria apply?
• Criterion 1.2 most likely to apply as L. monocytogenes
would be expected to grow in this product.
• Assess product parameters (aW, NaCl, preservatives use), historical
data, predictive mathematical modelling, challenge testing and shelflife testing to determine whether growth can occur
• Article 3 (2) requires FBOs to conduct studies in
accordance with Annex II to investigate compliance with
the criteria throughout the shelf-life, especially for RTE foods
that support the growth of L. monocytogenes.
• Article 5 (2) para. 3 requires FBOs producing RTE foods to
sample processing areas and equipment for L.
monocytogenes as part of their sampling scheme.
Case Study 3: Brie with herbs
• What is the appropriate response?
• A follow-up investigation should be carried out to establish
whether Criterion 1.2a (100 cfu/g) or 1.2b (absence in 25g at the
end of manufacture) applies.
• An assessment should be done of whether appropriate shelf-life
studies have been carried out.
• If an FBO does not have the in-house expertise to carry out the
appropriate studies they should seek support from those with the
appropriate knowledge.
Case Study 3: Brie with herbs
• Scenario #1: FBO carried out shelf-life studies
in accordance with Annex II:
• If FBO can demonstrate L. monocytogenes will not exceed 100
cfu/g during the shelf-life, then Criterion 1.2a (100 cfu/g when on
the market during the shelf-life) applies.
• Product complies with the criteria and product can be
placed on the market.
• The enforcement officer should inform the FBO and advise them
to investigate the source of the contamination taking account of
their obligations under Article 5 (2) and to undertake a review of
the food safety management procedures.
Case Study 3: Brie with herbs
• Scenario #2:The FBO has carried out some
studies in accordance with Annex II, but there
are concerns whether the evidence supports
the shelf-life applied:
• Where there are limitations in the evidence used to establish the
shelf-life, the FBO may not be able to demonstrate the product
complies with Criterion 1.2a throughout the shelf-life.
Case Study 3: Brie with herbs
• Advise FBO that further evidence needed to
support shelf-life, i.e.
•
•
•
•
predictive modelling (e.g. http://combase.cc), or
published or trade association data on similar products, or
results of routine testing, or
results of samples taken and tested on day of production
and then stored until the end of shelf-life
• More evidence = greater confidence in shelf-life and
storage data from samples of product known to
contain L. monocytogenes on day of production
Case Study 3: Brie with herbs
• If there are concerns that current shelf-life is a risk
to public health, consider removing the product from
the market
• Until further data demonstrate compliance with 100
cfu/g throughout shelf-life for future production the
FBO should either:
• shorten shelf-life to one that is supported by the available
evidence, or
• apply Criterion 1.2b (absence in 25g of the product at the
end of manufacture)
Case Study 3: Brie with herbs
• Scenario #3: FBO has not carried out studies
in accordance with Annex II:
• If FBO cannot provide evidence to show levels do not exceed 100
cfu/g during shelf-life, Criterion 1.2b applies and the FBO must
demonstrate
• L. monocytogenes is absent in 25g of the product at the end of
manufacture (not the case in this example)
• The FBO should provide guarantees that L. monocytogenes is
absent in 25g of the product at end of manufacture
• If they cannot provide such guarantees, the product does not
comply with the legislation and must not be placed on the
market.
Case Study 3: Brie with herbs
• What follow-up action is required?
• L. monocytogenes is a pathogen and should not be present in food.
However, occasional low levels of contamination can occur.
• FBO should include L. monocytogenes as a hazard in food safety
management procedures and apply and monitor controls to minimise
risk.
• Detection of L. monocytogenes in products at any level should initiate
an investigation.
• Food safety management procedures should be examined to ensure
they are effective and are being applied properly.
• FBO should revise controls and their monitoring where needed to
eliminate source of contamination and reduce L. monocytogenes risk
• An environmental swabbing and testing programme will help identify
possible sources of contamination.
Reporting Back:
Approach To Managing Case
Studies
Summing Up, Questions and
Close