microbiological criteria fishery products
TRANSCRIPT
BETTER TRAINING FOR SAFER FOOD BTSF
MICROBIOLOGICAL CRITERIA IN FISHERY PRODUCTS
Regulation (EC) 2073/2005
Else Marie ANDERSEN
BTSF
FOOD HYGIENE AND CONTROLS
PROGRAMME 2012-2013
Course on Fishery products & LBM – 11 – 15 June 2012 – Denmark
2
• Participants
⇨ Are informed about the legislation on Microbiological Criteria in Fishery products and have adequate knowledge to apply it in National systems
⇨ Have improved knowledge about control of most important hazards related with fishery products
⇨ Have acquired information about scientific opinions and international guidelines in the field
Objectives of this presentation
Content of this presentation
• General Requirements on Microbial Criteria
• The Scientific Backgrounds
• Microbiological Criteria and Control Measures in
Fisheries Products
• Other Microbiological Hazards and Control
Measures in Fisheries Products
4
Regulation 2073/2005, Annex I, Ch. 1 and Ch. 2.4 - Fisheries Products
HARMONIZED CRITERIA 1
Type of Product Food Safety Criteria
Process Hygiene Criteria
RTE able to support growth Listeria Listeria
RTE unable to support growth Listeria Listeria
Cooked crustaceans and molluscs shellfish Salmonella
Live bivalve molluscs and live echinoderms, tunicates and gastropods
Salmonella
Live bivalve molluscs and live echinoderms, tunicates and gastropods
Escherichia coli
5
Regulation 2073/2005, Annex I, Ch. 1 and Ch. 2.4 - Fisheries Products
HARMONIZED CRITERIA 2
Type of Product Food Safety Criteria
Process Hygiene Criteria
Fishery products from fish species associated with a high amount of histidine
Histamine
Fishery products undergone enzyme maturation treatment in brine from fish species associated with a high amount of histidine
Histamine
Shelled and shuched products of cooked crustaceans and molluscan shellfish
Escherichia coli
Shelled and shuched products of cooked crustaceans and molluscan shellfish
Coagulase-positive staphylococci
6
Elements in a Microbiological Criteria according to Regulation (EC) 2073/2005
• Food category • Micro-organism of concern • Sampling plan • Microbiological limits • Analytical method • Stage where criterion applies • Actions to be taken when
unsatisfactory results
7
Responsibilities of FBO (1)
• Ensure that:
⇨Raw material and foodstuffs under their control comply with Process Hygiene Criteria
⇨Food Safety Criteria throughout the shelf-life can be met.
Reg. 2073/
2005
Art. 3.1
8
• Perform testing against microbiological criteria as a part of validation or verification HACCP and GHP
• Take measures and corrective actions (HACCP) when unsatisfactory results
• Analysis of trends and take actions when observing a trend towards unsatisfactory results
Reg. 2073/
2005
art. 9
Reg.
2073/2005
art. 7.1
Responsibilities of FBO (3) Reg. 2073/
2005
art. 4.1
9
Sampling and analytical methods (3)
• FBO shall decide on sampling frequency
in the frame of the HACCP system, except when frequency is established in Annex I
• FBO can reduce number of sample units (Annex I) if effective HACCP-based procedures can be demonstrated
Reg.
2073/2005
art. 4.2
Reg.
2073/2005
art. 5.3
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Flexibility
• FBO can use other sampling and testing procedures if it provides equivalent guarantees
• For Process Hygiene Criteria it is allowed to test against alternative microorganisms
and related microbiological limits.
• FBO can use alternative analytical methods when
⇨ Method is validated against the reference method in Annex I
⇨ Method is certified in accordance EN/ISO 16140
Reg.
2073/2005
art. 5.5
To the
Satisfaction
CA
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• FBO’s shall take samples from processing areas and equipment when necessary (ISO Standard 18593)
⇨FBO producing ready to-eat foods with Listeria
monocytogenes risk shall always sample
processing areas and equipment
Sampling and analytical methods
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Responsibilities of CA (1)
• Verify FBO compliance with rules and criteria in Reg. 2073/2005
⇨Check manufacturing process
⇨Asses shelf life studies
⇨Verify corrective actions in HACCP
⇨Sampling and testing scheme (HACCP)
⇨Check trends of results
Reg.
2073/2005
art. 1
13
• Undertake sampling and testing for compliance with Food Safety Criteria
⇨At retail
⇨Border inspection posts
⇨In case of suspicion
• Undertake sampling and analysis of other micro-organisms, their toxins or metabolites when deemed necessary
Reg.
2073/2005
art. 1
Responsibilities of CA (2)
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Official Sampling and Analytical Methods
Information for official controls
Guidance document on Official controls concerning
microbiological sampling and testing of foodstuffs
http://ec.europa.eu/food/food/controls/foodfeed/sampling_
testing.pdf
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Unsatisfactory results
• Food safety criteria:
⇨ Product or batch must be withdrawn or recalled
⇨ Product not yet at retail can be submitted to further processing
• Process Hygiene Criteria:
⇨ Actions indicated in Annex I, ch.2
⇨ In both cases, FBO must take measures to find the cause and to prevent recurrence contamination
Reg.
2073/2005
art. 7.2 Reg.
178/2002
art. 19
Reg.
2073/2005
art. 7.4
Reg.
2073/2005
art. 7.1
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Absence of Community Criteria
• Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health
• Unsafe food products must not be placed on the market
Reg.
178/2002
art. 14 Reg.
2073/2005
Whereas 2
Source:
The EU Union
Summary Report on
trends and sources
of zoonoses,
zoonotic agents and
food-borne
outbreaks in the
European Union in
2010
http://ecdc.europa.e
u/en/publications/P
ublications/1203-
ECDC-EFSA-
zoonoses-food-
borne-report.pdf
Source:
The EU Union
Summary Report
on trends and
sources of
zoonoses,
zoonotic agents
and food-borne
outbreaks in the
European Union in
2010
http://ecdc.europa.
eu/en/publications/
Publications/1203-
ECDC-EFSA-
zoonoses-food-
borne-report.pdf
19
Fishery products Harmonized Criteria
20
Food Safety Criteria Listeria spp.
The Scientific Background
• Listeria monocytogenes (SCVPH 1999, SCF 2000, EFSA 2007)
• http://ec.europa.eu/food/fs/sc/scv/out25_en.html
• http://ec.europa.eu/food/fs/sc/scf/out63_en.pdf
• http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/biohaz_op_ej599_listeria_en.pdf?ssbinary=true 21
22
Food safety criteria: Listeria
• RTE able to support growth of Listeria ⇨ e.g. Smoked salmon ⇨ 100 cfu/g in products on the market during their
shelf-life (1) ⇨ Absence in 25 g before food leaves FBO (2) ⇨ n=5, c=0
(1)When manufacturer is able to demonstrate that the
product will not exceed limit 100 cfu/g during the shelf-life
(2) When operator is not able to demonstrate that the
product will not exceed limit 100 cfu/g during the shelf-life
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• RTE unable to support growth Listeria ⇨ 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
⇨100 cfu/g in products on the market during their shelf-life
⇨n=5, c=0
Food safety criteria: Listeria
Notification
Rates of
Listeriosis Source:
The EU
UnionSummary
Report on trends and
sources of zoonoses,
zoonotic agents and
food-borne outbreaks
in the European Union
in 2010
http://ecdc.europa.eu/
en/publications/Public
ations/1203-ECDC-
EFSA-zoonoses-food-
borne-report.pdf
Proportion of
non-compliant
samples
Source:
The EU Union
Summary Report on
trends and sources
of zoonoses,
zoonotic agents and
food-borne
outbreaks in the
European Union in
2010
http://ecdc.europa.eu
/en/publications/Publ
ications/1203-ECDC-
EFSA-zoonoses-
food-borne-
report.pdf
Codex Guidance
• GUIDELINES ON THE APPLICATION OF GENERAL PRINCIPLES OF FOOD HYGIENE TO THE CONTROL OF LISTERIA MONOCYTOGENES IN FOODS - CAC/GL 61 - 2007
32
• The Food Business Operator shall conduct studies to investigate compliance with microbiological criteria throughout the shelf-life
⇨ Guidance document on Listeria monocytogenes shelf-life studies for ready-to-eat food
http://ec.europa.eu/food/food/biosafety/salmonella/docs/guidoc_lister
ia_monocytogenes_en.pdf
⇨ Technical Guidance document on shelf-life studies for
Listeria monocytogenes in RTEF
http://ec.europa.eu/food/food/biosafety/salmonella/docs/shelflife_liste
ria_monocytogenes_en.pdf
Guidance to conduct Shelf Life Studies Reg. 2073/ 2005
art. 3.2
(ANNEX II)
• Predictive microbiology tools – Free available
• Download from Annex 4 in the updated SCVPH opinion on Listeria monocytogenes from 2007 – Annex 4
• http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/biohaz_op_ej599_listeria_en.pdf?ssbinary=true
• SSSP model: www.dfu.min.dk/micro/sssp
• PMP model: http://ars.usda.gov/Services/docs.htm?docid=11550
A simple case
based on Seafood Spoilage
and Safety
Predictor (SSSP)
http://sssp.dtuaqua
.dk/
Coordinated Monitoring Program 2011- 2012
• Commision Decision 678/2010 of 5. November 2010 Concerning the financial contribution from the Union towards a coordinated monitoring programme on the prevalence of Listeria monocytogenes in certain ready to eat foods to be carried out in member states
• Includes
• Hot smoked fishery products
• Cold smoked fishery products
• Gravad fishery products
• Analysis on day of sampling and on expire date
• Scientific background http://www.efsa.europa.eu/en/efsajournal/pub/300r.htm
EFSA BIOHAZ 2011:
• Scientific Opinion on risk based control of biogenic amine formation in fermented foods
• http://www.efsa.europa.eu/en/efsajournal/pub/2393.htm
• No scientific evaluations on Fresh, frozen fish or sterilised fish
38
Food safety criteria Histamine
• Fishery products from fish species associated with a high amount of histidine
• Products placed on the market during their shelf-life ⇨m= 100 mg/kg ⇨M= 200 mg/kg ⇨n=9, c=2
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• Fishery products undergone enzyme maturation treatment in brine from fish species associated with a high amount of histidine
• Products placed on the market during their shelf-life ⇨m= 200 mg/kg ⇨M= 400 mg/kg ⇨n=9, c=2
Food safety criteria Histamine
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Prevalence of histamine • Fishery products implicated in scombroid poisoning include tuna, mackerel and other fish with dark flesh,
⇨but any food that contains histidine and is subject to certain bacterial contamination and
growth may lead to scombroid poisoning
• Histamine fish poisoning is the most common form of toxicity caused by the ingestion of fish that contains high levels of histamine and possibly other vasoactive amines and compounds
41
• Histamine is produced in fish by decarboxylation
of the corresponding free amino acid (histidine)
histidine
decarboxylaze
+1N3H C H
COO1-
CH2
N H
+1 N H
+1N3H C H
H
CH2
N H
+1 N H
Histidine Histamine
mesophilic and psychrotolerant
species of Enterobacteriaceae,
e.g. Morganella Morgani i and
Morganella psychrotolerans
Development of histamine
42
Histamine - Control
• Rapid chilling of fish immediately after death
• Unbroken cold chain during distribution and sale (also in retail).
• Good hygiene practices on-board, at landing and during processing to avoid contamination or recontamination of the fish by bacteria capable of amino acid decarboxylation.
CASE 5.1 and 5.2
Contamination: Normal (10 cfu/g) Histidine level: High (10750ppm) Temperature:
5.1: Reduction from +20°C to + 2°C within 24 hours and keeping at 2°C untill day 10
5.2: Keeping at 20°C for 24 hours, then quick reduction from to + 2°C untill day 10.
Result: Formation of histamine after 10 – 11 days in the case with delayed chilling.
A case based on Seafood Spoilage and Safety Predictor (SSSP) http://sssp.dtuaqua.dk/
45
Scientific basis
• Salmonellae in foodstuffs (SCVPH, 2003) http://ec.europa.eu/food/fs/sc/scv/out66_en.pdf
• Campylobacter in animal and foodstuffs (EFSA, 2005)
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/biohaz_ej
173_op_campylobacter_en1,0.pdf?ssbinary=true
46
Food safety criteria Salmonella
• Cooked crustaceans and molluscan shellfish
• Live bivalve molluscs and live echinoderms, tunicates and gastropods ⇨Absence in 25 g ⇨Products placed on the market
during their shelf-life ⇨n=5, c=0
47
Salmonella Control measures
• Prevention of contamination (cross-contamination) of RTE foods
• Control of contamination in food processing areas incl. personal hygiene
• Low temperatures storage of foods to prevent growth
Status in EU
2010
• Cooked crustaceans and molluscs
• 80 single samples: 0 Positive
• 405 batches: 0,5% Positive
• Live Bivalve Molluscs
• 201 single samples: 1,5% positive
• 243 batches: 0% posive
Reference: See more details in The EU Union Summary Report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in the European Union in 2009.
49
Food safety Criteria Process Hygiene Criteria
E. coli
50
• Verotoxigenic E. coli in foodstuffs (SCVPH,
2003)
http://ec.europa.eu/food/fs/sc/scv/out58_en.pdf
Scientific basis
51
Food safety criteria: E. coli
• Live bivalve molluscs and live echinoderms, tunicates and gastropods ⇨230 MPN/100 g (flesh and intravalvular liquid) ⇨Products placed on the market
during their shelf-life ⇨n=1, c=0
52
Process hygiene criteria: E. coli
• Shelled and shucked products of cooked crustaceans and molluscan shellfish
⇨m= 1 cfu/g ⇨M= 10 cfu/g ⇨n=5, c=2 ⇨Applies to the end of the manufacturing process ⇨When unsatisfactory results: improvements in production hygiene
53
E. Coli - Control
• Use safe food handling techniques and proper personal hygiene to avoid contamination
• Properly heat foods to kill pathogens and hold food at appropriate temperatures
54
Process Hygiene Criteria Coagulase-positive
staphylococci
55
• Staphylococcal enterotoxins in milk (SCVPH, 2003)
http://ec.europa.eu/food/fs/sc/scv/out61_en.pdf
Scientific basis
56
Process hygiene criteria: Coagulase-pos. staphylococci
• Shelled and shucked products of cooked crustaceans and molluscan shellfish
⇨m= 100 cfu/g ⇨M= 1000 cfu/g ⇨n=5, c=2 ⇨Applies to the end of the manufacturing process ⇨When unsatisfactory results:
improvements in production hygiene
57
Stap. aureus - Control
• Growth and toxin formation can be prevented by proper chilling of products
• Avoidance of cross contamination of
heat treated (cooked) products is important (personal hygiene)
Other Potential Microbiological Hazards in
Fisheries Products - Pathogenic Bacteria
• Vibrio parahaemolyticus
• Vibrio vulnificus
• Vibrio cholera
• Aeromonas and Plesiomonas spp.
59
• Vibrato vulnificus and V. parahaemolyticus (SCVPH, 2001)
http://ec.europa.eu/food/fs/sc/scv/out45_e
n.pdf
Scientific basis
Codex Alimentarius 2010
• Guidelines on the Application of General Principles of Food Hygiene to the Control of Pathogenic Vibrio Species in Seafood
CAC/GL 73-2010 http://www.codexalimentarius.net/search/advancedsearch.do
Other Potential Microbiological Hazards in
Fisheries Products - Virus
• Norwalk-like virus
• Hepatitis A
• Astrovirus
• Rota virus
• Adenovirus
Source:
The EU Union
Summary Report
on trends and
sources of
zoonoses,
zoonotic agents
and food-borne
outbreaks in the
European Union in
2010
http://ecdc.europa.
eu/en/publications/
Publications/1203-
ECDC-EFSA-
zoonoses-food-
borne-report.pdf
63
Norwalk-like viruses (SCVPH, 2002)
http://ec.europa.eu/food/fs/sc/scv/out49_en.pdf
EFSA BIOHAZ Panel, 2011: Scientific Opinion on an update
on the present knowledge on the occurrence and control of
foodborne viruses
http://www.efsa.europa.eu/en/efsajournal/doc/2190.pdf
EFSA BIOHAZ Panel, 2012: Scientific Opinion on Norovirus
(NoV) in oysters: methods, limits and control options
http://www.efsa.europa.eu/en/efsajournal/pub/2500.htm
Scientific basis
Virus – EFSA Recommendations • Current treatment regimes for LBM (depuration and
relaying) do not effectively reduce Norovirus in oysters
• Focus on production from areas which are not faecally contaminated -
• Acceptabel limits for norovirus in LBM/oysters should be considered
• Testing for norovirus should be included to verify HACCP Plans
• Base-line study to quantify the impact on human exposure on microbial criteria
• PRC –based detection methods exist for Norovirus in LBM
• CODEX COMMITTEE ON FOOD HYGIENE. 42. Session, November 2010.
• STEP 3: PROPOSED DRAFT GUIDELINES ON THE APPLICATION OF GENERAL PRINCIPLES OF FOOD HYGIENE TO THE CONTROL OF VIRUSES IN FOOD.
CX/FH 10/42/5 and CX/FH 10/42/5 Add.1
http://www.codexalimentarius.net/web/archives.jsp?lang=en
Parasites
• Regulation 853/2004, Annex III, sec.VIII
• Fishery products shall undergo a treatment sufficient to kill viable parasites that may represent a health hazard to
consumers.
• 2010: EFSA Scientific opinion on risk assessment of parasites in fishery product
• Summary on the studies on effect of different treatments
• Farmed >< wild fish and fresh water >< marine water
Norwegian statement on parasites in Norwegian farmed salmon: http://www.mattilsynet.no/mattilsynet/multimedia/archive/00047/Statement_NIFES-para_47236a.pdf
67
Sources of information for Risk Assessment and Management
• The Community Summary Report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in the European Union in 2010
• http://ecdc.europa.eu/en/publications/Publications/1203-ECDC-EFSA-zoonoses-food-borne-report.pdf
• http://www.efsa.europa.eu/en/efsajournal/pub/2090.htm 2009
• Annual Epidemiological Report on Communicable Diseases in EU and EAA/EFTA Countries
• http://www.ecdc.europa.eu/en/publications/Publications/0910_SUR_Annual_Epidemiological_Report_on_Communicable_Diseases_in_Europe.pdf 2010
• http://www.ecdc.europa.eu/en/publications/Publications/1111_SUR_Annual_Epidemiological_Report_on_Communicable_Diseases_in_Europe.pdf 2011
• The Rapid Alert System for Food and Feed, Annual Report 2010
http://ec.europa.eu/food/food/rapidalert/docs/rasff_annual_report_2010_en.pdf
Some sources of information on fisheries products related hazards
• Histamine Dalgaard P. et. al, 2008 : Histamine and biogenic amines:
formation and importance in seafood. Published in “Improving
seafood products for the consumer”. Edited by T Børresen, Technical University of Denmark, Denmark. Woodhead Publishing Series in Food Science, Technology and Nutrition No. 158, 2008
http://www.woodheadpublishing.com/en/book.aspx?bookID=905#sec3
• General Huss, H.H, et. al. 2003: Assessment and Management of
Seafood Safety and Quality. FAO Fisheries Technical Paper
444. Rome, FAO. 2003. http://www.fao.org/docrep/006/y4743e/y4743e00.htm
• Thank You for your Attention
• Else Marie Andersen
• Tel: +4529627519
• Email: [email protected]
• In consortium with Agriconsulting S.A, AENOR, AINIA and EFET
Consultants
• Address : 17 av. André Marie Ampère, 64 140 Lons, France
• Tel/fav: +33 5 59 72 43 23 / + 33 5 59 72 43 24
• Email: [email protected]