BETTER TRAINING FOR SAFER FOOD BTSF

MICROBIOLOGICAL CRITERIA IN FISHERY PRODUCTS Regulation (EC) 2073/2005 Else Marie ANDERSEN
FOOD HYGIENE AND CONTROLS PROGRAMME 2012-2013
Course on Fishery products & LBM 11 15 June 2012 Denmark

Objectives of this presentation

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

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

Regulation 2073/2005, Annex I, Ch. 1 and Ch. 2.4 - Fisheries Products HARMONIZED CRITERIA 1

Type of Product

Food Safety Process Hygiene Criteria Criteria

Listeria Listeria Salmonella

RTE able to support growth Listeria RTE unable to support growth Listeria Cooked crustaceans and molluscs shellfish Live bivalve molluscs and live echinoderms, tunicates and gastropods

Salmonella

Live bivalve molluscs and live echinoderms, tunicates and gastropods

Escherichia coli

Regulation 2073/2005, Annex I, Ch. 1 and Ch. 2.4 - Fisheries Products HARMONIZED CRITERIA 2

Type of Product

Food Safety Process Hygiene Criteria 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

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
6

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

Reg. 2073/ 2005 art. 4.1

Responsibilities of FBO (3)

Reg. Perform testing against microbiological 2073/2005 criteria as a part of validation or art. 7.1 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

Sampling and analytical methods (3)

Reg. 2073/2005 art. 4.2

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 Reg. 2073/2005 procedures can be demonstrated
art. 5.3
9

Reg. 2073/2005 art. 5.5

Flexibility

FBO can use other sampling and testing procedures if it provides equivalent To the Satisfaction guarantees CA 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

10

Sampling and analytical methods

FBOs 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

11

Responsibilities of CA (1)
Verify FBO compliance with rules and criteria in Reg. 2073/2005 Reg. Check manufacturing process 2073/2005 art. 1 Asses shelf life studies Verify corrective actions in HACCP Sampling and testing scheme (HACCP) Check trends of results

12

Responsibilities of CA (2)
Undertake sampling and testing for compliance with Food Safety Criteria At retail Reg. Border inspection posts 2073/2005 art. 1 In case of suspicion Undertake sampling and analysis of other micro-organisms, their toxins or metabolites when deemed necessary
13

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
14

Reg. 2073/2005 art. 7.2

Unsatisfactory results
Reg. 178/2002 art. 19

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. 7.4

Reg. 2073/2005 art. 7.1

15

Absence of Community Criteria

Foodstuffs should not contain microorganisms 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.
Reg. 2073/2005 Whereas 2 178/2002 art. 14
16

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/1203ECDC-EFSAzoonoses-foodborne-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/1203ECDC-EFSAzoonoses-foodborne-report.pdf

Fishery products Harmonized Criteria

19

Food Safety Criteria Listeria spp.

20

The Scientific Background

Listeria monocytogenes (SCVPH 1999, SCF 2000, EFSA 2007) http://ec.europa.eu/food/fs/sc/scv/out25_e n.html http://ec.europa.eu/food/fs/sc/scf/out63_e n.pdf http://www.efsa.europa.eu/cs/BlobServer/S cientific_Opinion/biohaz_op_ej599_listeria_ en.pdf?ssbinary=true

21

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

22

Food safety criteria: Listeria

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

23

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-ECDCEFSA-zoonoses-foodborne-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-ECDCEFSA-zoonosesfood-bornereport.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

Guidance to conduct Shelf Life Studies

Reg. 2073/ 2005 art. 3.2 (ANNEX II)

The Food Business Operator shall conduct studies to investigate compliance with microbiological criteria throughout the shelf-life
Guidance document on Listeria monocytogenes shelflife 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
32

 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=t rue SSSP model: www.dfu.min.dk/micro/sssp PMP model: http://ars.usda.gov/Services/docs.htm?docid=11550

http://sss p.dtuaqua .dk/

A simple case based on Seafood Spoilage and Safety Predictor (SSSP)

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

Food safety Criteria Histamine

36

EFSA BIOHAZ 2011: Scientific Opinion on risk based control of biogenic amine formation in fermented foods http://www.efsa.europa.eu/en/efsajournal/pu b/2393.htm No scientific evaluations on Fresh, frozen fish or sterilised fish

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
38

Food safety criteria Histamine

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

39

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
40

Development of histamine
Histamine is produced in fish by decarboxylation of the corresponding free amino acid (histidine)

COO1+1N H 3

mesophilic and psychrotolerant species of Enterobacteriaceae, e.g. Morganella Morgani i and Morganella psychrotolerans
H H

C CH2

histidine decarboxylaze
H

+1N H 3

C CH2

+1

N N

+1

N N H 41

Histidine

Histamine

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.
42

A case based on Seafood Spoilage and Safety Predictor (SSSP) http://sssp.dtuaqua.dk/

CASE 5.1 and 5.2
Contamination: Normal (10 cfu/g) Histidine level: High (10750ppm) Temperature: 5.1: Reduction from +20C to + 2C within 24 hours and keeping at 2C untill day 10 5.2: Keeping at 20C for 24 hours, then quick reduction from to + 2C untill day 10.

Result: Formation of histamine after 10 11 days in the case with delayed chilling.

Food safety Criteria Salmonella

44

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

45

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

46

Salmonella Control measures

Prevention of contamination (crosscontamination) of RTE foods Control of contamination in food processing areas incl. personal hygiene Low temperatures storage of foods to prevent growth
47

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.

Food safety Criteria Process Hygiene Criteria E. coli

49

Scientific basis
Verotoxigenic E. coli in foodstuffs (SCVPH, 2003)
http://ec.europa.eu/food/fs/sc/scv/out58_en.pdf

50

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
51

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
52

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
53

Process Hygiene Criteria

Coagulase-positive staphylococci

54

Scientific basis
Staphylococcal enterotoxins in milk (SCVPH, 2003)
http://ec.europa.eu/food/fs/sc/scv/out61_en.pdf

55

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
56

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)
57

Other Potential Microbiological Hazards in Fisheries Products - Pathogenic Bacteria

Vibrio parahaemolyticus Vibrio vulnificus Vibrio cholera Aeromonas and Plesiomonas spp.

Scientific basis
Vibrato vulnificus and V. parahaemolyticus (SCVPH, 2001)

http://ec.europa.eu/food/fs/sc/scv/out45_e n.pdf

59

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/se arch/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/1203ECDC-EFSAzoonoses-foodborne-report.pdf

Scientific basis
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
63

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/Stat ement_NIFES-para_47236a.pdf

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-EFSAzoonoses-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_e n.pdf 67

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 Brresen, 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=90 5#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: elsemarie@emcon.org else-marie.andersen@aets-consultants.com

In consortium with Agriconsulting S.A, AENOR, AINIA and EFET

Address : 17 av. Andr Marie Ampre, 64 140 Lons, France Tel/fav: +33 5 59 72 43 23 / + 33 5 59 72 43 24 Email: contact@aets-consultants.com