1 of 14

Risk Assessment Project Activities

Created and presented by:

D-r Viktor ARSOV, MD,

Internal Medicine Specialist

Expert for Human Health Risk Assessment, Nutrition, Dietetics and Allergies

J.Associate for Human Health Risk Assessment Information Logistics

2 of 14

  • Protocol for Food safety risk prioritization
  • Objectives:

Ensure priority risk(s) for risk assessment including the human resources and economic costs

Insight in the national factual situation for the most important risks for food

inclusion of experts from the science community as well as other stakeholders from the private sector involved in the risk assessment of food and providing their expertise in certain area of the food safety by paid agreement or “pro bono”(PhD candidates researchers for their thesis)

risk-based allocation of food safety resources

reduction of the foodborne illnesses public health impact

  • Team: 
  • Employees in the Department for Risk Assessment and Risk Communication, at FVA and the other Departments within FVA, that collect data related to safety of food from nonanimal origin
  • Experts from the Scientific Panels (National Platform of Experts):
  • Link of the List of experts involved in the Scientific www.fva.gov.mk :
  • https://drive.google.com/file/d/1j5t-vl5jdiY8DrLnrgHY-lD5gNkQqHyF/view 
  • Other experts from the scientific community

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

3 of 14

Risk prioritisation of hazards in food safety

  • Methodology: Selection of the most important risk from the list of hazards following steps:

Identification of the hazards in the food item(s) having into the consideration the analysis of the data from available national database, public health impact of the possible foodborne diseases, economic costs of government, industry, consumers (expertise)

Identification and definition of the criteria by which each selected hazard/food will be quantified & Assignment of criterion-based points to the hazard/food/infected persons-hospitalizations combinations

  • Total score for certain contaminant/food category = C1(sum of points for 3 years for microbiological hazard) + C2(sum of points for 3 years for food item) + C3A (points for microbiological hazard) + C3B(points for food item) + C4(points) + C5A(points) + C5B(points)
  • *Alternative total score for certain contaminant/food item or food category = C1+2 (ALT)** + C3A (points for microbiological hazard) + C3B(points for food item) + C4(points) + C5A(points) + C5B(points) + C6***
  • **C1+2 (ALT) = Alternative Criterium (Microbiological hazard/Food item)
  • ***C6 = Additional criterium for emerging risk (see the explanation at bottom of final red table for risk priority in area of food safety regarding microbiological hazards

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

4 of 14

  1. MICROBIOLOGICAL HAZARDS: 
  2. Semiquantitative approach:
  3. 1. Criterium (hazard): frequency (number) of microbiological agents isolated in positive food samples gained from laboratories reports in the National Database for microbiological and chemical contaminants, ownership of the Department for Risk Assessment and Risk Communication and FVA as possible etiological causes of foodborne diseases (gastroenterocolitis)/alimentary toxiinfections/food poisonings from the previous last 3 years. The scoring system will be applied with points:

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

  1. Criterium (microbiological hazard/pathogenic microorganism)

Scoring

The most isolated hazard/pathogenic microorganism in the positive food samples

1

The 2nd most isolated hazard/pathogenic microorganism in the positive food samples

0.75

The 3rdmost isolated hazard/pathogenic microorganism in the positive food samples

0.5

The 4th most isolated hazard/pathogenic microorganism in the positive food samples

0.25

The 5thmost isolated hazard/pathogenic microorganism in the positive food samples

0.125

The 6thmost isolated hazard/pathogenic microorganism in the positive food samples

0.0625

The 7thmost isolated hazard/pathogenic microorganism in the positive food samples

0.03125

The 8thmost isolated hazard pathogenic microorganism in the positive food samples

0.015625

5 of 14

  • 2. Criterium (food item): most prevalent food item in which microbiological contaminant was isolated from the last 3 years / food carrier of the agent with scoring system (points) obtained from the National Database for microbiological and chemical contaminants according the following scoring system presented in the table (2.Criterium)

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

  1. Criterium (food item)

Scoring

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 1 point according the previous criterium (1.criterium hazard) table scoring system

0.3

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 0.75 point according the previous criterium (1.criterium hazard) table scoring system

0.2

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 0.5 point according the previous criterium (1.criterium hazard) table scoring system

0.1

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 0.25 point according the previous criterium (1.criterium hazard) table scoring system

0.05

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 0.125 point according the previous criterium (1.criterium hazard) table scoring system

0.025

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 0.0675 point according the previous criterium (1.criterium hazard) table scoring system

0.0125

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 0.03375 point according the previous criterium (1.criterium hazard) table scoring system

0.00625

Appointed to the combination: food item/food category that contained hazard/pathogenic microorganism assigned with 0.017125 point according the previous criterium (1.criterium hazard) table scoring system

0.003125

6 of 14

  • *Alternative Criterium (C1+2ALT) involving alternative scoring system with designated points for the combinations of microbiological hazards/food items according to total number samples for each combination. The calculations will be administered only to several, most prevalent ones, depending on the availability of data reports, economical costs, institutional development and politics. Summing this criterium in total score, excludes the previous mentioned two criteria (C1 and C2) in the final equation.

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

Alternative Criterium (Microbiological hazard/Food item) C1+2 (ALT)

Scoring

Appointed to the combination microbiological pathogen/food item or food category that has maximal total number of positive analytical reports related to certain pathogenic microorganism

3

Appointed to the combination microbiological pathogen/food item or food category that is ranged as 2nd on the list made of maximal total number of positive analytical reports related to certain pathogenic microorganism

2

Appointed to the combination microbiological pathogen/food item or food category that is ranged as 3nd on the list made of maximal total number of positive analytical reports related to certain pathogenic microorganism

1

Appointed to the combination microbiological pathogen/food item or food category that is ranged as 4nd on the list made of maximal total number of positive analytical reports related to certain pathogenic microorganism

0.5

Appointed to the combination microbiological pathogen/food item or food category that is ranged as 5nd on the list made of maximal total number of positive analytical reports related to certain pathogenic microorganism

0.25

Appointed to the combination microbiological pathogen/food item or food category that is ranged as 6nd on the list made of maximal total number of positive analytical reports related to certain pathogenic microorganism

0.125

Appointed to the combination microbiological pathogen/food item or food category that is ranged as 7nd on the list made of maximal total number of positive analytical reports related to certain pathogenic microorganism

0.0625

Appointed to the combination microbiological pathogen/food item or food category that is ranged as 8nd on the list made of maximal total number of positive analytical reports related to certain pathogenic microorganism

0.03125

7 of 14

  • 3. Criterium (reported acute communicable enteric diseases/food poisonings and infected persons-hospitalizations combinations): Number of infected persons / Number of hospitalized persons related to poisoning from certain specific microbiological agent from the past years records/reports/history of food poisonings. The scoring system with points will be applied as it is described in the following table:

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

3.Criterium (infected persons/hospitalized patients from the past records for food poisonings)

  1. Related to microbiological agent

Score A

  1. Related to food item

Score B

Appointed to the microbiological hazard that was the etiological cause of the food poisoning for the most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.3

Appointed to the food item/category that was vehicle for the microbiological agent that caused food poisoning with the most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.3

Appointed to the microbiological hazard that was the etiological cause of the food poisoning for the 2nd most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.2

Appointed to the food item/category that was vehicle for the microbiological agent that caused food poisoning with the 2nd most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.2

Appointed to the microbiological hazard that was the etiological cause of the food poisoning for the 3rd most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.1

Appointed to the food item/category that was vehicle for the microbiological agent that caused food poisoning with the 3rd most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.1

Appointed to the microbiological hazard that was the etiological cause of the food poisoning for the 4th most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.05

Appointed to the food item/category that was vehicle for the microbiological agent that caused food poisoning with the 4th most cumulative reported sum of numbers of infected persons + hospitalized patients in IPH monthly reports

0.05

8 of 14

  • 4. Criterium (reported acute communicable enteric diseases/food poisonings to EFSA for the three years time period 2020-2022):
  • Scoring system with assigned points to the three most present causes of food poisonings:

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

  1. Criterium (reported food poisonings in the previous three years to EFSA)

Scoring

Appointed to the most incriminated microbiological hazard that caused food poisonings in the last three-years period (2020-2022)

0.3

Appointed to the 2nd most incriminated microbiological hazard that caused food poisonings in the last three-years period (2020-2022)

0.2

Appointed to the 3rd most incriminated microbiological hazard that caused food poisonings in the last three-years period (2020-2022)

0.1

9 of 14

  • 5.Criterium (RASFF Window/Portal Notifications for pathogenic microorganisms in food item/category):

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

5.Criterium

  1. RASFF Notifications related to the most frequent pathogenic microorganisms in food for three years time period 2020-2022:

Score A

Appointed to the pathogenic microorganisms with the most number of RASFF Notifications

1

Appointed to the 2nd most reported pathogenic microorganisms in RASFF Notifications

0.75

Appointed to the 3nd most reported pathogenic microorganisms in RASFF Notifications

0.5

Appointed to the 4th most reported pathogenic microorganisms in RASFF Notifications

0.25

  1. RASFF Notifications related to food item/category in which pathogenic microorganism was detected

Score B

Appointed to the food item/category that was most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

1

Appointed to the food item/category that was 2nd most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

0.75

Appointed to the food item/category that was 3rd most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

0.5

Appointed to the food item/category that was 4th most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

0.25

Appointed to the food item/category that was 5th most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

0.125

Appointed to the food item/category that was 6th most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

0.0625

Appointed to the food item/category that was 7th most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

0.03125

Appointed to the food item/category that was 8th most reported for the certain pathogenic microorganism in RASFF Notifications (for each first five most reported microorganisms)

0.015625

10 of 14

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

PRIORITISATION OF RISKS - MICROBIOLOGICAL HAZARDS/PATHOGENIC MICROORGANISMS+FOOD CATEGORY COMBINATIONS

Microbiological hazard/food item combination

C1 + C2 + C3A + C3B + C4 + C5A + C5B = Total Score

C1+2(ALT)** + C3A + C3B + C4 + C5A + C5B = Total Score*

C1

C2

C3A

C3B

C4

C5A

C5B

Total

Score

Salmonella spp/

Meat and meat products incl. poultry and poultry products

0.75+0.75+1

3**

0.2+0.2+0.3

0.3

NA

0.2

1

1

5.7

5.5**

Escherichia coli/Meat and meat products incl. poultry and poultry products

1+1+0.75

2**

0.3+0.3+0.2

0.1

NA

NA

0.5

1

5.15

3.6**

Escherichia coli/Milk and dairy products

1+1+0.75

1**

0.3+0.3+0.2

0.1

NA

NA

0.5

0.5

4.65

2.1**

Campylobacter spp/Meat and meat products incl.poultry and poultry meat

0.5+0.25+0.75

0.5**

0.1+0.05+0.2

NA

NA

NA

0.25

1

3.1

1.75**

Listeria monocytogenes/Meat and meat products incl. fish and fish products

0.00625+0.5+0.5

0.25**

0.0125+0.1+0.1

NA

NA

NA

0.75

1

2.969

2**

Listeria monocytogenes/Milk and dairy products

0.0625+0.5+0.5

0.125**

0.0125+0.1+0.1

NA

NA

NA

0.75

0.5

2.525

1.38**

Staphyloccocus, coagulase positive/Milk and dairy products

0.125+0.0625+0

0.0625**

0.025+0.0125+0

0.3

NA

0.3

0.0625

NA

0.8875

0.73**

Enterobacteriacae/Milk and dairy products

0.25+0.0625+0.25

0.03125**

0.05+0.00125+0.05

0.05

NA

NA

NA

NA

0.714

0.08**

RISK PRIORITY IN AREA OF FOOD SAFETY REGARDING MICROBIOLOGICAL HAZARDS

Microbilogical hazard/Pathogenic microorganism

SALMONELLA SPP

Salmonella enteritidis

Food category/Food item

MEAT AND MEAT PRODUCTS INCL. POULTRY AND POULTRY PRODUCTS

Total Score/*

5.7/5.5*

11 of 14

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

PRIORITISATION OF RISKS - CHEMICAL HAZARDS/CONTAMINANTS,MYCOTOXINS,HEAVY METALS, PESTICIDES RESIDUES+FOOD CATEGORY COMBINATIONS

Chemical hazard/food item combination

C1 + C2 + C3A + C3B = Total Score

C1+2(ALT)** + C3A + C3B + C4****+ C6*** = Total Score*

C1

C2

C3A

C3B

Total

Score

Aflatoxin M1 + B1/Milk and dairy products

0.75+0.25+0.75

0.5**

0.1+0.05+0.2

1

0.0625

3.162

1.5625*

Aflatoxin M1 + B1/Nuts, nut products and seeds

0.75+0.25+0.75

NA*

0+0+0

1

1

3.75

 

Cadmium (Cd)/Meat and meat products

1+0.125+0

1**

0.3+0.025+0

0.25

0.25

1.95

1.5*

Cadmium (Cd)/Fruits and vegetables

1+0.125+0

NA**

0+0+0

0.25

1

2.375

Lead (Pb)/Meat and meat products

1+0.125+1

1**

0.3+0.025+0.3

0.0625

0.125

2.937

1.1875*

Lead (Pb)/

Fruits and vegetables

1+0.125+1

0.125**

0+0+0.3

0.0625

0.25

2.737

0.4375*

Mercury (Hg)/Meat and meat products

0.75+0.125+0

0.5**

0.2+0.025+0

0.125

0.25

1.475

0.875*

Mercury (Hg)/Fish and fish products

0.75+0.125+0

NA**

0+0+0

0.125

1

2

Polyphosphates/Meat and meat products

0.25+1+0

3**

0.025+0.3

NA

0.75

2.325

3.75*

Polycyclic aromatic hydrocarbons (PAH)/Meat and meat products

0+0+0.75

0.0625**

0+0+0.2

0.03125

0.125

1.106

0.2187*

Nitrates(NO2)/Meat and meat products

0+0.75+0

2**

0+0.2+0

NA

1

1.95

3*

Chlorpyrifos/Fruits and vegetables

0.5+0+0

0.25**

0.05+0+0

0.75

1

2.3

2*

RISK PRIORITY IN AREA OF FOOD SAFETY REGARDING CHEMICAL HAZARDS

Chemical hazard: Mycotoxin

Food Additive*

  • AFLATOXIN M1+B1
  • POLYPHOSPHATES*

Food category/Food item

  • MILK AND DAIRY PRODUCTS/NUTS, NUT PRODUCTS AND SEEDS
  • MEAT AND MEAT PRODUCTS*

Total Score

Total Score*

  • 3.162/3.75
  • 3.75*

12 of 14

  • Hazard identification and hazard characterization
  • Infected food and water
  • NONTYPHOIDAL SALMONELLOSIS
  • Food products with identified Salmonella spp.
  • ECDC: Annual Epidemiological Reports (2018-2021) - Salmonellosis
  • ECDC: Risk Assessments / Scientific and Technical Publications on Salmonellosis Outbreaks
  • RASFF Window

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

RASFF Notifications (2161) 01.01.2020 -15.03.2023

Salmonella spp. (all serovars) in Food Item/Category

Score

Code

1009

poultry meat and poultry meat products (311 notifications for Salmonella enteritidis, 78 Notifications for Salmonella Typhimurium)

1

1

293

herbs and spices

0.75

2

230

nuts, nut products and seeds

0.5

3

143

meat and meat products

0.25

4

30

fruits and vegetables

0.125

5

27

eggs and egg products

0.0625

6

15

confectionary

0.03125

7

11

milk and milk products

0.015625

8

10

cereals and bakery products

…….

9

8

dietetic products, food supplement and fortified food

…….

10

6

fish and fish products

…….

11

13 of 14

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert

RASFF Notifications (1194), 01.01.2020 - 15.03.2023

Aflatoxins in Food Item/Category

Scores

774

nuts, nut products and seeds

1

213

fruits and vegetables

0.75

87

cereals and bakery products

0.5

72

herbs and spices

0.25

32

feed materials

0.125

7

other food products/mixed food

0.0625

6

confectionery

0.03125

2

cocoa and cocoa preparations, coffee and tea

….

1

ices and desserts

….

14 of 14

  • Literature search related to hazard characterization (carcinogenicity and other human adverse health effects) of aflatoxins:
  • IARC Monographs Series 82 :
  • FAO JECFA Monographs
  • (83rd JECFA Meeting – Safety Evaluation of certain contaminants in food), 992 pages
  • WHO FOOD ADDITIVES SERIES : 74
  • Literature Research on Aflatoxins human toxicology >200 articles
  •  
  • National estimates of dietary exposure from scientific literature research
  • Dietary exposure assessments for aflatoxins (27 studies):
  • Aflatoxin B1 - 29
  • Aflatoxin B2 - 6
  • Aflatoxin G1 - 5
  • Aflatoxin G2 - 5
  • Aflatoxin M1 - 19

Created and presented by: D-r Viktor ARSOV, MD, Specialist Internist, Human Health Risk Assessment & Communication Expert