Transcript Risk Analysis_finx

Food safety risk assessment with
regard to industrial food products
Dr. Aija Melngaile
Institute of Food Safety, Animal Health and
Environment «BIOR»
Workshop on Industrial Control Based on Risk Assessment
26-27 November 2014
Food safety requirements
• Food shall not be placed on the market if it is
unsafe
• Food shall be deemed to be unsafe if it is
considered to be:
• (a) injurious to health
• (b) unfit for human consumption
Article 14, Regulation 178/2002
Risk – Hazard - Contamination
• ‘Risk’ means a function of the probability of
an adverse health effect and the severity of
that effect, consequential to a hazard
‘Hazard’ means a biological, chemical or
physical agent in, or condition of, food with the
potential to cause an adverse health effect
“Contamination" means the presence
or introduction of a hazard
REGULATION 178/2002
Regulation 852/2004
Physical hazards
Physical hazards which can be found in food
include:
• Objects naturally present in the food (animal
hair, bone chips, leaves, etc)
• Objects occurring in agriculture (dirt, manure,
leaves, etc)
• Objects added during processing (broken
glass, plastic, hair, metal, dirt, wood, etc)
Chemical hazards
• Naturally occurring poisonous chemicals (poison plants
such as mushrooms, poisonous animals such as puffer
fish, algal blooms, mould & bacterial toxins, etc)
• Environmental chemicals from contaminated water, soil,
air (heavy metals, dioxins, PAO, etc.)
• Agricultural chemicals from soils, plants and animals
(pesticides, antibiotics, heavy metals, etc)
• Chemicals added to foods during food processing (e.g.
food additives, flavourings)
• Chemicals formed during technological processing
(acrylamide, PAO, products of thermal degradation of
fats)
• Migration of chemicals from food contact materials
• Food allergens
• Chemicals used for cleaning/disinfection purposes, etc
• The EFSA Panel on Contaminants in the Food
Chain (CONTAM) deals with contaminants in the
food chain
Contaminants topics
• Acrylamide is a chemical compound that typically forms in
starchy food products during high-temperature cooking, including
frying, baking and roasting. It forms from sugars and an amino
acid that are naturally present in food
• Aflatoxins are mycotoxins produced by two species of Aspergillus,
a fungus which is especially found in areas with hot and humid
climates
• Dioxins and polychlorinated biphenyls (PCBs) are toxic chemicals
that persist in the environment and accumulate in the food chain
• Metals such as arsenic, cadmium, lead and mercury are natural
occurring chemical compounds
• Mycotoxins are toxic compounds produced by different types of
fungus, belonging mainly to the Aspergillus, Penicillium and
Fusarium genera, etc.
Biological hazards
• Bacteria – may cause infections e.g. Salmonella
spp., intoxications - Staphylococcus aureus,
Bacillus cereus, etc.
• Viruses, e.g. Hepatitis A virus, Noroviruses, etc.
• Yeasts and Moulds (ability to produce toxic
metabolites – mycotoxins - that are not destroyed
during food processing or home cooking; may
cause allergic reactions or infections – e.g.
Aspergillus spp.)
• Parasites – Trichinella spp. (T. britovi, T. murrelli, T.
nativa, T. nelsoni, T. spiralis) that encapsulates in
host muscle tissue
• Protozoa, e.g. Giuardia lamblia
• The Panel on Biological Hazards (BIOHAZ) deals
with biological hazards in relations to food safety
and food-borne diseases
Risk Analysis
• supports setting of priorities among different
food safety problems
• supports taking of decisions that are in
proportion to the public health risks involved
• strengthen the basis for trading foods
internationally and provides access to new
markets
• identifies gaps and uncertainties in scientific
knowledge on risks, which can help set research
priorities
Methodology of Risk Analysis
Food safety risk analysis, WHO,FAO, 2006
Generic components of risk analysis
• Risk analysis represents a structured decision-making
process with three distinct but closely connected three
components
Food safety risk analysis, WHO,FAO, 2006
Risk assessment
RA is the central scientific component of risk analysis,
characterizing the potential adverse effects to health
and resulting from exposure to hazards over a
specified time period
Scientifically based process
consisting of the following steps:
• hazard identification
RA has to be objective,
• hazard characterization
transparent, fully
documented
• exposure assessment
• risk characterization
Risk management
The process, distinct from risk assessment,
including
• Considering risk assessment and other factors
relevant for the health protection of
consumers and for the promotion of fair trade
practices
• Weighing policy alternatives in consultation
with all interested parties
• Selecting appropriate prevention and control
options, if needed
Risk communication
• The interactive exchange of information and
opinions throughout the risk analysis process
concerning risk, risk-related factors and risk
perceptions
• among risk assessors, risk managers,
consumers, industry, the academic community
and other interested parties
• including the explanation of risk assessment
findings and the basis of risk management
decisions
Risk assessment & Risk management
• Risk assessment is considered to be the
“science-based” component of risk analysis
• Risk management is the component in which
scientific information and other factors, are
integrated and weighed in choosing the
preferred risk management options
– Economic factors
– Social factors
– Cultural factors and
– Ethical considerations
Carrying out risk analysis
• The risk analysis process normally begins with
a RM step, to define the problem, articulate the
goals of the risk analysis and identify questions
to be answered by the risk assessment
• During the RA phase the science-based tasks of
“measuring” and “describing” the nature of the
risk are performed
RA & RM function separation
• Risk management and risk assessment are
separate but closely linked activities
• The functions of RA and RM should be carried
out separately
– functional separation is more obvious when
different bodies or officials are responsible for RA
and RM tasks
– RA tasks can be carried out separately from RM tasks
by people who act as both risk assessors and risk
managers
RA considerations
• Individual RAs should be “fit-for-purpose” and can
generate estimates of risks in various forms on base
of common methodology
– Case-by-case study
• Quantitative RAs have the additional advantage of
being able to model the effects of different
interventions
– Quantitative vs qualitative assessments
• Scientific approaches that combine RA,
epidemiology and economics are likely to be most
useful to risk managers trying to integrate and
balance risks and benefits
– Risk-benefit analysis
Risk assessment team
• Large-scale RAs generally requires a multidisciplinary team that may include experts with
biological, chemical, food technology,
epidemiological, medical, statistical and
modelling skills
• Small-scale RAs may be undertaken by very
small teams or even by individuals
– especially where a primary risk assessment is
already available and the scientific work involves
mostly adaptation using local data
• Assembled team must be free from potential
financial or personal conflicts of interest
Process of risk analysis
Risk Assessment and its Role in Risk Analysis, WHO, FAO, 2009
Risk analysis at the international level
• Internationally, Codex Committees that recommend
food safey standards act as risk managers (e.g., the
Committees on Food Hygiene, Meat Hygiene, Food
Additives, Contaminants, Pesticide Residues, and
Residues of Veterinary Drugs in Foods)
• Risk assessments are provided by the three Joint
FAO/WHO Expert Bodies to support development
of Codex standards:
– the Joint Expert Committee on Food Additives (JECFA)
– the Joint Meeting on Pesticide Residues (JMPR) and
– the Joint Expert Meeting on Microbiological Risk
Assessment (JEMRA)
Codex Committees
Codex Committees act as risk managers:
• organize and direct the decision-making process
• weigh the results of the RAs and other legitimate
factors such as the feasibility of RM options and the
interests of Codex members, and
• recommend standards to protect public health and
ensure fair practices in the food trade
• may develope RM tools referred to as related texts,
such as
– Guidelines
– Codes of practice and sampling plans
– Standards for specific food-hazard combinations
Risk analysis at the EU level
• In the European food safety (FS) system, risk
assessment is done separately from risk
management
• As the independent risk assessor, The European
Food Safety Authority (EFSA) produces scientific
opinions and advice to support risk managers
• The European Commission (EC), European
Parliament (EP) and EU Member States (MS) are
the risk managers in the EU FS system
– The EC has a key role in risk management
and frequently requests scientific advice
from EFSA
Risk analysis at the national level
(LV example)
• Risk Management
– Ministry of Agriculture
 Food and Veterinary
Service of Latvia
• Scientific Risk Assessment
 Institute of Food Safety,
Animal Health and
Environment “BIOR”
Generic risk management framework (RMF)
Application of the RMF represents
a systematic way of thinking about
FS issues that require RM
Parts of the RMF
can be repeated
as new
information
becomes
available, or
there is a need to
modify or reexamine the work
May range from simple,
qualitative processes to
complex scientific and
social evaluations
Generic for risk management framework
• Must be functional in both
– strategic, long-term situations (e.g. development of
international and national standards when sufficient
time is available) and
– the short-term work of national food safety
authorities (e.g. responding rapidly to a disease
outbreak)
• In all cases, it is necessary to strive to obtain the best
scientific information available on risks as a basis for
preliminary decisions on control measures
– e.g. human health surveillance data
– food-borne disease outbreak data, etc.
Preliminary risk management activities
(1st phase of RM)
•
•
•
•
•
•
•
•
Identify food safety issue
Develop risk profile
Establish goals of risk management
Decide on need for risk assessment
Establish risk assessment policy
Commission risk assessment, if necessary
Consider results of risk assessment
Rank risks, if necessary
Problem formulation
• RA may be initiated by RM, RA and scientific
communities
• Problem formulation or risk profiling is the
transition process from preliminary
considerations to formal risk assessments
– determines the need for—and, if needed, the
extent of—a risk assessment
– describes the food safety problem and aspects
relevant to prioritization in relation to other food
safety problems
The protection of human health should be the main
criterion for prioritization for risk assessment
Problem formulation might
include the following
• a brief description of the intended application of
the product (e.g. food additive) and the
commodities involved
• the issues expected to be affected (e.g. human
health, economic concerns) and the potential
consequences
• consumer perception of the hazards or risks
• the distribution of possible risks among different
segments of the population; and
• possible benefits associated with the use of the
chemical in food
PROCESS INITIATION: Microbiological RA
• Risk assessors should consider aspects of the
pathogen, host, and food-water matrix
Distribution of strong-evidence outbreaks by food vehicle
in the EU, 2012 (EFSA, 2014)
In 2012, the majority of the strong-evidence outbreaks were associated with foodstuffs of
animal origin ; the most common category reported as food vehicle was eggs and egg
products, responsible for 168 outbreaks (22.0 %); mixed foods – for 119 outbreaks (15.6 %)
Distribution of strong-evidence outbreaks, implicating eggs
and egg products, by causative agent in the EU, 2012
different food vehicles identified in the outbreaks
EFSA, 2014
Food – Pathogen
combination
Distribution of strong-evidence outbreaks, implicating
mixed food, by causative agent in the EU, 2012
Food – Pathogen
combination
EFSA, 2014
Distribution of strong-evidence outbreaks, implicating fish
and fish products, by causative agent in the EU, 2012
Food – Pathogen
combination
EFSA, 2014
Distribution of strong-evidence outbreaks, implicating food
of non-animal origin, by causative agent in the EU, 2012
Food –
Pathogen
combination
EFSA, 2014
Food of non-animal origin includes: cereal products including rice and
seeds/pulses (nuts, almonds) (4), drinks (1), fruit, berries and juices and other
products thereof (6), herbs and spices (2), sweets and chocolate (5), vegetables
and juices and other products thereof (38), mixed food (1) and other foods (1)
Distribution of strong-evidence outbreaks, implicating
vegetables, by causative agent in the EU, 2012
EFSA, 2014
Food –
Pathogen
combination
EFSA, 2014
Vegetables includes: vegetables and juices and other products
thereof (38) and other foods (1)
Distribution of strong-evidence outbreaks by settings in
the EU, 2012
Other settings (N = 61)
include: camp, picnic (3),
mobile retailer, market/
street vendor (4), farm
(primary production) (2)
and other settings (52).
N = 763
EFSA, 2014
The category ‘household/domestic kitchen’ (39.7 %) was the most
commonly reported setting; the next - restaurants , cafe, bars (23,9%)
Distribution of food vehicles in strong-evidence
outbreaks caused by Salmonella in the EU, 2012
Pathogen – Food
combination
EFSA, 2014
Distribution of food vehicles in strong-evidence
outbreaks caused by Campylobacter in the EU, 2012
Pathogen – Food
combination
EFSA, 2014
Distribution of food vehicles in strong-evidence
outbreaks caused by Bacillus toxins in the EU, 2012
Pathogen – Food
combination
EFSA, 2014
Other foodstuffs (N = 8): bakery products (1), broiler meat (Gallus gallus) and
products (1), eggs and egg products (1), other or mixed red meat and
products (1), poultry meat (1), turkey meat and products (1), other foods (2)
Distribution of food vehicles in strong-evidence
outbreaks caused by Clostridium toxins (including
Clostridium botulinum toxins) in the EU, 2012
N = 54
Pathogen – Food
combination
EFSA, 2014
Distribution of food vehicles in strong-evidence outbreaks
caused by staphylococcal toxins in the EU, 2012
Pathogen – Food
combination
EFSA, 2014
Other foodstuffs (N = 12) include: bovine meat and products (1), buffet meals (1),
crustaceans, shellfish, molluscs and products thereof (1), eggs and egg products (1),
meat and product thereof, unspecified (1), milk (1), other or mixed red meat and
products thereof (1), poultry meat and products thereof (1) and other foods (4)
Distribution food vehicles in strong-evidence outbreaks
caused by calicivirus, including norovirus in the EU, 2012
Pathogen – Food
combination
EFSA, 2014
Other foods (N = 7) include: broiler meat and products (1), cheese (2), eggs
and egg products (1), pig meat and products (1) and other foods (2)
Preliminary risk management activities
• After a food safety issue has been identified,
available scientific information is aggregated
into a risk profile that will guide further action
• Risk managers may seek additional and more
detailed scientific information, e.g.
– Risk assessment methodologies
– Risk ranking or epidemiology-based
approaches
Risk profile
A typical risk profile includes a brief description of:
• food product involved
• information on pathways by which consumers
are exposed to the hazard
• possible risks associated with that exposure
• consumer perceptions of the risks
• and the distribution of possible risks among
different segments of the population
Risk profile
• By gathering available information on risks, the
risk profile should assist risk managers in setting
work priorities, deciding how much further
scientific information on the risks is needed, and
developing a risk assessment policy
• By describing current control measures, the risk
profile can also assist risk managers in identifying
possible RM options
• In many situations, a risk profile can be thought
of as a preliminary risk assessment that
summarizes everything the risk managers know
about the possible risks at that time
Preliminary RM activity - ranking
Ranking is carried out to rank risks and prioritize
regulatory controls
• is performed using knowledge of risk factors
• takes into account epidemiological data on
human illness to apportion risks and contribute
to setting risk-based standards
– Case-control
– Analysis of surveillance data
– Focused research
• may or may not be based on risk assessments
Risk assessment will not be
commissioned...
... It is likely that a RA will not be commissioned
when:
• The risk is well described by definitive data
• The food safety issue is relatively simple
• The food safety issue is not of regulatory
concern or not subject to regulatory mandate
• An urgent regulatory response is required
Risk assessment will be commissioned...
...It is likely that a RA will be commissioned when:
• The hazard exposure pathway is complex
• Data on the hazard(s) and/or health impacts are
incomplete
• The issue is of significant regulatory and/or
stakeholder concern
• There is a mandatory regulatory requirement
for a risk assessment
• There is a need to verify that an interim (or
precautionary) regulatory response to an urgent
food safety problem is scientifically justified
Use of ranking tools
Risk factors vs Risk assessment
• “Comparative risk” scoring system based on certain
risk factors can be derived at a national level:
– Food business can be categorised against
specified risk factors, e.g. by type of food, type of
food preparation, type of business, compliance
record, food user subpopulation
– Food products can be categorised by ranking
hazard-food combinations
• Scoring systems may have subjective, arbitrary
elements, thus they are not equivalent substitutes
for ranking methodologies developed on RA basis
Risk-based food inspection
• http://www.fao.org/docrep/010/i0096e/i0096e00.htm
FOOD AND AGRICULTURE ORGANIZATION OF THE
UNITED NATIONS, Rome, 2008
New inspection philosophy and approach
• inspector’s traditional regulatory role is generally
limited to verifying that regulations are respected
• new approach - prioritizing inspections using a
risk-based approach
• vision of inspector as a food safety professional
actively contributing to improving the system
• philosophy relies on placing the inspector’s
emphasis on factors that are likely to lead to
foodborne disease
New inspection philosophy and approach
• To refocus the inspector’s attention from
environmental aspects and end product testing
to a risk-based process
• To change the focus from the simple
“verification” to an assessment of the controls
put in place by the operator to address foodborne disease risk factors that could put the
processor’s products at risk (i.e. cause disease)
Food-borne disease risk factors are those factors that
may cause food-borne disease if left uncontrolled
Examples of food-borne disease risk
factors
• Cross contamination (e.g. from a raw to a readyto-eat product).
• Food from unsafe sources
To make sure
• Inadequate cooking
that the food
• Improper holding temperatures control system
• Contaminated equipment
works all the
• Poor personal hygiene
time so that safe
• Food handlers’ health status.
products are
• Water quality.
consistently
produced
• Presence of pests
New inspection approach
• Review risk factors ahead of inspection
• Perform risk-based inspection of risk factors.
• Make recommendations for improving the
systems that are in place and progression to a
HACCP-based process when appropriate
Modern food safety control systems are based
on preventive rather than corrective measures
Risk-based thinking (PIGS)
• PRESENCE (e.g. heat-resistant toxins, pathogenic
microorganisms, chemical contaminants, physical
objects, etc. in raw-materials)
• INTRODUCTION (e.g. microbiological
recontamination after thermal processing, migration of
chemicals from FCM)
• GROWTH (e.g. incorrect food storage
temperature/time, etc.)
• SURVIVING (e.g. pathogenic micro-organisms of
concern have not been inactivated during processing,
metal objects have not been detected, etc.)
– of hazards
Establishment categorization
• The various industries that process foods are not
equally likely to be sources of food-borne diseases
• There is a process/product-related set of risk factors
for food-borne disease that should be evaluated
before inspection
• By identifying high-risk foods or high-risk food
processing/preparation processes, the inspector will
be able to focus on foods or processes that are most
likely to cause food-borne disease if uncontrolled
A bakery producing only bread, does not present the same risks
as bakery that produces pastries with cream filling (source of
intoxication with Staphylococcus aureus toxin)
The procedure for prioritization
• The establishment’s products are profiled on the basis of
– the level of food-borne disease risk factors they
present
– marketing characteristics (e.g. large volumes reaching
all populations, destined for children or infants,
speciality products to niche markets, etc.)
– “High” or “Low” risk classification is assigned to the
product profile
• The establishment profile - the history of compliance by
the establishment with its quality and safety
management system and pertinent regulations
– is designated “High” (good) or “Low” (bad) in
accordance with existing inspection records
The procedure for prioritization
• In addition, there are risk considerations
related to the number of expected consumers
• A product having wide distribution and large
consumption is more likely to cause extensive
outbreaks of food-borne disease than one
with reduced market reach
Matrix to assign a priority rating to
the establishment
• 1 = top priority (should be inspected
more frequently)
• 2 = medium priority
• 3 = low priority
Reviewing of establishment
categorisation
• The establishment categorization or priority
level for inspection should be reviewed and
updated after each inspection on the base of
changes in
• establishment profile (e.g. non-compliance
and violations are reported) or
• product profiles (e.g. new products, new
formulas, new processes), etc.
Product risk (LV example)
Risk
category
Rating
Description of risk category
1
High-risk food products – RTE
products to be stored under
specific conditions;
Food products to be stored
under specific conditions;
Food products for sensitive
consumers’ groups
High-risk food products - food products
which can be source of pathogenic microorganisms
and can promote growth of these micro-organisms
and/or toxin production; food products in which
the chemical contaminants are often found
- Canned fishery products made without using
sterilisation method, Mixed foods, in production of
which raw meat/raw fish was used, Dietetic foods,
Foods for infants and young children, Cream
pastries
2
High-risk food products – RTE
products to be consumed
after additional cooking
Thermally-processed food
products that do not require
specific storage conditions
Medium-risk food products - food products, which
may be source of pathogenic microorganisms, but
usually do not promote their growth; food
products that may be contaminated with chemicals
- Sausages (cooked, smoked), pates, meat jelly;
Dry milk products, pastry, sauces/salad dressings
Confectionnary, chocolate and cacao products
Fruit and vegetable juices, Food supplements
Product risk (LV example)
Risk
category
Rating
3
Food products intended to be
consumed without preliminary
thermal processing that do not
require specific storage
conditions
Mechanically processed food
products of plant-origin
4
Packaged food products that do
not require specific storage
conditions
Primary products of plant-origin
Description of risk category
Low-risk food products
Food products that are not usually
contaminated with pathogenic
microorganisms, but can promote growth of
microorganisms and/or toxin-production; Food
products which rarely have been
contaminated with harmful chemicals
Canned meat and fishery products (heat
sterilisation used); Processed grain products;
Fats and oils; Bee products
Very low-risk products
Food products that usually are not source of
pathogenic microoranisms and do not
promote growth of pathogenic
microorganisms; Food products, that usually
do not contain hatmful chemicals
Soft drinks ans alcoholic beverages
Sugar, salt, vinigar; Bottled drinking water;
Unprocessed fruits and vegetables
Food business risk (LV example)
Risk
categor
y
Rating
Description of risk category
1
Slaughter houses
Food production companies
producing/packing foods of animal-origin
Milk collection companies
Food businesses producing RTE high-risk
products
Wholesale companies involved in packing of
high-risk food products
Banquet services and street vendors
Institutional catering (in schools,
kindergartens, hospitals, eldery centres)
High-risk food establishments
Food establishments that provide
production/preparation of high-risk
food and use raw-materials that
must be stored under specific
conditions; or food businesse that
are involved in re-packing and
distribution of high-risk food;
Catering services that are
responsible for preparation and
serving of high-risk RTE foods in
large quantities
2
Home-made food production
Medium-risk food products production
Producing/packing of soft drinks and drinking
water
Restaurants, cafes, bars that offer food
preparation and service
Re-packing of high-risk foods at retail
Medium-risk food establishments
Establishments providing mediumrisk food production, packing and
re-packing; establishments
providing storage and re-packing of
high-risk food for retail purposes;
home-made food production sites
Food business risk (LV example)
Risk
category
Rating
Description of risk category
3
Food production establishments
responsible for running of simple
processing cycles
Egg grading and packing centres
Selling high-risk pre-packed foods at retail
Catering and other retail establishments
selling limited assortment of foods (e.g.
tea, coffee, pastries, drinks)
Wholesale of low-risk foods
Establishments providing packing and
disribution of low-risk foods
Low-risk food establishments
Establihments providing simple food
processing technologies (e.g.
shelling, peeling, chopping, grinding,
dilution, etc) or re-packing of lowrisk foods; egg packing centers;
fishing vessels
4
Wholesale and retail of low-risk food
products
Primary production and processing of
foods of non-animal origin in small
quantities
Primary production and selling of of food
of animal-origin in small quantities
Very low-risk food establishments
Establishments providing mediumrisk food production, packing and repacking; establishments providing
storage and re-packing of high-risk
food for retail purposes; home-made
food production sites
Risk category of food establishment (LV example)
Risk category of
food
establishment
Risk related with
Food Products
(product risk)
The
maxim
2
3
4
um
(medium (low-risk) (virtually
score*
- risk)
no risk)
Risk category
1
(highrisk)
60
45
30
15
60
Risk related with
60
45
30
15
60
Type of food
businesss
(food business
risk)
* the maximum score is used to decide on frequency of inspections
Food business risk (LV example)
Capacity/ size of establishments
• Additional criterion for characterisation of the
individual food business in matters of food
safety risk
• Additional criterion used to decide on
frequency of inspections
• Assessed by food inspectors at the beginning of
each calendar year on the base of stated
criteria
Capacity/size of food establishment (LV example)
Capacity / Size / Evaluation
criteria
Capacity / Size / Evaluation
criteria
Production of foods of non-animal
origin, mixed foods and honey
Production of fishery products
High
Medium
Low
 > 5000 t/year
 100 – 5000
 < 100
Production / packing of soft drinks
and drinking water
High
Medium
Low
 > 10 mln l/year
 1 – 10
 <1
Milk processing factories
High
Medium
Low
 > 10 000 t/year
 1000 – 10 000
 < 1000
High
Medium
Low
 1000 t/year
 500 – 1000
 < 500
Production of meat products
High
Medium
Low
 1000 t/year
 100 – 1000
 < 100
Egg packing establishments
High
Medium
Low
 100 mln eggs/year
 50 – 100
 < 50
Capacity/size of food establishment (LV example)
Capacity / Size / Evaluation criteria
Wholesale / Retail establishments
Sales or warehouse area
High
Medium
Low
 > 300 m2
 100 – 300
 < 100
Restaurants, cafes, bars
The average number of customers per day
High
Medium
Low
 101 and more
 25 – 100
 < 25
Institutional catering (in schools,
kindergartens, hospitals, eldery centres)
The average number of customers per day
High
Medium
Low
 201 and more
 50 – 200
 < 50
Example of scientific risk
ranking
• Scientific Opinion on the risk posed by
pathogens in food of non-animal origin
– Part 1: outbreak data analysis and risk
ranking of food/pathogen combinations
• EFSA, 2013
• EFSA Panel on Biological Hazards (BIOHAZ)
The focus - RTE unprocessed products
The aim of the EFSA research
• (i) to compare the incidence of foodborne
human cases linked to FoNAO and foodborne
cases linked to food of animal origin (FoAO),
and
• (ii) to identify and rank specific food/pathogen
combinations most often linked to foodborne
human cases originating from FoNAO in the
EU.
• For the purpose of this analysis, EU Zoonoses
Monitoring foodborne outbreak data from
2007 to 2011 were used
Outbreak data
• Using this data from 2007 to 2011
– FoNAO were associated with 10% of the
outbreaks, 26% of the cases, 35% of the
hospitalisations and 46% of the deaths
• If the data from the 2011 VTEC O104 outbreak
is excluded
– FoNAO was associated with 10% of the
outbreaks, 18% of cases, but only 8% of the
hospitalisations and 5% of the deaths
EFSA risk ranking model
In order to identify and rank specific food/ pathogen
combinations most often linked to human cases
originating from FoNAO in the EU, a model was
developed using seven criteria:
• strength of associations between food and pathogen
based on the foodborne outbreak data from EU
Zoonoses Monitoring (2007 - 2011)
• incidence of illness
• burden of disease
• dose-response relationship
• consumption
• prevalence of contamination and
• pathogen growth potential during shelf life
5 top ranking groups
Using all the 7 criteria in the model, the 5 top ranking
groups of food/pathogen combinations were:
• (i) Salmonella spp. and leafy greens eaten raw as
salads
• (ii) Salmonella spp. and bulb and stem vegetables;
Salmonella spp. and tomatoes; Salmonella spp. and
melons; and pathogenic Escherichia coli and fresh
pods, legumes or grain
• (iii) norovirus and leafy greens eaten raw as salads;
Salmonella spp. and sprouted seeds; and Shigella
spp. and fresh pods, legumes or grain
5 top ranking groups
Using all the 7 criteria in the model, the 5 top ranking
groups of food/pathogen combinations were:
• (iv) Bacillus spp. and spices and dry powdered herbs;
norovirus and bulb and stem vegetables; norovirus
and raspberries; Salmonella spp. and raspberries;
Salmonella spp. and spices and dry powdered herbs,
Salmonella spp. and leafy greens mixed with other
fresh FoNAO; Shigella spp. and fresh herbs,
pathogenic Escherichia coli and sprouted seeds; and
Yersinia and carrots
• (v) norovirus and tomatoes; norovirus and carrots;
Salmonella spp. and nuts and nut products and
Shigella spp. and carrots
Risk factors
• Scientific Opinion on the risk posed by
pathogens in food of non-animal origin
– Part 2: Salmonella and Norovirus in berries
• The second Opinion out of five
• EFSA Panel on Biological Hazards (BIOHAZ)
• Published: 18 June 2014
• Risk factors for berry contamination by
Salmonella and Norovirus were considered in
the context of the whole food chain
Risk factors
• Scientific Opinion on the risk posed by
pathogens in food of non-animal origin
• Part 2: Salmonella in melons
• The third Opinion out of five
• EFSA Panel on Biological Hazards (BIOHAZ)
October 2014
Risk factors
• Scientific Opinion on the risk posed by
pathogens in food of non-animal origin
• Part 2: Salmonella and Norovirus in tomatoes
• fourth Opinion out of five and addresses the
risk from Salmonella and Norovirus in
tomatoes
• EFSA Panel on Biological Hazards (BIOHAZ) 2
October 2014
Preliminary risk management activities
• Good risk communication is important
• If a risk assessment is needed, it should be
decided by means of discussions between risk
managers and risk assessors
• should determine the scope of the risk
assessment and
• should decide on questions that must be
answered to ensure that
– the scope of the risk assessment is reasonable and
achievable, and
– the results are presented in a readily understandable
form
WHO, FAO,2009
Risk assessment of contaminants
• The RA of chemical contaminants in food relies on the
integration of 2 components:
– knowledge about the human exposure to these substances
via food and other routes, and
– their potential to cause adverse health effects (i.e. the
hazard)
Generic description of the components of risk assessment
Risk assessment
should follow a
structured and
systematic process
Food safety risk analysis,
WHO,FAO, 2006
Risk assessment of
contaminants in food
and feed, EFSA, 2012
Hazard Identification
Chemical ...
- Contaminant
- Pesticide residue
- Food additive
- Food contact material
- Natural toxin
- Allergen
- --------------Microbiological
- Bacteria
- Virus
- Mould
- Parasite
- ----------------
• A description - of the nature of the hazard (e.g.
microorganism/toxin/chemical) capable of causing
adverse health effects and – the food of concern
Hazard identification
• Is designed to primarily address two questions:
– 1) the nature of any health hazard to humans that an
agent may pose and
– 2) the circumstances under which an identified hazard
may be expressed
• is based on analyses of a variety of data
(observations in humans or domestic animals and
studies in laboratory animals and in vitro)
• the nature of any toxicity or adverse health
effects occurring and the affected target organs
or target tissues are identified
Hazard Characterization
Dose-response relationship
• The relationship between
the amount of bacteria/
toxin....that people ingest
and the likelihood that they
will become ill
• Based on observations in
controlled clinical studies or
disease outbreaks, animal
trials
• Can be used to predict the
number of illness
• A description of the potential adverse health effects
attributable to the specific hazards, the mechanisms by
which it exerts its effects, and the associated doseresponse relationship
list of questions prior to hazard characterization
• What are the characteristics of the pathogen (e.g. infectivity,
pathogenicity, virulence)?
• What adverse health effects may be associated with exposure to the
pathogen (mild and self-limiting symptoms, life-threatening conditions)?
• Who is susceptible to infection (individual/subpopulation/population)?
• What are the characteristics of the exposed population that may affect its
susceptibility (age, immune status, concurrent illness, medical treatment,
genetic background, pregnancy, nutritional status, social status,
behavioural traits)?
• How frequently does infection give rise to clinical disease?
• What are the short- and long-term consequences (morbidity, mortality,
sequelae, years of life lost, impairment of quality of life)?
• What are the most important routes of transmission?
• How does the response of the organism to environmental stress (heat,
drying, pH, etc.) affect its ability to cause infection and illness?
• How does the matrix (food or water) affect the ability of the organism to
cause infection and illness?
Hazard characterization
• Relationship between the dose and the incidence of an
adverse health effect
• the critical effect = the first adverse effect observed as
the dose or exposure is increased—is determined
• In cases where the toxic effect is assumed to have a
threshold, hazard characterization usually results in the
establishment of health-based guidance values
– acceptable daily intake (ADI) for additives or residues
– tolerable intake (TI) for contaminants
• ADI may not need to be specified when a substance is
assessed to be of very low toxicity
A hazard characterization developed in one country may
serve the needs of risk managers in another countries
Health-based guidance value
• Whenever possible, the EFSA CONTAM Panel
establishes an exposure level at which there is
no appreciable health risk, called a healthbased guidance value (HBGV)
– such as a tolerable daily intake (TDI)
HBGV is established by dividing the RP by
uncertainty factors to account for
extrapolation from animals to humans and
for variability in human sensitivity
Reference point
• For the establishment of an HBGV, a reference
point (RP) needs to be identified, based, if
possible, on mathematical modelling of the
dose-response relationship
– benchmark dose lower confidence limit (BMDL)
- an estimate of the lowest dose that is 95 %
certain to cause specified change in response
– no-observed-adverse-effect level (NOAEL) - the
highest dose not causing a statistically
significant adverse effect compared to the
controls
Acute and long-term reference dose
• As some substances could give rise to acute health
effects in relation to short periods of intake (e.g.
certain metals, opium alkaloids, some mycotoxins or
marine biotoxins), an acute reference dose (ARfD) as
the HBGV has to be established for such substances
• When a substance shows a long biological half-life, and
tends to accumulate in the human body, exposure over
a longer time period is important - a tolerable weekly
intake as the HBGV usually is established (e.g. for
cadmium or the mycotoxin - ochratoxin A)
If human exposure to the substance from food and other
sources is below the HBGV, it is usually concluded that such
exposure does not pose an appreciable risk to human health
Genotoxic and carcenogenic substances
• For genotoxic and carcenogenic substances it is not
possible to identify a dose threshold of effect (e.g.
aflatoxins, polycyclic aromatic hydrocarbons – PAHs,
etc.)
• For setting priorities for action, margin of exposure
(MOE) approach was proposed by EFSA as a harmonised
approach for the RA of substances that are both
genotoxic and carcinogenic
– a dose that causes a low, but measurable cancer
incidence in animals - usually the BMDL for a 10 %
extra risk - is used as RP
Exposure Assessment
• Occurrence of hazard in
the environment, foods,
animal flocks
• Influence of food
processing
– Analytical
investigations
– Mathematical models
(e.g. predictive
microbiology)
• The qualitative and / or
• Behaviour of hazard in
quantitative evaluation on the
the food chain
likely intake of the hazard via food • Treatment of food
before consumption
• Consumption studies
Exposure assessment
• the occurrence and concentrations of the hazard
in the diet
• the consumption patterns of the foods containing
the hazard
• the likelihood of consumers eating large amounts
of the foods in question - high consumers and of
the hazard being present at high levels
• estimates may be broken down by subgroup of
the population (e.g. infants, children, adults)
exposure assessments are highly specific to the
production, processing and consumption patterns within
a country or region.
«From Farm to Fork» approach
• For microbiological hazards, the occurrence and
transmission of the hazard at various stages from food
production to consumption has to be evaluated, thus
moving “forward” through the various stages of the food
chain to estimate health risk
 Mistakes made at one
stage may have a potential
impact on food safety in
other stages
Observing the entire food
chain, traceability
information is of great
importance
Food supply chain
Risk assessment should be based on scientific data and
should take into account the whole “production-toconsumption” food pathway
Transmission pathways
• Risk assessments usually address a single
hazard or, in the microbiological field - a single
hazard-food combination
• Risk managers need to have good scientific
information on all transmission pathways and
their relative contributions to the aggregate
risk from the hazard
Typical seed production process &
seed processing chain EFSA, 2011
Epidemiology
• Epidemiology is increasingly being used in
food safety to study the links between
– the frequency and distribution of adverse health
effects in specific populations and
– specific foodborne hazards
• This includes
– observational studies of human illness such as
case-control
– analysis of surveillance data, and
– focused research
Food consumption
• Food consumption can be estimated through
food consumption (dietary) surveys targeted to
well-defined groups of individuals
– Dietary assessment methodologies (e.g. food
frequency, 24 h recall)
– Interviews
– Portion size measurment aids
• Establishment of a common database on food
consumption at national – international level
– Food description
– Food coding system
GUIDANCE OF EFSA: General principles for the collection of
national food consumption data in the view of a pan-European
dietary survey (2009)
Age classes (EFSA examples)
• Infants up to and including 11 months
• Toddlers from 12 up to and including 35 months of age
• Other children from 36 months up to and including 10
years of age
• Adolescents from 11 up to and including 17 years of
age
• Adults from 18 up to and including 64 years of age
• Elderly from 65 up to and including 74 years of age
EFSA, 2009
Risk characterization
Estimate about the variability
and uncertainty of the data
Prediction of relative risk and
the contributing factors
Need of correct
interpretation of the results
Experts scientific judgement
Output is the probability of
human illness (per serving of
a meal with a specific
pathogen; concerning
consumption pattern)
• The process of determining the qualitative and / or quantitative
estimation, incl. uncertainties, of the probability of occurence
and severity of known or potential adverse health effects in a
given population based on information from the hazard
identification & characterisation and exposure assessment
Risk characterization
• Restricted to the population of consumers only
• should include all key assumptions and describe
the nature, relevance and magnitude of any risks
to human health
• provides estimates of the potential risk to human
health under different exposure scenarios
• the information from the intake or exposure
assessment and the hazard characterization is
integrated into advice suitable for decision-making
in risk management
– qualitative or
– quantitative
Qualitative information may include
• statements or evidence that the chemical is of
no toxicological concern owing to the absence
of toxicity even at high exposure levels
• statements or evidence that the chemical is
safe in the context of specified uses; and
• description of the type and severity of adverse
health effects in microbiological risk
assessment
• recommendations to avoid, minimize or
reduce exposure
Quantitative information may include
• a comparison of dietary exposures with
health-based guidance values estimates of
risks at different levels of dietary exposure;
• risks at minimum and maximum dietary
intakes (e.g. nutrients) and
• margins of exposure
Risk characterization statement
• Should include a clear explanation of any
uncertainties in the risk assessment resulting
from gaps in the science base
• Should include information on susceptible
subpopulations, including those with greater
potential exposure or specific predisposing
physiological conditions or genetic factors
• Uncertainties in risk estimates and their origins
and impacts should be clearly documented,
and explained to risk managers
Generic risk management framework (RMF)
Identification and selection of risk
management options (2nd phase)
• Identify possible options
• Evaluate options
• Select preferred option(s)
Consists of identifying and evaluating a variety
of possible options for managing
- e.g. controlling, preventing, reducing,
eliminating or in some other manner
mitigating the risk
Identification and selection of risk
management options (2nd phase)
• Includes weighing the results of the risk
assessment as well as any economic, legal,
ethical, environmental, social and political
factors associated with the risk-mitigating
measures that might be implemented
• Economic evaluation of possible risk
management interventions enables risk
managers to examine the health impacts and
feasibility of a proposed intervention relative to
its cost
Identification and selection of risk
management options (2nd phase)
• When risk management options have been
selected, they must be implemented by the
relevant stakeholders
• Industry has the primary responsibility for
implementing regulatory standards
• National food safety authorities must validate and
verify implementation of regulatory standards
• In addition, some non-regulatory risk management
options may be selected, e.g.
– quality assurance schemes at the farm level, or
– consumer education concerning food handling in the
home
Implementation of risk management
decision (3rd phase)
• Validate control(s) where necessary
• Implement selected control(s)
• Verify implementation
The goal is to determine whether the selected
and implemented measures are
• achieving the risk management goals, and
• having any other unintended effects
Implementation of risk management
decision (3rd phase)
• Both industry and government bodies are
involved in monitoring and review activities
• Both sectors usually monitor levels of hazard
control
• Government generally carries out health
surveillance of the population to determine
the level of food-borne illness
Monitoring and review (4th phase)
• Monitor outcomes of control(s)
• Review control(s) where indicated
If monitoring information indicates a need to
review the decision as to risk management
options, the risk management process can begin
a new cycle, with all interested parties
participating as appropriate
The cyclical process can be repeated as many times as
is necessary
Interactions of risk assessment with risk management
(WHO, 2009)
Risk assessment - PAO in smoked meat
products (LV example)
- On base of Methdology developed by EFSA
- LV data used
Consumption of smoked meat products, LV
Backgroud
• National Food Consumption Survey of LATVIA, 2007
– 2009 (2000 individuals were interviewed in 2008;
age group 7-64)
• Dietary survey conducted in 2012 (2000
participants; age group 19-64)
– Food frequency questionnaire and
– 24-h recall
• Specific dietary research with regard to consumption
of smoked meat products carried out in 2014 (age
group 19-64)
Consumption of smoked meat products, LV
• Consumption of meat and fish during a year
N=1811
Average
Std. Dev.
25th percentile
Median
75th percentile
Meat, kg
81.8
± 1.5
65.9
34.9
64.1
110.8
Fish, kg
13.0
± 0.4
18.2
2.6
6.7
15.4
Meat and Fish, kg
94.8
± 1.7
74.1
42.1
73.7
125.2
Smoked meat and fish, kg
14.6
± 0.4
18.9
3.3
8.3
18.2
Grilled/barbequed meat and fish, kg
13.9
± 0.5
22.2
1.2
5.3
17.3
28.6
± 0.7
31.5
7.3
17.6
37.0
15.0
± 0.3
12.2
6.0
12.2
20.9
14.0
± 0.4
15.3
2.1
8.2
21.6
29.0
± 0.4
17.8
14.7
27.3
41.2
Smoked, grilled, barbequed meat and
fish kg
Smoked meat and fish,
% from all meat and fish consumed
Grilled/bbq meat and fish,
% from all meat and fish consumed
Smoked, grilled, barbequed meat and
fish, % from all meat and fish
consumed
Consumption of smoked meat products, LV
• Differences in meat consumption between men and
women are statistically significant at exceptionally high
levels (p<0.0001 independent sample Student t-test,
Mann-Whitney-Wilcoxon U-test)
– Women consume 171 grams of meat/meat products
per day
– Men consume significantly more – 280 grams meat/
meat products per day
• 33% of consumers purchase smoked products in
supermarkets, 23% in groceries and only 15 % - in farmermarkets or directly from farmers (containing higher BaP
and PAH 4 sum concentrations)
Consumption of smoked meat products (LV)
• Few families make smoked meat and fish products by
themselves
– Almost 15% do it on their own but 10% use
products smoked by friends, relatives or
neighbours
• The main factors consumers follow when purchasing
smoked products are:
– Low price (for traditionally smoked products
higher)
– Production place (made in Latvia)
– Colour of product (preference for darker colour)
Consumption of smoked meat products, LV
• 22% of respondents have planned or have already
reduced the consumption of smoked meat products
in order to reduce intake of BaP and PAH4
• 23% of respondents have pointed out that they
would not change anything in their eating habits to
reduce BaP and PAH intake – and they are worried
that there will be significant changes in taste of
traditionally smoked products if lower limits for BaP
and PAH4 sum will be set in legislation
Consumption of smoked meat products, LV
• Smoked chicken
• Most of consumers (31%) prefer chicken that looks like that
in Picture No 1
• 26% of consumers rates chicken in Picture No 4 as the
favourite one - the only one available in vacuum packaging
that makes it easier to bring home
Consumption of smoked meat products, LV
• Smoked pork fat
• 38.8%
of consumers prefer product in Picture No 1
• Only 7% of consumers prefer the one in Picture No 3
Consumption of smoked meat products, LV
• Home-made sausages
• These products are typically included in sandwiches
• Mainly consumed by senior-age consumers (may have strong
taste of garlic and other spices)
• Majority of consumers (52.3%) prefer sausage in Picture No 1
Content of PAHs in smoked meat products (LV)
• Mean, median, minimum, maximum of single PAH4
compounds and sum of PAH4 in smoked meat products µg/kg
(n=128)
– Levels below detection limits were set to zero
PAHs
Mean,
Median,
Maximum,
Minimum, µg/kg
µg/kg
µg/kg
µg/kg
BaA
2.38
0.76
14.21
0.05
Chr
2.44
0.82
14.50
0.10
BbF
0.82
0.32
4.60
<0.05
BaP
0.73
0.21
6.03
<0.05
PAH4 sum
6.36
2.10
34.65
0.15
Content of PAHs in smoked meat products (LV)
• If the existing maximum permitted limit for
BaP concentration (5 µg/kg) will be lowered to
2 μg/kg, about 14% of smoked meat products
would not be compliant with the new
legislative proposal
• If the new limit for 4PAH sum will be
introduced (i.e. 12 µg/kg instead of existing 30
µg/kg) about 20% of smoked meat products
would not be compliant with the new limit
Content of PAHs in smoked meat products (LV)
Conclusions
The higher concentrations of PAHs were observed in samples of
smoked meat products produced by small producers following
traditional smoking methods
• intensity of smoke deposition depends on the environmental
conditions (temperature and relative humidity)
• meat products come into direct contact with components of
smoke
• undesirable compounds of smoke are not separated/removed
• temperature of combustion can not be accurately controlled
• cleaning of equipment is carried out using simple methods
(e.g. mechanical)
• alder is the most famous firewood for smoking
Content of PAHs in smoked meat products (LV)
Smoked meat products with BaP levels below 2.0
µg/kg and PAH4 sum below 12.0 µg/kg for
manufacturers applying traditional smoking methods
could be problematic in light of
• need to change traditional small-scale production
practices (professional equipment needed to
assure permanent control of
technological/smoking parameters) – traditional
practices will dissapier...
• need to change local eating habits/consumer
preferences (flavour, visual appearance, traditional
taste of smoked products
Risk characterisation
EFSA Margin of Exposure (MOE) Approach
used
Dose-response modelling/MOE
– margin of exposure
Deriving of MOE: use of BMD Approach (EFSA)
a
benchmark response (e.g. 10% increase in tumour incidence
compared to background - 10% increase of tumour bearing
animals) have to be defined and corresponding benchmark dose
(e.g. BMD10) derived
BMDL10
MOE = ______________
60
% Response
50
40
BMD10
30
Human exposure
20
10
0
1
10%
Response
=
Daily dose
BMR
10
BMDL10
Model fitted to
data points
BMDL10 Benzo(a)pyrene: 0,07
BMDL10 PAH 4 Sum: 0,34
(mg/ kg b.w./ day)
Lower 95% confidence interval on dose giving a 10% response
PAHs (benzo(a)pyrene) MOE 10 000 safety factor of 10 000 introduced by EFSA
• MOE is a ratio: data on food intake and chemical
concentration are used
• MOE ≥ 10 000
MOE of 10 000 or higher
considered as of low concern
• MOE < 10 000
MOE lower than 10 000
considered as of high concern
The 10,000 value for the MOE results from consideration
of the following uncertainty factors (EFSA)
• - Factor 100
a) the difference between animals and man (inter-species
difference, factor 10)
b) the difference between various human beings (intra-species
difference, factor 10)
• - Factor 10
- for the special variability which extends beyond the variability
already obtained in the customarily applied factor 10 for the
intra-species difference and concerns the individual cancer risk
(depending, for instance, on DNA repair activity and cell cycle
control)
• - Factor 10
- for the fact that the BMDL is not an adequate substitute for a
threshold value for tumour induction
Risk characterisation (LV)
• To conclude on possible inpact of consumption of
smoked meat products on consumers’ health, two
different scenarios were developed:
• during the 1st scenario the data on average BaP
concentration and average 4 PAH sum were used, taking
into account the findings of the research
• during the 2nd scenario the worst possible scenario was
simulated, and the data on maximum allowed BaP
concentration and maximum allowed 4 PAH sum were
used
– 5 µg/kg and 30 µg/kg, respectively - according to
Regulation 1881/2006
Risk characterisation, LV
• MOE indicators for all consumer groups studied within
the research far exceeds 10 000 - the MOE value
derived on base of precautionary approach and
recommended by EFSA
• Relatively higher dietary exposure and thus a
comparatively lower MOE with regard to exposure to
BaP and 4 PAH was detected for men and middle-age
consumers
• Relatively lower MOE were calculated for consumers
living ouside Riga than for inhabitants of Riga
Risk characterisation, LV
• Even in the case of worst possible scenarios – that is,
if the high- risk consumers would always consume
only those meat products smoked according to the
traditional methods, and if the traditionally smoked
meat products would always contain the highest
allowed concentration of BaP (5 µg/kg) and 4 PAH
sum (30 µg/kg) (that, of course, is impossible!) - MOE
indicators would still remain significantly above the
reference value of 10 000
Risk characterisation, LV
Calculation of consumer exposure to BaP and 4PAH and
calculation of MOE indicator for all consumers of smoked meat
products (mean calculated values of BaP concentration and
4PAH sum used)
All
consumers
Consumption of smoked
meat products
(kg/ day)
Mean
Median
75 %tile
Benzo(a)pyrene
0,036
0,022
0,047
4PAH sum
0,036
0,022
0,047
Mean
concentration
BaP / ΣPAH 4
(µg/kg)
All producers
Consumer exposure
(ng / kg b.w. / day)
BMDL10
(ng / kg
b.w.
/day)
MOE
Mean
Median
75 %tile
Mean
Median 75 %tile
0,73
0,33
0,20
0,44
70000
209627 343026
160565
6,36
2,91
1,78
3,80
340000
116868 191238
89516
Risk characterisation, LV
Calculation of consumer exposure to BaP and 4PAH and
calculation of MOE indicator for all consumers of smoked meat
products in case of worst possible scenario (maximum allowed
values of BaP and 4PAH sum used)
All consumers
Consumption of smoked meat
products
(kg/ day)
Mean
Median
75 %tile
Benzo(a)pyrene
0,036
0,022
0,047
4PAH sum
0,036
0,022
0,047
Mean
concentration
BaP / ΣPAH 4
(µg/kg)
All producers
Consumer exposure
(ng / kg b.w. / day)
Mean
Median
75 %tile
5,00
2,29
1,40
2,99
30,00
13,72
8,39
17,92
BMDL10
(ng / kg
b.w.
/day)
MOE
Mean
Median
75 %tile
70000
30606
50082
23443
340000
24776
40542
18977
Risk characterisation, LV
Comparison of MOE indicators within different groups of
consumers (dietary exposure to BaP)
MOE (in case of mean BaP, calculated on
base of the research)
MOE (in case of maximum allowed BaP /
worst possible scenario)
Mean
Median
75 %tile
Mean
Median
75 %tile
All consumers
19 -35
years old
36 – 50
years old
51 – 64
years old
209627
343026
160565
30606
50082
23443
212702
350959
171199
31055
51240
24995
198174
297260
148630
28933
43400
21700
217697
383562
167808
31784
56000
24500
Men
172803
259204
127608
25229
37844
18631
Women
261486
424914
206019
38177
62038
30079
Inhabitants of
Riga
251553
419254
184063
36727
61211
26873
People living
outside Riga
210959
351598
165458
27545
45908
21604
Groups of
consumers
Risk characterisation, LV
Comparison of MOE indicators within different groups of
consumers (dietary exposure to PAH 4 sum)
Groups of
consumers
MOE (in case of mean PAH 4 sum,
calculated on base of the research)
MOE (in case of maximum allowed PAH 4
sum / worst possible scenario)
Mean
Median
75 %tile
Mean
Median
75 %tile
All consumers
19 -35
years old
36 – 50
years old
51 – 64
years old
116868
191238
89516
24776
40542
18977
118582
195660
95444
25139
41480
20234
110482
165723
82862
23422
35133
17567
121367
213836
93553
25730
45333
19833
Men
96338
144507
71142
20424
30635
15082
Women
Inhabitants of
Riga
180939
294025
142558
30905
50221
24349
140241
233735
102615
29731
49552
21754
117610
196017
92243
22298
37164
17489
People living
outside Riga
Conclusions (LV)
• Overall impact of consumption of traditionally smoked
meat products on dietary exposure to BaP and 4PAH
sum, as well as on MOE indicator is negligable
– the data on mean concentrations of BaP (0.73
µg/kg) and 4 PAH sum (6.36 µg/kg) were calculated
using resuilts on both - smoked meat products
produced in large-scale meat processing factories
products produced using traditional smoking
methods
Conclusions (LV)
• The results on risk characterisation using MOE approach
has revealed a low risk to consumers’ health. Even for
high-level consumers and in case if BaP concentration
and PAH 4 sum is equal to current legal limit - MOE is not
close to 10 000
• It was suggested, that the previous legal limit for BaP and
4 PAH sum in smoked meat products (5 µg/kg and 30
µg/kg, respectively) could be still applied in national
market without serious impact on consumers’ health
for meat products smoked using traditional small-scale
smoking methods
• Thank you for attention!