1. CODEX and the European Union’s food safety policy
Mike van Schothorst

2. Microbiological Risk Assessment Topic 1
Purpose of lecture
introduce the Risk Analysis framework
show its importance for international trade
make the link with Codex and EU regulations
introduce some important food safety
targets
In this lecture we will explain that Risk Analysis is a management tool that is still under development, but that the basic elements and functions are well established.
The main purpose of this course is to understand what Microbiological Risk Assessment is all about. In order to achieve this it is necessary to put it in the context of Risk Analysis. The two functions mentioned in this slide will be explained.
The international trade is regulated by the World Trade Organization (WTO) and food safety aspects are dealt with by the Sanitary and Phytosanitary Agreement (SPS) and Codex Alimentarius.
Understanding the functions of these international bodies and the relevant documents governed or issued by these bodies is essential for understanding Microbiological Risk Assessment as a tool in governmental food safety "control". It will be made clear that food safety is a responsibility shared by different shareholders. 2

3. Microbiological Risk Assessment Topic 1
Role of Governments according to
the General Principles of Food Hygiene
protect consumers adequately from illness
or injury caused by food
provide assurance that food is safe and
suitable for normal human consumption
maintain confidence in internationally
traded foods
provide health education programs which
effectively communicate the principles of
food hygiene to industry and consumers
The Codex Alimentarius Commission (which will be introduced later in this lecture) recognised that food safety is an important issue. Clearly, governments have to protect their population from illness as far as possible. They have to assurance that food produced locally or imported market is safe.
Note that certain foods should also be suitable for consumers with specific cultural or religious requirements such as Muslims and Jews. Maintaining confidence in internationally traded foods is also a responsibility and this aspect will be further discussed in the next slides.
Note also that education and information concerning how to make and keep foods safe is, according to Codex, also a governmental responsibility.
Codex Alimentarius 3

4. World Trade Organisation Agreements
Microbiological Risk Assessment Topic 1
World Trade Organisation Agreements
International trade in food regulated by World Trade Organisation (WTO)
Sanitary and Phytosanitary agreement (SPS)
Technical Barriers of Trade agreement (TBT)
In order to address the concern over food safety and other aspects of consumer protection the agreements mentioned in this slide were worked out. Although originally elaborated during the Uruguay round of multilateral trade agreements in the context of the GATT (signed in 1994), these agreements are now governed by the WTO, created in 1995.
The TBT deals, as the title indicates with all kinds of technical aspects of the foods that may have an effect on fairness in trade.
The SPS agreement covers all kind of food safety aspects of food. 4

5. GATT Sanitary and Phyto-Sanitary (SPS) agreement
Microbiological Risk Assessment Topic 1
GATT Sanitary and Phyto-Sanitary (SPS) agreement
SPS measures are measures taken to protect human,
animal and plant health
The agreement should
ensure sovereign rights to protect health
prevent misuse for protectionism purposes
prevent unnecessary trade barriers
Each country has, of course, the right to protect in its own manner the health of its consumers and institute food safety requirements. However the safety requirements for imported foods may not be set higher than for home produced products in order to protect its own industry. Local industries should also comply with these requirements. Moreover, these, and other requirements, should not become a barrier to fair trade. When conflicts arise it is the WTO who has the authority to judge and, if necessary, rectify the situation.
Note that animal and plant health are also covered by the SPS agreement
World Trade Organization (WTO) is the governing body 5

6. Microbiological Risk Assessment Topic 1
Sanitary measure
A sanitary measure is defined as
any measure applied to protect human or animal life or health, within the territory of a member,
from risks arising from additives,
contaminants, toxins or disease causing organisms in food, beverages or foodstuffs
A "sanitary measure" is defined as any measure applied to protect human, animal and plant health. The meaning of the term is similar to “control measure” used in Codex Alimentarius documents.
The SPS agreement regulates risks arising from additives, contaminants, toxins or disease causing organisms in food, beverages and animal feed.
Note that the word "risk" is already mentioned in this definition.
WTO/SPS agreement 6

7. Microbiological Risk Assessment Topic 1
Important notions
Imported food should not endanger a
population’s health
Appropriate Level of Protection (ALOP) is an
expression related to a population’s health
Microbiological Risk Assessment (MRA) is a
method to determine whether a pathogen/food
combination endangers the health
International Standards should define the
safety of a product.
The SPS stresses that a country has the right to require that imported food should not endanger the population's health, and introduces the term Appropriate Level of Protection (ALOP). The ALOP can be expressed as the number of illnesses caused by a certain food/pathogen combination.
Clearly an imported food should not increase this "burden of disease". In order to achieve this, the imported food should be as safe as the locally produced food. A tool to determine the risk of a food to a country's population is Microbiological Risk Assessment.
MRA is one of the elements of Risk Analysis. Risk Assessment is explicitly mentioned in the SPS agreement as a tool to evaluate the safety of a food particularly in cases where no international food safety standards have been developed. When such standards have been elaborated, they should be used. Those of the Codex Alimentarius are the standards of choice. 7

8. International Standards
Microbiological Risk Assessment Topic 1
International Standards
Basis for national measures
Presumption of correctness
Right to deviate based on scientific
justification or non - correspondence with
the appropriate level of protection (ALOP)
Codex Alimentarius is the reference
The international standards should, where appropriate, also be the basis for national ones in order to prevent "double standards". This is why the Codex standards, Codes and Guidelines have become so important since the acceptance of the SPS agreement. These standards are assumed to be correct, but deviation are allowed when the deviation can be backed up by scientific justifications (Risk Assessment) or when such a international standard would endanger the ALOP.
These notions are the basis
of the latest EU regulations 8

9. Microbiological Risk Assessment Topic 1
Codex Alimentarius
The main purposes of this
FAO/WHO Programme are
protecting health of the consumers
ensuring fair trade practices in the
food trade
promoting coordination of all food
standards work undertaken by
international governmental and
non-governmental organizations
The Codex Alimentarius was established after the second world war with the objectives mentioned in this slide.
Until the 1990’s all Codex Guidelines, Codes and Standards were of an advisory nature. Governments were encouraged to put them into the local laws and regulations.
This voluntary nature of adopting the Codex documents changed in the context of the WTO SPS agreement, where these documents were referred to as the international standards to be adhered to for food intended for international trade. 9

10. Microbiological Risk Assessment Topic 1
Codex Alimentarius,
important documents dealing with microbiology
General Principles of Food Hygiene
HACCP
Establishment of Microbiological Criteria
Principles of Microbiological Risk Assessment
Principles of Microbiological Risk Management
Validation of Food Hygiene Control Measures
Codes dealing with import and export regulation
The acceptable levels of microorganisms, chemicals etc. are mainly described in the specific Standards, Codes and Guidelines issued by the Codex Alimentarius. There are however a number of documents that are of particular importance in relation to the microbiological safety of foods.
The General Principles of Food Hygiene describe the practices that should be adhered to in order to achieve the required level of safety, the document dealing with the HACCP principles is an annexed to it.
When GHP and HACCP are applied the resulting products should meet certain Microbiological Criteria. How these must be established is described in a separate document.
Triggered by the SPS agreement, Codex has developed a documents laying down the principles of Microbiological Risk Assessment and Management
This last document, as well as the one on Validation is (in 2005) still in discussion. 10

11. Microbiological Risk Assessment Topic 1
Food Control Systems
This expression is used in relation with
governmental activities
to provide consumers with safe foods that meet
national and/or international regulations
Such activities may be
food safety policy establishment
regulatory activities
inspection / assessment functions
advice to industry
consumer education and information
FAO and WHO have issued a document dealing particularly with governmental "food control“.
In this course the term Food Control Systems is used to express various governmental activities and functions dealing with assuring the safety of food.
Meeting the ALOP is in this context clearly a condition for meeting national and international regulations. 11

12. Microbiological Risk Assessment Topic 1
Risk Analysis (1)
This is the process
adopted and described by the
Codex Alimentarius Commission
to deal with the organisation of
several aspects of Food Control Systems
Note that the Codex Alimentarius Commission does not deal with enforcement activities. 12

13. Microbiological Risk Assessment Topic 1
Risk Analysis (2)
Risk Analysis
is a management tool for
governmental bodies to define an appropriate level of public health protection and establish systems
and control measures
to ensure the supply of safe foods
(Adapted from Codex 1997)
Risk Analysis is not only an analysis, it is also a decision making framework to select effective control measures which will ensure that the consumer is appropriately protected against foodborne diseases.
In the context of the World Trade Organization and Codex Alimentarius the formulation of the Appropriate Level Of Protection (ALOP) is an important aspect of Risk Analysis.
Establishing a public health goal expressed as an ALOP makes the food control system more targeted than it has been, particularly in regard to pathogenic microorganisms. 13

14. Microbiological Risk Assessment Topic 1
Safety and Risk
Safety
Risk
safety means “no harm”
100% safety does not exist
there is always a (often very remote) chance
that a certain harm is caused by a specific
pathogen/food combination
Risk Assessment estimates this chance
Risk Analysis provides a framework for
managing the risk
The principle behind Risk Analysis is that by assessing the risk (probability and severity of illness consequent to consumption) of a food, ways to improve the safety of food can be determined.
In this context it is important to understand that in the perception of many people food should be 100% safe, but scientifically we have to admit that 100% safety does not exist. We can only try to reduce the risk of illness as much as is reasonably possible. However, there will always remain a (often very remote) chance that someone still may get ill. The scientific process to estimate such a probability is called Risk Assessment, an important component of Risk Analysis.
Another component is called Risk Management, which is dealing with selecting and implementing control measures that will assure that consumers are appropriately protected. Risk Management is not only a scientific process, it also deals with societal and economic factors. Topics 2 and 5 will deal with MRM in detail.
Risk Communication is a third component of Risk Analysis, it will be discussed in various lectures in the course. 14

15. Microbiological Risk Assessment Topic 1
Risk reduction
By reducing
the probability and severity of harm
the safety of
a food is
increased
To repeat part of what was explained in the last slide, Risk Analysis introduced science based decision making, with the emphasis on risk reduction rather than on food safety enhancement.
This does not mean that Risk Analysis is not a safety enhancement tool, because there is a direct relationship between risk reduction and safety enhancement. The difference is that Risk Analysis uses the estimation of risks as a decision making tool rather than the estimation of safety.
this is the basic principle of Risk Analysis 15

16. Codex Risk Analysis framework
Microbiological Risk Assessment Topic 1
Codex Risk Analysis framework
Policy based
Science based
Risk Assessment
Risk Management
Preliminary activities
Option Evaluation
Option Implementation
Monitoring & Review
Hazard Identification
Hazard Characterization
Exposure Assessment
Risk Characterization
As mentioned before, Risk Analysis is a structured food control system. In this slide the framework as described by Codex Alimentarius is presented.
Risk Analysis is based on the interaction of three elements:
Risk Assessment: examining the science
Risk Management: defining the policies
Risk Communication: communication between assessors, managers and interested parties as well as communicating the outcome of the Risk
Assessment to stakeholders of the food chain.
These three components will be further described in the next slides.
Risk Communication
Interactive exchange
of information and opinions
concerning risks,
risk management options and control measures 16

17. Microbiological Risk Assessment (MRA)
Microbiological Risk Assessment Topic 1
Microbiological Risk Assessment (MRA)
A scientific process which consists of determining the likelihood and severity of an adverse health effect in a population exposed to a certain pathogen / food combination
This is a description of Risk Assessment, but not the official Codex definition. It explains what it is, the Codex definition describes the components which will be explained in Topic 3.
A task of EU’s EFSA 17

18. Microbiological Risk Assessment Topic 1
Purposes of MRA
estimate the risk of illness from the
consumption of a certain pathogen/food
combination
estimate the risk-reduction that may be
obtained by certain control measures
support decision making by risk managers
by providing relevant data
Some purposes of performing an MRA are mentioned just to show what MRA is about. Topic 3 will cover much more.. 18

19. EU “food law” regulation No. 178 / 2002
deals with :
general principles and requirements
of food law
the European Food Safety Authority
procedures in matters of food safety
- risk analysis
- precautionary principle
- traceability
- responsibilities for producers and authorities

20. Tasks of Risk Management
Microbiological Risk Assessment Topic 1
Tasks of Risk Management
Setting Public Health goals and targets such as
acceptable level of risk (ALOP) and/or safety
(Food Safety Objective, FSO*)
Deciding on "control" activities such as
setting Performance Objectives (POs)
execution of education programmes
Implementing, monitoring and review
Setting public health goals is an important aspect of Risk Analysis, it makes food control more targeted, it may even be necessary in certain cases for foods entering the international trade.
The ALOP, as an expression of the Appropriate Level Of Protection and thus of risk may need to be translated into a Food Safety Objective (FSO), which expresses the level of a hazard in a food rather than the level of risk. This will be explained in detail later in the course.
Risk Managers have to decide which control measures are needed to meet the established public health goals (such as an ALOP and/or an FSO). Once control measures have been decided upon they need of course to be implemented, as will be discussed in Topic 6.
The term Performance Objective will also be explained in Topic 6.
The effect of the measures have to be monitored and if necessary the control measures have to be reviewed and/or revised.
Note that the execution of most control measures will be in the hands of the producers, processors and users of the foods, not the governmental Risk Managers.
* currently under discussion in the EU 20

21. Microbiological Risk Assessment Topic 1
Targets for food safety
“Zero" incidence of foodborne illness is an ideal public health goal
Realistically, it is not possible to achieve this
Therefore, there is a need to set targets for food safety considered to be
appropriate / acceptable / tolerable
This can be an FSO, a PO or in EU terminology
just a “target”
Although absence of all foodborne diseases would be the final goal, in the short term this can not be realised. Consequently public health goals have to be set that are realisable, which will in practice mean that a certain risk has to be accepted.
In the WTO/SPS agreement the expression of Appropriate Level Of Protection (ALOP) is used, but as alternative the expression “Acceptable Level of Risk” is mentioned.
Many people do not like to accept risks, but accept to tolerate risks because the risks cannot be sufficiently be reduced. 21

22. Appropriate Level Of Protection (ALOP)
Microbiological Risk Assessment Topic 1
Appropriate Level Of Protection (ALOP)
An expression of
the achieved, or to be achieved,
health status of a country’s population
regarding a pathogen or
pathogen / food combination
In this course we will use the expression ALOP for a target that is achieved or is set as a target to be achieved.
WTO / SPS agreement 22

23. Microbiological Risk Assessment Topic 1
Meeting an ALOP
The level of risk (ALOP) needs to be converted into a level of safety. Safety is related to the level of a hazard in a food.
This level of a hazard is referred to as a
Food Safety Objective (FSO)
in the Microbiological Risk Management
document of Codex
As mentioned, it is difficult to measure whether an ALOP is met, and for this reason the concept of FSO referring to the level of a hazard has been introduced.
How ALOP and FSO relate to each other will be shown in the next slide. 23

24. Risk Characterization curve
Microbiological Risk Assessment Topic 1
0.2
0.4
0.6
0.8
-1.5
-0.5
0.5
1.5
2.5
3.5
4.5
>4.5
L.m. curve
Risk Characterization curve
No of illnesses/
100,000 in the USA
(based on current market conditions
and eating habits in the USA)
In MRA the relationship between exposure and effect has been determined, and can be depicted in a graph such as shown in this slide.
Such a curve is helpful in explaining how an ALOP can be transformed into an FSO. For instance if we want to achieve a low incidence of listeriosis we can select a figure on the vertical axes. By drawing a horizontal line we will somewhere cross the curve and by drawing then a vertical line we will get the value of what can be an acceptable level of the hazard in the food.
This slide is used only to demonstrate the relationship between ALOP and FSO, more precise figures were given in Topic 3 – Lecture 3, the Listeria example.
ALOP
Log No L.m.
per serving
FSO
Based on FAO/WHO report 24

25. Examples of a public health goal and a target
Microbiological Risk Assessment Topic 1
Examples of a public health goal and a target
The yearly incidence of food-borne listeriosis
should not exceed 2.5 cases per 1,000,000 of
population (USA objective for the year 2005)
Absence of Salmonella in poultry by the year 2010
(EU regulation 2160 / 2003)
This is an example of a target which is reflecting a general “burden of disease” caused by Listeria monocytogenes and a particular one for smoked fish. If in a country this target is met, imported smoked fish should assure that not more people will get ill from this product. If imported fish would increase the number of illnesses it can be rightfully rejected by the importing country.
Reducing the incidence of salmonellosis is one of the priorities of many governments. Such a public health goal may be made more specific, for instance by specifying that the contamination of poultry should be reduced with 20% in the next five years and a further 5% in the subsequent period of 5 years. 25

26. Microbiological Risk Assessment Topic 1
Food Safety Objectives
Provide a link between public health goals and
Performance Objectives, performance/process
criteria, microbiological criteria etc.
Provide a basis for discussing food control
measures with stakeholders
Articulate a clear goal in terms pertinent to
food control measures
Provide a more objective means of establishing
stringency (and equivalence) of food control
systems
As can be seen FSOs serve various purposes. First it is the translation, as was mentioned, of public health goals (ALOPs) into a value which is meaningful for food producers, handlers, consumers etc,. The level of a hazard is expressed at the moment of consumption, but can also be expressed at other points in the food chain (POs) or transformed into changes in levels of a hazard due to control measures (for instance the effect of a cooking step) (Performance Criteria). When such levels have to be tested using microbiological methods they are expressed in the so called microbiological criteria. This will be explained in more detail later.
As mentioned before the outcome of food control measures needs to be discussed in terms that are understood by industries etc. FSOs/POs can be useful in this endeavour.
In the WTO/SPS agreement equivalence is an important goal to be achieved by importing and exporting countries. Setting a level of a hazard in a food product to be met by both local and imported food greatly helps to achieve this transparency. When the requirements are known, it can be assured that they are met and it can then also be demonstrated that the requirements are met.
Transparency in the WTO/SPS text means that when requirements are going to be changed (a new food safety objective as part of a food safety enhancement program to be met in for instance three years time) this new target has to be communicated to exporting markets. 26

27. Microbiological Risk Assessment Topic 1
Food Safety Assurance
Microbiological Risk Assessment Topic 1
Country level
PH goals
Standards
Policy
Risk Management / Food Control
high level, generic
policy bases guidance
specific standards, criteria
ALOP – FSO- PO PC
Food Chain Management / Hazard
control
Operational level
The function of an ALOP, FSO, PO or PC is presented here in the food safety assurance pyramid which was shown already before. It shows that they have indeed a role in the implementation of MRM decisions.
control measures
from farm to fork
HACCP
GAPs/GHPs/GMPs 27

28. Microbiological Risk Assessment Topic 1
FSO definition
The maximum frequency and/or concentration
of a hazard in a food
at the time of consumption
that provides or contributes to the
appropriate level of (health) protection (ALOP)
The hazard level in a product to which a population is exposed has two dimensions. The frequency of contamination is one, the concentration per contaminated product is the other. An FSO may describe the one or the other or both. In the example given here, the frequency of contamination is not mentioned, because it is not important. The concentration determines the risk more than the frequency.
The current Codex definition makes it very clear that the FSO is the level of a microbiological hazard at the moment of consumption. The proof of the pudding is in the eating. If no one gets ill there is a “100%” protection. However, specifying the target at an earlier point in the food chain is useful, particularly for food that needs to be heated before consumption.
The picture shows fried eggs, i.e. eggs at the moment of eating, the FSO could be “absence of Salmonella in a serving of fried eggs”. The yolk here is still semi-liquid, depending on whether the raw eggs contained Salmonella (and if so, their numbers) or not, would determine if this FSO would be met.
Example : < 100 L.m. / g at moment of consumption
Codex Alimentarius 28

29. Performance Objective (PO) definition
Microbiological Risk Assessment Topic 1
Performance Objective (PO) definition
The maximum frequency and / or concentration
of a hazard in a food
at a specified step in the food chain
before the time of consumption
that provides or contributes to
an FSO or ALOP, as applicable
This definition is very important because it stresses again that POs should be used at specific points in the food chain, not at the moment of consumption. It also expresses its function i.e. it should assure that an FSO or ALOP will, or can be, met.
This again is important for foods in international trade. The PO of a ready to eat food which is microbiologically stable may be the same as an FSO. If for instance microbiological testing could be used to check conformity it is not necessary to set a PO, the microbiological criterion can be directly related to the FSO.
If however, the microbiological status of a food may change during commercialisation and preparation a PO should be set if microbiological testing is a means of checking whether the FSO would be met. Many standards and microbiological criteria will therefore need to be linked to a PO rather than to an FSO.
Codex Alimentarius 29

30. Microbiological Risk Assessment Topic 1
Control measures
Actions and activities
that can be used
to prevent or eliminate
a food safety hazard or
reduce it to an acceptable level
What has been stated in one of the first slides is demonstrated here.
Formerly it was assumed that safe foods were produced by adhering to Good Agricultural Practices and Good Hygienic Practices. The control measures achieved that the hazard was reduced to an acceptable level. This was the basis of the HACCP concept. In reality it was not often known what this acceptable level was. Industries and governments just had the epidemiological evidence that the foods thus produced were indeed safe.
This definition of control measure is the one described in the Codex document on HACCP. In the risk analysis framework the application of control measures becomes targeted. The acceptable level is now defined as a PO or an FSO, targets that should assure that the ALOP as public health goal is met.
PO / FSO
Codex Alimentarius 30

31. Determination of control measures (HACCP)
Microbiological Risk Assessment Topic 1
Determination of control measures (HACCP)
Determine where measures must be
taken (CCPs)
Determine how and to what extent
they are to be controlled at these CCPs
Establish the critical limits and
monitoring procedures
Although the HACCP concept does not change, more guidance will in the risk analysis framework be given on what should be achieved at CCPs. The establishment of the critical limits and monitoring procedures have now a more precise function i.e. they should assure that POs during processing, and the PO of the final product should be achieved.
The extent of the change in levels of a hazard is called in the Codex document on MRM a Performance Criterion (PC).
The critical limits used to assure that a PC is achieved are the process parameters.
Performance
Objectives
and Criteria
Process
parameters 31

32. EU regulations No 2073 / 2005: “Micro criteria”
End-product criteria for pathogens
Indicators for “self-control” of industries
No 852 / 2004 : “Hygiene” & HACCP *
No 2160 / 2003 : “Salmonella” & other zoonotic agents
Targets as levels to be achieved
* HACCP can be applied with flexibility

33. Flexibility The EU regulation allows a certain flexibility
in the application of HACCP
An EU guidance document is based on the
Codex text
The ISO text on food safety management
is clearer and auditable
but leaves less room for flexibility

34. Process Hygiene Criterion
a criterion indicating the acceptable functioning of the production process
such a criterion is not applicable to products placed on the market
it sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with the food law
EU regulation 2072 / 2005

35. EU Criteria Not many criteria prescribed
Frequency of sampling and analysis
not prescribed in most cases
Actions in case of deviation:
Food safety criterion: lot not on market
Process hygiene criterion: improve hygiene,
in a few cases: check food safety criterion

36. Product / Pathogen / Pathway control
Microbiological Risk Assessment Topic 1
Product / Pathogen / Pathway control
time /
temp.
hazards in environment ? which levels ?
GAP
In order to understand the quantitative aspects of food safety assurance it is useful to look at this basic concept.
In any situation were food is produced, processed or prepared the raw material or the food to be prepared for consumption has an initial level of the pathogen of concern. The initial level may be near or equal to 0, but is also may be up to a 1000 or even more per gram.
Processing often implies that a certain reduction is achieved which has an effect on the numbers, but unfortunately the product may be recontaminated as well and often even more unfortunately somewhere along the line growth may occur.
All this will result in a certain level of the hazard in the product.
Initial
number of
pathogens H0 +
Reduction
Recontamination -
GHP +
Growth
Hazard level in product = 36

37. Codex policy Less emphasis on end-product testing
Outcome orientated, less process
prescriptions (PO rather than T/t)
Investigation and surveillance of
line- environment emphasised
(Listeria, E. sakazakii)

38. Microbiological Risk Assessment Topic 1
Country level
Target oriented
food safety
management
Public health burden
Guidance levels of hazard not to be surpassed
Food Safety Objective
Performance Objective
Performance Objective
Performance Objective
exposure
primary production
manufacturing
transport
retail
preparation
cooking
consumption
Performance criterion
Performance criterion
Performance criterion
Performance criterion
This slide complements the previous one in the sense that performance criteria and process parameters have been put in the overall context.
Process parameters
Process parameters
Control Measures
Control Measures
Operational food chain level
Operational actions, changes, outcomes 38

39. To Keep It Simple and Straight
Know what to do
and
Do it !