WO2003107247A1

WO2003107247A1 - Method for risk evaluation to ensure safety of a product available to the human body

Info

Publication number: WO2003107247A1
Application number: PCT/FR2003/000266
Authority: WO
Inventors: Jean-Jacques Ghigi; Jean-Hubert Blache
Original assignee: Spe Biotechnologies France S.A.
Priority date: 2002-06-14
Filing date: 2003-01-28
Publication date: 2003-12-24
Also published as: FR2841019A1; AU2003226858A1; FR2841019B1

Abstract

The invention concerns a method for risk evaluation to ensure safety of a product available to the human body for which a plurality of risks have been identified which consists, for each of the identified risks, in: defining at least one category of risks to which the risk belongs, identifying the content of risk factors associated with each of the categories of risks to which the risk belongs, identifying for each of the risk factors indicators whereof the associated parameters enable exact determination of the risk factor, defining for each of the indicators, a standardization of the taxonomic information to be obtained, determining the taxonomic information corresponding to standardization for the product being analyzed, and identifying specific measures to be prescribed to guarantee the safety of the product where there exists at least one risk which it has not been possible to eliminate.

Description

Risk assessment method intended to ensure the safety of a product which can be assimilated by the human body

TECHNICAL FIELD The present invention relates to the evaluation and elimination of risks of all kinds presented by the products which an individual is led to assimilate either as food products or as medicaments and relates more particularly to a risk evaluation method intended to ensure the safety of a product which can be assimilated by the human body.

State of the art

Today, consumers are increasingly faced with safety concerns posed mainly by food products. Questioning food safety, consumers have specific expectations resulting in a complete request for information and a strengthening of the products they consume. In the sphere of food supply (breeders, producers, agro-food industries), globalization leads to ever greater economic concentrations and increased productivism which contribute to numerous media deviations: dioxin, GMOs, heavy metals, mad cow, etc. In the sphere of demand, two parameters greatly complicate the situation: the population resulting from the papy boom and the longer life expectancy. The consequence is an aging population, the main characteristic of which is immunodeficiency. This population is therefore a population at risk which is the preferred target of the main epidemics and other infections or food-borne infectious diseases.

In addition to safety concerns, more and more people care about the quality of food and demand the highest possible standards from farmers, food companies and distributors. These requirements are long-term and it is a profound change in consumption, eating habits and the average budget devoted to food that is committed.

Although many initiatives based on the follow-up of products along the food chain have emerged but without however restoring confidence with consumers, none implements a methodology to ensure the safety of materials raw materials and the safety of finished products.

Statement of the invention

This is why the main aim of the invention is to carry out a method for evaluating the risks of a product which can be assimilated by the human body, enabling the identification of the specific measures taken against each risk with the aim of ensure product safety.

The object of the invention is therefore a risk assessment method intended to ensure the safety of a product which can be assimilated by the human body for which a plurality of risks have been identified and consisting, for each of the risks identified

- define at least one risk class to which the risk belongs,

- identify the content of the risk factors associated with each of the risk classes to which the risk belongs, identify for each of the risk factors, the indicators whose associated parameters allow an exact determination of the risk factor, - define for each of the indicators, standardization of the taxonomic information to be obtained, determining the taxonomic information corresponding to the standardization for the product being analyzed, and identify specific provisions to be prescribed to ensure product safety when there is at least one risk which cannot be eliminated.

Brief description of the drawings

The aims, objects and characteristics of the invention will appear more clearly on reading the description which follows with reference to the drawings in which, FIG. 1 represents a flowchart of the method used to determine whether a danger represents a risk, FIG. 2 is a schematic representation of the different levels of parameters to be identified in the method according to the invention applied to a raw material, FIG. 3 is a schematic representation of the different levels of parameters to be identified in the method according to the invention applied to fish, FIGS. 4A and 4B together represent a flow diagram of the method according to the invention and, FIG. 5 represents a block diagram of a data processing system implementing the method according to the invention.

Detailed description of the invention

The method according to the invention which is the subject of the description below has been applied to food products. However, it is clear that this method can also be applied to a drug or any other product which can be assimilated by the human body.

Before implementing the method according to the invention, it is necessary to have at a given place and at a given time exhaustive and relevant information concerning the product under consideration, but it is also necessary to control the risks associated with the product.

It is first necessary to correctly identify the risks. This can be done from identification of a given danger. The danger is that which threatens or compromises the security of an individual (for example the consumer), and can be of the micro-biological type, of the chemical type or of the physical type, while the risk is the probability of manifestation of a danger.

The risk must be controlled according to whether the associated danger is more or less serious or has a higher or lower probability of occurrence. Thus a benign danger must be controlled if it occurs frequently, while an average danger does not need to be controlled if it occurs only exceptionally. We can also establish the following table which defines the need to control a hazard according to the two parameters which are the probability of occurrence and the level of severity.

Risk identification can be done according to the flowchart in Figure 1. There is therefore at the outset identification of a potential danger (step 10). Using the table above, it is determined whether the hazard should be controlled (step 12). If it is not necessary, it is decided that there is no risk (step 14). If it is necessary to control the risk, it is checked whether there are preventive measures (step 16). If there are preventive measures, the next step consists of verifying whether these measures make it possible to reduce the probability of the occurrence of the danger to an acceptable level or even to eliminate the danger (step 18). If this is the case, it is then checked whether the danger can increase to an unacceptable level (for example contamination may occur) (step 20). If not, it is decided that there is no risk (step 22), but if it is, it is determined whether further action or some other factor can reduce the likelihood of occurrence of the hazard at an acceptable level or even eliminate it (step 24). If this is the case, it is decided that there is no risk (step 26).

On the other hand, in the case where there are no preventive measures, or if these measures do not reduce the probability of the occurrence of the danger to an acceptable level or if there are no subsequent measures to reduce this probability of occurrence of the danger at an acceptable level, there is identification of a risk (step 28).

The risks identified belong to 4 main classes of risks: 1. The risks of transmission of pathologies by genetic means (genetic risks) These risks arise from the origin of the subject, that is to say the ascendants for animals and l sowing, the seed for plant species. 2. The risks of contamination by tributaries (nutritional risks)

For both animal and plant species, the first element of nutritional traceability is the identification of the cadastral plot on which the animals graze or on which the plant is cultivated. In this quest for tributaries, the soil pedology, the analysis of the plants that make up the pasture, the knowledge of the residual heavy metal levels, the quality of the water tables, the monitoring of indicators, such as the fluorine level, all constitute determining parameters of quality and food safety. 3. Health risks

Beyond the regulatory measures for screening certain animal pathologies (Escherichia Coli 0157, salmonella, listeria, brucella, fluke, BSE, ...), it is a question of controlling the culture conditions (preventive and curative phytosanitary treatments, rate residuals, etc.).

4. The risks of non-identification of responsibilities

(administrative risks) The exchange of foodstuffs is framed by European regulations, relayed in the member states, by cerfa-type documents. These documents guarantee the conformity of exchanges and compliance with the regulations in force (economic, fiscal and health aspects), but also the definition of the commitments of the various players in the sector. For a given product (level n-3), any identified risk (level n-2) belonging to a given risk class includes a certain number of risk factors (level n-1) which depend on the risk class considered. Finally, each risk factor is composed of a plurality of indicators (level n).

The risk factors are diverse and vary depending on whether the product analyzed is a raw material or a finished product, a food product or a medicine. Thus, for a raw material, the most important risk factors are the following for each risk class.

Genetic risk class

For the animal species: ancestors, sperm, in vitro insemination, genetic engineering. For the plant species: seed, seed, cuttings, genetic engineering. Nutritional risk class

For the animal species: food (e.g. flour), food (e.g. grass), food supplements (e.g. vitamins, cereals), water, soil pedology, cadastral identification, geography, environment. Health risk class

All species: animal and plant pathologies, veterinary treatments (preventive and curative), phytosanitary treatments, residual substances, microorganisms, germs, parasites, slaughter, cutting, harvesting, picking, storage, transport, packaging, transformation processes, distribution. Administrative risk class

All species: Absence or defect of: regulatory compliance, approvals (health, administrative), health mark, operating authorization, placing on the market, transport ticket, license, license, identification of the upstream actor (supplier) , identification of the downstream actor (client and / or recipient).

The basic risk indicators, most of them quantitative, are associated with parameters which should allow specialists to diagnose the causes of the risks and the means of controlling these risks, that is to say the specific measures to be implemented. to ensure product safety, for example the safety of a raw material or the safety of a finished product.

Thus, the risk indicators can be the following:

time (time stamp, duration and time intervals), - temperature, chemical agents (salts, heavy metals, fluorine, chlorine, lead, magnesium, ammonia, nitrates, phosphates, SO2 potassium ferrocyanide, etc.) - quantity and nature of micro -organisms, physico-chemical analyzes (eg water activity factor: CW), cytobacteriological examinations (co-culture, throat swab).

The tree structure of the different levels for a product which, in this example, is a raw material, is illustrated in FIG. 2. As it mentioned, the risk factors are mainly the ascendants for the genetic risk, the tributaries for the nutritional risk , treatments for health risk and administrative actors for administrative risk. Note that the risk factors would be the raw materials in the case of a finished product.

Figure 3 shows the tree structure of the different levels in the case of fish. It turns out that in this case, the essential risks are the “heavy metal” risks. Applying the flow diagram in Figure 1 on risk identification demonstrates that only lead and mercury are identified as risks outside of administrative risks.

The method according to the invention is now described with reference to the combination of FIGS. 4A and 4B. First of all, the product for which we want to assess the risks is correctly defined (step 30). A risk for this product identified according to the method illustrated in Figure 1 is defined (step 32). A risk class among the 4 classes mentioned above is also defined (step 34). Then the content of each of the risk factors corresponding to this risk is identified

(step 36) and the indicators associated with each risk are also identified (step 38) for each of the risk factors.

At this stage where all the risk indicators have been identified, it is necessary to define a standardization of the taxonomic information which is associated with each indicator (step 40). This taxonomic information is defined by 5 criteria whose content is standardized: identification: definition of the subject of the information and connection to the product analyzed. - classification: attachment to the type of traceability (risk factor). quantification: metrological definition. qualification: acceptability criteria and corresponding decision. - time stamp: definition of the period of validity of the information.

From these standardized criteria, the client provides the taxonomic information constituted by the contents of the 5 criteria (step 42). Note that taxonomic information also formed from these 5 criteria is also associated with each risk factor.

It is then necessary to check whether there are interdependencies between the indicators (step 44). This taxonomic information is also provided by the client

(step 46).

In the following example, the product analyzed is a raw material. A risk factor for the nutritional risk class is soil pedology. To this risk factor are associated two indicators which are the level of fluorine and the level of magnesium. In this case, the taxonomic information associated with the risk indicators and the risk factor is presented as follows:

Identification: plot

Classification: clay Soil pedology Quantification: 3 core samples Qualification: OK Timestamp: 05/2002

Fluorine level Magnesium level Identification: fluorine 23 Magnesium identification 12 Classification: without interest Classification without interest Quantification: acceptance <20% Quantification> 30% Qualification: 5% <<10% Qualification: 10% <<15% Time-stamping: 06/2002 Timestamp: 05/2002

The interdependencies between indicators can be of several types. Thus, in the case of a process for processing a raw material (risk factor), the “time” and “temperature” indicators are interdependent in controlling microbiological contamination, the rise in temperature at 75 ° C for a certain time (eg 10 min) eliminating any contamination by microorganisms. Interdependence can also be considered with respect to a third indicator, the pH of the raw material which, for a given threshold (eg pH <3), can compensate for an unfavorable value of the time and / or temperature. In this way, despite unfavorable time and temperature indicators

(e.g. time <10 min and / or temperature <75 ° C), it is possible to obtain a satisfactory result in terms of traceability for the risk factor.

As another example of the interdependence of indicators in the case of the podiatry of soils mentioned above, this podiatry can be consistent despite a too low magnesium level of less than 10% if the fluorine level is between 5 and 10%.

The next process step according to the invention consists in checking whether the risk has been eliminated thanks to the taxonomic information provided (step 48) when there is interdependence between the indicators as in the example mentioned above. If the risk cannot be eliminated, specific measures must be taken to ensure the safety of the product (step 50).

In the case where there is no interdependence between the indicators for each risk factor or the risk can be eliminated when there is interdependence, it is checked whether another class is involved for the risk considered (step 52). If a class is involved, the method is looped back and the steps repeated from the step of defining the new class involved (step 30).

When all the classes involved for a given risk have been analyzed, it is checked whether there is interdependence between the classes involved (step 54). If this is the case, additional taxonomic information must be provided by the client (step 56). Even if this information is not directly involved in controlling the risk, it can have an influence on the interaction of two indicators associated with risk factors depending on two different classes. Thus, it can be assumed that the study of indicators in the nutritional risk class demonstrates that water is a vector of contamination by a certain microorganism while, in the health risk class, process P eliminates the risk of contamination by this microorganism. It is therefore essential to check in the administrative risk class if the workers have a training certificate concerning the implementation of the P process in the nutritional risk class.

The next step of the method according to the invention consists in checking whether the risk has been eliminated thanks to the taxonomic information provided (step 58) when there is interdependence between the indicators associated with several classes involved as in the example above . If the risk cannot be eliminated, specific measures must be taken to ensure product safety (step 60). In the event that there is no interdependence between indicators associated with several classes or that the risk cannot be eliminated when there is interdependence between indicators associated with different classes, it is checked whether all the risks were analyzed (step 62). If this is not the case, the method is looped back and the steps repeated from the step of defining a new risk (step 32).

When all the risks have been analyzed, it is necessary to determine whether there is a risk resulting from the interdependence between the risks which have just been analyzed (step 64). Thus, in a wine-growing operation, one can imagine that there is a risk of nutritional type due to the high residual rate of a certain number of substances and / or microorganisms present in the grapes, and that nevertheless this rate in the grapes from the holding in question are harmful to the health of the consumer. At the time of winemaking, the processes implemented using chemical substances, an increase in the residual rate of these substances and / or micro-organisms (eg fermentation yeasts) can be observed up to a threshold of toxicity for the consumer, which is part of the health risks. An administrative risk resulting from the interdependence between the two preceding risks then intervenes as a "trusted third party" because the residual rate of the substance mentioned could belong to the nomenclature of substances whose presence in the finished product (wine) is regulated.

If there is a risk resulting from the interdependence between other risks, then specific provisions are prescribed to ensure product safety (step 66). In the event that there is no risk resulting from the interdependence of other risks, the last step consists in identifying the specific provisions which may have been prescribed at different stages of the method (step 68).

The provisions to be taken into consideration can be of any kind, and mainly the following: a) prohibit the destination of the product for certain uses (eg do not consume raw or do not combine with other products), b) use the product only partially (eg remove the fifth quarter of a bovine affected by liver fluke), c) apply a specific process (eg bake at more than 75 ° C for more than 10 min or store at 3 ° C), d) add an element (eg increase the acidity of a preparation to eliminate the risk of microbial development), e) completely prohibit the use of the product, f) seize the product to destroy it possibly, or g) request additional information from the customer to decide (e.g. the information concerning the time-temperature couple does not allow to conclude that the risk has been eliminated and a pH measurement of the product must be requested). Note that the new information is integrated into the product taxonomy so as to complete the traceability of the product.

A practical example intended to illustrate the implementation of the specific provisions concerns a cattle slaughter line. In this case, the specific provisions will be of the type: c) implementation of a specific cleaning and disinfection plan throughout the slaughter chain, fl) seizure and destruction of the liver of the animal detected, f2) seizure and carcass isolation, g) requests the following information: - examination of the bile ducts and possible detection of adult flukes, - BSE screening: the test returns positive and conceals BSE contamination. The method which has just been described is implemented in a system illustrated in FIG. 5. All the data relating to the different risks incurred, the risk classes, the risk factors for each risk and the indicators for each risk are stored in a database 70. The software 72 for applying the method is entered by means of a data medium in a processor 74 where it is implemented after entry by suitable input devices, the definition of the product to be analyzed 76 and of the risks 78 associated with the product. Another input device allows the input of the taxonomic information 80 supplied by the client, and an output device allows to obtain the specific provisions 82 ensuring the security of the product after the execution of the software 72. Note that the system can be an expert system so as to be able to enrich new risks and / or taxonomic information as it is used for the analysis of new products.

Claims

1. Risk assessment method intended to ensure the safety of a product assimilable by the human body for which a plurality of risks have been identified, said method consisting for each of the risks identified in

- define (34) at least one risk class to which said risk belongs,

- identify (36) the content of the risk factors associated with each of said risk classes to which said risk belongs,

- identify (38) for each of said risk factors the indicators whose associated parameters allow an exact determination of said risk factor, - define (40) for each of said indicators, a standardization of the taxonomic information to be obtained, determine (42, 46 or 56) the taxonomic information corresponding to said standardization for the product under analysis, and - identify (68) specific provisions to be prescribed to ensure product safety when there is at least one risk which could not be eliminated.

2. Method according to claim 1, in which the said risk classes to which the said risk belongs are:

- the class of genetic risks, the class of nutritional risks,

- the health risk class, the administrative risk class.

3. Method according to claim 2, in which said normalization of the taxonomic information consists in defining for each of said indicators the following 5 criteria: - identification: defining the subject of taxonomic information,

- classification: defining the connection to the type of traceability to be considered, - quantification: defining the metrology to be applied,

- qualification: defining the acceptability criteria, and

- timestamp: defining the period of validity of the taxonomic information.

4. Method according to claim 3, in which a first additional taxonomic information must be determined (46) when there is interdependence between several indicators.

5. Method according to claim 2, 3 or 4, in which a second additional taxonomic information must be determined (56) when there is interdependence between several risk classes to which the analyzed product belongs.

6. Method according to one of claims 2 to 5, in which specific provisions intended to ensure the safety of the product are prescribed (66) when there is an additional risk resulting from the interdependence between at least two of said identified risks.

7. Method according to one of claims 1 to 6, in which the identification of each of the risks is done on the basis of a potential danger associated with the product by the steps consisting in - determining (16) if there are measures preventive measures against the said potential danger, determine (24) whether there are any subsequent measures to reduce the danger to an acceptable level when the said preventive measures do not make it possible to reduce the probability of the occurrence of the danger to an acceptable level, and - to identify (28) a risk when there are no such subsequent measures.

8. The method of claim 7, wherein there is identification of a risk when there are no preventive measures against said potential danger.

9. Data processing system allowing the evaluation of a risk in order to ensure the safety of a product assimilable by the human body for which a plurality of risks have been identified, comprising a processor (74), controlled by processing software (72), a database (70) storing the data relating to the various risks involved, the risk classes, the risk factors for each of the risks and the indicators for each risk, as well as a input means giving the definition of said product (76), means of input of said risk to be evaluated (78) and means of input of taxonomic information (80), said processor identifying in an output means (82) of the specific provisions to be prescribed to ensure the security of said product after execution of said software by using the definition of at least one risk class to which said risk belongs, the identification of the content of the factors risks associated with said risk class to which said risk belongs, the identification for each of said risk factors of indicators whose associated parameters allow an exact determination of said risk factor and the definition, for each of said indicators, of taxonomic information standardized for said product.