FAO-WHO Global Forum of Food Safety Regulators

Agenda Item 4.1 a) GF/CRD Italy-1

FAO/WHO Global Forum of Food Safety Regulators
Marrakech, Morocco, 28 - 30 January 2002

Country Paper proposed by Italy

Summary

National food control organisations

An example of risk management

Light and shade of the control system.

Proposals

SUMMARY

The contamination of food of animal origin (dioxin crisis) occurred in Europe in 1999 is an opportunity to evaluate the food control system in Italy.

The traumatic experience of the crisis has highlighted not only some deficiencies of the control system, but also the existence of a good traceability system of animal and product consignments coming from other EU Member States, which enabled our authorities to trace most of animal and product consignments coming form Belgium in the period in question.

The dioxin crisis strongly fostered the European Union to improve the feed control system, by setting up a more effective traceability system and to strengthen the rapid alert system of the EU Member States in each case food health emergency.

The experience of the European Union fosters the creation of a permanent international observatory in charge of alerting all the countries worldwide of any food emergency, which may occur. The FAO or the WHO, by means of the Codex Alimentarius, could manage a computerised system for gathering and circulating notifications of food health emergencies.

NATIONAL FOOD CONTROL ORGANISATIONS

The Italian control system is organised on three levels: central, regional and local under the direction of Ministry of health.

The official control of all food quality and safety (domestic and exported) is guaranteed by Municipal Inspection Services and District Public Health Laboratories. The official control of all food quality and safety imported is guaranteed directly by the Health Ministry. Specifically, inspections and samples collection at the plants are carried out in each Municipal Inspection Services by:

Veterinary Services (animal-derived foodstuffs ) and

Public Hygiene Services (other food categories).

Veterinary Services, that are in Ministry of Health, are entrusted of the official control of the entire food chain of animal-derived foodstuff.

The analyses on food samples (chemical, physical, microbiological and parasitological are performed by the official laboratories of:

the Experimental Zoo-prophylactic Institutes (100 labs) (animal-derived foodstuffs )

the District Prevention Units (103 labs) (other food categories)

Inspection services and laboratories are mutually independent.

All laboratories in charge of official controls must comply with the general criteria for the operation of testing laboratories laid down in EN ISO/IEC 17025, supplemented by standard operating procedures and the random audit of their compliance by quality assurance personnel from the National Health Institute of Rome. In assessing the laboratories, the National Health Institute applies the criteria established by the European Standard EN 45002.The ISS also performs direct controls on foods when the European Union Food Alert signals the presence of contaminants foods within the Union or in the case of infections or intoxication associated with the consumption of foods produced on an industrial scale.

AN EXAMPLE OF RISK MANAGEMENT

Risk analysis has become an integral part of the control plans of food productions based on the HACCP system. The application of risk analysis with its three elements (risk assessment, risk management and risk communication), leads to an overall evaluation of risks and benefits of food hygiene programmes implemented in a Country and to an improvement of the development on a scientific basis of food safety standards and guidelines.

The light and shade of the food control system currently implemented in Italy can be understood by means of a recent case of contamination of food of animal origin, caused by animal feed contaminated with oil coming from electric transformers, which occurred in Belgium but whose repercussions were felt to a greater or lesser extent throughout the European Union.

After the BSE crisis, this event has highlighted the importance of feed quality for the safety of food of animal origin. In fact, it has become evident as never before what tremendous impact of an unintentional accident (or fraud) at the basic levels of the food chain may have also across borders on the upper levels (feed material - feedingstuffs - live animal - product of animal origin - processed product) up to involve not only given production batches of a single business, but also whole market sectors (poultry and by-products, pigs and their by-products, milk and milk products).

In short, the case came to light when a veterinarian working in a poultry farm recorded a strong reduction in the eggs' opening rate, as well as a decrease in growth and a high mortality of chicks, and therefore raised certain doubts as to the quality of the feed used, thus allowing to discover the improper use of cooling oils of an electric transformer among the fats used by a feed mill, and, after a specific test, the presence of dioxins and PCBs in considerably large amounts.

When the marketing list of feed manufactured by the incriminated feed mill came out, the extent of the problem occurred in Belgium became clear: 2,542 suspected farms affected by the restrictive measures, 1,626 out of which in the swine sector, 505 in the poultry sector and 411 in the bovine sector.

In Italy no feed business turned out to have imported the suspected ingredient, and no Italian farm turned out to have used feed of Belgian origin.

However, the wide range of products of animal origin imported from Belgium and involved in the contamination (pig meat and its products, milk and milk products, eggs and egg products, bovine meat and its products) as well as the large amounts of some of them ( 50 thousand tons / year of pig meat and 300 thousand pigs / year) entailed a considerable involvement of the whole official control system, in order to single out and eliminate suspected foodstuffs.

Such an involvement was essentially based on the fact that at the beginning, the information supplied by the Belgian authorities on the issue have been long played down and were such as not to allow traceability of the exported goods.

When the contamination came to light, the lack of precise elements to carry out a selective withdrawal of the suspected product from the market was immediately felt by consumers as a high-risk situation, thus bringing about significant problems for handling it.

Therefore, ever since the emergency began, Italy has taken a very precautionary stance, and decided to impound and subsequently check all food products containing milk, eggs and pig meat imported from Belgium in the risk period. This led to strong health checks on those products affected by restriction measures and to a vast national co-ordination effort to ensure their implementation.

At the risk assessment level, considering the data obtained from the national monitoring or contained in the scientific literature concerning the daily intake recommended by the WHO, at an early stage our Country decided to adopt a very precautionary action limit of 100 ppb/f PCB on 7 co-genders, on the basis of the incidence of these products on the average national diet. Subsequently, when the scientific committee for human nutrition of the European Commission examined the issue Italy adjusted the action limit to the one proposed by the Scientific Committee (200 ppb/g PCB on 7 co-genders for egg and pig meat products).

At the risk management level, the lack of sufficient data to evaluate the degree of contamination of such substances in food manufacturing and/or distribution in Italy impeded a detailed definition of a monitoring plan (sampling and analysis) based on solid statistic criteria and feasible at the same time. In fact, the intrinsic technical difficulties of the analysis and the limited staff on the national territory capable of carrying out such analysis strongly limited the effective action possibilities. At any rate, we issued guidelines (sampling and methods of analysis) to cope with the emergency in the most pragmatic way possible. This is why policholorbyphenils (PCBs) were added to the xenobiotics investigated at first, in order to obtain a significant increase in the overall analytical potentialities. In fact, such substances recur at considerably higher levels than "dioxins" and their detection generally entails less technical difficulties.

At the early stages, the control activity consisted in a very high number of precautionary seizures of Belgian products - even though they were restricted to a precise import period. These activity was carried out on the whole national territory and is probably unprecedented in the history of health checks in our Country. Clearly this had a strong impact on the domestic market and a strong repercussion on exports, since goods had to be accompanied by certificates issued by accredited laboratories.

At the risk communication level, account was taken of the fact that the danger felt by consumers is often influenced by imagination and dramatisation, but not by the actual problems of food safety. Moreover, it was also considered that such an attitude is partly caused by the media, which are experts in making hazards real, lively and appalling. Therefore, it was decided to supply all the territorial services with simplified information in order to give a uniform and understandable response to consumers' doubts. Moreover, the media and consumers' associations were sent numerous bulletins integrated with data, in order to supply updated information as the situation developed; attention was paid not to give rise to interpretations.

LIGHT AND SHADE OF THE CONTROL SYSTEM.

The dioxin crisis has clearly highlighted certain deficiencies of the Italian control system and of the European co-ordination:

the particular nature of the "dioxin" contaminant made the monitoring activity rather slow, since only few Italian laboratories were accredited for such a substance. The situation has significantly improved when, after the early analyses, the constant presence of PCBs became clear as well as their use for a screening stage;

in certain cases, the lack of detailed rules on traceability has entailed difficulties in identifying all the products derived from the suspected raw materials;

the information system between Member States has turned out to be extremely fragmentary and in certain cases little transparent; this led to an exaggeration beyond any reasonable extent of the problem, which might have been circumscribed more rapidly and to a greater satisfaction of consumers;

the RASF (Rapid Alert System for Food- computerised system allowing the European Commission to timely inform all the Member States of the existence of food problems) was still at an early and little functional stage.

On the other hand, this crisis also had certain important positive aspects; in particular:

it was possible to verify on a large scale that the traceability system of animal and product consignments coming from other EU Members States, which is based on electronic messages called ANIMO (ANImal MOvement) and on the obligation for importers to pre-notify consignments (each trade operator importing animals or products of animal origin has to register at the territorial offices of the Ministry of Health and has to give notification of any introduction of food of animal origin at 24 hours' notice), turned out to be an important control tool, since it allowed to trace most of the animal and products consignments coming from Belgium in the high-risk period;

for the first time, a toll-free number was created at the Department for Food, Nutrition and Veterinary Public Health in order to answer consumers' questions.

The absolute need to improve the control on feedingstuffs became clear, by enhancing the control on their raw materials ( for instance control on those ingredient presenting most risks such as meals of animal origin, fish oil or on additives such as kaolins), by drawing up traceability procedures, compulsory labelling and a basic monitoring;

The White Book was drawn up by the European Commission, which represents as a matter of fact a concrete commitment to increase the food safety level;

A strong spur was given to improve the RASF ( Rapid Alert System for Food).

PROPOSALS

The lesson learnt from the dioxin crisis, considered in an international perspective, consists in a strong spur to create a permanent international observatory in charge of alerting all the countries of any food emergency, so that adequate measures can be taken to circumscribe risks deriving from food contamination as much as possible. The system put in place in the sector of animal infectious and diffusive diseases could be used as a model, where O.I.E. is the co-ordinating organisation. In our view FAO or WTO, by means of the Codex Alimentarius or another organisation depending on, could manage a computerised system for gathering and circulating notifications of contaminants in human food and animal feed presenting a hazard for health; Member States could give their contribution and have access to such system. This would undoubtedly limit the possibility for competent health authorities to adopt strict precautionary measures in world-wide trade in foodstuffs. In fact, often it is a poor knowledge of phenomena that arouses fear of them.



Agenda Item 4.1 a)	GF/CRD Italy-1
FAO/WHO Global Forum of Food Safety Regulators Marrakech, Morocco, 28 - 30 January 2002 Country Paper proposed by Italy Summary National food control organisations An example of risk management Light and shade of the control system. Proposals SUMMARY The contamination of food of animal origin (dioxin crisis) occurred in Europe in 1999 is an opportunity to evaluate the food control system in Italy. The traumatic experience of the crisis has highlighted not only some deficiencies of the control system, but also the existence of a good traceability system of animal and product consignments coming from other EU Member States, which enabled our authorities to trace most of animal and product consignments coming form Belgium in the period in question. The dioxin crisis strongly fostered the European Union to improve the feed control system, by setting up a more effective traceability system and to strengthen the rapid alert system of the EU Member States in each case food health emergency. The experience of the European Union fosters the creation of a permanent international observatory in charge of alerting all the countries worldwide of any food emergency, which may occur. The FAO or the WHO, by means of the Codex Alimentarius, could manage a computerised system for gathering and circulating notifications of food health emergencies. NATIONAL FOOD CONTROL ORGANISATIONS The Italian control system is organised on three levels: central, regional and local under the direction of Ministry of health. The official control of all food quality and safety (domestic and exported) is guaranteed by Municipal Inspection Services and District Public Health Laboratories. The official control of all food quality and safety imported is guaranteed directly by the Health Ministry. Specifically, inspections and samples collection at the plants are carried out in each Municipal Inspection Services by: Veterinary Services (animal-derived foodstuffs ) and Public Hygiene Services (other food categories). Veterinary Services, that are in Ministry of Health, are entrusted of the official control of the entire food chain of animal-derived foodstuff. The analyses on food samples (chemical, physical, microbiological and parasitological are performed by the official laboratories of: the Experimental Zoo-prophylactic Institutes (100 labs) (animal-derived foodstuffs ) the District Prevention Units (103 labs) (other food categories) Inspection services and laboratories are mutually independent. All laboratories in charge of official controls must comply with the general criteria for the operation of testing laboratories laid down in EN ISO/IEC 17025, supplemented by standard operating procedures and the random audit of their compliance by quality assurance personnel from the National Health Institute of Rome. In assessing the laboratories, the National Health Institute applies the criteria established by the European Standard EN 45002.The ISS also performs direct controls on foods when the European Union Food Alert signals the presence of contaminants foods within the Union or in the case of infections or intoxication associated with the consumption of foods produced on an industrial scale. AN EXAMPLE OF RISK MANAGEMENT Risk analysis has become an integral part of the control plans of food productions based on the HACCP system. The application of risk analysis with its three elements (risk assessment, risk management and risk communication), leads to an overall evaluation of risks and benefits of food hygiene programmes implemented in a Country and to an improvement of the development on a scientific basis of food safety standards and guidelines. The light and shade of the food control system currently implemented in Italy can be understood by means of a recent case of contamination of food of animal origin, caused by animal feed contaminated with oil coming from electric transformers, which occurred in Belgium but whose repercussions were felt to a greater or lesser extent throughout the European Union. After the BSE crisis, this event has highlighted the importance of feed quality for the safety of food of animal origin. In fact, it has become evident as never before what tremendous impact of an unintentional accident (or fraud) at the basic levels of the food chain may have also across borders on the upper levels (feed material - feedingstuffs - live animal - product of animal origin - processed product) up to involve not only given production batches of a single business, but also whole market sectors (poultry and by-products, pigs and their by-products, milk and milk products). In short, the case came to light when a veterinarian working in a poultry farm recorded a strong reduction in the eggs' opening rate, as well as a decrease in growth and a high mortality of chicks, and therefore raised certain doubts as to the quality of the feed used, thus allowing to discover the improper use of cooling oils of an electric transformer among the fats used by a feed mill, and, after a specific test, the presence of dioxins and PCBs in considerably large amounts. When the marketing list of feed manufactured by the incriminated feed mill came out, the extent of the problem occurred in Belgium became clear: 2,542 suspected farms affected by the restrictive measures, 1,626 out of which in the swine sector, 505 in the poultry sector and 411 in the bovine sector. In Italy no feed business turned out to have imported the suspected ingredient, and no Italian farm turned out to have used feed of Belgian origin. However, the wide range of products of animal origin imported from Belgium and involved in the contamination (pig meat and its products, milk and milk products, eggs and egg products, bovine meat and its products) as well as the large amounts of some of them ( 50 thousand tons / year of pig meat and 300 thousand pigs / year) entailed a considerable involvement of the whole official control system, in order to single out and eliminate suspected foodstuffs. Such an involvement was essentially based on the fact that at the beginning, the information supplied by the Belgian authorities on the issue have been long played down and were such as not to allow traceability of the exported goods. When the contamination came to light, the lack of precise elements to carry out a selective withdrawal of the suspected product from the market was immediately felt by consumers as a high-risk situation, thus bringing about significant problems for handling it. Therefore, ever since the emergency began, Italy has taken a very precautionary stance, and decided to impound and subsequently check all food products containing milk, eggs and pig meat imported from Belgium in the risk period. This led to strong health checks on those products affected by restriction measures and to a vast national co-ordination effort to ensure their implementation. At the risk assessment level, considering the data obtained from the national monitoring or contained in the scientific literature concerning the daily intake recommended by the WHO, at an early stage our Country decided to adopt a very precautionary action limit of 100 ppb/f PCB on 7 co-genders, on the basis of the incidence of these products on the average national diet. Subsequently, when the scientific committee for human nutrition of the European Commission examined the issue Italy adjusted the action limit to the one proposed by the Scientific Committee (200 ppb/g PCB on 7 co-genders for egg and pig meat products). At the risk management level, the lack of sufficient data to evaluate the degree of contamination of such substances in food manufacturing and/or distribution in Italy impeded a detailed definition of a monitoring plan (sampling and analysis) based on solid statistic criteria and feasible at the same time. In fact, the intrinsic technical difficulties of the analysis and the limited staff on the national territory capable of carrying out such analysis strongly limited the effective action possibilities. At any rate, we issued guidelines (sampling and methods of analysis) to cope with the emergency in the most pragmatic way possible. This is why policholorbyphenils (PCBs) were added to the xenobiotics investigated at first, in order to obtain a significant increase in the overall analytical potentialities. In fact, such substances recur at considerably higher levels than "dioxins" and their detection generally entails less technical difficulties. At the early stages, the control activity consisted in a very high number of precautionary seizures of Belgian products - even though they were restricted to a precise import period. These activity was carried out on the whole national territory and is probably unprecedented in the history of health checks in our Country. Clearly this had a strong impact on the domestic market and a strong repercussion on exports, since goods had to be accompanied by certificates issued by accredited laboratories. At the risk communication level, account was taken of the fact that the danger felt by consumers is often influenced by imagination and dramatisation, but not by the actual problems of food safety. Moreover, it was also considered that such an attitude is partly caused by the media, which are experts in making hazards real, lively and appalling. Therefore, it was decided to supply all the territorial services with simplified information in order to give a uniform and understandable response to consumers' doubts. Moreover, the media and consumers' associations were sent numerous bulletins integrated with data, in order to supply updated information as the situation developed; attention was paid not to give rise to interpretations. LIGHT AND SHADE OF THE CONTROL SYSTEM. The dioxin crisis has clearly highlighted certain deficiencies of the Italian control system and of the European co-ordination: the particular nature of the "dioxin" contaminant made the monitoring activity rather slow, since only few Italian laboratories were accredited for such a substance. The situation has significantly improved when, after the early analyses, the constant presence of PCBs became clear as well as their use for a screening stage; in certain cases, the lack of detailed rules on traceability has entailed difficulties in identifying all the products derived from the suspected raw materials; the information system between Member States has turned out to be extremely fragmentary and in certain cases little transparent; this led to an exaggeration beyond any reasonable extent of the problem, which might have been circumscribed more rapidly and to a greater satisfaction of consumers; the RASF (Rapid Alert System for Food- computerised system allowing the European Commission to timely inform all the Member States of the existence of food problems) was still at an early and little functional stage. On the other hand, this crisis also had certain important positive aspects; in particular: it was possible to verify on a large scale that the traceability system of animal and product consignments coming from other EU Members States, which is based on electronic messages called ANIMO (ANImal MOvement) and on the obligation for importers to pre-notify consignments (each trade operator importing animals or products of animal origin has to register at the territorial offices of the Ministry of Health and has to give notification of any introduction of food of animal origin at 24 hours' notice), turned out to be an important control tool, since it allowed to trace most of the animal and products consignments coming from Belgium in the high-risk period; for the first time, a toll-free number was created at the Department for Food, Nutrition and Veterinary Public Health in order to answer consumers' questions. The absolute need to improve the control on feedingstuffs became clear, by enhancing the control on their raw materials ( for instance control on those ingredient presenting most risks such as meals of animal origin, fish oil or on additives such as kaolins), by drawing up traceability procedures, compulsory labelling and a basic monitoring; The White Book was drawn up by the European Commission, which represents as a matter of fact a concrete commitment to increase the food safety level; A strong spur was given to improve the RASF ( Rapid Alert System for Food). PROPOSALS The lesson learnt from the dioxin crisis, considered in an international perspective, consists in a strong spur to create a permanent international observatory in charge of alerting all the countries of any food emergency, so that adequate measures can be taken to circumscribe risks deriving from food contamination as much as possible. The system put in place in the sector of animal infectious and diffusive diseases could be used as a model, where O.I.E. is the co-ordinating organisation. In our view FAO or WTO, by means of the Codex Alimentarius or another organisation depending on, could manage a computerised system for gathering and circulating notifications of contaminants in human food and animal feed presenting a hazard for health; Member States could give their contribution and have access to such system. This would undoubtedly limit the possibility for competent health authorities to adopt strict precautionary measures in world-wide trade in foodstuffs. In fact, often it is a poor knowledge of phenomena that arouses fear of them.