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10.4.2. Ingestion and food contamination/naturally occurring toxic substances (Food Safety)

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10.4.2. Ingestion and food contamination/naturally occurring toxic substances (Food Safety)





Acute Reference Dose


Bovine Spongiform Encephalopathy


Cumulative Risk Assessment


European Food Safety Authority


European Union Risk Analysis Information Network


Food and Agriculture Organization


General Food Law


Good Hygiene Practice


Genetically Modified Organism


Good Manufacturing Practice


Hazard Analysis Critical Control Point


International Estimate of Short Term Intake


Margin of Exposure


Maximum Residue Limits


Mass Spectrometry


Organisation for Economic Co-operation and Development


World Organisation for Animal Health


Primary Aromatic Amines


Perfluorinated Organic Compounds


Perfluorooctanesulfonic Acid


Plant protection products


Qualified presumption of safety


Rapid Alert System for Food and Feed


Somatic Cell Nuclear Transfer


Time of Flight mass spectroscopy


Transmissible Spongiform Encephalopathies


Verotoxigenic Escherichia coli


World Health Organisation Introduction


The past decades have seen the regulation of food safety within the European Union face unprecedented challenges, such as BSE, the contamination of food with dioxins and the increasing occurrence of infectious agents such as Salmonella, as well as the emergence of new products and technologies (genetically modified food) and a heightened sensitivity of the public towards biotechnology and animal welfare. As a consequence, most European countries and the EU institutions have witnessed major reforms to their regulatory systems on food safety, often characterised by a stricter separation of the scientific and political elements of risk analysis, a reference to the precautionary principle and a stronger commitment to the principles of transparency, participation and accountability.


In the aftermath of the food crises that characterised the 90s and in response to the damaging consequences of those crises for both consumer confidence and trade, a number of key directives were enacted, beginning with the landmark Regulation (EC) No 178/2002 which laid down the General Food Law (GFL) and established the European Food Safety Agency (EFSA). Using an integrated approach to cover the entire food chain, the ultimate goal of the Regulation is the protection of European public health while at the same time taking into consideration animal health and welfare, plant health and the environment. From a trade perspective, the GFL national food safety requirements and ensures the free movement of food and feed products within the EU.


One key achievement has been the separation of risk assessment and risk management, which together with risk communication form the three pillars of food safety. EFSA’s evidence-based assessments of riskcarried out in a framework of openness and transparency and in dialogue with all actors in the food chain – and the effective communication of risk in cooperation with Member States have done much to restore consumer confidence in the European food supply. Indeed, this has led to a notable decrease of “food scares” in recent years.


The food safety landscape is constantly evolving and one of the challenges facing European authorities is to identify and prevent future threats to the food supply. New technologies such as nanotechnology and animal cloning, and the relentless evolution of scientific knowledge, constantly push the frontiers of knowledge and oblige regulatory authorities in Europe and elsewhere to assess and re-assess the implications for the safety of the food supply. In addition, the sustainability of our food production systems, the effects of increasing trade globalisation and the threat represented by climate change must all be addressed.


White Paper and EU food law


To restore and maintain consumer confidence in the European food supply, an innovative White Paper on Food Safety was presented by David Byrne, at the time Health and Consumer Protection Commissioner, on 12 January. 2000. The White Paper was produced soon after the aforementioned crises and it identified several weaknesses in European food legislation systems, including the:


·                      crisis in confidence due to the lack of functional separation between risk assessment and risk management;

·                      limited resources within the Commission providing scientific support to underpin food and feed law;

·                      poor overview of the food chain as a result of not following the farm to fork principles;

·                      lack of coordination between existing data collection and information systems and gaps in some crucial areas;

·                      inadequate identification of emerging risks; and

·                      weaknesses in the rapid alert system.


The “white paper on food safety”, attempted to guarantee a high level of food safety by improving quality standards and reinforcing the systems of checks throughout the food chain. It outlines a comprehensive range of actions needed to make existing EU food legislation more coherent, promote better enforcement of that legislation and provide greater transparency to consumers.


In the White Paper, the Commission proposed a number of measures which have enabled food safety to be organized in a more coordinated and integrated manner. The principal proposed measures were:


·                      the establishment of an independent European food authority;

·                      an improved legislative framework covering the entire food chain "from farm to table";

·                      greater integration of national control systems; and

·                      transparent dialogue with consumers and other stakeholders.


Since then, a new legal framework addressing various aspects of the food chain has been developed: a) animal feed: labelling, feed additives, feed hygiene; b) animal health and welfare: reinforcement of measures to tackle zoonoses, and transmissible spongiform encephalopathies; c) food hygiene: assure consistency and clarity of legal requirements throughout the food production chain; d) food safety: limits on contaminants and residues of pesticides and veterinary medicines in food; additives, flavourings, packaging and irradiation of foodstuffs; e) RASFF and emergencies: RASFF extended to feed; possible safeguard measures in case of emergencies; f) consumer information as regards food: labelling of allergens, food supplements.


On 28th January 2002 the European Parliament and the Council adopted Regulation (EC) 178/2002 laying down the General Principles and requirements of Food Law (hereinafter General Food Law Regulation or GFL) [1]. The GFL lays down definitions, principles and obligations covering all stages of food/feed production and distribution.


The food law aims at ensuring a high level of protection of human life and health, taking into account the protection of animal health and welfare, plant health and the environment. This integrated "farm to fork" approach is now considered a general principle for EU food safety policy.


The GFL aims at harmonising national requirements in order to ensure the free movement of food and feed in the EU. It recognises the EU's commitment to its international obligations and fully considers international standards in its implementation, except where this might undermine the high level of consumer protection pursued by the EU. One of its important achievements has been to define food, which has enabled clarity in many other food law instruments.


The Regulation establishes the principles of risk analysis in relation to food and feed and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the European Food Safety Authority (EFSA).


Depending on the nature of the measure, food law, and in particular measures relating to food safety, must be underpinned by strong science. The EU has been at the forefront of the development of risk analysis principles and their subsequent international acceptance. Regulation EC 178/2002 establishes in EU law that the three inter-related components of risk analysis (risk assessment, risk management and risk communication) provide the basis for food law as appropriate to the measure under consideration.


Risk management


Risk management is the process of weighing policy alternatives in the light of results of a risk assessment and, if required, by selecting the appropriate actions necessary to prevent, reduce or eliminate the risk to ensure the high level of health protection deemed appropriate in the EU. In this risk management phase, the decision makers need to consider a range of information in addition to the scientific risk assessment. These include, for example, the feasibility of controlling a risk, the most effective risk reduction actions depending on the part of the food supply chain where the problem occurs, the practical arrangements needed, the socio-economic effects and the environmental impact. Regulation EC/178/2002 establishes the principle that risk management actions are not just based on a scientific assessment of risk but also take into consideration a wide range of other factors legitimate to the matter under consideration.


The Regulation establishes a framework for the greater involvement of stakeholders at all stages in the development of food law and establishes the mechanisms necessary to increase consumer confidence in food law. Transparency of legislation and effective public consultation are essential elements in building this greater confidence.


The GFL also establishes the basic principle that the primary responsibility for ensuring compliance with food law, and in particular the safety of the food, rests with the food business. It also formally establishes the Precautionary Principle as an option open to risk managers when decisions have to be made to protect health although scientific information concerning the risk is inconclusive or incomplete in some way.


The Precautionary Principle is relevant in those circumstances where risk managers have identified that there are reasonable grounds for concern that an unacceptable level of risk to health exists but the supporting information and data may not be sufficiently complete to enable a comprehensive risk assessment to be made. When faced with these specific circumstances, decision makers or risk managers, may take measures or other actions to protect health based on the precautionary principle, while seeking more complete scientific evidence and other data. Such measures have to comply with the normal principles of non-discrimination and proportionality and should be considered as provisional.


The identification of the origin of feed and food ingredients and food sources is of prime importance for the protection of consumers, particularly when products are found to be faulty. The Regulation contains general provisions for traceability which cover all food and feed and all food and feed business operators, without prejudice towards the existing legislation on specific sectors such as beef, fish, GMOs etc. Importers are similarly affected, as they are required to identify the source of the product in the country of origin. Unless there are specific provisions for further traceability, the requirement for traceability is limited to ensuring that businesses are at least able to identify the immediate supplier of the product and the immediate subsequent recipient, with the exemption of retailers to final consumers.


Finally, in addition to the general principles of food law and the creation of the European Food Safety Authority, the GFL lays down different procedures in matters of food safety. In particular, it provides for:


·                      the creation of the Rapid Alert System for Food and Feed (RASFF);

·                      the adoption of emergency procedures and crisis management; and

·                      and the creation of a Regulatory Committee (the Standing Committee on the Food Chain and Animal Health).


The all regulatory framework on food safety was completed in the years 2002 with Regulations 852 and 853/2004 on food hygiene and a series of Directives and Regulations concerning the official control of foodstuffs and a concerted series of actions against animal diseases that can be transmitted to humans mainly through food (i.e. zoonoses) as a result of eating products that have been contaminated by one or other of the previously discussed zoonotic pathogens such as salmonella, Campylobacter, Listeria or toxin-producing, E-coli.


A key tenet of the White Paper is that risk management, which along with risk assessment and risk communication forms the third pillar of risk analysis, requires legislative action and political decision-making and therefore will continue to be exercised by the European institutions.


Risk assessment and risk communication: the European Food Safety Authority (EFSA)


Scientific assessment of risk must be undertaken in an independent, objective and transparent manner based on the best available science. Based on these principles and guided by a comprehensive Founding Regulation, the European Food Safety Authority (EFSA) was established according to Regulation (EC) No 178/2002 of the European Parliament on 28 January 2002.


The European Food Authority would base its operations on the principle of the highest levels of independence, scientific excellence and transparency. It was envisaged that the Authority would become the key point of reference for food safety within the EU and would hold responsibility for scientific risk assessment and risk communication in close collaboration with national scientific agencies and institutions. The Authority would provide scientific advice, collate and analyse the necessary information and react in a timely manner to food safety crises.

EFSA acts as an independent scientific source of advice, information and risk communication in the areas of food and feed safety. In addition, it establishes networks that enable close collaboration with similar bodies in the EU Member States. While EFSA advises on possible risks related to food safety, the responsibility for risk management lies with the EU institutions (European Commission, European Parliament and the Council, i.e. EU Member States). It is the role of the EU institutions, taking into account EFSA’s advice as well as other considerations, to propose and adopt legislation as well as regulatory and control measures when and where required.


EFSA is a Community body with its own legal personality, funded from the Community budget but independent from the Community Institutions. It is not therefore managed by the Commission but by an Executive Director, who in turn reports to a Management Board.


Since its creation, EFSA has established key operating principles and rules which have been adopted by its Management Board. They include a commitment to openness and transparency in all of the Authority’s work. For example, EFSA undertakes to open up its meetings, organise consultations with stakeholders and the public, and ensure full access to all documents.


EFSA’s role can be broken down into two major areas of activity (a) risk assessment and (b) risk communication. Its work is undertaken in response to specific requests for scientific advice mainly coming from the European Commission, the European Parliament and EU Member States. In its first five years of operation, EFSA has delivered more than 500 scientific opinions on a wide variety of risk issues. These have included high-profile hazards such as BSE, the safety of food additives such as aspartame, allergenic food ingredients, GMOs, contaminants, pesticides, and animal health issues including avian influenza and Bluetongue. EFSA’s work also includes the development, proposition and implementation of new harmonised approaches of risk assessment methodologies across the Panels, the European Union and internationally.


The Authority has an important role in collecting and analysing scientific data to ensure European risk assessment is supported by the most complete scientific information available. This is done by working with the EU Member States to collate, share and analyse EU-wide data, as well as launch public consultations and calls for data to gather information from external sources.


EFSA’s risk assessment operations are organized into ten specific areas or Panels: (1) food additives and flavourings, (2) processing aids and materials in contact with food; (3) animal health and welfare; (4) biological hazards; (5) contaminants in the food chain; (6) additives and products or substances used in animal feed; (7) genetically modified organisms; (8) dietetic products, nutrition and allergies; (9) plant protection products and their residues; and (10) plant health. The Scientific Committee supports and coordinates the scientific panels to ensure consistency in the scientific opinions they produce.


In addition, EFSA’s Pesticide Risk Assessment Peer Review Unit is responsible for the peer review of active substances used in EU plant protection products, while the Zoonoses Unit analyses and reports data of zoonoses, antimicrobial resistance, microbiological contaminants and food-borne outbreaks. Data sources


The Rapid Alert System for Food and Feed ( is a system which ensures the sharing of information concerning food and feed safety. Whenever a member of the network has any information relating to the existence of a serious direct or indirect risk to human health, this information is immediately notified to the Commission under the RASFF. The Commission immediately transmits this information to the members of the network. Article 50.3 of the Regulation (EC) No 178/2002 gives further criteria for when a RASFF notification is required. States participating in the network shall immediately notify the Commission under the rapid alert system of: (a) any measure they adopt which is aimed at restricting the placing on the market or forcing the withdrawal from the market or the recall of food or feed in order to protect human health and requiring rapid action; (b) any recommendation or agreement with professional operators which is aimed, on a voluntary or obligatory basis, at preventing, limiting or imposing specific conditions on the placing on the market or the eventual use of food or feed on account of a serious risk to human health requiring rapid action; (c) any rejection, related to a direct or indirect risk to human health, of a batch, container or cargo of food or feed by a competent authority at a border post within the European Union.

There are two categories of notifications: (i) alert notifications, where a problem has been identified and the Member State detecting the problem has initiated relevant measures e.g. withdrawal or recall; (ii) information notifications, where a food or feed risk is identified but no rapid action is necessary because it has not got onto the market, mostly concerning food and feed consignments that have been tested and rejected at EU external borders. In the first case, consumers can be reassured that such products have been withdrawn or are in the process of being withdrawn from the market; in the second case, consumers can be reassured that such products have not reached the market or that all necessary actions have already been taken.

The number of notifications transmitted through the RASFF rose from 698 in 1999, to 823 in 2000, 1567 in 2001, 3024 in 2002, 4414 in 2003, 5562 in 2004, 7170 in 2005. In 2006, for the first time since the system has been operating, the number of notifications showed a decrease to 6840. The reason for this decrease lies with the reduced number of notifications for microbiological contamination and for the use of illegal dyes. There are similar European alert system and networks for events involving exposure to radio-chemicals or unsafe products.


Micro-organisms, contaminants and residues.


Article 33 of Regulation (EC) No 178/2002 foresees that EFSA shall search, collect, analyse and summarise data on, among others,


•          occurrence of micro-organisms; and

•          contaminants and residues.


In order to permit the conduct of risk assessments for chemical and biological agents potentially present in food (or feed), consumption levels of various food commodities in the EU are required at both aggregated and individual food level. This concerns food consumption by the general population as well as by subpopulations e.g. infants, pregnant women, immuno-compromised individuals or the aged. It is also important to be able to estimate low and high percentile consumption levels from information stored in the databases to identify vulnerabilities due to eating habits. High consumption levels are important for hazardous agents (see also Section 4.14.2).


Apart from Regulation 178/2002, there is also specific Community legislation that assigns EFSA tasks related to data collection. Specifically,


•          Directive 2003/99/EC on Zoonoses prescribes that EFSA has to examine the data submitted by the Member States on zoonoses, antimicrobial resistance and food-borne outbreaks and publish an annual Community Summary Report on the results.

•          Regulation (EC) No. 396/2005 provides that EFSA has to collect and analyse the results of the official controls on pesticide residues in food and feed.


Four CRLs have been established according to Regulation No. 882/2004 for the monitoring of the pesticide residues in the following areas:


•          cereals and feeding stuffs;

•          food of animal origin and commodities with high fat content;

•          CRL for fruit an vegetables including commodities with high water and high acid content; and

•          CRL for single residue methods.


The sampling methods for official control programmes have been harmonised in the Commission Directive 2002/6327,28


There are some significant attempts already in place across the EU to harmonise testing methodology for contaminants. Regulation No 882/2004 establishes Community Reference Laboratories in food and feed for:


•              marine biotoxins;

•              mycotoxins;

•              heavy metals in food and feed;

•              dioxins and PCBs;

•              polycyclic aromatic hydrocarbons; and

•              residues of veterinary medicines and contaminants in food of animal origin.


In addition, Regulation No. 882/2004 foresees a Community reference lab for food contact materials.


There are also a number of Commission regulations specifying in detail sampling and analytical protocols to follow for the official control of selected contaminants:


•          Commission regulation (EC) 401/2006 lays down the sampling and analysis methods sampling and analysis for the official control of levels of mycotoxins in foodstuffs;

•          Commission regulation (EC) 1882/2006 lays down the sampling and analysis methods for the official control of the levels of nitrates in certain foodstuffs;

•          Commission regulation (EC) 333/2007 lays down the sampling and analysis methods of some heavy metals, 3-MCPD and benzo(a)pyrene in foodstuffs; and

•          Commission regulation (EC) 1883/2006 lays down the sampling and analysis methods of dioxins and dioxin-like PCBs in certain foodstuffs.


Despite official specifications, there is still some incongruence in reporting the analysis. Specificity and sensitivity of the methods used are not always given. Sensitivity is more commonly geared to maximum limits in the legislation rather than the levels required for the exposure assessment. There is thus a need for further harmonisation. Commission regulation (EC) 1881/2006 specifies contaminants that should be regularly tested. However, the number of tests to be performed is not specified. Thus, implementation varies across Member States. For example, monitoring of nitrate in vegetables is compulsory with regular reporting to the Commission but the frequency of testing varies across Member States. Such surveillance is often targeted to problem areas and not random. It will thus not necessarily be representative for the exposure of the general population.


The legislation requires Member States to regularly check the compliance of food with the established pesticides maximum residue levels. The national control plans, which are mainly risk-based, focus on critical products with regard to compliance with MRL legislation. In addition to the national control programmes, the participation in a specific EU coordinated programme will be mandatory. The latter aims at generating data to estimate the actual dietary pesticide exposure throughout Europe. The programme is designed as a rolling programme covering major pesticide/commodity combinations in 3 year cycles. In the future, besides the crops of plant origin (fruits, vegetables, and cereals), also products of animal origin will be included in the European monitoring scheme. Article 32 of Regulation (EC) 396/2005 foresees that the EFSA takes over from DG Sanco's FVO the responsibility for the annual report on the national and Community pesticide control programmes.


Zoonoses and zoonotic agents 


Regulation No 882/2004 lists CRLs for the determination of the following micro-organisms in food or feed:


•          Salmonella;

•          viral and bacteriological contamination of bivalve molluscs;

•          Listeria monocytogenes;

•          Coagulase positive Staphylococci;

•          Escherichia coli, including Verotoxigenic E. coli;

•          Campylobacter;

•          parasites, in particular Trichinella, Echinococcus, and Anisakis;

•          antimicrobial resistance;

•          transmissible spongiform encephalopathy.


The European Community system for the monitoring and collection of information on zoonoses was established by Council Directive 92/117/ECC. This Directive required the European Member States to collect, evaluate and report data on specific zoonoses and zoonotic agents to the Commission each year. The revised Community legislation was adopted by the European Council and Parliament on 17 November 2003, and came into force on 12 June 2004. In order to obtain data that are comparable between Member States, it is essential that also other aspects than test methods are considered. In November 2005 the EFSA Task Force on zoonoses data collection issued its recommendations on the "Weeds to revise the Community Reports on Zoonoses and to harmonize the related data collection" (EFSA Journal (2005) 73: 1- 60).


Directive 2003/99/EC on the monitoring of zoonoses and zoonotic agents29 lays down the rules for monitoring and reporting of data on zoonoses and zoonotic agents in animals, foodstuffs and feedingstuffs.

This monitoring is mandatory for eight 'list A' zoonoses:

•          brucellosis;

•          campylobacteriosis;

•          echinococcosis;

•          listeriosis;

•          salmonellosis;

•          trichinellosis

•          tuberculosis due to Mycobacterium bovis; and

•          infections caused by verotoxigenic Escherichia coli.


Other 'list B' zoonoses should be included in the monitoring and reporting according to
the epidemiological situation in each Member State:


•          viral zoonoses: calicivirus, hepatitis A virus, influenza virus, rabies and viruses transmitted by arthropod

•          bacterial zoonoses: borreliosis, botulism, leptospirosis, psittacosis, tuberculosis other than in point A, vibriosis and yersiniosis;

•          parasitic agents: anisakiasis, cryptosporidiosis, cysticercosis, and toxoplasmosis; and

•          other zoonoses and agents thereof.


Food-borne outbreaks and antimicrobial resistance in Salmonella and Campylobacter strains are also to be reported on a mandatory basis. As in Directive 92/117, the requirement to monitor is mandatory.


Under the new Zoonoses, Directive the EFSA is responsible for examining the data collected from the Member States and for preparing the Community Summary Report from the results. In this summary report, EFSA may also take into account the data provided by other Community institutions. This applies, in particular, to data received from:


•          Communicable Disease Networks set up by Council Decision 21 19/98/EC;

•          the control and eradication programmes for animal diseases and zoonoses under Council Directive 64/432/EEC30; and

•          Council Decision 90/424/EEC31 and coordinated control programmes for foodstuffs based on Council Directive 89/397/EEC32.


Regulation No 882/2004 provides for Community reference laboratories for the diagnosis of the following diseases in animals: classical swine fever, African horse sickness, avian influenza, Newcastle disease, swine vesicular disease, fish diseases, bivalve mollusc diseases, rabies (vaccination monitoring), bluetongue, African swine fever, foot and mouth disease, and brucellosis.

The new legislation no longer covers reporting of zoonoses in humans. This information is now accessed from the Communicable Disease Networks set up by Council Decision No 2119/98/EC33. Nevertheless, the human cases linked to food-borne outbreaks will still be reported under the Zoonoses Directive. To foster good interaction between all parties involved, the Commission has adopted with the relevant Member State authorities, a plan to integrate human data on zoonoses provided through the Communicable networks with the data on zoonoses and zoonotic agents collected under directive 2003/99/EC.


EFSA has also been requested by the Commission to support the design, collation and analysis of a series of baseline surveys in laying hens, turkeys, slaughter pigs such as Campylobacter and Salmonella in broiler meat. The results of these surveys are used to set EU targets to reduce the prevalence of Salmonella in these various animal species and enable the consideration of risk management options for other zoonotic agents.

Whereas Directive 2003/99/EC establishes the monitoring for a number of zoonotic organisms, it currently does not serve as a Community-wide source of data for all micro-organisms. Hence, data on organisms not currently reported may need to come from other sources, particularly research projects.

The European Union Risk Analysis Information Network (EU-RAIN) is an EU-funded concerted action project involving 19 research institutes and consumer organisations from Europe and North America (Project number QLK1-CT-2002-0217). It aims at establishing a web-based database ( where scientists can access raw data from studies for microbial risk assessments. The type of studies for which raw data are included are baseline studies, bacterial growth and survival studies, dose response studies, and lifestyle studies.


For animal health, disease data are provided by the Member States to the Commission's Animal Disease Notification system (ADNS). Council Directive 82/894/EEC (as last amended by Commission Decision 2004/216/EC) makes it compulsory for the Member States to rapidly notify outbreaks of the many infectious animal diseases.


The ADNS is a notification system through which this information is provided. The Member States and the other countries connected to the application are responsible for supplying ADNS with the necessary information. The notification can be inserted directly into the ADNS system via internet or sent by a structured e-mail to the Commission; the information is then automatically inserted into the ADNS system.


It is mainly a management tool that ensures rapid and detailed exchange of information between the competent national authorities responsible for animal health and the Commission about outbreaks of these animal diseases in the countries that are connected to the application. The system allows the monitoring of outbreaks of contagious animal diseases and enables Member States and Commission services to take coordinated measures to prevent the spread of the above mentioned diseases.


The same Directive lays down the rules about the procedures for notification, in particular the information to be sent and the time limits for notification. Two types of outbreak are considered


•          Primary outbreak: an outbreak of a contagious animal disease not epi-zoo-tiologically linked with a previous outbreak in a region or the first outbreak in a previously unaffected region of a Member State. All members need to be immediately informed on this kind of outbreak. Council Directive 82/894/EEC provides that the notification must be sent within 24 hours from the confirmation of the outbreak.



•          Secondary outbreak: an outbreak following a primary outbreak in an already infected region. For the secondary outbreak, the notification must be sent at least on the first working day of each week.

Commission Decision 2005/176/EC (repealing Decision 2000/807/EC) lays down the codified form and the codes for the notification of these contagious animal diseases.


On the internet page of DG Health & Consumer Protection information can be found on the ADNS system. The page can be accessed via the following link: int/comm/food/animal/diseases/adns/index.en.htm. On this webpage, a summary of the number of outbreaks and the date of the last outbreak notified to the ADNS system is given for the current year and previous years. The report for the current year is updated on a weekly basis. In the case of a large outbreak of an infectious disease affecting more than one Member State, maps showing the location of the outbreaks and summary data sent to the ADNS system by the affected countries is also published.


Animals suspected of a transmissible spongiform encephalopathy (TSE) are examined in accordance with Article 12.2 of Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain TSE (TSE Regulation). The legal framework for the active monitoring of ruminants for the presence of TSE is laid down in Article 6 of the TSE Regulation and specified in its Annex III, Chapter A. At the beginning of 2005, an active monitoring was carried out in accordance with the amendments of the TSE Regulation laid down in Commission Regulation (EC) No 2245/2003 and Commission Regulation (EC) No 214/2005, providing for an increased monitoring in goats.


In accordance with Article 6.4 specified in Chapter B.I of Annex III of the TSE Regulation, Member States submit an annual report to the Commission on the monitoring programme performed and its outcome. The specifications laid down in Regulation (EC) No 36/2005, amending the TSE Regulation became applicable in 2205. All this information is introduced and processed in a database in order to summarise the information provided and elaborate summary tables to be distributed within the Commission, to Member States, Bulgaria and Norway. This database is accessible by EFSA.


In order to fulfil its mandate, the World Animal Health Organisation (OIE) manages the world animal health information System, based on the commitment of Member Countries to notify to the OIE the main animal diseases, including zoonoses. The most recent list was approved in May 2006 by the International Committee and came into force in 2007.


Immediate notifications of exceptional epidemiological events are published, on receipt, in the OIE's three official working languages (English, French and Spanish), under the headingAlert messages”. Immediate notifications and follow-up reports are published under the headingDisease information”.


An electronic distribution list calledOIE-Info” has been set-up to facilitate and widen the dissemination of animal health information, in the form of an immediate message sent to the Delegates of the Member Countries, the OIE References Laboratories and Collaborating Centres, international and regional organisations, as well as any institutions or individuals interested in receiving directly such information.


Animal Health Information for 2005 and thereafter is accessible from the new WAHID (World Animal Health Database) Interface available at: The monthly and annual data supplied by Member Countries on animal diseases and zoonoses prior to 2005 can be accessed in OIE database via the Web interface, Handistatus IL


A summary of the annual data is also contained in a publication entitledWorld Animal Health”, which also includes more detailed sanitary and general information. A special section is devoted to the bovine spongiform encephalopathy (BSE) situation worldwide in response to the many requests for information on the subject received by the OIE.


The Global Framework for Progressive Control of Transboundary Animal Diseases (GF-TADs) is a joint FAO/OIE initiative, which combines the strengths of both organisations to achieve agreed common objectives. GF-TADs is a facilitating mechanism which will endeavour to empower regional alliances in the fight against transboundary animal diseases (TADs), provide for capacity building and give assistance for establishing programmes for the specific control of certain TADs based on regional priorities. One of the thrusts of the GF-TADs programme is the development of Regional and Global Early Warning Systems for major animal diseases.



An important information source for the current Report has also been the 2006 RIVM Report, entitled “Our Food, Our Health”. Data description and analysis


Several years ago, the European Commission established the Rapid Alert System for Food and Feed (RASFF) to ensure the sharing of information concerning food and feed safety. In the frame of RASFF there are two categories of notifications : (i) alert notifications, where a safety problem has been identified in relation to specific products and the competent EU Member State has already adopted relevant measures(e.g. withdrawal or recall); (ii) information notifications, where a food or feed risk has been identified in relation to specific products but no rapid action is needed because they have not gone onto the market mainly because they were tested and rejected at EU external borders. Annual reports on the Rapid Alert System for Food and Feed summarise the number and origin of notifications, the countries involved, the identified products and risks. In 2006, there were 938 alert notifications with fish, crustacean and mollusc products the largest category (20%), and the-largest risk category being pathogenic micro organisms (16%). A total of 2009 information notifications were reported with the largest product category being nuts and nut products (33%) while the largest risk category was mycotoxins (40%). Reported risks from pesticide residues are way down the list at 2% of alert notifications and 4% of information notifications. The widening of the RASFF to become a more global international network is under active consideration by the Commission. Interested third countries are being encouraged to set up their own regional schemes to improve the protection of their consumers and consumers in the EU via their exported products (e.g. Thailand, Argentina and China). Once established, these regional alert networks could be interconnected to become a global RASFF.




Many biological hazards can be present in food (Table, in particular of animal origin, mainly associated with zoonoses (Table In humans, the severity of these diseases can vary from mild symptoms to life threatening conditions (Table The infection can be acquired directly from animals or through ingestion of contaminated foodstuffs or water). Salmonella in poultry, Listeria monocytogenes in dairy and meat products, biotoxins in live molluscs, Trichinella in horses, wild pigs and domestic swine and BSE from cattle in particular and many others, all pose serious risks to public health.


Table Association of pathogenic (micro-) organisms with various types of food

Source: RIVM (2006)



Starch containing products

Fruit and vegetables

Meat and

meat products           

Dairy products

Fish and shellfish



Bacteria - infectious







Aeromonas spp.






Arcobacter spp.



Cattle, Pig,




Brucella melitensis/








Campylobacter spp




cattle, pigs, sheep


Untreated milk


Coxiella burnettii






Enterobacter sakazakii




Baby milk powder



Escherichia coli

Shiga-toxin producing





Untreated milk



Francisella tularensis






Listeria monocytogenes



Meat products

Soft cheese

Smoked fish

Mycobacterium avium

ssp. avium







Mycobacterium bovis




Untreated milk


Mycobacterium avium

ssp. paratuberculosis







Salmonella (para)typh






Salmonella spp.– other


Sprouting Chicken, pig,

vegetables cattle, egg



Shigella spp






Vibrio cholera






Vibriomarine species






Yersinia enterocolotica







Bacteriatoxin producing







Bacillus cereus

Rice, pasta





Clostridium botulinum






Clostridium perfringens



Cattle, pig,




Staphylococcus aureus




Cheese, pastries




























Hepatitis A virus






Hepatitis E virus







Table Zoonotic diseases and food-born outbreaks in the EU






Main human exposure route






51.6 per 100 000

Increasing (7.8% in 2005)

Poultry meat and contaminated drinking water


35.0 per 100 000

Decreasing in eggs over the last 5 years34. Around one in five of the EU 15 large scale commercial egg produced have laying hens infected with the main salmomenna types.

Eggs, poultry, turkey and pig meats

Antibiotic resistance of Campylobacter and Salmonella isolates

High proportion



Verotoxigenic Escherichia coli and Yersinosis 





Rare, but severe consequences


Ready-to-eat foods

Food-born viruses (e.g. Caliciviruses)

Most important cause of food-born outbreaks


Fruit and vegetables
Contaminated drinking water

Trichinellosis and Echinococcosis

Low, but severe consequences



Source: EFSA



Table Disease symptoms associated with pathogenic (micro-) organisms in food

Source: RIVM (2006)


Severity of the disease symptoms


Mild 1

Severe 2

Chronic 3

Mortality 4




Aeromonas spp.





Arcobacter spp.





Brucella melitensis /abortus/suis





Campylobacter spp.

GE, ReA6




Coxiella burnettii


Endocarditis, hepatitis




Enterobacter sakazakii


Sepsis and meningitis

in neonates



Escherichia coliShiga-toxin






Escherichia coli – Other





Francisella tularensis





Listeria monocytogenes


Abortion, stillbirth, meningitis



Mycobacterium avium ssp. avium





Mycobacterium bovis


Extra pulmonary tuberculosis



Mycobacterium avium ssp.



Possible association






with Crohn’s disease


Salmonella (para)typhi


Typhoid (and paratyphoid)




Salmonella spp. - other





Shigella spp.





Vibrio cholerae





Vibrio marine species


Sepsis, wound infection


High (V. vulnificus),





Medium (other)

Yersinia enterocolotica






Bacteriatoxin producing


Bacillus cereus

GE (especially vomiting)




Clostridium botulinum





Clostridium perfringens





Staphylococcus aureus
























Neurologic symptoms



Hepatitis A virus




High, in adults

Hepatitis E virus




High, in pregnant women








GE (children)



















BSE prion






Very high




Following the food crises of the 1990s, new measures were taken by the Commission to increase the level of food safety and restore consumer confidence.


These measures, based on sound scientific opinions, include:


·          A co-ordinated and holistic approach towards food hygiene, covering all levels of the food chain and applying a transparent hygiene policy to all food and feed operators;

·          Increasing knowledge of sources and trends of pathogens by monitoring zoonotic agents throughout the food and animal feed chain;

·          Establishing control programs for Salmonella and other food-borne zoonotic diseases to reduce public health risk and provide the basis for adopting measures to manage these risks. Animal health is an important factor in food safety because some diseases, the so-called zoonoses such as brucellosis, salmonellosis and listeriosis, can be transmitted to humans through contaminated food. Community legislation on animal health covers certain zoonotic animal diseases, which can be transferred to humans via foodstuffs. There are specific measures against zoonoses in Community legislation relating to Veterinary Public Health.


An assessment of the safety and quality of all types of foodstuffs has to properly consider microbiological criteria, applicable at the site of food production as well as products on the market; microbiological criteria are tools that can be used in assessing the safety and quality of foods. Due to reasons related to sampling, methodology and uneven distribution of microorganisms, microbiological testing of finished food products on its own is insufficient to guarantee the safety of a foodstuff. The safety of foodstuffs must be mainly ensured through a more preventative approach, such as product and process design and the application of Good Hygiene and Manufacturing Practices (GHP, GMP) and of the Hazard Analysis Critical Control Point (HACCP) principles. Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs, applicable from 1 January 2006, lays down food safety criteria for certain important food-borne bacteria, their toxins and metabolites, such as Salmonella, Listeria, Enterobacter sakazakii, staphylococcal enterotoxins and histamine in specific foodstuffs.


As regards the TSEs (BSE, scrapie etc), the following actions have been taken:


·                      measures have been developed to avoid contagion of other animals or

            contamination of the consumers;

·                      harmonisation of TSE measures in Member States and the TSE import

            rules applicable to third countries;

·                     prohibition of the recycling into feed or technical products of certain animal by-products and identifying safe alternative methods for the use or disposal of animal waste.


Zoonoses are diseases or infections, which are transmissible from animals to humans. The infection can be acquired directly from animals, or through the ingestion of contaminated foodstuff. In humans, the severity of these diseases can vary from mild symptoms to life threatening conditions. The importance of a zoonosis as a human disease depends on several factors, such as severity of the disease, the case fatality, and number of cases (incidence) in the population.


In order to prevent these diseases from occurring, it is important to identify which animals and foodstuff are the main sources of the infections. For this purpose, information is collected and analysed from all European Union Member States in order to help the Community to improve control measures in the food production chain and to protect human health.


In 2005, twenty-four member States submitted information on the occurrence of zoonoses, zoonotic agents, antimicrobial resistance and food-borne outbreaks to the European Commission and the European Food Safety Authority (EFSA). Further information on zoonoses cases in humans was acquired from the European Centre for Disease Prevention and Control (ECDC). These data covered 16 zoonotic diseases. Assisted by its Zoonoses Collaboration Centre, EFSA and ECDC jointly analysed the information and published the results in their annual Community Summary Report. In addition, three countries non belonging to EU provided information on zoonoses for the report (EFSA, 2006a).


The main conclusions on the Community Summary Report in 2005 (EFSA, 2007) are:


·                     Campylobacteriosis is the most frequently reported zoonotic disease in humans within the EU. Reported Campylobacter cases in 2005 increased by 7.8% compared to the previous year, rising to an incidence rate of 51.6 cases per 100,000 people and to a total of 197,363 cases. Poultry meat is assumed to be amongst the most important sources of food-borne Campylobacter infections, and in line with this the highest proportion of Campylobacter positive samples in 2005 were reported for this food category. The proportion of positive samples in fresh poultry meat was high in most member states.

·                     Despite a decrease in the number of human cases when compared to 2004, salmonellosis remains the second most frequently reported zoonosis in the EU. The major sources of food-borne Salmonella infections are eggs as well as poultry and pig meat (up to 18%). In 2005, Salmonella was most frequently reported from fresh poultry and pig meat. An overall decreasing trend in Salmonella prevalence was apparent in table eggs over the last 5 years.

·                     Relatively high proportions of Campylobacter and Salmonella isolates from animals and food showed resistance to antimicrobials commonly used in human therapy. This is especially the case for resistance to fluoroquinolones in Campylobacter isolates from poultry. Food-borne infections caused by these resistant bacteria pose a particular risk to humans, as therapeutic options to treat the disease cases may be limited.

·                     Verotoxigenic Escherichia coli (VTEC) infections and yersiniosis are also important zoonotic diseases, with considerable incidences in EU. The lack of information on the association of the VTEC and Yersinia findings in food and animals to human disease cases, inhibits a proper assessment of the relevance of different foods and animal species as sources of human infections. There is a need for more detailed information on the serotypes and other virulence factors related to human pathogenic serotypes as well as for harmonisation of the analytical methodology.

·                     Listeriosis is an important zoonosis in humans due to the severity of the disease. Ready-to-eat food (RTE) are the main source of the food-borne infections. Among the large number of different types of RTE foods examined, typically very few carried Listeria monocytogenes at levels over the limit that poses a significant risk to human health (100 bacteria/g). However, in RTE fishery products more positive findings and samples over the 100 cfu/g limit were made indicating that this food category is of higher risk for consumers.

·                     Salmonella, Campylobacter and food-borne viruses are the most important causes of food-borne outbreaks. For Salmonella outbreaks egg products and broiler meat were the most frequent vehicles of the infection. For Campylobacter outbreaks broiler meat remained the major source of infection, though the largest Campylobacter outbreaks were caused by contaminated drinking water. Caliciviruses are the most common causative agents of food-borne virus outbreaks. The most common sources are drinking water, fruit and vegetables. Further harmonisation of the reporting on outbreaks would improve the quality of the Community analyses.

·                     The incidence of the two food-borne parasitic zoonoses, trichinellosis and echinococcosis, was low in humans, but relevant due to severity of the diseases. Trichinella was rarely detected in farm animals. For both zoonoses, wildlife is an important reservoir. There is a distinct geographical distribution of cases and related risk of acquiring disease within the EU.

·                     No information on human cases of Toxoplasma infections was available for 2005. Data on Toxoplasma in food was also sparse. There is a need to define the optimal monitoring schemes for the agent and to improve detection and reporting in the EU.

·                     The Community measures to eradicate brucellosis and bovine tuberculosis in animals have contributed towards most of the member States being officially free of the diseases or reporting no positive cases. However, the progress towards eradication of the diseases is slow in some of the non member States.

·                     Even though there were only few rabies cases reported in humans, the increased reporting of cases in domestic animals and wildlife in the eastern part of the EU is of some concern.

·                     The emergence of the bovine spongiform encephalopathy (BSE, mad cow disease) epidemic in the UK put TSEs out of the shadow, but only in 1996 the BSE agent was found to transmit to humans and cause a new type of TSE, vCJD. An afterwave occurred four years later when active surveillance proved the presence of BSE as much more widespread in continental Europe than what believed at political level. Science-based control measures by the EU and elsewhere succeeded in restricting the BSE epidemic to a continuous decline in recent years in most but not all countries. However, several questions are still to be solved (Budka Hebert in EFSA 2007b).


Chemical hazards


Non naturally occurring substances


Chemical contaminants may end up in food through a number of different pathways, including their occurrence in the environment, releases from food packaging materials, residues of plant protection agents and fertilizers in agriculture, residues of veterinary medicinal products to prevent or treat food animal diseases, through the use of food additives and technological adjuvants during food transformation as well as contaminants in feed (Table With respect to food safety, more dangerous food chemical contaminants include dioxins and related compounds, acrylamide, perfluorinated organic compounds, plant protection products, nitrates and aluminium. High levels of arsenic, one of the first chemicals recognised as carcinogen, are present as natural contaminant of ground water in specific areas of several European countries.



Table Not naturally occurring, potentially harmful chemical food constituents

Source: RIVM (2006)



Category, substance


Possible health effects

(in humans, or in experimental animals)


Existing legal standard          

Exposure, possible

exceedance of standards

Possibility to influence


Remarks, sources


Substances deliberately added to foods


Food additives

Many foods, for flavour,

smell, colour, consistency

or shelf life


Admission subject to legal

regulations; approx.1,800

additives in use; in EU

positive list

No problem, due to

admission policy

Admission policy

WHO, 200a; Barlow et al.,


Substances that are present in the diet as a result of human actions during food production




Pesticides that are no

longer admitted

(DDT, drins, HCB, etc.)    

Residues in crops

(import), human milk

Persistence in the         

environment and the     

marked accumulation in

fatty tissue; neurotoxic,

immunotoxic and


Prohibited, still  

occasionally used in           

third world countries            


Slight; concentrations have dropped markedly in recent years


Van Kasteren, 2000;

Richard et al., 2001;

Fiolet & van Veen, 2001








Pesticides that have been


Residues in crops


Given the current

situation of sporadic

incidents where standards

are exceeded, no effect

is anticipated; Various

effects in experimental


Approx. 400 active

substances admitted;

maximum residue limits

(MRL) established (NL

EU, Codex)

In 2001, from 2,900 samples

3.5% (the Netherlands) and

13% (import) involving

incidents where standards

were exceeded (especially

grapes, cucumber, pineapple)


Admission policy, ‘Good

Agricultural Practice’,

monitoring by random



Van der Schee, 2002;

KAP, 2003


Veterinary medicines








Antibacterial agents

Residues in meat

Development of

resistance by (possible) monitoring by random

human pathogens in

farm animals

EU regulations


Admission policy;

monitoring by random



EC, 1996


Growth promoting

substances (naturally

present in the body, e.g.

oestradiol; analogues,

e.g. trenbolone; others,

e.g. clenbuterol)

Residues in meat


At current levels of

exposure, natural growth

promoters have no effect;

incident involving

clenbuterol: heart rhythm

disorders, neurological

effects; hormonal effects.


Prohibited in Europe in

1988, following the DES

affair; nevertheless

increasingly used


Residues are regularly

 detected; sporadic high

exposure when injection

site is consumed

Monitoring by random

sampling; illegal

operations mean that it

is not always clear which

substances should be

searched for


EC, 1996; FAO, 2000; WHO,

2000b; Nielen et al., 2003;

Salleras et al., 1995



Process contaminants


Polycyclic aromatic

hydrocarbons (PAHs)

For example, in plant-

based oils; also as

products of pyrolysis

when frying and baking

in domestic kitchens

Proven or possible

carcinogenic (genotoxic);

most of the information

relates to benzo(a)pyrene;

it is estimated that the

carcinogenic potential of

all PAHs in food amounts

to about 10x that of


EU standards for PAHs

in preparation

Current oral exposure in

 the Netherlands to PAHs,   

about 100-200 ng per

person per day      

Management of the

industrial process;

research into processes

by industry and

government; avoid

overcooking food in

domestic kitchens


Baars et al., 2001;

Kroese et al., 2001;

SCF, 2002




Acid hydrolysis of

plant-based proteins



Possible carcinogen but

not genotoxic



EU standards for


in soy sauce



Occasional high

concentrations in soy sauce



Monitoring; research

into processes by industry

and government


Schlatter et al., 2002








Heterocyclic amines

Products of pyrolysis,

when frying and baking

in domestic kitchens

Genotoxic carcinogen


Exposure or actual effects


Avoid overcooking food

In domestic kitchens

Nagao & Sugimura, 2000


Deep-frying and baking

of potato and flour

products in industrial

processes or in the

domestic situation (crisps,

chips, biscuits)



Carcinogenic; neurotoxic





Theoretical risk calculated

at 75-130 cases of cancer per

year in the Netherlands



Research into conditions

of acrylamide formation;

monitoring, process





Konings et al., 2003



Environmental contaminants




Drinking water, via lead

Water pipes


Inhibits haemoglobin

synthesis and the

development of the

nervous system


As of 1-1-2006 standard

for lead in drinking water

to be reduced, means that

all lead water pipes must

be replaced; EU standards

for various foods



Exposure reduced by

measures; estimate for

early 1990s: effect in

several thousand children





(lead-free petrol)



IPCS, 1995; De Hollander

et al., 1999



Mercury (organic) in fish

Organic mercury:         




Intake via fish consumption

well below the standard

(WHO: 1.6 ug/kg body

weight per day)







ATSDR, 1999; EFSA, 2004


Dioxins and dioxin-like


(PCBs); see textbox 4.11


Oils and fats of animal

origin, human milk


Adverse effect on the

development of the

central nervous system;

persistent and accumulate

in body fat; harmful to

the immune system and

fertility, carcinogenic


EU standards for

dioxins in foods and

animal feed



In 1998/99 intake of

dioxins and dioxin-like

PCBs in 8% of the

population was above

EU/WHO intake standard




measures: strict

standards governing

emissions from waste

incineration; monitoring

of animal



Freijer et al., 2001;

SCF, 2001; WHO, 2002;

Baars et al., 2001; 2004









Non dioxin-like PCBs



Oils and fats of animal

origin, human milk


Adverse effect on the

development of the

central nervous system;

deleterious to the thyroid

gland and the immune



Consumer Goods Act

standards for the seven

indicatorPCBs; EU: risk

assessment by EFSA in



Intake in 5% of the

Population such that

health effects could appear

in the long term



equipment banned by

the end of 2003;

monitoring of oils, fats

and animal feed;

environmental measures


Bakker et al., 2003

Bromine-containing fire


(such as PBDEs)


Products of animal

origin, human milk,

via increasing use in all

kinds of products


Effects on the liver,

thyroid, immune system

embryonic development




Little is known about

exposure in the Dutch

situation; in Sweden, the

concentration in human

milk increased until 1997,

after which it declined


Alternative fire

 retardants 2003


De Winter-Sorkina et al.,




Community food legislation aims at the establishment of the right balance between risks and benefits of substances that are used intentionally and at the reduction of contaminants in accordance with the high level of consumer protection that is required by Article 152 of the Treaty establishing the European Community.

A risk analysis procedure based on sound scientific evaluation and taking into account other factors, such as the feasibility of control, underpins Community legislation is necessary to achieve this high level of health protection for the consumer,. For chemical substances in food, legislation is divided into the following areas:


•       The legislation on food additives is based on the principle that only additives that are explicitly authorised may be used in specific foodstuffs and in limited quantities. Food additives are evaluated for their safety before they can obtain authorisation by the Commission,.

•       The existing legislation on flavourings sets limits on the presence of undesirable compounds, while for the chemically defined flavouring substances a vast safety evaluation programme is ongoing. Only substances for which the outcome of the evaluation is favourable will be authorised for use in foodstuffs by means of a future positive list.

•       The legislation on contaminants is based on scientific advice and the principle that contaminant levels shall be kept as low as can be reasonably achieved following good working practices. Maximum levels have been set for certain contaminants (e.g. mycotoxins, dioxins, heavy metals, nitrates, chloropropanols) in order to protect public health.

•       The legislation on residues of veterinary medicinal products used in food-producing animals and on residues of plant protection products (pesticides) provides for a scientific evaluation before the products are authorised. If necessary, maximum residue limits (MRLs) are established and in some cases the use of substances is prohibited.

•       The legislation on food contact materials provides that these materials shall not transfer their components into food in quantities that could endanger human health or change the composition, taste or texture of the food



In 2005 the RASFF registered a significant increase in hazards arising from materials in contact with food, such as the migration of lead from ceramic ware, the migration of chromium and nickel from metal ware, or the migration of isopropyl thioxanthone from carton packagesnotified for the first time. In case of plastic materials and articles, rapid alerts of primary aromatic amines (PAA), suspected human carcinogens, were in most cases related to migration from nylon kitchen utensils imported from China (European Commission, 2006).


Persistence, increasing concentrations up the food chainbioaccumulation, and the atmospheric and marine transportation of chemicals over long distances may result in environmental and human exposure in areas far from where the chemicals were released. For example, there are serious concerns about the Arctic region being a global sink for mercury and other persistent chemicals, impacting not only the human population but also other mammals, fish and plant life. The Baltic Sea is affected by historical and current contamination with POPs and other toxic compounds. Furthermore, POPs are found in high-altitude mountain areas, such as the Alps, which serve as cold condensers for POPs (Kallenborn, 2006)


Dioxins and related compounds


In 2002 the Scientific Committee on Food assessed the risk of dioxin-like compounds in food and derived a tolerable weekly intake (TWI) of 14 pg WHO-TEQ/kg body weight for dioxins and dioxin-like polychlorinated biphenyls (dl-PBC). It also stressed that a considerable proportion of the European population still exceeds this TWI. As a consequence, the EU Commission has set maximum levels for dioxins and dl-PCB as well as for the sum of dioxins and dl-PBC in food and feed in order to cease highly contaminated specimens from the market. In addition, separate action levels for dioxins and dioxins-like PCB were set as an early warning tool of elevated contaminant levels. Moreover, the analytical network consisting of a Community reference laboratory, national reference laboratories and experienced field laboratories was intensified. Monitoring programmes recommended by the EU and performed by a number of EU Member States revealed a considerable decrease of human exposure to dioxin-like compounds during the past two decades. This is a clear indication that the numerous measures to reduce the emissions of dioxins and PCB have had beneficial effects (EFSA, 2007b).




Acrylamide is a synthetic substance that is carcinogenic, mutagenic, toxic to reproduction and neurotoxic. In the EU, 99,9% of acrylamide is used to manufacture polyacrylamide. About 80-90% of polyacrylamide is used in wastewater treatment and paper and pulp processing. Other uses of polyacrylamide include crude oil production, cosmetic additives and soil and sand stabilisation. The degradation of polyacrylamide to release free monomeric acrylamide is reported to be unlikely. Acrylamide can also be used in the formulation of grouting agents. A large-scale use of acrylamide grout and acrylamide based grouting agents occurred at Hallandsasen, a ridge in the South-east of Sweden where a tunnel had been under construction since 1994, and led in September 1997 to exposure of workers and leakage into the environment (EU 2002). During the follow-up of this incident, Swedish officials realised that there must be other sources of acrylamide as they found unexpected high levels in unexposed individuals.


On 24 April 2002, the European Commission informed via the Rapid Alert System for Food about acrylamide findings detected in foods in Sweden. In some cases high levels of acrylamide were detected in specific starch-containing foods such as potato crisps, crispbread, breakfast cereals and chips. The detected findings have been confirmed in other countries, too (e.g. Switzerland, Norway, United Kingdom, Germany, USA, Canada). The public health implications of these findings are unclear. Acrylamide causes cancer in animals. While there are no scientific reasons to doubt this risk in humans, in principle, it cannot be reliably estimated at present, how high the risk of contracting cancer is in humans after the intake of acrylamide-containing foods. In principle, the so-called ALARA principle, i.e. as low as reasonably achievable, applies to genotoxic and carcinogenic substances. Information about ongoing research and monitoring recommendations are available on and on


An ad hoc methodology to assess the risk of carcinogenic and untogenic chemicals, applicable to acrylamide has been developed by EFSA (EFSA/WHO, 2006).


Perfluorinated organic compounds


Perfluorinated organic compounds (PFCs) are a group of compounds of which especially perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) are widely used in the production of fluoropolymers and elastomers as well as in many industries and consumer products e.g. metal plating, fire fighting foams, the photographic industry, in semiconductor photolithography and aviation hydraulic fluids (OECD 2005), textiles, carpets, leather furniture, paper, packaging, cleaning products, cosmetics and plant protection products (Caliebe et al, 2006) Perfluorobutane sulfonate (PFBS) is used as replacement for PFOS, after the voluntary manufacturing phase-out of PFOS by the main producer. Further, OECD preliminary identified additional 17 substance groups that may degrade to PFCA (OECD, 2006).


PFCs, are ubiquitously found in the environment, particularly in wildlife animals (including marine mammals) and human samples. (Olsen et al, 2005, LGL 2006, Kannan et al, 2004, So et al, 2006). PFOS and PFOA were also detected in cord blood. This means they are able to pass the placental barrier and enter into foetal circulation (Inoue et al, 2004; Greenpeace and WWF, 2005). This gives special cause for concern as PFOS and PFOA are toxic to reproduction in animal experiments.


Maximum concentrations of 598ng/L have been found in drinking water in the Rhine-Ruhr area, with PFOA as major component (Skutlarek et al, 2006). The food chain is a major route of human exposure; however, there is currently no generally adopted legal limit for PFC concentrations in food. A provisional limit for fish was set by German authorities after high levels of PFC were found in trouts: 0.02µg/g fish based on a TDI (Tolerable daily intake) of 0.1µg PFOS/kg body weight (BfR 2006). This level may already be exceeded by background concentrations as a food survey in the UK showed an average intake of 0.13µg/kg bw (EFSA, 2006).


PFOS is currently discussed as candidate for inclusion in the Stockholm convention. At EU level, legislation was adopted to restrict the marketing and use of PFOS as of 27 June 2007 (Directive 2006/122/EC of 12 December 2006) while the US EPA invited producers on 25 January 2006 to participate in a voluntary PFOA Global Stewardship Programme. Participating companies committed themselves to achieve no later than 2010 a 95% reduction in emissions and content in products compared to a 2000 baseline and to work towards the elimination of PFOA by 2015.(


Plant protection products


Consumers may be directly exposed to pesticides present as residues in food or in drinking water. Protecting the health of consumers, users and of the environment is the driving principle behind regulatory control. It is expected that residues of pesticides will find their way into food supplies but conditions are set during regulatory approval to ensure that any residues present are not at levels which may cause harm and which should be as low as practically possible, even if higher levels would still be safe. The occurrence of any residues will be influenced by the pattern of use of plant protection products on the growing crops or subsequent use during storage and may be reduced during food processing. Measured residue levels in food also reflect our ability to detect and quantify them.


The Maximum Residue Level (MRL) is the maximum specified amount of a pesticide legally permitted on crops or foodstuffs, showing that the pesticide was applied in accordance with the approved conditions of use (Good Agricultural Practice). MRLs are set for each approved pesticide on a wide range of fruit and vegetables, cereals and animal products as appropriate. These levels do not correspond to the safety limits but are always set below, often far below, the safety limits. Detected surplus of the MRL are further investigated and may lead to enforcement activity by the regulators.


Pesticide residues in food will also be influenced by usage during production and storage. Systematic surveys of pesticide usage on farms in England and Wales started in 1965 on a wide range of agricultural and horticultural crops and have continued on average at 4 yearly intervals per crop type. This is the longest and best documented data set in Europe, with patterns of usage that have changed dramatically over this period.



For example in arable crops, which account for more than 90% of total pesticide usage in Great Britain between 1994 and 2004, whilst the area of crops grown increased by 3%, the area treated increased by 42%, but the total pesticide weight applied fell by 4% (Garthwaite et al, 2005). This resulted from increases in the average number of sprays applied and in the number of products used. Thus, the degree of tank mixing, from an average of 7 products per crop, to an average in 2004 of over 11 products per crop. The reduction in weight of pesticides applied each year through the ten years arises from the development and introduction of new molecules - intrinsically more active at lower doses - together with the greater use of reduced doses by farmers and growers. Thus, in this period the organochlorine insecticides were withdrawn, use of organophosphorus insecticides fell by 78% and the use of the pyrethroids, with lower rates of application, increased 3 fold by 2004. Whilst fungicide use increased by 56% and herbicides by 44%, total annual weights applied increased by only 14% and 25% respectively during the 10 years. At European level, national estimates of use derived from commercial sales data are available for the years from 1992 to 2003 (Eurostat 2007).


Since Regulation (EC) 396/2005 has not been fully implemented yet, the provisions of the previous MRL legislation on monitoring activities are still applied. According to Directive 86/362/EEC35, 86/363/EEC36 and 90/642/EEC37 Member States have to ensure through check sampling the compliance with the MRLs set at EU level. Each year since 1996 monitoring recommendations concerning a co-ordinated Community monitoring programme have been adopted to work towards a common strategy of control activities among Member States. The programme is designed as a rolling programme covering major pesticide/commodity combinations in 3 year cycles. Currently pesticide residues of about 85 active substances are being monitored in 27 crops38. Member States have set up national programmes in addition to the harmonised monitoring activities. The Food and Veterinary Office compiles the tables provided by Member States and summarises the overall results in the Annual Monitoring Report which is published on the website of the European Commission39.


Currently, a high number of samples is analysed in Europe. In 2005 Member States reported results for more than 62.000 samples. In total, 706 different pesticides were sought in the surveillance samples of fruit and vegetables. The methods applied by Member States covered 44 to 631 active substances40. As a rough estimation about 7.5 millions of individual data points were generated in 2005. However, the reporting format is not appropriate to use the data for detailed assessments. It is, therefore, necessary to change the structure for data collection. A database compatible with the database formats used at Member States level should be developed in close collaboration with all Member States.


The EU Member Countries generally have a nationwide surveillance programme to monitor pesticide residues in food and drink. Food samples bought by shoppers at retail and/or wholesale outlets are taken to laboratories where they are analysed. For instance, in the UK some 4000 food samples are analysed each year for a wide range of pesticides; this has produced a number of individual pesticide/food combinations of around 180,000. In addition to the dietary staples (potatoes, bread and milk), the annual surveillance programme includes a rolling programme which monitors different fruit and vegetables, cereals and cereal products, fish and fish products and products of animal origin every few years. Between 35 and 45 foodstuffs are surveyed each year depending on their dietary importance, past findings which might indicate a historical problem, intelligence from industry or monitoring schemes in other countries. In recent surveys no pesticide residues were detected in 70% of the samples, residues below the appropriate MRL were detected in almost 30% and in only 2% the statutory limits (MRLs) were exceeded. Very few of these gave rise to health concerns for the consumer. The survey results are published promptly (PSD website) and are reported to the European Commission on an annual basis as required by the European food monitoring programme.


At European level, harmonised provisions for MRLs have been progressively added to EU legislation for various pesticide/commodity combinations since 1976; currently,  some 250 pesticides are covered. The European Commission has a food standards programme to harmonise the remaining 650 pesticides which potentially could be present as residues in food (EC 2005). However, since many pesticides are no longer used in agriculture within or outside the EU, it is appropriate to set MRLs for such essentially obsolete pesticides as low as possible. Therefore, the Commission will propose that MRLs for 660 obsolete pesticides are set at the limit of determination, which is the lowest level that surveillance laboratories can achieve in monitoring analyses (0.01mg/kg). For the remaining approximately 240 pesticides, the Commission will review the temporary MRLs established nationally by the Member States and, after a comprehensive assessment of the active substances, will establish the final MRLs. In addition, the health of infants and young children are further protected by the provisions of the Baby Food Directive (European Commission 2006). This stipulates that, for practical purposes, there should be no pesticide residues in foodstuffs for particular nutritional uses intended for infants and young children and sets the level at 0.01mg/kg, again the limit of analytical determination.


Developments in analytical technology and methods have improved the analytical capability and  detection sensitivity, which has been paralleled by more demanding legislative requirements. This combination has led to an improved ability to monitor for pesticide residues in food. Chromatographic columns and detection systems have been improved; now it is possible to look for more pesticides in more samples with lower limits of detection and quantification, resulting in improved quality of pesticide residue data. In the mid-90s surveillance methods used gas liquid chromatography (GC) and were capable of detecting 30 to 40 compounds in multi-residue methods in several runs using selective detectors (e.g. fluorescence) with a reporting limit of 0.05 mg/kg. With the development of liquid chromatographyMass Spectrometry (LC-MS), currently monitoring programme now looks for over 200 compounds in two runs with a reporting limit of 0.01 mg/kg. The wider introduction of Time of Flight mass spectroscopy (TOFMS) will enable the collection of all screening data from a sample, with interpretation limited only by the data software and spectral libraries rather than by the selective limitations of the detector.


The general trend from the analytical results of surveillance laboratories over the last decade is that even though more residues are being detected, these are generally at lower levels. This reflects patterns of pesticide use and the more demanding legislative requirements regulating pesticide residues on or in food.


Regulation (EC) No 396/2005 will establish an obligatory system for the monitoring of pesticide residue levels in the EU and emphasizes the importance to carry out further work to develop a methodology to take into account the cumulative and synergistic effects of pesticides. Particularly, Chapter V (articles 26 through 34) considers the following elements: the design of the sampling system, the multi-annual Community and national control programmes, the information to be provided by the Member States and the EFSA annual report on pesticide residues.


Exposure to a mixture of compounds can result in an additive (cumulation, dose addition) effect or interaction resulting in a stronger or weaker than expected effect. Exposure to multiple residues of pesticides via food is common. However, available data indicate that the level of intake is below the reference values. Available experimental data indicate that interaction is not expected to occur at non-effective doses. Therefore, only cumulative risk assessment of compound sharing the same mode of action needs to be prioritised for discussion and assessment. A set of criteria to identify a “common mechanism group” of compounds (i.e. compounds that show dose-addition) has been put forward. Several methods have been proposed with different levels of detail and uncertainty, together with request of resources to carry out cumulative risk assessment. All have advantages and disadvantages. Cumulative risk assessments have been conducted, mainly by US EPA, but also in some European countries, on anticholinergic (organophosphorus and carbamate compounds), triazines, and chloroacetanilides. Results provide some reassurance, indicating that predicted cumulative-exposures are within acceptable levels. A number of criteria for selecting groups of compounds to be studied has been proposed. Continuous dialogue between the risk assessment community (toxicologists, expert in residues and food consumption) and risk managers is necessary to optimize the use of the scarce available resources (EFSA, 2007a).


Tin organic compounds


Tin organic compounds is one of the best known and documented examples of substances causing endocrine disruption in aquatic organisms (imposex in snails). They also have adverse effects on mammalians at low concentrations. The most sensitive parameter regarding human toxicity is the adverse effect on the immune system. The tolerable daily intake for tributyltin oxide is as low as 0. 00025 mg/kg body weight per day. The main exposure route for humans is food (especially seafood).


Naturally occurring substances


Moreover, a number of naturally-occurring toxic substances, identified in different food products, need careful attention to prevent their possible impact on consumer’s health (Table




In Europe, nitrate is consumed in the diet primarily in fruit and vegetables, but also from water and other foods. Nitrate is also formed endogenously. While it is relatively non-toxic, its metabolites nitrite, nitric oxide and n-nitroso compounds (NOCs), make nitrate of regulatory importance because of the potential detrimental effects on health. Thus, in order to protect public health, the European Commission has established maximum limits for nitrates in leafy vegetables such as spinach and lettuce. (Commission Regulation (EC) No 1881/2006). Despite the application of Good Agricultural Practice, these limits can be exceeded. EFSA was asked to perform a risk assessment to support a strategy for the management of the potential risks to human health arising from nitrate exposure. No new hazard data were found that would modify the JECFA 2002 review and derived ADI values for nitrate (0-3.7 mg/kg b.w) and nitrite (0-0.07 mg/kg b.w) (FAO/WHO, 2003). Exposure estimates were made by combining consumption with median nitrate concentrations from new analytical data for relevant vegetables. Using the WHO recommendation of 400 g fruit and vegetables/day (WHO,2003), but allocating the total intake as vegetables with at least one third consumed as leafy vegetables, nitrate exposure was just above or below the ADI for lettuce and spinach, respectively. This was considered to be an extreme case as only a minority of Europeans eat 400g vegetable/day. Additionally, nitrate may be reduced during preparation and/or cooking (EFSA, 2007b).



Table Naturally occurring, potentially harmful chemical food constituents

Source: RIVM (2006)



Category, substance


Possible health effects

(in humans, or in experimental animals)


Existing legal standard          

Exposure, possible

exceedance of standards

Possibility to influence


Remarks, sources

Normalfood constituents

Allergenic substances

Shellfish, fish, milk, nuts,

wheat etc.


Immunological: allergenic N.A.

reactions, from mild to life







Labelling, education


Taylor & Lehrer, 1996;

van Loveren, 2002; (see

textbox 4.10)



Mycotoxins: toxic substances formed by moulds on crops








Aflatoxins (B1, B2, G1, G2

and metabolite M1)


Especially on nuts, maize,

figs, when drying is

insufficient or storage

conditions too warm;

metabolite M1 in milk

via peanut chunks in

animal feed


Liver cancer (in

combination with

hepatitis) Liver

abnormalities, tumours

genotoxic carcinogen


EU standards for cereals,

Nuts (and groundnuts),

maize, spices, milk

metabolite M1);

standards for baby food

in preparation


Exposure below the

standard; the average daily

intake of aflatoxin B1 in the

Netherlands is approx.

0.03 ng/kg body weight per




Richard et al., 2003;

 Sizoo & van Egmond,

2004; WHO, 1998


Ochratoxin A


Cereals, coffee, wine,

raisins and other plant

based products, milk

and meat via animal feed




Kidney damage and

urinary tract tumours

(‘Balkan endemic


immunogenic; genotoxic




EU standards for cereals

and raisins, standards for

coffee, grape juice and

wine in preparation



Exposure well below the

human health-based limit







Richard et al., 2003;

Bakker & Pieters, 2002


Deoxynivalenol (DON)

Wheat and other cereals

Gastro-intestinal effects,

headache, dizziness;

growth retardation




Provisional EU


EU standards in



In 1999 several mg/kg

breakfast cereals.


Monitoring by VWA

and food industry


Pieters et al., 2001, 2002,

2004 (in press)



Apple and apple products

Haemorrhages, oedema,



EU standards for apple

juice/apple sauce


Exposure below the





WHO, 1996



Maize, wheat

Oestrogenic effect

In preparation

Exposure below the standard


WHO, 2001



Possible oesophageal

and liver cancer


In preparation

Exposure below the standard


WHO, 2001


Phycotoxins; toxic substances formed by algae, and which accumulate in shellfish and fish


PSP (Paralytic Shellfish





Blocks nerve conduction,

at extremely low

concentrations: tingling

sensations, respiratory

paralysis, mortality


EU regulations


Regularly in Europe,

not in Dutch fishing




Van Apeldoorn et al.,



DSP (Diarrhetic Shellfish



Shellfish, such as

mussels, oysters


Acute gastro-intestinal



EU regulations


DSP episodes occurred

several times in Europe

in recent years


Monitoring; autumn

2002 Wadden Sea

fishing grounds

temporarily closed


Van Apeldoorn et al.,



ASP (Amnesic Shellfish



Shellfish and fish

around ocean shores


Stomach cramps

disorientation, memory

loss; mortality


EU regulations


 Episode in 1987 in Canada:

3 deaths, 105 intoxications


Monitoring; 2002 catch

limits for scallops in



Van Apeldoorn et al.,



NSP (Neurotoxic Shellfish



Mainly fish, tropical and

subtropical areas


Neurotoxic effect, various






Van Apeldoorn et al.,





Shellfish, such as

mussels, oysters


Acute gastro-intestinal



EU regulations


Episode in 1995 in Ireland


Van Apeldoorn et al.,




Phytotoxins; toxic substances that are formed in plants (and toadstools)




Nightshade family:

potato, tomato, thornapple


Gastro-intestinal effects,

respiratory disorder,

coma, mortality


No standards, although

there is an admission

requirement for potatoes

on the Recommended

Varieties List.


Sporadic high exposure

Certain parts of the

potato should not be



Speijers & van Egmond,



Pyrrolizidine alkaloids

Various herbal teas

Effects in the liver,



NL; EU in preparation

Sporadic high exposure


Speijers & van Egmond,




Incorrectly prepared star

anise tea


Nausea, neurotoxicity,

epilepsy, hallucinations,

various acute symptoms


EU decision on conditions

governing use.


Episode in 2001 in the

Netherlands: star aniseed

species not intended for

consumption was

accidentally incorporated

into star anise tea.



Johanns et al., 2002


Nitrate, naturally occurring in leafy vegetables


Nitrate, the problem is the

formation of nitrite from

nitrate in the body, and the

possible formation of

nitrosamines from nitrite

and amines (fish)


Leafy vegetables


spinach, lettuce),

water; increased in both

through use of artificial



Methemoglobinemia in

infants (‘blue babies’,

especially with bottle

feeding); genotoxic




NL: certain vegetables;

EU: lettuce, spinach,

drinking water


Exposure via drinking water,

below standard; sporadic

incidents where standards

were exceeded, involving

private sources


Restrictions on the

consumption of nitrate-

drinking rich vegetables; avoid

using certain wells


WHO, 2002; Zeilmaker

et al., 2002;

Zeilmaker et al., 2004




Breast milk


The Section on “Biomonitoring” in Chapter 8.1.2. has pointed out how a number of organica xenobiotic chemicals have been detected in human milk as a result of persistant environmental contamination. These findings, however, should not be understood as an incentive not to use breast milk. On the contrary, several beneficial aspects of breast feeding justify the recommendation for exclusive breast feeding for at least four months. Solid foods should not be introduced in the diet before the fourth month for the bottle-fed babies and sixth month for the breast-fed ones.


Issues related to food safety, although largely under control, are still responsible for significant health loss in DALYs (see chapter 9.1). Control tools and policies


On January 1st, 1993, the European Common Market came into being, an area involving about 300 million consumers where goods, people, services and money are guaranteed free circulation as foreseen by the treaty of the European Union.


Since 1 January 1994, the regulations prohibiting quantity restrictions on the import of food or other products are applicable not only to the EEC Common Market, but to the entireEuropean Economic Area” which includes, besides the Member States of the EU, also Iceland and Norway.


The European Union Strategy for the implementation of the Common Market consisted in combining the adoption of rules harmonized at Community level, applicable to any product marketed within the Community, with the “subsidiaryprinciple based on the reciprocal acknowledgement of national regulations and technical specifications for issues which do not require Community legislation.


The Commission Communication 89/C271/03 on free circulation of food within the Community is useful to understand the evolution of Community Regulations. This Communication (which specifies the application range of articles 30 to 36 of the EEC Treaty in matters regarding food) establishes that, in the absence of EEC regulations, Member States are entitled to determine the rules for their own territories with regards to the production, contents, conditioning and presentation of food, in appliance with the subsidiary principle; on the other hand, they must allow food legally produced and marketed in other Member States to enter into their territory.


Barriers to the placement on the market of food legally produced and marketed in one Member State can be raised by another Member State in the absence of rules harmonized at Community level, only when the measures are such that:


·                      they are justified as necessary to respect an absolute value (i.e. public health, consumer defence, fairness in commercial operations, protection of the environment);

·                      they are in proportion with the set goal; and

·                      they are the most appropriate way to reach that goal in the presence of Community regulations, when these regulations have not been complied with.


Since public health, consumer protection, fairness of commercial operations and environment protection are areas where trade barriers are most probable, with time the Community has adopted a number of provisions harmonized at Community level. The implementation of the Common Market has caused, also for matters concerning food and drink, a remarkable acceleration in harmonization activities. Some concern horizontal dispositions (applicable to food in general) regulating in particular food additives, materials and objects that enter in contact with food, manufacturing or production processes, food labelling, presentation and packaging or food contaminants, while others concern more specific hygienic provisions for particular types of food (in particular food of animal origin such as meat and meat based products, milk and dairy products, eggs and egg products, and fish).


During the late 1990s, the European consumer was faced with a series of food crises (e.g. BSE and dioxins) that threatened public confidence in existing food legislation systems within the EU. This led the European Commission to forcefully promote food safety among its policy priorities during the following years. As stressed at the Helsinki European Council in December 1999, particular attention was to be focused on improving quality standards and reinforcing checking systems throughout the food chain, from farm to table.


EFSA is also proactive in identifying risks in the European food chain and, therefore it undertakes scientific work on its own initiative. This self-tasking is particularly relevant to fields such as emerging risks where scientific knowledge and approaches are still evolving. Within this framework, EFSA has addressed a series of new methodological approaches to improve risk assessment in specific areas, for which the main subjects are:


Qualified presumption of safety (QPS) of microorganism



The QPS approach is a system similar in concept and purpose to the GRAS (Generally Recognised As Safe) definition used in the USA, but modified to take into account the different regulatory practices in Europe. It represents a possible route towards the harmonisation of approaches for the safety assessment of micro-organisms used in feed/food production across the EFSA Panels and should ensure a better use of assessment resources by focusing on those organisms which represent the greatest risks or uncertainties. If introduced into Europe, QPS will permit the identification of what is required to make an adequate safety assessment. QPS is suggested as an operating tool within EFSA for safety assessment and priority setting (EFSA, 2005).


Safety assessment of compounds that are both genotoxic and carcinogenic


The EFSA provided a summary review of the biological processes leading to cancer and the problems of extrapolation of cancer dose-response data. EFSA then discussed the data requirements for the derivation of a Margin of Exposure (MOE), i.e. the point selected on the dose-response curve and the measure(s) of intakes that would be most suitable for the formulation of advice to risk managers. The Opinion adopted then provided guidance on the interpretation of the calculated MOE and the sources of uncertainly and variability that could influence the perceptions of the magnitude of the estimated figure. The Opinion gave basic guidance on how the MOE should be calculated, and advice on the magnitude of a value that would indicate a low concern from a public health point of view and that might be considered a low priority for risk management actions. (EFSA/WHO, 2006).


Methodologies and principles for setting tolerable intake levels for dioxins, furans and dioxin-like PCBs


There is general consensus on the science of dioxin toxicology, with respect to the state of knowledge and research needs. Differences in risk assessments and extrapolation from effects in the observable high dose range to background dietary exposure relate to the uncertainties regarding the interpretation of the available data. Research should focus on further reducing these uncertainties. There is currently less convincing evidence to support adding potencies across different classes of contaminants with different mode of actions, even when dealing with similar toxicological endpoints. However, there is a need for further consideration of additive response including criteria to be defined when the approach could be valid. Further research is needed to support a harmonized approach for the issue of dioxin carcinogenicity. (EFSA, 2004).


Principles of risk assessment of food producing animals


The hazard of interest is identified, the nature of the unwanted consequences (adverse events) is described, including temporal and spatial aspects, and potential control measures are identified at the initial stage of the risk assessment. This information is used to develop a risk profile. A risk profile also includes the risk question, the current understanding of the infection and disease, and realistic management. There is a need for risk managers to provide input into this process to make sure that the risk question is interpreted in the same way by all parties right from the start. With increasing levels of imports into the EU, it is important to consider the food chain globally, rather than at local level alone(EFSA, 2006c).


Fitness for purpose should be taken into consideration throughout all the risk assessment process. This affects decisions on:


·         The choice of qualitative and/or quantitative approaches, which should be based on their usefulness for the specific assessment;

·         The rationale for using a farm-to-fork or any other approach; and

·         The availability of resources devoted to the project.



Validation of results represents an integral part of risk assessment. While highly desirable, validation may be difficult or, in case of rare events, impossible to carry out. Statistical methods to validate results have been proposed. Moreover, experimental or epidemiological data, not available at the time the risk assessment model was developed, may be used (EFSA, 2006c).


Plant protection products (PPR)


Consumer risk assessment of pesticides residues


EFSA is possibly involved in the development and application of a model to calculate the expected short term and long term intake of pesticide residues via food, considering the different food consumption habits in Europe(EFSA PRIMO). To this end, consumption data from 14 MS, 41 diet sets for different groups of population and short term and long term consumption data have been utilized.


Two opinions have been published by the PPR Panel ( on the importance of acute dietary risk assessment of pesticide residues on food for the consumer. This is a principal factor used by the Member States and the European Commission to set EU-wide Maximum Residue Levels (MRLs), the highest concentrations of pesticide residues legally allowed in foods. The measure of acute dietary exposure that is used in MRL-setting is the International Estimate of Short Term Intake (IESTI). The IESTI is calculated using one of four standard equations, depending on the type of commodity involved. A MRL above the limit of detection is set for a commodity only if its IESTI does not exceed the Acute Reference Dose (ARfD) of the pesticide concerned. In order to establish international discussions about whether to change the way that IESTI equations are calculated, the Commission asked EFSA (the PPR Panel) for advice on how conservative the equation is in relation to the protection of the European consumer from intakes above the ARfD and how this might change if the IESTI was calculated differently. Working with a large team of experts from all Member States, using data on food consumption, body weight and residues to analyse a range of scenarios for different countries, age groups and pesticides, the PPR Panel estimated that in all scenarios over 99% of each national population is within safe levels and in most cases over 99.9%. The results suggest that the IESTI equation is a good tool to assess the safety of individual consumers exposed to maximum legal residue levels through foods, as originally intended, while the equation would need to be modified on the basis of substantial research to reliably assess the level of protection for the entire European population. Risk managers will now decide on any possible changes to the IESTI calculation as a basis for estimating acute exposure to pesticide residues.

While, according to old MRL legislation (Dir. 76/895/EEC, 86/363/EEC and 90/643/EEC), harmonized MRLs, national MRLs and no specific MRLs were established for about 250, 300 and 650 active substances, the situation is going to radically change with the implementation of Regulation 396/2005 (Figure 1).


Figure Entry into force of Reg. 396/2005





Regulation 396/2005 establishes:


·          Harmonised MRLs for all active substances;

·          Review programme for all MRLs

·          Monitoring of pesticides residues

·          Definition of the role of EFSA in the MRLs setting procedure


Under Regulation 396/2005:

·          Annex II deals with MRLs established under old MRLs legislation (about 250 substance);

·          Annex III deals with temporary MRLs derived from national MRLs (about 250 substance);

·          ANNEXIV deals with active substances for which no MRLs are necessary(rather minor number of substances);

·          A default MRL of 0,01 mg/kg applies to all active substances not explicitly mentioned(a very large number of substances).


EFSA tasks under Regulation 396/2005 include:

·          EFSA to provide risk assessment for all active substances for which temporary MRLs were proposedArticle 24;

·          assessment of existing MRLsArticle 12;

·          MRLs for all active substances included in Annex I of Dir. 91/414 before 01/09/2008 to be assessed within one year (Deadline: 01/09/2008). About 170 active substances to be assessed;

·          each active substance included or not included in Annex I of Dir 91/414 after 01/09/2008 to be assessed individually. (Deadline:1 year following the inclusion or non-inclusion);

·          reasoned opinion as indicated above;

·          assessment of MRLs applications for setting, modifying or deleting MRLs; for inclusion of active substances in Annex IV to the Regulation, submitted by the Evaluating Member State (EMS in not necessarily RMS); and based on the Evaluation Report (ER) of the EMS. – Articles 10 & 11;

·          database of the Authority on MRLs, including all relevant scientific information relating to the MRLs set out in regulation 396/2005; food Agricultural Practises (GAPs) relating to the MRLs set out in annex VI and processing factors set out in Annex VII; dietary intake assessment and toxicological reference values. – Article 41;

·          annual Monitoring Report, accessible to the public and summarizing the results of the control activities on about 80.000 samples and 190 active substances for assessing the actual exposures of European consumes Article 32 ;

·          peer review of active substances.


Within the framework of the EFSA peer review for the risk assessment on plant protection products carried out by Member State Authorities, the applicant must provide data on:


·          physical-chemical properties/analytical methods;

·          mammalian toxicology;

·          food and Feed residues, MRL;

·          environmental fate and behaviour; and

·          ecotoxicology


and provide risk assessment for:

·          those who apply the pesticide as well as agricultural workers and bystanders;

·          consumers from consumption of residue in treated food and residues in drinking water derived from groundwater;

·          terrestrial and aquatic wildlife and the microbialfunction” of soil; and

·          the potential for the contamination of groundwater above parametric drinking water standards (legal levels set in the EU legislation).


The work is, then, shared at EU level as follows, according to a tiered approach of evaluation of the active substances:


·          first: a designated rapporteur Member States (RMS) evaluates dossier and provides an initial report: draft assessment report (DAR)

·          second: EFSA (PRAPeR) peer reviews the DAR at EU level with all MS, applicant(s) and public EFSA conclusion; and

·          third: risk managers take decision (SCPHAW).


Pesticides peer review phases are as indicated here below:

·          phase to address the remaining (usually most contentious) issues;

·          joint peer review of the risk assessment by EFSA. This cornerstone of the peer review occurs thorugh the meetings of experts (PRAPeR expert meetings)


Between April 2004 and April 2008, 08PPAPeR expert meetingscovering the 5 areas of the data requirements were held in 16rounds” (Figure



Figure Pesticides Peer reviewstatus: evaluation of active substances.


The immediate tasks for April 2008-September 2008 include:

·          delivering conclusions on 37 active substances from list 3 to the Commission and their relevant publication;

·          delivering conclusions on 11 active substances from list 4 to the Commission and their relevant publication.


The main goals of PRAPeR peer review in the future include:

·          the promotion of consistency and technical quality in risk assessment in order to ensure that the risk assessment is maintained as a transparent sound scientific process separated from risk management;

·          the implementation of a new guidance document on risk assessment developed by the PPR panel

·          introduction of the new regulation (when finalised) on the authorisation of plant protection products;

·          reassessment of substances included in annex 1 following a period of 10 years of inclusion; and

·          dealing with the accelerated assessment procedure introduced by the Commission for substances withdrawn by applicants and not included with associated complications regarding the tasks EFSA has relating to MRLs.


Panel on Plant Protection Products and their Residues (PPR)


The Mandate of the PPR Panel (Art 22.6 of EFSA Regulation 178/2000):

·          provides independent scientific opinions and guidance for the Community’s legislation in the field of plant protection products (Directive 91/414 EEC);

·          deals with scientific questions related to the risk assessment of plant protection products in relation to the user/worker, the fate of treated products and the enviroment.


The main fields of scientific activities are:

·          Providing scientific opinions on generic opinions, on generic issues regarding pesticide risk assessment or on specific active substances based on questions from the European Commission, EFSA’s PRAPeR unit (self-tasking), the European Parliament or from Member States:

-          36 opinions have been adopted since 2003.

-          2 more by summer 2008.


·          Updating existing and developing new Guidance Documents on pesticides risk assessment: promoting new and harmonized scientific approaches and methodologies: 6 GDs are currently under preparation

·          Toxicology:GD on Pesticides Exposure Assessment for Workers, Operators, Bystranders and residents: works started (9 months contract ongoing funded by grants under Article 36 of the regulation EC 178/2002)

·          Toxcology/Residues: GD on the relevance of pesticide metabolites in food commodities (Art. 36 call in preparation)

·          Fate: GD on emissions from greenhouse, protected cultivations and covered crops


 The PPR Panel has also been asked to :

·          Develop an inventory of

-          protected crop systems

-          emissions from these systems to relevant environmental compartments

·          To provide guidance

-          On the importance of emission routes

-          Including the circumstance under which they are relevant

Priorities in ecotoxicology include:

·          Opinion on GD on the risk assessment for birds and mammals (second public consultation closed 27 January).


Adoption expected in June 2008

·          Updating the terrestrial ecotoxicology GD in autumn 2008 and the aquatic ecotoxicology GD in 2009

·          Updating of the GD on persistence in soil (European Community, 1997) is ongoing; the first public consultation closed on 25th March.


·          Fate of pesticides (in soil organisms), ( 2 WGs are working in parallel).


Within the framework of the Directive 91/414/EEC, methodologies and approaches are required to carry out appropriate exposure assessments and evaluate the risks involved in the use of pesticides. To further develop environmental risk assessments, the FOCUS (FOrum for the Coordination of pesticide fate models and their USe) was established under the auspices of DG SANCO. Its aim was to develop standardised methods for the evaluation of different aspects concerning risk assessment of pesticides with regard to ground water, surface water, degradation kinetics, air, etc.

The PPR Panel has now published five opinions on the final guidance documents of different FOCUS Working Groups. These cover the comparability of the FOCUS groundwater models and their consistency in the risk assessment for groundwater contamination; the FOCUS surface water scenarios; the FOCUS estimation of persistence and degradation kinetics of pesticides in soil; FOCUS landscape and mitigation factors in ecological risk assessment; and FOCUS guidance on the movement of pesticides in air and exposure assessment.


European consultations are currently under way to revise the Plant Protection Products Directive (91/414/EEC). EFSA was asked by the Commission to review the latest draft Annexes II and III which specify the data required to assess the safety of an active substance and its products. Six expert working groups of the PPR Panel considered the revised Annexes which had been prepared by a reporting Member State including extensive consultation around Europe. The PPR Panel has published six separate opinions on physical and chemical properties, analytical methods, residues, toxicological and metabolism studies, fate and behaviour in the environment and ecotoxicological studies which are now being the subject of further consideration by the Member States and the Commission.


EU-level guidance on conducting risk assessments on pesticides has historically been the responsibility of the European Commission and DG SANCO and also includes the production, revision and updating of the approximately 20 guidance documents in this pesticide area. This guidance is used by the Member States when carrying out safety evaluations and for notifying companies applying for market authorisations under 91/414/EEC. However, in 2006 this responsibility passed on to EFSA and the PPR Panel started a rolling work programme to revise existing or produce new guidance documents, the priority of which was agreed upon within the Member States. The first is a major revision of the Guidance Document on Risk Assessment for Birds and Mammals (SANCO 2000), which the Panel is carrying out using public consultation on the website and involving experts from both Member States and industry. The final draft should go for public consultation on the website by the end of 2007, before final adoption by the Panel in early 2008.


EFSA organises scientific colloquia aimed at achieving a better understanding of some of the fundamental scientific issues related to risk assessment on food and feed. In November 2006, the 7th colloquium was held in Parma to discuss the Cumulative Risk Assessment (CRA) of Pesticides to Human Health. During this well-attended international meeting, an greement was reached on the importance to get started with CRA using a stepwise approach. Substances that share a common mode of action (dose-addition), for which data are already available in the US, will be the first priority. Pesticides that were prioritised for work on CRA (dose-addition) are: oligophosphates, carbamates, conazoles, pyrethroids, dicarboxyamides, phalimide, spindle inhibitors, and dithiocarbamates. Whilst methodologies haver not yet been defined and may vary regarding compound and type of exposure (acute, chronic), guidelines will be needed eventually for probabilistic modelling and cumulative exposure assessment. Cooperation between the Member States, other bodies and EFSA will be needed to establish these guidelines.


Botanicals and botanical preparations intended for use as ingredients in food supplements.


A guidance document, endorsed by the EFSA’s Scientific Committee to assess safety of botanical preparations intends for use as ingredients in food supplements, is currently under testing within the framework of an ESCO cooperation project.

A general framework for safety assessment was advocated, in which botanicals or botanical preparations for which there is a suitable body of knowledge could benefit from a “presumption of safety” without any need for further testing. Issues that should be carefully considered in order to reach such a conclusion are discussed in detail in the present guidance document. Botanicals and botanical preparations for which a presumption of safety is not possible would be subject to a more extensive safety assessment using the methodology further developed in the present document.


Safety of meat and milk from cattle and pig clones and their offspring.


The yield of animal cloning by somatic cell nuclear transfer (SCNT) is low. This is due to incomplete or inappropriate genome reprogramming leading to more frequent altered development and abnormalities at birth. Although cloning has a major impact on clones health and welfare, the criteria currently used to evaluate the animals to be slaughtered after six months of age cannot make a distinction between healthy clones and normal animals. Although more data would be desirable to make the safety assessment, available scientific papers do not indicate any significant difference between healthy clones and normal animals with respect to meat and milk composition, toxicity and allergenicity. It should also be considered that sexual reproduction of clones gives birth to animals not different from controls. This is attributed to the fact that sexual reproduction includes a highly efficient reprogramming of genomes.


GMOs and novel foods


Novel foods are foods and food ingredients that have not been used for human consumption to a significant degree within the Community before 15 May 1997. Regulation EC 258/97 of 27 January 1997 of the European Parliament and the Council (3) lays out detailed rules for the authorisation of novel foods and novel food ingredients.


Foods commercialised in at least one Member State before the entry into force of the Regulation on Novel Foods on 15 May 1997, are on the EU market under the “principle of mutual recognition”. In order to ensure the highest level of protection of human health, novel foods must undergo a safety assessment before being placed on the EU market. Only those products considered to be safe for human consumption are authorised for marketing.


Novel foods or novel food ingredients may follow a simplified procedure, only requiring notifications from the company, when they are considered by a national food assessment body as “substantially equivalent” to existing foods or food ingredients (as regards their composition, nutritional value, metabolism, intended use and the level of unwanted substances contained therein).


Modern biotechnology has many applications in the pharmaceutical and agri-food industries. One example is the use of GMOs in the food production chain. GMOs are organisms such as plants, animals and microorganisms (bacteria, viruses, etc.), the genetic characteristics of which have been artificially modified to give them a new property (a plant’s resistance to a disease or insect, improvement of a food’s quality or nutritional value, increased crop productivity, herbicide tolerance etc.). In order to ensure that this development of modern biotechnology, and more specifically of GMOs, takes place in complete safety, the European Union has established a legal framework comprising various acts:


·                      The contained use of genetically modified microorganism, e.g. laboratory research (in a confined environment), is regulated by Directive 90/219/EC (4) on the contained use of genetically modified microorganisms;

·                      The experimental release of GMOs into the environment, in other words the introduction of GMOs into the environment for experimental purposes (e.g. for field testing), is governed by Directive 2001/18/EC (5) on the deliberate release into the environment of genetically modified organisms (mainly Part B thereof);

·                      The placing on the market of GMOs (products containing or consisting of GMOs), e.g. for cultivation, import or processing into industrial products, is subject to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (mainly Part C thereof);

·                      The placing on the market of food or feed products containing, consisting of or produced from GMOs is governed by Regulation (EC) 1829/2003 on genetically modified food and feed (6). Where a food product contains or consists of GMOs, the applicant has a choice: either the application as a whole is subject solely to Regulation (EC) 1829/2003, or the application is subject to both Regulation (EC) 1829/2003 and Directive 2001/18/EC on the deliberate release of a GMO into the environment;

·                      Unintentional movements of GMOs between Member States and exports of GMOs to third countries are governed by Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms (7).


GMOs and food products derived from GMOs placed on the market must also comply with labelling and traceability requirements. These requirements are found in Regulation (EC) 1829/2003 and in Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (8).


Guidelines for risk-benefit analysis and emerging risks


In addition to the many developments in risk assessment, EFSA has also undertaken a process to establish guidelines for “Risk-benefit analysis of foods” and for “the identification of “emerging risks


Risk-benefit analysis


The risk assessment of chemicals in food is a purely scientific process consisting of the following steps:


·                      The hazard identification describes the adverse effects of the substance;

·                      the hazard characterization describes and evaluates doseresponse relationships for the most sensitive adverse health effects reported in the available studies;

·                      the third step is the exposure assessment. Here, the intake of the compound from food is estimated; and

·                      finally, the risk characterization combines the hazard characterization and the exposure assessment and evaluates the qualitative and quantitative probability for a health risk in a given population as well as the seriousness of any health risk.


No such internationally agreed scientific approach is available for health benefit assessments of foods, food ingredients and nutrients. The need for direct evidence of benefit to humans (based on human data, primarily from intervention studies) in circumstances consistent with the likely use of the food is recognized as well as the usefulness of markers of proven validity intermediate effects when ideal endpoints are not accessible to measurements. An ad hoc scientific Colloquium on this subject was organized by EFSA. There was general consensus that a risk-benefit analysis should mirror the paradigm already well established for risk analysis, consisting of a risk-benefit assessment part, a risk-benefit management part, and a risk-benefit communication part. Consequently, the benefit assessment part of the risk-benefit assessment should include benefit identification, benefit characterisation (dose-response assessment), exposure assessment, and (probability for) benefit characterisation. In addition, the risk-benefit analysis should contain a means( possibly a quantitative one) to compare/weigh the potential risk against the potential benefit (a risk-benefit comparison).


The decision to initiate a risk-benefit analysis should be made on a case-by-case basis and, given the resources required to carry out such an analysis, should only be undertaken when clearly justified, such as for a food item (e.g. fish) containing useful nutrients with at the same time an undesirable contaminant The meeting stressed that problem formulation (“why is the risk-benefit analysis being done, why do we need it?”) is pivotal, and that the question asked by the risk-benefit manager to the risk-benefit assessor should be clearly understandable. For example, it should be made clear whether the health risk-benefit assessment is related to acute, short-term or long-term exposure, and whether only certain population groups, e.g. vulnerable groups, should be considered. For these reasons each risk-benefit analysis needs a narrative up-front to describe precisely both the risk(s) and the benefit(s) to be assessed and to formulate clearly the task, its scope and its intention, in order to ensure transparency.


It was also emphasized that, in order to provide confidence in the outcome of a risk-benefit analysis, the assumptions made for the assessment and analysis as well as the uncertainties in the outcome should be made very clear. The meeting considered that, provided the issues above were taken into account, risk-benefit analysis could improve risk communication to the consumer. There was, however, some debate about whether the termrisk-benefit analysis” was the appropriate terminology, as the process involves the weighing of the likelihood and severity of a hazard against the likelihood and magnitude of a benefit, and unless "benefit" includes considerations of probability as "risk" does, terminology such as hazard-benefit analysis or risk-chance [for benefit] analysis for benefit may be more appropriate. (EFSA, 2006 b)


Emerging risk


With regard to Article 23f and 34 of Regulation (EC) 178/2002, an emerging risk to human, animal and/or plant health is understood as a risk resulting from a newly identified hazard to which a significant exposure may occur, from an unexpected new or increased significant exposure and/or susceptibility to a known hazard

An assessment of an emerging risk is characterized by the early detection of facts related to the risk derived either from research and/or from monitoring programs or episodic observation. Assessment of emerging risks is distinct from the assessment of risks under emergency (or crisis) conditions, as the latter are dealt with through established Commission procedures.41

A procedure for emerging risks identification is being worked out by EFSA and in European Commission, considering that emerging risks are of interest, not only of EFSA, but also of other European Agencies(e.g. ECDL and EEA). A scientific Committee has undertaken a coordination activity to harmonize the outcome.


Risk communication


The second major component of EFSA’s mandate is risk communication regarding risks associated with the entire food chain based on the most current, independent scientific advice. By communicating on the improving food safety in Europe and building public confidence in the risks in a open and transparent manner, EFSA contributes to improving food safety in Europe and in building public confidence in the way risk is assessed. EFSA uses a variety of communication tools including its corporate website, webcasting, participation in events and conference , as well as a range of print publications and information materials, press events and information for the media such as press releases and news alerts.


EFSA raises awareness of food safety and explains the implications of assessments from its scientific panels by:


·          analysing the public perception of risks linked to food;

·          explaining and contextualising risk;

·          working with key actors including national authorities, stakeholders and media to tailor messages to the needs of different audience;

·          ensuring consistency by coordinating communications with other risk assessment bodies and risk managers such as the European Commission and EU Member States; and

·          using a wide range of on- and off-line communication tools.


EFSA coordinates with and takes advice from the heads of communications of national food safety authorities via the Advisory Forum Communications Working Group and has also established a multi-disciplinary expert Advisory Group on Risk Communications, which reports to the Executive Director.




Inspections are the main means by which the Food Veterinary Office (FVO), a Commission service based in Ireland, performs its role (Figure 1). FVO inspectors carry out inspections in Member States, Accession Countries, Candidate Countries and other third countries. These inspections are primarily aimed at verifying the effectiveness of national control systems for enforcing Community legislation in the fields of food safety, animal health and welfare and plant health. Each year a programme of FVO inspections is developed, identifying priority areas and countries for inspection. In order to ensure that the programme remains up to date and relevant, it is reviewed every six months.


The findings and conclusions of the inspections are presented in reports that are, in general, made public on the Directorate-General’s website. These reports include recommendations to the country’s competent authority to deal with any shortcomings revealed during the inspections. The competent authority is requested to present an action plan to the FVO on how it intends to address the recommendations.


Together with other Commission services, the FVO evaluates the action plan and monitors its implementation. Where an inspection identifies an immediate threat to consumer, animal or plant health, the Commission may take emergency or safeguard measures. Where serious, but less urgent problems are found or where a competent authority fails to take satisfactory corrective action, the Commission may use the inspection report as one element in deciding to start infringement proceedings against a Member State or, in the case of a third country, to refuse, withdraw or modify authorisations for exports into the EU.


Table FVO Inspection Objectives in 2006


In the past, Member Sates adopted national measures for governing food safety. The Community’s obligation to ensure the highest level of consumer protection and the necessity of free movement of food within the internal market made it essential for Member States to adopt principles and procedures governing food and feed at Community level. Today, national law governing the safety of the food chain is almost entirely based on the GFL, comprising a set of rules to ensure that this objective is attained and extending these rules to the production and the placing on the market of both feed and food.


Chapter II of the Regulation seeks to harmonise at Community level general food law principles (Articles 5 to 10) and requirements (Article 14 to 21), already existing in many Member Stateslegal history, by placing them in the European context and providing the basic framework of definitions, principles and requirements for future European food law. In particular, Article 17 of the Regulation defines the roles of competent Member States authorities and of the food and feed chain operators.


Given that a food business operator is best placed to devise a safe system for supplying food/feed and ensuring that this is safe, primary legal responsibility for ensuring compliance with food law and in particular food safety falls on the operators. Food business operators have therefore an obligation according to which they must actively participate in implementing EU food law requirements by verifying that such requirements are met. Member States are prohibited from maintaining or adopting nationally legal provisions which would exonerate any food business operator from this obligation.


Article 17 also establishes the roles for the competent Authorities in the European Member States in enforcing food law, monitoring and verifying that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution stages of the food chain.


Thus, the individual Member States have the central role in maintaining a system of official controls and other activities, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution. Member States shall also lay down the rules on measures and penalties applicable to the infringements of food and feed law.


The application in all Member States and all areas of food law of the General Food Law will consolidate the safety requirement and eliminate disparities resulting in barriers to trade and competitive distortion between food business operators.


Official controls


Member States are responsible for organising Official controls in order to enforce EU food and feed law as well as monitor and verify that the requirements of the legislation are fulfilled at all stages of production, processing and distribution.


On the 29th April 2004, Regulation EC 882/2004 on Official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (15) was adopted by the European Parliament and the Council. Veterinary checks in intra-Community trade (Council Directive N. 89/662/EEC (16)) and on products entering the EU from third countries (Council Directive N. 97/78/EC (17)) remain however in place since they are specifically designed for the organisation of the controls on feed and food of animal origin.


The objective of this Regulation is to ensure that a harmonised approach with regard to official controls is achieved throughout all Member States, and that Member States ensure from their side that official controls are carried out regularly, with a control frequency based on risk in order to achieve the objectives of the regulation.


Impartiality and effectiveness must be guaranteed by National competent authorities when performing official controls through respecting a number of operational criteria. They should have a sufficient number of suitably qualified and experienced staff and possess adequate facilities and equipment to carry out their duties properly.


Moreover, official controls should be carried out using appropriate techniques developed for this purpose, including routine surveillance checks and more intensive controls such as inspections, verifications, audits, sampling and testing of samples. Training of the staff performing controls is also a key tool in the harmonisation between Community and national control systems.


Member States should apply official control with the same care to exports outside the Community, to the placing on the market within the community and to the introduction from third countries as support of the harmonised import procedures that have already been established for food of animal origin.


In order to have a global and uniform approach with regard to official controls throughout Europe, Member States are in charge of both establishing and implementing multi-annual national control plans in accordance with the broad guidelines drawn up at Community level. These guidelines should promote coherent national strategies, identify risk-based priorities and the most effective control procedures. A Community strategy should take a comprehensive, integrated approach to the operation of controls.


Member States are also required to present an annual report to the Commission with information on the implementation of the multi-annual national control plans. This report should provide the results of the official controls and audits carried out during the previous year. Both the multi-annual nationals control plans and the annual report are shared with the FVO.


The designation of the competent authorities responsible for food safety and the official controls thereof are also responsibility of the Member States. The competent authorities shall ensure: (a) the effectiveness and appropriateness of official controls; (b) that staff carrying out official controls are free from any conflict of interest; (c) that adequate laboratory capacity for testing and a sufficient number of suitably qualified and experienced staff are present; (d) that they have appropriate and properly maintained facilities and equipment; (e) that they have the legal powers to carry out official controls and to take the measures provided for in this Regulation; (f) that they have contingency plans in place, and are prepared to operate such plans in case of an emergency; (g) that the feed and food business operators are obliged to undergo any inspection carried out in accordance with this Regulation and to assist the competent authority’s staff during the accomplishment of their tasks.


The competent authorities reported below have been designated by the 27 European Member States.


Table Food safety competent authorities in the 27 EU Member States and Norway (Source: EFSA, data for Norway communicated by Norwegian EUGLOREH partner)


Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH


Agence fédérale pour la sécurité de la chaine alimentaire AFSSA


Ministry of Agriculture and Forestry


Státní zemìdìlské a potravináøské inspekce

Czech Republic

Υπουργείου Υγείας της Κυπριακής Δημοκρατίας


Fødevarinstituttet Veterinaerinstituttet


Veterinaar-ja Toiduamet


Elintarviketurvallisuusvirasto EVIRA


Agence française de sécurité sanitaire des aliments


Bundesinstitut für Risikobewertung  BfR




Magyar Élelmiszer-biztonsági Hivatal


Ministero della Salute


Pārtikas un veterinārais dienests


Valstybineë maisto ir veterinarijos tarnyba


Sécurité Alimentaire Grand Duché du Luxembourg


Food Safety Commission


Główny Inspektorat Sanitarny


Autoridade de Segurança Alimentar e Económica


The Food Safety Authority of Ireland

Republic of Ireland

Autoritatea Nationala Sanitar-Veterinara si pentru  Siguranta Alimentelor


Štátna veterinárna a potravinová správa


Direktorat za varno hrano


Agencia Española de Seguridad Alimentaria y nutricion




Voedsel en Waren Autoriteit

The Netherlands

Food Standards Agency

United Kingdom

MattilsynetNorwegian Food Safety Authority





The Member Statescompetent authorities have another primary role in the registration or approval of certain feed and food businesses required by Community feed and food law. This is particularly the case for Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin, and Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector.


Crisis management: contingency plans for feed and food


Regulation (EC) No 178/2002 also specifies in Article 55 the requirement of the implementation of a general plan for crisis management in close cooperation with the Authority and the Member States. Member States are thus required to draw up operational contingency plans setting out measures to be immediately implemented when feed or food is found to pose a serious risk to humans or animals either directly or through the environment. These contingency plans shall specify: (a) the administrative authorities to be engaged; (b) their powers and responsibilities; and (c) the channels and procedures for sharing information between the relevant parties. Future developments


While old adversaries such as Salmonella and BSE will continue to make demands on food safety practitioners, new challenges associated to technological advances, increasing globalization of food trade and even climate change will have to be faced. Bluetongue – a vector-borne viral disease of domestic and wild ruminants – has been recently confirmed in Northern Europe, leading to speculation that climate change has enabled the establishment of the virus. Nanotechnology, while not new per se, has an increasing number of applications in food technology and the risk assessment of novel nanoparticles requires further attention.


The food safety landscape is constantly evolving; one of the challenges facing European authorities is to identify and prevent future threats to the food supply. New technologies, and the relentless evolution of scientific knowledge, constantly push the frontiers of knowledge and oblige implications for the safety of food supply. Added to this, the sustainability of our food production systems, the effects of increasing trade globalisation and the threat represented by climate change must all be addressed. References


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27 Method validation and quality control procedures for pesticide residues analysis in food and feed, Document No SANCO/2007/3131,31/10/2007.

28 Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods for sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p 30)

29 Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council decision 90/424/EEC and repealing Council Directive 92/117/EEC(OJ L 325,12.12.2003 p. 31)

30 OJ 121, 29.7.1964, p.1977

31 OJ L 224, 18.8.1990, p.19

32 OJ 186, 30.6.1989, p.23

33 Decision No 2119/98/EC of the European Parliament and of the Council setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (OJ L 268, 3.10.1998,p.1)

34 In August 2006 the European Commission set targets for Member States to meet in reducing the presence of Salmonella in poultry, and proposed trade bans on eggs from flocks with persistently high levels of the pathogen. Every Member State will have to work towards reducing the number of laying hens infected with Salmonella by a specific minimum percentage each year, in order to ultimately achieve a reduction in Salmonella levels to 2% or less. Salmonella is present on average in one in 10 pigs bred for human consumption. In 2006-2007, levels for the full range of Salmonella types detected in pigs varied from 0% to 29% between EU Member States

35 Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels of pesticides residues in and on cereals (OJ L 221, 7.8.1986, p 37).

36 Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels of pesticides residues in and on foodstuffs of animal origin (OJ L 221, 7.8.1986, p 43).

37 Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels of pesticides residues in and on certain products of plant origin, including fruit and vegetables (OJ L 350,14.12.1986, p 71).

38 Commission of the European Communities: Monitoring of Pesticide Residues in Products of Plant Origin in the European Union, Norway, Iceland and Liechtenstein, 2005.

39 http//

40 Commission f the European Communities:Monitoring of Pesticides Residues in Products of Plant Origin in the European Union, Norway,Iceland and Liechtenstein, 2005.


41 Commission Decision 2004/478EC concerning the adoption of a general plain for food/feed crisis management. Official Journal of the European Union l 160/98