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

 

Acronyms

 

ARD	Acute Reference Dose
BSE	Bovine Spongiform Encephalopathy
CRA	Cumulative Risk Assessment
EFSA	European Food Safety Authority
EU-RAIN	European Union Risk Analysis Information Network
FAO	Food and Agriculture Organization
GFK	General Food Law
GHP	Good Hygiene Practice
GMO	Genetically Modified Organism
GMP	Good Manufacturing Practice
HACCP	Hazard Analysis Critical Control Point
IESTI	International Estimate of Short Term Intake
MOE	Margin of Exposure
MRLs	Maximum Residue Limits
MS	Mass Spectrometry
OECD	Organisation for Economic Co-operation and Development
OIE	World Organisation for Animal Health
PAA	Primary Aromatic Amines
PFCs	Perfluorinated Organic Compounds
Pfos	Perfluorooctanesulfonic Acid
PPR	Plant protection products
QPS	Qualified presumption of safety
RASFF	Rapid Alert System for Food and Feed
SCNT	Somatic Cell Nuclear Transfer
TOFMS	Time of Flight mass spectroscopy
TSE	Transmissible Spongiform Encephalopathies
VTEC	Verotoxigenic Escherichia coli
WHO	World Health Organisation

 

10.4.2.1. 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 harmonises 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 risk – carried 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.

 

10.4.2.2. Data sources

 

The Rapid Alert System for Food and Feed (http://ec.europa.eu/food/food/rapidalert/index_en.htm) 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 (www.eu-rain.com) 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: http://europa.eu. 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 heading “Alert messages”. Immediate notifications and follow-up reports are published under the heading “Disease information”.

 

An electronic distribution list called “OIE-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: http://www.oie.int/wahid. 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 entitled “World 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”.

 

10.4.2.3. 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.

 

Biohazards

 

Many biological hazards can be present in food (Table 10.4.2.1), in particular of animal origin, mainly associated with zoonoses (Table 10.4.2.2). In humans, the severity of these diseases can vary from mild symptoms to life threatening conditions (Table 10.4.2.3 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 10.4.2.1. Association of pathogenic (micro-) organisms with various types of food

Source: RIVM (2006)

 

Organism	Starch containing products	Fruit and vegetables	Meat and meat products	Dairy products	Fish and shellfish
Bacteria - infectious
Aeromonas spp.					X
Arcobacter spp.			Cattle, Pig, Chicken
Brucella melitensis/ abortion/suis				X
Campylobacter spp			Chicken,            cattle, pigs, sheep	Untreated milk
Coxiella burnettii
Enterobacter sakazakii				Baby milk powder
Escherichia coli Shiga-toxin producing			Cattle	Untreated milk
Francisella tularensis
Listeria monocytogenes			Meat products	Soft cheese	Smoked fish
Mycobacterium avium ssp. avium			Pig
Mycobacterium bovis			Cattle	Untreated milk
Mycobacterium avium ssp. paratuberculosis			Cattle	Milk
Salmonella (para)typh
Salmonella spp.– other		Sprouting Chicken, pig, vegetables cattle, egg
Shigella spp
Vibrio cholera
Vibrio – marine species					X
Yersinia enterocolotica			Pig
Bacteria – toxin producing
Bacillus cereus	Rice, pasta	Spices
Clostridium botulinum	Potatoes	X	X		X
Clostridium perfringens			Cattle, pig, chicken
Staphylococcus aureus				Cheese, pastries	Shrimps
Viruses
Adenovirus
Astrovirus
Enteroviruses
Hepatitis A virus					Shellfish
Hepatitis E virus			Pig

 

Table 10.4.2.2. Zoonotic diseases and food-born outbreaks in the EU

 

Disease/micro-organism	Occurrence	Trend	Main human exposure route
Campylobacteriosis	51.6 per 100 000	Increasing (7.8% in 2005)	Poultry meat and contaminated drinking water
Salmonellosis	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	Growing
Verotoxigenic Escherichia coli and Yersinosis	Considerable	Unclear	Unclear
Listeriosis	Rare, but severe consequences	Growing	Ready-to-eat foods
Food-born viruses (e.g. Caliciviruses)	Most important cause of food-born outbreaks	Growing	Fruit and vegetables Contaminated drinking water
Trichinellosis and Echinococcosis	Low, but severe consequences		Wildilife
Source: EFSA

 

 

Table 10.4.2.3. Disease symptoms associated with pathogenic (micro-) organisms in food

Source: RIVM (2006)

 

Severity of the disease symptoms
Organism	Mild 1	Severe 2	Chronic 3	Mortality 4
Bacteria – Infectious
Aeromonas spp.	GR5			Low
Arcobacter spp.	GE			Low?
Brucella melitensis /abortus/suis	Influenza	Brucellosis	Brucellosis	Medium
Campylobacter spp.	GE, ReA6	GBS7		Medium
Coxiella burnettii		Endocarditis, hepatitis		Medium
Enterobacter sakazakii		Sepsis and meningitis in neonates		High
Escherichia coli – Shiga-toxin Producing	GE, HC9	HUS10	ESRD11	Medium
Escherichia coli – Other	GE			Medium
Francisella tularensis		Tularemia
Listeria monocytogenes		Abortion, stillbirth, meningitis		High
Mycobacterium avium ssp. avium			COPD12	Low
Mycobacterium bovis		Extra pulmonary tuberculosis		Unknown
Mycobacterium avium ssp. paratuberculosis		Possible association
			with Crohn’s disease	Low
Salmonella (para)typhi		Typhoid (and paratyphoid)		Medium
Salmonella spp. - other	GE, ReA			Medium
Shigella spp.	Dysentery	HUS		Low
Vibrio cholerae	Cholera			Low
Vibrio – marine species	GE	Sepsis, wound infection		High (V. vulnificus),
				Medium (other)
Yersinia enterocolotica	GE, ReA			Medium
Bacteria – toxin producing
Bacillus cereus	GE (especially vomiting)			Low
Clostridium botulinum		Botulism		High
Clostridium perfringens	GE			Low
Staphylococcus aureus	GE			Low
Viruses
Adenovirus	GE
Astrovirus	GE
Enteroviruses	GE	Neurologic symptoms	Diabetes	Medium
Hepatitis A virus	GE	Jaundice		High, in adults
Hepatitis E virus		Jaundice		High, in pregnant women
Norovirus	GE			Unknown
Rotavirus	GE (children)	Malabsorption		Low
		intussusception
Sapovirus	GE			Low
Prions
BSE prion			nvCJD13	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 10.4.2.4). 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 10.4.2.4. Not naturally occurring, potentially harmful chemical food constituents

Source: RIVM (2006)

 

Category, substance	Food	Possible health effects (in humans, or in experimental animals)	Existing legal standard	Exposure, possible exceedance of standards	Possibility to influence exposure	Remarks, sources
Substances deliberately added to foods
Food additives	Many foods, for flavour, smell, colour, consistency or shelf life	Various	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., 2002
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 teratogenic.	Prohibited, still   occasionally used in            third world countries	Slight; concentrations have dropped markedly in recent years	Monitoring	Van Kasteren, 2000; Richard et al., 2001; Fiolet & van Veen, 2001
Pesticides that have been admitted	Residues in crops	Given the current situation of sporadic incidents where standards are exceeded, no effect is anticipated; Various effects in experimental animals	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 sampling	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	N.A.	Admission policy; monitoring by random sampling	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 benzo(a)pyrene	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
Chloropropanols	Acid hydrolysis of plant-based proteins	Possible carcinogen but not genotoxic	EU standards for 3-monochloropropandiol 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	None	Exposure or actual effects unknown	Avoid overcooking food In domestic kitchens	Nagao & Sugimura, 2000
Acrylamide	Deep-frying and baking of potato and flour products in industrial processes or in the domestic situation (crisps, chips, biscuits)	Carcinogenic; neurotoxic	None	Theoretical risk calculated at 75-130 cases of cancer per year in the Netherlands	Research into conditions of acrylamide formation; monitoring, process management	RIVM/RIKILT, 2002; Konings et al., 2003
Environmental contaminants
Lead	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	Environmental measures (lead-free petrol)	IPCS, 1995; De Hollander et al., 1999
Mercury	Mercury (organic) in fish	Organic mercury:          neurotoxic		Intake via fish consumption well below the standard (WHO: 1.6 ug/kg body weight per day)	Environmental measures	ATSDR, 1999; EFSA, 2004
Dioxins and dioxin-like Polychlorobiphenyls (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	Environmental measures: strict standards governing emissions from waste incineration; monitoring of animal feeds	Freijer et al., 2001; SCF, 2001; WHO, 2002; Baars et al., 2001; 2004
Non dioxin-like PCBs (‘indicator’ 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 system	Consumer Goods Act standards for the seven ‘indicator’ PCBs; EU: risk assessment by EFSA in preparation	Intake in 5% of the Population such that health effects could appear in the long term	PCB-containing equipment banned by the end of 2003; monitoring of oils, fats and animal feed; environmental measures	Bakker et al., 2003
Bromine-containing fire retardants (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	None	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., 2003

 

 

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 packages – notified 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 chain – bioaccumulation, 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

 

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 http://ec.europa.eu/food/food/chemicalsafety/contaminants/acrylamide_en.htm and on http://www.acrylamide-food.org/.

 

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.(http://www.epa.gov/oppt/pfoa)

 

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.

(http://www.csl.gov.uk/newsAndResources/resourceLibrary/articles/puskm/).

 

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 chromatography – Mass 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 10.4.2.5).

 

Nitrates

 

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 10.4.2.5. Naturally occurring, potentially harmful chemical food constituents

Source: RIVM (2006)

 

Category, substance	Food	Possible health effects (in humans, or in experimental animals)	Existing legal standard	Exposure, possible exceedance of standards	Possibility to influence exposure	Remarks, sources
‘Normal’ food constituents
Allergenic substances	Shellfish, fish, milk, nuts, wheat etc.	Immunological: allergenic N.A. reactions, from mild to life threatening	N.A.	N.A.