10.4.2. Ingestion and food contamination/naturally occurring toxic
substances (Food Safety)
Acronyms
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.
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
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).
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.
|
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
day.
|
Monitoring
|
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
products
|
Kidney damage and
urinary tract tumours
(‘Balkan endemic
nephropathy’);
immunogenic; genotoxic
carcinogen
|
EU standards for cereals
and raisins, standards for
coffee, grape juice and
wine in preparation
|
Exposure well below the
human health-based limit
value
|
Monitoring
|
Richard et
al., 2003;
Bakker & Pieters, 2002
|
|
Deoxynivalenol (DON)
|
Wheat and other
cereals
|
Gastro-intestinal effects,
headache, dizziness;
growth retardation
immunosuppressive,
neurotoxic
|
Provisional EU
recommendation;
EU standards in
preparation
|
In 1999 several mg/kg
breakfast cereals.
|
Monitoring by VWA
and food industry
|
Pieters et
al., 2001, 2002,
2004 (in press)
|
|
Patulin
|
Apple and apple
products
|
Haemorrhages, oedema,
genotoxic?
|
EU standards for apple
juice/apple sauce
|
Exposure below the
standard
|
Monitoring
|
WHO, 1996
|
|
Zearalenone
|
Maize, wheat
|
Oestrogenic effect
|
In preparation
|
Exposure below the
standard
|
Monitoring
|
WHO, 2001
|
|
Fumonisins
|
Maize
|
Possible oesophageal
and liver cancer
|
In preparation
|
Exposure below the
standard
|
Monitoring
|
WHO, 2001
|
|
Phycotoxins; toxic substances formed by algae, and which
accumulate in shellfish and fish
|
|
PSP (Paralytic Shellfish
Poisoning)
|
Shellfish
|
Blocks nerve conduction,
at extremely low
concentrations: tingling
sensations, respiratory
paralysis, mortality
|
EU regulations
|
Regularly in Europe,
not in Dutch fishing
grounds
|
|
Van Apeldoorn et al.,
2004
|
|
DSP (Diarrhetic Shellfish
Poisoning)
|
Shellfish, such as
mussels, oysters
|
Acute gastro-intestinal
effects
|
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.,
2004
|
|
ASP (Amnesic Shellfish
Poisoning)
|
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
Scotland
|
Van Apeldoorn et al.,
2004
|
|
NSP (Neurotoxic Shellfish
Poisoning)
|
Mainly fish, tropical and
subtropical areas
|
Neurotoxic effect, various
effects
|
None
|
|
Monitoring
|
Van Apeldoorn et al.,
2004
|
|
Azaspiracids
|
Shellfish, such as
mussels, oysters
|
Acute gastro-intestinal
Effects
|
EU regulations
|
Episode in 1995 in Ireland
|
Monitoring
|
Van Apeldoorn et al.,
2004
|
|
Phytotoxins; toxic substances that are formed in plants
(and toadstools)
|
|
Glycoalkaloids
|
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
eaten
|
Speijers & van Egmond,
1999
|
|
Pyrrolizidine alkaloids
|
Various herbal teas
|
Effects in the liver,
carcinogenic
|
NL; EU in preparation
|
Sporadic high
exposure
|
Monitoring
|
Speijers & van Egmond,
1999
|
|
Anisatin
|
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.
|
Monitoring
|
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
(especiallyendives,
spinach, lettuce),
water; increased in both
through use of artificial
fertilizer
|
Methemoglobinemia in
infants (‘blue babies’,
especially with bottle
feeding); genotoxic
carcinogenic
(nitrosamines)
|
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).
10.4.2.4. 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 entire “European 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 “subsidiary” principle 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:
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
(http://www.efsa.europa.eu/en/science/pprippr_opinions.html) 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 10.4.2.1. 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 proposed – Article 24;
·
assessment
of existing MRLs – Article 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 microbial “function” 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, 08 “PPAPeR expert
meetings “covering the 5 areas of the data requirements were held in 16
“rounds” (Figure 10.4.2.2).
Figure 10.4.2.2. Pesticides Peer review – status:
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 dose–response 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 term
“risk-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.
Controls
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 10.4.2.6.
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 States’ legal 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 10.4.2.7. Food safety competent authorities
in the 27 EU Member States and Norway (Source: EFSA, data for Norway communicated by Norwegian EUGLOREH partner)
The Member States’ competent 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.
10.4.2.5. 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.
10.4.2.6.
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