I ^ 1 COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels. 30.04. !997 
COM(97) 183 final 
COMMUNICATION FROM THE COMMISSION 
CONSUMER HEALTH AND FOOD SAFETY 

INDEX 
Introduction Page 3 
Part 1 : Synopsis of objectives and instruments Page 6 
Part 2: Scientific Advice on Consumer Health: A proactive Page 9 
approach 
Part 3: Risk analysis Page 19 
Part 4: Control and inspection - a new approach Page 21 
Annex I: Present mandates of the existing Scientific Committees Page 31 
Annex II: Main legislative acts currently requiring the Commission to Page 34 
monitor or control the manner in which they are 
respected by Member States or third countries 
Introduction 
The aim of this Communication is to inform all interested parties, in particular the 
European Parliament and the Council, of the action that the Commission is taking to 
reinforce the manner in which it obtains and makes use of scientific advice, and in 
which it operates its food, veterinary and phytosanitary control and inspection 
services. The Commission undertakes to provide regular updates of its progress with 
the implementation of the approach laid down in this Communication. 
In his speech before the European Parliament on 18 February 1997 President Santer 
made "a plea for the gradual establishment of a proper food policy which gives pride 
of place to consumer protection and consumer health". This communication goes hand 
in hand with the Green Book on food legislation in laying the foundations for such a 
proper food policy. It places food safety and consumer health at the core of a new 
political departure based on three general principles outlined in President Santer's 
speech: 
first, that responsibility for legislation should be separate from that for 
scientific consultation; 
second, that responsibility for legislation should be separate from that for 
inspection; 
third, that there should be greater transparency and more widely-available 
information throughout the decision-making process and inspection measures. 
Henceforth all the relevant scientific committees and responsibility for inspection and 
control will be placed under the authority of the Commissioner for Consumer Policy 
and Health Protection. The relevant Directorate-General (DG XXIV) has been 
reorganised to have the particular responsibility for consumer health. 
Part 1 of this communication provides a synopsis of the objectives and instruments of 
this new political departure. Part 2 outlines the proactive approach for scientific 
advice on consumer health and the manner in which the Commission tackles its 
responsibilities. More time is needed for revising the mandates of the Scientific 
Committees. The compulsory or voluntary nature of consultations provided in 
existing legislation and the streamlining of the mandates without loosing sight of the 
often multidisciplinary nature of safety issues will need particular attention. 
Part 3 explains the risk analysis approach which will be followed in the field of 
consumer health. Part 4 puts forward the control and inspection procedures which the 
Commission intends to follow. Even an improved use of existing resources will not 
allow a serious coverage of the wide range of about 80 legislative acts currently 
requiring the Commission to monitor or control the manner in which they are 
respected by Member States or third countries. Respecting the principle of 
subsidiarity, a new approach is outlined for implementation over the medium-term 
which identifies high risk subjects for priority inspection, raises performance and 
strives for control excellency. In implementing this new approach policy, the 
Commission will act in a spirit of openness and dialogue with citizens. 
There is thus an urgent need for reinforced resources, in respect not only of the control 
services, but also for those involved in the preparation and the legislative follow-up of 
the scientific advice. 
The present communication explains in detail the new approach of the Commission 
on "consumer health"1 and food safety, in particular with respect to scientific advice 
and to control and inspection. President Santer explained in his speech before the 
European Parliament that the Commission has undertaken a radical reform of the 
departments dealing with consumer health. The Commission has in particular placed 
the management of all the relevant scientific committees under the responsibility of 
DG XXIV (the Directorate General for Consumer Policy and Consumer Health 
Protection), which will now also comprise the Food and Veterinary Office (FVO) and 
a new unit on the assessment of consumer health risks. The clear explanation of the 
1 See part 2, section 2.2 for a more detailed description of the scope of this term. 
new approach unavoidably leads to a presentation in some detail of the various tasks 
of these and other Commission services. However, it must be stressed that the new 
policy in the area of consumer health and food safety involves many of the 
Commission's services, and that this new policy will be implemented by the 
Commission as a whole, acting collectively. 
Part 1: Synopsis of objectives and instruments 
The principal objective of the new political departure is reinforcement of the 
protection of consumer health. For this purpose, food safety is a necessary 
prerequisite. Moreover, in order to restore the confidence of the consumer and answer 
concerns over some models of production in which productivity is over emphasised, it 
is also important to protect animal and plant health and to respect animal welfare. 
Recent experience has clearly demonstrated that food safety is not only of concern to 
the consumer, but is also at the very root of a proper functioning of the market. Food 
safety is therefore not only a prerequisite for protecting consumer health but will also 
serve the interests of producers and those involved in processing and marketing of 
foodstuffs and relevant agricultural products. 
To achieve these objectives the Commission has reorganised and intends to reinforce 
three complementary instruments which will serve as a platform for an effective 
policy for the protection of consumers and their health: scientific advice, risk analysis, 
and control. 
Scientific advice, on which the regulatory measures designed to protect consumer 
health are based, is mainly obtained from the work of the scientific committees. The 
re-grouping of these committees and the creation of a Scientific Steering Committee 
will pave the way to greater synergy and help co-ordinate their work. 
The three principles which must be at the basis of the good performance of the 
scientific committees are, the excellence of their members, their independence and the 
transparency of their advice. These principles are fleshed out in the second part of this 
communication. 
The formulation of the questions put to the scientific committees, as well as the use of 
these committees' advice by those responsible for preparing legislative proposals, 
requires close collaboration between the Commission's services. This collaboration 
will have to be as flexible and as unbureaucratic as possible. Likewise the 
Commission will re-examine the distinction between mandatory and optional 
consultation of the scientific committees provided for in Community legislation in 
force. 
Risk analysis is a three stage process, composed of the assessment, the management 
and the communication of the risk concerned, in the present context, risk assessment 
allows the identification and evaluation of hazards to consumer health, based on an 
estimation of the probability of their appearance in a specific situation. The essential 
task of risk management is to contain or reduce the level of risk identified through the 
assessment procedure in order to achieve an appropriate level of protection. Finally, 
through risk communication, information is exchanged between the parties concerned 
on the nature of the hazard and the measures to be taken to control it. 
The new approach for control and inspection will be based on the following three 
main orientations: Firstly, in view of the wide range of areas covered by this 
legislation, and the limited resources available, risk assessment procedures will be 
introduced to allow control priorities to be established. Secondly, control activities 
will be reorganised to ensure that the whole of the food production chain is properly 
covered ("plough to plate" approach). Thirdly, the approach will be further developed 
through the general introduction of formal audit procedures, to allow an assessment of 
the control systems operated by the competent national authorities (as is already the 
case in the food control sector). 
The principle of transparency will guide the activities of the control services in their 
dealings with national authorities, consumers and all other interested parties. 
In using the three regrouped instruments, scientific advice, risk analysis and control, 
the Commission will pay particular attention to their effectiveness and practicability. 
The Commission will ensure a rapid follow-up of emergencies related to consumer 
health. This will include action in respect of safeguard measures and the rapid alert 
system. Furthermore, information supplied by consumers and producers will be dealt 
with quickly. 
Scientific advice, risk analysis and control need to be used as the basis for action in a 
large number of fields, notably: 
the manner in which Member States respond to recommendations made on the 
basis of inspection visits; 
defence of Community interests in the international context e.g. WTO, WHO, 
OIE and FAO; 
ensuring the respect of Community legislation; 
and most importantly, taking account of the matters covered by the three 
regrouped instruments in the preparation of Community legislation. 
Recommendations for action will thus be based on the results of scientific advice, risk 
analysis or control missions. Moreover, there is a need to establish proper feedback 
mechanisms to ensure effective liaison between all interested parties, including 
monitoring the manner in which the recommended action is undertaken. 
The European Union is the largest importer in the world of agricultural and food 
products and one of the largest exporters. In these circumstances, it is important to 
ensure that our internal legislation and procedures provide adequate reassurance for 
our trading partners and that our exports do not encounter unjustified restrictions in 
gaining access to the world market. The European Union can draw benefits from 
international agreements. Decisions on food safety are taken in the context of the 
rights and obligations that flow from them, in the WTO, in other international 
organisations and bilaterally (e.g. European Economic Area, Association Agreements 
and veterinary and phytosanitary equivalency agreements). 
Part 2: Scientific Advice on Consumer Health: A proactive approach 
2.1. Objectives and Principles 
In matters relating to the health of the consumer, scientific advice is of the utmost 
importance at all stages of the drawing up of new legislation and for the execution and 
management of existing legislation. This is also the case in other areas such as animal 
health and animal welfare. The Commission will use this advice for the benefit of the 
consumer in order to ensure a high level of protection of health. 
As concerns foodstuffs, the objective of the European legislative framework is to 
continuously improve the availability of safe and wholesome products, by ensuring 
that primary agricultural products, finished products and all intermediate production 
processes and products are analysed and evaluated for potential risks. 
In reviewing its approach to scientific advice for consumer health protection the 
Commission will reinforce three main principles: excellence, independence and 
transparency. 
Scientific advice must be of the highest possible quality. It is therefore essential that 
the evaluation of potential hazards is undertaken by eminent scientists (principle of 
excellence). 
The Commission will ensure that scientists serving in the scientific bodies are free 
from interests which may be in conflict with the requirement to give independent 
advice as necessary to contribute to a high level of protection of consumer health 
(principle of independence). 
In line with the overall policy of transparency operated by the Commission, it is 
necessary for interested parties, including consumers, both individuals and 
associations, as well as for the Institutions of the European Union and the National 
Authorities to have easy access to information on the working procedures of the 
Committees and to their advice. In addition, the Commission will fully inform 
interested parties, including the consumer, about the different steps in the 
establishment of this advice. Communication is therefore essential in achieving these 
objectives (principle of transparency). 
At the same time it must be recognised that scientific advice has its limits, and its use 
can therefore be regarded as a major factor, albeit not the only one, in the decision­
making process. 
2.2. Scope of responsibilities 
Legislation has often, but not systematically, made scientific consultation compulsory 
on matters which may have an effect on public health. Several Scientific Committees 
were therefore established by the Commission and operated by the Directorates-
General with the corresponding responsibility for drafting legislation and covered the 
areas of food, veterinary matters (animal health, public health and welfare), 
toxicology and ecotoxicology of chemicals, pesticides, animal nutrition and cosmetics 
and, most recently, matters linked with Bovine Spongiform Encephalopathy within 
the Multidisciplinary Scientific Committee. A summary of the existing mandates is 
given in Annex I. 
Existing Scientific Committees cover matters on consumer health, animal health and 
welfare, plant health and environmental health resulting from certain uses of 
chemicals, from production and consumption of food and feedingstuffs, from the use 
of cosmetics or from use of chemicals in agricultural practice and food and 
feedingstuff production. For simplicity, these responsibilities, recently attributed to 
the Commissioner for Consumer Policy and Health Protection, will be referred to as 
"consumer health" throughout this Communication. 
On several occasions in the past joint opinions have been issued by several 
Committees and this positive experience will be used to guide the Commission 
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services to set up a sufficiently flexible structure which must ensure a reliable, 
independent and rapid response to health concerns in order to benefit from the input of 
different scientific disciplines and to avoid duplication of effort and possible 
confusion where divergences of understanding occur between the Committees. 
On the basis of the new policy orientations laid down in this Communication and the 
recommendations of the European Parliament, the Commission will revise and align 
all the mandates of the above mentioned Scientific Committees. The mandates of all 
Scientific Committees under DG XXIV will be the subject of a single Commission 
Decision to be adopted in July 1997. The mandate of the Scientific Steering 
Committee (previously called the Multidisciplinary Committee) will be adopted 
separately in May 1997. 
2.3. Reorganisation of the work of the Scientific Committees. 
The Commission will concentrate efforts to build a reliable and flexible structure 
which shall enable high quality and independent scientific advice, to ensure 
transparency and consideration of the scientific advice in the legislative activities of 
the Community Institutions. 
The requests for independent scientific advice originate, in many cases, from the 
obligations in Community legislation. There are however several legal acts on 
important matters relating to food and animal health and welfare where this advice has 
not been made compulsory. Therefore the Commission shall examine, in co-operation 
with the Scientific Steering Committee, those areas where a compulsory consultation 
of the Scientific Committees should be introduced. 
Most of the questions for scientific advice fall clearly within the current mandate of 
one of the Scientific Committees. However, a particular question may fall within the 
competence of several Committees, so that its allocation within a single Scientific 
Committee is not always obvious. Moreover, certain consultations have to involve the 
competence of several Scientific Committees. 
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A Scientific Steering Committee has therefore been created, which at present is 
composed of the Members of the multi-disciplinary committee and the chairpersons of 
the six other Scientific Committees. Its mandate shall include, the co-ordination of the 
different Committees and decisions on the involvement of several Committees in 
questions which need multiple expertise located within these Scientific Committees. 
The new Scientific Steering Committee will have eight members, in addition to the 
chairpersons referred to above. These eight members will advise the Commission in 
the selection procedure for members of the other Committees, in particular in respect 
of their excellence and independence. 
All existing Scientific Committees dealing with consumer health need to be 
maintained although some of them need to be reinforced. In order to respond 
immediately to specific questions arising from overlapping mandates of the Scientific 
Committee for Food and the Scientific Veterinary Committee, a joint sub-committee 
will be set up on food safety questions. 
When legislative acts are based on the evaluation carried out by scientists from 
organisations in the Member States, a consultation of the corresponding Commission 
Scientific Committees may in some cases be appropriate. The evaluation work carried 
out by these organisations in the Member States may serve as a base for peer review 
by the competent Scientific Committee. 
Most of the procedures for risk assessment of chemical hazards established by the 
Scientific Committees are in full accordance with evaluation procedures established 
and used by both national or international bodies such as the World Health 
Organisation. However, development of new risk assessment procedures relating to 
areas such as transmissibility of animal disease to man and food-borne diseases is 
becoming a major task. 
The Commission feels the need to have available at Community level highly 
specialised expertise on biotechnology. Following the suggestion of the Scientific 
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Steering Committee, a step by step approach will be followed. The possibility of 
establishing a specific working group under the Scientific Steering Committee will be 
examined. The Commission will come back to this issue in the context of the revision 
of Directive 90/220/EEC on the deliberate release of genetically modified organisms. 
The new mandates will continue to ensure that the Scientific Committees may invite 
external experts to give advice on specialist questions. The Commission will 
introduce the necessary flexibility and budgetary provisions for the organisation of 
meetings to deal with urgent matters concerning consumer health. 
2.4. The interim period. 
To avoid disruption to their work, and until the new mandates of all Scientific 
Committees are adopted by the Commission in July 1997 all Committees in their 
present composition shall continue their duties based on the existing mandates (cf. 
Annex I). They shall continue scheduled meetings including those of their working 
groups in order to respond to all existing and new requests for opinions. 
2.5 International relationships 
The Commission, in collaboration with Member States, must maintain an active 
participation in international fora where recommendations, standards or guidelines 
concerning consumer health are elaborated, particularly with a view to ensuring that 
such recommendations, standards or guidelines have a sound scientific basis. The 
advice of the Scientific Committees in these matters has a valuable contribution to 
make in guiding the Commission services in this work. 
As concerns international trade, the Agreement on the application of sanitary and 
phytosanitary measures (SPS) of the World Trade Organisation does not require its 
Members to change the level of protection they judge to be appropriate. The SPS 
Agreement provides, however, that any sanitary or phytosanitary measure is applied 
only to the extent necessary to protect human, animal or plant life or health, is based 
on scientific principles and is not maintained without sufficient scientific evidence. 
13 
But the Member is free to decide, on the basis of a risk assessment, whether the 
relevant international standard, guideline or recommendation is sufficient to achieve 
the appropriate level of sanitary or phytosanitary protection. The activities of the 
Scientific Committees may therefore include an evaluation of the scientific principles 
upon which the Community health standards have been based. This evaluation must 
take into account risk assessment techniques developed by the relevant international 
organisations. Similarly, responsibilities flowing from other international agreements, 
notably the veterinary and phytosanitary equivalency agreements, may have a bearing 
on the manner in which such evaluations are undertaken. 
2.6. Changes in legislation. 
In order to implement the Commission policy concerning scientific advice on matters 
relating to consumer health, the Commission will propose or adopt the necessary acts 
to introduce, where necessary, compulsory consultation of a Scientific Committee. 
In any event the Commission has the firm intention to consult the appropriate 
Scientific Committees on matters of particular concern related to consumer health 
even if Community legislation does not yet foresee compulsory consultation. In 
certain circumstances, however, including emergency situations or areas where the 
scientific situation is already clearly established, such consultation may be delayed or 
regarded as unnecessary. 
2.7. Functioning of the Committees. 
Scientific qualification and competence are the most important selection criteria for 
the Members of the Scientific Committees. The Commission will ensure that the 
selection process is transparent vis-à-vis the European Parliament, the Member States, 
consumer associations and other interested parties. The process may include an 
element of "call for expression of interest". 
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When appointing committee members particular attention shall be paid to their 
independence. The Commission will extend the existing requirements and procedures 
for declaration of interests of the members of all Scientific Committees. 
It may not always be possible to achieve consensus amongst the Members of 
Scientific Committees. The reports of the scientific evaluations and records of the 
meetings shall accurately mention the different views expressed during evaluation. 
The minutes of the meeting of the Scientific Committees, including minority views, 
shall be made publicly available. Minority views shall be attributed to Committee 
Members only at their request. 
Subject to the agreement of the budgetary authority, the Commission intends to 
attribute an indemnity to Committee Members, in addition to the usual daily 
allowances and travel expenses. An evaluation of the financial implications is 
included in the Proposal for the Supplementary and Amending budget. 
Rapporteurs can be appointed by the Scientific Committees. Particular attention has to 
be paid to ensure that the rapporteurs are acting independently from all socio­
economic pressure or personal interests. Since the rapporteurs have a particular task in 
gathering information, the setting up of data bases and drafting of the reports and 
advice, they shall receive an additional indemnity. 
The role of the secretariat of the Committees will continue to be assured by the 
services of the Commission, according to the rules in force. 
2.8. Co-ordination with legislative, official control and other functions. 
Scientific advice is an essential pre-requisite for legislative proposals or measures 
with a potential impact on food safety and consumer protection. It is an essential 
safeguard and a top priority to ensure that decisions are taken with full regard to the 
best available scientific evidence. The Commission re-inforces this priority in its 
new approach towards food safety. 
15 
At the same time and without prejudice to the important role to be given to scientific 
advice, it has to be acknowledged that there are some inescapable limitations on its 
role. In some cases, there may be demands - for instance, due to ethical or 
environmental considerations or specific control and production methods - to go 
further in the area of the health protection measures than the scientific evidence 
suggests is necessary. Conversely, in other cases, there may be reasons to balance the 
scientific or identifiable risks with society's tolerance of the risks concerned -
unhealthy diets and lifestyles being such examples. In still other cases, the scientific 
advice may not be sufficiently conclusive or complete to allow firm conclusions to be 
drawn. Finally, scientific advice is not infallible and is subject to change in the light 
of new developments and knowledge and must therefore be kept under review. 
One of the primary tasks of DG XXIV will be to ensure an appropriate follow up of 
the advice delivered by the Scientific Committees. It will transmit the scientific advice 
to the Directorates General in charge of legislation. Where appropriate, it will make 
recommendations. 
The necessary co-operation between the services must work in both directions, with 
other services and in particular those services responsible for preparing legislation 
being able to obtain scientific advice on request. 
The Commissioner responsible for Consumer Policy and Health Protection shall be 
associated with all legal texts and proposals on matters concerning consumer health 
on which scientific advice is delivered. 
The Commission, in discharging its political responsibilities, will make use of, where 
appropriate, scientific advice and the results of the risk analysis. 
On the basis of the risk assessment from the Scientific Committees, the Commission 
shall undertake interactive exchange of information and opinions with interested 
parties. 
16 
In the context of its official control responsibilities, the Commission may request 
advice from a Scientific Committee as a follow-up to an inspection in a Member State 
or a third country. 
Moreover, upon its own initiative, any Scientific Committee and the Scientific 
Steering Committee may draw the attention of the Commission to potential or 
emerging hazards in relation to consumer health. 
The Risk Analysis Unit in DG XXIV shall fulfil a forward looking role for identifying 
potential or emerging hazards relating to consumer health. 
DG XII, as the service responsible for science, research and development policy, will 
be associated in the activities of the scientific committees in particular, relating to the 
definition of their mandate, the selection of their members, the formulation of 
questions to be posed and the interpretation of the scientific advice. The Joint 
Research Centre, as the independent scientific body of the Commission, will provide 
support to the Scientific Committees, in particular with supplementary data and 
laboratory assistance to verify and complete information presented to the Scientific 
Committees by external parties. Any relevant results obtained under the Community 
specific research programmes will be made available to the Scientific Committees. 
The Commission will also rely on scientific data generated by Member States under 
the arrangements for scientific co-operation established by Directive 93/5/EEC. 
2.9. Public Credibility. 
Consumer confidence in the legislative activities of the European Union with regard 
to food and animal health and welfare is conditioned by the quality and transparency 
of the scientific advice and its use in the legislative and control processes. 
17 
Widest possible access to the scientific advice will be guaranteed. The agenda, 
minutes and opinions of the Scientific Committees will be made available to Member 
States, particularly the health authorities, the European Parliament, citizens, 
consumers and consumer associations, producers and their associations and other 
socio-economic operators, bearing in mind the need to respect commercial 
confidentiality. Efforts shall be made to present information in a form which is 
readily understood by laymen. The opinions of the Scientific Committees shall be 
released shortly after adoption and made available on the Internet. 
The Commission will organise regular presentations to interested parties such as the 
European Parliament, Member States and consumers. Special information sessions 
shall be held with journalists. 
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Part 3: Risk analysis 
Risk analysis is a systematic procedure comprising the scientific evaluation of 
hazards and the probability of their emergence in a given context (risk assessment), 
the assessment of all measures making it possible to achieve an appropriate level of 
protection (risk management), and the exchange of information with all the parties 
concerned: decision-makers, inspectors, consumers and producers in order to explain 
the reasons and to justify the management measures proposed (risk communication). 
Risk analysis comes within the remit of the Commission. These activities will 
comprise tasks falling within the competence of the different Directorates General 
responsible for scientific advice, for the preparation of legislative proposals and for 
control. Close collaboration and coordination between these departments is necessary 
for the performance of risk analysis. In order to achieve a high level of protection the 
Commission will prepare legislative proposals or adopt measures. The depth of the 
risk analysis undertaken will reflect the nature of the hazard identified. 
Risk assessment forms the foundation of scientific advice with regard to consumer 
health. Scientific risk assessment offers the Commission a sound basis for proposals 
and measures in the field of consumer health and food safety. The Commission will 
aim, where appropriate, to ensure that risk assessments are made in accordance with 
any internationally agreed procedures. This would give a basis for the defence of 
Community legislation based on such risk assessments in the event that it is 
challenged under World Trade Organisation (WTO) rules or in the European Court of 
Justice. 
Concerning risk management, the Commission will take into account available risk 
assessments as well as the recommendations transmitted by the Directorate General 
responsible for scientific advice to the Directorate General responsible for preparation 
of legislation. Risk management shall include the process of assessing the impact of 
policy alternatives in the light of the results of risk assessment and the desired level of 
protection. 
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Risk communication must be as transparent as possible. To achieve this, the 
Commission will assure the widest possible access to scientific advice, and will also 
fully inform all interested parties, including consumers, of the different steps of its 
development. This will include information on the reasons and the scientific grounds 
for proposals as well as exchange of information with interested parties at all 
appropriate stages. Consumer concerns in relation to possible health risks will be 
taken into account during the process of risk analysis which will be implemented by 
the Commission. 
The risk analysis thus defined in respect of the protection of consumer health must 
enable the Commission to play an interface role between the scientific community and 
the political world and other elements of civil society. Here it is useful to recall that -
since, there is no such thing as "zero risk" - information on the level of risk is 
essential for the consumer. The Commission will be guided in its risk analysis by the 
precautionary principle, in cases where the scientific basis is insufficient or some 
uncertainty exists. 
The Commission will, on matters relating to consumer health, and in close 
collaboration with the Member States, undertake a surveillance role on emerging or 
new hazards connected with developments in agricultural and industrial production, 
including data collection on possible risks. These activities will aim to identify new 
hazards and to anticipate rather than react to situations in proposing strategies for 
action for scientific research or surveillance measures. These activities will require the 
establishment of a network of a wide variety of disciplines and close collaboration 
between the services of the Commission. 
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PART 4: CONTROL AND INSPECTION - A NEW APPROACH 
4.1 Objectives 
Mission statement 
The Food and Veterinary Office (FVO) will have as its principal missions the 
monitoring of the observance of food hygiene2, veterinary and plant health 
legislation within the European Union and elsewhere, and to contribute towards 
the maintenance of confidence in the safety of food offered to the European 
consumer. 
Responsibility for the implementation of Community food veterinary and 
phytosanitary legislation rests with Member States. The Commission, acting through 
its control services3 in DG XXIV, monitors the manner in which they undertake these 
responsibilities. In the veterinary and phytosanitary sector, this is carried out through 
a programme of inspection and control missions to monitor the performance of the 
competent authorities, including on-the-spot inspections of individual establishments 
in both Member States and third countries. These may include direct interventions, 
such as the collection of samples for phytosanitary checks, in Member States in 
certain circumstances. As indicated in this paper, it is proposed to develop this 
approach through the introduction, where possible, of formal audit procedures to 
allow the performance of the competent authorities to be assessed. In doing so, this 
will bring inspection techniques in the veterinary and phytosanitary sectors more into 
line with those already in use in the food control sector. Priority will be given to the 
need to ensure that high levels of consumer, animal and plant health and animal 
welfare protection are being achieved. However, it must be recognised that the 
2 as defined in Article 2, Council Directive 93/43/EEC of 14 June 1993: "food hygiene shall 
mean all measures necessary to ensure the safety and wholesomeness of foodstuffs" 
3 comprising the Food and Veterinary Office, and a food control section, transferred from DG III, 
where it monitored and evaluated the equivalence and effectiveness of official food control systems 
operated by the competent authorities of the Member States 
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achievement of these objectives will be dependent upon sufficient resources being 
made available to the Commission services to carry out the full range of their 
proposed duties. 
4.2 Scope of responsibilities 
The control services will undertake the food, veterinary and phytosanitary inspection 
and control responsibilities required of the Commission in the relevant Community 
legislation, particularly that listed in Annex II. 
In addition, a possible future expansion of the activities of the control services into 
additional areas of concern to consumers, or where existing controls could usefully be 
rationalised, will be considered. This question will be discussed with interested parties, 
with a view to identifying any necessary action to achieve this goal. 
The Commission will aim to ensure that the responsibility of the control services for 
the control of the manner in which Community food hygiene, veterinary and 
phytosanitary legislation is operated is formally recognised in respect of both existing 
and future legislation. 
The control services will be fully consulted on the development of veterinary, 
phytosanitary and food legislation as, in many cases, their expertise will be needed to 
ensure that legislative proposals are properly informed by the situation in Member 
States and third countries. The findings of the control services will be widely 
disseminated to other concerned services within the Commission, so that they are kept 
fully informed of any developments. 
An internal administrative operations manual will be developed to establish the 
detailed rules to be followed in dealings between the control services and other parts 
of the Commission (including UCLAF in relation to suspect frauds) and other EU 
institutions 
22 
Close contacts will also be developed with consumer groups and socio economic 
operators to ensure that they are kept fully informed of developments (see section 8). 
4.3 Improved use of existing control and inspection resources 
The issues raised by the Parliament's Committee of Inquiry will not simply be 
resolved by the transfer of existing control and inspection resources to DG XXIV. 
However, operational improvements in the veterinary and phytosanitary sectors have 
been initiated by: 
the establishment of inspection priorities, taking into account the need to meet 
legislative commitments, through an informal risk assessment procedure. This 
will include an assessment of risk both on a country or regional basis, e.g. 
geography, climate, health situation, competence of official services, previous 
trade problems etc, and for individual production sectors, e.g. husbandry 
practices, presence of zoonoses, types of treatment and use of hazard analysis 
critical control point (HACCP) techniques in processing establishments, previous 
inspection reports etc 
the development and introduction of an inspection approach which follows the 
whole of the food production chain, and all parts of the plant health sector, 
through the use of multi-disciplinary, expert, inspection teams, each with a 
nominated team leader, with responsibility for all aspects of food production and 
plant health in specified geographical areas. 
These changes will allow the best use of existing veterinary and phytosanitary 
resources, whilst confirming that the control services are committed to developing an 
effective system of consumer protection. They will form the basis for the future 
activities of the control services. It must, however, be recognised that any routine 
inspection programme will be subject to the over-riding need to respond to 
emergencies. 
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The food control section will continue the development and operation of existing 
audit-based procedures for monitoring and evaluating official food control systems in 
Member States. As at present, these will include controls over the manner in which 
rules for the prevention of economic fraud, e.g. mislabelling and misrepresentation of 
food quality, are operated. 
As indicated above, the need to respond to emergencies will continue to be given the 
highest priority by the control services. Sufficient resources will be made available for 
these activities, even where this has an impact on more routine work. Inspectors, 
specially trained in epidemiology and disease outbreak control techniques, will be 
used to form temporary units to investigate such emergencies. 
Inspection programmes will be prepared in close co-operation with the relevant 
Commission legislative services, and will take full account of the principles outlined 
above. These services will also be able to propose areas for control or inspection 
activities to the control services. At the same time it is necessary to recognise that 
certain specific control and inspection responsibilities are laid down in Community 
legislation, and that these will have to be taken into account in developing the 
programmes. 
The above actions will help to allow potential or actual health problems to be rapidly 
identified, and socio-economic operators and consumers given early warning of 
hazard identification. It will also ensure that the work of the control services is 
integrated into the overall goals of the Commission. 
Standard procedures for the performance of inspections, and the subsequent 
presentation of findings through standardised report proformas, will be developed. 
Close working links will be maintained with the legislative services and formal 
administrative procedures established for these contacts. As part of the administrative 
operations manual described earlier, procedures for the submission of inspection 
reports and recommendations for action by the control services, and for responses by 
24 
the legislative services, will be established through agreement between the interested 
parties. 
Following the transfer of the Office to Ireland, a liaison section will be established in 
Brussels, to ensure that effective contact can be maintained with the Office, and to 
provide an initial inquiry point. 
4.4 Need for reinforcement of resources 
The Inspectorate General Service (IGS) of the Commission has reported on the 
reinforcement of resources needed to allow the proposed expansion of the control 
services to take place. A detailed account, based on the IGS report, of the resource 
requirements for the full and effective implementation of this reorganisation is 
submitted to the budgetary authorities, in the form of a supplementary and amending 
budget 
To respond to this need, it is proposed that the recruitment process be initiated as 
quickly as possible. Priority will be given in the first instance to filling the inspector 
posts, so that training of these staff can begin without delay. The recruitment process 
should be completed within a short time scale, to bring staff numbers to the level 
where the Office can begin to take up the full range of its duties. 
Sufficient support in terms of human, financial, informatics and equipment resources 
will have to be provided to ensure the efficient operation of the control services. 
4.5 Subsidiarity, improvements in performance, control excellence 
The control services will develop and introduce as quickly as possible, transparent 
operational systems, including a Manual of Procedures, so that Member State national 
authorities, the European Parliament, citizens, consumers and consumer associations, 
producers and producer associations and other socio-economic operators can be kept 
informed of their activities. In addition, they will discharge their responsibilities in a 
manner that respects the different roles attributed to the Commission and national 
authorities in the implementation of the relevant Community legislation. 
25 
An integral part of this approach in the veterinary and phytosanitary sectors will be 
the development by the control services of formal risk assessment procedures and 
audit systems, in support of the production chain controls described earlier. A small 
expert group will be established as quickly as possible within the control services so 
that an in-depth study of the action necessary to introduce these two new elements can 
be initiated. In conjunction with the risk analysis unit in DG XXIV, it will identify the 
elements to be taken into account in the risk assessment procedure, develop a hazard 
weighting system, and identify priorities for targeting by the control services. In 
addition, it will develop suitable audit procedures, and inspection and report 
protocols, for use in Member States and third countries, supported by the development 
of a system for establishing agreed corrective procedures in respect of deficiencies 
identified. The Manual of Procedures will be developed to ensure that these actions 
are implemented in a harmonised and transparent manner. 
The measured introduction of this new approach, based on: 
controls over the whole food, animal and plant production chains 
formal risk assessment procedures to identify control priorities 
audit systems to monitor competent authority performance 
will ensure the most cost effective use of resources, whilst respecting the principles of 
transparency and subsidiarity. It will also allow the operation of equivalency 
agreements, where the control services will be responsible for monitoring compliance, 
in both Member States and third countries. These developments will also be reflected 
in the reinforcement and expansion of the food control section to allow it to carry out 
its auditing activities in respect of official food control systems in Member States in 
an effective manner. 
The overall goal will be to provide a harmonised approach to control and inspection 
activities for all parts of the food production chain, through a managed programme 
based upon the careful targeting of inspection and control resources. Sufficient 
financial, expertise and personnel resources must be made available if this goal is to 
26 
be achieved. However, it must be emphasised that no control system can offer zero 
risk in terms of consumer health protection. 
Close links will be maintained with the scientific committees to ensure that inspection 
and control activities are kept informed of the most recent developments in the 
relevant fields. 
A wide-ranging training programme to equip staff with the skills necessary to face the 
challenges posed by the expansion of the inspection and control services will be given 
a high priority. With a view to promoting a common approach to controls in the food, 
veterinary and plant health sectors, the involvement of inspection staff from Member 
States, the European Economic Area and Associated Countries will be encouraged. 
In order to enhance controls over food safety and quality standards, and over 
compliance with veterinary and phytosanitary legislative requirements, the control 
services will, as far as possible, act in partnership with the Community's own 
laboratories (Joint Research Centre) in the collection of samples, e.g. for biochemical 
checks of foodstuffs. This control function will be developed by the Joint Research 
Centre in conjunction with the Community network of national research centres. 
A detailed examination of the benefits of applying an externally audited quality 
control system (e.g. EN 45004) to the management of the control services will be 
undertaken. Such a system would demonstrate the Commission's commitment to 
openness in the operation of these services, and ensure that their management was 
based upon the most up-to-date principles. This was proposed by the Parliament's 
Committee of Inquiry in respect of a future Agency, but it is considered appropriate to 
consider whether such a system could usefully be applied to the existing services. 
An inspector will be posted to each of a small number of EU delegations in certain 
third countries, to ensure that the Office can fulfil its mission in the most cost-
effective and efficient manner. It will also be necessary for a contact point to be 
27 
established for dealing with these offices and with third country authorities, outside 
organisations etc. 
4.6 Towards a Quality Assurance function 
As part of its commitment to consumer protection, an expansion of the role of the 
Commission's control services to include the monitoring of food quality assurance 
systems at both Community and national level will be considered. These are important 
areas for consumers, and a careful analysis, including consultation with all interested 
parties, of the consequences for the involvement of the control services will be 
undertaken. It will be important that any input into these fields supplements the core 
health protection functions of the control services. 
4.7 Independence 
This concern will continue to be taken fully into account during recruitment of 
inspection staff into the control services, and to receive due emphasis in their 
introductory training. In this context, the Staff Regulations of the European 
Commission, to which all inspectors are subject, clearly establish the principle of the 
independence of officials of the European Commission. 
The ability of the control services to perform their duties and to present their findings 
free from external influence will continue to be given the highest priority. 
The Commission recalls that it submitted a proposal to Council in May 1996 for the 
establishment of a Veterinary and Phytosanitary Inspection Agency. In the 
Commission's view, efforts to establish an independent Agency should continue. In 
the light of recent developments and reactions from the European Parliament and the 
Council, and on the basis of a proper, in-depth, analysis of the best way forward, the 
Commission will review the existing proposal. In performing this review, the 
Commission will ensure that the Parliament and Council are closely involved, and 
that the comments of the Parliament's Committee of Inquiry into BSE are taken into 
account. 
28 
4.8 Confidence built upon transparency 
The problems experienced because of the BSE crisis have demonstrated the need to 
involve in a more open fashion consumers and producers in all aspects of food 
production. The Commission, by bringing together the existing inspection services 
under a single Directorate General, with specific responsibilities for consumer 
interests and health protection, and through the action outlined in this paper, is 
contributing to this objective. To reinforce this undertaking, a number of initiatives 
are proposed: 
clear procedures, which will ultimately be published, will be established for 
external contacts between the control services and all interested parties in the 
food, veterinary and plant health sectors. 
through the publication of regular reports, consumers, producers, other socio­
economic operators, scientists and other outside organisations will have a right of 
access to the findings and activities of the control services, subject to the need to 
respect commercial confidentiality. 
members of the public will have direct access to the control services through 
widely publicised telephone, fax and e-mail contact numbers. An Internet site will 
provide up-to-date information on the activities of the control services. Audio­
visual and printed information will also be made available. 
the control services will extend the existing emergency information system to 
give Member States (notably the health authorities), the European Parliament, 
citizens, consumers and consumer associations, producers and producer 
associations and other socio-economic operators the maximum possible 
information on the identification of hazards, disease outbreaks and related 
emergencies. 
29 
links will be established with consumers and socio-economic operators so that 
mutual understanding can be developed, and in order to encourage a two-way 
flow of information on food hygiene and related matters. For example, consumers 
will be invited to give their views on food hygiene and quality matters, so that the 
control services can be properly informed of their concerns. 
an outline programme of missions to be undertaken by the control services will be 
presented to the regulatory committees on a regular basis and made freely 
available to other inquirers. 
30 
ANNEX î 
PRESENT MANDATES OF THE EXISTING SCIENTIFIC COMMITTEES 
MULTI-DISCIPLINARY SCIENTIFIC COMMITTEE (MDSC), 
Established by Commission decision establishing the committee (SEC(96) 1137). The 
main objectives are: 
• to ensure that scientific advice on BSE given to the Commission takes into 
account the widest possible range of expertise; 
• to provide a mechanism to obtain scientific advice from a single highly qualified 
committee for an issue which affects areas of competence of several DGs 
SCIENTIFIC COMMITTEE ON COSMETOLOGY 
The Scientific Committee on Cosmetology was established by Commission Decision 
n°78/45/EEC of 19.12.1977: 
The drawing up and amendment of the community rules governing the composition, 
manufacturing characteristics, packaging and labelling of cosmetic products involve 
the examination of scientific and technical problems of considerable complexity. 
The objective of the Committee is to assist the Commission on any problem of a 
scientific or technical nature in the field of cosmetic products. 
SCIENTIFIC COMMITTEE ON PESTICIDES 
The Committee was established by Commission Decision 78/436/EEC. The SCP 
may be consulted on scientific and technical questions relating to the marketing and 
use of plant protection products (pesticides use in agriculture). This includes: 
• physical and chemical properties; 
• fate and behaviour in the environment; 
• ecotoxicology; 
• mammalian toxicology including operator exposure and safety; 
• residues in food and animal feed; 
• efficacy 
31 
SCIENTIFIC VETERINARY COMMITTEE 
The Committee was established by Commission Decision 81/651/EEC. 
The Committee may be consulted by the Commission on all scientific and technical 
problems concerning : 
• Animal Health 
• Veterinary Public Health 
• Animal Welfare 
The Committee has 3 Sections corresponding to the fields indicated below. The 
Section concerned with Animal Health questions shall examine in particular problems 
concerning the cause, nature, pathogenesis, effects, diagnosis, epidemiology, 
prophylasis and therapy of animal disease, including zoonoses, and with the 
morphology, physiology and reproduction of healthy animals and with problems of 
animal health in general. 
The Section concerned with Veterinary Public Health questions shall examine in 
particular veterinary measures for the protection of the health of humans and hygiene 
conditions for the production, processing, handling and marketing of foodstuffs of 
animal origin and for the inspection of foodstuffs relative to the fixing of minimum 
criteria of wholesomeness and hygiene during processing, storage, distribution and 
preparation. 
The Section concerned with Animal Welfare questions shall examine in particular 
measures to ensure the protection of animals, especially those relating to animal 
rearing, management, transport, slaughter and experimentation. 
The Committee may draw the attention of the Commission to any problems in the 
above areas. 
SCIENTIFIC COMMITTEE FOR TOXICITY AND ECOTOXICITY OF 
CHEMICAL COMPOUNDS 
Mandate of this committee is established by the Commission Decision 78/618/EEC as 
lastly modified by Commission Decision 88/241/EEC and states: 
"To supply the Commission with opinions, at the latter's request, on all matters 
relating to the examination of the toxicity and ecotoxicity of those chemical 
compounds the use of which is liable to have detrimental effect on human health and 
on the various environmental media". 
32 
SCIENTIFIC COMMITTEE FOR ANIMAL NUTRITION 
The mandate is established in Commission Decision 76/791/EEC and reads as follows 
1. The Committee may be consulted by the Commission on scientific and technical 
questions relating to the nutrition and health of animals and to the quality and 
wholesomeness of products of animal origin. In particular, the committee may be 
consulted on questions concerning the composition of feedingstuffs, processes 
which are liable to modify feedingstuffs, additives, and substances and products 
which may be considered undesirable in feedingstuffs. 
2. The Committee may draw the attention of the Commission to any such problem. 
SCIENTIFIC COMMITTEE FOR FOOD 
The SCF was established by a Commission Decision in 1974 which was replaced by 
Decision 95/273/EC. Its mandate is given in Article 2 of that Decision : 
• The Committee shall be consulted by the Commission whenever a legal act 
requires so (this currently relates to seven Community framework acts and 
provides the basis for most of the SCF's work). 
• The Committee may be consulted by the Commission on any other problem 
relating to the protection of the health and safety of persons arising or likely to 
arise from the consumption of food. 
The Committee may draw to the attention of the Commission to any such problem. 
33 
ANNEX II 
MAIN LEGISLATIVE ACTS CURRENTLY REQUIRING THE 
COMMISSION TO MONITOR OR CONTROL THE MANNER IN WHICH 
THEY ARE RESPECTED IN MEMBER STATES OR THIRD COUNTRIES 
NB. All acts are Council Directives unless indicated otherwise. 
Veterinary 
Trade and general 
72/461/EEC (health controls on intra-Community trade in fresh meat) 
72/462/EEC (third country - live animals, fresh meat, meat products) 
80/215/EEC (health controls on intra-Community trade in meat products) 
89/662/EEC (veterinary checks for animal products in intra-community trade) 
90/425/EEC (veterinary checks for live animals and products in intra-community 
trade) 
90/424/EEC (Council Decision - expenditure in the veterinary field.) 
90/675/EEC (veterinary checks on products from third countries) 
91/496/EEC (veterinary checks on live animals from third countries) 
92/65/EEC (animals, semen, ova, embryos not in other Community legislation) 
92/117/EEC (zoonoses) 
92/118/EEC (animal products covered by other Community legislation) 
96/43/EC (financing of veterinary inspections and controls) 
96/93/EC (certification of animals and animal products) 
96/239/EC (Commission Decision on BSE emergency measures) 
Live animals and live animal products, e.g. semen, ova, embryos 
64/432/EEC (intra-Community trade in cattle and pigs) 
80/217/EEC (control of classical swine fever) 
80/1095/EEC (conditions for freedom from classical swine fever) 
85/511 /EEC (foot and mouth disease) 
92/3 5/EEC (African horse sickness) 
92/40/EEC (avian influenza) 
92/66/EEC (Newcastle disease) 
92/119/EEC (certain animal diseases, including swine vesicular disease) 
91/68/EEC (ovine and caprine animals) 
90/426/EEC (equidae) 
90/539/EEC (poultry and hatching eggs) 
88/407/EEC (deep-frozen semen of domestic animals of the bovine species) 
89/556/EEC (bovine embryos) 
90/429/EEC (porcine semen) 
90/667/EEC (disposal and processing of animal waste) 
91/67/EEC (aquaculture animals and their products) 
93/53/EEC (control of certain fish diseases) 
95/70/EC (bivalve molluscs) 
34 
Animal products, e.g. meat milk, game etc 
64/433/EEC (fresh meat) 
77/96/EEC (trichinellosis testing) 
77/99/EEC (meat products) 
71/118/EEC (poultry meat) 
91 /494/EEC (fresh poultry meat) 
91/495/EEC (rabbit meat and farmed game meat) 
92/45/EEC (wild game meat) 
94/65/EC (minced meat and meat preparations) 
86/469/EEC (residues testing programmes - valid until 1.7.97) 
88/146/EEC (hormonal substances - valid until 1.7.97) 
92/22/EC (thyrostats, hormones ban - from 1.7.97) 
96/23/EC (residues testing programmes - from 1.7.97) 
89/437/EEC (egg products) 
92/46/EEC (milk and milk based products) 
91 /492/EEC (live bivalve molluscs) 
91/493/EEC (fishery products) 
95/408/EC (Council Decision, prelisting of establishments) 
97/198/EC (Commission Decision. Imports of processed animal protein) 
97/199/EC (Commission Decision. Imports of petfoods) 
Animal welfare and zootechnics 
88/166/EEC 
91/628/EEC 
91/629/EEC 
91/630/EEC 
93/119/EEC 
94/28/EEC 
embryos) (laying hens kept in battery cages) 
(protection of animals during transport) 
(protection of calves) 
(protection of pigs) 
(protection of animals at slaughter) 
(zootechnical rules for importation of animals, sperm, ova and 
Foodstuffs controls 
89/397/EEC (official control of foodstuffs) 
93/43/EEC (hygiene of foodstuffs) 
93/99/EEC (official control of foodstuffs) 
35 
Plant health 
69/464/EEC (Potato Wart Disease) 
69/465/EEC (Potato Cyst Eelworm) 
74/647/EEC (Carnation leaf-rollers) 
93/85/EEC (Potato ring rot) 
77/93/EEC (organisms harmful to plants or plant products) 
2251/92/EEC (Commission Regulation on quality inspection of fresh fruit and 
vegetables) 
92/70/EEC (Commission Directive on recognition of protected zones) 
92/76/EEC (Commission Directive on protected zones exposed to particular health 
risks) 
92/90/EEC (Commission Directive on the registration of producers and importers) 
92/105/EEC (Commission Directive on plant passports) 
93/50/EEC (Commission Directive on the specification of certain plants) 
93/51 /EEC (Commission Directive on movement of plants in protected zones) 
94/3/EC (Commission Directive on interception of harmful organisms) 
95/44/EC (Commission Directive on movement of harmful organisms and plants) 
3 763/91/EEC (Council Regulation - agricultural products ref French overseas 
departments) 
1600/92/EEC (Council Regulation - agricultural products ref.Azores and Madeira) 
36 
ISSN 0254-1475 
COM(97) 183 final 
DOCUMENTS 
EN 05 10 15 
Catalogue number : CB-CO-97-202-EN-C 
ISBN 92-78-19575-8 
Office for Official Publications of the European Communities 
L-2985 Luxembourg 
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