Ellen Vos EU Food Safety Regulation in the Aftermath of the BSE Crisis

Ellen Vos
EU Food Safety Regulation in the
Aftermath of the BSE Crisis

ABSTRACT. Until the outbreak of the BSE crisis, many of the Community’s rules
relating to food safety regulation were mainly created on an ad hoc basis and/or
developed in the jurisprudence of the European Court of Justice. The BSE crisis,
however, clearly demonstrated that where important political interests are at stake,
this ad hoc approach is not sufficient to guarantee an effective and legitimate food
safety policy and decision-making free from manipulation and capture. Therefore,
the Commission has drastically revised its food safety policy. This article discusses
the main elements of the new policy followed by the Commission. It analyses the
new principles developed by both the Commission and the European Court of Justice.
In conclusion it discusses the remaining challenges and gives some suggestions to
further develop the emerging concept of Community food safety regulation.

The BSE1 crisis has shed some light on two issues which previously
had remained largely obscure: beef production and risk regulation. The
BSE crisis was first of all highly instructive in demonstrating the limits
of human intervention in nature, thus highlighting the necessity to
radically change the Community’s agricultural policy. It served to
enlighten some of the practices of intensive farming, which the general
public usually prefers to ignore:
[t]he link between the bright red, clean meat which appears on white plastic trays
wrapped in cling film on supermarket shelves and the animals – stunned, killed, bled,
eviscerated and sawn up on production lines in the slaughterhouse – has not been
obvious to the public now for many years (Chambers, 1999, p. 97).

   Apart from being upset by the thought that one could die from
eating meat, consumers were shocked by the realization that the agro-
food industry was producing beef by feeding meat and bone meal to
ruminants, “turning herbivores into carnivores and carnivores into
cannibals” (Chambers, 1999, p. 97). Obviously, most persons disliked
this revelation. Notwithstanding the efforts of several ministers and
heads of government at the Florence Summit in June 1996 to put
the public (and the beef industry) at ease by letting themselves be seen
whilst bravely eating beef, there was a dramatic drop in beef con-
sumption and a corresponding collapse of the beef market all over
the Community.

      Journal of Consumer Policy 23: 227–255, 2000.
       2000 Kluwer Academic Publishers. Printed in the Netherlands.

228                                                             Ellen Vos

   The BSE crisis was also an important lesson in risk regulation,
an increasingly important field for the Community to attend to. The
outbreak of the BSE crisis in March of 1996 clearly demonstrated
severe shortcomings in the Commission’s management in this
area.2 Not surprisingly, the institutional failures of the BSE crisis
resulted in a general public distrust in Commission action. It led to
an increasing awareness of both Community regulators and the general
public of the entanglement between law and science in Community
decision-making which necessitated drastic reform.
   This article aims at examining the impact which the BSE crisis
has had on food safety regulation by the Community. It starts with a
general discussion of the manner in which the EU has traditionally
regulated food safety. It will then consider the BSE crisis, the
institutional failures made by the Commissions, and the remedies
the Community has undertaken in response to the BSE crisis.
Subsequently, the main principles which currently govern food safety
regulation will be examined. In conclusion, the shortcomings of the
current system and the Commission’s attempts to address these short-
comings will be discussed, followed by a reflection on the remaining
challenges.

FOOD SAFETY REGULATION THROUGH COMMITTEES

Food law has a long-rooted tradition at national level, where regula-
tors combat food adulteration, fraud, and dangerous food.3 As these
national provisions generally constituted trade barriers, foodstuffs were
among the Community’s first priorities for harmonization to elimi-
nate trade barriers. Annually, numerous new food products enter the
market, increasing the range of products and processes the Community
needs to regulate. Today, the Community regulates a wide range of
food products varying from specific food substances to novel foods
(for an overview, see, e.g., O’Rourke, 1998). The Community must
hereby take account of both traditional products, i.e., those gener-
ally locally produced according to customary methods, and fabricated
products, often produced by big industries using modern technology.
   Importantly, food is, by its very nature, a means of survival for
human beings. Thus, the assurance of its safety and quality is of the
utmost importance to consumers, producers, and public authorities.

EU Food Safety Regulation in the Aftermath of the BSE Crisis         229

Food regulation by the Community must therefore accommodate
health and consumer protection (e.g., Chambolle, 1988), fair compe-
tition, new technologies, requirements relating to the Community’s
poorer regions, etc. The complexities of food regulation are enhanced
by continuously changing public attitudes to food and by the enormous
economic consequences of the Community’s harmonization activi-
ties in the food industry, which is one of its largest industries.4
    In this way, the Community is confronted with the general diffi-
culties stemming from product safety or risk regulation which relate
to the need to carry out assessments of the risks associated with
specific substances or products (risk assessment) and to decide on what
to do about these risks (risk management) (Breyer, 1993, p. 9 and
following; Lave, 1987). This entails inter alia the gathering of the
relevant scientific data, the assessment and management of risks,
and the establishment of monitoring procedures. To govern this
“republic of science” (Jasanoff, 1995, p. 93), the Community institu-
tions have designed ingenious but complex regulatory patterns by
means of which they reconcile the tensions between product safety,
market integration, and legitimate national regulatory concerns, viz.:
committees, agencies, and private bodies (self-regulation). For
example, for pharmaceutical products the Community has created an
agency (the European Agency for the Evaluation of Medicinal
Products) which inter alia advises the Commission on the safety of
medicines, whilst for technical consumer products the Community
relies on the private standardization bodies (CEN and CENELEC)
to elaborate the essential safety requirements. For food regulation
the Community has traditionally resorted to committees.
    The committee structure in the field of foodstuffs has been char-
acterized by the existence of the three main functional types of
committees, namely: the Scientific Committee on Foodstuffs (SCF),5
which is composed of independent scientific experts, the Standing
Committee on Foodstuffs (StCF),6 which consists of national repre-
sentatives, and the Advisory Committee on Foodstuffs (ACF), which
is composed of representatives of the various interest groups.7 All three
committees have a precise function. The Scientific Committee on
Foodstuffs is designed to incorporate scientific advice into the
decision-making process; the Advisory Committee on Foodstuffs exists
to inform the Commission of the opinions of the various interests
involved; and the Standing Committee on Foodstuffs is designed to

230                                                              Ellen Vos

ensure the political approval of the Member States in the implementing
phase. In this way, the Community distinguishes between risk assess-
ment, carried out by the SCF, and risk management, carried out by
the Commission together with the StCF and the ACF. Although the
latter committee was originally designed to enhance the social accept-
ability of Community food regulation, it is currently not consulted
by the Commission (Joerges & Neyer, 1997).
   Analysis of the committee structure in the food sector has revealed
the great impact which committees have on Community food regu-
lation and the important functions they perform in food regulation
(Vos, 1999a). In general, the Commission consults the SCF to obtain
scientific advice. The Commission subsequently discusses this advice
with the representatives of the Member States within the framework
of StCF and at times with representatives of interested parties within
the framework of ACF.
   Although the SCF has largely been neglected in the (institutional)
debate on comitology, practice reveals it to be one of the most impor-
tant committees, determining the scientific basis for every decision on
food. This was once more underlined by the BSE crisis. Since food-
stuffs issues are politically sensitive, it comes as no surprise that the
Commission has tended to follow closely the opinion of the SCF.
   The political sensitivity of foodstuffs may similarly explain the exis-
tence of the StCF, which gives the Member States particular weight
in the risk management of food by means of the regulatory com-
mittee procedure (Vos, 1999b).8 The Member States’ desire to be
involved in Community food safety regulation is not to be seen as
just a matter of promoting national protectionist interests, but much
more as the inevitable result of the fact that risk assessment and
management are so complex, uncertain, and controversial that they
cannot be conducted without reference to normative social values.
In its role as a regulatory committee, the StCF is able to influence
the Commission’s decision-making to a very great extent, even if
the Commission remains well aware of its own responsibility. Hence,
it provides an institutional response to the legitimate concerns of
the Member States to remain involved in the implementation of
food regulation, and allows them, during any phase of the decision-
making process, to check the exercise of powers by the Community
institutions.

EU Food Safety Regulation in the Aftermath of the BSE Crisis         231

THE OUTBREAK OF THE BSE CRISIS AND THE INSTITUTIONAL
FAILURES OF THE COMMUNITY

Until the outbreak of the BSE crisis, Community regulation on food
safety was largely led by pragmatic considerations. One lacked a
coherent concept of risk regulation in which the institutional struc-
tures were based on the need to accommodate the complexities of
science-based decision-making. This pragmatic approach could be
explained by the fact that the Community had not been designed to
deal with risk regulation. On the surface, for many years this com-
mittee-based food safety regulation appeared to function generally well
and both national authorities and the Commission were satisfied.
   Over the years the SCF, for example, had gained an outstanding
reputation due to its serious and independent working methods (Van
der Heijden, 1992). Confidence in the work of the SCF was expressed
by the European Court of Justice (ECJ) in several cases, ruling that
when Member States consider for approval or refusal the circulation
of a product on their markets, they should take account of the findings
of international scientific research and, not least, the work of the SCF.9
The same confidence led the Community legislature in many direc-
tives to make Commission consultation of the SCF compulsory
where questions of human health protection were involved. Therefore,
the functioning of this Committee and the rules developed by the
Commission attracted neither significant political nor academic
attention.
   The StCF, too, functioned to the great satisfaction of all participants
(Commission and national representatives), although it was also
criticized for often being too secretive, since neither its activities
nor its membership were made public. Consequently, it is argued
that the StCF constitutes a means of bridging the horizontal and
vertical division of powers and that it has secured subsidiarity in a
pragmatic way (Vos, 1997). In this vein, committees would be a forum
for the development of novel and mediating forms of interest for-
mation and decision-making and thus contribute to the legitimacy of
Community decision-making, based upon a model of “deliberative
supranationalism” (Joerges, 1999).
   Yet, the BSE crisis shattered this image. It provided important
insights into the actual regulatory policies on risk followed by the
Community authorities which shook up both regulators and the general
public (see, in general, Bradley, 1999; Westlake, 1997). From the time

232                                                           Ellen Vos

of the discovery of the disease in 1985, the United Kingdom, other
Member States, and the Community adopted various measures to try
to overcome this disease. Yet these measures proved insufficient for
its extermination.10 Moreover, in 1996, it was discovered that a link
between BSE and Creutzfeldt-Jacob disease could not be ruled out,
and effectively confirmed that BSE could be transmitted to humans.
The official announcement of this discovery by the UK authorities,
in March 1996, triggered a crisis of confidence in the manner beef was
produced and regulated among both citizens and regulators.
    Although the Commission immediately reacted and banned the
export of British beef,11 in hindsight it appears that the Community
authorities, in particular the Commission, made severe mistakes in
the handling of the BSE crisis. Evidence of mismanagement was
disclosed by the Temporary Committee of Inquiry into BSE, set up
by the Parliament in July 1996.12 This Committee revealed that during
1990–1994 when the disease had reached crisis levels, the Commission
had followed a true policy of “disinformation.”13 This policy had not
only been confined to misleading public opinion, but had played a
major role in relations both among the Community institutions
themselves (legislative activity on BSE by the Community had been
suspended and no debates on BSE were held in the Council) and
with the Member States (the then Commissioner on Agriculture,
MacSharry, had in 1990 prevented both France and Germany from
restricting the import of British beef by threatening them with
Court proceedings). The Inquiry Committee, moreover, observed that
the Commission had been very much influenced by “British thinking”
due to the number of British officials present in the two committees
operating in this field: the Scientific Veterinary Committee (composed
of scientists with a high-standing reputation) and the Standing
Veterinary Committee (composed of national representatives). The
operation of the Standing Veterinary Committee during this period had
been clearly put under political pressure, whilst the information
diffused by the Scientific Veterinary Committee had not been free
from political influence either.14 In addition, there had been little
co-ordination and co-operation between the various DG’s of the
Commission and the relevant scientific committees (e.g., with the
SCF).
    It was evident that this reconstruction of the regulatory policy of
the Commission necessitated a change in the Community’s approach
to risk regulation. The Inquiry Committee therefore urged for greater

EU Food Safety Regulation in the Aftermath of the BSE Crisis         233

transparency as regards action on BSE, particularly in relation to
the conditions of the functioning and work of the scientists on the
scientific committees; foremost advocating transparency and reform
of the rules governing the work of these committees to ensure inde-
pendence and appropriate funding of the scientists and the publication
of debates and dissenting opinions.15 Importantly, the BSE crisis
disclosed the deficiencies of the ad-hoc approach followed by the
Community and highlighted the need for a more conceptual approach
to food safety regulation; a concept which, taking into account the
increasing difficulties regarding the legal construction of scientifically
controversial issues in Community law which result from the entan-
glement between law and science, should define the nature and purpose
of risk assessment and management (viewed in the light of the trend
towards the internationalization of scientific expertise and risk assess-
ment procedures). Such a concept should explicitly recognize that risk
regulation is permeated by social and political considerations and
should be based on negotiation and deliberation with civil society.

REMEDIES BY THE COMMUNITY

The Commission’s Response

Being confronted with the evidence gathered by the Inquiry Committee
on BSE and accused of a lack of transparency and of manipulation
by the Parliament,16 it was not surprising that shortly after the pub-
lication of the Inquiry Committee’s Report, Jacques Santer, then
President of the Commission, rapidly announced before Parliament
that the Commission had developed a new approach to food safety and
that it would radically reform the Directorates dealing with human
health.17

Institutional reform of the Commission. Prior to the BSE catastrophe,
in addition to the SCF, the Commission had set up scientific com-
mittees in a wide range of fields, such as pesticides18 and cosmetics,19
each falling under the responsibility of the corresponding units of
the Directorates-General of the Commission. However, the opera-
tions of such committees had demonstrated, that they were not free
from “outside,” non-scientific influence. Therefore, the Commission
first carried out an internal re-organization. It decided to place all

234                                                              Ellen Vos

the relevant scientific committees under the authority of DG XXIV
in order to avoid future intermingling between economic (industrial
or agricultural policy) interests and health protection, and to control
the activities of these committees.20 At the same time, DG XXIV
was renamed into the Directorate-General on Consumer Policy and
Consumer Health Protection21 (now named DG SANCO).

The 1997 New Approach. The Commission speedily designed a New
Approach to Consumer Health and Food Safety.22 It moved away from
an approach emphasizing food security, i.e., the provision of food in
the context of agricultural policy as laid down in Article 33 (1) EC,
and moved towards an approach emphasizing food safety, linked to
the protection of consumers (Valverde, Piqueras García, & Cabezas
López, 1997). The Commission intended to adopt a more concep-
tual approach to food safety. It first stated that the main objective of
the Community’s approach to food safety is to reinforce consumer
health protection. Closely linked with this and in order to restore
consumer confidence in food regulation and the manner in which food
is produced, it declared that the protection of animal and plant health
and animal welfare would also be included in this objective.
    The Commission announced that it would base its approach on
three principles: separation of the responsibility for legislation and for
scientific advice, separation of the responsibility for legislation and
for inspection, and greater transparency and information throughout
the decision-making process and inspection (see below). It proclaimed
three instruments as being essential for an effective consumer health
policy: scientific advice, risk analysis, and control. It stressed that
scientific advice is and will be the basis for all the regulatory activ-
ities of the Community and that this would mainly come from
the scientific committees. These committees would be based on
excellence, independence, and transparency of activities. In addition,
it emphasized the need for risk assessment procedures in order to
identify control priorities, the reorganization of control activities to
ensure that the whole production chain is covered, as well as the intro-
duction of formal audit procedures to allow assessment by national
authorities.
    Together, these principles form part of six basic goals identified
by the Commission in its Green Paper on the General Principles of
Food Law in the EU,23 which it presented in addition to its New
Approach, to ensure a high level of protection of public health, safety

EU Food Safety Regulation in the Aftermath of the BSE Crisis       235

and the consumer; to ensure the free movement of goods within the
internal market; to ensure that the legislation is primarily based on
scientific evidence and risk assessment; to ensure competitiveness
of European industry and enhance its export prospects; to place the
primary responsibility for safe food on industry, producers, and sup-
pliers, using hazard analysis and critical control point (HACCP) type
systems, which must be backed by effective official control and
enforcement.

The Remedies of Amsterdam
BSE influenced the political agenda of the 1996/7 IGC, too. The
amendments to the Treaty of Amsterdam which concern health and
safety protection represent principally the institutional repercussions
of the BSE crisis (Duff, 1997; European Policy Centre, 1997). Hence,
the reformulation of Articles 95, 152 and 153 EC must all be inter-
preted as a strong desire of the Member States and the Community
institutions not to repeat the errors made in the BSE affair, hereby
taking particular account of the allegedly market-influenced policy
followed by the Commission.
   The Treaty of Amsterdam importantly inserts into Article 95 (3)
EC the Commission’s obligation to take particular account of “any
new development based on scientific facts” in addition to the already
existing obligation to start from a high level of health and safety
protection when proposing harmonization measures. This amendment,
which was not addressed by the individual preparatory documents
for the Intergovermental Conference,24 appears to appease the need for
a greater degree of rationality and quality of Community legislation.
It confirms the importance attached by the European Court of Justice
to scientific expertise as the basis for decision-making by the
Commission, particularly in Angelopharm (Joerges, 1997, p. 302 and
following).25 The new paragraph (5) of Article 95 EC allows Member
States to introduce new national measures based on new scientific
evidence relating to the protection of the environment or the working
environment only when a problem is specific to that Member State,
and has arisen after the adoption of a harmonization measure.
   Furthermore, the Amsterdam Treaty amends Article 152 EC so as
to require all Community policies and actions to “ensure” (and no
longer “contribute to”) a high level of human health protection in
general. Importantly, Community action is no longer directed solely

236                                                               Ellen Vos

towards the prevention of diseases but towards the improvement of
public health in general and the prevention of sources of danger to
human health. In addition, Article 152 EC empowers the Community
to adopt, by way of derogation from Article 37, veterinary and phyto-
sanitary measures which have as their direct objective the protection
of public health. The Amsterdam Treaty moreover adds to the current
text of Article 153 EC that the Community must contribute to pro-
tecting the health and safety and economic interests of consumers.

PRINCIPLES OF FOOD SAFETY REGULATION IN THE AFTERMATH OF
THE BSE CRISIS

The Obligation to Take Account of Scientific Facts Under Article
95 (3) EC

The insertion by the Amsterdam Treaty in Article 95 (3) EC of an
obligation for the Commission in its harmonization proposals to take
account of “any new development based on scientific facts” clearly
attempts to bring in some kind of scientific rationality. The phrasing
of the new Article 95 (3) EC calls attention to the Court’s case law
reviewing the proportionality of national legislative measures causing
trade barriers. In these cases, the ECJ has consistently obliged Member
States which invoked Article 30 EC or safeguard clauses to base
their views on scientific research (see, in general, Joerges, 1997), in
particular requiring them to take account of the findings of interna-
tional scientific research.26 The amendment by the Amsterdam Treaty
thus mirrors the ECJ’s jurisprudence: not only the Member States,
but the Commission, too, is obliged to take account of the newest
scientific evidence.
   Yet, the wording of the amendment is not non-problematic. First,
according to the text, the obligation to take account of scientific “facts”
is conferred on the Commission and not on the Community legisla-
ture: the Parliament and the Council. This does not, however, mean
that the Community legislature is not obliged to base its legislative
acts on scientific expertise. This seems to be confirmed by the require-
ment laid down in the second sentence of Article 95 (3) EC that within
their respective powers, the European Parliament and the Council
will also “seek” to achieve this objective. This requirement seems
to reject earlier case-law of the ECJ27 in which the latter demon-

EU Food Safety Regulation in the Aftermath of the BSE Crisis        237

strated great reluctance to question “the wisdom of any measures
approved by the Council,” merely examining whether the relevant
measure was vitiated by a manifest error or misuse of powers, or
whether the authority in question had manifestly exceeded the limits
of its discretion.
   For example, in the Hormones Case,28 the ECJ had to consider
the correct legal basis of Council Directive 85/649/EEC prohibiting
the use of hormones in livestock farming.29 The United Kingdom
argued that, in view of its health protection objectives, former Article
100 (now Article 94 EC) was the correct legal basis while the Council
defended its choice of former Article 43 (now Article 37 EC). After
having determined former Article 43 to be the correct legal basis of
this Directive, the ECJ was asked to judge whether the Council had
a duty to consider a scientific report, to which it would have had to
refer in its statement of reasons. The ECJ however refused to go into
scientific details and formalistically ruled that since the Hormones
Directive30 imposed such an obligation solely on the Commission,
the Council was not obliged to refer to such aspects.31 Advocate
General Lenz was more explicit. He claimed that the scientific report
highlighted only one aspect of the problem, viz., the health of con-
sumers, and pointed to the fact that account was also to be taken of
the prejudices of the consumers towards hormones in meat. Yet, he
was certainly wrong in asserting that once it was established that the
Hormones Directive served the agricultural policy, there was “really
no reason to examine the health problem.” To be sure, in the case at
issue scientific evidence had considered the use of growth hormones
in beef production to be harmless to human health (in contrast with
the results which are currently presented in the context of the EU-USA
conflict on beef with hormones in the framework of the WTO!).32 It
is highly unlikely that the ECJ or the Advocate General would have
used the same reasoning if scientific reports had come to the opposite
conclusion.
   Secondly, reference to “scientific facts” is likely to become a
subject of debate (and jurisprudence) since no such thing as “objec-
tive science” and hence “hard facts” exist; given the present state of
our knowledge, scientists are not likely to constrain themselves to
addressing “purely scientific issues” (Jasanoff, 1990). It is true that
in view of scientific uncertainty, adequate solutions cannot and
should not be furnished by science and scientists alone.33 Indeed, the
wording of Article 95 (3) EC does not (and cannot) oblige the

238                                                               Ellen Vos

Commission to adhere to scientific “facts,” but to “take account” of
them, thus keeping a potential use of the precautionary principle by
the Community legislature in this field open (see also below). Hereby
questions will be bound to arise as regards the nature of risk and
whether it is sufficient to prove the existence of a hypothetical risk.
Inevitably this phrasing will lead to questions as to the “frontiers of
science” in litigation about decisions based on scientific evidence
before the ECJ and may result in endless litigation procedures (see,
in the American context, Shapiro, 1997a).

Principles of Food Safety Regulation Laid Down in the
Commission’s 1997 New Approach
Excellence, independence, and transparency of scientific advice. The
New Approach principles of excellence, independence, and trans-
parency which will govern the functioning of the scientific committees
have been elaborated in a new decision on the eight scientific com-
mittees operating in the institutional structure of the Community
which the Commission formally adopted in July 1997.34 In this
Decision it laid down general requirements applicable to all of these
committees. It requires of its members excellence (risk evaluation is
undertaken by eminent scientists), independence (to ensure that the
scientists are free from conflicting interests), and transparency of activ-
ities (easy access to information on the activities of the committees
and their advice). In addition, the Commission created a new com-
mittee, the Scientific Steering Committee, which has to co-ordinate
the activities of these committees. 35 This Committee is composed of
the chairpersons of the scientific committees and eight scientific
experts not being members of any other scientific committee.
    In accordance with the principle of excellence, the Commission has
itself set selection criteria for the appointment of the committee
members. Consequently, a selection jury composed of members of
the Scientific Steering Committee will give “preference” to candidates
who possess: professional experience in the field of consumer health
and more specifically in the areas covered by the field of compe-
tence of the committee concerned; experience in risk assessment;
experience in delivering scientific opinion at national or international
level; professional experience in a multidisciplinary and international
environment; attested scientific excellence; experience in scientific
management.36

EU Food Safety Regulation in the Aftermath of the BSE Crisis         239

   As regards the principle of independence, the Decision determines
that the members of the scientific committees act “independently of
all external influence.”37 To this end, committee members must
annually inform the Commission of any interests which might be
considered prejudicial to their independence, and they (as well as
external experts) have to declare at each meeting any specific interest
potentially conflicting with their independence. Of further impor-
tance for the independence of committees is that the agenda is drawn
up by the committee themselves and not by the Commission. Although
provisions on this point were lacking, this has already occurred in
practice. More transparency on the activities of the scientific com-
mittees is ensured through publication of its membership, agendas,
minutes, and opinions (including minority opinions) whilst respecting
the need for commercial confidentiality.38 In this connection, partic-
ular use is made of the Internet.39 Importantly, committee members
and other experts are remunerated for their services, in addition to
the reimbursement of travel and subsistence allowances.40 In the past,
the lack of funds had made it difficult to attract scientific experts of
a high reputation.

The Commission’s definition of risk analysis. The Commission has
defined risk analysis as “a systematic procedure including risk assess-
ment, risk management, and risk communication”.41 Risk assessment
is defined by the Commission as scientific evaluation of hazards and
the probability of their emergence in a given context. It forms the foun-
dation of scientific advice, offering the Commission a sound basis
for proposals and measures on health and safety. Risk management
is viewed by the Commission as the assessment of all measures making
it possible to achieve an appropriate level of protection, which will
include the evaluation of policy alternatives resulting from scientific
assessment and the desired level of protection. Risk communication
consists of the exchange of information with all parties concerned,
which in the Commission’s view should be as transparent as possible.
In this way, risk analysis would enable the Commission to play an
interface role between the scientific community and the political world
and elements of civil society.

Control and inspection. The new approach to control and inspec-
tion confirms that the responsibility rests with the Member States.
The Commission’s intention is merely to monitor the manner in

240                                                             Ellen Vos

which the Member States undertake their responsibilities through its
Food and Veterinary Office. This Office is at present responsible for
monitoring the observance of food safety and veterinary and plant
health regulation, including on-the-spot inspections of individual
establishments in the Member States and under certain circumstances
direct interventions such as the collection of samples of phytosani-
tary checks. In addition, the Commission’s intention is to reinforce the
inspection and emergency systems, to have better priority setting,
and to introduce formal audit procedures to assess the performances
of national competent authorities.

Elements of a Precautionary Principle in the Court’s Case Law
The precautionary principle was explicitly introduced by the
Maastricht Treaty in the EC’s environmental policy, in addition to
the prevention principle and the polluter pays principle (Article 174
(2) EC). The principle finds its roots in German environmental policy
(Vorsorgeprinzip), which covers a combination of caution, care of
the future, and providing for the future (e.g., Boehmer-Christiansen,
1994). Although there is no unequivocal definition of the precautionary
principle, it may be said that it generally refers to situations in which
regulatory authorities are allowed to adopt measures to prevent the
occurrence of certain risks although strong scientific evidence on
causal relationships of the extent of damage is lacking. Broadly
speaking, the precautionary principle states that, with respect to the
environment, one should err on the side of caution; uncertainties
should be decided in favour of the environment.
   The judgment of the ECJ in the BSE Case demonstrates the ECJ’s
willingness to extend the use of the precautionary principle to the field
of human health protection. In this Case,42 the United Kingdom had
sought to annul the ban on the export of British beef and bovine
products that the Commission had imposed in March 1996. According
to the British Government, these products did not present a danger
to human health so the ban could not be justified on the basis of human
health protection; the risk to human health was “negligible, having
regard to the measures already adopted or related to the period before
steps to control BSE had been taken.” The British Government argued
that the underlying purpose of the ban was more of an economic nature
aimed at stabilizing the situation, reassuring consumers, and safe-
guarding the beef industry. With the Commission, however, the ECJ

EU Food Safety Regulation in the Aftermath of the BSE Crisis                     241

found that on the basis of new scientific findings BSE was no longer
considered to be merely a disease affecting cattle, but was a hazard
to human health. This authorized the Commission to adopt safeguard
measures which were based above all on considerations relating to
human health protection. The Court moreover rejected the United
Kingdom’s argument that the Commission’s decision bore no pro-
portion to the aim of health protection. The ECJ held here that:

[w]here there is uncertainty as to the existence or extent of risks to human health,
the institutions may take protective measures without having to wait until the reality
and seriousness of those risks become fully apparent. 43

   Importantly, the Court seems herewith to recognize that the
precautionary principle may be used in fields other than the envi-
ronment.44 Also the Court of First Instance seems to recognize the
use of the precautionary principle outside the field of the environ-
ment.45

Enhancing the Transparency of Committee Procedures
(Comitology)
The BSE crisis equally confirmed the long-lasting critique of the
obscurity of the activities of committees, and especially those which
assist the Commission in the exercise of implementing powers dele-
gated to the latter (generally indicated as comitology; see, for an
overview of the committee procedures, Vos, 1999b, and Weatherill
& Beaumont, 1999, pp. 61–67). Although these committees may
form a flexible and appropriate way of including the interests of the
Member States in risk management and of addressing subsidiarity
concerns, the flexibility has at the same time created secrecy about
their activities. In addition to the inter-institutional battle on the
legality of the procedures by means of which such committees need
to be consulted (see, e.g., Bradley, 1999), these committees have
generally been criticized for the lack of information about their rules
of procedures, membership, meeting dates, agendas, and opinions.
Only through empirical research and personal contacts has a layer
of this secrecy been peeled away (Joerges & Falke, 2000; Vos, 1999a).
Hence, from the point of view of transparency, these committees
have left much to be desired. In practice, therefore, under pressure
from the Parliament, various agreements were concluded in which
the Commission promised to make committee activities more open.46

242                                                           Ellen Vos

   The lingering battle on comitology was eventually addressed by the
1996/1997 IGC which, in a Declaration attached to the Amsterdam
Treaty, summoned the Commission to submit a proposal for a revision
of committee procedures. Consequently, on the proposal by the
Commission,47 the Council adopted a new Comitology Decision in
July 1999.48 Although not a direct consequence of the BSE crisis,
this Decision aims, in addition to the simplification of existing com-
mittee procedures, to break open the secrecy surrounding these
committees and to codify existing practice and case law.49 Hence,
the activities of the StCF and other committees will be governed by
these rules. The Decision requires the committees to adopt their own
rules of procedures and to apply the rules on public access to docu-
ments applicable to the Commission to committee documents.50
Moreover it obliges the Commission to inform the Parliament of the
committee agendas, draft measures submitted to the committees,
results of voting records, summary records of the meetings, and lists
of committee members. Furthermore, it requires the Commission to
publish annually a report on the operation of committees.

THE FUTURE OF EC FOOD SAFETY REGULATION

Shortcomings of the Current System

The measures adopted by the Commission have, however, proved
insufficient to restore public confidence. Subsequent scares of food
safety (in particular concerning dioxin contamination) increased public
awareness, further undermining the confidence of consumers in the
capacity of the food industry (in its broadest sense) and the public
authorities to ensure that their food is safe (Byrne, 1999). Moreover,
distrust in Community regulation, particularly its system of scien-
tific expertise, may underlie the ongoing conflict regarding British
beef, in which France and Germany continue to refuse the import of
British beef notwithstanding the Community’s lifting of the embargo
on the export of British beef51 based on the positive opinion of the
Scientific Steering Committee. At present, it is not clear whether the
antagonistic attitudes of France and Germany towards British beef
are prompted (and justified) by different approaches to risk regula-
tion and scientific expertise or rather by pure political motives.
    Although the principles of “excellence,” “independence,” and

EU Food Safety Regulation in the Aftermath of the BSE Crisis          243

“transparency” have been an important step in the direction of a
more coherent system of risk regulation, the question arises whether
the drawing up of rules which govern scientific advice should not
be a task for the Community legislature (instead of the Commission).
In addition, the Commission’s 1997 New Approach relates only to
scientific advice given by the scientific committees and does not
extend these principles to the rest of the process of risk regulation.
It thus fails to take account of the role of Member State representa-
tives within the StCF or of interest group representatives within the
ACF or otherwise. Although the activities of the StCF are governed
by the new Comitology decision, it will be necessary to reflect upon
its role and tasks, its relationship with other similar committees
operating in related fields, and more generally the part played by
the Member States within Community food safety regulation.
    Importantly, establishing these principles is not sufficient for effec-
tive and legitimate food safety regulation. What is strikingly lacking
in the 1997 New Approach of the Commission is the manner in
which the Community needs to deal with uncertainty, to define what
is acceptable risk, and thus to define the role of the precautionary prin-
ciple as a regulatory principle of food regulation. In other words,
attention should be paid not only to the scientific facts, but also the
manner in which one deals with them.
    This become even more important when the Community is called
upon to justify its safety measures in international fora, such as its ban
on hormones in beef within the framework of the World Trade
Organisation (WTO) (Scott, forthcoming). It is noteworthy that in
its approach the Commission insists on severing risk assessment from
risk management; with assessment performed by scientific experts
in the SCF and the acceptability of risk discussed by the Commission
and national representatives. However, such an approach denies the
difficulties of separating risk assessment from societal and political
values (Mayo & Hollander, 1991). This is underlined by the fact that
in situations where scientific activities attract great attention from
the public, even scientists – “very esoteric, sophisticated, all-knowing,
discerning individuals”52 – are likely to be subjected to powerful polit-
ical pressure. Pressure was, for instance, openly admitted by scientists
working on BSE within various scientific committees. It makes the
need for greater proceduralization of risk evaluation even more com-
pelling. This would likewise address the international debate, in which
so many diverging societal and political values emerge and which will

244                                                                          Ellen Vos

inevitably resort to apparent “objective” scientific evidence.53 Most
vitally, the 1997 New Approach fails to address the role of civil society
in food safety regulation.
   On a more practical level, it can be observed that the existing
committee system has struggled with the increase in demands placed
upon it. The ever-increasing flow of Community activities on food-
stuffs (such as novel foods) has led to an overburdening of both the
committees and their members, which makes it difficult to continue
on the current basis. One exhausted member of the Scientific Steering
Committee, for example, sketched his own situation as follows:
Last Monday I attended a meeting of the human risk exposure group of our BSE
committee which operates under the SSC. On Thursday I will have my 26th trip to
Brussels. Next week I will have two days which will be my 27th trip to Brussels on
BSE. I have a job where I am Professor of Nutrition at the University of Dublin. I have
to teach, organise research. I have to work within the university. I have to raise
funds. I have to work on Irish government committees and so on. Professor Pascal
asked a question yesterday, can this continue? The answer is no. It cannot continue. 54

   He therefore urged for a more permanent structure, such as a food
agency with a greater number of technical experts who would be
able to carry out a significant amount of the background work:
so that expert committees, when they come to Brussels, are not going to have to do
anything more than read a document prepared by others under their direction and
say: yes, you have it right. At the moment, before I go to a meeting, I must go on
the Internet and take off documents. I have to read them. I go to the meeting and
participate in that. I come out of the meeting with work. That work has to be done
quickly before the next meeting which is always two weeks away, because we meet
every two weeks. That is unsustainable. 55

    These issues have forced the Commission to rethink and refine
its approach to food safety.

The Commission’s 2000 White Paper on Food Safety
In its White Paper on Food Safety of 12 January 2000, the Commission
endeavours to address some of these problems.56 The Commission
emphasizes that the EU food policy must be built around high food
safety standards which serve to protect and promote the health of
the consumer. Although the Commission considers that health pro-
tection should take priority, it states that also economic, social, and
environmental issues should be taken into account. To ensure a high
level of consumer health protection, the Commission intends to base
its food safety policy on a “comprehensive and integrated approach,”

EU Food Safety Regulation in the Aftermath of the BSE Crisis        245

which would cover the whole food chain and all food sectors. It would
be used in the Member States and in international and EU decision-
making fora, and at all stages of decision-making. The three pillars
of food safety – risk assessment (scientific advice, data gathering
and analysis), risk management (regulatory and control aspects), and
risk communication (consumer information) – would form the means
for achieving such an integrated approach. The Commission recog-
nizes the importance of defining the role of all “stakeholders” (feed
and food producers, farmers, the national and international compe-
tent authorities, the Commission itself, and consumers) in the food
chain. Interestingly, although in practice the Commission has not
consulted the ACF for some years now, the Commission intends to
set up a new committee, the Advisory Committee on Food Safety,
in order to improve the involvement of these stakeholders in the
Community’s food policy, herewith streamlining the existing advisory
committees.57
   Importantly, the Commission has announced its plans to apply the
precautionary principle to food safety decisions, and further elaborates
on this in its recent Communication on the use of the said principle.58
Furthermore, the Commission emphasizes the importance of the prin-
ciple of transparency and confirms that risk analysis should be the
basis of its food safety policy. To create more coherent and transparent
food safety rules, the Commission intends to propose a general food
safety law, which will embody all the principles of food safety. The
Commission also considers that other legitimate factors relevant for
health protection and for the promotion of fair practices in food trade
can be taken into account in the decision-making process. In this
respect it refers to the work currently undertaken in particular by the
Codex Alimentarius, which studies the definition of the scope of
such legitimate factors. Moreover, the Commission proposes to
create, in close collaboration with the Member States, a general frame-
work for the development and operation of control systems. This
framework should be supported by the development of easier and more
rapid enforcement procedures in addition to the existing infringe-
ment procedures.
   The Commission promises to use the best available scientific advice
in developing food safety measures, based on risk assessment, risk
management, and risk communication. For scientific advice, the
Commission no longer wants to resort to the overburdened scientific
committees. Instead, it proposes the creation of an institutional novelty

246                                                           Ellen Vos

in this field: a – long awaited for (Snyder, 1994) – European Food
Authority.59 Whilst denying the Authority any regulatory powers,
the main tasks of this new agency will consist of the provision of
scientific advice, the gathering and analysis of information, and the
communication of risk. According to the Commission, the Authority
would have to demonstrate the highest levels of independence,
scientific excellence, and transparency in its operations. The Food
Authority would be at the centre of a network of scientific contacts,
i.e., the national scientific agencies and institutions. It would not
only act as a source of scientific excellence, it would also be able to
give consumers advice and guidance on important safety develop-
ments. In this way it would contribute to a high level of consumer
protection in the field of foodstuffs through which consumer confi-
dence would be restored. The Authority should have an “easily
accessible location.” Although the Commission has not yet disclosed
the institutional design of this agency, its functions, as well as the
proposed network system by means of which the agency should be
embedded in the national agencies and institutions, bear strong resem-
blance to those of the European Agency for the Evaluation of
Medicinal Products (EMEA), which assists the Commission in the
authorization of pharmaceuticals.

Remaining Challenges
Until the outbreak of the BSE crisis, many of the Community’s rules
relating to food safety regulation had been created on an ad hoc basis
and/or developed in the Court’s jurisprudence. The BSE crisis has
clearly demonstrated that where important political interests are
at stake, the ad hoc approach to food regulation followed by the
Commission is not sufficient to guarantee an effective and legitimate
food safety policy and decision-making free from manipulation and
capture. Consequently, the incoherence which resulted from the
essentially pragmatic approach of the Community institutions to
food safety and, more generally, risk regulation needed to be com-
pensated for by general rules, ensuring inter alia more openness and
legitimacy in regulatory decision-making on food as well as greater
consistency and generality of application. In response to the BSE
crisis, the Commission has, in fact, presented a more coherent
approach to food safety based on true “principles” of separation of the
responsibility for legislation and scientific advice, separation of the

EU Food Safety Regulation in the Aftermath of the BSE Crisis         247

responsibility for legislation and inspection, and greater transparency
and information throughout the decision-making process and inspec-
tion, whilst making sure that the scientific advice given is based on
excellence, independence, and transparency. In its White Paper on
Food Safety the Commission proposes to further refine and reinforce
these principles.
   Whilst the Commission’s initiatives are to be welcomed, a few
comments should be made.
   First, the creation of the proposed European Food Authority must
be viewed against a more general background in which there is a
call for a greater functional decentralization to agencies within the
context of the Commission’s reform (Dehousse & Majone, 1999). 60
The need for further reform of the Commission stems from criticism
of the way the Commission dealt with the BSE crisis, criticism that
was further exacerbated by the recent corruption scandals, revealing
both unacceptable conduct of some Commissioners and serious man-
agerial inadequacies of the Commission.61 To a large extent, therefore,
the desire to resort to agencies stems from attempts to encounter
deficiencies and sentiments of misgivings towards the Commission.
The advantages of agencies – as compared to committees – would
be that they would find it easier to use outside experts and to produce
valuable information and scientific expertise, and that they could foster
greater transparency and accountability, while reducing the
Commission’s workload so as to enable it to concentrate on policy
matters of a more strategic nature. Particularly in the aftermath of
the BSE crisis, resort to agencies could cultivate credibility, clarity,
and public confidence and thus enhance EU legitimacy. For example,
the European Food Authority could, as the Commission sees it, play
an important role in providing information to consumers on food safety
issues and ensure that they can make better informed choices, hereby
enhancing their confidence in food safety.
   The call for greater resort to agencies is first and foremost based
on the desire to relieve the Commission of specific administrative
tasks, which would leave the Commission greater room to concentrate
on giving political direction. The Commission should thus primarily
act as an “administration de mission” and identify the areas in which
action by the Community is necessary and would not be entangled
in the daily management of EU policies; agencies, bringing together
technical and economic expertise, should deal with the latter (Majone,
1996).

248                                                               Ellen Vos

    Yet, especially in health and safety and environmental regulation,
a strict division between mere managerial and scientific tasks and
policy-making is often difficult to uphold, and it is illusionary to
believe that the managerial and scientific tasks to be carried out by
Food Authority (and other agencies) do not embrace political issues
(Vos, forthcoming). One has to take into account that in many situa-
tions of scientific uncertainty and/or controversy, scientific analysis
and management are strongly intertwined (Cranor, 1993, p. 132; Rowe,
1992, p. 23) and that “objective scientific facts” simply do not exist.
It is for example very likely that scientific evidence relating to a highly
sensitive issue such as a request for an EU authorization of a specific
novel food will include some socio-economic elements.
    In this respect, comparisons with the EMEA are relevant. Opinions
adopted by EMEA’s scientific committee CPMP are likely to include
not only purely scientific, but also normative (nationally flavoured)
elements. This stems particularly from EMEA’s two-tiered manner
of formulating a scientific opinion, by means of which national
experts, representing their competent authorities, adopt an opinion only
after consultation with a pool of national scientific experts (Vos, 1999a,
pp. 288–230). Here, once EMEA’s scientific committee CPMP has
reached a consensus on the authorization of a specific medicinal
product (including all relevant considerations), the Commission is
likely to adhere to this opinion. This seems indeed to be confirmed
by the authorization practice. The difficulties in distinguishing infor-
mation and/or scientific evidence from policy-making emphasize the
need to examine the legitimacy potential of agency networks and the
escape from conventional governmental organization charts (Ladeur,
1996), or whether, alternatively, there is a need to build in mechanisms
that place agencies under greater political control (Shapiro, 1997b,
p. 287). Such an analysis could serve as a basis for reconsidering
the theoretical framework in which the proposed European Food
Authority should operate.62
    Closely linked with this is the use of the precautionary principle.
The Commission clearly intends to make more general use of this prin-
ciple also in the fields of human, animal, and plant health protection,
as is already allowed by the ECJ. However, its Communication on
the use of the precautionary principle seems to be intended to defend
and justify the Community’s refusal to allow American beef with
hormones within the WTO context. It pays only little attention to
the institutional designs by means of which the precautionary prin-

EU Food Safety Regulation in the Aftermath of the BSE Crisis        249

ciple may be implemented by the Community in food safety regula-
tion within the Community context. In addition, it remains unclear
whether and in how far Member States should be able to rely on
precaution within the Community context, in particular in relation
to the “opt out” clause of Article 95 (4–9) EC. This raises queries such
as “how certain” is “certain enough,” and entails the risk of creating
a “scientific trap” in which the public could be encouraged to demand
“certainty.” The request for political accountability for risk decisions
could push regulators towards the establishment of a “scientifically
correct” answer even when there is none, as has occurred, for example,
in the USA (Jasanoff, 1991). In turn, it leads to questions on the limits
of science in connection with cases before the ECJ about decisions
of the Community institutions based on scientific evidence (e.g., as
required by Article 95 (3)). Hence, as the Commission itself admits,
the Communication on precaution is merely a starting-point which
requires further in-depth investigation.
   Lastly, it should be underlined that the “limits” of science together
with the normative character of risk assessment means that food-
stuffs must not be regulated solely by scientific experts and/or national
and European bureaucrats in a closed, albeit deliberative, circle. Our
search for a more democratic and procedural account of rationality
in Community food safety and risk regulation in general should also
take account of the human dimensions of risk assessment and man-
agement. It therefore needs to be asked in what way those who are
most vulnerable to risks, i.e., the users of products, should be involved
in risk regulation (Shrader-Frechette, 1981).
   The importance of defining the role of what in Community jargon
is called the “stakeholders” is alluded to by the Commission in its
White Paper, but not further elaborated. To be sure, the increased
use of Green and White papers by the Commission already contributes
to the opening up of a truly Community-wide public debate on
risks inherent to food, but it is not sufficient. Recognizing this, the
Commission indeed proposes to create an advisory committee on food
safety to improve the involvement of the “stakeholders” which should
streamline the existing committees composed of interested parties.
   Three remarks deserve to be made, however.
   Firstly, it should be remembered that already in the 1970s the
Commission set up an advisory committee on foodstuffs, the
ACF, in order to hear the opinions of the various interest groups
involved. In practice, however, this Committee is no longer con-