Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety"
Date: 2001-03-28
Institutions: European Economic and Social Committee
Subjects: consumer protection, food inspection, foodstuff, public health

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Official Journal of the European Communities

29.5.2001

Opinion of the Economic and Social Committee on the ‘Proposal for a Regulation of the European
Parliament and of the Council laying down the general principles and requirements of food law,
establishing the European Food Authority, and laying down procedures in matters of food safety’

(2001/C 155/08)

On 22 December 2000 the Council of the European Union decided to consult the Economic and Social
Committee, under Articles 37, 95, 133 and 152 (4)
(b) of the Treaty establishing the European
Community on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 8 March 2001 The rapporteur
was Mr Verhaeghe.

At its 380th plenary session (meeting of 28 March 2001) the Economic and Social Committee adopted
the following opinion by 92 votes to six with five abstentions.

1.

Introduction and antecedents

1.1.
On 8 November 2000, the Commission approved its
proposal for a Regulation of the European Parliament and
Council laying down the general principles and requirements
of food law, establishing the European Food Authority, and
laying down procedures in matters of food safety.

1.2.
The proposal is a centre-piece of the 84 legislative
measures on food and feed safety to be proposed over the next
three years as a result of the Commission’s White Paper on
Food Safety, adopted in January 2000. The White Paper is a
fundamental rethink of the EU’s existing food and feed policy
and a response to the growing consumer concern over the
safety of our food.

1.3.
The White Paper was discussed in the ESC and lead to
an opinion (1), adopted by a very large majority, in May 2000.

1.4.
A number of suggestions included in the ESC report
on the White Paper have been incorporated in the proposal,
namely those concerning increased attention to crisis manage-
ment, the inclusion of some competence on nutrition as well
as of drinking water in the foodstuffs definition and questions
relating to aquaculture, fisheries and sea produce.

that the solution offered does not go far enough in giving
the European Food Authority (EFA) scientific precedence.
Article 35 demonstrates commitment to resolve problems
of coordination between the respective EU and national
authorities, again a point considered of primary importance in
ESC discussions on the White Paper.

1.6.
Suggestions not taken up include those concerning
social aspects, which have been referred to other legal instru-
ments. The Committee stresses that the opinions adopted by
the EFA may have significant consequences on aspects such as
safety at work, employment and industry competitiveness and
will return to these issues in future Opinions on specific
aspects of food safety.

1.7.
In earlier discussions on the subject of an EU Food
Authority, many members raised questions on the compo-
sition of the Board of the proposed European Food Authority
(EFA), underlining, for example, the need to include primary
food producers so as to underline the integrated approach to
the food chain. Also, major doubts were voiced about the
EFA’s ability, given its limited funding, to communicate with
the public.

look in detail at

This opinion will

1.8.
the proposal,
subdivided into Chapter 2 ‘General Food Law’, Chapter 3
‘European Food Authority (EFA)’, Chapter 4 ‘Rapid Alert
System, Crises Management and Emergencies’ and Chapter 5
‘Procedures and final provisions’.

1.5.
It is also worth noting that Article 29 of the proposal
reflects the major concerns raised by the ESC over potential
conflicts between national and EU scientific opinions,
although, as indicated in the detailed comments, the ESC feels

2. General comments

(1) OJ C 204 of 18.7.2000, p. 21.

2.1.
The Committee appreciates the efforts by the Com-
mission to bring this proposal forward speedily. It will ensure

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equally efficient treatment of the proposal and hopes the other
Institutions involved will do likewise, taking into account the
public concern in this field and the need to dispose as soon as
possible of an adequate European instrument for risk assess-
ment in these matters.

the body of the draft Regulation as found in the Articles. This
seems unjustified and could lead to further problems of
interpretation. By way of example, the fifth recital indicates
that the principles and definitions of food law listed in the
Regulation should form a common basis for all measures
governing food, while in Article 3 it is stated that the definitions
this Regulation’.
given there apply ‘for the purposes of

2.2.
The Committee regrets that revision of the legislative
measures set out in the White Paper antecedes agreement on
the new fundamental principles and requirements of EU Food
Law and the establishment of the EFA. Thus, the EFA will play
a key role in future food law development but will be
established only after these measures are revised. In view of
the timetable indicated at the Nice Summit in December 2000
(EFA to be operational in early 2002), the Committee invites
the European institutions to consider if some elements of the
proposal could be put in place before that date.

2.6.
The Committee welcomes this new approach to EU
Food Law, with its emphasis on food safety, but recommends
a continuous integration with firmly established key principles
on which much food regulation has been based, such as free
movement, mutual recognition, proportionality and subsidiar-
ity. Among the objectives of food law, reference should be
made not only to food safety but also to other aspects,
developing the ‘European food model’ based on the principles
of quality, diversity and safety, as defined at the Biarritz
Agriculture Council.

The Committee favours greater use of the Regulation as
2.3.
EU legislative means since this strengthens uniform application
and implementation and contributes to improved functioning
of the Single Market for the benefit of consumers and industry
alike. In this case however, the ESC is surprised at the high
number of concepts for which the definition is either vague or
non-existent (e.g. in Article 19, the expressions ‘where pos-
sible’, ‘at an appropriate stage’, ‘representative organisations’,
‘in appropriate fashion’, Article 6 paragraph 3, ‘other factors
as legitimate to the matter under consideration’, paragraph 1
‘the circumstances of the case or the nature of the measure’).
Since law laid down by Regulation is directly applicable such
vagueness could lead to problems of legal interpretation and
as such is unacceptable.

2.4.
The Committee feels more clarity is needed as to whom
exactly the various Articles of the Regulation are addressed.
There should be no place for ambiguity in respect of the
responsibilities of Member States, stakeholders and others.
One example of this potential for confusion is Article 8, where
the first indent seems to be addressed to Member States, while
the second seems to place an obligation on food producers.
The current proposal has also to take account of the fact that
the food-chain players are very diverse and have different
needs with regard to the rules they have to comply with, in
order to achieve the intended result, namely food safety. Hence
the special situation of the SMEs in the food chain should
receive appropriate attention.

The Committee is also convinced that the emphasis
2.7.
which it shares given to consumer protection will sustain other
prime objectives of the Union, such as the better functioning
of the Single Market and the competitiveness of the EU
food industry. Only by restoring consumer confidence and
guaranteeing proper monitoring, traceability and controls will
it be possible to avoid disruption of the Single Market and
neo-protectionist attitudes.

2.8.
As regards the EFA, the ESC reserves its right to
comment in more detail once the EFA has been in operation
for a reasonable period of time. Although structures, working
methods and the like appear to have been thoroughly thought
through, only the working of the new body in practice will
allow proper evaluation of
its strengths and weaknesses.
Therefore, the Committee insists that it be included with the
EU Institutions specifically listed to receive EFA working
programmes and activity reports (see comments on Article 24,
7, 3).

2.9.
The Committee feels that the proposed Regulation
should contain more of a blueprint for effective action. In
order to ensure that food safety remains a priority also within
the ESC, the Committee will organise periodically an ad hoc
evaluation of developments in this area, in order to enable
an on-going involvement of organised civil society and to
contribute to transparency, dialogue and communication
towards the public.

2.5.
The Committee is surprised at the degree of inconsist-
ency between the recitals on the one hand and on the other

2.10.
The ESC agrees with the term ‘Authority’ chosen for
this new body since this underlines the clear intent for this

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new structure to be the cornerstone of the new EU policy on
food safety. The ESC is, however, aware of the different
implications that the term ‘Authority’ might have in different
jurisdictions of the EU and therefore would recommend a list
of the key characteristics of this term, and of the specific topics
on which scientific advice must be required prior to any
legislative act. The new body should be empowered to act as a
final arbitrator in the case of conflicting scientific opinion, or,
at least, take precedence in cases of conflict concerning issues
within its realm of responsibility.

3.

Specific comments

Chapter I: Scope and definitions

Article 2 (‘Definition of

3.1.
foodstuff’). The definition
seems very broad and corresponds to the ‘integrated approach’
towards the food chain. On certain aspects, however, the
definition is much tighter. By defining foods in relation to
pharmaceuticals the definition runs the risk of not taking into
account recent developments in the food market. Foods
making health claims, such as ‘disease risk reduction’ claims,
which some would today consider to be equal to prevention
claims, could therefore fall under the definition of a medicine
and not under the category of foods with claimed health effects
where they actually belong.

3.1.1.
The second paragraph of the definition does not
include ‘food supplements’ even though a vertical Directive on
this is currently going through the co-decision process (1). The
Committee would recommend the inclusion of this term in
the definition, since in the past it has often given rise to
classification difficulties, especially in relation to pharmaceuti-
cal products.

Article 3 (‘Other definitions’). Under indent 1, it is
3.2.
interesting to note that while excluded from the definition of
‘foodstuff’, animal feed is considered to be an integral part of
‘Food Law’. It is the ESC’s view that the use of terms and
concepts in the various Articles should be double-checked in
order to avoid any kind of misunderstanding. Also indent 3
(food business operator) needs further explanation, particularly
when considering the translation given in other language
versions of the Regulation and the important responsibility
given to these ‘operators’, for example, under Article 10. The
Committee regrets the missed opportunity to define concepts
such as ‘misleading’, ‘adulteration’, etc.

Chapter II: General Food Law

3.3.
Article 5 (‘General objectives’). With reference to the
comment under point 2.7 above, the proper functioning of
the Single Market should be included in paragraph 1. The
Committee notes that questions relating to protection of
animals and the environment are included in a regulation on
food law. The Committee assumes that these two objectives
will be considered only to the extent that they are directly
relevant to food safety. The Committee also wonders how the
Commission intends to ensure that
these objectives are
also complied with by imported food, as provided for in
Article 16(1) (‘requirements which are at least equivalent’).

3.4.
Article 5 (‘General objectives’). Paragraph 3, while
generally in line with the basic principles of the SPS agreement,
is loosely phrased enabling the EU to opt out of international
obligations seemingly without having to provide detailed
justification.

3.5.
Article 6 (‘Protection of health’). As referred to above
(point 2.3), the statement in paragraph 1 that Food Law be
based on risk analysis ‘except where this is not appropriate to
the circumstances or the nature of the measure’, needs to be
clarified. Diverging from a principle which could be considered
as one of the most fundamental in the new approach, should
only be possible in well-defined circumstances. The reference
to ‘other factors as legitimate to the matter under consideration’
in paragraph 3 needs the same clarification/definition and also
pre-empts discussions currently being held at international
level. In conformity with the ESC’s opinion on the White
Paper, it should be decided how these ‘other legitimate factors’,
such as the environment, sustainability and animal welfare, are
to be properly represented and balanced in a food policy in
which safety is the primary objective (see White Paper opinion
point 3.18).

3.6.
Article 7 (‘Precautionary Principle’). It is not very logical
that a principle which has received such high-level attention
remains undefined in the Regulation. Moreover the concept of
‘scientific uncertainty’, on which the Precautionary Principle
seems to depend, needs to be made more specific. It is a
generally accepted fact that ‘scientific certainty’ is not a realistic
goal in this context. Concerning the Precautionary Principle,
the ESC refers to its own opinion on this issue, adopted on
12 July 2000 (see conclusions point 14.2) (2).

Article 8 (‘Protection of consumers’

interests’). The
3.7.
Committee shares the Commission’s fundamental concerns as

(1) OJ C 14, 16.1.2001.

(2) OJ C 268, 19.9.2000.

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voiced in this Article. However some further detail on how it
can be ensured that the labelling, advertising and presentation
of foods will not mislead the consumer should be considered.
Much research has, for example, been done on the labelling
needs of consumers and the frequent requests (see conclusions
of Intergroup Food of the EP) for a fundamental review of
existing EU labelling policy are not taken up in this proposal.

need to set priorities in the interest of efficiency. It is the view
of the ESC that the tasks and responsibilities of the EFA should
be clearly defined and demarcated. The extension of the EFA’s
responsibilities to areas which could jeopardise its core mission
should be avoided.

3.8.
Article 9 (‘Traceability’). The Committee thinks in
principle that the traceability of foodstuffs should be secured
at every stage — or in successive stages — from primary
production to final consumers. It assumes that a number of
open questions remain regarding the practical application of
this principle in the various food sectors and the financial
impact of the corresponding systems, and that these will
require clarification.

3.9.
Article 12 (‘Food safety requirements’). The exact
relation between the text of this Article and the General
Product Safety Directive needs clarification.

3.10.
Between Article 16 (‘Food imported into the Com-
munity’) and Article 17 (‘Food exported from the Community’),
the Commission should consider introducing an Article dealing
with so-called ‘transit goods’. Under indent 1 of Article 16, the
Committee feels the term ‘at least equivalent’ should be made
more precise in order to avoid many different interpretations.
As far as the exportation of food and feed under Article 17 is
concerned, the ESC feels that this should be done in accordance
with the laws and regulations of the importing country, taking
into account as a minimum the agreed Codex rules on the
respective issues, except when there is evidence that public
health is at risk.

3.11.
Article 19 (‘Public consultation’). The Committee
considers that this Article should be rephrased as follows:
‘There shall be open and effective stakeholder consultation
throughout all stages of the elaboration of food law.’

3.12.
Article 20 (‘Public information’). Communication of
this kind of potentially sensitive information should always be
correct and objective.
in line 4 of this
Article should be properly defined.

‘Public authorities’

3.13.1.
True to its position on the White Paper, the ESC
welcomes the inclusion of nutrition as an integral part of the
EFA’s mission and trusts that clear boundaries will be drawn
around its remit, which should relate to scientific issues and
focus on food safety. Health promotion programmes and the
like should remain the responsibility of the Commission and
its specialised services.

3.13.2. More clarity is needed on the accountability of the
EFA. The draft Regulation seems to indicate that the EFA is
ultimately only accountable to the Commission. This is not in
line with the ESC’s opinion on the White Paper, which stated
that the EFA should also be made accountable to the European
Parliament and the Member States (see White Paper Opinion
point 3.17).

3.13.3.
Under indent 3, in order to ensure that the opinions
of the EFA and the role of science in decision-making is
formally recognised, the ESC would suggest that during the
decision-making process on food matters the EFA should be
consulted to check the scientific logic and consistency of
proposals at the time of their introduction into the process
and before their final adoption.

indicates that

3.14.
Article 22 (‘Tasks of the Authority’). In indent a)
the ESC considers it be included under the ‘Community
Institutions’. Indent l) in combination with Article 39 (‘Com-
munication’)
the public will receive direct
information from the EFA on the Risk Assessment aspects of
a certain issue, while the Risk Managers will communicate on
the legislative and other measures taken on the same issue.
This gives rise to crucial questions about the means and
effectiveness of the EFA’s communications, which could affect
its public credibility and indeed its prospects of success. The
EFA has to command respect for the depth of its scientific
resources, the soundness of its judgements, and the speed of
its response to emergencies. It will need very quickly to win
the confidence of the consumers via the existing media, and it
is vital that the maximum benefit be gained from having a
single authoritative voice.

Chapter III: European Food Authority

3.13.
Article 21 (‘Mission of the Authority’). The Committee
welcomes the broad scope of this mission but emphasizes the

3.15.
Article 23 (‘Bodies of the Authority’). The Committee
feels that the change in the terminology for the scientific
bodies in indent d) could confuse users, or be seen as a
reduction in their authority and their capacity to provide
adequate technical scientific support in the longer term.

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3.16.
Article 24 (‘Management Board’). Clarification is
needed on the likely composition and procedures/criteria to
be used for the selection of candidates. As stated above, the
ESC would stress the need for primary, secondary and tertiary
operators of the food sector to be on the board so as to
underline the integrated approach to the food chain (see 1.7).
The ESC regrets that mention is made neither of this Com-
mittee nor of the Committee of the Regions, even though both
have proven that as far as food safety is concerned, their
membership provides valuable contributions.
In the same
spirit, the ESC draws attention to indent 7, paragraph 3, as
already referred to in point 2.8.

3.17.
Article 26 (‘Advisory Forum’), paragraph 6 and
Article 27 (‘Scientific Committee and scientific panels’), para-
graph 8. The participation of the Commission (Risk Manager)
in the meetings of the Advisory Forum, (as well as in the
Scientific Committee, the Scientific Panels and the Working
Groups, as scheduled under Article 27) must demonstrate an
overriding determination to keep a clear frontier between Risk
Assessment and Risk Management.; paragraph 8 of the Article
Indent 1 should provide
should therefore be reinforced.
for deputy representatives.
It is difficult to see how one
representative alone can ensure proper feed-back and involve-
ment of the widest possible national network.

3.18.
Article 27 (‘Scientific Committee and Scientific
Panels’). The ESC would like to see the possibility included of
organising specific Task Forces on issues which do not fall
specifically under the responsibility of one of the announced
Panels. The possibility of organising hearings should also be
included in this Article. The titles of the Panels should be more
flexible so as to include subjects as consequences of pollution
on the food chain, and food intolerance. The Committee
stresses also the need to include a panel on the delicate
question of traditional production and food safety.

3.21.
Article 32 (‘Collection of data’). The ESC should be
included in the list of Institutions mentioned in indent 6, to
which the EFA will communicate its results on data collection.

3.22.
Article 33 (‘Identification of emerging risks’). The
ESC should be included in the list of Institutions receiving
information on emerging risks.

Article 34 (‘System of Rapid Alert’). The ESC is aware
3.23.
of the concern of several Member States relating to the
management of the Rapid Alert System by the EFA. It should
be made absolutely clear what is understood by the ‘day to day
management’ of this system and what the specific roles of
Commission and EFA are.

Article 41 (‘Consumer and other interested parties’).
3.24.
The ESC notes that the Commission has taken on board its
recommendation regarding dialogue with consumers and
stakeholders, and hopes that the final text might be enhanced
with a statement to the effect that this dialogue should be
secured with all those involved in the food chain.

Article 42 (‘Adoption of the Authority’s budget’) in
3.25.
combination with Article 44 (‘Fees received by the Authority’).
The Committee feels that the terminology in certain language
versions should be changed in order to make it clear that it is
not a matter of taxes or duties but of the cost of services
rendered. Fees to be received for services performed should
never jeopardise the independence and objectivity of the
Authority. The ESC requests an indication of which services
performed by the EFA could potentially lead to the payment
of fees.

3.26.
Article 48 (‘Participation of third countries’). The ESC
feels that due to the imminent and crucial importance of this
issue, the suggested rules should be made much more precise
and specific.

3.19.
Article 28 (‘Scientific opinions’). The question arises
of how and by whom decisions will be made as to which of
the many opinions requested from the EFA will be given
priority.

Chapter IV: Rapid Alert System, Crises Management and Emer-
gencies

Article 29 (‘Conflicting scientific opinions’). Para-
3.20.
graph 3 seems to indicate that in case of conflict between Risk
Assessors the final decision on a risk assessment issue is taken
by the Risk Manager. Surely, as already mentioned in 2.10, the
final arbitrator in such cases must be the EFA. Paragraph 4
does not give a solution for this kind of potential conflict and
needs further clarification.

3.27.
Article 53 (‘Crisis unit’). The ESC feels that the role of
the Crisis Unit in this Article is focused too much on the
management of crises once they have occurred and does not
mention what this Committee considers of much greater
importance, i.e. the prevention of crises. The Crisis Unit should
therefore not be a body set up only once a crisis has occurred
but a permanent one intended to help avoid crisis situations.
In the case of an actual crisis, it could always be strengthened
by adding extra staff and resources.

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Chapter V: Procedures and final provisions

Article 59 (‘Mediation procedure’). This Article seems
3.28.
to introduce a special complaints procedure for free trade in
cases relevant to food safety. The ESC wonders if this is
necessary and if it would not be more appropriate to amend
the overall procedure.

the evaluation and then,

3.29.
Article 60 (‘Evaluation’). Paragraph 2 of Article 60,1
indicates that the Management Board will study the con-
clusions of
if necessary, make
recommendations to the Commission on changes to the EFA
and its working methods. Following a thorough evaluation of
conclusions would the Management Board itself not be in a
better position to decide on ways forward? Formulated like
this, the impression is easily gained that the EFA is to all
intents and purposes just another division of the Commission.
The ESC feels that this evaluation report should also be
presented to the other EU Institutions, including the ESC, and
that comments of all these need to be taken into account in
the ultimate conclusions.

3.30.
Article 62 (‘Competence of the European Medicines
Evaluation Agency’). Although this Article states that the
Regulation should apply ‘without prejudice to the competence’
of the EMEA, the ESC would like to stress, as it did already in
its opinion on the White Paper (see point 3.17 c), that the
EFA’s relationship with EMEA will be particularly important,
especially when dealing with borderline products where there
may be difficulties determining whether a product is a foodstuff
or a medicine. Some further detail on how this relationship
will develop in practice seems justified. The ESC also feels that,
in the same spirit, a special Article should be devoted to the
link between the EFA and the Dublin office for food controls
(FVO).

4. Conclusions

4.1.
As stated above, the Committee appreciates the major
effort by the Commission to bring the current proposal

Brussels, 28 March 2001.

together, which illustrates the key importance it attaches to
food safety. The introduction of an all encompassing plan,
involving the whole food chain
with improved structures,
and based on the principles of openness, excellence and
transparency can only be applauded.

However, the vagueness of certain articles and prin-
4.2.
ciples, the inconsistency between various parts of the docu-
ment as well as lack of clarity concerning the exact division of
various responsibilities requires further work if the Regulation
is to achieve its aims.

4.3.
The Regulation should primarily contain a blueprint
for effective action. The real challenge is to do things better
than before and to increase overall confidence in the whole
food chain. The ESC intends to follow future developments in
order to ensure that developments on food safety issues will
focus mainly on results and preventive measures;
it will
therefore organise periodical ad hoc evaluations of develop-
ments in this area, ensuring consistency and dialogue on these
issues.

4.4.
In order to be able to evaluate progress on food safety
matters and to judge if the new system is living up to its
expectations, the ESC stresses the need for evaluation criteria,
such as increased/decreased consumer confidence, the occur-
rence and handling of food crises, closer co-operation between
stakeholders, etc.

4.5.
If there is a general consensus about the important role
of the future EFA, the ESC feels that this should be taken to its
logical conclusion, which would be to allow the EFA a role
within the decision-making process on food, focusing on the
protection of scientific consistency, maintaining at all times
both a neutral stance and a realistic separation between Risk
Assessment and Risk Management. The ESC volunteers to
transform this concept into more concrete plans and suggests
setting up a joint working group on this issue with all the
other European institutions and relevant stakeholders.

The President

of the Economic and Social Committee

Göke FRERICHS

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APPENDIX

to the Opinion of the Economic and Social Committee

Defeated amendments

The following amendment, which received at least one quarter of the votes cast, was defeated during the discussion:

Point 3.8

Add the following:

‘It is therefore necessary to establish, depending on whether the product is for human or animal consumption, the
thresholds for substances and ingredients contained in the product, in order to make the traceability system feasible
and functional, in particular for SMEs’.

Reason

The proposed wording allows a reasonable interpretation of the traceability principle, by establishing the substance
thresholds for certain types of product, and thus enabling operators to fulfil their obligations.

Result of the vote

For: 24, against: 63, abstentions: 3.