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| European
Food Standards Authority |
CFG
01/01
Comments on the
EU Proposal for a Regulation laying down the general principles and
requirements of food law, establishing the European Food Standards
Authority, and laying down procedures in matters of food safety.
General Comments and Recommendations
Detailed Comments on the Articles:
The Consumers Food Group (CFG) welcomes the opportunity to comment
on this Commission proposal. CFG is an independent UK umbrella body
which is continuing the work of the Food Working Party of the Consumers
in Europe Group.
General Comments and Recommendations
CFG strongly supports the main objectives of the Regulation:
- to achieve high levels of protection for human health by ensuring
food safety throughout the production chain,
- raise consumer confidence by establishing the European Food
Authority as an independent source of scientific advice and information
to European institutions, Member States and the public. We are
especially concerned to see adequate consumer representation,
overall transparency, clarity in the risk assessment and management,
the inclusion of nutrition and proper independence of advice.
Its predecessor body, CEG, has campaigned for the establishment of
an independent European Food Authority for more than 10 years.
We welcome the recognition that for the Authority to gain public confidence,
independence, high scientific quality and transparency are essential.
We support the systematic approach to risk assessment and communication;
the use of the Precautionary principle in cases of scientific uncertainty;
and the proposal for closer links between competent bodies at national
and European level through the establishment of an Advisory Forum.
We believe that for the Authority to be effective it must cover all
aspects of the food chain from primary production to consumption and
we agree that the ultimate responsibility for ensuring the food placed
on the market is safe should lie with suppliers (food business operators).
The draft Regulation contains proposals for the structure, role and
methods of operation of the Authority. While CFG supports many of
the proposals and principles contained in the Commission's text, there
are a number of areas where the Regulation could be improved and the
public credibility of the Authority enhanced from the outset. Our
proposals are :
- Scope: The EFA should be able to advise the Commission
on risk management options based on the scientific risk assessments
it has carried out. The proposed division of responsibility for
risk assessment and risk management between the EFA and the Commission
will be a source of confusion unless there is clarity about the
roles and how the two bodies will work together. Such advice and
reasoning should be made public. We also recommend that the EFA
should have a proactive role in the development and promotion
of nutrition policies and public health (Art. 22). It should produce
a nutrition action plan and collect data on dietary patterns across
the Community to underpin nutrition policy objectives.
- Consumer Involvement: We strongly advocate the direct
involvement of consumer and public interest groups in the EFA's
work. The Authority's Scientific Committee and Scientific
Panels should we believe include at least two lay/consumer/public
interest member. Lay members can ensure that the committee's work
is conducted with appropriate rigour, question the received wisdom
of scientific experts, advise on how consumers may respond to
their findings, assist scientists in communicating their findings
in more accessible language and thereby contribute to public confidence.
Consumers International, for example, has consultants who participate
in Codex Committees and are recognised by the Codex Secretariat
for their positive contribution. The UK Food Standards Agency
has also adopted this approach.
- Independent Science: The Commission should define what
is meant by 'independent science' and the criteria necessary to
achieve it. Much of the leading expertise in food science comes
from the food industry. It is appropriate that this should be
fully taken into account, subject to the kind of principles laid
down in the UK, by the Committee on Standards in Public Life (the
Neill Committee) for example. However, the inherent industry bias
on Scientific Panels warrants further thought. At least, there
should be a full declaration of interests, and an open and transparent
selection process for appointment on merit. A multidisciplinary
approach to membership involving experts in tangential but related
fields on specialist committees could be a valuable addition (eg
on BSE to include experts on human health as well as animal neurological
disease.) A cross section of expertise can bring different ways
of looking at a problem and free scientists of the peer pressure
to conform to an accepted view or approach.
- Information: The EFA clearly has an important role
in informing the public, providing objective, reliable and easily
understandable information. We support the close co-operation
between the EFA and Member States regarding public information
campaigns to take account of regional differences and national
health policy objectives.
- Communication: The EFA should take account of consumer
and lay input in determining its communication strategy and content.
This will be essential if it is to succeed where the Commission
has failed in communicating science and risk to the public. There
needs to be a very clear remit for the EFA in respect of risk
communication. This is a difficult area in which risk needs to
be distinguished from other scientific information. Furthermore,
communication goes beyond the provision of information. The EFA
should promote an interactive process of public debate on the
issues it is addressing.
- Resources: To achieve its objectives the EFA will need
to be adequately resourced. The Scientific Committee and Panels
will need resources to undertake appropriate risk assessments,
to publish and communicate their findings and to fund lay participation.
It is not encouraging to note that funding for the EFA is estimated
at one third of the operating cost of the UK Food Standards Agency
and below the budget for the EMEA, which ‘has a more limited
scope and remit than the EFA (P.24 section 1 of explanatory memorandum).
The Commission’s own failure to respond to the food challenges
of the past decade is, at least in part, due to inadequate funding
of its food safety responsibilities, so the importance of adequate
resources to the success of the EFA should not be underestimated.
- Confidentiality: A Code of Practice should be drawn
up defining the material which can be considered confidential
and reinforcing the presumption in favour of openness to assist
staff providing information. In particular, where confidentiality
operates a statement should be required describing the type of
information being withheld and for what reason. This requirement
would probably reduce the misuse of confidentiality.
Detailed Comments on the Articles
Section 1 – Scope and Definitions
Article 1: Aim and Scope (P.33)
CFG supports the aim of the regulation to enable consumers to have
‘access to safe and wholesome foods’. However, it should
be stated more clearly, that it includes primary production. Currently
the only reference to primary production is made in the context of
private domestic use.
Article 2: Definition of ‘food’ (P.33)
We welcome the definition of food as set out in Article 2. Food supplements
should be included in the definition of food which should be clearly
differentiated from medicinal products.
The article states that the definition of food does not include ‘medicinal
products within the meaning of Directive 65/65/EEC’. However,
it does not specify that foods making health claims should be treated
as foods and be covered by food law. It is essential that these recent
developments in the food market should be taken into account. For
this reason, we propose that foods making health claims should also
fall under the definition of food.
Article 3: Other Definitions (P.34)
We particularly welcome the acknowledgement at Point (m) that ‘risk
management means ‘the process of weighing policy alternatives
in consultation with interested parties, considering risk assessment
and Other Legitimate Factors (OLFs).
We would like to see a definition of OLFs included in this list as
they come up when discussing risk management, but they are also intrinsic
in the risk assessment part of risk analysis. Consumers' International
has argued at Codex that OLFs in the risk assessment process should
also be made explicit, so that the whole process is as transparent
as possible. We support this view and would like to see a definition
of OLFs, both for risk assessment and risk management.
CFG would like to see further definition of food terminology in this
Article, in particular concepts such as ‘misleading’ and
‘adulteration’.
Section 2: General Food Law
Article 5: General objectives (P.36)
CFG welcomes the wide and integrated scope of the general objectives
of food law which include ‘protection of the environment, animal
health, welfare and protection of plant health and life’. However,
it might aid clarity if it specified that food law covers these issues
‘in so far as they are directly relevant to food safety’.
The third paragraph of this Article states that the Community will
take international food standards (presumably Codex standards) into
account in the elaboration of food law, except where such standards
would be ‘ineffective or ‘an’ inappropriate means for
the fulfilment of the legitimate objectives of food law’. Since
the EU and all the member states play an integral part in negotiating
Codex food standards at international level, it is difficult to imagine
that the EU would then wish to reject such standards on the basis
of them being ‘ineffective or inappropriate’. We believe
some explanation should be given for what is meant by ‘ineffective’
and ‘inappropriate’ in this context.
Article 6: Protection of health (P.36)
Article 6 states that Food Law shall be based on risk analysis, ‘except
where it is not appropriate to the circumstances or the nature of
the measure’. We would like some clarity on what specific circumstances
this could refer to and what is meant by ‘the nature of the measurement’.
We believe that these ‘circumstances' should be clearly defined.
Furthermore, the ‘other factors as legitimate to the matter under
consideration’ in paragraph 3 also need clarification of what
constitutes ‘other factors’ in this context.
Article 7: Precautionary Principle (P.37)
It would aid clarity if the precautionary principle itself was defined
before specifying the circumstances in which it can be invoked.
Article 8: Protection of consumer’s interests (P.37)
We welcome the fundamental protection which this Article establishes
for consumers of food. However, we would like it to indicate how consumers
will be protected from misleading ‘labelling, advertising and
presentation of foods’, or at least a reference to the relevant
food legislation which deals specifically with these matters. Likewise,
it would be reassuring to have some indication of the penalties applicable
if the rights guaranteed in this Article are infringed, or a reference
to the relevant legislation.
Article 9: Traceability (P.37)
The draft text includes a requirement for traceability but leaves
the detail on its application for the Committee on Food and Animal
Health to elaborate. There are already some sophisticated voluntary
systems in place in the UK, and there is also a lot of detail in the
European Lot Marking Directive. We suggest this body of knowledge
is taken into account when the Committee is drawing up the detail
on traceability systems and strongly support their introduction at
the earliest opportunity.
Section 3: Principles of Food Trade
Article 16: Food imported into the Community (P.42)
The concept of ‘equivalency’ comes up frequently in international
food policy, but is rarely defined. CFG would like an explanation
of how ‘equivalency’ with the requirements of Community
Food Law for third countries is measured. If it is not appropriate
to include this explanation under this article, perhaps equivalency
could be included in the list of definitions under Article 3.
Chapter 4: Principles of transparency
Article 19: Public consultation (P.43)
CFG believes that the onus should be to consult publicly on the elaboration
of food law at all times, with the exception that in
some cases it may not be possible. Those circumstances where public
consultation is not possible should be defined and limited, for example:
‘unless the need for urgent action makes consultation impossible’.
We believe this wording would give a clearer signal on the obligation
to consult and that this shift in emphasis would contribute to public
accountability.
Section III - European Food Authority
Article 22: Tasks of the Authority (P.46)
The role of the Authority with regard to nutrition should go much
further than assisting the Commission on ‘communication on health-policy
related nutritional issues’ (Article 22, point K). CFG and other
consumer organisations have consistently requested that the Authority
should undertake a proactive role in relation to the development and
promotion of nutrition policies and the promotion of public health
in relation to food. [CFG response to the White Paper, 2000]
Diet-related diseases such as cancer and heart disease are major killers
in the UK. As the Authority will be ideally placed to collate data
on dietary intakes across Europe, it will also be well placed to promote
health related nutrition policies. A nutrition action plan at EU level
has been proposed, we believe that the EFA would be the key body to
take this work forward.
Therefore, we would like to see the following included in the list
of tasks:
The Authority shall undertake to develop a nutrition
action plan to promote nutrition policies with regard to public
health; and shall develop the advisory capacity to inform the
Commission on nutrition matters in relation to the Common Agricultural
Policy and the Common Fisheries policy.
CFG firmly believes that consumers' trust and confidence in the new
Authority can only be gained by a greater degree of openness and participation
which goes beyond the dissemination of information. To achieve this,
we would like to see these principles incorporated into the list of
tasks of the Authority in the following way:
The Authority shall: ensure openness, transparency
and public accountability in the provision of scientific opinions,
technical data, risk assessment and all functions pertaining to
the Authority.
There is no indication of the role of the EFA with relation to international
food policy. As the EFA undertakes risk assessment at Community level,
it is well placed to contribute to discussions at Codex Committees
and should be encouraged to do so. We recommend this is specifically
included in the tasks of the EFA.
Article 24: Management Board (P.47)
It is recognised that the independence of the Authority is a key element
in gaining consumer confidence. We believe the Authority must both
act independently and be seen to do so. With this in mind we do not
believe that the proposed composition of the Management Board members
is in keeping with an independent food Authority. By making the appointments
onto the Management Board from the Council of Ministers, the European
Parliament and the Commission, the leadership of the Authority can
be perceived as a political one, where political pressures can be
exerted at the highest level. This would bring the Authority’s
independence into question.
CFG would like to see an independent Board governing the Authority.
We favour individuals being recruited as a result of public advertising
with a clear job specification and criteria published in each Member
State. This should specify that some members should have consumer
and environment backgrounds. The principles of disclosure of interests
and background information should apply to all Board members. While
the Commission would undertake the selection, we propose that the
appointments be ratified by the European Parliament through a Parliamentary
hearing.
Article 26: Advisory Forum (P.49)
The two main roles of the Advisory Forum as set out in paragraph 3
of Article 26 are to advise the Executive Director and to ensure close
co-operation between the Authority and the competent bodies in the
Member States.
CFG would like to see greater clarification on which aspects of the
Executive Director’s duties, the Advisory Forum will ‘advise’,
given that the Management Board has the responsibility to ‘ensure
that the Authority carries out its mission and performs the tasks
assigned to it under the Regulation’, and also that the Executive
Director is directly accountable to the Management Board. It may well
be that the Advisory Forum should play a guiding role, but unless
it is clearly defined, there may be scope for misunderstanding, in
particular bearing in mind that the Authority does not have a policy-making
function. Greater clarity is needed in defining the role of this Forum.
CFG believes that co-ordination and co-operation between member state
bodies is the most important role for the Advisory Forum, and importantly,
it would be a role that the Forum would be qualified to undertake.
We are concerned that without a clear definition of its advisory function,
there may be a) an in-built tension between the roles of the Management
Board and the Advisory Forum, and b) a mismatch of the expertise of
the members assigned to the Advisory Forum, both of which may dilute
the flexibility and mission of the Authority.
Article 27: Scientific Committee and Scientific Panels (P.49)
We believe that there is scope for a Panel on novel foods and functional
foods, as not all novel foods will involve genetically modified organisms,
equally not all functional foods/foods claiming health benefits will
be dietetic products.
It is not enough to publish findings of the Scientific Committee and
Panels, there must be public scrutiny of, and involvement in, the
process. The procedures for involving consumers and other public interest
representatives in the work of the Scientific Committee and Panels
should be clearly set out in this Article.
CFG would like some clarification as to whether the ‘independent
scientific experts’ who make up the Panels will be outside experts
who convene for the work of the Panels or in-house scientific experts.
We think in-house experts should have a place on each of the Panels
with equal standing to the outside experts, thus anchoring the work
of the Panels firmly within the Authority.
Article 29: Conflicting scientific opinion (P.52)
From the wording of paragraph 4 of this Article, it is not clear whether
conflicting scientific opinion between the Authority and a member
state body will be resolved by the Commission or the Advisory Forum.
It does say resolution should be sought ‘in consultation with
the Advisory Forum’, but does not specify to which Authority
‘ a joint document clarifying contentious issues’ should
be presented. Tighter wording of this clause would be helpful to reduce
ambiguity.
Article 30: Scientific and technical assistance (P.52)
The scientific and technical assistance provision of this article
could be construed as aspects of risk assessment. If this is the case,
it should be made explicit. CFG believes that the procedure for risk
assessment should be clear and transparent in the Regulation.
Article 36: Independence (P.55)
CFG warmly welcomes the emphasis on yearly declaration of interests
by all members of the Management Board, the Advisory Forum and the
Scientific Committee and Panels. We believe that this obligation should
be extended to all staff at the Authority.
Article 37: Transparency (P.55)
The Commission’s White Paper stated that ‘ Greater transparency
of Food Safety policy is the thread running through the whole White
Paper and will contribute fundamentally to enhancing consumer confidence
in EU Food Safety Policy’ (P.4). This intention is not adequately
reflected in Article 37 of the Regulation. As we have previously stated,
transparency goes beyond the public availability of documents. It
involves wide consultation and active participation of consumer representatives
and interested parties in decision-making committees. This wider definition
should be acknowledged in this Article.
Paragraph 2 of Article 37 states that the ‘Executive Director
may decide to hold some of its meetings in public and may
authorise consumer representatives or other interested parties to
observe the proceedings of some of the Authority’s activities’
– this is a very long way away from the seat at the table consumer
groups have been calling for. By actively encouraging all interested
parties to be involved in the work of the Authority, an opportunity
would be created to build trust and confidence in the EFA’s handling
of food safety and risk issues.
With regard to implementing transparency rules in relation to making
documents publicly available, full committee papers should be publicly
available (as in Codex Alimentarius). Where a Scientific Panel is
considering applications for approval these applications should also
be publicly available. Any advice given by the Panel and the reasoning
behind it, should also be made public.
Article 38: Confidentiality (P.56)
While in some circumstances it may be necessary to withhold confidential
information, the onus should always be on openness. There should be
clear definitions of what material can be considered confidential.
We suggest that a Code of Practice needs to be drawn up to assist
all staff providing information, and that this Code should also be
made publicly available.
The publication, Commercial Confidentiality (CFG 1999) sought to define
‘commercial confidentiality’ to strike a proper balance
between the public’s need for information and commercial enterprises’
need to keep some things confidential. We recommend that this may
provide useful advice to assist staff and committees. We are in the
process of finalising guidance on the release of commercially sensitive
information by public authorities. We also suggest this will provide
useful guidance.]
Article 39: Communication (P.56)
Article 39 states that the Authority should inform the public of the
results of its work. CFG considers that communication should happen
both while risk assessment and scientific research is ongoing, as
well as the scientific results and the options put forward for risk
management. We believe that risk communication should ‘not be
a one-way process, but a two-way dialogue between the Authority and
the public. Public debate should be stimulated to increase knowledge
and understanding, and to ensure that views are fed back to the Authority’.
(CFG response to White Paper). While risk communication as defined
in Article 3 embraces this concept, it is clearly not reflected in
the wording of Article 39 and in the way it is envisaged the Authority
will undertake its communications strategy.
Paragraph 2 of Article 39 states that the EFA will communicate directly
with consumers. There is little elaboration of how this will be done
or about the role of Member States. We are concerned about whether
the Authority should communicate directly to the public, given the
differences in language, media, cultural sensitivities and diet between
Member States. National Authorities and agencies seem better placed
to undertake this role.
We are mindful that Member States may be tempted to put a different
‘spin’ on the EFA’s assessment, and there may be differences
of opinion between the national bodies and the EFA. It is therefore
essential that EU consumers also have direct access to clear information
from the EFA. More thought needs to be given to the interface between
the Authority and the Member States in communicating risk and science.
We think clarification is needed as to whether scientists from the
Scientific Committee and Panels will communicate directly to the public.
The biotechnology debate and the BSE crisis have shown how difficult
it can be to communicate science and risk to the public. CFG would
like to see a separate department within the EFA, staffed by both
scientists and professional communicators, with a specific brief to
interpret the science into understandable language for lay people.
Article 41: Consumers and other interested parties (P.57)
Article 41 dealing specifically with consumer representatives simply
says ‘the Authority shall develop appropriate contacts’.
This will not be sufficient to engender confidence. CFG does not feel
that sufficient thought has been given to how the Authority will work
with Consumer organisations, their representatives or consumers themselves.
The ‘key’ objective of restoring consumer confidence has
barely been acknowledged in this Article. We would like to see the
Commission’s commitment to involving consumers in the work of
the EFA explicitly expressed and the procedures for this to be set
out in greater detail in this Article.
We would like to see the emphasis on all interested parties being
involved, to the fullest extent possible, in the work of the EFA,
and at all key stages in the risk assessment procedure. The involvement
of consumers and interested parties should consist of consultation
throughout the risk assessment process (including framing risk assumptions
and risk management options), and active participation on the Scientific
Committee and the Scientific Panels.
Article 44: Fees received by the Authority (P.58)
CFG would like some clarification on the services the Authority could
provide, for which a fee could be charged. This is the first time
this matter is referred to in the Regulation and it is under the section
on financial provisions. We consider that an explanation is required,
earlier in the Regulation in order to support this Article in the
financial provisions. This is because the Authority is to act in the
public interest and work for a sectional interest for a fee would
be likely to compromise its basic public commitment.
Article 48: Participation of third countries (P.59)
CFG considers it would be helpful to have some clarification of the
‘nature, extent and manner’ of participation of third countries
in the EFA, particularly since a large number of Eastern European
countries will soon acquire EU membership (approximately 12 countries
in two stages). If this Article refers to any other type of third
country participation, then this too needs to be made explicit.
Section 4: Rapid alert system, crisis management
and emergency situations
Article 51: Confidentiality rules for the rapid alert system (P.61)
Once again, CFG would like clarification on what would constitute
‘professional secrecy’. These terms need to be clearly defined
to assist openness and transparency in the work of the Authority.
Our comments under Article 38 apply equally to this Article.
Article 52; General plan for crisis management and Article 53:
Crisis Unit (P.62)
Clarification is needed about how the Commission’s general plan
for crisis management links to the Crisis Unit and how both of them
relate to the Authority’s Rapid Alert System. Furthermore, Article
53 does not appear to envisage a permanent crisis management unit
to identify prevention measures either in the light of past experience
or where there are indications that problems could arise. CFG considers
that there is a role for such ongoing activities within the crisis
management operations.
Section 5: Procedures and final provisions
Article 57: Committee on Food Safety and Animal Health (P.65)
This Committee is to be ‘composed of representatives of Member
States’. CFG would like to know what the background of these
members will be. We believe that there should be a full declaration
of interests of Committee members, and that there should be consumer
representatives on the Committee.
Article 60: Review clause (P.66)
We would question whether the Authority and the Commission are best
placed to undertake an ‘independent evaluation’ of the achievements
of the Authority. Even if there was no alternative, at the very least
the evaluation criteria should be widely consulted on before being
agreed. We believe that in order to assess whether the Authority has
made progress in food safety, the criteria should include indicators
such as: increased consumer confidence in EU food policy, increased
trust and public understanding of scientific issues relating to food,
effectiveness of the Rapid Alert System, effectiveness of communicating
food policy and food risks, usefulness of the data collection systems.
CFG also considers that the way the evaluation report is compiled
and its use raise wider issues of accountability. Any evaluation report
should be discussed among the EU institutions, Member States and stakeholders
and their comments should be taken into account in the conclusions
and recommendations for action by the Authority. This would enable
the Authority to get a perspective on how they are perceived, and
help them to be more responsive to the needs of the outside world
in the fulfilment of their remit.
Article 62: Competence of the European Medicines Evaluation Agency
(P.67)
Although this Article states that the Regulation shall apply ‘without
prejudice to the competence of the EMEA’, it does not specify
how the EFA should work with the EMEA. This seems an important omission
as there is an increasing grey area between the two with regard to
foods which claim medicinal properties.
More generally, there is no mention of how the EFA will work with
the remaining Commission bodies dealing with food related matters,
for instance veterinary and environmental matters. We would like to
see these relationships spelt out clearly in the Regulation.
June 2001
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