Amended proposal for an EU Regulation laying
down the general principles and requirements of food law,
establishing the European Food Authority, and laying down
procedures in matters of food safety - COM(2001) 475 final
The proposal outlines the general objectives and
problems that are encountered in the EU in relation to food
regulation. The primary hurdle is the huge diversity of concepts,
principles and definitions of food in the Member States. The
outcome of these differences is that the free movement of food is
impeded and there is no uniform safety standard, the proposal aims
to address these issues and harmonise standards across the
EU.
General Food Law
1. The definition of "Food" in the
proposals is broad, and is stated as:
"any substance or
product, whether processed, partially processed or unprocessed,
intended to be, or reasonably expected to be ingested by humans. It
includes drink, chewing gum and any substance, including water,
intentionally incorporated into the food during its manufacture,
preparation or treatment." (Article 2 definition of "food".)
2. "Food law" itself is defined as: "the laws,
regulations and administrative provisions governing food in
general, and food safety in particular, whether at community or
national level; it covers any stage of production, processing and
distribution of food, and also feed for food-producing animals."
(Article 3 Other definitions.)
3. The general objectives of European Food Law are
set out as the protection of not only human life and health but
also free movement in the Community of food and feed and the
protection of consumers' interests, including the promotion of fair
practices in food trade. International standards shall be taken
into consideration in this, except where they are deemed
ineffective, inappropriate or would result in a different level of
protection and/or there is a scientific justification for them to
be disapplied (see below Scientific Committee.)
4. To this end the proposed regulation states that
proper risk analysis be carried out in an independent, objective
and transparent manner. The "Precautionary Principle" (Article
7) means that, in the event of scientific uncertainty,
provisional risk management measures which are proportionate and no
more restrictive of trade than is required to achieve a high level
of health protection, will be adopted and regularly reviewed
according to a comprehensive risk assessment. There are also
measures for harmonisation of Community legislation over the import
and export of food and feed, and a requirement that the
presentation of food, including shape, appearance or packaging of
it, does not mislead the consumer.
5. The basic safety threshold stated is that food
shall be deemed unsafe if it is considered to be injurious to
health and/or unfit for human consumption. However, other matters
of fact will be taken into account in determining safety; namely,
the normal conditions of use of the food, the information provided
to the consumer, the effects of the food on the health of the
person consuming it and subsequent generations (i.e. cumulative
toxic effects of the food) and the particular health sensitivities
of a specific category of consumers where the food is intended for
that category of consumer. It is proposed that there will be public
consultation during the preparation of food law "except where
the urgency of the matter does not allow it." (Article 9.)
6. The test for who is responsible for ensuring
food safety at any stage of the production process is one of
"control" and Member states shall monitor and verify that all
relevant requirements of food law are fulfilled and will lay down
the rules on measures and penalties applicable to infringements, as
long as these are "effective, proportionate and dissuasive."
(Article 17(1) Responsibilities)
Positive obligations on food and feed business
operators are imposed in the form of:
- Traceability requirements; i.e. that at all stages of
the production and sale of the food or feed, those with control
over it know where it came from and where it is going;
- Notification requirements; where the food/feed business
operator "considers or suspects" unsafe food is on the market they
must notify the competent authorities;
- Collaboration requirements; with competent authorities
on action to avoid risks posed by a food they supply or have
supplied; and
- Withdrawal requirements; where the food/feed business
operator "considers or suspects" food or feed over which it has had
control was not in compliance with safety requirements.
Food which complies with specific Community
provisions of food law shall be deemed to be safe insofar as the
aspects covered by the specific Community provisions are concerned.
Where there are no specific Community provisions, food shall be
deemed to be safe when it conforms to the specific provisions of
national food law of the Member State in whose territory the food
is in circulation.
However, if there are indications that, despite
conformity with the provisions, the food is unsafe, the competent
authorities are not barred from taking appropriate measures to
impose restrictions on it. Where any unsafe food had formed part of
a batch, lot or consignment, it shall be presumed that all of the
food in that batch, lot or consignment is also unsafe, unless there
is no evidence of this following a detailed assessment.
European Food Authority
It is proposed that the main enforcer of the
regulations and requirements of European food law should be a newly
formed European Food Authority (the 'Authority'.) The Authority
therefore has a broad remit proposed for it. All features of the
food production chain as defined under food law and safety would be
dealt with by the new Authority which will commence operations on 1
January 2002.
The Authority shall comprise of 4 management
layers:
1.
Management Board: This will
monitor the organisation and devise its programme of work;
2. Executive Director and his staff: This
layer will deal with the administrative side and the implementation
of the programme of work;
3. Advisory Forum: This layer will advise
the Executive Director and help to pool data;
4. Scientific Committee & Scientific Panels:
This layer will ensure consistency of scientific opinion, collect
data and identify emerging risks.
It is proposed that the Authority would be totally
independent, objective and carry out its business in a wholly
transparent manner. It is possible to analyse the more general
proposals put forward as to how the Authority should run its
affairs using these three headings:
"Independent"
1. The Management Board will consist of a mix of
delegates from the European Parliament, Council, Commission and
representatives of consumers and industry.
2. The Executive Director will be appointed by the
Management Board after an open competition.
3. The Advisory Forum will consist of one
representative designated by each Member State.
4. Members of Scientific Committee and Panels will
be independent scientists recruited on the basis of an open
application procedure.
The Authority will be able to communicate
autonomously in the fields falling within its competence, its
purpose being to provide objective, reliable and easily
understandable information. However, the Commission will remain
fully responsible for communicating risk management measures; the
appropriate information will therefore be exchanged between the
Authority and the Commission.
Appropriate co-operation will take place between
the member states, competent bodies in the member states in the
form of advisory forums, and consumer and other interested groups.
The Authority may use national organisations to carry out certain
tasks but will at all times maintain overall consistency and
control.
It is proposed the Authority will be financed by
the Community budget and its accounts will be examined by the Court
of Auditors each year. However, the possibility of fees will be
examined again after the legislation enacting the Authority has
been in force for 3 years.
"Objective"
The Authority will not only undertake scientific
risk assessment but will also take into account societal, economic,
ethical and environmental factors and the feasibility of controls.
The Authority shall be open to the participation of 3rd countries
which have concluded agreements with the EU by which they have
adopted and apply EU legislation in food law, the scope of their
participation will be outlined in those agreements. (Article
49.)
One of the main roles proposed for the Authority is
that it would give the casting opinion on contentious scientific
issues; by having the "last word" it will clarify the European
Union's position in relation to inconsistent and conflicting
theories. This would also be in connection with the adoption of a
comprehensive approach to emergency food safety measures which
would allow effective action plans to be undertaken in a uniform
and consistent manner. Where there is a substantive divergence over
scientific issues the two sides to the debate will co-operate in
producing a joint document to the Commission which shall be made
public.
"Transparent"
(i) Risk Assessment: The risk analysis which
the Authority would undertake would have three inter-connected
principles: risk assessment, risk management and risk
communication. One of the main aspects of the Authority would
therefore be to provide a uniform and objective mouthpiece to
consumers and member states on all aspects of food safety.
The opinions of the Scientific Committee and
Scientific Panels, the information on which these opinions were
based, their study results and annual reports, and the annual
declarations of interest made by members of the Management Board,
Advisory Forum, Scientific Committee and Scientific Panels shall
all be made public.
(ii) Traceability: As part of the drive for
transparency, a comprehensive system of traceability within food
and food business is proposed, so that targeted and accurate
withdrawals can be undertaken or information given to consumers or
control officials, therefore avoiding the potential for unnecessary
wider disruption in the event of food safety problems. However, as
part of this proposal it is emphasised that a food business
operator is best placed to devise a safe system for supplying food
and ensuring that the food it supplies is safe and thus is it
proposed that food business operators should have primary legal
responsibility for ensuring food safety.
(iii) Review: Within 3 years of the
Authority commencing operations and every 6 months thereafter, the
Authority, in collaboration with the Commission, shall commission
an independent external evaluation of its achievements. The
evaluation will take into account the views of the stakeholders
both at EU and national levels. (Article 61)
Emergency Provisions
There is provision for information to be kept
confidential if this is specifically requested and deemed to be
justified but professional secrets will come secondary to the needs
of market surveillance and enforcement activities and in particular
there will be a 'rapid alert information system' which will
immediately disseminate information to members of any direct or
indirect risk to human health.
The emergency powers of the Authority, acting on
its own initiative or at the request of a Member State where it is
'evident' that there is a serious risk to human or animal health
and/or the environment that cannot be adequately contained by
measures of the Member States concerned, depending on the gravity
of the situation, are as follows:
- Suspension of placing on the market;
- Suspension of placing on the market or use;
- Special conditions;
- Any other appropriate interim measure; and
- Where imported from a 3rd country outside the community,
suspension of importation.
These provisions are extremely vague and
potentially very wide ranging, one safeguard is that within 10 days
the measures implemented must be put before a Standing Committee on
the Food Chain and Animal Health composed of representative of the
Member States and the measures must be reviewed and confirmed,
amended, revoked or extended. However, if there is any delay in
adopting community measures the individual Member State concerned
may adopt national interim protective measures until they are put
in place.
Article 55 proposes that the Community shall draw
up a 'General Plan' with the cooperation of the Authority
and Member States which will specify the types of situation and
risks which would involve the setting up of a 'Crisis
Unit' to evaluate the risks, identify which emergency option
is to be used and keep the public informed.
Comment:
The proposals are comprehensive and appear
largely similar to the UK's own Food Safety Act 1990 and Food
Standards Act 1999 in their aims and objectives. Possible drawbacks
with these proposals would be the increased regulatory burden, in
particular from the proposal that food business operators should
have primary legal responsibility for ensuring food safety as they
are "best placed" to do so, and positive obligations to fulfil in
connection with this. One only needs to look at the UK headlines
recently relating to condemned meat finding its way into
supermarkets to realise that, in the context of the often complex
webs of sale of produce contracts, this may be a rather simplistic
view to take.
The interim protective measures' option -
coupled with an 'anything goes' approach to emergency powers -
means that unless Member States press for more checks and balances
to be written into the General Plan or a producer element secures
strong representation in the Crisis Unit, there is a very real
danger that the Authority would have draconian legal powers without
any effective means of challenge or appeal against its
decisions.
The amended final proposal is available by copying
and pasting or clicking on the following link:
http://europa.eu.int/comm/food/fs/intro/efa_prop2_en.pdf
For further information please contact Jessica Burt
on +44 (0)20 7367 3589 or by e-mail at
jessica.burt@cms-cmck.com.