Memorandum by Consumers in Europe Group
1. Growth in the biotechnology sector of the
food industry in recent years has been enormous and is likely
to accelerate in the future. New technologies, new raw materials
and the use of genetic engineering in the food sector have resulted
in the rapid development of novel foods, ingredients and processes.
An increasing proportion of the food we eat is likely to come
from genetically modified organisms (GMOs) and their derivatives.
Such developments could potentially lead to significant changes
in the composition of individual foods and subsequently to overall
nutritional and toxicological effects on an individual's diet.
It is therefore of the utmost importance that a sound legislative
framework for evaluation and approval of new substances and foods
operates within the EU to guarantee to consumers that all necessary
steps are being taken to ensure the safety of genetically modified
2. CEG is not against biotechnology in itself
provided it is closely controlled. Preventing progress in developing
genetically modified (GM) foods is not in the consumer interest:
however, the emphasis must be on caution, maximum information
and learning from the past. It must be recognised that some customers,
for a range of reasons, may choose to avoid eating GM foods and
they must be able to express that choice.
3. The consumer interest must be represented
in the approval process to ensure the safety of new products
and processes, to maintain and open up choice, to create
access to information on the novel foods and processes
used to produce them, and to protect the environment.
4. CEG welcomes the steps taken to clarify the
approval procedures within the Commission's proposed revisions
to the current directive on release into the environment (90/220/EEC).
We acknowledge that the approvals process could be simplified
but this should not mean that the protection of human health comes
second to commercial interests. The pursuit of speed and reduction
of documentation should not reduce the opportunities available
for consumers to give their views.
5. There needs to be a link between all EU legislation
on GM products to ensure consistency of approach, especially between
the Novel Foods Regulation and Directive 90/220/EEC. This coherence
in policy was implied in the Commission's 1997 orientation on
6. Labelling of GM produce is a key area of
concern and, as such, needs to be covered in more depth than is
currently proposed in amending Directive 90/220/EEC. All seeds
and agricultural produce from GM plants must be labelled; animal
feed containing GM material must also be labelled. CEG does not
support the use of "may contain" labelling because it
does not give any helpful information to consumers. Moreover,
the information and labelling of GMOs and GM produce must enable
them to be traced back through the food supply. This would give
the opportunity to recall products should any adverse health effects
7. Further clarification is needed on the important
aspects of how the assessment of risk to health and to the environment
will be carried out. There needs to be a clear methodology developed
for risk assessment. Assessments must be standardised throughout
the EU. Where the scientific information needed for a risk assessment
is insufficient or inconclusive then this should be made clear
and any decisions based on that assessment should err on the side
of safety to the public.
8. Consumers are concerned that there may be
adverse long-term effects from the cultivation and use of GMOs.
These effects may not be apparent at the time of approval because
of their long-term nature. It is crucial that the approval process
requires that the impact on human health and on the environment
is monitored, and reported back to the regulatory authorities.
The impact of both individual products and also of genetically
modified products as a whole need to be considered. Guidelines
are needed on the methodology to be used for monitoring, for the
treatment of waste and for emergency response. The frequency of
monitoring and the techniques to be used should be specified.
In addition, farmers may need training to recognise potential
problems caused by horizontal gene transfer from GM crops to other
crops or weeds.
9. The approval process must be open and transparent.
The dossiers provided by companies for approval of releases must
be made available to interested parties. We consider that it is
particularly important for competent authorities to be provided
with the full dossier on request. They must be able to fully assess
the data in order to make any appropriate substantial objections
to the release and/or marketing of a GMO.
AT EU LEVEL
10. An effective approval process based on sound
scientific evaluation is of key importance for ensuring the safety
of novel foods and processes. These are essential for the consistent
assessment of applications by Member States. The Scientific Committee
for Food (SCF) should be closely involved in the approval procedures
for novel foods. The SCF should be consulted, and provided with
a copy of the initial assessment report, whenever an assessment
for authorisation is referred to the Standing Committee for Foodstuffs
and there are concerns for human health. The Scientific Committee
for Food's guidelines for applications should be reviewed and
updated once the new procedures have been in operation for a couple
11. All novel foods must undergo an appropriate
safety assessment by an officially-designated competent authority.
It should not be acceptable for companies to place novel foods
directly onto the market based only on their own evaluation of
substantial equivalence; however, this is allowed under the EU
Novel Foods Regulation. This loophole for establishing the substant
equivalence of novel foods should be closed as soon as possible.
Until then, the UK's Advisory Committee on Novel Foods and Processes
(ACNFP) should evaluate, as a matter of priority, all the supporting
evidence for substantial equivalence provided by companies to
the Commission and take immediate action if there are concerns
for human health.
12. The approval system must be transparent
so that consumers can find out what applications are in the approval
system and what procedures are being followed within it. An EU-wide
system for monitoring applications for novel foods in the approval
process should be put in place by the Commission and regular reports
Antibiotic resistance marker genes
13. The presence of antibiotic resistance marker
genes in GMOs may create a risk to human health. The concern is
that the marker genes could be transferred to a micro-organism
pathogenic to humans and so make the control of infection needlessly
difficult. This could happen if, for instance, GM maize containing
an antibiotic resistance marker gene is used unprocessed (i.e.,
with live genetic material) in animal feed. The probability that
resistance will be transferred is very low but the potential impact
on human health could be very great. The precautionary principle
should be applied in cases such as this.
14. Antibiotic resistance marker genes are often
used in the early stages of the development of GMOs. They serve
no purpose after this stage and alternative marker genes are available.
It is technically possible to excise the marker gene before the
GMO is marketed. To protect public health, GMOs containing viable
antibiotic resistance marker genes should not be marketed. The
guidelines for scientific assessment of novel foods should make
it clear that these marker genes are not acceptable in the final
product. Their use in GMO development should be phased out as
soon as possible.
15. The Novel Foods Regulation does not apply
to processing aids, additives, flavourings and extraction solvents.
However no EU legislation exists on processing aids at present.
This means that many enzymes used in the food industry (that are
increasingly derived from genetic modification) are not subject
to any safety assessment at an EU level. There is also no present
requirement to label processing aids. CEG considers that processing
aids should be regulated (with priority given to enzymes).
16. Representation of public interest in the
evaluation process is not specifically included in the Novel Foods
Regulation. Although some Member States may have some degree of
consumer involvement in their own systems, consumers are not represented
at the EU level. While the re-organisation of the Consumer Policy
and Health Protection Directorate-General (DG XXIV) has led to
more open decision-making by the scientific committees, there
is scope for more consumer representation. Representation by consumers
and public interest groups in the evaluation process of novel
foods should be increased.
Areas requiring research
17. Genetic modification is a relatively new
technology and there are still many unknowns and uncertainties
about its use, especially over the long-term. Research should
be directed at some of the assumptions made in the approval process
and into methods for detection of GM material in foodstuffs. Research
should be funded by the EU and UK into these areas and the effect
of processing on the viability of GM material.
18. We fully support the principles of consumer
choice and information. Therefore, all GM food must be clearly
labelled. Consumers must be able to make an informed choice between
those foodstuffs produced using genetic modification and those
which have been produced conventionally. This is particularly
important in the early years of this new technology's introduction.
As part of this, non-GM alternatives must be available to consumers
to make sure that they have a genuine choice of food products.
19. Segregation of GM produce at source and
traceability throughout the food supply chain are the best ways
to ensure full and accurate labelling for consumers. CEG considers
that the labelling of food from GM crops must be based on derivation,
not purely on analysis of chemical differences. This must include
processed products from GM crops; many of these would not need
to be labelled under EU Regulations. Without credible systems
for segregation and labelling, consumers will not know if they
are eating GM food, and their confidence in this new technology
is likely to be reduced. Segregation systems must be supported
by analytical spot-checks at points throughout the food chain
to check their validity.
20. The wording of the Novel Foods Regulation
is open to interpretation in several key areas including marketing
procedures and labelling. Therefore there is a risk that Member
States may decide to implement the Regulation in different ways,
undermining the Single Market and potentially restricting consumer
choice. It would be very helpful to have EU-wide guidelines on
the Novel Foods Regulation.
Monitoring long-term effects of consumption
21. Consumers are concerned that there may be
adverse long-term effects from the consumption of novel foods.
The impact of individual products and also of genetically modified
products as a whole need to be considered. Although the Novel
Foods Regulation recognises these concerns, more detail is needed
on how monitoring will operate.
22. There is a need for an "over-arching"
body, at both UK and EU level, to consider the broad picture of
the use of genetic modification and its impact on the environment
and food safety. Case by case assessments made under Directive
90/220/EEC or the Novel Foods Regulation do not cover this broader
viewpoint. It is disappointing that the Commission has not set
up a Scientific Committee on Biotechnology. The remit of such
a committee could extend beyond human health and incorporate environmental
and ethical considerations. It could be closely involved in the
approval process and be consulted alongside the SCF.
1 June 1998