MEMORANDUM SUBMITTED BY THE MINISTER OF
AGRICULTURE, FISHERIES AND FOOD AND THE SECRETARY OF STATE FOR
HEALTH (R 19)
INTRODUCTION
1. This Memorandum describes the current
approach in the UK to the regulation of genetically modified foods
(GM). In particular it addresses the way in which GM foods are
assessed for safety and labelled as part of a legally required
pre-approval process designed to prevent products entering the
food chain which might pose a threat to public health or mislead
consumers. It also addresses the issue of segregation of GM and
non-GM food ingredients in the supply chain. The Ministry of Agriculture,
Fisheries and Food and the Department of Health currently lead
on behalf of the United Kingdom in evaluating the safety of all
new GM foods but this role, together with responsibility for future
labelling requirements, will be taken over by the Food Standards
Agency once it is established. Applications are received directly
from the companies concerned or via the relevant authorities in
other member states.
2. In respect of food, the Government's
highest priority is to protect public health by promoting and
enforcing high standards of safety at all stages of its production,
processing and supply. A detailed system for assessing the safety
of novel foods, including those that have been produced using
genetic modification technology, has been in place for a number
of years. The first material for use in food production that was
produced using genetic modification technology, a bakers yeast,
was approved in 1990. There are however very few genetically-modified
food products currently on sale in this country. These are a form
of soya and a form of maize and, until recently, a tomato paste.
Although the genetically-modified soya and maize are used in quite
a wide range of processed foods, it is the same two products that
are used in each of these. Some cheeses and other products are
made with materials, such as enzymes, which have been produced
using genetic modification technology but these enzymes do not
themselves contain any genetically modified material.
SAFETY ASSESSMENT
PROCEDURES
3. Up until May 1997, the UK operated a
voluntary approval system for GM foods. Since that time the requirement
that all such foods should be assessed for safety before being
allowed onto the market has been enshrined in the EC Novel Foods
and Novel Food Ingredients Regualtion (258-97) which applies to
all member states. This requires companies who wish to market
new GM products to apply to the member state in whose territory
they first intend to sell the material for a safety assessment
to be carried out. That member state then has 90 days in which
to reach a conclusion on this after which its report is circulated
to all other member states via the EC Commission for their consideration.
Each member state then has 60 days in which to study this and
raise any concerns that it might have. If these are scientific
or technical and cannot be readily resolved, the Commission will
refer the application to the EC Scientific Committee for Food
for a futher assessment. The outcome of that assessment then forms
the basis for the final decision as to whether the product should
be allowed onto the market or not. This is reached by the member
states acting together under the qualified majority voting system.
In this way, a new product is not only assessed by the tenchical
experts in the lead member state but also those in other member
states and where necessary, an EC expert committee.
4. Many of the products will also have been
assessed beforehand by other countries, such as the USA and Canada,
from where most GM foods coming into Europe currently originate.
In all cases regulatory authorities base their safety assessment
on the concept of substantial equivalence developed by the World
Health Organisation. Substantial equivalence is a tool to aid
the safety assessment of novel foods whereby a novel food is compared
with a conventional counterpart and the safety assessment is then
focussed on any differences, including unintentional effects.
However, this comparison is only part of the safety assessment
process. All novel foods are scrutinised in great detail, far
more so than has been done for conventional foods. Toxicology
studies are required where they are likely to yield meaningful
information, they are required. The approach to the safety assessment
of GM foods was recently reviewed in detail by the Government
Chief Medical Officer, Prof Liam Donaldson, and the Chief Scientific
Adviser, Sir Robert May, who declared themselves satisfied with
the rigour of the procedures being followed whilst recognising
the fact that genetic modification is still a comparatively young
science so that there is a need for continued funding of research
to improve scientific understanding. A copy of their report is
at Annex 1 [not printed].
LABELLING
5. The Government is determined to ensure
that all foods containing genetically modified (GM) material (whether
protein or DNA) are clearly labelled to enable consumers to be
able to make informed decisions about the foods that they eat.
The EC Novel Foods Regulation (258-97) requires specific labelling
of all foods which consist of genetically modified organisms,
contain material which has health implications for some population
groups, or gives rise to ethical concerns. Labelling is also required
where a novel food is judged, on the basis of a scientific assessment,
not to be equivalent to an existing food.
6. Detailed rules (EC Regulation 1139-98)
for the labelling of ingredients obtained from GM soya and maize
came into force on 1 September 1998. These are seen as setting
a precedent for all future novel foods. The regulation, which
was unanimously agreed by all member states and the European Parliament,
requires clear labelling where genetically modified material is
present in the final foodstuff as sold to consumers. In the case
of highly refined products such as soya and maize oils, which
contain no genetic material, and are indistinguishable from the
oils obtained from conventional soya and maize, the European Community
considered that labelling would not convey any meaningful information
about the composition of the final food. In addition a labelling
requirement under such circumstances would be unenforceable. Where
there is any reason to believe that GM material may be present
the food must be labelled as GM.
7. In a move in which the UK leads the way
in Europe, the controls also apply to restaurants, cafes, bakers
and delicatessens. The UK has in this respect chosen not to take
advantage of the flexibility contained in the Food Labelling Directive
79/112/EEC which gives member states the ability to exempt catering
establishments from food labelling requirements. However, in recognition
of the fact that it is not always possible to provide labelling
for foods which are non-pre-packed or which have been pre-packed
for direct sale eg. food sold in restaurants, bakeries, delicatessens
etc., the GB Regulations allow businesses the alternative of providing
information to consumers about the presence of GM material via
their staff. Although the labelling requirements do not extend
to catering suppliers at present the Commission has recently issued
a proposal to amend the EC regulation making it a legal requirement
for all catering suppliers to have to label their products where
they contain GM material.
8. The Government is currently consulting
on the European Commission's proposals for the labelling of GM
food additives and a de minimis threshold to allow for
the adventitious contamination of non-GM supplies with low level
of GM material. The Commision intends to put both proposals to
a vote at the Standing Committee for Foodstuffs meeting on 21
October. The threshold proposal makes clear that such a limit,
below which labelling will not be required, will only apply to
ingredients obtained from non-GM sources. There will be no threshold
for supplies obtained from sources of unknown origin. To be able
to make use of this limit companies will need to be able to demonstrate
to the satisfaction of enforcement authorities that their ingredients
are of non-GM origin. It is possible that the use of clearly documented
and appropriately audited identity preservation systems could
satisfy this requirement. The proposal also makes it clear that
all steps should be taken to keep the level of adventitious contamination
in non-GM supplies to a minimum. The level proposed for such a
threshold is 1 per cent, although in practice the need to provide
proof that ingredients are of non-GM origin should ensure that
actual levels are kept well below this figure. The Government
is also pressing the Commision to develop detailed labelling rules
for animal feed as a matter of urgency and to publish proposals
for a negative list of materials that do not require labelling
as they do not contain GM materials and rules for GM free labelling.
The labelling of animal feed should enable farmers to meet the
needs of their customers for information about the use of GM materials.
There is no suggestion that the use of GM animal feed gives rise
to any safety concerns or affects the compositon of meat or other
animal products.
SEGREGATION
9. Many growers of commodity crops such
as soya and maize do not segregate GM from conventional varieties
at harvest. Although the Government appreciates the difficulties
associated with obtaining the complete segregation of GM and non-GM
crops on a large scale, this does not alter its view that segregation
would have been a better way of introducing GM crops onto the
UK market.
10. WTO rules allow trade restrictions to
be applied only where this is necessary to protect human, animal
or plant health. Measures must be based on sound science and must
not discriminate against particular trading partners. All the
GM materials currently allowed onto the European market have been
thoroughly assessed for safety. For governments to require segregation
of GM from non-GM crops or products as a condition of import would
be considered a restriction on trade.
11. This said, the labelling regime which
is now being introduced will help to ensure the identity of products
as many suppliers will choose to keep GM and non-GM materials
separate in order to be able to satisfy the demands of their customers
for information to pass onto consumers about the content of the
final food. The European Commission's Joint Research Centre at
Ispra has developed test methods for reliably detecting GM material
in foods at levels down to 1 per cent. In addition MAFF is organising
a proficiency scheme for organisations in the UK offering a commercial
detection service. With effective labelling, the ability of enforcement
authorities to be able to test label claims, and the availability
of non-GM alternatives, consumers will be in a position to purchase
products which best suit their needs. Indeed as indicated below
there is already ample evidence that the market is responding
strongly to consumer demand for non-GM alternatives.
12. The Government recognised shortly after
coming into office that to facilitate consumer choice there was
a need to encourage the development of an alternative market in
non-GM ingredients. With the co-operation of the Canadian and
US authorities, a list of suppliers and distributors of non-GM
soya was therefore published and placed on the Internet by MAFF
in 1998. More recently US grain handlers have indicated that they
would be prepared to offer segregation of non-GM varieties at
a premium (10-20 per cent).
13. In practice, segregation has become
a commercial decision for food retailers and food manufacturers
responding to market forces. Indeed a number of UK retailers and
manufacturers have now put in place procedures for obtaining non-GM
supplies from South America where little GM soya is currently
being grown. Many of these arrangements are being underpinned
by detailed audit procedures commissioned by the companies concerned.
In addition there are clear signs that the market-led segregation
of GM and non-GM varieties is becoming more common in response
to consumer demand. We welcome such developments where they are
designed to increase consumer choice. Companies will nevertheless
need to ensure that whatever arrangemnts they have in place to
preserve the identity of the non-GM materials that they are using,
all foods made with these ingredients comply with the labelling
rules. The responsibility for checking products on sale to the
consumer to ensure that this is so rests with Local Authorities.
12 October 1999
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