Sixth Report:
(1998-99 Session) Genetically Modified
Organisms
GENERAL UPDATE
1. The Committee did not make any specific
recommendations on GMOs in its sixth report. However, since Ministers
gave evidence to the Committee on 5 May there have been a number
of developments, these are detailed below.
SPECIFIC ACTION
New Government Advisory Committees
2. In May 1999 the Government published
the outcome of a public review of the regulatory system governing
genetically modified organisms (GMOs). The main concerns to emerge
were that current regulatory and advisory arrangements are of
necessity complex; they do not properly reflect the broader ethical
and environmental questions and views of potential stakeholders;
and they are not sufficiently forward looking for so rapidly developing
a technology. In responding to these points the Government has
decided to set up new bodies to complement existing advisory functions:
3. The Human Genetics Commission,
to advise on genetic technologies and their impact on humans;
and
The Agriculture and Environmental Biotechnology
Commission to advise on all other aspects of biotechnology
which impact on agriculture and the environment, except food,
which will be handled by the new Food Standards Agency.
4. These two new advisory commissions will
have wide ranging remits, including strategic analysis of biotechnological
developments, addressing broader issues including ethical considerations
regarding the acceptability of genetic modification, identifying
gaps in the regulatory and advisory framework and building a wider
picture from the lessons learnt form individual regulatory areas.
5. These new bodies will complement but
will not control the work of the existing scientific committees,
which will continue to assess new biotechnology products on a
robust case-by-case basis, in line with international legislation
and best practice. In addition, all committees involved in overseeing
developments in biotechnology and genetic modification will adopt
new guidelines on transparency and timeliness.
6. Selection and appointment of the Chair
and members of the AEBC is currently in hand.
Food Standards Agency
7. The Agency will be a non-Ministerial
government department, accountable to Parliament through Health
Ministers and to devolved equivalents. The Agency will take over
most of the existing functions of MAFF and the Department of Health
in relation to food safety and standards. It will be the primary
source of advice on these matters in Government, taking a strategic
view of policy across the whole food chain. The Meat Hygiene Service
will also transfer to the Agency. Its responsibilities will focus
on protecting public health and the interests of consumers in
relation to food. This remit will cover all food safety matters
as well as food labelling composition and advice on nutrition.
8. The main functions of the Agency are:
— developing policies and advising
Ministers and public authorities on food safety, other interests
of consumers of food, and on animal feedingstuffs;
— providing advice and, information
or assistance on food safety and standards matters and animal
feedingstuffs to the general public or other interests;
— obtaining and keeping under review
information about food safety and related issues (eg by commissioning
advice or undertaking or commissioning research);
— carrying out observations of the
safety or quality of food at any point in the food chain (including
on the farm) for the purposes of informing its general policy
work;
— setting standards for enforcement
and monitoring the performance of food law enforcement authorities
(this will mainly relate to local authorities).
Advisory committee on Novel Foods and Processes
(ACNFP)
9. The ACNFP represents the competent food
assessment body in the UK and carries out the initial safety evaluation
of GM and novel food applications received under the Novel Foods
Regulation (EC 258/97). Discussion on applications primarily takes
place at formal meetings which, due to the confidential nature
of some of the information discussed, are generally not open to
the public. However, there have been open meetings held with invited
observers on the issue of post market health surveillance. For
a number of years the ACNFP has been taking steps to ensure the
transparency of its safety assessment procedures. This includes,
for example, the advance publication of the agendas of its meetings,
the publication of minutes of meetings and secretariat papers
presented during its meetings, the publication of its reports
on evaluations once the assessment procedures have been completed
and the publication of an annual report.
10. More recently the Committee has taken
unprecedented steps to increase its openness and the involvement
of the public and others in its work. With effect from 21 December
1999, the UK Novel Foods Regulations, insofar as they apply to
England, have been amended. The amended Regulations will require
companies submitting novel food applications to the UK to permit
routine disclosure for public comments all non-confidential information
that they provide in support of an application. The public will
have 21 days in which to provide the secretariat with comments
to be taken into consideration during the committees' discussions.
GM Labelling
11. EC Regulation 1139/98, which came into
force in September 1998, requires all products containing GM soya
and maize to be labelled if they contain novel genetic material
(DNA or protein). National Regulations providing for enforcement
of these came into effect on 19 March 1999. In a move in which
the UK leads the way in Europe, the rules also apply to restaurants,
cafes, bakers and delicatessens.
12. Member States recently agreed to amend
EC Regulation 1139/98 to include a 1 per cent threshold and extend
the regulations to cover food sold to mass caterers. The aim of
the threshold is to ensure that food ingredients obtained from
non-GM sources do not need to be labelled as GM if they contain
low levels of GM material as a result of adventitious contamination.
Steps should be taken to keep the level of adventitious contamination
in non-GM supplies to a minimum. The threshold will only apply
to ingredients obtained from non-GM sources—there will be
no threshold for supplies obtained from sources of unknown origin.
Companies will need to demonstrate to enforcement authorities
that their ingredients are of non-GM origin; and it is possible
that the use of documented/audited identity preservation systems
could satisfy this requirement. The threshold is applied to maize
and soya ingredients and not the final food; the level in the
final food will be much lower. The amendments come into effect
on 10 April 2000.
13. MAFF is currently consulting on a draft
SI consolidating all rules on labelling in England. The consultation
exercise is due to end on 1 March 2000. MAFF is continuing to
press the Commission to review the threshold within two years
to ensure that it is kept at the lowest level that is feasibly
detectable and practically deliverable.
14. In addition a Regulation making foods
and food ingredients containing additives and flavourings produced
from GMOs subject to the same labelling rules as those of the
Novel Foods Regulation also comes into effect on 10 April 2000.
The Commission undertook to bring forward a proposal to set a
de minimis threshold for additives in due course.
15. The Commission has confirmed that it
is working on rules on the use of "GM-free" labelling;
and the "negative list" of highly processed food ingredients
where no novel DNA or protein remains, and which therefore do
not require labelling.
16. The labelling of food products derived
from animals fed on GM feed is not a requirement of the Novel
Foods Regulation. Member States are agreed that labelling should
be based on the presence of GM material in food sold to the consumer.
There is no evidence that DNA survives processing and passage
through an animal's digestive tract, and DNA or protein from plants
fed to animals has not been identified in meat, milk or eggs.
This view is reflected in the Royal Society's paper "Genetically
Modified Plants for Food Use", published in February. Nevertheless,
MAFF is funding several research projects on the effects of processing
on genetic material and the possibility of transfer.
17. There is no current product legislation
regulating the authorisation of non-viable animal feed materials.
These and other issues relating to GM feed, including labelling
should be covered in the proposed Novel Feeds Regulation. The
UK is pressing the Commission, with other Member States, to produce
its proposal for a Novel Feeds Regulation. This should ensure
fair and consistent labelling, and address increasing public interest
in this issue.
Advisory Committee on Releases to the Environment
(ACRE)
18. The ACRE appointed a number of new members
in 1999 as detailed in their press release of 18 June 1999. Professor
Alan Gray, a member of ACRE, is acting Chairman until a new Chair
is appointed.
Ministry of Agriculture, Fisheries and Food
February 2000
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