Memorandum by EuropaBio
1. It is essential for any revision of 90/220
that in addition to the necessary provisions for safeguarding
human health and the environment, the Directive provides for a
regulatory framework which enables biotechnology to play its full
part in benefiting European society.
2. Modern biotechnology has a crucial role to
play in the improvement of human and animal health and in agricultural
practices for the benefit of the rural community and the environment:
to mention but two areas where the potential contributions to
European society are most advanced. Sound investment must be encouraged.
The potential for employment is large (with an improvement in
the business environment, the value of products and services using
biotechnology in Europe could reach ECU 250 billion by 2005 and
provide more than three million jobs).
3. As the Explanatory Memorandum to the revision
of the Directive recognises "This growth sector has not yet
reached its full potential and its cruising speed. In addition
this new technology will maintain the competitiveness of Europe
on the world market and will make a major contribution to economic
growth by enhancing the competitive position of industry and agriculture".
4. Europabio's comments on the Commission proposals
are therefore based on the requirement for a balanced package
as expressed in the first paragraph, which also reduces trade
friction to the minimum. Again, in the words of the Explanatory
Memorandum "It is essential that regulation does not unnecessarily
hinder the potential for technological innovation".
5. The current 90/220 has not shown the ability
to ensure that European society can utilise the benefits of biotechnology.
It is subject to short-term political expediency. Any revision
must deal with the need for stability, consistency and timeliness
and be based solely on sound scientific criteria.
6. Europabio is concerned to ensure that the
legislation is able to keep pace with rapid technological improvement.
"International experience has shown that these figures, (i.e.,
number of product notifications), will increase rapidly in the
next few years" (Explanatory Memorandum).
7. In conformity with the above, Europabio has
been seeking improvements to 90/220 which:
(1) Will enable the regulators to keep pace
with the advances of the technology.
(2) Reinforce principles of sound science.
(3) Improve time lines and consistency of
(4) Relate properly to relevant vertical
sector specific legislation.
(5) Recognise the need for improved and streamlined
procedures for specific applications and products based on the
(6) Recognise the principle of the internal
8. In its Memorandum to the revision proposals,
the Commission recognises these concerns and has made proposals
to meet all these criteria, with varying degrees of appropriateness.
The following comments refer to required adjustments and Europabio's
concerns with the new provision of a fixed term approval and for
9. The multistate procedure introduced in Part
B does not make any distinction between Category I and Category
II releases (Article 9). It should be possible to shorten the
Category I procedure by a further 30 days.
10. The multistate procedure should be further
developed so review by one Member State only is required for multistate
11. A time-limit should be introduced concerning
the public consultation period.
12. The proposed seven year authorisation period
13. The authorisation period should be unlimited.
Should an unforeseen problem arise after authorisation, there
is always the possibility for revising or withdrawing the authorisation
The seven year authorisation proposal is ill
adapted to plant breeding. Improved varieties which incorporate
the same event come on the market every year: therefore for all
GM varieties which come on the market after the first year of
Part C authorisation the period of normal certainty that a product
can be commercialised is less than seven years, diminishing to
one. This is unacceptable. The system of variety registration
and the costs which go with it exacerbate the problem.
14. These comments also relate to the concept
of fixed renewal periods. Normally they should not be necessary.
15. All phases of the procedure should be subjected
to time disciplines, both by the Commission and the Member States.
For example, time limits should be laid down for the deliberations
of the Scientific Committee (Article 21).
16. Monitoring (Article 15). It is imperative
that monitoring be targeted only to those issues which could constitute
a risk from the GMO which is being authorised. There must be a
link between the monitoring required and the safety assessment
of the GMO. Monitoring should be restricted to possible ADVERSE
effects which may derive from the genetic modification itself.
It should be limited to that which is necessary for a company
to fulfil its legal obligations under the directive.
17. Where the following categories fall within
the scope of the Directive simplified fast Track procedures should
GMOs used for processing but not
for cultivation in the European Union.
GMOs developed by combining previously
authorised GMOs by traditional breeding methods.
new uses of GMOs previously approved.
18. Some definitions are open to different interpretations
e.g., "placing on the market" (Article 2(4)). This definition
continues to be too widely drawn and causes difficulties where
GMOs are made available to third parties for research and other
activities which fall short of actual commercialisation. These
movements to third parties for research and other activities should
be excluded from the definition.
3 June 1998