www.checkbiotech.org ; www.raupp.info ; www.czu.cz

Today the European Commission gave its support to an approach proposed by
Health and Consumer Protection Commissioner Markos Kyprianou and Environment
Commissioner Stavros Dimas on further steps to improve the scientific
consistency and transparency for Decisions on Genetically Modified Organisms
(GMOs), April 2006.

The measures proposed aim to bring about practical improvements which will
reassure Member States, stakeholders and the general public that Community
decisions are based on high quality scientific assessments which deliver a
high level of protection of human health and the environment. These
improvements will be made within the existing legal framework, in compliance
with EC and WTO law, and avoiding any undue delays in authorisation
procedures.

In light of recent practical experience acquired with the placing on the
market of GMOs, the Commission has decided that practical improvements could
be made to the system to improve the scientific consistency and transparency
for Decisions on GMOs and develop consensus between all interested parties.
These improvements will be made within the existing legal framework, in
compliance with EC and WTO law, and avoiding any undue delays in
authorisation procedures.

The Commission proposes that the following practices be implemented:

- in the scientific evaluation phase:

to invite the European Food Safety Authority (EFSA) to liaise more fully
with national scientific bodies, with a view to resolving possible diverging
scientific opinions with Member States;

to invite EFSA to provide more detailed justification, in its opinions on
individual applications, for not accepting scientific objections raised by
the national competent authorities;

The Commission will fully exercise its regulatory competences foreseen in
the basic legislation to specify the legal framework in which EFSA
assessment is to be carried out;

to invite EFSA to clarify which specific protocols should be used by
applicants to carry out scientific studies (for example regarding
toxicology) demonstrating safety;

Applicants and EFSA will also be asked to address more explicitly potential
long-term effects and bio-diversity issues in their risk assessments for the
placing on the market of GMOs;

- in the decision-making phase:


The Commission will also address specific risks identified in the risk
assessment or substantiated by Member States by introducing on a case by
case basis additional proportionate risk management measures in draft
decisions to place GMO products on the market, as appropriate; and

Where in the opinion of the Commission a Member State?s observation raises
important new scientific questions not properly or completely addressed by
the EFSA opinion, the Commission may suspend the procedure and refer back
the question for further consideration.


This development of the GMO authorisation process is not just the result of
the Commission?s internal reflections, but draws on discussions with Member
States and stakeholders. The Commission will discuss its proposals with the
Member States in the Council, and with EFSA, in the coming months with the
objective of building greater consensus and transparency in this area of
Community policy.

Background

Over the past five years, the EU has put in place a stringent system to
regulate the marketing and production of genetically modified food, feed and
crops. The EU authorisation procedure ensures that only GMOs which are safe
for human and animal consumption and for release into the environment can be
placed on the European market. Clear labelling rules allow farmers, other
users and consumers to choose whether or not to purchase such products and
the rules also ensure that each GMO can be traced at each stage of its use.

The EU regulatory system, one of the strictest in the world, is based on the
granting of individual authorisations for placing GMOs on the EU market,
following scientific evaluation on a case?by-case basis. Requests for
authorisations which do not fulfil all criteria have been and will continue
to be rejected.

[europa.eu.int]

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