Agriculture Reference
In-Depth Information
h e 1% threshold specii ed under Com-
mission Regulation (EC) 49/2000 for the
adventitious presence of approved GMOs
was lowered in Regulation (EC) 1829/2003
to a new
de minimis
threshold of 0.9%. On
15 July 2011, Regulation (EC) 619/2011 on
the low-level presence (LLP) of GMOs in
food and feed imports came into force,
regulating the adventitious presence of GM
food and feed not approved in the EU. As a
principle, this regulation follows the zero-
tolerance policy for non-approved GM
products. In order to implement this policy
in realistic and operational terms, the LLP
legislation dei nes the technical zero at the
level of 0.1%. h is is the lowest level of
GM material that can be detected reliably
by the EU Reference Laboratory during
the validation of quantitative detection
methods.
Recently, the European Commission has
published 'Commission Implementing
Regulation (EU) No 503/2013 of 3 April
2013 on applications for authorisation of
genetically modii ed food and feed in
accordance with Regulation (EC) No
1829/2003 of the European Parliament and
of the Council and amending Commission
Regulations (EC) No 641/2004 and (EC) No
1981/2006' (EC, 2013). h is regulation
came into force on 28 June 2013, with a
transitional period until 8 December 2013,
and enlists legally binding requirements
that will need to be taken into account in the
preparation and evaluation of GMO appli-
cations.
and to address any scientii c question or
issue on food and feed safety within Europe.
In the European food and feed safety
systems, risk assessment is carried out
independently from risk management.
Being the responsible risk assessment body
in the EU, the EFSA produces scientii c
opinions, guaranteeing a sound scientii c
foundation to European policies and
legislation and supporting the European
Commission, the European Parliament and
EU member states in taking ef ective and
timely risk management decisions. h e
EFSA's remit covers food and feed safety,
nutrition, animal health and welfare, plant
protection and plant health. In all these
i elds, the EFSA's most critical commitment
is to provide objective and independent
science-based advice and clear com-
munication grounded in the most up-to-
date scientii c information and knowledge.
h e EFSA also consults EU national
competent authorities on every GM plant
application and addresses scientii c concerns
that are raised by these national authorities.
With respect to GMO risk assessment,
the EFSA evaluates the data present in GMO
applications and reviews all the scientii c
information relevant for the safety of any
given GMO. h is provides the scientii c
foundation necessary for the risk managers
to authorize (or not) GM products into the
EU market. h e EFSA's work relies on the
close collaboration between a panel of
independent external experts on GMOs (the
EFSA GMO Panel) and a team of scientists
from the EFSA GMO Unit. h e panel meets
regularly in plenary sessions to discuss work
in progress and to adopt scientii c opinions.
Each opinion results from a collective
decision-making process, with every panel
member having an equal say. As part of its
remit, the GMO Panel also produces
guidance documents to explain its approach
to risk assessment, to detail scientii c
requirements and to ensure transparency in
its work. h e EFSA scientii c evaluation of
the risk assessment included in GMO
applications is published in the form of
'EFSA scientii c opinions', which are all
available on the EFSA website
(http://www.
Authority
Following a series of food crises in the late
1990s, Regulation (EC) No 178/2002
established the European Food Safety
Authority (EFSA) in January 2002 as part of
a comprehensive programme to improve EU
food safety, to ensure a high level of
consumer protection and to restore and
maintain coni dence in the EU food supply.
h e roles of the EFSA are to assess and
communicate the risks associated with the
food and feed chains, to advise risk managers
