Parma, Italy
July 6, 2006
In line with its commitment to
openness and transparency and encouraging scientific input from
all interested parties, the
European Food Safety Authority (EFSA) will today launch an
open consultation on the approach of its Panel on Genetically
Modified Organisms (GMO Panel) in assessing ‘hybrid’ 1
genetically modified (GM) plants. At the same time, EFSA will
also publish its final guidance document for the risk assessment
of GM microorganisms which has also been subject to an extensive
public consultation process.
EFSA will today launch a new
public consultation on the approach of its GMO Panel in carrying
out risk assessments on ‘hybrid’ GM plants. The Authority will
publish a draft guidance document explaining how its GMO Panel
evaluates the potential human health and environmental effects
of ‘hybrid’ GM plants. This concerns ‘hybrids’ obtained by
combining two GM plants which have been previously assessed. The
document informs applicants how its Panel evaluates the
potential interactions between the combined GM plants of the
‘hybrids’ in terms of their toxicity, allergenicity, nutritional
value and environmental impact and describes what type of
information and test results it expects applicants to deliver.
EFSA is interested in receiving input and comments on this
guidance document from potential applicants, national
authorities and other regulatory bodies, key stakeholders and
all interested parties. In line with its recently published GMO
strategy 2 , EFSA would particularly encourage Member States to
contribute.
The consultation document and
instructions on how to provide input are available at:
http://www.efsa.europa.eu/science/gmo/gmo_consultations/1596_en.html
(Deadline: 10 September 2006).
EFSA will also publish today its
guidance for the risk assessment of GM microorganisms (GMMs)
which is an aid to applicants requesting authorizations for GMMs
and their derived products intended for food and feed use.
During the consultation, a significant number of detailed
comments were received from national institutions, industry,
research institutions and NGOs amongst others. The document
provides guidance for the risk assessment of a broad spectrum of
GMMs and derived products ranging from single compounds used in
food and feed (e.g. amino acids and vitamins) to products
containing viable GMMs (e.g. probiotics and starter cultures for
dairy products or beverages). Typical GMMs covered by the
guidance document are various nonharmful bacteria, yeasts, fungi
and microalgae used in food or feed.
The GMM guidance is available at:
http://www.efsa.europa.eu/science/gmo/gmo_guidance/catindex_en.html.
1 ‘Hybrid’ GM plants are created
through genetically crossing or combining two different types of
GM plants. EFSA has already evaluated GMO hybrids, such as MON
863 X MON 810 hybrid maize.
2 EFSA’s ongoing strategy in relation to the assessment of GMOs
and its initiatives to build closer collaboration with the
Member States (http://www.efsa.europa.eu/press_room/press_release/1557_en.html). |