Agriculture Reference
In-Depth Information
environment (and in the case of feed
additives, for the target animal also). In the
EU, the relevant legal documents are
Directives 2009/41/EC (OJEU, 2009) and
2001/18/EC (OJEC, 2001), on the contained
use and deliberate release of GMOs, and
particularly regarding the authorization of
genetically modii ed (GM) food and feed,
Regulation 1829/2003 EC (OJEU, 2003a).
In the authorization process, the Euro-
pean Food Safety Authority (EFSA) is in the
central role as an independent body for
safety assessment (see also Chapter 3). h e
actual assessment is performed by scientii c
panels, whose members are independent
experts. After receiving the EFSA's opinion,
the European Commission makes the i nal
decision on authorization, with the help of
the Standing Committee on the Food Chain
and Animal Health (SCFCAH). h e SCFCAH
is formed by representatives of the member
states, and a qualii ed majority (representing
the majority of the member states and more
than half of the EU population) has to be
reached for a decision. If the SCFCAH cannot
reach a decision, the matter is shifted to the
Council of the European Union, consisting
of the relevant cabinet ministers of the
member states. If no conclusion is achieved
even there, the European Commission has
the i nal word.
Regarding GM feeds, the central EFSA
scientii c panels are the Panel on Genetically
Modii ed Organisms (GMO) and the Panel
on Additives and Products or Substances
used in Animal Feed (FEEDAP). According to
EFSA policy, the GMMs and derived pro-
ducts that are used for feeds are evaluated by
FEEDAP but take into account the specii c
guidelines of the GMO Panel. h e specii c
requirements for the safety assessment of
GMMs are dei ned in a recent guidance
document (EFSA, 2011a).
Category 1.
Chemically dei ned purii ed
compounds and their mixtures in which
both GMMs and newly introduced genes
have been removed (e.g. amino acids, vita-
mins).
Category 2.
Complex products in which
both GMMs and newly introduced genes are
no longer present (e.g. cell extracts, most
enzyme preparations).
Category 3.
Products derived from GMMs
in which GMMs capable of multiplication or
of transferring genes are not present, but in
which newly introduced genes are still
present
(e.g.
heat-inactivated
starter
cultures).
Category 4.
Products consisting of or
containing GMMs capable of multiplication
or of transferring genes (e.g. live starter
cultures for fermented foods and feed).
From the point of safety assessment,
Categories 1 and 2 represent the simplest
cases. h e basic requirement is the
demonstration of the absence of either
GMMs or the recombinant DNA in the
product. Categories 3 and 4 are more
complicated, Category 4 being the most
challenging. Generally, toxicological studies
may be needed and the potential of
horizontal gene transfer has to be assessed.
With Category 4 products, the ability of a
GMM itself to survive and multiply in
dif erent receiving environments and the
resulting consequences also have to be
assessed. Regarding feed use, it is also stated
in the guideline that in each case the product
has, in addition to the safety aspects related
to the GMM, also to fuli l the general safety
requirements for feed additives as dei ned in
Regulation 1831/2003EC (OJEU, 2003b).
for microbial feed additives
h e basic outline for the general assessment
of microorganisms and enzymes (and which
is basically adapted to other microbially
derived feed additives) is given in the
guidance document formulated by the
former Scientii c Committee on Animal
h e EFSA guidance document divides GMM
products into four categories:
