3rd International Poultry Meat Congress

O 05 EU Regulatory Environment For Feed Additives Involving GMOs
Ludovic Arnaud
FEFANA Asbl – The EU Association of Specialty Feed Ingredients and their Mixtures
Belgium
Since the 80s, the development of the techniques of genetic modification has started and
already by the beginning of the 90s, the European Union (EU) authorities have initiated the
first regulations of these products. The regulatory system established a mandatory evaluation
system for Genetically Modified Organisms (GMOs) used in plain field, particularly focusing
on their impact on the environment 1 . For Genetically Modified Microorganisms (GMMs) used
for industrial (fermentative) production processes, the control focused on the containment
measures linked to the safety profile of the microorganisms. A system of site authorization was
also established 7 .
At the beginning of the current century, as a follow up of different food safety issues in the
EU, a full set of regulations was installed with a view to increase the safety of food for human
health, animal health and the environment. Within this set of regulations, the Feed Additive
regulation 4 , published in 2003, sets up a pre-market authorization system, based on a thorough
evaluation of the safety of feed additives. For products produced by fermentation using a GMM,
the risk evaluation is based on a thorough description of the production organism and of its
genetic modification process (as described in the guidelines for the preparation and evaluation
of application dossiers 6 ). Thus, feed additives obtained by fermentation are only authorized if
the risk evaluation confirms that the production strain and the end product (the feed additive) are
safe under the defined conditions of use.
In parallel and linked to the development of GMO used in plain field, the EU authorities have
developed a set of regulations (GM regulations 2,3 ) aiming at further ensuring safety of GMOs
and their products in the food and feed chain. Considering that the feed additives produced
by fermentation with a GMM were already evaluated and that the final product is sufficiently
purified, the regulators excluded them, when purified (e.g. enzymes, amino-acids, vitamins,…),
from the scope of the GM Regulations 2,5 . Microbial biomass recovered from these processes,
consisting of the killed cells of the micro-organisms, where DNA is no longer transferable, and
which are intended to be used as feed materials are covered by the scope of the GM regulations.
Furthermore, with a view to provide the consumers with the freedom of choice based on relevant
information, the GMOs and their products need to be labelled with their GM origins (e.g. oil
produced from genetically modified soybean, betaine produced from GM sugar beet, etc.).
The overall regulatory system of Genetically Modified (GM) Food and Feed therefore ensures
that all products produced from or with the help of GMO (or GMM) are thoroughly evaluated
by the European Food Safety Authority (EFSA). In addition, a labeling system based on full
traceability has been established for the products containing or consisting of GMO, as well as
for products that involve the use of GMO in plain field (e.g. oil produced from GM soybean).
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