(Wednesday, July 2, 2003 -- CropChoice news) -- The following is an overview of the new European Union rules on genetically modified food and feed.
The new rules include a whole range of improvements compared to the
current legal situation.
1. Authorisation instead of notification for GM food / feed
All food and feed products which contain, consist of or have been produced
from GMOs will in the future have to undergo a uniform and consistent
authorisation procedure. GM food/ feed must not have adverse effects on
human health, animal health or the environment. But also "other legitimate
factors" will be taken into account by decision-makers. There will be a
ten-year limitation on product approvals.
Product approval: for the first time feed produced from GMOs will require
a pre-marketing authorisation.
The simplified fast-track notification procedure foreseen in the
Novel-Food-Regulation for allegedly "substantially equivalent" GM food
products, has been abandoned.
2. Dual-use authorisation requirement
Before products which are likely to be used as both food and feed may be
placed on the market, a marketing authorisation covering both uses is
required.
3. Exception from authorisation requirement: 0.5% for 3 years
While the Commission had suggested a tolerance level of 1% for the
"adventitious or technically unavoidable" presence of traces of "not yet
authorised GMOs", Council and Parliament agreed to halve this threshold;
the threshold will also automatically expire after three years. Upon the
expiry of these three years, zero-tolerance for unauthorised GMOs and GM
materials will apply, as originally demanded by Parliament.
4. Monitoring
In the case of all food and feed products that contain or consist of live
GMOs, post-marketing monitoring of environmental effects will be mandatory.
The Community may require monitoring of (long-term) effects on human health
in the case of all genetically modified food and feed products.
5. Mandatory labelling for all genetically modified food and feed
The current labelling rules (under which only GM products that contain DNA
or protein resulting from a GMO have to be labelled) will be extended to
include all genetically modified food and feed of GMO origin, irrespective
of the detectability of DNA or protein. Thus products, such as highly
refined GM soy oil and GM sugar, will have to be labelled under the new
Regulation.
Mandatory labelling: for all GM food / feed products, including GM
food/feed not containing any protein or DNA resulting from a GMO ( e.g
sweeteners, oils). And: feed produced from GMOs. The meat production sector
will finally get the possibility to avoid GM feed.
6. Exception from mandatory labelling
While the Commission had proposed to set a threshold for the labelling of
products which contain "adventitious or technically unavoidable" traces of
authorised GMOs in comitology, Parliament and Council have agreed on a
ceiling of 0.9%. This labelling threshold may be reduced to take into
account advances in science and technology. This new labelling threshold is
a clear improvement compared to the current legal situation. The current
deliberate release Directive (2001/18/EC) does not foresee any maximum
labelling threshold but leaves this decision to the comitology procedure.
Member States may also take co-existence measures in order to avoid as far
as possible any contamination (see below 9).
7. Mandatory labelling: ethical or religious concerns
Under the new Regulation the GM label will also indicate if a GM food or
feed product may give rise to ethical or religious concerns.
8. Traceability
In the future GMOs as well as GM food and feed shall be traceable from
cradle to grave. And as in the case of the new labelling scheme, GM
products shall be traceable irrespective of whether the genetic
modification is analytically detectable in the final product or not.
Traceability shall facilitate the monitoring and, where necessary, the
withdrawal of GM products as well as the control of compliance with the
labelling requirements.
9. Genetic contamination - Co-existence
At the core of the compromise are the new rules concerning genetic
contamination. According to most lawyers, the current deliberate release
Directive does not allow Member States to require producers or users of
GMOs already authorised for marketing by the EU, to take measures which aim
to prevent the genetic contamination of conventional or organic products.
Under current law, not only the farmers concerned but also Member States
seemed to have no other option than to let genetic contamination of
conventional and organic products happen and to accept the economic damage
caused by such GMO pollution.
The new co-existence rule, which will become part of the deliberate
release directive, will explicitly allow Member States to take appropriate
measures to avoid the unintended presence of GMOs in other products. The
Commission will publish guidelines regarding "co-existence" and shall bring
forward necessary proposals, including legislative proposals if there is a
need.
