12.3.2 EU
The European Union (EU) seems most confused on the issue of biotechnology. Many
leading scientific technical developments in biotechnology have occurred within the
borders of EU nations, but the application and deployment of the technologies is chaotically
skewed, with seemingly rapid commercialization of medical, food, and industrial biotech
applications, while lagging in GM crop approvals and releases. It seems contradictory
that hard cheese in the EU emanating from a GMO, albeit lacking in detectable GE
DNA or protein, is exempt from regulations or special labeling, but corn, canola, or
soybean oil, similarly lacking detectable GE DNA or protein, is so captured for both exten-
sive regulatory oversight and product labeling. Internally, the European Union is not so
united with regard to their views of regulation. Several member states appear at least some-
what supportive of agricultural applications of biotechnology, others are more hesitant, and
some remain rigidly hostile.
Regulations are split among several pieces of legislation. In the early days of agricultural
biotechnology, the EU split their regulations between two regulatory Directives, 90/ 119 /
EC covered contained use of genetically modified microorganisms, and 90/ 220 /EC,
which covered deliberate environmental release of genetically modified organisms. Both
of these were later substantially amended; 90/ 119 /EC was superseded in 1998 by
98 / 81 /EC, and 90/ 220 /EC was superseded by 2001/ 18 /EC in 2001. In addition,
Regulation (EC) No. 1830/2003 amended Directive 2001/ 18 /EC, outlining traceability
and labeling provisions for GMOs and their derived foodstuffs. Regulation EC 1829/
2003 provides specific details for labeling requirements.
A listing of the 18 GMOs authorized under Directive 90/ 220 /EC is available at http://
ec.europa.eu/environment/biotechnology/authorised_prod_1.htm, and those proceeding
under 2001/ 18 /EC can be found at http://ec.europa.eu/environment/biotechnology/
authorised_prod2.htm. The EU also provides a listing of biotech products pending
under 2001/ 18 /EC at [http://ec.europa.eu/environment/biotechnology/pending](http://ec.europa.eu/environment/biotechnology/pending_)
products.htm.
In addition to these primary regulatory documents, Regulation EC 258/97, superseded
by EC 1829/2003, covers approvals for “food and feed consisting of, containing or
produced from genetically modified organisms,” and Regulation EC 1946/2003 (http://
ec.europa.eu/environment/biotechnology/pdf/regu1946_2003.pdf) provides the EU
procedures governing the transboundary movements (i.e., international trade) of GMOs,
effectively implementing the Cartagena Protocol, as well as unintentional transboundary
movements.
Complicating this already complicated bureaucracy is the “safeguard clause,” which
allows member states to essentially opt out of accepting GMOs deemed safe under the
various regulatory directives. This escape clause has been used liberally by member
states hostile to GMOs. Member states invoking the safeguard clause are required to
submit scientifically sound justification for rejecting the determination of safety, but in
every case the scientific committee failed to find justification. In spite of this conflict
within the vast European bureaucracy, GMOs remain relatively scarce in the farmers’
fields (to date, although five member states—Czech Republic, France, Germany,
Portugal, and Spain—are cultivating GMOs, and those are on tightly limited acreages).
Foods derived from GMOs are even rarer, except for such examples as the hard cheeses
produced with enzymes from GMOs, which escape regulatory scrutiny and labeling due
to a convenient semantic distinction between foods producedfromGMOs (which are
12.3. REGULATION OF GE 299