Agriculture Reference
In-Depth Information
applied to GMO-derived foods. Another criticism was the reliance of the
notification procedure on the opinion of only one member-state without
involving the others.
The so-called moratorium was overturned by the first marketing
approval that was granted in accordance with the Novel Foods Regula-
tion for Bt11 sweet maize in May 2004 (see Table 1). This was, however,
not due to a change in member-states' voting behavior but to a decision
taken by the European Commission after neither the Standing Commit-
tee nor the Council had reached a qualified majority. In its decision the
Commission referred to the opinion of its Scientific Committee on Food
(SCF) that considered Bt11 maize as safe for human food as its conven-
tional counterparts, and stated that the methodology used for the safety
assessment was in line with recent guidelines prepared by the Scientific
Steering Committee (SSC)
29
and with Codex Principles and Guidelines
on Foods Derived from Biotechnology.
30
RegulationsonGM Food and Feed
The new regulations concerning GMO-derived foods and feeds, effective
as of April 2004, represented another attempt to respond to criticism.
Regulation (EC) No 1829/2003 on genetically modified food and feed
31
replaced the GM food related part of the Novel Foods Regulation. Thus,
it also dismissed the simplified notification procedure provided for in the
Novel Foods Regulation and requires an authorization procedure (see
Figure 1) for all GMO-derived products instead. The old system has been
replaced by a “one door - one key” procedure for the scientific assess-
ment and the authorization of GMO and derived food and feed. A single
29
The SSC Guidance Document for the risk assessment of genetically modified plants
and derived food and feed of March 6-7, 2003, was the basis for the EFSA Guidance
Document that as a requirement of Regulation (EC) No 1829/2003 was to be published
before entering into force of the Regulation in April 2004.
30
Codex Alimentarius. 2004. Principles for Risk Analysis and Guidelines for Safety
Assessment of Foods Derived from Modern Biotechnology. FAO and WHO. Rome.
31
Regulation (EC) No 1829/2003. Official Journal of the European Union L268: 1-23.
18.10.2003.
