Agriculture Reference
In-Depth Information
legal frame governing biotechnology in the
EU, has become Directive 2001/18/EC
(EC,
2001) of the European Parliament and of
the Council of 12 March 2001 on the
deliberate release into the environment of
GMOs. Directive 2001/18/EC repeals Council
Directive 90/220/EEC and strengthens
previously existing rules on the release of
GMOs into the environment,
inter alia
introducing principles for environmental
risk assessment, mandatory post-market
(environmental) monitoring, mandatory
supply of information to the public,
mandatory labelling and traceability at all
stages of placing on the market and the
establishment of a molecular register.
According to Directive 2001/18/EC,
authorizations granted under Council
Directive 90/220/EEC must be renewed in
order to avoid disparities and to take full
account of the conditions of consent of
Directive 2001/18/EC. h e authorization
(renewable) is granted for a maximum
period of 10 years, starting from its issue
date. Following the placing on the market of
a GMO, the notii er must ensure that post-
market monitoring and reporting are carried
out according to the conditions specii ed in
the authorization. Directive 2001/18/EC,
which is implemented in each member state
by national regulations, deals with both
small-scale i eld trials (voluntary releases
carried out for experimental purposes, dealt
with in part B of the Directive) and the
marketing provisions of GMOs (dealt with
in part C).
A 'sister' Directive, 'Council Directive
98/81/EC of 26 October 1998 Amending
Council Directive 90/219/EEC on the
Contained Use of Genetically Modii ed
Microorganisms', governs the contained use
of genetically modii ed microorganisms.
Since this chapter focuses on GM plants,
this Directive is not further detailed in this
section.
In 2003, two regulations amending or
repealing previous legal instruments were
published: Regulation (EC) 1829/2003
(EC, 2003) of the European Parliament and
of the Council of 22 September 2003 on
genetically modii ed food and feed and
Regulation (EC) 1830/2003 of the European
Parliament and of the Council of 22
and labelling of genetically modii ed
organisms and the traceability of food and
feed products produced from genetically
modii ed organisms, and amending Directive
2001/18/EC.
In Regulation (EC) 1829/2003, the
rules for safety assessment have been
strengthened and expanded. h is regulation
introduces, for the i rst time, specii c rules
on GM feed and enshrines labelling require-
ments for GM food and feed, previously
covered only partially by Council Regulation
(EC) 1139/98 and Commission Regulation
(EC) 49/2000.
As a main feature, this
regulation implements the 'one key-one
door' approach: one single authorization
covers both food and feed uses, therefore
i lling the legal vacuum for feed product
approval in the EU. h e implementation of
this regulation binds the risk assessment of
GM food and GM feed together in one single
process. Under Regulation (EC) 1829/2003
(in force since 18 April 2004), the applicant
must submit an application containing the
environmental and the food and feed safety
risk assessment of the genetically modii ed
event in question.
h e scientii c information provided in
applications is evaluated by the EFSA,
established by Regulation (EC) 178/2002
(EC, 2002) of the European Parliament and
of the Council of 28 January 2002. In
addition to evaluating these applications,
the EFSA provides scientii c advice to risk
managers of the member states and of the
European Commission, who are responsible
for decision making with respect to product
authorizations and inspection, and more in
general for the management of food and
feed safety.
h e EU recognizes consumers' rights for
information and labelling as a tool to make
an informed choice. Since 1997, labelling to
indicate the presence of GMOs as such or in
a product is mandatory. Regulation (EC)
1830/2003 reinforced the labelling rules on
GM food and feed: (i) mandatory labelling is
extended to all food and feed irrespective of
detectability; (ii) traceability is dei ned as
the ability to trace GMOs and products
produced from GMOs at all stages of their
placing on the market and is implemented
through their production and distribution
chains.
