Memorandum by AgrEvo
AgrEvo informed the Committee that they were
firmly in agreement with the position of EuropaBio (see pages
326-331) and the Green Industry Biotechnology Platform (GIBIP).
They forwarded the position paper below to the Committee.
1. The Green Industry Biotechnology Platform
(GIBIP), representing 20 European companies active in improving
plant using biotechnology, welcomes the adaptation of the regulatory
framework on modern biotechnology to the rapidly evolving scientific
knowledge and increasing familiarity with biotechnology. It is
of utmost importance that the regulatory framework provides for
both the necessary safeguards for human health and the environment
and enables the European society to fully benefit from biotechnology.
2. The Report on the Review of Directive 90/220/EEC
(Com(96)630) issued by the Commission in December 1996, presented
a good analysis of the functioning of the Directive, based on
the experience gathered in the Member States following the first
years of implementation. However, GIBIP believes that the current
Commission Proposal on the Revison of Directive 90/220/EEC does
not fully address the identified weaknesses of the current process.
Furthermore, the Proposal introduces new provisons which add even
further complexity. It is considered very important that the work
of the EU Risk Assessment Working Group is revitalized, in order
to harmonize Community risk assessment and to establish baseline
criteria which are science-based.
3. To facilitate the practical implementation
of the Directive, certain terms used such as "genetically
modified organisms" or "placing on the market"
require further clarification.
4. Clarification of the scope of the risk assessment
is necessary to avoid duplication of safety review, e.g., with
Dir.91/414/EEC or with the Novel Food Regulation.
5. Although other related legislation is being
introduced (e.g. the Novel Foods and Novel Food Ingredients Regulation),
the current Proposal does not make cross-references to this. It
should clearly exempt those categories of products which are covered
by other vertical (product) legislation as applicable.
6. Science-based legislation should foresee
a mechanism for rapid adaptation to technical progresses. The
current Proposal no longer provides for this regarding research
and development activities.
7. The current Proposal brings substantial improvement
to the procedure for research and development trials. The introduction
of a multistate approval procedure should, however, also foresee
different categories for genetically modified organisms according
to familiarity and be further expanded so that review by one Member
State only is required for a multistate trial (Article 6c).
8. A mechanism should be introduced whereby
questions, comments and objections raised by Member States during
the 60-day-review period and which fall outside of the scope of
the Directive should be automatically rejected (Article 13).
9. The duration of the complete procedure for
placing on the market is still not clearly defined, as critical
steps (Regulatory Committee, Scientific Committees) remain without
time-limitation. It is therefore questionable whether the amendments
introduced for certain steps will improve the predictability of
the duration of the process as compared to the current situation
(Articles 20a and 21).
10. The Proposal does not address the non-compliance
of the Member States regarding the specified time-lines.
11. The limitation of authorisations to 7 years
is neither coherent with other legislation on genetically modified
organisms (e.g., no time-limitation under the Novel Food Regulation),
nor adapted to the reality of plant breeding and marketing. The
proposed time-limit for authorisations under Directive 90/220/EEC
should be withdrawn as it does not contribute to the safeguard
of the environment or human health, but increases the development
risk for the European biotechnology industry. In any event, the
existing measures (Article 11 (6) or Article 16 of Directive 90/220/EEC)
require notification of any new information concerning potential
adverse effects and allow Member States to take safeguard measures,
including product withdrawal. This also applies to previously
authorised products (Articles 13b, 13c, 13d, and 22b).
12. Post-marketing product stewardship is common
practice for companies. Mandatory monitoring as introduced in
the Proposal should be related only to cases where potential risks
have been identified during the risk assessment under Directive
90/220. Monitoring will have to be based on sound scientific principles,
criteria and protocols, related to these potential risk(s) (Article
13. The Proposal should provide clarity on the
applicability, procedures and information requirements for the
following categories of genetically modified plants (GMPs);
GMPs used for processing but not
for cultivation in the European Union;
GMPs developed by combining previously
authorised GMPs by traditional breeding methods;
new uses of GMPs previously approved.
Where these products fall within the scope of
the Directive, simplified procedures should apply.
14. Public involvement (availability of a summary
of the dossier and publication of the Scientific Committee reports)
will improve transparency. However, public consultation should
start once the rapporteur Member State deems the dossier to be
complete. The procedure for addressing public comments requires
clarification (Article 17).
15. GIBIP strongly believes that only a clear,
transparent, timely and science-based regulatory framework, compatible
with international legislation, will ensure environmental and
human safety, while at the same time supporting the competitiveness
of the European biotech industry and enhancing products acceptance.