Plant Protection Products are subject to restrictive
These days placing Plant Protection Products on the market is a heavily
regulated affair, putting companies under serious pressure.
Regulation (EC) N° 1107/2009 adds new aspects to the existing
system making it even more complex.
Furthermore, new constraints have
been included such as compliance with potential hazardous property
thresholds (e.g. PBT, CMR, endocrine disrupting properties, etc.),
which require numerous inter-disciplinary skills. In addition, the
importance of several other regulatory requirements has increased
recently, like legislative control over adjuvants, biopesticides, data
protection, making again the need for regulatory experts.
CEHTRA can offer you all the solutions you need:
- Helping to develop strategy and testing proposals for the
of new molecules, new uses and new markets;
- Preparing and submitting all forms of technical dossiers
national) needed to get approvals (including section 7);
- Adapting/modifying “old” dossiers
Regulation (EC) N° 1107/2009 and dRR format;
- Supporting substances in the context of the EU Review
- Study monitoring in physico-chemistry and analytical
toxicology, ecotoxicology, environmental fate and biological
- Human and environmental exposure modeling for professional
- Being the contact with Legal Authorities (all RMS and
Commission) and following up dossiers with regular contacts and
- Carrying out due diligence and rationales for study waivers;
- Writing scientific position papers within a short timeframe.
Biological Assessment Dossier Services:
CEHTRA Group can provide design and advice on trials programs and
studies to address Annex III, Section 7 Efficacy requirements to
support applications for EU Zonal Authorisations. The full service
- Completeness checks and review reports on existing Annex
7 Efficacy data packages and writing of Biological Assessment Dossiers
Section 7, Part B (format dRR);
- Applications for National Experimental Trials Permits;
- Pre-submission meeting and addressing question of efficacy
CEHTRA’s experience is a guarantee:
Plant Protection Products are the historical basis of
CEHTRA’s activities. The two founding members –
Pierre-Gérard PONTAL, a medic, and Philippe ADRIAN, an
environmental chemist – were members of the Commission des
Toxiques at the INRA SSM in France where they gained an unrivaled
experience in dossier evaluation.
With more than 250 projects related to formulated pesticide products in
European countries, CEHTRA’s experience in regulatory
dossiers speaks for itself.
Over the last 10 years CEHTRA has dealt with nearly 20 active
substances Annex I of 91/414/EC Directive related projects of which a
dozen for complete dossiers and many others for dossier resubmissions.
Furthermore, over the same timeframe, CEHTRA has completed 22 worker
exposure study-related contracts of which 15 complete worker exposure
studies were performed, several of which were designed for modeling
CEHTRA is also managing support for the development of new active
substances in the EU. This work includes assistance in setting up
programs, laboratory selection, study monitoring, issue management,
registration strategy and dossier building up to the point of
submission when required.
CEHTRA has recently
succeeded in the Annex I inclusion of 2 active substances from List 4
compounds (1-NAA and 1-NAD). CEHTRA was also in charge of the
coordination of the Task Force, which allowed a very good cooperation
with the client.
CEHTRA managed all the
steps of these dossiers: study screening and data gap analysis, setting
up of study program, laboratory selection, study monitoring in all
sections (physic-chemistry and analytical methods, residues,
toxicology, e-fate, ecotoxicology), preparation of the complete
European dossier, and position papers contacts and follow up with the
RMS and European Commission.