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CEHTRA - Consultancy for Environmental & Human Toxicology and Risk AssessmentCEHTRA help with regulatory dossiers for agrochemicals
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Plant Protection Products

CEHTRA help with regulatory dossiers for agrochemicals CEHTRA provides support for successful registration and preparation of PPP dossiers.

Plant Protection Products are subject to restrictive regulations

These days placing Plant Protection Products on the market is a heavily regulated affair, putting companies under serious pressure. The new 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 offers solutions

  • Helping to develop strategy and testing proposals for the development of new molecules, new uses and new markets;
  • Preparing and submitting all forms of technical dossiers (zonal and national) needed to get approvals (including section 7);
  • Adapting/modifying “old” dossiers according to Regulation (EC) N° 1107/2009 and dRR format;
  • Supporting substances in the context of the EU Review Programme;
  • Study monitoring in physico-chemistry and analytical methods, toxicology, ecotoxicology, environmental fate and biological assessment;
  • Human and environmental exposure modeling for professional and amateur uses;
  • Being the contact with Legal Authorities (all RMS and European Commission) and following up dossiers with regular contacts and meetings;
  • 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 includes:

  • Completeness checks and review reports on existing  Annex III, Section 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 with Regulatory Authorities.

CEHTRA’s experience is a guarantee

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 purposes.

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.

Plant Protection Products are the historical basis of CEHTRA’s activities. The two founding members - Pierre-Gérard PONTAL, a medic, former head of HH Risk assessment department at Aventis CropScience, and Philippe ADRIAN, an environmental chemist, former head of regulatory affairs and head of ERA at FMC - were members of the Commission des Toxiques at the INRA SSM in France where they gained an unrivaled experience in dossier evaluation.
 
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®Cehtra • November 2017