Fields - Plant protection products - Biological assessment dossier

Context:

To obtain the registration of a Plant Protection Product ‘or’ Extension of an existing registered Product for New Uses, authorities ask for regulated efficacy, selectivity and residue trials in sufficient number and in relevant locations.

Efficacy and selectivity trials as a minimum are required to be conducted by Officially Recognised Efficacy Testing Facilities (ORETO) in accordance with Good Efficacy Practice (GEP) following specific European guidelines (EPPO) and may have additional national methods e.g. CEB methods in France. Additionally, in France, trials which are intended for the registration dossier have to be declared onto the Coleor system from the Ministry of Agriculture. Throughout the European Union (EU) Residue Trials must be carried out to Good Laboratory Practice (GLP) standard by a certified facility and have to be conducted following the OECD guidelines.

A Biological Assessment Dossier (BAD) compiles and summarises the data from the efficacy and selectivity trials. Since the entry into force of the European Regulation (EC) No. 1107/2009, the dossiers are zonal (one dossier for all the member states of a zone) and national addenda must be used for any national specific requirements. This dossier should be written according to the dRR (draft Registration Report) format.

At your request, A.S.C. can:

identify the necessary trials including number and geographical positioning
manage your trials discussing protocols, time-frame and costs with the CRO's

declare the French registration trials in Coleor
ensure trials and analyses run smoothly
visit field trials
review the draft reports to ensure a precise final report

summarise relevantly and clearly the whole data package in a BAD for zonal submission and write national addenda if necessary
present in a convincing way the biological properties of your formulated product
prepare the product label according to regulatory and agronomic requirements
liaise with Authorities, if necessary, before or after the dossier submission until the approval is granted.

A.S.C.’s agronomists have a broad experience and scientific knowledge base that enables them to compile complete, thoroughly peer reviewed, dossiers that fulfil the Authorities’ requirements.

A.S.C. can thus manage the biological part of your projects from drafting the trial protocols through to submitting the final Biological Assessment Dossier, ensuring a consistent and high quality result.