Nicholas Pear

Pesticide active substance approval and renewal

Mr. Pear has managed the EU approval of numerous new and existing active substances during his career, covering all aspects of regulatory support, including strategic advice, data gap analysis, study design and monitoring, dossier preparation, and post-submission support. This has included managing the entire renewal process for 19 active substances from the planning phase to the point of decision by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF). He has managed the preparation of active substance dossiers in OECD and IUCLID format.

Authorisation of plant protection products in the EU and U.K.

Mr. Pear has assisted clients in all aspects of product authorisation in EU Member States. This has included new products, label extensions, formulation changes, and other product updates in accordance with Article 33 and renewal of product authorisations in accordance with Article 43 of Regulation (EC) No 1107/2009. He has provided assistance over the full product development lifecycle including product design, data gap analysis, study monitoring, risk assessment, dossier preparation (dRR format), and dealing with requests from the authorities during evaluation.

European pesticide risk assessment and registration support

Mr. Pear has a thorough understanding of the data requirements and risk assessment requirements for pesticides in the EU and U.K., covering human health and the environment, and he works closely with the specialist teams in Exponent's Chemical Regulation and Food Safety practice to develop multidisciplinary solutions to complex problems that arise for active substances and products. Whilst having broad experience across numerous technical disciplines, Mr. Pear has in-depth knowledge of ecotoxicology, and he works closely with the ecotoxicology team within the practice to assist clients. 

Representation of clients at meetings with EU authorities for plant protection products 

During the course of the projects that Mr. Pear has managed for active substances and products, he has represented clients at many meetings with national authorities, the European Food Safety Authority (EFSA), and the European Commission. This has included leadership of presubmission meetings for active substances and products with most EU competent authorities and the U.K. authority. His previous position working for the U.K. authority for chemical regulation (CRD) has given Mr. Pear a valuable perspective that he can draw upon when communicating with authorities.

New technologies for plant protection in the EU (peptides, biopesticides, and RNAi)

Mr. Pear has provided strategic advice and general regulatory support, including dossier preparation, for peptide active substances, pheromones, microbial pesticides, and other non-conventional pesticides, including those with physical modes of action. This has included assistance in obtaining emergency authorisations and active substance approvals as well as product support at the national level.

Laffranque JP, Leblanc J, Pear N. La clomazone herbicide multicultures, Qu'est-ce que? Phytoma, La Défense des Végétaux 2002; 549 May.

Before joining Exponent, Mr. Pear served as Registration Manager for Europe, the Middle East, and Africa (EMEA) for FMC Corporation. In this role, he took overall responsibility for the regulatory management of three core active substances. This included preparing the dossiers to support reviews at the national and EU level, commissioning and monitoring of new studies, and dealing with all regulatory issues.

Mr. Pear held additional responsibility for regulatory issues at the national level for a number of European countries at different points, including the U.K., Ireland, Sweden, Norway, Denmark, Finland, Germany, Hungary, Poland, Spain, and France. He covered many country-specific tasks, including registration of new products, extensions to product labels and any other regulatory support for commercial goals. In addition to Mr. Pear's general regulatory management, he was also the ecotoxicology adviser for the EMEA team, problem solving, organizing and monitoring ecotox studies, and conducting or arranging environmental risk assessments. He was also responsible for giving strategic advice to the company on existing and new active substances and managed a significant part of the regulatory budget.

Mr. Pear began his career in regulatory affairs at the Pesticide Safety Directorate (PSD), which is now part of the Chemicals Regulation Division (CRD), a directorate of the U.K. Health and Safety Executive (HSE). He was a project manager for 6 years at PSD, coordinating the evaluation of applications for the approval of active substances and products. He also provided expert advice to colleagues in policy and legal branches, other government departments, and external organisations regarding the operation of regulatory controls and the registration procedures for pesticides and adjuvants at both the national and European level. His role involved regular engagement with the agrochemical companies to provide feedback on their applications and advice on procedural issues.