Pesticide authorisation dossiers

Pesticide dossiers support approval of crop protection products and their active substances. They combine evidence on efficacy and risks with summaries, evaluations, study reports and administrative documentation.

Approval and assessment

Pesticide authorisation resembles authorisation of human medicines: the toxicology data are nearly identical to drug-development nonclinical data, and environmental risk assessment has many similarities. ¹ Certain authorised pesticides from natural sources are also used in organic agriculture. ¹

In 2014, the EU process under Regulation (EC) No 1107/2009 was described at three levels. ²

1. EU active-substance approval: evaluation includes at least one pesticide product for one representative agricultural use. One member state acts as Rapporteur Member State, followed by peer review by the European Food Safety Authority (EFSA).
2. National product approval: once the active substance is approved, additional formulations containing it, called plant protection products, are approved at member-state level.
3. Zonal assessment: one member state can coordinate product-dossier evaluation for a group of member states in the same agricultural zone: North, Central or South.

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The approval criteria require data demonstrating the following under the proposed conditions of use. ²

• Sufficient efficacy against the targeted disease or pest.
• Acceptable risk to human health.
• Acceptable risk to the environment.

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The agencies involved and the dossier's format and content differ from those for human medicines. ²

Summary and complete dossiers

The Organisation for Economic Co-operation and Development (OECD) approach described in 2014 harmonised pesticide-dossier content and format across its member countries, distinguishing a Summary Dossier from a Complete Dossier. ³ The Summary Dossier used three tiers of increasingly high-level summaries and evaluations. ³

1. Tier 1: reference lists of submitted studies.
2. Tier 2: summary and evaluation of active-substance and formulation data.
3. Tier 3: overall assessment of the application and conclusions.

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The Complete Dossier included the Summary Dossier, individual study reports and supporting documentation such as administrative forms, completeness checks and details of agricultural uses. ³ Sections were assigned letters A–O. ³ It contained an Active Substance Dossier and a Formulation Dossier for products containing that substance. ⁴

In 2014, OECD guidance covered dossier preparation and presentation, while the European Commission's Directorate-General for Health and Consumers provided detailed guidance and templates for several sections. ^{3, 4} EFSA made submitted active-substance dossiers under evaluation available with confidential information removed, providing examples of actual dossier content and format. ⁴

Active Substance Dossiers were then submitted in Computer Aided Dossier and Data Supply (CADDY), an electronic XML format for exchanging, archiving and evaluating complex dossiers. ⁴ The software was freely available and included an XML-conformity checker and demonstration dossiers, while Commission guidance explained submission and technical preparation. ⁴

Product dossiers and national addenda

The stand-alone Pesticide Product Dossier was submitted at member-state level for products containing active substances already approved in the EU, using the same templates and guidance as the Active Substance Dossier. ⁵ For zonal assessment, the dossier contained two sections. ⁵

• Product Core Dossier: the sections relevant to a pesticide product dossier.
• National Addendum Product Dossier: the same format, containing national requirements not covered by the core dossier.

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Country-specific requirements needed checking; for example, Scandinavian countries used a particular approach to environmental metabolites in their North-zone guidance. ⁵ Despite movement towards harmonisation, national addenda could remain necessary. ⁵ Advice in 2014 was to contact the relevant member state six to twelve months before submission to establish whether addenda or national procedures applied, using the Commission's regularly updated contacts list. ⁵

Training and reference resources

Conferences and courses can develop dossier-writing competence and provide updates on evolving formats, guidelines and data requirements. ⁶ Four frequently used resources identified in 2014 were: ⁶

• Training taught by the UK Chemicals Regulation Directorate officials who evaluated pesticide dossiers.
• The biannual AgChemForum conferences, organised by Informa.
• The European Crop Protection Association's annual Regulatory Conference.
• EFSA's online database of guidance documents and pesticide dossiers.

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