Dossier preparation (draft registration report (dRR)) and submission
Enviresearch offers clients a comprehensive dossier preparation and submission service following the Plant Protection Products Regulation (Regulation (EC) No. 1107/2009). We are highly experienced in preparing full dossiers (dRR Part A, Part B and Part C), including preparing the core dossier and national addenda as well as the Biological Assessment Dossier (BAD). Dossier preparation support can be provided for a variety of application types from zonal authorisations (Article 33), label extensions (LEX), mutual recognition (Article 40) and product renewal (Article 43).
We have extensive capability of performing all required risk assessments according to the relevant guidance. This includes consumer dietary risk assessment, non-dietary human exposure assessment (operator, worker, bystander, residents), environmental fate and behaviour and ecotoxicology. Apart from carrying out the tier I risk assessments, we have expertise in providing higher-tier approaches and problem-solving for refined assessments. Enviresearch can also assist with submitting the completed dossiers to the relevant competent authorities.
Data gap analysis
To obtain approval for an active substance or gain product authorisation, applicants must include a complete data package that sufficiently addresses the data requirements as laid down in Regulation (EU) 283/2013 (active substance requirements) and 284/2013 (product requirements). An incomplete data package can delay or prevent the approval of an active substance or authorisation of a product. Early identification of data gaps is key to taking steps to generate the required data as early as possible and preventing delays in gaining the required approval and therefore bringing products to market.
Via a comprehensive data gap analysis service, Enviresearch offers a completeness check against mandatory data requirements to determine where data gaps exist and provides strategies for filling these gaps, which can include generating new data or presenting cases for data waiving. When new data generation is identified, Enviresearch can assist with all aspects of filling in the identified data gaps, from study design to commissioning, study monitoring and authoring study summaries for submission.
Contracting and monitoring of studies
New data may need to be generated to meet the data requirements to support active substance approval or product authorisation. Our regulatory experts are experienced in commissioning studies for support in all areas of the dossier, including physical and chemical properties, efficacy, residues, toxicology, environmental fate and ecotoxicology. Enviresearch assists clients with commissioning studies with contract research laboratories, and provides study monitoring, including reviewing study protocols, preliminary results and drafting reports to ensure studies are being conducted to the latest regulatory guidelines.
Liaising with competent authorities
Competent authorities are responsible for evaluating dossier submissions and granting authorisations. Therefore, liaising with competent authorities is key to ensuring the evaluation process is as smooth as possible. It may be useful for applicants to request a pre-submission meeting with the competent authority to gain advice and guidance prior to submission of their dossier to help address specific issues. Our technical experts can assist with the preparation of agendas and documents required for the meeting, attend a pre-submission meeting with clients and provide post-meeting support. Competent authorities will often request clarifications or additional information from applicants during the evaluation process. Enviresearch is experienced in providing post-submission support to address any competent authority requests.
Comparative assessments
The regulation of plant protection products in the EU requires products containing an active substance approved as a candidate for substitution (CfS) to undergo a comparative assessment as part of the evaluation process for authorisation in any EU Member State.
An active substance is classified as a CfS if its intrinsic hazardous properties meet any of the seven conditions defined in Annex II of Regulation (EC) No 1107/2009 that are considered less favourable compared with most active substances. The comparative assessment aims to improve the protection of health and the environment by replacing candidate products (i.e., the product containing a CfS) with alternative pest control methods of less concern while minimising the economic and practical disadvantages presented to agriculture. A separate assessment is required for each EU state in which the plant protection product is intended to be authorised, as several EU states have their own national guidance to follow.
Using data from the steps mentioned, we conclude whether the candidate product can be substituted by an alternative means of pest control without resulting in significant economic or practical disadvantages. Enviresearch has extensive experience in conducting comparative assessments as outlined in the European Commission guidance document for comparative assessment and substitution of plant protection products (SANCO/11507/2013 rev. 12). We can assist in all aspects of the comparative assessment, from identifying products that contain a CfS and compiling lists of alternative pest control measures available in EU states to conducting all aspects of the agronomic and health/environmental assessment steps.
Technical equivalence for new active substance sources
Article 38 of the Plant Protection Products Regulation (Regulation (EC) No. 1107/2009) outlines the requirements for technical equivalence between active substances. The purpose is to establish, via a tiered process, if the specification of an active substance from a new source is equivalent to the reference source (the source(s) on which the risk assessment in the Draft Assessment Report was based). This is to ensure that the chemical composition and hazard profile, from both a human health and environmental aspect, are comparable, regardless of source. The need for technical equivalence can arise when there is an additional manufacturer or the original manufacturer but an amended specification, new process or different manufacturing location. Technical equivalence should be applied for after the original active substance approval but before completing a product application.
The areas included in technical equivalence cover substance identification, methods of manufacture of the active substance and analytical data (five-batch analysis). Impurities should be considered and their status as significant or relevant should be covered. For a tier II evaluation, information on relevant toxicological and ecotoxicological endpoints is also likely to be required. Enviresearch can assist with the data gap analysis, provide guidance for the commissioning of missing data for both tier I and tier II evaluation, including carrying out QSAR assessments of any impurities in the technical material, as well as authoring a technical equivalence report for submission to the competent authority.
