Workshop on waiving the dog studies

Background

EFSA organised a workshop with relevant stakeholders in the framework of the self-task mandate of the Panel on Plant Protection Products and their Residues (PPR Panel) for the development of a scientific opinion on waiving the dog studies in the regulatory process of agrochemicals approval.

Under Regulation (EU) No. 283/2013 of setting out the data requirements for pesticidal active substances, short-term oral toxicity testing in rodents (90-day rat study) and in non-rodents (90-day dog study) are required (among others) to address hazard identification and human safety of plant protection products (PPPs), and to inform the approval of active substances in the European Union (EU). A retrospective analysis of the active substance approval process, previously conducted by EFSA, underlined that in 95% of the cases among 101 reviewed active substances, the dog was not the most sensitive species used for setting the Health-Based Guidance Values (HBGVs). The purpose of the scientific opinion is to review and update the abovementioned retrospective analysis with a broader database of active substances, and to develop a tiered assessment strategy to determine whether waiving of the dog studies in the regulatory process can be scientifically justified.

This event provided a platform to inform stakeholders on the approach proposed in the PPR Panel scientific opinion, as well as to gather feedback on the approach and start an international network on the topic.

Objectives of the workshop

The objectives of the workshop were to:

- Present an overview of ongoing similar projects in the context of plant protection products, chemicals, and drugs. 
- Share the assessment strategy proposed by EFSA PPR Panel to waive the dog study in the regulatory process of agrochemicals approval.
- Facilitate dialogue with stakeholders to gather feedback on the proposed assessment strategy.

The outcome of the workshop was summarised in a report including the major takeaways. The feedback from the workshop and the ongoing public consultation was considered in the finalisation of the Scientific Opinion.