Innovation and Regulatory Advancement

Crop protection is an area of ongoing innovation – with quests for greener and more sustainable crop protection products, come demands for evidence demonstrating their safety for both humans and the environment. Regulators are asking for increasingly complex endpoints to evidence safety claims and ensure informed decision making. In addition, demand for transparency on the scientific basis of decisions is also increasing, especially within the EU.

It is therefore crucial to keep ahead of the regulatory curve driving such innovation. You need to anticipate changes in the regulatory environment, truly understand their implications and build robust strategic plans to address them.

New priorities impacting crop protection regulation

Revisions to the General Food Law in the EU

The EU General Food Law (GFL) – Regulation (EC) No 178/2002 – covers the entire agri-food sector regulating the production, processing and distribution of food and feedstuffs. The GFL, published in 2002, has undergone a Fitness Check which identified some key changes and resulted in the adoption of Regulation (EC) 2019/1381 in 2019 that will come into force on 27 March 2021.

The new regulation, dubbed the Transparency regulation, is designed to:

• Increase transparency to allow the public to see study data on which regulatory decisions are made by the EU competent authorities
• Enhance governance through greater contributions from member states to the European Food Safety Authority (EFSA)  
•  Increase the independence of scientific studies through a register of studies, consultation with experts and the public on planned studies for authorizations or renewals, auditing of the laboratories conducting studies and allowing EFSA to perform their own verification studies
• More effective risk communication to stakeholders and the general public.

This focus on scientific rigor and transparency is to be welcomed; however, there are multiple implications that need to be considered and Covance by Labcorp is actively engaged in planning for. Key considerations include specifics around the protection of intellectual property and confidentiality and understanding the processes for study commissioning and submission to EFSA as it relates to crop protection. The requirement to submit crop protection active substance dossiers in IUCLID format is already possible based by Labcorp’s many years of experience under European Chemicals (Reach) and Biocides Regulations.

Labcorp is actively engaging with EFSA and other members of the crop protection industry to identify ways of addressing this new regulation. We will continue to keep you informed of the latest developments. Read more here.

New Recommendations for OECD TG 416 Two-Generation Reproduction Toxicity Studies

Based on recent EFSA review, the technical report doi:10.2903/sp.efsa.2019.EN-1837 published 26 March 2020 following the pesticides peer review meeting and ECHA consultation, EFSA has recommended additional parameters be added to the OECD TG 416 two-generation reproduction toxicity test guidelines. While the recommendation is not a formal guideline change, EFSA has identified best scientific practices to support endocrine disruptor testing. The additional parameters recommended include:

• Measure ano-genital distance of all F1 and F2 offspring (Ca. PND 1-4)
• Examine male offspring for the presence and number of nipples/areolae in all male F1 and F2 offspring (Ca. PND 13)
• Histopathological assessment of the mammary gland in parental and F1 adult males and females

We recommend adding these parameters to the study design of OECD 416 studies in order to comply with the best practice recommendation. We will stay up-to-date on any changes or additional recommendations in order to keep our clients informed and compliant.