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.
- Regulatory scientists with foresight and insight who can anticipate the impact of potential regulatory changes and engage proactively in thought leadership in this arena
- Access the latest regulatory thinking and innovative regulatory science to future-proof your crop protection portfolio
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. It covers everything moving ‘from farm to fork’. 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 is designed to:
- increase transparency to allow the public to see study data on which decisions are made
- 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 rigour and transparency is to be welcomed; however there are multiple implications that need to be considered and which Covance are 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 the EFSA as it relates to crop protection.
Covance 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.
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
Covance is recommending 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.