CropLife Europe Position Paper Flags Loss of 89 Active Substances in EU Over 6.5 Years

21 March 2026, Brussels: A position paper released by CropLife Europe has raised concerns over proposed changes to regulatory data protection under the European Union’s Food & Feed Safety Omnibus package, warning that the reforms could undermine innovation and further reduce the availability of crop protection solutions.

The paper comes in response to amendments proposed by the European Commission in December 2025, which seek to modify provisions related to regulatory data protection under Regulation (EC) No 1107/2009.

Concerns Over Innovation and Investment

According to CropLife Europe, predictable and enforceable regulatory data protection is essential to sustain investments in high-quality scientific studies required to meet the EU’s stringent safety standards.

The industry body emphasised that generating a full safety dataset for plant protection products is both time-intensive and costly, often involving 200 to 1,500 studies conducted over several years, with investments running into millions of euros.

Regulatory data protection ensures that companies can recover part of these investments while also supporting a robust scientific framework and avoiding unnecessary duplication of studies, particularly those involving vertebrate testing.

Proposed Shift to EU-Wide Protection

A key concern highlighted in the position paper is the proposal to move from a Member State-based system to an EU-wide territorial scope, where the data protection period would begin from the first authorisation granted anywhere in the EU.

CropLife Europe argues that this approach risks creating a timing mismatch, as Member States often complete product authorisations at different speeds.

As a result, products approved early in one country could see a significant portion of their protection period expire before gaining access to other EU markets. This, the paper warns, could reduce predictability for companies and weaken incentives to invest in new safety data.

Impact on Renewals and Market Availability

The issue is particularly significant for product renewals and reviews, where much of the current investment in safety data is concentrated and where protection periods are typically shorter.

CropLife Europe cautions that shortening effective protection periods could discourage companies from investing in renewal data, potentially leading to fewer products remaining available in the EU market.

The paper notes that the EU has already lost 89 active substances over the past 6.5 years, highlighting a shrinking crop protection toolbox for farmers.

Need for Harmonised Implementation

While supporting the European Commission’s objective of simplifying regulatory processes, CropLife Europe stressed that any reform must include harmonised implementation mechanisms across Member States.

The organisation suggested several possible solutions, including extending protection periods to better align with actual regulatory timelines, particularly for first authorisations and renewals.

It also proposed that when one Member State relies on protected studies during a renewal or review, other companies marketing equivalent products should be required, within a reasonable timeframe, to either access the same data through compensation or generate equivalent datasets.

Such measures, the paper argues, would ensure that data protection remains meaningful and enforceable across the EU.

Balancing Innovation and Competition

CropLife Europe concluded that while simplification and transparency are important policy goals, they must not come at the cost of weakening incentives for innovation.

A well-functioning regulatory data protection system, it noted, is critical to maintaining investment in high-quality safety studies, ensuring fair competition, and supporting continued access to crop protection solutions for farmers.

As discussions around the Food & Feed Safety Omnibus proposal progress, the issue of regulatory data protection is expected to remain central to the broader debate on the future of agriculture and innovation in the European Union.

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