As part of the Food & Feed Safety Omnibus, the European Commission has proposed a shift from the current national system of data protection to a single EU-wide approach. The intention is to streamline procedures and bring greater transparency. But unless this change is balanced with safeguards, it risks undermining investment in scientific studies that upholds the EU’s high safety standards. The way regulatory data is protected may seem technical, but it has direct implications for innovation, competitiveness and farmers’ continued access to essential tools.
How data protection works today
Under the system in place now, the safety data submitted for a plant protection product is protected in every Member State where the product is authorised. Each country grants ten years of protection for studies supporting the original authorisation, and two and a half years for studies supporting renewals or reviews. Because Member States complete their assessments on different timelines, data protection begins when each national decision is issued. This ensures companies investing in high-quality scientific studies have a fair and predictable opportunity to recover those costs across all markets in which the data is used.
What the Omnibus would change
The Omnibus introduces a single EU-wide protection period that begins on the date the first Member State grants an authorisation. While this may look simpler on paper, it creates a structural problem. Member States do not authorise products at the same time. Under a single start date, countries authorising later will do so after part, or even all, of the protection period has already expired. In some cases, data used for later national assessments may receive no effective protection at all.
Why renewal data is especially vulnerable
Most investment in regulatory data today is directed not at new products but at existing ones being reviewed to ensure they continue meeting EU safety standards. These reviews often require new studies. Under the proposed EU-wide system, however, the two and a half year protection period for renewal data would begin when the first Member State finalises its review. Any Member State completing its review later may do so after the protection period has already ended. In such cases, the same newly generated data would be unprotected, despite being essential for maintainingapprovals.
The risk for innovation and for farmers
If effective protection is lost, investment in new studies becomes harder to justify. Over time, this may discourage companies from generating the data needed to support renewals. As a result, some products could be withdrawn, reducing the range of tools available to farmers at a time when pest pressure and climate challenges are increasing. A reform meant to simplify could unintentionally accelerate the loss of crop protection solutions across the EU.
A smarter way forward
Simplification is a valuable goal, but it must not undermine the data that sustains Europe’s safety standards. If the EU moves toward an EU-wide trigger, the system must include mechanisms that preserve meaningful protection for all Member States, regardless of national timelines. That means ensuring the protection period remains effective wherever and whenever a Member State relies on the data. Protecting data protects investment in science and helps keep Europe’s food system safe, resilient and competitive.
Click here to learn more about our position on the data protection
Follow the link to see our Infographic on data protection in 1107/2009
And here Visual Timelines on Data Protection