OFFICIAL POSITION | Food and Feed Safety Simplification Omnibus

Executive Summary

ECCA welcomes the direction taken by the Feed and Food Safety Simplification Omnibus in addressing long-standing shortcomings in the current data protection framework under Regulation (EC) No 1107/2009.

In particular, the move towards EU-wide synchronization of data protection periods is a positive and necessary step towards a more coherent and better-functioning internal market.

However, to ensure that the reform fully delivers on its objectives, the revised framework should further strengthen four key elements:

• a clear and objective starting point for data protection periods.
• safeguards against unintended extensions of protection.
• clarity on the treatment of provisional authorizations.
• a transparent EU-level operational tool to support implementation.

A well-designed system must preserve the right balance between rewarding investment in regulatory data and enabling timely competition once protection expires. That balance is essential for legal certainty, fair competition, and the effective functioning of the internal market.

Why Further Refinement Is Needed

The current data protection regime is affected by fragmentation, legal uncertainty, and uneven implementation across Member States.
In practice, the effective duration of protection may still be influenced by:

• national administrative timelines.
• divergent procedural approaches.
• delays in authorization processes.

This creates outcomes that are difficult to reconcile with the core objectives of the legislation. Rather than strengthening the system, such features generate:

• unpredictability for applicants.
• delays to market access and competition.
• distortions within the internal market.
• reduced confidence in the consistency of the EU framework.

From an internal market perspective, protection periods should not depend on where, when, or how quickly national administrative steps are completed. A system in which effective exclusivity is shaped by procedural variability rather than clear legal rules risks undermining both harmonization and competitive neutrality.

The Omnibus proposal is therefore both timely and welcome. At the same time, further targeted refinement is needed to ensure that the revised framework is fully predictable, proportionate, and workable in practice.

The Key Principle for Reform

The revised framework should be guided by a simple principle:

Data protection must reflect legislative intent, not administrative timing.

Data protection is an important pillar of the EU regulatory framework for plant protection products. It must ensure adequate protection for the investments required to generate studies and regulatory data, while also ensuring that competition can take place as soon as the protection period has lawfully expired.
This balance can only be preserved where the system is:

• clear in law.
• predictable in application.
• uniform across the Union.
• transparent in practice.

Where protection periods are affected by delays, procedural sequencing, or national divergence, the result is not stronger protection, but weaker legal certainty and greater market distortion.

Key Issues That Should Be Addressed

A. Starting point of protection periods

For certain categories of data, particularly those related to active substance renewal, the effective start of protection is still linked to national procedural pathways.This leaves room for continued uncertainty and allows administrative or procedural delays to affect the effective duration of protection. A balanced system should be anchored to objective and legally certain triggers, not to procedural events that depend on Member States.

B. Unintended extension of protection

The proposal should more clearly prevent situations in which protection lasts longer in practice than intended by the legislator.
This is particularly relevant in relation to the so-called “10-year trick”, whereby renewal data may benefit from extended practical protection, 10 years instead of the intended 30 months, when first relied upon in new product authorization procedures.ECCA reworked the data of a previous survey to assess the impact of the proposed rules in practice. We have observed that, due to the prioritization given to new products authorization, in more than 50% of the cases a “10-year trick” would apply if an EU-wide data protection is in place.
If not addressed, this effect risks becoming highly significant under an EU-wide system, with dramatic consequences for competition, market entry, and legal predictability across the Union.

C. Provisional authorizations

The revised text should also remove ambiguity regarding provisional authorizations.
Without explicit clarification, divergent interpretations are likely to persist as to whether such authorizations trigger the start of data protection periods. This would run counter to the broader objective of reducing fragmentation and improving legal certainty.

D. Transparency and operability

Legal harmonization alone will not be sufficient unless accompanied by a practical implementation tool.
Authorities and applicants must be able to identify clearly:

• which data are protected.
• when protection starts.
• when it ends.
• how protection applies across the Union.

Without such transparency, even a well-designed legal framework may remain difficult to apply consistently in practice.

ECCA Recommendations

ECCA supports the proposal’s overall direction and recommends a limited number of targeted adjustments to ensure that the final framework is effective, balanced, and legally robust.

ECCA calls for:

1. A clear and objective EU-level trigger for data protection of renewal data
The legislation should establish a uniform and legally certain starting point for protection periods of active substance renewal data. That trigger should be independent from national administrative timelines and, where appropriate, linked to objective EU-level regulatory milestones.

2. Explicit safeguards against unintended extensions

The revised framework should expressly prevent situations in which data protection is artificially extended beyond the period intended by the legislator. In particular, downstream reliance of active substance renewal data in new product authorization procedures should not generate de facto extended protection – the “10-year trick”.

3. Legislative clarification on provisional authorizations
The text should clearly state that provisional authorizations trigger the start of data protection periods, thereby avoiding divergent interpretation across Member States.

4. A centralized EU data protection database
The reformed regime should be supported by a central EU-level database providing transparent information on protected studies and applicable timelines, including at least start dates, end dates, and the relevant regulatory context. This would significantly improve transparency, operability, and consistency for both authorities and applicants.

Conclusion

The Omnibus proposal offers an important opportunity to modernize the data protection framework under Regulation (EC) No 1107/2009.
ECCA supports this direction and considers the introduction of EU-wide synchronization to be a significant step forward. To fully realize its potential, however, the final framework should ensure:

• predictable legal triggers.
• protection periods aligned with legislative intent.
• clarity on key procedural questions.
• transparent and workable EU-level implementation.

With targeted refinements in these areas, the revised framework can better support innovation, legal certainty, market access, and fair competition across the European Union.

ECCA therefore encourages policymakers to strengthen the proposal accordingly during the legislative process and remains prepared to contribute to the ongoing discussions.

Click here for the full Position Paper.