ECCA Calls on Incoming Irish EU Presidency to Strengthen Legal Certainty in Omnibus X
La conferencia LATAM de Asociación Europea para el Cuidado de Cultivos (ECCA), representing the post-patent plant protection industry in Europe, is calling on the incoming Irish Presidency of the Council of the EU to support targeted amendments to the data protection provisions included in the Food and Feed Safety Simplification Omnibus (commonly referred to as Omnibus).
Proposed by the European Commission in December 2025, Omnibus X seeks to streamline and simplify EU food and feed legislation, reduce unnecessary administrative burdens and improve the efficiency of regulatory procedures.
“We welcome the direction of the Commission’s proposal and, in particular, the objective of introducing greater EU-wide alignment in the management of data protection periods for post-patent plant protection products (PPPs),” said Mónica Teixeira, President of ECCA. “However, a limited number of targeted amendments are necessary to prevent unintended extensions of data protection and ensure that the new framework delivers genuine legal certainty and harmonization across Member States.”
Following the Council’s agreement on parts of the Omnibus X package on 27 May, discussions have continued on the remaining proposal, which includes provisions of particular relevance to post-patent PPPs. As Ireland prepares to assume the Presidency of the Council of the EU on 1 July, it will have an important opportunity to facilitate further technical dialogue and help Member States work towards a balanced and workable Council position.
“The Irish Presidency will take office at a key stage of the legislative process, is well placed to help build consensus around a framework that supports European agriculture while providing greater predictability for authorities, data owners and post-patent applicants alike,” Teixeira added. “Delivering the final text of the Omnibus would directly contribute to the Irish Presidency’s aim to prioritize competitiveness, simplification and food security during its term.”
Establishing a clear EU-level starting point
Under the Commission proposal, the protection period applicable to data submitted for the renewal of an active substance would begin with the first relevant renewal decision taken by a Member State.
ECCA considers that linking the commencement of data protection to a national administrative decision could leave the effective duration of protection dependent on the timing of procedures in individual Member States. This could result in significant differences across the EU and prolong legal uncertainty for both applicants and competent authorities.
According to ECCA’s analysis, the proposed mechanism could, in practice, turn a nominal 30-month data protection period into an effective period averaging approximately 65 months. ECCA therefore recommends establishing a clear and legally certain EU-level trigger linked to the formal EU decision renewing the approval of the active substance.
“Data protection should reflect legislative intent, not administrative timing,” said Teixeira. “A common EU-level starting point would provide all market participants and national authorities with the clarity and predictability they need.”
Preventing unintended extensions of data protection
ECCA has also identified a potential unintended consequence concerning the subsequent use of renewal data.
In certain circumstances, data initially submitted in support of an active substance renewal and normally subject to a 30-month protection period could subsequently be relied upon in the context of a first product authorization. If such data were then considered necessary for the first authorization, they could potentially benefit from a new 10-year protection period.
ECCA believes that the legislation should explicitly prevent this outcome, ensuring that data receive the period of protection appropriate to the purpose for which they were originally submitted.
“This is a technical issue with material consequences for market access,” said Teixeira. “Where renewal data are subsequently used in an authorization procedure, this should not inadvertently result in a new ten-year protection period. Without an appropriate clarification, the intended benefits of harmonization could be significantly reduced.”
Clarifying the treatment of provisional authorizations
A further clarification is needed in relation to provisional authorizations granted under Article 30 of Regulation (EC) No 1107/2009.
Under the proposed framework, it is not sufficiently clear that a provisional authorization would trigger the start of the applicable data protection period. This could result in a product being present on the market for a significant period before the formal protection period begins, thereby unintentionally extending the effective duration of exclusivity.
ECCA therefore recommends explicitly confirming that provisional authorizations trigger the relevant data protection period under Article 59(6).
“A predictable framework requires the protection period to begin when the data first support access to the market,” Teixeira added. “Recognizing provisional authorizations as a trigger would improve consistency and prevent unintended differences between authorization pathways.”
ECCA’s recommendations
ECCA is calling for targeted amendments to the Omnibus X proposal that would:
- establish a legally certain EU-level trigger for the start of data protection, linked to the formal EU decision renewing the approval of an active substance;
- ensure that differences or delays in national administrative procedures do not unintentionally extend the effective duration of data protection;
- clarify that renewal data subsequently relied upon in a first authorization cannot automatically trigger a new 10-year protection period; and
- confirm that provisional authorizations granted under Article 30 trigger the applicable data protection period under Article 59(6).
As a complementary implementation measure, ECCA also encourages consideration of an EU-level transparency and tracking mechanism, such as a central database, to record applicable data protection periods and support more consistent management across Member States.
ECCA stands ready to work constructively with the incoming Irish Presidency, Member State representatives, the European Parliament, the European Commission and other stakeholders to ensure that the final text delivers greater legal certainty and supports a more predictable and effective internal market for post-patent PPPs.
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