STATEMENT | Feed & Food Safety Simplification Omnibus: Important starting point but further refinement is needed to address artificial extensions and legal ambiguity in data protection
The European Commission’s Feed & Food Safety Simplification Omnibus proposal represents a significant step for the post-patent plant protection industry, as it seeks, through targeted and clearly defined amendments, to address a number of issues that have emerged since Regulation (EC) No 1107/2009 came into force.
In this context, we, the European Crop Care Association (ECCA), representing Europe’s post-patent plant protection industry, welcome the approach of considering a broader targeted amendment covering areas for which simplification is essential for the efficient management of the workload related to the approval of active substances and renewal of authorisations of all categories of plant protection products, as only this can ensure that farmers have access to an adequate “toolbox” to protect their crops and safeguard their profitability.
However, while ECCA welcomes the European Commission’s effort to improve the current lack of clarity and harmonisation regarding the duration of data protection, an issue that is crucial for the registration of post-patent plant protection product formulations, the unresolved challenges arising from the proposed shape of Regulation (EC) No 1107/2009 must be noted.
In particular, challenges remain in situations where there is an artificial extension of the data protection period, which can reach up to ten years. This hinders post-patent companies from accessing the information and data needed to register new formulations, limiting the availability of innovative solutions for farmers.
Therefore, while the proposed amendment is an important starting point towards providing greater clarity and legal certainty for the post-patent plant protection industry, ECCA stands ready to continue working with the European Commission, Member States and the European Parliament will be essential to refine the text and address these critical issues in the coming months.
