This position paper explains our position on Data protection provisions in the Food and Feed Safety Omnibus. Below are our key messages:
Predictable, properly enforced regulatory data protection is essential to sustain investment in the high quality scientific studies required to meet the EU’s stringent safety standards.
An EU-wide territorial scope, with protection starting from “first authorisation” or first renewal, could materially shorten effective protection in later-authorising Member States. This could undermine predictability for data generators and will weaken incentives to invest in high quality studies, leading to a loss of products.
Any reform should explicitly safeguard meaningful and enforceable data protection across Member States and include mitigation measures to avoid unintended loss of protection and reduced incentives for innovation.
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