Biotechnologies play an essential role in the delivery of EU goals for competitive, healthy, resilient and sustainable economies and societies, specifically in the food and feed sectors. Current regulatory frameworks for food and feed for biotech-derived products are however often outdated and suffer from administrative burdens. Lengthy and unclear product classification and authorisation processes deter companies from applying for product authorisation on the EU market. Simplifying these procedures could help increase competitiveness and innovation, encouraging more companies to apply for product authorisation and/or manufacturing inside the EU. The upcoming omnibus should therefore clarify and streamline classification and authorisation processes for biotech-derived food and feed products, to drive both legal certainty, and innovation for businesses, whilst maintaining the highest EU level of safety. It should serve as a first step for the EU to achieve a truly enabling regulatory framework for biotech. The simplification measures outlined below should be complemented with forward-looking product-based frameworks (as opposed to the existing process-based) in the upcoming Biotech Act along with revised internal EFSA procedures resulting from the ongoing EFSA evaluation. The simplification omnibus must clarify and streamline existing product authorisation regulatory frameworks: 1. Clarify the legal status of fermentation products manufactured using genetically modified micro-organisms 2. Include scientific advice as part of the EFSA pre-submission advice 3. Align feed additives authorisation procedure with other legislation by removing the mandatory 10-year renewal procedure 4. Streamline feed additives authorisation procedures by tailoring data requirements to the application type 5. Remove the 6-month penalty for non-notification of studies 6. Clarify the status of feed additives intended for export only 7. Clarify the regulatory status of certain uses of food cultures Further details into these aspects are included in the attached document. EuropaBio is Europe's largest and most influential biotech industry group. The association represents corporate and associate members across sectors, plus national and regional biotechnology associations which, in turn, represent over 4500 biotech companies & SMEs.

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