EU Biotech Act and Food and Feed Safety Simplification Omnibus: what’s in it for the food and feed sector?
Posted: January 8, 2026 Filed under: Food Comments Off on EU Biotech Act and Food and Feed Safety Simplification Omnibus: what’s in it for the food and feed sector?
A new era for biotechnology innovation
December 2025 brought not one but two major regulatory proposals from the European Commission: the long-awaited first part of the EU Biotech Act and the Food and Feed Safety Simplification Omnibus. Together, these proposals signal a fundamental shift in how the EU approaches biotechnology and food innovation.
The EU Biotech Act aims to strengthen the competitiveness of the EU biotechnology sector whilst maintaining the highest safety standards for people, animals and the environment. The Food and Feed Safety Simplification Omnibus complements this by proposing amendments to ten existing regulations, simplifying procedures, reducing administrative burdens and accelerating market access for innovative products.
Whilst the EU Biotech Act focuses primarily on health biotech, both proposals contain significant changes for the food and feed sector. In this blog, we break down what these two proposals mean for food and feed businesses, so you can start 2026 fully up to speed!
EU Biotech Act
Expanded pre-submission advice and EFSA’s broader mandate
If it is up to the European Commission, the days of incomplete dossiers and lengthy EFSA procedures are numbered. Under the EU Biotech Act proposal, article 32a(1) of the General Food Law Regulation (GFL) will be revised. Whereas EFSA previously only provided advice regarding procedural aspects of the application for innovative foods or the notification thereof, this is now being expanded to include advice on the design of studies and testing strategies to support such an application or notification. This is particularly valuable for SMEs, helping them submit more complete dossiers and shorten time-to-market.
Additionally, EFSA’s general mandate in the field of human nutrition is being adjusted. Article 22(5)(a) GFL is being amended from “scientific advice and scientific and technical support on human nutrition in relation to Community legislation” to simply “scientific advice and scientific and technical support on human nutrition”. By removing the restriction “in relation to Community legislation”, EFSA is given more scope to provide broad advice on human nutrition, even outside the strict framework of existing EU legislation. Welcome expansions that will benefit biotech companies and ultimately support innovation, without compromising on safety standards.
Regulatory sandboxes: testing innovation in a controlled environment
In addition to expanding EFSA’s pre-submission advice, the European Commission is introducing regulatory sandboxes through the EU Biotech Act. These sandboxes provide a controlled environment where participants can test innovative products or substances and related processes under a set of defined rules and monitoring and for a limited period of time. Participants can be any natural or legal person. To enable these sandboxes, definitions are being added to article 3 GFL and new articles 49a to 49c GFL are being inserted. These articles govern the establishment, operation and conditions of the regulatory sandboxes.
Regulatory sandboxes enable innovative biotech companies to test their new products and processes in a safe, controlled environment before they enter the market. Rather than having to comply immediately with all existing regulations, participants can experiment with new technologies under the supervision of the authorities whilst simultaneously learning what data and studies are required for full market authorisation. This lowers the barrier to innovation, shortens development time and helps companies better understand what is expected of them, whilst safety and oversight remain guaranteed.
Amendments to the GMO Directive: a tailored framework for micro-organisms
A separate proposal accompanying the EU Biotech Act presents substantial changes to Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment. With the addition of new articles 24a to 24g, a specific extension for genetically modified micro-organisms (GMMs) within the existing GMO framework is being introduced.
The extension is intended to make the regulatory framework more fit for purpose for GMMs, acknowledging that the existing rules were largely designed with genetically modified plants in mind and do not always align well with the distinct characteristics, applications and risk profiles of micro-organisms. By tailoring Directive 2001/18/EC to the specificities of GMMs, the EU aims to strengthen its attractiveness as a location for their development, production and commercialisation. In particular, low-risk GMMs will benefit from faster market access procedures under the proposed changes. For the food and feed sector, this is widely viewed as a positive development: clearer and more proportionate rules should reduce regulatory uncertainty and lower barriers to market entry, while continuing to ensure a high level of safety. In the agri-food sector, GMMs offer significant potential, e.g. in the development of biofertilisers, biopesticides and biological food preservatives. A more tailored regulatory approach could therefore support innovation in sustainable food production, enhance efficiency and enable the introduction of new products to the market.
EU Food and Feed Safety Simplification Omnibus
The Food and Feed Safety Simplification Omnibus amends ten regulations with three overarching objectives: reducing administrative burdens, accelerating market access for safe products, and modernising outdated procedures. Here’s what’s changing:
Accelerating market access for safe products
Several regulations are moving away from time-limited approvals to unlimited authorisations for substances with proven safety profiles, freeing up regulatory capacity to focus on high-risk substances.
The proposed modification of the Plant Protection Products Regulation (No 1107/2009) introduces unlimited approval periods for active substances (article 5), whilst accelerating market access for biocontrol substances through EFSA’s new role as rapporteur Member State (article 7), priority assessment (article 11), tacit approval after 120 days (article 37), and treating the EU as one zone for products containing only biocontrol or low-risk substances (article 3, point 17). The regulation also provides a clear definition of biocontrol substances as occurring in nature (excluding heavy metals) and substances of biological origin or synthetically produced that are functionally identical and structurally similar. Additionally, article 3, point 36 introduces a definition for basic substances as active substances not predominantly used for plant protection but nevertheless useful in plant protection, with articles 23 and 23a clarifying their approval criteria and allowing their placing on the market without Member State authorisation to ensure easier access for farmers.
Similarly, the proposed modification of the Biocidal Products Regulation (528/2012) introduces unlimited approval duration for active substances (article 4), whilst the proposed modification of the Feed Additives Regulation (1831/2003) follows suit with unlimited authorisations (article 9(8)).
Finally, the proposed modification of the Official Controls Regulation (2017/625) tackles potential delays at borders by allowing border control posts to split consignments of plants and plant products and release parts for which controls are completed (article 50(3)), preventing food waste caused by lengthy laboratory analyses.
Reducing administrative burdens
Multiple regulations are being simplified to reduce unnecessary paperwork and duplicate procedures.
The proposed modification of the Plant Protection Products Regulation removes record-keeping obligations for products containing only biocontrol substances (article 67), whilst the proposed modification of the Biocidal Products Regulation simplifies EU authorisation procedures by publishing only summaries in the Official Journal rather than full decisions (article 44).
The proposed modification of the Feed Additives Regulation modernises labelling requirements by permitting digital labels for non-safety-critical information (article 16) and simplifies administrative changes such as transfers of authorisation holders.
The proposed modifications of the Hygiene Regulations (852/2004 and 853/2004) streamline notification procedures for national measures by adopting one uniform procedure instead of two different procedures, whilst the proposed modification of the Regulation 1099/2009 on animal welfare at slaughter removes duplicate reporting obligations on depopulation operations (article 18, paragraphs 4 and 6), as existing reporting under the Official Controls Regulation is sufficient.
The proposed modification of the Official Controls Regulation introduces flexibility in laboratory accreditation requirements, allowing alternative standards and permitting designation of reference laboratories without full accreditation for all methods under certain conditions (articles 41, 93 and 100), reducing costs whilst maintaining reliability.
Modernising outdated procedures
Several regulations are being updated to reflect current scientific knowledge, international standards and market realities.
Regulation 396/2005 on
maximum residue levels (MRLs) is being amended to set MRLs at zero (limit of quantification) for hazardous substances not approved in the EU (article 14), aligning import standards with EU production standards. Simultaneously, new paragraphs in articles 14 and 18 allow for transitional measures for products subject to the old MRLs, preventing unnecessary food waste. Additionally, article 3(2)(f) is amended to replace the term ‘limit of determination (LOD)’ with ‘limit of quantification (LOQ)’.
The proposed modification of the Regulation 1829/2003 on genetically modified food and feed clarifies that products obtained using genetically modified micro-organisms (GMMs) as production strains are not considered ‘produced from GMOs’ where the GMMs are not present in the final product and any residues are limited to non-viable cells (article 2(10)), resolving long-standing uncertainty for the fermentation sector. This clarification represents a parallel approach to the GMM framework introduced under the EU Biotech Act as discussed above. The EU Biotech Act adapts Directive 2001/18/EC to the specificities of GMMs that are deliberately released or placed on the market for various applications, providing tailored regulatory rules and faster procedures for low-risk micro-organisms. The Food and Feed Safety Simplification Omnibus focuses specifically on GMMs used as production strains for food and feed, ensuring legal certainty for businesses by clarifying when they fall out of scope of the regulation.
The TSE Regulation (999/2001) is being modernised to enable swift updates to BSE control measures through delegated acts (articles 5, 6, 8 and 16) and removes outdated restrictions on gelatine and collagen from ruminant bones (article 16).
Conclusion
The EU Biotech Act and the Food and Feed Safety Simplification Omnibus represent a pragmatic recalibration of EU food and feed regulation. By introducing regulatory sandboxes, expanding EFSA’s advisory role and removing time-limited approvals for proven-safe substances, the European Commission is creating space for innovation whilst maintaining rigorous safety standards.
For food and feed businesses, these proposals offer tangible benefits: faster market access for biocontrol substances and feed additives, reduced administrative burdens through digital labelling and streamlined procedures, and greater legal certainty for fermentation-based products. At the same time, stricter import standards for hazardous pesticide residues and modernised BSE controls demonstrate that simplification does not mean compromising on safety.
The second part of the EU Biotech Act is expected to be released in Q3 2026. Meanwhile, the European Parliament and Council will review the legislative proposals under the Food and Feed Safety Simplification Omnibus, for which a plenary session is planned for March 2026. As these proposals move through the legislative process, business should prepare for a regulatory landscape that rewards innovation, values efficiency and maintains Europe’s reputation for the highest food safety standards. The message is clear: the EU is open for biotech business, but safety remains non-negotiable.
Curious to know what these proposals mean to your business? Let’s get in touch!
This blogpost is written by Karin Verzijden, Jasmin Buijs and Maartje Hop.
Images are by Freepik.