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.
Probiotic health claims remain tricky
Posted: September 11, 2025 Filed under: Advertising, Food, Health claims Comments Off on Probiotic health claims remain tricky
“Supports your intestinal flora” sounds harmless. Yet that promise cannot simply be used in advertising. This becomes extra clear in a recent ruling by the Dutch Advertising Code Committee (ACC). In this blog, I will analyse how the ACC reaches its decision, and what it reveals about the scope, or rather the limitations, for such and similar health claims.
The case
The label of the product Beautiful Immunity Kefir Mild contains, among others, the statements that kefir supports the intestinal flora (in Dutch: kefir ondersteunt de darmflora) and that their kefir drinks are high in protein, low in fat and a source of calcium and vitamin B12 (In Dutch: onze Kefir-drankjes bevatten veel eiwitten, weinig vet en zijn een bron van calcium en vitamine B12). Furthermore, two claims are made: calcium and vitamin B12 for your gut health* and support of your immune system** (In Dutch: calcium en vitamine B12 voor uw darmgezondheid* en ondersteuning van uw immuunsysteem**). The label also contains claims about *calcium supporting the normal function of digestive enzymes (in Dutch: *Calcium draagt bij tot de normale werking van spijsverteringsenzymen) and **vitamin B12 supporting the normal function of the immune system (in Dutch: **Vitamine B12 draagt bij tot de normale werking van het immuunsysteem).
Designation kefir mild
According to the complainant, the naming of the product “kefir mild” is confusing consumers. They would think this variant of kefir contains yeasts and alcohol, like the traditional kefir does, but in reality, it doesn’t. The ACC mentions that the advertiser must use a customary or descriptive name for the product. Kefir is designated as a milk product. In the Netherlands, kefir is not a protected product name or a legally established designation, like other dairy products as milk or cheese. According to Beautiful Immunity, a distinction must be made between commercial and traditional kefir. Since shops will mainly sell the commercial variety, which, like “mild kefir”, does not contain yeasts, the ACC does not consider this designation for “mild kefir” to be incorrect or insufficiently specific. The average consumer will think that it is kefir with a mild taste and not traditional kefir with yeasts. Therefore, the naming of the product “kefir mild” isn’t confusing for consumers. The ACC rejects this complaint. Nevertheless, Beautiful Immunity currently designates its product just as “kefir”.
Health claim
Secondly, the complaint states the text displayed on the label contains a misleading health claim. This concerns the claim that the kefir product supports the intestinal flora and contains billions of live cultures. According to the complainant, this suggests a broader effect than the product actually offers, especially since the product does not contain yeasts and does not undergo a traditional fermentation process. The ACC rules that the claim “supports the intestinal flora” qualifies as a health claim. According to article 10 of the Claims Regulation, only authorised health claims can be used. A quick research in the EU Health Claims Register reveals there is no authorised health claim linked to kefir.
Furthermore, article 5(1)(b) of the Claims Regulation requires a health claim to be specifically linked to ingredients or substances. In this case, the advertiser attributes the claimed effect to kefir and not to the ingredients calcium or vitamin B12. More specifically, Beautiful Immunity indicates that the health claim about kefir supporting the intestinal flora is a generic health claim that is accompanied by to the authorised claim for calcium stated on the back of the packaging (article 10(3) of the Claims Regulation).
The ACC does not agree. According to the ACC, the health claim “supports the intestinal flora” is located under the word “kefir” on the front of the packaging. Consumers will read that Beautiful Immunity claims that kefir supports intestinal flora. The name of the product and the health claim follow each other directly and appear to be related. This claim cannot be linked to the claim “Calcium contributes to the normal function of digestive enzymes”. The reason is that the claim is located on the back of the packaging and an asterisk that can clarify the link between the claims is missing. It is therefore an independent health claim, see the ruling of the Court of Justice of 30 January 2020, case C-524/18.
Because there is no authorised health claim for kefir, the health claim that kefir supports the intestinal flora is contrary to article 10(1) of the Claims Regulation. This results in the ACC concluding that this claim is not in accordance with the law as referred to in article 2 of the Dutch Advertising Code, so the ACC upholds the complaint.
For gut health
Beautiful Immunity states that it regularly updates its labelling and that the claim “supports intestinal flora” no longer appears on the new label. Instead, the text “For gut health” is used. This claim is more generic, but if it substitutes the text “supports the intestinal flora”, it is still displayed under the word “kefir”. So, it remains an independent claim about kefir, that is unauthorised. This shows claims about gut health, intestinal flora and probiotics remain tricky.
Intestinal flora and probiotic claims
In this procedure the ACC rules that the health claim that kefir supports the intestinal flora is not permitted and therefore contrary to article 2 of the Dutch Advertising Code. The health claim was actually intended for calcium. What is striking is that the ACC attributes the unauthorised nature of the health claim to the fact that it refers to kefir rather than calcium. The ACC does not assess the admissibility of claims about intestinal flora in general here. Would the health claim “supports the intestinal flora” be permitted if it referred to calcium rather than kefir?
One could argue that in this case article 10(3) of the Claims Regulation is complied with, assuming that the claim is accompanied by the authorised calcium health claim, but caution should still be exercised with health claims about intestinal flora. In the Netherlands, the list of the on hold claims, drawn up by the Dutch Health Advertising Knowledge and Advice Council (in Dutch: Keuringsraad), distinguishes between the categories of digestion and intestinal flora. This suggests that the claim about intestinal flora cannot be accompanied by the authorised claim that calcium contributes to the normal function of digestive enzymes. In fact, there still aren’t any authorised health claims on intestinal flora or probiotics, see our previous blog about probiotic claims.
In the meantime, the European Ombudsman closed a case about probiotic health claims. This case was about the interpretation of the term probiotics by the European Commission. According to the European Commission, the word probiotics suggests a health claim, while the complainant, an association of producers of probiotics, argued that this word rather suggests a nutrition claim. The European Commission intends to protect consumers from potentially misleading information about food. As such, it is not surprising for the Commission to interpret claims about probiotics as health claims. The European Ombudsman accepts the explanation of the European Commission that it does not rule out submitting new applications to authorise probiotic health claims in the future, if the health benefits are scientifically proven.
Conclusion
The ACC rejects the complaint about the name “kefir mild”, as it is accurate and sufficiently specific. The average consumer will think that the term “kefir mild” refers to kefir with a mild taste, and not to traditional kefir containing yeast (including alcohol). The ACC however upholds the complaint regarding the health claim “supports the intestinal flora”. In essence, the ACC rules that consumers would think that the claim is about kefir. And the claim that kefir supports the intestinal flora is an unauthorised health claim. In fact, all health claims about intestinal flora are unauthorised. The same applies to health claims about probiotics. This may change in future, if and when these types of claims are substantiated by scientific evidence regarding the health benefits offered. So, think twice, when selling the health benefits of your gut health product. And of course, I would be happy to help out in case of doubt.
The full case can be read here (in Dutch).
Image: https://nl.beautifulimmunity.eu/