Four Priorities for Food and Feed

1. Treat food security as biosecurity

The Commission text safeguards biosecurity, but excludes food-and-feed security, and provides a narrow definition of biosecurity. The FAO definition of biosecurity is broader and includes food security. The Commission's own Public Procurement Act proposal of 9 September 2026 already treats food supply as a security matter, so recognising food-and-feed security in Biotech Act I aligns the two texts.³ Europe still treats food as a reserve to stockpile rather than as a capacity to develop, and a stockpile only lasts as long as the stock itself. Protein produced by precision fermentation and microbial production is both a sustainable choice and a biodefence asset. It can be produced at scale in Europe, thereby avoiding the risks associated with our current supply chain.

Our ask: Add food-and-feed security to Recital 4, a new Recital 4a, and Article 1(1). Extend the definition in Article 2(22) to reflect the FAO definition, including risks from strategic dependencies on third-country suppliers.

2. Turn slow approvals into a competitive edge

EFSA assessments frequently take far longer than the regulated nine months: in practice the novel-foods process, regulated at 18 to 24 months, often takes three to five years, with 47 per cent of evaluation time absorbed by avoidable clock-stops.⁴ The resulting costs have become unaffordable for innovative companies: the average study costs around EUR 250,000 in the EU compared to EUR 100,000 in Singapore and even less in the United States, while the EU carries the highest timeline uncertainty of any comparable jurisdiction.⁵ EFSA's expanded pre-submission advice helps, but it works case by case and cannot fix the systemic causes, which include divergent national practices, unclear data requirements, and weak mutual understanding between applicants and assessors.

Our ask: Insert a new Article 32a(2) and make a consequential change to Recital 110. This will allow Member States to set up voluntary regulatory dialogue and learning platforms, offering structured pre-submission dialogue, common dossier tools, and joint training.

A clear safeguard applies – the platforms grant no authorisation, no preferential treatment, and no role in decisions. The independence of EFSA and national authorities is fully preserved. Member States decide whether to take part, and no new Union body is created. Our Biotech Act II position asks for a durable legal basis for the same arrangement.

3. Open the door to food innovation: correct the novel foods exclusion

Biotech Act I excludes novel foods from the sandbox framework. This exclusion was made without an impact assessment, is hard to reconcile with the objectives of the Act, and forecloses controlled testing where real-world evidence is most useful.

Our ask: Amend Recital 115 and Article 49a(2)(a) to allow the use of novel foods in sandboxes. Each Member State decides whether to open a sandbox to novel foods, so the change creates no new obligation. Testing within a sandbox does not involve placing products on the market, and all novel foods remain subject to the full novel-foods authorisation procedure before they can be taken to market. Deleting the exclusion only helps if the sandbox can then be used in practice. Limiting sandboxes to cases where no authorisation pathway exists would put novel foods back outside the scope, since Regulation (EU) 2015/2283 provides one, so the Act should state that an existing authorisation procedure does not in itself preclude inclusion in duly justified cases. The Public Procurement Act proposal confirms this – its new innovation procedure might look like a testing pathway, but a novel food can only enter it once authorised (Article 44(4)). A sandbox therefore remains the only place where a novel food can be tested under controlled conditions, and our clause is consistent with this limitation.

4. Fund scale-up in Europe, not abroad: from lab to fab

This is where Biotech Act I needs the most strengthening, and where Biotech Act II needs to deliver. The EU health biotechnology investment pilot in Article 22 depends on the term 'biotech-specific risk profiles', which the Act leaves undefined. That gap lets implementing partners apply generic risk models that ignore regulatory milestones, so a European company with a product validated in a comparable market can be treated like a pre-commercial startup. Public capital is misallocated and companies scale up outside the Union, despite the fact that food-related biotech markets could be worth almost 400 billion dollars by 2040.⁶

We propose four fixes.

Our asks:

Define the term – Give 'biotech-specific risk profiles' statutory content in Recital 44 and a new Recital 44a, with minimum content covering the stage of regulatory development, prior approval in a comparable third-country jurisdiction, and manufacturing readiness at industrial scale. Carry this into Article 22(3).

Establish market validation equivalence – Approval in a comparable jurisdiction should be recognised as substantially reducing investment risk in EIBG, EIB, and InvestEU assessments. A completed EFSA assessment resolves technology risk and should count the same way. Companies meeting either test must not be classified as pre-commercial. State this in Recital 44a and Article 22(3).

Allow milestone-based scale-up funding – As in medical biotechnology, amend Article 22(4)(c) so that disbursement can be linked to the submission for approval, the regulatory decision, and a commercial production threshold, thereby bridging the funding gap created by long regulatory approval timelines.

Apply equal terms across all sectors – All biotech sectors, including food-and-feed biomanufacturing, should be assessed on the same terms as health biotechnology. Otherwise, the pilot penalises the sectors facing the longest timelines. Food biomanufacturing is already strategic under STEP; the financing should match.⁷