TFA, New Novel Foods and Fermentation Scale-Up

Executive summary: 

EFSA’s new TFA assessment does not yet constitute a statutory maximum level, but should inform risk-based assessment of raw materials and water. Novel foods are creating concrete new product opportunities, while two German scale-up projects show biotechnology-derived ingredients moving closer to industrial production. The distinction between technical feasibility, regulatory permissibility and actual supply capability remains crucial.

TFA: a new assessment benchmark, but not yet a new legal limit

EFSA has lowered the acceptable daily intake for trifluoroacetic acid (TFA) from 0.05 to 0.014 mg per kg body weight per day. A new acute reference dose of 0.07 mg per kg body weight has also been established. The assessment draws on new toxicological findings, including changes in the thyroid hormone thyroxine. Data gaps remain concerning long-term toxicity and possible effects on the immune system. [1]

These values serve health risk assessment. They are not yet a new statutory maximum level and do not trigger an automatic marketing prohibition. Manufacturers should therefore first understand possible inputs through water, agricultural raw materials and concentrates. Origin data, existing monitoring results and the reliability of the analytical methods used should be reviewed before establishing a routine programme.

The timing alongside the PPWR’s application is relevant, but must not be confused with a direct legal connection. From 12 August 2026, the PPWR restricts PFAS in food-contact packaging materials. [2] EFSA’s values, by contrast, concern total oral TFA intake. Companies therefore face two separate assessment paths: TFA in food and PFAS compliance of packaging. Evidence for one does not automatically establish compliance in the other.

Three new opportunities in novel food

Three changes took effect or were adopted in July which are directly relevant to product development and market entry.

For galacto-oligosaccharides, the permitted proportion in food supplements for the general population, excluding infants and young children, increases from 33.3 to 45 per cent from 10 August 2026. This broadens formulation options for higher-dose powders and sachets. [3]

Since 26 July, Rhizomucor pusillus mycelium may also be used in various foods. The fermentation-derived fungal biomass is authorised for applications including cereals, bars, milk analogues, drinks and meal replacements. Adult food supplements are subject to a maximum of 6 g per day. The authorisation relies on protected data and is initially reserved in principle for The Protein Brewery. Manufacturers must therefore check raw-material identity and entitlement to supply, as well as the list entry. [4]

A further enzymatically produced egg membrane hydrolysate has been authorised since 23 July for adult food supplements at up to 500 mg per day. Products must exclude people under 18 and pregnant and breastfeeding women; egg allergen labelling remains required. This authorisation is also initially tied to a data holder. [5]

The same practical rule applies to all three changes: trade names and supplier statements are insufficient. Before formulation approval, raw-material identity, manufacturing process, specification, inclusion level, target group and supply route must match the authorised entry.

Biotechnology-derived ingredients move closer to industrial scale

The COCO-AI project coordinated by Fraunhofer IME combines plant cell culture with artificial intelligence, using cocoa as its first application. By 2030, cell cultures are to be transferred to bioreactors of up to 10,000 litres, with six ingredient formulations and two chocolate prototypes developed. The project is particularly interesting because it aims beyond a new raw material: standardised data and development processes could shorten the path from cell line to reproducible manufacturing. It nevertheless remains research, rather than a source of cocoa available in the short term. [6]

Scale-up is also central to microbial proteins. On 21 July, MicroHarvest reported completion of the feasibility study for a planned fermentation plant in Leuna. According to the company, annual capacity of 15,000 tonnes and a production start in the first half of 2028 are planned. The plant is initially intended for feed; human food would require a later extension and novel food authorisation. The announcement is therefore an important industry signal, but does not yet demonstrate food-market readiness or future supply capability. [7]

For manufacturers, the central question is the same in both projects: is the supplier already describing an actually specified, reproducible ingredient suitable for food use—or primarily a technology and development plan?

Berief acquisition strengthens plant-based private labels

On 6 July, Berief Food reported completion of its sale to Unternehmensgruppe Theo Müller. According to the company, Berief is to remain largely independent, with two new filling lines for plant-based drinks also planned. The acquisition gives a major European dairy group additional expertise in plant-based products and private labels. Customers will now be particularly interested in possible changes to capacity, contacts, minimum quantities and approval processes. The purchase price and precise timetable for the new lines were not disclosed. [8]

Wishing you every success, Andreas Gebhart

Sources

1. EFSA: Neubewertung von TFA, 22. Juli 2026.
2. PPWR – Verordnung (EU) 2025/40.
3. Durchführungsverordnung (EU) 2026/1749 – Galacto-Oligosaccharide.
4. Durchführungsverordnung (EU) 2026/1507 – Rhizomucor-pusillus-Myzel.
5. Durchführungsverordnung (EU) 2026/1427 – Eimembranhydrolysat.
6. Fraunhofer IME: Projekt COCO-AI.
7. MicroHarvest: Planung der Produktionsanlage Leuna, Unternehmensmitteilung vom 21. Juli 2026.
8. Berief Food: Closing der Übernahme, Unternehmensmitteilung vom 6. Juli 2026.

Note: This article provides professional information and does not constitute legal advice. The specific product, target market and legislation in force at the time of the decision are decisive. Image: AI-generated.