Cellulase (4-(1,3;1,4)-β-D-glucan 4-glucanohydrolase, EC 3.2.1.4) produced with the genetically modified Trichoderma reesei strain NZYM-FS for Novozymes A/S (EFSA-Q-2025-00591) was assessed for four food manufacturing processes. The genetic modifications did not raise a safety concern. The preparation was considered free from viable cells of the production organism and from its DNA. Residual TOS are removed in two processes, so exposure was not calculated for those. For the two processes where exposure remains relevant, the highest estimate in European populations is 0.140 mg TOS/kg bw per day. The 90-day rat study identified a NOAEL of 1292 mg TOS/kg bw per day, the highest dose tested. The margin of exposure is at least 9229. Genotoxicity tests did not indicate a concern. Amino-acid sequence homology found no match to known allergens. A dietary allergic reaction cannot be excluded, but the likelihood was judged low.
Those figures belong to one dossier. They do not travel to another T. reesei strain or to a use list the Panel did not assess. They do not close Regulation (EC) No 1331/2008 or 1332/2008. The Union list of food enzymes has not fully replaced the transitional regime in Article 17 of Regulation 1332/2008. A FEZ opinion is input to a Commission decision, not the decision. It is not a health claim under Regulation 1924/2006 and it does not enter the 2318-claim set in C.L.A.I.M.S.
What the Panel calculated and what it did not decide
| Item | In opinion e10331 | Not granted |
|---|---|---|
| Identity | Cellulase, EC 3.2.1.4, GM strain NZYM-FS, Novozymes A/S, EFSA-Q-2025-00591 | Clearance for another Trichoderma strain |
| Uses | 4 processes; TOS removed in 2; exposure from the other 2 | Process names are in the opinion; this note does not invent them |
| Exposure | Up to 0.140 mg TOS/kg bw/day | An ADI or a supplement label dose |
| Toxicology | NOAEL 1292; MoE ≥9229; genotoxicity without concern | A waiver of batch documentation |
| Allergenicity | No match to known allergens; dietary risk not excluded, likelihood low | A guarantee of no reaction in a sensitised consumer |
| Legal effect | No safety concern under the assessed conditions | A 1332/2008 list entry or a start-of-sale date |
Working glossary
- TOS
- Total Organic Solids — the exposure unit in FEZ assessments, not a FIC label nutrient.
- NOAEL
- 1 292 mg TOS/kg bw per day in the 90-day oral rat study, the highest dose tested.
- MoE
- NOAEL divided by estimated dietary exposure; here at least 9229 (1292 / 0.140).
- Regulation 1332/2008
- Food enzymes. Union use tracks the list and, until it is complete, Article 17 transitional national law from before 20 January 2010.
- NZYM-FS
- The production-strain code in this dossier. Another code, even with the same enzyme name and EC number, is another procedure.
What to do with the opinion
- Match the supplier specification to strain NZYM-FS, EC 3.2.1.4 and applicant Novozymes A/S.
- Separate the processes that remove TOS from those that leave a residue. Do not guess process names from outside the opinion.
- Do not print MoE 9229 as a permitted dose on a food or supplement label.
- Keep traceability (Art. 18 of Regulation 178/2002) and ask the supplier about Article 17 status.
- Do not turn “no safety concern” into a health claim under Regulation 1924/2006.
Sources
EFSA FEZ Panel, Safety evaluation of the food enzyme cellulase from the genetically modified Trichoderma reesei strain NZYM-FS, published 1 October 2026, doi:10.2903/j.efsa.2026.10331. Adopted at the 22nd FEZ plenary, 8–9 September 2026 (EFSA-Q-2025-00591). Regulation (EC) No 1332/2008 Art. 17; Regulation (EC) No 1331/2008; Regulation (EC) No 178/2002 Arts. 14 and 18.
This note is not legal advice in an individual matter. Supplemental.pl is the law practice. FOODLAW.ai is the tool platform. C.L.A.I.M.S. searches 2318 claims and is not a Commission register.