Aspergillopepsin I (EC 3.4.23.18) from the non-genetically modified Aspergillus sp. strain LPL 3U-3-10 was assessed for sixteen food manufacturing processes. The preparation was considered free from viable cells of the production organism. Residual TOS are removed in two processes; dietary exposure was estimated for the remaining fourteen and reached 4.673 mg TOS/kg bw per day in European populations. The 90-day rat study identified a NOAEL of 1800 mg TOS/kg bw per day (highest dose). The margin of exposure is at least 385. Genotoxicity tests did not indicate a concern. Sequence homology matched three respiratory allergens and one injected allergen; 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 strain or another use list. 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.
What the Panel calculated and what it did not decide
| Item | In opinion e10338 | Not granted |
|---|---|---|
| Identity | Aspergillopepsin I, EC 3.4.23.18, strain LPL 3U-3-10, non-GM | Clearance for another Aspergillus strain |
| Uses | 16 processes; TOS removed in 2; exposure from 14 | A blanket for all proteolytic enzymes |
| Exposure | Up to 4.673 mg TOS/kg bw/day | An ADI or a supplement label dose |
| Toxicology | NOAEL 1800; MoE ≥385; genotoxicity without concern | A waiver of batch documentation |
| 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
- 1 800 mg TOS/kg bw per day in the 90-day oral rat study.
- MoE
- NOAEL divided by estimated dietary exposure; here at least 385.
- 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.
What to do with the opinion
- Match the supplier specification to strain LPL 3U-3-10 and EC 3.4.23.18.
- Separate processes that remove TOS from those that leave a residue.
- Do not print MoE 385 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, doi:10.2903/j.efsa.2026.10338, published 30 September 2026, adopted 9 September 2026. Regulation (EC) No 1332/2008 Art. 17; Regulation (EC) No 1331/2008; Regulation (EC) No 178/2002 Arts. 14 and 18.