We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Safety evaluation of the food enzyme leucyl aminopeptidase from the non‐genetically modified Aspergillus sp. strain AE‐MB.
- Authors
Lambré, Claude; Barat Baviera, José Manuel; Bolognesi, Claudia; Cocconcelli, Pier Sandro; Crebelli, Riccardo; Gott, David Michael; Grob, Konrad; Lampi, Evgenia; Mengelers, Marcel; Mortensen, Alicja; Rivière, Gilles; Steffensen, Inger‐Lise; Tlustos, Christina; Van Loveren, Henk; Vernis, Laurence; Zorn, Holger; Roos, Yrjö; Aguilera, Jaime; Andryszkiewicz, Magdalena; Cavanna, Daniele
- Abstract
The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non‐genetically modified Aspergillus sp. strain AE‐MB by Amano Enzyme Inc. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in five food manufacturing processes: processing of dairy products for the production of (1) flavouring preparations; processing of plant‐ and fungal‐derived products for the production of (2) protein hydrolysates; processing of meat and fish products for the production of (3) protein hydrolysates, (4) modified meat and fish products and processing of (5) yeast and yeast products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.273 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 183 mg TOS/kg bw per day. The calculated margin of exposure for each age group was 135 (infants), 81 (toddlers), 83 (children), 109 (adolescents), 160 (adults) and 184 (the elderly). A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. The safety of the food enzyme could not be established given the derived margins of exposure. Therefore, the Panel concluded that this food enzyme could not be considered safe under the intended conditions of use.
- Subjects
AMINO acid sequence; FOOD safety; ASPERGILLUS; PROTEIN hydrolysates; FISHERY processing
- Publication
EFSA Journal, 2024, Vol 22, Issue 1, p1
- ISSN
1831-4732
- Publication type
Article
- DOI
10.2903/j.efsa.2024.8506