Sostanze in database
Scheda d'esempio
Accesso al database
Ultima azienda iscritta

Safety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520)

Undefined

Published on: Wed, 02 May 2018 00:00:00 +0200

The food enzyme considered in this opinion is aqualysin 1 (EC 3.4.21.111), produced from the genetically modified strain Bacillus subtilis LMGS 25520 by Puratos NV. The production strain was not detected in the food enzyme. Aqualysin 1 is intended to be used in baking processes. Based on the maximum use level recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.13 mg TOS/kg body weight per day in European populations. Genotoxicity tests indicated no genotoxic concerns. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens and 23 matches were found (20 respiratory and 3 dermal allergens). However, the Panel considered that there are no indications for food allergic reactions to the food enzyme. The genetic modifications performed, the manufacturing process, the compositional and biochemical data, the allergenicity and the genotoxicity assessment did not raise safety concerns. The Panel considered the margin of exposure (MOE) calculated from the no observed adverse effect level (NOAEL) determined from the repeated dose 90‐day oral toxicity study and the estimated dietary exposure as insufficient to conclude that there is no safety concern for this food enzyme under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.

© European Food Safety Authority, 2015

Safety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520)


Ultimi Tweets

06/06/2016 - 11:11
Nuovo componente inserito: Simmondsia Chinensis (Jojoba) Seed Oil https://t.co/mGvGLRQ05k
29/05/2016 - 10:04
Nuovo componente inserito: Linum Usitatissimum seed oil Error
27/05/2016 - 16:38
Nuovo componente inserito: Soybean oil https://t.co/9prxB7xyiu

NOAEL-crew

Coordinatore progetto

Inserimento ingredienti cosmetici

Revisione contenuti

Amministrazione del sito

Adesioni e contatti

Per informazioni tecniche sul progetto andare alla sezione FAQ o contattare Roberto Narducci:
 
infoATnoaelproject.it o robymagnoATgmail.com
 
Per informazioni riguardo i costi e le modalità di adesione contattare Federica Cambiganu:
 
federica.cambiganuATpin.unifi.it
 +390574602511
PIN s.c.r.l. - Piazza Giovanni Ciardi 25, 59100 - Prato