Substances in database
Example sheet
Database access
Last subscription

Safety evaluation of a food enzyme containing aspergillopepsin I and II from the Aspergillus niger var. macrosporusstrain PTG8398

Undefined

The food enzyme with aspergillopepsin I (EC 3.4.23.18) and aspergillopepsin II (EC 3.4.23.19) activities is produced with a non-genetically modified Aspergillus niger var. macrosporus strain PTG8398 by Meiji Seika Pharma Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in wine production. Based on the maximum use levels, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.14 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 919 mg TOS/kg bw per day, the highest dose tested which, when compared with the estimated dietary exposure, results in a margin of exposure above 6,700. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Last 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

Project coordinator

Content revision

Toxicological datasheet creation

Website Administration

Subscriptions & Contacts

To get more info about the NOAEL project, go to FAQ section or contact Roberto Narducci at this address:
 
infoATnoaelproject.it or robymagnoATgmail.com
 
For info about subscription costs click the following link or contact Federica Cambiganu:
 
federica.cambiganuATpin.unifi.it
+390574602511
PIN s.c.r.l. - Piazza Giovanni Ciardi 25, 59100 - Prato