Acknowledgements: The Panel wishes to thank the member of the Working Group on Applications: Davor Zeljezic for the preparatory work on this scientific output and EFSA staff members: Margarita Aguilera-Gomez and Magdalena Andryszkiewicz for the support provided to this scienti fic output.Publisher PD

Arcella, Davide

Bolognesi, Claudia

Castle, Laurence

Chipman, Kevin

Cravedi, Jean-Pierre

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Engel, Karl-Heinz

Fowler, Paul

Franz, Roland

Gomes, Ana

Grob, Konrad

Gürtler, Rainer

Herman, Lieve

Husøy, Trine

Jany, Klaus-Dieter

Kovalkovičová, Natália

Kärenlampi, Sirpa

Liu, Yi

Maia, Joaquim

Marcon, Francesca

Mennes, Wim

Milana, Maria Rosaria

Penninks, André

Pfaff, Karla

Riviere, Gilles

Silano, Vittorio

Smith, Andrew

Srinivasan, Jannavi

Tavares Poças, Maria de Fátima

Tlustos, Christina

Wölfle, Detlef

Zorn, Holger

EFSA Journal

English

Acknowledgements: The Panel wishes to thank the member of the Working Group on Applications: Davor Zeljezic for the preparatory work on this scientific output and EFSA staff members: Margarita Aguilera-Gomez and Magdalena Andryszkiewicz for the support provided to this scienti fic output

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Aberdeen University Research

Safety evaluation of food enzyme glucan 1,4-α-maltohydrolase produced with a genetically modified Bacillus subtilis (strain MAM)

The food enzyme considered in this opinion is a glucan 1,4-a-maltohydrolase (maltogenic alpha-amylase; EC 3.2.1,133) produced with the genetically modified Bacillus subtilis strain MAM by the company DSM Food Specialties B.V. The food enzyme contains neither the production microorganism nor recombinant DNA; therefore, no environmental risk assessment is required. However, the Panel emphasises that this conclusion only covers the food enzyme recovered via filter press. The glucan 1,4-alpha-maltohydrolase is intended for use in baking processes. Based on the maximum use levels 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 0.175 mg TOS/kg body weight (bw) per day in European populations. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (986 mg TOS/kg bw per day for both males and females), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; one match was found. However, the Panel considered that there are no indications for food allergic reactions to this glucan 1,4-alpha-maltohydrolase by dietary exposure. No safety concerns were identified in relation to the genetic modifications, the manufacturing process, the compositional data provided, as well as the exposure, allergenicity and systemic toxicity assessments. However, owing to the incompleteness of the genotoxicity data, the Panel is not able to conclude on the safety of the food enzyme

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF),

Jany, Klaus‐Dieter

Engel, Karl‐Heinz

ProdInra

Safety evaluation of food enzyme glucan 1,4‐α‐maltohydrolase produced with a genetically modified Bacillus subtilis (strain MAM)

International audienceThe food enzyme considered in this opinion is a glucan 1,4-a-maltohydrolase (maltogenic alpha-amylase; EC 3.2.1,133) produced with the genetically modified Bacillus subtilis strain MAM by the company DSM Food Specialties B.V. The food enzyme contains neither the production microorganism nor recombinant DNA; therefore, no environmental risk assessment is required. However, the Panel emphasises that this conclusion only covers the food enzyme recovered via filter press. The glucan 1,4-alpha-maltohydrolase is intended for use in baking processes. Based on the maximum use levels 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 0.175 mg TOS/kg body weight (bw) per day in European populations. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (986 mg TOS/kg bw per day for both males and females), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; one match was found. However, the Panel considered that there are no indications for food allergic reactions to this glucan 1,4-alpha-maltohydrolase by dietary exposure. No safety concerns were identified in relation to the genetic modifications, the manufacturing process, the compositional data provided, as well as the exposure, allergenicity and systemic toxicity assessments. However, owing to the incompleteness of the genotoxicity data, the Panel is not able to conclude on the safety of the food enzyme

Cravedi, Jean Pierre,

Rivière, Gilles

Penninks, Andre

Kovalkovicova, Natalia

HAL Descartes

null null

Vittorio Silano

Claudia Bolognesi

Laurence Castle

Kevin Chipman

Jean‐Pierre Cravedi

Paul Fowler

Roland Franz

Konrad Grob

Rainer Gürtler

Trine Husøy

Sirpa Kärenlampi

Wim Mennes

Maria Rosaria Milana

Karla Pfaff

Gilles Riviere

Jannavi Srinivasan

Maria de Fátima Tavares Poças

Christina Tlustos

Detlef Wölfle

Holger Zorn

Lieve Herman

Klaus‐Dieter Jany

Francesca Marcon

André Penninks

Andrew Smith

Davide Arcella

Ana Gomes

Natália Kovalkovičová

Yi Liu

Joaquim Maia

Karl‐Heinz Engel

Crossref

https://aura.abdn.ac.uk/bitstream/2164/17399/1/Silano_etal_EFSA_Safety_Evaluation_Of_Food_VoR.pdf

Safety evaluation of food enzyme glucan 1,4-α-maltohydrolase produced with a genetically modified Bacillus subtilis (strain MAM)

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Aberdeen University Research

ProdInra

HAL Descartes

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