Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN)
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10400.14/33259 |
Resumo: | The food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM-AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA; therefore, there is no safety concern for the environment. The α-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. |
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Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN)1,4-α-d-glucan glucanohydrolase4-α-d-glucan glucanohydrolaseAlpha-amylaseBacillus licheniformisEC 3.2.1.1Food enzymeGenetically modified microorganismThe food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM-AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA; therefore, there is no safety concern for the environment. The α-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.Veritati - Repositório Institucional da Universidade Católica PortuguesaEFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Poças, Maria de Fátima Tavares2021-05-26T10:41:38Z2018-072018-07-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.14/33259eng1831-473210.2903/j.efsa.2018.53178506223420132625959000441351400008info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-12T17:38:55Zoai:repositorio.ucp.pt:10400.14/33259Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T18:27:02.751409Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) |
title |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) |
spellingShingle |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 1,4-α-d-glucan glucanohydrolase 4-α-d-glucan glucanohydrolase Alpha-amylase Bacillus licheniformis EC 3.2.1.1 Food enzyme Genetically modified microorganism |
title_short |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) |
title_full |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) |
title_fullStr |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) |
title_full_unstemmed |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) |
title_sort |
Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN) |
author |
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) |
author_facet |
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Poças, Maria de Fátima Tavares |
author_role |
author |
author2 |
Poças, Maria de Fátima Tavares |
author2_role |
author |
dc.contributor.none.fl_str_mv |
Veritati - Repositório Institucional da Universidade Católica Portuguesa |
dc.contributor.author.fl_str_mv |
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Poças, Maria de Fátima Tavares |
dc.subject.por.fl_str_mv |
1,4-α-d-glucan glucanohydrolase 4-α-d-glucan glucanohydrolase Alpha-amylase Bacillus licheniformis EC 3.2.1.1 Food enzyme Genetically modified microorganism |
topic |
1,4-α-d-glucan glucanohydrolase 4-α-d-glucan glucanohydrolase Alpha-amylase Bacillus licheniformis EC 3.2.1.1 Food enzyme Genetically modified microorganism |
description |
The food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM-AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA; therefore, there is no safety concern for the environment. The α-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. |
publishDate |
2018 |
dc.date.none.fl_str_mv |
2018-07 2018-07-01T00:00:00Z 2021-05-26T10:41:38Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10400.14/33259 |
url |
http://hdl.handle.net/10400.14/33259 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
1831-4732 10.2903/j.efsa.2018.5317 85062234201 32625959 000441351400008 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799131987684884480 |