Bibliographic review on the potential of microorganisms, microbial products and enzymes to induce respiratory sensitization

Martel, Cyril Jean‐Marie; Nielsen, Gunnar D.; Mari, Adriano; Licht, Tine Rask; Poulsen, Lars

doi:10.2903/sp.efsa.2010.en-75

Cited by 49 publications

(46 citation statements)

References 149 publications

(77 reference statements)

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“…However, respiratory allergy, e.g. baker's asthma, following occupational exposure to xylanase has been described in some epidemiological studies (Elms et al, 2003;Harris-Roberts et al, 2009;Martel et al, 2010;Budnik et al, 2017) and case reports (Tarvainen et al, 1991;Baur et al, 1998;Merget et al, 2001;Lipi nska-Ojrzanowska et al, 2016). However, several studies have shown that adults with occupational asthma to an enzyme may be able to ingest the corresponding allergen without acquiring clinical symptoms of food allergy (Brisman, 2002;Poulsen, 2004;Armentia et al, 2009).…”

Section: Allergenicity 29mentioning

confidence: 99%

Safety evaluation of the food enzyme xylanase from Bacillus pumilus (strain BLXSC)

Silano¹,

Baviera²,

Bolognesi³

et al. 2019

EFS2

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The food enzyme 1,4-b-D-xylan xylanohydrolase (EC 3.2.1.8) is produced with the non-genetically modified strain Bacillus pumilus (strain BLXSC) by Advanced Enzyme Technologies Ltd. The food enzyme is intended to be used in baking processes, grain treatment for the production of starch and gluten fractions, and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation and during grain treatment, dietary exposure was only calculated for baking processes. Based on the maximum recommended use levels for baking processes, and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.138 mg TOS/kg body weight (bw) per day. As the production strain of B. pumilus meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that under the intended conditions of use (other than distilled alcohol production), the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but is considered to be low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

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Section: Allergenicity 29mentioning

confidence: 99%

Safety evaluation of the food enzyme xylanase from Bacillus pumilus (strain BLXSC)

Silano¹,

Baviera²,

Bolognesi³

et al. 2019

EFS2

View full text Add to dashboard Cite

show abstract

“…However, respiratory allergy, e.g. baker's asthma, following occupational exposure to xylanase has been described in some epidemiological studies (Elms et al, 2003;Martel et al, 2010) and case reports (Baur et al,1998;Merget et al, 2001). However, several studies have shown that adults with occupational asthma to an enzyme may be able to ingest the corresponding allergen without acquiring clinical symptoms of food allergy (Brisman, 2002;Poulsen, 2004;Armentia et al, 2009).…”

Section: Allergenicity 16mentioning

confidence: 99%

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Silano¹,

Baviera²,

Bolognesi³

et al. 2018

EFS2

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The food enzyme xylanase (EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain RF5703 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The food enzyme is intended to be used in brewing processes and grain treatment for the production of starch and gluten fractions. Since residual amounts of the food enzyme are removed during grain treatment, dietary exposure was only calculated for brewing processes. Based on the maximum recommended use levels for brewing processes, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.023 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise 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 at the highest dose tested of 1,000 mg TOS/kg bw per day, resulting in a high margin of exposure of at least 43,000. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. 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 of such reactions to occur is considered to be low. Based on the data provided and the removal of TOS during the intended food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

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“…No information is available on oral sensitisation and elicitation reactions of this endo-1,4-b-xylanase. Several cases of respiratory allergy following occupational inhalation of xylanase have been reported (Elms et al, 2003;Martel et al, 2010). However, some studies have shown that adults with occupational asthma to an enzyme used in food can commonly ingest the corresponding allergen without acquiring clinical symptoms of food allergy (Cullinan et al, 1997;Brisman, 2002;Poulsen, 2004;Armentia et al, 2009).…”

Section: Allergenicitymentioning

confidence: 99%

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus niger (strain XEA)

Silano¹,

Bolognesi²,

Castle³

et al. 2018

EFS2

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The food enzyme is an endo-1,4-b-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes 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 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with this endo-1,4-b-xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo-1,4-b-xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

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Bibliographic review on the potential of microorganisms, microbial products and enzymes to induce respiratory sensitization

Cited by 49 publications

References 149 publications

Safety evaluation of the food enzyme xylanase from Bacillus pumilus (strain BLXSC)

Safety evaluation of the food enzyme xylanase from Bacillus pumilus (strain BLXSC)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus niger (strain XEA)

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