Xylanase | whatsinit

About

What it is and where it shows up.

Xylanase (EC 3.2.1.8) is a microbial enzyme that catalyses the random hydrolysis of 1,4-β-D-xylose linkages in xylans and arabinoxylans, which are hemicellulose components of cereal grain flours. It is used as a processing aid in baking, brewing, and grain processing to improve dough rheology, bread volume, and texture.

Safety summary

The regulatory and scientific consensus.

Multiple EFSA and FDA assessments have found no genotoxic concern; a 90-day rodent study yielded a NOAEL of 443 mg TOS/kg bw per day, which provides a wide margin of safety compared with estimated consumer dietary exposures of up to approximately 0.75 mg TOS/kg bw per day. The enzyme is largely inactivated during baking and at typical food-processing temperatures. Occupational respiratory sensitization (baker's asthma) has been documented in bakery workers handling the enzyme powder, but the likelihood of food allergy from oral ingestion in the general population is considered low.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Fungal xylanase approved as a food processing aid (Ref. 29/Std/PA/Ree/Ref-(955/2014)/FSSAI/2018, effective 01.05.2018) by M/s Advanced Enzyme Technologies Ltd. Use as a health supplement or nutraceutical is not permitted; FSSAI directed food business operators to discontinue marketing xylanase-containing products as nutraceuticals/health supplements.source
FDA (Food and Drug Administration) (United States)	Approved	Multiple GRAS notices accepted with no objection from FDA, including GRN 000589 (xylanase from Aspergillus niger, DSM Food Specialties) and GRN 000628 (endo-1,4-β-xylanase from Trichoderma reesei, AB Enzymes GmbH), for use in baking, brewing, grain processing, cereal manufacture, and potable alcohol production. Exempt from premarket approval under proposed 21 CFR 170.36.source
EFSA (European Food Safety Authority) (European Union)	Under_review	Regulated under Regulation (EC) No 1332/2008 on food enzymes. A Union-wide positive list of authorised food enzymes has not yet been finalised; EFSA's CEF/CEP Panel is systematically evaluating individual xylanase preparations. Multiple individual EFSA opinions (e.g., B. subtilis XAN, B. subtilis LMG S-27588, A. luchuensis RF7398, T. citrinoviride strain 278, T. reesei DP-Nzd66) have concluded no safety concern under intended conditions of use. National rules apply until the EU list is established.source

Who should approach with care

Whose guidance would steer them away.

Gluten Intolerance — Certain xylanase enzyme preparations use wheat-based or gluten-containing carriers, which may pose a concern for individuals with gluten intolerance or celiac disease, as noted in multiple EFSA safety assessments of specific preparations.

Other — Bakery workers and food-manufacturing personnel with documented occupational respiratory sensitization to xylanase (baker's asthma) should exercise caution, as EFSA notes that allergic reactions upon oral ingestion in respiratory-sensitized individuals cannot be entirely excluded, though the likelihood is considered low.

Research citations

The sources behind this verdict.

1EFSA. Safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified Bacillus subtilis strain XAN, 2023. efsa.europa.eu
2EFSA. Safety evaluation of the food enzyme xylanase from the genetically modified Aspergillus luchuensis Inui strain RF7398, 2020. efsa.europa.eu
3FDA. Agency Response Letter GRAS Notice No. GRN 000628: endo-1,4-β-xylanase from Trichoderma reesei, 2018. fda.gov
4FDA. Agency Response Letter GRAS Notice No. GRN 000589: Xylanase (endo-1,4-β-xylanase) from Aspergillus niger, 2018. fda.gov
5EFSA. Safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S-27588), 2018. efsa.europa.eu

Independently researched5 citations