==== Front EFSA J EFSA J 10.1002/(ISSN)1831-4732 EFS2 EFSA Journal 1831-4732 John Wiley and Sons Inc. Hoboken 10.2903/j.efsa.2023.8101 EFS28101 Scientific Opinion Scientific Opinion Updated safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT Updated safety evaluation of the non‐GM α‐amylase from C. funkei strain AE‐AMT EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)fip@efsa.europa.eu Lambré Claude Barat Baviera José Manuel Bolognesi Claudia Cocconcelli Pier Sandro Crebelli Riccardo Gott David Michael Grob Konrad Lampi Evgenia Mengelers Marcel Mortensen Alicja Rivière Gilles Steffensen Inger‐Lise Tlustos Christina Van Loveren Henk Vernis Laurence Zorn Holger Roos Yrjö Cavanna Daniele Di Piazza Giulio Liu Yi Chesson Andrew * Correspondence: fip@efsa.europa.eu 30 6 2023 6 2023 21 6 10.1002/efs2.v21.6 e08101© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/ This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT by Amano Enzyme Inc. In a previous opinion, a safety evaluation of this food enzyme was completed, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in starch processing for maltodextrin production. The applicant has now provided new data to extend the use of this food enzyme to six additional food manufacturing processes: baking processes, cereal‐based processes, plant processing for the production of dairy analogues, processing of tea, herbal and fruit infusions, brewing processes and the production of non‐wine vinegar. For its use in a total of seven food manufacturing processes, the dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Using the toxicological data provided in the previous opinion, with a NOAEL of 230 mg TOS/kg bw per day (the highest dose tested), the Panel derived a margin of exposure of at least 19,167. Based on the revised exposure calculation and the outcome of the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. food enzyme α‐amylase EC 3.2.1.1 4‐α‐d‐glucan glucanohydrolase Microbacterium imperial Cellulosimicrobium funkei source-schema-version-number2.0 cover-dateJune 2023 details-of-publishers-convertorConverter:WILEY_ML3GV2_TO_JATSPMC version:6.3.0 mode:remove_FC converted:30.06.2023 Suggested citation: EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) , Lambré C , Barat Baviera JM , Bolognesi C , Cocconcelli PS , Crebelli R , Gott DM , Grob K , Lampi E , Mengelers M , Mortensen A , Rivière G , Steffensen I‐L , Tlustos C , Van Loveren H , Vernis L , Zorn H , Roos Y , Cavanna D , Di Piazza G , Liu Y and Chesson A , 2023. Updated safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT. EFSA Journal 2023;21 (6 ):8101, 11 pp. 10.2903/j.efsa.2023.8101 Requestor European Commission Question number EFSA‐Q‐2022‐00532 Panel members José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn. Declarations of interest If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu. EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source. Adopted: 8 June 2023 Appendix A is available under the Supporting Information section . ==== Body pmc1 Introduction Article 3 of the Regulation (EC) No 1332/2008 1 provides definition for ‘food enzyme’ and ‘food enzyme preparation’. ‘Food enzyme’ means a product obtained from plants, animals or micro‐organisms or products thereof including a product obtained by a fermentation process using micro‐organisms: (i) containing one or more enzymes capable of catalysing a specific biochemical reaction; and (ii) added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods. ‘Food enzyme preparation’ means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution. Before January 2009, food enzymes other than those used as food additives were not regulated or were regulated as processing aids under the legislation of the Member States. On 20 January 2009, Regulation (EC) No 1332/2008 on food enzymes came into force. This Regulation applies to enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids. Regulation (EC) No 1331/2008 2 established the European Union (EU) procedures for the safety assessment and the authorisation procedure of food additives, food enzymes and food flavourings. The use of a food enzyme shall be authorised only if it is demonstrated that: it does not pose a safety concern to the health of the consumer at the level of use proposed; there is a reasonable technological need; its use does not mislead the consumer. All food enzymes currently on the European Union market and intended to remain on that market, as well as all new food enzymes, shall be subjected to a safety evaluation by the European Food Safety Authority (EFSA) and approval via an EU Community list. The ‘Guidance on submission of a dossier on food enzymes for safety evaluation’ (EFSA, 2009a) lays down the administrative, technical and toxicological data required. 1.1 Background and Terms of Reference as provided by the requestor 1.1.1 Background as provided by the European Commission Only food enzymes included in the Union list may be placed on the market as such and used in foods, in accordance with the specifications and conditions of use provided for in Article 7(2) of Regulation (EC) No 1332/20081 on food enzymes. Alpha‐Amylase from a non‐genetically modified strain of Microbacterium imperial (strain AE‐AMT) is a food enzyme included in the Register of food enzymes 3 to be considered for inclusion in the Union list and thus subject to a risk assessment by the European Food Safety Authority (EFSA). On 7 July 2022, EFSA concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use in starch processing to produce maltodextrin. On 24 June 2022, a new application has been introduced by the applicant “Amano Enzyme Inc” for an extension of the conditions of use for the above food enzyme in starch processing for the production of maltodextrin, baking processes, dairy analogue production, cereal‐based processes, processing of tea, herbal and fruit infusions and brewing processes. 1.1.2 Terms of Reference The European Commission requests the European Food Safety Authority to carry out the safety assessment and the assessment of possible confidentiality requests of an extension of the condition of use for the following food enzyme: Alpha‐Amylase from a non‐genetically modified strain of Microbacterium imperial (strain AE‐AMT), in accordance with Regulation (EC) No 1331/2008 establishing a common authorization procedure for food additives, food enzymes and food flavourings. 4 1.1.3 Interpretation of the Terms of Reference The present scientific opinion addresses the European Commission's request to carry out the safety assessment of an extension of the conditions of use for the food enzyme α‐amylase from Microbacterium imperial strain AE‐AMT. The production microorganism was reclassified as Cellulosimicrobium funkei at the species level in the previously published scientific opinion (EFSA CEP Panel, 2022). Therefore, EFSA continued to use the name C. funkei (instead of M. imperial) also in the present opinion. 2 Data and methodologies 2.1 Data The applicant has submitted a dossier in support of the application for the authorisation of the extension of use of the food enzyme α‐amylase from non‐genetically modified C. funkei (strain AE‐AMT). Additional information was requested from the applicant during the assessment process on 13 February 2023 and received on 15 February 2023 (see ‘Documentation provided to EFSA’). 2.2 Methodologies The assessment was conducted in line with the principles described in the EFSA ‘Guidance on transparency in the scientific aspects of risk assessment’ (EFSA, 2009b) and following the relevant existing guidance documents of EFSA Scientific Committee. The current ‘Scientific Guidance for the submission of dossiers on Food Enzymes’ (EFSA CEP Panel, 2021a) has been followed for the evaluation of the application. 2.3 Public consultation According to Article 32c(2) of Regulation (EC) No 178/2002 5 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 16 May to 6 June 2023. No comments were received. 3 Assessment IUBMB nomenclature α‐amylase Systematic name 4‐α‐d‐glucan glucanohydrolase Synonyms Glycogenase, endo‐amylase, Taka‐amylase IUBMB No EC 3.2.1.1 CAS No 9000‐90‐2 EINECS No 232–565‐6 α‐amylases catalyse the hydrolysis of 1,4‐α‐glucosidic linkages in starch (amylose and amylopectin), glycogen and related polysaccharides and oligosaccharides, resulting in the generation of soluble dextrins and other malto‐oligosaccharides. All aspects concerning the safety of this food enzyme when used in starch processing for maltodextrin production were evaluated in July 2022 (EFSA CEP Panel, 2022). Under the current assessment, EFSA evaluates this food enzyme when used in seven food manufacturing processes: starch processing for maltodextrin production, baking processes, cereal‐based processes, plant processing for the production of dairy analogues, processing of tea, herbal and fruit infusions, brewing processes and production of non‐wine vinegar. 3.1 Source of the food enzyme See previous evaluation (EFSA CEP Panel, 2022). 3.2 Production of the food enzyme See previous evaluation (EFSA CEP Panel, 2022). 3.3 Characteristics of the food enzyme See previous evaluation (EFSA CEP Panel, 2022). 3.4 Toxicological data In the previous evaluation, the Panel identified a no observed adverse effect level (NOAEL) of 230 mg total organic solids (TOS)/kg body weight (bw) per day, the highest dose tested (EFSA CEP Panel, 2022). 3.5 Dietary exposure 3.5.1 Revised intended use of the food enzyme The food enzyme is intended to be used in seven food manufacturing processes at the recommended use levels summarised in Table 1. Table 1 Intended uses and recommended use levels of the food enzyme as provided by the applicant 6 , 7 Food manufacturing process (a) Raw material (RM) Maximum recommended use level (mg TOS/kg RM) (b) Starch processing to produce maltodextrin Starch 109.0 Baking processes Flour 1.0 Cereal‐based processes Flour, grains, cereals 1.0 Plant processing for the production of dairy analogues Oat flour, almond flour, rice flour, buckwheat, pulses, legumes, oil seeds, nuts, etc. 2.0 Processing of tea, herbal and fruit infusions Leaf extract 2.0 Brewing processes Rice, cereals 0.2 Production of non‐wine vinegar Corn, wheat, rice 2.0 TOS: total organic solids. (a) The name has been harmonised by EFSA according to the ‘EC working document describing the food processes in which food enzymes are intended to be used’ – not yet published at the time of adoption of this opinion. (b) The numbers in bold were used for calculation. The use of this food enzyme in starch processing to produce maltodextrin was evaluated previously. The food enzyme–TOS was considered to be removed from the maltodextrin products (EFSA CEP Panel, 2022). In baking processes, the food enzyme is added to flour during dough preparation. 8 The activity of α‐amylase reduces the viscosity of the dough and increases the volume of the final product. The food enzyme remains in the baked foods. In cereal‐based processes, the food enzyme is added to the cereal slurry. 9 The hydrolysis by α‐amylase reduces the viscosity of the slurry, facilitating the downstream processing steps, such as extrusion. The food enzyme remains in the final foods, such as breakfast cereals. In the production of dairy analogues, the food enzyme is added to a variety of plant materials together with water during saccharification. 10 α‐amylase hydrolyses the gelatinised starch to reduce the viscosity of the slurry, allowing higher inclusion of plant materials in the plant‐based beverages and the corresponding fermented semi‐solid foods. The present α‐amylase hydrolyses starch primarily to maltotriose. 11 The food enzyme remains in the final foods. In the processing of tea, herbal and fruit infusions, the α ‐amylase is added to the leaf extracts from Stevia. The food enzyme acts on steviol glycosides in Stevia leaves, which alters their glycosylation pattern and thus their sensory properties. 12 The food enzyme–TOS remains in the final processed foods. In brewing processes, the food enzyme is added to cereals at the mashing step. 13 The α‐amylase, along with other saccharifying enzymes, converts the liquefied starch to fermentable sugars. The food enzyme–TOS remains in the beer. In the production of non‐wine vinegar, the food enzyme is added to milled grains or cereals during slurry mixing. The food enzyme acts on the starch present in different grains and cereals. 14 The food enzyme–TOS remains in the final processed foods. Based on the thermostability evaluated previously (EFSA CEP Panel, 2022) and the downstream processing steps applied in the food processes, it is expected that the food enzyme is inactivated in all the relevant final foods. 3.5.2 Dietary exposure estimation In accordance with the guidance document (EFSA CEP Panel, 2021a), dietary exposure was not calculated for starch processing to produce maltodextrin (EFSA CEP Panel, 2022), but only for the six additional food manufacturing processes, where the food enzyme–TOS remains in the final foods: baking processes, cereal‐based processes, plant processing for the production of dairy analogues, processing of tea, herbal and fruit infusions, brewing processes and production of non‐wine vinegar. Chronic exposure to the food enzyme–TOS was calculated by combining the maximum recommended use level with individual consumption data (EFSA CEP Panel, 2021a). The estimation involved selection of relevant food categories and application of technical conversion factors (EFSA CEP Panel, 2021b). Exposure from all FoodEx categories was subsequently summed up, averaged over the total survey period (days) and normalised for bw. This was done for all individuals across all surveys, resulting in distributions of individual average exposure. Based on these distributions, the mean and 95th percentile exposures were calculated per survey for the total population and per age class. Surveys with only day per subject were excluded and high‐level exposure/intake was calculated for only those population groups in which the sample size was sufficiently large to allow calculation of the 95th percentile (EFSA, 2011). Table 2 provides an overview of the derived exposure estimates across all surveys. Detailed mean and 95th percentile exposure to the food enzyme–TOS per age class, country and survey, as well as contribution from each FoodEx category to the total dietary exposure are reported in Appendix A – Tables 1 and 2. For the present assessment, food consumption data were available from 43 dietary surveys (covering infants, toddlers, children, adolescents, adults and the elderly), carried out in 22 European countries (Appendix B). The highest dietary exposure was estimated to be about 0.012 mg TOS/kg bw per day in infants and toddlers at the 95th percentile. Table 2 Summary of the estimated dietary exposure to the food enzyme–TOS in six population groups Population group Estimated exposure (mg TOS/kg body weight per day) Infants Toddlers Children Adolescents Adults The elderly Age range 3–11 months 12–35 months 3–9 years 10–17 years 18–64 years ≥ 65 years Min–max mean (number of surveys) 0.001–0.004 (12) 0.003–0.007 (15) 0.004–0.006 (19) 0.002–0.004 (21) 0.001–0.003 (22) 0.001–0.003 (23) Min–max 95th percentile (number of surveys) 0.003–0.012 (11) 0.007–0.012 (14) 0.006–0.011 (19) 0.003–0.008 (20) 0.003–0.005 (22) 0.002–0.005 (22) TOS: total organic solids. 3.5.3 Uncertainty analysis In accordance with the guidance provided in the EFSA opinion related to uncertainties in dietary exposure assessment (EFSA, 2006), the following sources of uncertainties have been considered and are summarised in Table 3. Table 3 Qualitative evaluation of the influence of uncertainties on the dietary exposure estimate Sources of uncertainties Direction of impact Model input data Consumption data: different methodologies/representativeness/underreporting/misreporting/no portion size standard +/− Use of data from food consumption surveys of a few days to estimate long‐term (chronic) exposure for high percentiles (95th percentile) + Possible national differences in categorisation and classification of food +/− Model assumptions and factors Exposure to food enzyme–TOS was always calculated based on the recommended maximum use level + Selection of broad FoodEx categories for the exposure assessment + The consumption data covered all types of tea and herbal infusion products, not only the stevia infusion. + Use of recipe fractions to disaggregate FoodEx categories +/− Use of technical factors in the exposure model +/− Exclusion of one process from the exposure assessment: starch processing to produce maltodextrin − +: uncertainty with potential to cause overestimation of exposure. –: uncertainty with potential to cause underestimation of exposure. The conservative approach applied to estimate the exposure to the food enzyme–TOS, in particular assumptions made on the occurrence and use levels of this specific food enzyme, is likely to have led to overestimation of the exposure. The exclusion of one food manufacturing process from the exposure assessment was based on > 99% of TOS removal. This is not expected to have an impact on the overall estimate derived. 3.6 Margin of exposure A comparison of the NOAEL (230 mg TOS/kg bw per day) identified from the 90‐day rat study (EFSA CEP Panel, 2022) with the derived exposure estimates of 0.001–0.007 mg TOS/kg bw per day at the mean and from 0.002–0.012 mg TOS/kg bw per day at the 95th percentile resulted in a margin of exposure (MOE) of at least 19,167. 4 Conclusion Based on the data on the additional food manufacturing processes, and the evaluation of the data previously submitted, the Panel concludes that the food enzyme α‐amylase produced with the non‐genetically modified C. funkei strain AE‐AMT does not give rise to safety concerns under the revised intended conditions of use. 5 Documentation as provided to EFSA Application for authorisation of α‐amylase from Microbacterium imperial AE‐AMT in accordance with the Regulation (EC) No 1331/2008. June 2022. Submitted by Amano Enzymes Inc. Additional information. February 2023. Submitted by Amano Enzymes Inc. Abbreviations bw body weight CAS Chemical Abstracts Service CEP EFSA Panel on Food Contact Materials, Enzymes and Processing Aids EC European Commission EINECS European Inventory of Existing Commercial Chemical Substances EU European Union IUBMB International Union of Biochemistry and Molecular Biology MoE margin of exposure NOAEL no observed adverse effect level RM raw material TOS total organic solids Appendix A – Dietary exposure estimates to the food enzyme–TOS in details 1 Appendix A can be found in the online version of this output (in the ‘Supporting information’ section). The file contains two sheets, corresponding to two tables. Table 1: Average and 95th percentile exposure to the food enzyme–TOS per age class, country and survey. Table 2: Contribution of food categories to the dietary exposure to the food enzyme–TOS per age class, country and survey. Appendix B – Population groups considered for the exposure assessment 1 Population Age range Countries with food consumption surveys covering more than day Infants From 12 weeks on up to and including 11 months of age Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Portugal, Slovenia, Spain Toddlers From 12 months up to and including 35 months of age Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Netherlands, Portugal, Republic of North Macedonia*, Serbia*, Slovenia, Spain Children From 36 months up to and including 9 years of age Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Portugal, Republic of North Macedonia*, Serbia*, Spain, Sweden Adolescents From 10 years up to and including 17 years of age Austria, Belgium, Bosnia and Herzegovina*, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Montenegro*, Netherlands, Portugal, Romania, Serbia*, Slovenia, Spain, Sweden Adults From 18 years up to and including 64 years of age Austria, Belgium, Bosnia and Herzegovina*, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Montenegro*, Netherlands, Portugal, Romania, Serbia*, Slovenia, Spain, Sweden The elderly (a) From 65 years of age and older Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Montenegro*, Netherlands, Portugal, Romania, Serbia*, Slovenia, Spain, Sweden * Consumption data from these pre‐accession countries are not reported in Table 3 of this opinion, however, they are included in Appendix A for testing purpose. (a) The terms ‘children’ and ‘the elderly’ correspond, respectively, to ‘other children’ and the merge of ‘elderly’ and ‘very elderly’ in the Guidance of EFSA on the ‘Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment’ (EFSA, 2011). Supporting information Dietary exposure estimates to the food enzyme–TOS in details Click here for additional data file. Notes 1 Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on Food Enzymes and Amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97. OJ L 354, 31.12.2008, pp. 7–15. 2 Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. OJ L 354, 31.12.2008, pp. 1–6. 3 https://ec.europa.eu/food/sites/food/files/safety/docs/fs_food-improvement-agents_enzymes_register.pdf 4 OJ L 354, 31.12.2008, p. 1. 5 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, p. 1–24. 6 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/p. 10. 7 Technical dossier/Additional information February 2023. 8 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/pp. 1–2. 9 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/pp. 4–5. 10 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/pp. 2–3. 11 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/p. 2. 12 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/pp. 5–6. 13 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/pp. 6–7. 14 Technical dossier/Proposed conditions of use and, where applicable, normal and maximum use levels/pp. 8–9. ==== Refs References EFSA (European Food Safety Authority) , 2006. 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