Scientific Guidance for the submission of dossiers on Food Enzymes

et al. 2021

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Technical data for exposure assessment of food enzymes Dietary exposure is part of the overall assessment of food enzymes. In order to develop food process‐based exposure models, a number of different input data are required in tandem with technical conversion factors. This allows for a combination of use levels with food consumption data, which are typically reported as consumed. The use levels are expressed as total organic solids/kg raw materials. For each food process, EFSA identified a list of food groups and collated technical conversion factors. To ensure uniform application of FoodEx food categories and technical conversion factors in the assessment of food enzyme dossiers, stakeholders were consulted via open calls‐for‐data. Feedback was analysed. This document reports the consolidated input parameters for each food process. Regular updates have been made on a yearly basis since 2018, as further process‐specific parameters were generated. The consolidated input data have been used to calculate dietary exposure during the evaluation of food enzyme applications. As well as publishing the input parameters, process‐specific calculators of the food enzyme intake models (FEIM) have also been developed on the basis of summary statistics. These calculators have been deposited at https://zenodo.org/ for open access.

Section: Development Of Assessment Toolsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Process‐specific technical data used in exposure assessment of food enzymes

Lambré¹,

Baviera²,

et al. 2021

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156

220

“…The current ‘Guidance on the submission of a dossier on food enzymes for safety evaluation’ (EFSA, 2009a ) as well as the ‘Statement on characterisation of microorganisms used for the production of food enzymes’ (EFSA CEP Panel, 2019 ) have been followed for the evaluation of the application with the exception of the exposure assessment, which was carried out in accordance to the updated ‘Scientific Guidance for the submission of dossiers on food enzymes’ (EFSA CEP Panel, 2021a ).…”

Section: Data and Methodologiesmentioning

confidence: 99%

Safety evaluation of the food enzyme glucose oxidase from the genetically modified Aspergillus niger strain DP‐Aze23

Lambré¹,

Baviera²,

et al. 2022

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The food enzyme glucose oxidase (β‐D‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with the genetically modified Aspergillus niger strain DP‐Aze23 by Danisco US, Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes, cereal‐based processes and egg processing. Based on the maximum use levels, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.05 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 of 19.55 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure above 380. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

“…The current ‘Guidance on the submission of a dossier on food enzymes for safety evaluation’ (EFSA CEF Panel, 2009 ) has been followed for the evaluation of the application with the exception of the exposure assessment, which was carried out in accordance with the updated ‘Scientific Guidance for the submission of dossiers on food enzymes’ (EFSA CEP Panel, 2021 ).…”

Section: Data and Methodologiesmentioning

confidence: 99%

Safety evaluation of the food enzyme containing trypsin, chymotrypsin, α‐amylase and triacylglycerol lipase from porcine pancreas

Lambré¹,

Baviera²,

et al. 2022

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The food enzyme complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), α‐amylase (1,4‐α‐ d ‐glucan glucanohydrolase, EC 3.2.1.1) and triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3), is obtained from porcine pancreas by American Laboratories, Inc., USA. The food enzyme is intended primarily for the hydrolysis of milk proteins to be used in foods for special medical or nutritional dietary management. ■■■■■ is extensively used in the manufacturing process, and residual amounts of the solvent remain in the food enzyme. The applicant estimates a typical range of ■■■■■ in the food enzyme to be 10,000–13,000 mg/kg. Directive 2009/32/EC sets a maximum residue level of 10 mg/kg for foods and food ingredients produced in the EU or imported into the EU. The use of ■■■■■ for the production of a food enzyme falls within the scope of Directive 2009/32/EC. Consequently, the food enzyme does not comply with the existing requirements within the EU governing residual amount of solvent.