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.

Following a request from the European Commission, EFSA developed an updated scientific guidance to assist applicants in the preparation of applications for food enzymes. This guidance describes the scientific data to be included in applications for the authorisation of food enzymes, as well as for the extension of use for existing authorisations, in accordance with Regulation ( EC ) No 1331/2008 and its implementing rules. Information to be provided in applications relates to source, production and characteristics of the food enzyme, toxicological data, allergenicity and dietary exposure estimation. Source, production and characteristics of the food enzyme are first considered only for enzymes of microbial origin and subsequently for those enzymes derived from plants and for enzymes from animal sources. Finally, the data requested for toxicology, allergenicity and dietary exposure applies to all food enzymes independent of the source. On the basis of the submitted data, EFSA will assess the safety of food enzymes and conclude whether or not they present a risk to human health under the proposed conditions of use.

Food enzymes are used for technical purposes in the production of food ingredients or foods‐as‐consumed. In the European Union, the safety of a food enzyme is evaluated by EFSA on the basis of a technical dossier provided by an applicant. Dietary exposure is an integral part of the risk assessment of food enzymes. To develop exposure models specific to each food manufacturing process in which food enzymes are used, different input data are required which are then used in tandem with technical conversion factors. This allows the use levels of food enzyme to be related to food consumption data collected in dietary surveys. For each food manufacturing process, EFSA identified a list of food groups (FoodEx1 classification system) and collated technical conversion factors. To ensure a correct and uniform application of these input data in the assessment of food enzyme dossiers, stakeholders were consulted via open calls‐for‐data. In addition to publishing and updating the identified input parameters on an annual basis, single‐process‐specific calculators of the Food Enzyme Intake Models (FEIMs) have been developed. These calculators have been deposited at https://zenodo.org/ since 2018 for open access. By 2023, EFSA had compiled the input data for a total of 40 food manufacturing processes in which food enzymes are employed. In this document, the food manufacturing processes are structured, food groups classified initially in the FoodEx1 system are translated into the FoodEx2 system, and technical factors are adjusted to reflect the more detailed and standardised FoodEx2 nomenclature. The development of an integrated FEIM‐web tool using this collection of input data is carried out for a possible release in 2024. This tool will be able to estimate the exposure to the food enzyme–total organic solids (TOS) when employed in multiple food manufacturing processes.

This document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 17.3 of Regulation (EC) No 1332/2008, for the authorisation of food enzymes. It specifically covers the characterisation of microorganisms used as production organisms.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) was asked by the European Commission to update its 2005 risk assessments of di-butylphthalate (DBP), butylbenzyl-phthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), di-isononylphthalate (DINP) and diisodecylphthalate (DIDP), which are authorised for use in plastic food contact material (FCM). Dietary exposure estimates (mean and high (P95)) were obtained by combining literature occurrence data with consumption data from the EFSA Comprehensive Database. The highest exposure was found for DINP, ranging from 0.2 to 4.3 and from 0.4 to 7.0 lg/kg body weight (bw) per day for mean and high consumers, respectively. There was not enough information to draw conclusions on how much migration from plastic FCM contributes to dietary exposure to phthalates. The review of the toxicological data focused mainly on reproductive effects. The CEP Panel derived the same critical effects and individual tolerable daily intakes (TDIs) (mg/kg bw per day) as in 2005 for all the phthalates, i.e. reproductive effects for DBP (0.01), BBP (0.5), DEHP (0.05), and liver effects for DINP and DIDP (0.15 each). Based on a plausible common mechanism (i.e. reduction in fetal testosterone) underlying the reproductive effects of DEHP, DBP and BBP, the Panel considered it appropriate to establish a group-TDI for these phthalates, taking DEHP as index compound as a basis for introducing relative potency factors. The Panel noted that DINP also affected fetal testosterone levels at doses around threefold higher than liver effects and therefore considered it conservative to include it within the group-TDI which was established to be 50 lg/kg bw per day, expressed as DEHP equivalents. The aggregated dietary exposure for DBP, BBP, DEHP and DINP was estimated to be 0.9-7.2 and 1.6-11.7 lg/kg bw per day for mean and high consumers, respectively, thus contributing up to 23% of the group-TDI in the worst-case scenario. For DIDP, not included in the group-TDI, dietary exposure was estimated to be always below 0.1 lg/kg bw per day and therefore far below the TDI of 150 lg/kg bw per day. This assessment covers European consumers of any age, including the most sensitive groups. Based on the limited scope of the mandate and the uncertainties identified, the Panel considered that the current assessment of the five phthalates, individually and collectively, should be on a temporary basis. ):5838 related chronic hepatic and renal effects in rats was identified. An uncertainty factor of 100 was applied for deriving the TDI of 0.15 mg/kg bw per day for DINP.-For DIDP, a NOAEL of 15 mg DIDP/kg bw per day for liver effects in dogs wasidentified. An uncertainty factor of 100 was applied for deriving the TDI of 0.15 mg/kg bw per day for DIDP. 1 ECHA (2017a) used a factor of 3 (total UF 300) for the extrapolation from LOAEL to NAEL.The CEP Panel considers that the effect on the liver is still the most sensitive endpoint for these two phthalates. However, the possibility to establish HBGVs for re...