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EFSA developed ahazard assessment protocol upfront to the re-evaluation of Bisphenol A to ensure an efficient and transparent assessment, in line with the principles highlighted in the EFSA project PROmoting METHods for Evidence Use in scientific assessments. After undergoing a public consultation, the protocol was revised according to the comments received and published in its draft version in 2017 (10.5281/zenodo.1116881). Prior to being applied, and still during its implementation in the BPA assessment, the protocol was tested and slightly revised. This is the final version of the protocol used for the BPA re-evaluation, annexed (Annex A) to the opinion on BPA risk assessment of the EFSA CEP Panelpublished in April 2023 (https://doi.org/10.2903/j.efsa.2023.6857). The protocol states in detail the methods and/or the criteria that were used in the BPA re-evaluation for data collection, study inclusion, evidence appraisal and integration.

[EN] The food enzyme ß-amylase (4-¿-d-glucan maltohydrolase, EC 3.2.1.2) is produced with the non-genetically modified Bacillus flexus strain AE-BAF by Amano Enzyme Inc. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is intended to be used in baking and brewing processes, and in starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for this food process. Based on the maximum use levels recommended by the applicant for the baking and brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure was estimated to be up to 2 mg TOS/kg body weight (bw) per day in European populations. Toxicological studies were not considered necessary given the QPS status of the production strain and the nature of the manufacturing process. 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, 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, in particular, the QPS status of the production strain and that no issues of concern arose from the production process, the Panel concluded that the food enzyme ß-amylase produced with B. flexus strain AE-BAF does not give rise to safety concerns under the intended conditions of use.

This Statement presents a proposal for harmonising the establishment of Health‐Based Guidance Values (HBGVs) for regulated products that are also nutrients. This is a recurrent issue for food additives and pesticides, and may occasionally occur for other regulated products. The Statement describes the specific considerations that should be followed for establishing the HBGVs during the assessment of a regulated product that is also a nutrient. It also addresses the elements to be considered in the intake assessment; and proposes a decision tree for ensuring a harmonised process for the risk characterisation of regulated products that are also nutrients. The Scientific Committee recommends the involvement of the relevant EFSA Panels and units, in order to ensure an integrated and harmonised approach for the hazard and risk characterisation of regulated products that are also nutrients, considering the intake from all relevant sources., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6480/full

[EN] The food enzyme ß-amylase (4-¿-d-glucan maltohydrolase, EC 3.2.1.2) is produced with the non-genetically modified Bacillus flexus strain AE-BAF by Amano Enzyme Inc. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is intended to be used in baking and brewing processes, and in starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for this food process. Based on the maximum use levels recommended by the applicant for the baking and brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure was estimated to be up to 2 mg TOS/kg body weight (bw) per day in European populations. Toxicological studies were not considered necessary given the QPS status of the production strain and the nature of the manufacturing process. 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, 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, in particular, the QPS status of the production strain and that no issues of concern arose from the production process, the Panel concluded that the food enzyme ß-amylase produced with B. flexus strain AE-BAF does not give rise to safety concerns under the intended conditions of use.

The European Parliament requested EFSA to develop a holistic risk assessment of multiple stressors in honey bees. To this end, a systems‐based approach that is composed of two core components: a monitoring system and a modelling system are put forward with honey bees taken as a showcase. Key developments in the current scientific opinion (including systematic data collection from sentinel beehives and an agent‐based simulation) have the potential to substantially contribute to future development of environmental risk assessments of multiple stressors at larger spatial and temporal scales. For the monitoring, sentinel hives would be placed across representative climatic zones and landscapes in the EU and connected to a platform for data storage and analysis. Data on bee health status, chemical residues and the immediate or broader landscape around the hives would be collected in a harmonised and standardised manner, and would be used to inform stakeholders, and the modelling system, ApisRAM, which simulates as accurately as possible a honey bee colony. ApisRAM would be calibrated and continuously updated with incoming monitoring data and emerging scientific knowledge from research. It will be a supportive tool for beekeeping, farming, research, risk assessment and risk management, and it will benefit the wider society. A societal outlook on the proposed approach is included and this was conducted with targeted social science research with 64 beekeepers from eight EU Member States and with members of the EU Bee Partnership. Gaps and opportunities are identified to further implement the approach. Conclusions and recommendations are made on a way forward, both for the application of the approach and its use in a broader context., This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6608/full

EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases of the different epidemiological study designs. It describes key epidemiological concepts relevant for evidence appraisal. Regarding study reliability, measures of association, exposure assessment, statistical inferences, systematic error and effect modification are explained. Regarding study relevance, the guidance describes the concept of external validity. The principles of appraising epidemiological studies are illustrated, and an overview of Risk of Bias (RoB) tools is given. A decision tree is developed to assist in the selection of the appropriate Risk of Bias tool, depending on study question, population and design. The customisation of the study appraisal process is explained, detailing the use of RoB tools and assessing the risk of bias in the body of evidence. Several examples of appraising experimental and observational studies using a Risk of Bias tool are annexed to the document to illustrate the application of the approach. This document constitutes a draft that will be applied in EFSA's assessments during a 1‐year pilot phase and be revised and complemented as necessary. Before finalisation of the document, a public consultation will be launched.

International audience; The substance isobutane is intended to be used as a foaming agent at max 4.5% to produce expanded polystyrene (EPS) to be used for packaging foods, such as fruits, vegetables, meat, fish and cheese, at room temperature or lower. Isobutane is approved in Europe as a food additive (E943b) to be used quantumsatis as a gas propellant only in vegetable oil pan spray (for professional use only) and water-based emulsion spray according to Regulation (EC) No1333/2008. The purity requirements for the use of isobutane as a food additive are described in Commission Regulation (EU) No231/2012. The substance is a gas at room temperature. It is a saturated hydrocarbon, obtained with a high level of purity, and is not expected to react under the processing conditions used to make foamed polystyrene materials and articles. Data on migration of isobutane from trays at 20 degrees C for 10days ranged from 0.2 to 0.4mg/kg food. Considering the intended applications, estimated exposure is extremely low based on migration data. In the absence of genotoxicity alerts and given the very low toxicity following repeated exposure with no observed adverse effect concentration (NOAEC) of several thousands of mg/m(3) by inhalation, it was considered that the use of isobutane as a foaming agent, at the expected exposure from food, does not raise a safety concern.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process EstPak Plastik (EU register No RECYC150), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, mainly bottles, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed and dried PET flakes are preheated before being submitted to solid‐state polycondensation (SSP) in a continuous reactor (one single reactor or several reactors in parallel) at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control the performance of the process are well defined and are temperature, pressure, residence time and gas flow for steps 2 and 3. Under these conditions, it was demonstrated that the recycling process under evaluation, using the Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long‐term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this PET are not intended to be used, and should not be used, in microwave and conventional ovens.