Naturally occurring bisphenol F in plants used in traditional medicine.

Bisphenol F (BPF, 4-[(4-hydroxyphenyl)methyl]phenol) is a bisphenol that is structurally similar to bisphenol A (BPA). In response to consumer concern towards BPA, industry has started to substitute BPA for BPF and other bisphenol analogues in the production of epoxy resins and coatings for various applications. In 2016, it was reported that commercially sold mustard contained naturally occurring BPF. Here, the existing literature was reviewed to investigate whether other natural sources of BPF among edible plants exist, including their impact on human exposure to BPF. Coeloglossum viride var. bracteatum (rhizome), Galeola faberi (rhizome), Gastrodia elata (rhizome), Xanthium strumarium (seeds) and Tropidia curculioides (root) were found to contain naturally occurring BPF. Botanical extracts from these plants are used in traditional Chinese medicine. The highest values of BPF were recorded for G. elata and T. curculioides. Information on precise doses of the plant extracts used is scarce; however, for G. elata, also known as Tian Ma and available in powder form, a daily exposure of BPF from this source could theoretically amount up to 4.5 µg/kg body weight per day (based on a 70 kg body weight). Therefore, herbal products used in traditional Chinese medicine should be considered as a potential source contributing to the overall human exposure when assessing endocrine-active bisphenolic compounds.

Computational identification of structural factors affecting the mutagenic potential of aromatic amines: study design and experimental validation.

A grid-based, alignment-independent 3D-SDAR (three-dimensional spectral data-activity relationship) approach based on simulated 13C and 15N NMR chemical shifts augmented with through-space interatomic distances was used to model the mutagenicity of 554 primary and 419 secondary aromatic amines. A robust modeling strategy supported by extensive validation including randomized training/hold-out test set pairs, validation sets, "blind" external test sets as well as experimental validation was applied to avoid over-parameterization and build Organization for Economic Cooperation and Development (OECD 2004) compliant models. Based on an experimental validation set of 23 chemicals tested in a two-strain Salmonella typhimurium Ames assay, 3D-SDAR was able to achieve performance comparable to 5-strain (Ames) predictions by Lhasa Limited's Derek and Sarah Nexus for the same set. Furthermore, mapping of the most frequently occurring bins on the primary and secondary aromatic amine structures allowed the identification of molecular features that were associated either positively or negatively with mutagenicity. Prominent structural features found to enhance the mutagenic potential included: nitrobenzene moieties, conjugated π-systems, nitrothiophene groups, and aromatic hydroxylamine moieties. 3D-SDAR was also able to capture "true" negative contributions that are particularly difficult to detect through alternative methods. These include sulphonamide, acetamide, and other functional groups, which not only lack contributions to the overall mutagenic potential, but are known to actively lower it, if present in the chemical structures of what otherwise would be potential mutagens.

Azo dyes in clothing textiles can be cleaved into a series of mutagenic aromatic amines which are not regulated yet.

Azo dyes represent the by far most important class of textile dyes. Their biotransformation by various skin bacteria may release aromatic amines (AAs) which might be dermally absorbed to a major extent. Certain AAs are well known to have genotoxic and/or carcinogenic properties. Correspondingly, azo dyes releasing one of the 22 known carcinogenic AAs are banned from clothing textiles in the European Union. In the present study, we investigated the mutagenicity of 397 non-regulated AAs potentially released from the 470 known textile azo dyes. We identified 36 mutagenic AAs via publicly available databases. After predicting their mutagenicity potential using the method by Bentzien, we accordingly allocated them into different priority groups. Ames tests on 18 AAs of high priority showed that 4 substances (22%) (CASRN 84-67-3, 615-47-4, 3282-99-3, 15791-87-4) are mutagenic in the strain TA98 and/or TA100 with and/or without rat S9 mix. Overall, combining the information from the Ames tests and the publicly available data, we identified 40 mutagenic AAs being potential cleavage products of approximately 180 different parent azo dyes comprising 38% of the azo dyes in our database. The outcome of this study indicates that mutagenic AAs in textile azo dyes are of much higher concern than previously expected, which entails implications on the product design and possibly on the regulation of azo dyes in the future.

Identification of non-regulated aromatic amines of toxicological concern which can be cleaved from azo dyes used in clothing textiles.

Azo dyes in textiles may release aromatic amines after enzymatic cleavage by skin bacteria or after dermal absorption and metabolism in the human body. From the 896 azo dyes with known chemical structure in the available textile dyes database, 426 azo dyes (48%) can generate one or more of the 22 regulated aromatic amines in the European Union in Annex XVII of REACH. Another 470 azo dyes (52%) can be cleaved into exclusively non-regulated aromatic amines. In this study, a search for publicly available toxicity data on non-regulated aromatic amines was performed. For a considerable percentage of non-regulated aromatic amines, the toxicity database was found to be insufficient or non-existent. 62 non-regulated aromatic amines with available toxicity data were prioritized by expert judgment with objective criteria according to their potential for carcinogenicity, genotoxicity, and/or skin sensitization. To investigate the occurrence of azo dye cleavage products, 153 random samples of clothing textiles were taken from Swiss retail outlets and analyzed for 22 high priority non-regulated aromatic amines of toxicological concern. Eight of these 22 non-regulated aromatic amines of concern could be detected in 17% of the textile samples. In 9% of the samples, one or more of the aromatic amines of concern could be detected in concentrations >30 mg/kg, in 8% of the samples between 5 and 30 mg/kg. The highest measured concentration was 622 mg/kg textile. There is an obvious need to assess consumer health risks for these non-regulated aromatic amines and to fill this gap in the regulation of clothing textiles.

The TTC Approach in Practice and its Impact on Risk Assessment and Risk Management in Food Safety. A Regulatory Toxicologist's Perspective.

There are many substances in food and drinking water from different contamination sources for which only insufficient or no toxicity data exist. In order to prioritize and preliminarily assess the human health risks, the threshold of toxicological concern (TTC) approach was developed between 1996 and 2004. This concept has since been applied increasingly by regulatory food safety authorities. In parallel, the safety of this approach has been discussed by stakeholders, primarily on a conceptual basis. However, real examples showing the practical benefits of this approach have not been discussed. In this paper, the technical feasibility, applicability, safety, and further benefits of the TTC approach are illustrated and discussed based on four real cases: 1) halogenated contaminants of unknown origin in the drinking water (polychlorinated butadienes), 2) an unwanted by-product from epoxy resin coatings in canned fish (Cyclo-di-BADGE), 3) two cyclic compounds occurring in polyamide food packaging materials and kitchen utensils, and 4) mycotoxins (from Alternaria). These examples from different fields of application clearly demonstrate that the results of the TTC approach are an extremely useful starting point for adequate decisions and actions (if necessary) by risk assessment and risk management in food safety.

Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map.

BACKGROUND: The presence of polyethylene terephthalate (PET) oligomers in food contact materials (FCMs) is well-documented. Consumers are exposed through their migration into foods and beverages; however, there is no specific guidance for their safety evaluation. OBJECTIVES: This systematic evidence map (SEM) aims to identify and organize existing knowledge and associated gaps in hazard and exposure information on 34 PET oligomers to support regulatory decision-making. METHODS: The methodology for this SEM was recently registered. A systematic search in bibliographic and gray literature sources was conducted and studies evaluated for inclusion according to the Populations, Exposures, Comparators, Outcomes, and Study type (PECOS) framework. Inclusion criteria were designed to record hazard and exposure information for all 34 PET oligomers and coded into the following evidence streams: human, animal, organism (non-animal), ex vivo, in vitro, in silico, migration, hydrolysis, and absorption, distribution, metabolism, excretion/toxicokinetics/pharmacokinetics (ADME/TK/PK) studies. Relevant information was extracted from eligible studies and synthesized according to the protocol. RESULTS: Literature searches yielded 7445 unique records, of which 96 were included. Data comprised migration (560 entries), ADME/TK/PK-related (253 entries), health/bioactivity (98 entries) and very few hydrolysis studies (7 entries). Cyclic oligomers were studied more frequently than linear PET oligomers. In vitro results indicated that hydrolysis of cyclic oligomers generated a mixture of linear oligomers, but not monomers, potentially allowing their absorption in the gastrointestinal tract. Cyclic dimers, linear trimers and the respective smaller oligomers exhibit physico-chemical properties making oral absorption more likely. Information on health/bioactivity effects of oligomers was almost non-existent, except for limited data on mutagenicity. CONCLUSIONS: This SEM revealed substantial deficiencies in the available evidence on ADME/TK/PK, hydrolysis, and health/bioactivity effects of PET oligomers, currently preventing appropriate risk assessment. It is essential to develop more systematic and tiered approaches to address the identified research needs and assess the risks of PET oligomers.

Regulatory assessment of in vitro skin corrosion and irritation data within the European framework: Workshop recommendations.

Validated in vitro methods for skin corrosion and irritation were adopted by the OECD and by the European Union during the last decade. In the EU, Switzerland and countries adopting the EU legislation, these assays may allow the full replacement of animal testing for identifying and classifying compounds as skin corrosives, skin irritants, and non irritants. In order to develop harmonised recommendations on the use of in vitro data for regulatory assessment purposes within the European framework, a workshop was organized by the Swiss Federal Office of Public Health together with ECVAM and the BfR. It comprised stakeholders from various European countries involved in the process from in vitro testing to the regulatory assessment of in vitro data. Discussions addressed the following questions: (1) the information requirements considered useful for regulatory assessment; (2) the applicability of in vitro skin corrosion data to assign the corrosive subcategories as implemented by the EU Classification, Labelling and Packaging Regulation; (3) the applicability of testing strategies for determining skin corrosion and irritation hazards; and (4) the applicability of the adopted in vitro assays to test mixtures, preparations and dilutions. Overall, a number of agreements and recommendations were achieved in order to clarify and facilitate the assessment and use of in vitro data from regulatory accepted methods, and ultimately help regulators and scientists facing with the new in vitro approaches to evaluate skin irritation and corrosion hazards and risks without animal data.

Biomonitoring of ochratoxin A, 2'R-ochratoxin A and citrinin in human blood serum from Switzerland.

Biomonitoring of mycotoxins and their metabolites in biological fluids is increasingly used to assess human exposure. In this study, biomarkers of ochratoxin A (OTA) and citrinin (CIT) exposure were determined in a large number of serum samples from healthy blood donors in Switzerland. In 2019, 700 samples from different regions were obtained. From 240 donors, a second sample (taken 2-9 months later) was available for analysis. Moreover, 355 blood donor samples from 2005 from all regions in Switzerland and 151 additional samples from the southern Swiss region of Ticino from 2005 could be analysed.OTA, 2'R-ochratoxin A (2'R-OTA), ochratoxin alpha (OTα), CIT and dihydrocitrinone (DH-CIT) were analysed using validated targeted methods including precipitation and online SPE clean-up.OTA and 2'R-OTA were frequently detected (OTA in 99%; 2'R-OTA in 51% of the tested samples). The mean concentration in all positive samples was 0.4 ng/mL for OTA and 0.2 ng/mL for 2'R-OTA. OTα was not detected in any sample above the limit of quantification (LOQ). In contrast to OTA, CIT and DH-CIT were only quantifiable in 2% and 0.1% of the samples, respectively. No significant trend was observed between the samples from 2005 and the more recent samples, but OTA concentrations were usually higher in serum samples from the southern Swiss region of Ticino and in males compared to females.Our extensive data fit well within the framework of previously published values for the healthy adult European population.

Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: Protocol for a systematic evidence map.

BACKGROUND: Polyethylene terephthalate (PET) oligomers are ubiquitous in PET used in food contact applications. Consumer exposure by migration of PET oligomers into food and beverages is documented. However, no specific risk assessment framework or guidance for the safety evaluating of PET oligomers exist to date. AIM: The aim of this systematic evidence map (SEM) is to identify and organize existing knowledge clusters and associated gaps in hazard and exposure information of PET oligomers. Research needs will be identified as an input for chemical risk assessment, and to support future toxicity testing strategies of PET oligomers and regulatory decision-making. SEARCH STRATEGY AND ELIGIBILITY CRITERIA: Multiple bibliographic databases (incl. Embase, Medline, Scopus, and Web of Science Core Collection), chemistry databases (SciFinder-n, Reaxys), and gray literature sources will be searched, and the search results will be supplemented by backward and forward citation tracking on eligible records. The search will be based on a single-concept PET oligomer-focused strategy to ensure sensitive and unbiased coverage of all evidence related to hazard and exposure in a data-poor environment. A scoping exercise conducted during planning identified 34 relevant PET oligomers. Eligible work of any study type must include primary research data on at least one relevant PET oligomer with regard to exposure, health, or toxicological outcomes. STUDY SELECTION: For indexed scientific literature, title and abstract screening will be performed by one reviewer. Selected studies will be screened in full-text by two independent reviewers. Gray literature will be screened by two independent reviewers for inclusion and exclusion. STUDY QUALITY ASSESSMENT: Risk of bias analysis will not be conducted as part of this SEM. DATA EXTRACTION AND CODING: Will be performed by one reviewer and peer-checked by a second reviewer for indexed scientific literature or by two independent reviewers for gray literature. SYNTHESIS AND VISUALIZATION: The extracted and coded information will be synthesized in different formats, including narrative synthesis, tables, and heat maps. SYSTEMATIC MAP PROTOCOL REGISTRY AND REGISTRATION NUMBER: Zenodo: https://doi.org/10.5281/zenodo.6224302.

In vitro genotoxicity of polychlorinated butadienes (Cl4-Cl6).

Tetrachlorinated butadienes (TetraCBDs), pentachlorinated butadienes (PentaCBDs) and hexachloro-1,3-butadiene (hexachlorobutadiene or HexaCBD) are environmental contaminants that can occur in groundwater and drinking water at specific sites. While some toxicological data exist for HexaCBD, only few or no toxicity data are available for TetraCBDs and PentaCBDs. In view of structural alerts for potential genotoxicity and carcinogenicity, the genotoxicity of these substances was examined in the Salmonella typhimurium mutagenicity assay (Ames test) and in the in vitro chromosome aberration test. All of the tested polychlorinated butadienes induced chromosome aberrations. Such an effect of HexaCBD is reported here for the first time. In addition, 1,1,3,4-TetraCBD and 1,2,3,4-TetraCBD were positive in the Ames test while the other polychlorinated butadienes including HexaCBD were negative. From these findings it is concluded that certain incompletely chlorinated butadienes have a different genotoxic profile than the completely halogenated HexaCBD, which is of relevance for the risk assessment of these compounds.

TTC-based risk assessment of tetrachlorobutadienes and pentachlorobutadienes--the in vitro genotoxic contaminants in ground and drinking water.

Tetrachlorinated butadienes (TetraCBDs), pentachlorinated butadienes (PentaCBDs) and hexachlorobutadiene (HexaCBD) were detected in groundwater wells of drinking water supplier near Basel up to maximally 157 ng/L (sum value), 15 ng/L (sum value), and <50 ng/L, in 2006. HexaCBD is toxicologically well characterized and the WHO has derived a TDI of 0.2 µg/kg body weight (bw)/day and a drinking-water guideline value of 600 ng/L. However, due to insufficient toxicity data, neither health-based guideline values nor maximum contaminant levels have been established for the TetraCBDs and PentaCBDs yet. Since TetraCBDs and PentaCBDs show structural alerts for potential genotoxicity, the genotoxicity of TetraCBDs and PentaCBDs was examined in vitro. All the TetraCBDs and PentaCBDs as well as HexaCBD were clastogenic in the chromosome aberration test. In addition, 1,1,3,4-TetraCBD and 1,2,3,4-TetraCBD were positive in the Ames test while the other polychlorinated butadienes including HexaCBD were negative. Using the threshold of toxicological concern (TTC) concept, the target value for TetraCBDs and PentaCBDs in drinking water was set at 75 ng/L (sum value of both substance groups). For the main component 1,1,4,4-TetraCBD, which is negative in the Ames, it is recommended to perform a third in vitro genotoxicity test, the HPRT test, before it can be decided whether to refer to the guideline value of HexaCBD at 600 ng/L or still to use the conservative TTC-based target value of 75 ng/L.

Risk assessment of chlorinated paraffins in feed and food.

The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of chlorinated paraffins in feed and food. The data for experimental animals were reviewed and the CONTAM Panel identified the liver, kidney and thyroid as the target organs for the SCCP and MCCP mixtures tested in repeated dose toxicity studies. Decreased pup survival and subcutaneous haematoma/haemorrhage were also identified as critical effects for an MCCP mixture. For the LCCP mixtures tested, the liver was identified as the target organ. The Panel selected as reference points a BMDL 10 of 2.3 mg/kg bw per day for increased incidence of nephritis in male rats, and of 36 mg/kg bw per day for increased relative kidney weights in male and female rats for SCCPs and MCCPs, respectively. For LCCPs, a reference point relevant for humans could not be identified. Due to the limitations in the toxicokinetic and toxicological database, the Panel concluded that derivation of a health-based guidance value was not appropriate. Only limited data on the occurrence of SCCPs and MCCPs in some fish species were submitted to EFSA. No data were submitted for LCCPs. Thus, a robust exposure assessment and consequently a complete risk characterisation could not be performed. A preliminary risk characterisation based only on the consumption of fish was performed, and the calculated margins of exposure suggested no health concern for this limited scenario. The Panel noted that dietary exposure will be higher due to the contribution of CPs from other foods. The Panel was not able to identify reference points for farm animals, horses and companion animals. No occurrence data for feed were submitted to EFSA. Therefore, no risk characterisation could be performed for any of these animal species.

Safety evaluation of the food enzyme α-amylase from a genetically modified strain of Bacillus licheniformis (DP-Dzb54).

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP-Dzb54 by Danisco. The α-amylase is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated. The parental strain meets all the requirements for the Qualified Presumption of Safety approach for risk assessment, except the absence of acquired antimicrobial resistance genes. However, this has no practical consequence for the food enzyme as it has been shown not to contain viable cells and DNA from the production strain. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. 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 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.

Safety assessment of the process Sharpak Bridgewater, based on Starlinger Decon technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Sharpak Bridgewater (EU register number RECYC166). The input is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles, with no more than 5% PET from non-food consumer applications. The flakes are preheated before being submitted to solid-state polycondensation (SSP) in a continuous reactor 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 to control the performance of these critical steps are temperature, pressure, residence time and gas flow. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process when used at 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 recycled PET are not intended to be used, in microwave and conventional ovens and such use is not covered by this evaluation.

Safety assessment of the process 'Jász-Plasztik', based on Vacurema Prime technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the recycling process Jász-Plasztik (EU register number RECYC0157). The input are hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers and containing no more than 5% PET from non-food applications. They are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum before being extruded into pellets. Having examined the results of the challenge test provided, the Panel concluded that the decontamination in the batch reactors (step 2) and in the continuous reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process when 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 recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.

Safety evaluation of the food enzyme 4-α-glucanotransferase from Aeribacillus pallidus (strain AE-SAS).

The food enzyme 4-α-glucanotransferase (1,4-α-d-glucan:1,4-α-d-glucan 4-α-d-glycosyltransferase, EC 2.4.1.25) is produced with a non-genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.050 mg TOS/kg body weight (bw) per day. Exposure assessment for the modified dextrins was not considered necessary. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 900 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure to the food enzyme used in baking, this results in a Margin of Exposure (MOE) of at least 18,000. The Panel considers that any additional exposure to the food enzyme from the use of modified dextrins will be covered by the above MOE. A search was made for similarity of the amino acid sequence of the food enzyme with those of known allergens. One match was found with a known respiratory allergen, an α-amylase. The Panel considered that an allergic reaction upon oral ingestion of 4-α-glucanotransferase produced by A. pallidus AE-SAS in individuals respiratory sensitised to α-amylase cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.

Safety evaluation of the food enzyme phospholipase C from a genetically modified Komagataella phaffii (strain PRF).

The food enzyme phospholipase C (EC 3.1.4.3) is produced with a genetically modified Komagataella phaffii (formerly Pichia pastoris) (strain PRF) by DSM. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This phospholipase C is intended to be used in fats and oils processing for degumming. The residual amounts of total organic solids (TOS) are removed during refinement steps applied during fats and oils processing. Consequently, no dietary exposure was calculated. 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 (NOAEL) of at least 1,672 mg TOS/kg body weight per day, the highest dose tested. 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 is considered to be low. Based on the data provided and the removal of TOS during the fats and oils processing for degumming, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme endo-1,4-ß-xylanase from a genetically modified Bacillus licheniformis (strain NZYM-CE).

The food enzyme endo-1,4-ß-xylanase (4-ß-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified Bacillus licheniformis (strain NZYM-CE) by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal-based processes. Based on the maximum use levels recommended for the respective food processes and individual data from the EFSA Comprehensive European Food Consumption Database, 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. Genotoxicity tests did not indicate a genotoxic concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of at least 1,020 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure, this results in a margin of exposure (MoE) of at least 85,000. 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 upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that based on the data provided and the derived MoE, this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety assessment of the process Alimpet, based on EREMA MPR B2B technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the Alimpet recycling process (EU register number RECYC159), which is based on the EREMA Multi-Purpose Reactor (MPR) technology. The input is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5% PET from non-food consumer applications. They are treated in a continuous reactor under vacuum and high temperature. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation 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, derived from the exposure scenario for infants. Therefore, the Panel concluded that recycled PET obtained from the process is not of safety concern when used to manufacture articles intended for food contact applications if it is produced in compliance with the conditions specified in the conclusion of this opinion. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.

Safety assessment of the process Texplast, based on EREMA Advanced technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the Texplast recycling process (EU register number RECYC158), which is based on the EREMA Advanced technology. The input is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5% PET from non-food consumer applications. They are heated in a continuous reactor under vacuum. Having examined the results of the challenge test provided, the Panel concluded that this continuous reactor step (step 3) is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation 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, derived from the exposure scenario for infants. Therefore, the Panel concluded that recycled PET obtained from the process is not of safety concern when used to manufacture articles intended for food contact applications if it is produced in compliance with the conditions specified in the conclusion of this opinion. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.