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Determining the extent of pollution in the marine environment remains challenging. Polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs), and metals can, during dredging operations, be transported from a port or harbour into the open sea, where they may exert a harmful effect on the marine ecosystem. To fully understand the impact of these chemicals, monitoring programs should not only focus on sediment concentrations, but should also take into account the bioaccumulated concentration in the tissue of multiple target organisms. In this study, the concentration of primary contaminants is determined in common starfish (Asterias rubens), flying crab (Liocarcinus holsatus), and brown shrimp (Crangon crangon) and the difference in the concentration of contamination between different dredge disposal sites at open sea is investigated. Different factors such as lipid weight, dry weight, grain size, and total organic carbon were measured and used to understand the difference between the observed bioaccumulation and the measured sediment concentrations. KEY MESSAGE: Different contaminants are detected in biota such as common starfish, flying crab and brown shrimp. These contaminants can be linked to dredging activities, with disposal sites associated with industrial ports showing higher contamination., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

This opinion deals with the re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. Saccharin is the chemically manufactured compound 1,2-benzisothiazol-3(2H)-one-1,1-dioxide. Along with its sodium (Na), potassium (K) and calcium (Ca) salts, they are authorised as sweeteners (E 954). E 954 can be produced by two manufacturing methods i.e. Remsen-Fahlberg and Maumee. No analytical data on potential impurities were provided for products manufactured with the Maumee process; therefore, the Panel could only evaluate saccharins (E 954) manufactured with the Remsen-Fahlberg process. The Panel concluded that the newly available studies do not raise a concern for genotoxicity of E 954 and the saccharins impurities associated with the Remsen-Fahlberg manufacturing process. For the potential impurities associated with the Maumee process, a concern for genotoxicity was identified. The data set evaluated consisted of animals and human studies. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) and considered the decrease in body weight in animal studies as the relevant endpoint for the derivation of a reference point. An ADI of 9 mg/kg body weight (bw) per day, expressed as free imide, was derived for saccharins (E 954). This ADI replaces the ADI of 5 mg /kg bw per day (expressed as sodium saccharin, corresponding to 3.8 mg /kg bw per day saccharin as free imide) established by the Scientific Committee on Food. The Panel considered the refined brand-loyal exposure assessment scenario the most appropriate exposure scenario for the risk assessment. The Panel noted that the P95 exposure estimates for chronic exposure to saccharins (E 954) were below the ADI. The Panel recommended the European Commission to consider the revision of the EU specifications of saccharin and its sodium, potassium and calcium salts (E 954)., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The present opinion is the follow-up of the conclusions and recommendations of the Scientific Opinion on the re-evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the risk assessment of silicon dioxide (E 551) for its use in food for infants below 16 weeks of age is performed. Based on the newly available information on the characterisation of the SAS used as E 551 and following the principles of the 2021 EFSA Guidance on Particle-TR, the conventional safety assessment has been complemented with nano-specific considerations. Given the uncertainties resulting from the limitations of the database and in the absence of genotoxicity concern, the Panel considered that it is not appropriate to derive an acceptable daily intake (ADI) but applied the margin of exposure (MOE) approach for the risk assessment. The Panel concluded that the MOE should be at least 36 for not raising a safety concern. The calculated MOEs considering the dietary exposure estimates for all population groups using the refined non-brand loyal scenario, estimated at the time of the 2018 re-evaluation, were all above 36. The Panel concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels. The use of E 551 in food for infants below 16 weeks of age in FC 13.1.1 and FC 13.1.5.1 does not raise a safety concern at the current exposure levels. The Panel also concluded that the technical data provided support an amendment of the specifications for E 551 laid down in Commission Regulation (EU) No 231/2012. The paucity of toxicological studies with proper dispersion protocol (with the exception of the genotoxicity studies) creates uncertainty in the present assessment of the potential toxicological effects related to the exposure to E 551 nanosize aggregates., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

In low-income countries, a widespread but poorly studied type of cottage industry consists of melting scrap metal for making cookware. We assessed the exposure to lead (Pb) among artisanal workers, and their families, involved in manufacturing cookware from scrap metal. In a cross-sectional survey, we compared artisanal cookware manufacturing foundries with carpentry workshops (negative controls) and car battery repair workshops (positive controls), all located in residential areas, in Lubumbashi (DR Congo). We collected surface dust in the workspaces, and blood and urine samples among workers, as well as residents living in the cookware workshops. Trace elements were quantified in the samples by Inductively Coupled Plasma Mass Spectrometry (ICP-MS). In surface dust, median Pb concentrations were higher in cookware foundries (347 mg/kg) than in carpentries (234 mg/kg) but lower than in battery repair workshops (22,000 mg/kg). In workers making the cookware (n = 24), geometric mean (GM) Pb blood cencentration was 118 μg/L [interquartile range (IQR) 78.4-204], i.e. nearly twice as high as among carpenters [60.2 μg/L (44.4-84.7), n = 33], and half the concentration of battery repair workers [255 μg/L (197-362), n = 23]. Resident children from the cookware foundries, had higher urinary Pb [6.2 μg/g creatinine (2.3-19.3), n = 6] than adults [2.3 (2.2-2.5), n = 3]. Our investigation confirms the high Pb hazard linked to car battery repair and reveals a high exposure to Pb among artisanal cookware manufacturers and their families, especially children, in residential areas of a city in a low-income country., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Quillaia extract (E 999) was re-evaluated in 2019 by the EFSA Panel on Food Additives and Flavourings (FAF). EFSA derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999. Following a European Commission call for data to submit data to fill the data gaps, the present follow-up opinion assesses data provided by interested business operators (IBOs) to support an amendment of the EU specifications for E 999. Additionally, this opinion deals with the assessment of the proposed extension of use for E 999 in food supplements supplied in a solid and liquid form, excluding food supplements for infants and young children and, as a carrier in botanical nutrients. The Panel concluded that the proposed extension of use, if authorised, could result in an exceedance of the ADI at the maximum of the ranges of the mean for children, adolescents and the elderly, and for all populations at the 95th percentile. An additional proposed extension of use for E 999 to be used as a carrier for glazing agents on entire fresh fruits and vegetables has been received. Since no information on the proposed use levels of E 999 on a saponins content basis has been provided by this applicant, the Panel was not able to evaluate the safety of this extension of use. Considering the technical data submitted, the Panel recommended some modifications of the existing EU specifications for E 999, mainly to lower the limits for lead, mercury and arsenic and to include a maximum limit for cadmium and for calcium oxalate. The Panel also recommended that the limits would be expressed on a saponins basis. The Panel proposed to revise the definition of E 999 to better describe the composition in a qualitative way., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Previous assessments of a selection of face masks intended for the general population in Belgium found that silver (Ag)-based biocides were present in masks advertised for antimicrobial properties; whereas titanium dioxide (TiO 2 ) particles were detected in all the face masks in at least one layer corroborating its widespread use in the textile industry. The presence of Ag-based biocides and TiO 2 particles in face masks raised questions on the possibility of release under normal wearing conditions, which could potentially cause a health risk to the consumers. Direct measurement of release of Ag and TiO 2 particles during normal wearing is problematic by the lack of methodology to test release and to quantify inhaled particles. Therefore in this study, we investigated leaching experiments using artificial acid sweat as a method to evaluate the release of Ag-based biocides and TiO 2 particles present in face masks. Leaching experiments were proposed as an alternative method to evaluate the quality of face masks, and as a higher tier method to assess face masks that are not safe-by-design. Results from leaching experiments showed that Ag was released in amounts varying from 0.03 up to 36 % of total Ag content, in four out of the eight face masks that claimed antimicrobial properties and that contained Ag. The leaching data of titanium (Ti) showed that despite TiO 2 being detected in all face masks, only in one mask Ti was measured in detectable concentrations in artificial sweat (0.35 % of total Ti content). Comparison of leachable Ag and Ti with respective acceptable exposure limit values derived from inhalation exposure limits indicate that three face masks would need further risk assessment and could not be considered as intrinsically safe., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Calcium carbonate (E 170) was re-evaluated in 2011 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of calcium carbonate (E 170) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators (IBOs) to provide the requested information to complete the risk assessment. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for calcium carbonate and that, in principle, there are no safety concern with respect to the exposure to calcium carbonate per se at the currently reported uses and use levels in all age groups of the population, including infants below 16 weeks of age. With respect to the calcium intake resulting from the use of E 170 in food for the general population and infants < 16 weeks of age, the Panel concluded that it contributes only to a small part to the overall calcium dietary exposure. However, the unavoidable presence of aluminium in E 170 is of concern and should be addressed. In addition, the Panel concluded that the technical data provided by the IBO support further amendments of the specifications for E 170 laid down in Commission Regulation (EU) No 231/2012., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Indigo carmine (E 312) was re-evaluated in 2014 by the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). The ANS Panel confirmed the acceptable daily intake (ADI) of 5 mg/kg body weight (bw) per day for indigo carmine allocated by JECFA (1975). The ANS Panel indicated that the ADI was applicable to a material with a purity of 93% pure colouring and manufactured using processes resulting in comparable residuals as material used in the Borzelleca et al. studies (1985, 1986) and Borzelleca and Hogan (1985) which were the basis for deriving the ADI. The ANS Panel considered that any extension of the ADI to indigo carmine of lower purity and/or manufactured using a different process would require new data to address the adverse effects on the testes observed in the Dixit and Goyal (2013) study. Following a European Commission call for data to submit data to fill the data gaps, an IBO submitted technical and toxicological data. Considering the technical data, the EFSA Panel on Food Additives and Flavourings (FAF Panel) recommended some modifications of the existing EU specifications for E 132, mainly to lower the limits for toxic elements. Considering the toxicological data, an IBO has submitted a 56-day dietary study to address the adverse effects on testes using a material with 88% purity. The results of this study submitted did not confirm the severe adverse effects observed in the Dixit and Goyal study. Considering all the available information, the Panel confirmed the ADI of 5 mg/kg bw per day for indigo carmine (E 132) disodium salts, meeting the proposed revisions of the specifications (85% minimum for the colouring matter). The Panel concluded that there is no safety concern for the use of indigo carmine (E 132) disodium salts at the reported use levels and submitted analytical data., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Glycerol esters of wood rosin (GEWR) (E 445) were re-evaluated in 2018. On the toxicity database and given the absence of reproductive and developmental toxicity data, the acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) established by the Scientific Committee on Food (SCF) in 1994 was considered temporary. The conclusions of the assessment were restricted to GEWR derived from Pinus palustris and Pinus elliottii and with a chemical composition in compliance with GEWR used in the toxicological testing. Following a European Commission call for data to submit data to fill the data gaps, the present follow-up opinion assesses data provided by interested business operators (IBOs). Considering the technical data submitted by IBOs, the EFSA Panel on Food Additives and Flavourings (FAF Panel) recommended some modifications of the existing EU specifications for E 445, mainly a revision of the definition of the food additive and lowering the limits for toxic elements. Considering the available toxicological database evaluated during the re-evaluation of E 445 by the ANS Panel in 2018, and the toxicological studies submitted by the IBOs, the Panel established an ADI of 10 mg/kg bw per day based on the no observed adverse effect level (NOAEL) of 976 mg/kg bw per day from the newly available dietary reproduction/developmental toxicity screening study in rats and applying an uncertainty factor of 100. Since GEWR from P. palustris and P. elliottii were tested in the toxicity studies considered to establish the ADI and in the absence of detailed information on the chemical composition (major constituents) in GEWR generated from other Pinus species, thus not allowing read across, the ADI is restricted to the GEWR (E 445) manufactured from P. palustris and P. elliottii . The Panel concluded that there was no safety concern for the use of GEWR (E 445), at either the maximum permitted levels or at the reported uses and use levels., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Sucrose esters of fatty acids (E 473) was re-evaluated in 2004 by the former EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC Panel). In addition, the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) issued scientific opinions on the safety of sucrose esters of fatty acids (E 473) in 2010, 2012 and 2018. As a follow-up to these assessments, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of sucrose esters of fatty acids (E 473) for its uses as food additive in food for infants below 16 weeks of age. In addition, the FAF Panel was requested to address the issues already identified by the EFSA AFC and ANS Panels when used in food for the general population. The process involved the publication of calls for data to allow the interested business operators to provide the requested information to complete the risk assessment. The Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for sucrose esters of fatty acids (E 473) laid down in Commission Regulation (EU) No 231/2012. According to the available information, E 473 is not used in food categories (FCs) 13.1.1 and 13.1.5.1, including all types of food for infants below 16 weeks of age, and in FC 13.1.5.2. As a consequence, an assessment of the safety for the uses of E 473 as food additive in these FCs and age group was not performed. When the updated exposure estimates considering the provided use levels for some food categories are taken into account the estimates of exposure to sucrose esters of fatty acids (E 473) exceeded the group acceptable daily intake (ADI) of 40 mg/kg body weight (bw) per day for many population groups., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Silver-based biocides are applied in face masks because of their antimicrobial properties. The added value of biocidal silver treatment of face masks to control SARS-CoV-2 infection needs to be balanced against possible toxicity due to inhalation exposure. Direct measurement of silver (particle) release to estimate exposure is problematic. Therefore, this study optimized methodologies to characterize silver-based biocides directly in the face masks, by measuring their total silver content using ICP-MS and ICP-OES based methods, and by visualizing the type(s) and localization of silver-based biocides using electron microscopy based methods. Thirteen of 20 selected masks intended for general use contained detectable amounts of silver ranging from 3 μg to 235 mg. Four of these masks contained silver nanoparticles, of which one mask was silver coated. Comparison of the silver content with limit values derived from existing inhalation exposure limits for both silver ions and silver nanoparticles allowed to differentiate safe face masks from face masks that require a more extensive safety assessment. These findings urge for in depth characterization of the applications of silver-based biocides and for the implementation of regulatory standards, quality control and product development based on the safe-by-design principle for nanotechnology applications in face masks in general., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Over the last decade, the consumption of tea and herbal tea has gained more and more popularity across the globe, but the potential presence of chemical contaminants (e.g. pesticides, trace elements, synthetic drugs) may raise health concerns. This study analysed selected teas available in Belgian retail stores and performed a risk assessment for these samples. No chemical adulteration could be detected in dry tea material. More than 38% of the dry leaves samples contained at least one pesticide exceeding the maximal residue level (MRL) set by the EU. However, further risk assessment, based on the values of pesticide residues and the toxic trace elements encountered in the brew, demonstrate that the consumption of these teas will not give rise to health concerns. Nonetheless, attention should be given to the leaching potential of nickel from teas and the presence of arsenic in brews from algae containing teas.

Total selenium (Se) and Se species concentrations were determined in 50 infant formulas and milk samples commercialized in Brazil and Belgium. Infant formula categories were starter, follow-up, specialized and plant-based (soy and rice), while milk samples included whole, skimmed, semi-skimmed and plant-based products. Total Se content was determined by Inductively Coupled Plasma Mass Spectrometry (ICP-MS), after microwave digestion. An enzymatic extraction method was applied to evaluate the Se species, mostly selenomethionine (SeMet), Se(IV) and Se(VI), through High Performance Liquid Chromatography coupled to ICP-MS (LC-ICP-MS). Starters and follow-up samples presented the highest total Se concentrations and values up to 30 µg/kg were observed in the reconstituted product. The lowest level (below the LOQ = 10 µg/kg) was verified in an anti-regurgitation specialized formula. The relative agreement between the measured total Se and the Se content declared on the label varied from 55 % to 317 %. Concentrations in infant formulas were not markedly different from concentrations in milk except for rice and oat milk samples that showed values below the LOQ. SeMet was the main species found in milks, while in infant formulas the species concentrations varied according to the product. The daily intake (DI) of Se via infant formula consumption was calculated and compared with the Adequate Intake (AI) value and the Dietary Reference Intake (DRI) established by the EFSA NDA Panel and ANVISA, respectively. Estimated maximum intakes of total Se obtained for reconstituted infant formula were 40.6 mg/day, corresponding to 400 % and 202 % of the DRI and AI, respectively., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Sulfur dioxide-sulfites (E 220-228) were re-evaluated in 2016, resulting in the setting of a temporary ADI of 0.7 mg SO 2 equivalents/kg bw per day. Following a European Commission call for data, the present follow-up opinion assesses data provided by interested business operators (IBOs) and additional evidence identified in the publicly available literature. No new biological or toxicological data addressing the data gaps described in the re-evaluation were submitted by IBOs. Taking into account data identified from the literature search, the Panel concluded that there was no substantial reduction in the uncertainties previously identified in the re-evaluation. Therefore, the Panel considered that the available toxicity database was inadequate to derive an ADI and withdrew the current temporary group acceptable daily intake (ADI). A margin of exposure (MOE) approach was considered appropriate to assess the risk for these food additives. A lower confidence limit of the benchmark dose of 38 mg SO 2 equivalents/kg bw per day, which is lower than the previous reference point of 70 mg SO 2 equivalents/kg bw per day, was estimated based on prolonged visual evoked potential latency. An assessment factor of 80 was applied for the assessment of the MoE. At the estimated dietary exposures, when using a refined exposure scenario (Data set D), MOEs at the maximum of 95th percentile ranges were below 80 for all population groups except for adolescents. The dietary exposures estimated using the maximum permitted levels would result in MOEs below 80 in all population groups at the maximum of the ranges of the mean, and for most of the population groups at both minimum and maximum of the ranges at the 95th percentile. The Panel concluded that this raises a safety concern for both dietary exposure scenarios. The Panel also performed a risk assessment for toxic elements present in sulfur dioxide-sulfites (E 220-228), based on data submitted by IBOs, and concluded that the maximum limits in the EU specifications for arsenic, lead and mercury should be lowered and a maximum limit for cadmium should be introduced., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Glycerol (E 422) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to that assessment, in this opinion, the Panel on Food Additives and Flavourings (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 422 in Commission Regulation (EU) No 231/2012. The Panel performed a risk assessment of undesirable impurities present in E 422. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 422. The Panel recommended setting a numerical limit value for acrolein in the specifications for E 422. The potential exposure to free 3-monochloropropanediol at the maximum limit of 0.1 mg/kg, as laid out in the specifications for E 422, does not give rise to a health concern. The Panel recommended to consider modifying the definition of E 422 in Commission Regulation (EU) No 231/2012 indicating that E 422 is obtained only from vegetable oils and fats and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol. Overall, the Panel concluded that the technical data provided support an amendment of the specifications for glycerol (E 422)., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Polyglycerol esters of fatty acids (PEFA, E 475) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, in this opinion, the Panel on Food Additives and Flavouring (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 475. The Panel performed a risk assessment of undesirable impurities and constituents potentially present in E 475. The Panel concluded that the maximum limits in the EU specifications for the 4 toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 475. The Panel also concluded that maximum limits for erucic acid, 3-monochloropropanediol and glycidyl esters should be included in the EU specifications for E 475. Alternatively, the Panel recommends an amendment of the definition of E 475 to include a requirement that the fats and oils used in the manufacturing of E 475 comply with the respective EU legislation regarding suitability for human consumption. Further, the Panel concluded that there is no need for setting a specification limit for the content of trans -fatty acids in E 475 as a limit is established in the Regulation (EU) No 2019/649, i.e. 2 g of trans -fat per 100 g fat in food for the final consumer. Finally, the Panel recommends a modification of the definition of E 475 indicating that polyglycerol used for the manufacturing of E 475 should be produced from glycerol meeting the specifications for E 422 (Commission Regulation (EU) No 231/2012). In this case, respective specification limits for epichlorohydrin, acrolein and butanetriol would not be needed for E 475., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Polyglycerol polyricinoleate (PGPR, E 476) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, in this opinion, the Panel on Food Additives and Flavouring (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 476. Additionally, this opinion deals with the assessment of the proposed extension of use for E 476 in edible ices and a revision of the maximum permitted level in emulsified sauces. The Panel concluded that the proposed extension of use, if authorised, would not give rise to a safety concern. Additionally, the Panel performed a risk assessment of undesirable impurities potentially present in E 476. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury, cadmium) should be lowered based on actual levels in the commercial food additive E 476. The Panel also concluded that maximum limits for glycidyl esters and 3-monochloropropanediol should be included in the EU specifications for E 476. Alternatively, the Panel recommends an amendment of the definition of E 476 to include a requirement that the fats and oils used in the manufacturing of E 476 comply with the respective EU legislation regarding suitability for human consumption. Further, the Panel recommends a modification of the definition of E 476 indicating that polyglycerol used for the manufacturing of E 476 should be produced from glycerol meeting the specifications for E 422 (Commission Regulation (EU) No 231/2012). In this case, respective specification limits for epichlorohydrin, acrolein and butanetriol would not be needed for E 476. Finally, the Panel concluded that the proposed method based on the determination of ricinoleic acid is suitable for the determination of E 476 content in food., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Although titanium dioxide (TiO 2 ) is a suspected human carcinogen when inhaled, fiber-grade TiO 2 (nano)particles were demonstrated in synthetic textile fibers of face masks intended for the general public. STEM-EDX analysis on sections of a variety of single use and reusable face masks visualized agglomerated near-spherical TiO 2 particles in non-woven fabrics, polyester, polyamide and bi-component fibers. Median sizes of constituent particles ranged from 89 to 184 nm, implying an important fraction of nano-sized particles (< 100 nm). The total TiO 2 mass determined by ICP-OES ranged from 791 to 152,345 µg per mask. The estimated TiO 2 mass at the fiber surface ranged from 17 to 4394 µg, and systematically exceeded the acceptable exposure level to TiO 2 by inhalation (3.6 µg), determined based on a scenario where face masks are worn intensively. No assumptions were made about the likelihood of the release of TiO 2 particles itself, since direct measurement of release and inhalation uptake when face masks are worn could not be assessed. The importance of wearing face masks against COVID-19 is unquestionable. Even so, these results urge for in depth research of (nano)technology applications in textiles to avoid possible future consequences caused by a poorly regulated use and to implement regulatory standards phasing out or limiting the amount of TiO 2 particles, following the safe-by-design principle., (© 2022. The Author(s).)

Despite the health benefits of food supplements (FS) based on algae or cyanobacteria, the elevated arsenic (As) concentrations in these FS may raise a health concern. In the present study 33 FS containing algae or cyanobacteria were collected and As (species) were analysed to estimate consumer exposure. Based on hazard and exposure data, potential risks were evaluated using inorganic arsenic (As i ) and the potentially toxic As fraction (As tot minus arsenobetaine (AB)). As tot concentrations were in the range 0.053-57 mg/kg with highest concentrations in FS containing brown algae. As i concentrations were in the range <0.02-4.7 mg kg -1 . A large part of As in FS containing algae or cyanobacteria was identified as potentially toxic AsSugars species. Negligible amounts of AB were detected. According to a tentative risk evaluation, the intake of As i related to all FS collected was of no health concern for the general population. In 8 out of 33 of the analysed FS, however, the As i concentration was of concern for population groups with increased cancer risks. If all As species except the non-toxic AB were taken into consideration, only 26 out of 33 of the FS showed 'no concern' for the general population, while for the other 7 FS a potential health risk was identified. This study indicates the need to obtain more data on toxicity of AsSugars and to develop limits for As (species) in FS.

Clay products for oral use form a particular group of food supplements in relation to potential arsenic (As) toxicity, because - certainly in case of pure clay- all arsenic in these supplements is expected to be present in the most toxic inorganic form (As i ). In terms of risk, the most important questions to answer relate to the bioaccessibility and bioavailability of the inorganic arsenic present, rather than to the As species distribution, which often receives most attention in standard foodstuffs. In the present study, clay products for oral use were bought on the Belgian market and analysed for total arsenic (As tot ), arsenic species (As i , arsenobetaine, dimethylarsenate and monomethylarsenate)) and bioaccessible arsenic, in order to perform an exposure assessment and risk characterisation. Total As concentrations differed considerably between the samples and ranged from 0.20 to 6.4 mg As tot /kg. Bioaccessibility of As i , determined via the Unified Barge Method (extraction making use of digestive enzymes) varied between 8% and 51%. The As i concentration determined via HPLC-ICP-MS after extraction with diluted HNO 3 +   H 2 O 2 (as in the CEN method for foodstuffs) was only a poor predictor of the bioaccessible As i fraction, despite the significant relationship (R 2  = 0.36; p < .05). The risk characterisation did not reveal acute risks related to As i exposure. However, a potential concern with regard to chronic As i intake was identified for the general population in 42% of the analysed food supplements, and for sensitive population groups in 67% of the samples, even after taking into account the bioaccessible fraction. The data presented illustrate that consumption of some of these clay products may contribute significantly to dietary As i intake and that these should not be taken chronically.

Advances in biotechnology and the chemical synthesis of peptides have made biopharmaceuticals and synthetic peptide drugs viable pharmaceutical compounds today and an important source for tomorrow's drugs and therapies. Unfortunately, also falsifications and counterfeit versions of these powerful and promising drugs are offered illegally via the internet. Since these falsified preparations are produced outside the legally required quality systems, end-users have no guarantee regarding the efficacy and safety of these products. Although falsified samples of biotherapeutics were already analysed, looking at a specific aspect of their quality or identity, no systematic studies have been performed regarding the presence of different impurities or possible contaminations. Therefore, in order to obtain a better understanding of the potential health risks related to the usage of falsified polypeptide drugs we performed a systematic screening of the ten most frequently encountered falsified peptide drugs on the Belgian market acquired from three different suspected illegal internet pharmacies. The screening incorporated the analysis of the active pharmaceutical ingredient (API), API-related impurities, small molecule contaminants (defined as organic small molecules not belonging to the other categories), elemental impurities and residual solvents. This comprehensive study showed that these type of falsified drugs not only have a high variation in amount of drugs per unit and a low purity (ranging between 5% and 75% for cysteine containing peptides), but also contained the known toxic class one elemental impurities arsenic (As) and lead (Pb). One sample was contaminated with Pb while multiple samples were found with concentrations up to ten times the ICH toxicity limit for parenteral drugs. Subsequent speciation of As confirmed the elevated concentrations for As and demonstrated that all As was present in the more toxic inorganic form. Together with the (sometimes) high amount of peptide impurities and the inherent dangers associated with the use of unauthorized peptide drugs (such as doping peptides or preclinical drugs) this study confirms the reported potential health risks patients/users take when resorting to falsified peptide drugs. Moreover, the presence of the carcinogen As and the known accumulation in human tissues of Pb raises questions about potential sub-acute to chronic toxicity due to the long term administration of these falsified peptide drugs., (Copyright © 2018 Elsevier B.V. All rights reserved.)

In this study the concentration of total arsenic (As) and arsenic species (inorganic As, arsenobetaine, dimethylarsinate, and methylarsonate) was monitored in different foodstuffs (rice, vegetables, algae, fish, crustacean, molluscs) before and after preparation using common kitchen practices. By measuring the water content of the foodstuff and by reporting arsenic concentrations on a dry weight base, we were able to distinguish between As release effects due to food preparation and As decrease due to changes in moisture content upon food preparation. Arsenic species were released to the broth during boiling, steaming, frying, or soaking of the food. Concentrations declined with maxima of 57% for total arsenic, 65% for inorganic As, and 32% for arsenobetaine. On the basis of a combination of our own results and literature data, we conclude that the extent of this release of arsenic species is species specific, with inorganic arsenic species being released most easily, followed by the small organic As species and the large organic As species.

The fate and effects of toxic trace metals in soil freshly spiked soluble metal salts do not mimic those of metals in the field. This study was set up to test the magnitude of effects of salinity, acidification, and ageing on toxicity of lead (Pb) to plants, invertebrates and soil microbial processes. Three soils were spiked with Pb2+ salts up to a concentration of 8000 mg Pb/kg and were tested either after spiking, after soil leaching followed by pH correction, or after a 5-year outdoor ageing period with free drainage followed by pH correction. Soil solution ionic strength exceeded 150 mmol/L in soils tested directly after spiking and this decreased partially after leaching and returned back to background values after 5-year outdoor equilibration. Chronic toxicity to two plants, two invertebrates, and three microbial endpoints was consistently found in all spiked soils that were not leached. This toxicity significantly decreased or became absent after 5 years of ageing in 19 of the 20 toxicity tests by a factor 8 (median factor; range: 1.4->50), measured by the factor increase of total soil Pb dose required to induce 10% inhibition. The toxicity of Pb in leached soils was intermediate between the other two treatments. The lowest detectable chronic thresholds (EC10) in aged soils ranged 350-5300 mg Pb/kg. Correlation analysis, including data of Pb2+ speciation in soil solution, suggests that reduced ionic strength rather than acidification or true ageing is the main factor explaining the soil treatment effects after spiking. It is suggested that future toxicity studies should test fine PbO powder as a relevant source for Pb in soils to exclude the confounding salt effects., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Human exposure biomonitoring in the African Copperbelt (Katanga, southern D.R. Congo) revealed elevated cobalt (Co) exposure in the general population. This study was designed to identify the Co exposure routes for the non-occupationally exposed population in that area. The concentration of Co was measured in environmental and urine samples collected in urban and rural communities close to metal mining and/or refining plants, villages near a lake receiving effluents from metal refining plants, and control rural areas without industrial pollution. Drinking water, uncooked food items (maize flour, washed vegetables, fish and meat), indoor and outdoor dust samples were collected at each location. A food questionnaire was used to estimate dietary Co intake for adults and children. Geometric mean urine-Co (U-Co) concentrations were 4.5-fold (adults) and 6.6-fold (children) higher in the polluted than in the control area, with U-Co values being intermediate in the lakeside area. Average Co concentrations in environmental samples differed 6-40-fold between these areas. U-Co was positively correlated with most environmental Co concentrations, the highest correlations being found with Co in drinking water, vegetables and fruit. Estimated average total Co intake for adults was 63 (±42) μg/day in the control area, 94 (±55) μg/day in the lakeside villages and 570 (±100) μg Co/day in the polluted areas. U-Co was significantly related to modelled Co intake (R(2)=0.48, adults and R(2)=0.47, children; log-log relationship). Consumption of legumes, i.e. sweet potato leaves (polluted) and cereals+fish (lakeside) was the largest contributor to Co intake in adults, whereas dust ingestion appeared to contribute substantially in children in the polluted area. In conclusion, dietary Co is the main source of Co exposure in the polluted area and Co is efficiently transferred from soil and water in the human food chain., (Copyright © 2014 Elsevier B.V. All rights reserved.)

The dissolved organic matter (DOM) is the term used for organic components of natural origin present in the soil solution and is probably the most available C-source that primes microbial activity in subsoils. Contrasting effects of organic C components on pesticide degradation have been reported; however, most studies have used model organic compounds with compositions and concentrations which differ substantially from those found in the environment. Degradation of atrazine (AT) by Chelatobacter heintzii SalB was monitored in liquid batch assays in the absence or presence of well-defined model C compounds (glucose, gluconate and citrate) as model DOM (mDOM) or complex, less-defined, environmental DOM solutions (eDOM: isolated humic substances, soil and plant residue extracts) at environmentally relevant concentrations. Glucose significantly increased AT degradation rate by more than a factor of 8 at and above 2.5 mg C L( - 1). Optical density measurements showed that this stimulation is related to microbial growth. Gluconate and citrate had no effects unless at non-relevant concentrations (1,000 mg DOC L( - 1)) at which stimulations (gluconate) or inhibitions (citrate) were found. The effects of eDOM added at 10 mg DOC L( - 1) on AT degradation were generally small. The AT degradation time was reduced by factors 1.4-1.9 in the presence of humic acids and eDOM from soils amended with plant residues; however, no effects were found for fulvic acids or eDOM from a soil leachate solution or extracted from unamended peat or forest soil. In conclusion, DOM supplied as both mDOM and eDOM did not inhibit AT degradation at environmentally relevant concentrations, and stimulation can be found for selected DOM samples and this is partly related to its effect on growth.

This study was set up to relate lead (Pb) bioavailability with its toxicity to plants in soils. Tomato and barley seedlings were grown in six different PbCl(2) spiked soils (pH: 4.7-7.4; eCEC: 4.2-41.7 cmol(c)/kg). Soils were leached and pH corrected after spiking to exclude confounding factors. Plant growth was halved at 1600-6500 mg Pb/kg soil for tomato and at 1900-8300 mg Pb/kg soil for barley. These soil Pb threshold were unrelated to soil pH, organic carbon, texture or eCEC and neither soil solution Pb nor Pb(2+) ion activity adequately explained Pb toxicity among soils. Shoot phosphorus (P) concentrations significantly decreased with increasing soil Pb concentrations. Tomato grown in hydroponics at either varying P supply or at increasing Pb (equal initial P) illustrated that shoot P explained growth response in both scenarios. The results suggest that Pb toxicity is partially related to Pb induced P deficiency, likely due to lead phosphate precipitation., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

A series of long-term Zn-contaminated soils was sampled around a galvanized pylon. The potential nitrification rate (PNR) was unaffected by the soil total Zn concentrations up to 25 mmol Zn kg(-1) whereas spiking the uncontaminated control soil with ZnCl(2) to identical total concentrations completely eliminated nitrification. The larger sensitivity of the PNR to spiked ZnCl(2) than to the Zn added in the field was equally found when relating the PNR to the Zn concentrations in the pore water of these soils, suggesting differences in Zn tolerance of the nitrifying communities. Zinc tolerance in the long-term Zn-contaminated soil was demonstrated by showing that (i) the nitrifying community of long-term Zn-contaminated soil samples was less sensitive to Zn than that of the uncontaminated control soil when both communities were inoculated in sterile ZnCl(2)-contaminated soil samples, and, that (ii) addition of ZnCl(2) to the long-term Zn-contaminated soil samples affected nitrification less than equal additions of ZnCl(2) to uncontaminated control samples. Denaturing gradient gel electrophoresis fingerprinting of polymerase chain reaction amplified 16SrRNA gene fragments of ammonia-oxidizing bacteria showed that the community structure in uncontaminated and long-term contaminated soil samples was different and could be related to soil Zn concentrations.