Iodine is an essential element of human milk. However, high therapeutic maternal doses of potassium iodide (KI) during breastfeeding and its effect on the infant have been insufficiently studied. Therefore, human milk samples were collected within the UmbrelLACT study to determine human milk iodine concentration (HMIC) and estimate infant exposure during and after high maternal KI intake. One mother used KI 3 × 50 mg/day as preparation for thyroidectomy at 5 months postpartum. Human milk samples were collected opportunistically during and within 2 weeks after KI discontinuation. Furthermore, milk samples were collected over 24-h periods at 3 weeks post-discontinuation and monthly from 1 month up to 5 months after discontinuation of KI intake. Breastfeeding was temporarily interrupted during maternal treatment, with partial resumption of breastfeeding 1 week after KI discontinuation, complemented with infant formula upon the participant’s decision. HMIC were analysed using inductively coupled plasma tandem mass spectrometry (ICP-MS/MS) after basic extraction with tetra-methyl ammonium hydroxide (TMAH) and infant exposure was estimated. Median HMIC were 70.8 (46.6–80.8) µg/mL during and 0.064 (0.016–0.227) µg/mL from day six after maternal treatment stop onwards. After discontinuation of KI intake, HMIC decreased quickly and remained within reference range (0.1–0.2 µg/mL). Using the infant requirement of 15 µg/kg/day, relative infant recommended dose (RID recommended ) during and after KI intake was 70805% and 98%, respectively. The infant’s thyroid values were within normal ranges at 3 months after discontinuation of maternal treatment and no adverse events were reported for the infant. Post-discontinuation HMIC are in line with mean concentrations in Nordic countries (68–90 ng/mL). High therapeutic doses of KI should not be combined with breastfeeding, but based on these results (exclusive) breastfeeding could be resumed from 3 weeks after finalisation of maternal treatment. Further research is warranted to determine exposure and safety for breastfed infants. Registration UmbrelLACT study: NCT06042803 ( https://clinicaltrials.gov/study/NCT06042803?cond=umbrellact&rank=1 ).

BACKGROUND:Human exposure to a chemical commonly arises from multiple sources, yet traditional assessments often treat these sources in isolation, overlooking their aggregated impact. OBJECTIVE:Introducing a novel approach to aggregated chemical exposure assessment that explicitly accounts for these intertwined exposure pathways. METHODS:A conceptual framework was developed that describes this approach in multiple steps, namely: 1) the comprehensive integration of diverse datasets, such as consumption surveys, demographics, chemical measurements, and market presence data; 2) the modeling of singular exposure to distinct sources using Bayesian inference; 3) the estimation of aggregated exposure through a simulation-based strategy reflecting the full spectrum of individual exposure scenarios. The value of this approach is demonstrated using the case of titanium dioxide, a chemical found in foods, dietary supplements, medicines, and personal care products that has been banned as a food additive in the European Union since 2022. A comparison was hereby made between exposure before and after the ban, as well as between sources. RESULTS:Through this case study, common data challenges in the context of aggregated exposure assessment, including missing values, limited sample sizes, uncertainties, and inconsistencies, were effectively showcased and addressed by leveraging the advantages of Bayesian inference. As such, robust estimates of aggregated exposure were derived between and across sources and populations, while incorporating relevant prior knowledge. SIGNIFICANCE:By capturing the complexity of real-world exposures, this comprehensive Bayesian approach provides decision-makers with more reliable probabilistic estimates to inform public health policies.

Within the European Union, iron oxides and hydroxides with specifications defined in Commission Regulation No 231/2012 are allowed as food additive E 172 in numerous food categories. In this work, a detailed physicochemical characterisation of twelve commercially available E 172 iron oxides was performed. Based on material colour, crystal structure and particle shape, four main forms were identified by electron microscopy and X-ray diffraction: red spheroidal hematite; red elongated hematite; yellow elongated goethite; black spheroidal magnetite. Each type contained a fraction of nanoparticles. Raman spectroscopy and X-ray photoelectron spectroscopy identified maghemite at the surface of magnetite particles. Time-of-flight secondary ions mass spectrometry showed differences in surface chemistry and trace contaminants between E 172 forms. Inorganic impurity levels measured by inductively coupled plasma mass spectrometry remained below EU regulatory limits. The results provide insight into the distinct forms that are applied as E 172, and address current data gaps on physicochemical characterisation.

The present opinion deals with the re-evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5-chloro-acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).

Abstract The present opinion deals with the re‐evaluation of neotame (E 961) as a food additive. Neotame is the chemically manufactured compound N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine 1‐methyl ester. The main impurity of neotame (E 961) is also a degradation product (de‐esterified form), N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐L‐phenylalanine (NC‐00751) and the primary metabolite. No new data were received following the call for biological and toxicological data. A summary of the toxicological studies available in the EFSA opinion of 2007 is presented and studies gathered from the literature are summarised. Neotame is rapidly absorbed and pre‐systemically metabolised, systemic intact neotame is likely to be excreted in the urine with its metabolites. The potential aneugenic effects at the site of contact are not expected to occur; overall, there is no concern for genotoxicity of neotame (E 961) at the maximum permitted levels or reported use levels. A review of the other endpoints from the already available toxicological database did not indicate an adverse effect for neotame at the highest doses tested. The Panel established an acceptable daily intake (ADI) of 10 mg/kg bw per day for neotame based on the no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day from a 52‐week chronic and 104‐week carcinogenicity studies in rats. This ADI replaces the ADI of 2 mg/kg bw per day established by EFSA in 2007. The resulting exposure to methanol and its metabolite formaldehyde from the use of neotame at the ADI of 10 mg/kg bw per day does not raise a concern. The dietary exposure estimates of neotame (E 961) for the different population groups of all exposure scenarios did not exceed the ADI. The Panel concluded that there is no safety concern for neotame (E 961) at the currently permitted and reported uses and use levels. The Panel recommended the European Commission to consider revising the EU specifications of neotame (E 961).

Abstract This updated risk assessment evaluated evidence on potential adverse health effects of fluoride related to all sources of oral exposure as mandated by the European Commission. Fluoride benefit assessment was not included. Effects on the central nervous system, thyroid and bone were prioritised. Evidence from human studies indicates that total fluoride intake is associated with adverse effects on the developing brain at drinking water concentrations > 1.5 mg/L. The evidence of such associations below 1.5 mg/L was not sufficiently consistent to draw conclusions for risk assessment. Using drinking water concentration of 1.5 mg/L as a reference point, a safe level of intake including all sources of oral exposure of 3.3 mg/day was established for pregnant women to protect the fetus. This safe level of intake was extended to apply to other adults and children > 8 years. It is considered protective also against possible adverse effects on thyroid function and bone mineralisation, for which associations have been observed at water concentrations > 1.5 mg/L. Dental fluorosis was considered the most sensitive endpoint for children ≤ 8 years. Tolerable upper intake levels (UL) of 1.0, 1.6 and 2.0 mg/day were established for infants, toddlers and children 4–8 years, respectively. These ULs are considered protective against other possible adverse effects of fluoride, including neurodevelopmental outcomes. Aggregate exposure included intake of fluoride from food, drinking water, discretionary salt and (ingested) dental care products. Aggregate exposure based on the mean concentration of fluoride in EU drinking water (submitted data) was below the above health‐based guidance values (HBGVs) for all age groups. Aggregate exposure exceeds the HBGVs at the 95th percentile of intake in the scenario of the P95 concentration of fluoride in EU drinking water, for all age groups except adolescents. The risk assessment suggests that the current legal limit for drinking water (1.5 mg/L) in the EU is not sufficiently protective.

Starting from August 7, 2022, with the publication of the European Regulation EU 2022/63, the European Commission has prohibited the use of titanium dioxide (TiO2) (E 171) as a food additive within the European Union (EU). As the food industry has the obligation to adapt the formulation of their products accordingly, it is now crucial for EU member states' competent authorities and official control laboratories to have adequate analytical methods to ensure compliance with this new regulation. The existing literature predominantly focuses on quantitatively determining the elemental titanium (Ti) concentration by ICP-based techniques after complete digestion of the analyte and the food matrix. Compared to this approach, Raman spectroscopy would offer the possibility of a more rapid albeit qualitative screening by identifying the insoluble fraction of titanium dioxide after removing the food matrix. It is also important to note that compliance with the EU ban requires determining the presence of TiO2 in particulate form, an information that Raman spectroscopy can easily deliver. As a further advantage, an analytical approach based on Raman spectroscopy eliminates the need for using particularly harmful acids, which are necessary for the complete digestion of TiO2, when ICP-based analytical methods are employed. In the present study, the aim was first to gather information on the commonly occurring total Ti levels in food and, second, to discuss the potential of a newly developed Raman procedure based on TiO2 extraction by mild acid digestion of the food product as a rapid, safer albeit qualitative screening method. To evaluate the effectiveness of the Raman procedure in verifying compliance with the European Regulation, the qualitative results obtained using a macro-Raman instrument were compared with those obtained through ICP-based techniques on the same food samples, used as benchmark. In total 22 food-samples belonging to 6 different food categories were analysed. The sampling was conducted in the Italian, Belgian, and French markets both before and after the EU ban on E 171 entered into force. The limit of detection, qualitatively established, was 50 mg kg-1, which effectively encompasses the majority of food items containing E 171, as supported by the extensive literature review. The results obtained with the Raman screening method were found to align well with information reported on product labels and benchmark quantitative data.

Acetic, lactic, tartaric, mono- and diacetyltartaric, mixed acetic and tartaric acids esters of mono- and diglycerides of fatty acids (E 472a,b,d,e,f) were re-evaluated in 2020 by the Food Additives and Flavourings (FAF) Panel. The Panel issued several recommendations to amend the specifications of these food additives in Commission Regulation (EU) No 231/2012. The present opinion deals with the assessment of the data provided by interested business operators (IBOs) in support of an amendment of the EU specifications for these food additives. It also includes an assessment of dietary exposure to E 472d, E 472e and E 472f. The Panel concluded that the technical data provided by an IBO support amendments to the specifications for E 472a, E 472b and E 472e in Commission Regulation (EU) No 231/2012. However, regarding E 472d and E 472f, the Panel was unable to confirm that technical data provided by IBOs adequately support an amendment of the specifications as no supporting technical data were provided for these food additives. Dietary exposure estimates for E 472d, E 472e and E 472f, across all population groups and exposure scenarios, were found to be below the acceptable daily intake (ADI) of 480 mg/kg body weight (bw) per day for E 472d and 600 mg/kg bw per day for E 472e and E 472f, based on the food categories included in the assessment.

Abstract 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.

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.

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).

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.

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.

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 (TiO2) 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 TiO2 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 TiO2 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 TiO2 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 TiO2 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.

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.