Evaluation of new safety decontamination approaches at lab scale for recycled highdensity polyethylene (rHDPE) intended for food contact.

BACKGROUND: The increasing use of plastic packaging materials generates concerns related to the environmental problem generated by their waste. As a result, the search for new recycling methodologies to extend the lifecycle of plastic packaging is becoming more important, without forgetting to ensure the safety of these materials. Currently, the use of recycled polyolefins as food contact materials is not widespread yet. This is because the decontamination processes currently available are insufficient to produce clean, safe materials suitable for such applications. This work is focused on the evaluation of the safety of recycled high-density polyethylene (rHDPE), and the search for strategies to achieve its decontamination. RESULTS: To this end, three batches of flakes and three batches of pellets of rHDPE coming from the mechanical recycling of post-consumer milk bottles were analyzed. The analysis of the volatile and semi-volatile compounds present in the samples was carried out using gas chromatography-mass spectrometry (GC-MS), finding a total of 67 compounds. The strategy to achieve the decontamination of flakes and pellets of this material has been based on the application of high temperature and vacuum at lab scale, obtaining a clear decrease in volatile compounds, below 50% of the initial value in most cases when applying 120 °C during 5 h. The migration test performed in the samples (treated and untreated) to different food simulants (10 % ethanol and 3 % acetic acid, 95 % ethanol) revealed also a clear decrease of concentrations of volatiles. SIGNIFICANCE: The findings are highly encouraging, demonstrating substantial progress toward the safe and effective use of rHDPE in specific food packaging applications. This indicates a significant step forward in the potential uses of rHDPE. Nevertheless, the lack of toxicity data for many migrants necessitates additional toxicological testing to obtain a more precise risk assessment.

Designing safe recycled high-density polyethylene (HDPE) for child toys.

New high-density polyethylene (HDPE) manufactured from different percentage of post-consumer recycled HDPE milk bottles was studied through two static and dynamic migration tests using saliva simulant to assess the potential hazard to children. Sixty-nine compounds were identified, including several additives used in PE synthesis such as alkanes, alkenes, antioxidants and plasticizers as well as non-intentionally added substances (NIAS) like degradation products such as 2,6-di-tert-butyl-1,4-benzoquinone, 2,4-di-tert-butylphenol, phenol, 2,5-bis(1,1-dimethylethyl)-, 3,5-di-tert-butyl-4-hydroxybenzaldehyde, and 3,5-di-tert-butyl-4-hydroxyacetophenone, or various residues from flavoring agents, cleaning products and essential oils. Some of these compounds as the isomers p and o t-butylcyclohexyl acetate, 3-Octanol, 3,7-dimethyl- and thujanol acetate (3-) pose a potential risk to children, as their concentrations exceed the recommended Cramer values for high percentages of recycling. This suggests improving recycling processes by incorporating advanced cleaning to remove residual products and contaminants.

Extreme founder effect associated with hyperglycemia and hyperlipidemia on the island of NIAS/Indonesia.

The island of Nias/Indonesia shows an extremely reduced genetic diversity indicating a strong founder effect. As a consequence, the prevalence of some disease genes should significantly differ among populations depending on the gene pool passed on to the founder population and their successive expansion as it has already been documented for several monogenic diseases. Results of the current study based on routine laboratory blood examination give rise to the notion that this might also hold true for polygenic disorders. We observed very high prevalence of hyperglycemia (non-fasting glucose above 200 mg/dL in 14 % Nias population compared to 1.5 % in the population of the neighboring island of Sumatra) accompanied by hypertriglyceridemia, high non-HDL-cholesterol, and low HDL-cholesterol levels. These findings suggest that the Nias population may be disproportionally affected by prediabetes and type 2 diabetes mellitus. By contrast, laboratory parameters potentially indicative of other polygenic disorders such as total plasma cholesterol, electrolytes, creatinine, urea, and uric acid were comparable between the inhabitants of Nias and Sumatra islands. To our knowledge this is the first study suggesting that the extremely strong genetic bottleneck seen in the Nias population translates into the widespread metabolic disease with potentially deleterious influence on public health.

Synthesis and quantification of oligoesters migrating from starch-based food packaging materials.

The term oligomer refers to structurally diverse compounds coming from incomplete polymerisation or polymer degradation. Their ability to migrate into foodstuffs along with recent studies about their bioavailability and toxicity have risen concerns about the scarcity of standards needed to perform thorough analytical and toxicological studies. In this work, migration extracts of three starch-based biopolymers films for the packaging of fruits and vegetables were analysed according to European legislation 10/2011. Oligoesters analysed by UPLC-MS(QTOF) were the main non-intentionally added substances (NIAS) identified in the food simulants. A stepwise synthesis approach was used to synthesise and isolate eleven cyclic and linear oligoester standards ranging from 2 to 8 monomers based on adipic acid, 1,4-butanediol, isophtalic acid and propylene glycol monomers. These standards were characterised by 1H and 13C NMR as well as high resolution mass spectrometry. An overall high purity of > 98 % was achieved as detected by UPLC-MS(Orbitrap). The standards were then used to unequivocally identify the oligoesters in the migration assay samples by comparing their UPLC-MS/MS spectra, and to semi-quantify or fully quantify these migrant oligoesters. The oligoester quantification results deemed safe only one out of the three biopolymer films according to their threshold of toxicological concern concept. The work herein described aims to contribute towards the oligomers knowledge gaps, opening the door for comprehensive toxicological risk and absorption, distribution, metabolism, excretion and toxicity (ADMET) studies.

Psychometric properties of the nine-item avoidant/restrictive food intake disorder screen (NIAS) in Turkish adolescents.

BACKGROUND: This study evaluates the psychometric properties of the Turkish version of the Nine-Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS) in a population of Turkish adolescents. METHOD: The NIAS, designed to screen for ARFID symptoms, including picky eating, fear-related eating behaviors, and low appetite, was administered to secondary school students between 13 and 18 ages in Mugla, Turkiye. RESULTS: Based on a sample of 268 adolescents, the NIAS's reliability and validity in this demographic are supported. The research utilized confirmatory factor analysis to verify its three-factor structure and various reliability tests, including Cronbach's alpha and test-retest reliability, confirming the scale's internal consistency and temporal stability. The descriptive analysis highlighted significant differences in NIAS scores across BMI categories, with underweight adolescents scoring higher, suggesting a potential link between ARFID symptoms and lower body weight. Criterion validity was supported by significant correlations between NIAS subscales and measures of anxiety, depression, and eating behaviors, indicating the scale's effectiveness in reflecting relevant psychopathological features. CONCLUSION: Overall, the study establishes the Turkish NIAS as a useful tool for identifying ARFID in Turkish adolescents, aiding early detection and intervention in this at-risk age group. Further research is recommended to explore the scale's utility across different clinical settings and refine its diagnostic accuracy, enhancing our understanding of ARFID's impact on youth mental health and nutritional status.

Cross-culturally reliable tools for assessing symptoms of Avoidant/Restrictive Food Intake Disorder (ARFID) in young people are crucial, especially during adolescence, a critical period for the emergence of various eating and feeding disorders. The Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS) is a brief and practical instrument designed to assess and rate symptoms across three phenotypes associated with ARFID: 'picky eating,' 'fear,' and 'appetite,' which can lead to restricted food volume or variety. This study, focusing on a sample of Turkish adolescents, validates the reliability and accuracy of the NIAS in this particular demographic. The findings offer a foundational understanding of the ARFID profile among Turkish adolescents. The psychometric robustness of the NIAS in self-reporting among adolescents is demonstrated by significant correlations between its subscales and other measures of anxiety, depression, and eating behaviors, indicating that the scale effectively captures related psychopathological traits.

The autoxidation of polyether-polyurethane open cell soft foam: An analytical aging method to reproducibly determine VOC emissions caused by thermo-oxidative degradation.

We present a new method for investigating the oxidation and emission behavior of air-permeable materials. Employing this method, a differentiated statement can be made about the extent to which critical volatile organic compounds (VOCs) such as formaldehyde, acetaldehyde, and acrolein are contained in the material as impurities or formed by thermo-oxidative degradation of the polymer matrix in the use phase. The parameters affecting methods of VOC analysis are reviewed and considered for the developed method. The molecular mechanisms of VOC formation are discussed. Toxicological implications of the reaction kinetics are put into context with international guidelines and threshold levels. This new method enables manufacturers of cellular materials not only to determine the oxidative stability of their products but also to optimize them specifically for higher durability. ENVIRONMENTAL IMPLICATION: Cellular materials are ubiquitous in the technosphere. They play a crucial role in various microenvironments such as automotive interiors, building insulation, and cushioning. These materials are susceptible to oxidative breakdown, leading to the release of formaldehyde, acetaldehyde, and acrolein. The ecotoxicological profiles of these compounds necessitate monitoring and regulation. The absence of reproducible and reliable analytical methods restricts research and development aimed at risk assessment and mitigation. This work significantly enhances the toolbox for optimizing the oxidative stability of any open-cell cellular material and evaluating these materials in terms of their temperature-dependent oxidation and emission behavior.

Study on the Properties of PLA- and PP-Based Films for Food Applications Incorporating Orange Peel Extract from Agricultural by-Products.

The aim of this work was to develop active packaging based on polypropylene (PP) and polylactic acid (PLA) matrices using a high value by-product extracted from orange peel as an active compound for food packaging applications. Different films with and without orange peel extract (OPE) based on PP and PLA were obtained via cast extrusion and characterized in terms of their mechanical, thermal, optical, and sealing properties. The films obtained were transparent, but when OPE was incorporated, the transmittance spectrum decreased, causing slight coloration. Mechanical properties were affected by the incorporation of OPE, as elongation at break and tensile strength increased in the cross-direction of the PP film, although the main differences found were related to the polymer itself. In addition, sealing strength also increased via the incorporation of OPE in the PP matrix. However, thermal properties were not affected by OPE in the PP matrix but slightly decreased stability in PLA. Regarding antimicrobial activity in in vitro studies, no inhibition of the growth of Listeria innocua, Saccharomyces cerevisiae, Aspergillus niger, or Escherichia coli was observed. Finally, antioxidant activity was observed in in vitro studies with 2,2-Diphenyl-1picrylhydrazyl (DPPH) radical. The results of this study showed that the obtention of materials with OPE incorporated into the PLA and PP matrix is feasible. The new materials obtained can be used for applications of oxidation-sensitive fresh products.

Strategy proposal using QSAR models to approach mutagenicity assessment of non intentionally added substances in recycled plastic resins.

CONTEXT: Transition to the use of recycled plastics raises an issue concerning safety assessment of Non Intentionally Added Substances (NIAS). To assess the mutagenic potential of the recycled polyethylene impurities and to evaluate the need to perform in vitro assays on recycled resins, this study lies in identifying existing NIAS associated with recycled Low/High Density Polyethylene and assessing the mutagenicity data-gaps by employing in silico tools. METHODS: Quantitative Structure-Activity Relationship (QSAR) models predicting Ames mutagenicity were selected from literature, then NIAS were run to 1/evaluate performances of each model, 2/apply a QSAR strategy on the NIAS molecular space and address data-gaps. RESULTS: Among the 165 NIAS identified, experimental Ames results were not found for 50 substances while the substances with experimental data were predominantly negatives. No individual model was able to predict all NIAS due to applicability domain limitations. Taking into account 1/calculated performances, 2/availability of applicability domain, 3/description of the Training Set, an Integrated Strategy was founded including Sarpy, Consensus and Protox to extend the applicability domain. CONCLUSION & PERSPECTIVES: Existing data and predictions generated by this strategy suggest a low mutagenic potential of NIAS. Further investigation is needed to explore other genotoxicity mechanisms.

Control of Polarity in Kagome-NiAs Bismuthides.

A 2×2×1 superstructure of the P63/mmc NiAs structure is reported in which kagome nets are stabilized in the octahedral transition metal layers of the compounds Ni0.7Pd0.2Bi, Ni0.6Pt0.4Bi, and Mn0.99Pd0.01Bi. The ordered vacancies that yield the true hexagonal kagome motif lead to filling of trigonal bipyramidal interstitial sites with the transition metal in this family of "kagome-NiAs" type materials. Further ordering of vacancies within these interstitial layers can be compositionally driven to simultaneously yield kagome-connected layers and a net polarization along the c axes in Ni0.9Bi and Ni0.79Pd0.08Bi, which adopt Fmm2 symmetry. The polar and non-polar materials exhibit different electronic transport behaviour, reflecting the tuneability of both structure and properties within the NiAs-type bismuthide materials family.

Avoidant/restrictive food intake disorder prevalence is high in children with gastroparesis and functional dyspepsia.

BACKGROUND: Avoidant/restrictive food intake disorder (ARFID) prevalence in children with gastroparesis (Gp) and/or functional dyspepsia (FD) is unknown. We aimed to identify ARFID prevalence and trajectory over 2 months in children with Gp, FD, and healthy children (HC) using two screening questionnaires. We also explored the frequency of a positive ARFID screen between those with/without delayed gastric emptying or abnormal fundic accommodation. METHODS: In this prospective longitudinal study conducted at an urban tertiary care hospital, patients ages 10-17 years with Gp or FD and age- and gender-matched HC completed two validated ARFID screening tools at baseline and 2-month follow-up: the Nine Item ARFID Screen (NIAS) and the Pica, ARFID, and Rumination Disorder Interview-ARFID Questionnaire (PARDI-AR-Q). Gastric retention and fundic accommodation (for Gp and FD) were determined from gastric emptying scintigraphy. KEY RESULTS: At baseline, the proportion of children screening positive for ARFID on the NIAS versus PARDI-AR-Q was Gp: 48.5% versus 63.6%, FD: 66.7% versus 65.2%, HC: 15.3% versus 9.7%, respectively; p < 0.0001 across groups. Of children who screened positive at baseline and participated in the follow-up, 71.9% and 53.3% were positive 2 months later (NIAS versus PARDI-AR-Q, respectively). A positive ARFID screen in Gp or FD was not related to the presence/absence of delayed gastric retention or abnormal fundic accommodation. CONCLUSIONS & INFERENCES: ARFID detected from screening questionnaires is highly prevalent among children with Gp and FD and persists for at least 2 months in a substantial proportion of children. Children with these disorders should be screened for ARFID.

Psychometric properties of the nine-item avoidant/restrictive food intake disorder screen (NIAS) in Turkish children.

BACKGROUND: The nine item avoidant/restrictive food intake disorder screen (NIAS) is a short and practical assessment tool specific to ARFID with three ARFID phenotypes such as "Picky eating," "Fear," and "Appetite". This study aimed to evaluate the psychometric properties of the Turkish translation of the NIAS parent form and to investigate the relationship between ARFID symptoms and anxiety, depression symptoms, and eating behaviors in a sample of Turkish children. METHOD: Parents were asked to provide their children's sociodemographic data and to complete the NIAS, Eating Disorder Examination Questionnaire-Short (EDE-QS), Children's Eating Behavior Questionnaire (CEBQ), and Revised Child Anxiety and Depression Scale (RCADS) scales. RESULTS: The sample included 440 participants between 6 and 12 ages. Turkish NIAS demonstrated good internal consistency. The three-factor model of the Turkish NIAS was in an acceptable structure. The Turkish NIAS scale was shown to be valid and reliable. NIAS scores were shown to be higher in underweight participants. The NIAS-parent version subscales showed expected convergent and divergent validity with the CEBQ, EDEQ-S, and RCADS scales in children, except CEBQ emotional overeating and desire to drink subscales were correlated with NIAS. CONCLUSION: The Turkish version of the NIAS is valid and reliable in evaluating ARFID symptoms in children.

Assessment tools for avoidant/restrictive food intake disorder (ARFID), which is quite common in children, are quite limited. NIAS-parent version is a practical and valuable scale that can be used in the clinic. This study found that the Turkish version of the NIAS is valid and reliable in evaluating ARFID symptoms in children. In the psychometric properties of the Turkish NIAS, ARFID symptoms were associated with anxiety and depression symptoms and food-avoidant eating behavior. It was also found that ARFID was not associated with eating disorder symptoms. In addition, the paper shows initial data concerning the psychometric properties related to the Turkish NIAS-parent version. It is the first study to evaluate the relationship of ARFID subtypes with anxiety, depression symptoms, appetite characteristics, and BMI percentages in children.

Translation of the nine item avoidant/restrictive food intake disorder screen (NIAS) questionnaire in French (NIAS-Fr).

BACKGROUND: The Nine Item Avoidant/Restrictive Food Intake Disorder (ARFID) Screen (NIAS) questionnaire is originally available in English. Given the significant overlap of ARFID-like symptoms in gastrointestinal (GI) diseases, ARFID screening becomes crucial in these patient populations. Consequently, the translation of the NIAS questionnaire into French is necessary for its utilization in French-speaking countries. METHODS: Clinical experts in neuro-gastroenterology and dietetics from four medical centres in two French-speaking countries (France and Belgium) took part in a well-structured questionnaire translation procedure. This process involved six steps before final approval: translation from English to French, backward translation, comparison between the original and retranslated versions, testing the translated version on patients, making corrections based on patient feedback, and testing the corrected version on an additional sample of patients. KEY RESULTS: The NIAS questionnaire in French (NIAS-Fr) was tested on 18 outpatients across the involved centres. For the majority of native French-speaking patients, the translated questionnaire was well understood and clear. After incorporating two relevant modifications suggested by the patients, the translated questionnaire was approved through testing on an additional sample of patients. CONCLUSIONS AND INFERENCES: The involvement of two French-speaking countries was crucial for the harmonization and cultural adaptation of the questionnaire. As a result, the NIAS-Fr is now available for use in 54 French-speaking countries, serving approximately 321 million French speakers across five continents for screening ARFID, for both clinical and research purposes.

Modulation of hepatic cellular tight junctions via coculture with cholangiocytes enables non-destructive bile recovery.

Estimation of the biliary clearance of drugs and their metabolites in humans is crucial for characterizing hepatobiliary disposition and potential drug-drug interactions. Sandwich-cultured hepatocytes, while useful for in vitro bile analysis, require cell destruction for bile recovery, limiting long-term or repeated dose drug effect evaluations. To overcome this limitation, we investigated the feasibility of coculturing a human hepatic carcinoma cell line (HepG2-NIAS cells) and a human cholangiocarcinoma cell line (TFK-1 cells) using the collagen vitrigel membrane in a variety of coculture configurations. The coculture configuration with physiological bile flow increased the permeability of fluorescein-labeled bile acids (CLF) across the HepG2-NIAS cell layer by approximately 1.2-fold compared to the HepG2-NIAS monoculture. This enhancement was caused by paracellular leakage due to the loosened tight junctions of HepG2-NIAS, confirmed by the use of an inhibitor for bile acid transporters, the increase of permeability of dextran, and the decrease of the transepithelial electrical resistance (TEER) value. Based on the results of loosening hepatic tight junctions via coculture with TFK-1 in the CLF permeability assay, we next attempted to collect the CLF accumulated in the bile canaliculi of HepG2-NIAS. The recovery of the CLF accumulated in the bile canaliculi was increased 1.4 times without disrupting hepatic tight junctions by the coculture of HepG2-NIAS cells and TFK-1 cells compared to the monoculture of HepG2-NIAS cells. This non-destructive bile recovery has the potential as a tool for estimating the biliary metabolite and provides valuable insights to improve in vitro bile analysis.

Migration Studies and Endocrine Disrupting Activities: Chemical Safety of Cosmetic Plastic Packaging.

The endocrine activity and endocrine disruptor (ED) chemical profiles of eleven plastic packaging materials covering five major polymer types (3PET, 1HDPE, 4LDPE, 2 PP, and 1SAN) were investigated using in vitro cell-based reporter-gene assays and a non-targeted chemical analysis using gas chromatography coupled to mass spectrometry (GC-MS). To mimic cosmetic contact, six simulants (acidic, alkaline, neutral water, ethanol 30%, glycerin, and paraffin) were used in migration assays performed by filling the packaging with simulant. After 1 month at 50 °C, simulants were concentrated by Solid Phase Extraction (SPE) or Liquid-Liquid Extraction (LLE). The migration profiles of seven major endocrine disrupting chemicals detected from GC-MS in the different materials and simulants were compared with Estrogen Receptor (ER) and Androgen Receptor (AR) activities. With low extraction of ED chemicals in aqueous simulants, no endocrine activities were recorded in the leachates. Paraffin was shown to be the most extracting simulant of antiandrogenic chemicals, while glycerin has estrogenic activities. Overall, ED chemical migration in paraffin was correlated with hormonal activity. The NIAS 2,4-di-tert-butyl phenol and 7,9-di-tert-butyl1-oxaspiro (4,5) deca-6,9-diene-2,8-dione were two major ED chemicals present in all polymers (principally in PP and PE) and in the highest quantity in paraffin simulant. The use of glycerin and liquid paraffin as cosmetic product simulants was demonstrated to be relevant and complementary for the safety assessment of released compounds with endocrine activities in this integrated strategy combining bioassays and analytical chemistry approaches.

Psychometric properties of an Arabic translation of the Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS) in a community sample of adults.

BACKGROUND: No epidemiological data is yet available on Avoidant/Restrictive Food Intake Disorder (ARFID) in Arab countries, which may in part be due to the lack of measures available in Arabic language. This constitutes a major obstacle to further progress of our understanding of the nature, aetiology, course, treatment, and prevention of ARFID, especially as some evidence suggested that ARFID may vary across cultures and food environments. We aimed to contribute to the literature in the eating disorders field by examining the psychometric properties of an Arabic translation of the Nine Item ARFID Screen (NIAS). METHOD: This was a cross-sectional, web-based study. A total of 515 Lebanese community adults (mean age of 27.55 ± 10.92 years, 69.9% females) participated. The forward-backward method was adopted to translate the NIAS from English to Arabic. RESULTS: Confirmatory Factor Analyses provided evidence for the adequate fit indices for the three-factor model (i.e., Picky eating, Fear, and Appetite) and the 9-item version of the NIAS. An adequate reliability of the Arabic NIAS was achieved, with McDonald's ω ranging from .75 to .90 for the total score and all three subscores. Multi-group analyses demonstrated measurement invariance by sex (males vs. females) and weight groups (underweight/healthy weight [BMI ≤ 25] vs. overweight/obese [BMI > 25]) at the configural, metric, and scalar levels. Adequate patterns of correlations between the NIAS and measures of disordered eating symptoms, psychological distress and well-being were seen. In particular, fear was significantly associated with non-ARFID disordered eating symptoms. Appetite and Picky eating, but not Fear, were inversely correlated with well-being. All three NIAS subscores and the total score were positively correlated with psychological distress. CONCLUSION: Findings provided evidence that the Arabic NIAS is a short, valid and reliable self-report measure to screen for ARFID symptoms. In light of these findings, we recommend its use for clinical and research purposes among Arabic-speaking adults.

Avoidant/restrictive food intake disorder (ARFID) is an eating disorder characterized by food avoidance or dietary restriction associated with at least one of four consequences­­weight loss, nutritional deficiency, nutritional supplement dependence, and/or psychosocial impairment. The Nine Item ARFID Screen (NIAS) was developed as a screening measure to detect ARFID symptoms and has nine items with three subscales that map onto symptoms of each ARFID presentation. The NIAS have been translated into multiple languages but not yet validated in Arabic. To that end, we aimed to translate and validate the Arabic version of the NIAS in the present study, which would in turn facilitate improved research and clinical practices related to ARFID in Arabic-speaking nations. The present findings provide support for the psychometric properties of the Arabic version of the NIAS in examining ARFID in Arabic-speaking adults in Lebanon.

The crystal structure of quaternary (Sn,Pb,Bi)Pt.

Quaternary (Sn,Pb,Bi)Pt was synthesized by melting of the elements in an evacuated silica glass ampoule. The crystal structure was established by single-crystal X-ray diffraction and adopts an atomic arrangement of the NiAs type with additional occupation of the voids. Decisive for the refinement was the composition of the crystals as determined by energy dispersive X-ray spectroscopy (EDXS), resulting in a formula of (Sn0.15Pb0.54Bi0.31)Pt.

Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits.

Risk assessments for cosmetic packaging are required according to the EU Cosmetics Regulation (EC) No. 1223/2009, however, the assessment method is well-established for food packaging but limited for cosmetic packaging. In food packaging assessments, Cramer class III TTC (90 µg/day) is applied as the threshold for systemic toxicity when the Ames test including the process of sample concentration steps provides the negative results. However, the human health risks of mutagenic and carcinogenic migrants at exposure levels where the Ames test with the concentrated samples cannot detect are unclear. In the present study, to confirm the applicability of the Ames test for cosmetic packaging assessments, the toxicological data on 37 candidate migrants with Ames test-positive results was collected. For these migrants, the carcinogenic risk levels through cosmetics use were compared to the detection levels of the Ames test for concentrated samples. Regarding at least 32 migrants, the case study showed the negative result from the Ames test incorporating the sample concentration process would indicate negligible mutagenic and carcinogenic risks of packaging extracts. Therefore, application of the Ames test to cosmetic packaging assessments would be helpful to ensure the safety for mutagenicity and carcinogenicity as well as use Cramer-TTC for systemic toxicity.

Interlaboratory Study to Evaluate a Testing Protocol for the Safety of Food Packaging Coatings.

According to European regulations, migration from food packaging must be safe. However, currently, there is no consensus on how to evaluate its safety, especially for non-intentionally added substances (NIAS). The intensive and laborious approach, involving identification and then quantification of all migrating substances followed by a toxicological evaluation, is not practical or feasible. In alignment with the International Life Sciences Institute (ILSI) and the European Union (EU) guidelines on packaging materials, efforts are focused on combining data from analytics, bioassays and in silico toxicology approaches for the risk assessment of packaging materials. Advancement of non-targeted screening approaches using both analytical methods and in vitro bioassays is key. A protocol was developed for the chemical and biological screening of migrants from coated metal packaging materials. This protocol includes guidance on sample preparation, migrant simulation, chemical analysis using liquid chromatography (LC-MS) and validated bioassays covering endocrine activity, genotoxicity and metabolism-related targets. An inter-laboratory study was set-up to evaluate the consistency in biological activity and analytical results generated between three independent laboratories applying the developed protocol and guidance. Coated packaging metal panels were used in this case study. In general, the inter-laboratory chemical analysis and bioassay results displayed acceptable consistency between laboratories, but technical differences led to different data interpretations (e.g., cytotoxicity, cell passages, chemical analysis). The study observations with the greatest impact on the quality of the data and ultimately resulting in discrepancies in the results are given and suggestions for improvement of the protocol are made (e.g., sample preparation, chemical analysis approaches). Finally, there was agreement on the need for an aligned protocol to be utilized by qualified laboratories for chemical and biological analyses, following best practices and guidance for packaging safety assessment of intentionally added substances (IAS) and NIAS to avoid inconsistency in data and the final interpretation.

Characterization of a new polymeric food contact coating with emphasis on the chemical analysis and safety assessment of non-intentionally added substances (NIAS).

Regulators have established safety requirements for food packaging raw materials and finished products, including by-products of polymer synthesis known as non-intentionally added substances (NIAS). However, there are no official guidance or regulations for best practices to evaluate the safety of NIAS. Here we described the process we followed to identify, characterize, and prioritize for safety assessment low molecular weight NIAS from an epoxy coating (V70) made with tetramethyl bisphenol F-based diglycidyl ether resin (TMBPF-DGE). We assembled a database of 15000 potential oligomers with masses up to 1000 Da and conducted extraction and migration testing of V70 coating. Acetonitrile extract contained higher number and concentration of substances compared to ethanolic-based food simulants. The extract contained 16 substances with matches in the database with estimated concentration of 18.27 µg/6 dm2; seven of these substances have potentially genotoxic oxirane functionality. TMBPF-DGE + hydroquinone (TMBPF-DGE + HQ) was most abundant (55% of total concentration) and was synthesized and prioritized for safety assessment. TMBPF-DGE + HQ exposure from can beverage was estimated at 5.2 µg/person/day, and it was not mutagenic or genotoxic in in vitro assays. The overall mixture of substances that migrated into ethanolic simulant was also negative in the mutagenicity bioassay. Our findings suggest that exposure to TMBPF-DGE + HQ from the V70 coating is exceedingly small and that the coating migrates are not genotoxic.

Chemical contaminants from food contact materials and articles made from or containing wood and bamboo - a review.

Due to recently introduced 'so-called' bio- and plant-based friendly food contact materials and articles (FCM/FCA), some neglected safety issues need to be raised. In this review, potential chemical contaminants from FCM/FCA made from or containing wood and bamboo are presented. Sources, migration, and analytical issues in determining contaminants including intentionally and non-intentionally added substances (IAS and NIAS, respectively) are reviewed. Most of the contaminants are components from melamine-formaldehyde-resin (MFR), paints and coatings, preservatives, and bleaching agents. Tableware made of MFR containing bamboo fibres as a filler are not always suitable for use as tableware since harmful amounts of melamine and formaldehyde can migrate from the tableware into food and even accelerate the degradation of certain polymers with which they are mixed. In addition, in the EU bamboo in plastic FCM is not authorized under Regulation (EU) 10/2011. Paints and coatings used to provide surface coverage for bamboo and wooden articles also pose a risk of migration of heavy metals. Limits on preservatives in wood FCM are covered by legislation in many countries, nevertheless their contamination should not be ignored. Some wood species are considered 'toxic' or contain 'toxic' constituents that should not be used in contact with food, which are worth considering for legislation. IAS analyses in bamboo and wooden FCM is generally not a problem, but has proven to be more challenging for NIAS. Due to a complex mixture of substances contained in plant-based materials, there is a need to improve databases for non-target screening of such chemicals.