A. Kourkopoulos et al.
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elements were found to migrate from paper and board FCMs, including uranium (six) and tungsten (five) (Food Packaging Forum, 2024). Toxic elements play a significant role in non-communicable diseases (NCDs). Exposure to heavy metals, such as lead, cadmium, arsenic, and mercury, has been linked to various NCDs, including carcinogenicity, cardiovascular diseases, neurocognitive disorders, and metabolic disorders (Lawal et al. , 2021). For instance, exposure to arsenic and lead is known to cause alterations in genetic material and impair- ment of associated repair mechanisms, which is ultimately associated with carcinogenicity (Zeliger, 2015; Lawal et al. , 2021). In addition, arsenic, cadmium, lead, and mercury are positively associated with metabolic disorders such as meta- bolic syndrome (Xu et al. , 2021; Mitra et al. , 2022) In the European Union (EU), the legal requirements governing the migration limits of toxic elements from FCMs to food are established in a harmonized manner. The Regulation (EC) 1935/2004 provides a harmonized legal framework that mandates that FCMs do not release their constituents into food at levels harmful to human health. In addition, the Commission Regulation (European Commission, 2011) on plastic materials and articles sets the specific migration limits (SMLs) for toxic elements, including nickel, lithium, lead, and mercury, concerning various types of plastic FCMs. In 2023, the EU introduced the Regulation (EU) 2023/915 (European Commission, 2023), which sets the maximum levels for certain contaminants in food. This regulation estab- lishes stricter limits for contaminants, such as lead (0.10 mg/kg in most foods), cadmium (0.05 mg/kg in cereals and cereal products), mercury (0.01 mg/kg in fish and fishery products), and arsenic (0.1 mg/kg in rice and rice products). In the Netherlands, the regulatory limits for toxic elem- ents in FCMs are aligned with EU legislation. In addition, the Netherlands Commodities Act Regulation on Packaging and Consumer Goods of 2014 (Netherlands Ministry of Health, Welfare and Sport, 2014a) stipulates that the total concentration of lead, cadmium, mercury, and hexava- lent chromium in packaging or a packaging component must not exceed 100×10 -6 by weight, which is equivalent to 100 mg/kg of packaging material. The updated Netherlands Commodities Act Regulation (Packagings and Consumer Articles) (Netherlands Ministry of Health, Welfare and Sport, 2014b) of 14 March 2014 sets out SMLs for aluminum (1 mg/kg of food), chromium (maximum 0.1 mg/kg of food), zinc (5 mg/kg of food), arsenic (0.01 mg/kg of food), cad- mium (0.01 mg/kg of food), tin (0.05 mg/kg of food), barium (1 mg/kg of food), and mercury (0.005 mg/kg of food). The migration of heavy metals from paper and board FCMs to food simulants is influenced by factors, such as contact time, temperature, and the composition of the food simulant and FCM (Jickells et al. , 2005; Triantafyllou et al. , 2005; Zhang et al. , 2008; Pocas et al. , 2011; Zurfluh et al. , 2013; Shruti and Kutralam-Muniasamy, 2024). Migration testing conditions for plastic FCMs are established via the Commission Regulation, listing specific food simulants and introducing time and tem- perature conditions for migration studies. The Regulation (EC) No. 1935/2004 provides a consistent legal framework across the EU for all FCMs, ensuring that they do not release harmful substances into food. For plas- tics, safety testing protocols are detailed in the Commission Regulation (EU) 10/2011, which defines six food simulants
for five different food categories. These include 3% (volume fraction) acetic acid for acidic foods (simulant B), 10% (volume fraction) ethanol for aqueous foods (simulant A), 20% (volume fraction) ethanol for alcoholic foods and bev- erages (simulant C), 50% (volume fraction) ethanol or vege- table oil for fatty foods (simulants D1 and D2), and Tenax for dry foods (simulant E). The regulation also prescribes spe- cific temperature and time conditions for accelerated testing to mimic various realistic food contact scenarios, such as long-term storage at room temperature or exposure to hot foods and beverages. In addition, it sets SMLs for common contaminants in plastic FCMs. Food simulants and standard- ized conditions are used in testing to provide a consistent, controlled environment that accurately reflects the range of interactions that might occur with real food, ensuring repro- ducibility and comparability of the results. The use of real food in standardized screening is reported to be inappropriate due to its complex and variable nature, leading to analytical limitations and inconsistent results, which makes accurate as- sessment of the migration of chemicals from FCMs difficult (Störmer et al. , 2024). Despite the comprehensive nature of the Regulation (EC) No 1935/2004, there remains a lack of harmonized EU regulations for many other types of FCMs, including paper. Migration and extraction approaches in FCM sample preparation assess safety and compliance. Migration testing mimics real-use conditions, whereas extraction testing uses solvents to extract potential migrants under aggressive con- ditions, identifying total extractable substances (Franz and Störmer, 2008). Both methods are crucial: migration testing estimates consumer exposure and extraction testing assesses worst-case chemical migration. A comparison between the two approaches is important because it provides quantita- tive information regarding the capacity of both approaches to estimate risks derived from the presence and migration of heavy metals in recycled paper FCMs. In addition, it ensures that both scenarios, i.e. typical consumer and worst-case ex- posure, are thoroughly evaluated, safeguarding public health and ensuring compliance with regulatory standards. This research examines the influence of these methods on toxic element migration from recycled paper FCMs and compares detected elemental levels to EU and Dutch regulatory SMLs and tolerable intake values, determining whether migration results in unacceptable toxic element levels in food simulants and food.
Materials and Methods Materials
Acetic acid (VWR Chemicals, Product No. 20102.292; Radnor, PA, USA), ethanol (Merck, Product No. 1.00983.2500; Darmstadt, Germany), anhydrous methyl alcohol (Macron Fine Chemicals, Product No. 3004-25; Center Valley, PA, USA), and acetone (Sigma-Aldrich, Product No. 179124; St. Louis, MO, USA) were utilized for sample preparation. Migration/exhaustive extraction The migration and extraction approaches used for sample preparation are introduced in Figure 1. The migration sample preparation method adhered to the conditions specified in the Commission Regulation (EU) 10/2011 for plastic FCMs, which were used because of the
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