EFSA developed an updated guidance document on the submission of data for the evaluation of the safety and efficacy of decontaminating substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption (referred to as ‘food’). The decontaminating substances may be either chemicals (e.g. carboxylic acids, peroxy acids or proteins), biological agents (e.g. bacteriophages) or combinations thereof. The purpose of the treatment, including the food(s) and the pathogenic microorganisms intended to be targeted, the application methods (e.g. dipping, spraying) and conditions of the treatment used (e.g. concentration) need to be stated. Information to be provided relates to (i) the safety to humans of the applied substances and their reaction products (including degradation products) remaining in the treated food; (ii) the efficacy, i.e. whether a reduction of the prevalence and/or numbers of target pathogenic microorganisms is consistently achieved and is statistically significant compared to a control sample; (iii) the potential emergence of acquired reduced susceptibility to the substance itself and/or to other biocides and/or of resistance to therapeutic antimicrobials; and (iv) the environmental safety of the decontaminating substances.

The presence of per- and polyfluoroalkyl substances (PFAS) in the environment raises concerns for food safety, particularly for households producing their own food. This study investigated PFAS bioaccumulation, distribution and depuration in 27 laying chickens, reared near industrially PFAS-contaminated sites in Belgium. Twenty-two chickens were euthanized before depuration to assess PFAS concentrations across nine biological matrices, i.e., serum, breast, fat, gizzard, heart, kidney, liver, skin, and thigh. The remaining five chickens were relocated to a PFAS-free environment to study depuration by periodically collecting eggs. After a period of at least 28 days, the chickens were also euthanized, and the nine biological matrices were analyzed. Thirty-two PFAS, including short- and long-chain carboxylic (PFCA) and sulfonic (PFSA) substances, and emerging PFAS, were quantified using very sensitive validated analytical methods. Biological matrices from chickens before depuration showed PFAS concentrations up to twenty-three times higher and a broader PFAS profile than after the depuration period. Serum, liver, and kidneys were the primary accumulation sites before depuration, with fat containing similar levels before and after depuration. PFAS levels in eggs decreased progressively during the monitoring period, with PFOS dominating the PFSA profile. Both PFSA and PFCA compounds showed consistent declines, illustrating that egg production could be a significant pathway for PFAS elimination. These findings demonstrate how environmental exposure and depuration dynamics influence PFAS contamination in biological matrices. PFAS accumulation in chicken tissues and eggs can enter the human food chain through the consumption of meat and eggs, representing a potential risk to food safety.

Abstract The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process Starlinger viscotec deCON (EU register number RECYC339). The input is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are preheated batchwise before being submitted to solid state polycondensation (SSP) in batch or semi‐continuous reactor(s), at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the SSP reactor (step 3) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, residence time, pressure and gas flow rate. It was demonstrated that this process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food (depending on the molar mass of the contaminant substance) derived from the exposure scenario for infants when such recycled PET is used at up to 55% together with virgin PET, and of 0.156 or 0.312 μg/kg food, derived from the exposure scenario for toddlers, when used at up to 100%. The Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 55% in mixture with virgin PET for manufacturing materials and articles for contact with all types of foodstuffs, including drinking water, and at up to 100% for contact with all types of foodstuffs except drinking water, and used for long‐term storage at room temperature or below, with or without hot‐fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

Abstract The EFSA Panel on Food Contact Materials (FCM) assessed the safety of (2E,2′E)‐2,4,8,10‐tetraoxaspiro[5.5]undecane‐3,9‐diylbis(2‐methylpropane‐2,1‐diyl) bis(2‐cyano‐3‐(3,4‐dimethoxyphenyl)acrylate, which is intended to be used as an additive at up to 0.75% w/w in polyethylene terephthalate (PET) single‐use articles for contact with all types of food, for long‐term storage at room temperature including hot fill and/or heating up to 100°C for a maximum of 2 h. Migration tests were carried out into the food simulants 3% acetic acid, 10% ethanol and olive oil, using PET samples containing the substance at the maximum intended level. The specific migration of the substance was up to 33 μg/kg food. The individual migration of its impurities was generally below the limits of quantification or not detected at the limits of detection, both in the few μg/kg food range, except for 3,4‐dimethoxybenzaldehyde and spiroglycol in 10% ethanol (up to 45 and 46 μg/kg food, respectively). The specific migration of potential reaction or degradation products was below 50 μg/kg food. Genotoxicity studies demonstrated that the substance does not raise a concern. Impurities and the potential degradation or reaction products do not raise a concern for genotoxicity, based on genotoxicity studies, literature data or in silico assessment. The Panel concluded that the substance is not of safety concern for the consumers (i) if it is used as an additive at up to 0.75% w/w in PET intended for contact with all types of foods, except human milk, infant formula and water that could be used to reconstitute infant formula; (ii) if it is used for long‐term storage at room temperature, including hot fill and/or heating conditions up to 100°C for a maximum of 2 h; and (iii) if the migration of its impurity 3,4‐dimethoxybenzaldehyde does not exceed 50 μg/kg food.

Abstract The EFSA Panel on Food Contact Materials assessed the safety of the 1,3‐benzenedicarboxamide, 5‐[[[cis‐4‐(1,1‐dimethylethyl)cyclohexyl]carbonyl]amino]‐N1,N3‐bis[cis‐4‐(1‐methylethyl)cyclohexyl]‐, to be used as a clarifying agent in polypropylene at up to 0.08% w/w. The final articles are intended for contact with all types of food except foods containing more than 10% ethanol, infant formula or mineral water intended to be used to reconstitute infant formula. They are intended for long‐term storage at room temperature and below, including hot fill and heating conditions. The migration of the substance was below the limit of quantification of 0.05 mg/kg food in 10% ethanol, with values estimated up to 0.031 mg/kg in olive oil. The migration of the trans isomers can be estimated up to 0.0006 mg/kg food. The total mass transfer of all impurities was individually below 0.05 mg/kg food. The Panel excluded genotoxicity concerns for the substance based on in vitro studies. Trans isomers and relevant impurities were assessed using in silico and literature data and did not raise concerns for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 0.08% w/w in polypropylene homo‐ and co‐polymers, and the manufactured materials and articles are: (i) for single and repeated use, in contact up to and above 6 months at room temperature and below, including hot‐fill conditions and/or heating up to 70°C ≤ T ≤ 100°C for maximum t = 120/2^((T − 70)/10) min; and (ii) are used in contact with all types of food, excluding beverages with an ethanol content above 10%, infant formula, including reconstituted infant formula and human milk.

Abstract The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the Bandera Twin recycling process (EU register number RECYC341). The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are extruded at high temperature and vacuum (step 2). Having examined the challenge test provided, the Panel concluded that the operating parameters to control the performance of the critical step 2 are temperature, pressure and ■■■■■. It was demonstrated that this recycling process ensures that the levels of migration of potential unknown contaminants into food are below the conservatively modelled migration and that therefore the recycled PET obtained from the process is not of safety concern when used at up to (i) 9% for the manufacture of materials and articles for contact with drinking water, for long‐term storage at room temperature, with or without hot‐fill; (ii) 30% for the manufacture of materials and articles for contact with milk, other liquid milk‐based products, non‐alcoholic beverages (other than drinking water) and solid foods specifically intended for infants and toddlers, for long‐term storage at room temperature, with or without hot‐fill); and (iii) 100% for the manufacture of materials and articles for contact with all types of foodstuffs other than drinking water, milk, liquid milk‐based products and non‐alcoholic beverages, and solid foods specifically intended for infants and toddlers, for long‐term storage at room temperature or below, with or without hot‐fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

Abstract The EFSA Panel on Food Contact Materials assessed the safety of l‐aspartic acid, N‐benzoyl, disodium salt to be used as a nucleating agent in polypropylene at up to 0.07% w/w. Final articles are intended for single and repeated use in contact with all food types. The migration of the substance was detected in ethanolic simulants up to 0.03 mg/kg food. The Panel excluded genotoxicity concerns for the substance based on in vitro studies. Migration of impurities and reaction/degradation products was either not detectable or below 0.05 mg/kg food, except for sodium benzoate and sodium l‐aspartate. The first migrated at 1.5 mg/kg food; the latter was below the limit of quantification of 0.224 mg/kg food in acetic acid. Both substances do not raise safety concerns being, respectively, the sodium salt of benzoic acid, FCM No 116, authorised without restrictions, and a salt of aspartic acid. For benzamide, given its thresholded mechanism of indirect genotoxicity as a PARP inhibitor, a sufficient margin of exposure exists to rule out concern at the observed migration levels. Four remaining impurities and reaction products were assessed using read‐across from the substance and in silico tools, and did not raise concerns for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer, if (i) it is used at up to 0.07% w/w in polypropylene homo‐ and co‐polymers to manufacture food contact materials for single and repeated use; (ii) final articles are in contact with all types of food, excluding infant formula, human milk and water that could be used to reconstitute infant formula; (iii) final articles are used for storage up to and above 6 months at room temperature and below, including hot‐fill conditions and/or heating up to 121°C for maximum 2 h; and (iv) the migration of the substance does not exceed the 0.05 mg/kg food.

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of poly(2-ethyl-2-oxazoline) intended to be used as an additive to manufacture repeated use filter membranes based on ■■■■■. The filter membranes are used to process aqueous and alcoholic foods, for up to 24 h per day up to ■■■■■ at temperatures up to 35°C. The substance is a polymer with ≤ ■■■■■% w/w low molecular weight fraction (LMWF, < 1000 Da). Migration tests simulated the actual use conditions by repeatedly flushing ■■■■■-based filter membranes with the food simulant 20% ethanol in consecutive contact steps. The specific migration of the sum of the LMW oligomers was below 50 μg/kg food. The specific migration of the monomer and of some impurities was not detected at the respective limits of detection (≤ 4 μg/kg food). The specific migration of the remaining impurities was not measured but calculated and was generally below 0.15 μg/kg food. Genotoxicity studies on 2-hydroxy-N-(hydroxyethyl)propanamide, which is structurally related to the LMW oligomers, demonstrated that the LMW oligomers do not raise a concern for genotoxicity. The in silico assessment of the impurities did not show the presence of structural alerts for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumers if (i) it is used in repeated use ■■■■■-based filter membranes at temperatures up to 35°C for the processing of foodstuffs for which simulants A, B, C are laid down in Regulation (EU) 10/2011, except human milk, liquid infant formula and water that could be used to reconstitute infant formula; and (ii) its content in the filter membrane does not exceed 40.7% w/w, calculated based on the levels of the substance and ■■■■■ in the initial wet membrane solution and considering a residual level of other components of 2% w/w.

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process KREYENBORG IR Clean+ (universal) (EU register number RECYC329). The input is hot washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous infrared (IR) dryer (step 2) before being processed in a finisher reactor (step 3). Having examined the challenge test provided, the Panel concluded that both steps are critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency of these critical steps are temperature, air/PET ratio and residence time. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of a contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature or below, with or without hot-fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

Abstract The European Commission asked EFSA to review whether the authorisation of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) is still in accordance with Regulation (EC) No 1935/2004, as provided for in Article 12(3). The FCM Panel concluded that some uses of the substance N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) are not in accordance with this Regulation, since the migration is likely to exceed the current SML(T) of 1.2 mg/kg food under certain conditions of use. Based on the provided data, the FCM Panel concluded that the FCM substance No 19, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine, is not of safety concern for the consumer if (i) the substance is used at up to 0.1% w/w as polymer production aid and as processing aid to manufacture polyolefin materials and articles of thickness up to 1 mm that are intended for contact with all types of food except infant foods. This exception for infant foods and the restriction for maximum thickness do not apply to caps of bottles; (ii) the migration does not exceed 5 mg/kg food; (iii) the source of the alkyl group is either from hydrogenated vegetable oil or synthetic from ethylene oligomers with a high degree of linear structure and (iv) the impurities do not exceed 5% w/w. As they bear unsaturation, PFAEO‐coco, PFAEO‐oleyl, PFAEO‐HT, PFAEO‐T and PFAO‐C18 do not fall within the scope of the FCM substance No 19. The information related to these substances was only considered supportive for FCM substance No 19. If they were intended to be used to manufacture FCMs, a proper application following the EFSA Guidance documents should be submitted. No uses of the FCM substance No 20, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides, were claimed and no information was provided to support that the current authorisation is in accordance with the Regulation (EC) No 1935/2004.

The SILIFOOD tool was created to support the safety assessment of food contact material (FCM) substances. By combining the retrieval of existing toxicological data with (quantitative) structure-activity relationship [(Q)SAR] predictions, the tool is particularly relevant for FCM substances with limited or no toxicological data like non-intentionally added substances (NIAS) and substances migrating from non-plastic FCM. Existing databases and lists of substances containing toxicological information were identified and curated. In addition to an in-house database with FCM-related information, the European Food Safety Authority (EFSA) OpenFoodTox database, the European Chemicals Agency (ECHA) lists of evaluated substances as well as lists of compounds with toxicological concerns were chosen. (Q)SAR models predicting toxicological endpoints relevant for FCM were selected from VEGAHUB. The endpoints of interest were bioavailability/bioaccumulation potential, genotoxicity, carcinogenicity, developmental and reproductive toxicity, and sub-chronic toxicity. Moreover, models for endocrine activity and Cramer class identification were included. Next, a stand-alone and publicly available software was developed to automatically collect information from the selected lists and databases and to combine them with (Q)SAR predictions. The SILIFOOD tool, developed specifically for single organic FCM substances, was evaluated using case studies.

Abstract The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process brtCOMBIPET (EU register number RECYC338). The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried (step 6), melted in an extruder (step 7) and pelletised, dried and crystallised (step 8). The pellets are then preheated, further crystallised, then decontaminated in a solid‐state polymerisation (SSP) reactor (step 9) and cooled down. Having examined the challenge tests provided, the Panel concluded that the extrusion, the preheating and the SSP are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance are the temperature and the pressure for step 7 (extrusion) as well as the temperature, residence time and gas flow rate for step 9 (preheating and SSP). It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of the contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hot‐fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

This study provides occurrence data for acrylamide in various foodstuffs, including those covered by Recommendation (EU) 2019/1888, from 210 samples purchased on the Belgian market. Detection frequencies exceeded 84% in potato-based products other than fries, vegetable crisps, black olives, cocoa powders, coffee substitutes and cereals and snacks. Large variations in acrylamide levels were found in cereals and snacks, with no correlation between cereal type or processing. Snacks containing chia did not show higher acrylamide levels than other cereal-based snacks. Maximum levels found were 4389 and 3063 µg kg-1 in coffee substitutes and vegetable crisps, respectively. Potato-based products contained 2 to 27 times less acrylamide when prepared in oven, compared to deep fryer processing. Artificially oxidised "Californian-style" black olives contained five times more acrylamide than "Greek-style" olives. In bread, pastries, nuts, oilseeds, dried fruits and confectionaries, detection frequencies varied from 27 to 69% and the average acrylamide content was <30 µg kg-1.

Abstract The EFSA Panel on Food Contact Materials assessed the safety of N,N′‐(2‐(4‐(2‐aminobenzamido)butyl)pentane‐1,5‐diyl)bis(2‐aminobenzamide) to be used at up to 650 mg/kg in polyethylene terephthalate (PET) to scavenge acetaldehyde (AA). Final articles are intended for contact with aqueous, acidic and low‐alcoholic beverages for long‐term storage at room temperature and below. The migration of the substance from PET bottles into 20% ethanol was 0.0038 mg/kg food. The Panel calculated the potential migration of the summed reaction products not to exceed 0.02 mg/kg food. From experimental studies, the Panel excluded genotoxicity concerns for the substance, for 2‐aminobenzamide +1 formaldehyde and 2‐aminobenzamide +1 AA, both with desaturation. In silico predictions, previous EFSA evaluations and the use of the threshold of toxicological concern (TTC) excluded genotoxicity concerns for 15 other impurities/reaction products. A tentatively identified by‐product was predicted as possible DNA‐reactive in vitro mutagen and clastogen, due to its aromatic hydroxylamine group. Its modelled migration would not exceed 0.14 μg/kg food, leading to a potential exposure below the TTC of 0.0025 μg/kg body weight per day. Non‐identified reaction products are expected to be structurally related to the identified ones and, hence, not to raise concern for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer, if it is used as an additive at up to 650 mg/kg in PET intended for contact with foods simulated by simulants A, B and C, for storage above 6 months at room temperature and below, including hot‐fill conditions and/or heating up to 70°C ≤ T ≤ 100°C for maximum t = 120/2((T−70)/10) minutes. The substance should not be used for infant formula (including water used for reconstitution) and human milk. The migration of the substance should not exceed 0.05 mg/kg food. The substance should not contain aromatic hydroxylamine derivatives at more than 0.15% w/w.

Per- and polyfluoroalkyl substances (PFAS) are persistent organic pollutants (POP) that can accumulate in food systems. This chapter examines their sources, detection, and mitigation strategies in food. Sources include environmental contamination through soil, water, and air, as well as animal feed, and migration from food contact materials. Analyzing these substances at the required levels is complex due to the diversity of PFAS and food matrices, analytical limitations, and contamination risks. Furthermore, it remains challenging to obtain monitoring data for exposure assessment and to comply with current European regulations. Mitigation strategies for agriculture include soil amendments and phytoremediation, while animal exposure can be reduced through improved practices. Case studies highlight regional variation in PFAS contamination and variation concerning the impact food processing may have on these substances. This stresses the need for more sensitive analytical methods, extended regulations, reduced exposure risk and innovative remediation approaches to address PFAS contamination more effectively.

Abstract The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process EREMA Vacurema Basic_Sheet (EU register number RECYC 337). The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with below 5% PET from non‐food consumer applications. The flakes are heated in a continuous flake reactor (step 2) under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the step 2 is critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency are the temperature, the pressure (vacuum) and the residence time. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.156 or 0.312 μg/kg food, depending on the molar mass of the contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with foodstuffs, excluding drinking water, reconstituted infant formula and human milk, and used for long‐term storage at room temperature or below, with or without hot‐fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

The EFSA Panel on Food Contact Materials (FCM) was requested by the European Commission to re-evaluate the potential genotoxicity of styrene after oral exposure and its safety for use in plastic FCM with a specific migration limit (SML) of 40 μg/kg food. A rigorous assessment of the in vivo genotoxicity studies (i) provided by third parties, (ii) identified by a targeted literature search and (iii) reported in the 2019 IARC Monograph was performed. All studies were assessed for reliability and relevance and the results integrated in the weight of evidence. The results provided by reliable in vivo oral genotoxicity studies, covering different genetic endpoints and target tissues, including liver, the primary site of metabolism, demonstrated that the oral administration of styrene in mice and rats up to the maximum tolerated dose (300 and 500 mg/kg body weight (bw), respectively) did not induce genotoxic effects. The Panel concluded that there was no evidence that styrene is genotoxic following oral exposure. For substances demonstrated to be non-genotoxic, according to the EFSA Note for Guidance for FCM, an SML up to 50 μg/kg food would not be of safety concern. Consequently, the use of styrene in the manufacture of FCM respecting the SML of 40 μg/kg food proposed by the European Commission is not of safety concern.

To search for evidence of micro- and nanoplastics (MNP) release during the uses of food contact materials (FCM), a structured literature review was carried out on studies published between 2015 and 20 th January 2025. It identified 1711 publications of which 122 were selected for data extraction. Eight additional publications were added to provide more context. Most studies concern microplastics, while data on nanoplastics are almost entirely absent. Most publications use water or aqueous food simulants as FCM contact medium for suspension and subsequent isolation of released MNP. Foods other than mineral water were tested in only few cases. Despite the large number of publications investigating the release of MNP from FCM, the available evidence concerning the characteristics and quantities of released MNP from FCM remains limited. Many publications are affected by methodological shortcomings in test conditions, in sample preparation, and by deficiencies in the reliability of analytical data, with the consequence of frequent misidentification and miscounting. Based on the findings on release mechanisms, contaminations, mimicking substances, particle numbers and masses generated during the use of FCMs, it is concluded that (i) there is evidence of microplastics released during the uses of FCM, (ii) this release is due to mechanical stress, such as abrasion or friction, or due to materials with open or fibrous structures, (iii) despite the uncertainties, the actual release is much lower than the results presented in many publications. In view of all this, there is no sufficient basis at this stage to estimate MNP exposure from FCM during their uses. This review identifies methodological shortcomings and data gaps, and makes recommendations on related future research needs.