Assessment of the impact of the IARC Monograph Vol. 121 on the safety of the substance styrene (FCM No 193) for its use in plastic food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) was requested by the European Commission to re-evaluate the safety of styrene (FCM No 193) for use in plastic food contact materials (FCM) following the classification by the International Agency for Research on Cancer (IARC) as 'probably carcinogenic to humans'. The IARC Monograph pertains to hazard identification, based on studies on high-dose occupational exposures by inhalation and animal studies, also mainly by inhalation. The Panel considered that the IARC conclusions cannot be directly applied to the evaluation of risks for consumers from the oral exposure to styrene, but also concluded that, based on the data provided in the IARC Monograph and by the industry, a concern for genotoxicity associated with oral exposure to styrene cannot be excluded. The migration of styrene into foods packed in styrenic plastics is below 10 µg/kg for the majority of the foods, but up to 230 µg/kg was reported. Migration tends to be high for contact with fatty foods, and/or with high surface to volume ratios of the FCM. Dietary exposure of the consumers to styrene migrating from styrenic plastics was estimated in the order of 0.1 µg/kg body weight (bw) per day. It is in the same range as exposure from styrene present in foods as such. The dietary exposure (food component plus migration from styrenic plastics) is similar or lower than that by inhalation in the general population. Taking the human exposure data into account, the Panel concluded that a systematic review of genotoxicity and mechanistic data, comparative toxicokinetics and analysis of species differences is required for assessing the safety of styrene for its use in FCM.

Safety assessment of the substance N,N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of N,N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids (SABOFOG F1), FCM No 1081, which is intended to be used as an antistatic and anti-fog agent in all types of polymers at up to 2% w/w. It was requested for use in contact with dry food, acidic foods and alcoholic beverages (represented by simulants E, B and C, respectively) with storage up to 6 months at ambient temperature. The migration data provided did not enable the assessment of the safety of applications intended for contact with foods represented by simulants B and C. In the migrate into simulant E, the non-esterified N,N-bis(2-hydroxyethyl)stearylamine was the main constituent. Its mono- and di-esters migrated to a lower extent. According to the data provided, the Panel concluded that the substance does not raise concern for genotoxicity and accumulation in humans. Based on the results of 28-day oral toxicity study with SABOFOG F1 and on the 90-day oral toxicity study with the read-across substance bis(2-hydroxyethyl)oleylamine, the Panel considered the current SML(T) of 1.2 mg/kg food provided a margin sufficiently large to accommodate the uncertainties related to the read-across approach. Overall, the CEP Panel concluded that N,N-bis(2-hydroxyethyl)stearylamine, of which at least ■■■■■ is partially or fully esterified with saturated C16/C18 fatty acids is not of safety concern for the consumer when used at up to 2% (w/w) in all polymers intended for contact with foods represented by simulant E for up to 6 months at room temperature. Additionally, the migration of the sum of N,N-bis(2-hydroxyethyl)stearylamine and its mono- and di-ester, calculated as N,N-bis(2-hydroxyethyl)stearylamine, should not exceed 1.2 mg/kg, i.e. the SML(T) for FCM substances 19 and 20, in which also the migration of the mono- and di-ester of N,N-bis(2-hydroxyethyl)stearylamine should be included.

Review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011 on plastic materials and articles intended to come into contact with food.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) was requested by the European Commission to review the substances for which a Specific Migration Limit (SML) is not assigned in Regulation (EU) No 10/2011. These substances had been covered by the Generic SML of 60 mg/kg food, but with Regulation (EU) 2016/1416 it was removed, necessitating their re-examination. EFSA was requested to identify those substances requiring an SML to ensure the authorisation is sufficiently protective to health, grouping them in high, medium and low priority to serve as the basis for future re-evaluations of individual substances. The CEP Panel established a stepwise procedure. This took into account existing hazard assessments for each substance on carcinogenicity/mutagenicity/reprotoxicity (CMR), bioaccumulation and endocrine disruptor (ED) properties along with the use of in silico generated predictions on genotoxicity. Molecular weights and boiling points were considered with regard to their effect on potential consumer exposure. This prioritisation procedure was applied to a total of 451 substances, from which 78 substances were eliminated at the outset, as they had previously been evaluated by EFSA as food contact substances. For 89 substances, the Panel concluded that a migration limit should not be needed. These are in the lists 0 and 1 of the Scientific Committee for Food (SCF), defined as substances for which an Acceptable Daily Intake (ADI) does not need to be established, along with substances that are controlled by existing restrictions and/or generic limits. Of the remaining 284 substances, 179 were placed into the low priority group, 102 were placed into the medium priority group and 3 were placed into the high priority group, i.e. salicylic acid (FCM No 121), styrene (FCM No 193) and lauric acid, vinyl ester (FCM No 436).

Safety assessment of the substance benzophenone-3,3',4,4'-tetracarboxylic dianhydride, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of benzophenone-3,3',4,4'-tetracarboxylic dianhydride (BTDA), FCM substance No 1083, as co-monomer for the production of polyimides used in repeated use materials and articles that are in contact with acidic and fatty foods at temperatures up to 250°C. Migration of BTDA from a polyimide containing 43% BTDA, ■■■■■ into olive oil was below the limit of quantification of about 3 µg/kg food, and in 3% acetic acid it decreased from 30.3 µg/kg in the first test to 22.1 µg/kg in the third test (2 h/100°C). In a semi-quantitative screening using acetonitrile and acetonitrile/water to extract the polymer powder, linear and cyclic oligomers were detected at levels below 1 mg/kg material. In thermal desorption of the polymer powder at 250°C, phenol, tentatively identified ■■■■■ were found, but the modelled migrations of these were far below a level of potential concern. ■■■■■. The substance did not induce gene mutations in bacterial and mammalian cells. In an in vitro chromosomal aberration test, the substance was found to be directly clastogenic in the absence of metabolic activation. In an in vivo follow-up, the substance did not induce the formation of micronuclei in experimental conditions associated with evidence of systemic exposure and therefore the Panel considered that the substance does not raise concern for genotoxicity. The CEP Panel concluded that the use of the substance BTDA is not of safety concern for the consumer if it is applied at up to 43% as a co-monomer in the production of polyimides for repeated use contact with acidic or fatty foods at temperatures up to 250°C. In addition, the migration of BTDA should not exceed 50 µg/kg.

Safety assessment of the substance (triethanolamine-perchlorate, sodium salt) dimer, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance (triethanolamine-perchlorate, sodium salt) dimer, FCM substance No 1080, intended to be used as a thermal stabiliser at up to 0.15% w/w in rigid poly(vinyl chloride) (PVC) for repeated use bottles in contact with water. No thermal degradation of the substance is expected during the manufacture of the PVC articles. In water, the substance fully dissociates into triethanolamine, sodium (cations) and perchlorate. Therefore, migration would lead to exposure to triethanolamine and perchlorate and not to the substance itself. Specific migration of perchlorate, ethanolamine, diethanolamine and triethanolamine was tested under repeated use conditions covering the requested uses. After the second and third contacts, perchlorate was detected at ca. 0.3 µg/kg food. Ethanolamine, diethanolamine and triethanolamine were not detected in any of the three contacts at an estimated limit of detection of 0.03 mg/kg food. The available in vitro studies on the substance confirmed the lack of concern for genotoxicity, as anticipated by the dissociation of the substance into authorised non-genotoxic substances. Therefore, the CEP Panel concluded that the substance is not of safety concern for the consumer if used, under the condition requested by the applicant, as an additive at up to 0.15% w/w in rigid PVC for repeated use bottles intended for contact with water. Additionally, the migration of triethanolamine and perchlorate should not exceed the specific migration limits (SMLs) of 50 µg/kg food and 2 µg/kg food, respectively, set in the Regulation (EU) 10/2011. This evaluation also covers acidic foods such as fruit juices that can reasonably be foreseen to be in contact.

Safety assessment of the substance phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate, FCM substance No 1082, which is intended to be used at up to ■■■■■% w/w ■■■■■ for the production of kitchen countertops and sinks. These composite articles are intended for repeated contact with all food types. The contact time is not expected to exceed several hours at room temperature or a short time at high temperature (1 h at 70°C). The substance is thermally stable under the manufacturing conditions. Under conservative conditions of testing, the specific migration into 10% ethanol, 95% ethanol and 3% acetic acid was up to 24.8 µg/6 dm2. Screening tests for migrating oligomers and reaction products resulting from the use of the substance ■■■■■. Based on the negative results observed in the Ames and in vitro micronucleus tests, the Panel concluded that the substance does not raise concern for genotoxicity. The CEP Panel concluded that the substance phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate, is not of safety concern for the consumer if used as a co-monomer at up to ■■■■■% to manufacture ■■■■■ food preparation surfaces, such as countertops or sinks, intended for repeated contact with all food types. Additionally, the migration of phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate should not exceed 0.05 mg/kg food expressed as the sum of the mono-, di- and triesters of phosphoric acid and the mono-, di-, tri- and tetraesters of diphosphoric acid.

Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH), CAS No 147398-31-0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl-terminated or with crotyl- and hexenyl end-groups from dehydration of hydroxyl end-groups. In the absence of calibration standards, the total oligomer migration was set at the overall migration values. Other degradation products are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCMs with a specific migration limit (SML) of 0.05 mg/kg food. For (E)-2-hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its group evaluation of flavouring substances in FGE.05Rev2 (EFSA CEF Panel, 2010b). The other migrating substances detected, ■■■■■, are from the authorised substance 'palm oil and/or palm fatty acid distillate' (FCM substance No 9) used as a carbon source for the fermentation and do not give rise to safety concern. A PHBH oligomer mixture was synthesized to simulate that migrating. It did not give rise to concern for genotoxicity. From the repeated dose 90-day oral toxicity study in rats, the Panel identified the no-observed-adverse-effect level (NOAEL) at the highest dose tested in males, 1,364 mg/kg body weight (bw) per day. The Panel concluded that the potential for bioaccumulation of oligomers is low. Overall, the CEP Panel concluded that the substance PHBH is not of safety concern for the consumer if it is used alone or blended with other polymers in contact with all kinds of food during more than 6 months at room temperature or below, including hot-fill or a short heating up phase. The specific migration of all oligomers < 1,000 Da should not exceed 5 mg/kg food. The migration of crotonic acid should not exceed the SML of 0.05 mg/kg food. As the migration of (E)-2-hexenoic acid can be expected to be always lower than that of crotonic acid, no individual restriction is necessary.

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long-term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 µm or less and the average size is 9 µm, has a layered structure with layers of a thickness below 100 nm. When incorporated in PLA, nanosized layers can be dispersed in the matrix, but are not expected to migrate. Thermal degradation is not expected at the maximum manufacturing temperature. No loss of integrity of the PLA surface due to interaction with bottled water was observed. The overall migration was very low. No migration of HDTA was detected at the limit of detection ■■■■■. Migration of aluminium was below or at the limit of detection ■■■■■, which would conservatively correspond to approximately ■■■■■. Comparative analysis of bottled water with and without the modified clay did not reveal additional peaks corresponding to impurities identified in the modifier and/or in the modified clay. Moreover, ■■■■■, and the modifier HDTA have been evaluated and authorised. Therefore, the CEP Panel concluded that the substance montmorillonite clay modified with HDTA bromide is not of safety concern for the consumer if the substance is used as an additive at up to ■■■■■ in PLA plastic bottles and other containers intended for long-term storage of water at ambient temperature or below, as requested by the applicant.

Safety assessment of the substance trimellitic acid, tris (2-ethylhexyl) ester, for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2-ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and articles, such as wrap films (single uses) and tubing (repeated uses) at up to approximately 10% and 40%, respectively. Under the tested conditions, the substance migrated up to 165 µg/kg food from wrap films and was not detected in food simulant in contact with tubing. Based on the three reported in vitro genotoxicity studies, the Panel concluded that the substance does not raise concern for genotoxicity. The lowest no observed adverse effect level (NOAEL), derived from a 90-day oral toxicity study, was 225 mg/kg body weight (bw) per day. Based on data on toxicokinetic and metabolism, the substance does not give rise to concern for accumulation in humans. The substance does not cause developmental effects as induced by phthalic acid, bis(2-ethylhexyl) ester (DEHP). Assuming that impurities migrate pro-rata to a migration of the substance up to 5 mg/kg food, their estimated migration does not raise a safety concern. The Panel concluded that the substance does not raise safety concern for the consumer when used in the manufacture of soft PVC under the conditions requested by the applicant for (i) single use wrap films in contact with food for which simulants A, B and D1 are assigned, as well as (ii) tubing for repeated contacts with food for which simulants A and B are assigned. Overall, the use of the substance does not raise a safety concern if its migration does not exceed 5 mg/kg food. Due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered.

Update of the risk assessment of 'wood flour and fibres, untreated' (FCM No 96) for use in food contact materials, and criteria for future applications of materials from plant origin as additives for plastic food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) was asked by the European Commission to review whether the authorisation of 'wood flour and fibres, untreated' (FCM No 96) is still in accordance with Regulation (EC) No 1935/2004. The additive was included in the list of additives for use in plastic food contact materials (FCM) based on the assumption of its inertness. No toxicological evaluation underlying the inclusion of this entry in the positive list is available. In a literature search, general information on the chemical composition of wood was retrieved showing that wood may contain toxic components and contaminants. The information on migration of substances from wood was found to be limited to its use in the production of wine. Data on migration of substances resulting from the use of wood (flour, fibres) as plastic additive were not available. The Panel therefore concluded that there is insufficient information to support that the current authorisation of 'wood flour and fibres, untreated' (FCM No 96) is still in accordance with Regulation (EC) No 1935/2004. As a second step, as requested by the mandate, the Panel set out criteria for future evaluations of wood and similar materials from plant origin as additives for plastic for food contact applications. The Panel noted that due to the chemical differences in composition of plant materials, the safety of migrants from these materials must be evaluated on a case-by-case basis, considering beyond species also origin, processing, treatment for compatibilisation with the host polymer and assessment of the low molecular weight constituents migrating into food. Migration of substances resulting from using wood or other plant materials should be tested comparatively in samples made with and without the additive. Toxicological data should cover the substances detected in this analysis.

Safety assessment of the substance phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the substance 'phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters', obtained by reaction of ■■■■■, when used as an additive at up to 0.2% w/w in high impact polystyrene. The plastic, in the form of films and articles, is intended for contact with aqueous, acidic, low-alcohol and fatty foods for long-term storage at room temperature and below, after hot-fill and/or heating up to 100°C for up to 2 h. Based on genotoxicity tests with negative results, the Panel considered that there is no evidence of mutagenicity and chromosomal damage of the substance and its phosphate form. From a repeated dose 90-day oral toxicity study in rats, the Panel identified the no-observed-adverse-effect level as 50 mg/kg body weight (bw) per day. No effects of induced delayed neurotoxicity in hens were observed. Migration from high impact polystyrene containing the substance at 0.2%, measured through the phosphorous content of the substance, reached 0.001 mg/kg in 10% ethanol and 0.1 mg/kg in 95% ethanol. Migration into acidic food/simulant is expected to be below 0.001 mg/kg. Regarding the oligomers and other reaction/degradation products detected, the phosphorous-containing substances were adequately represented in the toxicity experiments conducted. Those not containing phosphorous were hydrolysis products either listed in Regulation (EU) 10/2011 and their estimated worst-case migrations were well below their respective specific migration limits (SMLs) or no alerts for genotoxicity were noted. Overall, the CEP Panel concluded that the substance 'phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters' does not raise a safety concern for the consumer if it is used at up to 0.2% w/w in high impact polystyrene materials and articles and its migration does not exceed 0.05 mg/kg food.

Safety assessment of the substance, titanium dioxide surface treated with fluoride-modified alumina, for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) is a safety assessment of the additive titanium dioxide surface treated with fluoride-modified alumina, a defined mixture of particles of which ■■■■■% in number have a diameter in the range of 1-100 nm. It is intended to be used as filler and colourant up to 25% w/w in potentially all polymer types. Materials and articles containing the additive are intended to be in contact with all food types for any time and temperature conditions. The data provided demonstrate that the additive particles stay embedded even in swollen polar polymers such as polyamide, and do not migrate. Moreover, the additive particles resisted release by abrasion and did not transfer into a simulant for solid/dry foods. Thus, the additive particles do not give rise to exposure via food and to toxicological concern. Migration of solubilised ionic fluoride and aluminium occurs from the surface of the additive particles and particularly from swollen plastic. The Panel concluded that the substance does not raise safety concern for the consumer if used as an additive up to 25% w/w in polymers in contact with all food types for any time and temperature conditions. However, uses in polar polymers swelling in contact with foodstuffs simulated by 3% acetic acid should be limited to conditions simulated by contact up to 4 h at 100°C. This is due to the fact that when used at 25%, and contact was followed by 10 days at 60°C, the migration of aluminium and fluoride largely exceeded the specific migration limit (SML) of 1 and 0.15 mg/kg food, respectively. The Panel emphasises that the existing SMLs for aluminium and fluoride should not be exceeded in any case.

Mineral oil in food, cosmetic products, and in products regulated by other legislations.

For a few years, mineral oils and their potential adverse health effects have been a constant issue of concern in many regulatory areas such as food, cosmetics, other consumer products, and industrial chemicals. Analytically, two fractions can be distinguished: mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). This paper aims at assessing the bioaccumulative potential and associated histopathological effects of MOSH as well as the carcinogenic potential of MOAH for consumer-relevant mineral oils. It also covers the absorption, distribution, metabolism, and excretion of MOSH and MOAH upon oral and dermal exposures. The use and occurrence of consumer-relevant, highly refined mineral oils in food, cosmetics and medicinal products are summarized, and estimates for the exposure of consumers are provided. Also addressed are the challenges in characterizing the substance identity of mineral oil products under REACH. Evidence from more recent autopsy and biopsy studies, along with information on decreasing food contamination levels, indicates a low risk for adverse hepatic lesions that may arise from the retention of MOSH in the liver. With respect to MOAH, at present there is no indication of any carcinogenic effects in animals dermally or orally exposed to highly refined mineral oils and waxes. Such products are used not only in cosmetics but also in medicinal products and as additives in food contact materials. The safety of these mineral oil-containing products is thus indirectly documented by their prevalent and long-term use, with a simultaneous lack of clinical and epidemiological evidence for adverse health effects.

Release of aluminium and thallium ions from uncoated food contact materials made of aluminium alloys into food and food simulant.

In order to investigate the release of aluminium ions from food contact materials, three different types of uncoated aluminium menu trays for single use were tested with the foodstuffs sauerkraut juice, apple sauce and tomato puree, as well as with the food simulants 5 g/L citric acid solution and artificial tap water. To mimic a consumer relevant exposure scenario, the aluminium trays were studied using time and temperature gradients according to the Cook & Chill method, also taking into account storage time at elevated temperatures during the delivery period. The release of aluminium was found to exceed the specific release limit (SRL) of 5 mg aluminium per kilogram of food specified by the Council of Europe by up to six times. Furthermore, a release of thallium was also detected unexpectedly. Kinetic studies showed a comparable behaviour in the release of aluminium, manganese and vanadium as components of the aluminium alloy itself. In contrast, thallium could be identified as a surface contaminant or impurity because of an entirely different kinetic curve. Kinetic studies also allowed activation energy calculations. Additional camping saucepans were tested as an article for repeated use. In three subsequent release experiments with citric acid (5 g/L), artificial tap water and tomato puree as benchmark foodstuffs, the results were comparable to those of the uncoated wrought alloy aluminium trays.

Transfer of primary aromatic amines from coloured paper napkins into four different food matrices and into cold water extracts.

The aim of this study was to compare the transfer of primary aromatic amines (PAAs) from napkins into cold water extract (CWE) with transfer into four different food matrices. An HPLC-MS/MS multi-analyte method for quantification of 26 PAAs in CWE was validated and applied. In addition, the method was validated for seven different PAAs in four different food matrices (cucumber, rice, pickled gherkin and butter cookie) representing wet, dry, acidic and fatty food. The CWEs of 12 coloured napkin samples were analysed, and 3 napkins released more than 0.01 mg kg-1 PAAs into the CWE. These three napkins were chosen for transfer testing with food samples. In total, seven different PAAs were quantified in the food samples. Results show that the transfer of the tested PAAs into the CWE is in most cases comparable to the transfer into the tested food samples. In some cases, the CWE overestimates transfer into food, except for the transfer of aniline into pickled gherkin, where the CWE underestimates transfer. Therefore, the CWE serves as an adequate and certainly not overestimating simulation of reality for the tested transfer of PAAs into the food samples.

Validation and application of an LC-MS/MS method for the determination of cyclic oligomers originating from polyamide 6 and polyamide 66 in food simulant.

Polyamides (PAs) are used in the production of various food contact materials (FCMs) and articles such as kitchen utensils and packaging material. Cyclic oligomers have been identified as potential migrants from PA. This study describes the development, validation and application of a multi-oligomer analytical method based on LC-ESI-MS/MS for the identification and quantification of eight cyclic oligomers of PA 6 and four PA 66 migrating from FCMs into food simulant B (3% acetic acid) and beverages. It was proved that doubly charged precursor ions of the cyclic PA 6 and PA 66 oligomers above a mass of 500 Da are formed during the ionisation process of the electrospray technique used. Direct injection of a diluted food simulant into the LC-ESI-MS/MS system after migration makes the validated method a valuable tool for investigating migration of cyclic PA oligomers. The validation results demonstrate that the multi-oligomer method is applicable for the analysis of cyclic PA 6 and PA 66 oligomers in food simulant B. For all investigated cyclic PA oligomers, detection limits were in the range of 0.1-1.1 µg/l. Linearity (r2 ≥ 0.99), trueness values between 91% and 122%, and intra-day (RSDr < 10%) and inter-day precision (RSDR < 19%) were determined and satisfied validation criteria set out by the European Reference Laboratory for FCMs. The method was extended to tap water and tea. Finally, the multi-oligomer method was successfully applied to determine cyclic PA oligomers in migration solutions originating from different PA FCMs. In all migration solutions, concentrations of cyclic PA oligomers were determined above the LOQ. A preliminary risk assessment based on in silico tools was performed. The results demonstrate the urgent need for toxicological data that would facilitate the evaluation of the health risk of cyclic PA oligomers.

Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229).

The food enzyme considered in this opinion is an endo-1,4-ß-xylanase (EC 3.2.1.8) produced with a genetically modified Bacillus subtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo-1,4-ß-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes, dietary exposure to the food enzyme-total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is up to 0.008 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria nor clastogenic activity in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level was derived, which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no matches were found. The Panel considered that there are no indications for food allergic reactions to this xylanase. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety assessment of the active substance selenium nanoparticles, for use in active food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of selenium nanoparticles, FCM substance No 1070, which is intended to be used as an antioxidant. Selenium nanoparticles are incorporated into the adhesive middle layer of multilayer laminates with an outside polyethylene terephthalate (PET) layer and an inner polyolefin (food contact) layer. The final materials are intended to be used for contact with all food types that are susceptible to oxidation. The specific migration of total selenium was tested using multilayer pouches containing selenium nanoparticles at 0.002 mg/dm2 and filled with 3% acetic acid and 20%, 50% or 95% ethanol for 10 days at 60°C. In all tests, migration of selenium was not detectable. Taking into account current knowledge on the diffusional properties of nanoparticles in polymers, the CEF Panel concluded that there is no safety concern for the consumer if selenium nanoparticles are used in multilayer films and separated from the food by a polyolefin food contact layer for any type of food and under any food contact conditions.

Safety assessment of the substance isobutane, for use in food contact materials.

The substance isobutane is intended to be used as a foaming agent at max 4.5% to produce expanded polystyrene (EPS) to be used for packaging foods, such as fruits, vegetables, meat, fish and cheese, at room temperature or lower. Isobutane is approved in Europe as a food additive (E 943b) to be used quantum satis as a gas propellant only in vegetable oil pan spray (for professional use only) and water-based emulsion spray according to Regulation (EC) No 1333/2008. The purity requirements for the use of isobutane as a food additive are described in Commission Regulation (EU) No 231/2012. The substance is a gas at room temperature. It is a saturated hydrocarbon, obtained with a high level of purity, and is not expected to react under the processing conditions used to make foamed polystyrene materials and articles. Data on migration of isobutane from trays at 20°C for 10 days ranged from 0.2 to 0.4 mg/kg food. Considering the intended applications, estimated exposure is extremely low based on migration data. In the absence of genotoxicity alerts and given the very low toxicity following repeated exposure with no observed adverse effect concentration (NOAEC) of several thousands of mg/m3 by inhalation, it was considered that the use of isobutane as a foaming agent, at the expected exposure from food, does not raise a safety concern.

Safety assessment of the process 'Morssinkhof Plastics', used to recycle high-density polyethylene and polypropylene crates for use as food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process 'Morssinkhof Plastics', EU register No RECYC0142. The input consists of crates, boxes, trays, pallets and containers, hereafter termed 'crates', used in food contact, made of high-density polyethylene (HDPE) or polypropylene (PP). It comprises unused damaged crates, prewashed used crates and parts of crates originating from closed and controlled product loops. The process separates crates by material type and food type (fruit, vegetables and prepacked meat vs unpacked meat). Flakes from recycled HDPE or PP are produced that will be used by customers to manufacture new crates for food contact. The Panel considered that the management system put in place to ensure compliance of the origin of the input with Commission Regulation (EC) No 282/2008 and to provide full traceability from input to final product is the critical process step. It concluded that the input of the process 'Morssinkhof Plastics' originates from product loops which are in closed and controlled chains designed to ensure that only materials and articles which have been intended for food contact are used and that any contamination can be ruled out when run under the conditions described by the applicant. The recycling process 'Morssinkhof Plastics' is, therefore, able to produce recycled HDPE and PP suitable for manufacturing HDPE and PP crates intended to be used in contact with dry food, fruits and vegetables, prepacked and unpacked meat. The use of regrind from 'external' recyclers only based on private agreements, does not give reassurance to fall under the scope of Art. 4 c (i) of Commission Regulation (EC) No 282/2008 and is excluded from the present evaluation.