Migration of styrene oligomers from food contact materials: in silico prediction of possible genotoxicity.

Styrene oligomers (SO) are well-known side products formed during styrene polymerization. They consist mainly of dimers (SD) and trimers (ST) that have been shown to be still residual in polystyrene (PS) materials. In this study migration of SO from PS into sunflower oil at temperatures between 5 and 70 °C and contact times between 0.5 h and 10 days was investigated. In addition, the contents of SD and ST in the fatty foodstuffs créme fraiche and coffee cream, which are typically enwrapped in PS, were measured and the amounts detected (of up to 0.123 mg/kg food) were compared to literature data. From this comparison, it became evident, that the levels of SO migrating from PS packaging into real food call for a comprehensive risk assessment. As a first step towards this direction, possible genotoxicity has to be addressed. Due to technical and experimental limitations, however, the few existing in vitro tests available are unsuited to provide a clear picture. In order to reduce uncertainty of these in vitro tests, four different knowledge and statistics-based in silico tools were applied to such SO that are known to migrate into food. Except for SD4 all evaluated SD and ST showed no alert for genotoxicity. For SD4, either the predictions were inconclusive or the substance was assigned as being out of the chemical space (out of domain) of the respective in silico tool. Therefore, the absence of genotoxicity of SD4 requires additional experimental proof. Apart from SD4, in silico studies supported the limited in vitro data that indicated the absence of genotoxicity of SO. In conclusion, the overall migration of all SO together into food of up to 50 µg/kg does not raise any health concerns, given the currently available in silico and in vitro data.

Characterisation of Elastomers as Food Contact Materials-Part 1: Quantification of Extractable Compounds, Swelling of Elastomers in Food Simulants and Release of Elements.

Elastomers are not a uniform class of materials but comprise a broad spectrum of chemically different polymers. Sealing gaskets, gloves, teats, conveyor belts and tubing are examples of elastomers being used as food contact materials (FCMs). Ten elastomer samples were evaluated with respect to the content of extractable compounds, migration of substances into ethanolic food simulants, swelling in food simulants and release of elements in different food simulants. The number of extractable substances <1000 Da was determined by comprehensive two-dimensional gas chromatography coupled with flame ionisation detection (GC × GC-FID) analysis of tetrahydrofuran (THF) extracts. The number of signals ranged from 61 (a thermoplastic elastomer (TPE)) to 690 (a natural rubber/styrene-butadiene-rubber blend (NR/SBR)). As for risk assessment, the decisive factor is which substances reach the food. The extent of substances that migrate into ethanolic food simulants was investigated. Elastomer FCMs can be the source of food contamination with heavy metals. Notably, contamination with lead was detected in some samples investigated in this study. It was shown that food simulants harbour the potential to morphologically alter or even disintegrate elastomeric materials. The results presented here highlight the importance to carefully choose the elastomer type for the intended use as FCMs as not every application may prove safe for consumers.

Aggregated aluminium exposure: risk assessment for the general population.

Aluminium is one of the most abundant elements in earth's crust and its manifold uses result in an exposure of the population from many sources. Developmental toxicity, effects on the urinary tract and neurotoxicity are known effects of aluminium and its compounds. Here, we assessed the health risks resulting from total consumer exposure towards aluminium and various aluminium compounds, including contributions from foodstuffs, food additives, food contact materials (FCM), and cosmetic products. For the estimation of aluminium contents in foodstuff, data from the German "Pilot-Total-Diet-Study" were used, which was conducted as part of the European TDS-Exposure project. These were combined with consumption data from the German National Consumption Survey II to yield aluminium exposure via food for adults. It was found that the average weekly aluminium exposure resulting from food intake amounts to approx. 50% of the tolerable weekly intake (TWI) of 1 mg/kg body weight (bw)/week, derived by the European Food Safety Authority (EFSA). For children, data from the French "Infant Total Diet Study" and the "Second French Total Diet Study" were used to estimate aluminium exposure via food. As a result, the TWI can be exhausted or slightly exceeded-particularly for infants who are not exclusively breastfed and young children relying on specially adapted diets (e.g. soy-based, lactose free, hypoallergenic). When taking into account the overall aluminium exposure from foods, cosmetic products (cosmetics), pharmaceuticals and FCM from uncoated aluminium, a significant exceedance of the EFSA-derived TWI and even the PTWI of 2 mg/kg bw/week, derived by the Joint FAO/WHO Expert Committee on Food Additives, may occur. Specifically, high exposure levels were found for adolescents aged 11-14 years. Although exposure data were collected with special regard to the German population, it is also representative for European and comparable to international consumers. From a toxicological point of view, regular exceedance of the lifetime tolerable aluminium intake (TWI/PTWI) is undesirable, since this results in an increased risk for health impairments. Consequently, recommendations on how to reduce overall aluminium exposure are given.

Risk assessment of food contact materials.

Bisphenol A (BPA) is authorised for use as a chemical compound for the production of plastic food contact materials (FCMs) under Regulation (EU) No 10/2011. But according to requirements of the Regulation (EU) No 2018/213, BPA has been banned in the manufacture of polycarbonate drinking cups or feeding bottles intended for infants and young children. Food has been identified as the main source of human exposure to BPA, followed by dermal absorption, air and dust inhalation, revealing ubiquitous and continuous contact with BPA. Considering that BPA is able to enter the food chain through the migration from food packaging into foodstuffs, assessment of dietary exposure is necessary for accurate estimations and identification of potential exposure from food sources. In 2015, EFSA set a temporary tolerable daily intake (TDI) for BPA of 4 µg/kg body weight (bw) per day and concluded that no health concern from BPA exposure for any age group was to be expected. In 2023, EFSA has re-evaluated BPA safety and the new TDI was reduced by a factor of 20,000 resulting in a TDI of 0.2 ng/kg bw per day. In this case, the CEP Panel concluded that there is a health concern from dietary exposure to BPA. Amongst others, the BfR identified several points of criticism which, in the opinion of the BfR, call into question the risk assessment carried out by EFSA. The BfR derived a TDI of 200 ng/kg bw per day and suggests taking this into account for risk assessment. In the proposed EU-FORA programme, the fellow had the opportunity to gain experience in the exposure assessment and then integrate the data together with the BfR hazard assessment to perform a comprehensive risk assessment. As second objective of the work programme, the fellow was in charge of performing a toxicokinetic analysis in an attempt to correlate external exposure with urinary BPA levels.

Safety assessment of 'waxes, paraffinic, refined, derived from petroleum-based or synthetic hydrocarbon feedstock, low viscosity' for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the 'waxes, paraffinic, refined, derived from petroleum-based or synthetic hydrocarbon feedstock, low viscosity' (FCM No. 93), for which the uses were requested to be extended for articles in contact with fatty foods. Migration from low-density polyethylene samples containing 1% w/w of a representative wax was tested in food simulants. In fatty food simulants, the migration of mineral oil saturated hydrocarbons (MOSH) ≤ C35 was 142 mg/kg food, exceeding the overall migration limit for plastic FCM. Mineral oil aromatic hydrocarbons (MOAH) with at least two rings are largely removed during the manufacturing process. Based on various lines of evidence, the Panel concluded that any concern for the potential presence of MOAH with two or more conjugated aromatic rings can be ruled out. Based on the genotoxicity studies and on the content of polycyclic aromatic hydrocarbons (PAHs), the substance does not raise a concern for genotoxicity. Available toxicokinetic data showed a limited accumulation of MOSH. No adverse effects were observed up to the highest tested dose of 9 g/kg body weight per day in a 90-day repeated oral toxicity study in Sprague-Dawley rats. The available results showed that FCM No. 93 is devoid of endocrine activity. The provided information on chronic toxicity and carcinogenicity was limited and inadequate to reach conclusions on these endpoints. Therefore, the CEP Panel concluded that under the intended and tested conditions of uses, the substance does not raise safety concern for the consumer if used to a level ensuring that its migration into food is no more than 5 mg/kg.

Safety assessment of the substance poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters (OLA8), which is intended to be used as a plasticiser into polylactic acid (PLA) in contact with non-fatty foods. OLA8 is intended to be used at up to 5% and 15% w/w with or without starch, respectively (or with other additives with similar function). The migration for 10 days at 40°C from the film without starch was 0.16 mg/kg in 10% ethanol and 0.01 mg/kg in 3% acetic acid, while from the film with the starch it was well above 0.05 mg/kg food in all simulants. Some of the testing conditions were inconsistently reported. The substance did not induce gene mutations in bacterial cells and did not induce structural chromosomal aberrations or polyploidy in mammalian cells, thus, does not raise concern for genotoxicity. Instead of providing a 90-day oral toxicity study, a hydrolysis study in ■■■■■ was submitted to read-across from the authorised starting substances, ■■■■■ and the ■■■■■. However, the data provided did not allow to perform the read-across, thus no appropriate toxicological data were provided to support migration above 0.05 mg/kg food (including for contact with 10% ethanol and use in combination with starch). The Panel concluded that OLA8 does not raise a safety concern for the consumer if it is used as an additive at up to 15% w/w in the manufacture of PLA articles that do not contain starch (and other additives with similar function), that are intended to be in contact for 10 days at 40°C with foods simulated by 3% acetic acid and from which the migration does not exceed 0.05 mg/kg food.

Degradation and epimerization of ergot alkaloids after baking and in vitro digestion.

The degradation and epimerization of ergot alkaloids (EAs) in rye flour were investigated after baking cookies and subsequently subjecting them to an in vitro digestion model. Different steps of digestion were analyzed using salivary, gastric, and duodenal juices. The degradation and bidirectional conversion of the toxicologically relevant (R)-epimers and the biologically inactive (S)-epimers for seven pairs of EAs were determined by a HPLC method coupled with fluorescence detection. Baking cookies resulted in degradation of EAs (2-30 %) and a shift in the epimeric ratio toward the (S)-epimer for all EAs. The applied digestion model led to a selective toxification of ergotamine and ergosine, two ergotamine-type EAs. The initial percentage of the toxic (R)-epimer in relation to the total toxin content was considerably increased after digestion of cookies. Ergotamine and ergosine increased from 32 to 51 % and 35 to 55 %, respectively. In contrast, EAs of the ergotoxine type (ergocornine, α- and ß-ergocryptine, and ergocristine) showed an epimeric shift toward their biologically inactive (S)-epimers. Further experiments indicated that the selective epimerization of ergotamine EAs occurs in the duodenal juice only. These results demonstrate that toxification of EAs in the intestinal tract should be taken into consideration.

Ergotaminine.

The title compound {systematic name: (6aR,9S)-N-[(2R,5S,10aS,10bS)-5-benzyl-10b-hy-droxy-2-methyl-3,6-dioxoocta-hydro-8H-oxazolo[3,2-a]pyrrolo-[2,1-c]pyrazin-2-yl]-7-methyl-4,6,6a,7,8,9-hexa-hydro-indolo[4,3-fg]quinoline-9-carboxamide}, C(33)H(35)N(5)O(5), was formed by an epimerization reaction of ergotamine. The non-aromatic ring (ring C of the ergoline skeleton) directly fused to the aromatic rings is nearly planar [maximum deviation = 0.317 (4) Å] and shows an envelope conformation, whereas ring D, involved in an intra-molecular N-H⋯N hydrogen bond exhibits a slightly distorted chair conformation. The structure displays chains running approximately parallel to the diagonal of bc plane that are formed through N-H⋯O hydrogen bonds.

Lysergol monohydrate.

IN THE TITLE COMPOUND [SYSTEMATIC NAME: (7-methyl-4,6,6a,7,8,9-hexa-hydro-indolo[4,3,2-fg]quinoline-9-yl)methanol monohydrate], C(16)H(18)N(2)O·H(2)O, the non-aromatic ring (ring C of the ergoline skeleton) directly fused to the aromatic rings is nearly planar, with a maximum deviation of 0.659 (3) Å, and shows an envelope conformation. In the crystal, hydrogen bonds between the lysergol and water mol-ecules contribute to the formation of layers parallel to (10[Formula: see text]).

Risk Assessment of Food Contact Materials II.

Food contact materials (FCMs) are materials and articles intended to be placed in direct or indirect contact with foodstuffs, or which can reasonably be expected to come into contact with food under normal or foreseeable conditions of use. Substances intentionally used to manufacture FCMs, as well as non-intentionally added substances resulting from impurities, by-products and/or degradation products, can migrate from FMCs into food and, consequently, are taken up by humans. To protect consumers' health, EU legislation requires that FCMs must be sufficiently inert to prevent substances from being transferred into the food in quantities that could endanger human health. At the German Federal Institute for Risk Assessment (BfR), Unit 74 'Safety of Food Contact Materials' deals with the risk assessment of FCMs and provides recommendations on the use of substances for the production of FCMs for which no specific European measures exist yet (e.g. silicone, rubber, paper and board). The BfR 'Recommendations on Food Contact Materials' are not legally binding; however, they represent the current state of the scientific and technical knowledge for the conditions under which these materials meet the requirements for consumer safety. As part of the EU-FORA programme, the fellow was involved in the risk assessment tasks and projects undertaken by Unit 74, which include: (i) the scientific evaluation of analytical and toxicological data from dossiers for adding new substances to the database 'BfR Recommendations on Food Contact Materials'; (ii) the hazard assessment of cyclic volatile methylsiloxanes (cVMS) migrating from silicone FCMs into foodstuff; and (iii) in vitro metabolic stability study of cyclic methylsiloxanes in the presence of S9 fraction, performed in the BfR laboratories. Moreover, the EU-FORA fellowship was a great opportunity for the fellow to build a strong network of food safety experts and to be part of an international community of risk assessment professionals.

Risk assessment of food contact materials.

In the EU, any material or article intended to come into contact with food, which is placed on the market, has to comply with the requirements of the Regulation (EC) No 1935/2004 - the so called 'framework regulation' for food contact materials (FCM). FCM covers a wide range of materials, including plastics, paper, metal and glass, which contain chemicals that might migrate into food. These chemicals must not migrate into the foodstuff in quantities that could endanger human health, bring about an unacceptable change in the composition of the food, or bring about a deterioration in the organoleptic characteristics thereof. Despite of this general regulation, the safety of new and specific materials that are not covered must be assessed case-by-case. In addition, national authorities can set their own regulations, and in this context, the BfR sets recommendations, which are not legal norms, but represent a standard for the production of materials not subjected to any specific legislation and are well accepted by other European Commission member states according to the mutual recognition principle. The BfR Unit 74 is responsible not only to deal with chemical risk assessment of FCM but also to evaluate application dossiers to include new substances in the positive list of FCM chemicals. In the proposed EU-FORA programme, the fellow had the opportunity to gain experience in the evaluation of toxicological data from applicant dossiers and in the methodologies of migration tests performed in the laboratories. Moreover, the fellow also made a bibliographic review on scientific literature on the migration studies from starch-based materials.

Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the combined use of cyclooctene homopolymer (PCOE) and cobalt stearate (CoS) intended as a oxygen scavenger in the packaging of all kinds of food stored at room temperature or below for up to 6 months. The CoS is the oxidation catalyst and the PCOE is intentionally oxidised for the oxygen scavenging function. They are incorporated into a plastic layer that is intended to be either in direct or indirect contact with the food. The potential migration of cobalt and cyclooctene monomer were below their respective specific migration limit (SML). The potential migration of PCOE non-oxidised oligomeric low molecular weight fraction (LMWF) < 1,000 Da was estimated to be up to ■■■■■ The Panel concluded that this fraction does not raise concern for genotoxicity potential and that the no observed adverse effect level (NOAEL) derived from a subchronic toxicity study would ensure a margin of exposure large enough to not raise a safety concern. However, the Panel considered the analysis of the oxidised PCOE LMWF not sufficiently comprehensive, i.e. that additional oxidation products of different nature may be formed, and that the limit of detection corresponding to ca. ■■■■■ for individual substances is too high. The oxidised PCOE LMWF was not covered by the genotoxicity tests or the 90-day study on the PCOE oligomers. The assessment of the identified potential oxidised migrants was considered conclusive, but not that of the migrants having remained undetected. Therefore, the CEP Panel was not able to conclude on the safety of the proposed use of cyclooctene homopolymer and cobalt stearate together as active substances in a layer for scavenging oxygen, either in direct contact with the food or separated from the food by a passive layer of polymer.

Safety assessment of the substance nano precipitated calcium carbonate for use in plastic food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance 'nano precipitated calcium carbonate', FCM substance No. 1087, the particles size of which is in the range of ■■■■■, with a median of ■■■■■. The substance is intended to be used as a filler in all plastics at up to 5% w/w for contact with acidic food and at up to 40% w/w for contact with all other types of food. Articles made with the substance are intended for long-term storage at room temperature or below. The particulate form of the calcium carbonate dissolved rapidly under simulated gastric conditions and, therefore, in accordance with the EFSA Guidance on Particle - Technical Requirements (2021), an assessment of the particles in nanoform is not required and a conventional risk assessment is sufficient. Calcium carbonate, not in nanoform, is authorised for use in plastic FCM without specific migration limit (FCM No. 21) and for use as a food additive (E 170). Migration, from low-density polyethylene (LDPE) containing 40% of the substance, was below 0.03 mg/kg in isooctane and 95% ethanol, and 5.4 mg/kg in 10% ethanol. For LDPE containing 5% of the substance, corresponding to the maximum intended amount for contact with acidic foods, the migration was 17 mg/kg. Therefore, the CEP Panel concluded that the substance nano precipitated calcium carbonate is not of safety concern for consumers when used as a filler in all types of polymer for all types of food, except for infant food formulae. The Panel noted, however, that for acidic foods, the overall migration limit may be exceeded.

Safety assessment of the substance chopped carbon fibres, from carbonised polyacrylonitrile, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of chopped carbon fibres, from carbonised polyacrylonitrile, as food contact material (FCM) substance No 1086, which is intended to be used as a filler for polyether ether ketone (PEEK) polymer at up to 40% w/w. The plastic is intended for repeated use in contact with all types of foods under all conditions of use. The chopped carbon fibres have a length of ■■■■■ and a diameter of ■■■■■, with no fragments lower than ■■■■■ in any dimension. They do not include a fraction of particles at the nanoscale and are fully embedded in the PEEK matrix, and therefore the fibres and any fragments are not expected to migrate. Based on the results of a battery of three genotoxicity tests, the Panel concluded that the substance does not raise a concern for genotoxicity. Therefore, the CEP Panel concluded that the substance chopped carbon fibres, from carbonised polyacrylonitrile, with a minimum carbon content of 95% (at sizes not at the nanoscale) does not raise a safety concern for the consumer if the substance is used as a filler at up to 40% w/w for PEEK plastic in contact with all food types and under all conditions of use.

Safety assessment of the substance fatty acid-coated nano precipitated calcium carbonate for use in plastic food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance identified by the applicant as 'fatty acid-coated nano precipitated calcium carbonate'. It is intended to be used as a filler in all plastics at up to 5% for contact with acidic food and at up to 40% for contact with all other types of food. Articles made with the substance are intended for long-term storage over 6 months at room temperature and below. No information was provided on the mechanism of coating as to whether there is chemical modification of the surface and/or physical adsorption. The substance was not properly characterised, either as pristine material or when incorporated into plastic. Contrary to the non-coated material, data show that the coated material does not dissolve fully and quickly under pH conditions simulating gastrointestinal tract. Surface analysis with electron microscopy of low-density polyethylene (LDPE) samples before and after migration experiments showed major differences that indicate release of the substance from the surface after the tests with 3% acetic acid and to a lesser extent with 10% ethanol. This is consistent with measurable migrations that were up to 39 mg CaCO3/kg when using an LDPE sample made with 5% of the substance in contact with acetic acid for 64 days at 40°C. The required data on the release of nanoparticles and on the potential toxicity of the substance in nanoform were not provided. Therefore, the Panel could not conclude on the safe use of the substance.

Safety assessment of diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate for use in a food contact material.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate, FCM substance No. 1007, which is intended to be used in the polymerisation reaction to make poly(ethylene 2,5-furandicarboxylate) (PEF) plastic. The substance is intended to become a component of the backbone of the polymer and has an antioxidant function that provides thermal stability to the polyester during heat processing. The resulting plastic is intended to be used in contact with all types of food under any condition of time and temperature. A PEF sample made using 0.1% w/w of the substance (which is the maximum intended use) was used in a comprehensive set of migration tests with food simulants. The migration of the substance was below the quantification limits estimated around 10 µg/kg. Solvent extraction tests showed no presence of impurities or breakdown products of the substance. The toxicological data provided are the same as those submitted by the same applicant and previously evaluated. The resulting assessment and conclusions are considered still valid by the CEP Panel. Therefore, the CEP Panel concluded that the substance diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate does not raise a safety concern for the consumer if used at up to 0.1% w/w (based on the weight of the polymer) in the polymerisation to make PEF intended for contact with all types of foods under any contact conditions.

Safety assessment of bleached cellulose pulp for use in plastic food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids assessed the safety of the substance bleached cellulose pulp, consisting of cellulose fibres (70-92%) and hemicellulose (8-30%) obtained from pine and spruce wood. The substance is intended to be used ■■■■■ in polyethylene and polypropylene food contact materials. The final articles are intended to be used for all food types and for long-term storage at room temperature, with or without a short time at higher temperature, including hot-fill. Low-density polyethylene samples containing ■■■■■ of the substance were subjected to a broad set of migration tests with food simulants and extraction tests with dichloromethane. The limits of detection ranged from ■■■■■ (when specified). The Panel noted that they do not ensure the detection of genotoxic substances at a concentration leading to a human exposure above the Threshold of Toxicological Concern. Moreover, not all possibly migrating substances were identified or amenable to the analytical methods applied. No toxicological data were provided for the substance itself, as its migration into food is not expected. The safety of the potentially migrating substances of low molecular mass detected was addressed individually and was considered adequate. However, the Panel considered this approach insufficient owing to a substantial fraction of unidentified components. The Panel concluded that the information provided by the applicant does not allow the safety assessment of the substances below 1,000 Da from bleached cellulose pulp from pine and spruce wood used in plastic food contact materials potentially migrating into food. Therefore, the Panel could not conclude on the safety of the use of bleached cellulose pulp from pine and spruce wood as a plastic additive.

Safety assessment of the substance phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (FCM No 1076), 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 ■■■■■ This food contact material (FCM) substance No 1076 was evaluated by the CEP Panel in 2019 for its use in high impact polystyrene. This opinion deals with the safety assessment of the substance when used as an additive at up to 0.025% w/w in acrylonitrile-butadiene-styrene (ABS) copolymers. The plastic is intended for repeated use in contact with aqueous, acidic, alcoholic and oil-in-water emulsion foods, for long-term storage at room temperature and below. Migration from ABS formulated with the substance at 0.02% w/w was up to 0.002 mg/kg in 10% ethanol, 0.005 mg/kg in 3% acetic acid and 0.027 mg/kg in 50% ethanol. Migration levels into 50% ethanol declined under repeated-use test conditions and this decline was considered to also cover repeated contacts with 10% ethanol and 3% acetic acid simulants. The toxicological data are the same as those submitted by the same applicant in a previous dossier (EFSA-Q-2018-00411). They were reported in the scientific opinion of the CEP Panel in 2019 and the conclusions on toxicity are still valid. Overall, the CEP Panel concluded that the substance phosphorous acid, triphenyl esters, 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 as an additive at up to 0.025% w/w in ABS materials and articles for single and repeated use in contact with aqueous, acidic, alcoholic and oil-in-water emulsion foods, for long-term storage at room temperature and below, and if its migration does not exceed 0.05 mg/kg food.

Safety assessment of the substance silver nanoparticles for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the additive silver nanoparticles intended to be used in plastics. All the silver particles are in the size range of 1-100 nm, with about 15 nm mean diameter and 99% by number of particles below 20 nm. The additive is intended to be used as a surface biocide at up to 0.025% w/w in non-polar plastics for contact with a wide variety of foods, times, temperatures and food contact surface/mass of food ratios. The particulate form is maintained when the additive is incorporated into plastics, albeit with some aggregation/agglomeration observed. The data and information on theoretical considerations, on specific migration and abrasion tests show that, under the intended and tested conditions of uses, the silver nanoparticles stay embedded in the polymer, do not migrate and resist release by abrasion, thus, do not give rise to exposure via food and to toxicological concern. There is migration of silver in soluble ionic form up to 6 µg/kg food from the surface of the additive particles. This is below the group restriction of 50 µg silver/kg food proposed by the AFC Panel in 2004 and would lead to a maximum exposure from FCM that would be below the acceptable daily intake (ADI) of 0.9 µg silver ions/kg body weight (bw) per day established by ECHA. Therefore, the Panel concluded that the substance does not raise safety concern for the consumer if used as an additive at up to 0.025% w/w in polymers, such as polyolefins, polyesters and styrenics, that do not swell in contact with aqueous foods and food simulants. The Panel noted, however, that exposure to silver from other sources of dietary exposure may exceed the ADI set by ECHA.