ABSTRACT
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 â â â â â was submitted to read-across from the authorised starting substances, â â â â â and the â â â â â . 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.
ABSTRACT
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 â â â â â 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 â â â â â 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 â â â â â (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.
ABSTRACT
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of 2-methyloxolane as an extraction solvent under the intended conditions of use and the maximum residue limits (MRLs) proposed by the applicant. 2-Methyloxolane is intended to be used in processes currently applying hexane for oil and protein extraction from plant sources or for extraction of food additives. The proposed MRLs for the following uses are: (i) 1 mg/kg in fat, oil or butter; (ii) 10 mg/kg in defatted protein products, defatted flour and other defatted solid ingredients; (iii) 1 mg/kg in food category 13 (foods intended for particular nutritional uses as defined by Directive 2009/39/EC); and (iv) 1 mg/kg for the extraction of food additives. The Panel calculated the dietary exposure with the highest potential maximum (95th percentile) for toddlers as 0.32 mg/kg body weight (bw) per day. Based on the available toxicological data, the Panel concluded that 2-methyloxolane was rapidly metabolised with a low bioaccumulation potential and does not raise a concern for genotoxicity. The Panel identified different no observed adverse effect levels (NOAELs) in a subchronic oral toxicity study in rats, an oral developmental toxicity study and an extended one-generation reproductive toxicity study, and a TDI of 1 mg/kg bw per day for 2-methyloxolane was derived based on the lowest identified NOAEL (100 mg/kg bw per day) for reproductive and developmental toxicity. This TDI was not exceeded in any of the population groups at the mean and 95th percentile exposure. The Panel concluded that the extraction solvent 2-methyloxolane does not raise a safety concern when used according to the intended conditions and at the proposed MRLs in the extracted foods or food ingredients.
ABSTRACT
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 â â â â â , with a median of â â â â â . 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.
ABSTRACT
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 â â â â â and a diameter of â â â â â , with no fragments lower than â â â â â 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.
ABSTRACT
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 â â â â â 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.
ABSTRACT
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.
ABSTRACT
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 â â â â â , 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.
ABSTRACT
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 active substances carboxymethylcellulose, acetylated distarch phosphate (FCM substance No 1071), bentonite, boric acid and aluminium sulfate (FCM substance No 1072). The mixture is intended to be used as a liquid absorber in the packaging of perishable foods to extend their shelf-life. All substances have been evaluated and approved for use as additives in plastic food contact materials and/or as food additives. Migration of boron into foods was up to 0.7 mg/kg food. Migration of aluminium was not detected (limit of detection (LOD) of 0.001 mg/kg). The CEF Panel concludes that the substances carboxymethylcellulose, acetylated distarch phosphate, bentonite, boric acid and aluminium sulfate are not of safety concern for the consumer when used as active components in moisture and liquid absorbers. The absorbent pads must be used under conditions in which direct contact between the active mixture and the food is avoided and the fluid absorption capacity of the absorber is not exceeded.
ABSTRACT
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of [3-(2,3-epoxypropoxy)propyl]trimethoxy silane as a component for sizing glass fibres used for manufacturing glass-fibre-reinforced plastics. The substance is typically applied at up to around 0.2% related to the final plastic. The resulting food contact materials are intended for various scenarios of use, i.e. long-term contact at ambient temperature (e.g. storage tanks) or short-term contact at elevated temperatures (e.g. kitchen utensils). In extracts of treated fibres, neither the substance was detectable at 10 µg/kg fibre nor its hydrolysis product and oligomers at 60 µg/kg fibre. Based on the detection limits, modelling for the plastics and scenarios of intended use resulted in maximum migrations of 0.05 µg/kg food for the substance and 0.15 µg/kg food for the sum of the reaction products. The Panel concludes that the substance has a genotoxic potential. This may also apply to some of its reaction products which contain the epoxy function. However, due to the very low exposure, if any, [3-(2,3-epoxypropoxy)propyl]trimethoxy silane does not raise safety concern if used as a component of sizing agents to treat glass fibres imbedded into low diffusivity plastics (polyethylene terephthalate, polycarbonate, polybutylene terephthalate, thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In addition, the residues in the treated glass fibres must not be detectable at 10 µg/kg for the substance and 60 µg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).