Re-assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materials.

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.

Safety assessment of the substance N,N'-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide) for use in plastic food contact materials.

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.

New approach methodologies in human health risk assessment across European regulatory frameworks: Status quo, barriers and drivers for regulatory acceptance and use.

The traditional approaches to chemical risk assessment for human health are continuously challenged by their limitations, such as validity concerns, societal pressure to use animal-free methods, and resource constraints. New Approach Methodologies (NAMs) are considered a promising avenue toward modernisation of chemical risk assessment practices but their implementation in practice has been slow. This article aims to investigate the perspectives of human health risk assessors on the status quo, barriers and drivers of the acceptance and use of NAMs across different regulatory frameworks.

Update of the safety assessment of N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amines (FCM No 19) and N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides (FCM No 20) for their use in plastic materials and articles intended to come into contact with food.

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.

Safety assessment of the substance 2,2'-oxydiethylamine for use in plastic food contact materials.

The EFSA Panel on Food Contact Materials assessed the safety of 2,2'-oxydiethylamine, which is intended to be used at up to 14% w/w as a monomer along with adipic acid and caprolactam to make polyamide thin films intended for single use, in contact with all types of food under all conditions of time and temperature. Specific migration of 2,2'-oxydiethylamine was tested from a polyamide film in water and was below the limit of quantification (LOQ) of 0.015 mg/kg.

Cross-mapping of terms used in chemical risk assessment with those used in systematic review: research protocol.

The focus on implementation of systematic review (SR) principles in chemical risk assessments (CRAs) is growing as it has the potential to advance the rigour and transparency of the CRAs. However, the SR and CRA communities use their own specific terminologies. Understanding the meaning of core SR and CRA terms and where they overlap is critical for application of SR methods and principles in CRAs.

Safety assessment of the substance amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of amines, di-C14-C18-alkyl, oxidised, renamed by the Panel as amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil. The substance amines, bis(hydrogenated tallow alkyl) oxidised, consisting of the same components, but originating from tallow, is currently authorised as FCM substance No 768. The vegetable-sourced substance is intended to be used at up to 0.

Safety assessment of the substance calcium -butylphosphonate for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids assessed the safety of calcium -butylphosphonate, which is intended to be used as a nucleating agent up to 0.15% w/w for the manufacture of polyolefin food contact materials (FCM) and articles for single and repeated use, in contact with all types of food, including infant formula and human milk. Specific migration was tested using polyethylene samples in 10% ethanol, 3% acetic acid and 95% ethanol for 2 h at 100°C, followed by 238 h at 40°C.

Safety assessment of the substance 'phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl esters', for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance 'phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl esters', when used as an additive in all types of polyolefins. The substance is a polymer containing ≤ 13% w/w of a low molecular weight fraction (LMWF, < 1000 Da). A polyethylene sample with 0.

Protocol for designing INVITES-IN, a tool for assessing the internal validity of studies.

This protocol describes the design and development of a tool for evaluation of the internal validity of studies, which is needed to include the data as evidence in systematic reviews and chemical risk assessments. The tool will be designed specifically to be applied to cell culture studies, including, but not restricted to, studies meeting the new approach methodology (NAM) definition. The tool is called INVITES-IN (IN VITro Experimental Studies INternal validity).

A comprehensive item bank of internal validity issues of relevance to in vitro toxicology studies.

Context: toxicology studies are increasingly being included as evidence in systematic reviews and chemical risk assessments. INVITES-IN, a tool for assessing the internal validity of studies, is currently under development. The first step in developing INVITES-IN involves the creation of an "item bank," an overview of study assessment concepts that may be relevant to evaluating the internal validity of toxicology studies.

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.

Prediction of prenatal chlorpyrifos exposure leading to developmental neurotoxicity in humans based on toxicity data by quantitative extrapolation.

: Epidemiological studies in children suggested that in utero exposure to chlorpyrifos (CPF), an organophosphate insecticide, may cause developmental neurotoxicity (DNT). We applied quantitative - extrapolation (QIVIVE) based on concentration and non-choline esterase-dependent effects data combined with Benchmark dose (BMD) modelling to predict oral maternal CPF exposure during pregnancy leading to fetal brain effect concentration. By comparing the results with data from epidemiological studies, we evaluated the contribution of the endpoints to the mode of action (MoA) for CPF-induced DNT.

- Extrapolation by Physiologically Based Kinetic Modeling: Experience With Three Case Studies and Lessons Learned.

Physiologically based kinetic (PBK) modeling has been increasingly used since the beginning of the 21st century to support dose selection to be used in preclinical and clinical safety studies in the pharmaceutical sector. For chemical safety assessment, the use of PBK has also found interest, however, to a smaller extent, although an internationally agreed document was published already in 2010 (IPCS/WHO), but at that time, PBK modeling was based mostly on data as the example in the IPCS/WHO document indicates. Recently, the OECD has published a guidance document which set standards on how to characterize, validate, and report PBK models for regulatory purposes.

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.

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.

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.

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.

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.

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.