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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.

Introduction: Cannabis sativa L. is attracting worldwide attention due to various health-promoting effects. Extraction solvent type is critical for the recovery of bioactive compounds from the plant, especially cannabinoids. However, the choice of solvent is varied and not adequately warranted elsewhere, causing confusion in involved fields., Objective: The present work aimed to investigate the effect of extraction solvent on C. sativa (hemp) with regard to cannabinoid recovery and phytochemical profile of the extracts, considering most of the related solvents., Methodology: The majority of solvents reported for C. sativa (n = 14) were compared using a representative hemp pool. Quantitative results for major and minor cannabinoids were rapidly and reliably obtained using ultrahigh-performance liquid chromatography coupled with photodiode array detection (UPLC-PDA). In parallel, high-performance thin-layer chromatographic (HPTLC) fingerprinting was employed, involving less toxic mobile phase than in relevant reports. Various derivatisation schemes were applied for more comprehensive comparison of extracts., Results: Differential selectivity towards cannabinoids was observed among solvents. MeOH was found particularly efficient for most cannabinoids, in addition to solvent systems such as n-Hex/EtOH 70:30 and ACN/EtOH 80:20, while EtOH was generally inferior. For tetrahydrocannabinol (THC)-type compounds, EtOAc and n-Hex/EtOAc 60:40 outperformed n-Hex, despite its use in the official EU method. Solvents that tend to extract more lipids or more polar compounds were revealed based on HPTLC results., Conclusion: Combining the observations from UPLC quantitation and HPTLC fingerprinting, this work allowed comprehensive evaluation of extraction solvents, in view of robust quality assessment and maximised utilisation of C. sativa., (© 2023 The Authors. Phytochemical Analysis published by John Wiley & Sons Ltd.)

Abstract Dimethyl ether was previously evaluated by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) and considered to give rise to no safety concerns under the conditions of use and the maximum residual limits proposed by the applicant. The present scientific opinion of the EFSA CEF Panel deals with the re‐evaluation of the safety of dimethyl ether as an extraction solvent under new intended conditions of use and new maximum residual limits. The applicant requests a change in the residual limit of dimethyl ether in defatted animal protein products (in particular collagen) from 0.009 mg/kg to 3 mg/kg, and a new use for the extraction of protein products to yield gelatin with a residual limit of 0.009 mg/kg is also requested. The Panel notes the maximum residual limit requested by the applicant is much higher than the existing limit. Nonetheless, the margin of exposure for this new application is considered to be adequate. No new toxicity data were provided for dimethyl ether and, since the previous EFSA evaluation, only two in vitro genotoxicity studies have become available. These studies do not indicate any genotoxic potential for the assessed substance. The Panel thus considers that the use of dimethyl ether as an extraction solvent, under the intended conditions of use and with the proposed residual limits of 3 mg/kg in the defatted protein products and 9 μg/kg specifically in gelatin, is of no safety concern.