PMID- 35317123
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220324
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 20
IP  - 3
DP  - 2022 Mar
TI  - Safety assessment of 2-methyloxolane as a food extraction solvent.
PG  - e07138
LID - 10.2903/j.efsa.2022.7138 [doi]
LID - e07138
AB  - 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.
CI  - (c) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety 
      Authority.
CN  - EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
FAU - Lambre, Claude
AU  - Lambre C
FAU - Barat Baviera, Jose Manuel
AU  - Barat Baviera JM
FAU - Bolognesi, Claudia
AU  - Bolognesi C
FAU - Chesson, Andrew
AU  - Chesson A
FAU - Cocconcelli, Pier Sandro
AU  - Cocconcelli PS
FAU - Crebelli, Riccardo
AU  - Crebelli R
FAU - Gott, David Michael
AU  - Gott DM
FAU - Grob, Konrad
AU  - Grob K
FAU - Lampi, Evgenia
AU  - Lampi E
FAU - Mengelers, Marcel
AU  - Mengelers M
FAU - Mortensen, Alicja
AU  - Mortensen A
FAU - Steffensen, Inger-Lise
AU  - Steffensen IL
FAU - Tlustos, Christina
AU  - Tlustos C
FAU - Van Loveren, Henk
AU  - Van Loveren H
FAU - Vernis, Laurence
AU  - Vernis L
FAU - Zorn, Holger
AU  - Zorn H
FAU - Bignami, Margherita
AU  - Bignami M
FAU - Furst, Peter
AU  - Furst P
FAU - Tard, Alexandra
AU  - Tard A
FAU - Van Haver, Ellen
AU  - Van Haver E
LA  - eng
PT  - Journal Article
DEP - 20220315
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC8923129
OTO - NOTNLM
OT  - 2-methyloxolane
OT  - CAS No. is 96-47-9
OT  - extraction solvent
OT  - maximum residue limit
OT  - safety assessment
EDAT- 2022/03/24 06:00
MHDA- 2022/03/24 06:01
PMCR- 2022/03/15
CRDT- 2022/03/23 05:08
PHST- 2022/03/23 05:08 [entrez]
PHST- 2022/03/24 06:00 [pubmed]
PHST- 2022/03/24 06:01 [medline]
PHST- 2022/03/15 00:00 [pmc-release]
AID - EFS27138 [pii]
AID - 10.2903/j.efsa.2022.7138 [doi]
PST - epublish
SO  - EFSA J. 2022 Mar 15;20(3):e07138. doi: 10.2903/j.efsa.2022.7138. eCollection 2022 
      Mar.