Statement on the BfR opinion regarding the toxicity of 2‐chloroethanol

In accordance with Art. 31(1) of Regulation (EC) No 178/2002, the Commission asked EFSA to provide a scientific review on the BfR opinion on the ‘Health risk assessment of ethylene oxide residues in sesame seeds’ (Opinion No 024/2021) regarding the toxicity of 2‐chloroethanol. In addition, EFSA was asked to clarify under which circumstances the use of the MOE approach is considered appropriate. Based on the information available to EFSA, i.e. the studies assessed in the frame of the BfR opinion and additional data provided by stakeholders not assessed by BfR, EFSA considers the genotoxicity of 2‐chloroethanol as inconclusive. On this basis, EFSA would not recommend setting reference points for risk assessment or health‐based guidance values until the genotoxic potential of 2‐chloroethanol is clarified. EFSA therefore recommends performing new in vitro gene mutation and in vitro micronucleus tests with 2‐chloroethanol following the recommendations of the most recent OECD technical guidelines to clarify its genotoxic potential. If the result of any of the test is positive, the recommendations of the EFSA Scientific Committee (2011) should be followed. If the genotoxic potential of 2‐chloroethanol is finally clarified and overall negative, EFSA would recommend setting the reference point for deriving health‐based guidance values based on existing toxicity studies on 2‐chloroethanol.