Flavouring Group Evaluation 88, (FGE. 88) Consideration of Phenol and Phenol Derivatives evaluated by JECFA (55th meeting) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (EFSA-Q-2008-081) Adopted on 6 March 2008

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular the Scientific Panel is requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments. The Panel has considered three substances in the JECFA flavouring group of phenol and phenol derivatives. The Panel concluded that no corresponding Flavouring Group Evaluation (FGE) is available. Considering the EU Risk Assessment Report on phenol, the Panel concluded that the available data do not preclude the evaluation of phenol [FL-no: 04.041] and its two esters, phenol acetate [FL-no: 09.688] and phenyl salicylate [FL-no: 09.689] through the Procedure. However, the Panel did not fully agree with the application of the Procedure as performed by the JECFA for the three substances considered in this FGE. Due to the possible formation of toxic metabolites like hydroquinones and quinones, the Panel considered that phenol and its two esters could not be predicted to be metabolised to innocuous products. Accordingly, the evaluation proceeded via the B-side while JECFA has evaluated them via the A-side. The Panel considered that on the basis of the default Maximised Survey-derived Daily Intake (MSDI) approach the three substances [FL-no: 04.041, 09.688 and 09. 689], which have been evaluated using the Procedure, would not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances. For all three substances evaluated through the Procedure use levels are needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation. In order to determine whether the conclusion for the three JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications: Specifications including complete purity criteria and identity tests are available for two of the three JECFA evaluated substances. For one substance [FL-no: 09.689] an identity test is lacking. Thus, for phenyl salicylate [FL-no: 09.689] the Panel has a reservation (a missing identity test). For the remaining two of the three JECFA evaluated substances, phenol and phenyl acetate [FL-no: 04.041 and 09.688] the Panel agrees with the JECFA conclusion "no safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.