Scientific Opinion on the use of oregano and lemon balm extracts as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of oregano and lemon balm extracts when used as a food additive. The Panel notes that the petitioner has provided only limited chemical characterisation of the compounds present in the extracts and that the specifications as proposed are not in line with what would be expected for a botanical or botanical preparation. The Panel notes that oregano and lemon balm have a safe history of use as herbal food ingredients, and that oregano and lemon balm natural extractives are listed as natural extractives generally recognized as safe (GRAS). However, the Panel considers that this presumption of safety might not be applicable to the specific conditions of use and use levels as a food additive. The potential mean exposure to oregano or lemon balm extracts phenolics from the eight food category sources for which use and use levels were proposed by the petitioner amounted to respectively 2.0 mg/kg bw/day for women and 2.3 mg/kg bw/day for men. The Panel concludes that the intake of phenolics resulting from the use of oregano and lemon balm extracts as food additive at the proposed uses and use levels would be in the range of the intake resulting from the use of oregano and lemon balm leaves for preparation of herbal teas. However, the Panel also notes the inadequate specifications and characterisation of the extracts and the absence of data on genotoxicity, reproductive and developmental toxicity and long-term toxicity of oregano and lemon balm extracts. Altogether, with reference to the SCF ´Guidance on submissions for food additive evaluations, the Panel concludes that due to the lack of an appropriate dossier supporting the use of oregano and lemon balm extracts as additives, the safety of oregano and lemon balm extracts at the proposed uses and use levels cannot be assessed.