Incomplete dossier prevents bakery extracts appraisal, EFSA
Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of oregano and lemon balm extracts when used as a food additive.
The ANS reported that the petitioner, Israeli based Frutarom, requested the authorization of certain extracts of oregano (Origanum vulgare) and lemon balm (Melissa officinalis) under Directive 95/2/EC as a food additive antioxidant for use in a range of foods.
Antioxidants are a functional class of food additives regulated under Directive 95/2/EC4 on food additives other than colours and sweeteners.
The additive, according to the Frutarom dossier, is produced as an aqueous extract of oregano and lemon balm with the antioxidant effect derived from the water soluble plant phenolics present in these herbs.
The company, according to the ANS, argued that oregano and lemon balm leaves are food, that they are not considered to be toxic and have no limit set for their consumption. The petitioner, reports EFSA, also indicated that oregano and lemon balm leaves have been consumed by humans for centuries.
But the ANS noted that Frutarom had provided only limited chemical characterisation of the compounds present in the extracts, did not include data on genotoxicity, reproductive and developmental toxicity and the panel added that the specifications as proposed were not in line with for a botanical or botanical preparation.
The ANS added that the presence of compounds of concern such as estragole, carvacrol and thymol are also not specified in the dossier, and it added that lemon balm may contain estragole - a compound that is known to be both genotoxic and carcinogenic.
Dr Rina Reznik, Origanox business manager of Frutarom, told this publication said it is important to note that the company's oregano and lemon balm extracts are aqueous and that they are expected to be almost devoid of oil soluble compounds, such as carvacrol, thymol and estragole. “The analytical data supporting this claim would be submitted to the EFSA in due time,” she added.
Reznik argues that the benefits of using oregano and lemon balm aqueous extracts in food products, includes their ability to reduce the level of unhealthy oxidation products which are absorbed through the intestine into the blood stream.
The Panel notes that oregano and lemon balm have a safe history of use as herbal food ingredients, and that they are natural extractives listed as generally recognized as safe (GRAS). However, the ANS said 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 including, among others, pasta, pastries, breakfast cereals and bread 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, reports the ANS.
The Panel found 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 herbal teas.
But EFSA also said that the intake estimates provided by the petitioner did not include estimation of intake by high level consumers.
EFSA concluded that due to the lack of an appropriate dossier supporting the use of oregano and lemon balm extracts as additives, the safety of these at the proposed uses and use levels cannot be assessed.
This article was amended from the version orginally published on the 25 February 2010 to include the comments of Dr Rina Reznik, Origanox business manager of Frutarom.
