25 Feb 2010 --- Following a request from the European Commission, the 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 extracts contain various phenolic compounds which possess antioxidant properties.

The Panel notes that the petitioner has provided only limited chemical characterisation of the compounds present in the oregano and lemon balm extracts.

The Panel notes that the specifications as proposed by the petitioner are not in line with what would be expected for a botanical or botanical preparation and that the presence of compounds of concern such as for example estragole, carvacrol and thymol are not specified.

In a literature study on the phenolic acids recovered in human urine after single ingestion of Origanum onites extract the main identified phenolic constituent in the extract was rosmarinic acid, representing 75% of the identified phenolic acids. Other phenolic acids, including protocatechuic acid, p-coumaric acid, ferulic acid, chlorogenic acid and gallic acid, were present in the extract in notably lower amounts. The extract also contained minor amounts of the flavonoids luteolin and eriodictyol.

Most phenolics in the oregano and lemon balm extracts are absorbed, quickly metabolized and excreted. Concentrations of a variety of phenolic acids have also been found in human fecal water.

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) in the USA. Herbs and flower tips of Origanum vulgare and herbs, flowers and flower tips of Melissa officinalis have been allocated the status N2 by the Council of Europe. The category N2 comprises admissible natural sources of flavourings, and refers to flavourings prepared from kitchen herbs, spices or seasonings frequently eaten in small quantities in an average diet, provided they are used technologically in amounts corresponding to those present in foodstuffs after traditional usage of the source materials. 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 2.0 mg/kg bw/day for women and 2.3 mg/kg bw/day for men, respectively.

Given that the oregano and lemon balm extracts are aqueous extracts, the Panel considered that the exposure to oregano and lemon balm extract phenolics from the use of these herbs as teas can be estimated based on the intake of total tea as consumed (both black tea and herbal tea) by UK adults. Assuming that extraction of the leaves provides 20% dry matter and that this extract contains 22% phenolics (according to the petitioner), this would imply a mean intake of phenolics by UK men of 4.3 mg/kg bw/day and by UK women of 5.3 mg/kg bw/day. The Panel notes however that using intake levels of black or herbal tea to estimate intake of oregano and lemon balm tea may result in an overestimation of intake.

If the potential exposure to phenolics from both the proposed use in foodstuffs and in teas are considered, the combined mean exposure is 6.6 mg/kg bw/day for men and 7.3 mg/kg bw/day for women.

The Panel also notes that the intake estimates provided by the petitioner do not include estimation of intake by high level consumers. However, at this stage the Panel does not consider additional exposure estimates essential.
The Panel concludes that the intake of phenolics resulting from the use of oregano and lemon balm extract 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.