Flavouring substance considered a safety concern
The flavouring substance p-Mentha-1,8-dien-7-al (also called “Perilla aldehyde”) has been shown to be genotoxic (damaging to DNA) in a new study on animals, evaluated by EFSA’s experts. Under EFSA’s process for the safety assessment of food flavourings, once a substance is characterised as a genotoxin, EFSA concludes on this aspect only without taking into account consumer exposure.
In 2002, an international evaluation of Perilla aldehyde as a food flavouring found it to be “no safety concern at current levels of intake”. In 2008, the European Commission asked EFSA to re-evaluate this substance as part of the evaluation of all food flavourings authorised for use in the EU.
The flavouring industry first submitted data for this flavouring substance in 2012 following an EFSA request. EFSA’s experts then concluded in 2013 that the substance was potentially genotoxic and requested an additional study to determine the potential effects on the liver and stomach. The new study submitted in 2014 is the focus of the current EFSA opinion, which concludes that Perilla aldehyde induces DNA damage in the liver. EFSA’s experts noted, however, some weaknesses in the historical control data (i.e. concerning the test animals not exposed to the specific substance under examination) of the laboratory that carried out this test.
Under the EU system devised to evaluate flavourings, Perilla aldehyde is also a proxy for evaluating nine other structurally similar chemicals known collectively as “alicyclic aldehydes”. EFSA’s experts, therefore, indicate there is also a potential safety concern for these other substances unless further evidence proves otherwise.
Perilla aldehyde occurs naturally in the peel of citrus fruits. It is produced in limited quantities and added to some baked foods, puddings, meat products and both alcoholic and non-alcoholic drinks to produce a pungent citrus smell and a woody, spicy, citrus taste.
EU risk managers will consider how to best use EFSA’s scientific opinion in weighing up possible follow-up measures.
- The process EFSA uses for the safety assessment of flavourings is described in EFSA’s Guidance on the data required for the risk assessment of flavourings to be used in or on foods. With regards to the assessment of the potential genotoxicity of a substance, EFSA’s scientists follow the Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment.
- The European Union list of flavourings authorised for use in foods in the EU entered into force in October 2012. Since 2003, EFSA has played an important part in preparing this list by evaluating the safety of thousands of flavouring substances. Over 2,000 flavouring substances have been deemed fit for inclusion in the EU list. This significant programme of scientific work, which is still ongoing, has played and continues to play a critical role in ensuring that flavouring substances used in foods are of no safety concern for consumers.
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