No risk posed from magnolia bark extract in gum and mints, says ACNFP
The bark of the Magnoliae officinalis tree, a member of the biloba subspecies, has been used in traditional Chinese herbal medicine for thousands of years, and is reputed to have anti-stress properties. It is used in dietary supplements in some countries.
The US-based William Wrigley Jr Company filed a submission for novel foods approval for the extract with the UK’s Food Standards Agency (FSA) in September 2009.
It deemed the application necessary because the ingredient has been isolated from the plant. Moreover, it does not have a safe history of use in the European Union in chewing gum and confectionery products.
In the UK, the assessment of novel foods is carried out by the ACNFP, which an independent committee of scientists appointed by the FSA.
Clarification requests met
The draft opinion of the Committee is open for stakeholder consultation until 5 July 2010, with the ACNFP adding that all comments received by stakeholders will be taken into account before it adopts its final opinion on the ingredient.
The Committee stated that it is satisfied with the information provided by Wrigley and that all its questions or concerns have been addressed.
It had sought more data from the US group regarding protein analyses, clarification of MBSE compositional data, gender-specific increases in total blood bilirubin levels seen in a rodent study, data on the metabolism of magnolol in the liver, information on shelf-life, the marketing of products, additional data on MBSE use levels, as well as information on ecology relating to the bark stripping process.
Proposed use
Wrigley’s Magnola Supercritical Carbon Dioxide Extract (MBSE) has two active compounds, phenols magnolol and honokiol.
The confectionery giant is proposing that MBSE be used in gums and mints at a maximum level of 0.2 per cent. This means that a 1.5g piece of gum or mint would contain a maximum of 3mg MBSE.
Wrigley is not anticipating that the ingredient will be used in products aimed at “candy consumers”, such as Everton mints and Hubba Bubba; rather, it expects it will find a use in products consumed to freshen breath, but which are not marketed with the use of medicinal claims.
Storage stability
According to the ACNFP, the applicant carried out stability analyses of MBSE in chewing gum and mints over a 12 week period under accelerated storage conditions and concluded that the results demonstrate the stability of the ingredient in chewing gum and mints over the three months.
At the request of the Committee, the applicant also provided real-time stability data for MBSE-containing gum (different flavours) over a longer duration. “Magnolol content was assessed as a measure of stability and was shown to be stable within each flavour and there was no detectable degradation over 10 months of shelf-life,” states the committee.
Research
Typically mint is used in such products to sweeten the breath and mask any unpleasant odours. However the company has conducted research into the breath-freshening efficacy of MBSE, including the action underlying its ability to combat oral odours.
For a study published in the Journal of Agricultural and Food Chemistry in 2007, Wrigley scientists Michael Greenberg, Philip Urnezis, and Minmin Tian investigated how the extract, and magnolol and honokiol, could inhibit bacteria in human saliva samples.
These experiments showed that MBE and its two main constituents strongly inhibited Porphyromonas gingivalis, Fusobacterium nucleatum, and Streptococcus mutans, bacteria responsible for bad breath (halitosis).
The ACNFP draft opinion is available online here.
Wrigley’s novel foods submission can be downloaded here.