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EFSA not reconsidering new preservative ADI

By Jess Halliday , 15-Oct-2009
Last updated on 16-Oct-2009 at 09:07 GMT2009-10-16T09:07:46Z

EFSA has found no grounds to justify a re-evaluation of preservative ethyl lauroyl arginate following the presentation of new information on toxicology – even though its ADI is lower than those set by other authorities.

In 2007 The European Food Safety Authority’s AFC panel (on food additives, flavourings, processing aids and materials in contact with food) established an acceptable daily intake (ADI) for ethyl lauroyl arginate of 0.5mg per kg of bodyweight per day.

The panel came to this conclusion because of studies in rats showed that there was a consistent effect on white blood cell counts. These could not be discounted, it said, because the same effect was seen in different rat strains and sexes.

However other food safety bodies around the world have interpreted the data differently. Ethyl lauroyl arginate has been generally recognised as safe (GRAS) in the US since 2005, at levels up to up to 200 mg of the active ingredient ethyl-Nα-lauroyl-Larginate HCl /kg. Last year JECFA recognised it as a food additive and allocated an ADI of 0-4 mg/kg bw, and the additive was recently approved in Australia and New Zealand.

The application, Spain’s Laboratorios Miret SA (LAMIRSA), originally proposed to EFSA that the preservative be used in non alcoholic beverages made with fruit juice, energy and sports drinks, and meat products, at a dosage of 115 to 225 ppm. However EFSA saw that this dosage would mean the potential exposure to the chemical could be at or above the ADI it established.

Following the publication of EFSA’s ADI the applicant, Spain’s Laboratorios Miret SA (LAMIRSA), sent the European Commission further documentation about the white blood cell effect.

On receipt of the new information, the Commission passed it on to EFSA for its ANS panel (on food additives and nutrient sources added to food) to determine whether it constituted new scientific evidence that could address the AFC panel’s concerns. (The AFC panel was part replaced by the ANS panel in 2008).

Expert opinions

The ANS panel has deemed that the information is the opinions of three experts – RR Maronpol, G Brown and G Escolar on the white blood cell data from the studies originally included in the application.

The experts all independently concluded that the data is toxicologically not significant since the observed effects are “inconsistent between the studies considered and did not demonstrate a dose-effect relationship”.

Moreover, the effects on white blood cells were not accompanied by changes to the tissue in any of the studies.

However the panel maintains that the toxicological relevance of the findings could not be assessed, since the mechanism of action is not clear.

Whole the experts proposed mechanism of action, these were “speculative and not consistent”, EFSA said.

“Therefore the panel concludes that the scientific evidence of a plausible mechanism for the alterations in white blood cell counts has not been provided and that the concerns and uncertainties expressed in the opinion of the AFC panel have not been addressed by the new information provided.”

Awaiting approval

A spokesperson for LAMIRSA told FoodNavigator.com that the preservative is awaiting approval by the European Commission, and until it is received and an E number attributed, ethyl lauroyl arginate cannot be used in the bloc.

The approval is expected to be granted in March next year.

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