EFSA calls for more data before decision on flavourings safety

By Ben Bouckley

- Last updated on GMT

Related tags: Flavor

The European Food Safety Authority (EFSA) has advised that safe usage levels of seven flavouring substances commonly used in or on food in member states should be reassessed, due to reservations about industry data submitted.

The implications of the advice is significant, given that the flavonoids (flavouring substances) are commonly used throughout the EU in a wide variety of foodstuffs, including dairy products, fats and oils, edible ices, cereals, confectionery and meat, as well as beverages.

All seven belong to chemical groups 25 and 30, annex 1 of EC Regulations No.1565/2000. They comprise three flavanones: FL-no 16.058 (a glycoside) 16.083 and 16.097 and four dihydrochalcones: FL-no 16.061, 16.109, 16.110 and 16.112.

One of the flavouring substances Naringin (16.058) occurs naturally in citrus fruits, especially grapefruits, and also occurs naturally in tomato skins (8-42 mg/kg). Hesperetin (16.097) is a major flavanon glycosides in oranges, while Phloretin (16.109), an aglycone of phloridzin occurs in apples (80-420mg/kg in peel) and strawberries (2-5 mg/kg).

Of the remaining four flavonoids, the panel cited industry claims that, trilobatin (16.112) neohesperidin dihydrochalcone (16.061) and naringin dihydrochalcone (16.110) do not occur naturally in food. However, the sodium salt 16.083 has been identified in the medicinal plant Eriodictyon californicum​, while phloretin had been​identified in Malus trilobata ​and other non-food plants.

Daily intake safety assessment

EFSA’s Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids used the MSDI (maximised survey-derived daily intake) approach to estimate safe per capita intake levels of the flavouring substances in Europe.

Its report said:“It is considered on the basis of the default MSDI approach, that the seven flavouring substances will not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances.”

According to EFSA’s default MSDI approach, the three flavanones have daily per capita intakes (as flavouring substances) of 0.61-280 microgram per person per day, which are below the threshold of concern of 540 micrograms for substances belonging to this class.

Two of the four dihydrochalcones (16.061 and 16.109) have daily per capita intakes of 12 and 61 micrograms, respectively, which are below the class threshold of concern of 90 micrograms.

The panel concluded that the remaining two dihydrochalcones belonging to structural class III [FL-no: 16.110 and 16.112], “have daily per capita intakes as flavouring substances of 120 and 1200 micrograms”​, where a similar NOAEL (no observed adverse effect level) of 500mg per kg of body weight per day was accepted for the structurally related 16.061, neohesperidin dihydrochalcone.

The panel concluded: “The combined intake of the three three flavanones from structural class II [FL-no: 16.058, 16.083 and 16.097] and the combined intake of the four dihydrochalcones from structural class III [FL-no: 16.061, 16.109, 16.110 and 16.112], do not pose a safety concern at the estimated levels of intakes.”

Grossly underestimate intake levels

“However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the industry.”

“In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.”

Lacking more precise information that would enable it to make a “more realistic estimate of the intakes of the flavouring substances”​ , the panel decided to estimate daily intakes per person using a “more conservative”​ mTAMDI (modified theoretical added maximum daily intake) approach based upon upper-use levels levels reported by industry for flavourable foods and drinks in general.

This approach indicated that intake levels might be too high, and the panel chose not a carry out a formal safety assessment using the procedure, and required “more precise data on use and use levels”.

The European Flavour Association told FoodNavigator.com that it needed more time to study the opinion before issuing a response.

To view the opinion, click here

Related topics: Regulation & Safety

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