Industry ‘grossly underestimated’ consumption levels for flavouring agents, EFSA panel
The European Food Safety Authority’s (EFSA’s) Panel on Food Contact Materials, Enzymes, Flavours and Processing Aids published a new scientific opinion today on the safety of 28 chemically defined flavouring substances called ‘pyrazine derivatives’.
Two substances from the group – quinoaxaline and 2-methyquinoxaline1 – could not be evaluated due to genotoxic potential, and FL-no: 14.05 could not be assessed due to lack of intake data.
But the remaining 25 were assessed within the content of structure-activity relationships, intake from current uses, toxicological threshold of concern and availability metabolism and toxicity data.
All 28 flavouring substances belong to group 24, annex 1 of EC Regulation No 1565/2000, and are so-called ‘pyrazine derivatives’, which the panel said had been reported as naturally occurring in “a wide range of food items”.
Naturally occurring in foodstuffs
According the EFSA panel, these include: beef, chicken, cocoa, coffee, green tea, fruit juice, beer, potato, pork, whisky, sherry, nuts, peanut, roasted sesame seeds, peas and malt or wild rice.
Upon the basis of industry intake estimates for consumers – Maximised Survey-Derived Daily Intakes (MSDI’s), the panel concluded that 24 substances out of the 25 assessed did not give rise to safety concerns at estimated levels of dietary intake; one substance (FL-no: 14.052) required additional toxicity data.
The MSDI approach suggested intakes of 0.0024 to 12 micrograms per person per day for the 24 substances, which EFSA noted was below relevant thresholds of concern.
In addition to the safety assessment, the EFSA panel also examined the specifications for the ‘materials of commerce’ for these 24 substances, and decided that for FL-no: 14.102 its composition of mixture was not sufficiently specified.
But the panel criticised MSDI data supplied by industry, and said: “When the panel examined the information provided by the European flavouring industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases, would grossly underestimate intake by regular consumers of products flavoured at the use level reported by industry, especially in those cases where the annual production values were reported to be small.”
Thus, the EFSA panel decided to estimate intake levels itself, upon a modified ‘Theoretical Added Maximum Daily Intake’ (mTAMDI) basis, and not conduct a formal safety assessment – without further data – when this approach indicated that intake of a flavouring substance might exceed its threshold of concern.
However, the panel said that using its “conservative” mTAMDI approach – that predicted much higher daily intake levels for flavouring substances, “more reliable exposure data” was required for 10 agents.
“On the basis of such additional data, the flavouring substances should be re-evaluated using the procedure. Subsequently, additional toxicity data might become necessary,” the panel said.
A link to the EFSA panel’s full Scientific Opinion is available here.