Extension of use of extracts of rosemary (E 392) in fat-based spreads

food additive, extracts of rosemary, E 392, extension of use
First published in the EFSA Journal
7 May 2015
15 April 2015
Scientific Opinion


Following a request from the European Commission, a refined exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for extracts of rosemary (E 392) and the extension of its use in fat-based spreads at the levels proposed by the applicant of 30 mg/kg and 100 mg/kg. This was not covered by the previous re-evaluation of the safety of extracts of rosemary (E 392) as a food additive performed by EFSA in 2008. In that previous opinion, it was noted that, whilst the data were insufficient to establish a numerical ADI, the margin of safety was high enough to conclude that dietary exposure resulting from the proposed uses and use levels was not of safety concern. In providing a scientific opinion on the safety of the proposed extensions of use, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of extracts of rosemary. The Panel concluded that, since the two additional uses for rosemary extracts in fat-based spreads would not change the estimated exposure to the food additive compared with the already approved permitted uses in any part of the population, the conclusions made by the AFC Panel in 2008 regarding safety remain valid. Therefore, the Panel considered that it is unlikely that there is a safety concern with the current permitted uses together with the additional proposed extension of uses compared with the current permitted uses alone. The Panel recommends that a refined exposure assessment is carried out to decrease the existing uncertainties arising from its conservative estimates based on current MPLs.

Panel members at the time of adoption

Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Panel on Food Additives and Nutrient Sources Added to Food
fip [at] efsa.europa.eu
EFSA Journal 2015;13(5):4090
Question Number
On request from
European Commission