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

Abstract

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.

Refined exposure assessment of extracts of rosemary (E 392) from its use as food additive

“…Following a request by the European Commission in 2014, EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion on the safety of the proposed extensions of use for extracts of rosemary (E 392) in fat-based spreads at 30 mg/kg and 100 mg/kg in 2015 (EFSA ANS Panel, 2015). In this opinion, only the scenarios based on the maximum permitted levels (MPLs) at that time and on the MPLs and proposed new use levels at that time were performed; no refined exposure scenario was done.…”

Safety and efficacy of two solvent extracts of rosemary (Rosmarinus officinalis L.) when used as feed additive for cats and dogs (Kemin Nutrisurance Europe SRL)

“…The EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC Panel) issued one opinion on the safety of rosemary extract when used as a food additive (E 392) (EFSA AFC Panel, 2008). The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) issued another opinion on the extension of use of rosemary extract in fat‐based spreads (EFSA ANS Panel, 2015 ) and a refined exposure assessment of extracts of rosemary (EFSA ANS Panel, 2018 ).…”