Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling

Article

作者: Vinceti, Marco ; Turck, Dominique ; Bohn, Torsten ; Van Loveren, Hendrik ; Hirsch‐Ernst, Karen Ildico ; Naska, Androniki ; de Henauw, Stefaan ; Siani, Alfonso ; Castenmiller, Jacqueline ; Maciuk, Alexander ; McArdle, Harry J ; Marchelli, Rosangela ; Mangelsdorf, Inge ; Thies, Frank ; Pentieva, Kristina ; Knutsen, Helle Katrine ; Valtueña Martínez, Silvia ; Tsabouri, Sophia ; Hirsch-Ernst, Karen Ildico

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to review a scientific assessment related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 - for permanent exemption from labelling. The EC requested EFSA to consider comments raised by the German authorities in relation to: (a) the maximum amount of mustard protein that could be consumed from the emulsifiers manufactured from behenic acid (E470a, E471 and E477) on a single occasion and (b) the minimal observed eliciting dose (MOED) triggering allergic reactions in mustard-allergic individuals. The maximum amount of mustard protein content in behenic acid was re-assessed in view of new analytical data provided by the applicant. Intake estimates by the EFSA ANS Panel for E471 (adults) were used as a proxy for the combined intake (E470a, E471 and E477). Food challenge data and systematic reviews thereof deriving population minimal observed eliciting dose distributions for mustard protein were used to calculate the MOED and estimate the risk. The margin of exposure between the MOED (0.26 mg mustard protein) and the maximum amount of mustard protein that could be consumed from the emulsifiers on a single occasion (0.00895475 mg) is 29. It is predicted that between 0.1% and 1% of the mustard allergic population would react with mild objective symptoms to that dose. Overall, the assessment is conservative, particularly in relation to the exposure. Based on the information and data available, the NDA Panel concludes that it is extremely unlikely (≤ 1% probability) that oral consumption of emulsifiers to be manufactured using behenic acid from mustard seeds (i.e. E470a, E471 and E477) will trigger an allergic reaction in mustard-allergic individuals under the proposed conditions of use.

2021-11-01·EFSA Journal3区 · 农林科学

Opinion on the re‐evaluation of mono‐ and diglycerides of fatty acids (E 471) as food additive in foods for infants below 16 weeks of age and follow‐up of their re‐evaluation as food additives for uses in foods for all population groups

3区 · 农林科学

ArticleOA

作者: Guertler, Rainer ; Engel, Karl-Heinz ; Fowler, Paul ; Passamonti, Sabina ; Younes, Maged ; Manco, Melania ; Aquilina, Gabriele ; Shah, Romina ; Gundert-Remy, Ursula ; Wright, Matthew ; Wolfle, Detlef ; Castle, Laurence ; Moldeus, Peter ; Frutos Fernandez, Maria Jose ; Mennes, Wim ; Dusemund, Birgit ; Vianello, Giorgia ; Tard, Alexandra ; Fuerst, Peter ; Waalkens-Berendsen, Ine ; Mortensen, Alicja ; Barmaz, Stefania ; Turck, Dominique ; Husoey, Trine

Mono- and diglycerides of fatty acids (E 471) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavouring was requested to assess mono- and diglycerides of fatty acids (E 471) for its use as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive in 2017 when used in food for the general population. The Panel considered that there is no indication of adverse effects from the available animal studies at the highest dose tested and from the post marketing data. A comparison was made between the daily exposure to the sum of mono- and di-acylglycerols from breast milk and that resulting from the use of E 471 in the infant formula. The Panel noted that the resulting exposures are in the same order of magnitude. Overall, the Panel concluded that there is no reason for a safety concern when E 471 used as food additive in FC 13.1.1 and 13.1.5.1 and according to the Annex III to Regulation (EC) No 1333/2008. The risk assessment for toxic elements and impurities clearly indicated the need to lower the current maximum limits for arsenic, lead, cadmium and mercury and to include limits for glycidyl esters, 3-monochloropropane diol and erucic acid in the EU specifications of E 471.

2018-07-01·Journal of Chromatography A2区 · 化学

Characterization of E 471 food emulsifiers by high-performance thin-layer chromatography–fluorescence detection

2区 · 化学

Article

作者: Oellig, Claudia ; Brändle, Klara ; Schwack, Wolfgang

Mono- and diacylglycerol (MAG and DAG) emulsifiers, also known as food additive E 471, are widely used to adjust techno-functional properties in various foods. Besides MAGs and DAGs, E 471 emulsifiers additionally comprise different amounts of triacylglycerols (TAGs) and free fatty acids (FFAs). MAGs, DAGs, TAGs and FFAs are generally determined by high-performance liquid chromatography (HPLC) or gas chromatography (GC) coupled to mass selective detection, analyzing the individual representatives of the lipid classes. In this work we present a rapid and sensitive method for the determination of MAGs, DAGs, TAGs and FFAs in E 471 emulsifiers by high-performance thin-layer chromatography with fluorescence detection (HPTLC-FLD), including a response factor system for quantitation. Samples were simply dissolved and diluted with t-butyl methyl ether before a two-fold development was performed on primuline pre-impregnated LiChrospher silica gel plates with diethyl ether and n-pentane/n-hexane/diethyl ether (52:20:28, v/v/v) as the mobile phases to 18 and 75 mm, respectively. For quantitation, the plate was scanned in the fluorescence mode at UV 366/>400 nm, when the cumulative signal for each lipid class was used. Calibration was done with 1,2-distearin and amounts of lipid classes were calculated with response factors and expressed as monostearin, distearin, tristearin and stearic acid. Limits of detection and quantitation were 1 and 4 ng/zone, respectively, for 1,2-distearin. Thus, the HPTLC-FLD approach represents a simple, rapid and convenient screening alternative to HPLC and GC analysis of the individual compounds. Visual detection additionally enables an easy characterization and the direct comparison of emulsifiers through the lipid class pattern, when utilized as a fingerprint.

100 项与 MW-436 相关的药物交易

登录后查看更多信息