Benign tumours affecting the liver, pancreas, pituitary, thyroid, adrenals, testes, skin, brain salivary gland, ovary, uterus, prostate and connective tissue were also found. The frequency is not known. The sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS‐PAGE) protein pattern of the standard soya lecithin is very similar to that of soya flour. glycerophosphocholine, phosphocholine, phosphatidylcholine, sphingomyelin). Furthermore, the Panel noted that information from the Mintel's GNPD (Appendix B) indicated that approximately 65% of the food products in which lecithins (E 322) was labelled, were included in the current exposure estimates. From the refined estimated exposure scenario considering only food categories for which direct addition of lecithins (E 322) to food is authorised, in the brand‐loyal scenario, mean exposure to lecithins (E 322) ranged from 7 mg/kg bw per day in adolescents to 82 mg/kg bw per day in children. However, not all available data could be included in the assessment as a result of specific restrictions/exceptions regarding products not referenced in the FoodEx classification. According to the EMA, lecithins are used as active ingredients which do not fulfil the criteria of traditional use in daily dosages up to 9,000 mg daily in several Member States of the EU (HMPC, 2016a; draft). Another Ames test with S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100 tester strains was performed both in the absence and presence of rat liver S9 metabolic activation. The survival rate exceeded the value of 85% compared to the untreated control at all concentrations assayed and no mutagenic activity was detected (Document provided to EFSA n.10). Recorded problems are that it can be a local irritant and in large amounts can cause teeth erosion. Friehe H and Fontaine R, 1978. According to Commission Regulation No 231/2012, lecithins appear as a brown liquid or viscous semiliquid or powder. Food Additives Codes… It is thought that this has been brought about by misunderstanding and confusion over the word Krebs. Total choline intake mean estimates ranged from 269 to 468 mg/day in adults aged from 18 to ≥ 75 years (corresponding to 4–7 mg/kg bw per day). Both egg white‐ and egg yolk‐derived proteins have been described to trigger clinical allergic reactions. During sacrifice at the end of the study, no gross pathological changes were observed. There were no deaths or clinical signs observed in male and female rats to which purified phosphatidylinositol from soya lecithin (Asahi Kasei PI) was orally administrated once in single doses up to 2,000 mg/kg bw (Honda et al., 2009). The present opinion deals with the re‐evaluation of lecithins (E 322) when used as a food additive. Code erreur E01 : Le code panne E01 s’affiche quand le lave-vaisselle Bosch détecte une alimentation électrique insuffisante. lecithins are natural constituents of all cells in the human body and also are natural components of the diet. The 95th percentile of exposure to lecithins (E 322) ranged from 66 mg/kg bw per day to 232 mg/kg bw per day in toddlers (not presented in Table 8). Because lecithins (E 322) is also authorised in food categories 13.1.5.1 and 13.1.5.2, a refined estimated exposure assessment scenario taking into account these two food categories was performed to estimate the exposure of infants and toddlers who may eat and drink these foods for special medical purposes (FSMP). The Panel considered that the refined exposure assessment approach resulted in more realistic long‐term exposure estimates compared to the maximum level exposure assessment scenario. The content of choline that can theoretically be released from phosphatidylcholine containing two linoleate groups is 13.2% and from lyso phospatidyl choline containing one linoleate group is 20.2%. Six more dogs received the solvent only and served as controls. When cooled to 0°, a precipitate of potassium soap is obtained, Lecithins: not more than 35 mg of potassium hydroxide per gram, Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram. A study performed by Szepsenwol (1969) focussing on the development of brain nerve cell tumours in TM strain mice was regarded by the Panel as invalid due to several deficiencies (no complete histopathology performed, unknown mouse strain, no exact specification of the tumour type). Healthy full‐term infants were fed from birth exclusively human milk (n = 16), standard term formula (n = 15) or the same formula supplemented with egg yolk lecithin providing docosahexaenoic a(DHA) 0.15% and arachidonic acids (AA) 0.30% (n = 18) (Bondía‐Martínez et al., 1998). For the purpose of this Scientific Opinion, the Mintel GNPD1818 Information on the identity of the substance. Merci beaucoup ! This lesion was also found in rats in which no nodules were seen at necropsy. FDE (Food Drink Europe), 2013. It is made for all, by all, and it is funded by all. We need your donations to fund the Open Food Facts 2021 budget and to continue to develop the project. At 1 and 3 months, the infants of the non‐supplemented formula group showed a decreased in DHA and AA in the serum. According to older literature, human milk is reported to contain 160–210 mg (1.5–2 mmol)/L of total choline, delivered as choline, phosphocholine, glycerophosphocholine, phosphatidylcholine and sphingomyelin (Zeisel et al., 1986; Holmes‐McNary et al., 1996). On GD 29, the dams were laparotomised and examined for corpora lutea, implantations and resorptions in the uterus or ovaries, as well as for the condition of the fetuses. Foods sold in the European Union (EU) have had full ingredient labelling since the mid-1980s. Mean breast milk concentrations of phosphocholine (722 vs 553 μmol/L) and free choline (106 vs 83 μmol/L) were significantly higher in the supplemented group than in the placebo group, whereas phosphatidylcholine was not significantly different. (2016). Edition 254. The main source of lecithins is soya bean oil. The food intakes of all treated male groups were slightly higher than those of controls, whereas females from treated and control groups consumed similar amounts of food daily. Use the link below to share a full-text version of this article with your friends and colleagues. In humans, the relationship between dietary lecithin intake and plasma choline levels has been investigated in several studies. Uncertainties in the exposure assessment of lecithins (E 322) have been discussed above. No treatment‐related effects were observed on external, visceral or skeletal examination of the fetuses. Overall, even if not frequently reported after oral exposure, allergic reactions to residual proteins present in soya bean or egg lecithin cannot be excluded. The results of SDS‐PAGE demonstrated the presence of only three proteins, with molecular weights of about 58–67 kDa in soya oil, and suggested that soya lecithin also contains these proteins. PPC‐R (containing 95.2% of phosphatidylcholine, 1.3% lysolecithins and 0.13% kephalin) as administered by gavage up to 1,000 mg PPC‐R/kg bw per day (treatment from GD 1 to 6) did not influence the implantation in rabbits and the of the fetuses. A group of six dogs was taken as a control. Overall, the Panel considered, that in view of the limited information on health effects of excessive intake of lecithins or choline, respectively, especially by infants, children, pregnant and lactating women, estimated total choline intake including the use of lecithins (E 322) as a food additive should not lead to a significant exceedance of AIs for choline for infants or ULs defined by IOM (1998). For efficiency and practical purposes, the re‐evaluation should, as far as possible, be conducted by group of food additives according to the main functional class to which they belong. Available online: http://www.efsa.europa.eu/en/press/news/150428.htm Therefore, information on actual use levels is required for performing a more realistic exposure assessment, especially for those food additives for which no MPL is set and which are authorised according to QS. Against the background that choline availability as a precursor of acetylcholine may possibly influence neurotransmitter systems, several neurodevelopmental toxicity studies were conducted with lecithin. And fatty acids can be printed out a doubling of the sample with constant.. Of massive amounts of e322 food code were distributed in all publications classification, the Panel noted that this has described... The other phospholipid components of the plasma choline levels at this dose oral administration with! The untreated control in both strains and at all three dosages, the.. 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