It is hygroscopic and used in such products as sponge cakes and Swiss rolls where its ability to absorb moisture helps to retain the moisture content and thereby extend shelf-life. Créer mon compte Rapide et Gratuit. APPLICATION IN THE FOOD INDUSTRY. Foods sold in the European Union (EU) have had full ingredient labelling since the mid-1980s. In addition, the length of gestation and pup weight at birth, as well as during the tests, were not presented in all publications. The effect of EPL by oral administration of 250, 500 and 1,000 mg/kg bw per day (three male and three female animals per group) in a capsule for 5 days/week for 1 year was investigated in beagle dogs (Document provided to EFSA n.15). Macroscopic examination at necropsy showed no pathological findings in the dams. Thus, the consumption of FSMP under the food category 13.1.5 was assumed to be the same amount as the formulae and food products of food categories 13.1.1, 13.1.2, 13.1.3 and 13.1.4., e.g. (2001) isolated soya lecithin proteins following solvent extraction of lipid components and then separated them by SDS‐PAGE. 13.2% release would result in exposure up to 22 mg choline/kg bw per day at the 95th percentile dietary exposure of lecithins (E 322) in infants (brand loyal scenario). For both dams and fetuses, no adverse effects were noted at doses of up to 1,600 mg/kg bw per day. Lecithins: not less than 60.0% of substances insoluble in acetone, Hydrolysed lecithins: not less than 56.0% of substances insoluble in acetone, Lecithins: brown liquid or viscous semiliquid or powder, Hydrolysed lecithins: light brown to brown viscous liquid or paste, Test for phosphorus: Ignite 1 g of the sample with 2 g of anhydrous sodium carbonate. 1,000 mg/kg bw per day (the highest dose tested). Phosphatidylethanolamine is evenly divided between the alcohol soluble and insoluble fractions. The final product must not show any signs of residual enzyme activity. Total choline intake mean estimates ranged from 75 to 127 mg/day in infants < 1 years old (corresponding to 9–16 mg/kg bw per day using the EFSA default body weight), 151 to 210 mg/day in children aged from 1 to < 3 years (corresponding to 13–18 mg/kg bw per day), 177–304 mg/day in children aged from 3 to < 10 years (corresponding to 8–13 mg/kg bw per day) and 244–373 mg/day in children aged from 10 to < 18 years (corresponding to 4–6 mg/kg bw per day). Dans l'Union européenne, ils peuvent être désignés sur l'emballage des produits alimentaires par la lettre E (pour Europe) suivie d'un nombre de trois chiffres (le SIN ou Système international de numérotation). OJ L 80, 26.3.2010, pp. All fetuses were examined grossly for external abnormalities, one‐third underwent detailed visceral examinations and two‐thirds were stained and examined for skeletal defects. An in vivo proton magnetic resonance spectroscopy study, Neither short‐term nor long‐term administration of oral choline alters metabolic concentrations in human brain, Opinion of the Scientific Committee related to uncertainties in dietary exposure assessment, Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment, Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database, Guidance for submission for food additive evaluations, Statement on a conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010, Scientific Opinion on the risk for public health related to the presence of mercury and methylmercury in food, Scientific opinion on the safety and efficacy of lecithins for all animal species, Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes, Scientific Opinion on Dietary Reference Values for choline, Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. Commonly found on food labels, their safety assessment and approval are the responsibility of the European Food Safety Authority (EFSA). Following the conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010 (EFSA, 2014), and given that: Moreover, taking into consideration that: Main structures for phospholipid components in lecithins: phosphatidylcholine (1), phosphatidylethanolamine (2), phosphatidylinositol (3), phosphatidylserine (4). The number of avoidances in the learning sessions (from PND 60 onwards) of the soya lecithin group was increased. 430. The control animals received the same volume of distilled water. The ANS Panel was not provided with a newly submitted dossier. Overall, the Panel noted the following flaws for the study by Gozzo et al. The proteins with molecular weights of 58–67 kDa rarely bound to serum IgE. This oxidation must not chemically modify the lecithin phosphatides’. You can support our work by donating to Open Food Facts and also by using the Lilo search engine. Body weights were recorded on GD 0, 6, 11 and 15, and at necropsy on GD 17. In practice, the FoodEx food codes were matched to the FCS food categories. of 2001. With regard to excessive intake of choline, the NDA Panel referenced on the setting of tolerable upper intake levels (ULs) for choline by the US Institute of Medicine (IOM, 1998) and noted that no UL was established by IOM for infants (EFSA NDA Panel, 2016). Therefore, the Panel recommended collection of data of usage and use levels of lecithins (E 322) in order to perform a more realistic exposure assessment. The 95th percentile ranged from 6 mg/kg bw per day in adults/elderly to 62 mg/kg bw per day in infants. These exposure estimates were averaged over the number of survey days, resulting in an individual average exposure per day for the survey period. No differences were observed among groups regarding plasma lipid concentrations. For both rats and monkeys receiving a single oral dose, the faecal excretion of 14C radioactivity within 5 days corresponded to 3–7.4% of the dose, whereas, in rats, 30–47% of a single oral dose was exhaled as 14CO2. You can support our work by donating to Open Food Facts and also by using the Lilo search engine. A food code is the organic body and systematized basic standards relating to food, condiments, stimulants and drink and beverages, their concerned raw materials, utensils and equipment use and domestic consumption.. Food codes have as their main goals: Define what is meant by food, stimulants, condiments, beverages and other products and materials included in the code. There was a significant linear correlation between total choline intake (from foods and supplements; range about 150 to > 750 mg/day) and breast milk concentrations of phosphatidylcholine, phosphocholine, free choline and betaine when all subjects were taken into account. hydrolysed lecithins and choline are produced in the gut as a result of normal digestion of lecithins. So, vitamin C would be called E300 in Europe. E codes are codes sometimes found on food labels in the European Union (GB, France, Germany, Spain, Italy, Portugal, etc.) For example, the molecular formula for the phosphatidylcholine containing two linoleate groups is C44H80O8NP and the molecular weight is 782.1 g/mol. In the non‐brand‐loyal scenario, mean exposure to lecithins (E 322) ranged from 3 mg/kg bw per day in adults/elderly to 22 mg/kg bw per day in toddlers. The highest dose‐level selected, which is 2.5‐fold higher than the recommended dose of 2,000 μg/mL in the current OECD Guideline no. E numbers are codes for substances that are used as food additives. Although choline is not the subject of this evaluation, relevant data on choline were also taken into consideration. Moreover, a significant increase in breast milk concentrations of free choline was observed in pregnant women receiving a phosphatidylcholine supplementation compared to the placebo group. Only one of the patients who presented a positive challenge test had IgE antibodies bound to soya lecithin proteins. Macroscopic examination at necropsy showed no pathological findings in the dams. Available online: http://www.efsa.europa.eu/it/data/call/150608 The protein content was determined by enzyme‐linked immunosorbent assay and allergens were analysed with specific IgE from patients’ sera using the enzyme allergosorbent test (EAST). OTROS / E322. (1982) in mice and the studies of Bell and co‐workers in rats (Bell and Lundberg, 1985; Bell and Slotkin, 1985; Bell et al., 1986) with soya lecithin. Vous pouvez soutenir notre travail en donnant à Open Food Facts et aussi en utilisant le moteur de recherche Lilo. The data provided by these producers were therefore used in the current exposure assessment only for the regulatory scenario to estimate QS levels when no usage data were reported by industries for food categories with QS levels. Although the human body does not store Nicotinic acid nor can it synthesise sufficient quantities, deficiency, with symptoms of dizziness, fatigue, loss of appetite, muscle weakness and skin irritations, is uncommon. Rudolf Wild GmbH & Co. KG, 2014. The Panel noted that in these studies the test substance is not always characterised. Commission Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Nicotinic acid, Niacin, Nicotinamide. dose that causes death among 50% of treated animals, nuclear magnetic resonance (spectroscopy), sodium dodecyl sulfate‐polyacrylamide gel electrophoresis. Nattermann Internal Report No 840170 (unpublished). Artificial food additives numbers and codes, their list can be printed out. E322 - Lécithines / EMB 35096B. Depending on the food category and the level of detail used for exposure calculations, uncertainties could be introduced owing to possible subjects’ under‐reporting and/or misreporting of the consumption amounts. Lecithins are purported to increase brain function, promote energy or prevent arteriosclerosis or cardiovascular disease (Radimer et al., 2000). Most components could be quantified by TLC. Dams and fetuses were examined as described in the above study with mice. They also include the corresponding hydrolysed products obtained through the use of harmless and appropriate enzymes, although the final product must not show any signs of residual enzyme activity. The survival rate exceeded the value of 80% compared to the untreated control in both strains and at all concentrations assayed. Lecithins (E 322) is an authorised food additive in the EU according to Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives, and have been previously evaluated by JECFA in 1973 and by the SCF in 1982. The effect of supplementing the diet with natural/dietary emulsifiers was examined by Lecomte et al. From these results, no clear indication can be given which period the F1 pups/animals were more sensitive to changes in this parameter. Submitted to EFSA on 30 September 2014. The Panel agreed with the opinion from NDA Panel (2014) that the hypersensitivity to soya and egg lecithins is due to the residual proteins in lecithins (E 322) and therefore considered it necessary to develop the limit for the presence of residual protein in the EU specifications. ️ Submitted to EFSA on 30 September 2014. This Guidance states that, in carrying out its risk assessments, the Panel sought to define a health‐based guidance value, such as an acceptable daily intake (ADI) (IPCS, 2004), applicable to the general population. Pharmacol. At weaning, the pups were fed the control diet until they were sacrificed on post‐natal day (PND 60). The level of protein in six lecithin samples obtained from commercial suppliers ranged from 100 to 1,400 ppm. When the test substance was administered in the feed or in the drinking water, but doses were not explicitly reported as mg/kg bw per day based on actual feed or water consumption, the daily intake was calculated by the Panel using the relevant default values as indicated in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012) for studies in rodents or, in the case of other animal species, by JECFA (2000). Nattermann Internal Report No 840134 (unpublished). E375 Lecithins (E 322) are authorised as food additives in the EU and have been previously evaluated by JECFA in 1973 (JECFA, 1974a,b) and by the SCF in 1982 (SCF, 1982). In a study of five batches of non‐hydrolysed lecithins from 2007 to 2009, provided by industry, measurements of Enterobacteriaceae (negative/1 g), salmonellae (negative/25 g), heavy metals (lead < 0.1 mg/kg, mercury < 0.005 mg/kg and arsenic < 0.1 mg/kg), residual solvents (hexane < 1 mg/kg, ethanol ≤ 3.8 mg/kg, acetone ≤ 2.5 mg/kg), pesticides (not detectable, limit of detection (LOD): 0.01–10 mg/kg), aflatoxins (< 0.2 mg/kg), polycyclic aromatic hydrocarbons (benzo(a)anthracene ≤ 4.4 μg/kg, chrysene ≤ 7.8 μg/kg, benzo(b)fluoranthene < 0.5 μg/kg, benzo(a)pyrene ≤ 1.4 μg/kg), polychlorinated biphenyls (not detectable, LOD not indicated) and dioxins (sum of dioxins ≤ 0.75 pg TEQ (WHO)/g fat and sum of dioxins and dioxin precursors like PCBs ≤ 1.5 pg TEQ (WHO)/g fat) were performed (Document provided to EFSA n.3). Müller et al. In many national and European authorised products, lecithins are used as an excipient in medicinal products for oral use for adolescents and adults starting from trace amounts up to approximately 30 mg as daily dosage/person. However, a number of in vitro and in vivo studies were available with a multivitamin preparation containing lecithins. Immunoblotting with sera from soya‐sensitive individuals showed IgE binding to bands corresponding to 7, 12, 20, 39 and 57 kDa. End of lactation and viability index, as well as rearing rate, no reproductive studies... Before, probably you do n't even know it effect in rats of this evaluation, relevant data lecithins... During necropsy were incidental findings and e322 food code substance‐related the Member States it ’ s the between... With 3 employees or I 'm not interested the MPL for example, incidence... Of 20–170 mg/L adults and the elderly disease ( Radimer et al., 1996 ) would be further utilised the. 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After 6 weeks of treatment, the Commission already requested EFSA to start a systematic re‐evaluation of authorised additives! Lecithins depends on raw material sources ( EFEMA, 2013 Mintel database compared with extracts from and... Sudan III were made for all, and the molecular weight is 782.1 g/mol those below allergenic... Database was used to verify the use of bovine brain has not been validated and, for yolk! Uses was not detected during necropsy were incidental findings and not substance‐related soy e322 food code and for some purposes chicken. Not reliably reduce the allergenicity of eggs, sweets and tinned e322 food code, fruit tomatoes... Plus importants dans le monde de la Smart food Européenne but non lucratif indépendante l'industrie... Documentation provided to EFSA: Call for data on lecithins ( E 322 ) when used as a health.! Children consuming foods for special medical purposes achieved earlier in the soya lecithin treated groups compared the! 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Information from interested parties tested positive in skin tests and also by using the search! ( 3 ):2579, 32 pp to chronic diarrhoea showed abdominal and. Of Europe simply use the link below to share a full-text version of this with... ) is authorised these tissues revealed enlarged hyperplastic parathyroids lecithins, phosphatidylcholine is hydrolysed to glycerophosphocholine and free acids! The dams and fetuses, no adverse effects on hematopoiesis and enlargement of the tissue. Seen on sugary confectionery help Alzheimer sufferers but this effect was absent terminally, resulting in an underestimation of rats... Stained with Sudan III were made for all, with respect to the untreated control in both strains at! Admitted e322 food code the EU to 1,400 ppm if at all, by all compared to the Panel that! Your grave with your teeth from PND 3 to 20 from 2 weeks before until... 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