Моно- и диглицериды жирных кислот (E471)

Источники

1. Регуляторное

   EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, et al. Re-evaluation of mono- and di-glycerides of fatty acids (E 471) as food additives EFSA Journal, 2017.

   doi:10.2903/j.efsa.2017.5045PubMed 32625340

   Финансирование и результат

   Финансирование

   European Food Safety Authority; requestor: European Commission.

   Результат

   Mono- and diglycerides are very likely hydrolysed by gastrointestinal lipases to glycerol and fatty acids. No need for a numerical ADI and no safety concern at reported uses. At mean exposure E 471 supplies 0.8 to 3.5% of the recommended daily fat intake of adults. Specific studies of E 471 and the gut microbiota were not available. Monoglycerides and diglycerides are esters of glycerol in which one or two hydroxyl groups are esterified with a long-chain fatty acid; the JECFA definition states that E 471 is usually manufactured by glycerolysis of edible fats and oils but may also be prepared by esterification of fatty acids with glycerol, and glycerolysis of natural or hydrogenated fats and oils runs at 200 to 250 °C under alkaline catalysis. In Mintel's GNPD, E 471 was labelled on 33,090 EU food and beverage products in 2012 to 2017, mainly chilled desserts, edible ices, bread and bread products, sandwiches, baking ingredients and mixes, pasta and margarines, and on up to about 75% of dairy ice cream and frozen yoghurt. E 471 is authorised in Group I and at quantum satis in 77 of 84 food categories. Rats absorbed 97.8 ± 0.4% of cottonseed-oil monoglycerides, and in a model digestive system 1,3-diolein was nearly completely hydrolysed to free fatty acids. Glycidyl esters form mainly from diglycerides when vegetable oils are heated above 200 °C and are hydrolysed in the gastrointestinal tract to free glycidol, classified as probably carcinogenic to humans (IARC 2A) and as genotoxic and carcinogenic by the EFSA CONTAM Panel. Chronic studies of diacylglycerol oil at up to 7,800 mg/kg bw per day in mice and 2,000 mg/kg bw per day in rats showed no carcinogenic potential. JECFA established an ADI 'not limited' in 1973. Mean adult exposure in the non-brand-loyal scenario was 10 to 26 mg/kg bw per day. The Panel recommended specification limits for toxic elements, glycerol impurities, residual solvents, trans fatty acids, glycidyl esters and erucic acid, and more data on 3-MCPD and glycidyl esters.

2. Независимое

   Yen CE, Nelson DW, Yen MI. Intestinal triacylglycerol synthesis in fat absorption and systemic energy metabolism Journal of Lipid Research, 2015.

   doi:10.1194/jlr.R052902PubMed 25231105

   Финансирование и результат

   Финансирование

   This work was funded by the National Institutes of Health Grant DK088210 and US Department of Agriculture Grant WIS01442.

   Результат

   Narrative review. Triacylglycerol forms the bulk of animal fats and plant oils and accounts for approximately 95% of dietary fat. Pancreatic lipase prefers sn-1 and sn-3 ester bonds and yields fatty acids and sn-2 monoacylglycerol. In enterocytes the monoacylglycerol pathway, with MGAT2 and DGAT1 in the endoplasmic reticulum, accounts for more than 75% of postprandial intestinal triacylglycerol synthesis; DGAT1 is the only DGAT detected in human intestine. Triacylglycerol forms the core of ApoB-containing chylomicrons, whose assembly requires MTP.

3. Регуляторное

   European Commission. Commission Regulation (EU) 2023/1428 of 7 July 2023 amending the Annex to Regulation (EU) No 231/2012 as regards mono- and diglycerides of fatty acids (E 471) Official Journal of the European Union, L 175, 10 July 2023, p. 6, 2023.

   https://eur-lex.europa.eu/eli/reg/2023/1428/oj

   Финансирование и результат

   Финансирование

   European Commission.

   Результат

   Recital 7: in 2020 a RASFF notification reported high levels of genotoxic and carcinogenic glycidyl fatty acid esters, expressed as glycidol, in E 471 used to produce a bread spread, and industry analyses in response to the EFSA call for data found a broad range and high levels in commercial samples. Annex, replacement entry for E 471: mixtures of glycerol mono-, di- and tri-esters of fatty acids occurring in food oils and fats, which may contain small amounts of free fatty acids and glycerol; glycerol used must comply with the specifications for E 422, and the fats and oils with Union food safety requirements; content of mono- and di-esters not less than 70%; erucic acid not more than 0.2% if added to food for infants and young children and 0.5% for all other uses; arsenic, lead, mercury and cadmium each not more than 0.1 mg/kg; sum of 3-MCPD and its fatty acid esters, as 3-MCPD, not more than 0.75 mg/kg for food for infants and young children and 2.5 mg/kg for other uses; glycidyl fatty acid esters, as glycidol, from 30 July 2023 not more than 5 mg/kg for food for infants and young children and 10 mg/kg for other uses, and from 30 January 2024 not more than 5 mg/kg for all uses.

4. Регуляторное

   National Health Commission of the People's Republic of China; State Administration for Market Regulation. 食品安全国家标准 食品添加剂使用标准 (National food safety standard: Standard for uses of food additives), GB 2760—2024 National standard of the People's Republic of China, issued 8 February 2024, in force from 8 February 2025, replacing GB 2760—2014, 2024.

   https://file.jgvogel.cn/134/upload/resources/file/595476.pdf

   Финансирование и результат

   Финансирование

   Issued by the National Health Commission and the State Administration for Market Regulation; the standard carries no funding statement. The text was read in a copy hosted by a third party, as the issuing bodies' sites refused automated access; its title page, contents and Table A.1 are those of GB 2760—2024.

   Результат

   Table A.1, ascorbic acid (vitamin C), CNS 04.014, INS 300, functions flour treatment agent and antioxidant: used in various foods in appropriate amounts according to production needs (按生产需要适量使用), except the food categories numbered 1 to 5, 10 to 62 and 68 in Table A.2, which comprise milks, fermented milk, milk powder and cream, butter, fresh fruit, vegetables, fungi and algae, cereals, rice, flours and raw noodles, fresh meat, aquatic products, eggs, sugars, honey, salt, spices, infant formulae and complementary foods for infants, drinking waters, fruit and vegetable juices, tea and coffee; maximum 5.0 g/kg in peeled or pre-cut fresh fruit (04.01.01.03) and in peeled, cut or shredded vegetables (04.02.01.03), 0.2 g/kg in wheat flour (06.03.01) and 1.5 g/kg in fruit and vegetable juices (14.02.01), as ready to drink. Table A.1, sodium carbonate (碳酸钠, CNS 01.302, INS 500(i)), function acidity regulator: according to production needs in various foods except categories 1 to 30 and 33 to 68 in Table A.2, and in fermented rice products; categories 31 and 32 are raw wet and raw dry noodle products. Sodium hydrogen carbonate (碳酸氢钠, CNS 06.001, INS 500(ii)), functions raising agent, acidity regulator and stabiliser: according to production needs in various foods except categories 1 to 56 and 58 to 68 in Table A.2, and in fermented rice products; category 57 is cereal-based complementary foods for infants and young children. Sodium sesquicarbonate (碳酸氢三钠, also named 倍半碳酸钠, CNS 01.305, INS 500(iii)), function acidity regulator: according to production needs in dairy products other than listed exceptions, only goat milk, and in pastries (07.02) and biscuits (07.03). Table A.1, phospholipids (磷脂, CNS 04.010, INS 322), functions antioxidant and emulsifier: according to production needs in various foods, except the categories numbered 1 to 4, 6, 8 to 53 and 59 to 68 in Table A.2, which comprise pasteurised and sterilised milk, fermented milk, milk and cream powder, vegetable oil, animal fats, butter, fresh fruit, vegetables, fungi and algae, cereals, rice, flours and noodle products, fresh, chilled and frozen meat, aquatic products, eggs, sugars, honey, salt, spices, drinking waters, fruit and vegetable juices, wines, and tea and coffee; cream (category 5), hydrogenated vegetable oil (7) and infant formulae and complementary foods for infants (54 to 58) are not among the exceptions. Table A.1, mono- and diglycerides of fatty acids (单,双甘油脂肪酸酯, CNS 10.006, INS 471), functions emulsifier and coating agent (乳化剂、被膜剂): according to production needs in various foods, except the 59 categories numbered 1 to 4, 6 to 11, 13 to 14, 16 to 30, 32 to 53 and 59 to 68 in Table A.2; cream (5), surface-treated fresh fruit (12) and vegetables (15), raw wet noodle products (31) and infant formulae and complementary foods for infants (54 to 58) are not among the exceptions; maximum 20.0 g/kg in butter and concentrated butter (02.02.01.01), 30.0 g/kg in raw dry noodle products (06.03.02.02), 6.0 g/kg in brown sugar, raw sugar, other sugars and syrups (11.01.02) and 5.0 g/kg in spices (12.09). Table A.1, phosphoric acid and phosphates (磷酸及磷酸盐), a group entry that includes disodium dihydrogen pyrophosphate (焦磷酸二氢二钠), tetrasodium pyrophosphate (焦磷酸钠), tetrapotassium pyrophosphate (焦磷酸四钾), trisodium monohydrogen diphosphate (焦磷酸一氢三钠) and calcium acid pyrophosphate (酸式焦磷酸钙); its INS numbers include 450(i), 450(ii), 450(iii), 450(v) and 450(vii); functions water-retention agent, raising agent, acidity regulator, stabiliser, coagulant and anticaking agent (水分保持剂、膨松剂、酸度调节剂、稳定剂、凝固剂、抗结剂). Maximum levels apply singly or in combination, expressed as phosphate (PO4 3-), for example 5.0 g/kg in dairy products other than listed exceptions, 15.0 g/kg in bakery wares (07.0), 5.0 g/kg in prepared and cooked meat products, 20.0 g/kg in non-dairy creamer and compound seasonings and 80.0 g/kg in seasoning packets for instant wet noodles (12.10.01.03); in infant formulae (13.01.01, 13.01.02) and complementary foods for infants and young children (13.02), 1.0 g/kg using only calcium hydrogen phosphate and sodium dihydrogen phosphate.

5. Независимое

   Chazelas E, Deschasaux M, Srour B, Kesse-Guyot E, Julia C, Alles B, et al. Food additives: distribution and co-occurrence in 126,000 food products of the French market Scientific Reports, 2020.

   doi:10.1038/s41598-020-60948-wPubMed 32132606

   Финансирование и результат

   Финансирование

   PhD grant from Paris 13 University (E. Chazelas); post-doctoral fellowship from the Fondation pour la Recherche Médicale (ARF201809007046, M. Deschasaux); French Ministry of Health (DGS Arrêté 29 Novembre 2019); French National Cancer Institute (INCa_14059); European Research Council (ERC CoG ADDITIVES_864219). Researchers were independent from funders. Funders had no role in the study design, the collection, analysis, and interpretation of data, the writing of the report, and the decision to submit the article for publication. Open Food Facts is a non-profit association.

   Результат

   53.8% of products contained at least one additive and 11.3% five or more. Appendix 7, products containing each additive: citric acid E 330 18,302; lecithins E 322 13,102; E 14XX modified starches 10,100; sodium carbonates E 500 8587; ascorbic acid E 300 7919; xanthan gum E 415 7327; sodium nitrite E 250 7144; diphosphates E 450 6529; pectins E 440 6504; mono- and diglycerides of fatty acids E 471 6060. Specific starches: E 1442 209, E 1422 173, E 1414 55, E 1450 30, E 1412 27, E 1420 19, E 1404 18, E 1440 5, E 1410 1. The footnote and the Discussion state that the number of products containing each specific modified starch may be underestimated because packaging often states only 'modified starch'. E 500 had the highest squared loading (0.64) in cluster 3, 'stabilizers and emulsifiers mostly used in biscuits and cakes'; sodium carbonate (E 500), diphosphates (E 450) and lecithins (E 322) co-occurred in 1667 products, mostly biscuits. The authors describe E 500, E 450, E 503 and E 422 as widely used in biscuits and cakes as acidity regulators, stabilizers and emulsifiers. Additive doses were not available.

6. Независимое

   Chazelas E, Druesne-Pecollo N, Esseddik Y, de Edelenyi FS, Agaesse C, De Sa A, et al. Exposure to food additive mixtures in 106,000 French adults from the NutriNet-Santé cohort Scientific Reports, 2021.

   doi:10.1038/s41598-021-98496-6PubMed 34608173

   Финансирование и результат

   Регистрация

   NCT03335644

   Участники

   106 489

   Финансирование

   NutriNet-Santé: Ministère de la Santé, Santé Publique France, INSERM, INRAE, CNAM and University Sorbonne Paris Nord. E. Chazelas: doctoral funding from University Sorbonne Paris Nord; C. Debras: French National Cancer Institute. Project: European Research Council (Horizon 2020, grant agreement No 864219), French National Cancer Institute (INCa_14059), French Ministry of Health (arrêté 29.11.19) and IdEx Université de Paris (ANR-18-IDEX-0001). Researchers were independent from funders; funders had no role in the study design, the collection, analysis and interpretation of data, the writing of the report, and the decision to submit the article for publication.

   Поддержка в натуральной форме

   Some of the 2677 ad hoc laboratory assays of additive doses were ordered by the consumers' association UFC Que Choisir.

   Результат

   Intakes of 90 additives were estimated from repeated 24-h records matched to brand-level composition data (OQALI, Open Food Facts, Mintel GNPD), with doses from 2677 laboratory assays, EFSA dose data by food category or Codex GSFA levels; descriptive analyses were weighted to the 2016 French census. Table 1, % consumers; median, 95th percentile and mean (SD) in mg/day; mean (SD) in mg/kg bw/day: modified starches E 14xx 91.48%; 1304.66, 4270.38, 1596.45 (1394.44); 24.33 (21.84). Citric acid E 330 91.15%; 1380.84, 6193.84, 1956.51 (2231.41); 29.84 (34.31). Lecithins E 322 86.57%; 35.36, 168.33, 53.94 (71.99); 0.83 (1.1). Xanthan gum E 415 79.74%; 303.60, 1401.31, 439.26 (508.65); 6.62 (7.62). Mono- and diglycerides of fatty acids E 471 78.07%; 101.90, 547.24, 160.8 (197.42); 2.44 (2.98). Sodium carbonates E 500 67.10%; 560.00, 4950.00, 1267.46 (1913.51); 19.62 (29.73), with median 8.51 and 95th percentile 76.73 mg/kg bw/day. The ADI column reads NA for all six. Diphosphates E 450 64.36%; 62.86, 715.67, 178.33 (308.05); 2.74 (4.67); ADI 40 mg/kg bw/day, exceeded by 0.02% of all participants and 0.03% of consumers. Additives without a specified ADI can be used quantum satis, that is with no limitations other than current good manufacturing practice. The authors state that information on the health impact of regular and cumulative intake of food additives in humans, and on effects of their mixtures, is still missing.

7. Независимое

   Naimi S, Viennois E, Gewirtz AT, Chassaing B. Direct impact of commonly used dietary emulsifiers on human gut microbiota Microbiome, 2021.

   doi:10.1186/s40168-020-00996-6PubMed 33752754

   Финансирование и результат

   Финансирование

   European Research Council Starting Grant ERC-2018-StG-804135; Chaire d'Excellence from IdEx Université de Paris (ANR-18-IDEX-0001); Innovator Award from the Kenneth Rainin Foundation; Marie Sklodowska-Curie Individual Fellowship; NIH grants DK099071 and DK083890. Funders had no role in the design of the study and data collection, analysis, and interpretation, nor in manuscript writing.

   Результат

   Of 20 emulsifiers tested, carboxymethylcellulose (E466) and polysorbate 80 (E433) altered microbiota composition without reversal after exposure; polysorbate 80 also altered the metatranscriptome. Carrageenans and gums altered density, composition and expression of pro-inflammatory molecules. Soy lecithin (E322) and mono- and diglycerides did not alter the measured parameters; sunflower lecithin altered alpha diversity only. Faecalibacterium fell with polysorbate 80, iota carrageenan, hydroxypropyl methylcellulose and mono- and diglycerides according to the Discussion; the Results text names polysorbate 80, iota carrageenan, agar agar and DATEM. Three of the products are listed as E471 in Table 1: mono- and diglycerides (Modernist Pantry), glyceryl stearate and glyceryl oleate (Lonza). All faecal samples came from one healthy donor; emulsifiers were added at 0.1% to the medium from 72 to 216 h. Glyceryl stearate increased bacterial density in the treatment and post-treatment phases, caused a non-reversible decrease in evenness, increased bioactive lipopolysaccharide significantly in the post-treatment phase and altered the metatranscriptome; Table 2 classes its effects as non-reversible. Glyceryl oleate caused an irreversible decrease in bacterial density and no other change.

8. Независимое

   Sellem L, Srour B, Javaux G, Chazelas E, Chassaing B, Viennois E, et al. Food additive emulsifiers and cancer risk: Results from the French prospective NutriNet-Santé cohort PLoS Medicine, 2024.

   doi:10.1371/journal.pmed.1004338PubMed 38349899

   Финансирование и результат

   Регистрация

   NCT03335644

   Участники

   92 000

   Наблюдение

   mean 6.7 years

   Финансирование

   NutriNet-Santé public institutions (Ministère de la Santé, Santé Publique France, INSERM, INRAE, CNAM, Université de Paris, University Sorbonne Paris Nord); European Research Council (grant agreement 864219); French National Cancer Institute (INCa_14059); French Ministry of Health; IdEx Université de Paris (ANR-18-IDEX-0001); Bettencourt-Schueller Foundation Research Prize 2021. Researchers were independent from funders. Funders had no role in the study design, the collection, analysis, and interpretation of data, the writing of the report, and the decision to submit the article for publication.

   Результат

   2604 incident cancers (750 breast, 322 prostate, 207 colorectal) over 615,749 person-years. Highest versus lowest intake of E471: overall cancer HR 1.15 (95% CI 1.04 to 1.27), breast 1.24 (1.03 to 1.51), prostate 1.46 (1.09 to 1.97); total carrageenans and breast cancer 1.32 (1.09 to 1.60). No emulsifier was associated with colorectal cancer. Modelled absolute risks at age 60 by intake category (eTable C): overall cancer 11.2%, 11.8% and 12.4% for E471; breast cancer 4.2%, 4.7% and 5.1% for E471 and 4.1%, 4.6% and 5.2% for total carrageenans; prostate cancer 3.6%, 4.2% and 4.9% for E471. E471 was coded in sex-specific thirds (cut-offs 34 and 187.3 mg/day in men, 40.4 and 177.8 mg/day in women; category means 7.16, 104.17 and 376.1 mg/day). eTable D, cases/participants by third of E471 intake: overall cancer 790/30,667, 1018/30,729 and 796/30,604, HR 1.00, 1.16 (1.05 to 1.27) and 1.15 (1.04 to 1.27), p-trend 0.01; breast cancer 211/24,090, 292/24,153 and 245/24,027; prostate cancer 86/6,577, 133/6,576 and 103/6,577. Total mono- and diglycerides of fatty acids (E471, E472, E472a, E472b, E472c, E472e) and overall cancer: HR 1.12 (1.02 to 1.23) and 1.03 (0.93 to 1.14), p-trend 0.4. Diphosphates (E450) were consumed by 72.6%, mean 246.7 (SD 341.0) mg/day, and coded in sex-specific thirds (cut-offs 47.3 and 259.5 mg/day in women, 28 and 264.3 mg/day in men; category means in women 4.85, 145.42 and 580.06 mg/day). eTable D, E450 by third: premenopausal breast cancer 61/16,560, 120/17,021 and 113/19,382, HR 1.00, 1.56 (1.13 to 2.15) and 1.45 (1.04 to 2.02), p-trend 0.03 (false-discovery-rate-adjusted p-trend 0.1); overall cancer 838/30,683, 1036/30,658 and 730/30,659, HR 1.00, 1.03 (0.94 to 1.13) and 0.98 (0.88 to 1.09), p-trend 0.97; breast cancer HR 1.14 (0.94 to 1.40) for the highest third, p-trend 0.08. eTable C modelled absolute risk of premenopausal breast cancer at age 40 by E450 third: 1.7%, 2.1% and 2.5%. Additive doses were estimated from laboratory assays, EFSA doses by food category or Codex GSFA doses; the study period was 2009 to 2021. The authors state that further human, epidemiological and preclinical studies are required to elucidate the potential underlying mechanisms.

9. Независимое

   Salame C, Javaux G, Sellem L, Viennois E, de Edelenyi FS, Agaësse C, et al. Food additive emulsifiers and the risk of type 2 diabetes: analysis of data from the NutriNet-Santé prospective cohort study The Lancet Diabetes & Endocrinology, 2024.

   doi:10.1016/S2213-8587(24)00086-XPubMed 38663950

   Финансирование и результат

   Регистрация

   NCT03335644

   Участники

   104 139

   Наблюдение

   mean 6.8 years

   Финансирование

   NutriNet-Santé public institutions (Ministère de la Santé, Santé Publique France, INSERM, INRAE, CNAM, University Sorbonne Paris Nord); European Research Council (grant agreement 864219, ADDITIVES); French National Cancer Institute (INCa_14059); French Ministry of Health; IdEx Université de Paris (ANR-18-IDEX-0001); Bettencourt-Schueller Foundation Research Prize 2021. The funders had no role in study design; the collection, analysis, and interpretation of data; the writing of the report, or the decision to submit the manuscript for publication.

   Результат

   1056 incident cases of type 2 diabetes. Hazard ratios per 100 mg/day: total carrageenans 1.03 (95% CI 1.01 to 1.05), E407 1.03 (1.01 to 1.05); mean total carrageenan intake 59.0 mg/day. Associations were also reported for E340 (1.15, 1.02 to 1.31, per 500 mg/day), E472e, E331, E412, E414 and xanthan gum E415 (hazard ratio 1.08, 95% CI 1.02 to 1.14, per increment of 500 mg/day, p = 0.013). Xanthan gum was found in 5% of foods according to EFSA data cited by the authors. Appendix eTable3 (https://ars.els-cdn.com/content/image/1-s2.0-S221385872400086X-mmc1.pdf), per 500 mg/day, fully adjusted and mutually adjusted for other emulsifiers: E471 0.99 (0.91 to 1.08), p = 0.84, minimally adjusted 1.07 (0.98 to 1.16); total mono- and diglycerides of fatty acids 1.00 (0.95 to 1.05). E471 was consumed by 80.3%, mean 165.4 mg/day. eTable3, per 500 mg/day, fully adjusted: diphosphates E450 1.01 (0.98 to 1.04), p = 0.49; tripotassium phosphate E340 1.15 (1.02 to 1.31), p = 0.023, with a false-discovery-rate-adjusted p of 0.10 (Figure 4 legend); trisodium phosphate E339 1.03 (0.92 to 1.14), p = 0.64. E450 was consumed by 70.4%, mean 244.5 (SD 351.7) mg/day; E340 by 5.2%, mean 6.9 (SD 90.5) mg/day. Absolute risks by intake level are not reported.

10. Регуляторное

    EFSA Panel on Contaminants in the Food Chain (CONTAM). Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food EFSA Journal, 2016.

    doi:10.2903/j.efsa.2016.4426

    Финансирование и результат

    Финансирование

    European Food Safety Authority, on request from the European Commission (Question number EFSA-Q-2014-00535).

    Результат

    3- and 2-MCPD fatty acid esters are produced in vegetable oils on refining; glycidyl esters form from diacylglycerols when oils are heated above 200 °C, for example during deodorisation. Mean middle-bound concentrations (µg/kg) of 3-MCPD from esters: sunflower seed oil 521, maize oil 503, soya bean oil 394, rapeseed oil 232, palm oil/fat 2,912; of glycidol from esters: sunflower 269, maize 650, soya bean 171, rapeseed 166, palm 3,955. Glycidol increased tumour incidence in several tissues of rats and mice, likely via a genotoxic mode of action. Animal studies show extensive hydrolysis of esterified 3-MCPD and glycidol after oral administration; with no in vivo data for glycidyl esters, dose-response considerations assumed complete hydrolysis of the esters to free glycidol after ingestion. There is strong evidence from in vitro data and some evidence from in vivo studies that glycidol is genotoxic.

11. Регуляторное

    EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, Castle L, Engel KH, Fowler P, et al. 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 EFSA Journal, 2021.

    doi:10.2903/j.efsa.2021.6885PubMed 34765031

    Финансирование и результат

    Финансирование

    European Food Safety Authority; requestor: European Commission; question number EFSA-Q-2018-00100. Technical data were submitted in response to a call for data by the European Food Emulsifiers Manufacturers Association (EFEMA) and Specialised Nutrition Europe.

    Результат

    Data from one interested business operator (EFEMA, documentation 1 to 3): free and bound 3-MCPD, as free 3-MCPD, from below 0.1 to 4.45 mg/kg and glycidyl esters, as glycidol, from below 0.1 to 111.25 mg/kg in around 80 batches of E 471, the highest in E 471 from unsaturated rapeseed oil with about 40% monoglycerides; trans fatty acids 0.01% to below 1% in 15 samples from fully hardened, 0.34% to 1.59% in 12 from non-hardened and 15.88% to 59.92% in 7 from partially hardened raw materials; the operator stated that the manufacture uses no solvents. At the lowest technologically achievable levels proposed by the operator (glycidyl esters 10 mg/kg, 3-MCPD 2.5 mg/kg, erucic acid 20 g/kg), margins of exposure for glycidol were 785 to 4,130 against 25,000 of low concern, and reference values were exceeded for 3-MCPD in infants below 16 weeks and for glycidyl esters and erucic acid in all population groups. For infants below 16 weeks, exposure from infant formulae at the maximum permitted level of 4,000 mg/kg was 800 mg/kg bw per day at mean and 1,040 at high consumption (418 and 543 at the mean reported use level of 2,089 mg/kg); daily exposure to mono- and diacylglycerols from breast milk and from formula containing E 471 was of the same order of magnitude, and the Panel concluded that there is no reason for a safety concern for use in food categories 13.1.1 and 13.1.5.1. The Panel recommended lower limits for lead, cadmium, mercury and arsenic and new limits for 3-MCPD, glycidyl esters and erucic acid in the EU specifications.

12. Независимое

    Sellem L, Srour B, Javaux G, Chazelas E, Chassaing B, Viennois E, et al. Food additive emulsifiers and risk of cardiovascular disease in the NutriNet-Santé cohort: prospective cohort study BMJ, 2023.

    doi:10.1136/bmj-2023-076058PubMed 37673430

    Финансирование и результат

    Регистрация

    NCT03335644

    Участники

    95 442

    Наблюдение

    median 7.4 years

    Финансирование

    NutriNet-Santé: Ministère de la Santé, Santé Publique France, INSERM, INRAE, Conservatoire National des Arts et Métiers and University Sorbonne Paris Nord. Project: European Research Council (grant agreement 864219), French National Cancer Institute (INCa_14059), French Ministry of Health, IdEx Université de Paris (ANR-18-IDEX-0001) and a Bettencourt-Schueller Foundation research prize 2021. Researchers were independent from funders. The funders had no role in the design; collection, analysis, and interpretation of data; writing of the report; and decision to submit the article for publication.

    Результат

    1995 cardiovascular events over 666,509 person-years. Hazard ratios per 1 SD of intake: total celluloses (E460-E468) 1.05 (95% CI 1.02 to 1.09) for cardiovascular disease and 1.07 (1.02 to 1.12) for coronary heart disease; carboxymethylcellulose (E466, SD 32.0 mg/day) 1.03 (1.01 to 1.05) and 1.04 (1.02 to 1.06); total mono- and diglycerides of fatty acids (E471 and E472) 1.07 (1.04 to 1.11) for cardiovascular disease. Supplementary eTable2: total mono- and diglycerides of fatty acids (E471, E472, E472a, E472b, E472c and E472e; SD 287.5 mg/day) 1.07 (1.04 to 1.11), 1.08 (1.03 to 1.14) for coronary heart disease and 1.07 (1.01 to 1.13) for cerebrovascular disease; E471 alone (SD 208.6 mg/day) 1.03 (0.98 to 1.09), P = 0.2, for cardiovascular disease, and 1.03 (0.96 to 1.11) for coronary heart disease and for cerebrovascular disease. E471 was consumed by 81.6%, mean 161.2 mg/day. Diphosphates (E450) were consumed by 72.6%, mean 244.5 (SD 338.2) mg/day; eTable2 hazard ratios per SD (349.7 mg/day) were 0.99 (0.93 to 1.04) for cardiovascular disease, 0.96 (0.89 to 1.04) for coronary heart disease and 1.01 (0.93 to 1.09) for cerebrovascular disease. Trisodium phosphate (E339) was associated with coronary heart disease, 1.06 (1.00 to 1.12) per SD (58.4 mg/day), P = 0.03, not significant after correction for multiple testing (adjusted P = 0.3). Carrageenans and lecithins were not associated. Mean E466 intake 3.8 mg/day, consumed by 10.8%; E433 consumed by 1.1% and not analysed individually. Absolute risks by intake level are not reported.

13. Регуляторное

    US Food and Drug Administration. Mono- and diglycerides, 21 CFR 184.1505: direct food substances affirmed as generally recognized as safe Code of Federal Regulations, title 21, section 184.1505, read in the electronic Code of Federal Regulations, title 21 amended to 14 October 2026, 2026.

    https://www.ecfr.gov/current/title-21/section-184.1505

    Финансирование и результат

    Финансирование

    US Food and Drug Administration; the text is federal regulation codified by the Office of the Federal Register.

    Результат

    Mono- and diglycerides consist of a mixture of glyceryl mono- and diesters, and minor amounts of triesters, prepared from fats or oils or fat-forming acids derived from edible sources; the most prevalent fatty acids include lauric, linoleic, myristic, oleic, palmitic and stearic. They are manufactured by the reaction of glycerin with fatty acids or with triglycerides in the presence of an alkaline catalyst and purified to a mixture of glycerides, free fatty acids and free glycerin containing at least 90 percent-by-weight glycerides, meeting the Food Chemicals Codex, 3rd edition (1981), p. 201. In accordance with 184.1(b)(1) the ingredient is used in food with no limitation other than current good manufacturing practice; the GRAS affirmation rests on use as a dough strengthener, emulsifier and emulsifier salt, flavoring agent and adjuvant, formulation aid, lubricant and release agent, solvent and vehicle, stabilizer and thickener, surface-active agent, surface-finishing agent and texturizer at levels not exceeding current good manufacturing practice. Source: 54 FR 7403, 21 February 1989, as amended at 57 FR 10616, 27 March 1992.

14. Регуляторное

    Ministry of Health, Labour and Welfare; Consumer Affairs Agency. 第10版 食品添加物公定書 (Japan's Specifications and Standards for Food Additives, 10th edition) Ministry of Health, Labour and Welfare and Consumer Affairs Agency, Japan; Appendix 1, classification table of listed additives, and Section F, standards for use, 2024.

    https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/syokuten/kouteisho10e.html

    Финансирование и результат

    Финансирование

    Ministry of Health, Labour and Welfare and Consumer Affairs Agency, Japan; the compendium carries no funding statement.

    Результат

    Appendix 1 classifies L-ascorbic acid (Ｌ－アスコルビン酸, code FA001100) as a designated additive (指定), the category listed in Appended Table 1 of the Food Sanitation Act Enforcement Regulations; calcium and sodium L-ascorbate, L-ascorbic acid 2-glucoside and the stearate and palmitate esters are also designated. Section F, standards for use, has entries for erythorbic acid and sodium erythorbate and none for L-ascorbic acid or its salts. Appendix 1 classifies グリセリン脂肪酸エステル (Glycerol Esters of Fatty Acids, code FA018600) as designated; the Section D monograph (https://www.mhlw.go.jp/content/11130500/001208483.pdf) defines it as esters of fatty acids with glycerol or polyglycerol and their derivatives, comprising glycerol fatty acid esters, glycerol acetic, lactic, citric, succinic and diacetyltartaric acid fatty acid esters, glycerol acetic acid esters, polyglycerol fatty acid esters and polyglycerol condensed ricinoleic acid esters.