Opinion on the re‐evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as food additive for uses in foods for all population groups

Flavourings,; Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Engel, Karl‐Heinz; Fowler, Paul; Fürst, Peter; Gürtler, Rainer; Husøy, Trine; Manco, Melania; Mennes, Wim; Moldéus, Peter; Passamonti, Sabina; Shah, Romina; Waalkens‐Berendsen, Ine; Wright, Matthew; Dusemund, Birgit; Mortensen, Alicja; Turck, Dominique; Barmaz, Stefania; Smeraldi, Camilla; Tard, Alexandra; Vianello, Giorgia; Rincón, Ana María; Gundert‐Remy, Ursula

doi:10.2903/j.efsa.2020.6266

Cited by 17 publications

(11 citation statements)

References 35 publications

(49 reference statements)

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“…Authorities such as the European Food Safety Authority (EFSA) and the FDA require safety assessments of emulsifiers before approval for food use. In this context, an acceptable daily intake (ADI) level and maximum food additive use and exposure levels could be established [ 15 ]. A maximum use level of an additive could be defined as the highest additive concentration determined to be functionally effective in a food category.…”

Section: Emulsifiers In Processed Foodsmentioning

confidence: 99%

“…Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs [ 28 ]. The EFSA re-evaluated lecithin as a food additive in foods for infants below 16 weeks of age and follow-up and in foods for all population groups [ 15 ]. Concerning the dietary exposure to the food additive for infants below 16 weeks of age, the maximum use levels of lecithins were defined at 260 mg/kg per day.…”

Section: Emulsifiers In Processed Foodsmentioning

confidence: 99%

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Food Emulsifiers and Metabolic Syndrome: The Role of the Gut Microbiota

Siena

Raoul

Costantini

et al. 2022

Foods

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The use of emulsifiers in processed foods and the rapid epidemic development of metabolic syndrome in Western countries over the past 20 years have generated growing interest. Evidence for the role of emulsifiers in metabolic syndrome through gut microbiota has not been clearly established, thus making it challenging for clinical nutritionists and dietitians to make evidence-based associations between the nature and the quantity of emulsifiers and metabolic disorders. This narrative review summarizes the highest quality clinical evidence currently available about the impact of food emulsifiers on gut microbiota composition and functions and the potential development of metabolic syndrome. The state-of-the-art of the different common emulsifiers is performed, highlighting where they are present in daily foods and their roles. Recent findings of in vitro, in vivo, and human studies assessing the effect of different emulsifiers on gut microbiota have been recently published. There is some progress in understanding how some food emulsifiers could contribute to developing metabolic diseases through gut microbiota alterations while others could have prebiotic effects. However, there are still many unanswered questions regarding daily consumption amounts and the synergic effects between emulsifiers’ intake and responses by the microbial signatures of each individual.

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Section: Emulsifiers In Processed Foodsmentioning

confidence: 99%

Section: Emulsifiers In Processed Foodsmentioning

confidence: 99%

Food Emulsifiers and Metabolic Syndrome: The Role of the Gut Microbiota

Siena

Raoul

Costantini

et al. 2022

Foods

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show abstract

“…Proteases used in milk hydrolysis are manufactured in an equivalent manner to those used in pharmaceutical preparations. Foods in which the enzyme has been applied have been on the market with only rare reports of adverse allergic reactions in infants (EFSA FAF Panel, 2020 ). The specificity of these adverse reactions has not been established.…”

Section: Assessmentmentioning

confidence: 99%

Safety evaluation of the food enzyme containing trypsin, chymotrypsin, α‐amylase and triacylglycerol lipase from porcine pancreas

Lambré¹,

Baviera²,

Bolognesi³

et al. 2022

EFS2

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The food enzyme complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), α‐amylase (1,4‐α‐ d ‐glucan glucanohydrolase, EC 3.2.1.1) and triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3), is obtained from porcine pancreas by American Laboratories, Inc., USA. The food enzyme is intended primarily for the hydrolysis of milk proteins to be used in foods for special medical or nutritional dietary management. ■■■■■ is extensively used in the manufacturing process, and residual amounts of the solvent remain in the food enzyme. The applicant estimates a typical range of ■■■■■ in the food enzyme to be 10,000–13,000 mg/kg. Directive 2009/32/EC sets a maximum residue level of 10 mg/kg for foods and food ingredients produced in the EU or imported into the EU. The use of ■■■■■ for the production of a food enzyme falls within the scope of Directive 2009/32/EC. Consequently, the food enzyme does not comply with the existing requirements within the EU governing residual amount of solvent.

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“…The protease produced with the aim of hydrolysis of milk proteins is made according to similar procedures as the drug. Foods in which the enzyme has been applied have been on the market with only rare reports of adverse allergic reactions in infants (EFSA FAF Panel, 2020). The specificity of these adverse reactions has not been established.…”

Section: Allergenicitymentioning

confidence: 99%

Safety evaluation of the food enzyme trypsin from porcine pancreas

Lambré¹,

Baviera²,

Bolognesi³

et al. 2022

EFS2

Self Cite

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The food enzyme trypsin (EC 3.4.21.4) is extracted from porcine pancreas by Ningbo Linzyme Biosciences Co., Ltd. It is intended to be used for the hydrolysis of whey proteins for use in infant formulae and follow‐on formulae. Based on maximum use levels and the maximum permitted protein content in infant formula, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be 16.8 mg TOS/kg body weight (bw) per day for infants. In the toxicological evaluation, clinical studies with pancreatic enzymes were considered. Hypersensitivity to the pharmaceuticals was identified as the major side effect. However, allergic reactions to porcine pancreatic enzymes in hydrolysed foods have not been reported. The Panel considered that a risk of allergic sensitisation to this food enzyme after consumption of products prepared by hydrolysis of milk proteins could not be excluded in infants, but it considered the likelihood to be low. Based on the origin of the food enzyme from an edible tissue of pigs, the data provided by the applicant, the information from the evaluation of clinical studies based on pancreatic enzymes and the estimated dietary exposure, the Panel concluded that the trypsin from porcine pancreas does not give rise to safety concerns under the intended conditions of use.

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Opinion on the re‐evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as food additive for uses in foods for all population groups

Abstract: Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as food additive for uses in foods for all population groups EFSA Panel on Food Additives and Flavourings (FAF),

Cited by 17 publications

References 35 publications

Food Emulsifiers and Metabolic Syndrome: The Role of the Gut Microbiota

Food Emulsifiers and Metabolic Syndrome: The Role of the Gut Microbiota

Safety evaluation of the food enzyme containing trypsin, chymotrypsin, α‐amylase and triacylglycerol lipase from porcine pancreas

Safety evaluation of the food enzyme trypsin from porcine pancreas

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