Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes

Products, Efsa Panel on Dietetic

doi:10.2903/j.efsa.2014.3894

Cited by 117 publications

(64 citation statements)

References 1,375 publications

(2,087 reference statements)

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“…The sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) protein pattern of the standard soya lecithin is very similar to that of soya flour. The lowest MED reported in soya-allergic patients undergoing DBPCFC was 0.2 mg of soya protein, although the majority of patients only reacted to higher doses (EFSA NDA Panel, 2014).…”

Section: Information On Existing Evaluations and Authorisations Lecitmentioning

confidence: 89%

Re‐evaluation of lecithins (E 322) as a food additive

Mortensen¹,

Aguilar²,

Crebelli³

et al. 2017

EFS2

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The present opinion deals with the re-evaluation of lecithins (E 322) when used as a food additive. 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. Among lecithins, phosphatidylcholine is hydrolysed in choline in the cytidine-5-diphosphate-choline pathway in all cells of the body. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/ 2010, the Panel concluded that there was no need for a numerical ADI for lecithins (E 322) and that there was no safety concern for the general population from more than 1 year of age at the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive. The Panel further concluded that there is no safety concern for the exposure to the choline from lecithins (E 322) as a food additive at use and use levels reported by industry. For infants (from 12 weeks up to 11 months of age), the Panel concluded that there was no safety concern at the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive and for the choline from lecithins (E 322) as a food additive at use and use levels reported by industry. For infants and young children consuming foods for special medical purposes, the Panel concluded that there was no safety concern with respect to the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive and for exposure to choline resulting from these uses of lecithins (E 322).

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Section: Information On Existing Evaluations and Authorisations Lecitmentioning

confidence: 89%

Re‐evaluation of lecithins (E 322) as a food additive

Mortensen¹,

Aguilar²,

Crebelli³

et al. 2017

EFS2

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“…Increased synthesis of prostaglandins can also induce bronchoconstriction. In addition, in experimental models, sulphites may contribute to the persistence of chronic asthma symptoms and enhance allergic sensitization and airway inflammation' (EFSA, NDA Panel, 2014). The Panel agreed with this conclusion.…”

Section: Discussionmentioning

confidence: 81%

Scientific Opinion on the re‐evaluation of sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228) as food additives

Reculusa

Arbault

2016

EFS2

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The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re‐evaluating sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228) when used as food additives. The Panel noted that sulfur dioxide, bisulfite and sulfite ions existed in a series of equilibria and that these would favour bisulfite ions at the pH of the stomach and sulfite ions at physiological pHs. Therefore, it was considered that once ingested, based on their capacity to form sulfite ions, read across between the different sulfite sources is possible; however, the Panel noted the uncertainties about the reactivity of sulfites in different foods and the resulting reaction products. The overall limited database did not indicate any concern for genotoxicity and did not report any effect in the available chronic, carcinogenicity and reprotoxicity studies after oral exposure in the diet, by gavage, or in the drinking water. A no observed adverse effect level (NOAEL) of 70 mg SO2 equivalent/kg body weight (bw) per day was identified from a long‐term toxicity study in rats. However, the Panel noted several uncertainties and limitations in the database and concluded that the current group acceptable daily intake (ADI) of 0.7 mg SO2 equivalent/kg bw per day (derived using a default uncertainty factor) would remain adequate but should be considered temporary while the database was improved. The Panel recommended that the database and the temporary group ADI should be re‐evaluated and noted that the recommended studies could require 5 years for completion. The Panel further concluded that exposure estimates to sulfur dioxide and sulfites were higher than the group ADI of 0.7 mg SO2 equivalent/kg bw per day for all population groups.

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“…These observations likely indicate that the initial positive response to AvHPPD-03 was caused by non-specific proteins other than the recombinant AvHPPD-03 protein. In addition to the human sera data provided, the GMO Panel also considered that the current clinical evidence supporting oat as a strong source of allergy is limited (EFSA NDA Panel, 2014;Burman et al, 2019). Moreover, the AvHPPD-03 protein in soybean SYHT0H2 is almost identical to that expressed in oat (a single amino acid difference) and highly similar to HPPD proteins expressed in other crops (see Section 3.3.3.1), evidencing an existing exposure to proteins highly similar to AvHPPD-03 with no indications of allergenicity.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteinsmentioning

confidence: 99%

Assessment of genetically modified soybean SYHT0H2 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2012‐111)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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The scope of application EFSA-GMO-DE-2012-111 is for food and feed uses, import and processing of genetically modified (GM) soybean SYHT0H2 in the European Union. Soybean SYHT0H2 was developed to confer tolerance to the herbicidal active substances mesotrione and other p-hydroxyphenylpyruvate dioxygenase (HPPD)-inhibiting herbicides and glufosinate ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues except for sequence similarity of AvHPPD-03 to bacterial haemolysins that was considered in food/feed safety assessment. The outcome of the comparative analysis (agronomic/phenotypic and compositional characteristics) did not need further assessment except for the changes in seed levels of a-tocopherol and c-tocopherol that were assessed for food and feed relevance. The GMO Panel does not identify toxicological and allergenicity concerns for the AvHPPD-03 and PAT proteins expressed in soybean SYHT0H2 and finds no evidence that the genetic modification would change the overall allergenicity of soybean SYHT0H2. The nutritional impact of food/ feed from soybean SYHT0H2 is expected to be the same as that of food/feed from the conventional counterpart and commercial non-GM soybean reference varieties. The GMO Panel concludes that soybean SYHT0H2 is as safe as and nutritionally equivalent to the conventional counterpart and the tested non-GM soybean reference varieties, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean SYHT0H2 grains into the environment, soybean SYHT0H2 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean SYHT0H2. In conclusion, the GMO Panel considers that soybean SYHT0H2, as described in this application, is as safe as its conventional counterpart and the tested non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

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Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes

Cited by 117 publications

References 1,375 publications

Re‐evaluation of lecithins (E 322) as a food additive

Re‐evaluation of lecithins (E 322) as a food additive

Scientific Opinion on the re‐evaluation of sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228) as food additives

Assessment of genetically modified soybean SYHT0H2 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2012‐111)

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