Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling
Abstract Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to review a scientific assessment related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of ce...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-09-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.8240 |
| _version_ | 1797670899572277248 |
|---|---|
| author | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Karen Ildico Hirsch‐Ernst Helle Katrine Knutsen Alexander Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Rosangela Marchelli Hendrik Van Loveren Silvia Valtueña Martínez Stefaan deHenauw |
| author_facet | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Karen Ildico Hirsch‐Ernst Helle Katrine Knutsen Alexander Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Rosangela Marchelli Hendrik Van Loveren Silvia Valtueña Martínez Stefaan deHenauw |
| author_sort | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) |
| collection | DOAJ |
| description | Abstract Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to review a scientific assessment related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling. The EC requested EFSA to consider comments raised by the German authorities in relation to: (a) the maximum amount of mustard protein that could be consumed from the emulsifiers manufactured from behenic acid (E470a, E471 and E477) on a single occasion and (b) the minimal observed eliciting dose (MOED) triggering allergic reactions in mustard‐allergic individuals. The maximum amount of mustard protein content in behenic acid was re‐assessed in view of new analytical data provided by the applicant. Intake estimates by the EFSA ANS Panel for E471 (adults) were used as a proxy for the combined intake (E470a, E471 and E477). Food challenge data and systematic reviews thereof deriving population minimal observed eliciting dose distributions for mustard protein were used to calculate the MOED and estimate the risk. The margin of exposure between the MOED (0.26 mg mustard protein) and the maximum amount of mustard protein that could be consumed from the emulsifiers on a single occasion (0.00895475 mg) is 29. It is predicted that between 0.1% and 1% of the mustard allergic population would react with mild objective symptoms to that dose. Overall, the assessment is conservative, particularly in relation to the exposure. Based on the information and data available, the NDA Panel concludes that it is extremely unlikely (≤ 1% probability) that oral consumption of emulsifiers to be manufactured using behenic acid from mustard seeds (i.e. E470a, E471 and E477) will trigger an allergic reaction in mustard‐allergic individuals under the proposed conditions of use. |
| first_indexed | 2024-03-11T21:06:33Z |
| format | Article |
| id | doaj.art-1839c370a7d54af18c795a71393a62f4 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-11T21:06:33Z |
| publishDate | 2023-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-1839c370a7d54af18c795a71393a62f42023-09-29T11:30:29ZengWileyEFSA Journal1831-47322023-09-01219n/an/a10.2903/j.efsa.2023.8240Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labellingEFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerKaren Ildico Hirsch‐ErnstHelle Katrine KnutsenAlexander MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiRosangela MarchelliHendrik Van LoverenSilvia Valtueña MartínezStefaan deHenauwAbstract Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to review a scientific assessment related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling. The EC requested EFSA to consider comments raised by the German authorities in relation to: (a) the maximum amount of mustard protein that could be consumed from the emulsifiers manufactured from behenic acid (E470a, E471 and E477) on a single occasion and (b) the minimal observed eliciting dose (MOED) triggering allergic reactions in mustard‐allergic individuals. The maximum amount of mustard protein content in behenic acid was re‐assessed in view of new analytical data provided by the applicant. Intake estimates by the EFSA ANS Panel for E471 (adults) were used as a proxy for the combined intake (E470a, E471 and E477). Food challenge data and systematic reviews thereof deriving population minimal observed eliciting dose distributions for mustard protein were used to calculate the MOED and estimate the risk. The margin of exposure between the MOED (0.26 mg mustard protein) and the maximum amount of mustard protein that could be consumed from the emulsifiers on a single occasion (0.00895475 mg) is 29. It is predicted that between 0.1% and 1% of the mustard allergic population would react with mild objective symptoms to that dose. Overall, the assessment is conservative, particularly in relation to the exposure. Based on the information and data available, the NDA Panel concludes that it is extremely unlikely (≤ 1% probability) that oral consumption of emulsifiers to be manufactured using behenic acid from mustard seeds (i.e. E470a, E471 and E477) will trigger an allergic reaction in mustard‐allergic individuals under the proposed conditions of use.https://doi.org/10.2903/j.efsa.2023.8240behenic acidemulsifiersmustardfood allergyminimal observed eliciting doselabelling exemption |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Karen Ildico Hirsch‐Ernst Helle Katrine Knutsen Alexander Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Rosangela Marchelli Hendrik Van Loveren Silvia Valtueña Martínez Stefaan deHenauw Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling EFSA Journal behenic acid emulsifiers mustard food allergy minimal observed eliciting dose labelling exemption |
| title | Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling |
| title_full | Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling |
| title_fullStr | Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling |
| title_full_unstemmed | Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling |
| title_short | Re‐evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling |
| title_sort | re evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to article 21 2 of regulation eu no 1169 2011 for permanent exemption from labelling |
| topic | behenic acid emulsifiers mustard food allergy minimal observed eliciting dose labelling exemption |
| url | https://doi.org/10.2903/j.efsa.2023.8240 |
| work_keys_str_mv | AT efsapanelonnutritionnovelfoodsandfoodallergensnda reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT dominiqueturck reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT torstenbohn reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT jacquelinecastenmiller reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT karenildicohirschernst reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT hellekatrineknutsen reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT alexandermaciuk reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT ingemangelsdorf reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT harryjmcardle reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT andronikinaska reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT kristinapentieva reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT alfonsosiani reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT frankthies reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT sophiatsabouri reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT marcovinceti reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT rosangelamarchelli reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT hendrikvanloveren reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT silviavaltuenamartinez reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling AT stefaandehenauw reevaluationofbehenicacidfrommustardseedstobeusedinthemanufacturingofcertainemulsifierspursuanttoarticle212ofregulationeuno11692011forpermanentexemptionfromlabelling |