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Re‐evaluation of pullulan (E 1204) as a food additive and new application for its extension of use.

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Title: Re‐evaluation of pullulan (E 1204) as a food additive and new application for its extension of use.
Authors: Castle, Laurence (AUTHOR), Andreassen, Monica (AUTHOR), Aquilina, Gabriele (AUTHOR), Bastos, Maria Lourdes (AUTHOR), Boon, Polly (AUTHOR), Fallico, Biagio (AUTHOR), Fitzgerald, Reginald (AUTHOR), Frutos Fernandez, Maria Jose (AUTHOR), Grasl‐Kraupp, Bettina (AUTHOR), Gundert‐Remy, Ursula (AUTHOR), Gürtler, Rainer (AUTHOR), Houdeau, Eric (AUTHOR), Kurek, Marcin (AUTHOR), Louro, Henriqueta (AUTHOR), Morales, Patricia (AUTHOR), Passamonti, Sabina (AUTHOR), Barat Baviera, José Manuel (AUTHOR), Degen, Gisela (AUTHOR), Gott, David (AUTHOR), Leblanc, Jean‐Charles (AUTHOR)
Source: EFSA Journal. Mar2025, Vol. 23 Issue 3, p1-31. 31p.
Subject Terms: *Food additives, *Manufacturing processes, Short-chain fatty acids, Aureobasidium pullulans, Dietary supplements, Internet in public administration
Abstract: The present opinion deals with the re‐evaluation of pullulan (E 1204) when used as a food additive and with the new application on the extension of use to several food categories. Pullulan (E 1204) is obtained by fermentation of a food‐grade hydrolysed starch with non‐genetically modified Aureobasidium pullulans ■■■■■. Based on the available information, the Panel considered that the manufacturing process of pullulan (E 1204) using this microorganism does not raise a safety concern. The Panel confirmed that pullulan (E 1204) is of no concern for genotoxicity. In vitro, pullulan (E 1204) is broken down by salivary and pancreatic amylase and intestinal iso‐amylase and it is further metabolised to short chain fatty acids in the colon by fermentation. Human adult volunteer studies suggested that effects of pullulan (E 1204) are similar to the effects of other poorly digestible carbohydrate polymers including modified celluloses and that mild undesirable gastrointestinal symptoms (i.e. abdominal fullness, flatulence, bloating and cramping) may occur at doses of 10 g pullulan per day and greater. The Panel compared the dose of 10 g pullulan per day with the dietary exposure estimates to pullulan (E 1204) in its currently permitted uses and considering the proposed changes to the currently permitted uses. The Panel concluded that there is no need for a numerical ADI for pullulan (E 1204) and there is no safety concern for the currently reported uses and use levels. Additionally, the Panel concluded that the exposure estimates considering the proposed changes to the currently permitted uses and use levels of pullulan (E 1204) are of no safety concern. The estimates for dietary exposure to pullulan (E 1204) indicate that individuals with a high level of exposure, principally coming from food supplements, may experience mild gastrointestinal symptoms at the currently reported uses and use levels. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Re‐evaluation of pullulan (E 1204) as a food additive and new application for its extension of use.
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Mar2025, Vol. 23 Issue 3, p1-31. 31p.
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  Data: *<searchLink fieldCode="DE" term="%22Food+additives%22">Food additives</searchLink><br />*<searchLink fieldCode="DE" term="%22Manufacturing+processes%22">Manufacturing processes</searchLink><br /><searchLink fieldCode="DE" term="%22Short-chain+fatty+acids%22">Short-chain fatty acids</searchLink><br /><searchLink fieldCode="DE" term="%22Aureobasidium+pullulans%22">Aureobasidium pullulans</searchLink><br /><searchLink fieldCode="DE" term="%22Dietary+supplements%22">Dietary supplements</searchLink><br /><searchLink fieldCode="DE" term="%22Internet+in+public+administration%22">Internet in public administration</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: The present opinion deals with the re‐evaluation of pullulan (E 1204) when used as a food additive and with the new application on the extension of use to several food categories. Pullulan (E 1204) is obtained by fermentation of a food‐grade hydrolysed starch with non‐genetically modified Aureobasidium pullulans ■■■■■. Based on the available information, the Panel considered that the manufacturing process of pullulan (E 1204) using this microorganism does not raise a safety concern. The Panel confirmed that pullulan (E 1204) is of no concern for genotoxicity. In vitro, pullulan (E 1204) is broken down by salivary and pancreatic amylase and intestinal iso‐amylase and it is further metabolised to short chain fatty acids in the colon by fermentation. Human adult volunteer studies suggested that effects of pullulan (E 1204) are similar to the effects of other poorly digestible carbohydrate polymers including modified celluloses and that mild undesirable gastrointestinal symptoms (i.e. abdominal fullness, flatulence, bloating and cramping) may occur at doses of 10 g pullulan per day and greater. The Panel compared the dose of 10 g pullulan per day with the dietary exposure estimates to pullulan (E 1204) in its currently permitted uses and considering the proposed changes to the currently permitted uses. The Panel concluded that there is no need for a numerical ADI for pullulan (E 1204) and there is no safety concern for the currently reported uses and use levels. Additionally, the Panel concluded that the exposure estimates considering the proposed changes to the currently permitted uses and use levels of pullulan (E 1204) are of no safety concern. The estimates for dietary exposure to pullulan (E 1204) indicate that individuals with a high level of exposure, principally coming from food supplements, may experience mild gastrointestinal symptoms at the currently reported uses and use levels. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=8gh&AN=184169676
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      – Type: doi
        Value: 10.2903/j.efsa.2025.9267
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      – Code: eng
        Text: English
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      – SubjectFull: Food additives
        Type: general
      – SubjectFull: Manufacturing processes
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      – SubjectFull: Short-chain fatty acids
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      – SubjectFull: Aureobasidium pullulans
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      – SubjectFull: Internet in public administration
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