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Safety evaluation of jagua (genipin‐glycine) blue as a food additive.

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Title: Safety evaluation of jagua (genipin‐glycine) blue as a food additive.
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. Dec2025, Vol. 23 Issue 12, p1-41. 41p.
Subject Terms: *Food additives, *Toxicology, Safety, Coloring matter, Risk assessment, Coloring matter in food
Abstract: The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of jagua (genipin‐glycine) blue as a new food additive. Jagua (genipin‐glycine) blue is obtained by water extraction of the ground pulp of the peeled, unripe fruits of Genipa americana L. and is the result of a reaction between genipin (iridoid present in the fruit) and externally added glycine. This reaction leads to the formation of a blue‐coloured polymer and minor colouring components. In vitro Caco‐2 cell permeability test demonstrated a low permeability of jagua (genipin‐glycine) blue, but repeated dose toxicity studies showed organs discoloration and green‐coloured urine, demonstrating some absorption. The toxicological data set comprised acute, sub‐chronic toxicity, genotoxicity studies and also a 12‐month toxicity study including in utero exposure. Jagua (genipin‐glycine) blue was not genotoxic, and no adverse effects were observed in the repeated dose toxicity studies up to the highest doses tested. The Panel derived an acceptable daily intake (ADI) of 34 mg/kg bw per day or 12 mg/kg bw per day expressed as blue polymer, based on a no observed adverse effect level (NOAEL) of 3385 mg/kg bw per day, the highest dose tested, from the 12‐month toxicity study and an uncertainty factor of 100. At the proposed maximum use level exposure assessment scenario, the 95th percentile of exposure approximately ranged from 1 mg/kg bw per day in the elderly to 27 mg/kg bw per day in toddlers. The Panel noted that both the mean and 95th percentile estimates of exposure did not exceed the proposed ADI in all population groups. The same was true for the exposure to the blue polymer assuming a 40% content in the proposed food additive. The Panel concluded there is no safety concern for jagua (genipin‐glycine) blue as a food additive at the proposed use 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: Safety evaluation of jagua (genipin‐glycine) blue as a food additive.
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  Data: <searchLink fieldCode="AR" term="%22Castle%2C+Laurence%22">Castle, Laurence</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Andreassen%2C+Monica%22">Andreassen, Monica</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Aquilina%2C+Gabriele%22">Aquilina, Gabriele</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bastos%2C+Maria+Lourdes%22">Bastos, Maria Lourdes</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Boon%2C+Polly%22">Boon, Polly</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fallico%2C+Biagio%22">Fallico, Biagio</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22FitzGerald%2C+Reginald%22">FitzGerald, Reginald</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Frutos+Fernandez%2C+Maria+Jose%22">Frutos Fernandez, Maria Jose</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Grasl‐Kraupp%2C+Bettina%22">Grasl‐Kraupp, Bettina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gundert‐Remy%2C+Ursula%22">Gundert‐Remy, Ursula</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gürtler%2C+Rainer%22">Gürtler, Rainer</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Houdeau%2C+Eric%22">Houdeau, Eric</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kurek%2C+Marcin%22">Kurek, Marcin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Louro%2C+Henriqueta%22">Louro, Henriqueta</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Morales%2C+Patricia%22">Morales, Patricia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Passamonti%2C+Sabina%22">Passamonti, Sabina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Barat+Baviera%2C+José+Manuel%22">Barat Baviera, José Manuel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Degen%2C+Gisela%22">Degen, Gisela</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gott%2C+David%22">Gott, David</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Leblanc%2C+Jean‐Charles%22">Leblanc, Jean‐Charles</searchLink> (AUTHOR)
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– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of jagua (genipin‐glycine) blue as a new food additive. Jagua (genipin‐glycine) blue is obtained by water extraction of the ground pulp of the peeled, unripe fruits of Genipa americana L. and is the result of a reaction between genipin (iridoid present in the fruit) and externally added glycine. This reaction leads to the formation of a blue‐coloured polymer and minor colouring components. In vitro Caco‐2 cell permeability test demonstrated a low permeability of jagua (genipin‐glycine) blue, but repeated dose toxicity studies showed organs discoloration and green‐coloured urine, demonstrating some absorption. The toxicological data set comprised acute, sub‐chronic toxicity, genotoxicity studies and also a 12‐month toxicity study including in utero exposure. Jagua (genipin‐glycine) blue was not genotoxic, and no adverse effects were observed in the repeated dose toxicity studies up to the highest doses tested. The Panel derived an acceptable daily intake (ADI) of 34 mg/kg bw per day or 12 mg/kg bw per day expressed as blue polymer, based on a no observed adverse effect level (NOAEL) of 3385 mg/kg bw per day, the highest dose tested, from the 12‐month toxicity study and an uncertainty factor of 100. At the proposed maximum use level exposure assessment scenario, the 95th percentile of exposure approximately ranged from 1 mg/kg bw per day in the elderly to 27 mg/kg bw per day in toddlers. The Panel noted that both the mean and 95th percentile estimates of exposure did not exceed the proposed ADI in all population groups. The same was true for the exposure to the blue polymer assuming a 40% content in the proposed food additive. The Panel concluded there is no safety concern for jagua (genipin‐glycine) blue as a food additive at the proposed use and use levels. [ABSTRACT FROM AUTHOR]
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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.)
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        Value: 10.2903/j.efsa.2025.9738
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        Text: English
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