Opinion of the Scientific Panel on Dietetic products, nutrition and allergies [NDA] related to the safety of noni juice (juice of the fruits of Morinda citrifolia)
Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Pagona Lagiou,
Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Andreu Palou,
Hildegard Przyrembel, Seppo Salminen, John Sean Strain, Stephan Strobel, Henk van den
Berg, Hendrik van Loveren, and Hans Verhagen.
Acknowledgment
The Scientific Panel on Dietetic Products, Nutrition and Allergies wishes to thank Wulf
Becker, Karl-Heinz Engel, Werner Grunow, Geltrude Mingrone, and Annette Pöting for their
contributions to the draft opinion.
No abstract available
On the basis of the “Opinion on Tahitian Noni® juice” adopted by the Scientific Committee on Food (SCF) on 4 December 2002, the Commission authorised the use of “noni juice” (juice of the fruit of Morinda citrifolia L.) as a novel food ingredient to be used in pasteurised fruit drinks on 5 June 2003, under Regulation (EC) Nº 258/97. On 20 June 2005, the Austrian Competent Authority informed the Commission of a case report that might be of concern with respect to the safety of noni juice. The Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES) upon request of the Austrian Competent Authority delivered an opinion on this case report and on two further recently published cases. As this new information might possibly have an impact on the opinion on the safety of noni juice and because of the Community interest in this matter, the European Commission has decided to seek the opinion of the European Food Safety Authority.
In response to a request by EFSA, the manufacturer provided additional information on noni juice regarding analysis for the presence of anthraquinones, updated data on consumption, information on reports of any adverse effects associated with the consumption, data on genotoxicity and cytoxicity and a report on a study in humans.
The Panel agrees with the conclusions of the SCF regarding the studies on acute, subacute and subchronic toxicity as well as genotoxicity and allergenicity. From a toxicological point of view noni juice has been adequately tested and the studies evaluated by the SCF as well as the additional toxicological studies provided do not raise concern. The Panel considers the SCF opinion to be appropriate.
On the basis of the available toxicological information and against the background of the data provided on consumption of noni juice without the reporting of hepatotoxic effects, the Panel considers it unlikely that consumption of noni juice, at the observed levels of intake, induces adverse human liver effects. This would also apply to the anthraquinones potentially present in the commercially produced noni juice.
The Panel concluded that there is no convincing evidence for a causal relationship between the acute hepatitis observed in the case studies reported and the consumption of noni juice.
On the basis of the “Opinion on Tahitian Noni® juice” adopted by the Scientific Committee on Food (SCF) on 4 December 2002, the Commission authorised the use of “noni juice” (juice of the fruit of Morinda citrifolia L.) as a novel food ingredient to be used in pasteurised fruit drinks on 5 June 2003, under Regulation (EC) Nº 258/97. On 20 June 2005, the Austrian Competent Authority informed the Commission of a case report that might be of concern with respect to the safety of noni juice. The Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES) upon request of the Austrian Competent Authority delivered an opinion on this case report and on two further recently published cases. As this new information might possibly have an impact on the opinion on the safety of noni juice and because of the Community interest in this matter, the European Commission has decided to seek the opinion of the European Food Safety Authority.
In response to a request by EFSA, the manufacturer provided additional information on noni juice regarding analysis for the presence of anthraquinones, updated data on consumption, information on reports of any adverse effects associated with the consumption, data on genotoxicity and cytoxicity and a report on a study in humans.
The Panel agrees with the conclusions of the SCF regarding the studies on acute, subacute and subchronic toxicity as well as genotoxicity and allergenicity. From a toxicological point of view noni juice has been adequately tested and the studies evaluated by the SCF as well as the additional toxicological studies provided do not raise concern. The Panel considers the SCF opinion to be appropriate.
On the basis of the available toxicological information and against the background of the data provided on consumption of noni juice without the reporting of hepatotoxic effects, the Panel considers it unlikely that consumption of noni juice, at the observed levels of intake, induces adverse human liver effects. This would also apply to the anthraquinones potentially present in the commercially produced noni juice.
The Panel concluded that there is no convincing evidence for a causal relationship between the acute hepatitis observed in the case studies reported and the consumption of noni juice.
Noni juice, case reports, hepatotoxicity, liver, transaminases.
