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Food supplements containing curcuma

The Italian Ministry of Health has published new information to clearly report the labelling requirements to be complied with for food supplements containing curcuma.

This information is based on the work of the Ministry following cases of cholestatic hepatitis reported after the intake of food supplements containing extracts and preparations of Curcuma longa.

The diet and nutrition section of the technical committee for nutrition and animal health, along with the interdisciplinary group of experts set up on purpose to evaluate the reports, concluded that the causes of the cases of cholestatic hepatitis are ascribable to special individual conditions of sensitivity or to persistent hepatic and biliary alterations, or concomitant intake of drugs.

The analysis carried out on samples of the concerned products did not indicate any presence of contaminants; moreover, these products contained different curcuma preparations and extracts and the doses taken were very variable.

The evaluation of the literature and information provided by other Member States also indicated report of acute cholestatic hepatitis related with the use of extracts of curcuma in other countries.

The Ministry of Health has therefore considered appropriate to define a new mandatory warning to be reported in the labelling of all food supplements containing preparations and extract of one of the Curcuma species allowed for us among their ingredients.

The mandatory waring is the following: ‘The product is not recommended for use in case of hepatic, biliary alterations, or biliary tract calculosis. If you are taking drugs, please ask your doctor for advice.’

The Ministry has also forbidden the possibility to report any indication of physiological effects regarding the ‘hepatic function’, ‘digestive function’ and ‘digestive system’.

These new provisions are included in Decree 26 July 2019 updating Annex 1 of the Ministry Decree 10 August 2018 “Discipline on the use of herbal substances and preparations in food supplements” already amended with Decree 9 January 2019.

The Ministry indicated 1 January as the date to comply with the new provisions. Therefore, 31 December is the deadline for the presence of curcuma-containing food supplements not complying with the new provisions of the Ministry of Health.

All stakeholders are therefore invited to update the labelling of their food supplements, in order to have products complying with the new requirements.

In fact, the responsibility of compliance is always of the FBO that submitted the Ministry notification.

Written by: Federica Montozzi