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Herbal substances and preparations in food supplements

The provisions of Decree 10 August 2018 of the Ministry of Health, as updated by Decree 9 January 2019 regarding Annex I regulating the use of herbal substances and preparations in food supplement is in force as of 9th January 2019.

The Decree includes a detailed list of admitted ingredients specifying the botanical name and the family of the herbal substance and any synonyms, where present.

The parts of the plant that are admitted are also specified as well as any additional warning to be reported in the label and, for some ingredients, the indications to be complied with to ensure a high level of safety for the consumers.

The physiological effects already reported in the Ministry reference guidelines have been included directly into the updated Annex I.

The Decree also reminds that the FBOs marketing a food supplement containing herbal substances and preparations (botanicals) should draft and maintain updated a dossier reporting information regarding the type of herbal ingredient, the manufacturing process and the finished product demonstrating the compliance of the supplement with the regulations in force.

The Authorities can request such documentation during official controls. This must be kept by companies in electronic or paper format.

Stocks of food supplements containing plants or their parts not complying with Decree 10 August 2018 can be sold off if marketed or labelled no later than 9th January 2019.

Products in compliance with the provisions of Annex 1 of Ministry Decree 10 August 2018 not in line with amendments of Decree 9 January 2019 can be marketed until 31st March 2019.

Companies shall therefore check the composition of the food supplements containing herbal substances and preparations, to ensure that the products comply with the new provisions of the decree. Moreover, the drafting of the technical documentation supporting the use of herbal ingredients is also required. As specified in the annex to the decree.

Di Renzo Regulatory Affairs is able to support companies in complying with the requirements of the regulations thanks to the competence of its experts. In particular, we can offer assistance in the assessment of the composition to check that all ingredients can be admitted and the compliance with the concentration limits; in the review of labels and claims; in the drafting of the documentation regarding the herbal substances and preparations, in the supplement online notification , in the applications of FSCs and in the registration of the company as Food Business Operator (FBO).

Written By: Federica Montozzi