Food supplements containing extracts or preparations of Curcuma longa and spp.: label adjustment by 31/12/2022
The Ministry of Health, after a case of death due to acute hepatitis, the cause of which was linked to the use of a food supplement containing curcumin and piperine, reactivated the interdisciplinary group of experts established in 2019 when cases of cholestatic hepatitis related to the intake of dietary supplements containing extracts/preparations of Curcuma longa spp. were reported.
In this context, The Ministry of Health issued a note on food supplements containing extracts of Curcuma longa spp. in which it amended Annex 1 of the August 10, 2018 DM.
Directorial Decree Number 28 of July 2022, protocol 33391 of August 1, 2022, amended Annex 1 of DM August 10, 2018 by introducing the following warning: “In case of impaired liver function, biliary function, or gallstones, the use of the product is not recommended. Do not use during pregnancy and lactation. Do not use for prolonged periods without consulting your doctor. If you are taking medication, you should seek medical advice.”
The directorial decree also eliminated the claims of physiological effects previously provided in the ministerial guidelines for Curcuma longa and spp. which, therefore, can no longer be used.
The adjustment of the labels of dietary supplements containing extracts and preparations of Curcuma longa and spp., which can also be carried out by means of adhesive labels, also affects products already placed on the market.
This adjustment must be made no later than December 31, 2022.
As a reminder, the use of plants/plant parts/derivatives/extracts contained in the list of the July 10, 2018 Ministerial Decree is always subject to the assessment of the non-applicability of Regulation (EU) 2015/2283.
Accordingly, curcumin as such is a novel food and, therefore, cannot be used in food supplements.
“Curcuminoids,” on the other hand, are subject to the novel food regulation when processes have been adopted to increase their solubility and bioavailability such as cases where there is a high curcumin content or the addition of piperine.
October 20, 2022 was the deadline for data collection of products with high curcumin content from Curcuma longa and spp. and similar species in food products before May 15, 1997.
We are, therefore, awaiting updates on this issue.
We offer strategic-regulatory consulting services in domestic and international markets
