On August 1, 2022, the Italian Ministry of Health published an update on Curcuma longa(turmeric) and spp (multiple species) in food supplements. Operators must comply with these new requirements before December 31, 2022.
Botanicals in food supplements
In Italy, Annex 1 to DM 10 agosto 2018 sulla disciplina dell’impiego negli integratori alimentari di sostanze e preparati vegetali (Ministerial Decree of August 10, 2018, on the use of botanicas in food supplements) lists the botanicals permitted in food supplements. Only botanicals included in the list can be used in food supplements marketed in Italy.
For each plant substance, the Decree specifies its botanical name, synonyms, label warnings, conditions of use, and physiological effects. Physiological effects must appear on Italian labels. As stated in the Decree, products can display such claims until the EU competent authorities clarify which claims on botanicals are allowed or not. Currently, the questions on botanical claims are on hold by the European Food Safety Authority (EFSA).
Turmeric warnings and physiological effects
The update revises the warnings and physiological effects of Curcuma longa in the Italian Decree on the use of botanicals in food supplements, bringing two main changes:
Firstly, it adds some additional warnings (in red the additional warnings) to be affixed on labels: “Important warning. In the event of altered liver function, biliary system or gallstones, the use of the product is not recommended. Do not use it during pregnancy or breastfeeding. Do not use it for extended periods without consulting a doctor. If you are taking any medications, you should consult your doctor.”
Secondly, the update excludes the physiological effects previously included: antioxidant, joint function, contrasting menstrual cycle disorders. In fact, the committee of experts appointed by the Italian Ministry of Health reviewed the scientific literature and concluded that insufficient proof supports these effects. Therefore, they can no longer be claimed.
Deadlines
Labels of food supplements containing Curcuma longa spp available in Italy must comply with the new requirements before December 31, 2022.
Do you want to know more? Check Obelis food supplements’ services and contact us now!
Francesca Santacatterina
Publications Department
06.09.2022
References:
– European Food Safety Authority. (2022). General function” health claims under Article 13. Retrieved on 06/09/2022.
– Ministero della Salute. (2022). Integratori alimentari contenenti estratti e preparati di piante di Curcuma longa e spp: modifica all’allegato 1 del DM 10 agosto 2018. Retrieved on 06/09/2022.
– Ministero della Salute. (2018). DM 10 agosto 2018 sulla disciplina dell’impiego negli integratori alimentari di sostanze e preparati vegetali. Retrieved on 06/09/2022.