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October 03, 2018

Food supplements: published the new list of substances and herbal preparations that can be used in such foods (DM 10/08/18)

The Ministry of Health with Decree of 10 August 2018, has provided for the new list of substances and herbal preparations that can be used in food supplements.

The Decree in question, which enters into force on 11 October 2018, shall apply from 9 January 2019, excluding food supplements lawfully manufactured or marketed in another Member State of the European Union or in Turkey or manufactured in one Member State of the European Free Trade Association (EFTA), Contracting Party to the Agreement on the European Economic Area (EEA). In these circumstances, documentation must be provided to the Ministry of Health certifying that the product has been legally marketed as a food supplement. Member State of origin where the contained plant substances and preparations are not considered new foods (see news A34439 of 22/12/12) 2015 and A37814 of 11/01/2018).

Provisions envisaged by the Decree of 10 August 2018

The new provision:

  • includes the new list of substances and herbal preparations that can be used in food supplements;
  • provides for some of these substances:

-) the indications that must be shown on the label;
-) the relevant additional warnings;

  • provides specific indications on the fulfilments that the food operator must perform for its use (preparation of appropriate documentation and procedures to be followed for use)
  • or in support of their safety and in order to raise the level of consumer protection.

Notification procedure

The Decree in question, in reconfirming the provisions of the previous legislation, subjects to the notification procedure provided for by the national legislation, the marketing of food supplements containing the substances in question.

The notification in question has the purpose of allowing the Ministry to be able to carry out the evaluation of the products in relation to the constituent complex, to the daily injections and to the indications on the label.

Transitional provisions

The new Decree allows the marketing of food supplements that do not comply with the new provisions and are placed on the market or labeled before January 9, 2019, until stocks are exhausted.