Food supplements: a reminder on notifications

More and more frequently the Italian authority is requesting that food supplements are withdrawn from the market. The Italian task force against counterfeiting (NAS), in the course of their continuous controls at business premises, has recently seized several packs of food supplements.

In particular, in Padua they seized food supplements of a company for more than 7,000 euros and more than 1,250 packs of food supplements of another.

In both cases, the reason for the seizure was the missing notification of the concerned food supplements to the Italian Competent Authority: the Ministry of Health.

The product were marketed by the companies without compliance with a mandatory legal requirement. In order to market food supplements in Italy, it is in fact necessary to perform an online notification to the Ministry of Health.

This notification is also requested in the case of products sold in the web, on the company’s website as well as on online sale platforms. The notification to the Ministry of Health should be performed directly by the FBO (Food Business Operator) responsible for the product. However, through a proxy, another operator can also notify the product on behalf of the FBO.

Most data to be reported in the notification can be taken from the label of the product: the information requested includes the composition (full list of the ingredients, quantity, admitted sources for vitamins; botanic name, part used and drug/extract ratio for ingredients of herbal origin), but also the sale formats and the confirmation on the presence of any claim.

To complete the notification, the label is also requested along with the payment receipt of the Ministry fee. The label should report every information requested by the regulations and should be in Italian. Multilanguage labels are also accepted, but Italian should always be present.

To notify the product, along with the information on the food supplement, the Italian FBOs are also requested to include the manufacturing site. The latter should be registered as FBO. This registration is a mandatory requirement; in fact, during their controls, the NAS also controls the compliance of the site with the regulations. Moreover, the address of the Italian manufacturing site is a mandatory requirement to be reported in the label.

The Ministry of Health also assesses the notifications received (both for new products and for variations of food supplements previously notified).

If the product receives a positive opinion, it is published in the register of food supplements, that is updated periodically by the Ministry of Health. On the other hand, in case of observations or requests by the Ministry a message is sent to the FBO, that must reply and bring the product and/or the label in line with the Ministry requests. Only after further assessment by the Ministry the product is published in the registry.

In any case, the responsibility of the information reported in the label and of the safety of the food supplement remains with the FBO that notified the product.

The FBO is also responsible in case of any adverse reaction related to the use of the food supplement and should therefore have a surveillance system.

The notification procedure should also be carried out for other classes of products used as food: infant formulae and follow-on formulae, gluten-free food intended for celiac people, food for special medical purposes (FSMP).

Written by: Federica Montozzi