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Food supplements – updates on regulations

The world of food supplements is under continuous development and growth. More and more Italian and foreign companies are opting for this sector or are widening their offer of products classified as food supplements in response to a growing request from consumers.

Therefore, the growing interest about this kind of food products also requires a continuous update on the reference regulations.

Food supplements are full-fledged foods, therefore they have not much in common with drugs, if not, at times, the forms used (such capsules, powders, etc.). Except for such resemblance in the forms of presentation, drugs and supplements are fully distinguished, and it is important to stress that the general reference regulation for supplements is the one on foods, to which other specific regulations add, that are specific for food supplements.

Regarding the marketing in Italy, it is necessary to make a notification to the Ministry of Health, however this is not a Ministry authorization as the responsibility about the compliance of the food supplement with the regulations is of the FBO that is marketing it.

According to the latest survey, the Italian market is the most important European market. The outbreak of the supplement market in recent years involves traditional formulations, such as vitamin- and mineral-containing products, as well as more complex products based on plants and fungi preparations, the so called botanicals.

The substances titrated from plants represent an interesting point of innovation and diversification of the market for the companies. They can, however, also pose several safety problems along with a continuous update on regulation to protect public health.

The latest European updates on the topic of botanicals regards three ingredients: monacolin, epigallocatechin gallate, and aloe.

For monacolin K, the use will be admitted for doses lower than 3 mg, for which use warnings and monitoring will be provided for; also for epigallocatechin gallate restrictions will be provided for (dosages lower than 800 mg, warnings and monitoring); while for aloe and for species containing hydroxyanthracenes some forbidden species will be indicated and others will undergo Community surveillance.

Regarding, the manufacturing of food supplements, the most relevant news regards the preparation of a draft of a UNI norm on the GMP for the manufacturing of food supplements. This is a document, already under public consultation, reporting the requirements for good manufacturing practice in the manufacturing of food supplements. The documents used as reference to draft the norm are those currently available, the same used as reference by the experts of the sector to draft the guideline.

The document is going to be under consultation until 20 March, therefore it is important to read it and evaluate it with great attention, sending comments, if any, in order to contribute to the project.

The manufacturing site of food supplements shall be duly authorized, and the competence of such activity is managed at regional level, however the management of the manufacture and the manufacturing requirements shall of course be compliant with the national regulation.

The document will therefore be at the base of the harmonisation on the theme of manufacturing quality of food supplements over the whole Italian territory.

Written: Federica Montozzi

Foto di MarcOliver_Artworks da Pixabay