The Ministry of Health has introduced a new procedure for updating the National Register of Food Supplements, allowing companies to temporarily remove products that are no longer marketed from the Register through the so-called “freeze procedure“.
The measure aims to make the Register more reliable and streamline monitoring activities. Companies operating in the sector must check the status of their notified products on the NSIS platform and assess whether to discontinue or freeze food supplements that are no longer on the market.
The National Register of Food Supplements is a key tool for ensuring the traceability of products notified to the Ministry of Health. In recent years, however, the Register has accumulated numerous product entries that are no longer marketed, have never been placed on the market, or no longer comply with current legislation.
To address this issue, the Ministry of Health has begun updating its procedures by introducing a new method for managing food supplements that are no longer marketed: the so-called product freeze procedure, which allows companies to temporarily remove certain product entries from the Register without losing the option to place them back on the market at a later date.
Why the National Register of Food Supplements is being updated
During discussions with industry associations, Office IV of the Directorate-General for Food Hygiene and Safety highlighted the presence in the Register of a large number of products that are:
- no longer marketed;
- never actually placed on the market;
- no longer compliant with composition or labelling requirements.
These product entries continue to be listed as active because many operators have not used the “Product Discontinuation” function available on the NSIS platform.
The continued presence of these products makes the Register less representative of the actual market and slows down the monitoring and enforcement activities carried out by the Ministry.
What changes with the freezing of food supplements
To address the needs of companies, the Ministry has introduced a new procedure that allows food supplements that are temporarily unavailable on the market to be frozen.
The objective is twofold:
- to remove from the Register products that are not currently marketed;
- to allow companies to reinstate them in the future without having to submit an entirely new notification and without incurring additional costs, provided that the product has not undergone any changes.
This therefore represents an intermediate solution between permanent discontinuation and the submission of a completely new notification.
How the procedure works
The procedure established by the Ministry involves two steps.
The first consists of discontinuing the product through the NSIS platform, using the procedure already in place.
The operator must then submit to Office IV an Excel file containing the list of food supplements it intends to place under frozen status. The Office will then temporarily remove these product entries from the National Register.
When a frozen product can be re-notified
One of the most significant aspects of the new procedure concerns the possibility of placing a previously frozen product back on the market.
If the operator decides to resume marketing the food supplement, a new notification may be submitted by means of a self-declaration certifying that the composition, claims and labelling have not changed compared with the original notification.
This avoids having to repeat the entire administrative procedure for products that had already been notified and were simply temporarily withdrawn from the market.
What companies need to do
Companies that manufacture or market food supplements should review their portfolio of notified products.
In particular, it is advisable to identify:
- food supplements that are no longer marketed;
- product entries that have never been placed on the market;
- products that no longer comply with current legislation;
- food supplements that may be reintroduced in the future.
This analysis makes it possible to choose the most appropriate procedure between permanent discontinuation and freezing, while keeping the Register up to date and reducing the risk of issues arising during any inspections by the Ministry. Companies may also consider seeking specialist support for the management of notifications and other regulatory compliance requirements.
A more up-to-date Register for more effective monitoring
The Ministry of Health’s initiative aims to make the National Register of Food Supplements a tool that more accurately reflects the actual market situation.
Removing obsolete product entries will help streamline monitoring activities, improve the efficiency of controls and ensure more transparent management of notifications. At the same time, the possibility of temporarily freezing a product gives companies greater flexibility in managing their product portfolios, avoiding unnecessary costs and administrative requirements if the product is marketed again in the future.
Companies operating in the sector are therefore advised to promptly review the status of the notifications listed in the Register and adopt the most appropriate procedure based on the marketing status of their food supplements.
