Food Supplements and Brexit
As of 2021, United Kingdom is no more a Member of the European Union; the Brexit transition period has in fact concluded on 31 December 2020. The consequences on norms and regulatory affairs are many, and affect all sectors.
For food supplements and food subject to notification, the Italian Ministry of Health will not accept any notification by Food Business Operators (FBOs) legally located in the UK, as this is now a third country outside EU. In general, in order to market food supplements on the Italian territory, it is required that FBOs perform the relevant notification in the online portal of the Italian Ministry of Health enclosing the label of the product.
After a positive evaluation by the authority, the supplement with the relevant code is published in a register available in the Ministry website. In any case, the responsibility for the marketing and conformity of the food supplement to the regulations is still of the FBO marketing it. Currently, on the Ministry of Health website, there are two registers available: the Food Supplement Register (“Registro degli integratori alimentari”), including all published products, already assessed by the Ministry; and the National Register of Food Supplements (“Registro nazionale degli integratori alimentari”), including all products notified via the electronic notification system, regardless their notification status.
The Italian Ministry of Health has in fact informed companies with legal office in the UK intending to market food supplements and other foods subject to notification in Italy that they need to appoint a FBO legally located in the European Union. This operator will be responsible for the product safety, and as such shall comply with all legal obligations provided for by the European food legislation, including the payment of a fee and the notification on the online portal of the Ministry of Health.
In compliance with the regulations, this FBO shall be reported in the label as responsible for the product. Foods duly notified and already marketed in Italy before 31 December 2020 by FBOs located in the United Kingdom can remain on the market until the expiry date reported in their packaging. However, they need to be notified again by a company with legal office in the European Union.
It follows that all companies with legal office in UK that notified food subject to notification to the Ministry of Health shall perform a new notification availing themselves of a FBO with legal office in the European Union. This implies the payment of a new fee and the submission of a new notification, as the online system does not allow a data transfer from one operator to another.
Other European countries also provided indications to manage notifications from English FBOs. In France, only companies with legal office in the EU can register and notify products in the Teleicare system.
However, the French system allows the transfer of a notification from an operator to another, so companies located in the UK that performed a notification within last year can transfer such notification to the European responsible operator with no need of a new notification.
As in Italy, also in France and Spain products notified by UK companies and on the market on 1 January 2021 can be marketed until expiry. It is therefore clear the English companies intending to enter or stay on the market of the EU countries shall comply with the norms considering that they are now companies of an extra-EU country.
Written by: Federica Montozzi
Foto di Garak01 da Pixabay
