What is changing in the regulation ?

 

In Belgium, the sale of food for special medical purposes (FSMP) is currently regulated by the Royal Decree of 18 February 1991 on food for special nutrition. This royal decree provides that the direct sale of FSMP to consumers is only authorized in pharmacies. Belgium now wants to better structure the sale and delivery of these foodstuffs, depending on the type of food and the target consumer.

Thus, in a new royal decree of 21/06/2021 amending the royal decree of 18 February 1991, it is stipulated that the Minister sets, by ministerial decree, the rules governing the sale and delivery of foodstuffs intended for medical purposes for the end user.

A ministerial decree was then also published on 21/06/2021 to set the conditions for the sale and / or delivery of FSMP.

As a reminder, at European level, Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council with regard to the specific requirements for composition and information applicable to FSMP provides that these products are to be used under medical supervision, but does not define the sale and delivery of these products.

New distribution channels for FSMP in Belgium ?

 

Therefore, the Belgian ministerial decree suggests to expand the distribution of FSMP through 4 new distribution channels in addition to pharmacies :

• Health care establishments recognized by one of the federated entities, to the condition that the FSMP is provided on medical prescription and only to institutionalized patients
• Health establishments recognized by one of the federated entities and only to patients institutionalized for FSMP administered orally and intended for adults, with the aim of meeting nutritional needs in the event of undernutrition or risk of undernutrition not associated with other diseases or disorders, in case of dehydration or risk of dehydration or in case of swallowing problems
• Services outside a hospital (distributors and suppliers of home medical devices) on medical prescription
• The retail trade, provided that the FSMP are administered orally, intended for adults, and intended to meet nutritional needs in cases of undernutrition or a risk of undernutrition not associated with other diseases or troubles.

Specific conditions are also provided for distance selling (reserved for pharmacists or retailers under the conditions described above).

A scientific opinion of the Superior Council of Public Health in June 2017 on the sale of food for special medical purposes is at the origin of these new regulatory texts.

 

Any questions on European regulations ? Contact our team of regulatory experts !