Notification Detail | TRIS - European Commission

Ministerial decree laying down the conditions for the sale and/or delivery of food for medical purposes to the end user

Notification Number:

2021/0363/B (Belgium)

Date received:

21/06/2021

End of Standstill:

22/09/2021 (closed)

Draft Text:

NL BG HU PL DA PT CS MT DE RO ET SK ES EL EN SL SV FI LT LV HR IT FR

Final Text:

NL SK HU BG RO SL EN SV HR PT DA MT PL LV DE ET CS EL LT FI IT ES FR

Click here for a printable version of this page

Message

Message 002

Communication from the Commission - TRIS/(2021) 02238
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2021/0363/B

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 202102238.EN)
1. MSG 002 IND 2021 0363 B EN 21-06-2021 B NOTIF

2. B

3A. FOD Economie, KMO, Middenstand en Energie
Algemene Directie Kwaliteit en Veiligheid - Dienst Normalisatie en Competitiviteit - BELNotif
NG III – 2de verdieping
Koning Albert II-laan, 16
B - 1000 Brussel
Tel: 02/277.53.36
belspoc@economie.fgov.be

3B. Federale Overheidsdienst Volksgezondheid, Veiligheid Voedselketen en Leefmilieu
Directoraat-generaal Dier, Plant en Voeding
Dienst Voedingsmiddelen, Dierenvoeders en Andere Consumptieproducten
Galileelaan 5/2
B - 1210 Brussel

4. 2021/0363/B - C00A

5. Ministerial decree laying down the conditions for the sale and/or delivery of food for medical purposes to the end user

6. Ministerial Decree concerning the conditions for the sale and supply of food for medical purposes

7. — Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing the (EU) Regulation No 609/2013 of the European Parliament and of the Council as regards to the particular composition and information requirements relating to food for medical use provides that these products should be used under medical supervision, but does not frame the sale and delivery of these products.

8. The current Royal Decree and Ministerial Decree lays down rules governing the sale and delivery of food for medical use. These foods are intended for specific target groups and should be used under medical supervision in accordance with the Delegated Regulation (EU) 2016/128 as regards the particular composition and information requirements relating to food for medical use. The framework for sales and delivery is not provided for in this Delegated Regulation. The framework defines 4 distribution channels: dispensing chemists, health care facilities recognised by one of the federated entities, health care facilities, services outside a hospital (distributors and providers of home medical devices) and retail. Additional conditions are imposed for certain distribution channels (restriction to certain foods for medical use, target group and/or need for medical prescription). Specific conditions are also laid down for distance selling.

Keywords: sale and delivery, food for medical purposes

9. The sale of foods for medical purposes (FSMP) is today regulated by the Royal Decree (Royal Decree) of 18 February 1991 concerning foodstuffs intended for particular nutritional uses. This Royal Decree provides that the direct sale of FSMPs to the consumer is only permitted to dispensing chemists.

The principle that FSMPs should be used under medical supervision remains applicable under the European Regulation 2016/127, without further clarification. In order to determine the need to maintain, adapt or abolish the above-mentioned obligation to sell FSMPs exclusively through dispensing chemists, as in the current Royal Decree, the scientific advice of the Hoge Gezondheidsraad (Superior Council on Public Health)(https://www.health.belgium.be/fr/avis-9371-fsmp).

Belgium wishes to further frame the sale and delivery of food for medical purposes, but has adapted the distribution channels, taking into account the type of food intended for medical purposes and the target audience. The proposal is underpinned by arguments that consider the safe and correct use and a guarantee of the accessibility of the products to the target group.

10. There are no basic texts.

11. No

12. -

13. No

14. No

15. -

16. TBT aspect

NO – The draft does not have a major impact on international trade.

SPS aspect

NO – The draft does not have a major impact on international trade.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

message-id	Year	Number	Country	Type	Title	Date received	Is answer to

Languages

Stakeholders Contributions

The TRIS website makes it easy for you or your organization to share your views on any given notification.

Due the notification’s status or the end of standstill, we are currently not accepting any further contributions for this notification via the website.