Message 001
Communication from the Commission - TRIS/(2024) 1419
Directive (EU) 2015/1535
Notification: 2024/0294/FR
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20241419.EN
1. MSG 001 IND 2024 0294 FR EN 03-06-2024 FR NOTIF
2. France
3A. Ministères économiques et financiers
Direction générale des entreprises
SCIDE/SQUALPI - Pôle Normalisation et réglementation des produits
Bât. Sieyès -Teledoc 143
61, Bd Vincent Auriol
75703 PARIS Cedex 13
3B. Ministère du travail, de la santé et des solidarités
Direction générale de la santé
Ministère de l'économie, des finances et de la souveraineté industrielle et numérique
Direction générale de la concurrence, de la consommation de la répression des fraudes
4. 2024/0294/FR - S00S - HEALTH, MEDICAL EQUIPMENT
5.
Order suspending the placing on the market of products sold in powder form intended for intranasal consumption
6. Products sold in powder form intended for intranasal consumption which are confused with the consumption of narcotic drugs.
7.
8. In view of the dangers posed by products sold in powder form intended for intranasal consumption which are confused with the consumption of narcotic drugs, this text suspends for one year the placing on the market of these products, whether free of charge or in return for payment.
This description excludes medicinal products, medical devices and tobacco products.
The order also requests a withdrawal/recall of products placed on the market.
Finally, those responsible for the first placing on the market of these products are asked to inform consumers of the dangerous nature of these powders.
9. The French authorities have observed that products containing powder presented as ‘energising’ to be consumed by the nose (‘sniff’) were made available to French consumers on the internet and at various physical sales outlets.
Several elements have alerted the authorities:
- By their presentation, general appearance, specific way of intranasal consumption and promotion of the expected stimulating effects, these products, which are sometimes even sold with a sniffing straw, imitate cocaine, a substance whose consumption and sale are illegal in France, and deliberately create confusing with the consumption of narcotics, thereby trivialising their use by young people in particular;
- by their route of administration (intranasal), these products present a proven risk, in case of repeated use, of weakening nasal passages, bleeding, congestion, sinus infections, which may even lead to a rupture of the septum;
- the active substances contained in these powders are likely to have harmful effects on the nasal epithelium and its environment;
- the use of a straw that accompanies some of these products poses a risk of trauma to nasal passages and also an exacerbated risk of transmission of infectious diseases when used collectively.
In view of these warnings and their unexpected media coverage in recent days, which has aroused considerable concern among both the general public and health professionals about the dangers of these products and heightened interest in products that were hitherto little known to the public, the health authorities considered that these products pose a serious and immediate danger, justifying the urgent suspension of their placing on the market and the issuing of warnings to consumers.
10. References to basic texts: There are no reference texts
11. Yes
12. In response to unpredictable media exposure, the French authorities had to take urgent measures to deal with a serious situation relating to the protection of the health of persons, minors in particular, and public order.
Over the last few days, the French authorities have been confronted with significant and unexpected media coverage of these products, which has led to widespread concern among both the general public and health professionals about the dangers of these products due to their absorption route, in particular their claimed similarity to the use of narcotics, but also a lot of interest in products that have so far been little known to the public, in a way that was not foreseeable.
This is why the French authorities considered that urgent measures to suspend their placing on the market and the issue of warnings to consumers were necessary in order to put an end to the serious and immediate danger posed by these products in the light of the warnings mentioned in point 9.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
