Message 001
Communication from the Commission - TRIS/(2024) 1191
Directive (EU) 2015/1535
Notification: 2024/0241/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: 20241191.EN
1. MSG 001 IND 2024 0241 FR EN 02-05-2024 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. Agence nationale de sécurité du médicament et des produits de santé (ANSM)
4. 2024/0241/FR - X00M - GOODS AND MISCELLANEOUS PRODUCTS
5. Decision amending the list of substances classified as narcotic drugs
6. Narcotic drugs
7.
8. The ANSM's draft decision concerns the classification of the following cannabinoids on the list of narcotic drugs:
- H2-CBD and H4-CBD;
- A family of substances derived from the benzo[c]chromene ring excluding cannabinol (CBN);
- 5F-Cumyl-Pegaclone (or 5F-SGT-151), Cumyl-CH-Megaclone (or SGT-270), 7APAICA, 5F-7APAICA, Cumyl-P7AICA, 5F-Cumyl-P7AICA, BZO-Hexoxizid (or MDA-19) and BZO-Poxizid (or 5C-MDA-19).
This decision follows, in particular, reports of serious effects, received by the French addictovigilance network, relating to the consumption of these substances.
Their consumption can lead to immediate effects such as loss of consciousness, coma, convulsions, paranoia, anxiety or even panic attacks, vomiting, high blood pressure, tachycardia or chest pains that may indicate a heart attack. Cases of kidney failure have also been reported.
These effects may be much more intense than those felt during cannabis use and may require urgent care by healthcare professionals. The intensity of the effects also depends on the mode of consumption and the higher the concentration of the product, the more serious the complications can be. In addition, these products are likely to lead to dependence.
Furthermore, it has been noted that some of these products, in particular H4-CBD, are available to the general public through sale on the Internet or in CBD shops. These substances are available in the form of oils, resins, herbs, sprays, sweets or gummies and e-liquids. They can be ingested, vaped or smoked.
In addition to the ease of access to some of these products in shops, these substances have similar effects to THC, potentially exposing consumers to unintended effects that may have consequences for their health and require medical attention.
9. The aim of the draft decision to classify these new cannabinoids on the list of narcotic drugs is to prohibit their circulation and thus ensure better protection of public health.
This decision follows, in particular, reports of serious effects, received by the French addiction vigilance network, relating to the consumption of these substances.
Their consumption can lead to immediate effects such as loss of consciousness, coma, convulsions, paranoia, anxiety or even panic attacks, vomiting, high blood pressure, tachycardia or chest pains that may indicate a heart attack. Cases of kidney failure have also been reported.
These effects may be much more intense than those felt during cannabis use and may require urgent care by healthcare professionals.
In addition, some of them are available to the general public, particularly through sales on the Internet or in CBD shops.
Classification on the list of narcotic drugs therefore makes it illegal to make these substances available, thereby ensuring the best possible protection of public health in France, pending a European or international decision on these substances.
10. References to reference texts:
11. Yes
12. The urgency of the situation is based on the risks to public health considering:
- an increase in the number of serious cases related to their consumption, with clinical signs and severe complications that may require emergency medical care;
- that these substances have effects similar to THC, which is classified as a narcotic drug at the
international level;
- the easy access to some of these products in shops, particularly in forms such as gummies and sweets, which are traditionally intended for children;
- the presence of these various substances in the products consumed is often unknown to the consumer and their concentration is generally high;
- the need to ensure as soon as possible, given the harmfulness of these substances, the best possible protection of public health in France.
Moreover, the Olympic and Paralympic Games in France in July-August-September 2024 represent a context which may lead to a particular and sensitive risk in terms of public health.
Pending a European or international decision on this family of substances, there is therefore an urgent need to publish this decision on classification of these products as narcotic drugs, which does not constitute an obstacle to freedom of trade and industry in the case of products that are partly sold in CBD shops but that are, in their entirety, sold by drug trafficking networks.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
