Notification Detail

Government Decree amending Annex IV to the Government Decree on substances, preparations and plants to be classified as narcotics The following 9 new substances are classified: 4-chloro-isobutyrfentanyl, 4-Fluoro-isobutyrfentanyl, 3-phenylpropanoylfentanyl, benzodioxole fentanyl, benzoyl fentanyl, cyclopentyl fentanyl, cyclopropyl fentanyl, methoxyacetyl fentanyl and tetramethylcyclopropyane fentanyl.

Notification Number: 2017/437/FIN (Finland)
Date received: 12/09/2017
End of Standstill: 25/09/2017
Invocation of the Emergency Procedure: Yes

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Message 002

Communication from the Commission - TRIS/(2017) 02416
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2017/0437/FIN

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: 201702416.EN)

1. Structured Information Line
MSG 002 IND 2017 0437 FIN EN 12-09-2017 FIN NOTIF


2. Member State
FIN


3. Department Responsible
Työ- ja elinkeinoministeriö
Työelämä- ja markkinaosasto
PL 32
FI-00023 VALTIONEUVOSTO

Puhelin +358 29 504 7120
maaraykset.tekniset@tem.fi


3. Originating Department
Sosiaali- ja terveysministeriö
(yhteyshenkilö: elina.kotovirta@stm.fi)


4. Notification Number
2017/0437/FIN - C00C


5. Title
Government Decree amending Annex IV to the Government Decree on substances, preparations and plants to be classified as narcotics

The following 9 new substances are classified:
4-chloro-isobutyrfentanyl, 4-Fluoro-isobutyrfentanyl, 3-phenylpropanoylfentanyl, benzodioxole fentanyl, benzoyl fentanyl, cyclopentyl fentanyl, cyclopropyl fentanyl, methoxyacetyl fentanyl and tetramethylcyclopropyane fentanyl.


6. Products Concerned
4-chloro-isobutyrfentanyl (4Cl-iBF) (N-(4-chlorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl]-propanamide)
IUPAC name: N-(4-chlorophenyl)-N-(1-phenylethylpiperidin-4-yl)isobutyramide
CAS number: 244195-34-4 (HCl salt)

4-Fluoro-isobutyrfentanyl (4Cl-iBF) (N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl]-propanamide)
IUPAC name: N-(4-fluorophenyl)-N-(1-phenylethylpiperidin-4-yl)isobutyramide
CAS number: 244195-34-4 (HCl salt)

3-phenylpropanolfentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-3-phenylpropanamide)
IUPAC name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-3-phenylpropaneamide
CAS number: 79279-02-0

Benzodioxole fentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-2H-1,3-benzodioxole-5-carboxamide)
IUPAC name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-2H-1,3-benzodioxole-5-carboxamide
CAS number: unknown

Benzoyl fentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-benzamide)
IUPAC name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-benzamide
CAS number: unknown

Cyclopentyl fentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]cyclopentanecarboxamide)
IUPAC name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]cyclopentanecarboxamide
CAS number: unknown

Cyclopropyl fentanyl (N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]cyclopropanecarboxamide)
IUPAC name: (N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]cyclopropanecarboxamide)
CAS number: 1169-68-2

Methoxyacetyl fentanyl (2-methoxy-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide)
IUPAC name: 2-methoxy-N-phenyl-N-[1-(2-phenylethyl)piperidine-4-yl]acetamide
CAS number: 101365-54-2 (HCl salt)

Tetramethylcyclopropane fentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-2,2,3,3-tetramethyl cyclopropane-1-carboxamide)
IUPAC name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]-2,2,3,3-tetramethyl cyclopropane-1-carboxamide
CAS number: unknown


7. Notification Under Another Act
-


8. Main Content
Finland intends to define the substances as narcotics in accordance with the Narcotics Act (373/2008); as a result, the manufacture, import, export, sale or possession of the substance without a separate permit from the Finnish Medicines Agency will be prohibited.


9. Brief Statement of Grounds
These substances are synthetic opioids, derivatives of fentanyl that is classified as a narcotic substance by its chemical structure and also used in medicine. As fentanyls are increasingly manufactured for use as narcotics, the United Nations conventions do not only include fentanyl derivatives but also precursors used for their synthesis. Fentanyls have an analgesic and soporific effect. However, the most serious side effect from an overdose is hypoventilation, which may result in apnoea or respiratory arrest and death. For high potency substances, an overdose is easily achieved as the effective doses are very small. These substances are marketed without adequate information about the product’s content or purity, meaning that there is no assurance that these are not sold as other products or substances.

Based on their health effects and pharmacological properties, these substances should be equated to narcotics, which, when abused, will cause damage similar to that caused by substances classified as narcotics. The substances are not controlled substances in the UN or EU. These substances have been reported to the Early Warning System of the European Monitoring Centre for Drugs and Drug Addiction and now their abuse has spread to Finland.


10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Narcotics Act (373/2008)

Government Decree amending Annex IV to the Government Decree on substances, preparations and plants to be classified as narcotics


11. Invocation of the Emergency Procedure
Yes


12. Grounds for the Emergency
Protection of public health. The substances should be urgently classified as narcotics, as there is a potential user population. Health risks reported as being caused by these substances have included fatal poisonings. Due to their structural similarities and based on user reports, the health risks resulting from abuse of these substances are comparable to those of other opioids. Abuse of these substances has already spread to Finland.


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
Yes


16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft has no significant impact on international trade.



**********
Euroopan komissio

Yhteysviranomainen direktiivin (EU) 2015/1535
Telekopio: +32 229 98043
Sähköposti: grow-dir2015-1535-central@ec.europa.eu

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