G/TBT/N/EU/168  
 
31 October 2013  
(13-6007)  Page: 1/3  
Committee on Technical Barriers to Trade  Original: English  
 
 NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  European Commission 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
European Commission 
EU-TBT Enquiry Point 
Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
Website:  http://ec.europa.eu/enterprise/tbt/    
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [ X ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided  in addition, where applicable):  The EU 
proposal for a Regulation covers "new psychoactive substances", also known as "legal 
highs", which are available on the market as legal alternatives to drugs subjected to 
international control. 
New psychoactive substances are natural or synthetic substances that, when consumed by 
humans, have the capacity to produce central nervous system stimulation or depression, 
resulting in hallucinations, alterations in motor function, thinking, behaviour, perception, awareness or mood, which are intended for human consumption or are likely to be consumed by humans even if not intended fo r them with the purpose of inducing one or 
more of the effects mentioned above, and which are neither controlled under the 1961 
United Nations Single Convention on Narcotic Drugs (as amended by the 1972 Protocol), nor the 1971 United Nations Convention on Psychotropic Substances. 
Alcohol, caffeine, tobacco and tobacco products are excluded from this definition. 
Many new psychoactive substances have or could have other uses, for example in the 
medical, chemical or high tech industry, as active substances for medicines, for instance. 
Around a fifth of the substances notified through the EU-level mechanism of exchange of 
information have some other, legitimate, uses.  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council on new psychoactive substances 
(COM(2013) 619 final) (43 pages in  English; 47 pages, in French ; 46 pages, in Spanish).     
6. Description of content:  The proposal for a regulation establishes rules for the 
restrictions to the free movement of new psychoactive substances in the EU. 
This instrument sets out the principle of free movement of new psychoactive substances, 
but only for commercial and industrial uses as well as for scientific research and 
development purposes. It then introduces rules for the adoption of restrictions to this free movement at the EU level, which are graduated, proportionate and calibrated to the G/TBT/N/EU/168 
 
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  risks that substances pose, and which ensure that legitimate uses of the substances and 
research are not unduly hindered. 
According to the proposed rules, when a substance raises concerns across the European 
Union because of the health, social and safety risks that it poses when consumed by 
humans, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and 
Europol draft a joint report on this substance. On the basis of this joint report, the 
Commission decides whether to request a scientific risk assessment of the substance.  
If the joint report shows that the substance poses immediate risks to public health (for 
example, it is highly toxic and is causing fatalities across Europe), the Commission can 
also subject it to temporary market restrictio n. This will forbid the sale of the substance 
to consumers for one year, but legitimate uses of the substance (for instance in industry or in research) will not be affected. In this way, consumers are protected during the risk assessment of the substance, while industrial, commercial or scientific uses of the 
substance are not impeded. 
Once the risks of the substance have been assessed, action will be taken depending on 
its level of risk. The EU can: 
(i) take no action, if the substance poses low risks;  
(ii) ban the substance from the consumer market if it poses moderate risk: this will 
forbid the sale of the substance to consumers, but legitimate uses of the 
substance will not be affected; or 
(iii) ban the substance from the consumer market as well as restrict its commercial 
and industrial uses (specifically authorised uses will remain allowed), if it presents severe risks. Criminal measures, introduced at national level, would accompany 
the ban on severe-risks substances. Member States will have to adopt within one 
year the necessary national provisions to subject the substance to the criminal law provisions applicable to illicit drugs. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This proposal for a Regulation aims at ensuring that the health and safety 
of individuals are protected from harmful new psychoactive substances, and that trade in 
these substances having industrial and commercial uses is not hindered and the functioning of the EU internal market is improved.  
8. Relevant documents:    Press package on the website of the European Commission 
http://ec.europa.eu/justice/newsroom/anti-drugs/news/130917_en.htm  
- European Commission Communication COM(2011) 689 final " http://new.eur-
lex.europa.eu/search.html?or0=DTT% 3DPC,DTT%3DDC&DTN=0689&DTA=2011&qid=1
379320482988&DTC=false&DTS_DOM=ALL&ty pe=advanced&DTS=5&SUBDOM_INIT=AL
L_ALL&DTS_SUBDOM=ALL_ALL  
- EMCDDA " http://www.emcdda.e uropa.eu/edr2013 " 
- UNODC " http://www.unodc.org/unodc/en/frontpage/2013/March/new-unodc-
report-sheds-light-on-the-phenomenon-of-new-psychoactive-substances-
worldwide.html ". 
9. Proposed date of adoption:   
Proposed date of entry into force:    By the end of 2015 Twenty days following the publication of the 
adopted act in the Official Journal of the EU. 
10. Final date for comments:  90 days from notification. G/TBT/N/EU/168 
 
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  11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
European Commission 
EU-TBT Enquiry Point 
Fax:  + (32) 2 299 80 43 E-mail:  mailto:eu-tbt@e c.europa.eu  
The text is available on the EU-TBT Website:  http://ec.europa.eu/enterprise/tbt/     
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2013:0619:FIN:EN:PDF  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2013:0619:FIN:FR:PDF  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2013:0619:FIN:ES:PDF