Nine substances used to make drugs come under licence from 18 September: without one, selling them is a criminal offence

Nine chemicals that were not controlled anywhere in the European Union move, from 18 September 2026, into the most closely watched category of the drug precursors regime. Commission Delegated Regulation (EU) 2026/314, adopted in Brussels on 9 February 2026 and published on 28 April 2026 in the Official Journal of the European Union, adds them to the lists of the two regulations that supervise trade in precursors, one for trade inside the Union and the other for trade with countries outside it. For the rules to bind in Romania, no law voted in Bucharest is needed: a European regulation applies directly, as happened with the regulation that placed all 41 counties and Bucharest in the severest African swine fever zone. For a chemical producer, a distributor or a laboratory in the country, this means a licence, a file, records and reports, from a fixed date.

The substances are propiophenones and their brominated derivatives, plus one nitro compound. The act lists them in recital (2) and explains what they are for in recital (3): 3’-chloropropiophenone and 2-bromo-3’-chloropropiophenone lead to 3-CMC, also called clophedrone; 3’-methylpropiophenone and 2-bromo-3’-methylpropiophenone lead to 3-MMC; 4’-methylpropiophenone and 2-bromo-4’-methylpropiophenone lead to mephedrone, that is 4-MMC; 4’-chloropropiophenone and 2-bromo-4’-chloropropiophenone lead to 4-CMC, or clephedrone; and phenyl-2-nitropropene leads to amphetamine. The first four are synthetic cathinones, the party drugs that have replaced the classic stimulants over the past decade.

All five are already controlled drugs in Romania. Mephedrone, 4-CMC, 3-MMC and 3-CMC appear in Table no. I of Law no. 143/2000, the list of high-risk drugs: 4-CMC entered it in April 2022, through Law no. 80/2022, and 3-MMC and 3-CMC in April 2023, through Law no. 77/2023. Amphetamine has been in Table no. II of the same law from the start. What is new on 18 September 2026 happens at the level of the raw material. Until now, the very substance a controlled drug is made from could be bought with no formality whatsoever.

The reason is written into recitals (2) and (5). National authorities reported an increase in seizures of the nine substances, and the Commission asked the European Union Drugs Agency for an assessment. The agency’s conclusion, quoted in the act, is what explains why the Commission went straight to the severest category: the substances can be turned into drugs „through straightforward and scalable methods, needing only basic equipment and minimal technical proficiency”. Recital (6) draws the conclusion and states it plainly: they go into Category 1 because „they pose the greatest risk when diverted towards illicit production”.

The part that hits the lawful economy, though, is in recital (5) and recital (10). Three of the nine substances have real medical uses: 3’-chloropropiophenone is used in making bupropion, a medicine for depression and for smoking cessation, 2-bromo-3’-chloropropiophenone is an intermediate of the same bupropion, and 4’-methylpropiophenone is used in making tolperisone, a muscle relaxant authorised for spasms and spasticity. Phenyl-2-nitropropene can be used in amphetamine-based medicines. Beyond that, the European agency confirms that all nine are used as reference standards in analytical laboratories. So the rule does not catch traffickers alone: it also catches a quality-control laboratory keeping a reference vial on a shelf.

In Romania, the application does not go to the health ministry or to the anti-drug agency, as many would expect. The competent authority for precursors is, under Article 2(1) of Law no. 142/2018, the General Inspectorate of the Romanian Police, and contact is made through the specialised structure inside it, which acts as a single point of contact. The name changed fairly recently: until 13 March 2025 the law named the National Anti-Drug Agency, and the replacement was made by Government Emergency Ordinance no. 147 of 12 December 2024. The licence is granted for 3 years, and the holder has to apply for a new one at least 30 days before it expires.

The penalties come in two kinds, and both are in Law no. 142/2018. Record-keeping and reporting lapses draw a fine of 4,000 to 10,000 lei, under Article 18. But placing on the market, importing, exporting, intermediary activities and even the mere holding of a scheduled substance without a licence are criminal offences, punishable by 6 months to 5 years in prison or by a fine, under Article 20(1). Anyone supplying such substances to a person without a licence faces 3 months to 3 years. The criminal investigation in these cases falls to DIICOT, the directorate whose jurisdiction over connected offences was confirmed by the Constitutional Court in September 2026.

What it changes in practice

For trade inside the Union, and therefore for sales between two Romanian companies as well, Category 1 means six obligations that apply cumulatively. First: a licence from the General Inspectorate of the Romanian Police to hold or place the substance on the market, under Article 3(2) of Regulation (EC) No 273/2004. Second: the designation of an officer responsible for the trade in scheduled substances, whose name and contact details are notified to the authority, plus a criminal record certificate for that person. Third: supply only to other licence holders who have signed a customer declaration, one for each substance separately. Fourth: labelling the substance with the name from the annex, before supply. Fifth: documenting every transaction and keeping the documents for at least three years from the end of the calendar year in which it took place. Sixth: immediate notification of the authority of any unusual order or transaction.

For trade with countries outside the Union, Regulation (EC) No 111/2005 adds a layer on top of the licence. Importing a Category 1 substance requires an import authorisation, under Article 20, exporting requires an export authorisation, under Article 12(1), and every export must be preceded by a notification sent to the authorities of the country of destination, under Article 11(1). The authorisations are granted for one operation rather than once and for all, so every consignment is authorised separately.

Pharmacies, veterinary practices, certain categories of public authority and the armed forces do not take the usual route. They can obtain a special licence, valid only for their official activity, granted for an unlimited period, with certification every 3 years that the conditions still hold. The Government decision implementing the Romanian law provides that the special licence is granted within 30 days of the registration of the application, and that pharmacies and veterinary practices also attach their operating authorisation to the application. For a pharmacy keeping one of these substances as a reagent or as an analytical reference, the road is therefore shorter, but not non-existent.

The powers of control grow along with the obligations. Article 10 of Regulation (EC) No 273/2004 requires Member States to give the authorities the right to request information about any order, to enter the business premises of operators and users to gather evidence, and to detain and seize non-compliant consignments. Until 18 September 2026 the only thing available for the nine substances was the optional variant in paragraph (2), the monitoring of suspicious transactions involving non-scheduled substances. From 18 September the hard variant becomes mandatory.

There is one more effect that has nothing to do with licences. Recital (7) links the scheduling to criminal law: once on the list, the nine substances become „precursors” within the meaning of Article 1, point 2, of Framework Decision 2004/757/JHA, which defines the minimum elements of trafficking offences. Article 2(1)(d) of the same Framework Decision requires Member States to punish the production, transport or distribution of precursors where the person doing it knows what they are to be used for. The substance does not have to have been turned into a drug: it is enough that it was moved, knowingly.

What has changed compared with the previous situation

Until 18 September 2026, the nine substances were what the act itself calls them in recital (2): non-scheduled substances. They could be manufactured, sold, bought, imported and exported without a licence, without a customer declaration, without a label bearing the official name, without a transaction register and without a transport authorisation. The only obligation that could touch an operator was to answer, if asked, a request for information about a suspicious transaction, and even that was not mandatory for the Member State. Moving into Category 1 skips Categories 2 and 3, which have intermediate regimes, and goes straight to the maximum.

The most practical difference turns on a phrase in Article 3(2) of Regulation (EC) No 273/2004: the licence is needed not only to place on the market, but also to „hold”. A laboratory that already has a reference standard vial of one of the nine on the shelf has nothing to sell, but it needs a licence to keep it. This is where it becomes clear why the Commission deferred the application: recital (11) says the deferral is intended to give economic operators time to obtain the import or export authorisations and the appropriate licences.

The way the substances are identified at customs has changed as well. The nine new entries sit under three Combined Nomenclature codes, and six of them share a single code, 2914 79 00. That code also covers goods with no connection whatsoever to precursors, so it does not by itself tell you whether a consignment falls under the licensing regime. What decides is the CAS number, set out in the annex for each substance. A customs declarant therefore cannot stop at the tariff-code filter.

Finally, the manufacturing chain of two medicines has changed. Bupropion and tolperisone were made from unrestricted raw materials; from 18 September 2026, two of bupropion’s intermediates and one of tolperisone’s move only between licence holders. Pharmaceutical use gets no exemption: the legitimate use is recognised in recital (10) as a reason for deferring the application, not as a reason for exemption.

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