EU: Amendment on chemical substances classified as drug precursors

 

The EU has published a draft Commission Delegated Regulation amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain precursors of synthetic cathinone and amphetamine in the list of scheduled substances.

Drug precursors are chemical substances that can be used in the illicit manufacture of narcotic drugs or psychotropic substances. Regulation (EC) No 273/2004 of the European Parliament and of the Council establishes rules for monitoring trade in drug precursors within the EU, while Council Regulation (EC) No 111/2005 governs trade between the EU and third countries. These substances may be either scheduled (listed in the annexes to the Regulations) or non-scheduled. Together, the two Regulations implement the measures set out in Article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 19 December 1988 (the “1988 UN Convention”).

At the request of a Member State, the European Commission tasked the European Drugs Agency (EUDA) with assessing both the legitimate and illicit uses of nine non-scheduled substances: 3’-chloropropiophenone, 2-bromo-3’-chloropropiophenone, 3’-methylpropiophenone, 2-bromo-3’-methylpropiophenone, 4’-methylpropiophenone, 2-bromo-4’-methylpropiophenone, 4’-chloropropiophenone, 2-bromo-4’-chloropropiophenone, and phenyl-2-nitropropene.

The EUDA confirmed that all nine substances can be used to illicitly produce synthetic cathinones and amphetamines using simple, scalable methods requiring only basic equipment and limited technical skills. Seizures of these precursors have increased across the EU in recent years, indicating their role in illicit drug manufacture. However, four of the substances also have legitimate industrial and pharmaceutical uses. Two are key intermediates in the production of EU-approved medicines: 3’-chloropropiophenone is used in the synthesis of bupropion (an antidepressant and smoking cessation aid), and 4’-methylpropiophenone is used to produce tolperisone (a muscle relaxant prescribed for muscle spasms and spasticity). Phenyl-2-nitropropene may serve in the production of amphetamine-based medicines, while 2-bromo-3’-chloropropiophenone is also used in bupropion manufacture. Additionally, all nine substances are employed as reference standards in analytical laboratories.

Given that these substances can be easily diverted for illicit drug production, the European Commission should amend Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 to include them in Category 1—the category subject to the highest level of control. This classification would impose strict licensing, import/export authorisation, and secure storage requirements on operators and users. Although these measures may increase compliance costs for pharmaceutical producers and suppliers, they are justified by the necessity of preventing the diversion of these precursors into illegal drug manufacture.