Key data
| Regulation | Delegated Regulation (EU) 2026/314 of the Commission, of 9 February 2026 |
|---|---|
| Publication | 28 April 2026 |
| Entry into force | 9 February 2026 |
| Amended regulations | Regulation (EC) No. 273/2004 and Regulation (EC) No. 111/2005 |
| Substances added | Precursors of synthetic cathinones and amphetamine |
| Affected parties | Chemical, pharmaceutical and laboratory companies that manufacture, import, export or market these compounds |
| Category | European Regulation |
| Year | 2026 |
If your company manufactures, imports, exports or markets chemical compounds related to synthetic cathinones or amphetamine, your legal situation changed on 9 February 2026. The Delegated Regulation (EU) 2026/314 expands the EU's lists of catalogued substances and imposes a set of reinforced obligations that, if not complied with, can result in criminal or administrative sanctions.
The regulation amends two existing European regulations: the Regulation (EC) No. 273/2004, which regulates drug precursors within the internal market, and the Regulation (EC) No. 111/2005, which regulates the external trade of these substances with third countries. Both are updated to include the new compounds.
What does this regulation establish?
Regulation 2026/314 responds to the growing detection of synthetic cathinones and amphetamine in the European illicit drug market. Trafficking networks had identified and exploited a legal gap: these precursors were not catalogued and, therefore, could circulate without specific controls. The regulation closes that gap.
The specific changes it introduces are as follows:
| Aspect | Previous situation | Situation after Regulation 2026/314 |
|---|---|---|
| Precursors of synthetic cathinones | Not catalogued: no specific control obligations | Catalogued: subject to licenses, registrations and notifications |
| Precursors of amphetamine | Not catalogued under these regulations | Catalogued: subject to licenses, registrations and notifications |
| Regulation (EC) No. 273/2004 (internal market) | Did not include these compounds | Modified to include them in the list of catalogued substances |
| Regulation (EC) No. 111/2005 (external trade) | Did not include these compounds | Modified to include them in the list of catalogued substances |
Once a substance is catalogued, economic operators handling it are subject to a reinforced control regime that includes four main obligations:
- Licenses: obtain the corresponding administrative authorization to operate with the substance.
- Registrations: maintain documented records of operations carried out with these substances.
- Customer declarations: require and retain declarations from customers acquiring these compounds.
- Notification of suspicious operations: communicate to the competent authorities any transaction that raises doubts about the final use of the substance.
Economic and operational impact
The impact is not only documentary compliance: it involves real operational costs and, in some cases, may affect the commercial viability of certain product lines.
The main cost and impact areas are:
- Obtaining and renewing licenses: administrative process with cost in time and fees according to each Member State.
- Adaptation of registration systems: companies must implement or update internal processes to document all operations with these substances.
- Management of customer declarations: requires modifying sales flows to collect and retain additional documentation in each transaction.
- Staff training: sales, purchasing and compliance teams must understand the new obligations and know how to identify suspicious operations.
- Risk of sanctions: non-compliance can result in administrative or criminal sanctions. The specific sanctions regime is determined by the national legislation of each Member State, so companies operating in several EU countries must verify the applicable regulations in each one.
Companies that already operated with other catalogued substances have an advantage: they can extend their existing systems. For those without prior experience with this regime, the operational impact is significantly greater.
Who does it affect?
The regulation affects any economic operator involved in the value chain of the now catalogued compounds:
- Manufacturers of chemical products that include precursors of synthetic cathinones or amphetamine in their production process.
- Distributors and marketers that sell these compounds in the European internal market.
- Importers that introduce these substances into the EU from third countries.
- Exporters that send these compounds outside the EU.
- Pharmaceutical companies that use these precursors in the synthesis of active ingredients.
- Research and analysis laboratories that work with these compounds, including university laboratories with commercial or service activities.
If your company works with broad catalogs of chemical products, the review is mandatory even if you are not certain you are affected: some compound in your portfolio may have been catalogued without you having identified it yet.
Practical example
A chemical reagent distribution company that supplies university laboratories and research centers in Spain has several organic synthesis compounds in its catalog. Until 8 February 2026, some of those compounds—precursors of synthetic cathinones—were marketed without special control obligations.
As of 9 February 2026, those same compounds are catalogued under Regulation 2026/314. This means the company must:
- Identify which references in its catalog correspond to the now catalogued precursors.
- Request the corresponding license from the Spanish competent authority to continue operating with those substances.
- Implement a registration system for all sales of those compounds.
- Require each customer to provide a declaration on the final use of the substance before completing the transaction.
- Establish an internal protocol to detect and report operations that show signs of illicit use.
If the company continues selling these compounds without complying with these obligations, it is exposed to administrative or criminal sanctions according to applicable Spanish regulations.
What should companies do now?
- Review the product catalog immediately: identify if any substance that the company manufactures, imports, exports or markets corresponds to the precursors of synthetic cathinones or amphetamine now catalogued. This review should be done with technical-chemical and legal support.
- Verify if they already have a license: if the company already operated with other catalogued substances, check whether the existing license covers the new compounds or if it is necessary to expand it or request a new one.
- Request the necessary licenses from the competent authority: in Spain, the competent body in matters of drug precursors is the Spanish Agency for Medicines and Health Products (AEMPS). The process and timelines vary depending on the type of operator.
- Update registration and documentation systems: implement or adapt internal processes to register all operations with the new catalogued substances and retain customer declarations.
- Train the staff involved: sales, purchasing, logistics and compliance teams must understand the new obligations and know how to act in the event of a suspicious operation.
- Establish a protocol for reporting suspicious operations: define internally who is responsible for notifying the competent authorities of any transaction that raises doubts about the final use of the substance.