The EU is repealing its existing drug precursor regulations and replacing with a unified act. Significant changes in licencing and scheduling are proposed

The EU is repealing it 2 current acts dealing with drug precursors - regulations (EC) No 273/2004 and (EC) No 111/2005. In place will be a new unified act “REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on monitoring and controlling drug precursors”

This was announced on the 3^rd December 2025. It has not yet been adopted, however there are provisions for previous licences and permits issued under the old acts to remain valid for a period of 3 years while new systems are put in place and industry has time to plan and adapt. 

The new act has new licencing requirements designed to streamline the process, new schedules and lower barriers for R&D use. But it also brings in the capability to control via chemical space (generic statements), with stated plans to make use of this.

The regulation and the supporting documents are very long, however a summary of the key points are given below.

The proposed new act was announced on the 3^rd December 2025. It has not yet been adopted, however there are provisions for previous licences and permits issued under the old acts to remain valid for a period of 3 years while new systems are put in place and industry has time to plan and adapt. Closer to the final enactment time the schedule changes will be made in Controlled Substances Squared. This may include the old and new regulations being maintained in Controlled Substances Squared to allow customers to understand what former licences / permits remain valid during the 3 year transition period.

The regulation and the supporting documents are very long, however a summary of the key points are given below.

The EU considered 3 different policy paths. The one chosen was policy 2 at a high level leads to:-

• Streamlining and reorganisation of the existing categories of substances: The new set of categories therefore aim to clarify and streamline obligations and controls based on an updated perception of the risk-profile of a group of substances.
• Introducing a new category for designer precursors with an a priori ban: Designer precursors are different from traditional designer precursors in that their legal use is often limited to research activities, but other future legitimate uses cannot be excluded a priori. Use or transactions of such precursors in small quantities for research and innovation should be subject to a prior notification to national authorities, while transactions and use in larger quantities is to be subject to a licence.
• Adapt the rules to the inclusion of groups of substances (generic statements), for instance based on a chemical base molecule and a limited number of precise modifications to these base molecules.
• A merger of the two regulations into a single regulation, aligning rules for both the internal market and external trade wherever possible.
• Fewer categories of scheduled drug precursors, from 4 to 3. Introducing a specific category for designer precursors provides greater clarity to operators and national authorities alike that such substances are subject to an outright ban. In addition, the initiative includes an exemption to this ban for small quantities for research and innovation – however prior notification is required (see below). In case a legitimate use for a Category 3 drug precursor is discovered, the Commission and Member States will assess if such a substance should be placed in another category or exempt from the scope of the regulation.
• Due to the risk of diversion, the proposal does not exempt micro enterprises. However, where reasonable the proposal foresees exemptions for small quantities and for pharmacies and veterinary dispensaries.
• Digital applications for licences (new Categories 1 and 3) and registration for external trade (new Category 2).
• Digital controls for imports and exports by the EU Single Window Environment for Customs and the lifting of the Pre-Export Notification (PEN) waiting period.
• Reporting obligations are automated by aggregating the data entered into the central electronic system. The process of verifying customers will be digitalised.

The key articles in the regulations from a perspective of what is classed as a drug precursor and what licencing restriction are therefor in place are:-

Article 5 lists the 3 categories of scheduled drug precursors and sets out the conflict rules to be used to determine the requirements in specific cases where either a substance belongs to two categories, or a mixture contains substances belonging to two or three categories.

Articles 9 to 14 lay down the requirements for placing on the market, use, possession, import, export or intermediary activities with Category 1 drug precursors. These are the drug precursors with legitimate uses in the chemical industry with the highest risk of diversion. Therefore, they are subject to strict control measures. In addition to the requirement to hold a licence, the operators have to designate a responsible officer, secure premises and trade in the internal market only with operators also holding a licence. Equally, operators using or possessing Category 1 drug precursors also have to keep the documentation, in similar conditions as those for operators trading with any scheduled drug precursor. 

Article 15 lays down the requirements for import, export or intermediary activities with Category 2 drug precursors. External traders of Category 2 scheduled drug precursors will no longer need to apply for, and subsequently be granted, a registration for import, export, or intermediary activities. Instead, they will simply register information on their activities, including the estimates of maximum quantities envisaged during a validity period of three years, after which they can start activities involving the scheduled drug precursors they register. This information will be updated as required. Competent authorities may decide to suspend or cease the activities included in the registration in case the conditions declared are no longer fulfilled or in case of suspicion of risk of diversion towards illicit purposes.

Articles 16 to 19 set out the requirements for the newly introduced Category 3 drug precursors concerning designer precursors. Category 3 drug precursors contain substances which have no known legitimate use other than research or innovation at the moment of placing them under control. Therefore, the trade, use or possession of such substances should, a priori, be banned. Transactions, use or possession of small quantities for research and innovation should be allowed subject to a prior notification. If needed in larger quantities or for other legitimate uses, a licence is to be requested.

Article 25 sets out a Drug Precursors Information Repository, which is to replace the existing Voluntary Monitoring List. The Repository is to contain information on the scheduled and non-scheduled drug precursors. It has several purposes: to support the operators in identifying suspicious transactions and in determining if specific substances are within the scope of the Regulation in case of including groups of substances identified in a generic way, and to support the Commission and national authorities in identifying the need to place new substances under control. The Repository is to be developed and maintained by the European Union Drugs Agency. 

The Categories

The new and old categories do have overlaps, but also key difference. For example Chloropseudoephedrines are now in Schedule 3 rather than Schedule 1. This leads to a tighter level of control as this covers no legitimate use beyond R&D and general trade is banned. Generally the newly controlled precursors in recent years have been moved to Category 3

Article 5

Categories of scheduled drug precursors

1.Scheduled drug precursors shall belong to one of the following categories:

(a)Category 1 drug precursors containing or consisting of substances covered by Annex I;

(b)Category 2 drug precursors:

(i)containing or consisting of substances covered by Part I, of Annex II; or

(ii)medicinal products and veterinary medicinal products containing substances covered by Part II, of Annex II;

(c)Category 3 drug precursors containing or consisting of substances covered by Annex III which are designer precursors with no known legitimate use except research and innovation at the moment of their scheduling. The substances covered by Annex III shall be either listed individually or identified in a generic way by listing groups of substances. Individual substances included in such a group that have a legitimate use other than research and innovation and that are not included in Annex I or Annex II, shall be exempted from Category 3 and listed in Part II, Section 2, of Annex III.

2.Scheduled drug precursors which are mixtures containing substances covered by Annex I above the concentration threshold set out in that Annex, organisms or substances which occur in nature containing such substances, and in addition containing substances covered by Annex II or Annex III shall be subject to the requirements for Category I drug precursors.

3.Scheduled drug precursors, which are mixtures containing substances covered by Annex III above the concentration threshold set out in that annex, organisms or substances which occur in nature containing such substances, and in addition containing substances covered by Annex II shall be subject to the requirements for Category 3 drug precursors.

4.Scheduled drug precursors containing or consisting of a substance covered by Annex I or Annex II, which are also identified in a generic way in Part II, Section 1, of Annex III shall be subject to the requirements for Category 1 or, respectively, Category 2 drug precursors.

Annex I

The salts of the substances listed in this Annex, whenever the existence of such salts is possible and not being the salts of cathine.

The stereoisomeric forms of the substances listed in this category not being cathine, whenever the existence of such forms is possible. 

ANNEX II

Category 2 drug precursors

Part I

Individually listed substances

Category 2 drug precursors contain or consist of:

The salts of the substances listed in this Annex, whenever the existence of such salts is possible, with the exception of salts of hydrochloric acid and sulphuric acid.

Part II
Medicinal products and veterinary medicinal products

Category 2 drug precursors also consist of the following medicinal products:

ANNEX III

Category 3 drug precursors

Part I
Individually listed substances

Category 3 drug precursors contain or consist of:

The stereoisomeric forms of the substances listed in this Part, whenever the existence of such forms is possible.

The salts of the substances listed in this part whenever the existence of such salts is possible.

A new section for allowing the addition of generic statements. The overview also mentioned that the EU wished to pursue the route more widely.

Part II
Groups of substances identified in a generic way

Section 1
Groups of substances

Section 2
Substances exempted in accordance with Article 5(1)(c) or Article 37(2)

The following substances are exempt from the groups of substances included in Section 1 of this Part:

Do you want to be able to easily and automatically check if your chemicals are controlled and regulated around the world - even for novel and propriatory chemicals - then you need Controlled Substances Squared.