Customer declaration for drug precursors (within the European Union)

Within the European Union, operators who supply drug precursors of category 1 or 2 are required, before each delivery, to obtain a customer declaration from the customer. This is laid down in Regulation (EC) No. 273/2004 and aims to prevent the misuse of these substances for the illegal manufacture of drugs.

Category 1 scheduled substances
For category 1 substances (such as ephedrine, pseudo-ephedrine, ergometrine, ergotamine, etc.), supply is permitted only to operators or users who hold a valid licence and who have signed a customer declaration in advance.

• Use the model set out in Annex III, point 1 of Regulation (EC) No. 273/2004.
• A separate declaration must be submitted for each individual substance.
• The supplier must stamp and date a copy of the declaration to confirm it matches the original.
• This copy must accompany the substances during all transport within the European Union and be made available to the authorities upon request.

Category 2 scheduled substances
For category 2 substances (such as acetic anhydride, anthranilic acid, piperidine, potassium permanganate, red phosphorus, etc.), the supplier may accept two kinds of customer declaration:

• a declaration per transaction (Annex III, point 1),
• or a declaration covering multiple transactions within a period of no more than one year (Annex III, point 2).

A multiple-transaction declaration may only be accepted if all the following conditions are met:

1. The supplier has supplied the substance to this customer at least three times in the past 12 months;
2. There is no reason to suspect that the substance will be used for illicit purposes;
3. The quantities ordered are consistent with the known usage of the customer.

Exemption from customer declaration requirement
The customer is exempt from providing a customer declaration for category 2 substances if the annual quantities do not exceed the thresholds listed below:

Application to pharmacies
Public pharmacies and hospital pharmacies are also required to provide a customer declaration when purchasing category 1 or 2 substances, unless an exemption applies.

More information
Drug precursor legislation
drugprecursor@fagg-afmps.be