COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on monitoring and controlling drug precursors and repealing Regulations (EC) No 273/2004 and (EC) No 111/2005
Date: 2025-12-03
Institutions: Directorate-General for Taxation and Customs Union, European Commission
Subjects: administrative cooperation, drug traffic, exchange of information, export monitoring, free movement of goods, illicit trade, labelling, market approval, psychotropic substance, surveillance concerning imports

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   EUROPEAN COMMISSION  Brussels, 3.12.2025  SWD(2025) 399 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council  on monitoring and controlling drug precursors and repealing Regulations (EC) No 273/2004 and (EC) No 111/2005               {COM(2025) 747 final} - {SEC(2025) 328 final} - {SWD(2025) 397 final} - {SWD(2025) 398 final}  
 
 
Executive Summary Sheet 

Impact  assessment  on  a  proposal  for  a  regulation  of  the  European  Parliament  and  of  the  Council  on  drug 
precursors 

What is the problem and why is it a problem at EU level? 

A. Need for action 

The  evaluation  of  Regulations  (EC)  No  273/2004  and  (EC)  No  273/2004  (the  EU  drug  precursor  regulations) 
identified  some  deficiencies  in  them.  On  the  one  hand,  drug  precursors  continue  to  be  available  for  the  illicit 
production of drugs. This increasingly concerns designer precursors. These are substances that can be used as 
precursors and do not have a known legal use other than research and innovation. On the other hand, economic 
operators  engaged  in  the  legal  trade  in  the  substances,  as  well  as  public  authorities,  have  to  contend  with 
unnecessary burdens and inefficiencies in performing their activities.   

What should be achieved?  

This initiative should reduce the availability of drug precursors for illicit drug  production. It should also facilitate 
the legitimate trade in and use of drug precursors. 

What is the value added of action at EU level (subsidiarity)? 

The two EU drug precursor regulations set the rules for the legitimate trade  in chemical substances, in the EU 
and with non-EU countries, that can also be used in illegal drug production. The monitoring and control of trade 
between the EU and non-EU countries falls  under a  policy area  in which the EU has  exclusive powers  and to 
which the subsidiarity principle therefore does not apply.  
For the internal market, any changes to the scope or requirements of such rules must be made at EU level to 
avoid: (i) distorting the market; (ii) creating barriers to the free movement of goods or (iii) undermining efforts to 
prevent the diversion of drug precursors.  

B. Solutions 

What are the various options to achieve the objectives? Is there a preferred option or not? If not, why? 
In addition to the baseline of no action, the impact assessment identifies three policy options. 

Policy option 1 proposes technical adaptations to address the problems by providing guidance on substances 
and  mixtures,  such  as  a  library  of  substances.  In  accordance  with  an  agreement  with  the  Parliament  and 
Council,  adding  substances  to  the  regulations  would  be  sped  up.  Controls  of  scheduled  designer  precursors 
would  be  adapted  to  focus  on  the  need  to  prove  legitimate  use  and  to  enable  the  use  of  small  quantities  for 
research  purposes.  For  external  trade,  rules  would  remain  the  same  so  that  imports  would  continue  to  be 
controlled. Reporting obligations for internal trade would be simplified. 

Policy  option  2  would  entail  a  comprehensive  review  of  the  rules  and  a  merging  of  the  two  drug  precursor 
regulations.  Substances  would  be  subject  to  control  regimes  using  the  comitology  urgency  procedure.  A  new 
regime to ban a moderate range of designer precursors would be introduced, with exemptions if authorities are 
given advance notice. Larger quantities would require a licence. The obligations of economic operators would be 
adapted  to  reflect  the  risk  of  various  transactions,  avoid  creating  loopholes  in  the  control  regime  and  avoid 
imposing an unnecessary burden. Procedures would be fully digitalised. 

Policy option 3 would be a comprehensive review with a stronger focus on controls, also including a merging of 
the two drug precursor regulations. More emphasis would be placed on preventing diversion, with the result that 
a  wider  range  of  designer  precursors  would  be  included  within  the  control  regime.  A  more  limited  number  of 
obligations  for  economic  operators  would  be  lifted  while,  depending  on  the  substance,  some  additional 
obligations would be introduced. Procedures would be fully digitalised. 

These  policy  options  would  be  accompanied  by  a  set  of  flanking  measures  intended  to  improve  the 
implementation  of  rules  and  strengthen  EU  countries’  enforcement  capacity  (e.g.  compliance  checks  and 
assistance with testing capacity). 

The preferred policy option is option 2 as it addresses the risks of designer precursors and diversion without 
hampering legal trade, innovation and research. Policy option 1 was considered to have a very limited impact on 
the achievement of both objectives. The scope of policy option 3 was considered too broad, and the cost of the 

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attendant controls considered too high, to result in a reasonable cost benefit balance for the achievement of both 
objectives. 

What are different stakeholders’ views? Who supports which option? 
Industry  stakeholders  welcomed  the  measures  under  option  1  but  there  was  more  support  for  the  burden 
reduction and digitisation measures under policy option 2. Industry welcomed better and more targeted controls 
of designer precursors but highlighted the need for clear and unambiguous identification of the substances  that 
fall  under  the  scope  of  the  legislation.  They  were  opposed  to  some  of  the  additional  control  measures  under 
option 3. 

Again, EU countries welcomed the measures under option 1 but preferred the regulatory measures under option 
2.  They  expected  administrative  cost  savings  would  arise  out  of  these.  EU  countries  were  less  critical  of  the 
tighter control measures that would be introduced under option 3, but also pointed out that option 3 might entail 
very high enforcement costs. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise the main ones)? 

The  impact  assessment  considers  that  policy  option  2  would  lead  to  a  substantial  decline  in  the  trafficking  of 
designer  precursors  and  other  non-scheduled  precursors  (for  two  years  based  on  similar  previous  measures) 
and a more robust supply chain control system.  

Option 2 would also entail quicker and more efficient processes that would be more harmonised and less prone 
to  error.  Lower  compliance  costs  for  economic  operators  to  fulfil  specific  obligations  and  the  removal  of 
compliance costs for the fulfilment of certain obligations (overall annual costs would be down EUR 25.27 million 
compared to the baseline) and hassle costs would also be reduced. At the same time, public authorities would 
benefit  from  more  efficient  processes  that  would  reduce  licence  application/registration  costs  by  25-50%  and 
would reduce them altogether for export/import and annual reporting. 

Licence  application  and  registration  costs  would  be  reduced  (recurring  costs  would  fall  by  approximately  EUR 
72 000/year and one-off costs by just over EUR 250 000), while the digitalisation of customer verification would 
reduce  costs  by  EUR  17.6  million/year.  Import/export  authorisation  costs  (approximately  EUR  6.4  million/year) 
and annual reporting costs (EUR 3.2 million/year) would be eliminated. 

What are the costs of the preferred option (if any, otherwise the main ones)? 

The preferred option would entail an investment in a new IT infrastructure which would amount to EUR 17-26.6 
million, and an additional annual cost for EU countries of about EUR 1.38 million. A repository managed by the 
European  Drug  Agency  would  cost  1  full-time  equivalent  +  EUR  182  000,  while  there  would  be  higher 
enforcement costs for EU country authorities (+30%) to fully implement rules in the online environment.  

Due  diligence  administrative  costs  for  economic  operators  linked  to  the  ban  on  designer  precursors  would 
amount to EUR 7.7 million (one-off), assuming a list of 150 substances. Moderate additional costs are estimated 
to be +10% for EU countries to implement the ban. 

What are the impacts on SMEs and competitiveness? 

Policy option 2 would enable small and medium-sized enterprises (SMEs) to reap the benefits of the digital age 
by  streamlining  procedures  and  reducing  hassle  costs  (such  as  waiting  times  for  import  and  export 
authorisations).  It  would  also  reduce  the  burden  for  both  SMEs  and  larger  companies.  The  rules  on  designer 
precursors  would  be  designed  so  as  not  to  hamper  research  and  innovation.  Policy  option  2  should  therefore 
also have a positive impact not only on competitiveness for SMEs, but also for the EU economy as a whole. 

Will there be significant impacts on national budgets and administrations? 
EU countries may face some adaptation costs to adjust to new procedures, especially IT procedures, estimated 
to  be  EUR  1.38  million  annually.  They  will  benefit  from  the  removal  of  reporting  requirements  and  from 
streamlined  administrative  procedures.  The  scheduling  designer  precursors  is  expected  to  lead  to  some 
enforcement costs. 

Will there be other significant impacts? 
No other significant impacts have been identified. 

Proportionality? 
The  preferred  option  does  not  exceed  what  is  needed  to  achieve  the  objectives.  It  will  clearly  set  out  and 

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facilitate the rules for legal trade in drug precursors. 

D. Follow-up 

When will the policy be reviewed? 
The new regulation will be evaluated 10 years after its entry into application. 

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