COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid 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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  EN 

   EUROPEAN COMMISSION  Brussels, 3.12.2025  SWD(2025) 397 final  COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid 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) 398 final} - {SWD(2025) 399 final}  
 
 
Subsidiarity Grid 

1.  Can the EU act? What is the legal basis and competence of the EU’s intended action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy 
initiative? 

The  legislative  proposal  has  the  same  legal  bases  as  Regulation  (EC)  No  273/2004  on  drug 
precursors  and  Regulation  (EC)  No  111/2005 of  22  December  2004  laying  down  rules  for  the 
monitoring of trade between the Community and third countries. Regulation (EC) No 273/2004 is 
based on Article 114 of the Treaty on the Functioning of the EU (TFEU), for the approximation of 
measures  to  control  and  monitor  drug  precursors  in  EU  countries,  while  Regulation  (EC)  No 
111/2005 is based on Article 207 TFEU on common commercial policy, for custom controls of drug 
precursors.  

1.2 Is the EU competence represented by this Treaty article exclusive, shared or supporting? 

In  the  case  of  measures  to  control  and  monitor  drug  precursors  in  the  internal  market,  EU 
competence is shared, while for custom controls measures, competence is exclusive. Given that 
the subsidiarity principle does not apply to policy areas where the EU has exclusive competence 
as defined in Article 3 TFEU, this subsidiarity grid will further down refer only to the subsidiarity 
and  proportionality  of  the  measures  proposed  concerning  the  control  and  monitoring  of  drug 
precursors in the internal market.  

2.  Subsidiarity principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 21: 

-  Has wide-ranging consultation been carried out before proposing the act? 
- 

Is there a detailed statement with qualitative and, where possible, quantitative 
indicators making it possible to establish whether EU action is the best course to take? 

For  the  preparation  of  this  proposal,  the  Commission  consulted  national  authorities,  industry 
associations, companies (including small and medium-sized enterprises), and civil society. It also 
consulted  the  Expert  Group  on Drug Precursors. The  proposal,  based on  a comparative  impact 
assessment  of  a  number  of  policy  options,  reflects  the  option  that  scored  best  in  terms  of 
economic, social, environmental and health impacts, effectiveness, efficiency and coherence.  It 
will replace Regulation (EC) No 273/2004 on drug precursors. It will also replace Regulation (EC) 
No 111/2005.  
The  evaluation  of  the  Regulations2  concluded  that  they  had  added  value  for  preventing  the 
diversion  of  drug  precursors  and  for  the  functioning  of  the  internal  market.  It  also  highlighted 
regulatory fragmentation alongside the Regulations (such as additional rules in some EU countries) 
and differing approaches that lead to an imbalance in the level of controls and in administrative 
burdens for economic operators. 
During  the  impact  assessment,  it  became  clear  that  EU  countries  and  industry  welcomed,  in 
particular, a coherent approach to the challenge of designer precursors, in cases where separate 
national rules have been introduced.  

2.2 Does  the  explanatory  memorandum  (and  any  impact  assessment)  accompanying  the 
Commission’s  proposal  contain  an  adequate  justification  for  following  the  principle  of 
subsidiarity? 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  
2 EUR-Lex - 52020DC0768 - EN - EUR-Lex 

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Yes, they do.  
The explanatory memorandum points out: ‘The Union has shared competence in setting out rules 
on the control and monitoring of drug precursors within the internal market. The EU has set out 
harmonisation  rules  on  drug  precursors  since  1990.  Two  key  arguments  continue  to  justify  EU 
action in this field. Firstly, illegal drug production is a Union-wide problem, not confined to a few 
Member States. EU action is needed to ensure that the efficiency of controls of drug precursors 
across the Union is not diminished by the existence of differing national rules with various degrees 
of strictness, which would inadvertently lead to weaknesses. Secondly, Member States have the 
obligation to control and monitor transactions with drug precursors, in accordance with the UN 
Convention  against  Illicit  Traffic  in  Narcotic  Drugs  and  Psychotropic  Substances3.  Maintaining 
harmonised rules would ensure a smooth licit trade of chemicals in the single market. EU action 
would  have  clear  benefits  for  businesses,  national  authorities  and  society  as  a  whole,  by 
empowering  national  authorities  to  better  fight  against  illicit  drug  production,  ensuring  the 
smooth  functioning  of  the  internal  market  and  reducing  administrative  burdens  for  economic 
operators and national authorities.’ 
The impact assessment also contains a section on the principle of subsidiarity (Section 3.2).  

2.3 Based on the answers to the questions below, can the objectives of the proposed action be 

achieved sufficiently by EU countries acting alone (need for EU action)? 

No, the objectives of the proposal cannot be sufficiently achieved by EU countries acting alone, 
due  to  the  EU-wide  problems  with,  and  significant  cross-border  legitimate  trade  in,  drug 
precursors and incidents of diversion towards the illicit manufacture of drugs.  

(a)  Are  there  significant/appreciable  transnational/cross-border  aspects  to  the  problems 

being tackled? Have these been quantified? 

Illegal drug production is an EU-wide problem. The 500 illegal production sites dismantled in 2023 
suggest that a significant amount of drug production activities take place in the EU.  
Drug  precursors  are  chemicals  needed  for  the  illicit  production  of  drugs.  Many  of  them  have 
extensive  legitimate  uses  as  critical  components  of  various  industrial  supply  chains,  such  as 
pharma, cosmetic, textile, oil refinery, food additive, or dyes industries. The legal use of precursors 
in the EU exceeds 10.6 million tonnes a year, unevenly spread across EU countries, depending on 
the degree of development of their chemical industries. 4000 economic operators are involved in 
supply  chains  with  the  major  drug  precursors.  Such  supply  chains  are  often  complex,  with 
operators  from  two  or  more  Member  States  performing  various  roles.  Although  these  supply 
chains represent a small proportion of the chemical industry overall, there are plenty of risks of 
drug  precursors  being  diverted  from  licit  channels  towards  the  illicit  manufacture  of  drugs  all 
across the EU.    

(b)  Would national action or the absence of EU action conflict with the achievement of core 
objectives of the Treaty4 or significantly damage the interests of other EU countries? 

No longer maintaining harmonisation rules in this sector would unavoidably impede the smooth 
functioning  of  the  internal  market.  The  control  and  monitoring  of  drug  precursors  is  an 
international obligation of the EU and EU countries. Setting up national control systems to replace 
the existing harmonised one  would weaken the  fight  against  the diversion of these substances 
towards illicit channels. The evaluation and the impact assessment have identified an increase in 

3 The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, adopted 
in Vienna on 19 December 1988. 
4 https://europa.eu/european-union/about-eu/eu-in-brief_en  

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the  number  of  challenges  in  this  sector,  pointing  to  the  need  to  strengthen  the  existing  rules, 
instead of replacing them with various national rules, given the EU-wide nature of the situation.  

(c)  To  what  extent  do  EU  countries  have  the  ability  or  possibility  to  enact  appropriate 

measures? 

If  the  EU  decides  to  no  longer  maintain  harmonisation  rules,  EU  countries  would  have  the 
obligation to adopt such measures at national level, to meet their international obligations. While 
such measures could tackle efficiently internal issues, they would not be sufficient in dealing with 
cross-border  incidents,  which  are  common  in  the  illicit  manufacture  of  drugs.  In  addition, 
legitimate  trade  would  face  unnecessary  burden  when  extending  their  activities  to  other  EU 
countries.  

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

nationally, regionally and locally in the EU? 

Some EU countries have a more developed chemical industry. This increases the risk of diversion 
of drug precursors from licit to illicit channels.  
Illegal drug manufacturing and drug consumption  is also not evenly spread, resulting in various 
degrees of awareness of, and commitment to identifying, suspicious transactions among national 
authorities and economic operators.   

(e)  Is the problem widespread across the EU or limited to a few EU countries? 

The problems are widespread. See question (a) for more details.  

(f)  Are EU countries overstretched in their efforts to achieve the objectives of the planned 

measure? 

No. The consultation activities carried out as part of the evaluation and impact assessment show 
a strong commitment from EU countries to monitoring and controlling drug precursors.  

(g)  How do the views/preferred courses of action of national, regional and local authorities 

differ across the EU? 

National authorities share the objective of fighting the illegal manufacture of drugs. Nevertheless, 
there are significant discrepancies: both the chemical industry and illegal activities are not evenly 
spread across the EU, resulting in various degrees of prioritisation of the control of drug precursors 
across the EU. The evaluation points to uneven implementation across the EU. This is also because 
of  the  variations  in  the  resources  mobilised  at  national  level  to  control  and  monitor  drug 
precursors.  
Authorities and industry advocate a targeted approach to drug precursors that does not lead to 
undue enforcement costs and administrative burdens for legitimate businesses. 

2.4 Based on the answers to the questions below, can the objectives of the proposed action be 
better achieved at EU level by reason of the scale or effects of that action (EU added value)? 

Yes, the objectives of the proposal can be better achieved at EU level, as harmonised control and 
monitoring measures will reduce the administrative burden for economic operators and improve 
the efficiency of national authorities’ controls.  

(a)  Does EU action have clear benefits?  

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The proposal is expected to lead to a reduction of the illicit trade in drug precursors and a decline 
in the trafficking of designer precursors and other non-scheduled precursors (no less than -60% 
for  two  years  based  on  similar  previous  measures).  This  would  reduce  the  availability  of  drug 
precursors  for  the  illicit  manufacture  of  drugs,  with  social  benefits  that  cannot  be  estimated 
because of their indirect nature.  
Based on Section 8 of the impact assessment, the proposal would lead to significant simplification 
of the existing rules on drug precursors and to net benefits for operators. The net benefits of the 
proposed option for economic operators would amount to approximately EUR 25.27 million a year. 

(b)  Are there economies of scale? Can the objectives be achieved more efficiently at EU level 
(greater benefits per unit cost)? Will the functioning of the internal market be improved? 

The functioning of the internal market will be improved by maintaining harmonised rules and by 
adapting them to new developments. Both more efficient monitoring measures and the reduction 
of burden for industry and authorities will be ensured by the implementation of a centralised IT 
system.   

(c)  What  are  the  benefits  of  replacing  different  national  policies  and  rules  with  a  more 

homogenous policy approach? 

Such benefits have not been estimated as there are currently no national policies to be replaced. 
Harmonisation  rules  for  drug  precursors  have  been  in  place  for  more  than  three  decades.  This 
proposal is aimed at adapting the existing 20-year old EU rules.  

(d)  Do the benefits of EU action outweigh the loss of competence of EU countries and local 
and regional authorities (besides the costs and benefits of acting nationally, regionally and 
locally)? 

EU  countries  agreed  to  common  rules  on  drug  precursors  in  the  1990s,  when  the  European 
Economic  Community  was  notified  to  the  United  Nations  as  being  responsible  for  the 
implementation  of  Article  12  of  the  Convention.  Ever  since,  the  harmonisation  rules  for  drug 
precursors have proven their usefulness in both ensuring the smooth functioning of the internal 
market  and  the  fight  against  the  illicit  manufacture  of  drugs.  The  evaluation,  while  drawing 
attention to the need to adapt the harmonisation rules to new developments, showed no evidence 
that EU action would no longer have added value. On the contrary, evidence gathered both during 
the evaluation and the impact assessment showed the advantages of a common stance against 
the diversion of drug precursors towards the illicit manufacture of drugs.   

(e)  Will there be greater legal clarity for those who have to implement the legislation? 

Yes, the proposal would lead to significant simplification of the existing legal framework. The two 
Regulations would be replaced with a single Regulation, streamlining the procedures applicable to 
both  internal  and  extra-EU  trade.  More  details  are  available  in  Section  8.1  of  the  impact 
assessment.  

3.  Proportionality: How the EU should act 

3.1 Does  the  explanatory  memorandum  (and  any  impact  assessment)  accompanying  the 
Commission’s  proposal  contain  an  adequate  justification  regarding  the  proportionality  of 
the proposal and a statement that makes it possible to establish the proposal’s compliance 
with the principle of proportionality? 

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Yes.  The  explanatory  memorandum  says:  ‘The  proposal  does  not  exceed  what  is  necessary  for 
reaching the objectives pursued. The measures target a limited number of precursors, thus better 
targeting the controls without unduly hampering legal trade and innovation. The proposal better 
reflects  the  risks  associated  with  each  category  of  precursors  and  takes  full  advantage  of 
digitisation. It strikes a fair balance between the need to reduce the availability of drug precursors 
for  the  illicit  manufacture  of  drugs  and  the  need  to  facilitate  legitimate  trade.  Thus,  despite  a 
reduction in controls notably on bulk materials with significant legitimate uses, the diversion risk 
is properly addressed by strengthening the enforcement.’ 

3.2 Based on the answers to the questions below and on information available from any impact 
assessment,  the  explanatory  memorandum  or  other  sources,  is  the  proposed  action  an 
appropriate way to achieve the intended objectives? 

The proposal is an appropriate way of achieving the objectives pursued and does not exceed what 
is strictly necessary to do so.  

(a)  Is the initiative limited to objectives that EU countries cannot achieve satisfactorily on their 

own, and where the EU can therefore do better? 

Yes. The proposed measures would harmonise the various formalities operators are to follow and 
enable national authorities to efficiently monitor transactions with drug precursors, while ensuring 
the  smooth  functioning  of  the  internal  market.  EU  countries  would  remain  responsible  for 
adopting the national measures needed to enforce the Regulation (rules on penalties) and to react 
promptly in case of suspicious transactions.  
The  rules  would  identify  the  substances  concerned,  to  limit  the  application  of  the  control  and 
monitoring measures to what is necessary for achieving the objectives of the proposal.  

(b)  Is the form of EU action (choice of instrument) justified, as simple as possible, and coherent 
with  the  satisfactory  achievement  of,  and  ensuring  compliance  with,  the  objectives 
pursued  (e.g.  choice  between  regulation,  (framework)  directive,  recommendation,  or 
alternative regulatory methods such as co-legislation, etc.)? 

The control and monitoring rules on drug precursors should continue to be set out in a Regulation, 
as this instrument is directly applicable and will ensure uniform implementation for all economic 
operators across the EU.  

(c)  Does  EU  action  leave  as  much  scope  for  national  decision-making  as  possible  while 
achieving the objectives that have been set? (For example, is it possible to limit EU action 
to minimum standards or use a less stringent policy instrument or approach?) 

The  adoption  of  control  and  monitoring  rules  on  drug  precursors  in  the  internal  market  is  an 
international obligation of EU countries. Such rules cannot be replaced by minimum standards.  

(d)  Does  the  initiative  create  financial  or  administrative  costs  for  the  EU,  national 
governments, regional or local authorities, economic operators or citizens? Are these costs 
commensurate with the objective to be achieved? 

Yes, the adoption of the proposal will lead to costs for the EU, national authorities and economic 
operators. These costs are justified by the objectives to be achieved (to reduce the availability of 
drug precursors for the illicit manufacture of drugs and to facilitate the legitimate trade in drug 
precursors).  

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(e)  While respecting EU law, have individual EU countries’ special circumstances been taken 

into account? 

N/A.  

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