EN    EN 
 EUROPEAN 
COMMISSION  
Brussels, 27.9.2012  
COM(2012) 548 final 
2012/0261 (COD) 
  
[…] 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
Amending Regulation (EC) No 273/2004 on drug precursors 
(Text with EEA relevance) 
{SWD(2012) 278 final} 
{SWD(2012) 279 final}   
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
General Context  
Many chemicals are used in a wide variety of  important industrial processes (e.g. in the 
synthesis of plastics, pharmaceuticals, cosmetic s, perfumes, detergents and aromas) and they 
are traded for these licit uses on regional and global markets. Some of these chemicals can, 
however, be misused for the illicit manufac ture of narcotic drugs and psychotropic 
substances. The chemicals produced for a licit purpose which can be mi sused in the illegal 
drug production are called drug precursors . 
Drug precursors are rarely produced by the crimin als that intend to use them in the illicit 
manufacture of drugs, as  their production often requires im portant industrial infrastructure. 
Therefore, criminals try to divert these substances from the licit trade .  
The trade in drug precursors is not in itself prohibited because of their important legitimate 
uses. However, in order to prevent their di version to illicit drug production, a specific 
regulatory framework has been set up on intern ational level through Article 12 of the United 
Nations Convention against the Illicit Traffic in  Narcotic Drugs and Psychotropic Substances 
(hereafter referred as UN 1988 Convention). The European Union is a Party to the 
Convention and has implemented its obliga tions through Regulation (EC) No 273/2004 
governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) 
No 111/2005 governing the external trade . The Union regulatory framework provides for the 
monitoring and control of the legitimate trade in drug precurso rs. Operators, i.e. 
manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals 
engaged in the legitimate trade of drug precursor s are required to take measures against theft, 
check their customers, detect suspicious transa ctions and notify the authorities thereof. This 
industry-authority partnership is key to the well functioning of the regulatory framework. 
Public authorities monitor  that companies dealing with dr ug precursors properly exercise 
their obligations under the legisl ation by conducting on-site inspect ions and via administrative 
procedures such as granti ng licences and registrations. 
Grounds for and objectives of the proposal  
Traffickers purchase the drug precursors they n eed from different regions of the world and 
exploit weaknesses of control to  their benefit. This proposal aims to address a specific 
weakness  which has been detected in the Euro pean Union, when large quantities of acetic 
anhydride ("AA"), the main drug precursor for heroin,  were diverted from the EU-
internal trade : in 2008, 75% of the global seizur es of AA happened in the EU. Heroin  use 
has been contributing to  public health problems in Europe since the 1970s. It still accounts for 
the greatest share of morbidity and morta lity-related drug use in the European Union. 
Even though the quantities of AA seized in the EU have decrea sed very substantially since 
2008, the INCB1 continues to mention in its annual re ports that the European legislative 
                                                 
1 United Nations’ International Narcotics Control Board.  
EN 3   EN control measures are not sufficiently strict to  prevent the diversion of the main heroin 
precursor from the intra-EU trade. 
On 7 January 2010, the European Commission adopted a Report  on the implementation and 
functioning of the existing EU legislation on drug precursors2 which concluded that the 
legislation is overall functioning well but al so identified some weaknesses and made 
recommendations how to address these3. 
This proposal addresses, by amending Regula tion (EC) No 273/2004, the recommendation of 
the Commission Report to improve the prevention of the diversion  from the EU-internal 
trade of AA, the main drug precursor for heroin, by extending the registration 
requirement , which so far applies only to operat ors placing AA on the market, to also 
include users of the substance and by enhancin g the harmonised registration provisions to 
achieve a more robust level playing field preser ving the internal market and avoiding adoption 
of divergent national measures. 
Consistency with other policy and objectives of the Union  
This proposal is fully consistent with th e objectives of the EU  Drugs Strategy 2005-20124 and 
the EU Drugs Action Plan (2009-2012)5, which set out the objective to reduce the diversion 
and trafficking in/via the Union of drug precursors used for the production of illicit drugs. 
As the drug problem is a complex phenomenon, it requires a multidisciplinary approach of 
combining demand and supply reduction6. Preventing the diversion and trafficking of drug 
precursors aims at reducing the supply  of illicit drugs  – the ultimate objective being a high 
level of protection, well-being and social cohesion for EU citizens by preventing and reducing drug use in line with the EU Drug Strategy. Th e European Commission Services are currently 
carrying out an evaluation of the 2005-2012 EU Dr ugs Strategy; in preparation of the EU 
Drug Strategy from 2013
7. This evaluation is, however, not  questioning the pillar ‘supply 
reduction’ (which includes th e prevention of diversion of drug precursors) and the Union 
being a Party to Article 12 of  the 1988 UN Convention is in any case bound to work towards 
the objective of preventing the diversion of drug precursors. 
A high level of human health protection  is a basic principle of the Treaty, which shall be 
ensured in the definition and implementation of  all policies and activities of the EU. The 
control of drug precursor diversion contributes to the protec tion of human health, specifically 
                                                 
2 Report from the Commission to the Council and the European Parliament pursuant to Article 16 of 
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and to Article 32 of Council Regulation (EC) No 111 /2005 on the implementation and functioning of the 
Community legislation on monitoring and control of trade in drug precursors, COM(2009)709 final, 
available at: http://eur-lex.europa.eu/LexUriServ /LexUriServ.do?uri=COM:2 009:0709:FIN:en:PDF. 
3 For further details, see under Section 4.2.2 "Strength and weaknesses of the legislation" of the above-
mentioned Report COM(2009)709 final. 
4 EU Drugs Strategy 2005-2012, endorsed by the European Council of November 2004 (15074/04 
CORDROGUE 77 SAN 187 ENFOPOL 187 RELEX 564). 
5 EU Drugs Action Plan for 2009-2012 ( 2008/C 326/09).  
6 The EU Drug Strategy additionally complements these two key dimensions with three cross-cutting 
themes: coordination; international cooperation and information; research and evaluation. 
7 For further details see http://ec.europa.eu/justice/newsroom/anti-drugs/opinion/111027_en.htm.  
EN 4   EN in the area of drugs-related health damage where the Treaty invites the Union to complement 
Member States’ actions on prevention of drug-use8. 
In addition, the initiative is also in line with th e principle of the Treaty that the Union shall 
endeavour to ensure a high level of security  through measures to prevent and combat crime, 
and through measures for coordination and c ooperation between police and other competent 
authorities9. 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
Consultations of interested parties,  collection and use of expertise  
The Commission Services consulted in 2009 and early 2010 all stakeholders on the 
implementation of Regulation (EC) No 273/2004 and presented its findings in a Report to the 
European Parliament and the Council, which was adopted on 7 January 201010. In May 2010, 
the Council adopted conclusions on the Commis sion’s Report, recognisi ng the importance of 
continuing active co-operation among author ities and industry and of improving the 
implementation of the European legislation. The Council invited the Commission to set up a 
work programme to address the identified weakne sses of the legislation in co-operation with 
Member States and to propose legislative ame ndments before the end of 2011 after carefully 
assessing their potential impacts on Member  States authorities and economic operators11. 
The Commission subsequently developed six poten tial policy options (see the next section for 
details) and discussed them with the Member St ates and industry representatives in a special 
meeting of the Drug Precursor Working Group in June 2010.  
Member States and industry stakeholders we re further consulted on the six options via a 
written consultation, carried ou t from 23 July to 18 October 2010. Three main target groups 
were identified: manufacturers a nd traders (operators), end-user s and competent authorities of 
Member States. In addition, an SME-consultati on was carried out via the Enterprise Europe 
network from 1 October until 24 November 2010 to  ensure that the con cerns of a specific 
target group – end-users of dr ug precursors most of which are SMEs – were considered. 
Finally, the Commission mandated a study to an external consultant to evaluate in detail the 
administrative costs on companies and authoritie s that would result from each of the policy 
options.  
Impact assessment  
The main problem driver being the insuffici ent control by competent authorities over all 
economic players involved in the leg itimate trade with drug precursors, all policy options  
examined seek to improve control via enha nced reporting, notific ation or registration 
obligations imposed on the economic players. Th e impacts of the following six policy options 
have been analysed: 
                                                 
8 Article 168 TFEU (Treaty on the F unctioning of the European Union). 
9 Article 67 TFEU. 
10 See footnote 1. 
11 Council conclusions on the functioning and implementation of the EU drug precursor legislation – 
3016th Competitiveness Council meeting Brussels, 25 May 2010.  
EN 5   EN – Option 1 (baseline option): no action: the current EU legislation will remain unchanged; 
– Option 2: strengthened reporting obligations;  
– Option 3: strengthened rules and obligations on operators related to cu stomer declarations 
from end-users; 
– Option 4: require operators to systematically  notify new end-users to the authorities to 
allow verification; 
– Option 5: require registration for end-user s and reinforce requirements regarding 
registration; 
– Option 6: move AA from category 2 to  category 1 scheduled substances. 
For options 2 to 5, two sub-options were analysed, i.e. to either limit them specifically to AA 
or to apply them to all scheduled substances in category 2. 
The overall conclusion of the impact assessment12 was that both, opti on 4 (for only AA) and 
option 5 (for only AA) would be good choices to  address the identified objectives. Both 
would have effects on SMEs as end-users dea ling with AA are primarily SMEs, but option 5 
would be less burdensome than option 4 in term s of annual costs for enterprises (provided 
authorities do not pass on all costs to regist rants by imposing fees), an argument which is 
particular relevant for SMEs. All in all th e strong political support which option 5 has from 
most Member States, combined with views e xpressed on international level that a more 
systematic control of (all) AA end-users is lacking in the European legislation, and the 
somewhat lower burden on SMEs tip the ba lance in the end in favour of option 5. 
3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
Legal basis  
The legal basis of the proposal is Article 114 of  the Treaty on the Func tioning of the European 
Union (TFEU). Article 114 has the objective to es tablish an internal market while ensuring a 
high level of protection of huma n health and the environment. 
Subsidiarity principle  
The subsidiarity principle as set out in Arti cle 5(3) of the Treaty on the European Union 
applies insofar as the proposal does not fall under the exclusive competence of the Union.  
The general objective of Regulation (EC) No 2 73/2004 is to prevent the diversion of drug 
precursors from legitimate trade in accordance w ith the Union's obligations under Article 12 
of the 1988 UN Convention. It co ntributes to the world-wide combat against the illicit 
production and trafficking of narcotic drugs and psychotropic substa nces, while ensuring a 
proper functioning of the internal market for drug precursors by subjecting operators to the 
same, harmonised rules within the EU whilst avoiding unnecessary obstacles to legitimate 
trade and administrative burden for ente rprises and competent authorities.  
                                                 
12 The report on the impact assessment is available at: 
http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm .   
EN 6   EN The objective of this proposal, namely to st rengthen control measures on AA in order to 
prevent it diversion from the EU internal mark et while avoiding market  distortions, cannot be 
sufficiently achieved by the Member States alone and action by the Union will be more 
efficiently achieved for the following reasons: 
– Some Member States feel legally prevented from adopting national control measures going 
beyond the EU legislation on the basis of Article 10 of Regulation (EC) No 273/2004, 
which empowers Member States to adopt national measures wh ich are necessary to enable 
its authorities to perform their control and monitoring duties. They argue that the EU legislation is subjecting only operators  to control measures (no obligations are imposed on 
end-users), which should be understood as a deliberate and binding decision of the EU-
legislator that end-users should not be subject to the cont rol of the drug precursor 
legislation 
– On the contrary, other Member States are cont emplating or have already based substantive 
national controls on Article 10, leading in first instance to different approaches of control 
in different Member States which might be detrimental to the functioning of the Union 
Market and, secondly, isolated actions in individual Member States risks shifting the 
problem from one Member State to the next, as traffickers will expl oit the “weakest link” 
in the Union market. A combination of different  national measures will not be as effective 
as a harmonised approach at EU-level. This  is also confirmed by the fact that both, 
Member States and concerned industry sect ors have called on the Commission to act to 
preserve the internal market with a level playing field, and not to rely too much on 
supplementary national measures.  
Proportionality principle
 
The proposal does not go beyond what is necessary in order to achieve the intended 
objectives, in accordance with the principle of pr oportionality, as set out in  Article 5(4) of the 
Treaty on European Union. By preventing the dive rsion of drug precursor from the legal trade 
to illicit drug production, this proposal is expe cted to contribute to th e fight against illicit 
trafficking in narcotic drugs a nd psychotropic substances, and cons equently to protect citizens 
from the health damage related to drug addict ion. Furthermore by ensu ring that operators and 
users engaged in the legal trad e of those drug precurs ors are subject to harmonised rules, it 
should ensure a proper functioni ng of the Union market by a voiding unnecessary barriers to 
such legitimate trade and by reducing administ rative burdens for operators and competent 
authorities. 
The proposal only tackles the weaknesses identi fied in the evaluation on the functioning and 
on the implementation of the Regulations on Drug Precursors, namely by requiring 
registration not only for operato rs placing AA on the market but also for users possessing it 
for their own uses or processes (i.e. end-us ers). The proposal does not  extend the envisaged 
provisions for AA to other schedu led substances in category 2. 
Choice of the instrument  
The chosen legal instrument is a Regulation as it aims to harmonise the rules applicable to 
economic operators (end-users) dealing with AA for their own uses or processes. It amends the already existing Regulation (EC) No 273/2004. 
Main provisions of the proposal 
  
EN 7   EN The proposal introduces the requirement that e nd-users of AA must obta in a registration as 
already exists for operators placing the substa nce on the market, and strengthens the rules for 
registration.  
Additionally it proposes to establish and maintain a Europ ean Database on Drug Precursors in 
order to modernize the collection of the in formation provided by Member States on drug 
precursor seizures and stopped shipments, in accordance with current Article 13 of Regulation 
(EC) No 273/2004, and to maintain a list of EU licensed or registered operators and users 
legally trading or using drug precursors, as well as to enable operators to provide competent 
authorities in summary form with informati on about their transacti ons involving scheduled 
substances in accordance with current Ar ticle 8 (2) of Regulation (EC) No 273/2004.  
Finally, the draft Regulation adapts the provi sions of Regulation (EC) No 273/2004 regarding 
ex-Comitology to the new rules of the Lisbon Treaty. 
4. BUDGETARY  IMPLICATION   
The proposal has no impact on the European Union budget because no additional resources 
are required to implement the action proposed. The necessary resources to implement the European database are already included in the allocations gr anted during the budget procedure 
and within the Internal Market  line. Therefore it does not ha ve a budgetary impact over and 
above the appropriations already foreseen for the years to come in the official programming of the Commission. 
5. ADDITIONAL
 INFORMATION 
– The proposal is subject to a notification to the WTO in the framework of the TBT 
Agreement.  
– The proposed act is relevant for the European Economic Area (EEA).  
– The proposed act contains tr ansitional period for the coming into force of the new 
registration obligations for end-users of AA. 
– The proposed act includes a re view clause to assess whethe r the amended Regulation will 
have been effective to prevent the diversion of AA.  
EN 8   EN 2012/0261 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
Amending Regulation (EC) No 273/2004 on drug precursors 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eu ropean Economic and Social Committee
1, 
Having regard to the opinion of the European Data Protection Supervisor2, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Pursuant to Article 16 of Regulation (E C) No 273/2004 of the European Parliament 
and of the Council of 11 February 2004 on drug precursors
3, the Commission adopted 
on 7 January 2010 a report to the Council and the European Parliament on the 
implementation and functioning of the ex isting EU legislation on drug precursors4. 
(2) In that report, the Commi ssion recommended further analys ing ways to strengthen the 
control of the trade of acetic anhydride (scheduled substance in Category 2) in order to 
better prevent the diversion of acetic anhydr ide for the illicit production of heroin.  
(3) In its Conclusions on the functioning a nd implementation of the EU drug precursor's 
legislation of 25 May 2010, the Council invi ted the Commission to propose legislative 
amendments after assessing their potenti al impacts on competent authorities and 
economic operators. 
                                                 
1 OJ C , , p. . 
2  OJ C…p…. 
3 OJ L 47, 18.2.2004, p. 1. 
4 Report from the Commission to the Council and the European Parliament pursuant to Article 16 of 
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and 
to Article 32 of Council Regulation (EC) No 111 /2005 on the implementation and functioning of the 
Community legislation on monitoring and control of trade in drug precursors, COM(2009)709 final.  
EN 9   EN (4) The definition of scheduled substances s hould be clarified: the term 'pharmaceutical 
preparation' stemming from the United Nations  Convention against Illicit Traffic in 
Narcotic Drugs and Psychotropic Substan ces adopted in Vienna on 19 December 
1988, (hereinafter referred to as the "Unite d Nations Convention") should be replaced 
by the relevant terminology of the Union legi slation, 'medicinal products', and the term 
'other preparations' should be deleted as it duplicates the term 'mixtures' already used 
in the definition. 
(5) A definition of the term 'user' should be introduced for companies possessing 
substances for purposes other th an placing them on the market.  
(6) It should be clarified that companies using scheduled substances in category 1 for 
other purposes than placing them on the ma rket are obliged to obtain a licence. 
(7) More detailed rules on registration should be introduced to ensure uniform conditions 
of registration in all Member States for scheduled substances  in category 2 of Annex I. 
For substances scheduled in a new subcateg ory 2A of Annex I, not only operators but 
also users should be subject to a registration requirement. 
(8) In order to safeguard the competitivene ss of microenterprises, no fees should be 
imposed on them for obtaining a registration or a licence. 
(9) Explicit provisions should be foreseen to clarify that Member States have the 
possibility to act with rega rd to suspicious transact ions involving non-scheduled 
substances in order to enable them to react more quickly with regard to new trends in 
the illicit production of drugs. 
(10) A European database on dr ug precursors should be create d to simplify the reporting by 
Member States with regard to seizures a nd stopped shipments, to create a European 
register of operators and users holding a licen se or a registration which will facilitate 
verification of the legitimacy of comme rcial transactions involving scheduled 
substances, and to enable operators to provide the competent authorities with 
information about their legal transact ions involving scheduled substances. 
(11) Regulation (EC) No 273/2004 envisages the processing of data. Such processing of 
data may also cover personal data which should be carried out in accordance with 
Union Law. 
(12) Acetic anhydride, currently  scheduled in category 2 of A nnex I, should be included in 
a new subcategory 2A of Annex I to allo w increased control of its trade. The 
remaining substances of category 2 should be listed as subcategory 2B. 
(13) Regulation (EC) No 273/2004 confer s powers on the Commi ssion in order to 
implement some of its provisions, to be exercised in accordance with the procedures 
laid down in Council Decision 1999/468/ EC of 28 June 1999 laying down the 
procedures for the exercise of implem enting powers conferred on the Commission5 as 
amended by Council Decision 2006/512/EC6. 
                                                 
5 OJ L 184, 17.7.1999, p. 23. 
6 OJ L 200, 22.7.2006, p. 11.  
EN 10   EN (14) As a consequence of the entry into force of the Lisbon Treaty, thos e powers need to be 
aligned to Articles 290 and 291 of the Tr eaty on the Functioning of the European 
Union.  
(15) In order to achieve the objectives of Regulation (EC) No 273/2004, the power to adopt 
acts in accordance with Artic le 290 of the Treaty on the Functioning of the European 
Union should be delegated to the Commission to specify the requirements and 
conditions for the granting of the licence and registration, fo r obtaining and using 
customer declarations, for the docum entation and labelling of mixtures,  for provision 
of information by the operators on transact ions involving scheduled substances, for 
listing operators and users ha ving obtained a licence or re gistration in the European 
register and in order to amend the Annexes.  It is of particular importance that the 
Commission carry out appropria te consultations during its preparatory work, including 
at expert level.  
(16) The Commission, when preparing and dr awing-up delegated ac ts, should ensure a 
simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council. 
(17) In order to ensure uniform conditions  for the implementation of Regulation (EC) 
No 273/2004, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU)  No 182/2011 of the 
European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms  for control by the Member States of the 
Commission's exercise of implementing powers
7. 
(18) The examination procedure should be us ed for the adoption of the implementing acts 
in order to set up details on how customer declarations should be provided in electronic form; to set up deta ils on how to prov ide the information about transactions 
of operators with scheduled subs tances to a European database. 
(19) Since the objectives of this Regulation, namely to stre nghen the rules for registration 
of operators placing on the in ternal market or possessing  scheduled substances of 
category 2, in particular acetic anhydride, in order to prevent its diversion towards the 
illicit production of drugs, cannot be suffi ciently achieved by Member States because 
traffickers gain from national differences in  registration and move their illicit business 
where drug precursors are easiest to divert a nd can therefore be be tter achieved at the 
level of the Union, the Union may adopt meas ures, in accordance with the principle of 
subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance 
with the principle of proportiona lity, as set out in that Article, this Regulation does not 
go beyond what is necessary in or der to achieve those objectives. 
Regulation (EC) No 273/2004 should therefore be amended accordingly, 
                                                
 
7 OJ L 55, 28.2.2011, p. 13.  
EN 11   EN HAVE ADOPTED THIS REGULATION: 
Article 1 
Regulation (EC) No 273/2004 is amended as follows: 
(1) Article 2 is amended as follows: 
(a) point (a) is replaced by the following: 
"(a) 'scheduled substance’ means any substance used for the illicit 
manufacture of narcotic dr ugs or psychotropic substances and listed in Annex I 
including mixtures and natural products  containing such substances. This 
excludes natural products and mixtures which contain scheduled substances 
and which are compounded in such a way that the scheduled substances cannot 
be easily used or extracted by readily a pplicable or economically viable means 
and medicinal products within the mean ing of Article 1(2) of Directive 
2001/83/EC of the European Parliament and of the Council8;" 
(b) the following point (h) is inserted: 
"(h) 'user' means any natural or legal person who possesses a scheduled 
substance and is engaged in the proce ssing, formulation, consumption, storage, 
keeping, treatment, filling into containe rs, transfer from one container to 
another, mixing, transformation or any other utilisation of scheduled 
substances." 
(2) Article 3 is amended as follows: 
(a) paragraphs 2 and 3 are replaced by the following:  
"2. Operators and users shall be re quired to obtain a licence from the 
competent authorities before they may possess or place on the market 
scheduled substances of category 1 of  Annex I. Special licences may be 
granted by the competent authorities to pha rmacies, dispensaries of veterinary 
medicine, certain types of public author ities or armed forces. Such special 
licences shall only be valid for the use of  scheduled substances of category 1 of 
Annex I within the scope of the offici al duties of the operators concerned. 
3. Any operator holding a licence referred to in paragraph 2 shall supply 
scheduled substances of cat egory 1 of Annex I only to  operators or users who 
hold such a licence and have signed a cust omer declaration as provided for in 
Article 4(1)." 
(b) paragraph 5 is replaced by the following: 
"5. Without prejudice to paragraph 9, th e competent authorities may either 
limit the validity of the licence to a period not exceeding three years or may 
oblige the operators to demonstrate at intervals not exceeding three years that 
                                                 
8 OJ L 311, 28.11.2001, p. 67.  
EN 12   EN the conditions under which the licence was granted are still fulfilled. The 
licence shall mention the operation or operations for which it is valid, as well as the substances concerned. Special li cences within the meaning of paragraph 
2 shall be granted in principle for an unlimited duration but may be suspended or revoked by the competent authoritie s under the conditions of paragraph 4, 
third sentence."  
(c) paragraph 6 is replaced by the following: 
"6. From [18 months after the date of publication] operators shall be 
required to obtain a regist ration from the competent authorities before placing 
on the market scheduled substances of category 2 of Annex I. Furthermore, 
users shall be required to obtain a regi stration from the competent authorities 
before possessing scheduled substances of  subcategory 2A of Annex I. Special 
registrations may be granted by co mpetent authorities to pharmacies, 
dispensaries of veterinary  medicine, certain types of  public authorities or the 
armed forces. Such registrations shall be  considered valid only for the use of 
scheduled substances of cat egory 2 of Annex I within the scope of the official 
duties of the operators or users concerned." 
(d) the following paragraphs 6a and 6b are inserted: 
"6a. Any operator holding a registrati on referred to in paragraph 6 shall 
supply scheduled substances of subcategory 2A of Annex I only to other operators or users who hold such a re gistration and have signed a customer 
declaration as provided for in Article 4(1). 
6b. When considering whether to gr ant a registration, the competent 
authorities shall take into  account in particular the competence and integrity of 
the applicant the registration is to be re fused if there are reasonable grounds for 
doubting the suitability and reliability of the applicant or of the officer 
responsible for the trade in scheduled substances. The registration may be 
suspended or revoked by the competen t authorities whenever there are 
reasonable grounds for believing that the holder is no longer a fit and proper 
person to hold a registration, or that the conditions under which the registration 
was granted are no longer fulfilled."  
(e) in paragraph 7, the following sentence is added: 
"An operator or user who is a microent erprise within the meaning of Article 
2(3) of the Annex to the Com mission Recommendation of 6 May 2003 
concerning the definition of micro, small and medium-sized companies
9 shall 
not be required to pay any such fees." 
(f) the following paragraphs 8 and 9 are added: 
"8. The competent authorities shal l enter operators and users having 
obtained a licence referred to in paragr aph 2 or a registration referred to in 
                                                 
9 OJ L 124, 20.5.2003, p.36.  
EN 13   EN paragraph 6 in a European Database on dr ug precursors to be developed by the 
Commission as provided for in Article 13a.  
9. The Commission shall be empowered  to adopt delegated acts in 
accordance with Article 15a concerning: 
(a) the requirements and conditions for the granting of the licence referred to 
in paragraph 2; 
(b) the requirements and conditions for the granting of th e registration 
referred to in paragraph 6. 
(c) the requirements and conditions fo r listing operators and users having 
obtained a licence or registration in a European Database on drug precursors referred to in paragraph 8." 
(3) Article 4 is amended as follows: 
(a) paragraph 1 is replaced by the following: 
"1. Without prejudice to paragraph 4, Articles 6 and 14, any operator 
established within the Community who supplies a customer with a scheduled 
substance of categories 1 or 2 of Anne x I shall obtain a declaration from the 
customer which shows the specific use or  uses of the scheduled substances. A 
separate declaration shall be required for each scheduled substance. This declaration shall conform to the model se t out in point 1 of Annex III. In the 
case of legal persons, the declaration shall be made on headed notepaper."  
(b) the following paragraph 4 is added: 
"4. The Commission shall be empower ed to adopt delegated acts in 
accordance with Article 15a  concerning the requirements and conditions for 
obtaining and using customer declarations." 
(4) In Article 5, the following paragraph 7 is added: 
"7. The Commission shall be empowered to  adopt delegated acts in accordance 
with Article 15a concerning the requiremen ts and conditions for the documentation 
of mixtures containing substa nces listed in Annex I." 
(5) In Article 7, the following second paragraph is added: 
"The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 15a concerning the requ irements and conditions for the labelling of mixtures 
containing substances listed in Annex I." 
(6) Article 8 is replaced by the following: 
"1 Operators shall notify the compet ent authorities im mediately of any 
circumstances, such as unusual orders or transactions involving scheduled substances 
to be placed on the market, which suggest that such substances might be diverted for the illicit manufacture of narc otic drugs or psychotropic substances. To this end,  
EN 14   EN operators shall provide any available inform ation allowing the competent authorities to 
verify the legitimacy of the relevant order or transaction.  
2. Operators shall provide the competen t authorities in summary form with 
relevant information about their transac tions involving scheduled substances.  
3. The Commission shall be empowered to  adopt delegated acts in accordance 
with Article 15a concerning the requirements and conditions for operators to provide information as referred to in paragraph 2."  
(7) In Article 9, paragraph 1 is  replaced by the following: 
“In order to facilitate c ooperation between the competen t authorities, the operators, 
and the chemical industry, in particular as regards non-scheduled substances, the 
Commission shall draw up and update guidelin es to assist the chemical industry.”  
(8) In Article 10, paragraph 2 is replaced by the following: 
"2. Each Member State may adopt the measures necessary to enable its competent 
authorities to control and monitor suspic ious transactions with non-scheduled 
substances, in particular: 
(a) to obtain information on any orders for non-scheduled substances or operations 
involving non-scheduled substances; 
(b) to enter operators' business premises in  order to obtain evidence of suspicious 
transactions with non-scheduled substances. 
3. The competent authorities shall resp ect confidential business information." 
(9) The following Article 13a is inserted: 
"Article 13a  
Database 
The Commission shall develop a European  Database on drug precursors with the 
following functions:  
(a) facilitating the communication of info rmation pursuant to Article 13(1), its 
synthesis and analysis on the level of  the Union, and the reporting to the 
International Narcotics Control Board pursuant to Article 13(2); 
(b) creating a European register of operators and users, which have been granted a 
licence pursuant to Article 3(2) or re gistration pursuant to Article 3(6); 
(c) enabling operators to provide the compet ent authorities with information about 
their transactions according to Article 8( 2) in electronic form, as specified in 
implementing measures adopted pursuant to Article 14." 
(10) The following Article 13b is inserted: 
“Article 13b   
EN 15   EN Data protection 
1. The processing of personal data by the competent authorities in the Member 
States shall be carried out in accordance with Directive 95/46/EC10 and under the 
supervision of the public independent author ity of the Member St ate referred to in 
Article 28 of this Directive. 
2. The processing of personal data by the Commission, including for the purpose 
of the European Database provided for in  Article 13a, shall be carried out in 
accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council
11 and under the supervision of the Eur opean Data Protection Supervisor." 
(11) Articles 14 and 15  are replaced by the following:  
“Article 14  
Implementing Acts  
1. The Commission may adopt the following implementing acts: 
(a) rules on how to provide customer declar ations referred to in Article 4 in 
electronic form, wh ere appropriate; 
(b) rules on how to provide the information refe rred to in Article 8(2) in electronic 
form to a European database, where appropriate. 
2. The acts referred to in paragraph 1 of  this Article shall be adopted in 
accordance with the examination proce dure referred to in Article 14a(2). 
Article 14a 
Committee Procedure 
1. The Commission shall be assisted by the Drug Precursors Committee 
established by Article 30 of Council Regulation (EC) No 111/200512. That 
committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 
2. When reference is made to this pa ragraph, Article 5 of Regulation (EU) 
No 182/2011 shall apply. 
Article 15 
Adaptation of Annexes 
The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 15a in order to adapt Annexes I, II and III to new trends in diversion of drug 
                                                
 
10 OJ L 281, 23.11.1995, p. 31. 
11 OJ L 8, 12.1.2001, p. 1. 
12 OJ L 22, 26.1.2005, p.1.  
EN 16   EN precurors and to follow an amendment to the tables in the Annex to the United 
Nations Convention. 
Article 15a 
Exercise of delegation 
1. The power to adopt delegated acts is  conferred on the Commission subject to 
the conditions laid down in this Article. 
2. The delegation of power referred to  in Article 3(9), 4(4), 5(7), 7 , 8(2), 13a(2), 
15 shall be conferred for an indeterminat e period of time from [date of entry into 
force of this amending Regulation]. 
3. The delegation of powers referred to in Article 3(9), 4(4), 5(7), 7,  8(2), 13a(2), 
15 may be revoked at any time by the Eur opean Parliament or by the Council. A 
decision of revocation shall pu t an end to the delegation of power spedified in that 
decision. It shall take effect the day follo wing the publication of the decision in the 
Official Journal of the European Union or at  a later date specified therein. It shall not 
affect the validity of any dele gated acts already in force. 
4. As soon as it adopts a delegated act, the Commission shall notify it 
simultaneously to the European Parliament and the Council. 
5. A delegated act adopted pursuant to Artic le 3(9), 4(4), 5(7), 7, 8(2), 13a(2), 15 
shall enter into force only if no objection ha s been expressed either by the European 
Parliament or the Council within a period of 2 months of notifica tion of that act to 
the European Parliamant and the Council or if, before the expiry of that period, the 
European Parliament and the Council have both informed the Commission that they 
will not object. That period shall be extended  by 2 months at the initiative of the 
European Parliament or the Council.” 
(12) Article 16 is replaced by the following: 
"Article 16 
Information about measures adopted by Member States 
1. Member States shall inform the Commi ssion of the measures it adopts pursuant 
to this Regulation, and in pa rticular of the measures a dopted pursuant to Articles 10 
and 12. They shall also notify any subsequent amendments thereof. 
2. The Commission shall communicate that information to the other Member 
States.  
3. The Commission shall evaluate the im plementation and functioning of this 
Regulation by [78 months after of the date of entry into force of this amending 
Regulation]." 
(13) Annex I  is amended as follows: 
(a) the title of Annex I is replaced by the following:  
EN 17   EN "List of scheduled substances";  
(b) the text set out for Categor y 2 is replaced by the text set out in the Annex to 
this Regulation; 
(14) In Annex III, the term "author isation/" shall be deleted. 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  This Regulation shall be binding in its entirety 
and directly applicable in all Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President  
EN 18   EN ANNEX  
"CATEGORY 2 
SUBCATEGORY 2A 
Substance CN designation  
(if different) CN code(1) CAS No(2) 
Acetic anhydride  2915 24 00 108-24-7 
The salts of the substances listed in this category, whenever the existence of such salts is possible. 
___________________________________________________________________________ 
(1) OJ L290, 28.10.2002, p.1. 
(2) The CAS No is the 'chemical abstract s service registry number', which is a unique numeric identifier specific 
to each substance and its structure. Th e CAS No is specific to  each isomer and to each salt of each isomer. It 
must be understood that the CAS Nos for the salts of th e substances listed above will be different to those given.   
___________________________________________________________________________ 
SUBCATEGORY 2B 
Substance CN designation  
(if different) CN code(1) CAS No(2) 
Phenylacetic acid  2916 34 00 103-82-2 
Anthranilic acid  2922 43 00 118-92-3 
Piperidine  2933 32 00 110-89-4 
Potassium 
permanganate  2841 61 00 7722-64-7 
The salts of the substances listed in this category, whenever the existence of such salts is possible. 
___________________________________________________________________________ 
(1) OJ L290, 28.10.2002, p.1.  
(2) The CAS No is the 'chemical abstract s service registry number', which is a unique numeric identifier specific 
to each substance and its structure. Th e CAS No is specific to  each isomer and to each salt of each isomer. It 
must be understood that the CAS Nos for the salts of th e substances listed above will be different to those given.   
___________________________________________________________________________ 
EN 19   EN LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
 1.1. Title of the proposal/initiative  
 1.2. Policy area(s) concerned in the ABM/ABB structure  1.3. Nature of the proposal/initiative  
 1.4. Objective(s)   1.5. Grounds for the proposal/initiative   1.6. Duration and financial impact   1.7. Management method(s) envisaged  
2. MANAGEMENT
 MEASURES   
 2.1. Monitoring and reporting rules  
 2.2. Management and control system   2.3. Measures to prevent fraud and irregularities  
3. ESTIMATED
 FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
 3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected  
 3.2. Estimated impact on expenditure   
 3.2.1. Summary of estimated impact on expenditure  
 3.2.2. Estimated impact on operational appropriations   3.2.3. Estimated impact on appropriations  of an administrative nature 
 3.2.4. Compatibility with the current multiannual financial framework  3.2.5. Third-party participation in financing   3.3. Estimated impact on revenue 
EN 20   EN LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a Regulation of the European  Parliament and of the Council amending 
Regulation (EC) No 273/ 2004 on Drug Precursors  
1.2. Policy area(s) concerned in the ABM/ABB structure25  
Title 2: Enterprise and Industry 
Chapter 02.03: Internal market for goods and sectoral policies 
1.3. Nature of the proposal/initiative  
 The proposal/initiative relates to  a new action   
 The proposal/initiative relates to a new action following a pilot project/preparatory action26  
X The proposal/initiative relates to the extension of an existing action   
 The proposal/initiative relates to an action redirected towards a new action   
1.4. Objectives 
1.4.1. The Commission's multiannual strategic objecti ve(s) targeted by the proposal/initiative  
 
1a. Competitiveness for gr owth and employment 
Following the continuous review of existing in ternal market acquis and its implementation, 
the new legislative proposal aims at improvi ng efficiency of exiting legislation on drug 
Precursors.  
1.4.2. Specific objective(s) and ABM /ABB activity(ies) concerned  
Specific objective No . 
The development of a European Database aims  at facilitating exchange of information 
between the Member States Competent Aut horities and the Commission, and the economic 
operators and the Member Stat es Competent Authorities.  
ABM/ABB activity(ies) concerned  
Title 2 – Chapter 02.03 Internal mark et for goods and sectoral policies 
                                                 
25 ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
26 As referred to in Article 49(6)(a) or (b) of the Financial Regulation.  
EN 21   EN 1.4.3. Expected result(s) and impact 
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 
The proposal, amending Regulation (EC) No  273/2004 aims mainly at improving the 
prevention of the diversion fr om the EU-internal trade of acetic anhydride, the main 
drug precursor for heroin, by extending the registration requirement, which so far 
applies only to operators placing acetic anhydride  on the market, to also include users of 
the substance and by enhancing the harmonised registration provisions to achieve a more 
robust level playing field preserving the intern al market and avoiding adoption of divergent 
national measures.  
Additionally, it proposes to es tablish and maintain a Eu ropean Database on Drug 
Precursors in order to modernize the annual collection of the info rmation provided by 
Member States on seizures and stopped shipme nts of drug precursors, in accordance with 
Article 13 of Regulation (EC) No 273/2004, as well as to maintain a list  of EU licensed or 
registered operators and users legally  trading or usi ng drug precursors; 
The EU Database on Dugs precursors aims at  providing a modern t ool for strengthening 
the control of legitimate trade in drug precursors:  
- to Member States' Competent Authorities to comply with their reporting obligations to  
 the Commission in accordance with Article 13 of Regulation (EC) No 273/2004 and  
 Article 29 of Commission Regulation (EC) No1277/2005;  
- to Member States' Competent Authorities and to EU industry operators to facilitate  
 checking the legitimacy of potential client s and to reduce the burdens for operators  
 related to the yearly reporting of their transactions  involving drug precursors in accordance with Articles 4 
and 8.2 of Regulation (EC) No 273/2004 and with Articles17  
 and 19 of Council Regulation (EC) No 111/2005, 
- to the Commission to facilitate completion of its obligations towards the International  
 Narcotics Control Board under Article 13 (1) of Regulation (EC) No 273/2004 and  
 Article 32 (1) of Regulation No 111/2005 as well as towards Member States under  
 Article 29 of Commission Regulation ( EC) No 1277/2005.  
Finally, the proposal adapts the provisions of Regulation (EC) No 273/2004 regarding ex-
Comitology to the new rules of the Lisbon Treaty. 
1.4.4. Indicators of results and impact  
Specify the indicators for monitoring implementation of the proposal/initiative. 
The proposed Regulation aims to improve the prevention of the diversion of drug 
precursors – in particular a cetic anhydride - by trafficker s from the legitimate trade 
towards production of illicit dr ugs. Annual trends in EU dive rsion of drug precursors will 
continue to be collected a nd reported, to the general public , the Member States and the 
International Narcotics Contro l Board. The objective is to achieve a decreasing trend in 
seizures and stopped shipments.  
EN 22   EN 1.5. Grounds for the proposal/initiative  
1.5.1. Requirement(s) to be met in the short or long term  
The main aim of the proposal to amend Re gulation (EC) No 273/2004 is to address the 
weaknesses identified in the f unctioning of that Regulation in preventing the diversion of 
certain drug precursors (in particular acetic  anhydride) from the legitimate trade to 
production of illicit drugs, through control and monitoring of this legitimate trade.  
The EU Drug Precursors' Database should faci litate the monitoring an d control activities 
by Member States, as well as the reporting tasks for Member States and operators.  
1.5.2. Added value of EU involvement 
The objective of this proposal, namely to st rengthen control measures on acetic anhydride 
in order to prevent it diversion from the EU internal market while avoiding market 
distortions, cannot be sufficiently achieved by the Member States alone and action by the 
Union will be more efficient for the following reasons: 
1. Some Member States feel legally preven ted from adopting national control measures 
going beyond the EU legislation on the ba sis of Article 10 of Regulation (EC) 
No 273/2004, which empowers Member States to adopt national me asures which are 
necessary to enable its authorities to perf orm their control and monitoring duties. They 
argue that the EU legisl ation is subjecting only operators  to control measures (no 
obligations are imposed on end-users), whic h should be understood as a deliberate and 
binding decision of the EU-legis lator that end-users should not be subject to the control of 
the drug precursor legislation. 
2. On the contrary, other Member States are contemplating or have already based 
substantive national controls on Article 10, leadi ng in first instance to different approaches 
of control in different Member States which might be detrimental to the functioning of the 
Union Market and, secondly, isolated actions in individual Member States risks shifting the 
problem from one Member State to the next, as traffickers will exploit the “weakest link” 
in the Union market. A combination of different  national measures will not be as effective 
as a harmonised approach at EU-level. This  is also confirmed by the fact that both, 
Member States and concerned industry sect ors have called on the Commission to act to 
preserve the internal market with a level playing field, and not to rely too much on 
supplementary national measures. 
1.5.3. Lessons learned from sim ilar experiences in the past 
The Commission has conducted a thorough analys is of the functioning of the existing 
Regulation (EC) No 273/2004 and on 7 January  2010, the European Commission adopted a 
Report  on the implementation and functioning of  the existing EU legislation on drug 
precursors27. While the Commission’s eval uation concluded that th e legislation is overall 
                                                 
27 Report from the Commission to the Council and the European Parliament pursuant to Article 16 of Regulation 
(EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and to Article 32 of 
Council Regulation (EC) No 111/2005 on the implementation and functioning of the Community legislation on monitoring and control of trade in drug precursors, COM(2009)709 final, available at:  
http://eur-lex.europa.eu/LexUriServ/Lex UriServ.do?uri=COM:2009:0709:FIN:en:PDF .  
EN 23   EN functioning well28, it identified some weaknesses a nd made recommendations how to 
address these, including in particular a m odification of some requirements for category 2 
substances – either specifically for acetic anhy dride or for all category 2 substances – in 
order to discourage diversion fr om the EU internal market.  
This proposal aims to address this r ecommendation of the Commission Report by 
amending Regulation (EC) No 273/2004, mainly  to improve the prevention of the 
diversion from the EU -internal trade of acetic anhydride, the main drug precursor for 
heroin, by extending the registration requirement, which so far applies only to operators 
placing acetic anhydride on the market, to al so include users of the substance and by 
enhancing the harmonised registration provision s to achieve a more robust level playing 
field preserving the internal market and avoi ding adoption of diverg ent national measures. 
1.5.4. Coherence and possible synergy wi th other relevant instruments 
This proposal is fully consistent with the objectives of the EU  drugs strategy 2005-2012 
and the EU drugs Action Plan (2009-2012), setting out the objective to reduce the 
diversion and trafficking in/v ia the Union of Drug Precurso rs used in the production of 
illicit drugs, ultimately aiming at reducing th e supply of illicit drugs to EU citizens while 
ensuring a high level of human health pr otection and a high level of security.  
                                                 
28 For further details, see under Section 4.2.1 "Strength and weaknesses of the legislation" of the above-
mentioned Report COM(2009)209 final.  
EN 24   EN  
1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
–  Proposal/initiative in effect fr om [DD/MM]YYYY to [DD/MM]YYYY  
–  Financial impact from YYYY to YYYY  
⌧ Proposal/initiative of unlimited duration  
– Implementation with a start-up period  from January 2014 to December 2014, 
– followed by full-scale operation from 01 January 2015 (Estimated). 
1.7. Management mode(s) envisaged29  
⌧ Centralised direct management  by the Commission  
 Centralised indirect management  with the delegation of implementation tasks to: 
–  executive agencies  
–  bodies set up by the Communities30  
–  national public-sector bodies/bodies with public-service mission  
–  persons entrusted with the implementation of specific actions pur suant to Title V of 
the Treaty on European Union and identified in the relevant basic act within the 
meaning of Article 49 of the Financial Regulation  
 Shared management with the Member States  
 Decentralised management with third countries   
 Joint management with international organisations (to be specified) 
If more than one management mode is indicated, pl ease provide details in the "Comments" section. 
Comments  
                                                 
29 Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: 
http://www.cc.cec/budg/man/b udgmanag/budgmanag_en.html  
30 As referred to in Article 185 of the Financial Regulation.  
EN 25   EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions. 
(1) Members States will yearly communicat e to the Commission the information on the 
cases where the delivery of drug prec ursors was suspended or seized.  
(2) The Member States will regularly fo rward to the Commission the information 
concerning their licensed and registered opera tors and users trading or possessing drug 
precursors, their respective transactions.  
(3) The Commission in turn will regularly compile a report on the basis of the information 
collected from Member States and will yearly submit the overall EU information on 
seizures and stopped shipments of  drug precursors in the Uni on to the Member States and 
to the International Narcotics Control Board. Furthermore the Commission will prepare for 
public release its annual report on EU drug prec ursor's seizures and stopped shipments. 
2.2. Management and control system  
2.2.1. Risk(s) identified  
The main risks are:  
- Failure of Members States to comply with their reporting obligations and/or the provision of information on 
licensed/registered operators and users;  
- Non uniform implementation of the le gislation in the Member States;  
- Insufficient control systems in the Members States in particular on licensed and/or registered operators and 
users.  
2.2.2. Control method(s) envisaged  
The Member States have already designated authorities responsible  for overseeing the 
implementation of the legislation and for granting licenses & registration to legitimate 
operators & users invo lved in the trade of drug precursors;  
Implementation of the legislati on is monitored through regular meetings of the designated 
national competent authorities responsible for the EU Drug Precursors legislation; 
The day to day management of the EU Data base on Drug Precursors will fall under the 
responsibility of the Commission Services in charge of following the EU Drug Precursors 
legislation, mainly DG ENTR and DG TAXUD. 
2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection measures. 
No particular risk of fraud or irregularities has been identified.  
EN 26   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected  
• Existing expenditure budget lines  
In order  of multiannual financial framewor k headings and budget lines. 
Budget line  Type of  
expenditureContribution  
Heading of 
multiannual 
financial 
framework Number  
[Description………………………...……….]  Diff./non-
diff 
(31) from 
EFTA32 
countries from 
candidate 
countries33 from third 
countries within the 
meaning of 
Article 18(1)(aa) 
of the Financial 
Regulation  
1a. 
Competi
tiveness 
for 
growth 
and 
employ
ment  Article 02.03.01 
Operation and development of the 
internal market, particularly in the fields of notificat ion, certification and 
sectoral approximation Diff./ 
DA YES NO NO NO 
• New budget lines requested  
In order  of multiannual financial framework headings and budget lines. 
Budget line  Type of 
expenditureContribution  
Heading of 
multiannual 
financial 
framewor k Number  
[Heading……………………………………..]  Diff./non-
diff. from 
EFTA 
countries from 
candidate 
countries from third 
countries within the 
meaning of 
Article 18(1)(aa) 
of the Financial 
Regulation  
       
                                                 
31 Diff. = Differentiated appropriations / Non- Diff. = Non-differentiated appropriations. 
32 EFTA: European Free Trade Association.  
33 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 27   EN 3.2. Estimated impact on expenditure  
3.2.1. Summary of estimated impact on expenditure  
EUR million (to 3 decimal places)  
Heading of multiannual financial 
framework:  Number 
1a Competitiveness for growth and employment 
 
DG: ENTR   Year 
201434 Year 
2015 Year 
2016 Year 
2017 Year 
2018 Year 
2019 Year 
202035 TOTAL 
y Operational appropriations          
Commitments (1) 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.315 Article 02.03.01 – Operation and development 
of the internal market, particularly in the fields 
of notification, certification and sectoral 
approximation  Payments (2) 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.315 
Commitments (1a)         Number of budget line  Payments (2a)         
Appropriations of an administrative nature financed 
from the envelope fo r specific programmes36         
Number of budget line   (3)         
Commitments = 1+1a 
+3 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.315 
TOTAL appropriations 
for DG ENTR  
Payments = 2+2a 
+3 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.315 
                                                 
34 Year N is the year in which implem entation of the proposal/initiative starts. 
35 Costs also foreseen after 2020 because of the nature of the project (database maintenance). 
36 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (f ormer "BA" lines), indi rect research, direct 
research.  
EN 28   EN  
Commitments (4)         y TOTAL operational appropriations  
Payments (5)         
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments = 4+ 6         TOTAL appropriations  
under HEADING <….> 
of the multiannual financial framework  Payments = 5+ 6         
If more than one heading is affected by the proposal / initiative:  
Commitments (4)         y TOTAL operational appropriations  
Payments (5)         
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments = 4+ 6         TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount)  Payments = 5+ 6         
  
EN 29   EN  
Heading of multiannual fi nancial framework:  5 " Administrative expenditure "  
EUR million (to 3 decimal places) 
DG: ENTR   Year
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018 Year 
2019 Year 
2020 TOTAL 
y Human resources   0.108 0.108 0.108 0.108 0.108 0.108 0.108 0.756 
y Other administrative expenditure          
TOTAL DG ENTR  Appropriations  0.108 0.108 0.108 0.108 0.108 0.108 0.108 0.756 
 
TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework   (Total commitments 
= Total payments) 0.108 0.108 0.108 0.108 0.108 0.108 0.108 0.756 
EUR million (to 3 decimal places) 
   Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018 Year 
2019 Year 
2020 TOTAL 
Commitments  0.153 0.153  0.153  0.153  0.153  0.153  0.153  1.071 TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework   Payments  0.153  0.153  0.153  0.153  0.153  0.153  0.153  1.071  
EN 30   EN 3.2.2. Estimated impact on opera tional appropriations  
–  The proposal/initiative does not requir e the use of operational appropriations. 
– ⌧ The proposal/initiative requires the use of ope rational appropriations, as explained below37: 
Commitment appropriations in EU R million (to 3 decimal places) 
  Year 
2014  Year 
2015  Year 
2016  Year 
2017  Year 
2018 Year 
2019 Year 
2020 TOTAL  Indicate 
objectives 
and outputs  
Ø OUTPUTS  
 Type 
of 
output
38 Avera
ge 
cost  
of the 
output 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost Total 
number 
of 
outputs Total  
cost 
SPECIFIC OBJECTIVE No 139…                 
- Output   1 0.045 1 0.045 1 0.045 1 0.045 1 0.045 1 0.045 1 0.045 7 0.315  
- Output                   
- Output                   
Sub-total for specific objective N°1                 
SPECIFIC OBJECTIVE No 2…                 
- Output                   
Sub-total for specific objective No 2                 
TOTAL COST  1 0.045 1 0.045 1 0.045 1 0. 045 1 0.045 1 0.045 1 0.045 7 0.315  
                                                 
37 No information on the outputs is yet available as the pilot project of the European Database is not yet developed. 
38 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc .). 
39 As described in Section 1.4.2. "Specific objective(s)…"  
EN 31   EN 3.2.3. Estimated impact on appropriations  of an administrative nature 
3.2.3.1. Summary  
–  The proposal/initiative does not require the use of administrative 
appropriations  
– ⌧ The proposal/initiative re quires the use of administ rative appropriations, as 
explained below: 
EUR million (to 3 decimal places) 
 Year 
2014 Year 
2015 Year 
2016 Year 
2017 Year 
2018 Year 
2019 Year 
2020 TOTAL 
 
HEADING 5 
of the multiannual 
financial framework         
Human resources  0.108 0.108 0.108 0.108 0.108 0.108 0.108 0.756 
Other administrative 
expenditure          
Subtotal HEADING 5 
of the multiannual 
financial framework          
 
Outside HEADING 540 
of the multiannual 
financial framework          
H u m a n  r e s o u r c e s           
Other expenditure  
of an administrative 
nature         
Subtotal  
outside HEADING 5 
of the multiannual 
financial framework          
 
TOTAL  0.108 0.108 0.108 0.108 0.108 0.108 0.108 0.756
                                                 
40 Technical and/or administrative assistance and expenditure in support of the implementation of EU 
programmes and/or actions (former "BA" li nes), indirect research, direct research.  
EN 32   EN 3.2.3.2. Estimated requirements of human resources  
–  The proposal/initiative does not require the use of human resources  
– ⌧ The proposal/initiative requires the us e of human resources, as explained 
below: 
Estimate to be expressed in full amounts (or at most to one decimal place) 
 Year
2014 Year
2015 Year 
2016 Year 
2017 Year 2018 Year 
2019 Year 
2020 
y Establishment plan posts (officials and temporary agents)  
02 01 01 01 (Headquarters and Commission’s 
Representation Offices)  0.108 0.108 0.108 0.108 0.108 0.108 0.108 
XX 01 01 02 (Delegations)        
XX 01 05 01 (Indirect research)        
10 01 05 01 (Direct research)        
y External personnel (in Full Time Equivalent unit: FTE)41 
XX 01 02 01 (CA, INT, SNE from the "global 
envelope")         
XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations)        
- at Headquarters43        
XX 01 04 yy 42 
- in delegations         
XX 01 05 02 (CA, INT, SNE - Indirect 
research)        
10 01 05 02 (CA, INT, SNE - Direct research)        
Other budget lines (specify)        
TOTAL  0.108 0.108 0.108 0.108 0.108 0.108 0.108 
02 is the policy area or  budget title concerned. 
The human resources required will be met by st aff from the DG who are already assigned to 
management of the action and/or have been re deployed within the DG, together if necessary 
with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints. 
Description of tasks to be carried out: 
Officials and temporary agents Management and development of EU legislatio n ensuring a Single Market for chemicals – in 
particular for drug precursors.  
Prepare, chair and write reports of meetings of working groups and regulatory committees to 
ensure uniform implementation of  the legislation. Assist Me mber States and industry.  
Prepare relevant guidance documents, as well as agreed 'questions and answers' in close co-
                                                 
41 CA= Contract Agent; INT= agency staff (" Intérimaire") ; JED= " Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert. 
42 Under the ceiling for  external personnel from operational appropriations (former "BA" lines). 
43 Essentially for Structural Funds, European Agricultural Fund for Rural Development (EAFRD) and 
European Fisheries Fund (EFF).  
EN 33   EN operation with Member States aut horities and other stakeholders. 
Publish annual reports on seizur es and stopped shipments.  
Oversee maintenance and further development of European Database on Drug Precursors. 
Answer parliamentary questions. 
Prepare adaptations to technical progress and conduct interservices consultations.  
Ensure close co-operation with DG TAXUD, who is responsible for monitoring external trade in 
drug precursors. 
External personnel   
EN 34   EN 3.2.4. Compatibility with the current multiannual financial framework  
– ⌧ Proposal/initiative is compatible with  the multiannual financial framework 2014-
2020. 
–  Proposal/initiative will entail reprogram ming of the relevant heading in the 
multiannual financial framework. 
Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 
–  Proposal/initiative requires appl ication of the flex ibility instrument or revision of the 
multiannual financial framework44. 
Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts. 
3.2.5. Third-party contributions  
– ⌧ The proposal/initiative does not provid e for co-financing by third parties  
–  The proposal/initiative provides for the co-financing estimated below: 
Appropriations in EUR m illion (to 3 decimal places) 
 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  Total 
Specify the co-financing 
body          
TOTAL appropriations 
cofinanced          
 
                                                 
44 See points 19 and 24 of the Interinstitutional Agreement.  
EN 35   EN 3.3. Estimated impact on revenue  
– ⌧ Proposal/initiative has no financial impact on revenue. 
–  Proposal/initiative has the following financial impact: 
–  on own resources  
–  on miscellaneous revenue  
EUR million (to 3 decimal places)  
Impact of the proposal/initiative45 
Budget revenue line: Appropriations 
available for the 
ongoing budget 
year Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … insert as many columns as necessary 
in order to reflect the duration of the 
impact (see point 1.6)  
Article ………….         
For miscellaneous assigned revenue, specify  the budget expenditure line(s) affected. 
… 
Specify the method for calcula ting the impact on revenue. 
… 
                                                 
45 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 25% for collection costs.