EN    EN 
 EUROPEAN 
COMMISSION  
Brussels, 27.9.2012  
COM(2012) 521 final 
2012/0250 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amendin g Council Re gulation (EC) No 111/2005 la ying down rules for the monitorin g of 
trade between the Community and third countries in drug precursors 
(Text with EEA relevance) 
{SWD(2012) 267 final} 
{SWD(2012) 268 final}   
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
1.1. Background 
Drug precursors are chemical substances having a wide variety of licit uses, such as in the 
synthesis of plastics, pharmaceuticals, cosmetic s, perfumes, detergents, or aromas. They are 
traded for legitimate purposes on regional and global markets, but some of them can also be diverted from the licit distribu tion channels for the illicit ma nufacture of narcotic drugs. 
Therefore, controlling drug precurs ors is a key component in the fight against narcotic drugs. 
Taking into account the wide le gitimate uses of drug precurs ors, their trade cannot be 
prohibited. A specific regul atory framework, both at internati onal and at EU level, has been 
put in place to monitor their legal trade an d to identify suspicious transactions, thus 
preventing their diversion for illicit use. 
Ephedrine and pseudoephedrine ar e chemical substances used fo r the manufacture of cold or 
allergy medicines. These two substances are al so the main precursors for the manufacture of 
methamphetamine
1. While ephedrine and pseudoephedrine ar e controlled at international and 
EU level, the medicinal products  containing them are not contro lled when they are exported 
from or transiting through the Union customs territory. They are therefore targeted by drug traffickers as a source of precursors for the illicit manufacture of methamphetamine because the ephedrine or pseudoephedrine contained in  these products can be easily extracted (by 
using cheap home-made equipment and through a simple chemical process). 
The fact that medicinal products for human us e containing ephedrine or pseudoephedrine are 
excluded from the provisions of Regulation (E C) 111/2005, which applies to trade in drug 
precursors between the EU and third countries, has led to a situation where these products 
could not be stopped or seized by Member Stat es' competent authorities when these products 
were exported from or transiting through the Un ion customs territory, even though it was very 
likely that they would be misused for the il licit manufacture of methamphetamine in their 
country of destination. 
The EU is criticized internati onally for not taking adequate control measures across Member 
States to tackle this weakness. Therefore, the EU is expected to close the loophole in the 
current legislation as regards the powers conferred to custom s and police authorities who can 
stop and seize ephedrine and ps eudoephedrine but cannot stop and seize medicinal products 
containing ephedrine or pseudoephedrine. 
In its Conclusions of 25 May 2010, the Co uncil invited the Commission to present a 
legislative proposal in this sense. 
1.2. Scale of the problem (metham phetamine and its precursors) 
In 2009 almost 7400 seizures of methamphetamine, amounting to about 600 kg of the drug, 
were reported in Europe. Bo th the number of seizures and quantities increased over 2004-
                                                
 
1 Methamphetamine is a synthetic drug wh ich belongs to the amphetamines-group . This drug manipulates pleasure 
centres of the brain and can be more potent than cocaine and usually have a longer last ing effect. Taken as pills, 
smoked, inhaled or injected, it is pa rticularly attractive to young people because it produces a sense of high energy, 
a release of social inhibitions and feelings of clever ness, competence and power. The physical and psychological 
effects (feelings of anxiety, hyper s timulation and paranoi a) occur rapidly .  
EN 3   EN 2009. In 2009 illicit methamphetamine laboratories were seized for the first time in several 
European countries. This is an indication that  methamphetamine markets may be expanding in 
Europe. 
At global level, in 2009, North America accounted for nearly half of global seizures of 
methamphetamine. Seizures in East and South- East Asia rose by more than one third and 
there are signs that methamphetamine is reach ing the region from Africa and the Islamic 
Republic of Iran. West Africa is also emerging as a new source of methamphetamine for the illicit Asian markets. 
Ephedrine and pseudoephedrine are the main pr ecursors for methamphetamine. Seizures of 
methamphetamine precursors contained in medici nal products have fluctuated considerably 
from 2007 until 2010. At European level, while  in 2007 hardly any preparations were 
recorded out of the overall quant ities seized, in 2008 and 2009 th e amount of preparations out 
of the total quantities seized increased shar ply and decreased consid erably again in 2010
2. 
After the continued incr ease of seizures of medicinal produc ts from 2007 to 2009, as a result 
of strengthened controls  of medicinal products containing ephedrine and pseudoephedrine in 
several countries, particularly in Mexico and c ountries in Central America, the total amount of 
medicinal products seized worldwide decreased in 2010. 
However, the increasing or decreasing level of seizures is only one indicator to illustrate that 
illicit manufacture is taking pla ce in a given part of the wo rld. The absence of a control 
mechanism for medicinal products containing  ephedrine and pseudoephedrine remains a 
concern both at European and at global level. 
By imposing EU control over these medicinal products, we are aiming to make it more 
difficult, expensive and risky for criminals to source the chemicals they need to manufacture 
drugs. This proposal should work as a deterren t: it focuses on preventing the diversion of 
precursors. It concentrates on the supply reduction of the chemicals to make drugs and not on 
the supply of the drugs for the consumers. 
1.3. Consistency with other EU policies 
Effectively preventing the diversion of drug precu rsors to the production of illicit drugs aims 
to reduce the supply of illicit drugs . It is thus consistent with the drug policy outlined in the 
EU Drugs Strategy 2005-2012, provid ing for action to reduce the supply of precursors, and, 
thereby, decrease the production of drugs.  
This initiative aims to regulate the external trade in medicinal produc ts containing ephedrine 
and pseudo-ephedrine. These pr oducts are regulated by Directive 2001/83/EC. However, the 
objective pursued by that Di rective is of a different nature, i.e. to safeguard public health by 
controlling the production, distribution and use of medicinal products in order to ensure their 
quality, safety and efficacy. This  explains why the control mech anisms foreseen in Directive 
2001/83/EC and in Regulation (EC) 111/2005 are different. 
The medicinal products legislation has recen tly been amended by Directive 2011/62/EU 
which relates to the prevention of  the entry into the legal supply chain of falsified medicinal 
                                                 
2 I n 2007, 8mt of these precursors were sei zed of which nearly 4 % were in the form of medicinal products; in 2008 
3,5mt of which 51% were in the form of medicinal produ cts; in 2009 1,4mt of which 43% were in the form of 
medicinal products; in 2010 2.9mt out of which 3% were in  the form of medicinal pr oducts. These seizures were 
made on the basis of national legislation.  
EN 4   EN products. The Directive addresses inter alia  the distribution chain fo r medicines within the 
EU, importation of active substances, and 'intr oduction' of medicines, i.e. medicines brought 
into the customs territory without the inte ntion of placing them on the market. These 
provisions are focused on preventing products that fall within the definition of falsified  
medicinal products from entering  the legal supply chain. Given that the principal issue with 
drug precursors is one of legitimately  produced products leaving  the legal supply chain, it is 
unlikely that these new provisions will make a significant contribution to tackling the issue of controlling medicinal products containing ephedr ine or pseudoephedrine being exported or 
transiting through the EU. 
2. RESULTS
 OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
2.1. Consultation of interested parties 
A stakeholder consultation was held. This was not a public consultati on, given the sensitivity 
and the peculiarity of the matter at stake3. Only the most concerned stakeholders were 
therefore consulted, namely national competent authorities (customs, police and health) and the pharmaceutical industry. To avoid providing sens itive information to traffickers, the 
responses of the stakeholders  were treated confidentially. 
In response to this consultation the Commission received 31 contributions. Of these, 22 were 
from national authorities (3 of which were partial replies) and 8 from the industry (6 
manufacturing companies and 2 pharmaceutical associations).  
In general terms, the industry is satisfied with  the current situation but would not be opposed 
to improve it to the extent that it woul d not impose increased administrative burden on 
exporting companies. Among Member States' comp etent authorities two thirds plead for an 
amendment of the legislation, though to differe nt degrees, while one th ird is in favour of 
maintaining the current situation, thus not amending the legislation. 
2.2. Impact Assessment 
The impact assessment report identified and assessed policy options aiming to prevent the 
diversion of medicinal products containing e phedrine or pseudoephedrine to the illicit 
manufacture of methamphetamine by introducing control measures over these products when 
traded between the Union and third countri es while maintaining their free flow. 
The impact assessment report contains five policy options. The first one provides for the so-
called "baseline scenario", where the Commis sion would take no action and the status quo 
would be maintained. Option 2 considers cont ributing to improve th e situation through 
voluntary measures by Member States, while opti ons 3, 4 and 5 consider resolving it through 
compulsory control measures. The last three opti ons have been built as a crescendo as to the 
number and strength of the control measures  envisaged. Another policy option suggesting a 
trade ban on these products has been considered and discarded without fu rther analysis of its 
impact. 
                                                
 
3 On the one hand, the subject matter, drug precursors, is not widely known a nd would have most likely entailed 
responses concerning the overall drug situ ation, which would have been irreleva nt for this exercise. On the other 
hand, the problem at stake and the envi saged options only affect a very specifi c aspect of drug precursor control.   
EN 5   EN Option 1 should be excluded if the Commission was to respond adequately to the Council's 
request to address the weaknesses identified in  the control system of the drug precursor 
legislation and to concerns expres sed by the international community. 
Option 2 would only partially address the identi fied problem. It suggest s voluntary measures 
which will not be effective unless adopted  across all Member St ates. A compulsory 
application of these measures cannot be enfo rced by the instrument foreseen under this 
option. 
Options 3, 4 and 5 would all provide a clear le gal basis for competent authorities to stop 
and/or seize medicinal products containing ephedrine or pseudoe phedrine at export from or in 
transit through the Union customs territory. They  would all reduce the cr iticism expressed by 
the UN International Narcotics Control Board on the alleged lack of EU action to control 
these products. They would all increase the chan ces to prevent the diversion of these products, 
thus reducing the supply of ephedrine and ps eudoephedrine for the illicit manufacture of 
methamphetamine, though to different degrees. 
When comparing these three opt ions requiring legisl ative amendments, option 3 (possibility 
for authorities to stop suspicious shipments)  would generate only minor administrative 
burden; the same can be expected for option 4 ( possibility for authorities to stop suspicious 
shipments and pre-export notificat ion of legal shipments), while option 5 (full control of trade 
in medicinal products containing ephedrine a nd pseudoephedrine) would impose the highest 
administrative burden for both competent auth orities and economic ope rators. Even though 
option 5 could be considered the most effe ctive by applying the st rictest controls, the 
requirements would be disproportio nate to the objective pursued by the present initiative. The 
added value provided by option 4 if compared to option 3 is that, under this option, the 
synergy of two combined measures increases th e effectiveness of each individual measure, 
with a limited additional burden given that the pre-export notifica tion system is up and 
running and that the number of pre-export notifica tions that could be seemingly sent per year 
by Member States' competent authorities is relatively small. Moreover, as pre-export 
notifications are already compulsory for sche duled substances of category 1, it would seem 
logical to make them compulsory also for th e products containing them, such as medicinal 
products containing ephedrine or pseudoephedrine.  
The impact assessment concluded that option 4 would be the most  suitable one to address the 
identified problem, as it would provide for a legal basis, impose only one extra control 
requirement and generate hardly any additional administrative burden. 
3. LEGAL  BASIS  AND  SUBSIDIARITY 
The legal basis of the proposal is Article 207 of the Treaty on the Functioning of the European 
Union (TFEU). Article 207 defines the EU co mmon commercial policy. Moreover, Article 
3(1) of the TFEU provides exclusive competen ce of the European Union in the area of 
common commercial policy.  
Council Regulation (EC) No 111/2005 lays down rules for the monitoring of trade in drug 
precursors between the Union and third coun tries, and therefore falls under the common 
commercial policy.  
EN 6   EN 4. BUDGETARY  IMPLICATION   
The proposal will not have an impact on human resources and on the European Union budget 
and is therefore not accompanied by the financial statement foreseen under Article 28 of the Financial Regulation (Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the Eu ropean Communities). 
5. ADDITIONAL
 INFORMATION   
The proposal contains some other amendments aiming at facilitating the implementation of 
the Regulation and at increasing its effectiveness. 
The proposal includes: - the possibility to amend the Annex to the Regulation in order to react more quickly to new 
emerging trends in precursors diversion;  
- a reference to the database, created by Regulation (EC) No 273/2004 as amended, to 
simplify the reporting by Member States' author ities in accordance with Article 12(12) of the 
United Nations Convention; 
- a review clause to assess whether the amen ded Regulation will have been effective to 
prevent the diversion of medicinal products containing ephedrine or pseudoephedrine; 
- the adaptation of the provisions of Regulati on (EC) No 111/2005 in accordance with the 
rules on delegated and implementing acts unde r the Treaty on the Functioning of the 
European Union (TFEU). 
The Commission has been granted implemen ting powers under the current Regulation in 
accordance with Articles 4 and 7 of Decisi on 1999/468/EC. As this Regulation is being 
amended, these powers have to be aligned in accordance with Articles 290 and 291 of the 
TFEU. The alignment in the proposal has been made in accordance with the provisions of the Common Understanding on Delegated Acts betw een the European Parliament, the Council 
and the Commission and Regulation (EU) No  182/2011 laying down the rules and general 
principles concerning mechanisms for cont rol by Member States of the Commission’s 
exercise of implementing powers. 
The proposal is subject to the WTO-TBT Agreement, thus subj ect to a notification to the 
WTO.  
EN 7   EN 2012/0250 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amending Council Regulation (EC) No 111/2005 l aying down rules for the monitoring of 
trade between the Community and third countries in 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 207 thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, After consulting the European  Data Protection Supervisor
1, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Pursuant to Article 32 of Council Re gulation (EC) No 111/2005 of 22 December 2004 
laying down rules for the monitoring of trade between the Community and third 
countries in drug precursors
2, the Commission presented on 7 January 2010 a report to 
the Council and the European Parliament on  the implementation and functioning of the 
Community legislation on monitoring a nd control of trade in drug precursors3. 
(2) The Commission report pointed out that, in the existing Union control system for drug 
precursors, medicinal products containi ng ephedrine and pseudoephedrine, whose 
trade was not controlled, were diverted into  the illicit drug ma nufacture outside the 
Union, as a substitute to internationally  controlled ephedrine and pseudoephedrine. 
The Commission therefore recommended streng thening the control of international 
trade in medicinal products containing ephedr ine or pseudoephedrine exported from or 
transiting through the Union customs territo ry which are diverted for the illicit 
manufacture of drugs. 
                                                 
1 OJ C , , p.  
2 OJ L 22, 26.1.2005, p. 1. 
3 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 fu nctioning of the Community legislation on monitoring 
and control of trade in drug precursors, COM(2009)709 final.   
EN 8   EN (3) In its Conclusions on the functioning and implementation of the Union drug precursors 
legislation of 25 May 2010, the Council of  the European Union invited the 
Commission to make a proposal to ame nd Council Regulation (EC) No 111/2005 
accordingly. 
(4) It is important that the definition of sc heduled substances be clarified: the term 
'pharmaceutical preparation' stemming from  the United Nations Convention against 
Illicit Traffic in Narcotic Drugs and Psychot ropic Substances adopted in Vienna on 19 
December 1988 (hereinafter referred to as the "United Nations Convention") should be 
replaced by the relevant terminology of th e Union legislation, 'medicinal products', 
and the term 'other preparati ons' should be deleted as it dup licates the term 'mixtures' 
already used in the definition. 
(5) Rules on suspending or revoking a registrati on should be introduced in order to match 
the existing rules for suspending or revoking a licence. 
(6) Medicinal products containing ephedrin e or pseudoephedrine should therefore be 
controlled without impeding their legitimate trade. 
(7) To this end, any export of medici nal products containing ephedrine or 
pseudoephedrine should be preceded by a pre-export notification sent by the 
competent authorities in the Union to the competent authorities of the country of 
destination. 
(8) Member States' competent authorities s hould be given the powers to stop or seize 
those products when there are reasonable grounds for suspecting that they are intended for the illicit drug manufacture, when they  are exported, imported or in transit. 
(9) With a view to enabling Member States to react more quickly with regard to new 
emerging trends in drug precursors' diversi on, their possibilities to  act in cases of 
suspicious transactions involving non-sc heduled substances should be clarified. 
(10) The European Database on drug precursors should be used to simplify the reporting by 
Member States with regard to seizures and stopped shipments, to establish a European 
register of operators holding a licence or  a registration, whic h will facilitate 
verification of the legitimacy  of their transactions invol ving scheduled substances and 
to enable operators to provide the competen t authorities with information about their 
export, import or intermediary activ ities involving scheduled substances. 
(11) Regulation (EC) No 111/2005 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) Regulation (EC) No 111/2005 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 Commission
4 as 
amended by Council Decision 2006/512/EC5. 
                                                 
4 OJ L 184, 17.7.1999, p. 23.  
5 OJ L 200, 22.7.2006, p. 11.   
EN 9   EN (13) 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 (the Treaty). 
(14) In order to achieve the objectives of Regulation (EC) No 111/2005, the power to adopt 
acts in accordance with Artic le 290 of the Treaty on the Functioning of the European 
Union should be delegate d to the Commission in or der to lay down provisions 
determining cases where a licence is not requi red and to set out fu rther conditions for 
granting licences, to establish the conditions for exemptions from the controls of certain categories of operators and of  operators engaged in the export of small quantities of 
scheduled substances listed in Category 3, to establish the criteria to determine how the licit 
purposes of the transaction may be demonstrat ed, to determine the information that is 
required by the competent authorities to monitor export, import or interm ediary activities of 
operators, to determine th e countries of destination to whic h exports of scheduled substances 
of Category 2 and 3 of the Annex should be preceded by a pre-expo rt notification, to 
determine simplified pre-export procedures and to  establish the common cr iteria thereof, to 
determine the countries of destination to whic h exports of scheduled substances listed in 
Category 3 of the Annex should be subject to  an export authorisation, to determine 
simplified export authorisation procedures and to establish the common criteria thereof, and 
to introduce additional substances into the Annex to this Regulation, as well as other 
amendments necessary to respond to new trends of drug precursor diversion. It is of particular importance that the Commission car ries out appropriate consultations during 
its preparatory work, incl uding at expert level.  
(15) 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. 
(16) In order to ensure uniform conditions for the implementation of Regulation (EC) No 
111/2005, implementing powers should be co nferred on the Commission, namely to 
establish a model for licences . Those powers should be exer cised 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 ge neral principles concerning mechanisms 
for control by the Member States of th e Commission's exercise of implementing 
powers.
6 
(17) Since this Regulation is based on th e common commercial policy, the examination 
procedure should be used for the adoption of the implementing acts.  
(18) Regulation (EC) No 111/2005 shoul d therefore be amended accordingly, 
HAVE ADOPTED THIS REGULATION: 
Article 1 
Regulation (EC) No 111/2005 is amended as follows: 
(1) Article 2 is amended as follows: 
                                                 
6 OJ L 55, 28.2.2011, p. 13.  
EN 10   EN (a) point (a) is replaced by the following: 
"(a) 'scheduled substance’ means any substance used for the illicit ma nufacture of narcotic 
drugs or psychotropic substances and listed in  the Annex, including mixtures and natural 
products containing such substances. This ex cludes 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 applicable or  economically viable 
means and medicinal products within the meaning of Article 1(2) of Directive 2001/83/EC of 
the European Parliament and of the Council7;" 
(b) point (j) is deleted. (2) Article 6 is amended as follows: 
(a) in paragraph 1, the third subparagraph is replaced by the following: "The Commission shall be empower ed to adopt delegated acts in accordance with Article 30b 
to lay down provisions for determining cases wh ere a licence is not required and to set out 
further conditions for granting licences." 
(b) the following paragraphs 3 and 4 are added: "3. The Commission shall establish a model for licences by means of implementing acts. 
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 30(2). 
4. The delegated acts referred to in the th ird subparagraph of paragraph 1 and the 
implementing acts referred to in paragraph 3 shall guarantee a systematic and consistent control and monitoring of operators." 
(3) Article 7 is amended as follows: 
(a) in paragraph 1, the follo wing subparagraph is added: 
"In considering whether to grant a registration, the competent authority shall take into account 
the competence and integr ity of the applicant." 
(b) paragraph 2 is replaced by the following: 
"2. The Commission shall be empowered to adopt delegated acts in accordance with 
Article 30b to establish the conditions for exemption from the controls of certain categories of operators and of operators engaged in the export of small quantities of scheduled substances listed 
in Category 3, ensuring that the risk of divers ion of scheduled substances is minimised." 
(c) The following paragraph 3 is added: "3. The registration may be suspended or re voked by the competent au thorities whenever 
the conditions under whic h the registration was issued are no  longer fulfilled or where there 
are reasonable grounds for suspecting that ther e is a risk of diversion of scheduled 
substances." 
                                                
 
7 OJ L 311, 28.11.2001, p. 67.   
EN 11   EN (4) In Article 8, paragraph 2 is  replaced by the following: 
"2. The Commission shall be empowered to adopt delegated acts in accordance with 
Article 30b to establish the criteria to determ ine how the licit purposes of the transaction may 
be demonstrated, in order to ensure that all movements of scheduled substances within the 
Union customs territory can be monitored by the competent authorities and the risk of 
diversion be minimised." 
(5) In Article 9,  
(a) The following is added at the end of paragraph 1: "To this end, operators shall provide any av ailable information allowing the competent 
authorities to verify the legitimacy of th e relevant order or transaction, such as: 
- the name of the scheduled substance; - the quantity and weight of the scheduled substance; and - the names and addresses of the exporter, the importer, the ultimate consignee and, where 
applicable, the person involved in  the intermediary activities. 
This information will only be used for the purp oses of preventing the diversion of scheduled 
substances." 
(b) Paragraph 2 is replaced by the following: 
"2. Operators shall provide the competent aut horities with information in summary form 
about their export, import or in termediary activities. The Co mmission shall be empowered to 
adopt delegated acts in accordan ce with Article 30b to determine the information that is 
required by the competent authorities in order to allow them to monitor those activities, including rules on how to provide such information in electronic form to a European database, 
where appropriate." 
(6) Article 11 is amended as follows: 
(a) in paragraph 1, the first subpara graph is replaced by the following: 
"1. All exports of scheduled substances lis ted in Category 1 of the Annex, exports of 
scheduled substances listed in Category 2 an d 3 of the Annex to certain countries of 
destination and all exports of medicinal products  containing ephedrine or pseudoephedrine, 
shall be preceded by a pre-expo rt notification sent from the competent authorities in the 
Union to the competent authorities of the country  of destination, in accordance with Article 
12(10) of the United Nations Convention. The Commission shall be empowered to adopt 
delegated acts in accordance with Article 30 b to determine the list of the countries of 
destination in order to minimise the risk of diversion of scheduled substances and medicinal 
products containing ephedrine or  pseudoephedrine, by ensuring systematic and consistent 
monitoring of exports of such substan ces and products to those countries." 
(b) paragraph 3 is replaced by the following:  
EN 12   EN "3. Simplified pre-export no tification procedures may be applied by the competent 
authorities where they are satisfied that this will not result in any risk of diversion of scheduled substances and of medicinal products containing e phedrine or pseudoephedrine. 
The Commission shall be empowered to adopt dele gated acts in accordance with Article 30b to 
determine such procedures and to establish th e common criteria to be applied by the competent 
authorities." 
(7) In Article 12(1), the third subpara graph is replaced by the following: 
"However, exports of scheduled su bstances listed in Category 3 of the Annex shall only be 
subject to an export authorisation where pre-e xport notifications are re quired, or where those 
substances are exported to certain countries  of destination. The Commission shall be 
empowered to adopt delegated acts in accordance with Article 30b to determine the list of such countries of destination in order to ensure an appropriate level of control." 
(8) Article 19 is replaced by the following: 
"Article 19 
Simplified procedures to grant an export au thorisation may be applied by the competent 
authorities where they are satisfied that this will not result in any risk of diversion of scheduled 
substances. The Commission shall be empowered to adopt delegated acts  in accordance with 
Article 30b to determine such procedures and to establish the common criteria to be applied by 
the competent authorities." 
(9) Article 26 is amended as follows: 
(a) paragraph 1 is replaced by the following: "1. Without prejudice to the pr ovisions of Articles 11 to 25 a nd to paragraphs 2 and 3 of 
this Article, the competent authorities of each Member State shall prohibit the introduction of 
scheduled substances, as well as of me dicinal products containing ephedrine or 
pseudoephedrine, into the Union customs territory  or their departure fr om it, if there are 
reasonable grounds for suspecting that such subs tances and products are intended for the illicit 
manufacture of narcotic drugs or psychotropic substances." 
(b) the following paragraph 3a is added: "3a. Each Member State may adopt the measures necessary to enable its competent 
authorities to control and monitor suspicious transactions with non-scheduled substances, in 
particular: 
(a) to obtain information on any orders for or operations i nvolving non-scheduled 
substances; 
(b) to enter operators' business premises in order to obtain evidence of suspicious 
transactions with non-scheduled substances." 
(10) Article 28 is replaced by the following: 
"Article 28  
EN 13   EN In addition to the measures referred to in Article 26, the Commission shall be empowered to 
lay down, where necessary, by means of implementi ng acts, measures to ensure the effective 
monitoring of trade between the Union and thir d countries in drug precursors for the purpose 
of preventing the diversion of such  substances, in particular with  regard to the design and use 
of export and import authorisation forms. T hose implementing acts shall be adopted in 
accordance with the examination proce dure referred to in Article 30(2)." 
(11) Article 29 is deleted.  
(12) Article 30 is replaced by the following: 
"Article 30 
1. The Commission shall be assisted by th e Drug Precursors Committee (hereinafter 
referred to as the Committee). That committee shall be a committee within the meaning of 
Regulation (EU) No 182/2011. 
2. Where reference is made to this paragr aph, Article 5 of Regulation (EU) No 182/2011 
shall apply." 
(13) The following Articles 30a and 30b are inserted: 
"Article 30a 
The Commission shall be empowered to adopt de legated acts in accordance with Article 30b 
in order to adapt the Annex to new trends in  diversion of drug precursors, in particular 
substances which can be easily  transformed into scheduled substances, and to follow an 
amendment to the tables in the Anne x to the United Nations Convention. 
Article 30b 
1. The power  to adopt delegated acts is confer red on the Commission subject to the 
conditions laid down in this Article. 
2. The delegation of power referred to in Ar ticles 6(3) third s ubparagraph, 7(2), 8(2), 
9(2), 11(1) and (3), 12(1), 19, 28  and 30a shall be conferred for an indeterminate period of 
time from [OPOCE insert date of entry into force of this amending Regulation]  
3. The delegation of powers referred to in Ar ticles 6(3) third subparagraph, 7(2), 8(2), 
9(2), 11(1) and (3), 12(1), (19) , 28 and 30a may be revoked at any time by the European 
Parliament or by the Council. A decision of re vocation shall put an en d to the delegation of 
power specified in that decisi on. It shall take effect the da y following 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 a ny delegated acts already in force. 
4. As soon as it adopts a delegated act, th e Commission shall notify it simultaneously to 
the European Parliament and the Council. 
5. A delegated act adopted pursuant to Article s 6(3) third subparagraph, 7(2), 8(2), 9(2), 
11(1) and (3), 12(1), (19), 28 and 30a shall en ter into force only if no objection has been 
expressed either by the European Parliament or  the Council within a period of 2 months of 
notification of that act to the European Parliament and the Counc il or if, before the expiry of  
EN 14   EN 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." 
(14) In Article 32, the thir d subparagraph is replaced by the following: 
"The Commission shall evaluate the implemen tation and functioning of Articles 11 and 26 
insofar as they concern medicinal products containing ephedrine or  pseudoephedrine and 
Article 30a by [OPOCE insert date 5 years after entr y into force of this amending 
Regulation] ". 
(15) The following Article 32a is inserted: 
"Article 32a 
Database 
The Commission shall use a European Database on drug precursors, as established by 
Regulation (EC) No 273/2004 of the Eur opean Parliament and of the Council8, with the 
following functions: 
(a) facilitating the communication of information pursuant to Article 32 first 
subparagraph, as well as the reporting to the International Narc otics Control Board 
pursuant to Article 32 second subparagraph; 
(b) managing a European register of operato rs, which have been  granted a licence 
pursuant to Articles 6(1) or regist ration pursuant to Articles 7(1); 
(c) enabling operators to provide the competent authorities with information about their 
export, import or intermediary ac tivities according to Article 9(2)." 
(16) Article 33 is replaced by the following: 
"Data protection provisions 
1. The processing of personal data by the competent authorities in the Member States 
shall be carried out in accordance with Dire ctive 95/46/EC and under th e supervision of the 
public independent authority of th e Member State 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 referred to under Article 32 a, shall be carried out in accordance with 
Regulation (EC) No 45/2001 and under the supe rvision of the European Data Protection 
Supervisor." 
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 . 
                                                 
8 OJ L 86, 24.3.2004, p. 21   
EN 15   EN 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