Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
Date: 2012-09-27
Institutions: European Commission
Subjects: drug traffic, export monitoring, market supervision, medicinal product, psychotropic substance, surveillance concerning imports, third country

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 

amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of 
trade between the Community and third countries in drug precursors 

(Text with EEA relevance) 

{SWD(2012) 267 final} 
{SWD(2012) 268 final} 

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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,  cosmetics,  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 distribution channels for the illicit manufacture of narcotic drugs. 

Therefore, controlling drug precursors is a key component in the fight against narcotic drugs. 
Taking  into  account  the  wide  legitimate  uses  of  drug  precursors,  their  trade  cannot  be 
prohibited. A specific regulatory framework, both at international and at EU level, has been 
put  in  place  to  monitor  their  legal  trade  and  to  identify  suspicious  transactions,  thus 
preventing their diversion for illicit use. 

Ephedrine and pseudoephedrine are chemical substances used for the manufacture of cold or 
allergy medicines. These two substances are also the main precursors for the manufacture of 
methamphetamine1. While ephedrine and pseudoephedrine are controlled at international and 
EU level, the medicinal products containing them are not controlled 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 use containing ephedrine or pseudoephedrine are 
excluded  from  the  provisions  of  Regulation  (EC)  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 States' competent authorities when these products 
were exported from or transiting through the Union customs territory, even though it was very 
likely  that  they  would  be  misused  for  the  illicit  manufacture  of  methamphetamine  in  their 
country of destination. 

The EU is criticized internationally 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 customs and police authorities who can 
stop and seize ephedrine and pseudoephedrine but cannot stop and seize medicinal products 
containing ephedrine or pseudoephedrine. 

In  its  Conclusions  of  25  May  2010,  the  Council  invited  the  Commission  to  present  a 
legislative proposal in this sense. 

1.2. 

Scale of the problem (methamphetamine and its precursors) 

In 2009 almost 7400 seizures of methamphetamine, amounting to about 600 kg of the drug, 
were  reported  in  Europe.  Both  the  number  of  seizures  and  quantities  increased  over  2004-

1 

Methamphetamine is a synthetic drug which 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 lasting effect. Taken as pills, 
smoked, inhaled or injected, it is particularly attractive to young people because it produces a sense of high energy, 
a release of social inhibitions and feelings of cleverness, competence and power. The physical and psychological 
effects (feelings of anxiety, hyper stimulation and paranoia) occur rapidly. 

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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  reaching  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  precursors  for  methamphetamine.  Seizures  of 
methamphetamine  precursors  contained  in  medicinal  products  have  fluctuated  considerably 
from  2007  until  2010.  At  European  level,  while  in  2007  hardly  any  preparations  were 
recorded out of the overall quantities seized, in 2008 and 2009 the amount of preparations out 
of the total quantities seized increased sharply and decreased considerably again in 20102. 

After the continued increase of seizures of medicinal products from 2007 to 2009, as a result 
of strengthened controls of medicinal products containing ephedrine and pseudoephedrine in 
several countries, particularly in Mexico and countries 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  place  in  a  given  part  of  the  world.  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  deterrent:  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 precursors 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, providing 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 products containing ephedrine 
and pseudo-ephedrine. These products are regulated by Directive 2001/83/EC. However, the 
objective pursued by that Directive 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 mechanisms foreseen in Directive 
2001/83/EC and in Regulation (EC) 111/2005 are different. 

The  medicinal  products  legislation  has  recently  been  amended  by  Directive  2011/62/EU 
which relates to the prevention of the entry into the legal supply chain of falsified medicinal 

2 

In 2007, 8mt of these precursors were seized of which nearly 4 % were in the form of medicinal products; in 2008 
3,5mt  of  which  51%  were  in  the  form  of  medicinal  products;  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 products. These seizures were 
made on the basis of national legislation. 

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products.  The  Directive  addresses  inter  alia  the  distribution  chain  for  medicines  within  the 
EU, importation of active substances, and 'introduction' of medicines, i.e. medicines brought 
into  the  customs  territory  without  the  intention  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  ephedrine  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 consultation, 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  sensitive  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  would  not  impose  increased  administrative  burden  on 
exporting  companies.  Among  Member  States'  competent  authorities  two  thirds  plead  for  an 
amendment  of  the  legislation,  though  to  different  degrees,  while  one  third  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  ephedrine  or  pseudoephedrine  to  the  illicit 
manufacture of methamphetamine by introducing control measures over these products when 
traded between the Union and third countries 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  Commission  would  take  no  action  and  the  status  quo 
would  be  maintained.  Option  2  considers  contributing  to  improve  the  situation  through 
voluntary measures by Member States, while options 3, 4 and 5 consider resolving it through 
compulsory control measures. The last three options 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 further analysis of its 
impact. 

3 

On  the  one  hand,  the  subject  matter,  drug  precursors,  is  not  widely  known  and  would  have  most  likely  entailed 
responses concerning the overall drug situation, which would have been irrelevant for this exercise. On the other 
hand, the problem at stake and the envisaged options only affect a very specific aspect of drug precursor control. 

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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 expressed by the international community. 

Option 2 would only partially address the identified problem. It suggests voluntary measures 
which  will  not  be  effective  unless  adopted  across  all  Member  States.  A  compulsory 
application  of  these  measures  cannot  be  enforced  by  the  instrument  foreseen  under  this 
option. 

Options  3,  4  and  5  would  all  provide  a  clear  legal  basis  for  competent  authorities  to  stop 
and/or seize medicinal products containing ephedrine or pseudoephedrine at export from or in 
transit through the Union customs territory. They would all reduce the criticism expressed by 
the  UN  International  Narcotics  Control  Board  on  the  alleged  lack  of  EU  action  to  control 
these products. They would all increase the chances to prevent the diversion of these products, 
thus  reducing  the  supply  of  ephedrine  and  pseudoephedrine  for  the  illicit  manufacture  of 
methamphetamine, though to different degrees. 

When comparing these three options  requiring legislative 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 notification of legal shipments), while option 5 (full control of trade 
in medicinal products containing ephedrine and pseudoephedrine) would impose the highest 
administrative  burden  for  both  competent  authorities  and  economic  operators.  Even  though 
option  5  could  be  considered  the  most  effective  by  applying  the  strictest  controls,  the 
requirements would be disproportionate 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  the  effectiveness  of  each  individual  measure, 
with  a  limited  additional  burden  given  that  the  pre-export  notification  system  is  up  and 
running and that the number of pre-export notifications that could be seemingly sent per year 
by  Member  States'  competent  authorities  is  relatively  small.  Moreover,  as  pre-export 
notifications  are  already  compulsory  for  scheduled  substances  of  category  1,  it  would  seem 
logical  to  make  them  compulsory  also  for  the  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  common  commercial  policy.  Moreover,  Article 
3(1)  of  the  TFEU  provides  exclusive  competence  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  countries,  and  therefore  falls  under  the  common 
commercial policy. 

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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 European 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' authorities in accordance with Article 12(12) of the 
United Nations Convention; 

-  a  review  clause  to  assess  whether  the  amended  Regulation  will  have  been  effective  to 
prevent the diversion of medicinal products containing ephedrine or pseudoephedrine; 

-  the  adaptation  of  the  provisions  of  Regulation  (EC)  No  111/2005  in  accordance  with  the 
rules  on  delegated  and  implementing  acts  under  the  Treaty  on  the  Functioning  of  the 
European Union (TFEU). 

The  Commission  has  been  granted  implementing  powers  under  the  current  Regulation  in 
accordance  with  Articles  4  and  7  of  Decision  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  between  the  European  Parliament,  the  Council 
and  the  Commission  and  Regulation  (EU)  No  182/2011  laying  down  the  rules  and  general 
principles  concerning  mechanisms  for  control  by  Member  States  of  the  Commission’s 
exercise of implementing powers. 

The  proposal  is  subject  to  the  WTO-TBT  Agreement,  thus  subject  to  a  notification  to  the 
WTO. 

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2012/0250 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Regulation (EC) No 111/2005 laying 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 COUNCIL 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 Supervisor1, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

1 
2 
3 

Pursuant to Article 32 of Council Regulation (EC) No 111/2005 of 22 December 2004 
laying  down  rules  for  the  monitoring  of  trade  between  the  Community  and  third 
countries in drug precursors2, 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 and control of trade in drug precursors3. 

The Commission report pointed out that, in the existing Union control system for drug 
precursors,  medicinal  products  containing  ephedrine  and  pseudoephedrine,  whose 
trade  was  not  controlled,  were  diverted  into  the  illicit  drug  manufacture  outside  the 
Union,  as  a  substitute  to  internationally  controlled  ephedrine  and  pseudoephedrine. 
The  Commission  therefore  recommended  strengthening  the  control  of  international 
trade in medicinal products containing ephedrine or pseudoephedrine exported from or 
transiting  through  the  Union  customs  territory  which  are  diverted  for  the  illicit 
manufacture of drugs. 

OJ C , , p.  
OJ L 22, 26.1.2005, p. 1. 
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. 

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(3) 

(4) 

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  amend  Council  Regulation  (EC)  No  111/2005 
accordingly. 

It  is  important  that  the  definition  of  scheduled  substances  be  clarified:  the  term 
'pharmaceutical  preparation'  stemming  from  the  United  Nations  Convention  against 
Illicit Traffic in Narcotic Drugs and Psychotropic Substances adopted in Vienna on 19 
December 1988 (hereinafter referred to as the "United Nations Convention") should be 
replaced  by  the  relevant  terminology  of  the  Union  legislation,  'medicinal  products', 
and the term 'other preparations' should be deleted as it duplicates the term 'mixtures' 
already used in the definition. 

(5) 

Rules on suspending or revoking a registration should be introduced in order to match 
the existing rules for suspending or revoking a licence. 

(6)  Medicinal  products  containing  ephedrine  or  pseudoephedrine  should  therefore  be 

controlled without impeding their legitimate trade. 

(7) 

To 
this  end,  any  export  of  medicinal  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  should  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'  diversion,  their  possibilities  to  act  in  cases  of 
suspicious transactions involving non-scheduled 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,  which  will  facilitate 
verification of the legitimacy of their transactions involving scheduled substances and 
to enable operators to provide the competent authorities with information about their 
export, import or intermediary activities 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  confers  powers  on  the  Commission  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 implementing powers conferred on the Commission4 as 
amended by Council Decision 2006/512/EC5. 

4 
5 

OJ L 184, 17.7.1999, p. 23. 
OJ L 200, 22.7.2006, p. 11. 

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(13)  As a consequence of the entry into force of the Lisbon Treaty, those powers need to be 
aligned  to  Articles  290  and  291  of  the  Treaty  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 Article 290 of the Treaty on the Functioning of the European 
Union  should  be  delegated  to  the  Commission  in  order  to  lay  down  provisions 
determining cases where a licence is not required and to set out further 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  demonstrated,  to  determine  the  information  that  is 
required by the competent authorities to monitor export, import or intermediary activities of 
operators, to determine the countries of destination to which exports of scheduled substances 
of  Category  2  and  3  of  the  Annex  should  be  preceded  by  a  pre-export  notification,  to 
determine simplified pre-export procedures and to establish the common criteria thereof, to 
determine  the  countries  of  destination  to  which  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 carries out appropriate consultations during 
its preparatory work, including at expert level.  

(15)  The  Commission,  when  preparing  and  drawing-up  delegated  acts,  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  conferred  on  the  Commission,  namely  to 
establish a model for licences. 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.6 

(17)  Since  this  Regulation  is  based  on  the  common  commercial  policy,  the  examination 

procedure should be used for the adoption of the implementing acts.  

(18)  Regulation (EC) No 111/2005 should 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. 

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(a) 

point (a) is replaced by the following: 

"(a) 
'scheduled substance’ means any substance used for the illicit manufacture of narcotic 
drugs  or  psychotropic  substances  and  listed  in  the  Annex,  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  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 empowered to adopt delegated acts in accordance with Article 30b 
to  lay  down  provisions  for  determining  cases  where  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  third  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 following subparagraph is added: 

"In considering whether to grant a registration, the competent authority shall take into account 
the competence and integrity of the applicant." 

(b) 

paragraph 2 is replaced by the following: 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
"2. 
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 diversion of scheduled substances is minimised." 

(c) 

The following paragraph 3 is added: 

"3. 
The registration may be suspended or revoked by the competent authorities whenever 
the conditions under which the registration was issued are no longer fulfilled or where there 
are  reasonable  grounds  for  suspecting  that  there  is  a  risk  of  diversion  of  scheduled 
substances." 

7 

OJ L 311, 28.11.2001, p. 67. 

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(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 determine 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  available  information  allowing  the  competent 
authorities to verify the legitimacy of the 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  purposes  of  preventing  the  diversion  of  scheduled 
substances." 

(b) 

Paragraph 2 is replaced by the following: 

"2. 
Operators  shall  provide  the  competent  authorities  with  information  in  summary  form 
about  their  export,  import  or  intermediary  activities.  The  Commission  shall  be  empowered  to 
adopt  delegated  acts  in  accordance  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 subparagraph is replaced by the following: 

"1. 
All  exports  of  scheduled  substances  listed  in  Category  1  of  the  Annex,  exports  of 
scheduled  substances  listed  in  Category  2  and  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-export  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  30b  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 substances and products to those countries." 

(b) 

paragraph 3 is replaced by the following: 

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11 

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"3. 
Simplified  pre-export  notification  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  ephedrine  or  pseudoephedrine. 
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." 

(7) 

In Article 12(1), the third subparagraph is replaced by the following: 

"However,  exports  of  scheduled  substances  listed  in  Category  3  of  the  Annex  shall  only  be 
subject to an export authorisation where pre-export notifications are required, 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  authorisation  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 provisions of Articles 11 to 25 and 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  medicinal  products  containing  ephedrine  or 
pseudoephedrine,  into  the  Union  customs  territory  or  their  departure  from  it,  if  there  are 
reasonable grounds for suspecting that such substances 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: 

to  obtain  information  on  any  orders  for  or  operations  involving  non-scheduled 

(a) 
substances; 

to  enter  operators'  business  premises  in  order  to  obtain  evidence  of  suspicious 

(b) 
transactions with non-scheduled substances." 

(10) 

Article 28 is replaced by the following: 

EN 

"Article 28 

12 

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In addition to the measures referred to in Article 26, the Commission shall be empowered to 
lay down, where necessary, by means of implementing acts, measures to ensure the effective 
monitoring of trade between the Union and third 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.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure 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  the  Drug  Precursors  Committee  (hereinafter 
referred  to  as  the  Committee).  That  committee  shall  be  a  committee  within  the  meaning  of 
Regulation (EU) No 182/2011. 

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 

2. 
shall apply." 

(13) 

The following Articles 30a and 30b are inserted: 

"Article 30a 

The Commission shall be empowered to adopt delegated 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 Annex to the United Nations Convention. 

Article 30b 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 

1. 
conditions laid down in this Article. 

2. 
The  delegation  of  power  referred  to  in  Articles  6(3)  third  subparagraph,  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  Articles  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 revocation shall put an end to the delegation of 
power specified in that decision. It shall take effect the day 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 any delegated acts already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 

4. 
the European Parliament and the Council. 

5. 
A delegated act adopted pursuant to Articles 6(3) third subparagraph, 7(2), 8(2), 9(2), 
11(1)  and  (3),  12(1),  (19),  28  and  30a  shall  enter  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 Council or if, before the expiry of 

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13 

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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 third subparagraph is replaced by the following: 

"The  Commission  shall  evaluate  the  implementation  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  entry  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  European  Parliament  and  of  the  Council8,  with  the 
following functions: 

(a) 

(b) 

(c) 

the  communication  of 

facilitating 
to  Article  32  first 
subparagraph,  as  well  as  the  reporting  to  the  International  Narcotics  Control  Board 
pursuant to Article 32 second subparagraph; 

information  pursuant 

managing  a  European  register  of  operators,  which  have  been  granted  a  licence 
pursuant to Articles 6(1) or registration pursuant to Articles 7(1); 

enabling operators to provide the competent authorities with information about their 
export, import or intermediary activities according to Article 9(2)." 

(16) 

Article 33 is replaced by the following: 

"Data protection provisions 

The  processing  of  personal  data  by  the  competent  authorities  in  the  Member  States 
1. 
shall be carried out in accordance with Directive 95/46/EC and under the supervision of the 
public independent authority of the Member State referred to in Article 28 of this Directive. 

The processing of personal data by the Commission, including for the purpose of the 
2. 
European  Database  referred  to  under  Article  32a,  shall  be  carried  out  in  accordance  with 
Regulation  (EC)  No  45/2001  and  under  the  supervision  of  the  European  Data  Protection 
Supervisor." 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 2 

8 

OJ L 86, 24.3.2004, p. 21 

EN 

14 

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This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

15 

   EN