Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment procedure on new psychoactive substances
Date: 2016-08-29
Institutions: Directorate-General for Migration and Home Affairs, European Commission
Subjects: European Monitoring Centre for Drugs and Drug Addiction, drug traffic, exchange of information, health risk, market approval, psychotropic substance

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 29.8.2016  COM(2016) 547 final 2016/0261 (COD)   Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 1920/2006 as regards information exchange, early warning system and risk assessment procedure on new psychoactive substances  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Over the past decade there has been a massive growth in new psychoactive substances (NPS), 
at global level and in Europe as well, and there are no signs of a slowdown. In 2015, 100 new 
substances were reported for the first time to the EU Early Warning System (EWS), bringing 
the total number of new substances monitored to more than 560 – with more than 380 (70%) 
of these detected in the last five years alone.1

The  United  Nations  General  Assembly  at  the  Special  Session  on  the  world  drug  problem 
(UNGASS,  19-21  April  2016)  adopted  the  outcome  document  "Our  joint  commitment  to 
effectively addressing and countering the world drug problem"2. A specific section deals with 
addressing  emerging  and  persistent  challenges  and  threats  including  NPS.  The  joint 
commitment  calls  for  strengthening  action  to  address  the  challenge  of  NPS  as  well  as  for 
enhancing information-sharing and early warning networks.  

On 17 September 2013, the Commission put forward a package of two legislative proposals 
on  new  psychoactive  substances:  a  proposal  for  a  Regulation  on  new  psychoactive 
substances3  and  a  Directive  amending  Council  Framework  Decision  2004/757/JHA  of  25 
October 2004 laying down minimum provisions on the constituent elements of criminal acts 
and  penalties  in  the  field  of  illicit  drug  trafficking,  as  regards  the  definition  of  drug4.  The 
objective was to reduce the availability of new psychoactive substances that pose risk through 
swifter,  more  effective  action  on  Union  level  compared  to  the  currently  applicable  system 
based on Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk 
assessment and control of new psychoactive substances5. 

Inter-institutional  negotiations  of  this  legislative  package  have  been  ongoing  for  more  than 
two years. The European Parliament adopted its legislative resolutions on 17 April 20146. The 
Council  did  not  adopt  a  general  approach  on  the  proposals;  during  the  examination  of  the 
proposals Member States expressed doubts concerning the choice of Article 114 of the Treaty 
on  the  Functioning  of  the  European  Union  (TFEU)  as  the  legal  basis  for  the  proposed 
Regulation.   

To achieve the same objective of a swifter, more effective EU action on NPS, the Permanent 
Representatives  Committee  (COREPER)  on  6  April  20167  agreed  to  the approach  proposed 
by  the  Netherlands  Presidency  in  its  discussion  paper,  including  amendments  of  the  draft 
Directive  based  on  Article  83  TFEU  that  will  in  particular  contain  a  definition  of  new 
psychoactive  substances  and  provisions  on  swift  Union  level  decision  making  in  order  to 
criminalise  harmful  new  psychoactive  substances  in  all  Member  States.  COREPER  also 
invited  the  Commission  to  present  a  proposal  on  amending  the  founding  Regulation  of  the 
European  Monitoring  Centre  for  Drugs  and  Drug  Addiction  (EMCDDA),  Regulation 

1 
2 
3 
4 
5 

6 
7 

EU Drugs Market Report 2016, p. 28. 
General Assembly Resolution A/RES/S-30/1. 
COM(2013) 619 final. 
COM(2013) 618 final. 
OJ L 127, 10.5.2005, p. 32. The different policy options have been analysed in the impact assessment 
accompanying both proposals, SWD(2013) 319 final. 
European Parliament Document P7_TA(2014)0453. 
Summary record, Council document 7908/1/16 REV 1 of 27 May 2016. 

EN 

2 

   EN 

   
                                                 
1920/2006.  According  to  the  Summary  Record  of  the  2580th  meeting  of  COREPER  this 
decision triggers the start of the 3 months' opt-in deadline for the Member States concerned 
by Protocol 21 and has consequences under Protocol 22 annexed to the TEU. The European 
Parliament is informed about this change by a letter from the Council. 

Given that the decision of COREPER aims to achieve the same objectives as proposed by the 
package  of  2013,  the  Commission  proposes  targeted  amendments  of  Regulation  1920/2006 
integrating  the  draft  provisions  on early  warning  system  and  risk  assessment  procedure  that 
were part of the 2013 Commission proposal for a Regulation on new psychoactive substances 
into the founding Regulation of the EMCDDA. The Commission will consider the withdrawal 
of the proposal on a Regulation on new psychoactive substances in preparing Commission's 
Work Programme for 2017.  

The new proposal as the previous one aims at strengthening the EU early warning system and 
the risk  assessment and  at streamlining procedures to  ensure  more effective and fast action. 
Therefore, in order to speed up the process, deadlines are substantially shortened compared to 
the  current  system  based  on  Council  Decision  2005/387/JHA.  For  the  purpose  of  swift  and 
effective  collection  of  information  on  NPS,  the  EMCDDA  should  conclude  working 
arrangements  with  Europol,  the  European  Medicines  Agency,  the  European  Chemicals 
Agency  and  the  European  Food  Safety  Authority  without  undue  delay  following  the 
publication of the Regulation in the Official Journal.  

This proposal also ensures a participation of EUROPOL in the early warning system and risk 
assessment  procedure,  in  particular  as  input  on  the  involvement  of  criminal  groups  in  the 
manufacture and distribution of new psychoactive substances is concerned.  

According  to  Article  23  of  Regulation  1920/2006  the  Commission  may  propose,  if 
appropriate, and in the light of developments in respect of regulatory agencies on the basis of 
the next evaluation of the Centre further amendments to the EMCDDA founding Regulation.  

• 

Consistency with existing policy provisions in the policy area 

The proposal reflects the priorities set out by the European Agenda on Security8 adopted on 
28  April  2015.  The  European  Agenda  of  Security  stresses  that  the  market  for  illicit  drugs 
remains the most dynamic of criminal markets, with a recent trend being the proliferation of 
new  psychoactive  substances.  It  also  states  that  the  production  of  these  substances  is 
increasingly  taking  place  in  the  Union  thus  pointing  to  the  urgency  of  adopting  a  new 
legislative framework. 

This  proposal  has  to  be  read  in  conjunction  with  Directive  (EU)  …/  …  [amending  Council 
Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on 
the constituent elements of criminal acts and penalties in the field of illicit drug trafficking9]. 
Both  instruments  are  designed  to  replace  the  mechanism  established  by  Council  Decision 
2005/387/JHA. 

8 
9 

COM(2015) 185 final.  
OJ L 335, 11.11.2004, p.8. 

EN 

3 

   EN 

                                                 
2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposal is based on Article 168(5) TFEU, which empowers the European Parliament and 
the  Council  to  adopt  measures  concerning  monitoring,  early  warning  of  and  combating 
serious  cross  border  threats  to  health  whilst  excluding  any  harmonisation  of  the  laws  and 
regulations of the Member States.  

• 

Subsidiarity 

There  is  a  clear  need  for  EU  action  on  new  psychoactive  substances.  Member  States  alone 
cannot  reduce  the  problems  caused  by  the  spread  of  harmful  new  psychoactive  substances. 
Uncoordinated national action in this area can produce adverse knock-on effects, for instance 
displacement of harmful substances from one Member State to another. Criminal groups may 
exploit this situation. 

Consequently,  EU-level  action  is  necessary  to  ensure  that  potentially  harmful  new 
psychoactive  substances,  which  cause  EU-wide  concern,  can  be  identified,  assessed  and,  if 
they pose risks, incriminated in all Member States. This Regulation has therefore to be read in 
conjunction  with  Directive  (EU)  …/  …  [amending  Council  Framework  Decision 
2004/757/JHA  of  25  October  2004  laying  down  minimum  provisions  on  the  constituent 
elements of criminal acts and penalties in the field of illicit drug trafficking]  since both acts 
are designed to replace the mechanism established by Council Decision 2005/387/JHA.  

• 

Proportionality 

The  proposal  is  proportionate  and  does  not  go  beyond  what  is  necessary  to  achieve  the 
objectives because it only addresses new psychoactive substances that are a concern at the EU 
level. 

• 

Choice of the instrument 

The  proposal  concerns  the  amendment  of  a  Regulation.  There  are  no  indications  that  a 
different instrument than a Regulation would be appropriate. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Stakeholder consultations 

This  proposal  follows  an  agreement  by  COREPER  on  6  April  2016  on  a  compromise 
approach  proposed  by  the  Netherlands  Presidency  of  the  Council.  In  the  meeting  of  the 
Committee on Civil Liberties, Justice and Home Affairs (LIBE) of the European Parliament 
of  15  June  2016,  the  Rapporteurs  and  the  Shadow  Rapporteurs  announced  that  they  have 
taken  the  decision  to  pursue  this  new  approach  as  a  package  and  work  together  with  the 
Council and the Commissions to reach agreement. As the content reflects this agreement, this 
new proposal does not require further stakeholder consultations. 

• 

Impact assessment 

The Commission conducted an impact assessment of policy alternatives in the context of the 
package  of  two  proposals  put  forward  on  17  September  of  2013.  The  impact  assessment  in 
particular  concluded  that  the  quality  and  quantity  of  information  available  at  EU  level  and 
shared  by  Member  States  as  well  as  the  capacity  to  rapidly  identify  and  assess  new 

EN 

4 

   EN 

psychoactive  substances  needs  to  be  improved.10  Therefore,  no  new  impact  assessment  is 
required for this proposal.  

4. 

BUDGETARY IMPLICATIONS 

The EMCDDA is tasked with the exchange of information, the early warning system and the 
risk assessment procedure on new psychoactive substances. The subsidy for the Centre forms 
already part of the Union's budget. 

However,  for  the  Centre  to  adequately  deal  with  the  growing  number  of  requests  related  to 
information  exchange  on  new  psychoactive  substances  as  well  as  with  the  proposed 
streamlined  procedures  for  the  EU  early  warning  system  and  risk  assessment  procedure,  an 
amount of EUR 676.000 in total for the period 2017-2020 for the system development and an 
amount of EUR 100.000 per year to finance three additional contract agents will need to be 
added to the Centre's budget.  

5. 

• 

OTHER ELEMENTS 

Monitoring, evaluation and reporting arrangements 

The  EMCDDA  is  on  a  regular  basis  evaluated  according  to  Article  23  of  Regulation 
1920/2006. According to this article, the Commission shall initiate an external evaluation of 
the EMCDDA every six years to coincide with the completion of two of the Centre's three-
year programmes. 

• 

Detailed explanation of the specific provisions of the proposal 

Article 1 provides for the following amendments to Regulation 1920/2006: 

New  point  (f)  in  Article  2  (Tasks)  –  this  provision  clarifies  that  tasks  of  the  EMCDDA  are 
information  exchange  and  early  warning  on  new  psychoactive  substances  as  well  as  risk 
assessment.  The  Centre  also  monitors  all  new  psychoactive  substances  that  have  been 
reported by Member States. 

New Article 5a (Exchange of information, early warning system and risk assessment on new 
psychoactive  substances)  – this provision establishes the respective roles  of Member States, 
the EMCDDA and Europol in the process of exchange of information and early warning on 
new psychoactive substances. 

New Article 5b (Initial report) – this provision lays down the contents and the procedures for 
the  drawing  up  and  the  transmission  by  the  EMCDDA  of  an  initial  report  on  a  new 
psychoactive substance. Europol, the European Medicines Agency, the European Chemicals 
Agency  and  the  European  Food  Safety  Authority  are  associated  to  the  collection  of 
information for an initial report. 

New  Article  5c  (Risk  assessment  procedure  and  report)  –  this  provision  empowers  the 
Commission to request the EMCDDA to assess the risks of a new psychoactive substance on 
which an initial report has been drawn up. It lays down the procedures for the risk assessment, 
which is to be conducted by the Scientific Committee of the EMCDDA, and for the drawing 
up and the transmission of a risk assessment report.  

New Article 5d (Exclusion from risk assessment) – this provision details such circumstances in 
which no risk assessment is to be conducted on a new psychoactive substance. 

10 

SWD(2013) 319 final, p. 46-75. 

EN 

5 

   EN 

                                                 
Article 2 establishes when the Regulation shall enter into force.  

EN 

6 

   EN 

2016/0261 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 1920/2006 as regards information exchange, early 
warning system and risk assessment procedure on new psychoactive substances 

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 168(5) 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 European Economic and Social Committee1,  
Having regard to the opinion of the Committee of the Regions2,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

1 
2 
3 

4 

5 

New  psychoactive  substances  can  pose  serious  cross  border  threats  to  health  which 
makes necessary to enhance monitoring, early warning and combating of those threats. 

During  the  past  years,  Member  States  have  notified  an  increasing  number  of  new 
psychoactive substances via the mechanism for rapid exchange of information which 
was  established  by  Joint  Action  97/396/JHA  adopted  by  the  Council  on  the  basis  of 
Article  K.3  of  the  Treaty  on  European  Union  concerning  the  information  exchange, 
risk assessment and the control of new synthetic drugs3 and was further strengthened 
by Council Decision 2005/387/JHA4. 

New psychoactive substances that pose health and social risks across the Union should 
be  addressed  at  the  Union  level.  This  Regulation  has  therefore  to  be  read  in 
conjunction  with  Council  Framework  Decision  2004/757/JHA5  [as  amended  by 
Directive  (EU)  …/…]  since  both  acts  are  designed  to  replace  the  mechanism 
established by Council Decision 2005/387/JHA. 

It  is  necessary  to  insert  provisions  concerning  the  information  exchange  and  early 
warning  system  on  new  psychoactive  substances  as  well  as  the  risk  assessment 
procedure  into  Regulation  (EC)  1920/2006  of  the  European  Parliament  and  of  the 

OJ C , , p.  
OJ C , , p. . 
Council  Joint  Action  97/396/JHA  of  16  June  1997  concerning  the  information  exchange,  risk 
assessment and control of new synthetic drugs (OJ L 167, 25.6.1997, p. 1). 
Council  Decision  2005/387/JHA  of  10  May  2005  on  the  information  exchange,  risk  assessment  and 
control of new psychoactive substances (OJ L 127, 20.5.2005, p. 32).  
Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on 
the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 
11.11.2004, p. 8). 

EN 

7 

   EN 

                                                 
(5) 

(6) 

Council.6 In particular provisions concerning the early warning on new psychoactive 
substances should be strengthened and the procedures for drawing up an initial report 
and  organising  the  risk  assessment  procedure  should  be  made  more  efficient. 
Substantially shortened deadlines for all stages of the procedure should be set. 

Any  Union  action  on  new  psychoactive  substances  should  be  based  on  scientific 
evidence.  

Following the  risk assessment procedure, the Commission  should determine  whether 
the  new  psychoactive  substances  should  be  incriminated,  in  line  with  the  procedure 
provided for in Council Framework Decision 2004/757/JHA [as amended by Directive 
(EU)  …/…].  This  Regulation  will  enter  into  force  on  the  same  day  as  the  day  for 
transposition  of  the  Directive  since  both  acts  are  designed  to  replace  the  mechanism 
established by Council Decision 2005/387/JHA. 

(7) 

No  risk  assessment  should  be  conducted  on  a  new  psychoactive  substance  if  it  is 
subject  to  an  assessment  under  international  law,  or  if  it  is  an  active  substance  in  a 
medicinal product or in a veterinary medicinal product. 

(8) 

Regulation (EC) 1920/2006 should therefore be amended accordingly. 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Amendments to Regulation (EC) No 1920/2006 

Regulation (EC) No 1920/2006 is amended as follows: 

(1) In Article 2 the following point (f) is added: 

 "(f)  

Exchange  of  information,  early  warning  system  and  risk  assessment  on  new 
psychoactive substances 

(i)  

collecting,  collating,  analysing,  and  assessing  the  available  information  from 
the  Reitox  National  Focal  Points  and  the  Europol  National  Units  on  new 
psychoactive  substances  as  defined  in  Article  […]  of  Council  Framework 
Decision  2004/757/JHA  [as  amended  by  Directive  (EU)  …/…]  and 
communicating  this  information  to  the  Reitox  National  Focal  Points  and  the 
Europol National Units as well as to the Commission without undue delay; 

(ii)  

drawing  up  the  initial  report  or  combined  initial  report  in  accordance  with 
Article 5b;  

(iii)  

organising  the  risk  assessment  procedure  in  accordance  with  Articles  5c  and 
5d; 

6 

Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on 
the European Monitoring Centre for Drugs and Drug Addiction (OJ L 376, 27.12.2006, p.1). 

EN 

8 

   EN 

 
 
 
 
 
 
                                                 
(iv)   monitoring,  in  cooperation  with  Europol  and  with  the  support  of  the  Reitox 
National  Focal  Points  and  the  Europol  National  Units,  all  new  psychoactive 
substances that have been reported by Member States." 

(2) In Article 5 (2) the second and third subparagraphs are deleted.  

(3) The following Articles 5a, 5b, 5c and 5d are inserted: 

"Article 5a 

Information exchange and early warning system on new psychoactive substances 

Each  Member  State  shall  ensure  that  its  Reitox  National  Focal  Points  and  the  Europol 
National  Unit  provide  timely  and  without  any  undue  delay  to  the  Centre  and  Europol  the 
available information on new psychoactive substances. The information shall be related to the 
detection  and  identification,  use  and  patterns  of  use,  potential  and  identified  risks, 
manufacture,  extraction,  distribution,  trafficking,  commercial,  as  well  as  medical  and 
scientific use of these substances. 

The Centre, in cooperation with Europol, shall collect, analyse, assess, and communicate this 
information  in  a  timely  manner  to  Member  States  with  a  view  to  providing  Member  States 
with  any  information  required  for  the  purposes  of  early  warning  and  for  the  purposes  of 
allowing  the  Centre  to  draw  up  the  initial  report  or  the  combined  initial  report  pursuant  to 
Article 5b. 

 Article 5b 

Initial report  

1. 

Where  the  Centre,  the  Commission  or  the  Council,  acting  by  a  simple  majority  of 
Member  States,  consider  that  the  information  shared  on  a  new  psychoactive 
substance collected pursuant to Article 5a in one or more Member States gives rise to 
concerns that the new psychoactive substance may pose health or social risks at the 
Union  level,  the  Centre  shall  draw  up  an  initial  report  on  the  new  psychoactive 
substance. 

2. 

The initial report shall contain:  

(a) 

(b) 

(c) 

(d) 

a first indication of the nature or scale of health and social risks associated with 
the new psychoactive substance; 

a  chemical  and  physical  description  of  the  new  psychoactive  substance,  the 
methods and the precursors used for its manufacture or extraction; 

a  pharmacological  and  toxicological  description  of  the  new  psychoactive 
substance; 

information  on  the  involvement  of  criminal  groups  in  the  manufacture  and 
distribution of the new psychoactive substance; 

EN 

9 

   EN 

 
 
 
 
(e) 

(f) 

(g) 

information on the human and veterinary medical use of the new psychoactive 
substance, including as an active substance in a medicinal product or veterinary 
medicinal product; 

information  on  whether  the  new  psychoactive  substance  is  subject  to  any 
restrictive measures in the Member States. 

information  on  whether  the  new  psychoactive  substance  is  currently  under 
assessment, or has been under assessment, within the system established by the 
1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, 
or the 1971 Convention on Psychotropic Substances (United Nations system). 

For the purpose of the initial report, the Centre shall use information which is already 
at its disposal. 

Where  the  Centre  considers  it  necessary,  it  shall  request  the  Reitox  National  Focal 
Points  to  provide  additional  information  on  the  new  psychoactive  substance.  The 
Reitox National Focal Points shall provide that information within two weeks of the 
receipt of the request. 

The Centre shall request the European Medicines Agency to provide information on 
whether, in the Union or in any Member State, the new psychoactive substance is: 

(a) 

(b) 

(c) 

(d) 

an  active  substance  in  a  medicinal  product  or  a  veterinary  medicinal  product 
that has obtained a marketing authorisation; 

an  active  substance  in  a  medicinal  product  or  a  veterinary  medicinal  product 
that is the subject of an application for a marketing authorisation; 

an  active  substance  in  a  medicinal  product  or  a  veterinary  medicinal  product 
that has obtained a marketing authorisation, but the marketing authorisation has 
been suspended by the competent authority;  

an  active  substance  in  an  unauthorised  medicinal  product  in  accordance  with 
Article  5  of  Directive  2001/83/EC  of  the  European  Parliament  and  of  the 
Council7 or in a veterinary medicinal product prepared extemporaneously by a 
person authorised to do so under national legislation in accordance with Article 
10(1)(c)  of  Directive  2001/82/EC  of  the  European  Parliament  and  of  the 
Council8; 

(e)   an active substance in authorised clinical trials and in investigational medicinal 
products  in  accordance  with  Article  2(d)  of  Directive  2001/20/EC  of  the 
European Parliament and of the Council9. 

The  Centre  shall  request  Europol  to  provide  information  on  the  involvement  of 
criminal  groups  in  the  manufacture  and  distribution  of  the  new  psychoactive 
substance, and in any use of the new psychoactive substance.   

Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 
Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1) 
Directive  2001/20/EC  of  the  European  Parliament  and  of  the  Council  of  4  April  2001  on  the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the implementation of good clinical practice in the conduct of clinical trials on medicinal products for 
human use (OJ L 121, 1.5.2001, p. 34). 

3. 

4. 

5. 

6. 

7 

8 

9 

EN 

10 

   EN 

                                                 
7. 

8. 

9. 

10. 

11. 

1. 

2. 

The  Centre  shall  request  the  European  Chemicals  Agency  and  the  European  Food 
Safety  Authority  to  provide  the  information  and  data  at  their  disposal  on  the  new 
psychoactive substance.   

The  details  of  the  cooperation  between  the  Centre  and  the  bodies  and  agencies 
referred  to  in  paragraphs  5,  6  and  7  shall  be  governed  by  working  arrangements. 
Such  working  arrangements  shall  be  concluded  in  accordance  with  the  second 
paragraph of Article 20. 

The  Centre  shall  respect  the  conditions  on  use  of  the  information,  which  are 
communicated  to  the Centre, including conditions on information  and  data security 
and protection of confidential business information. 

The Centre shall submit the initial report to the Commission and the Council within 
five weeks from the requests for information referred to in paragraphs 5, 6 and 7. 

When the Centre collects information on several new psychoactive substances with 
similar  chemical  structure,  it  shall  submit  to  the  Commission  and  the  Council 
individual initial reports or combined reports dealing with several new psychoactive 
substances, provided that the characteristics of each new psychoactive substance are 
clearly identified, within six weeks from the launch of the initial report. 

 Article 5c 

Risk assessment procedure and report 

Within two weeks from the receipt of the initial report referred to in Article 5b(10) 
the  Commission  may  request  the  Centre  to  assess  the  potential  risks  posed  by  the 
new  psychoactive  substance  and  to  draw  up  a  risk  assessment  report.  The  risk 
assessment shall be conducted by the Scientific Committee.  

Within  two  weeks  from  the  receipt  of  the  combined  initial  report  referred  to  in 
Article 5b(11), the Commission may request the Centre to assess the potential risks 
posed by several new psychoactive substances with similar chemical structure and to 
draw up a combined risk assessment report. The combined risk assessment shall be 
conducted by the Scientific Committee of the Centre. 

3. 

The risk assessment report or combined risk assessment report shall contain:  

(a) 

(b) 

(c) 

(d) 

information  on  the  chemical  and  physical  properties  of  the  new  psychoactive 
substance,  the  methods  and  the  precursors  used  for  its  manufacture  or 
extraction; 

information  on  the  pharmacological  and  toxicological  properties  of  the  new 
psychoactive substance; 

an analysis of the health risks associated with the new psychoactive substance, 
in  particular  with  respect  to  its  acute  and  chronic  toxicity,  abuse  liability, 
dependence-producing  potential,  and  its  physical,  mental  and  behavioural 
effects;  

an analysis of the social risks associated with the new psychoactive substance, 
in  particular  its  impact  on  social  functioning,  public  order  and  criminal 
activities,  the  involvement  of  criminal  groups  in  the  manufacture  and 
distribution of the new psychoactive substance; 

EN 

11 

   EN 

 
(e) 

(f) 

information on the prevalence and patterns of the use of the new psychoactive 
substance, its availability and potential for diffusion within the Union; 

information  on  the  commercial  and  industrial  use  of  the  new  psychoactive 
substance, the extent of such use(s), as well as its use for scientific research and 
development purposes. 

The  Scientific  Committee  shall  assess  the  risks  posed  by  the  new  psychoactive 
substance  or  group  of  new  psychoactive  substances.  The  Committee  may  be 
extended  as  deemed  necessary  by  the  Director,  acting  on  the  advice  of  the 
chairperson  of  the  Scientific  Committee,  by  including  experts  representing  the 
scientific fields relevant for ensuring a balanced assessment of the risks of the new 
psychoactive substance. The Director shall designate them from a list of experts. The 
Management Board shall approve the list of experts every three years.  

The  Commission,  the  Centre,  Europol  and  the  European  Medicines  Agency  shall 
each have the right to nominate two observers. 

The  Scientific  Committee  shall  carry  out  the  risk  assessment  on  the  basis  of  the 
available information and of any other relevant scientific evidence. It shall take into 
account  all  opinions  held  by  its  members.  The  Centre  shall  organise  the  risk 
assessment  process,  including  identifying  future  information  needs  and  relevant 
studies.  

The  Centre  shall  submit  the  risk  assessment  report  to  the  Commission  within  six 
weeks from the receipt of the request from the Commission. 

Upon duly motivated request of the Centre, the Commission may extend the period 
to complete the risk assessment or combined risk assessment to allow for additional 
research  and  data  collection  to  take  place.  The  request  of  the  Centre  shall  contain 
information  on  the  period  of  time  needed  to  complete  the  risk  assessment  or 
combined risk assessment. 

 Article 5d 

Exclusion from risk assessment 

No risk assessment shall be carried out where the new psychoactive substance is at 
an advanced stage of assessment within the United Nations system, namely once the 
World Health Organisation expert committee on drug dependence has published its 
critical  review  together  with  a  written  recommendation,  except  where  there  is 
significant information that is new or of particular relevance for the Union and that 
has not been taken into account by the United Nations system. 

No  risk  assessment  shall  be  carried  out  where  the  new  psychoactive  substance  has 
been  assessed  within  the  United  Nations  system,  but  it  has  been  decided  not  to 
schedule it under the 1961 Single Convention on Narcotic Drugs, as amended by the 
1972  Protocol,  or  the  1971  Convention  on  Psychotropic  Substances,  except  where 
there is significant information that is new or of particular relevance for the Union. 

4. 

5. 

6. 

7. 

1. 

2. 

3. 

No risk assessment shall be carried out where the new psychoactive substance is:  

(a) 

an  active  substance  in  a  medicinal  product  or  a  veterinary  medicinal  product 
that has obtained a marketing authorisation;  

EN 

12 

   EN 

 
(b)   an  active  substance  in  a  medicinal  product  or  a  veterinary  medicinal  product 

that is the subject of an application for a marketing authorisation; 

(c) 

an  active  substance  in  a  medicinal  product  or  a  veterinary  medicinal  product 
that has obtained a marketing authorisation, but the marketing authorisation has 
been suspended, but has not yet been withdrawn, by the competent authority; 

(d) 

an active substance involved in authorised clinical trials and in investigational 
medicinal products." 

(4) In Article 13 (2) the fourth subparagraph is replaced by the following: 

"For the purpose of assessing the risks posed by the psychoactive substance or group of new 
psychoactive substances, the Scientific Committee may be extended following the procedure 
laid down in Article 5c(4)." 

Article 2 

This  Regulation  shall  enter  into  force  on  [the  same  day  as  the  day  for  transposition  of 
Directive (EU) …/ … [amending Council Framework Decision 2004/757/JHA of 25 October 
2004  laying  down  minimum  provision  on  the  constituent  elements  of  criminal  acts  and 
penalties in the field of illicit drug trafficking].  

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 

13 

   EN 

 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

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 mode(s) planned  

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 contributions  

3.3.  Estimated impact on revenue

EN 

14 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

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 1920/2006  of 12 December 2006 on the European Monitoring 
Centre  for  Drugs  and  Drug  Addiction  as  regards  information  exchange,  early 
warning system and risk assessment procedure on new psychoactive substances 
Policy area(s) concerned in the ABM/ABB structure20  

1.2. 

18 – Migration and Home Affairs 

1.3. 

Nature of the proposal/initiative  

  The  proposal/initiative  relates  to  a  new  action  in  the  mandate  of  the  Agency 
(exponential growth) 

  The  proposal/initiative 
project/preparatory action21  

relates 

to  a  new  action 

following  a  pilot 

 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. 

Objective(s) 

1.4.1.  The  Commission's  multiannual 

strategic  objective(s) 

targeted  by 

the 

proposal/initiative  

The Commission Work Programme 2016, title "An area of justice and fundamental 
rights based on mutual  trust" refers to  the implementation  of the European  Agenda 
on Security (COM(2015) 185 final adopted on 28.4.2015. The European Agenda on 
Security states:  

"The market for illicit drugs remains the most dynamic of criminal markets, with a 
recent  trend  being  the  proliferation  of  new  psychoactive  substances  (NPS).  The 
production of NPS increasingly  takes  place  in  the  EU and  points  to  the urgency of 
adopting a new legislative framework." 

1.4.2.  Specific objective(s) and ABM/ABB activity(ies) concerned  

Relevant general objective:  

Contribute  to  ensuring  a  high  level  of  security  in  the  European  Union  while 
facilitating  legitimate  travel,  through  a  uniform  and  high  level  of  control  at  the 
external borders and the effective processing of Schengen visas, in compliance with 
the Union’s commitment to fundamental freedoms and human rights. 

Specific objective 6:  

To support initiatives in the field of drugs policy as regards judicial cooperation and 
crime  prevention  aspects  closely  linked  to  the  general  objective  of  the  Justice 
Programme, insofar as they are not covered by the ISF of by the Health for Growth 
programme. 

20 
21 

ABM: activity-based management; ABB: activity-based budgeting. 
As referred to in Article 54(2)(a) or (b) of the Financial Regulation. 

EN 

15 

   EN 

                                                 
Specific objective 7:  

To contribute to reducing drug use and trafficking, and the harms that drugs cause to 
individuals and to society, through measures to reduce the availability of new drugs, 
to improve the quality of drug-demand reduction services and the understanding of 
drug  supply,  by  supporting  actions  to  raise  awareness  about  the  risks  of  drugs, 
enhance  the  effectiveness  of  treatment  and  support  cross-border  operational 
cooperation against drug  

ABM/ABB activity(ies) concerned 

Anti-drugs 

1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

Providing  for  an  effective  and  efficient  early  warning  system  and  risk  assessment 
procedure  on  new  psychoactive  substances  in  order  to  proactively  protect, identify, 
validate, respond and prevent serious harms caused by new psychoactive substances, 
and  to  ensure  that  harmful  new  psychoactive  can  be  incriminated  in  all  Member 
States on the basis of  Council Framework Decision 2004/757/JHA [as amended by 
Directive (EU) …/…] 

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

Result indicator 1 (objective 6):  

Number  of  new  psychoactive  substances  assessed  (including  through  testing,  if 
necessary)  to  enable  the  EU  or  the  Member  States  to  take  appropriate  action  to 
protect  consumers,  depending  on  the  type  and  level  of  risk  that  may  pose  when 
consumed by humans. 

Result indicator 3 (objective 7):  

Degree to which new psychoactive substances which are notified by several Member 
States  and  which  seem  to  pose  risks  are  subjected  to  risk  assessment  (including  to 
testing,  if  necessary)  to  enable  the  EU  or  the  Member  States  to  take  appropriate 
action to protect consumers. 

EN 

16 

   EN 

 
1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

-  

-  

-  

To  protect  the  health  of  individuals  from  the  risks  posed  by  harmful  new 
psychoactive substances 

To  provide  a  basis  for  decision-making  on  Union 
level  concerning 
incrimination of harmful new psychoactive substances on the basis of Council 
Framework Decision 2004/757/JHA [as amended by Directive (EU) …/…] 

To  improve  the  capacity  to  rapidly  identify  and  assess  new  psychoactive 
substances 

1.5.2.  Added value of EU involvement 

A  strengthened  early  warning  system  would  boost  the  exchange  of  information 
among  Member  States,  with  the  clear  added  value  of  alerting  Member  States  to 
potentially  harmful  substances  that  have  emerged  in  other  Member  States,  to  help 
them  anticipate  a  potential  public  health  threat.  The  assessment  of  risk  of  new 
psychoactive  substances  at  EU  level  has  the  added  value  of  pooling  scientific 
resources  and  analytical  capacities  from  across  the  Union  and  to  provide  the  best 
evidence available on a substance, thus forming a solid basis of decision making on 
Union level on new psychoactive substances based on Council Framework Decision 
2004/757/JHA [as amended by Directive (EU) …/…] 

1.5.3.  Lessons learned from similar experiences in the past 

The  current  system  based  on  Council  Decision  2005/387/JHA  on  the  information 
exchange, risk-assessment and control of new psychoactive substances is too slow to 
address effectively the fast growing number of new psychoactive substances. 

1.5.4.  Compatibility and possible synergy with other appropriate instruments 

Action  in  the  field  of  new  psychoactive  substances  is  in  compliance  with  Union 
strategic policy documents, in particular the European Agenda on Security22 and the 
EU  Drugs  Strategy  2013-2020.  EU  action  in  the  field  of  new  psychoactive 
substances is also fully consistent with action at the United Nation's level. 

1.6. 

Duration and financial impact  

 Proposal/initiative of limited duration  

–   Proposal/initiative in effect from [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 2017 to 2020, 

–   followed by full-scale operation. 

1.7. 

Management mode(s) planned23 

 Direct management by the Commission 

22 
23 

COM(2015) 185 final. 
Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the 
BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 

EN 

17 

   EN 

                                                 
–   by its departments, including by its staff in the Union delegations;  

–   by the executive agencies  

 Shared management with the Member States  

 Indirect management by entrusting budget implementation tasks to: 

–   third countries or the bodies they have designated; 

–   international organisations and their agencies (to be specified); 

–  the EIB and the European Investment Fund; 

–   bodies referred to in Articles 208 and 209 of the Financial Regulation; 

–   public law bodies; 

–   bodies governed by private law with a public service mission to the extent 

that they provide adequate financial guarantees; 

–    bodies  governed  by  the  private  law  of  a  Member  State  that  are  entrusted 
with  the  implementation  of  a  public-private  partnership  and  that  provide 
adequate financial guarantees; 

–    persons  entrusted  with  the implementation  of  specific  actions in  the CFSP 

pursuant to Title V of the TEU, and identified in the relevant basic act. 

–  If  more  than  one  management  mode  is  indicated,  please  provide  details  in  the  ‘Comments’ 

section. 

Comments  

EN 

18 

   EN 

 
2. 

MANAGEMENT MEASURES  

2.1. 

Monitoring and reporting rules  

Specify frequency and conditions. 

According  to  Article  23  of  Regulation  No  1920/2006  establishing  the  European 
Monitoring  Centre  for  Drugs  and  Drug  Addiction  an  external  evaluation  of  the 
Centre  takes  place  every  six  years  which  coincide  with  the  completion  of  two 
subsequent 3-year working programmes of the Centre. 

According  to  Article  9(7)  of  Regulation  No  1920/2006  establishing  the  European 
Monitoring  Centre  for  Drugs  and  Drug  Addiction  "The  Management  Board  shall 
adopt  the  annual  report  on  the  Centre’s  activities  and  forward  it  by  15  June  to  the 
European  Parliament,  the  Council,  the  Commission,  the  Court  of  Auditors  and  the 
Member States." 

2.2. 

Management and control system  

2.2.1.  Risk(s) identified  

Possible delays in implementation to be mitigated by regular monitoring 

2.2.2. 

Information concerning the internal control system set up 

Standard  Commission  control/infringment  procedures  concerning  the  application  of 
the amended Regulation 

2.2.3.  Estimate  of  the  costs  and  benefits  of  the  controls  and  assessment  of  the  expected 

level of risk of error  

Not relevant as no risks identified 

2.3. 

Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

According  to  Article  16  of  Regulation  No  1920/2006  establishing  the  European 
Monitoring  Centre  for  Drugs  and  Drug  Addiction,  in  order  to  combat  fraud, 
corruption  and  any  other  illegal  activies  affecting  the  Communities  financial 
interests, the provisions of Regulation 1073/1999 shall apply without restrictions to 
the Centre. 

EN 

19 

   EN 

3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

 

Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Heading of 
multiannual 
financial 
framework 

Number  
Heading 3 

Type of  
expenditure 

Diff./Non-
diff.24  

Contribution  

from 
EFTA 
countries
25 

from 
candidate 
26 
countries

from third 
countries 

within the 
meaning of 
Article 21(2)(b) of 
the Financial 
Regulation  

European  Monitoring  Centre  for  Drugs 
and Drug Addiction (EMCDDA) 

18 06 02 

Diff. 

NO 

NO 

NO 

NO 

Heading of 
multiannual 
financial 
framework 

 

New budget lines requested - NA 

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure 

Contribution  

Number  
[…][Heading…………………………………
……] 

Diff./Non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the 
meaning of 
Article 21(2)(b) of 
the Financial 
Regulation  

[…][XX.YY.YY.YY] 

YES/N
O 

YES/NO 

YES/N
O 

YES/NO 

24 
25 
26 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

20 

   EN 

 
 
 
 
 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1.  Summary of estimated impact on expenditure  

Heading of multiannual financial  
framework  

Number 

 Heading 3 

EUR million (to three decimal places) 

Year 
201727 

Year 
2018 

Year 
2019 

Year 
2020 

Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

TOTAL 

EMCDDA 

 Operational appropriations  

Number of budget line 18 06 02 

Number of budget line 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

15,1356  15,1356  15,2866  15,5886 
15,1356  15,1356  15,2866  15,5886 

Appropriations  of  an  administrative  nature  financed  from  the 
envelope of specific programmes28  

Number of budget line 

TOTAL appropriations 
for EMCDDA 

 TOTAL operational appropriations  

Commitments 

Payments 

Commitments 

Payments 

(3) 

=1+1a 
+3 

=2+2a 

+3 

(4) 

(5) 

1 

1 

1 

1 

15,1356  15,1356  15,2866  15,5886 

15,1356  15,1356  15,2866  15,5886 

15,1356  15,1356  15,2866  15,5886 

15,1356  15,1356  15,2866  15,5886 

61,1464 
61,1464 

61,1464 

61,1464 

61,1464 

61,1464 

27 
28 

EN 

Year N is the year in which implementation of the proposal/initiative starts. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, 
direct research. 

21 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(6) 

TOTAL appropriations  
under HEADING 3 
of the multiannual financial framework 

Commitments 

=4+ 6 

15,1356  15,1356  15,2866  15,5886 

Payments 

=5+ 6 

15,1356  15,1356  15,2866  15,5886 

61,1464 

61,1464 

If more than one heading is affected by the proposal / initiative: NA 

 TOTAL operational appropriations  

Commitments 

Payments 

  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

Commitments 

=4+ 6 

Payments 

=5+ 6 

EN 

22 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

5 

‘Administrative expenditure’ 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  

TOTAL 

EUR million (to three decimal places) 

DG: HOME 

 Human resources  

 Other administrative expenditure  

0,402 

0,402 

0,402 

0,402 

TOTAL DG HOME 

Appropriations  

0,402 

0,402 

0,402 

0,402 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

0,402 

0,402 

0,402 

0,402 

1,6080 

1,6080 

1,6080 

Year29 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6) 

TOTAL 

EUR million (to three decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

15,5376  15,5376  15,6886 

Payments 

15,5376  15,5376  15,6886 

15,990
6 

15,990
6 

62,7544 

62,7544 

29 

Year N is the year in which implementation of the proposal/initiative starts. 

EN 

23 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.2.  Estimated impact on operational appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–    The proposal/initiative requires the use of additional operational appropriations, as explained below: 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

Enter as many years as necessary to show the 
duration of the impact (see point 1.6) 

TOTAL 

o
N

Cost  N

o

Cost 

o
N

Cost 

o
N

Cost  N

o

Cost  N

o

Cost  N

o

Cost 

Total 
No 

Total 
cost 

Indicate 
objectives and 
outputs*  

 

30

Type

Aver
age 
cost 

SPECIFIC OBJECTIVES No 6 & 7

31

- Output 

System 
develop
ment 

- Output 

 develop 

1 

0,2416 

1 

0,2416 

1 

0,0966 

1 

0,0966 

Subtotal for specific objectives No 6 & 7 

TOTAL COST 

1 

1 

0,2416 

0,2416 

1 

1 

0,2416 

0,2416 

1 

1 

0,0966 

0,0966 

1 

1 

0,0966 

0,0966 

* The output presented only covers the new task linked to the NPS. 

0,676 

0,676 

0,676 

30 
31 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in point 1.4.2. ‘Specific objective(s)…’  

EN 

24 

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  appropriations  of  an 
administrative nature  

–    The proposal/initiative requires the use of appropriations of an  administrative 
nature, as explained below: 

EUR million (to three decimal places) 

2017 32 

2018 

2019 

2020 

Enter as many years as necessary to show the 
duration of the impact (see point 1.6) 

TOTAL 

HEADING 5 
of the multiannual 
financial framework 

Human resources (FTE 
DG HOME) 

Other administrative 
expenditure  

Total HEADING 5 
of the multiannual 
financial framework  

2017 

2018 

2019 

2020 

0,402 

0,402 

0,402 

0,402 

0,402 

0,402 

0,402 

0,402 

TOTAL 

0,402 

0,402 

0,402 

0,402 

The  appropriations  required  for  human  resources  and  other  expenditure  of  an  administrative  nature  will  be  met  by 
appropriations from the DG that are already assigned to management of the action and/or have been redeployed 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. 

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  use  of  human  resources,  as  explained 
below: 

Estimate to be expressed in full time equivalent units 

1,6080 

1,6080 

1,6080 

Year 
N 

Year 
N+1 

Year N+2 

Ye
ar 
N+
3 

Enter 
as 
many 
years 
as 
necessa
ry to 
show 
the 
duratio
n of the 
impact 
(see 
point 
1.6) 

32 

Year N is the year in which implementation of the proposal/initiative starts. 

EN 

25 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 Establishment plan posts (officials and temporary staff) 

18 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

 External staff (in Full Time Equivalent unit: FTE)33  

XX 01 02 01 (AC, END, INT from the ‘global 
envelope’) 

XX 01 02 02 (AC, AL, END, INT and JED in the 
delegations) 

XX 01 04 yy34 

- at Headquarters 

- in Delegations  

XX 01 05 02 (AC, END, INT – Indirect research) 

10 01 05 02 (AC, END, INT – Direct research) 

Other budget lines (specify) 

TOTAL 

3 

3 

3 

3 

3 

3 

3 

3 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to management of the 
action  and/or  have  been  redeployed  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 staff 

External staff 

Represent  the  Commission  in  the  Management  Board  of  the  Agency.  Draw  up 
Commissin  opinion  on  the  annual  work  programme  and  monitor  its  implementation. 
Supervise the preparation of the Agency's budget and monitor implementation of the 
budget.  Assist  the  Agency  in  developing  its  activities  in  line  with  EU  policies 
including by participating in experts meetings. 

3.2.4.  Compatibility with the current multiannual financial framework  

–    The  proposal/initiative  is  compatible  with  the  current  multiannual  financial 
framework. 

–    The proposal/initiative will entail reprogramming of the relevant heading in the 
multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 

–    The  proposal/initiative  requires  application  of  the  flexibility  instrument  or 
revision of the multiannual financial framework. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 

3.2.5.  Third-party contributions  

33 

34 

AC=  Contract  Staff;  AL  =  Local  Staff;  END=  Seconded  National  Expert;  INT  =  agency  staff; 
JED= Junior Experts in Delegations. 
Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 

EN 

26 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
–    The proposal/initiative does not provide for co-financing by third parties.  

–  The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to three 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 
co-financed  

3.3. 

Estimated impact on revenue  

–    The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

–    on own resources  

–    on miscellaneous revenue  

Appropriation
s available for 
the current 
financial year 

Budget revenue line: 

Article …………. 

EUR million (to three decimal places) 

Impact of the proposal/initiative

35

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) 

For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected. 

Specify the method for calculating the impact on revenue. 

35 

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. 

EN 

27 

   EN