Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on European statistics on demography
Date: 2011-12-20
Institutions: European Commission
Subjects: EU statistics, data transmission, population statistics, statistical method

EUROPEAN COMMISSION 

Brussels, 20.12.2011 
COM(2011) 903 final 

2011/0440 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on European statistics on demography 

(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Aims and objectives of the proposal  

The aim of this proposal is to develop a Regulation on statistics on demography, which would 
regulate the harmonisation and provision of data on population and on vital events linked to 
the population. 

•  General context 

Due to increasing and complex demographic challenges, a clear need for common legislation 
at  European  level  on  the  subject  of  demographic  statistics  has  emerged.  The  European 
Commission needs high quality information on the population and vital events linked to the 
population  in  the  Union.  In  almost  every  policy  area  in  which  the  EU  is  active,  be  it 
economic,  social  or  environmental,  there  is  a  requirement  for  high  quality  demographic 
statistics  to  help  formulate  operational  objectives  and  to  evaluate  progress,  for  instance  in 
order  to  make  valid  comparisons  between  Member  States.  The  data  might  be  used  either 
directly  or  to  build  indicators  of  various  types  (demographic  indicators  and  'per  capita' 
indicators). 

The democratic process within the Union demands annual population estimates of the highest 
possible quality. Every year, total population data concerning the Member States, which are 
collected  and  published  by  Eurostat,  are  used  during  the  decision-making  process  of  the 
Union (qualified majority voting in the Council). Currently one criterion is that, if a Member 
State so requests, a qualified majority shall represent Member States comprising at least 62 % 
of the population of the EU calculated according to the population figures. The importance of 
population weights will be even greater when, under the terms of Article 16(4) of the Treaty 
on European Union, as from 1 November 2014 a qualified majority shall be defined as at least 
55  %  of  the  members  of  the  Council,  comprising  at  least  fifteen  of  them  and  representing 
Member States comprising at least 65 % of the population of the EU ('double majority'). 

The long-term assessment of the sustainability of the public finance of the Member States is 
conducted,  among  others,  on  the  basis  of  Eurostat  population  projections;  these,  in  turn, 
require timely, accurate, reliable and consistent time series on population, births and deaths, 
together  with  sound  assumptions  concerning  the  future  development  of  fertility,  life 
expectancy and migration flows. 

The  monitoring  of  the  EU  sustainable  development  strategy,  launched  by  the  European 
Council in Gothenburg in 2001 and renewed in 2006, is assessed via the Eurostat monitoring 
report which uses time series on old-age dependency ratios, fertility rates and life expectancy 
in the EU. 

The  monitoring  of  the  progress  made  in  the  EU  towards  achieving  economic,  social  and 
territorial cohesion is assessed by means of a report based, among others, on Eurostat regional 
demographic data. 

•  Existing provisions on the issue targeted by the proposal 

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There are no existing provisions on the issue targeted by the proposal. 

•  Consistency with other EU policies and objectives 

EU  legislation  requires  Eurostat  to  provide  population  data  of  the  highest  possible  quality. 
Moreover,  many  policy  areas  in  which  the  EU  is  active  require  information  on  vital  events 
linked  to  the  population  in  order  to  help  formulate  operational  objectives  and  evaluate 
progress. The data must be timely, accurate, complete, coherent and comparable at EU level, 
and are often requested at a level of regional detail, variable breakdown and quality that can 
only be guaranteed by European legislation on demographic statistics. 

The  proposed  Regulation  on  European  statistics  on  demography  enshrines  the  principles  of 
the European Statistics Code of Practice relating to quality commitment, sound methodology, 
cost-effectiveness, relevance, accuracy and reliability, coherence and comparability. 

Decision No 1578/2007/EC of the European Parliament and of the Council of 11 December 
2007 on the Community Statistical Programme 2008 to 20121 states that the key objective for 
demographic  statistics  will  be  to  provide  the  comprehensive  set  of  data  and  analyses 
necessary to assess the implications of demographic change in Europe. 

Data  covered  under  this  proposal  have  already  been  collected  for  a  number  of  years  on  a 
voluntary  basis.  This  may  involve  a  diversity  of  demographic  definitions,  concepts  and 
methods  adopted  in  the  Member  States  and  a  high  risk  of  heterogeneity,  incomparability, 
inconsistency  and  lack  of  timeliness  of  the  data  concerned.  Additionally,  following  the 
adoption of Regulation (EC) No 862/2007 of the European Parliament and of the Council of 
11 July 2007 on Community statistics on migration and international protection and repealing 
Council Regulation (EEC) No 311/76 on the compilation of statistics on foreign workers2 and 
of  Regulation  (EC)  No  763/2008  of  9  July  2008  on  population  and  housing  censuses3,  the 
current proposal is intended to complete the harmonisation in the field of human population 
data. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

•  Internal exchanges/discussions between Commission services 

The main Commission services concerned during the development process were DG SG, DG 
EMPL, DG REGIO, DG SANCO, DG ECFIN and DG AGRI. Their opinions were officially 
requested  through  written  consultation  during  the  preparatory  phase  (ex-ante  evaluation)  of 
the  proposal.  There  has  been  frequent  and  regular  communication  throughout  the 
development  process,  including  both  bilateral  discussions  and  regular  attendance  in  the 
Demography Working Group. All of the services consulted expressed a favourable opinion on 
the project, underlining their needs as well as the legal and political basis for these needs. 

•  Consultation of interested parties 

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3 

OJ L 344, 28.12.2007, p. 15. 
OJ L 199, 31.7.2007, p. 23. 
OJ L 218, 13.8.2008, p. 14. 

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Member States have been aware for some time already that Eurostat is planning a legislative 
initiative  in  the  area  of  demographic  data.  Preparatory  work  of  various  kinds  for  a  draft 
framework  Regulation  on  annual  demographic  statistics  has  been  going  on  in  the 
Commission's Annual Statistical work Programmes since 2007. 

Since  March  2008,  Eurostat  has  actively  provided  information  to  the  Member  States  at  the 
meetings of the Demography Working Group. In November 2009, the Demography Working 
Group acknowledged the need for European legislation on the collection of demographic data. 
On that occasion, an ex-ante evaluation of the proposal was presented and discussed together 
with the first draft version of the Regulation. Comments on the first draft were received from 
Member  States  and  incorporated  in  the  revised  draft  that  was  sent  at  the  end  of  2010  for 
further comments. This second round of comments was incorporated in the second version of 
the  Regulation  that  was  discussed  in  the  Demography  Working  Group  in  April  2011.  The 
European Directors of Social Statistics were kept regularly informed of the state of progress. 

The  proposal  was  also  presented  to  the  European  Statistical  System  Committee  on  17 
November 2011.  

In addition to regular meetings, information was circulated via a dedicated CIRCA website. 

•  Collection and use of expertise 

The  international  recommendations  of  the  United  Nations  on  Population  and  Housing 
Censuses and on Vital Statistics are the reference source for the proposed definitions. 

•  Analysis of effects and implications 

The proposed framework for European Union statistics on demography ensures that the data 
are  timely,  more  coherent,  comparable,  consistent  and  thus  more  relevant  for  users  at  both 
European and national levels, in particular with the aim of counting each resident/birth/death 
only once in the statistics. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

The  objective  of  this  Regulation  is  to  establish  a  common  framework  for  the  systematic 
production of European Union statistics on demography, through the collection, compilation, 
processing  and  transmission  by  the  Member  States  of  harmonised  European  statistics  on 
population and vital events. 

•  Legal basis 

Article 338 of the Treaty on the Functioning of the European Union provides the legal basis 
for  European  statistics.  Acting  in  accordance  with  the  ordinary  legislative  procedure,  the 
European  Parliament  and  the  Council  shall  adopt  measures  for  the  production  of  statistics 
where  necessary  for  the  performance  of  the  activities  of  the  Union.  It  sets  out  the 
requirements relating to the production of European statistics, stating that they must conform 
to standards of impartiality, reliability, objectivity, scientific independence, cost-effectiveness 
and statistical confidentiality. It must not entail excessive burdens on economic operators. 

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•  Subsidiarity principle 

The  subsidiarity  principle  applies  insofar  as  the  proposal  does  not  fall  within  the  exclusive 
competence of the European Union. 

The objectives of the proposal cannot be sufficiently achieved by the Member States for the 
following reason. 

Two central quality concerns with any statistical data are coherence and comparability. Given 
that  data  on  population  and  vital  events  are  used  to  help  to  comply  with  EU  legislation,  to 
evaluate EU policies and/or to compare the results of national policies at a European level, it 
is  clearly  essential  that  the  underlying  data  must  be  comparable  at  a  European  level.  The 
Member  States  cannot  achieve  this  result  to  the  necessary  extent  without  a  clear  EU 
framework,  i.e.  EU  legislation  laying  down  common  statistical  concepts  and  quality 
requirements.  To  this  end,  a  Regulation  on  demography  is  proposed  for  adoption.  Without 
such  statistics,  collected  and  compiled  using  a  common  EU  framework,  the  relevance  and 
effectiveness of the national systems of demographic statistics would be diminished. 

Action by Member States alone would adversely affect the Member States’ interests for the 
following reason: 

The  lack  of  a  common  EU  framework  using  common  concepts  and  definitions  would 
jeopardise  or  completely  exclude  the  possibility  of  using  demographic  statistics  of  high 
quality. Past experience clearly shows that an informal understanding without an agreed, clear 
and  supervised  framework  does  not  result  in  statistical  output  of  the  quality  needed  in  the 
future. 

Action at European level will better achieve the objectives of the proposal for the following 
reasons: 

The objectives of the proposal can be better achieved at European level on the basis of an EU 
legal  act  because  only  the  Commission  can  coordinate  the  harmonisation  of  statistical 
information  at  EU  level.  However,  the  collection  of  data  and  compilation  of  comparable 
statistics  on  demography  can  be  organised  by  the  Member  States  by  using  the  most 
appropriate sources and methods to provide the required information. The EU may therefore 
take action to this end in accordance with the principle of subsidiarity, as set out in Article 5 
of the Treaty. 

The aim of the proposal is to harmonise concepts, subjects covered and characteristics of the 
required information, coverage, quality criteria and reporting deadlines and results, to achieve 
relevant, timely, comparable and coherent European statistics. 

The Member States will compile the data using their own national sources and practices, but 
are obliged to ensure the quality of the data and metadata transmitted, and to ensure that the 
chosen data sources and methodology meet common definitions. The Member States have to 
report  on  the  data  sources,  definitions  and  estimation  methods  used  to  fulfil  the  obligations 
and must provide information on any changes thereto. They shall provide Eurostat with all the 
information necessary to evaluate the quality of the statistical information. 

The proposal therefore complies with the subsidiarity principle. 

•  Proportionality principle 

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The proposal complies with the proportionality principle for the following reason: 

The Regulation is limited to the minimum required to achieve its objective and does not go 
beyond what is necessary for that purpose. The free choice of data sources in accordance with 
national laws and principles, together with the possibility of using estimation techniques and 
statistical  methods,  should  reduce  the  financial  and  administrative  burden  on  respondents, 
national, regional or local authorities and on citizens. 

•  Choice of instruments 

Proposed instrument: Regulation of the European Parliament and of the Council. 

Other means would not be adequate for the following reason: 

The  selection  of  the  appropriate  instrument  depends  on  the  legislative  goal.  Given  the 
information  needs  at  European  level,  the  trend  in  European  statistics  has  been  to  use 
regulations rather than directives as the basic acts. A regulation is preferable because it lays 
down the same law throughout the EU, leaving the Member States with no leeway to apply it 
incompletely or selectively. It is directly applicable, which means that it does not need to be 
transposed into national law. Directives, on the other hand, aim to harmonise national laws, 
are  binding  on  Member  States  as  regards  their  objectives,  but  leave  it  up  to  the  national 
authorities  to  choose  the  form  used  to  achieve  these  objectives.  They  also  have  to  be 
transposed into national law. The use of a regulation is in line with other European statistical 
legal acts adopted since 1997. 

4. 

BUDGETARY IMPLICATION 

The proposal has no implication for the Union budget. 

5. 

ADDITIONAL INFORMATION 

•  Repeal of existing legislation 

The adoption of the proposal will not lead to the repeal of existing legislation. 

•  European Economic Area 

The proposed act concerns an EEA matter and should therefore be extended to the European 
Economic Area. 

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2011/0440 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on European statistics on demography 

(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 338(1) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

In  accordance  with  Article  16(4)  of  the  Treaty  on  European  Union,  as  from  1 
November 2014, a qualified majority shall be defined on the basis of the population of 
the Member States. 

The  Economic  and  Financial  Affairs  Council  regularly  gives  a  mandate  to  the 
Economic  Policy  Committee  to  assess  the  long-term  sustainability  and  quality  of 
public finances on the basis of populations projections produced by Eurostat. 

In accordance with Regulation (EC) No 1059/2003 of the European Parliament and of 
the  Council  of  26  May  2003  on  the  establishment  of  a  common  classification  of 
territorial units for statistics (NUTS)4, all Member States’ statistics transmitted to the 
Commission  which  are  broken  down  by  territorial  units  must  use  the  NUTS 
classification.  Consequently,  in  order  to  establish  comparable  regional  statistics,  the 
territorial units should be defined in accordance with the NUTS classification. 

Pursuant to Article 175 of the Treaty on the Functioning of the European Union, the 
Commission  submits  every  three  years  a  report  to  the  European  Parliament,  the 
Council,  the  Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on 
the  progress  made  towards  achieving  economic,  social  and  territorial  cohesion.  The 
preparation of these reports and the regular monitoring of demographic developments 
and of possible future demographic challenges in the EU regions, including different 
types  of  regions  such  as  cross-border  regions,  metropolitan  regions,  rural  regions, 
mountain  and  island  regions,  require  annual  regional  data  at  NUTS  3  regional  level. 
Since demographic ageing displays strong regional differences,  Eurostat  is requested 

4 

OJ L 154, 21.6.2003, p.1. 

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to  prepare  regional  projections  on  a  regular  basis  in  order  to  complement  the 
demographic picture of the NUTS 2 regions in the European Union. 

In  accordance  with  Article  159  of  the  Treaty  on  the  Functioning  of  the  European 
Union the Commission shall draw up a report each year on progress in achieving the 
objectives of Article 151, including the demographic situation in the Union. 

The  Commission  in  its  Communication  on  "Solidarity  in  health:  reducing  health 
inequalities in the EU"5 supported the further development and collection of data and 
health indicators by age, sex, socio-economic status and geographic dimensions. 

The  EU  sustainable  development  strategy,  launched  by  the  European  Council  in 
Gothenburg in 2001 and renewed in June 2006, seeks the continuous improvement of 
the quality of life for current and future generations. The Eurostat monitoring report, 
which  is  published  every  two  years,  provides  an  objective  statistical  picture  of 
progress, based on the EU set of sustainable development indicators. 

Annual statistical data on demography are fundamental for the study and definition of 
a  wide  range  of  policies,  with  particular  regard  to  social  and  economic  issues,  at 
national and regional level. Statistics on population are an important denominator for a 
wide range of policy indicators. 

Demographic  statistics  on  population  constitute  an  essential  component  for  the 
estimation of total population in the framework of the European System of Accounts 
(ESA). 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

In order to ensure the quality, and in particular the comparability, of the data provided 
by the Member States, and in order for reliable overviews to be drawn up at European 
Union level, the data used should be based on the same concepts and refer to the same 
reference date or period. 

(11)  The  information  on  demography  should  be  consistent  with  the  relevant  information 
collected  pursuant  Regulation  (EC)  No  862/2007  of  the  European  Parliament  and  of 
the  Council  of  11  July  2007  on  Community  statistics  on  migration  and  international 
protection and repealing Council Regulation (EEC) No 311/76 on the compilation of 
statistics  on  foreign  workers6  and  Regulation  (EC)  No  763/2008  of  the  European 
Parliament and of the Council of 9 July 2008 on population and housing censuses7. 

(12)  Regulation  (EC)  No  223/2009  of  the  European  Parliament  and  of  the  Council  of  11 
March  2009  on  European  statistics8  provides  a  reference  framework  for  European 
statistics  on  demography.  In  particular,  it  requires  conformity  with  the  principles  of 
professional 
statistical 
confidentiality and cost effectiveness. 

independence, 

impartiality, 

objectivity, 

reliability, 

(13) 

In the development, production and dissemination of European statistics, the national 
and European statistical authorities should take account of the principles set out in the 

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8 

COM(2009) 567 
OJ L 199, 31.7.2007, p.23. 
OJ L 218, 13.8.2008, p.14. 
OJ L 87, 31.3.2009, p. 164. 

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European  Statistics  Code  of  Practice  as  reviewed  and  updated  by  the  European 
Statistical System Committee on 28 September 2011. 

(14)  This  Regulation  ensures  the  right  to  respect  for  private  and  family  life  and  to  the 
protection  of  personal  data,  as  set  out  in  Articles  7  and  8  of  the  Charter  of 
Fundamental Rights of the European Union9. 

(15)  Since  the  objective  of  this  Regulation,  namely  the  establishment  of  a  common  legal 
framework for the systematic production of European statistics on demography in the 
Member  States,  cannot  be  sufficiently  achieved  by  the  Member  States  and  can 
therefore,  by  reason  of  the  scale  and  effects  of  the  action,  be  better  achieved  at 
European  level,  the  Union  may  adopt  measures,  in  accordance  with  the  principle  of 
subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In  accordance 
with the principle of proportionality, as set out in that Article, this Regulation does not 
go beyond what is necessary to achieve that objective. 

(16) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing powers should be conferred on the Commission. Those powers should 
be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011  of  the  European 
Parliament and of the Council of 16 February 2011 laying down the rules and general 
principles concerning mechanisms for control by Member States of the Commission’s 
exercise of implementing powers10, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Subject matter 

This  Regulation  establishes  a  common  framework  for  the  development,  production  and 
dissemination of European statistics on population and vital events. 

Article 2 

Definitions 

For the purpose of this Regulation, the following definitions shall apply: 

(a) 

(b) 

'national'  means  the  same  as  in  Article 2(f) of Regulation (EC)  No 763/2008, 
where  the  territory  is  as  defined  in  Regulation  (EC)  No  1059/2003  in  the 
version applicable at the reference time; 

'regional' means the same as in Article 2(g) of Regulation (EC) No 763/2008 ; 
for  countries  that  are  not  members  of  the  European  Union,  it  means  the 
statistical regions at level 1, 2 or 3 as agreed between those countries and the 
Commission  (Eurostat),  according  to  the  version  applicable  at  the  reference 
time; 

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10 

OJ C 303, 14.12.2007, p. 1. 
OJ L 55, 28.2.2011, p. 13. 

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(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

'usually resident population' means all persons having their usual residence in a 
Member State at the reference time; 

'usual  residence'  means  the  same  as  in  Article  2(d)  first  paragraph  of 
Regulation  (EC)  No  763/2008.  The  following  persons  alone  shall  be 
considered to be usual residents of the geographical area in question: 

i 

ii 

those  who  have  lived  in  their  place  of  usual  residence  for  a 
continuous  period  of  at  least  12  months  before  the  reference 
time; or 

those who arrived in their place of usual residence during the 
12  months  before  the  reference  time  with  the  intention  of 
staying there for at least one year. 

In applying the definition of 'usual residence', Member States shall treat special 
cases as in the Annex to Commission Regulation (EC) No 1201/200911. 

'live birth' means the birth of a child who breathes or shows any other evidence 
of life, such as beating of the heart, pulsation of the umbilical cord or definite 
movement of voluntary muscles, regardless of gestational age; 

'death'  means  the  permanent  disappearance of all evidence of life at any time 
after live birth has taken place; 

'vital events' means live births and deaths as defined in points (e) and (f); 

'validated  data'  means  data  that  fulfil  a  set  of  quality  criteria  for  data 
compilation, including all the checks made in terms of the quality of the data to 
be published or already published. 

Article 3 

Data on population and on vital events 

1. 

2. 

3. 

Member States shall provide the Commission (Eurostat) with data on the population 
as referred to in Article 2(c) and (d) at the reference time. Where the circumstances 
described  in  Article  2  (d)i.  or  (d)ii.  cannot  be  established,  Member  States  shall 
provide the Commission (Eurostat) with data on population at their place of legal or 
registered  residence  at  the  reference  time;  in  this  case,  they  shall  undertake 
proportionate efforts to compute data which are the closest possible approximation to 
the population referred to in Article 2(c) and (d). 

Member States shall provide the Commission (Eurostat) with data on vital events at 
the reference time, regardless of the place where the events occurred. Member States 
shall use the same population definition as for the data referred to in paragraph 1. 

Member States shall use the same population definition for all national and regional 
levels as defined in Article 2 (a) and (b). 

11 

OJ L 329, 15.12.2009, p. 29.  

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4. 

Uniform conditions related to the breakdown of data referred to in paragraphs 1 and 
2,  as  well  as  to  the  frequency,  deadlines  and  revisions  of  data,  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 9(2). 

Article 4 

Total population for specific Union purposes 

For the purposes of qualified majority voting in the Council, Member States shall provide the 
Commission  (Eurostat)  with  data  on  the  total  population  at  national  level  at  the  reference 
time, as referred to in Article 2(c), within 8 months from the end of the reference year. For the 
purposes of this Article, Member States shall not provide data on population at their place of 
legal or registered residence at the reference time. 

Article 5 

Reference time 

1. 

2. 

3. 

The reference time for population data shall be the midnight of 31 December . 

The reference time for vital events data shall be the calendar year in which the events 
occurred. 

The first reference time to be taken into account for the purposes of this regulation 
shall be 2013. The last reference time shall be 2027. 

Article 6  

Provision of data and metadata 

Member States shall transmit to the Commission (Eurostat) the data and metadata required by 
this Regulation in accordance with the data and metadata exchange standards specified by the 
Commission  (Eurostat).  Member  States  shall  transmit  these  data  and  metadata  through  the 
Single  Entry  Point  or  shall  make  them  available  so  that  the  Commission  (Eurostat)  can 
retrieve them by electronic means. 

Article 7 

Data sources 

The data shall be based on the data sources chosen by the Member State in accordance with 
national  laws  and  practices.  Scientifically  based  and  well  documented  statistical  estimation 
methods shall be used where appropriate. 

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Article 8  

Quality requirements 

Member States shall ensure the quality of the data transmitted. 

For the purposes of this Regulation, the quality criteria referred to in Article 12(1) of 
Regulation (EC) No 223/2009 shall apply to the data to be transmitted. 

Member  States  shall  report  to  the  Commission  (Eurostat)  on  reference  metadata  in 
accordance with the Euro SDMX Metadata Structure, reporting in particular on the 
data sources, definitions and estimation methods used for the first reference year and 
Member  States  shall  keep  the  Commission  (Eurostat)  informed  of  any  changes 
thereto. 

At the request of the Commission (Eurostat), Member States shall provide it with all 
the information necessary to evaluate the quality of the statistical information. 

Member States shall ensure that the population data as required by Article 3 of this 
Regulation  are  consistent  with  those  required  by  Article  3  of  Regulation  (EC)  No 
862/2007. 

Article 9  

Committee 

The  Commission  shall  be  assisted  by  the  European  Statistical  System  Committee 
established by Regulation (EC) No 223/2009. 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 shall apply. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

Article 10 

Entry into force 

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

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

This Regulation shall cease to apply on 31 December 2027. 

Done at […], 

For the European Parliament 
The President 

For the Council 
The President 

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