REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL ON THE IMPLEMENTATION OF REGULATION (EU) 182/2011
Date: 2016-02-26
Institutions: European Commission, Secretariat-General
Subjects: European Commission, activity report, comitology, committee (EU), powers of the institutions (EU), transfer of competence

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 26.2.2016  COM(2016) 92 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL ON THE IMPLEMENTATION OF REGULATION (EU) 182/2011  
 
 
REPORT FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT AND THE COUNCIL ON THE 
IMPLEMENTATION OF REGULATION (EU) 182/2011 

1.  Introduction    

The Lisbon Treaty substantially modified the framework for the conferral of powers upon the 
Commission  by  introducing  a  distinction  between  delegated  and  implementing  powers. 
Article  291  (3)  TFEU  foresees  that,  unlike  for  delegated  acts  under  Article  290  TFEU,  the 
rules  and  general  principles  concerning  mechanisms  for  control  by  Member  States  of  the 
Commission's exercise of power be laid down in advance in regulations adopted by ordinary 
legislative procedure. This has led to the adoption of Regulation (EU) 182/20111.  

Article 15 of Regulation (EU) 182/2011 requires the Commission to  report to  the European 
Parliament and the Council on the implementation of the Regulation five years after its entry 
into  force.  This  report  complies  with  this  requirement.  In  doing  so,  it  concentrates  on  the 
elements newly introduced by Regulation (EU) 182/2011 compared to the Council Decision 
1999/468/EC, as amended by Council Decision 2006/512/EC, which provided the applicable 
framework before Regulation (EU) 182/2011. 

2. Overall context and functioning of Regulation (EU) 182/2011 

Regulation  (EU)  182/2011  entered  into  force  on  1  March  2011.  It  did  not  require  any 
measures to be taken by the Member States. On the Commission side, the standard rules of 
procedure for committees referred to in Article 9 of Regulation (EU) 182/2011 were adopted 
on 8 July 2011 and published in the Official Journal on 12 July 20112. The rules of procedure 
of  the  individual,  existing  committees  were  over  time  adapted  to  the  new  standard  rules  of 
procedure. The register foreseen in Article 10 of the Regulation  already existed since  2002, 
was thoroughly revamped in 2008 and in 2011 and is being continuously improved.  

The transitional provisions in Article 13, which provided for an automatic application of the 
new  procedures  to  existing  legislation,  and  in  Article  14,  which  addressed  pending 
procedures,  allowed  for  an  immediate  application  of  Regulation  (EU)  182/2011  as  from  1 
March 2011 and hence a smooth transition.     

The Commission reports to the European Parliament and the Council in its annual reports on 
the  working  of  the  committees3.  The  table  below  gives  an  overall  summary  of  data  on  the 
working  of  the  committees  since  the  entry  into  force  of  Regulation  (EU)  182/2011  and  the 
two  preceding  years.  The  annual  reports  also  cover  data  on  the  regulatory  procedure  with 

1   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 powers, OJ L 55, 28.2.2011, p. 13–18 

2   OJ C 206, 12.7.2011, p.11 
3   Annual reports on the functioning of the committees, available on 

http://ec.europa.eu/transparency/regcomitology/index.cfm?do=Report.Report  

2 

 
 
 
                                                            
scrutiny (RPS), a procedure foreseen under Decision 1999/468/EC, which still applies where 
foreseen in the basic act4.  

Committees   Opinions   Measures adopted   Positive 
opinions  
2 003 
1 783 

1 808 (131 RPS) 
1 812 (164 RPS)  

2 091 
1 904 

266 
259 

No 
opinions  
78 
121 

Negative  
opinions  
10 
0 

2009 
2010 

268 
270 
302 
287 

2011* 
2012 
2013 
2014 
Table 1, data from the annual reports on the functioning of the committees, the total number of positive opinions 
delivered  by  committees  may  differ  from  the  number  of  acts  adopted  by  the  Commission  if  opinions  are 
delivered one year but the acts are not adopted until the following year. * Figures relate to the entire year 2011  

1 788 (163 RPS) 
1 824 (167 RPS) 
1 887 (171 RPS) 
1 728 (165 RPS)  

1 868 
1 923 
1 916 
1 889 

1 789 
1 845 
1 845 
1 838 

75 
78 
50 
51 

4 
0 
0 
0 

Overall  the  figures  indicate  that  the  Regulation  has  allowed  a  seamless  continuation  of  the 
system.  When  comparing  the  figures  since  2011  to  the  years  before  the  application  of 
Regulation  (EU)  182/2011,  both  the  number  of  committees  and  their  activity  has  remained 
stable.  The  number  of  committees  was  at  266  in  2009  and  at  287  in  2014.  Similarly  the 
number of measures adopted was at 1808 in 2009 and at 1728 in 2014.  

Building  on  experience,  the  Regulation  introduced  in  its  Article  3  a  number  of  provisions 
linked to the working of the committees that reflected common practice, but were not spelled 
out in the legislation before. This includes provisions on the use of the written procedure, an 
explicit requirement for the chair to find solutions that command the widest possible support 
within  the  committee  and  the  possibility  to  amend  the  draft  acts  prior  to  the  vote  to  take 
account  of  the  discussions  of  the  committee.  These  common  provisions  continued  to  be 
effective  and  useful  in  ensuring  a  proper  functioning  of  the  committees.  The  written 
procedure  is  widely  used  -  in  2014  there  were  773  committee  meetings  and  893  written 
procedures and figures are similar in the years before - and it is an efficient tool. The work of 
the  committees  remains  consensual:  the  overwhelming  percentage  of  opinions  (well  over 
90%) are positive opinions, the majority of these adopted by unanimous vote or by consensus 
of the committee members, and there are hardly any negative and relatively few no opinions. 

Regulation (EU) 182/2011 provides a comprehensive and exhaustive legal framework for the 
Commission's  exercise  of  implementing  powers.  The  outcome  of  the  negotiations  on  the 
Interinstitutional  Agreement  on  Better  Law-Making5  foresees  a  commitment  by  the 
institutions to refrain from adding, in Union legislation, procedural requirements which would 
alter the mechanisms for control established by Regulation (EU) 182/20116.  

4   See Article 12 of Regulation(EU) 182/2011 
5   Based on COM(2015) 216 final  
6   The signature of the Interinstututional Agreement by the three institutions is expected to follow the formal 

approval by the European Parliament in the coming weeks  

3 

 
 
 
 
                                                            
In the framework of the Communication on Better Regulation7 the Commission committed to 
several measures intended to improve the mechanisms to listen more closely to citizens and 
stakeholders, and be open to their feedback, at every stage of the policy making process. In 
relation  to  implementing  acts  the  Commission  committed  that  important  implementing  acts 
which  are  subject  to  committee  opinion  will  be  made  public  for  four  weeks,  allowing 
stakeholders  to  submit  comments  before  any  vote  by  Member  States  in  the  relevant 
committee.  This  will  significantly  increase  the  transparency  for  implementing  acts  in  the 
phase before the committee vote. 

3. Main changes 

3.1 The reduction of the number of committee procedures 

One of the objectives of Regulation  (EU) 182/2011 was to  simplify the system by reducing 
the  number  of  committee  procedures.  The  old  regulatory  and  management  procedures  were 
replaced  by  the  examination  procedure,  while  the  advisory  procedure  was  maintained.  The 
reduction of the number of procedures has not raised particular issues.  

3.2 The creation of the appeal committee  

The  appeal  committee  was  a  novelty  introduced  by  Regulation  (EU)  182/2011.  It  was 
introduced to create a second layer to address issues on which the committee could not find 
agreement. Referral to the appeal committee is a rather exceptional step in the procedure. It is 
a  possibility  to  move  ahead  in  case  of  a  negative  opinion  or  a  no  opinion  with  a  blocking 
effect8 if the implementing act is deemed necessary.      

The  appeal  committee  adopted  its  rules  of  procedure  on  29  March  2011.  The  Commission 
already  made  in  accordance  with  Article  14  of  the  rules  of  procedure  (the  review  clause)  a 
first evaluation how these rules of procedure operate in practice. The outcome of this review 
was included in the 2013 Annual Report on the working of the committees9.   

Overall number of 
Appeal 
Committees 
referrals  
8 

2011 

2012 

6 

DGs/policy 
areas 
concerned  

Appeal 
committee 
positive  

Appeal 
committee 
negative 

Appeal 
committee 
no opinion 

Plant 
protection 
products, 
medicinal 
products  
Genetically 
modified 
food and feed  

2 

0 

1 

0 

5 

6 

Measures 
adopted 
in 
case  of  no 
opinion 
5 

6 

7   COM(2015) 215 of 19.05.2015 
8   A no opinion has a blocking effect in the cases listed in Article 5(4) of Regulation (EU) 182/2011, i.e. in the 
areas of taxation, financial services, the protection of the health or safety of humans, animals or plants, or 
definitive multilateral safeguard measures, the basic act provides that the draft implementing act may not 
be  adopted  where  no  opinion  is  delivered;  or  a  simple  majority  of  the  component  members  of  the 
committee opposes it. 

9   COM(2014) 572 final 

4 

 
 
 
                                                            
0 

0 

9 

8 

2013 

9 

2014 

13 

Genetically 
modified 
food and 
feed, plant 
protection 
products, 
biocidal 
products, 
community 
customs code   
Genetically 
modified 
food and 
feed, rules 
and standards 
on ship 
inspections   

2 

0 

1 

11 

11 

31 

30 

Total   
Table 2, data from the Comitology Register and the annual reports  

36 

4 

So far the appeal committee has mainly been convened in relation to one policy area, namely 
health and consumer protection, and more specifically in relation to genetically modified food 
and  feed  and  plant  protection  products.  In  these  cases  the  appeal  committee  has  so  far 
confirmed  the  no  opinion  outcome  of  the  committee.  The  Commission  Communication 
'Reviewing  the  decision-making  process  on  genetically  modified  organisms  (GMOs)10' 
provides a detailed analysis of the decision-making process in the area of genetically modified 
food and feed.  

Overall the referral to the appeal committee has taken place with a comparable frequency to 
the earlier referrals to the Council, which are no longer permitted under the new institutional 
framework. Those referrals occurred in similar policy areas and with similar outcomes. On the 
practical  side,  experience  shows  that  Member  States  were  so  far  in  nearly  all  cases 
represented by members of the Permanent Representation.  

     3.3 The flexibility for the Commission to adopt in case of a no opinion (examination 
procedure)  

Regulation (EU) 182/2011 introduced more flexibility for the Commission in case there is no 
qualified majority in favour or against the draft (referred to as a no opinion) in the committee 
in the examination procedure. Previously, both the management and the regulatory procedure 
foresaw that in case of a no opinion in the committee, respectively if the Council did not act, 
the  Commission  'shall'  adopt  the  measure.  Regulation  (EU)  182/2011  provides  that  the 
Commission  'may'  adopt,  either  in  case  of  a  no  opinion  in  the  committee,  or  in  the  appeal 
committee. Increased flexibility was introduced to enable the Commission to reconsider draft 
measures  and to  be  in  a position to decide whether or  not to adopt the draft measures or  to 
present  an  amended  draft  to  the  committee,  taking  account  inter  alia  of  positions  expressed 
within the committee.  

10   COM(2015) 176 final 

5 

 
 
 
                                                            
This  increased  flexibility  is  subject  to  a  number  of  exceptions  listed  in  Article  5(4)  of 
Regulation  (EU)  182/2011,  i.e.  in  certain  policy  areas  (taxation,  financial  services,  the 
protection  of  the  health  or  safety  of  humans,  animals  or  plants,  or  definitive  multilateral 
safeguard  measures),  if  the  basic  act  provides  that  the  draft  implementing  act  may  not  be 
adopted  where  no  opinion  is  delivered  (no  opinion  clause)  or  if  a  simple  majority  of  the 
component members of the committee opposes it. In these cases the Commission is prevented 
from adopting the draft. If the act is nevertheless deemed necessary the chair can submit an 
amended version of the implementing act to the committee or refer it to the appeal committee. 
The inclusion of a no opinion clause in the basic act must respond to a specific need and must 
be  justified  by  the  legislator.  Since  the  entry  into  force  of  Regulation  (EU)  182/2011  the 
Commission has made statements in that sense in about 30 cases in response to the legislator 
which  had  introduced  such  clauses  in  basic  legal  acts  without  providing  justifications  for 
doing so. The majority of actual no opinion votes have so far, however, taken place in areas 
that are either already covered by the specific policy areas listed in Article 5(4), and where the 
Commission  cannot  adopt  without  going  to  the  appeal  committee,  or  in  areas  (notably 
customs,  agriculture,  development  cooperation  and  trade)  in  which  none  of  the  three 
exceptions apply and the Commission could adopt the act anyhow without having to seize the 
appeal committee.    

Commission adopted measure 

Commission  did  not 
measure 

adopt 

2011 
2012 
2013 
2014 
Total  
Table 3, data extracted from the Comitology Register (excluding the appeal committee), data may differ from 
that in the annual report  

63 
70 
47 
42 
222 

4 
3 
2 
3 
12 

The  data  above  shows  that  the  Commission  does  not  frequently  use  the  possibility  to  not 
adopt  the  act  in  case  of  no  opinion.  In  practice  the  Commission's  flexibility  is  significantly 
reduced in cases relating to the authorisation of products or substances, such as in the area of 
genetically  modified  food  and  feed,  as  the  Commission  is  required  to  adopt  a  decision 
(authorising or prohibiting the placing on the market) within a reasonable amount of time. It 
cannot abstain from taking a position. In these cases the Commission is also prevented from 
adopting the draft act in case of no opinion of the committee, to do so it must first refer the 
draft act to the appeal committee. This also partially explains why the appeal committee was 
so far mainly convened in this policy area. To address the particular situation in the field of 
genetically  modified  food  and  feed,  and  following  the  solution  found  for  cultivation 
authorisations,  the  Commission  adopted  in  April  2015  a  proposal11  to  amend  the  legislative 
framework. While the authorisation process is maintained, the proposal foresees that Member 

11   Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  amending  Regulation  (EC)  No 
1829/2003  as  regards  the  possibility  for  the  Member  States  to  restrict  or  prohibit  the  use  of  genetically 
modified food and feed on their territory, COM/2015/0177 final of 22.04.2015  

6 

No  opinions 
in 
examination 
procedure   
67 
73 
49 
45 
234 

 
 
 
                                                            
States may restrict or prohibit the use of genetically modified food or feed on their territory. 
The  use  of  this  possibility  has  to  be  based  on  grounds  other  than  those  related  to  risks  to 
human and animal health and to the environment, which are addressed at EU level.  

The  newly  granted  flexibility  for  the  Commission  to  decide  whether  to  adopt  a  draft 
implementing act in the case of no opinion is useful. Even though used so far in few cases12, it 
allowed  the  Commission  to  reassess  the  draft  measure  after  the  voting  results  and  the 
discussion in the committee had shown that it did not enjoy the widest possible support within 
the committee.  

3.4 The criteria for the choice between the procedures  

Regulation  (EU)  182/2011  sets  out  the  criteria  for  the  choice  of  procedures.  Article  2(2) 
establishes  a  number  of  cases  in  which  the  examination  procedure  is  generally  assumed  to 
apply.  The  advisory  procedure  applies  in  principle  to  all  cases  to  which  the  examination 
procedure does not apply. The criteria for the choice of the examination procedure are similar 
to  those  provided  for  in  the  1999  Comitology  Decision.  Overall,  the  choice  of  procedure 
appears  to  have  been  uncontroversial.  One  notable  exception  is  the  case  of  the  conciliation 
committee  discussing  mainly  about  the  choice  of  procedure  (relating  to  Macro-financial 
assistance to Georgia13). 

adopted 

Acts 
procedure   

under 

examination 

adopted  under 

Acts 
procedure  

the 

advisory 

2011 
2012 
2013 
2014 
Table 4, data extracted from the Comitology Register, data may differ from that in the annual report  

1 311 
1 591 
1 579 
1 437 

77 
121 
143 
122 

The examination procedure is clearly the procedure applicable in the majority of cases, only 
about 10% of the opinions are adopted by advisory procedure. This reflects largely the split of 
management/regulatory versus advisory procedure under the previous regime.   

3.5 The scrutiny right for the European Parliament and the Council in case of basic 
acts adopted under the ordinary legislative procedure 

Both  legislators  must  be  properly  and  continuously  informed  of  committee  proceedings 
through  the  Comitology  Register.  The  legislators  have  a  right  of  scrutiny  over  draft 
implementing acts based on acts adopted under the ordinary legislative procedure. This means 
that at any stage of the procedure they can indicate to the Commission that the draft exceeds 
the  implementing  powers  provided  in  the  basic  act.  In  such  case  the  Commission  has  to 
review  the  draft  and  inform  the  European  Parliament  and  the  Council  whether  it  intends  to 
maintain, amend or withdraw it.    

12   One of them was the draft Commission Implementing Regulation amending Implementing Regulation (EU) 

No 29/2012 on marketing standards for olive oil, which the Commission decided not to adopt. 

13   2010/0390(COD) 

7 

 
 
 
                                                            
The  two  main  differences  here  in  relation  to  the  situation  before  are  that  there  is  no  fixed 
scrutiny  period  any  longer  and  that  now  the  scrutiny  right  also  applies  to  the  Council.  The 
abolition of the one month standstill period has brought efficiency gains and has not proved 
problematic, especially given the fact that in practice the average time between the vote in the 
committee and the adoption of the implementing act lies between 30 and 50 days (thus in any 
case  longer  than  the  previous  one  month  period).  The  scrutiny  right  has  not  been  used  by 
Council and only in 4 cases by the European Parliament by the end of January 201614. In one 
of  these,  the  European  Parliament  adopted  a  resolution15  after  the  implementing  act  was 
adopted  criticising  the  short  timeline  between  the  transmission  to  the  committee  and  the 
adoption.  

3.6 The specific procedural requirements for trade defence measures (anti-dumping 
and countervailing measures)  

A  novelty  compared  to  the  earlier  system  is  that  trade  defense  measures  (anti-dumping  and 
countervailing  measures)  are  now  also  submitted  to  committee  control,  albeit  with  specific 
safeguards. First, in case of antidumping and countervailing measures in which the committee 
delivers  no  opinion  and  a  simple  majority  opposes  the  draft  implementing  act  the  appeal 
committee  must  be  seized.  A  consultation  process  of  Member  States  and  specific  shorter 
timeframes are also foreseen. Second, at the stage of the appeal committee specific rules are 
in  place  blocking  the  Commission  from  the  adoption  of  definitive  multilateral  safeguard 
measures in the absence of a positive opinion.   

In practice, before these changes could take effect, the respective trade legislation had to be 
adapted  to  make  decisions  in  this  field  subject  to  the  procedures  for  the  control  of  the 
Commission's  implementing  acts  by  Member  States.  This  was  not  the  case  before,  so  the 
alignment  provisions  in  Regulation  (EU)  182/2011  could  not  yet  apply.  Regulation  (EU) 
182/2011 thus only started applying with the adoption of respective alignment legislation in 
January 201416. The experiences with the specific provisions are therefore relatively limited 
until now and relate to the activities of one committee only, the Trade Defence Instruments 
Committee (C 44100). 

Opinions  Measures 
adopted*  
30 
43 

35 
43 

Positive 
opinions 

No 
opinions 

Negative  
opinions 

 Appeal 
Committee  
0 
0 

25 
2014 
2015 
40 
Table  5,  data  extracted  from  the  Comitology  Register  and  the  annual  report*,  The  total  number  of  positive 
opinions delivered by committees may differ from the number of acts adopted by the Commission if opinions are 
delivered one year but the acts are not adopted until the following year.  

10 
2 

0 
1 

In  the  cases  of  no  opinions  so  far  there  has  not  been  a  simple  majority  against  the  draft 
implementing act and the appeal committee therefore has so far not been used.   

14   P7_TA(2014)0096, P8_TA(2015)0409, P8_TA-PROV(2015)0456 and P8_TA-PROV(2015)0455 
15   P7_TA(2014)0096  
16   Regulation (EU) No 37/2014 of the European Parliament and of the Council of 15 January 2014 amending 

certain regulations relating to the common commercial policy as regards the procedures for the adoption of 
certain measures,  OJ L 18, 21.1.2014, p. 1–51 

8 

 
 
  
                                                            
3.7 Specific procedures  

Regulation (EU) 182/2011 foresees in Article 8 the possibility for the Commission to, on duly 
justified  imperative  grounds  of  urgency  and  if  so  provided  in  the  basic  act,  adopt  an 
implementing act without its prior submission to the committee. The committee's opinion is 
obtained  afterwards  and  where  the  examination  procedure  applies  the  Commission  must 
repeal the act in case of a negative opinion. Specific rules apply for provisional anti-dumping 
and countervailing measures.  The Commission  has  only  made use  of this procedure in  very 
few cases, mainly in the field of trade defence instruments under the advisory procedure. 

Another  provision,  foreseeing  for  the  possibility  of  adopting  acts  despite  a  negative  or  no 
opinion  in  order  to  avoid  creating  a  significant  disruption  of  the  markets  in  the  area  of 
agriculture or a risk for the financial interest of the Union, is set out in Article 7. There has so 
far been no necessity to use this procedure.  

3.8 The alignment of the existing acquis to the new procedures  

Regulation  (EU)  182/2011  provides  in  its  Article  13  for  the  automatic  alignment  of  all 
references to existing committee procedures to the new procedures with the exception of the 
regulatory  procedure  with  scrutiny.  This  automatic  alignment  has  ensured  a  smooth 
changeover  to  the  new  system.  As  regards  legislative  acts  in  force  which  currently  contain 
references to the regulatory procedure with scrutiny, no automatic alignment was foreseen in 
Regulation  (EU)  182/2011.  The  Commission  made  a  commitment  to  review  the  provisions 
attached to this procedure, in order to adapt them in due course according to the criteria laid 
down in the Treaty on the Functioning of the European Union (a statement in this sense was 
published in the Official Journal together with the Comitology Regulation17). In line with this 
commitment the Commission made three horizontal alignment legislative proposals in 201318. 
Due to the stagnation of the interinstitutional negotiations on these files, the Commission, as  
announced  in  its  2015  Work  Programme19,  withdrew  them20.  In  the  Interinstitutional 
Agreement on Better Law-Making21 the Commission committed to submit by the end of 2016 
a  new  proposal  for  the  alignment  of  legislative  acts  which  still  contain  references  to  the 
regulatory procedure with scrutiny. Pending this, a large number of measures are still adopted 
under  the  regulatory  procedure  with  scrutiny  (see  table  1)22.  In  the  interim,  whenever  the 
Commission  makes  a  proposal  for  an  amendment  of  the  substantive  provisions  of  an 
individual  legislative  act  making  reference  to  the  regulatory  procedure  with  scrutiny  that 
proposal  also  contains  an  alignment  of  the  provisions  referring  to  the  regulatory  procedure 
with scrutiny to the new regime.  

17   OJ L 55 of 28.2.2011, p. 19 
18   COM(2013) 451 final,  COM(2013) 452 final and COM(2013) 751 final 
19   COM(2014) 910 final 
20   (2015/C 80/08), OJ C 80 of 7.02.2015, p. 17 
21 See footnote 6 
22   The alignment of some 160 basic acts which had not been aligned to the regulatory procedure with scrutiny 
(mainly basic acts which were not under the co-decision procedure before the entry into force of the Lisbon 
Treaty) is being progressively carried out and has been achieved with few exceptions. 

9 

 
 
 
                                                            
4.  Conclusions  

Regulation  (EU)  182/2011  has  allowed  over  the  last  five  years  the  effective  use  of  the 
Commission's  implementing  powers  under  the  control  of  Member  States.  The  existing 
framework allows for an efficient and constructive cooperation between the Commission and 
Member  States.  The  Commission  has  not  identified  issues  that  would  require  or  warrant  a 
legislative  proposal  to  amend  Regulation  (EU)  182/2011  at  this  point  of  time.  The 
Commission invites the European Parliament and the Council to take note of this report. 

10