Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL adapting to Article 290 and 291 of the Treaty on the Functioning of the European Union a number of legal acts providing for the use of the regulatory procedure with scrutiny
Date: 2013-10-30
Institutions: European Commission
Subjects: European Commission, Treaty of Lisbon, comitology, delegated legislation













EUR-Lex - 52013PC0751 - EN











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52013PC0751

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL adapting to Article 290 and 291 of the Treaty on the Functioning of the European Union a number of legal acts providing for the use of the regulatory procedure with scrutiny /* COM/2013/0751 final - 2013/0365 (COD) */









EXPLANATORY MEMORANDUM
1.           BACKGROUND TO THE
PROPOSAL
Following the proposal for a Regulation of
the European Parliament and of the Council adapting to Article 290 TFEU a
number of legal acts providing for the use of the regulatory procedure with
scrutiny (RPS) (COM(2013)451) and the proposal for a Regulation of the European
Parliament and of the Council adapting to Article 290 TFEU a number of legal
acts in the area of Justice providing for the RPS (COM(2013)452), the present
proposal concerns the alignment of the remaining basic acts referring to the
RPS.
The Commission has carried out a careful
examination of all legislative instruments still referring to the RPS in order
to analyse whether the RPS measures meet the criteria of the TFEU. The analysis showed that some of the
measures do not fall into the scope of Article 290 TFEU. In cases where those
measures fulfil the criteria of Article 291 TFEU, it is therefore proposed that
the Commission is empowered to adopt implementing acts. In few cases where the powers
given to the Commission are not in accordance with the Treaty, it is proposed
that the provisions in question are deleted.
2.           METHOD OF THE ADAPTATION
The approach followed in this proposal is similar
to the one followed in the preceding proposals (COM(2013)451
and COM(2013)452). Accordingly, the present framework
regulation provides that where legal acts listed in Annex I provide for the use
of Article 5a of the Council Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers conferred on the Commission[1]
("the Comitology Decision"), the Commission is empowered to adopt
delegated acts, while for legal acts providing for the use of Article 5a of the
Comitology Decision which are listed in Annex II, the Commission is empowered
to adopt implementing acts. 
In cases where one provision contains a
list of empowerments which, in light of the criteria of Articles 290 and 291
TFEU, are of a differing nature (some empowerments are of delegated and some of
implementing nature), it is proposed that the empowerment is split.
In case of measures listed in Annex I, the
proposal adapts the urgency procedure according to Article 5a(6) of the
Comitology Decision to the urgency procedure for delegated acts (Article 3 of the
proposal).
For measures listed in Annex II, the
proposal adapts the urgency procedure according to Article 5a(6) of the
Comitology Decision to the procedure for immediately applicable implementing
acts under Article 8 of Regulation 182/2011[2]
("the Comitology Regulation") (Article 4(2) of the proposal).
Adaptation to the delegated act regime and
the implementing act regime will not affect pending procedures in which an
opinion has already been delivered by a committee in accordance with the
Comitology Decision.
Basic acts which are adapted to the delegated
acts regime are listed in Annex I of the proposal. Basic acts which are adapted
to the implementing acts regime are listed in Annex II of the proposal. Annex III
contains amendments to the basic acts the provisions of which are deleted. The
lists are organised according to policy areas and chronological order of the
adoption of the instruments.
3.           LIST OF BASIC ACTS SUBJECT
TO A SEPARATE REVISION
The instruments listed hereunder referring
to the RPS for which a separate substantial revision is envisaged, are not
included in this proposal, nor in the two preceding alignment proposals. Their alignment
will be part of those envisaged revisions.
 Field || Instrument 
 AGRI ||               Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 
 ESTAT ||               Regulation (EC) No 471/2009 of the European Parliament and of the Council of 6 May 2009 on Community statistics relating to external trade with non-member countries and repealing Council Regulation (EC) No 1172/95 
 ESTAT ||               Regulation (EC) No 638/2004 of the European Parliament and of the Council of 31 March 2004 on Community statistics relating to the trading of goods between Member States and repealing Council Regulation (EEC) No 3330/91 
 ESTAT ||               Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics 
 HOME ||               Regulation (EC) N° 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas 
 MARKT ||               Directive 2007/64/EC of the European Parliament and of the Council of 13 November 2007 on payment services in the internal market amending Directives 97/7/EC, 2002/65/EC, 2005/60/EC and 2006/48/EC and repealing Directive 97/5/EC 
 OLAF ||               Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters 
 SANCO ||               Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EC 
 SANCO ||               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 
2013/0365 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
adapting to Article 290 and 291 of the
Treaty on the Functioning of the European Union a number of legal acts providing
for the use of the regulatory procedure with scrutiny
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 Articles 43(2), 53(1), 62,
100(2), 114, 168(4)a, 168(4)b, 172, 192(1), 207, 214(3), 338(1) 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 Committee[3],
Having regard to the opinion of the
Committee of the Regions[4],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       The
Treaty of Lisbon introduced a distinction between the powers delegated to the
Commission to adopt non-legislative acts of general application to supplement
or amend certain non-essential elements of a legislative act (delegated acts),
and the powers conferred upon the Commission to adopt uniform conditions for
implementing legally binding Union acts (implementing acts).
(2)       The
measures which can be covered by delegations of powers, as referred to in
Article 290(1) of the Treaty on the Functioning of the European Union (TFEU),
correspond in principle to those covered by the regulatory procedure with
scrutiny established by Article 5a of Council Decision 1999/468/EC[5]. 
(3)       It is necessary to adapt
to Article 290 of the TFEU a number of legal acts already in force which provide for the use of
the regulatory procedure with scrutiny and which fulfil the criteria of Article
290(1) TFEU.
(4)       When the Commission
prepares delegated acts on the basis of the legal acts adapted by this
Regulation, it is of particular importance that it carry out appropriate
consultations, including at expert level. The
Commission, when preparing and drawing up delegated acts, should ensure a
simultaneous, timely and appropriate transmission of relevant documents to the
European Parliament and to the Council.
(5)       It is necessary to adapt
to Article 291 of the TFEU a number of legal acts already in force which provide for the use of
the regulatory procedure with scrutiny and which fulfil the criteria of Article
291(2) of the TFEU.
(6)       When implementing powers are
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.[6]
(7)       As a consequence of the
entry into force of the Treaty of Lisbon, it is also necessary to amend a
number of legal acts already in force which provide for
the use of the regulatory procedure with scrutiny by deleting certain measures covered by that procedure.
(8)       This Regulation should not
affect pending procedures in which the committee has already delivered its
opinion in accordance with Article 5a of Decision 1999/468/EC before the entry
into force of this Regulation.
(9)       Since the adaptations and amendments
to be made by this Regulation concern only procedures, they do not, in the case
of directives, need to be transposed by the Member States,
HAVE ADOPTED THIS REGULATION:
Article 1
1. Where provisions
listed in Annex I to this Regulation provide for the use of the regulatory
procedure with scrutiny referred to in Article 5a(1) to (5) of Decision
1999/468/EC, the Commission shall be empowered to adopt delegated acts in
accordance with Article 2 of this Regulation.
2. Where
provisions listed in Annex I provide for the use of the urgency procedure
referred to in Article 5a(6) of Decision 1999/468/EC, the Commission shall be
empowered to adopt delegated acts in accordance with the urgency procedure
provided in Article 3 of this Regulation.
Article 2
1. The power to
adopt delegated acts is conferred on the Commission subject to the conditions
laid down in this Article. 
2. The power to
adopt delegated acts shall be conferred on the Commission for an indeterminate
period of time.
3. The
delegation of power may be revoked at any time by the European Parliament or by
the Council. A decision to revoke shall put an end to the delegation of the
power specified in that decision. It shall take effect the day following the
publication of the decision in the Official Journal of the European Union
or at a later date specified therein. It shall not affect the validity of any
delegated acts already in force. 
4. As soon as
it adopts a delegated act, the Commission shall notify it simultaneously to the
European Parliament and to the Council. 
5. An adopted
delegated act shall enter into force only if no objection has been expressed
either by the European Parliament or the Council within a period of two months
of notification of that act to the European Parliament and the Council or if,
before the expiry of that period, the European Parliament and the Council have
both informed the Commission that they will not object. That period shall be
extended by two months at the initiative of the European Parliament or of the
Council.
6. Where
provisions listed in Annex I to this Regulation provide that the time-limit
laid down in Article 5a(3)(c) of Decision 1999/468/EC is curtailed pursuant to
Article 5a(5)(b) of that Decision, the periods laid down in paragraph 5 of this
Article shall be set at one month. 
Article 3
1. Delegated acts adopted under this
Article shall enter into force without delay and shall apply as long as no
objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to
the Council shall state the reasons for the use of the urgency procedure.
2. Either the European Parliament or the
Council may object to a delegated act in accordance with the procedure referred
to in Article 2(5). In such a case, the Commission shall repeal the act without
delay following the notification of the decision to
object by the European Parliament or by the Council.
Article 4
1. Where
provisions listed in Annex II provide for the use of the regulatory procedure
with scrutiny referred to in Article 5a(1) to (5) of Decision 1999/468/EC, the
Commission shall be empowered to adopt implementing acts in accordance with the
examination procedure of Article 5 of Regulation (EU) No 182/2011.
2. Where provisions listed in Annex II provide for the use of the
urgency procedure referred to in Article 5a(6) of Decision 1999/468/EC, the
Commission shall be empowered to adopt immediately applicable implementing acts
in accordance with Article 8 in conjunction with Article 5 of Regulation (EU)
No 182/2011.
Article 5
Regulation (EC) No 66/2010 of the
European Parliament and of the Council, Regulation (EC) No 1221/2009 of the
European Parliament and of the Council, Council Directive 97/70/EC, Regulation
(EC) No 1333/2008 of the European Parliament and the Council, , Directive
2002/46/EC of the European Parliament and the Council and Council Regulation
(EC) No 1257/96 are amended as set out in Annex III to this Regulation.
Article 6
This Regulation
shall not affect pending procedures in which a committee has already delivered
its opinion in accordance with Article 5a of Decision 1999/468/EC.
Article 7
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.
Done at Brussels, 
For the European Parliament                       For
the Council
The President                                                 The
President
ANNEX I 
Provisions of legal acts making reference to the regulatory
procedure with scrutiny referred to in Article 5a of Decision 1999/468/EC which
are adapted to the regime of delegated acts[7].
A. Communications Networks, Content
and Technology
1.           Regulation (EC) No 733/2002 of
the European Parliament and of the Council of 22 April 2002 on the
implementation of the .eu Top Level Domain
Article 3(1)a**
Article 5(1)
Article 5(2)
2.           Directive 2002/22/EC of
the European Parliament and of the Council of 7 March 2002 on universal service
and users' rights relating to electronic communications networks and services
(Universal Service Directive)
Article 35
3.           Directive No 2002/21/EC of
the European Parliament and of the Council of 7 March 2002 on a common
regulatory framework for electronic communications networks and services
(Framework Directive)
Article 13a(4)
B. Climate action
4.           Decision
No 406/2009/EC of the European Parliament and of the Council of
23 April 2009 on the effort of Member States to reduce their greenhouse
gas emissions to meet the Community’s greenhouse gas emission reduction
commitments up to 2020
Article
3(6)
Article
11(3)
5.           Directive 2003/87/EC of the
European Parliament and of the Council of 13 October 2003 establishing a scheme
for greenhouse gas emission allowance trading within the Community and amending
Council Directive 96/61/EC
Article 3d(3)
Article 3f(9)
Article 10(4)
Article 10a(1)
Article 10a(7)
Article 10a(8)
Article 10a(13)
Article 11a(9)
Article 11b(7)
Article 14(1)
Article 15 fifth paragraph
Article 19(3)
Article 22
Article 24(1)b
Article 24(3)
Article 24a(1)
Article 24a(2)
Article 25(2)
Article 25a(1)
Annex IV Part A
C. Energy
6.           Directive 2008/92/EC of
the European Parliament and of the Council of 22 October 2008 concerning a
Community procedure to improve the transparency of gas and electricity prices
charged to industrial end-users (recast)
Article 6
D. Enterprise and Industry
7.           Regulation (EC) No
715/2007 of the European Parliament and of the Council of 20 June 2007 on type
approval of motor vehicles with respect to emissions from light passenger and
commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and
maintenance information
Article 5(3)
Article 8
Article 14(2)
Article 14(3)
8.           Directive 2006/42/EC of
the European Parliament and of the Council of 17 May 2006 on machinery, and
amending Directive 95/16/EC (recast)
Article 8(1)a
E. Environment
9.           Regulation (EC) No 66/2010
of the European Parliament and of the Council of 25 November 2009 on the EU
Ecolabel
Article 6(7)
Article 8(2)
Article 15
10.         Regulation (EC) No
1221/2009 of the European Parliament and of the Council of 25 November 2009 on
the voluntary participation by organisations in a Community eco-management and
audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission
Decisions 2001/681/EC and 2006/193/EC
Article 17(3)
Article 48(2)
F. Statistics
11.         Regulation (EC) No 453/2008
of the European Parliament and of the Council of 23 April 2008 on quarterly
statistics on Community job vacancies
Article 2(1)
Article 3(1)
Article 7(1)
Article 7(3)
12.         Regulation (EC) No 177/2008
of the European Parliament and of the Council of 20 February 2008 establishing
a common framework for business registers for statistical purposes and
repealing Council Regulation (EEC) No 2186/93
Article 3(6)
Article 5(2)
Article 6(3) as to the adoption of
"measures relating to common quality standards" in conjunction with Article
15(1)(c) as to the adoption of "common quality standards"
Article 8(3)
Article 15(1)
13.         Regulation (EC) No 716/2007
of the European Parliament and of the Council of 20 June 2007 on Community
statistics on the structure and activity of foreign affiliates
Article 5(4)
Article 6(3) as to the adoption of "common
quality standards" in conjunction with Article 9(2)(a)
Article 9(2)(b)
Article 9(2)(c) as to the definition of
"proper common quality standards"
14.         Regulation (EC) No
1445/2007 of the European Parliament and of the Council of 11 December 2007
establishing common rules for the provision of basic information on Purchasing
Power Parities and for their calculation and dissemination
Article 7(4) as to the adoption of "the
common quality control criteria" in conjunction with Article 12(3)(c) as
to the definition of "quality criteria"
Article 12(3)
15.         Regulation (EC) No
1552/2005 of the European Parliament and of the Council of 7 September 2005 on
statistics relating to vocational training in enterprises
Article 5(2)
Article 7(3)
Article 8(2)
Article 9(4) as to the adoption of “quality
requirements and any measures necessary for assessing or improving the quality”
Article 10(2)
Article 13
16.         Regulation (EC) No 184/2005
of the European Parliament and of the Council of 12 January 2005 on Community
statistics concerning balance of payments, international trade in services and
foreign direct investment.
Article 4(3) as to the adoption of “common
quality standards”
Article 10 
17.         Regulation (EC) No
1177/2003 of the European Parliament and of the Council of 16 June 2003
concerning Community statistics on income and living conditions (EU-SILC)
Article 6(2) 
Article 15(5) in conjunction with Article
15(2)(a) as to "the definition of the list of target primary variables to
be included in each area for the cross-sectional component and the list of
target variables included in the longitudinal component, including the specification
of variable codes"
Article 15(5) in conjunction with Article 15(2)(c)
Article 15(5) in
conjonction with Article 15(2)(e)
Article 15(5) in
conjonction with Article 15(2)(f)
18.         Regulation (EC) No 450/2003
of the European Parliament and of the Council of 27 February 2003 concerning
the labour cost index
Article 2(4)
Article 3(2)
Article 4(1)
Article 4(2)
Article 8(1)
Article 11(a)
Article 11(b)
Article 11(d)
Article 11(e)
Article 11(f) as to the adoption of "the
separate quality criteria for current and back data transmitted"
Article 11 (i)
Annex point 3
19.         Regulation (EC) No 437/2003
of the European Parliament and of the Council of 27 February 2003 on
statistical returns in respect of the carriage of passengers, freight and mail
by air
Article 5
Article 7(2)
Article 10(2)
20.         Regulation (EC) No
2150/2002 of the European Parliament and of the Council of 25 November 2002 on
waste statistics
Article 1(5)
Article 3(1)
Article 4(3)
Article 5(4)
Article 6(2)(a) 
Article 6(2)((b)
Article 6(2)(c) as to the "definition of
the proper quality evaluation criteria"
Article 6(2)(d)
Article 8(3)
Annex I section 7, point 1
Annex II section 7, point 1
G. Internal Market and Services
21.         Directive 2009/110/EC of
the European Parliament and of the Council of 16 September 2009 on the taking
up, pursuit and prudential supervision of the business of electronic money
institutions amending Directives 2005/60/EC and 2006/48/EC and repealing
Directive 2000/46/EC
Article 14(1)
22.         Directive 2009/81/EC of the
European Parliament and of the Council of 13 July 2009 on the coordination of
procedures for the award of certain works contracts, supply contracts and
service contracts by contracting authorities or entities in the fields of
defence and security, and amending Directives 2004/17/EC and 2004/18/EC
Article 68(1)***
Article 69(2)***
H. Mobility and Transport
23.         Regulation (EC) No 391/2009
of the European Parliament and of the Council of 23 April 2009 on common rules
and standards for ship inspection and survey organisations
Article 13
Article 14(1)
Article 14(2)
24.         Directive 2009/45/EC of the
European Parliament and of the Council of 6 May 2009 on safety rules and
standards for passenger ships (Recast)
Article 10(3)
25.         Regulation (EC) No 725/2004
of the European Parliament and of the Council of 31 March 2004 on enhancing
ship and port facility security
Article 10(2)**
26.         Directive 2000/59/EC of the
European Parliament and of the Council of 27 November 2000 on port reception
facilities for ship-generated waste and cargo residues
Article 15
27.         Council Directive 97/70/EC
of 11 December 1997 setting up a harmonised safety regime for fishing vessels
of 24 metres in length and over
Article 8(b)
I. Health and Consumers
28.         Regulation (EC) No
1223/2009 of the European Parliament and of the Council of 30 November 2009 on
cosmetic products
Article 2 (3)
Article 13 (8)
Article 14 (2)
Article 15 (1)
Article 15 (2)**
Article 16 (8)
Article 16(9)**
Article 20 (2)
Article 31(1) **
Article 31 (2)
Article 31 (3)
29.         Regulation (EC) No 1107/2009
of the European Parliament and of the Council of 21 October 2009 concerning the
placing of plant protection products on the market and repealing Council
Directive 79/117/EEC and 91/414/EEC
Article 8(4) the last sentence in conjunction
with Article 78(1)(b)
Article 25(3) in conjunction with Article
78(1)(e)
Article 26 in conjunction with Article 78(1)(f)
Article 27(2) in conjunction with Article
78(1)(h)
Article 29(6) first subparagraph, second
sentence in conjunction with Article 78(1)(c)
Article 30(3) in conjunction with Article
78(1)(i)
Article 52(4) last subparagraph in conjunction
with Article 78(1)(j)
Article 54(5) in conjunction with Article
78(1)(k)
Article 58(2) in conjunction with Article
78(1)(l)
Article 65(1) in conjunction with Article
78(1)(m)
Article 68 third subparagraph in conjunction
with Article 78(1)(n)
Article 78(1)(a)
Annex II, point 3.6.5
30.         Regulation (EC) No
1069/2009 of the European Parliament and of the Council of 21 October 2009
laying down health rules as regards animal by-products and derived products not
intended for human consumption and repealing Regulation (EC) No 1774/2002
Article 5(1)**
Article 5(2)*
Article 6(1)
Article 6(2)*
Article 7(4)
Article 11(2)
Article 15(1)
Article 17(2)
Article 18(3)
Article 19(4)
Article 20(11)
Article 21(6)
Article 27
Article 31(2)
Article 32(3)
Article 40 (a) 
Article 40 (b)
Article 40 (f)
Article 42(2) (a)
Article 42(2) (b) 
Article 42(2) (c)
Article 43(3)
Article 48(7) (a) 
Article 48(7) (b) 
Article 48(7) (d)
Article 48(8)
31.         Regulation (EC) No 767/2009
of the European Parliament and of the Council of 13 July 2009 on the placing on
the market and use of feed, amending European Parliament and Council Regulation
(EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission
Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC,
93/113/EC and 96/25/EC and Commission Decision 2004/217/EC 
Article 6(2)**
Article 17(4)
Article 20(2)
Article 27(1)
Article 32(4)
32.         Regulation (EC) No 470/2009
of the European Parliament and of the Council of 6 May 2009 laying down
Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin, repealing
Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the
European Parliament and of the Council and Regulation (EC) No 726/2004 of the
European Parliament and of the Council
Articles 13(2)
Article 19(3)
Article 24(4)
33.         Regulation (EC) No
1334/2008 of the European Parliament and of the Council of 16 December 2008 on
flavourings and certain food ingredients with flavouring properties for use in
and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC)
No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC
Article 8(2)**
Article 22**
Article 25(3)
34.         Regulation (EC) No
1333/2008 of the European Parliament and of the Council of 16 December 2008 on
food additives
Article 9(2)
Article 24(3)*
Article 30(1)*
Article 30(2)*
Article 30(3)*
Article 30(5)
Article 31*
35.         Regulation (EC) No
1332/2008 of the European Parliament and of the Council of 16 December 2008 on
food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC)
No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and
Regulation (EC) No 258/97
Article 17(5)
36.         Regulation (EC) No
1331/2008 of the European Parliament and of the Council of 16 December 2008
establishing a common authorisation procedure for food additives, food enzymes
and food flavourings
Article 7(4)
Article 7(5)*
Article 7(6) **
37.         Regulation (EC) No
1925/2006 of the European Parliament and of the Council of 20 December 2006 on
the addition of vitamins and minerals and of certain other substances to foods
Article 3(3)**
Article 4 second subparagraph
Article 5(1)
Article 6(6)
Article 7(1)
Article 8(2)
Article 8(5)**
38.         Regulation (EC) No
1924/2006 of the European Parliament and of the Council of 20 December 2006 on
nutrition and health claims made on foods 
Article 1(2) 
Article 1(4)
Article 3(d)
Article 4(1) first subparagraph
Article 4(1) sixth subparagraph 
Article 4(5)
Article 8(2) 
Article 28(4)(b)
39.         Directive 2004/23/EC of the
European Parliament and of the Council of 31 March 2004 on setting standards of
quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells
Article 8(5)
Article 28**
40.         Regulation (EC) No
1829/2003 of the European Parliament and of the Council of 22 September 2003 on
genetically modified food and feed
Article 12(4)
Article 14(1) third indent
Article 24(4)
Article 32 sixth subparagraph
Article 47(3)
41.         Directive 2002/98/EC of the
European Parliament and of the Council of 27 January 2003 setting standards of
quality and safety for the collection, testing, processing, storage and
distribution of human blood and blood components and amending Directive
2001/83/EC
Article 29 first subparagraph**
Article 29 second subparagraph (a) 
Article 29 second subparagraph (b)**
Article 29 second subparagraph (c)**
Article 29 second subparagraph (d)**
Article 29 second subparagraph (e)**
Article 29 second subparagraph (f)**
Article 29 second subparagraph (g)**
Article 29 second subparagraph (h)
42.         Directive 2002/46/EC of the
European Parliament and of the Council of 10 June 2002 on the approximation of
the laws of the Member States relating to food supplements
Article 4(2)
Article 4(5)**
Article 5(4) as to the adoption of
"minimum amounts of vitamins and minerals"
43.         Directive 2002/32/EC of the
European Parliament and of the Council of 7 May 2002 on undesirable substances
in animal feed
Article 7(2)**
Article 8(1)**
Article 8(2) second indent
ANNEX II
Provisions of legal acts making reference to the regulatory
procedure with scrutiny referred to in Article 5a of Decision 1999/468/EC which
are adapted to the regime of implementing acts[8].
A. Communications Networks, Content
and Technology
1.           Decision No 626/2008/EC of
the European Parliament and of the Council of 30 June 2008 on the selection and
authorisation of systems providing mobile satellite services (MSS)
Article 9(3)*
2.           Directive 2002/22/EC of
the European Parliament and of the Council of 7 March 2002 on universal service
and users' rights relating to electronic communications networks and services
(Universal Service Directive)
Article 26(7)
Article 27a(5)
3.           Directive No 2002/21/EC of
the European Parliament and of the Council of 7 March 2002 on a common
regulatory framework for electronic communications networks and services
(Framework Directive)
Article 9b(3)
Article 10(4)
Article 15(4)
Article 17(6)a
Article 19(4)
B. Climate action
4.           Decision
No 406/2009/EC of the European Parliament and of the Council of
23 April 2009 on the effort of Member States to reduce their greenhouse
gas emissions to meet the Community’s greenhouse gas emission reduction
commitments up to 2020
Article 3(2)
5.           Directive 2003/87/EC of
the European Parliament and of the Council of 13 October 2003 establishing a
scheme for greenhouse gas emission allowance trading within the Community and
amending Council Directive 96/61/EC
Article 11a(8)
Article 16(12)
C. Enterprise and Industry
6.           Directive 2006/42/EC of
the European Parliament and of the Council of 17 May 2006 on machinery, and
amending Directive 95/16/EC (recast)
Article 8(1)b in conjunction with Article 9(3)
D. Environment
7.           Regulation (EC) No
1221/2009 of the European Parliament and of the Council of 25 November 2009 on
the voluntary participation by organisations in a Community eco-management and
audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission
Decisions 2001/681/EC and 2006/193/EC
Article 46(6)
E. Statistics
8.           Regulation (EC) No
453/2008 of the European Parliament and of the Council of 23 April 2008 on
quarterly statistics on Community job vacancies
Article 5(1)
9.           Regulation (EC) No
177/2008 of the European Parliament and of the Council of 20 February 2008
establishing a common framework for business registers for statistical purposes
and repealing Council Regulation (EEC) No 2186/93
Article 6(3) as to the adoption of “the content
and periodicity of the quality reports” in conjunction with Article 15(1)(c) as
to the adoption of "the content and periodicity of the quality reports”
10.         Regulation (EC) No 716/2007
of the European Parliament and of the Council of 20 June 2007 on Community
statistics on the structure and activity of foreign affiliates
Article 6(3) as to the adoption of “the content
and periodicity of the quality reports” in conjunction with Article 9(2) (c) as
to the definition of “the content and periodicity of the quality reports”
11.         Regulation (EC) No
1445/2007 of the European Parliament and of the Council of 11 December 2007
establishing common rules for the provision of basic information on Purchasing
Power Parities and for their calculation and dissemination
Article 7 (4) as to the adoption of “structure
of the quality reports” in conjunction with Article 12 (3) (c) as to the
definition of the “structure of the quality reports”
12.         Regulation (EC) No
1552/2005 of the European Parliament and of the Council of 7 September 2005 on
statistics relating to vocational training in enterprises
Article 9(4) as to the adoption of
"structure of the quality reports"
13.         Regulation (EC) No 184/2005
of the European Parliament and of the Council of 12 January 2005 on Community
statistics concerning balance of payments, international trade in services and
foreign direct investment. 
Article 4(3) as to the adoption of “content and
periodicity of the quality reports”
14.         Regulation (EC) No
1177/2003 of the European Parliament and of the Council of 16 June 2003
concerning Community statistics on income and living conditions (EU-SILC)
Article 8(3)
Article 15(5) in conjunction with Article
15(2)(a) as to the definition of "technical format of transmission to
Eurostat", 
Article 15(5) in conjunction with Article
15(2)(b) 
Article 15(5) in conjunction with Article
15(2)(d)
15.         Regulation (EC) No 450/2003
of the European Parliament and of the Council of 27 February 2003 concerning
the labour cost index
Article 8(2) in conjunction with Article 11(f)
as to the adoption of "content of quality reports"
16.         Regulation (EC) No
2150/2002 of the European Parliament and of the Council of 25 November 2002 on
waste statistics
Article 6(2)(c) as to the adoption of
"content of quality reports"
F. Internal Market and Services
17.         Directive 2009/110/EC of
the European Parliament and of the Council of 16 September 2009 on the taking
up, pursuit and prudential supervision of the business of electronic money
institutions amending Directives 2005/60/EC and 2006/48/EC and repealing
Directive 2000/46/EC
Article 14(2)
G. Mobility and Transport
18.         Regulation (EC) No 725/2004
of the European Parliament and of the Council of 31 March 2004 on enhancing
ship and port facility security
Article 10(3)**
19.         Council Directive 97/70/EC
of 11 December 1997 setting up a harmonised safety regime for fishing vessels
of 24 metres in length and over
Article 8(a) First indent
H. Health and Consumers
20.         Regulation (EC) No
1223/2009 of the European Parliament and of the Council of 30 November 2009 on
cosmetic products
Article 18(2)
21.         Regulation (EC) No 1107/2009
of the European Parliament and of the Council of 21 October 2009 concerning the
placing of plant protection products on the market and repealing Council
Directive 79/117/EEC and 91/414/EEC
              Article 17 second
subparagraph in conjunction with Article 78(1)(d)
Article 29(4) in conjunction with Article
78(1)(g)
22.         Regulation (EC) No
1069/2009 of the European Parliament and of the Council of 21 October 2009
laying down health rules as regards animal by-products and derived products not
intended for human consumption and repealing Regulation (EC) No 1774/2002
Article 40 (c)
Article 40 (d)
Article 40 (e)
Article 41(1)
Article 41(3)
Article 42(2) (d)
Article 45(4)
Article 48(7) (c)
23.         Regulation (EC) No 767/2009
of the European Parliament and of the Council of 13 July 2009 on the placing on
the market and use of feed, amending European Parliament and Council Regulation
(EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission
Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC,
93/113/EC and 96/25/EC and Commission Decision 2004/217/EC
Article 7(2)
Article 10(5)*
Article 26(3) 
24.         Regulation (EC) No 470/2009
of the European Parliament and of the Council of 6 May 2009 laying down
Community procedures for the establishment of residue limits of pharmacologically
active substances in foodstuffs of animal origin, repealing Council Regulation
(EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament
and of the Council and Regulation (EC) No 726/2004 of the European Parliament
and of the Council
Article 18**
25.         Regulation (EC) No
1925/2006 of the European Parliament and of the Council of 20 December 2006 on
the addition of vitamins and minerals and of certain other substances to foods
Article 6(1)
Article 6(2)
26.         Regulation (EC) No 1924/2006
of the European Parliament and of the Council of 20 December 2006 on nutrition
and health claims made on foods 
Article 13(3)
Article 13(4)
Article 17(3) first subparagraph
Article 17(3) second subparagraph (b)
Article 18(5) first subparagraph
Article 18(5) second subparagraph (b)
Article 28(6)(a)(ii)
27.         Directive 2004/23/EC of the
European Parliament and of the Council of 31 March 2004 on setting standards of
quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells 
Article
8(6)
Article
9(4)
28.         Regulation (EC) No
1829/2003 of the European Parliament and of the Council of 22 September 2003 on
genetically modified food and feed
Article 3(2)
Article 14(1) first indent
Article 14(1) second indent
Article 15(2)
Article 26(1)
29.         Directive 2002/98/EC of the
European Parliament and of the Council of 27 January 2003 setting standards of
quality and safety for the collection, testing, processing, storage and
distribution of human blood and blood components and amending Directive
2001/83/EC
Article
29 second subparagraph i)
30.         Directive 2002/46/EC of the
European Parliament and of the Council of 10 June 2002 on the approximation of
the laws of the Member States relating to food supplements
Article 5(4) as to the adoption of
"maximum amounts of vitamins and minerals"
ANNEX III
Amendments to Regulation (EC) No 66/2010 of the European Parliament
and of the Council, Regulation (EC) No 1221/2009 of the European Parliament and
of the Council, Council Directive 97/70/EC, Regulation (EC) No 1333/2008 of the
European Parliament and the Council, Directive 2002/46/EC of the European
Parliament and the Council and to Council Regulation (EC) No 1257/96 
A. ENVIRONMENT
1) In paragraph 5 of Article 6 of Regulation
(EC) No 66/2010, the second subparagraph is deleted.
2) Regulation (EC) No 1221/2009 is amended as
follows:
(a) in Article 16, paragraph 4 is deleted; 
(b) in Article 30, paragraph 6 is deleted.
B. Mobility and Transport
3) In point a) of Article 8 of Directive
97/70/EC, the second indent is deleted.
C. Health and Consumers
4) In Article 23 of Regulation (EC) No
1333/2008, paragraph 4, second sentence is deleted.
5) In Article 12 of Directive 2002/46/EC,
paragraph 3 is deleted.
D. Humanitarian Aid
6) In Article 15 of Regulation (EC) No 1257/96,
paragraph 1 is deleted.
[1]               OJ
L 184, 17.7.1999, p. 23. 
[2]               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.
[3]               OJ C , , p. .
[4]               OJ C , , p. .
[5]               Council
Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers
conferred on the Commission, OJ L 184, 17.7.1999, p. 23. 
[6]               Regulation (EU) No 182/2011 of 16 February 2011
laying down the rules and general principles concerning mechanisms for control
by the Member States of the Commission's exercise of implementing powers, OJ L
55, 28.02.2011, p. 13.
[7]               For information purposes, provisions referring to the
curtailed time limit pursuant to Article 2(6) are indicated in this Annex with
*, provisions referring to the urgency procedure pursuant to Article 3 are indicated
in this Annex with ** and provision referring to the urgency procedure pursuant
to Article 3 and to the curtailed time limit pursuant to Article 2(6) are
indicated in this Annex with ***.
[8]               For information purposes, provisions referring to the
urgency procedure pursuant to Article 8 of Regulation (EU) No 182/2011 are
indicated in this Annex with **