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II.

Comments applicable to both provisions

4.

The conferral of delegated or implementing powers on the Commission must be carried out inaccordance with Articles 290 and 291 TFEU. The possibility of conferring such powers on theCommission has to be assessed on a case-by-case basis in the framework and in the light of
the treaty system. It should be noted that the legislature is entitled to establish not only the
essential elements of an act, but also, if considered appropriate and subject to the principle ofsubsidiarity, all the rules of law for a specific area.

5.

As was already the case before the entry into force of the Lisbon Treaty, only the power toadopt non-essential rules may be conferred on the Commission The first subparagraph of
Article 290(1) TFEU stipulates that the legislature may delegate to the Commission the power
to supplement or amend "non-essential elements of the legislative act" and the second
subparagraph adds that "[t]he essential elements of an area shall be reserved for thelegislative act and accordingly shall not be the subject of a delegation of power".

6.

Article 291 TFEU makes no explicit reference to this point only because it is obvious that theimplementation of a basic act cannot affect its essential elements 1.

7.

The legislature has a considerable margin of discretion in determining the essential and nonessential elements of the acts it adopts. However, the case law of the Court of Justice has
defined the limits of the concept. The classification of "essential" "must be reserved forprovisions which are intended to give concrete shape to the fundamental guidelines ofCommunity policy" 2. Accordingly, the modification of the material 3, geographical or temporal1

2
3

The distinction made in the past by the case law of the Court of Justice between "...rules
which, since they are essential to the subject-matter envisaged, must be reserved to theCouncil' s power, and those which, being merely of an implementing nature, may be delegatedto the Commission" (Judgment of 27 October 1992, Germany v Commission "German
sheepmeat", C-240, ECR 1992, p. I 5383, paragraph 36 of the judgment, underlining added)
remains applicable to implementing acts adopted by the Commission pursuant to Article 291
TFEU.
See German sheepmeat case referred to above, paragraph 37 of the judgment.
See paragraphs 64 et seq. of the judgment of 23 October 2007, Parliament v Commission,
C-403/05. See in this respect the opinion of the Legal Service of 21 September 2007
(13150/07, paragraph 7).

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scope of a basic act constitutes an essential element of that act, which the legislature cannot in
principle confer on the Commission under either Article 290 or Article 291 TFEU. No
exception can be made unless the powers conferred on the Commission are so strictly
circumscribed that its margin of discretion is either non-existent or extremely limited. The
Legal Service has already expressed the view that the power to alter the temporal scope of anact would certainly interfere with its essential elements, unless it is strictly circumscribed 4.
8.

Likewise, the obligations imposed under an act and the consequences of any violation are
essential elements which the basic act should define, at least with respect to their generalnature 5.

9.

When the Commission is granted the power to update the basic act, without any margin of
discretion, in the light of scientific data which may become available over time, unless thosescientific data are in themselves crucial to the choices made by the legislature in the basic act,
it may be considered that such power does not affect the essential elements of the basic act.

10.

With regard to the respective scope of the two provisions, an initial observation must be
made. In terms of procedure, there is a manifest difference between the delegation oflegislative powers and the granting of implementing powers. However, it is just as clear thatin use, the two procedures are not exclusive categories, but overlap considerably. While there
are certain measures which can come only under Article 290 or under Article 291, there aremany others which, depending on how they are presented, can constitute either acts that
supplement "certain non-essential elements of the legislative act" or rules establishing"uniform conditions for implementing" basic acts. There are thus many cases in which it is
not possible to determine by means of legal analysis, in a non-arbitrary way, that it is essential
to choose Article 290 as the legal basis rather than 291 TFEU.

4
5

See the opinion of the Legal Service of 31 March 2010 (8177/10, paragraph 14).
See the opinion of the Legal Service of 17 March 2010 (7635/10), paragraphs 18-19.

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III. Delegation of powers to the Commission pursuant to Article 290 TFEU
A.
11.

General considerations

Pursuant to Article 290 TFEU, the legislature may delegate to the Commission the power toadopt non-legislative acts of general application to supplement or amend certain non-essential
elements of the basic legislative act 6 ("delegated acts"). Thus, the definition of a delegated act
is similar to that of the measures which could be adopted under the regulatory procedure withscrutiny (PRAC) pursuant to Article 5a of the 1999 Decision on Committee Procedure (asamended in 2006) 7. It should, however, be borne in mind that it is not possible toautomatically replace all the existing provisions providing for the regulatory procedure withscrutiny with provisions providing for the power to adopt delegated acts. It is for thelegislature to establish on a case-by-case basis, in the light of the provisions concerned,
whether the measures in question come under the scope of Article 290 TFEU 8 or Article 291
TFEU 9. The legislature may also in all cases decide to incorporate in the basic act any
provisions which were subject to the regulatory procedure with scrutiny, rather than making
use of either Article 290 or 291 TFEU.

6

7

8

9

The procedure applicable within the Council for the implementation of Council prerogatives
arising from Article 290 TFEU was the subject of a note of 25 February 2011 from theSecretary-General to the Directors-General of the GSC, of which all delegations received acopy.
Accordingly, the opinions delivered by the Legal Service distinguishing the scope of theregulatory procedure with scrutiny from that of other the committee procedures remain valid(see in particular 12336/06, 12813/06, 15038/06, 5658/07, 14179/09, 16323/09). It should
also be noted that the new Regulation on Committee Procedure does not repeal Article 5a(PRAC) of Decision 1999/468/EC. In the statements accompanying the new Regulation on,
the Commission undertakes to submit, by 2014, proposals amending basic acts containing theregulatory procedure with scrutiny to align them with the new provisions of the Lisbon
Treaty.
Moreover, the legislature must make a choice concerning the objectives, content, scope andduration of the delegation of power (Article 290(1), second paragraph, TFEU), as well as theconditions to which the delegation is subject (article 290(2), TFEU).
See also Article 13(4) of the Regulation on Committee Procedure, which establishes that the
automatic alignment of the previous committee procedures with the new procedures must notprejudge the nature of the acts concerned, i.e. their classification as delegated acts or
implementing acts.

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12.

According to the case law of the Court of Justice, "[…] when the Community legislature
wishes to delegate its power to amend aspects of the legislative act at issue, it must ensurethat that power is clearly defined and that the exercise of the power is subject to strict review
in the light of objective criteria […]" 10. The second subparagraph of Article 290(1) TFEU
states that the "[…] objectives, content, scope and duration of the delegation of power shallbe explicitly defined" in the basic legislative act.

13.

In the light of the above, the delegation of powers to the Commission must be strictly
circumscribed and the use of words such as "in particular" and other not clearly defined
formulas for delegating powers 11 should be avoided.
B.

14.

Scope of Article 290 TFEU

Only measures of general application fall within the scope of Article 290 TFEU. Where thelegislature wishes to confer powers on the Commission to adopt individual measures (e.g.
individual authorisations to be granted to one or more Member States 12), it may not do so by
reference to Article 290 TFEU.

10
11
12

Judgment of 12 July 2005, Alliance for Natural Health and others, C-154/04 and C-155/04,
ECR 2005, p. I-6451, paragraph 90.
See mutatis mutandis the opinion of the Legal Service of 6 October 2009 (14179/09),
paragraphs 4 and 8.
It should be noted, however, that the Court of First Instance held that derogations from thegeneral arrangements provided for under a Directive can, in certain circumstances, concern its
general nature, "given that they are addressed in abstract terms to undefined classes of
persons and apply to objectively defined situations." (see Order of the Court of First Instanceof 11 July 2000, Fédération nationale d’agriculture biologique des régions de France andothers v Council, T 268/99, ECR p. II-2893, paragraphs 37 and 38, confirmed by the Order of
the Court of Justice of 10 May 2001, Fédération nationale d’agriculture biologique desrégions de France and others v Council, C 345/00 P ECR. p. I-3811; Order of the Court ofFirst Instance of 16 February 2005, Fost Plus VZW. v Commission, T 142/03, paragraph 47).

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15.

Moreover, only legally binding measures may be delegated under Article 290 13. The
delegated acts which the Commission can adopt are acts which supplement or amend
elements of legislative act. There are thus of a quasi-legislative nature and cannot take theform of mere recommendations or guidelines.

16.

As already pointed out by the Legal Service in relation to the regulatory procedure withscrutiny, the term "amend" has a precise meaning. It means to make changes to a text bydeleting, replacing or adding non-essential elements. The procedure provided for under
Article 290 TFEU thus applies where the legislature envisages the basic act being amended by
the addition of new non-essential elements or by the replacement or deletion of non-essential
elements in the basic act itself (whether in an article of the basic act or in an annex).

17.

The meaning of the term "supplement" is more complex, and relates to a grey area between
the scope of Article 290 and that of Article 291 TFEU. To determine whether an act to be
adopted by the Commission actually "supplements" the basic act, the legislature must in
principle evaluate whether the future measure will add new (non-essential) rules which
expand the legislative framework of the basic act, particularly by leaving a considerable
margin of discretion to the Commission. If the answer is affirmative, then it could beconsidered, depending on the specific circumstances, that the measure "supplements" thebasic act. Conversely, measures intended solely to give effect to existing rules in the basicact 14, without adding new elements to the act, or to implement aspects already clearly definedby the legislature, would fall more under the scope of Article 291 TFEU than of Article 290
TFEU.

13
14

See mutatis mutandis the opinion of the Legal Service of 19 November 2009 (16323/09).
The Legal Service has already held that the implementing powers conferred on theCommission for the adoption of annual work programmes are not designed to make changes
to the text of the basic instrument by deleting or replacing certain of its elements, or by
supplementing the basic act by the addition of new non-essential elements. On the contrary,
they are designed to implement specific existing rules in the basic act without allowing theCommission to add new elements and thus "supplement" it (Opinion of 26 January 2007,
5658/07, paragraph 6).

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18.

It is for the legislature to decide whether the text of the basic act needs to be "supplemented"
and, if so, by what. The basis for the assessment must be given in the statement of reasons.
While the legislature is entitled to regulate an entire area without providing for implementing
measures, it may also regulate just a part of that area, leaving it to the Commission to"supplement" the rules by delegated acts on non-essential aspects 15, provided of course thatsuch delegation is properly defined and restricted.
C.

19.

Conditions and procedures for the delegation of powers

The Legal Service notes that the legislature has three options regarding the two conditions forthe delegation of powers set out in Article 290 TFEU: first, it may decide not to impose
conditions on the delegation of powers (i.e. not provide for any right to revoke the delegation
nor any right to express objections to the delegated act); second, it may provide for a single
condition; third, it may provide for both conditions cumulatively, in the basic legislative act.

15

Some recent examples of measures that "supplement" the basic act:
- The adoption of criteria and conditions to be fulfilled by categories of persons established by
the basic act (see Article 12(4)(a) of Directive 2011/24/EU of the European Parliament and of
the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare,
OJ L 88, 4.4.2011, p. 45);
- The adoption of specifications relating to the conditions required for the addition of a
species to an Annex to the basic act (see Article 1(6) of Regulation (EU) No 304/2011 of theEuropean Parliament and of the Council of 9 March 2011 amending Council Regulation (EC)No 708/2007 concerning use of alien and locally absent species in aquaculture, OJ L 88,
4.4.2011, p. 1);- The establishment of essential characteristics for which the manufacturer must declare theperformance of the product when it is placed on the market or the setting of threshold levels
for the performance in relation to the essential characteristics to be declared (see Article 3(3)of Regulation (EU) No 305/2011 of the European Parliament and of the Council of
9 March 2011 laying down harmonised conditions for the marketing of construction products
and repealing Council Directive 89/106/EEC, text with EEA relevance, OJ L 88, 4.4.2011,p. 5);- The adoption of supplementary procedural rules for drafting documents provided for by thebasic act (see Article 19(3) of Regulation No 305/2011).

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20.

As the Legal Service has already stated 16, the legislature may not lay down conditions
different from those provided for by Article 290(2), i.e.: revocation of the delegation of
powers, or objection. This does not preclude the legislature from making the Commission's
exercise of delegated powers subject to the existence of objective triggering circumstances oflaw or of fact. The "conditions" mentioned in Article 290 are in fact procedural requirements
for the use of delegation, not prerequisites determining when delegated powers come intoplay. However, this right cannot make it obligatory that there be prior intervention (e.g.
through consultation) by EU institutions, their preparatory bodies or other bodies operating
under a committee procedure.

21.

On the other hand, there is nothing to prevent the legislature from providing, besides suchobjective circumstances considered as prerequisites, for the Commission to consult, at the
preparatory stage of delegated acts, experts from e.g. Member States or interested parties(industry, NGOs, etc.), provided that that consultation is not a compulsory element of thedelegated act 17 and that its outcome does not bind the Commission 18. Note too that in thefinancial services field, Declaration 39 annexed to the Final Act of the IGC which adopted theLisbon Treaty spells out "the Commission's intention to continue to consult experts appointed
by the Member States in the preparation of draft delegated acts in the financial services area,in accordance with its established practice."

16
17

18

See in particular the abovementioned Legal Service opinion 8177/10, point 13.
The Common Understanding agreed by the European Parliament, the Council and theCommission on the procedural requirements for application of Article 290 TFEU in factprovides for the inclusion of such consultation in recitals (not in the enacting terms) oflegislative acts conferring on the Commission powers to adopt delegated acts.
However, note that the legislative acts belonging to the financial supervision package define
precisely the ways the Commission can diverge from draft delegated acts drawn up by theauthorities instituted by the package (see in particular Article 10 of Regulation (EU)No 1095/2010 of the European Parliament and of the Council of 24 November 2010
establishing a European Supervisory Authority (European Securities and Markets Authority),
amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC,
OJ L 331, 15.12.2010, p. 84).

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22.

Although not provided for by Article 290 TFEU, the delegation of powers can be tacitly (orautomatically) extended. That extension is not a new condition of the Commission's exercise
of its delegated powers. It represents a procedure linked to the delegation that the Commission
proposed in its communication of December 2009 19, it being understood that the delegation
can be revoked at any time. The legislature has also included it in a number of acts 20.

23.

Finally, it should be pointed out that the introduction of an "urgency procedure" in the basic
legislative act to allow the Commission to adopt a delegated act that comes into force without
delay raises reservations as regards its compatibility with Article 290 TFEU. The Common
Understanding agreed by the three institutions provides for the use of such a procedure only
in exceptional cases of urgency. Although the Common Understanding does not define theexceptional cases in which the procedure applies, restricting itself to listing certain fields by
way of example (public health, security, international relations, including humanitariancrises), the Legal Service considers that use of the urgency procedure should be confined tocases where there are imperative or overriding general-interest requirements, in line with thecase law of the Court 21.

19
20

21

COM(673)2009, 9 December 2009.
See in particular Article 1(7) of Regulation (EU) No 438/2010 of the European Parliamentand of the Council of 19 May 2010 amending Regulation (EC) No 998/2003 on the animal
health requirements applicable to the non-commercial movement of pet animals, OJ L 132,
29.5.2010, p. 3, and Article 25(1) of Directive 2010/45/EU of the European Parliament and of
the Council of 7 July 2010 on standards of quality and safety of human organs intended fortransplantation, OJ L 207, 6.8.2010, p. 14. See also point 9 of the Common Understanding.
See inter alia the judgments of 20 February 1979, Rewe v Bundesmonopolverwaltung für
Branntwein (120/78, ECR 1979, p. 649), of 29 November 1983, Roussel Laboratoria andothers (181/82, ECR 1983, p. 3849), and of 9 July 1992, Commission v Belgium (C-2/90,
ECR 1992, p. I-4331).

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IV.

Conferral of implementing POWERS on the Commission under Article 291 TFEU
A.

24.

General considerations

While Article 290 TFEU is an innovation, Article 291 is in line with previously existing
provisions (see Article 202 TEC and, before the Amsterdam Treaty, Article 145 TEC).

25.

The Treaty first recalls one of the main features of the Union's legal system, namely that it isprimarily for Member States to implement Union law (Article 291(1) TFEU) 22 . It then states
that, where uniform conditions for implementing legally binding Union acts are needed, thelegislature will confer on the Commission 23 the power to adopt implementing measures atUnion level 24.

22
23

24

On this point see pages 2 and 3 of the Legal Service's opinion of 19 October 1998 (11987/98)
and point 7 of the Legal Service's opinion of 2 February 2006 (5923/06).
It should be noted that the Commission also has certain implementing powers conferred
directly by the treaties. See for instance, in relation to competition rules, Article 106(3)
TFEU: "The Commission shall ensure the application of the provisions of this Article andshall, where necessary, address appropriate directives or decisions to Member States."
It should be noted that Article 291(2) TFEU still provides for the possibility of conferring on
the Council implementing powers for legally binding acts of the Union in duly justified cases.
As was the case in applying Article 202 TEC, reasons must be given for such a decision; thus,
the legislature must duly justify, on the basis of the nature and content of the basic act to be
implemented, any exception to the rule that, in the treaty system, when it is necessary to take
implementing measures at Union level for a basic act, it is for the Commission to exercise thatpower (mutatis mutandis, see point 8 of the Legal Service's opinion of 30 July 2009,
12506/09). The Court has already judged adequate a justification contained in relatively
general recitals which, analysed in the context of the adoption of the act, showed clearly thegrounds justifying the reservation of powers to the Council (see judgment of 18 January 2005,
C-257/01, Commission v Council, paragraphs 53 to 59).
In conferring such powers on the Council, the legislature may provide that the latter act on a
proposal of the Commission (on this, see points 10 and 11 of the Legal Service's opinion of
4 February 2011, 6134/11) or without a proposal from the Commission.

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26.

Although in its Vreugdenhil judgment 25 the Court acknowledged that "the concept of
implementation must be given a wide interpretation", it also rejected generalising that ruling,emphasising that "such a wide interpretation of the Commission' s powers can be accepted
only in the specific framework of the rules on agricultural markets".

27.

The basic act must in any case define the implementing powers conferred on the Commission,by spelling out inter alia the purpose of the powers conferred on the Commission 26, thereasons for which Commission intervention is necessary, whether or not it must 27 beaccompanied by procedures for control by Member States (in that case applying theRegulation on Committee Procedure) and, when the latter option is used, what type ofprocedure the Commission is to use for the adoption of the implementing acts concerned.

25
26

27

Judgment of 29 June 1989, Vreugdenhil and others v Minister van Landbouw en Visserij(22/88, ECR 1989, p. 2049), paragraph 17.
As the Legal Service has stated, criteria should be established in the basic act to govern theexercise of the power to adopt the implementing measures conferred on the Commission.
These criteria may be general and the purpose of their insertion would include enabling
economic operators to be aware of the conditions in which, for instance, they could be thesubject of an implementing measure adopted pursuant to the basic act (see point 12 of theopinion of 28 September 2009, 13772/09 + COR 1).
It will be recalled that, as was the case under Article 202 TEC, the legislature still retains theright to decide that control by the Member States of implementing powers conferred on theCommission is not necessary. In that case, the Commission can adopt implementing measures
without a committee procedure. Article 1 of Regulation (EU) No 182/2011 of the European
Parliament and of the Council of 16 February 2011 laying down the rules and generalprinciples concerning mechanisms for control by Member States of the Commission's
exercise of implementing powers (OJ L 55, 28.2.2011, p. 13, hereinafter "the Regulation on
Committee Procedure") also states that it applies "where a legally binding Union act(hereinafter a "basic act") identifies the need for uniform conditions of implementation andrequires that the adoption of implementing acts by the Commission be subject to the controlof Member States" (our emphasis).

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B.
28.

Scope of Article 291 TFEU

In contrast to Article 290 TFEU, Article 291 TFEU does not restrict the possibility ofconferring implementing powers on the Commission solely to legislative acts. Any legallybinding Union act may thus confer implementing powers on the Commission (or theCouncil) 28.

29.

As ruled by the Court and as provided by the Regulation on Committee Procedure, theconcept of implementation for the purposes of Article 291 comprises both the drawing up of
implementing rules (in the form of acts of general scope) and the application of rules tospecific cases by means of acts of individual application 29.

28

29

-

To make this note more readable, the term "the legislature" is used to refer to the author of
legally binding acts conferring implementing powers on the Commission, even if the acts inquestion are not only legislative acts within the meaning of Article 289 TFEU.
Judgment of 24 October 1989, Commission v Council 16/88, ECR 3457, paragraph 11.
Examples of implementing powers that a basic act may confer on the Commission pursuant to
Article 291 TFEU:
defining the format or content of a report or a notification the submission of which by
Member States is made obligatory by the basic act;
granting (general) authorisations to produce/use/place on the market a given product or
substance;
verifying data provided by Member States, transmission of which is made obligatory by abasic act;drawing up studies, analyses and reports;
establishing a list of projects eligible for EU funding, following verification that they meet all
the conditions and criteria set out by the basic act;
adopting decisions of individual application, e.g. granting individual authorisations to one ormore Member States pursuant to the basic act;
adopting guidelines essentially designed to provide a practical guide for submitting projects
eligible for EU funding;drawing up guidelines on the application of the basic act, including strategic guidelines or
strategy papers (in particular within the broader category of "external financial instruments").

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30.

Regulation on Committee Procedure

Under Article 291(3) TFEU, rules and general principles concerning mechanisms for control
by Member States of the Commission’s exercise of implementing powers are laid down by
Parliament and the Council acting in accordance with the ordinary legislative procedure. The
Legal Service notes that the Regulation on Committee Procedure, like Decision 1999/468/EC
which preceded it, is "supra-legislative" in nature as the legislature is subject to theRegulation when exercising its legislative powers. Only those mechanisms for control laid
down in advance in the Regulation in accordance with Article 291(3) TFEU may be used by
the legislature 30.

31.

The Regulation on Committee Procedure, which came into force on 1 March 2011, follows
the same logic as that on which Decision 1999/468/EC was based. It does, however, introduce
a number of significant changes in relation to the previous system, including the following inparticular:-

it applies to all Union policies 31;-

the three previous procedures (advisory, management and regulatory) are replacedby two new procedures (advisory and examination);

30

31

However, whilst it may happen that legislative acts impose an obligation on the Commission
to consult agencies, specific committees, specialised bodies or even Member States
designated in general in connection with the exercise of the implementing powers conferredon it, the involvement of such agencies, committees (not being those referred to in theRegulation on Committee Procedure) or bodies cannot form part of the committee procedure
itself. If and when such committees or bodies are involved, their role should be limited topurely advisory functions prior to the committee procedure (see in this regard the opinions of
the Legal Service of 21 November 2008 (16204/08, point 4) and of 30 July 2009 (12506/09,
point 11)). Note, however, that in the legislative acts forming part of the financial supervision
package referred to in the footnote on page 18, it is the authorities themselves that draw up thedraft implementing acts which are then adopted by the Commission; the Commission may notchange the content of a draft implementing technical standard prepared by an authority
without prior coordination with that authority (see in particular Article 15 of Regulation (EU)No 1095/2010 referred to above).
Regarding competition law, recital 22 of the Regulation on Committee Procedure states that"[t]he Commission’s powers, as laid down by the TFEU, concerning the implementation of
the competition rules are not affected by this Regulation". Concerning the common
commercial policy, trade defence measures are now included in the scope of the Regulation
on Committee Procedure, though a number of arrangements are provided for to take accountof their specific characteristics.

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appeal committee made up of representatives of the Member States has been set
up;-

in certain cases, the Commission may adopt measures even if the appeal
committee delivers a negative opinion (or if no opinion is delivered) 32.

32.

The Legal Service considers it necessary at this stage to clarify certain aspects relating to theapplication of the new Regulation as regards the selection of procedures, the use of the option
envisaged in point (b) of the second subparagraph of Article 5(4) or of that envisaged in
Article 8, and the transition between Decision 1999/468/EC and the new Regulation.

(i)

Selection of procedures

33.

Article 2 of the Regulation on Committee Procedure lays down general criteria for theselection of procedures, while allowing the legislature some flexibility depending on thenature or the impact of the measure to be adopted by the Commission.

34.

The scope of the examination procedure is very broad: in addition to measures in the areas set
out in Article 2(2)(b) 33, it applies to the adoption of measures of general scope, regardless ofarea 34. Furthermore, the list of implementing acts to which the examination procedure applies(Article 2(2)) is not exhaustive.

35.

The advisory procedure applies in principle to all individual measures in areas other thanthose referred to in Article 2(2)(b).

32
33

34

See Article 7 of the Regulation on Committee Procedure.
The examination procedure applies in principle to external financial instruments. Suchmeasures fall within the scope of Article (2)(2)(b)(i). Moreover, according to recital 12 of theRegulation on Committee Procedure, "[p]rovided that the basic act confers implementing
powers on the Commission relating to programmes with substantial budgetary implications
or directed to third countries, the examination procedure should apply."
See Article 2(2)(a) of the Regulation on Committee Procedure.

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36.

Any decision by the legislature to deviate from the criteria set out in Article 2 must be duly
justified.

(ii)

Use of the option envisaged in point (b) of the second subparagraph of Article 5(4) of theRegulation on Committee Procedure 35

37.

The purpose of Article 5(4) of the Regulation on Committee Procedure is to make provision,as part of the examination procedure, for the consequences of an absence of an opinion fromthe committee to which the Commission refers a draft implementing act. The firstsubparagraph of this provision enables the Commission to adopt the draft implementing act in
the absence of an opinion from the committee. However, three exceptions are set out in thesecond subparagraph and one of them (point (b)) allows the legislature to stipulate in the basic
act that the draft implementing act may not be adopted by the Commission where no opinion
is delivered by the committee.

38.

In the light of the specific features of each case, it is therefore up to the legislature to
determine whether or not to avail itself, in the basic act, of the option made available bypoint (b) of the second subparagraph of Article 5(4) of the Regulation on Committee
Procedure, thus preventing the Commission from adopting a draft implementing act in theabsence of an opinion from the committee. No legal considerations limit the use of thisoption. Unlike other provisions of the Regulation on Committee Procedure 36, Article 5(4)requires no specific justification for this choice.

39.

Regarding the recasting or amendment of acts which referred to the regulatory procedureprovided for in Decision 1999/468/EC, it should be noted that the procedure in the newRegulation on Committee Procedure which is closest to that old procedure is the one referred
to in point (b) of the second subparagraph of Article 5(4). This interpretation is confirmed by
the fact that the transitional provisions in Article 13(1)(c) of the Regulation provide for the
automatic substitution of the procedure in Article 5 for the regulatory procedures which
existed on 1 March 2011.

35
36

Points 37 to 40 are taken from the opinion of the Legal Service of 4 March 2011 (7325/11).
See, in particular, Article 8(1), which states: "a basic act may provide that, on duly justified
imperative grounds of urgency, this Article is to apply" (our emphasis).

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Naturally, the decision on whether or not to use point (b) of the second subparagraph of
Article 5(4) is entirely a matter for the legislature. This also applies to the old regulatory
procedures, the old advisory procedures and the old management procedures.

(iii) Use of the option provided for in Article 8 of the Regulation on Committee Procedure
41.

Article 8 of the Regulation on Committee Procedure allows the legislature to make provision,in the basic act, for what could be referred to as an "urgency" procedure to apply where there
are duly justified imperative grounds of urgency 37. This is not a self-standing procedure but
an arrangement that is possible as part of an advisory or examination procedure.

42.

Use of the urgency procedure and the situations in which it is possible must be set out
explicitly in the basic act. It is therefore up to the legislature to determine the circumstances
under which the urgency procedure will apply. Although the Regulation on Committee
Procedure does not define cases of imperative urgency, the Legal Service considers that use of
the urgency procedure should be limited to cases where there are imperative or overriding
general-interest requirements, in line with the case law of the Court. The main characteristicof this procedure is that the implementing act is adopted by the Commission without firstreferring the matter to a committee. The adopted act comes into force immediately andremains in force for a period not exceeding six months, unless the basic act provides
otherwise. If, under the examination procedure, the committee delivers a negative opinion on
an act adopted by the urgency procedure, the Commission is required to repeal that act
immediately. The matter is not referred to the appeal committee.

37This should not be confused with the option available to the Commission under Article 7 of
the Regulation on Committee Procedure, in the context of the examination procedure, to adopt
an implementing act despite a negative opinion (or in the absence of an opinion) by thecommittee where the act needs to be adopted without delay in order to avoid creating asignificant disruption of the markets in the area of agriculture or a risk for the financial
interests of the Union within the meaning of Article 325 TFEU. The legislature does not haveto make provision for this option in the basic act; its use by the Commission is made possible
directly by the Regulation on Committee Procedure.

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(iv) Transition between Decision 1999/468/EC and the new Regulation on Committee Procedure
43.

As set out in Article 13(1) of the Regulation on Committee Procedure, from 1 March 2011
onwards, the advisory procedure provided for under the Regulation on Committee Procedure
applies where reference is made to the advisory procedure under Decision 1999/468/EC,
while the examination procedure applies where reference is made to the management or
regulatory procedures under the same Decision 38. Even where texts originating before theentry into force of the Regulation on Committee Procedure are not formally amended,
application of the new procedures does not require the adoption of a particular act.

44.

Under Article 14, the Regulation on Committee Procedure does not affect ongoing proceduresin which a committee has already delivered an opinion under Decision 1999/468/EC. This
provision also covers cases where no opinion is delivered, provided that the vote in committeethat led to the absence of an opinion was held before 1 March 2011. In such situations, thematter would still be referred to the Council under the relevant provisions ofDecision 1999/468/EC.

38

Specific arrangements on the replacement of the old management and regulatory proceduresby the new examination procedure are set out in Article 13(1)(b) and (c).

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