Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Two
Date: 2009-03-11
Institutions: Council of the European Union, European Parliament
Subjects: EU act, European Commission, capacity to exercise rights, drafting of EU law, power of implementation, powers of the institutions (EU)

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REGULATION (EC) No 219/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 March 2009

adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to
Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny

Adaptation to the regulatory procedure with scrutiny — Part Two

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(2)

Having regard to the Treaty establishing the European Community,
and in particular Articles 37, 44(1), 71, 80(2), 95, 152(4)(b), 175
(1), 179 and 285 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

the European
In accordance with the statement of
Parliament, the Council and the Commission (6) concerning
Decision 2006/512/EC, for the regulatory procedure with
scrutiny to be applicable to instruments adopted in
accordance with the procedure laid down in Article 251
of the Treaty which are already in force, those instruments
must be adjusted in accordance with the applicable
procedures.

(3)

this
Since the amendments made to instruments for
purpose are technical
in nature and concern committee
procedure only, they do not, in the case of directives, need
to be transposed by the Member States,

Having regard to the opinion of the European Central Bank (2),

HAVE ADOPTED THIS REGULATION:

After consulting the Committee of the Regions,

Article 1

Acting in accordance with the procedure laid down in Article 251
of the Treaty (3),

The instruments listed in the Annex are hereby adapted,
accordance with that Annex,
amended by Decision 2006/512/EC.

in
to Decision 1999/468/EC, as

Whereas:

(1) Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of
implementing
powers conferred on the Commission (4) has been amended
by Decision 2006/512/EC (5), which introduced the
regulatory procedure with scrutiny for the adoption of
measures of general scope designed to amend non-essential
elements of a basic instrument adopted in accordance with
the procedure laid down in Article 251 of the Treaty, inter
alia, by deleting some of those elements or by supplement-
ing the instrument with new non-essential elements.

Article 2

References to provisions of the instruments listed in the Annex
shall be understood to be references to those provisions as
adapted by this Regulation.

Article 3

This Regulation shall enter into force on the 20th day following
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 Strasbourg, 11 March 2009.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

A. VONDRA

(1) OJ C 224, 30.8.2008, p. 35.
(2) OJ C 117, 14.5.2008, p. 1.
(3) Opinion of the European Parliament of 23 September 2008 (not yet
Journal) and Council Decision of

published in the Official
16 February 2009.

(4) OJ L 184, 17.7.1999, p. 23.
(5) OJ L 200, 22.7.2006, p. 11.

(6) OJ C 255, 21.10.2006, p. 1.

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ANNEX

1.

HUMANITARIAN AID

Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid (1)

As regards Regulation (EC) No 1257/96, the Commission should be empowered to adopt implementing measures for that
Regulation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC)
No 1257/96, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 1257/96 is hereby amended as follows:

1.

in Article 13, the fourth paragraph shall be replaced by the following:

‘Decisions to continue operations adopted by the emergency procedure shall be taken by the Commission, acting in
accordance with the management procedure referred to in Article 17(2) and within the limits set in the second indent
of Article 15(2).’;

2.

Article 15 shall be replaced by the following:

‘Article 15

1. The Commission shall adopt implementing measures for this Regulation. Those measures, designed to amend
non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 17(4).

2. Acting in accordance with the regulatory procedure referred to in Article 17(3), the Commission shall:

— decide on Community financing for the humanitarian-aid protection operations referred to in Article 2(c),

— decide to take direct Commission action or finance action by Member States’ specialised agencies,

3. Acting in accordance with the management procedure referred to in Article 17(2), the Commission shall:

— approve global plans intended to provide for actions in a given country or region where the scale and
complexity of the humanitarian crisis is such that it seems likely to continue, and the budgets for those plans. In
this context, the Commission and the Member States shall examine the priorities to be established in the
implementation of these global plans,

— decide on projects in excess of ECU 2 million, without prejudice to Article 13.’;

3.

Article 17 shall be replaced by the following:

‘Article 17

1. The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard
to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.

3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard
to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.

4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

(1) OJ L 163, 2.7.1996, p. 1.

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2.

ENTERPRISE

2.1. Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States

relating to aerosol dispensers (1)

As regards Directive 75/324/EEC, the Commission should be empowered to adopt the necessary technical adaptations
to that Directive and the required amendments to adapt the Annex to technical progress. Since those measures are of
general scope and are designed to amend non-essential elements of Directive 75/324/EEC, they must be adopted in
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 75/324/EEC is hereby amended as follows:

1.

Article 5 shall be replaced by the following:

‘Article 5

The Commission shall adopt the amendments required to adapt the Annex to this Directive to technical
progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 7(2).’;

2.

Article 7 is hereby amended as follows:

(a)

paragraph 2 shall be replaced by the following:

‘2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/
EC shall apply, having regard to the provisions of Article 8 thereof.’;

(b)

paragraph 3 shall be deleted;

3.

in Article 10, paragraph 3 shall be replaced by the following:

‘3. The Commission may adopt necessary technical adaptations of this Directive. Those measures, designed to
amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 7(2).

In that case, the Member State having adopted safeguard measures may maintain them until the entry into force
of the adaptations.’

2.2. Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing

on the market and supervision of explosives for civil uses (2)

As regards Directive 93/15/EEC, the Commission should be empowered to adapt the Directive to take account of any
future amendments to the United Nations recommendations and to set the conditions for the application of
Article 14, second paragraph. Since those measures are of general scope and are designed to amend non-essential
elements of Directive 93/15/EEC by supplementing it with new non-essential elements, they must be adopted in
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 93/15/EEC is hereby amended as follows:

1.

Article 13 shall be replaced by the following:

‘Article 13

1. The Commission shall be assisted by a committee.

2. The committee shall examine any matter concerning the application of this Directive.

3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

(1) OJ L 147, 9.6.1975, p. 40.
(2) OJ L 121, 15.5.1993, p. 20.

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4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

5. The Commission shall, in accordance with the management procedure referred to in paragraph 3, adopt
implementing measures in particular to take account of any future amendments to the United Nations
recommendations.’;

2.

the second paragraph of Article 14 shall be replaced by the following:

‘Member States shall ascertain whether such undertakings possess a system for keeping track of explosives such
that those holding explosives can be identified at any time. The Commission may adopt measures setting the
conditions for the application of this paragraph. Those measures, designed to amend non-essential elements of
this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 13(4).’

2.3. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of
the laws of the Member States relating to the noise emission in the environment by equipment for use
outdoors (1).

As regards Directive 2000/14/EC, the Commission should be empowered to adopt implementing measures for the
adaptation to technical progress of Annex III. Since those measures are of general scope and are designed to amend
non-essential elements of Directive 2000/14/EC, they must be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2000/14/EC is hereby amended as follows:

1.

Article 18 shall be amended as follows:

(a)

paragraph 2 shall be replaced by the following:

‘2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/
EC shall apply, having regard to the provisions of Article 8 thereof.’;

(b)

paragraph 3 shall be deleted;

2.

the following Article shall be inserted:

‘Article 18a

The Commission shall adopt implementing measures for the adaptation to technical progress of Annex III,
provided they do not have any direct impact on the measured sound power level of equipment listed in
Article 12, in particular through the inclusion of references to relevant European standards.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 18(2).’;

3.

in Article 19, point (b) shall be replaced by the following:

‘(b)

assist the Commission in the adaptation to technical progress of Annex III.’

2.4. Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to

fertilisers (2)

As regards Regulation (EC) No 2003/2003, the Commission should be empowered to adapt its annexes to technical
progress, to adapt the measuring, sampling and analysis methods, to adopt rules regarding control measures and to
include new types of EC fertilisers. Since those measures are of general scope and are designed to amend non-essential
elements of Regulation (EC) No 2003/2003, they must be adopted in accordance with the regulatory procedure with
scrutiny provided for in Article 5a of Decision 1999/468/EC.

(1) OJ L 162, 3.7.2000, p. 1.
(2) OJ L 304, 21.11.2003, p. 1.

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Accordingly, Regulation (EC) No 2003/2003 is hereby amended as follows:

1.

in Article 29, paragraph 4 shall be replaced by the following:

‘4. The Commission shall adapt and modernise the measuring, sampling and analysis methods and shall,
wherever possible, use European Standards. Those measures, designed to amend non-essential elements of this
Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Arti-
cle 32(3). The same procedure shall apply to the adoption of implementing rules needed to specify the control
measures provided for in this Article and in Articles 8, 26 and 27. Such rules shall in particular address the
question of the frequency with which tests need to be repeated, as well as measures that are designed to ensure
that the fertiliser put on the market is identical with the fertiliser tested.’;

2.

Article 31 is hereby amended as follows:

(a)

paragraph 1 shall be replaced by the following:

‘1. The Commission shall adapt Annex I to include new types of fertilisers.’;

(b)

paragraph 3 shall be replaced by the following:

‘3. The Commission shall adapt the Annexes to take account of technical progress.’;

(c)

the following paragraph shall be added:

‘4. The measures referred to in paragraphs 1 and 3, designed to amend non-essential elements of this
Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 32(3).’;

3.

Article 32 shall be replaced by the following:

‘Article 32

Committee procedure

1. The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

2.5. Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection

and verification of good laboratory practice (GLP) (codified version) (1)

As regards Directive 2004/9/EC, the Commission should be empowered to adapt Annex I to technical progress and
change the formula in Article 2(2). Since those measures are of general scope and are designed to amend non-essential
elements of Directive 2004/9/EC, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/9/EC is hereby amended as follows:

1.

Article 6(3) shall be replaced by the following:

If the Commission considers that amendments to this Directive are necessary in order to resolve the

‘3.
matters referred to in paragraph 1, it shall adopt those amendments.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 7(3).’;

(1) OJ L 50, 20.2.2004, p. 28.

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2.

Article 7 shall be replaced by the following:

‘Article 7

1. The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/
548/EEC (*), hereinafter “the Committee”.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ 196, 16.8.1967, p. 1.’;

3.

Article 8(2) shall be replaced by the following:

‘2. The Commission shall adopt implementing measures for the following:

(a)

the adaptation of the formula referred to in Article 2(2);

(b)

the adaptation of Annex I to take account of technical progress.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 7(3).’

2.6. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the
harmonisation of laws, regulations and administrative provisions relating to the application of the principles
of good laboratory practice and the verification of their applications for tests on chemical substances
(codified version) (1)

As regards Directive 2004/10/EC, the Commission should be empowered to adapt Annex I to technical progress.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/10/EC,
they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision
1999/468/EC.

Accordingly, Directive 2004/10/EC is hereby amended as follows:

1.

the following Article shall be inserted:

‘Article 3a

The Commission may adapt Annex I to technical progress, with regard to principles of GLP.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 4(2).’;

2.

Article 4 shall be replaced by the following:

‘Article 4

1. The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/
548/EEC (*).

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ 196, 16.8.1967, p. 1.’;

(1) OJ L 50, 20.2.2004, p. 44.

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3.

in Article 5(2) the third subparagraph shall be replaced by the following:

‘The Commission may adopt implementing measures to introduce necessary technical adaptations of this
Directive.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 4(2).

In the case referred to in the third subparagraph, the Member State which adopted the safeguard measures may
maintain them until the entry into force of those adaptations.’

2.7. Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug

precursors (1)

As regards Regulation (EC) No 273/2004, the Commission should be empowered to adopt implementing measures.
Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC)
No 273/2004, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in
Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 273/2004 is hereby amended as follows:

1.

Article 14 is hereby amended as follows:

(a)

the introductory sentence shall be replaced by the following:

‘Where necessary, the Commission shall adopt implementing measures concerning the following:’;

(b)

the following paragraphs shall be added:

‘The measures referred to in points (a) to (e) of the first paragraph, designed to amend non-essential
elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 15(3).

The measures referred to in point (f) of the first paragraph shall be adopted in accordance with the
management procedure referred to in Article 15(2).’;

2.

Article 15 shall be replaced by the following:

‘Article 15

Committee procedure

1. The Commission shall be assisted by the Committee set up by Article 30 of Council Regulation (EC)
No 111/2005 (*).

2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 22, 26.1.2005, p. 1.’

2.8. Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on

detergents (2)

As regards Regulation (EC) No 648/2004, the Commission should be empowered to adapt its annexes and to adopt
any amendments or additions necessary for applying the rules of that Regulation to solvent-based detergents, where
necessary. Since those measures are of general scope and are designed to amend non-essential elements of Regulation
(EC) No 648/2004, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in
Article 5a of Decision 1999/468/EC.

(1) OJ L 47, 18.2.2004, p. 1.
(2) OJ L 104, 8.4.2004, p. 1.

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Accordingly, Regulation (EC) No 648/2004 is hereby amended as follows:

1.

2.

Recital 27 shall be deleted;

Article 12 shall be replaced by the following:

‘Article 12

Committee procedure

1. The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’;

3.

Article 13 shall be replaced by the following:

‘Article 13

Adaptation of the Annexes

1. The Commission shall adopt any amendments necessary for adapting the Annexes and shall, wherever
possible, use European Standards.

2. The Commission shall adopt any amendments or additions necessary for applying the rules of this
Regulation to solvent-based detergents.

3. The measures referred to in paragraphs 1 and 2, designed to amend non-essential elements of this
Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12
(3).’;

4.

in Annex VII, point A, the sixth paragraph shall be replaced by the following:

‘If individual risk-based concentration limits for the fragrance allergens are subsequently established by the
SCCNFP, the Commission shall propose the adoption of such limits to replace the limit of 0.01 % mentioned
above. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’

2.9. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down
Community procedures for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency (1)

As regards Regulation (EC) No 726/2004, the Commission should be empowered to adapt certain provisions and
annexes, to adopt new provisions, and to lay down specific conditions of application. Since those measures are of
inter alia, by
general scope and are designed to amend non-essential elements of Regulation (EC) No 726/2004,
supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 726/2004 is hereby amended as follows:

1.

Article 3(4) shall be replaced by the following:

‘4. After the competent committee of the Agency has been consulted, the Commission may adapt the Annex
to technical and scientific progress and may adopt any necessary amendments without extending the scope of
the centralised procedure.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

(1) OJ L 136, 30.4.2004, p. 1.

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2.

in Article 14(7), the third subparagraph shall be replaced by the following:

‘The Commission shall adopt a Regulation laying down provisions for granting such authorisation. That
measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

3.

Article 16(4) shall be replaced by the following:

‘4. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of
variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-
essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 87(2a).’;

4.

Article 24 is hereby amended as follows:

(a)

in paragraph 2, the first subparagraph shall be replaced by the following:

‘The holder of the marketing authorisation for a medicinal product for human use shall ensure that all
suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of
any infectious agent occurring in the territory of a third country are reported promptly to Member States
and the Agency, and no later than 15 days following receipt of the information. The Commission shall
adopt provisions for the reporting of suspected unexpected adverse reactions which are not serious,
whether occurring in the Community or in a third country. Those measures, designed to amend non-
essential elements of this regulation by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 87(2a).’;

(b)

paragraph 4 shall be replaced by the following:

‘4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with
its operation. Those measures, designed to amend non-essential elements of this regulation, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

5.

Article 29 shall be replaced by the following:

‘Article 29

The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter
in order to take account of scientific and technical progress. Those measures, designed to amend non-essential
elements of this regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred
to in Article 87(2a).’;

6.

Article 41(6) shall be replaced by the following:

‘6. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of
variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-
essential elements of this regulation by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 87(2a).’;

7.

Article 49 is hereby amended as follows:

(a)

in paragraph 2 the first subparagraph shall be replaced by the following:

‘The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all
suspected serious unexpected adverse reactions, and adverse human reactions, and any suspected
transmission via a medicinal product of any infectious agent occurring in the territory of a third country
are reported promptly to the Member States and the Agency, and no later than 15 days following receipt
of the information. The Commission shall adopt provisions for the reporting of suspected unexpected
adverse reactions which are not serious, whether occurring in the Community or in a third country. Those
measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

(b)

paragraph 4 shall be replaced by the following:

‘4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with
its operation. Those measures, designed to amend non-essential elements of this regulation, shall be
adopted in accordance with the procedure referred to in Article 87(2a).’;

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8.

Article 54 shall be replaced by the following:

‘Article 54

The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter
in order to take account of scientific and technical progress. Those measures, designed to amend non-essential
elements of this regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred
to in Article 87(2a).’;

9.

Article 70(2) shall be replaced by the following:

‘2. However, the Commission shall adopt provisions establishing the circumstances in which small and
medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

10.

in Article 84(3), the first subparagraph shall be replaced by the following:

‘At the Agency's request, the Commission may impose financial penalties on the holders of marketing
authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection
with the authorisations. The maximum amounts as well as the conditions and methods for collection of these
penalties shall be laid down by the Commission. Those measures, designed to amend non-essential elements of
this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 87(2a).’;

11. Article 87 is hereby amended as follows:

(a)

the following paragraph shall be inserted:

‘2a. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/
EC shall apply, having regard to the provisions of Article 8 thereof.’;

(b)

paragraph 4 shall be deleted.

3.

ENVIRONMENT

3.1. Council Directive 82/883/EEC of 3 December 1982 on procedures for the surveillance and monitoring of

environments concerned by waste from the titanium dioxide industry (1)

As regards Directive 82/883/EEC, the Commission should be empowered to adapt to scientific and technical progress
the contents of the Annexes as regards parameters listed in the ‘optional determination’ column and reference
methods of measurement. Since those measures are of general scope and are designed to amend non-essential
elements of Directive 82/883/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 82/883/EEC is hereby amended as follows:

1.

Article 9 shall be replaced by the following:

‘Article 9

The Commission shall adopt the requisite amendments to adapt to scientific and technical progress the contents
of the Annexes as regards parameters listed in the “optional determination” column and reference methods of
measurement.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 11(2).’;

2.

Article 11 shall be replaced by the following:

‘Article 11

1. The Commission shall be assisted by the committee.

(1) OJ L 378, 31.12.1982, p. 1.

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2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

3.2. Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the

soil, when sewage sludge is used in agriculture (1)

As regards Directive 86/278/EEC, the Commission should be empowered to adapt to technical and scientific progress
the provisions of the Annexes. Since those measures are of general scope and are designed to amend non-essential
elements of Directive 86/278/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 86/278/EEC is hereby amended as follows:

1.

Article 13 shall be replaced by the following:

‘Article 13

The Commission shall adapt to technical and scientific progress the provisions of the Annexes to the Directive,
except for the parameters and values listed in Annexes I A, I B and I C, any factors likely to affect the evaluation
of the values, and the parameters for analysis referred to in Annexes II A and II B.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 15(2).’;

2.

Article 15 shall be replaced by the following:

‘Article 15

1. The Commission shall be assisted by the Committee.

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

3.3. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging

waste (2)

As regards Directive 94/62/EC, the Commission should be empowered to examine and, where necessary, review the
illustrative examples for the definition of packaging and to determine the conditions under which concentration levels
of heavy metals present in packaging or packaging components will not apply to some materials and product loops,
the types of packaging exempted from the requirement regarding concentration levels and the technical measures
necessary to deal with any difficulties encountered in applying the provisions of this Directive. Since those measures
are of general scope and are designed to amend non-essential elements of Directive 94/62/EC,
inter alia, by
supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 94/62/EC is hereby amended as follows:

1.

in Article 3(1), the fourth subparagraph shall be replaced by the following:

‘The Commission shall, as appropriate, examine and, where necessary, review the illustrative examples for the
definition of packaging given in Annex I. As a priority, the following items shall be addressed: CD and video
cases, flower pots, tubes and cylinders around which flexible material is wound, release paper of self-adhesive
labels and wrapping paper. Those measures, designed to amend non-essential elements of this Directive, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).’;

2.

Article 11(3) shall be replaced by the following:

‘3. The Commission shall determine the conditions under which the concentration levels referred to in
paragraph 1 will not apply to recycled materials and to product loops which are in a closed and controlled
chain, as well as the types of packaging which are exempted from the requirement referred to in the third indent
of paragraph 1.

(1) OJ L 181, 4.7.1986, p. 6.
(2) OJ L 365, 31.12.1994, p. 10.

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Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).’;

3.

Article 12(3) shall be replaced by the following:

In order to harmonise the characteristics and presentation of the data prod uced and to make the data of
‘3.
the Member States compatible, Member States shall provide the Commission with their available data in formats
which shall be adopted on the basis of Annex I II, in accordance with the regulatory procedure referred to in
Article 21(2).’;

4.

Article 19 shall be replaced by the following:

‘Article 19

Adaptation to scientific and technical progress

1. The amendments necessary for adapting to scientific and technical progress the identification system (as
referred to in Article 8(2) and Article 10, second paragraph, last indent) and the formats relating to the database
system (as referred to in Article 12(3) and Annex III) shall be adopted in accordance with the regulatory
procedure referred to in Article 21(2).

2. The Commission shall adopt the amendments necessary for adapting to scientific and technical progress the
illustrative examples on the definition of packaging (as referred to in Annex I). Those measures, designed to
amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 21(3).’;

5.

Article 20(1) shall be replaced by the following:

‘1. The Commission shall determine the technical measures necessary to deal with any difficulties encountered
in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in
very small quantities (i.e. approximately 0,1 % by weight) in the Community, primary packaging for medical
devices and pharmaceutical products, small packaging and luxury packaging. Those measures, designed to
amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 21(3).’;

6.

Article 21(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

3.4. Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain

liquid fuels (1)

As regards Directive 1999/32/EC, the Commission should be empowered to establish criteria for the use of emission
abatement technologies by ships of all flags in enclosed ports, harbours and estuaries in the Community and to adopt
amendments necessary to make technical adaptations to some provisions in the light of scientific and technical
progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive
1999/32/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with
the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 1999/32/EC is hereby amended as follows:

1.

Article 4c(3) shall be replaced by the following:

‘3. Criteria shall be established by the Commission for the use of emission abatement technologies by ships of
all flags in enclosed ports, harbours and estuaries in the Community. Those measures, designed to amend non-
essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 9(2). The Commission shall communicate these criteria to the
IMO.’;

2.

Article 7(4) shall be replaced by the following:

‘4. Any amendments necessary to make technical adaptations to Article 2, points 1, 2, 3, 3a, 3b and 4, or
Article 6(2) in the light of scientific and technical progress shall be adopted by the Commission. Those
measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 9(2). Such adaptations shall not result in any direct
changes to the scope of this Directive or to limits on sulphur in fuel specified in this Directive.’;

(1) OJ L 121, 11.5.1999, p. 13.

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3.

Article 9 shall be replaced by the following:

‘Article 9

Committee procedure

1. The Commission shall be assisted by a committee.

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

3.5. Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national

emission ceilings for certain atmospheric pollutants (1)

As regards Directive 2001/81/EC, the Commission should be empowered to update the methodologies to be used in
accordance with Annex III. Since those measures are of general scope and are designed to amend non-essential
elements of that Directive, inter alia, by supplementing it with new non-essential elements, they must be adopted in
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2001/81/EC is hereby amended as follows:

1.

Article 7(4) shall be replaced by the following:

‘4. Any updating of the methodologies to be used in accordance with Annex III shall be adopted by the
Commission. Those measures, designed to amend non-essential elements of this Directive,
inter alia, by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 13(3).’;

2.

Article 13(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

3.6. 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 (2)

As regards Directive 2003/87/EC, the Commission should be empowered to adopt provisions necessary for the
implementation of Article 11b(5), to adopt guidelines for the monitoring and reporting of emissions, to adopt a
Regulation for a standardised and secured system of registries including provisions concerning the use and
identification of CERs and ERUs in the Community scheme and the monitoring of the level of such use, to amend
Annex III as laid down in Article 22, to approve inclusion of activities and greenhouse gases not listed in Annex I, to
draw up any necessary provisions relating to the mutual recognition of allowances under agreements with third
countries, and to adopt standardised or accepted methods for monitoring of emissions of other greenhouse gases.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 2003/87/EC,
inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2003/87/EC is hereby amended as follows:

1.

in Article 11b, paragraph 7 shall be replaced by the following:

‘7.
Provisions for the implementation of paragraphs 3 and 4, particularly in respect of the avoidance of double
counting, shall be adopted by the Commission in accordance with the regulatory procedure referred to in
Article 23(2). The Commission shall adopt provisions for the implementation of paragraph 5 of this Article
where the host party meets all eligibility requirements for JI project activities. Those measures, designed to
amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 23(3).’;

2.

in Article 14(1), the first sentence shall be replaced by the following:

‘The Commission shall adopt guidelines for the monitoring and reporting of emissions resulting from the
activities listed in Annex I of greenhouse gases specified in relation to those activities. Those measures, designed
to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 23(3).’;

(1) OJ L 309, 27.11.2001, p. 22.
(2) OJ L 275, 25.10.2003, p. 32.

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3.

Article 19(3) shall be replaced by the following:

‘3.
In order to implement this Directive, the Commission shall adopt a Regulation for a standardised and
secured system of registries in the form of standardised electronic databases containing common data elements
to track the issue, holding,
to provide for public access and
confidentiality as appropriate and to ensure that there are no transfers which are incompatible with the
obligations resulting from the Kyoto Protocol. That Regulation shall also include provisions concerning the use
and identification of CERs and ERUs in the Community scheme and the monitoring of the level of such use.
That measure, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted
in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’;

transfer and cancellation of allowances,

4.

Article 22 shall be replaced by the following:

‘Article 22

Amendments to Annex III

The Commission may amend Annex III, with the exception of criteria 1, 5 and 7, for the period from 2008 to
2012 in the light of the reports provided for in Article 21 and of the experience of the application of this
Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’;

5.

Article 23(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’;

6.

Article 24 shall be amended as follows:

(a)

paragraph 1 shall be replaced by the following:

‘1. Taking into account all relevant criteria, in particular the effects on the internal market, potential
distortions of competition, the environmental integrity of the scheme and the reliability of the planned
monitoring and reporting system, Member States may, from 2008, apply emission allowance trading in
accordance with this Directive to:

(a)

(b)

installations which are not listed in Annex I, provided that inclusion of such installations is
approved by the Commission in accordance with the regulatory procedure referred to in Article 23
(2), and

activities and greenhouse gases which are not listed in Annex I, provided that the inclusion of such
activities and greenhouse gases is approved by the Commission. Those measures, designed to amend
non-essential elements of this Directive by supplementing it, shall be adopted in accordance with
the regulatory procedure with scrutiny referred to in Article 23(3).

From 2005, Member States may under the same conditions apply emissions allowance trading to
installations carrying out activities listed in Annex I below the capacity limits referred to in that Annex.’;

(b)

paragraph 3 shall be replaced by the following:

‘3. The Commission may, on its own initiative, or shall, on request by a Member State, adopt monitoring
and reporting guidelines for emissions from activities, installations and greenhouse gases which are not
listed in Annex I if the monitoring and reporting of these emissions can be carried out with sufficient
accuracy.

Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’;

7.

Article 25(2) shall be replaced by the following:

‘2. Where an agreement referred to in paragraph 1 has been concluded, the Commission shall adopt any
necessary provisions relating to the mutual recognition of allowances under that agreement. Those measures,
designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 23(3).’;

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8.

in Annex IV, the paragraph under the heading ‘Monitoring of emissions of other greenhouse gases’ shall be
replaced by the following:

‘Standardised or accepted methods shall be used, developed by the Commission in collaboration with all
relevant stakeholders. Those measures, designed to amend non-essential elements of
this Directive, by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 23(3).’.

3.7. Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent

organic pollutants (1)

As regards Regulation (EC) No 850/2004, the Commission should be empowered to establish some concentration
limits in the annexes, to amend annexes whenever a substance is listed in the Convention or the Protocol, to modify
the existing entries and to adapt annexes to scientific and technical progress. Since those measures are of general scope
and are designed to amend non-essential elements of Regulation (EC) No 850/2004, they must be adopted in
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 850/2004 is hereby amended as follows:

1.

Article 7 shall be amended as follows:

(a)

in paragraph 4, point (a) shall be replaced by the following:

‘(a) waste containing or contaminated by any substance listed in Annex IV may be otherwise disposed
of or recovered in accordance with the relevant Community legislation, provided that the content of
the listed substances in the waste is below the concentration limits to be specified in Annex IV.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 17(3). Until such time
as concentration limits are established in accordance with such procedure, the competent authority
of a Member State may adopt or apply concentration limits or specific technical requirements in
respect of the disposal or recovery of waste under this point.’;

(b)

in paragraph 5, the first subparagraph shall be replaced by the following:

‘Concentration limits in Annex V, part 2 shall be established by the Commission for the purposes of
paragraph 4(b) of this Article. Those measures, designed to amend non-essential elements of this
Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 17(3).’;

2.

Article 14 shall be replaced by the following:

‘Article 14

Amendment of Annexes

1. Whenever a substance is listed in the Convention or the Protocol, the Commission shall, where appropriate,
amend Annexes I, II and III accordingly.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 16(3).

2. Whenever a substance is listed in the Convention or the Protocol, the Commission shall, where appropriate,
amend Annex IV accordingly.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 17(3).

3. The Commission shall adopt modifications to the existing entries in Annexes I, II and III, including their
adaptation to scientific and technical progress.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 16(3).

4. The Commission shall adopt modifications to the existing entries in Annex IV and modifications to
Annex V, including their adaptation to scientific and technical progress.

(1) OJ L 229, 29.6.2004, p. 5.

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Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 17(3).’;

3.

Article 16(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’;

4.

Article 17(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’.

3.8. Directive 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to

arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air (1)

As regards Directive 2004/107/EC, the Commission should be empowered to adapt certain provisions and Annexes to
scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential
elements of Directive 2004/107/EC, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/107/EC is hereby amended as follows:

1.

Article 4 shall be amended as follows:

(a)

paragraph 9 shall be replaced by the following:

Irrespective of concentration levels, one background sampling point shall be installed every
‘9.
100 000 km2 for the indicative measurement, in ambient air, of arsenic, cadmium, nickel, total gaseous
mercury, benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in paragraph 8, and
of the total deposition of arsenic, cadmium, mercury, nickel, benzo(a)pyrene and the other polycyclic
aromatic hydrocarbons referred to in paragraph 8. Each Member State shall set up at least one measuring
station. However, Member States may, by agreement, and in accordance with guidelines to be drawn up
under the regulatory procedure referred to in Article 6(2), set up one or several common measuring
stations, covering neighbouring zones in adjoining Member States, to achieve the necessary spatial
resolution. Measurement of particulate and gaseous divalent mercury is also recommended. Where
appropriate, monitoring shall be coordinated with the European Monitoring and Evaluation of Pollutants
(EMEP) monitoring strategy and measurement programme. The sampling sites for these pollutants shall be
selected in such a way that geographical variation and long-term trends can be identified. Sections I, II and
III of Annex III shall apply.’;

(b)

paragraph 15 shall be replaced by the following:

‘15. Any amendments necessary to adapt the provisions of this Article and of Section II of Annex II and
of Annexes III, IV and V to scientific and technical progress shall be adopted by the Commission. Those
measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with
the regulatory procedure with scrutiny referred to in Article 6(3). They may not result in any direct or
indirect changes to target values.’;

2.

Article 5(4) shall be replaced by the following:

‘4. The Commission shall adopt, in accordance with the regulatory procedure referred to in Article 6(2), any
detailed arrangements for forwarding the information to be provided under paragraph 1 of this Article.’;

3.

Article 6(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’;

4.

Annex V, point V shall be replaced by the following:

‘V.

Reference air quality modelling techniques

Reference air quality modelling techniques cannot be specified at present. The Commission may make
amendments to adapt this point to scientific and technical progress. Those measures, designed to amend
non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 6(3).’

(1) OJ L 23, 26.1.2005, p. 3.

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3.9. Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments

of waste (1)

As regards Regulation (EC) No 1013/2006, the Commission should be empowered to amend the annexes as laid
down in Article 58 of Regulation (EC) No 1013/2006 and to adopt certain additional measures as laid down in
Article 59 of Regulation (EC) No 1013/2006. Since those measures are of general scope and are designed to amend
non-essential elements of Regulation (EC) No 1013/2006, inter alia, by supplementing it with new non-essential
elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a
of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 1013/2006 is hereby amended as follows:

1.

in Article 11(3), the third subparagraph shall be replaced by the following:

‘If there is no satisfactory solution, either Member State may refer the matter to the Commission. The issue shall
then be determined in accordance with the regulatory procedure referred to in Article 59a(2).’;

2.

Article 58 shall be replaced by the following:

‘Article 58

Amendment of Annexes

1. The Commission may amend the Annexes to take account of scientific and technical progress. Those
measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 59a(3). In addition:

(a)

(b)

(c)

(d)

(e)

Annexes I, II, III, IIIA, IV and V shall be amended to take account of changes agreed under the Basel
Convention and the OECD Decision;

unclassified wastes may be added to Annex IIIB, IV or V on a provisional basis pending a decision on their
inclusion in the relevant Annexes to the Basel Convention or to the OECD Decision;

following the submission of a request by a Member State, mixtures of two or more wastes listed in
Annex III may be considered for inclusion in Annex IIIA in the cases referred to in Article 3(2) on a
provisional basis pending a decision on their inclusion in the relevant Annexes to the Basel Convention or
to the OECD Decision. Annex IIIA may contain the proviso that one or more of the entries therein shall
not apply for exports to countries to which the OECD Decision does not apply;

the exceptional cases referred to in Article 3(3) shall be determined and, where necessary, such waste shall
be added to Annexes IVA and V and deleted from Annex III;

Annex V shall be amended to reflect agreed changes to the list of hazardous waste adopted in accordance
with Article 1(4) of Directive 91/689/EEC;

(f)

Annex VIII shall be amended to reflect relevant international conventions and agreements.

2. When amending Annex IX, the Committee established by Council Directive 91/692/EEC of 23 December
1991 standardising and rationalising reports on the implementation of certain Directives relating to the
environment (*) shall be fully associated with the deliberations.

(*) OJ L 377, 31.12.1991, p. 48.’;

3.

Article 59 shall be replaced by the following:

‘Article 59

Additional measures

1. The Commission may adopt, in accordance with the regulatory procedure referred to in Article 59a(2), the
following additional measures related to the implementation of this Regulation:

(a)

guidelines for the application of Article 12(1)(g);

(b)

guidelines on the application of Article 15 in relation to the identification and tracking of waste
undergoing substantial changes in the interim recovery or disposal operation;

(1) OJ L 190, 12.7.2006, p. 1.

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(c)

(d)

guidelines for the cooperation of competent authorities with regard to illegal shipments as referred to in
Article 24;

technical and organisational requirements for the practical implementation of electronic data interchange
for the submission of documents and information in accordance with Article 26(4);

(e)

further guidance concerning the use of languages referred to in Article 27;

(f)

further clarification of the procedural requirements of Title II as regards their application to exports,
imports and transit of waste from, to, and through the Community;

(g)

further recommendations concerning undefined legal terms.

2. The Commission may adopt implementing measures concerning the following:

(a)

a method for calculating the financial guarantee or equivalent insurance as set out in Article 6;

(b)

further conditions and requirements in relation to pre-consented recovery facilities as referred to in
Article 14.

Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 59a(3).’;

4.

The following Article shall be inserted:

‘Article 59a

Committee procedure

1. The Commission shall be assisted by the committee set up by Article 18(1) of Directive 2006/12/EC.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’;

5.

Article 63 shall be amended as follows:

(a)

in paragraph 2, the third subparagraph shall be replaced by the following:

‘With the exception of glass waste, paper waste and waste pneumatic tyres, this period may be extended
until no later than 31 December 2012 in accordance with the regulatory procedure referred to in
Article 59a(2).’;

(b)

in paragraph 4, the third subparagraph shall be replaced by the following:

‘This period may be extended until no later than 31 December 2012 in accordance with the regulatory
procedure referred to in Article 59a(2).’;

(c)

paragraph 5 shall be amended as follows:

(i)

the third subparagraph shall be replaced by the following:

‘This period may be extended until no later than 31 December 2015 in accordance with the
regulatory procedure referred to in Article 59a(2).’;

(ii)

the fifth subparagraph shall be replaced by the following:

‘This period may be extended until no later than 31 December 2015 in accordance with the
regulatory procedure referred to in Article 59a(2).’

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4.

EUROSTAT

4.1. Council Regulation (EEC) No 3924/91 of 19 December 1991 on the establishment of a Community survey of

industrial production (1)

As regards Regulation (EEC) No 3924/91, the Commission should be empowered to update the list of products
concerned by that Regulation. It should also be empowered to adopt detailed rules as regards representativeness and
periodicity for certain products and to establish the arrangements for survey contents and implementing measures,
including the measures for adjustment to technical progress concerning the collection of data and the processing of
the results. Since those measures are of general scope and are designed to amend non-essential elements of Regulation
inter alia, by supplementing it with new non-essential elements, they must be adopted in
(EEC) No 3924/91,
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EEC) No 3924/91 is hereby amended as follows:

1.

Article 2(6) shall be replaced by the following:

‘6. The Prodcom list and the information actually collected for each heading shall be updated by the
Commission. Those measures, designed to amend non-essential elements of this Regulation,
inter alia, by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 10(3).’;

2.

Article 3 shall be amended as follows:

(a)

in paragraph 2 the words ‘in accordance with the procedure laid down in Article 10’ shall be replaced by
the words ‘in accordance with the management procedure referred to in Article 10(2).’;

(b)

paragraph 5 shall be replaced by the following:

‘5. Detailed rules for applying paragraph 3, including measures for the adjustment to technical progress,
shall be adopted, as necessary, by the Commission. Those measures, designed to amend non-essential
elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 10(3).’;

3.

Article 4 shall be replaced by the following:

‘Article 4

Survey periods

The survey shall cover an annual period of one calendar year.

However, for certain headings in the Prodcom list, the Commission may decide that monthly or quarterly
surveys are to be conducted. Those measures, designed to amend non-essential elements of this Regulation, inter
alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to
in Article 10(3).’;

4.

Article 5(1) shall be replaced by the following:

‘1. The required information shall be collected by the Member States using survey questionnaires the content
of which shall comply with the arrangements defined by the Commission. Those measures, designed to amend
non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 10(3).’;

5.

Article 6 shall be replaced by the following:

‘Article 6

Processing of results

Member States shall process the completed questionnaires referred to in Article 5(1) or the information from
other sources referred to in Article 5(3) in accordance with the detailed rules adopted by the Commission. Those
measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 10(3).’;

6.

in Article 7(2) the words ‘in accordance with the procedure laid down in Article 10’ shall be replaced by the
words ‘in accordance with the management procedure referred to in Article 10(2)’;

(1) OJ L 374, 31.12.1991, p. 1.

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7.

8.

Article 9 shall be deleted;

Article 10 shall be replaced by the following:

‘Article 10

Committee procedure

1. The Commission shall be assisted by the Statistical Programme Committee established by Council Decision
89/382/EEC, Euratom (*).

2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 181, 28.6.1989, p. 47.’

4.2. Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk products (1)

As regards Directive 96/16/EC, the Commission should be empowered to adopt the definitions for the agricultural
holdings among which Member States must conduct surveys of the production of milk and its use, adopt the list of
milk products covered by the surveys and draw up standard definitions to be used when communicating the results to
the Commission. Since those measures are of general scope and are designed to amend non-essential elements of
Directive 96/16/EC by supplementing it with new non-essential elements, they must be adopted in accordance with
the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 96/16/EC is hereby amended as follows:

1.

in Article 1, point 2 shall be replaced by the following:

‘2)
shall carry out annual surveys of the production of milk and its use among agricultural holdings as defined
by the Commission. The measures defining agricultural holdings, designed to amend non-essential elements of
this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 7(3).’;

2.

Article 3(2) and (3) shall be replaced by the following:

‘2. The list of milk products covered by the surveys shall be adopted by the Commission. Those measures,
designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 7(3).

3. The standard definitions to be used when communicating the results for the various products shall be
drawn up by the Commission. Those measures, designed to amend non-essential elements of this Directive by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 7(3).’;

3.

in Article 5(2) and Article 6(1), the words ‘in accordance with the procedure laid down in Article 7’ shall be
replaced by the words ‘in accordance with the regulatory procedure referred to in Article 7(2).’;

4.

Article 7 shall be replaced by the following:

‘Article 7

1. The Commission shall be assisted by the Standing Committee on Agricultural Statistics set up by Decision
72/279/EEC.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

(1) OJ L 78, 28.3.1996, p. 27.

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3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

4.3. Directive 2001/109/EC of the European Parliament and of the Council of 19 December 2001 concerning the
statistical surveys to be carried out by the Member States in order to determine the production potential of
plantations of certain species of fruit trees (1)

As regards Directive 2001/109/EC, the Commission should be empowered to amend the list of species of fruit trees
and the table of species surveyed in the Member States, to adopt the detailed rules for the application of certain articles
and to determine the boundaries of the production areas to be adopted for Member States. Since those measures are of
general scope and are designed to amend non-essential elements of Directive 2001/109/EC,
inter alia, by
supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2001/109/EC is hereby amended as follows:

1.

the third subparagraph of Article 1(2) shall be replaced by the following:

‘The list of said species and the said table may be amended by the Commission. Those measures, designed to
amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 8(2).’;

2.

Article 2(2) shall be replaced by the following:

‘2. Detailed rules for the organisation of the surveys that provide relevant results shall be adopted by the
Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it,
shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 8(2).’;

3.

Article 3(4) shall be replaced by the following:

‘4. Detailed rules for the random sampling arrangements shall be adopted by the Commission. Those
measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 8(2).’;

4.

Article 4(2) shall be replaced by the following:

‘2. The results referred to in paragraph 1 shall be supplied for each production area. The boundaries of the
production areas to be adopted for Member States shall be determined by the Commission. Those measures,
designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 8(2).’;

5.

Article 8 shall be replaced by the following:

‘Article 8

1. The Commission shall be assisted by the Standing Committee on Agricultural Statistics set up by Council
Decision 72/279/EEC (*).

2. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(a) and Article 7 of Decision 1999/
468/EC shall apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 179, 7.8.1972, p. 1.’

4.4. Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail

transport statistics (2)

As regards Regulation (EC) No 91/2003, the Commission should be empowered to adapt the definitions and adopt
additional provisions, to adapt the content of the annexes and to specify the information to be supplied for the reports
on the quality and comparability of the results. Since those measures are of general scope and are designed to amend
non-essential elements of Regulation (EC) No 91/2003,
inter alia, by supplementing it with new non-essential
elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a
of Decision 1999/468/EC.

(1) OJ L 13, 16.1.2002, p. 21.
(2) OJ L 14, 21.1.2003, p. 1.

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Accordingly, Regulation (EC) No 91/2003 is hereby amended as follows:

1.

Article 3(2) shall be replaced by the following:

‘2. The definitions referred to in paragraph 1 may be adapted, and additional definitions needed to ensure
harmonisation of statistics may be adopted by the Commission. Those measures, designed to amend non-
essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 11(3).’;

2.

Article 4 is hereby amended as follows:

(a)

paragraph 2 shall be replaced by the following:

‘2. Annexes B and D set out simplified reporting requirements, which may be used by Member States as
alternatives to the normal detailed reporting requirements set out in Annexes A and C, for undertakings
for which the total volume of goods or passenger transport is less than 500 million tonne-km or
200 million passenger-km respectively. These thresholds may be adapted by the Commission. Those
measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 11(3).’;

(b)

paragraph 5 shall be replaced by the following:

‘5. The contents of the Annexes may be adapted by the Commission. Those measures, designed to
amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 11(3).’;

3.

Article 10 shall be replaced by the following:

‘Article 10

Implementing procedures

1. The arrangements for the transmission of data to Eurostat shall be made in accordance with the regulatory
procedure referred to in Article 11(2).

2. The Commission shall adopt the following implementing measures:

(a)

adaptation of the thresholds for simplified reporting (Article 4);

(b)

adaptation of the definitions and adoption of additional definitions (Article 3(2));

(c)

adaptation of the contents of the annexes (Article 4);

(d)

specification of information to be supplied for the reports on the quality and comparability of the results
(Article 8(2)).

Those measures, designed to amend non-essential elements of this Regulation, inter alia,, by supplementing it,
shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3).’;

4.

Article 11 shall be replaced by the following:

‘Article 11

Committee procedure

1. The Commission shall be assisted by the Statistical Programme Committee established by Decision 89/382/
EEC, Euratom.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(a) and Article 7 of Decision 1999/
468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

5.

in point 5 of Annex H the words ‘according to the procedure of Article 11(2)’ shall be replaced by the words ‘in
accordance with the regulatory procedure with scrutiny referred to in Article 11(3).’

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4.5. 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 (1)

As regards Regulation (EC) No 437/2003, the Commission should be empowered to establish standards of accuracy,
specify data files and adopt certain implementing measures. Since those measures are of general scope and are
designed to amend non-essential elements of Regulation (EC) No 437/2003, inter alia, by supplementing it with new
non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for
in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 437/2003 is hereby amended as follows:

1.

Article 5 shall be replaced by the following:

‘Article 5

Accuracy of statistics

The collection of data shall be based on complete returns, unless other standards of accuracy are established by
the Commission. Those measures, designed to amend non-essential elements of
this Regulation by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 11(3).’;

2.

Article 7(2) shall be replaced by the following:

‘2. The results shall be transmitted according to the data files shown in Annex I. The files shall be specified by
the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3).

The medium to be used for transmission shall be specified by the Commission in accordance with the regulatory
procedure referred to in Article 11(2).’;

3.

Article 10 shall be replaced by the following:

‘Article 10

Implementing measures

1. The following implementing measures shall be adopted in accordance with the regulatory procedure
referred to in Article 11(2):

— the list of Community airports covered by Article 3(2),

— description of the data codes and the medium to be used for transmission of results to the Commission

(Article 7),

— dissemination of statistical results (Article 8),

2. The Commission shall adopt the following implementing measures:

— adaptation of the specifications in the Annexes to this Regulation,

— adaptation of the data collection characteristics (Article 3),

— accuracy of statistics (Article 5),

— description of the data files (Article 7),

Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3).’;

(1) OJ L 66, 11.3.2003, p. 1.

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4.

Article 11 shall be replaced by the following:

‘Article 11

Committee procedure

1. The Commission shall be assisted by the Statistical Programme Committee established by Decision 89/382/
EEC, Euratom.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The time limit laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(a) and Article 7 of Decision 1999/
468/EC shall apply, having regard to the provisions of Article 8 thereof.’.

4.6. Regulation (EC) No 48/2004 of the European Parliament and of the Council of 5 December 2003 on the
production of annual Community statistics on the steel industry for the reference years 2003-2009 (1)

As regards Regulation (EC) No 48/2004, the Commission should be empowered to update the list of characteristics
concerned by that Regulation. Since those measures are of general scope and are designed to amend non-essential
elements of Regulation (EC) No 48/2004, inter alia, by supplementing it with new non-essential elements, they must
be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/
468/EC.

Accordingly, Regulation (EC) No 48/2004 is hereby amended as follows:

1.

Article 7 shall be replaced by the following:

‘Article 7

Implementing measures

1. The measures for the implementation of this Regulation concerning transmission formats and the first
transmission period shall be adopted in accordance with the regulatory procedure referred to in Article 8(2).

the list of
2. The measures for the implementation of
characteristics, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall
be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 8(3), provided that
no significant additional burden is imposed upon the Member States.’;

this Regulation concerning the updating of

2.

Article 8(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

5.

INTERNAL MARKET

Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (2)

As regards Directive 2004/25/EC, the Commission should be empowered to adopt rules for the application of Article 6(3)
to the contents of the offer document. Since those measures are of general scope and are designed to amend non-essential
elements of Directive 2004/25/EC, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Directive 2004/25/EC provided for a time restriction concerning the implementing powers conferred on the Commission.
In their statement concerning Decision 2006/512/EC amending Decision 1999/468/EC, the European Parliament, the
Council and the Commission have stated that Decision 2006/512/EC provides a horizontal and satisfactory solution to the
European Parliament's wish to scrutinise the implementation of instruments adopted under the co-decision procedure and
that, accordingly,
implementing powers should be conferred on the Commission without time limit. Following the
introduction of the regulatory procedure with scrutiny, the provision establishing that time restriction in Directive 2004/25/
EC should be deleted.

(1) OJ L 7, 13.1.2004, p. 1.
(2) OJ L 142, 30.4.2004, p. 12.

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Accordingly, Directive 2004/25/EC is hereby amended as follows:

1.

Article 6(4) shall be replaced by the following:

‘4. The Commission may adopt rules modifying the list in paragraph 3. Those measures, designed to amend non-
essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 18(2).’;

2.

Article 18 shall be amended as follows:

(a)

paragraph 2 shall be replaced by the following:

‘2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’;

(b)

paragraph 3 shall be deleted.

6.

HEALTH AND CONSUMER PROTECTION

6.1. Council Directive 79/373/EEC of 2 April 1979 on the circulation of compound feedingstuffs (1)

As regards Directive 79/373/EEC, the Commission should be empowered to adopt exceptions to the prescriptions on
the packaging of feedingstuffs and to amend the Annex. Since those measures are of general scope and are designed to
amend non-essential elements of Directive 79/373/EEC,
inter alia, by supplementing it with new non-essential
elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a
of Decision 1999/468/EC.

Accordingly, Directive 79/373/EEC is hereby amended as follows:

1.

Article 4(2) shall be replaced by the following:

‘2. The Commission shall adopt exceptions to the principle of paragraph 1 to be authorised at Community
level. Those measures, designed to amend non-essential elements of this Directive, inter alia, by supplementing it,
shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3), provided
that the identity and quality of the compound feedingstuffs concerned are ensured.’;

2.

Article 10 shall be replaced by the following:

‘Article 10

In the light of advances in scientific and technical knowledge, the Commission shall:

(a)

establish categories grouping several feed materials;

(b)

adopt methods of calculating the energy value of compound feedingstuffs;

(c)

adopt amendments to the Annex.

All the above measures, designed to amend non-essential elements of this Directive, inter alia, by supplementing
it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’;

3.

Article 13(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’.

6.2. Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (2)

As regards Directive 82/471/EEC, the Commission should be empowered to adopt amendments and to lay down the
criteria required to define the products included in the Directive. Since those measures are of general scope and are
designed to amend non-essential elements of Directive 82/471/EEC by supplementing it with new non-essential

(1) OJ L 86, 6.4.1979, p. 30.
(2) OJ L 213, 21.7.1982, p. 8.

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elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a
of Decision 1999/468/EC. On the grounds of urgency, it is necessary to apply the urgency procedure provided for in
Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to the Directive.

Accordingly, Directive 82/471/EEC is hereby amended as follows:

1.

Article 6 is hereby amended as follows:

(a)

paragraph 1 shall be replaced by the following:

‘1. Amendments to be made to the Annex as a result of developments in scientific or technical
knowledge shall be adopted by the Commission. Those measures, designed to amend non-essential
elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 13(3). In the case of the products referred to in Sections 1.1 and 1.2 of the Annex,
the Commission shall consult the Scientific Committee for Animal Nutrition and the Scientific Committee
for Food.

However, in the case of products obtained from yeasts of the “Candida” variety and cultivated on n-
alkanes, referred to in Article 4(1), the Commission shall adopt a position within two years of notification
of this Directive, after consulting the Scientific Committee for Animal Nutrition and the Scientific
Committee for Food.’;

(b)

paragraph 3 shall be replaced by the following:

‘3. Criteria making it possible to define the products included in this Directive, particularly the criteria of
composition and purity and the physico-chemical and biological properties, may be laid down by the
Commission in the light of scientific and technical knowledge. Those measures, designed to amend non-
essential elements of this Directive by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 13(3).’;

2.

in the second subparagraph of Article 7(2), the words ‘the procedure laid down in Article 13’ shall be replaced
by the words ‘the regulatory procedure referred to in Article 13(2).’;

3.

Article 8(3) shall be replaced by the following:

‘3.
If the Commission considers that amendments to this Directive are necessary to alleviate the difficulties
referred to in paragraph 1 and to ensure the protection of human or animal health, it shall adopt such measures.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the urgency procedure referred to in Article 13(4). The Member State that has adopted safeguard measures
may in that event retain them until the amendments have entered into force.’;

4.

Article 13 shall be amended as follows:

(a)

paragraph 3 shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/
EC shall apply, having regard to the provisions of Article 8 thereof.’;

(b)

the following paragraph shall be added:

‘4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

5.

Article 14 shall be deleted.

6.3. Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials (1)

As regards Directive 96/25/EC, the Commission should be empowered to draw up and amend the list of materials
whose circulation or use for animal nutrition purposes is restricted or prohibited and to amend the annex in the light
of advances in scientific and technical knowledge. Since those measures are of general scope and are designed to
amend non-essential elements of Directive 96/25/EC, inter alia, by supplementing it with new non-essential elements,
they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision
1999/468/EC.

(1) OJ L 125, 23.5.1996, p. 35.

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When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be
complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of
Decision 1999/468/EC for the amendment of the list of materials whose circulation or use for animal nutrition
purposes is restricted or prohibited.

On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny must be curtailed for the
adoption of amendments to the annex in the light of advances in scientific and technical knowledge.

Accordingly, Directive 96/25/EC is hereby amended as follows:

1.

the second indent of Article 5(1)(g) shall be replaced by the following:

‘— Community measures included on a list to be drawn up by the Commission. That measure, designed to
amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with
the regulatory procedure with scrutiny referred to in Article 13(3);’;

2.

Article 11 shall be replaced by the following:

‘Article 11

1. A numerical coding system for the listed feed materials based on glossaries concerning the origin, part of
the product/by-product used, processing and maturity/quality of the feed materials enabling feed to be identified
at international level — in particular by name and description — may be adopted in accordance with the
regulatory procedure referred to in Article 13(2).

2. The list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited shall
be drawn up by the Commission in order to ensure their compliance with Article 3. That measure, designed to
amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 13(3).

3. The list referred to in paragraph 2 shall be amended by the Commission in the light of advances in scientific
and technical knowledge. Those measures, designed to amend non-essential elements of this Directive, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). On imperative
grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 13(5)
with a view to adopting those measures.

4. Amendments to be made to the Annex as a result of developments in scientific or technical knowledge shall
be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive,
shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(4).’;

3.

Article 13 shall be amended as follows:

(a)

paragraph 3 shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/
EC shall apply, having regard to the provisions of Article 8 thereof.’;

(b)

the following paragraphs shall be added:

‘4. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The periods laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two
months, one month and two months respectively.

5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

6.4. Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable

substances in animal feed (1)

As regards Directive 2002/32/EC, the Commission should be empowered to amend Annexes I and II and adapt them
in the light of developments in scientific and technical knowledge, and to lay down additional criteria for
detoxification processes. Since those measures are of general scope and are designed to amend non-essential elements
of Directive 2002/32/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(1) OJ L 140, 30.5.2002, p. 10.

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When, on imperative grounds of urgency, the time limits normally applicable for the regulatory procedure with
scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in
Article 5a(6) of Decision 1999/468/EC for the adaptation of Annexes I and II in the light of developments in scientific
and technical knowledge.

Accordingly, Directive 2002/32/EC is hereby amended as follows:

1.

the first subparagraph of Article 7(2) shall be replaced by the following:

‘2. An immediate decision shall be taken as to whether Annexes I and II should be amended. Those measures,
designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency
procedure referred to in Article 11(4).’;

2.

Article 8(1) and (2) shall be replaced by the following:

‘1. The Commission shall adapt Annexes I and II in the light of developments in scientific and technical
knowledge. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 11(3). On imperative grounds of
urgency, the Commission may have recourse to the urgency procedure referred to in Article 11(4) with a view to
adopting those amendments.

2.

Furthermore the Commission:

— shall periodically adopt consolidated versions of Annexes I and II incorporating any adaptations made
pursuant to paragraph 1, in accordance with the regulatory procedure referred to in Article 11(2),

— may define acceptability criteria for detoxification processes as a complement to the criteria provided for
products intended for animal feed which have undergone such processes. Those measures, designed to
amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with
the regulatory procedure with scrutiny referred to in Article 11(3).’;

3.

Article 11 shall be replaced by the following:

‘Article 11

1. The Commission shall be assisted by the Standing Committee for Feedingstuffs set up by Article 1 of
Council Decision 70/372/EEC (*).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/
468/EC shall apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 170, 3.8.1970, p. 1.’;

4.

Article 12 shall be deleted.

6.5. Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal

health requirements applicable to the non-commercial movements of pet animals (1)

As regards Regulation (EC) No 998/2003, the Commission should be empowered to amend the list of species of
animals set out in Part C of Annex I and the lists of countries and territories set out in Parts B and C of Annex II, draw
up specific requirements in respect of diseases other than rabies with regard to Member States and territories listed in
section 2 of Part B of Annex II, adopt conditions applicable to the movement of animals of the species listed in Part C
of Annex I from third countries and adopt requirements of a technical nature in respect of the movement of animals
of the species listed in Parts A and B of Annex I. Since those measures are of general scope and are designed to amend
non-essential elements of that Regulation, inter alia, by supplementing it with new non-essential elements, they must
be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/
468/EC.

(1) OJ L 146, 13.6.2003, p. 1.

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On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny should be curtailed for the
adoption of the list of certain third countries.

Accordingly, Regulation (EC) No 998/2003 is hereby amended as follows:

1.

Article 7 shall be replaced by the following:

‘Article 7

Movement between Member States or from a territory listed in section 2 of Part B of Annex II of animals of the
species listed in part C of Annex I shall not be subject to any requirement with regard to rabies. The Commission
shall draw up, if necessary, specific requirements, including a possible limit on the number of animals, in respect
of other diseases. Those measures, designed to amend non-essential elements of
this Regulation by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 24(4). A model certificate to accompany such animals may be drawn up in accordance with the
regulatory procedure referred to in Article 24(2).’;

2.

Article 9 shall be replaced by the following:

‘Article 9

The conditions applicable to the movement of animals of the species listed in Part C of Annex I from third
countries shall be adopted by the Commission. Those measures, designed to amend non-essential elements of
this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 24(4). The model certificate which must accompany the movement of animals shall be
drawn up in accordance with the regulatory procedure referred to in Article 24(2).’;

3.

Article 10 is hereby amended as follows:

(a)

the introductory phrase shall be replaced by the following:

‘The list of third countries provided for in part C of Annex II shall be drawn up by the Commission. To be
included on that list, a third country must first demonstrate its status with regard to rabies and that:’;

(b)

the following subparagraph shall be added:

‘Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 24(5).’;

4.

in Article 17, the first paragraph shall be replaced by the following:

‘For the movement of animals of the species listed in Parts A and B of Annex I, requirements of a technical
nature other than those laid down by this Regulation may be adopted by the Commission. Those measures,
designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 24(4).’;

5.

Article 19 shall be replaced by the following:

‘Article 19

Part C of Annex I and parts B and C of Annex II may be amended by the Commission to take account of
developments in the situation within the Community or in third countries as regards diseases affecting the
species of animals covered by this Regulation, in particular rabies, and, if need be, limit, for the purposes of this
Regulation, the number of animals which can be moved. Those measures, designed to amend non-essential
elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred
to in Article 24(4).’;

6.

Article 21 shall be replaced by the following:

‘Article 21

Any transitional provisions may be adopted by the Commission to permit the changeover from the current
arrangements to the arrangements established by this Regulation. Those measures, designed to amend non-
essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 24(4).’;

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7.

Article 24 is hereby amended as follows:

(a)

paragraph 4 shall be replaced by the following:

‘4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/
EC shall apply, having regard to the provisions of Article 8 thereof.’;

(b)

the following paragraph shall be added:

‘5. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The periods laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two
months, one month and two months respectively.’.

6.6. Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the

monitoring of zoonoses and zoonotic agents (1)

As regards Directive 2003/99/EC, the Commission should be empowered to establish coordinated monitoring
programmes concerning zoonoses and zoonotic agents. Since those measures are of general scope and are designed to
amend non-essential elements of Directive 2003/99/EC,
inter alia, by supplementing it with new non-essential
elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a
of Decision 1999/468/EC.

On grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/
468/EC for the adoption of amendments to Annex I to Directive 2003/99/EC in order to add zoonoses and zoonotic
agents to, or delete them from, the lists provided for therein.

Accordingly, Directive 2003/99/EC is hereby amended as follows:

1.

in Article 4, paragraph 4 shall be amended as follows:

(a)

the introductory phrase shall be replaced by the following:

‘Annex I may be amended by the Commission to add zoonoses or zoonotic agents to, or delete them
from, the lists therein, taking account in particular of the following criteria:’;

(b)

the following subparagraph shall be added:

‘Those measures, designed to amend non-essential elements of this Directive, shall be adopted in
accordance with the urgency procedure referred to in Article 12(4).’;

2.

Article 5(1) shall be replaced by the following:

‘1.
If data collected through routine monitoring in accordance with Article 4 are not sufficient, coordinated
monitoring programmes concerning one or more zoonoses and/or zoonotic agents may be established by the
Commission, especially when specific needs are identified, to assess risks or to establish baseline values related
to zoonoses or zoonotic agents at the level of Member States or at Community level. Those measures, designed
to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 12(3).’;

3.

Article 11 shall be replaced by the following:

‘Article 11

Amendments to the Annexes and transitional or implementing measures

Annexes II, III and IV may be amended by the Commission. Those measures, designed to amend non-essential
elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred
to in Article 12(3).

Transitional measures of general scope designed to amend non-essential elements of this Directive, inter alia, by
supplementing it with new non-essential elements, in particular further specifications of the requirements laid
down in this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 12(3).

(1) OJ L 325, 12.12.2003, p. 31.

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Other implementing or transitional measures may be adopted in accordance with the regulatory procedure
referred to in Article 12(2).’;

4.

Article 12 shall be amended as follows:

(a)

paragraph 3 shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/
EC shall apply, having regard to the provisions of Article 8 thereof.’;

(b)

the following paragraph shall be added:

‘4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

6.7. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene

of foodstuffs (1)

As regards Regulation (EC) No 852/2004, the Commission should be empowered to adopt provisions relating to
specific hygiene rules and to the approval of establishments, and to grant derogations from Annexes I and II subject to
certain conditions. Since those measures are of general scope and are designed to amend non-essential elements of
Regulation (EC) No 852/2004, inter alia, by supplementing it with new non-essential elements, they must be adopted
in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 852/2004 is hereby amended as follows:

1.

Article 4(4) shall be replaced by the following:

‘4. The criteria, requirements and targets referred to in paragraph 3, and associated sampling and analysis
methods shall be laid down by the Commission. Those measures, designed to amend non-essential elements of
this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 14(3).’;

2.

Article 6(3)(c) shall be replaced by the following:

‘(c)

by a decision adopted by the Commission. That measure, designed to amend non-essential elements of
this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 14(3).’;

3.

Article 12 shall be replaced by the following:

‘Article 12

Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia,
by supplementing it with new non-essential elements, in particular further specifications of the requirements
laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 14(3).

Other implementing or transitional measures may be adopted in accordance with the regulatory procedure
referred to in Article 14(2).’;

4.

Article 13 shall be amended as follows:

(a)

paragraph 1 shall be amended as follows:

(i)

the introductory sentence shall be replaced by the following:

‘Annexes I and II may be adapted or updated by the Commission taking into account:’;

(ii)

the following subparagraph shall be added:

‘Those measures, designed to amend non-essential elements of this Regulation,
inter alia, by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 14(3).’;

(1) OJ L 139, 30.4.2004, p. 1.

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(b)

paragraph 2 shall be replaced by the following:

‘2. Derogations from Annexes I and II may be granted by the Commission, in particular to facilitate the
implementation of Article 5 for small businesses, taking into account the relevant risk factors, provided
that such derogations do not affect the achievement of the objectives of this Regulation. Those measures,
designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 14(3).’;

5.

Article 14(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’.

6.8. Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down

specific hygiene rules for food of animal origin (1)

As regards Regulation (EC) No 853/2004, the Commission should be empowered to adopt provisions relating to the
general obligations of food business operators and to the special guarantees for placing food on the market in Sweden
or Finland, and to allow derogations from the annexes subject to certain conditions. Since those measures are of
general scope and are designed to amend non-essential elements of Regulation (EC) No 853/2004,
inter alia, by
supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 853/2004 is hereby amended as follows:

1.

in Article 3(2), the first sentence shall be replaced by the following:

‘Food business operators shall not use any substance other than potable water — or, when Regulation (EC)
No 852/2004 or this Regulation permits its use, clean water — to remove surface contamination from products
of animal origin, unless use of the substance has been approved by the Commission. Those measures, designed
to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with
the regulatory procedure with scrutiny referred to in Article 12(3).’;

2.

Article 8(3) shall be replaced by the following:

‘3. (a) The requirements of paragraphs 1 and 2 may be updated by the Commission, in particular to take
account of changes in Member States’ control programmes or of the adoption of microbiological criteria
in accordance with Regulation (EC) No 852/2004. Those measures, designed to amend non-essential
elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 12(3).

(b) In accordance with the regulatory procedure referred to in Article 12(2), the rules laid down in
paragraph 2 of this Article in respect of any of the foodstuffs referred to in paragraph 1 of this Article
may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a
control programme recognised as equivalent to that approved for Sweden and Finland in respect of the
food of animal origin concerned.’;

3.

Article 9 shall be replaced by the following:

‘Article 9

Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia,
by supplementing it with new non-essential elements, in particular further specifications of the requirements
laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 12(3).

Other implementing or transitional measures may be adopted in accordance with the regulatory procedure
referred to in Article 12(2).’;

4.

Article 10 is hereby amended as follows:

(a)

paragraph 1 shall be amended as follows:

(i)

the introductory wording shall be replaced by the following:

‘Annexes II and III may be adapted or updated by the Commission taking into account:’;

(1) OJ L 139, 30.4.2004, p. 55.

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(ii)

the following subparagraph shall be added:

‘Those measures, designed to amend non-essential elements of this Regulation,
inter alia, by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 12(3).’;

(b)

paragraph 2 shall be replaced by the following:

‘2.
Exemptions from Annex II and III may be granted by the Commission, provided that they do not
affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-
essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 12(3).’;

5.

the introductory wording of Article 11 shall be replaced by the following:

‘Without prejudice to the general application of Article 9 and Article 10(1), implementing measures may be laid
down in accordance with the regulatory procedure referred to in Article 12(2), and amendments to Annex II or
III, as measures designed to amend non-essential elements of this Regulation, may be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 12(3):’;

6.

Article 12(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

6.9. Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down
specific rules for the organisation of official controls on products of animal origin intended for human
consumption (1)

As regards Regulation (EC) No 854/2004, the Commission should be empowered to amend or adapt the annexes
thereto and to adopt transitional measures, in particular further specifications of the requirements laid down in the
provisions of that Regulation. Since those measures are of general scope and are designed to amend non-essential
elements of Regulation (EC) No 854/2004, inter alia, by supplementing it with new non-essential elements, they must
be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/
468/EC.

Accordingly, Regulation (EC) No 854/2004 is hereby amended as follows:

1.

Article 16 shall be replaced by the following:

‘Article 16

Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia,
by supplementing it with new non-essential elements, in particular further specifications of the requirements
laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 19(3).

Other implementing or transitional measures may be adopted in accordance with the regulatory procedure
referred to in Article 19(2).’;

2.

Article 17(1) and (2) shall be replaced by the following:

‘1. Annexes I, II, III, IV, V and VI may be amended or supplemented by the Commission to take account of
scientific and technical progress. Those measures, designed to amend non-essential elements of this Regulation,
inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 19(3).

2.
Exemptions from Annexes I, II, III, IV, V and VI may be granted by the Commission, provided that they do
not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-
essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 19(3).’;

(1) OJ L 139, 30.4.2004, p. 206.

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3.

the introductory wording of Article 18 shall be replaced by the following:

‘Without prejudice to the general application of Article 16 and Article 17(1), implementing measures may be
laid down in accordance with the regulatory procedure referred to in Article 19(2), and amendments to
Annexes I, II, III, IV, V or VI, as measures designed to amend non-essential elements of this Regulation, may be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3), to specify:’;

4.

Article 19(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

6.10. Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down

requirements for feed hygiene (1)

As regards Regulation (EC) No 183/2005, the Commission should be empowered to define the microbiological
criteria and targets to be met by feed business operators, to adopt measures for the approval of establishments, to
amend Annexes I, II and III, and to grant derogations from those annexes. Since those measures are of general scope
and are designed to amend non-essential elements of Regulation (EC) No 183/2005, inter alia, by supplementing it
with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 183/2005 is hereby amended as follows:

1.

the second subparagraph of Article 5(3) shall be replaced by the following:

‘The criteria and targets referred to in points (a) and (b) shall be defined by the Commission. Those measures,
designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 31(3).’;

2.

in Article 10, point (3) shall be replaced by the following:

‘(3)
approval is required by a Regulation adopted by the Commission. This measure, designed to amend non-
essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 31(3).’;

3.

Article 27 shall be replaced by the following:

‘Article 27

Amendments to Annexes I, II and III

Annexes I, II and III may be amended to take account of:

(a)

the development of codes of good practice;

(b)

the experience gained from the implementation of HACCP-based systems pursuant to Article 6;

(c)

technological developments;

(d)

scientific advice, particularly new risk assessments;

(e)

the setting of feed safety targets;

and

(f)

the development of requirements relating to specific operations.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 31(3).’;

(1) OJ L 35, 8.2.2005, p. 1.

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4.

Article 28 shall be replaced by the following:

‘Article 28

Derogations from Annexes I, II and III

Derogations from Annexes I, II and III may be granted by the Commission for particular reasons, provided that
such derogations do not affect the achievement of the objectives of this Regulation. Those measures, designed to
amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 31(3).’;

5.

Article 31(3) shall be replaced by the following:

‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

7.

ENERGY AND TRANSPORT

7.1. Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport (1)

As regards Regulation (EEC) No 3821/85, the Commission should be empowered to make the necessary amendments
to adapt the Annexes to technical progress. Since those measures are of general scope and are designed to amend non-
essential elements of Regulation (EEC) No 3821/85, they must be adopted in accordance with the regulatory
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EEC) No 3821/85 is hereby amended as follows:

1.

in Article 5, the second subparagraph shall be replaced by the following:

‘The system's security must comply with the technical requirements laid down in Annex IB. The Commission
shall ensure that the said Annex stipulates that recording equipment may not be granted EC component type-
approval until the whole system (the recording equipment itself, driver card and electrical gearbox connections)
has demonstrated its capacity to resist attempts to tamper with or alter the data on driving times. Those
measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 18(2). The tests necessary to establish this shall be
carried out by experts familiar with up-to-date tampering techniques.’;

2.

Article 17(1) shall be replaced by the following:

‘1. The amendments required to adjust the annexes to technical progress, designed to amend non-essential
elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred
to in Article 18(2).’;

3.

Article 18 shall be replaced by the following:

‘Article 18

1. The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’.

7.2. 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 (2)

As regards Directive 97/70/EC, the Commission should be empowered to adopt provisions for the harmonised
interpretation of provisions of the Annex to the Torremolinos Protocol and for the implementation of the Directive.
The Commission should also be empowered to amend certain provisions of the Directive and of the annexes thereto
in order to apply, for the purpose of the Directive, subsequent amendments to the Torremolinos Protocol which
entered into force after the adoption of the Directive. Since those measures are of general scope and are designed to
amend non-essential elements of Directive 97/70/EC, they must be adopted in accordance with the regulatory
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(1) OJ L 370, 31.12.1985, p. 8.
(2) OJ L 34, 9.2.1998, p. 1.

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Accordingly, Directive 97/70/EC is hereby amended as follows:

1.

in Article 4(4)(b), the words ‘in accordance with the procedure laid down in Article 9’ shall be replaced by the
words ‘in accordance with the regulatory procedure referred to in Article 9(2).’;

2.

in Article 8, the first subparagraph shall be replaced by the following:

‘The following adaptations, designed to amend non-essential elements of this Directive, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 9(3):

(a)

provisions may be adopted and incorporated for:

— a harmonised interpretation of those provisions of the Annex to the Torremolinos Protocol which
have been left to the discretion of the administrations of individual contracting parties, as far as
necessary to ensure their consistent implementation in the Community,

— the implementation of this Directive without broadening its scope,

(b) Articles 2, 3, 4, 6 and 7 of this Directive may be adapted and its Annexes may be amended in order to
apply, for the purpose of this Directive, subsequent amendments to the Torremolinos Protocol which have
entered into force after the adoption of this Directive.’;

3.

Article 9 shall be replaced by the following:

‘Article 9

Committee procedure

1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from
Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the
Council (*).

2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June
1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (**)
shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 324, 29.11.2002, p. 1.
(**) OJ L 184, 17.7.1999, p. 23.’

7.3. Council Directive 1999/35/EC of 29 April 1999 on a system of mandatory surveys for the safe operation of

regular ro-ro ferry and high-speed passenger craft services (1)

As regards Directive 1999/35/EC, the Commission should be empowered to adapt the Annexes, definitions and
references to Community instruments and instruments of the International Maritime Organisation (IMO) in order to
bring them into line with Community or IMO measures which have subsequently entered into force. The Commission
should also be empowered to amend the annexes in order to improve the regime established by the Directive. Since
those measures are of general scope and are designed to amend non-essential elements of Directive 1999/35/EC, they
must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision
1999/468/EC.

Accordingly, Directive 1999/35/EC is hereby amended as follows:

1.

in Article 4(1)(d), last sentence, Article 11(6) and (8) and Article 13(3), second and last sentences, the words ‘the
procedure laid down in Article 16’ shall be replaced by the words ‘the regulatory procedure referred to in
Article 16(2).’;

(1) OJ L 138, 1.6.1999, p. 1.

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2.

Article 16 shall be replaced by the following:

‘Article 16

Committee procedure

1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from
Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the
Council (*).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 324, 29.11.2002, p. 1.’;

3.

Article 17 shall be replaced by the following:

‘Article 17

Amendment procedure

The Annexes to this Directive, the definitions, the references to Community instruments and references to IMO
instruments may be adapted to the extent necessary to bring them into line with Community or IMO measures
which have entered into force, but without broadening the scope of this Directive.

The Annexes may also be adapted when it is necessary to improve the arrangements established by this
Directive, but without broadening its scope.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 16(3).

The amendments to the international instruments referred to in Article 2 may be excluded from the scope of
this Directive pursuant to Article 5 of Regulation (EC) No 2099/2002.’

7.4. Regulation (EC) No 417/2002 of the European Parliament and of the Council of 18 February 2002 on the
accelerated phasing-in of double hull or equivalent design requirements for single hull oil tankers (1)

As regards Regulation (EC) No 417/2002, the Commission should be empowered to amend certain references to the
relevant Regulations in MARPOL 73/78 and to Resolutions MEPC 111(50) and 94(46), in order to align the references
with amendments to these Regulations and Resolutions adopted by the International Maritime Organization (IMO), in
so far as such amendments do not broaden the scope of that Regulation. Since those measures are of general scope
and are designed to amend non-essential elements of Regulation (EC) No 417/2002, they must be adopted in
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 417/2002 is hereby amended as follows:

1.

Article 10 shall be replaced by the following:

‘Article 10

Committee procedure

1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from
Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the
Council (*).

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 324, 29.11.2002, p. 1.’;

(1) OJ L 64, 7.3.2002, p. 1.

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2.

in Article 11, the first paragraph shall be replaced by the following:

‘The Commission may amend the references in this Regulation to the Regulations of Annex I to MARPOL 73/
78, as well as to Resolutions MEPC 111(50) and 94(46) as amended by MEPC Resolutions 99(48) and 112(50),
in order to align the references with amendments to those Regulations and Resolutions adopted by the IMO, in
so far as such amendments do not broaden the scope of this Regulation. Those measures, designed to amend
non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 10(2).’

7.5. Regulation (EC) No 782/2003 of the European Parliament and of the Council of 14 April 2003 on the

prohibition of organotin compounds on ships (1)

As regards Regulation (EC) No 782/2003, the Commission should be empowered to establish a harmonised survey
and certification regime for certain ships, to take certain measures as regards ships sailing under the flag of a third
State, to establish port State control procedures, and to amend certain references and annexes to take account of
developments at international level, in particular in the IMO, or to improve the effectiveness of that Regulation in the
light of experience. Since those measures are of general scope and are designed to amend non-essential elements of
Regulation (EC) No 782/2003, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 782/2003 is hereby amended as follows:

1.

Article 6 shall be amended as follows:

(a)

in paragraph 1(b), the second subparagraph shall be replaced by the following:

‘If necessary, the Commission may establish a harmonised survey and certification regime for these ships.
this Regulation, shall be adopted in
That measure, designed to amend non-essential elements of
accordance with the regulatory procedure with scrutiny referred to in Article 9(2).’;

(b)

paragraph 3 shall be replaced by the following:

If the AFS-Convention has not entered into force by 1 January 2007, the Commission shall adopt
‘3.
appropriate measures in order to allow ships flying the flag of a third State to demonstrate their
compliance with Article 5. Those measures, designed to amend non-essential elements of this Regulation,
shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 9(2).’;

2.

in Article 7, the second paragraph shall be replaced by the following:

‘If the AFS-Convention has not entered into force by 1 January 2007, the Commission shall establish
appropriate procedures for these controls. Those measures, designed to amend non-essential elements of this
Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 9
(2).’;

3.

Article 8 shall be replaced by the following:

‘Article 8

In order to take account of developments at international level and in particular in the International Maritime
Organisation (IMO), or to improve the effectiveness of
this Regulation in the light of experience, the
Commission may amend the references to the AFS-Convention, to the AFS-Certificate, to the AFS-Declaration
and to the AFS-Statement of Compliance and the Annexes to this Regulation, including relevant IMO guidelines
in relation to Article 11 of the AFS-Convention. Those measures, designed to amend non-essential elements of
this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 9(2).’;

4.

Article 9 shall be replaced by the following:

‘Article 9

Committee procedure

1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from
Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the
Council (*).

(1) OJ L 115, 9.5.2003, p. 1.

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2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 324, 29.11.2002, p. 1.’

7.6. Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion

of cogeneration based on a useful heat demand in the internal energy market (1)

As regards Directive 2004/8/EC, the Commission should be empowered to examine harmonised efficiency reference
values for separate production of electricity and heat, to adapt the threshold values set out in Article 13 to technical
progress, and to establish and adapt to technical progress the detailed guidelines for the implementation and
application of Annex II of that Directive, including the determination of the power to heat ratio. Since those measures
inter alia, by
are of general scope and are designed to amend non-essential elements of Directive 2004/8/EC,
supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/8/EC is hereby amended as follows:

1.

Article 4(2) shall be replaced by the following:

‘2. The Commission shall examine the harmonised efficiency reference values for separate production of
electricity and heat referred to in paragraph 1, for the first time on 21 February 2011, and every four years
thereafter, to take account of technological developments and changes in the distribution of energy sources. Any
measures resulting from this examination, designed to amend the non-essential elements of this Directive, shall
be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(2).’;

2.

Article 13 shall be replaced by the following:

‘Article 13

Adaptation to technical progress

1. The Commission shall adapt the threshold values used for the calculation of electricity from cogeneration
referred to in Annex II(a) to technical progress. Those measures, designed to amend non-essential elements of
this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 14(2).

2. The Commission shall adapt the threshold values used for the calculation of efficiency of cogeneration
production and primary energy savings referred to in Annex III(a) to technical progress. Those measures,
designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 14(2).

3. The Commission shall adapt the guidelines for determining the power to heat ratio referred to in
Annex II(d) to technical progress. Those measures, designed to amend non-essential elements of this Directive,
shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(2).’;

3.

Article 14 shall be replaced by the following:

‘Article 14

Committee procedure

1. The Commission shall be assisted by a committee.

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’;

4.

in Annex II, point (e) shall be replaced by the following:

‘(e)

The Commission shall establish detailed guidelines for the implementation and application of Annex II,
including the determination of the power to heat ratio. Those measures, designed to amend non-essential
elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 14(2).’

(1) OJ L 52, 21.2.2004, p. 50.

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7.7. Directive 2004/52/EC of

the European Parliament and of

the Council of 29 April 2004 on the

interoperability of electronic road toll systems in the Community (1)

As regards Directive 2004/52/EC, the Commission should be empowered to adapt the annex and to take decisions
relating to the definition of the European electronic toll service. The Commission should also be empowered to take
technical decisions relating to the realisation of the European electronic toll service. Since those measures are of
general scope and are designed to amend non-essential elements of Directive 2004/52/EC, inter alia, by supplementing
it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/52/EC is hereby amended as follows:

1.

Article 4 shall be amended as follows:

(a)

paragraph 2 shall be replaced by the following:

‘2. Where appropriate, the Annex may be adapted for technical reasons. Those measures, designed to
amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 5(2).’;

(b)

paragraphs 4, 5 and 6 shall be replaced by the following:

‘4. The decisions relating to the definition of the European electronic toll service shall be taken by the
Commission. Those measures, designed to amend non-essential elements of
this Directive by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred
to in Article 5(2). Such decisions shall only be taken if all the conditions, evaluated on the basis of
appropriate studies, are in place to enable interoperability to work from all points of view, including
technical, legal and commercial conditions.

5. Technical decisions relating to the realisation of the European electronic toll service shall be taken by
the Commission. Those measures, designed to amend non-essential elements of this Directive by
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to
in Article 5(2).’;

2.

Article 5 shall be replaced by the following:

‘Article 5

Committee procedure

1. The Commission shall be assisted by an Electronic Toll Committee.

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.’

7.8. Regulation (EC) No 725/2004 of the European Parliament and of the Council of 31 March 2004 on enhancing

ship and port facility security (2)

As regards Regulation (EC) No 725/2004, the Commission should be empowered to decide whether amendments to
the Annexes, which concern certain special measures to enhance maritime security of the International Convention
for the Safety of Life at Sea, and of the International Code for the security of ships and of port facilities, that apply
automatically to international traffic should also apply to ships operating domestic services and the port facilities
serving them. Since those measures are of general scope and are designed to amend non-essential elements of
Regulation (EC) No 725/2004, inter alia, by supplementing it with new non-essential elements, they must be adopted
in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Regulation (EC) No 725/2004 lays down security requirements and measures and is based on international
instruments that are subject to amendment. Where, on imperative grounds of urgency, the normal time-limits for the
regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the
urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC.

(1) OJ L 166, 30.4.2004, p. 124.
(2) OJ L 129, 29.4.2004, p. 6.

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Accordingly, Regulation (EC) No 725/2004 is hereby amended as follows:

1.

Article 10(2) shall be replaced by the following:

‘2. The Commission shall decide on the integration of amendments to the international instruments referred
to in Article 2 in respect of ships operating domestic services and the port facilities serving them to which this
Regulation applies, in so far as they constitute a technical update of the provisions of the SOLAS Convention
and the ISPS Code. Those measures, designed to amend non-essential elements of this Regulation, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(4); on imperative
grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 11(5).
The procedure for checking conformity established in paragraph 5 of this Article shall not apply in these cases.’;

2.

Article 10(3) shall be replaced by the following:

‘3. The Commission may adopt provisions in order to define harmonised procedures for the application of the
mandatory provisions of the ISPS Code, without broadening the scope of this Regulation. Those measures,
designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 11(4).

On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in
Article 11(5).’;

3.

Article 11 shall be replaced by the following:

‘Article 11

Committee procedure

1. The Commission shall be assisted by a committee.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.

3. Where reference is made to this paragraph, Articles 6 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The periods laid down in Article 6(b) and (c) respectively of Decision 1999/468/EC shall be set at one month.

4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/
468/EC shall apply, having regard to the provisions of Article 8 thereof.’.

7.9. Regulation (EC) No 789/2004 of the European Parliament and of the Council of 21 April 2004 on the transfer

of cargo and passenger ships between registers within the Community (1)

As regards Regulation (EC) No 789/2004, the Commission should be empowered to amend certain definitions in
order to take account of developments at international level, in particular in the International Maritime Organisation
(IMO), and to improve the effectiveness of the Regulation in the light of experience and technical progress. Since those
measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 789/2004,
they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision
1999/468/EC.

(1) OJ L 138, 30.4.2004, p. 19.

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Accordingly, Regulation (EC) No 789/2004 is hereby amended as follows:

1.

Article 7 shall be replaced by the following:

‘Article 7

Committee procedure

1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from
Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the
Council (*).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

(*) OJ L 324, 29.11.2002, p. 1.’;

2.

Article 9(1) shall be replaced by the following:

‘1.
In order to take account of developments at international level, in particular in the International Maritime
Organisation (IMO), and to improve the effectiveness of this Regulation in the light of experience and technical
progress, the Commission may amend the definitions in Article 2 insofar as such amendments do not broaden
the scope of the Regulation. Those measures, designed to amend non-essential elements of this Regulation, shall
be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’

7.10. Directive 2005/44/EC of the European Parliament and of the Council of 7 September 2005 on harmonised

river information services (RIS) on inland waterways in the Community (1)

As regards Directive 2005/44/EC, the Commission should be empowered to adapt the annexes to technical progress.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 2005/44/EC,
they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision
1999/468/EC.

Accordingly, Directive 2005/44/EC is hereby amended as follows:

1.

Article 10 shall be replaced by the following:

‘Article 10

Amendment procedure

Annexes I and II may be amended in the light of the experience gained from the application of this Directive and
adapted to technical progress. Those measures, designed to amend non-essential elements of this Directive, shall
be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(4).’;

2.

Article 11 shall be replaced by the following:

‘Article 11

Committee procedure

1. The Commission shall be assisted by the Committee set up by Article 7 of Council Directive 91/672/EEC of
16 December 1991 on the reciprocal recognition of boatmasters’ certificates for the carriage of goods and
passengers by inland waterway (*).

2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

(1) OJ L 255, 30.9.2005, p. 152.

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3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

5. The Commission shall regularly consult representatives of the sector.

(*) OJ L 373, 31.12.1991, p. 29.’

7.11. Directive 2005/65/EC of the European Parliament and of the Council of 26 October 2005 on enhancing port

security (1)

As regards Directive 2005/65/EC, the Commission should be empowered to adapt the Annexes thereto. Since those
measures are of general scope and are designed to amend non-essential elements of Directive 2005/65/EC, they must
be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/
468/EC.

Directive 2005/65/EC lays down security requirements and measures and is based on international instruments that
are subject to amendment. Where, on imperative grounds of urgency, the normal time-limits for the regulatory
procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency
procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adaptation of its Annexes.

Accordingly, Articles 14 and 15 of Directive 2005/65/EC shall be replaced by the following:

‘Article 14

Adaptations

The Commission may adapt Annexes I to IV without broadening the scope of this Directive. Those measures, designed
to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 15(2).

On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in
Article 15(3).

Article 15

Committee procedure

1. The Commission shall be assisted by the committee set up by Regulation (EC) No 725/2004.

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC
shall apply, having regard to the provisions of Article 8 thereof.’

(1) OJ L 310, 25.11.2005, p. 28.

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Chronological index

(1)

Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to
aerosol dispensers

(2)

Council Directive 79/373/EEC of 2 April 1979 on the circulation of compound feeding stuffs

(3)

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition

(4)

Council Directive 82/883/EEC of 3 December 1982 on procedures for the surveillance and monitoring of
environments concerned by waste from the titanium dioxide industry

(5)

Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport

(6)

(7)

(8)

Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil,
when sewage sludge is used in agriculture

Council Regulation (EEC) No 3924/91 of 19 December 1991 on the establishment of a Community survey of
industrial production

Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the
market and supervision of explosives for civil uses

(9)

European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste

(10) Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk products

(11) Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials

(12) Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid

(13) 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

(14) Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels

(15) Council Directive 1999/35/EC of 29 April 1999 on a system of mandatory surveys for the safe operation of regular

ro-ro ferry and high-speed passenger craft services

(16) Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the
laws of the Member States relating to the noise emission in the environment by equipment for use outdoors

(17) Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission

ceilings for certain atmospheric pollutants

(18) Directive 2001/109/EC of the European Parliament and of the Council of 19 December 2001 concerning the
statistical surveys to be carried out by the Member States in order to determine the production potential of plantations
of certain species of fruit trees

(19) Regulation (EC) No 417/2002 of the European Parliament and of the Council of 18 February 2002 on the accelerated

phasing-in of double hull or equivalent design requirements for single hull oil tankers

(20) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in

animal feed

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(21) Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport

statistics

(22) 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

(23) Regulation (EC) No 782/2003 of the European Parliament and of the Council of 14 April 2003 on the prohibition of

organotin compounds on ships

(24) Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health

requirements applicable to the non-commercial movements of pet animals

(25) Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to

fertilisers

(26) 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

(27) Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of

zoonoses and zoonotic agents

(28) Regulation (EC) No 48/2004 of the European Parliament and of the Council of 5 December 2003 on the production

of annual Community statistics on the steel industry for the reference years 2003-2009

(29) Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug

precursors

(30) Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion of

cogeneration based on a useful heat demand in the internal energy market

(31) Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and

verification of good laboratory practice (GLP) (codified version)

(32) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of
laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice
and the verification of their applications for tests on chemical substances (codified version)

(33) Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents

(34) Regulation (EC) No 725/2004 of the European Parliament and of the Council of 31 March 2004 on enhancing ship

and port facility securit

(35) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down
Community procedures for the authorisation and supervision of medicinal products for human and veterinary use
and establishing a European Medicines Agency

(36) Regulation (EC) No 789/2004 of the European Parliament and of the Council of 21 April 2004 on the transfer of

cargo and passenger ships between registers within the Community

(37) Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids

(38) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic

pollutants

(39) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of

foodstuffs

(40) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific

hygiene rules for food of animal origin

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(41) Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific
rules for the organisation of official controls on products of animal origin intended for human consumption

(42) Directive 2004/52/EC of the European Parliament and of the Council of 29 April 2004 on the interoperability of

electronic road toll systems in the Community

(43) Directive 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to arsenic,

cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air

(44) Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down

requirements for feed hygiene

(45) Directive 2005/44/EC of the European Parliament and of the Council of 7 September 2005 on harmonised river

information services (RIS) on inland waterways in the Community

(46) Directive 2005/65/EC of the European Parliament and of the Council of 26 October 2005 on enhancing port security

(47) Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of

waste