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

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

Article 1

The instruments listed in the Annex are hereby adapted, in accordance with that Annex, to Decision 1999/468/EC, as amended by Decision 2006/512/EC.

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.

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:

‘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).’;

‘Article 15

— 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,

— 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.’;

‘Article 17

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

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

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(²)

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:

‘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).’;

(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. 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.’

2.3.   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(³).

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:

(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;

‘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).’;

‘(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(⁴)

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.

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

‘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 Article 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.’;

(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).’;

‘Article 32 Committee procedure

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

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)(⁵)

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:

‘3. If the Commission considers that amendments to this Directive are necessary in order to resolve the 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).’;

‘Article 7

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

‘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)(⁶)

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:

‘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).’;

‘Article 4

‘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(⁷)

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:

(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).’;