Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 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 Four

REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 18 June 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 Four

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 47(2), 55, 71(1), 80(2), 95, 152(4)(a) and (b), 175(1), and 285(1) thereof,

Having regard to the proposal from the Commission,

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

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

After consulting the Committee of the Regions,

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

(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 supplementing the instrument with new non-essential elements.

(2) In accordance with the statement of the European 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) Since the amendments made to instruments for this 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,

HAVE ADOPTED THIS REGULATION:

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. ENTERPRISE

1.1.   Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (⁷)

As regards Directive 97/68/EC, the Commission should be empowered in particular to establish the conditions under which amendments which are necessary in the light of adaptation to technical progress should be adopted. Since those measures are of general scope and are designed to amend non-essential elements of Directive 97/68/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 97/68/EC is hereby amended as follows:

1.in Article 4(2), the last sentence shall be replaced by the following: ‘The Commission shall amend Annex VIII. 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 7a(4) shall be replaced by the following: ‘4.  The Commission shall adapt Annex VII to integrate the additional and specific information which may be required as regards the type-approval certificate for engines to be installed in inland waterway vessels. 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).’;

3.Article 14 shall be replaced by the following: ‘Article 14 The Commission shall adopt any amendments which are necessary in order to adapt the Annexes, with the exception of the requirements specified in section 1, sections 2.1 to 2.8 and section 4 of Annex I, 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 15(2).’;

4.Article 14a shall be replaced by the following: ‘Article 14a The Commission shall study possible technical difficulties in complying with the stage II requirements for certain uses of the engines, in particular mobile machinery in which engines of classes SH:2 and SH:3 are installed. If the Commission studies conclude that for technical reasons certain mobile machinery, in particular, multi-positional, hand-held engines intended for professional use, cannot meet those requirements by the deadlines laid down, it shall submit, by 31 December 2003, a report accompanied by appropriate proposals for extensions of the period referred to in Article 9a(7) and/or further derogations, not exceeding five years in duration, save in exceptional circumstances, for such machinery. 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 15(2).’;

5.Article 15 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.in Annex I, point 4.1.2.7, the last sentence shall be replaced by the following: ‘The Commission shall define the control area to which the percentage not to be exceeded is to apply and the excluded engine operating conditions. 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).’;

7.in Annex III, the last paragraph of point 1.3.2 shall be replaced by the following: ‘Prior to the introduction of the cold/hot composite test sequence, the Commission shall modify the symbols (Annex I, section 2.18), the test sequence (Annex III) and the calculation equations (Annex III, Appendix 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 15(2).’.

1.2.   Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (⁸)

As regards Directive 98/79/EC, the Commission should be empowered in particular to adopt particular health monitoring measures and to amend Annex II. Since those measures are of general scope and are designed to amend non-essential elements of Directive 98/79/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.

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 have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of prohibitions, restrictions or particular requirements for certain products.

Accordingly, Directive 98/79/EC is hereby amended as follows:

1.Article 7 shall be replaced by the following: ‘Article 7

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

2.Article 10(5) shall be replaced by the following: ‘5.  Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12. The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

3.Article 11(5) shall be replaced by the following: ‘5.  Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

4.Article 12(3) shall be replaced by the following: ‘3.  The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

5.Article 13 shall be replaced by the following: ‘Article 13 Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States, giving the reasons for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures. 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). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4).’;

6.Article 14(1) shall be replaced by the following: ‘1.  Where a Member State considers that: (a)the list of devices in Annex II should be amended or extended; or (b)the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. Where those measures concern matters referred to in point (a), designed to amend non-essential elements of this Directive, they shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). Where those measures concern matters referred to in point (b), they shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’.

1.3.   Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (¹⁰)

As regards Directive 1999/5/EC, the Commission should be empowered in particular to adopt a decision specifying, for apparatus within certain equipment classes or apparatus of particular types, which of the additional requirements apply, to determine the date of application, including, where appropriate, a transitional period, of certain additional essential requirements to specific equipment classes or apparatus of particular types, and to decide on the form of the equipment class identifier to be affixed on specific types of radio equipment. Since those measures are of general scope and are designed to amend non-essential elements of Directive 1999/5/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 1999/5/EC is hereby amended as follows:

1.Article 3(3) shall be replaced by the following: ‘3.  The Commission may decide that apparatus within certain equipment classes or apparatus of particular types shall be so constructed that: (a)it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the Community; and/or that (b)it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; and/or that (c)it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; and/or that (d)it supports certain features ensuring avoidance of fraud; and/or that (e)it supports certain features ensuring access to emergency services; and/or that (f)it supports certain features in order to facilitate its use by users with a disability. 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 15a.’;

2.Article 5(3) shall be replaced by the following: ‘3.  In the case of shortcomings of harmonised standards with respect to the essential requirements, the Commission may, after consulting the committee and in accordance with the procedure laid down in Article 14, publish in the Official Journal of the European Union recommendations on the interpretation of harmonised standards or on the conditions under which compliance with those standards raises a presumption of conformity. After consultation of the committee and in accordance with the procedure laid down in Article 14, the Commission may withdraw harmonised standards by publication of a notice in the Official Journal of the European Union.’;

3.Article 6(2) shall be replaced by the following: ‘2.  In taking a decision regarding the application of essential requirements under Article 3(3), the Commission shall determine the date of application of the requirements. If it is determined that an equipment class needs to comply with particular essential requirements under Article 3(3), any apparatus of the equipment class in question which is first placed on the market before the date of application of the Commission’s determination can continue to be placed on the market for a reasonable period to be determined by the Commission. The measures referred to in the first and second subparagraphs, 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 15a.’;

4.the following Article shall be inserted: ‘Article 15a Regulatory procedure with scrutiny Where reference is made to this Article, 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.point 5 of Annex VII shall be replaced by the following: ‘5.The equipment class identifier must take a form to be decided 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 15a.’.

1.4.   Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (¹¹)

As regards Regulation (EC) No 141/2000, the Commission should be empowered in particular to adopt definitions of ‘similar medicinal product’ and ‘clinical superiority’. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 141/2000, 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 141/2000 is hereby amended as follows:

1.Article 3(2) shall be replaced by the following: ‘2.  The Commission shall, in accordance with the regulatory procedure referred to in Article 10a(2), adopt the necessary provisions for implementing paragraph 1 of this Article in the form of an implementing Regulation.’;

2.Article 5(8) shall be replaced by the following: ‘8.  The Agency shall forthwith forward the final opinion of the Committee to the Commission, which shall adopt a decision within 30 days of receipt of the opinion. Where, in exceptional circumstances, the draft decision is not in accordance with the opinion of the Committee, the decision shall be adopted in accordance with the regulatory procedure referred to in Article 10a(2). The decision shall be notified to the sponsor and communicated to the Agency and to the competent authorities of the Member States.’;

3.Article 8(4) shall be replaced by the following: ‘4.  The Commission shall adopt definitions of “similar medicinal product” and “clinical superiority” in the form of an implementing 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 10a(3).’;

4.the following Article shall be inserted: ‘Article 10a