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

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

1.5.   Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (¹⁴)

As regards Directive 2001/20/EC, the Commission should be empowered in particular to adopt principles relating to good clinical practice and detailed rules in line with those principles, to lay down specific requirements and to adapt certain provisions. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/20/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 2001/20/EC is hereby amended as follows:

1.Article 1(3) shall be replaced by the following: ‘3.  The Commission shall adopt the principles relating to good clinical practice and detailed rules in line with those principles and shall, if necessary, revise those principles and detailed rules to take account of technical and scientific 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 21(3). The principles and detailed rules shall be published by the Commission.’;

2.Article 13(1) shall be replaced by the following: ‘1.  Member States shall take all appropriate measures to ensure that the manufacture or importation of investigational medicinal products is subject to the holding of authorisation. The Commission shall lay down the minimum requirements which the applicant and, subsequently, the holder of the authorisation must meet in order to obtain the authorisation. 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 20 shall be replaced by the following: ‘Article 20 The Commission shall adapt this Directive to take account of 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 21(3).’;

4.Article 21 shall be replaced by the following: ‘Article 21

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

1.6.   Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (¹⁶)

As regards Directive 2001/82/EC, the Commission should be empowered in particular to adapt certain provisions and annexes, and to lay down specific conditions of application. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/82/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 2001/82/EC is hereby amended as follows:

3.in Article 13(1), the fourth subparagraph shall be replaced by the following: ‘However, the 10-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated 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 89(2a).’;

4.in Article 17(1), the second subparagraph shall be replaced by the following: ‘If it appears justified in the light of new scientific evidence, the Commission may adapt points (b) and (c) of the first subparagraph. 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 89(2a).’;

5.in Article 39(1), the third subparagraph shall be replaced by the following: ‘The Commission shall adopt those arrangements in the form of an implementing regulation. 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 89(2a).’;

6.Article 50a(2) shall be replaced by the following: ‘2.  The Commission shall adopt any amendments which may be necessary in order to adapt the provisions of paragraph 1 to take account of 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 89(2a).’;

7.in Article 51, the first paragraph shall be replaced by the following: ‘The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted by the Commission in the form of a Directive addressed to the Member States. 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 89(2a).’;

8.in Article 67, point (aa) shall be replaced by the following: ‘(aa)veterinary medicinal products for food-producing animals. However, Member States may grant exemptions from this requirement according to criteria established by the Commission. The establishment of those criteria, being a 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 89(2a). Member States may continue to apply national provisions until either: (i)the date of application of the decision adopted in accordance with the first subparagraph; or (ii)1 January 2007, if no such decision has been adopted by 31 December 2006;’;

9.Article 68(3) shall be replaced by the following: ‘3.  The Commission shall adopt any amendments to the list of substances referred to in paragraph 1. 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 89(2a).’;

10.Article 75(6) shall be replaced by the following: ‘6.  The Commission may amend paragraph 5 in the light of the experience gained from its operation. 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 89(2a).’;

11.Article 79 shall be replaced by the following: ‘Article 79 The Commission shall adopt any amendments which may be necessary to update Articles 72 to 78 to take account of 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 89(2a).’;

12.Article 88 shall be replaced by the following: ‘Article 88 The Commission shall adopt any changes which are necessary in order to adapt 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 89(2a).’;

13.Article 89 shall be 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 replaced by the following: ‘4.  The rules of procedure of the Standing Committee shall be made public.’.

1.7.   Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (¹⁷)

As regards Directive 2006/42/EC, the Commission should be empowered in particular to establish the conditions for updating the indicative list of safety components and for the measures regarding the restriction of the placing on the market of potentially hazardous machinery. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2006/42/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 2006/42/EC is hereby amended as follows:

1.Article 8 shall be replaced by the following: ‘Article 8 Specific measures

(a)updating the indicative list of safety components in Annex V referred to in Article 2(c); (b)restricting the placing on the market of machinery referred to in Article 9. 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 22(3).

2.Article 9(3) shall be replaced by the following: ‘3.  In the cases referred to in paragraph 1, the Commission shall consult the Member States and other interested parties, indicating the measures it intends to take in order to ensure, at Community level, a high level of protection of the health and safety of persons. Taking due account of the results of this consultation, it shall adopt the necessary 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 22(3).’;

3.Article 22 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)paragraph 4 shall be deleted.

2. ENVIRONMENT

2.1.   Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT) (¹⁸)

As regards Directive 96/59/EC, the Commission should be empowered in particular to fix the reference methods of measurement to determine the PCB content of contaminated materials and the technical standards for the other methods of disposing of PCBs, and, if necessary, to determine, solely for the purpose of Article 9(1)(b) and (c), other less hazardous substitutes for PCBs. Since those measures are of general scope and are designed to amend non-essential elements of Directive 96/59/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 96/59/EC is hereby amended as follows:

1.Article 10 shall be replaced by the following: ‘Article 10

(a)fix the reference methods of measurement to determine the PCB content of contaminated materials. Measurements effected before the determination of the reference methods shall remain valid; (b)if necessary determine, solely for the purpose of Article 9(1)(b) and (c), other less hazardous substitutes for PCBs. The Commission may fix technical standards for the other methods of disposing of PCBs referred to in the second sentence of Article 8(2). 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 10a(3).’;

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

2.2.   Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (²⁰)

As regards Directive 98/83/EC, the Commission should be empowered in particular to adapt Annexes II and III to scientific and technical progress and to set out certain details on monitoring in Annex II. Since those measures are of general scope and are designed to amend non-essential elements of Directive 98/83/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 98/83/EC is hereby amended as follows:

1.Article 7(4) shall be replaced by the following: ‘4.  Community guidelines for the monitoring prescribed in this Article may be drawn up in accordance with the management procedure referred to in Article 12(2).’;

2.Article 11(2) shall be replaced by the following: ‘2.  At least every five years, the Commission shall amend Annexes II and III to make the necessary adaptations 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 12(3).’;

3.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.’;

4.Article 13 shall be amended as follows: (a)paragraph 4 shall be replaced by the following: ‘4.  The formats and the minimum information for the reports provided for in paragraph 2 shall be determined having special regard to the measures referred to in Article 3(2), Article 5(2) and (3), Article 7(2), Article 8, Article 9(6) and (7) and Article 15(1), and shall if necessary be amended in accordance with the management procedure referred to in Article 12(2).’; (b)paragraph 6 shall be replaced by the following: ‘6.  Together with the first report on this Directive as mentioned in paragraph 2, Member States shall also produce a report to be forwarded to the Commission on the measures they have taken or plan to take to fulfil their obligations pursuant to Article 6(3) and Annex I, Part B, note 10. As appropriate, a proposal on the format of this report shall be submitted in accordance with the management procedure referred to in Article 12(2).’;

5.Article 15(3) shall be replaced by the following: ‘3.  That request shall be examined in accordance with the management procedure referred to in Article 12(2).’;

6.in Annex I, Part C, point 1 of note 10 shall be replaced by the following: ‘1.The Commission shall adopt the measures required under Note 8 on monitoring frequencies, and Note 9 on monitoring frequencies, monitoring methods and the most relevant locations for monitoring points in Annex II. 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). When elaborating those measures the Commission shall take into account, inter alia, the relevant provisions under existing legislation or appropriate monitoring programmes including monitoring results as derived from them.’;

7.in Annex II, table A, point 2 shall be replaced by the following: ‘2.   Audit monitoring The purpose of audit monitoring is to provide the information necessary to determine whether or not all of the Directive’s parametric values are being complied with. All parameters set in accordance with Article 5(2) and (3) must be subject to audit monitoring unless it can be established by the competent authorities, for a period of time to be determined by them, that a parameter is not likely to be present in a given supply in concentrations which could lead to the risk of a breach of the relevant parametric value. This point does not apply to the parameters for radioactivity, which, subject to Notes 8, 9 and 10 in Annex I, Part C, will be monitored in accordance with monitoring requirements 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 12(3).’;

8.in Annex III, point 1, the first subparagraph shall be replaced by the following: ‘The following principles for methods of microbiological parameters are given either for reference, whenever a CEN/ISO method is given, or for guidance, pending the possible future adoption by the Commission of further CEN/ISO international methods for those parameters. Member States may use alternative methods, providing the provisions of Article 7(5) are met. Those measures on further CEN/ISO international methods, 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 12(3).’.

2.3.   Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer (²¹)

As regards Regulation (EC) No 2037/2000, the Commission should be empowered in particular to amend Annex VI; to establish and reduce the calculated level of methyl bromide that can be placed on the market or used by importers or producers for their own account for quarantine and preshipment purposes; to determine a mechanism for the allocation of quotas of the calculated levels of methyl bromide to each producer and importer; to adopt, if necessary, modifications and, where appropriate, time frames for phase-out of the critical uses of halons listed in Annex VII; to take a decision on whether to adapt the end-date of prohibition of the use of hydrochlorofluorocarbons; to modify the list and dates with regard to control of the use of hydrochlorofluorocarbons; to modify the list of items related to the request for an import licence and Annex IV; to amend the list of products containing controlled substances and of Combined Nomenclature codes in Annex V; and to advance the date of export prohibition of recovered, recycled and reclaimed halon for critical uses, and to modify the reporting requirements. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 2037/2000, 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 2037/2000 is hereby amended as follows:

1.in Article 2, the 16th indent shall be replaced by the following: ‘—“processing agent” means controlled substances used as chemical processing agents in those applications listed in Annex VI, in installations existing on 1 September 1997, and where emissions are insignificant. The Commission shall, in the light of those criteria, and in accordance with the management procedure referred to in Article 18(2), establish a list of undertakings in which the use of controlled substances as processing agents shall be permitted, laying down maximum emission levels for each of the undertakings concerned. In the light of new information or technical developments, including the review provided for in Decision X/14 of the Meeting of the Parties to the Protocol, the Commission may: (a)amend the list of undertakings referred to above in accordance with the management procedure referred to in Article 18(2); (b)amend Annex VI. 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(3).’;

2.Article 4 shall be amended as follows: (a)the third subparagraph of point (iii) of paragraph 2 shall be replaced by the following: ‘The Commission shall take measures to reduce the calculated level of methyl bromide which producers and importers may place on the market or use for their own account for quarantine and preshipment in the light of technical and economic availability of alternative substances or technologies, and of the relevant international developments under the Protocol. 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 18(3).’; (b)paragraph 3(ii) shall be replaced by the following: ‘(ii)The Commission may amend the mechanism for the allocation of quotas to each producer and importer of the calculated levels set out in points (d) to (f), applicable for the period 1 January 2003 to 31 December 2003 and for each 12-month period thereafter. 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 18(3).’; (c)paragraph 4(iv) shall be replaced by the following: ‘(iv)Paragraph 1(c) shall not apply to the placing on the market and use of halons that have been recovered, recycled or reclaimed in existing fire protection systems until 31 December 2002 or to the placing on the market and use of halons for critical uses as set out in Annex VII. Each year the competent authorities of the Member States shall notify to the Commission the quantities of halons used for critical uses, the measures taken to reduce their emissions and an estimate of such emissions, and the current activities to identify and use adequate alternatives. Each year the Commission shall review the critical uses listed in Annex VII and, if necessary, adopt modifications and, where appropriate, time frames for phase-out, taking into account the availability of both technically and economically feasible alternatives or technologies that are acceptable from the standpoint of the environment and health. 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 18(3).’;

3.Article 5 shall be amended as follows: (a)the fifth subparagraph of point (c)(v) of paragraph 1 shall be replaced by the following: ‘The Commission shall submit the result of the review to the European Parliament and to the Council. It shall, as appropriate, take a decision on whether to adapt the date of 1 January 2015. 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 18(3).’; (b)paragraph 6 shall be replaced by the following: ‘6.  The Commission may, in the light of experience with the operation of this Regulation or to reflect technical progress, amend the list and the dates set out in paragraph 1 but may in no case extend the periods set out therein, without prejudice to the exemptions provided for in paragraph 7. 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 18(3).’;

4.Article 6(5) shall be replaced by the following: ‘5.  The Commission may amend the list of items mentioned in paragraph 3 and 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 18(3).’;

5.Article 9(2) shall be replaced by the following: ‘2.  A list of products containing controlled substances and of Combined Nomenclature codes is given in Annex V for guidance of the Member States’ customs authorities. The Commission may add to, delete items from or amend that list in the light of the lists established by the Parties. 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(3).’;

6.Article 11(1)(d) shall be replaced by the following: ‘(d)recovered, recycled and reclaimed halon stored for critical uses in facilities authorised or operated by the competent authority to satisfy critical uses listed in Annex VII until 31 December 2009, and products and equipment containing halon to satisfy critical uses listed in Annex VII. Following a review undertaken by 1 January 2005 by the Commission of exports of such recovered, recycled and reclaimed halon for critical uses the Commission may prohibit such exports earlier than 31 December 2009. 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 18(3).’;

7.Article 18(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.’;

8.Article 19(6) shall be replaced by the following: ‘6.  The Commission may amend the reporting requirements laid down in paragraphs 1 to 4 to meet commitments under the Protocol or to improve the practical application of those reporting requirements. 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(3).’.

2.4.   Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register (²²)

As regards Regulation (EC) No 166/2006, the Commission should be empowered in particular to adopt measures referred to in Article 8(3); to adapt Annexes II or III to scientific or technical progress; and to adapt Annexes II and III as a result of the adoption by the Meeting of the Parties to the UNECE Protocol on Pollutant Release and Transfer Registers of any amendment to the Annexes to that Protocol. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 166/2006, 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 166/2006 is hereby amended as follows:

1.Article 8(3) shall be replaced by the following: ‘3.  Where the Commission determines that no data on the releases from diffuse sources exist, measures to initiate reporting on releases of relevant pollutants from one or more diffuse sources shall be taken using, where appropriate, internationally approved methodologies. 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 19(3).’;

2.Article 18 shall be replaced by the following: ‘Article 18 Amendments to the Annexes The Commission shall make any necessary amendments to the annexes for the following purposes: (a)the adaptation of Annexes II or III to scientific or technical progress; (b)the adaptation of Annexes II and III as a result of the adoption by the Meeting of the Parties to the Protocol of any amendment to the Annexes to the Protocol. 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 19(3).’;

3.the following paragraph shall be added to Article 19: ‘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 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality (²³)

As regards Directive 2006/7/EC, the Commission should be empowered in particular to adapt, in the light of scientific and technical progress, the methods of analysis for the parameters and sampling rules set out in Annex I and Annex V respectively, and to specify the EN/ISO standard on the equivalence of microbiological methods. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2006/7/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 2006/7/EC is hereby amended as follows:

1.Article 15 shall be replaced by the following: ‘Article 15 Technical adaptations and implementing measures

(a)detailed rules for the implementation of Article 8(1), Article 12(1)(a) and Article 12(4); (b)guidelines for a common method for the assessment of single samples.

(a)the specification of EN/ISO standard on the equivalence of microbiological methods for the purposes of Article 3(9); (b)any amendments necessary in order to adapt the methods of analysis for the parameters set out in Annex I in the light of scientific and technical progress; (c)any amendments necessary in order to adapt Annex V in the light of scientific and technical progress. 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 16(3).

2.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.’.

2.6.   Directive 2006/21/EC of the European Parliament and of the Council of 15 March 2006 on the management of waste from extractive industries (²⁴)

As regards Directive 2006/21/EC, the Commission should be empowered in particular to adopt provisions necessary for the implementation of Article 13(6); to complete the technical requirements for waste characterisation contained in Annex II; to interpret the definition in point 3 of Article 3; to define the criteria for the classification of waste facilities in accordance with Annex III; to determine harmonised standards for sampling and analysis methods; and to adapt the Annexes to scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2006/21/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 2006/21/EC is hereby amended as follows:

1.Article 22 shall be replaced by the following: ‘Article 22

(a)provisions necessary for the harmonisation and regular transmission of the information referred to in Article 7(5) and Article 12(6); (b)technical guidelines for the establishment of the financial guarantee in accordance with the requirements of Article 14(2); (c)technical guidelines for inspections in accordance with Article 17.

(a)the implementation of Article 13(6), including technical requirements relating to the definition of weak acid dissociable cyanide and its measurement method; (b)the completion of the technical requirements for waste characterisation contained in Annex II; (c)the interpretation of the definition contained in point 3 of Article 3; (d)the definition of the criteria for the classification of waste facilities in accordance with Annex III; (e)the determination of any harmonised standards for sampling and analysis methods needed for the technical implementation of this Directive. 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 23(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 23(3).’;

2.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.’.

3. EUROSTAT

3.1.   Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonised indices of consumer prices (²⁵)

As regards Regulation (EC) No 2494/95, the Commission should be empowered in particular to adopt rules to be followed to ensure the comparability of HICPs and to maintain and improve their reliability and relevance. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 2494/95, 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 2494/95 is hereby amended as follows:

1.in Article 3, the words ‘in Article 14’ shall be replaced by the words ‘in Article 14(2)’;

2.the third paragraph of Article 4 shall be replaced by the following: ‘The Commission (Eurostat) shall adopt rules to be followed to ensure the comparability of HICPs. 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).’;

3.Article 5(3) shall be replaced by the following: ‘3.  The Commission shall adopt implementing measures for this Regulation which are necessary in order to ensure the comparability of HICPs and to maintain and improve their reliability and relevance. 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). The Commission shall request the ECB to provide an opinion on the measures which it proposes to submit to the Committee.’;

4.in Article 8(3), the words ‘in Article 14’ shall be replaced by the words ‘in Article 14(2)’;

5.Article 9 shall be replaced by the following: ‘Article 9 Production of results Member States shall process the data collected in order to produce the HICP, which shall be a Laspeyres-type index, covering the categories of the Coicop international classification (classification of individual consumption by purpose) (²⁶), which shall be adapted by the Commission for the purposes of establishing comparable HICPs. The Commission shall determine the methods, procedures and formulae to ensure that the comparability requirements are met. 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).

6.in Article 11, the words ‘in Article 14’ shall be replaced by the words ‘in Article 14(2)’;

7.Article 14 shall be replaced by the following: ‘Article 14 Committee procedure

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

8.the second paragraph of Article 15 shall be replaced by the following: ‘In those reports, the Commission shall state its views on the operation of the procedures described in Article 14 and shall propose any amendments it considers appropriate.’.

3.2.   Council Regulation (EC) No 577/98 of 9 March 1998 on the organisation of a labour force sample survey in the Community (²⁹)

As regards Regulation (EC) No 577/98, the Commission should be empowered in particular to adopt additional variables, to adapt the definitions, the edits to be used and the codification of the variables, and to draw up the list of structural variables, the minimum sample size and the survey frequency. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 577/98, 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 577/98 is hereby amended as follows:

1.in the third indent of the fifth paragraph of Article 1, the words ‘in Article 8’ shall be replaced by the words ‘in Article 8(2)’;

2.paragraphs 2, 3 and 4 of Article 4 shall be replaced by the following: ‘2.  A further set of variables, hereinafter referred to as an “ad hoc module”, may be added to supplement the information described in paragraph 1. Each year a programme of ad hoc modules covering several years shall be adopted by the Commission. That programme shall specify, for each ad hoc module, the subject, the reference period, the sample size (equal to or less than the sample size determined according to Article 3) and the deadline for the transmission of the results (which may be different from the deadline according to Article 6). The Member States and regions covered and the detailed list of information to be collected in an ad hoc module shall be drawn up at least 12 months before the beginning of the reference period for that module. The volume of an ad hoc module shall not exceed 11 variables. 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 8(3).

3.Article 8 shall be replaced by the following: ‘Article 8 Committee procedure

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

3.3.   Council Regulation (EC) No 1165/98 of 19 May 1998 concerning short-term statistics (³²)

As regards Regulation (EC) No 1165/98, the Commission should be empowered in particular to approve and implement the European sample schemes, to adapt the Annexes and to determine the measures for implementing this Regulation, including the measures to accommodate economic and technical developments concerning the collection and statistical processing of data and the transmission of the variables. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1165/98, 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 1165/98 is hereby amended as follows:

1.Article 4(2)(d) shall be replaced by the following: ‘(d)participation in European sample schemes coordinated by Eurostat in order to produce European estimates. The details of the schemes referred to in the first subparagraph shall be as specified in the Annexes. Measures for their approval and implementation shall 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 18(3). European sample schemes shall be established when national sample schemes do not meet the European requirements. Furthermore, Member States may opt to take part in European sample schemes when such schemes create possibilities for substantial reductions in the cost of the statistical system or the burden on business which meeting the European requirements entails. Participation in a European sample scheme shall satisfy the conditions of a Member State for the supply of the variable concerned in accordance with the objective of such a scheme. European sample schemes may target the conditions, the level of detail and the deadlines for data transmission.’;

2.in Article 16(1), the words ‘in Article 18’ shall be replaced by the words ‘in Article 18(2)’;

3.Articles 17 and 18 shall be replaced by the following: ‘Article 17 Implementing measures The Commission shall determine the measures for implementing this Regulation, including the measures to accommodate economic and technical developments concerning the collection and statistical processing of data and the transmission of the variables. In doing so, consideration shall be given to the principle that the benefits of the measure must outweigh its cost, and to the principle that major additional resources are not involved either for Member States or for enterprises as compared with the original provisions of this Regulation. In particular, the measures for implementing this Regulation shall include: (a)the use of particular units (Article 2); (b)the updating of the list of variables (Article 3); (c)the definitions and the appropriate forms of the transmitted variables (Article 3); (d)the establishment of European sample schemes (Article 4); (e)the frequency of compilation of the statistics (Article 5); (f)the levels of breakdown and aggregation to be applied to the variables (Article 6); (g)the transmission deadlines (Article 8); (h)the criteria for the measurement of quality (Article 10); (i)the transition periods (Article 13(1)); (j)derogations granted during the transition periods (Article 13(2)); (k)the institution of pilot studies (Article 16); (l)the first base year to be applied for time series in NACE Rev. 2; (m)for time series prior to 2009, to be transmitted according to NACE Rev. 2, the level of detail, the form, the first reference period, and the reference period. The measures referred to in points (j) and (k) shall be adopted in accordance with the regulatory procedure referred to in Article 18(2). The measures referred to in points (a) to (i) and (l) and (m), 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 18(3).

Article 18

Committee procedure

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

4.Annex A (Industry) shall be amended as follows: (a)point (a) (Scope) shall be replaced by the following: ‘(a)   Scope This Annex applies to all activities listed in Sections B to E of NACE Rev. 2, or, as the case may be, to all products listed in Sections B to E of the CPA. The information is not required for 37, 38.1, 38.2 and 39 of NACE Rev. 2. The list of activities may be revised 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 18(3).’; (b)paragraph 3 of point (b) (Observation unit) shall be replaced by the following: ‘3.The use of other observation units may be decided 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 18(3).’; (c)point (c) (List of variables) shall be amended as follows: (i)the last sentence of paragraph 2 shall be replaced by the following: ‘The Commission shall determine the conditions for assuring the necessary data quality. 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 18(3).’; (ii)paragraphs 3 and 4 shall be replaced by the following: ‘3.Starting from the beginning of the first reference period the information on new orders (Nos 130, 131, 132) may be approximated by an alternative leading indicator, which may be calculated from business opinion survey data. This approximation is permitted for a period of five years from the date of entry into force of the Regulation. This period shall be extended by up to five years more unless decided differently 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 18(3). 4.Starting from the beginning of the first reference period the information on persons employed (No 210) may be approximated by the number of employees (No 211). This approximation is permitted for a period of five years from the date of entry into force of the Regulation. This period shall be extended by up to five years more unless decided differently 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 18(3).’; (iii)the last sentence of paragraph 8 shall be replaced by the following: ‘The list of activities may be revised 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 18(3).’; (iv)the last sentence of paragraph 10 shall be replaced by the following: ‘The list of activities may be revised 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 18(3).’; (d)paragraph 2 of point (d) (Form) shall be replaced by the following: ‘2.In addition, the production variable (No 110) and the hours-worked variable (No 220) are to be transmitted in working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The list of variables to be transmitted in working-day adjusted form may be amended 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 18(3).’; (e)paragraphs 8 and 9 of point (f) (Level of detail) shall be replaced by the following: ‘8.For the import price variable (No 340), the Commission may determine the terms for applying a European sample scheme as defined in point (d) of the first subparagraph of Article 4(2). 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 18(3). 9.The variables on the non-domestic markets (Nos 122, 132 and 312) are to be transmitted according to the distinction into euro-zone and non-euro-zone. The distinction is to be applied to the total industry defined as NACE Rev. 2 Sections B to E, the MIGs, the Section (1 letter) and Division 2-digit level of NACE Rev. 2. The information on NACE Rev. 2 D and E is not required for variable 122. In addition, the import price variable (No 340) is to be transmitted according to the distinction into euro-zone and non-euro-zone. The distinction is to be applied to the total industry defined as CPA Sections B to E, the MIGs, the Section (1 letter) and Division 2-digit level of CPA. For the distinction into the euro-zone and non-euro-zone, the Commission may determine the terms for applying European sample schemes as defined in point (d) of the first subparagraph of Article 4(2). 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 18(3). The European sample scheme may limit the scope of the import price variable to the import of products from non-euro-zone countries. The distinction into the euro-zone and non-euro-zone for the variables 122, 132, 312 and 340 does not need to be transmitted by those Member States that have not adopted the euro as their currency.’; (f)in point (j) (Transition period), all references to Article 18 shall be replaced by references to Article 18(2);

5.Annex B (Construction) shall be amended as follows: (a)paragraph 4 of point (b) (Observation unit) shall be replaced by the following: ‘4.The use of other observation units may be decided 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 18(3).’; (b)point (c) (List of variables) shall be amended as follows: (i)paragraph 3 shall be replaced by the following: ‘3.Starting from the beginning of the first reference period the information on persons employed (No 210) may be approximated by the number of employees (No 211). This approximation is permitted for a period of five years from the date of entry into force of the Regulation. This period shall be extended for up to five years more unless decided differently 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 18(3).’; (ii)the last subparagraph of paragraph 6 shall be replaced by the following: ‘The Commission shall decide no later than 11 August 2008 whether to invoke Article 17(b) so as to replace the construction costs variable with the output price variable with effect from base year 2010. 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 18(3).’; (c)paragraph 2 of point (d) (Form) shall be replaced by the following: ‘2.In addition, the variables on production (Nos 110, 115, 116) and the hours-worked variable (No 220) are to be transmitted in working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The list of variables to be transmitted in working-day adjusted form may be amended 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 18(3).’; (d)in point (j) (Transition period), all references to Article 18 shall be replaced by references to Article 18(2);

6.Annex C (Retail trade and repair) shall be amended as follows: (a)paragraph 2 of point (b) (Observation unit) shall be replaced by the following: ‘2.The use of other observation units may be decided 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 18(3).’; (b)point (c) (List of variables) shall be amended as follows: (i)paragraph 3 shall be replaced by the following: ‘3.Starting from the beginning of the first reference period the information on persons employed (No 210) may be approximated by the number of employees (No 211). This approximation is permitted for a period of five years from the date of entry into force of the Regulation. This period shall be extended for up to five years more unless decided differently 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 18(3).’; (ii)the last subparagraph of paragraph 4 shall be replaced by the following: ‘The Commission shall decide no later than 11 August 2008 whether to invoke Article 17(b) so as to include the variable hours worked (No 220) and the variable gross wages and salaries (No 230) with effect from the base year 2010. 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 18(3).’; (c)paragraph 2 of point (d) (Form) shall be replaced by the following: ‘2.The turnover variable (No 120) and the volume of sales variable (No 123) are also to be transmitted in a working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The list of variables to be transmitted in working-day adjusted form may be amended 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 18(3).’; (d)paragraph 2 of point (g) (Deadlines for data transmission) shall be replaced by the following: ‘2.The variables shall be transmitted for turnover (No 120) and the deflator of sales/volume of sales (No 330/123) within one month for the level of detail specified in paragraph 3 under heading (f) of this Annex. Member States may choose to participate for the turnover and deflator of sales/volume of sales variables No 120 and 330/123 with contributions according to the allocation of a European sample scheme as defined in point (d) of the first subparagraph of Article 4(2). The terms of the allocation are to be determined 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 18(3).’; (e)in point (j) (Transition period), all references to Article 18 shall be replaced by references to Article 18(2);

7.Annex D (Other services) shall be amended as follows: (a)paragraph 2 of point (b) (Observation unit) shall be replaced by the following: ‘2.The use of other observation units may be decided 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 18(3).’; (b)point (c) (List of variables), is amended as follows: (i)paragraph 2 shall be replaced by the following: ‘2.Starting from the beginning of the first reference period the information on persons employed (No 210) may be approximated by the number of employees (No 211). This approximation is permitted for a period of five years from the date of entry into force of the Regulation. The period shall be extended by up to five years more unless decided differently 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 18(3).’; (ii)the last subparagraph of paragraph 4 shall be replaced by the following: ‘The Commission shall decide no later than 11 August 2008 whether to invoke Article 17(b) so as to include the variable hours worked (No 220) and the variable gross wages and salaries (No 230) with effect from base year 2010. 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 18(3).’; (c)paragraph 2 of point (d) (Form) shall be replaced by the following: ‘2.The turnover variable (No 120) is also to be transmitted in working-day adjusted form. Wherever other variables show working-day effects, Member States may also transmit those variables in working-day adjusted form. The list of variables to be transmitted in working-day adjusted form may be amended 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 18(3).’; (d)the last paragraph of point (e) (Reference period) shall be replaced by the following: ‘The Commission shall decide no later than 11 August 2008 whether to invoke Article 17(e) in connection with a revision of the frequency of compilation of the turnover variable. 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 18(3).’; (e)paragraph 6 of point (f) (Level of detail) shall be replaced by the following: ‘6.The Commission may amend the list of activities and groupings no later than 11 August 2008. 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 18(3).’; (f)in points (i) (First reference period) and (j) (Transition period), all references to Article 18 shall be replaced by references to Article 18(2).

3.4.   Council Regulation (EC) No 530/1999 of 9 March 1999 concerning structural statistics on earnings and on labour costs (³⁵)

As regards Regulation (EC) No 530/1999, the Commission should be empowered in particular to adapt the definition and breakdown of the information to be provided, and to lay down the quality evaluation criteria. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 530/1999, 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 530/1999 is hereby amended as follows:

1.Articles 11 and 12 shall be replaced by the following: ‘Article 11 Implementation measures The following measures necessary for the implementation of this Regulation, including measures to take account of economic and technical changes, shall be adopted by the Commission for each reference period at least nine months before the beginning of the reference period: (i)the definition and breakdown of the information to be provided (Article 6), (ii)the appropriate technical format for the transmission of the results (Article 9), (iii)quality evaluation criteria (Article 10), (iv)derogations, in duly justified cases, for the years 2004 and 2006 respectively (Article 13(2)). The measures referred to in points (ii) and (iv) shall be adopted in accordance with the regulatory procedure referred to in Article 12(2). The measures referred to in points (i) and (iii), 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).

Article 12

Committee procedure

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

2.Article 13(2) shall be replaced by the following: ‘2.  For the years 2004 and 2006 respectively, derogations from Articles 3 and 6 may be decided in so far as the national statistical system requires major adaptations, in accordance with the regulatory procedure set out in Article 12(2).’.

3.5.   Regulation (EC) No 450/2003 of the European Parliament and of the Council of 27 February 2003 concerning the labour cost index (³⁸)

As regards Regulation (EC) No 450/2003, the Commission should be empowered in particular to adapt the definitions and amend the technical specifications, include new sections in the survey, adapt the breakdown of indices by economic activities, define the quality criteria, establish feasibility studies and take decisions pursuant to their results, and determine the methodology to be used for chaining the index. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 450/2003, 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 450/2003 is hereby amended as follows:

1.Article 2(4) shall be replaced by the following: ‘4.  The Commission may take measures to redefine the technical specification of the index and revise the weighting structure. 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).’;

2.Article 3(2) shall be replaced by the following: ‘2.  The inclusion of economic activities defined by NACE Rev.2 sections O to S in the scope of this Regulation shall be determined by the Commission, taking into account the feasibility studies defined in Article 10. 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).’;

3.Article 4 shall be replaced by the following: ‘Article 4 Breakdown of variables