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 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.

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

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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).’;

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).’;

1 The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC.

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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

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).’;

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.’;

1 The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, referred to in Article 121(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use .

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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).’;

1 The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, referred to in Article 121(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use .

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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).’;

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).’;

1 The Commission may take any appropriate measure relating to the following: (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 The Commission, acting in accordance with the advisory procedure referred to in Article 22(2), may take any appropriate measure connected with the practical application of this Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission, as provided for in Article 19(1).’;

1 The Commission shall make available, in accordance with the regulatory procedure referred to in Article 10a(2), a list of the production names of capacitors, resistors and inductance coils containing PCBs.

2 The Commission shall: (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).’;

1 The Commission shall be assisted by the Committee set up by Article 18 of Directive 2006/12/EC of the European Parliament and of the Council .

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

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.

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).’;

1 The Commission shall, in accordance with the regulatory procedure referred to in Article 16(2), lay down the following: (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.

2 The Commission shall adopt the following measures: (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).

3 The Commission shall present a draft of the measures to be taken in accordance with paragraph 1(a) with respect to Article 12(1)(a) by 24 March 2010. Before doing so, it shall consult representatives of Member States, regional and local authorities, relevant tourist and consumer organisations and other interested parties. After the adoption of relevant rules, it shall publicise them via the Internet.’;

1 The Commission shall, in accordance with the regulatory procedure referred to in Article 23(2), adopt the following: (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.

2 The Commission shall lay down provisions necessary for the following, prioritising points (b), (c) and (d): (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).

3 The Commission shall make the necessary amendments to the Annexes for the purpose of adapting them to scientific and technical progress. Those amendments shall be made with a view to achieving a high level of environmental protection. 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).’;

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) , 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).

1 The Commission shall be assisted by the Statistical Programme Committee established by Council Decision 89/382/EEC, Euratom , hereinafter referred to as “the Committee”.

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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).

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

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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).

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

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

1 The data shall be broken down by economic activities defined by NACE Rev. 2 sections and by further disaggregations, defined by the Commission, not beyond the level of NACE Rev. 2 divisions (2-digit level) or groupings of divisions, taking account of contributions to total employment and to labour costs at Community and national levels. 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). Labour cost indices shall be provided separately for the three labour cost categories identified below: (a) total labour costs; (b) wages and salaries, defined by reference to item D.11 in Annex II to Regulation (EC) No 1726/1999; (c) employers’ social contributions plus taxes paid by the employer less subsidies received by the employer, as defined by the sum of items D.12 and D.4 less D.5 in Annex II to Regulation (EC) No 1726/1999.

2 An index estimating total labour costs, excluding bonuses, where bonuses are defined by D.11112 in Annex II to Regulation (EC) No 1726/1999, shall be provided, broken down by economic activities defined by the Commission, and shall be based on the NACE Rev. 2 classification, 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).’;

1 The current data and back data transmitted shall satisfy separate quality criteria to be defined by the Commission. That measure, 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 The Member States shall provide annual quality reports to the Commission, beginning in 2003. The content of the reports shall be defined by the Commission. That measure, 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).’;

The following measures for implementing this Regulation, including measures to take account of economic and technical changes, shall be laid down by the Commission: (a) the definition, in accordance with Article 4(1), of the disaggregations to be included in the fixed structure; (b) the technical specification of the index (Article 2); (c) the inclusion of NACE Rev. 2 sections O to S (Article 3); (d) the breakdown of indices by economic activities (Article 4); (e) the format for transmission of results and the adjustment procedures to be applied (Article 6); (f) the separate quality criteria for current and back data transmitted and contents of quality reports (Article 8); (g) the transition period (Article 9); (h) the establishment of feasibility studies and decisions pursuant to their results (Article 10); and (i) the methodology to be used for chaining the index (Annex). The measures referred to in points (e), (g) and (h) shall be adopted in accordance with the regulatory procedure referred to in Article 12(2). The measures referred to in points (a), (b), (c), (d), (f) and (i), 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).

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

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

The measures necessary to take account of economic and technical developments concerning the collection, transmission and processing of the data 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 14(3). Other measures for the implementation of this Regulation, including the appropriate technical format and interchange standard of the electronically transmitted data, shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 14(2).

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

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

The Commission shall adopt the measures necessary for the revision of the CPV. 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 3(2). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 3(3).

1 The Commission shall be assisted by the Committee established by Council Decision 71/306/EEC .

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

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

1 The Commission shall be assisted by the Committee established by Council Decision 71/306/EEC .

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

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

4 Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at four, two and six weeks respectively.

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

1 The Commission may amend, in accordance with the advisory procedure referred to in Article 68(2): (a) the procedure for sending and publishing data referred to in Annex XX, on grounds of technical progress or for administrative reasons; (b) the procedures for the drawing-up, transmission, receipt, translation, collection and distribution of the notices referred to in Articles 41, 42, 43 and 63; (c) in the interests of administrative simplification as provided for in Article 67(3), the procedures for the use, drawing-up, transmission, receipt, translation, collection and distribution of the statistical reports referred to in Article 67(1) and (2).

2 The Commission may amend the following: (a) the list of contracting entities in Annexes I to X so that they fulfil the criteria set out in Articles 2 to 7; (b) the procedures for specific references to particular positions in the CPV nomenclature in the notices; (c) the reference numbers in the nomenclature set out in Annex XVII, in so far as this does not change the material scope of the Directive, and the procedures for reference in the notices to particular positions in that nomenclature within the categories of services listed in the Annex; (d) the reference numbers in the nomenclature set out in Annex XII, insofar as this does not change the material scope of the Directive, and the procedures for reference to particular positions of that nomenclature in the notices; (e) Annex XI; (f) the technical details and characteristics of the devices for electronic receipt referred to in points (a), (f) and (g) of Annex XXIV; (g) the technical procedures for the calculation methods set out in the second subparagraph of Article 69(1) and the second subparagraph of Article 69(2). 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 68(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 68(5).’.

1 The Commission shall be assisted by the Committee established by Council Decision 71/306/EEC .

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

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

4 Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at four, two and six weeks respectively.

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

1 The Commission may amend, in accordance with the advisory procedure referred to in Article 77(2): (a) the procedures for the drawing-up, transmission, receipt, translation, collection and distribution of the notices referred to in Articles 35, 58, 64 and 69 and the statistical reports provided for in the fourth subparagraph of Article 35(4) and in Articles 75 and 76; (b) the procedure for sending and publishing data referred to in Annex VIII, on grounds of technical progress or for administrative reasons.

2 The Commission may amend the following: (a) the technical procedures for the calculation methods set out in the second subparagraph of Article 78(1) and in Article 78(3); (b) the procedures for specific reference to specific positions in the CPV nomenclature in the notices; (c) the lists of bodies and categories of bodies governed by public law in Annex III, when, on the basis of the notifications from the Member States, such amendment proves necessary; (d) the lists of central government authorities in Annex IV, following the adaptations necessary to give effect to the Agreement; (e) the reference numbers in the nomenclature set out in Annex I, in so far as this does not change the material scope of this Directive, and the procedures for reference to particular positions of that nomenclature in the notices; (f) the reference numbers in the nomenclature set out in Annex II, in so far as this does not change the material scope of this Directive, and the procedures for reference in the notices to particular positions in that nomenclature within the categories of services listed in the Annex; (g) the technical details and characteristics of the devices for electronic receipt referred to in points (a), (f) and (g) of Annex X. 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 77(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 77(5).’.

The Commission shall adopt: (a) a list of intended uses as set out in the Annex no later than 30 June 1994 in accordance with the regulatory procedure referred to in Article 9(2). That list shall contain: the indications referred to in points (b), (c), (d) and (e) of Article 5(1), and, where appropriate, the indications referred to in Article 5(2) and Article 5(4), second subparagraph, (b) general provisions regarding the application of the indications referred to in point (a), including applicable tolerances; (c) amendments to the measures adopted in accordance with points (a) and (b) in line with developments in scientific and technical knowledge. The measures provided for in points (b) and (c), designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 9(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 9(4).’;

1 The plan must conform to the sampling levels and frequencies laid down in Annex IV. However, at the request of a Member State the Commission may, in accordance with the regulatory procedure referred to in Article 33(2), adjust for the Member States concerned the minimum control requirements laid down in Annex IV provided that it is clearly established that such adjustments increase the overall effectiveness of the plan in respect of the Member State concerned and in no way reduce its ability to identify residues of, or cases of illegal treatment with, substances listed in Annex I.

2 Re-examination of the groups of residues to be checked for in accordance with Annex II and determination of the sampling levels and frequencies covering the animals and products referred to in Article 3 and not already laid down in Annex IV shall be carried out by the Commission and on the first occasion within a maximum of 18 months of the adoption of this Directive. In doing so, the Commission shall take account of experience gained under existing national measures and of information forwarded to the Commission under existing Community requirements making such specific product groups subject to monitoring for residues. 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 33(4).’;

1 The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up pursuant to Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matter of food safety .

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at fifteen days.

3 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

Without prejudice to Article 6(2), Annexes I, III, IV and V may be amended or supplemented by the Commission. In particular, those Annexes may be amended with a view to risk assessment of the following factors: potential toxicity of residues in foodstuffs of animal origin, likelihood of residues occurring in foodstuffs of animal origin, 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 33(4).

The Commission may adopt transitional measures required for the implementation of the arrangements laid down by this Directive. Transitional measures of general scope, designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, and in particular further specifications of the requirements laid down in this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(4). Other transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 33(2).

Detailed rules for the protection of the information provided by the applicant shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’;

The Annex may be amended or supplemented by the Commission. Those measures, designed to amend non-essential elements of this Decision, 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).’.

The Commission shall adopt temporary measures, if these prove necessary in order to facilitate the application of this Directive. Temporary measures of general scope designed to amend non-essential elements of this Directive, including those supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in the provisions of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3). Other temporary measures may be adopted in accordance with the regulatory procedure referred to in Article 20(2).’.

1 The adaptation to scientific and technical progress of the measurement methods laid down in Article 4 and the definitions relating thereto shall 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 10(3).

2 The adaptation to scientific and technical progress of health warnings to be shown on unit packets of tobacco products as set out in Annex I and the frequency of rotation of the health warnings shall 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 10(3).

3 The Commission shall, in accordance with the procedure laid down in Article 10(2), adapt to scientific and technical progress the marking for identification and tracing purposes of tobacco products.’;

1 The Commission shall be assisted by a committee.

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

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.’.

1 The Commission shall be assisted by a Committee.

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

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

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

5 Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.’.

1 The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, hereinafter referred to as ‘the Committee’.

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

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

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

1 The Commission shall be assisted by a Committee.

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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

1 Amendments to the Annexes shall be adopted by the Commission following a request to the Authority for scientific and/or technical assistance. 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 Amendments to the list referred to in Article 6(1) shall be adopted in accordance with the regulatory procedure referred to in Article 19(2) following a request to the Authority for scientific and/or technical assistance.’;

Appropriate transitional or implementing measures, including the necessary amendments to the relevant health certificates, may be adopted by the Commission. Transitional measures of general scope designed to amend non-essential elements of this Regulation, including those supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in the provisions of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3). Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 14(2).’;

1 Transitional measures of general scope, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, in particular any modification of the standards referred to in Article 12(2), a definition of what feed is to be regarded as feed of animal origin for the purpose of this Regulation, and further specifications of the requirements laid down in the provisions of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 62(4). Other transitional and implementing measures necessary in order to ensure the uniform application of this Regulation may be laid down in accordance with the regulatory procedure referred to in Article 62(3). This applies in particular to: the delegation of control tasks to control bodies referred to in Article 5, where those control bodies were already in operation before the entry into force of this Regulation, non-compliance as referred to in Article 28 which gives rise to expense arising from additional official controls, expenditure incurred pursuant to Article 54, rules on microbiological, physical and/or chemical analysis in official controls, in particular in cases involving a suspicion of risk and including the surveillance of the safety of products imported from third countries,

2 In order to take account of the specificity of Regulations (EEC) No 2092/91, (EEC) No 2081/92 and (EEC) No 2082/92, specific measures to be adopted by the Commission may provide for the necessary derogations from, and adjustments to, the rules laid down in this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 62(4).’;

The following 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 62(4): (1) the Annexes to this Regulation may be updated, except for Annex I, Annex IV and Annex V, without prejudice to Article 27(3), in particular in order to take account of administrative changes and scientific and/or technological progress; (2) the references to the European standards mentioned in this Regulation may be updated in the event that CEN amends those references.’.

Amendments to Annexes I and II shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’;

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

2 Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months.

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

1 The Commission shall be assisted by a Committee on Safe Seas and the Prevention of Pollution from Ships (hereinafter called COSS).

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.

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

COSS shall exercise the powers conferred on it by virtue of the Community legislation in force. Article 2(2) may be amended in accordance with the regulatory procedure with scrutiny referred to in Article 3(3) in order to include a reference to the Community acts conferring implementing power on COSS that have entered into force following the adoption of this Regulation. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the procedure referred to in Article 3(3).’.

1 The Commission shall be assisted by the committee established by Article 12 of Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation .

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

1 The Commission shall be assisted by the committee set up by Article 12 of Regulation (EEC) No 3922/91.

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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

5 The Committee may furthermore be consulted by the Commission on any other matter concerning the application of this Directive.’;

The Commission may amend the Annexes to this Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(4).’.

1 The Commission shall be assisted by the Committee established by Article 11 of Council Regulation (EEC) No 2408/92 of 23 July 1992 on access for Community air carriers to intra-Community air routes .

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

3 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

The Commission shall adapt to technical progress the Annexes to this Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3).’;

1 The Commission shall be assisted by a committee.

2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

1 The Commission shall be assisted by the Committee referred to in Article 12 of Regulation (EEC) No 3922/91 (hereinafter referred to as the Committee).

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

3 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.

4 Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be one month, one month and two months respectively.

5 The Commission may consult the Committee on any other matter concerning the application of this Regulation.’.