What changed, Regulation (EC) No 596/2009

+ ### 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 mach…
+ 
+ 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…
+ 
+ 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 ad…
+ 
+ 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…
+ 
+ 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 re…
+ 
+ 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 …
+ 
+ 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 wi…
+ 
+ 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, restricti…
+ 
+ Accordingly, Directive 98/79/EC is hereby amended as follows:
+ 
+ 1. Article 7 shall be replaced by the following:
+ 
+ ‘Article 7
+ 
+ 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 (9) 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.
+ 
+ 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, re…
+ 
+ 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…
+ 
+ 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 appropr…
+ 
+ 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 interpre…
+ 
+ 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 th…
+ 
+ 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 a…
+ 
+ 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 ad…
+ 
+ 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
+ 
+ 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 (12).
+ 
+ 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC (13) 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.
+ 
+ 1.5. ****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 product…
+ 
+ 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 …
+ 
+ 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 …
+ 
+ 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
+ 
+ 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 (15).
+ 
+ 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.
+ 
+ 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 al…
+ 
+ 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 …
+ 
+ 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 sup…
+ 
+ 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 regulato…
+ 
+ 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…
+ 
+ Accordingly, Directive 2006/42/EC is hereby amended as follows:
+ 
+ 1. Article 8 shall be replaced by the following:
+ 
+ ‘Article 8
+ 
+ Specific measures
+ 
+ 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, …
+ 
+ 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 p…
+ 
+ Accordingly, Directive 96/59/EC is hereby amended as follows:
+ 
+ 1. Article 10 shall be replaced by the following:
+ 
+ ‘Article 10
+ 
+ 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).’;
+ 
+ 2. the following Article shall be inserted:
+ 
+ ‘Article 10a
+ 
+ 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 (19).
+ 
+ 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.
+ 
+ 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 Dir…
+ 
+ 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 a…
+ 
+ (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 appropri…
+ 
+ 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 b…
+ 
+ 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 com…
+ 
+ 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 alterna…
+ 
+ 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…
+ 
+ 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 manage…
+ 
+ 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…
+ 
+ (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 co…
+ 
+ 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 fr…
+ 
+ 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 wit…
+ 
+ (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).’;
+ 
… diff truncated at 500 changed lines …