What changed, Regulation (EC) No 219/2009

+ 1. in Article 13, the fourth paragraph shall be replaced by the following: ‘Decisions to continue operations adopted by the emergency procedure shall be taken by the Commission, acting in accordance with the management procedure referred to in Article 17(2) and within the limits set in the second in…
− 1. in Article 13, the fourth paragraph shall be replaced by the following:
+ 2. Article 15 shall be replaced by the following: ‘Article 15 **1.** The Commission shall adopt implementing measures for 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 wit…
− ‘Decisions to continue operations adopted by the emergency procedure shall be taken by the Commission, acting in accordance with the management procedure referred to in Article 17(2) and within the limits set in the second indent of Article 15(2).’;
+ 3. Article 17 shall be replaced by the following: ‘Article 17 **1.** The Commission shall be assisted by a Committee. **2.** Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in A…
− 2. Article 15 shall be replaced by the following:
− 
− ‘Article 15
− 
− 1. The Commission shall adopt implementing measures for 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 17(4).
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− 2. Acting in accordance with the regulatory procedure referred to in Article 17(3), the Commission shall:
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− — decide on Community financing for the humanitarian-aid protection operations referred to in Article 2(c),
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− — decide to take direct Commission action or finance action by Member States’ specialised agencies,
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− 3. Acting in accordance with the management procedure referred to in Article 17(2), the Commission shall:
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− — approve global plans intended to provide for actions in a given country or region where the scale and complexity of the humanitarian crisis is such that it seems likely to continue, and the budgets for those plans. In this context, the Commission and the Member States shall examine the priorities …
− 
− — decide on projects in excess of ECU 2 million, without prejudice to Article 13.’;
− 
− 3. Article 17 shall be replaced by the following:
− 
− ‘Article 17
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− 1. The Commission shall be assisted by a Committee.
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− 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
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− The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
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− 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.
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− The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.
− 
− 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.’
+ 1. Article 5 shall be replaced by the following: ‘Article 5 The Commission shall adopt the amendments required to adapt the Annex to this Directive to technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory pr…
− 1. Article 5 shall be replaced by the following:
+ 2. Article 7 is hereby amended as follows: (a) paragraph 2 shall be replaced by the following: **‘2.** Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’; (b) paragraph 3 shall be d…
− ‘Article 5
+ 3. in Article 10, paragraph 3 shall be replaced by the following: **‘3.** The Commission may adopt necessary technical adaptations of this Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny…
− The Commission shall adopt the amendments required to adapt the Annex to this Directive to technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(2).’;
− 
− 2. Article 7 is hereby amended as follows:
− 
− (a) paragraph 2 shall be replaced by the following:
− 
− ‘2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
− 
− (b) paragraph 3 shall be deleted;
− 
− 3. in Article 10, paragraph 3 shall be replaced by the following:
− ‘3. The Commission may adopt necessary technical adaptations of this Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(2).
− 
− In that case, the Member State having adopted safeguard measures may maintain them until the entry into force of the adaptations.’
− 
+ 1. Article 18 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 d…
− 1. Article 18 shall be amended as follows:
+ 2. the following Article shall be inserted: ‘Article 18a The Commission shall adopt implementing measures for the adaptation to technical progress of Annex III, provided they do not have any direct impact on the measured sound power level of equipment listed in Article 12, in particular through the …
− (a) paragraph 2 shall be replaced by the following:
+ 3. in Article 19, point (b) shall be replaced by the following: ‘(b) assist the Commission in the adaptation to technical progress of Annex III.’
− ‘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;
− 
− 2. the following Article shall be inserted:
− 
− ‘Article 18a
− 
− The Commission shall adopt implementing measures for the adaptation to technical progress of Annex III, provided they do not have any direct impact on the measured sound power level of equipment listed in Article 12, in particular through the inclusion of references to relevant European standards.
− Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2).’;
− 
− 3. in Article 19, point (b) shall be replaced by the following:
− 
− ‘(b) assist the Commission in the adaptation to technical progress of Annex III.’
− 
+ 1. in Article 29, paragraph 4 shall be replaced by the following: **‘4.** The Commission shall adapt and modernise the measuring, sampling and analysis methods and shall, wherever possible, use European Standards. Those measures, designed to amend non-essential elements of this Regulation, shall be …
− 1. in Article 29, paragraph 4 shall be replaced by the following:
+ 2. Article 31 is hereby amended as follows: (a) paragraph 1 shall be replaced by the following: **‘1.** The Commission shall adapt Annex I to include new types of fertilisers.’; (b) paragraph 3 shall be replaced by the following: **‘3.** The Commission shall adapt the Annexes to take account of tech…
− ‘4. The Commission shall adapt and modernise the measuring, sampling and analysis methods and shall, wherever possible, use European Standards. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny refe…
− 
− 2. Article 31 is hereby amended as follows:
+ 3. Article 32 shall be replaced by the following: ‘Article 32 Committee procedure **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 p…
− (a) paragraph 1 shall be replaced by the following:
− 
− ‘1. The Commission shall adapt Annex I to include new types of fertilisers.’;
− 
− (b) paragraph 3 shall be replaced by the following:
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− ‘3. The Commission shall adapt the Annexes to take account of technical progress.’;
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− (c) the following paragraph shall be added:
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− ‘4. The measures referred to in paragraphs 1 and 3, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).’;
− 
− 3. Article 32 shall be replaced by the following:
− 
− ‘Article 32
− 
− Committee procedure
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− 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. Article 6(3) shall be replaced by the following: **‘3.** If the Commission considers that amendments to this Directive are necessary in order to resolve the matters referred to in paragraph 1, it shall adopt those amendments.Those measures, designed to amend non-essential elements of this Directi…
− 1. Article 6(3) shall be replaced by the following:
+ 2. Article 7 shall be replaced by the following: ‘Article 7 **1.** The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/548/EEC (*1), hereinafter “the Committee”. **2.** Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468…
− ‘3. If the Commission considers that amendments to this Directive are necessary in order to resolve the matters referred to in paragraph 1, it shall adopt those amendments.
− 
− Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
+ 3. Article 8(2) shall be replaced by the following: **‘2.** The Commission shall adopt implementing measures for the following:(a) the adaptation of the formula referred to in Article 2(2);(b) the adaptation of Annex I to take account of technical progress.Those measures, designed to amend non-essen…
− 2. Article 7 shall be replaced by the following:
− ‘Article 7
− 
− 1. The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/548/EEC (*1), hereinafter “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 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.
− 
− 3. Article 8(2) shall be replaced by the following:
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− ‘2. The Commission shall adopt implementing measures for the following:
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− (a) the adaptation of the formula referred to in Article 2(2);
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− (b) the adaptation of Annex I to take account of technical progress.
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− Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’
− 
+ 1. the following Article shall be inserted: ‘Article 3a The Commission may adapt Annex I to technical progress, with regard to principles of GLP. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny ref…
− 1. the following Article shall be inserted:
+ 2. Article 4 shall be replaced by the following: ‘Article 4 **1.** The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/548/EEC (*2). **2.** Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall a…
− ‘Article 3a
+ 3. in Article 5(2) the third subparagraph shall be replaced by the following: ‘The Commission may adopt implementing measures to introduce necessary technical adaptations of this Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance wit…
− The Commission may adapt Annex I to technical progress, with regard to principles of GLP.
− 
− Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2).’;
− 2. Article 4 shall be replaced by the following:
− 
− ‘Article 4
− 
− 1. The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/548/EEC (*2).
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− 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. in Article 5(2) the third subparagraph shall be replaced by the following:
− 
− ‘The Commission may adopt implementing measures to introduce necessary technical adaptations of this Directive.
− 
− Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2).
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− In the case referred to in the third subparagraph, the Member State which adopted the safeguard measures may maintain them until the entry into force of those adaptations.’
− 
+ 1. Article 14 is hereby amended as follows: (a) the introductory sentence shall be replaced by the following: ‘Where necessary, the Commission shall adopt implementing measures concerning the following:’; (b) the following paragraphs shall be added: ‘The measures referred to in points (a) to (e) of …
− 1. Article 14 is hereby amended as follows:
− 
− (a) the introductory sentence shall be replaced by the following:
− 
− ‘Where necessary, the Commission shall adopt implementing measures concerning the following:’;
− 
− (b) the following paragraphs shall be added:
+ 2. Article 15 shall be replaced by the following: ‘Article 15 Committee procedure **1.** The Commission shall be assisted by the Committee set up by Article 30 of Council Regulation (EC) No 111/2005 (*3). **2.** Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shal…
− ‘The measures referred to in points (a) to (e) of the first paragraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
− 
− The measures referred to in point (f) of the first paragraph shall be adopted in accordance with the management procedure referred to in Article 15(2).’;
− 
− 2. Article 15 shall be replaced by the following:
− 
− ‘Article 15
− 
− Committee procedure
− 
− 1. The Commission shall be assisted by the Committee set up by Article 30 of Council Regulation (EC) No 111/2005 (*3).
− 
− 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
− 
− The period laid down in Article 4(3) 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.
+ 2. Article 12 shall be replaced by the following: ‘Article 12 Committee procedure **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 p…
− 2. Article 12 shall be replaced by the following:
+ 3. Article 13 shall be replaced by the following: ‘Article 13 Adaptation of the Annexes **1.** The Commission shall adopt any amendments necessary for adapting the Annexes and shall, wherever possible, use European Standards. **2.** The Commission shall adopt any amendments or additions necessary fo…
− ‘Article 12
− 
− Committee procedure
− 
− 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.
+ 4. in Annex VII, point A, the sixth paragraph shall be replaced by the following: ‘If individual risk-based concentration limits for the fragrance allergens are subsequently established by the SCCNFP, the Commission shall propose the adoption of such limits to replace the limit of 0.01 % mentioned a…
− 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. Article 13 shall be replaced by the following:
− 
− ‘Article 13
− 
− Adaptation of the Annexes
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− 1. The Commission shall adopt any amendments necessary for adapting the Annexes and shall, wherever possible, use European Standards.
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− 2. The Commission shall adopt any amendments or additions necessary for applying the rules of this Regulation to solvent-based detergents.
− 
− 3. The measures referred to in paragraphs 1 and 2, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’;
− 
− 4. in Annex VII, point A, the sixth paragraph shall be replaced by the following:
− 
− ‘If individual risk-based concentration limits for the fragrance allergens are subsequently established by the SCCNFP, the Commission shall propose the adoption of such limits to replace the limit of 0.01 % mentioned above. Those measures, designed to amend non-essential elements of this Regulation,…
− 
− 1. Article 3(4) shall be replaced by the following:
+ 1. Article 3(4) shall be replaced by the following: **‘4.** After the competent committee of the Agency has been consulted, the Commission may adapt the Annex to technical and scientific progress and may adopt any necessary amendments without extending the scope of the centralised procedure.Those me…
− ‘4. After the competent committee of the Agency has been consulted, the Commission may adapt the Annex to technical and scientific progress and may adopt any necessary amendments without extending the scope of the centralised procedure.
+ 2. in Article 14(7), the third subparagraph shall be replaced by the following: ‘The Commission shall adopt a Regulation laying down provisions for granting such authorisation. That measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordan…
− 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 87(2a).’;
+ 3. Article 16(4) shall be replaced by the following: **‘4.** The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-essential elements of this Reg…
− 2. in Article 14(7), the third subparagraph shall be replaced by the following:
+ 4. Article 24 is hereby amended as follows: (a) in paragraph 2, the first subparagraph shall be replaced by the following: ‘The holder of the marketing authorisation for a medicinal product for human use shall ensure that all suspected serious unexpected adverse reactions and any suspected transmiss…
− ‘The Commission shall adopt a Regulation laying down provisions for granting such authorisation. 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 87(2a).’;
+ 5. Article 29 shall be replaced by the following: ‘Article 29 The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this regulat…
− 3. Article 16(4) shall be replaced by the following:
+ 6. Article 41(6) shall be replaced by the following: **‘6.** The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-essential elements of this reg…
− ‘4. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordan…
+ 7. Article 49 is hereby amended as follows: (a) in paragraph 2 the first subparagraph shall be replaced by the following: ‘The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious unexpected adverse reactions, and adverse human reactions, a…
− 4. Article 24 is hereby amended as follows:
+ 8. Article 54 shall be replaced by the following: ‘Article 54 The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this regulat…
− (a) in paragraph 2, the first subparagraph shall be replaced by the following:
+ 9. Article 70(2) shall be replaced by the following: **‘2.** However, the Commission shall adopt provisions establishing the circumstances in which small and medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance. Those measures, designed to ame…
− ‘The holder of the marketing authorisation for a medicinal product for human use shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to …
+ 10. in Article 84(3), the first subparagraph shall be replaced by the following: ‘At the Agency's request, the Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection with t…
− (b) paragraph 4 shall be replaced by the following:
− 
− ‘4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. 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 87(2a).’;
+ 11. Article 87 is hereby 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 del…
− 5. Article 29 shall be replaced by the following:
− 
− ‘Article 29
− 
− The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the regulatory proced…
− 
− 6. Article 41(6) shall be replaced by the following:
− 
− ‘6. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-essential elements of this regulation by supplementing it, shall be adopted in accordan…
− 
− 7. Article 49 is hereby amended as follows:
− (a) in paragraph 2 the first subparagraph shall be replaced by the following:
− 
− ‘The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious unexpected adverse reactions, and adverse human reactions, and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third countr…
− 
− (b) paragraph 4 shall be replaced by the following:
− 
− ‘4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the procedure referred to in Article 87(2a).’;
− 
− 8. Article 54 shall be replaced by the following:
− 
− ‘Article 54
− 
− The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the regulatory proced…
− 
− 9. Article 70(2) shall be replaced by the following:
− 
− ‘2. However, the Commission shall adopt provisions establishing the circumstances in which small and medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance. Those measures, designed to amend non-essential elements of this Regulation by supplemen…
− 
− 10. in Article 84(3), the first subparagraph shall be replaced by the following:
− 
− ‘At the Agency's request, the Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection with the authorisations. The maximum amounts as well as the conditions and methods for …
− 
− 11. Article 87 is hereby 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 deleted.
− 
+ 1. Article 9 shall be replaced by the following: ‘Article 9 The Commission shall adopt the requisite amendments to adapt to scientific and technical progress the contents of the Annexes as regards parameters listed in the “optional determination” column and reference methods of measurement. Those me…
− 1. Article 9 shall be replaced by the following:
− 
− ‘Article 9
+ 2. Article 11 shall be replaced by the following: ‘Article 11 **1.** The Commission shall be assisted by the committee. **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.’
− The Commission shall adopt the requisite amendments to adapt to scientific and technical progress the contents of the Annexes as regards parameters listed in the “optional determination” column and reference methods of measurement.
− 
− 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 11(2).’;
− 
− 2. Article 11 shall be replaced by the following:
− 
− ‘Article 11
− 
− 1. The Commission shall be assisted by the committee.
− 
− 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.’
− 
− 1. Article 13 shall be replaced by the following:
+ 1. Article 13 shall be replaced by the following: ‘Article 13 The Commission shall adapt to technical and scientific progress the provisions of the Annexes to the Directive, except for the parameters and values listed in Annexes I A, I B and I C, any factors likely to affect the evaluation of the va…
− ‘Article 13
+ 2. Article 15 shall be replaced by the following: ‘Article 15 **1.** The Commission shall be assisted by the Committee. **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.’
− The Commission shall adapt to technical and scientific progress the provisions of the Annexes to the Directive, except for the parameters and values listed in Annexes I A, I B and I C, any factors likely to affect the evaluation of the values, and the parameters for analysis referred to in Annexes I…
− 
− 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 15 shall be replaced by the following:
− ‘Article 15
− 
− 1. The Commission shall be assisted by the Committee.
− 
− 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.’
− 
+ 1. in Article 3(1), the fourth subparagraph shall be replaced by the following: ‘The Commission shall, as appropriate, examine and, where necessary, review the illustrative examples for the definition of packaging given in Annex I. As a priority, the following items shall be addressed: CD and video …
− 1. in Article 3(1), the fourth subparagraph shall be replaced by the following:
+ 2. Article 11(3) shall be replaced by the following: **‘3.** The Commission shall determine the conditions under which the concentration levels referred to in paragraph 1 will not apply to recycled materials and to product loops which are in a closed and controlled chain, as well as the types of pac…
− ‘The Commission shall, as appropriate, examine and, where necessary, review the illustrative examples for the definition of packaging given in Annex I. As a priority, the following items shall be addressed: CD and video cases, flower pots, tubes and cylinders around which flexible material is wound,…
+ 3. Article 12(3) shall be replaced by the following: **‘3.** In order to harmonise the characteristics and presentation of the data prod uced and to make the data of the Member States compatible, Member States shall provide the Commission with their available data in formats which shall be adopted o…
− 2. Article 11(3) shall be replaced by the following:
+ 4. Article 19 shall be replaced by the following: ‘Article 19 Adaptation to scientific and technical progress **1.** The amendments necessary for adapting to scientific and technical progress the identification system (as referred to in Article 8(2) and Article 10, second paragraph, last indent) and…
− ‘3. The Commission shall determine the conditions under which the concentration levels referred to in paragraph 1 will not apply to recycled materials and to product loops which are in a closed and controlled chain, as well as the types of packaging which are exempted from the requirement referred t…
+ 5. Article 20(1) shall be replaced by the following: **‘1.** The Commission shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantiti…
− 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).’;
+ 6. Article 21(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. Article 12(3) shall be replaced by the following:
− ‘3. In order to harmonise the characteristics and presentation of the data prod uced and to make the data of the Member States compatible, Member States shall provide the Commission with their available data in formats which shall be adopted on the basis of Annex I II, in accordance with the regulat…
− 
− 4. Article 19 shall be replaced by the following:
− 
− ‘Article 19
− 
− Adaptation to scientific and technical progress
− 
− 1. The amendments necessary for adapting to scientific and technical progress the identification system (as referred to in Article 8(2) and Article 10, second paragraph, last indent) and the formats relating to the database system (as referred to in Article 12(3) and Annex III) shall be adopted in a…
− 
− 2. The Commission shall adopt the amendments necessary for adapting to scientific and technical progress the illustrative examples on the definition of packaging (as referred to in Annex I). Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance wi…
− 
− 5. Article 20(1) shall be replaced by the following:
− 
− ‘1. The Commission shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1 % by weight) in the Community,…
− 
− 6. Article 21(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.’
− 
+ 1. Article 7(4) shall be replaced by the following: **‘4.** Any updating of the methodologies to be used in accordance with Annex III shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, *inter alia,* by supplementing it, shall be adopted in…
− 1. Article 7(4) shall be replaced by the following:
− 
− ‘4. Any updating of the methodologies to be used in accordance with Annex III shall be adopted by the Commission. 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 …
+ 2. Article 13(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. Article 13(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.’
− 
+ 1. in Article 11b, paragraph 7 shall be replaced by the following: **‘7.** Provisions for the implementation of paragraphs 3 and 4, particularly in respect of the avoidance of double counting, shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 23(2)…
− 1. in Article 11b, paragraph 7 shall be replaced by the following:
+ 2. in Article 14(1), the first sentence shall be replaced by the following: ‘The Commission shall adopt guidelines for the monitoring and reporting of emissions resulting from the activities listed in Annex I of greenhouse gases specified in relation to those activities. Those measures, designed to …
− ‘7. Provisions for the implementation of paragraphs 3 and 4, particularly in respect of the avoidance of double counting, shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 23(2). The Commission shall adopt provisions for the implementation of parag…
+ 3. Article 19(3) shall be replaced by the following: **‘3.** In order to implement this Directive, the Commission shall adopt a Regulation for a standardised and secured system of registries in the form of standardised electronic databases containing common data elements to track the issue, holding,…
− 2. in Article 14(1), the first sentence shall be replaced by the following:
+ 4. Article 22 shall be replaced by the following: ‘Article 22 Amendments to Annex III The Commission may amend Annex III, with the exception of criteria 1, 5 and 7, for the period from 2008 to 2012 in the light of the reports provided for in Article 21 and of the experience of the application of thi…
− ‘The Commission shall adopt guidelines for the monitoring and reporting of emissions resulting from the activities listed in Annex I of greenhouse gases specified in relation to those activities. Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall b…
+ 5. 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. Article 19(3) shall be replaced by the following:
+ 6. Article 24 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: **‘1.** Taking into account all relevant criteria, in particular the effects on the internal market, potential distortions of competition, the environmental integrity of the scheme and the reliability of t…
− ‘3. In order to implement this Directive, the Commission shall adopt a Regulation for a standardised and secured system of registries in the form of standardised electronic databases containing common data elements to track the issue, holding, transfer and cancellation of allowances, to provide for …
+ 7. Article 25(2) shall be replaced by the following: **‘2.** Where an agreement referred to in paragraph 1 has been concluded, the Commission shall adopt any necessary provisions relating to the mutual recognition of allowances under that agreement. Those measures, designed to amend non-essential el…
− 4. Article 22 shall be replaced by the following:
+ 8. in Annex IV, the paragraph under the heading ‘Monitoring of emissions of other greenhouse gases’ shall be replaced by the following: ‘Standardised or accepted methods shall be used, developed by the Commission in collaboration with all relevant stakeholders. Those measures, designed to amend non-…
− ‘Article 22
− Amendments to Annex III
− 
− The Commission may amend Annex III, with the exception of criteria 1, 5 and 7, for the period from 2008 to 2012 in the light of the reports provided for in Article 21 and of the experience of the application of this Directive. Those measures, designed to amend non-essential elements of this Directiv…
− 
− 5. 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.’;
− 
− 6. Article 24 shall be amended as follows:
− 
− (a) paragraph 1 shall be replaced by the following:
− 
− ‘1. Taking into account all relevant criteria, in particular the effects on the internal market, potential distortions of competition, the environmental integrity of the scheme and the reliability of the planned monitoring and reporting system, Member States may, from 2008, apply emission allowance …
− 
− (a) installations which are not listed in Annex I, provided that inclusion of such installations is approved by the Commission in accordance with the regulatory procedure referred to in Article 23(2), and
− 
− (b) activities and greenhouse gases which are not listed in Annex I, provided that the inclusion of such activities and greenhouse gases is approved by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with …
− 
− From 2005, Member States may under the same conditions apply emissions allowance trading to installations carrying out activities listed in Annex I below the capacity limits referred to in that Annex.’;
− 
− (b) paragraph 3 shall be replaced by the following:
− 
− ‘3. The Commission may, on its own initiative, or shall, on request by a Member State, adopt monitoring and reporting guidelines for emissions from activities, installations and greenhouse gases which are not listed in Annex I if the monitoring and reporting of these emissions can be carried out wit…
− 
− 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 23(3).’;
− 
− 7. Article 25(2) shall be replaced by the following:
− 
− ‘2. Where an agreement referred to in paragraph 1 has been concluded, the Commission shall adopt any necessary provisions relating to the mutual recognition of allowances under that agreement. Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be a…
− 
− 8. in Annex IV, the paragraph under the heading ‘Monitoring of emissions of other greenhouse gases’ shall be replaced by the following:
− 
− ‘Standardised or accepted methods shall be used, developed by the Commission in collaboration with all relevant stakeholders. 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 re…
− 
+ 1. Article 4 shall be amended as follows: (a) paragraph 9 shall be replaced by the following: **‘9.** Irrespective of concentration levels, one background sampling point shall be installed every 100 000 km2 for the indicative measurement, in ambient air, of arsenic, cadmium, nickel, total gaseous me…
− 1. Article 4 shall be amended as follows:
+ 2. Article 5(4) shall be replaced by the following: **‘4.** The Commission shall adopt, in accordance with the regulatory procedure referred to in Article 6(2), any detailed arrangements for forwarding the information to be provided under paragraph 1 of this Article.’;
− (a) paragraph 9 shall be replaced by the following:
+ 3. Article 6(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.’;
− ‘9. Irrespective of concentration levels, one background sampling point shall be installed every 100 000 km2 for the indicative measurement, in ambient air, of arsenic, cadmium, nickel, total gaseous mercury, benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in paragraph 8, a…
+ 4. Annex V, point V shall be replaced by the following: ‘V. **Reference air quality modelling techniques** Reference air quality modelling techniques cannot be specified at present. The Commission may make amendments to adapt this point to scientific and technical progress. Those measures, designed …
− (b) paragraph 15 shall be replaced by the following:
− ‘15. Any amendments necessary to adapt the provisions of this Article and of Section II of Annex II and of Annexes III, IV and V to scientific and technical progress shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in ac…
− 
− 2. Article 5(4) shall be replaced by the following:
− 
− ‘4. The Commission shall adopt, in accordance with the regulatory procedure referred to in Article 6(2), any detailed arrangements for forwarding the information to be provided under paragraph 1 of this Article.’;
− 
− 3. Article 6(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. Annex V, point V shall be replaced by the following:
− 
− ‘V. **Reference air quality modelling techniques**
− 
− Reference air quality modelling techniques cannot be specified at present. The Commission may make amendments to adapt this point to scientific and technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory proce…
− 
+ 1. in Article 11(3), the third subparagraph shall be replaced by the following: ‘If there is no satisfactory solution, either Member State may refer the matter to the Commission. The issue shall then be determined in accordance with the regulatory procedure referred to in Article 59a(2).’;
− 1. in Article 11(3), the third subparagraph shall be replaced by the following:
+ 2. Article 58 shall be replaced by the following: ‘Article 58 Amendment of Annexes **1.** The Commission may amend the Annexes to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the re…
− ‘If there is no satisfactory solution, either Member State may refer the matter to the Commission. The issue shall then be determined in accordance with the regulatory procedure referred to in Article 59a(2).’;
+ 3. Article 59 shall be replaced by the following: ‘Article 59 Additional measures **1.** The Commission may adopt, in accordance with the regulatory procedure referred to in Article 59a(2), the following additional measures related to the implementation of this Regulation:(a) guidelines for the appl…
− 2. Article 58 shall be replaced by the following:
+ 4. The following Article shall be inserted: ‘Article 59a Committee procedure **1.** The Commission shall be assisted by the committee set up by Article 18(1) of Directive 2006/12/EC. **2.** Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard…
− ‘Article 58
− 
− Amendment of Annexes
+ 5. Article 63 shall be amended as follows: (a) in paragraph 2, the third subparagraph shall be replaced by the following: ‘With the exception of glass waste, paper waste and waste pneumatic tyres, this period may be extended until no later than 31 December 2012 in accordance with the regulatory proc…
− 1. The Commission may amend the Annexes to take account of scientific and technical progress. 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 59a(3). In addition:
− 
− (a) Annexes I, II, III, IIIA, IV and V shall be amended to take account of changes agreed under the Basel Convention and the OECD Decision;
− 
− (b) unclassified wastes may be added to Annex IIIB, IV or V on a provisional basis pending a decision on their inclusion in the relevant Annexes to the Basel Convention or to the OECD Decision;
− 
− (c) following the submission of a request by a Member State, mixtures of two or more wastes listed in Annex III may be considered for inclusion in Annex IIIA in the cases referred to in Article 3(2) on a provisional basis pending a decision on their inclusion in the relevant Annexes to the Basel Con…
− 
− (d) the exceptional cases referred to in Article 3(3) shall be determined and, where necessary, such waste shall be added to Annexes IVA and V and deleted from Annex III;
− 
− (e) Annex V shall be amended to reflect agreed changes to the list of hazardous waste adopted in accordance with Article 1(4) of Directive 91/689/EEC;
− 
− (f) Annex VIII shall be amended to reflect relevant international conventions and agreements.
− 
− 2. When amending Annex IX, the Committee established by Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment (*4) shall be fully associated with the deliberations.
− 
− 3. Article 59 shall be replaced by the following:
− 
− ‘Article 59
− 
− Additional measures
− 
− 1. The Commission may adopt, in accordance with the regulatory procedure referred to in Article 59a(2), the following additional measures related to the implementation of this Regulation:
− 
− (a) guidelines for the application of Article 12(1)(g);
− 
− (b) guidelines on the application of Article 15 in relation to the identification and tracking of waste undergoing substantial changes in the interim recovery or disposal operation;
− 
− (c) guidelines for the cooperation of competent authorities with regard to illegal shipments as referred to in Article 24;
− 
− (d) technical and organisational requirements for the practical implementation of electronic data interchange for the submission of documents and information in accordance with Article 26(4);
− 
− (e) further guidance concerning the use of languages referred to in Article 27;
− 
− (f) further clarification of the procedural requirements of Title II as regards their application to exports, imports and transit of waste from, to, and through the Community;
− 
− (g) further recommendations concerning undefined legal terms.
− 
− 2. The Commission may adopt implementing measures concerning the following:
− 
− (a) a method for calculating the financial guarantee or equivalent insurance as set out in Article 6;
− 
− (b) further conditions and requirements in relation to pre-consented recovery facilities as referred to in Article 14.
− 
− 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 59a(3).’;
− 
− 4. The following Article shall be inserted:
− 
− ‘Article 59a
− 
− Committee procedure
− 
− 1. The Commission shall be assisted by the committee set up by Article 18(1) of Directive 2006/12/EC.
− 
− 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.’;
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