What changed, Regulation (EC) No 219/2009

+ ### 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. **HUMANITARIAN AID**
+ 
+ Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid (7)
+ 
+ As regards Regulation (EC) No 1257/96, the Commission should be empowered to adopt implementing measures for that Regulation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1257/96, by supplementing it with new non-essential elements,…
+ 
+ Accordingly, Regulation (EC) No 1257/96 is hereby amended as follows:
+ 
+ 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 indent of Article 15(2).’;
+ 
+ 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).
+ 
+ 2. Acting in accordance with the regulatory procedure referred to in Article 17(3), the Commission shall:
+ 
+ — decide on Community financing for the humanitarian-aid protection operations referred to in Article 2(c),
+ 
+ — decide to take direct Commission action or finance action by Member States’ specialised agencies,
+ 
+ 3. Acting in accordance with the management procedure referred to in Article 17(2), the Commission shall:
+ 
+ — 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
+ 
+ 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 Article 4(3) of Decision 1999/468/EC shall be set at one month.
+ 
+ 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 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.’
+ 
+ 2. **ENTERPRISE**
+ 
+ 2.1. **Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (8)**
+ 
+ As regards Directive 75/324/EEC, the Commission should be empowered to adopt the necessary technical adaptations to that Directive and the required amendments to adapt the Annex to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Direc…
+ 
+ Accordingly, Directive 75/324/EEC is hereby amended as follows:
+ 
+ 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 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.’
+ 
+ 2.2. **Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses (9)**
+ 
+ As regards Directive 93/15/EEC, the Commission should be empowered to adapt the Directive to take account of any future amendments to the United Nations recommendations and to set the conditions for the application of Article 14, second paragraph. Since those measures are of general scope and are de…
+ 
+ Accordingly, Directive 93/15/EEC is hereby amended as follows:
+ 
+ 1. Article 13 shall be replaced by the following:
+ 
+ ‘Article 13
+ 
+ 1. The Commission shall be assisted by a committee.
+ 
+ 2. The committee shall examine any matter concerning the application of this Directive.
+ 
+ 3. 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.
+ 
+ 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 Commission shall, in accordance with the management procedure referred to in paragraph 3, adopt implementing measures in particular to take account of any future amendments to the United Nations recommendations.’;
+ 
+ 2. the second paragraph of Article 14 shall be replaced by the following:
+ 
+ ‘Member States shall ascertain whether such undertakings possess a system for keeping track of explosives such that those holding explosives can be identified at any time. The Commission may adopt measures setting the conditions for the application of this paragraph. Those measures, designed to amen…
+ 
+ 2.3. **Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (10).**
+ 
+ As regards Directive 2000/14/EC, the Commission should be empowered to adopt implementing measures for the adaptation to technical progress of Annex III. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2000/14/EC, they must be adopted in accord…
+ 
+ Accordingly, Directive 2000/14/EC is hereby amended as follows:
+ 
+ 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 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.’
+ 
+ 2.4. **Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (11)**
+ 
+ As regards Regulation (EC) No 2003/2003, the Commission should be empowered to adapt its annexes to technical progress, to adapt the measuring, sampling and analysis methods, to adopt rules regarding control measures and to include new types of EC fertilisers. Since those measures are of general sco…
+ 
+ Accordingly, Regulation (EC) No 2003/2003 is hereby amended as follows:
+ 
+ 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 adopted in accordance with the regulatory procedure with scrutiny refe…
+ 
+ 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 technical progress.’;
+ 
+ (c) the following paragraph shall be added:
+ 
+ ‘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
+ 
+ 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.’
+ 
+ 2.5. **Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version) (12)**
+ 
+ As regards Directive 2004/9/EC, the Commission should be empowered to adapt Annex I to technical progress and change the formula in Article 2(2). Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/9/EC, they must be adopted in accordance with…
+ 
+ Accordingly, Directive 2004/9/EC is hereby amended as follows:
+ 
+ 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 Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
+ 
+ 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 (13), 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:
+ 
+ ‘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-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’
+ 
+ 2.6. **Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chem…
+ 
+ As regards Directive 2004/10/EC, the Commission should be empowered to adapt Annex I to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/10/EC, they must be adopted in accordance with the regulatory procedure with scruti…
+ 
+ Accordingly, Directive 2004/10/EC is hereby amended as follows:
+ 
+ 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 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 (15).
+ 
+ 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).
+ 
+ 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.’
+ 
+ 2.7. **Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (16)**
+ 
+ As regards Regulation (EC) No 273/2004, the Commission should be empowered to adopt implementing measures. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 273/2004, they must be adopted in accordance with the regulatory procedure with …
+ 
+ Accordingly, Regulation (EC) No 273/2004 is hereby amended as follows:
+ 
+ 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 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 (17).
+ 
+ 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.
+ 
+ 2.8. **Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (18)**
+ 
+ As regards Regulation (EC) No 648/2004, the Commission should be empowered to adapt its annexes and to adopt any amendments or additions necessary for applying the rules of that Regulation to solvent-based detergents, where necessary. Since those measures are of general scope and are designed to ame…
+ 
+ Accordingly, Regulation (EC) No 648/2004 is hereby amended as follows:
+ 
+ 1. Recital 27 shall be deleted;
+ 
+ 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 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 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 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,…
+ 
+ 2.9. **Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (19)**
+ 
+ As regards Regulation (EC) No 726/2004, the Commission should be empowered to adapt certain provisions and annexes, to adopt new provisions, and to lay down specific conditions of application. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (E…
+ 
+ Accordingly, Regulation (EC) No 726/2004 is hereby amended as follows:
+ 
+ 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 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).’;
+ 
+ 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 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 Regulation by supplementing it, shall be adopted in accordan…
+ 
+ 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 transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to …
+ 
+ (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).’;
+ 
+ 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.
+ 
+ 3. **ENVIRONMENT**
+ 
+ 3.1. **Council Directive 82/883/EEC of 3 December 1982 on procedures for the surveillance and monitoring of environments concerned by waste from the titanium dioxide industry (20)**
+ 
+ As regards Directive 82/883/EEC, the Commission should be empowered 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. Since those measures are of general scope and are de…
+ 
+ Accordingly, Directive 82/883/EEC is hereby amended as follows:
+ 
+ 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 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.’
+ 
+ 3.2. **Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (21)**
+ 
+ As regards Directive 86/278/EEC, the Commission should be empowered to adapt to technical and scientific progress the provisions of the Annexes. Since those measures are of general scope and are designed to amend non-essential elements of Directive 86/278/EEC, they must be adopted in accordance with…
+ 
+ Accordingly, Directive 86/278/EEC is hereby amended as follows:
+ 
+ 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 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.’
+ 
+ 3.3. **European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (22)**
+ 
+ As regards Directive 94/62/EC, the Commission should be empowered to examine and, where necessary, review the illustrative examples for the definition of packaging and to determine the conditions under which concentration levels of heavy metals present in packaging or packaging components will not a…
+ 
+ Accordingly, Directive 94/62/EC is hereby amended as follows:
+ 
+ 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 cases, flower pots, tubes and cylinders around which flexible material is wound,…
+ 
+ 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 packaging which are exempted from the requirement referred t…
+ 
+ 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 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.’
+ 
+ 3.4. **Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels (23)**
+ 
+ As regards Directive 1999/32/EC, the Commission should be empowered to establish criteria for the use of emission abatement technologies by ships of all flags in enclosed ports, harbours and estuaries in the Community and to adopt amendments necessary to make technical adaptations to some provisions…
+ 
+ Accordingly, Directive 1999/32/EC is hereby amended as follows:
+ 
+ 1. Article 4c(3) shall be replaced by the following:
+ 
+ ‘3. Criteria shall be established by the Commission for the use of emission abatement technologies by ships of all flags in enclosed ports, harbours and estuaries in the Community. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in acc…
+ 
+ 2. Article 7(4) shall be replaced by the following:
+ 
+ ‘4. Any amendments necessary to make technical adaptations to Article 2, points 1, 2, 3, 3a, 3b and 4, or Article 6(2) in the light of 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…
+ 
+ 3. Article 9 shall be replaced by the following:
+ 
+ ‘Article 9
+ 
+ Committee procedure
+ 
+ 1. The Commission shall be assisted by a 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.’
+ 
+ 3.5. **Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants (24)**
+ 
+ As regards Directive 2001/81/EC, the Commission should be empowered to update the methodologies to be used in accordance with Annex III. Since those measures are of general scope and are designed to amend non-essential elements of that Directive, *inter alia,* by supplementing it with new non-essent…
+ 
+ Accordingly, Directive 2001/81/EC is hereby amended as follows:
+ 
+ 1. Article 7(4) shall be replaced by the following:
+ 
… diff truncated at 500 changed lines …