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Brussels, 19.12.2007

COM(2007) 824 final

2007/0293 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC, as amended by Decision 2006/512/EC, with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny Part Two

(presented by the Commission)

TABLE OF CONTENTS

ANNEX 8

1. Humanitarian aid 8

1.1. Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid 8

2. Enterprise 9

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 9

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 10

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 11

2.4. Regulation (EC) No 2003/2003 of the European Parliament and of the Councilof 13 October 2003 relating to fertilisers 12

2.5. Directive 2004/9/EC of the European Parliament and of the Council of11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version) 13

2.6. Directive 2004/10/EC of the European Parliament and of the Council of11 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 chemical substances(codified version) 14

2.7. Regulation (EC) No 273/2004 of the European Parliament and of the Councilof 11 February 2004 on drug precursors 15

2.8. Regulation (EC) No 648/2004 of the European Parliament and of the Councilof 31 March 2004 on detergents 16

2.9. Regulation (EC) No 726/2004 of the European Parliament and of the Councilof 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use andestablishing a European Medicines Agency 18

3. Environment 21

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 21

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

3.3. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste 22

3.4. Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels and amending Directive 93/12/EEC 24

3.5. Directive 2001/81/EC of the European Parliament and of the Council of23 October 2001 on national emission ceilings for certain atmospheric pollutants 25

3.6. Directive 2003/87/EC of the European Parliament and of the Council of13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC 25

3.7. Regulation (EC) No 850/2004 of the European Parliament and of the Councilof 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC 27

3.8. Directive 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air 29

3.9. Regulation (EC) No 1013/2006 of the European Parliament and of the Councilof 14 June 2006 on shipments of waste 31

4. Eurostat 34

4.1. Council Regulation (EEC) No 3924/91 of 19 December 1991 onthe establishment of a Community survey of industrial production 34

4.2. Council Directive 96/16/EC of 19 March 1996 on statistical surveys ofmilk and milk products 36

4.3. Directive 2001/109/EC of the European Parliament and of the Councilof 19 December 2001 concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain species of fruit trees 37

4.4. Regulation (EC) No 91/2003 of the European Parliament and of the Councilof 16 December 2002 on rail transport statistics 38

4.5. Regulation (EC) No 437/2003 of the European Parliament and of the Councilof 27 February 2003 on statistical returns in respect of the carriage of passengers, freight and mail by air 40

4.6. Regulation (EC) No 48/2004 of the European Parliament and of the Council of 5 December 2003 on the production of annual Community statistics on the steel industry for the reference years 2003-2009 42

5. Internal market 43

5.1. Directive 2004/25/EC of the European Parliament and of the Council of21 April 2004 on takeover bids 43

6. Health and consumer protection 44

6.1. Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs 44

6.2. Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition 45

6.3. Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC 47

6.4. Directive 2002/32/EC of the European Parliament and of the Council of7 May 2002 on undesirable substances in animal feed 48

6.5. Regulation (EC) No 998/2003 of the European Parliament and of the Councilof 26 May 2003 on the animal health requirements applicable to the non-commercial movements of pet animals and amending Council Directive 92/65/EEC. 50

6.6. Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC. 51

6.7. Regulation (EC) No 852/2004 of the European Parliament and of the Councilof 29 April 2004 on the hygiene of foodstuffs 53

6.8. Regulation (EC) No 853/2004 of the European Parliament and of the Councilof 29 April 2004 laying down specific hygiene rules for food of animal origin 54

6.9. Regulation (EC) No 854/2004 of the European Parliament and of the Councilof 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption 56

6.10. Regulation (EC) No 183/2005 of the European Parliament and of the Councilof 12 January 2005 laying down requirements for feed hygiene 57

7. Energy and transport 58

7.1. Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport 58

7.2. Council Directive 97/70/EC of 11 December 1997 setting up a harmonised safety regime for fishing vessels of 24 metres in length and over 59

7.3. Council Directive 1999/35/EC of 29 April 1999 on a system ofmandatory surveys for the safe operation of regular ro-ro ferry andhigh-speed passenger craft services 60

7.4. Regulation (EC) No 417/2002 of the European Parliament and of the Councilof 18 February 2002 on the accelerated phasing-in of double hull or equivalent design requirements for single hull oil tankers and repealing Council Regulation (EC) No 2978/94 62

7.5. Regulation (EC) No 782/2003 of the European Parliament and of the Councilof 14 April 2003 on the prohibition of organotin compounds on ships 63

7.6. Directive 2004/8/EC of the European Parliament and of the Council of11 February 2004 on the promotion of cogeneration based on a useful heatdemand in the internal energy market and amending Directive 92/42/EEC 64

7.7. Directive 2004/52/EC of the European Parliament and of the Council of 29 April 2004 on the interoperability of electronic road toll systems in the Community 66

7.8. Regulation (EC) No 725/2004 of the European Parliament and of the Councilof 31 March 2004 on enhancing ship and port facility security 67

7.9. Regulation (EC) No 789/2004 of the European Parliament and of the Councilof 21 April 2004 on the transfer of cargo and passenger ships between registers within the Community and repealing Council Regulation (EEC) No 613/91 68

7.10 . Directive 2005/44/EC of the European Parliament and of the Council of7 September 2005 on harmonised river information services (RIS) on inland waterways in the Community 69

7.11. Directive 2005/65/EC of the European Parliament and of the Council of26 October 2005 on enhancing port security 70

Chronological index 71

2007/0293 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC, as amended by Decision 2006/512/EC, with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny Part Two

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37, 44(1), 71, 80(2), 95, 152(4)(b), 175(1), 179 and 285 thereof,

Having regard to the proposal from the Commission[1],

Having regard to the opinion of the European Economic and Social Committee[2],

Having regard to the opinion of the European Central Bank[3],

Following consultation of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty[4],

Whereas:

1. Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[5] was amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure laid down in Article 251 of the Treaty, inter alia by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

2. In accordance with the joint statement of the European Parliament, the Council and the Commission[6] on Decision 2006/512/EC, for this new procedure to be applicable to instruments adopted in accordance with the procedure laid down in Article 251 of the Treaty which are already in force, those instruments must be adopted in accordance with the applicable procedures.

3. The amendments that need to be made to instruments for this purpose concern only the committee procedures and so, in the case of Directives, do not require transposition by the Member States,

HAVE ADOPTED THIS REGULATION:

Article 1

The instruments listed in the Annex are hereby adapted, in accordance with that Annex, to Decision 1999/468/EC, as amended by Decision 2006/512/EC.

Article 2

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

Article 3

This Regulation shall enter into force on the twentieth 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.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX

HUMANITARIAN AID

Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid[7]

As regards Council Regulation (EC) No 1257/96, power should in particular be conferred on the Commission to adopt implementing Regulations for that Regulation. Since those measures are of general scope and are designed to supplement Regulation (EC) No 1257/96 by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC

Accordingly, Regulation (EC) No 1257/96 is amended as follows:

(1) In Article 13, the fourth paragraph is replaced by the following:

“Decisions to continue operations adopted by the emergency procedure shall be taken by the Commission, acting in accordance with the procedure laid down in Article 17(2) and within the limits set in the second indent of Article 15(2).”

(2) Article 15 is replaced by the following:

“Article 15

1. The Commission shall adopt implementing Regulations for this Regulation. That measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted according to the regulatory procedure with scrutiny referred to in Article 17(4).

2. Acting in accordance with the procedure laid down 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 procedure laid down in Article 17(2), the Commission shall:

- approve global plans intended to provide a coherent framework for action 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 to be established in the implementation of these global plans,

- decide on projects in excess of ECU 2 million, without prejudice to Article 13.”

(3) Article 17 is 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 time limit laid down in Article 4(3) of Decision 1999/468/EC shall be 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 time limit laid down in Article 5(6) of Decision 1999/468/EC shall be 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.”

ENTERPRISE

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 , power should in particular be conferred on the Commission 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 that Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 75/324/EEC is amended as follows:

(1) Article 5 is 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 amended as follows:

(a) Paragraph 2 is 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 is deleted.

(3) In Article 10, paragraph 3 is 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.”

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 , powers are conferred on the Commission in particular 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 designed to amend non-essential elements of Directive 93/15/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 93/15/EEC is amended as follows:

(1) Article 13 is 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 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 is 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 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 13(4).”

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 , power should in particular be conferred on the Commission to establish the conditions under which amendments which are necessary, in the light of adaptation to technical progress, should be adopted. Since those measures are of general scope and are designed to amend non-essential elements of that Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2000/14/EC is amended as follows:

(1) Article 18 is amended as follows:

(a) paragraph 2 is 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 is deleted.

(2) The following Article 18a is 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) is replaced by the following:

“(b) assist the Commission in the adaptation to technical progress of Annex III”.

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, power should in particular be conferred on the Commission 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 scope and are designed to amend non-essential elements of Regulation (EC) No 2003/2003, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 2003/2003 is amended as follows:

(1) In Article 29, paragraph 4 is 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 referred to in Article 32(3). The same procedure shall apply to the adoption of implementing rules needed to specify the control measures provided for in this Article and in Articles 8, 26 and 27. Such rules shall in particular address the question of the frequency with which tests need to be repeated, as well as measures that are designed to ensure that the fertiliser put on the market is identical with the fertiliser tested.”

(2) Article 31 is amended as follows:

(a) Paragraph 1 is replaced by the following:

“1. The Commission shall adapt Annex I to include new types of fertilisers.”

(b) Paragraph 3 is replaced by the following:

“3. The Commission shall adapt the Annexes to take account of technical progress.”

(c) The following paragraph 4 is 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 is 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 time limit laid down in Article 5(6) of Decision 1999/468/EC shall be 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.”

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 , power should in particular be conferred on the Commission 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 the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/9/EC is amended as follows:

(1) Article 7 is replaced by the following:

“Article 7

1. The Commission shall be assisted by the Committee established by Article 29(1) of Directive 67/548/EEC(*), 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 time limit laid down in Article 5(6) of Decision 1999/468/EC shall be 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.

_____________________

(*) OJ 196, 16.8.1967, p. 1, as amended by Council Regulation (EC) No 807/2003 of 14 April 2003, OJ L 122, 16.5.2003"

(2) In Article 8, paragraph 2 is replaced by the following:

“2. The Commission shall adopt implementing measures for the following:

(a) 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).”

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 chemical substances (codified version)[13]

As regards Directive 2004/10/EC , power should in particular be conferred on the Commission to adapt the Annex 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 scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/10/EC is amended as follows:

(1) The following Article 3a is inserted:

“Article 3a

The Commission may adapt the Annex 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 is replaced by the following:

“Article 4

1. The Commission shall be assisted by the Committee established by Article 29(1) of Directive 67/548/EEC(*).

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

_____________________

(*) OJ 196, 16.8.1967, p. 1, as amended by Council Regulation (EC) No 807/2003 of 14 April 2003, OJ L 122, 16.5.2003."

(3) In Article 5(2) the third subparagraph is 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.”

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors[14]

As regards Regulation (EC) No 273/2004, power should in particular be conferred on the Commission to adopt measures for the implementation of the Regulation. 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 scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 273/2004 is amended as follows:

(1) Article 14 is amended as follows:

(a) the introductory sentence is replaced by the following:

“Where necessary, the Commission shall adopt implementation measures concerning the following:”

(b) the following second and third paragraphs are 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 procedure referred to in Article 15(2)”

(2) Article 15 is replaced by the following:

“Article 15

Committee

1. The Commission shall be assisted by the Committee set up in Article 30 of Council Regulation (EC) No 111/2005(*).

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 time limit laid down in Article 4(3) of Decision 1999/468/EC shall be 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.

_______________________

(*) OJ L 22, 26.1.2005, p. 1.”

Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents[15]

As regards Regulation (EC) No 648/2004, power should in particular be conferred on the Commission to adapt its annexes and to adopt any amendments or additions necessary for applying the rules of this Regulation to solvent-based detergents, where necessary. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 648/2004, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 648/2004 is amended as follows:

(1) Article 12 is 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 time limit laid down in Article 5(6) of Decision 1999/468/EC shall be 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 13 is 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).”

(3) In Annex VII, point A, the antepenultimate paragraph is 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, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).”

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[16]

As regards Regulation (EC) No 726/2004, power should in particular be conferred on the Commission to adapt certain provisions and annexes, to adopt arrangements and principles and guidelines, 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 (EC) No 726/2004 and/or to supplement this Regulation by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 726/2004 is amended as follows:

(1) In Article 3, paragraph 4 is replaced by the following:

“4. After the competent committee of the Agency has been consulted, the Commission may re-examine the Annex in the light of 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 is replaced by the following:

“The Commission shall adopt a Regulation laying down provisions for granting such authorisation. 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 87(2a).”

(3) In Article 16, paragraph 4 is 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 accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).”

(4) Article 24 is amended as follows:

(a) in paragraph 2, the first subparagraph is 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 Member States and the Agency, and no later than 15 days following receipt of the information. The Commission shall adopt provisions for the reporting of suspected unexpected adverse reactions which are not serious, whether occurring in the Community or in a third country. 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 87(2a).”

(b) paragraph 4 is 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 is 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 procedure with scrutiny referred to in Article 87(2a).”

(6) In Article 41, paragraph 6 is 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 accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).”

(7) Article 49 is amended as follows:

(a) in paragraph 2 the first subparagraph is 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 country are reported promptly to the Member States and the Agency, and no later than 15 days following receipt of the information. The Commission shall adopt provisions for the reporting of suspected unexpected adverse reactions which are not serious, whether occurring in the Community or in a third country. Those measures, designed to amend non-essential elements of this regulation by supplementing it, shall be adopted in accordance with the procedure referred to in Article 87(2a).”

(b) paragraph 4 is replaced by the following:

“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 is 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 procedure with scrutiny referred to in Article 87(2a).”

(9) In Article 70, paragraph 2 is 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 supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).”

(10) In Article 84(3), the first subparagraph is 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 collection of these penalties shall be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).”

(11) Article 87 is amended as follows:

a) The following paragraph 2a is 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 is deleted.

ENVIRONMENT

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[17]

As regards Directive 82/883/EEC , power should in particular be conferred on the Commission to adapt the contents of the Annexes as regards parameters listed in the ‘optional determination’ column and reference methods of measurement to scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 82/883/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 82/883/EEC is amended as follows:

(1) Article 9 is 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 is replaced by the following:

“Article 11

1. The Commission shall be assisted by the committee on adaptation to technical progress.

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.”

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[18]

As regards Directive 86/278/EEC , power should in particular be conferred on the Commission to adapt to technical and scientific progress 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 the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 86/278/EEC is amended as follows:

(1) Article 13 is 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 II A and II B.

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 is replaced by the following:

“Article 15

1. The Commission shall be assisted by the Committee for adapting this Directive to technical and scientific progress.

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.”

European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste[19]

As regards Directive 94/62/EC , power should in particular be conferred on the Commission 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 apply to some materials and product loops, the types of packaging exempted from the requirement regarding concentration levels and the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive. Since those measures are of general scope and are designed to amend non-essential elements of Directive 94/62/EC or to supplement that Directive by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 94/62/EC is amended as follows:

(1) In Article 3(1), the fourth subparagraph is 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, release paper of self-adhesive labels and wrapping paper. 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)."

(2) In Article 11, paragraph 3 is 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 to in paragraph 1, third indent.

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) In Article 12, paragraph 3 is replaced by the following:

“3. In order to harmonise the characteristics and presentation of the data produced and to make the data of the Member States compatible, Member States shall provide the Commission with their available data by means of formats which shall be adopted on the basis of Annex III, in accordance with the regulatory procedure referred to in Article 21(2).”

(4) Article 19 is replaced by the following:

“Article 19

Adaptation to scientific and technical progress

(a) 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 accordance with the regulatory procedure referred to in Article 21(2).

(b) 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 with the regulatory procedure with scrutiny referred to in Article 21(3).”

(5) In Article 20, paragraph 1 is replaced by the following:

“1. The Commission shall determine technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive in particular to inert packaging materials, put on the market in very small quantities (i.e. approximately 0.1% by weight) in the Community, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging. 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) In Article 21, paragraph 3 is 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.”

Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels and amending Directive 93/12/EEC[20]

As regards Directive 1999/32/EC , power should in particular be conferred on the Commission 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 in the light of scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 1999/32/EC or to supplement that Directive by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 1999/32/EC is amended as follows:

(1) In Article 4c, paragraph 3 is 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 accordance with the regulatory procedure with scrutiny referred to in Article 9(2). The Commission shall communicate these criteria to the IMO.”

(2) In Article 7, paragraph 4 is 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 accordance with the regulatory procedure with scrutiny referred to in Article 9(2). Such adaptations shall not result in any direct changes to the scope of this Directive or to limits on sulphur in fuel specified in this Directive.”

(3) Article 9 is replaced by the following:

“Article 9

Committee

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.”

Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants[21]

As regards Directive 2001/81/EC , power should in particular be conferred on the Commission 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, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2001/81/EC is amended as follows:

(1) In Article 7, paragraph 4 is 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 referred to in Article 13(3).”

(2) In Article 13, paragraph 3 is 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.”

Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC[22]

As regards Directive 2003/87/EC , power should in particular be conferred on the Commission to adopt provisions necessary for the implementation of Article 11b(5), to adopt a Regulation for a standardised and secured system of registries including provisions concerning the use and identification of CERs and ERUs in the Community scheme and the monitoring of the level of such use, to amend Annex III as laid down in Article 22, to approve inclusion of activities and greenhouse gases not listed in Annex I, to draw up any necessary provisions relating to the mutual recognition of allowances under agreements with third countries, and to adopt standardised or accepted measures for monitoring of emissions of other greenhouse gases. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2003/87/EC or to supplement that Directive by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2003/87/EC is amended as follows:

(1) In Article 11b, paragraph 7 is 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). The Commission shall adopt provisions for the implementation of paragraph 5 where the host party meets all eligibility requirements for JI project activities. 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).”

(2) In Article 19, paragraph 3 is 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, transfer and cancellation of allowances, to provide for public access and confidentiality as appropriate and to ensure that there are no transfers incompatible with obligations resulting from the Kyoto Protocol. That Regulation shall also include provisions concerning the use and identification of CERs and ERUs in the Community scheme and the monitoring of the level of such use. 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 23(3).”

(3) Article 22 is 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 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 23(3).”

(4) In Article 23, paragraph 3 is 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."

(5) In Article 24, paragraph 1 is replaced by the following:

“1. Taking into account all relevant criteria, in particular effects on the internal market, potential distortions of competition, the environmental integrity of the scheme and reliability of the planned monitoring and reporting system, Member States may from 2008 apply emission allowance trading in accordance with this Directive to:

a) installations which are not listed in Annex I, provided that inclusion of such installations is approved by the Commission in accordance with the procedure referred to in Article 23(2), and

b) activities and greenhouse gases which are not listed in Annex I, provided that inclusion of such activities and greenhouse gases is approved 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 23(3).

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.”

(6) In Article 25, paragraph 2 is 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 adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).”

(7) In Annex IV, the paragraph under the heading “Monitoring of emissions of other greenhouse gases” is 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 referred to in Article 23(3).”

Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC[23]

As regards Regulation (EC) No 850/2004 , power should in particular be conferred on the Commission to specify some concentration limits in the annexes, to amend annexes whenever a substance is listed in the Convention or the Protocol, to modify the existing entries and to adapt annexes to scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 850/2004, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 850/2004 is amended as follows:

(1) Article 7 is amended as follows:

(a) In paragraph 4, point (a) is replaced by the following:

“(a) waste containing or contaminated by any substance listed in Annex IV may be otherwise disposed of or recovered in accordance with the relevant Community legislation, provided that the content of the listed substances in the waste is below the concentration limits to be specified in 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 17(3). Until such time as concentration limits are specified in accordance with such procedure, the competent authority of a Member State may adopt or apply concentration limits or specific technical requirements in respect of the disposal or recovery of waste under this subparagraph;”

(b) In paragraph 5, the first subparagraph is replaced by the following:

“Concentration limits in Annex V, part 2 shall be established by the Commission for the purposes of paragraph 4(b) of this Article. 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 17(3)”

(2) Article 14 is replaced by the following:

“Article 14

Amendment of Annexes

1. Whenever a substance is listed in the Convention or the Protocol, the Commission shall amend Annexes I, II and III accordingly where appropriate.

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 16(3).

2. Whenever a substance is listed in the Convention or the Protocol, the Commission shall amend Annex IV accordingly where appropriate.

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 17(3).

3. The Commission shall adopt modifications to the existing entries in Annexes I to III, including their adaptation to 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 16(3).

4. The Commission shall adopt modifications to the existing entries in Annex IV and modifications to Annex V, including their adaptation to 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 17(3).”

(3) Article 16 is amended as follows:

(a) Paragraph 1 is replaced by the following:

“1. The Commission shall be assisted by the Committee established by Article 29 of Council Directive 67/548/EEC(*) for all matters under this Regulation except for those relating to waste.

____________________________

(*) OJ 196, 16.8.1967, p. 1, as amended by Council Regulation (EC) No 807/2003 of 14 April 2003, OJ L 122, 16.5.2003.”

(b) paragraph 3 is 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) In Article 17, paragraph 3 is 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.”

Directive 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air[24]

As regards Directive 2004/107/EC , power should in particular be conferred on the Commission to adapt certain provisions and Annexes to scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/107/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/107/EC is amended as follows:

(1) Article 4 is amended as follows:

(a) Paragraph 9 is replaced by the following:

“9. Irrespective of concentration levels, one background sampling point shall be installed every 100000 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 and of the total deposition of arsenic, cadmium, mercury, nickel, benzo(a)pyrene and the other polycyclic aromatic hydrocarbons referred to in paragraph 8. Each Member State shall set up at least one measuring station; however, Member States may, by agreement, and in accordance with guidelines to be drawn up under the procedure referred to in Article 6(2), set up one or several common measuring stations, covering neighbouring zones in adjoining Member States, to achieve the necessary spatial resolution. Measurement of particulate and gaseous divalent mercury is also recommended. Where appropriate, monitoring shall be coordinated with the European Monitoring and Evaluation of Pollutants (EMEP) monitoring strategy and measurement programme. The sampling sites for these pollutants shall be selected in such a way that geographical variation and long-term trends can be identified. Sections I, II and III of Annex III shall apply.”

(b) Paragraph 15 is 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 accordance with the regulatory procedure with scrutiny referred to in Article 6(3). They may not result in any direct or indirect changes to target values.”

(2) In Article 5, paragraph 4 is replaced by the following:

“4. The Commission shall adopt, in accordance with the procedure referred to in Article 6(2), any detailed arrangements for forwarding the information to be provided under paragraph 1 of this Article.”

(3) In Article 6, paragraph 3 is 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 is 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 procedure with scrutiny referred to in Article 6(3).”

Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste[25]

As regards Regulation (EC) No 1013/2006 , power should in particular be conferred on the Commission to determine an issue as described in Article 11(3) of Regulation 1013/2006, to amend the annexes as laid down in Article 58 of Regulation 1013/2006 and to adopt additional measures as laid down in Article 59 of Regulation 1013/2006. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1013/2006 or to supplement Regulation (EC) No 1013/2006 by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 1013/2006 is amended as follows:

(1) In Article 11(3), the third subparagraph is 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)."

(2) Article 58 is replaced by the following:

“Article 58

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 Convention or to the OECD Decision. Annex IIIA may contain the proviso that one or more of the entries therein shall not apply for exports to countries to which the OECD Decision does not apply;

(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 shall be fully associated with the deliberations.”

(3) Article 59 is 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 guidance 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 59a is inserted:

"Article 59a

Committee procedure

1. The Commission shall be assisted by the committee set up in 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 time limit laid down in Article 5(6) of Decision 1999/468/EC shall be 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.

_______________________

(*) OJ L 114, 27.4.2006, p. 9.”

(5) Article 63 is amended as follows:

(a) in paragraph 2, the third subparagraph is 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 procedure referred to in Article 59a(2)”

(b) in paragraph 4, the third subparagraph is replaced by the following:

“This period may be extended until no later than 31 December 2012 in accordance with the procedure referred to in Article 59a(2).”

(c) paragraph 5 is amended as follows:

(i) the third subparagraph is replaced by the following:

“This period may be extended until no later than 31 December 2015 in accordance with the regulatory procedure referred to in Article 59a(2).”

(ii) the fifth subparagraph is replaced by the following:

“This period may be extended until no later than 31 December 2015 in accordance with the regulatory procedure referred to in Article 59a(2)”

EUROSTAT

Council Regulation (EEC) No 3924/91 of 19 December 1991 on the establishment of a Community survey of industrial production[26]

As regards Regulation (EEC) No 3924/91, power should in particular be conferred on the Commission to establish and update the list of products concerned by that Regulation. Power should also be conferred on it to adopt detailed rules as regards representativeness and periodicity for certain products and to establish the arrangements for survey contents and implementing measures, including the measures for adjustment to technical progress concerning collection of data and the processing of the results. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EEC) No 3924/91, inter alia by supplementing it by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EEC) No 3924/91 is amended as follows:

(1) In Article 2, paragraph 6 is replaced by the following:

“6. The Prodcom list, the information actually collected for each heading and the other implementing procedures of this Regulation shall be established and updated by the Commission. Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3).”

(2) Article 3 is amended as follows:

a) In paragraph 2 the words “in Article 10” are replaced by the words “in Article 10(2)”.

b) Paragraph 5 is replaced by the following:

“5. Detailed rules for applying this Article, including measures for adjustment to technical progress, shall be adopted, as necessary, by the Commission. Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3).”

(3) Article 4 is replaced by the following:

“Article 4

Survey periods

The survey shall cover an annual period of one calendar year.

However, for certain headings in the Prodcom list, monthly or quarterly surveys may be decided by the Commission. Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3).”

(4) In Article 5, paragraph 1 is replaced by the following:

“1. The required information shall be collected by the Member States using survey questionnaires the content of which shall comply with the arrangements defined by the Commission. Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3).”

(5) In Article 6 and in Article 7(2) the words “in Article 10” are replaced by the words “in Article 10(2)”.

(6) Articles 9 and 10 are replaced by the following:

“Article 9

Implementing measures

The measures for adjustment to technical progress concerning collection of data and the processing of the results shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be laid down in accordance with the regulatory procedure with scrutiny referred to in Article 10(3). Other measures for implementing this Regulation shall be adopted by the Commission in accordance with the procedure referred to in Article 10(2).

Article 10

Committee

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

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

The time limit laid down in Article 4(3) of Decision 1999/468/EC shall be three months.

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

____________________________

(*) OJ L 181, 28.6.1989, p. 47.”

Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk products[27]

As regards Directive 96/16/EC, power should in particular be conferred on the Commission to adopt the definitions for the agricultural holdings among which Member States must conduct surveys of the production of milk and its use, determine the list of milk products covered by the surveys and lay down standard definitions to be used for communicating the results to the Commission. Since those measures are of general scope and are designed to supplement Directive 96/16/EC by adding new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 96/16/EC is amended as follows:

(1) Article 1(2) is replaced by the following:

"2) shall carry out annual surveys of the production of milk and its use among agricultural holdings as defined by the Commission; the measures defining agricultural holdings, 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)."

(2) Article 3(2) and (3) are replaced by the following:

"2. The list of milk products covered by the surveys shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

3. The standard definitions to be used for communicating the results for the various products shall be drawn up 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 7(3)."

(3) In Article 4(2) and Article 6(1), the words "in Article 7" are replaced by "in Article 7(2)".

(4) Article 7 is replaced by the following:

"Article 7

1. The Commission shall be assisted by the Standing Committee on Agricultural Statistics set up by Council Decision 72/279/EEC(*).

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 time limit laid down in Article 5(6) of Decision 1999/468/EC shall be 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.

____________________

(*) OJ L 179, 7.8.1972, p. 1."

Directive 2001/109/EC of the European Parliament and of the Council of 19 December 2001 concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain species of fruit trees[28]

As regards Directive 2001/109/EC, power should in particular be conferred on the Commission to amend the list of species of fruit trees and the table of species surveyed in the Member States, to adopt the detailed rules for the application of certain articles and to determine the boundaries of the production areas to be adopted for Member States. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/109/EC and to supplement the Directive by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2001/109/EC is amended as follows:

(1) The third subparagraph of Article 1(2) is replaced by the following:

"The list of said species and the said table may be amended by the Commission. 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 8(2)."

(2) Article 2(2) is replaced by the following:

"2. Detailed rules for applying this Article shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 8(2)."

(3) Article 3(4) is replaced by the following:

"4. Detailed rules for applying this Article shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 8(2)."

(4) Article 4(2) is replaced by the following:

"2. The results referred to in paragraph 1 shall be supplied for each production area. The boundaries of the production areas to be adopted for Member States shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 8(2)."

(5) Article 8 is replaced by the following:

"Article 8

1. The Commission shall be assisted by the Standing Committee on Agricultural Statistics set up by Council Decision 72/279/EEC(*).

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

(*) OJ L 179, 7.8.1972, p.1."

Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics[29]

As regards Regulation (EC) No 91/2003, power should in particular be conferred on the Commission to adapt the definitions and adopt additional provisions, to adapt the content of the annexes and to define the guidelines for the reports on the quality and comparability of the results. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 91/2003 and to supplement it by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 91/2003 is amended as follows:

(1) Article 3(2) is replaced by the following:

"2. The definitions referred to in paragraph 1 may be adapted, and additional definitions needed to ensure harmonisation of statistics may be adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3)."

(2) Article 4 is amended as follows:

a) Paragraph 2 is replaced by the following:

"2. Annexes B and D set out simplified reporting requirements, which may be used by Member States as alternatives to the normal detailed reporting set out in Annexes A and C, for undertakings for which the total volume of goods or passenger transport is less than 500 million tonne-km or 200 million passenger-km respectively. These thresholds may be adapted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3)."

b) Paragraph 5 is replaced by the following:

"5. The contents of the Annexes may be adapted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3)."

(3) Article 10 is replaced by the following:

"Article 10

Implementing procedures

1. The arrangements for transmission of the data to Eurostat shall be made in accordance with the procedure specified in Article 11(2).

2. The Commission shall adopt the following implementing measures:

a) adaptation of the thresholds for simplified reporting (Article 4);

b) adaptation of the definitions and adoption of additional definitions (Article 3(2));

c) adaptation of the contents of the annexes (Article 4);

d) definition of the guidelines for the reports on the quality and comparability of the results (Articles 8 and 9).

Those measures, designed to amend or supplement non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3)."

(4) Article 11 is replaced by the following:

"Article 11

Committee

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

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

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

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

_____________________

(*) OJ L 181, 28.6.1989, p. 47."

(5) In point 5 of Annex H, and in Annex J, the words "in Article 11(2)" are replaced by "in Article 11(3)".

Regulation (EC) No 437/2003 of the European Parliament and of the Council of 27 February 2003 on statistical returns in respect of the carriage of passengers, freight and mail by air[30]

As regards Regulation (EC) No 437/2003, power should in particular be conferred on the Commission to amend the definitions in the Regulation, to adopt additional provisions and to adapt the content of the annexes thereto. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 437/2003, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 437/2003 is amended as follows:

(1) Article 3(2) is replaced by the following:

"2. Each Member State shall collect all data set out in Annex I for all Community airports in its territory with traffic in excess of 150 000 passenger units annually.

A list of Community airports covered by the first subparagraph shall be drawn up by the Commission and, if necessary, updated. 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 11(3)."

(2) Article 5 is replaced by the following:

"Article 5

Accuracy of statistics

The collection of data shall be based on complete returns, unless other standards of accuracy are established by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3)."

(3) Article 7(2) is replaced by the following:

"2. The results shall be transmitted according to the data files shown in Annex I. The files shall be specified by the Commission. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3).

The medium to be used for transmission shall be specified by the Commission in accordance with the procedure laid down in Article 11(2)."

(4) Article 10 is replaced by the following:

"Article 10

Implementing arrangements

1. The following implementing measures shall be adopted in accordance with the procedure referred to in Article 11(2):

— description of the data codes and the medium to be used for transmission of results to the Commission (Article 7),

— dissemination of statistical results (Article 8).

2. The Commission shall adopt the following implementing measures:

— adaptation of the specifications in the Annexes to this Regulation,

— adaptation of the data collection characteristics (Article 3),

— the list of Community airports covered by Article 3(2),

— accuracy of statistics (Article 5),

— description of the data files (Article 7).

Those measures, designed to amend or supplement non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3)."

(5) Article 11 is replaced by the following:

"Article 11

Committee

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

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

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

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

___________________________

(*) OJ L 181, 28.6.1989, p. 47."

Regulation (EC) No 48/2004 of the European Parliament and of the Council of 5 December 2003 on the production of annual Community statistics on the steel industry for the reference years 2003-2009[31]

As regards Regulation (EC) No 48/2004, powers should in particular be conferred on the Commission to establish and update the list of characteristics concerned by that Regulation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 48/2004, inter alia by supplementing it by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 48/2004 is amended as follows:

(1) Article 7 is replaced by the following:

“Article 7

Implementing measures

1. The measures for the implementation of this Regulation concerning transmission formats and the first transmission period shall be adopted in accordance with the procedure referred to in Article 8(2).

2. The measures for the implementation of this Regulation concerning any alteration to the list of characteristics, provided that no significant additional burden is imposed upon the Member States, 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 8(3).”

(2) In Article 8, paragraph 3 is 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.”

INTERNAL MARKET

Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids[32]

As regards Directive 2004/25/EC , power should be conferred on the Commission to adopt rules for the application of Article 6(3) on the contents of the offer document. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia by supplementing it or by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Directive 2004/25/EC provided for a time restriction concerning the implementing powers conferred on the Commission. In their joint statement on Decision 2006/512/EC amending Decision 1999/468/EC, the European Parliament, the Council and the Commission have stated that Decision 2006/512/EC provides a horizontal and satisfactory solution to the European Parliament's wish to scrutinise the implementation of instruments adopted under the co-decision procedure and that, accordingly, implementing powers should be conferred on the Commission without time limit. Following the introduction of the regulatory procedure with scrutiny, the provision establishing that time restriction in Directive 2004/25/EC should be deleted.

Accordingly, Directive 2004/25/EC is amended as follows:

(1) In Article 6, paragraph 4 is replaced by the following:

“4. The Commission shall adopt rules for the application of paragraph 3. 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 18(2).”

(2) Article 18 is amended as follows:

(a) paragraph 2 is 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 is deleted.

HEALTH AND CONSUMER PROTECTION

Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs[33]

As regards Directive 79/373/EEC, power should in particular be conferred on the Commission to adopt exceptions to the prescriptions on the packaging of feedingstuffs and to amend the Annex. Since those measures are of general scope and are designed to amend non-essential elements of Directive 79/373/EEC and to supplement the Directive by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 79/373/EEC is amended as follows:

(1) Article 4(2) is replaced by the following:

"2. The Commission shall adopt exceptions to the principle of paragraph 1 to be authorised at Community level. Those measures, designed to amend non-essential elements of this Directive, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3), provided that the identity and quality of the compound feedingstuffs concerned are ensured."

(2) Article 10 is replaced by the following:

"Article 10

In the light of advances in scientific and technical knowledge:

a) categories grouping several feed materials shall be established not later than 22 January 1991 in accordance with the procedure laid down in Article 13(2);

b) methods of calculating the energy value of compound feedingstuffs may be established in accordance with the procedure laid down in Article 13(2);

c) amendments to the Annex shall be adopted by the Commission; 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 13(3)."

(3) Article 13(3) is 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."

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition[34]

As regards Directive 82/471/EEC, power should in particular be conferred on the Commission to adopt amendments and to lay down the criteria required to define the products included in the Directive. Since those measures are of general scope and are designed to amend non-essential elements of Directive 82/471/EEC and to supplement the Directive by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. On grounds of urgency, the urgent procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to the Directive must be used.

Accordingly, Directive 82/471/EEC is amended as follows:

(1) Article 6 is amended as follows:

(a) Paragraph 1 is replaced by the following:

"1. Amendments to be made to the Annex as a result of developments in scientific or technical knowledge shall be adopted by the Commission. 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 13(3). In the case of the products referred to in Sections 1.1 and 1.2 of the Annex, the Commission shall consult the Scientific Committee for Animal Nutrition and the Scientific Committee for Food.

However, in the case of products obtained from yeasts of the ‘Candida’ variety and cultivated on n-alkanes, referred to in Article 4(1), the Commission shall adopt a position within two years of notification of this Directive, after consulting the Scientific Committee for Animal Nutrition and the Scientific Committee for Food."

(b) Paragraph 3 is replaced by the following:

"3. Criteria making it possible to define the products included in this Directive, particularly the criteria of composition and purity and the physico-chemical and biological properties, may be adopted by the Commission in the light of scientific and technical knowledge. 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 13(3)."

(2) In the second subparagraph of Article 7(2), "Article 13" is replaced by "Article 13(2)".

(3) Article 8(3) is replaced by the following:

"3. If the Commission considers that amendments to this Directive are necessary to alleviate the difficulties referred to in paragraph 1 and to ensure the protection of human or animal health, it shall adopt such measures. 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 13(4). The Member State that has adopted safeguard measures may in that event retain them until the amendments have entered into force."

(4) Article 13 is amended as follows:

(a) Paragraph 3 is 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) The following paragraph 4 is added:

"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."

(5) Article 14 is deleted.

Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC[35]

As regards Directive 96/25/EC, power should in particular be conferred on the Commission to lay down and amend the list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited and to amend the annex in the light of advances in scientific and technical knowledge. Since those measures are of general scope and are designed to amend non-essential elements of Directive 96/25/EC and to supplement the Directive by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission must be able to use the urgent procedure provided for in Article 5a(6) of Decision 1999/468/EC for the amendment of the list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited.

On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny must be curtailed for the adoption of amendments to the annex in the light of advances in scientific and technical knowledge.

Accordingly, Directive 96/25/EC is amended as follows:

(1) The second indent of Article 5(1)(g) is replaced by the following:

"- Community measures included on a list to be drawn up 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 13(3)."

(2) Article 11 is replaced by the following:

"Article 11

1. A numerical coding system for the listed feed materials based on glossaries concerning the origin, part of the product/by-product used, processing and maturity/quality of the feed materials enabling feed to be identified at international level — in particular by name and description — may be adopted in accordance with the procedure referred to in Article 13(2).

2. The list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited shall be drawn up by the Commission in order to ensure their compliance with Article 3. 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 13(3).

3. The list referred to paragraph 2 shall be amended by the Commission in the light of advances in scientific and technical knowledge. 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 13(3). On imperative grounds of urgency, the Commission may use the urgent procedure referred to in Article 13(5) with a view to adopting those measures.

4. Amendments to be made to the Annex as a result of developments in scientific or technical knowledge shall be adopted by the Commission. 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 13(4)."

(3) Article 13 is amended as follows:

a) Paragraph 3 is 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) The following paragraphs 4 and 5 are added:

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

The time limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be two months, one month and two months respectively.

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

Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed[36]

As regards Directive 2002/32/EC, power should in particular be conferred on the Commission to amend Annexes I and II and adapt them in the light of developments in scien