Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Two

REGULATION (EC) No 219/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 March 2009

adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny

Adaptation to the regulatory procedure with scrutiny — Part Two

Article 1

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

Article 2

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

Article 3

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

1. HUMANITARIAN AID

Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid([^E0001])

As regards Regulation (EC) No 1257/96, the Commission should be empowered to adopt implementing measures for that Regulation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1257/96, by supplementing it with new non-essential elements, 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 hereby amended as follows:

• 1. in Article 13, the fourth paragraph shall be replaced by the following: ‘Decisions to continue operations adopted by the emergency procedure shall be taken by the Commission, acting in accordance with the management procedure referred to in Article 17(2) and within the limits set in the second indent of Article 15(2).’;

• 1. Article 15 shall be replaced by the following: ‘Article 15

— 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,

— approve global plans intended to provide for actions in a given country or region where the scale and complexity of the humanitarian crisis is such that it seems likely to continue, and the budgets for those plans. In this context, the Commission and the Member States shall examine the priorities to be established in the implementation of these global plans, — decide on projects in excess of ECU 2 million, without prejudice to Article 13.’;

• 1. Article 17 shall be replaced by the following: ‘Article 17

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.

2. ENTERPRISE

2.1.   Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers([^E0002])

As regards Directive 75/324/EEC, the Commission should be empowered to adopt the necessary technical adaptations to that Directive and the required amendments to adapt the Annex to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 75/324/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 75/324/EEC is hereby amended as follows:

• 1. Article 5 shall be replaced by the following: ‘Article 5 The Commission shall adopt the amendments required to adapt the Annex to this Directive to technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(2).’;

• 1. Article 7 is hereby amended as follows:
• (a) paragraph 2 shall be replaced by the following: ‘2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
• (b) paragraph 3 shall be deleted;

• 1. in Article 10, paragraph 3 shall be replaced by the following: ‘3. The Commission may adopt necessary technical adaptations of this Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(2). In that case, the Member State having adopted safeguard measures may maintain them until the entry into force of the adaptations.’

2.3.   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([^E0004]).

As regards Directive 2000/14/EC, the Commission should be empowered to adopt implementing measures for the adaptation to technical progress of Annex III. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2000/14/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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

• 1. Article 18 shall be amended as follows:
• (a) paragraph 2 shall be replaced by the following: ‘2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
• (b) paragraph 3 shall be deleted;

• 1. the following Article shall be inserted: ‘Article 18a The Commission shall adopt implementing measures for the adaptation to technical progress of Annex III, provided they do not have any direct impact on the measured sound power level of equipment listed in Article 12, in particular through the inclusion of references to relevant European standards. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2).’;

• 1. in Article 19, point (b) shall be replaced by the following:
• ‘(b) assist the Commission in the adaptation to technical progress of Annex III.’

2.4.   Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers([^E0005])

As regards Regulation (EC) No 2003/2003, the Commission should be empowered to adapt its annexes to technical progress, to adapt the measuring, sampling and analysis methods, to adopt rules regarding control measures and to include new types of EC fertilisers. Since those measures are of general 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 hereby amended as follows:

• 1. in Article 29, paragraph 4 shall be replaced by the following: ‘4. The Commission shall adapt and modernise the measuring, sampling and analysis methods and shall, wherever possible, use European Standards. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny 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.’;

• 1. Article 31 is hereby amended as follows:
• (a) paragraph 1 shall be replaced by the following: ‘1. The Commission shall adapt Annex I to include new types of fertilisers.’;
• (b) paragraph 3 shall be replaced by the following: ‘3. The Commission shall adapt the Annexes to take account of technical progress.’;
• (c) the following paragraph shall be added: ‘4. The measures referred to in paragraphs 1 and 3, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).’;

• 1. Article 32 shall be replaced by the following: ‘Article 32 Committee procedure

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

2.5.   Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version)([^E0006])

As regards Directive 2004/9/EC, the Commission should be empowered to adapt Annex I to technical progress and change the formula in Article 2(2). Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/9/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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

• 1. Article 6(3) shall be replaced by the following: ‘3. If the Commission considers that amendments to this Directive are necessary in order to resolve the matters referred to in paragraph 1, it shall adopt those amendments. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

• 1. Article 7 shall be replaced by the following: ‘Article 7

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

• 1. Article 8(2) shall be replaced by the following: ‘2. The Commission shall adopt implementing measures for the following: (a) the adaptation of the formula referred to in Article 2(2); (b) the adaptation of Annex I to take account of technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’

2.6.   Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version)([^E0008])

As regards Directive 2004/10/EC, the Commission should be empowered to adapt Annex I to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/10/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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

• 1. the following Article shall be inserted: ‘Article 3a The Commission may adapt Annex I to technical progress, with regard to principles of GLP. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2).’;

• 1. Article 4 shall be replaced by the following: ‘Article 4

• 1. in Article 5(2) the third subparagraph shall be replaced by the following: ‘The Commission may adopt implementing measures to introduce necessary technical adaptations of this Directive. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2). In the case referred to in the third subparagraph, the Member State which adopted the safeguard measures may maintain them until the entry into force of those adaptations.’

2.7.   Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors([^E0010])

As regards Regulation (EC) No 273/2004, the Commission should be empowered to adopt implementing measures. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 273/2004, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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

• 1. Article 14 is hereby amended as follows:
• (a) the introductory sentence shall be replaced by the following: ‘Where necessary, the Commission shall adopt implementing measures concerning the following:’;
• (b) the following paragraphs shall be added: ‘The measures referred to in points (a) to (e) of the first paragraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). The measures referred to in point (f) of the first paragraph shall be adopted in accordance with the management procedure referred to in Article 15(2).’;

• 1. Article 15 shall be replaced by the following: ‘Article 15 Committee procedure

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

2.8.   Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents([^E0012])

As regards Regulation (EC) No 648/2004, the Commission should be empowered to adapt its annexes and to adopt any amendments or additions necessary for applying the rules of that Regulation to solvent-based detergents, where necessary. Since those measures are of general scope and are designed to 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 hereby amended as follows:

• 1. Recital 27 shall be deleted;

• 1. Article 12 shall be replaced by the following: ‘Article 12 Committee procedure

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

• 1. Article 13 shall be replaced by the following: ‘Article 13 Adaptation of the Annexes

• 1. in Annex VII, point A, the sixth paragraph shall be replaced by the following: ‘If individual risk-based concentration limits for the fragrance allergens are subsequently established by the SCCNFP, the Commission shall propose the adoption of such limits to replace the limit of 0.01 % mentioned above. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’

2.9.   Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency([^E0013])

As regards Regulation (EC) No 726/2004, the Commission should be empowered to adapt certain provisions and annexes, to adopt new provisions, and to lay down specific conditions of application. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 726/2004, inter alia, by supplementing it with 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 hereby amended as follows:

• 1. Article 3(4) shall be replaced by the following: ‘4. After the competent committee of the Agency has been consulted, the Commission may adapt the Annex to technical and scientific progress and may adopt any necessary amendments without extending the scope of the centralised procedure. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. in Article 14(7), the third subparagraph shall be replaced by the following: ‘The Commission shall adopt a Regulation laying down provisions for granting such authorisation. That measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. Article 16(4) shall be replaced by the following: ‘4. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. Article 24 is hereby amended as follows:
• (a) in paragraph 2, the first subparagraph shall be replaced by the following: ‘The holder of the marketing authorisation for a medicinal product for human use shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to 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 shall be replaced by the following: ‘4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. Article 29 shall be replaced by the following: ‘Article 29 The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. Article 41(6) shall be replaced by the following: ‘6. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation. Those measures, designed to amend non-essential elements of this regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. Article 49 is hereby amended as follows:
• (a) in paragraph 2 the first subparagraph shall be replaced by the following: ‘The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious unexpected adverse reactions, and adverse human reactions, and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third 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 regulatory procedure with scrutiny referred to in Article 87(2a).’;
• (b) paragraph 4 shall be replaced by the following: ‘4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the procedure referred to in Article 87(2a).’;

• 1. Article 54 shall be replaced by the following: ‘Article 54 The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. Article 70(2) shall be replaced by the following: ‘2. However, the Commission shall adopt provisions establishing the circumstances in which small and medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;

• 1. in Article 84(3), the first subparagraph shall be replaced by the following: ‘At the Agency's request, the Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection with the authorisations. The maximum amounts as well as the conditions and methods for 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).’;

• 1. Article 87 is hereby amended as follows:
• (a) the following paragraph shall be inserted: ‘2a. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
• (b) paragraph 4 shall be deleted.

3. ENVIRONMENT

3.1.   Council Directive 82/883/EEC of 3 December 1982 on procedures for the surveillance and monitoring of environments concerned by waste from the titanium dioxide industry([^E0014])

As regards Directive 82/883/EEC, the Commission should be empowered to adapt to scientific and technical progress the contents of the Annexes as regards parameters listed in the ‘optional determination’ column and reference methods of measurement. Since those measures are of general scope and are 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 hereby amended as follows:

• 1. Article 9 shall be replaced by the following: ‘Article 9 The Commission shall adopt the requisite amendments to adapt to scientific and technical progress the contents of the Annexes as regards parameters listed in the “optional determination” column and reference methods of measurement. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(2).’;

• 1. Article 11 shall be replaced by the following: ‘Article 11

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([^E0015])

As regards Directive 86/278/EEC, the Commission should be empowered to adapt to technical and scientific progress the provisions of the Annexes. Since those measures are of general scope and are designed to amend non-essential elements of Directive 86/278/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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

• 1. Article 13 shall be replaced by the following: ‘Article 13 The Commission shall adapt to technical and scientific progress the provisions of the Annexes to the Directive, except for the parameters and values listed in Annexes I A, I B and I C, any factors likely to affect the evaluation of the values, and the parameters for analysis referred to in Annexes 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).’;

• 1. Article 15 shall be replaced by the following: ‘Article 15

3.3.   European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste([^E0016])

As regards Directive 94/62/EC, the Commission should be empowered to examine and, where necessary, review the illustrative examples for the definition of packaging and to determine the conditions under which concentration levels of heavy metals present in packaging or packaging components will not 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, inter alia, by supplementing it with 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 hereby amended as follows:

• 1. in Article 3(1), the fourth subparagraph shall be replaced by the following: ‘The Commission shall, as appropriate, examine and, where necessary, review the illustrative examples for the definition of packaging given in Annex I. As a priority, the following items shall be addressed: CD and video cases, flower pots, tubes and cylinders around which flexible material is wound, 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).’;

• 1. Article 11(3) shall be replaced by the following: ‘3. The Commission shall determine the conditions under which the concentration levels referred to in paragraph 1 will not apply to recycled materials and to product loops which are in a closed and controlled chain, as well as the types of packaging which are exempted from the requirement referred to in the third indent of paragraph 1. 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).’;

• 1. Article 12(3) shall be replaced by the following: ‘3. In order to harmonise the characteristics and presentation of the data prod uced and to make the data of the Member States compatible, Member States shall provide the Commission with their available data in formats which shall be adopted on the basis of Annex I II, in accordance with the regulatory procedure referred to in Article 21(2).’;

• 1. Article 19 shall be replaced by the following: ‘Article 19 Adaptation to scientific and technical progress

• 1. Article 20(1) shall be replaced by the following: ‘1. The Commission shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1  % by weight) in the Community, 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).’;

• 1. Article 21(3) shall be replaced by the following: ‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

3.5.   Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants([^E0018])

As regards Directive 2001/81/EC, the Commission should be empowered to update the methodologies to be used in accordance with Annex III. Since those measures are of general scope and are designed to amend non-essential elements of that Directive, inter alia, by supplementing it with new non-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 2001/81/EC is hereby amended as follows:

• 1. Article 7(4) shall be replaced by the following: ‘4. Any updating of the methodologies to be used in accordance with Annex III shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’;

• 1. Article 13(3) shall be replaced by the following: ‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’

3.6.   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([^E0019])

As regards Directive 2003/87/EC, the Commission should be empowered to adopt provisions necessary for the implementation of Article 11b(5), to adopt guidelines for the monitoring and reporting of emissions, 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 methods 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, inter alia, by supplementing it with 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 hereby amended as follows:

• 1. in Article 11b, paragraph 7 shall be replaced by the following: ‘7. Provisions for the implementation of paragraphs 3 and 4, particularly in respect of the avoidance of double counting, shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 23(2). The Commission shall adopt provisions for the implementation of paragraph 5 of this Article 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).’;

• 1. in Article 14(1), the first sentence shall be replaced by the following: ‘The Commission shall adopt guidelines for the monitoring and reporting of emissions resulting from the activities listed in Annex I of greenhouse gases specified in relation to those activities. Those measures, designed to 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).’;

• 1. Article 19(3) shall be replaced by the following: ‘3. In order to implement this Directive, the Commission shall adopt a Regulation for a standardised and secured system of registries in the form of standardised electronic databases containing common data elements to track the issue, holding, transfer and cancellation of allowances, to provide for public access and confidentiality as appropriate and to ensure that there are no transfers which are incompatible with the 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).’;

• 1. Article 22 shall be replaced by the following: ‘Article 22 Amendments to Annex III The Commission may amend Annex III, with the exception of criteria 1, 5 and 7, for the period from 2008 to 2012 in the light of the reports provided for in Article 21 and of the experience of the application of 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).’;

• 1. Article 23(3) shall be replaced by the following: ‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

• 1. Article 24 shall be amended as follows:
• (a) paragraph 1 shall be replaced by the following: ‘1. Taking into account all relevant criteria, in particular the effects on the internal market, potential distortions of competition, the environmental integrity of the scheme and the reliability of the planned monitoring and reporting system, Member States may, from 2008, apply emission allowance 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 regulatory procedure referred to in Article 23(2), and (b) activities and greenhouse gases which are not listed in Annex I, provided that the inclusion of such activities and greenhouse gases is approved by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with 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.’;
• (b) paragraph 3 shall be replaced by the following: ‘3. The Commission may, on its own initiative, or shall, on request by a Member State, adopt monitoring and reporting guidelines for emissions from activities, installations and greenhouse gases which are not listed in Annex I if the monitoring and reporting of these emissions can be carried out with sufficient accuracy. 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).’;

• 1. Article 25(2) shall be replaced by the following: ‘2. Where an agreement referred to in paragraph 1 has been concluded, the Commission shall adopt any necessary provisions relating to the mutual recognition of allowances under that agreement. Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’;

• 1. in Annex IV, the paragraph under the heading ‘Monitoring of emissions of other greenhouse gases’ shall be replaced by the following: ‘Standardised or accepted methods shall be used, developed by the Commission in collaboration with all relevant stakeholders. Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’.

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([^E0021])

As regards Directive 2004/107/EC, the Commission should be empowered 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 hereby amended as follows:

• 1. Article 4 shall be amended as follows:
• (a) paragraph 9 shall be replaced by the following: ‘9. Irrespective of concentration levels, one background sampling point shall be installed every 100 000  km² for the indicative measurement, in ambient air, of arsenic, cadmium, nickel, total gaseous 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 regulatory 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 shall be replaced by the following: ‘15. Any amendments necessary to adapt the provisions of this Article and of Section II of Annex II and of Annexes III, IV and V to scientific and technical progress shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in 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.’;

• 1. Article 5(4) shall be replaced by the following: ‘4. The Commission shall adopt, in accordance with the regulatory procedure referred to in Article 6(2), any detailed arrangements for forwarding the information to be provided under paragraph 1 of this Article.’;

• 1. Article 6(3) shall be replaced by the following: ‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

• 1. Annex V, point V shall be replaced by the following: ‘V.   Reference air quality modelling techniques Reference air quality modelling techniques cannot be specified at present. The Commission may make amendments to adapt this point to scientific and technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3).’

3.9.   Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste([^E0022])

As regards Regulation (EC) No 1013/2006, the Commission should be empowered to amend the annexes as laid down in Article 58 of Regulation (EC) No 1013/2006 and to adopt certain additional measures as laid down in Article 59 of Regulation (EC) No 1013/2006. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1013/2006, inter alia, by supplementing it with 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 hereby amended as follows:

• 1. in Article 11(3), the third subparagraph shall be replaced by the following: ‘If there is no satisfactory solution, either Member State may refer the matter to the Commission. The issue shall then be determined in accordance with the regulatory procedure referred to in Article 59a(2).’;

• 1. Article 58 shall be replaced by the following: ‘Article 58 Amendment of Annexes

(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.

• 1. Article 59 shall be replaced by the following: ‘Article 59 Additional measures

(a) guidelines for the application of Article 12(1)(g); (b) guidelines on the application of Article 15 in relation to the identification and tracking of waste undergoing substantial changes in the interim recovery or disposal operation; (c) guidelines for the cooperation of competent authorities with regard to illegal shipments as referred to in Article 24; (d) technical and organisational requirements for the practical implementation of electronic data interchange for the submission of documents and information in accordance with Article 26(4); (e) further guidance concerning the use of languages referred to in Article 27; (f) further clarification of the procedural requirements of Title II as regards their application to exports, imports and transit of waste from, to, and through the Community; (g) further recommendations concerning undefined legal terms.

(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).’;

• 1. The following Article shall be inserted: ‘Article 59a Committee procedure

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

• 1. Article 63 shall be amended as follows:
• (a) in paragraph 2, the third subparagraph shall be replaced by the following: ‘With the exception of glass waste, paper waste and waste pneumatic tyres, this period may be extended until no later than 31 December 2012 in accordance with the regulatory procedure referred to in Article 59a(2).’;
• (b) in paragraph 4, the third subparagraph shall be replaced by the following: ‘This period may be extended until no later than 31 December 2012 in accordance with the regulatory procedure referred to in Article 59a(2).’;
• (c) paragraph 5 shall be amended as follows:
• (i) the third subparagraph shall be 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 shall be 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).’

4. EUROSTAT

4.1.   Council Regulation (EEC) No 3924/91 of 19 December 1991 on the establishment of a Community survey of industrial production([^E0024])

As regards Regulation (EEC) No 3924/91, the Commission should be empowered to update the list of products concerned by that Regulation. It should also be empowered 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 the 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 with 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 hereby amended as follows:

• 1. Article 2(6) shall be replaced by the following: ‘6. The Prodcom list and the information actually collected for each heading shall be 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).’;

• 1. Article 3 shall be amended as follows:
• (a) in paragraph 2 the words ‘in accordance with the procedure laid down in Article 10’ shall be replaced by the words ‘in accordance with the management procedure referred to in Article 10(2).’;
• (b) paragraph 5 shall be replaced by the following: ‘5. Detailed rules for applying paragraph 3, including measures for the 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).’;

• 1. Article 4 shall be 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, the Commission may decide that monthly or quarterly surveys are to be conducted. 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).’;

• 1. Article 5(1) shall be 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).’;

• 1. Article 6 shall be replaced by the following: ‘Article 6 Processing of results Member States shall process the completed questionnaires referred to in Article 5(1) or the information from other sources referred to in Article 5(3) in accordance with the detailed rules adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3).’;

• 1. in Article 7(2) the words ‘in accordance with the procedure laid down in Article 10’ shall be replaced by the words ‘in accordance with the management procedure referred to in Article 10(2)’;

• 1. Article 9 shall be deleted;

• 1. Article 10 shall be replaced by the following: ‘Article 10 Committee procedure

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

4.2.   Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk products([^E0026])

As regards Directive 96/16/EC, the Commission should be empowered to adopt the definitions for the agricultural holdings among which Member States must conduct surveys of the production of milk and its use, adopt the list of milk products covered by the surveys and draw up standard definitions to be used when communicating the results to the Commission. Since those measures are of general scope and are designed to amend non-essential elements of Directive 96/16/EC by supplementing it with 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 hereby amended as follows:

• 1. in Article 1, point 2 shall be 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).’;

• 1. Article 3(2) and (3) shall be 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).

• 1. in Article 5(2) and Article 6(1), the words ‘in accordance with the procedure laid down in Article 7’ shall be replaced by the words ‘in accordance with the regulatory procedure referred to in Article 7(2).’;

• 1. Article 7 shall be replaced by the following: ‘Article 7

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

4.5.   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([^E0030])

As regards Regulation (EC) No 437/2003, the Commission should be empowered to establish standards of accuracy, specify data files and adopt certain implementing measures. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 437/2003, inter alia, by supplementing it with 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 437/2003 is hereby amended as follows:

• 1. Article 5 shall be 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).’;

• 1. Article 7(2) shall be 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. 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). The medium to be used for transmission shall be specified by the Commission in accordance with the regulatory procedure referred to in Article 11(2).’;

• 1. Article 10 shall be replaced by the following: ‘Article 10 Implementing measures

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

— adaptation of the specifications in the Annexes to this Regulation, — adaptation of the data collection characteristics (Article 3), — accuracy of statistics (Article 5), — description of the data files (Article 7), 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).’;

• 1. Article 11 shall be replaced by the following: ‘Article 11 Committee procedure

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

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([^E0031])

As regards Regulation (EC) No 48/2004, the Commission should be empowered to 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 with 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 hereby amended as follows:

• 1. Article 7 shall be replaced by the following: ‘Article 7 Implementing measures

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

5. INTERNAL MARKET

Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids([^E0032])

As regards Directive 2004/25/EC, the Commission should be empowered to adopt rules for the application of Article 6(3) to the contents of the offer document. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/25/EC, 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 statement concerning 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 hereby amended as follows:

• 1. Article 6(4) shall be replaced by the following: ‘4. The Commission may adopt rules modifying the list in paragraph 3. 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).’;

• 1. Article 18 shall be amended as follows:
• (a) paragraph 2 shall be replaced by the following: ‘2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
• (b) paragraph 3 shall be deleted.

6. HEALTH AND CONSUMER PROTECTION

6.1.   Council Directive 79/373/EEC of 2 April 1979 on the circulation of compound feedingstuffs([^E0033])

As regards Directive 79/373/EEC, the Commission should be empowered 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, inter alia, by supplementing it with 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 hereby amended as follows:

• 1. Article 4(2) shall be 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.’;

• 1. Article 10 shall be replaced by the following: ‘Article 10 In the light of advances in scientific and technical knowledge, the Commission shall:
• (a) establish categories grouping several feed materials;
• (b) adopt methods of calculating the energy value of compound feedingstuffs;
• (c) adopt amendments to the Annex. All the above 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).’;

• 1. Article 13(3) shall be replaced by the following: ‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’.

6.2.   Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition([^E0034])

As regards Directive 82/471/EEC, the Commission should be empowered 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 by supplementing it with 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 the grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to the Directive.

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

• 1. Article 6 is hereby amended as follows:
• (a) paragraph 1 shall be 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 shall be 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 laid down 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).’;

• 1. in the second subparagraph of Article 7(2), the words ‘the procedure laid down in Article 13’ shall be replaced by the words ‘the regulatory procedure referred to in Article 13(2).’;

• 1. Article 8(3) shall be 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 urgency procedure 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.’;