Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 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 Four

Labour cost indices shall be provided separately for the three labour cost categories identified below: (a)total labour costs; (b)wages and salaries, defined by reference to item D.11 in Annex II to Regulation (EC) No 1726/1999; (c)employers’ social contributions plus taxes paid by the employer less subsidies received by the employer, as defined by the sum of items D.12 and D.4 less D.5 in Annex II to Regulation (EC) No 1726/1999.

4.Article 8 shall be replaced by the following: ‘Article 8 Quality

5.Articles 11 and 12 shall be replaced by the following: ‘Article 11 Implementing measures The following measures for implementing this Regulation, including measures to take account of economic and technical changes, shall be laid down by the Commission: (a)the definition, in accordance with Article 4(1), of the disaggregations to be included in the fixed structure; (b)the technical specification of the index (Article 2); (c)the inclusion of NACE Rev. 2 sections O to S (Article 3); (d)the breakdown of indices by economic activities (Article 4); (e)the format for transmission of results and the adjustment procedures to be applied (Article 6); (f)the separate quality criteria for current and back data transmitted and contents of quality reports (Article 8); (g)the transition period (Article 9); (h)the establishment of feasibility studies and decisions pursuant to their results (Article 10); and (i)the methodology to be used for chaining the index (Annex). The measures referred to in points (e), (g) and (h) shall be adopted in accordance with the regulatory procedure referred to in Article 12(2). The measures referred to in points (a), (b), (c), (d), (f) and (i), 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 12(3).

Article 12

Committee procedure

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

6.point 3 of the Annex shall be replaced by the following: ‘3.The methodology for chaining the index will be defined 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 12(3).’.

3.6.   Regulation (EC) No 1552/2005 of the European Parliament and of the Council of 7 September 2005 on statistics relating to vocational training in enterprises (⁴⁰)

As regards Regulation (EC) No 1552/2005, the Commission should be empowered in particular to adapt the definitions and sampling methods, to define the specific data to be collected and to determine the quality requirements for the data and the transmission arrangements. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1552/2005, 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 1552/2005 is hereby amended as follows:

1.Article 5(2) shall be replaced by the following: ‘2.  Having regard to the specific national size distribution of enterprises and the evolution of policy needs, Member States may extend the definition of the statistical unit in their country. The Commission may also decide to extend that definition, if such extension would substantially enhance the representativeness and the quality of the result of the survey in the Member States concerned. 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 14(3).’;

2.Article 7(3) shall be replaced by the following: ‘3.  Sampling and precision requirements, the sample sizes needed to meet those requirements, and the detailed specifications of the NACE Rev. 2 and size categories into which the results can be broken down shall be determined 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 14(3).’;

3.Article 8(2) shall be replaced by the following: ‘2.  The specific data to be collected with respect to training and non-training enterprises and to the different forms of vocational training shall be determined 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 14(3).’;

4.Article 9(4) shall be replaced by the following: ‘4.  The quality requirements for the data to be collected and transmitted for Community statistics on vocational training in enterprises, the structure of the quality reports referred to in paragraph 2 and any measures necessary for assessing or improving the quality of the data shall be determined 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 14(3).’;

5.Article 10(2) shall be replaced by the following: ‘2.  The Commission shall determine the first reference year for which the data are to be collected. 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 14(3).’;

6.Articles 13 and 14 shall be replaced by the following: ‘Article 13 Implementing measures The measures necessary to take account of economic and technical developments concerning the collection, transmission and processing of the data shall be adopted 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 14(3). Other measures for the implementation of this Regulation, including the appropriate technical format and interchange standard of the electronically transmitted data, shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 14(2).

Article 14

Committee procedure

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

4. INTERNAL MARKET

4.1.   Regulation (EC) No 2195/2002 of the European Parliament and of the Council of 5 November 2002 on the Common Procurement Vocabulary (CPV) (⁴²)

As regards Regulation (EC) No 2195/2002, the Commission should be empowered in particular to update the structure and codes of the CPV and to make technical adjustments to any of the Annexes to that Regulation in order to provide users with a tool adapted to their needs and to developments in the market. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 2195/2002, 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 should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments of a purely technical nature.

Accordingly, Articles 2 and 3 of Regulation (EC) No 2195/2002 shall be replaced by the following:

The Commission shall adopt the measures necessary for the revision of the CPV. 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 3(2). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 3(3).

4.2.   Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (⁴⁴)

As regards Directive 2004/17/EC, the Commission should be empowered in particular to make technical adjustments to certain provisions of the Directive and its Annexes, in line with technical progress or developments in Member States, and to revise the thresholds for application of the arrangements. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/17/EC, 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 efficiency and because of the time-limits imposed by the procedures laid down for calculation and publication, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the revision of certain thresholds.

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments of a purely technical nature.

Accordingly, Directive 2004/17/EC is hereby amended as follows:

1.Article 68 shall be replaced by the following: ‘Article 68 Committee procedure

The time-limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at four, two and six weeks respectively.

2.Article 69 shall be amended as follows: (a)the first subparagraph of paragraph 1 shall be replaced by the following: ‘The Commission shall verify the thresholds established in Article 16 every two years from 30 April 2004, and shall, if necessary, with regard to the second subparagraph, revise them. 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 68(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 68(5).’; (b)the first subparagraph of paragraph 2 shall be replaced by the following: ‘At the same time as performing the revision under paragraph 1, the Commission shall align the thresholds laid down in Article 61 (design contests) with the revised threshold applicable to service contracts. 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 68(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 68(5).’;

3.Article 70 shall be replaced by the following: ‘Article 70 Amendments

(a)the procedure for sending and publishing data referred to in Annex XX, on grounds of technical progress or for administrative reasons; (b)the procedures for the drawing-up, transmission, receipt, translation, collection and distribution of the notices referred to in Articles 41, 42, 43 and 63; (c)in the interests of administrative simplification as provided for in Article 67(3), the procedures for the use, drawing-up, transmission, receipt, translation, collection and distribution of the statistical reports referred to in Article 67(1) and (2).

(a)the list of contracting entities in Annexes I to X so that they fulfil the criteria set out in Articles 2 to 7; (b)the procedures for specific references to particular positions in the CPV nomenclature in the notices; (c)the reference numbers in the nomenclature set out in Annex XVII, in so far as this does not change the material scope of the Directive, and the procedures for reference in the notices to particular positions in that nomenclature within the categories of services listed in the Annex; (d)the reference numbers in the nomenclature set out in Annex XII, insofar as this does not change the material scope of the Directive, and the procedures for reference to particular positions of that nomenclature in the notices; (e)Annex XI; (f)the technical details and characteristics of the devices for electronic receipt referred to in points (a), (f) and (g) of Annex XXIV; (g)the technical procedures for the calculation methods set out in the second subparagraph of Article 69(1) and the second subparagraph of Article 69(2). 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 68(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 68(5).’.

4.3.   Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (⁴⁶)

As regards Directive 2004/18/EC, the Commission should be empowered in particular to make technical adjustments to certain provisions of the Directive and its Annexes, in line with technical progress or developments in Member States, and to revise the thresholds for application of the arrangements. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/18/EC, 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 efficiency and because of the time-limits imposed by the procedures laid down for calculation and publication, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the revision of certain thresholds.

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments of a purely technical nature.

Accordingly, Directive 2004/18/EC is hereby amended as follows:

1.Article 77 shall be replaced by the following: ‘Article 77 Committee procedure

2.Article 78 shall be amended as follows: (a)the first subparagraph of paragraph 1 shall be replaced by the following: ‘The Commission shall verify the thresholds established in Article 7 every two years from 30 April 2004 and shall, if necessary, revise them. 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 77(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 77(5).’; (b)paragraph 2 shall be replaced by the following: ‘2.  At the same time as the revision under paragraph 1, the Commission shall align: (a)the thresholds established in point (a) of the first paragraph of Article 8, in Article 56 and in the first subparagraph of Article 63(1) on the revised threshold applying to public works contracts; (b)the threshold established in Article 67(1)(a) on the revised threshold applying to public service contracts awarded by the contracting authorities referred to in Annex IV; (c)the thresholds established in point (b) of the first paragraph of Article 8 and in Article 67(1)(b) and (c) on the revised threshold applying to public service contracts awarded by contracting authorities other than those referred to in Annex IV. 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 77(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 77(5).’;

3.Article 79 shall be replaced by the following: ‘Article 79 Amendments

(a)the procedures for the drawing-up, transmission, receipt, translation, collection and distribution of the notices referred to in Articles 35, 58, 64 and 69 and the statistical reports provided for in the fourth subparagraph of Article 35(4) and in Articles 75 and 76; (b)the procedure for sending and publishing data referred to in Annex VIII, on grounds of technical progress or for administrative reasons.

(a)the technical procedures for the calculation methods set out in the second subparagraph of Article 78(1) and in Article 78(3); (b)the procedures for specific reference to specific positions in the CPV nomenclature in the notices; (c)the lists of bodies and categories of bodies governed by public law in Annex III, when, on the basis of the notifications from the Member States, such amendment proves necessary; (d)the lists of central government authorities in Annex IV, following the adaptations necessary to give effect to the Agreement; (e)the reference numbers in the nomenclature set out in Annex I, in so far as this does not change the material scope of this Directive, and the procedures for reference to particular positions of that nomenclature in the notices; (f)the reference numbers in the nomenclature set out in Annex II, in so far as this does not change the material scope of this Directive, and the procedures for reference in the notices to particular positions in that nomenclature within the categories of services listed in the Annex; (g)the technical details and characteristics of the devices for electronic receipt referred to in points (a), (f) and (g) of Annex X. 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 77(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 77(5).’.

5. HEALTH AND CONSUMER PROTECTION

5.1.   Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (⁴⁸)

As regards Regulation (EEC) No 315/93, the Commission should be empowered in particular to establish maximum tolerances for specific contaminants. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EEC) No 315/93 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.

Any delay in the establishment of maximum tolerances for specific contaminants could represent a threat to human or animal health. When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of those tolerances.

Accordingly Regulation (EEC) No 315/93 is hereby amended as follows:

1.the first subparagraph of Article 2(3) shall be replaced by the following: ‘In order to protect public health and pursuant to paragraph 1, the Commission may where necessary establish the maximum tolerances for specific contaminants. 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 8(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 8(4).’;

2.Article 4(2) shall be replaced by the following: ‘2.  The Commission shall examine the reasons given by the Member State referred to in paragraph 1 as soon as possible in the Standing Committee for Foodstuffs, set up by Council Decision 69/414/EEC (⁴⁹), and shall deliver its opinion immediately and take any necessary measures aimed at confirming, amending or repealing the national measure, in accordance with the regulatory procedure laid down in Article 8(2).

3.in the fourth subparagraph of Article 5(3), the words ‘Article 8’ shall be replaced by the words ‘Article 8(2)’;

4.Article 8 shall be amended as follows: (a)paragraph 3 shall be replaced by the following: ‘3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Council Decision 1999/468/EC (⁵⁰) shall apply, having regard to the provisions of Article 8 thereof. (b)the following paragraph shall be 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.’.

5.2.   Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (⁵¹)

As regards Directive 93/74/EEC, the Commission should be empowered in particular to adopt general provisions regarding the application of the indications contained in the list of intended uses and to adopt amendments, in line with developments in scientific and technical knowledge, to the list of intended uses and the general provisions regarding the application of the indications contained in the list of intended uses. Since those measures are of general scope and are designed to amend non-essential elements of Directive 93/74/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.

Feedingstuffs intended for particular nutritional purposes are playing an increasing role in the diet of pet animals and are also used in the rearing of productive livestock. The composition and preparation of such feedingstuffs must be specially designed to meet the particular nutritional needs of categories of pets or productive livestock whose process of assimilation, absorption or metabolism could briefly be impaired or is temporarily or irreversibly impaired. Users of such feedingstuffs therefore need to be provided immediately with accurate and meaningful information so that they can make appropriate choices. When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of general provisions regarding the application of the indications contained in the list of intended uses and for the adoption of amendments, in line with developments in scientific and technical knowledge, to the list of intended uses and the general provisions regarding the application of the indications contained in the list of intended uses.

Accordingly, Directive 93/74/EEC is hereby amended as follows:

1.Article 6 shall be replaced by the following: ‘Article 6 The Commission shall adopt: (a)a list of intended uses as set out in the Annex no later than 30 June 1994 in accordance with the regulatory procedure referred to in Article 9(2). That list shall contain: —the indications referred to in points (b), (c), (d) and (e) of Article 5(1), and, —where appropriate, the indications referred to in Article 5(2) and Article 5(4), second subparagraph, (b)general provisions regarding the application of the indications referred to in point (a), including applicable tolerances; (c)amendments to the measures adopted in accordance with points (a) and (b) in line with developments in scientific and technical knowledge. The measures provided for in points (b) and (c), 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(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 9(4).’;

2.Article 8(2) shall be replaced by the following: ‘2.  The Commission shall initiate as soon as possible the regulatory procedure laid down in Article 9(2) with a view to adopting any appropriate measures aimed at confirming, amending or repealing the national measure.’;

3.Article 9(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.

5.3.   Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and products (⁵²)

As regards Directive 96/23/EC, the Commission should be empowered in particular to adopt amendments to the Annexes. Since those measures are of general scope and are designed to amend non-essential elements of Directive 96/23/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 96/23/EC is hereby amended as follows:

1.Article 6 shall be replaced by the following: ‘Article 6

2.Article 8 shall be amended as follows: (a)the second and third subparagraphs of paragraph 1 shall be replaced by the following: ‘Once the Commission has established their conformity, it shall submit the plans for approval in accordance with the regulatory procedure referred to in Article 33(3). In order to take account of changes in the situation in a given Member State or in a region thereof, of the results of national surveys or of investigations carried out in the framework of Articles 16 and 17, the Commission may, at the request of the Member State concerned or on its own initiative, decide, in accordance with the regulatory procedure referred to in Article 33(2), to approve an amendment or addition to a plan previously approved pursuant to paragraph 2.’; (b)the fifth subparagraph of paragraph 2 shall be replaced by the following: ‘Where there are comments from Member States or where the Commission deems the update not to be in conformity or to be insufficient, the Commission shall submit the updated plans to the Standing Veterinary Committee, which must act under the regulatory procedure referred to in Article 33(3).’;

3.the third subparagraph of Article 14(1) shall be replaced by the following: ‘A list of such designated laboratories shall be drawn up in accordance with the regulatory procedure referred to in Article 33(3).’;

4.the second subparagraph of Article 15(1) shall be replaced by the following: ‘The detailed rules for the taking of official samples and the routine and reference methods to be employed for the analysis of such official samples shall be specified 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 33(4).’;

5.the sixth subparagraph of Article 20(2) shall be replaced by the following: ‘In the light of the experts’ opinion, appropriate measures may be taken in accordance with the regulatory procedure referred to in Article 33(2).’;

6.the second subparagraph of paragraph 1 and paragraph 2 of Article 21 shall be replaced by the following: ‘The Member State concerned shall take the measures necessary to take account of the results of those verifications and shall notify the Commission of the measures taken. Where the Commission considers that the measures taken are insufficient, it shall, after consultation with the Member State in question and having regard to the measures necessary to safeguard public health, take appropriate measures in accordance with the regulatory procedure referred to in Article 33(2).

7.Article 29 shall be amended as follows: (a)the fourth subparagraph of paragraph 1 shall be replaced by the following: ‘The Commission shall approve the plan in accordance with the regulatory procedure referred to in Article 33(3). Under the same procedure, guarantees other than those resulting from the implementation of this Directive may be accepted.’; (b)paragraph 2 shall be replaced by the following: ‘2.  Where the requirements of paragraph 1 are not complied with, inclusion of a third country on the lists of third countries laid down by Community legislation or as a result of the benefit of pre-listing may be suspended in accordance with the regulatory procedure referred to in Article 33(3), at the request of a Member State or by the Commission on its own initiative.’;

8.the first subparagraph of Article 30(3) shall be replaced by the following: ‘3.  If, in cases involving third countries which have concluded equivalence agreements with the Community, the Commission, after making enquiries of the competent authorities of the third countries concerned, concludes that they have failed to fulfil their obligations and the guarantees given by the plans referred to in Article 29(1), it shall cease to allow the country concerned, under the regulatory procedure referred to in Article 33(2), to benefit from the said agreements for the animals and products in question until that third country has made good its shortcomings. The suspension shall be revoked under the same procedure.’;

9.Article 32 shall be deleted;

10.Articles 33, 34 and 35 shall be replaced by the following: ‘Article 33

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

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

Article 34

Without prejudice to Article 6(2), Annexes I, III, IV and V may be amended or supplemented by the Commission. In particular, those Annexes may be amended with a view to risk assessment of the following factors: —potential toxicity of residues in foodstuffs of animal origin, —likelihood of residues occurring in foodstuffs of animal origin, 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 33(4).

Article 35

The Commission may adopt transitional measures required for the implementation of the arrangements laid down by this Directive. Transitional measures of general scope, designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, and in particular further specifications of the requirements laid down in this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(4). Other transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 33(2).

5.4.   Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (⁵⁵)

As regards Regulation (EC) No 258/97, the Commission should be empowered in particular to adopt data protection arrangements. Since those measures are of general scope and are designed to supplement Regulation (EC) No 258/97 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 258/97 is hereby amended as follows:

1.in Article 1(3), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’;

2.in the second subparagraph of Article 3(4), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’;

3.in Article 4(5), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’;

4.in Article 7(1), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’;

5.in Article 8(3), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’;

6.Article 10 shall be replaced by the following: ‘Article 10 Detailed rules for the protection of the information provided by the applicant shall be 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 13(3).’;

7.Article 12(2) shall be replaced by the following: ‘2.  The Commission shall examine the grounds referred to in paragraph 1 as soon as possible within the Standing Committee for Foodstuffs. It shall take the appropriate measures aimed at confirming, amending or repealing the national measure in accordance with the regulatory procedure laid down in Article 13(2). The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.’;

8.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.’.

5.5.   Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (⁵⁶)

As regards Decision No 2119/98/EC, the Commission should be empowered in particular to establish the communicable diseases and the criteria for selection of those diseases to be covered by the Community network, as well as the epidemiological and microbiological surveillance methods. Since those measures are of general scope and are designed to amend non-essential elements of Decision No 2119/98/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.

When an emergency situation occurs with regard to the appearance or to new developments of a serious communicable disease, the epidemiological surveillance system should be triggered as soon as possible, in order to ensure protection of the population and public health. When on imperative grounds of urgency the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of decisions determining the communicable diseases, the criteria for the selection of those diseases and the epidemiological and microbiological surveillance methods, as well as for the amendments to the Annex to Decision No 2119/98/EC containing the list of categories of communicable diseases.

Accordingly, Decision No 2119/98/EC is hereby amended as follows:

1.Article 3 shall be amended as follows: (a)the introductory words shall be replaced by the following: ‘With a view to the effective operation of the Community network with regard to epidemiological surveillance and to achieving uniform information within this framework, the following shall be adopted by the Commission:’; (b)the following paragraphs shall be added: ‘The measures referred to in points (a), (b) and (e), designed to amend non-essential elements of this Decision, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4). The measures referred to in points (c), (d), (f), (g) and (h) shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

2.Article 6(5) shall be replaced by the following: ‘5.  Procedures concerning the information and consultation referred to in paragraphs 1, 2 and 3 and procedures concerning the coordination referred to in paragraphs 1 and 4 shall be established in accordance with the regulatory procedure referred to in Article 7(2).’;

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

4.Article 8 shall be replaced by the following: ‘Article 8 The Annex may be amended or supplemented by the Commission. Those measures, designed to amend non-essential elements of this Decision, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4).’.

5.6.   Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (⁵⁷)

As regards Directive 2000/13/EC, the Commission should be empowered in particular to adopt certain measures necessary for its implementation. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2000/13/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.

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the amendment of the lists of certain categories of ingredients.

Accordingly, Directive 2000/13/EC is hereby amended as follows:

1.Article 4(3) shall be replaced by the following: ‘3.  The Community provisions referred to in paragraphs 1 and 2 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 20(3).’;

2.Article 6 shall be amended as follows: (a)point (d) of the second subparagraph of paragraph 3a shall be replaced by the following: ‘(d)as regards other products, being measures designed to amend non-essential elements of this Directive, in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).’; (b)the second subparagraph of paragraph 6 shall be amended as follows: (i)the first indent shall be replaced by the following: ‘—ingredients which belong to one of the categories listed in Annex I and are constituents of another foodstuff need only be designated by the name of that category. Alterations to the list of categories in Annex I may be effected 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 20(3). However, the designation “starch” listed in Annex I must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten,’; (ii)the second indent shall be replaced by the following: ‘—ingredients belonging to one of the categories listed in Annex II must be designated by the name of that category, followed by their specific name or EC number; if an ingredient belongs to more than one of the categories, the category appropriate to the principal function in the case of the foodstuff in question shall be indicated. Amendments to Annex II based on advances in scientific and technical knowledge, being measures designed to amend non-essential elements of this Directive, shall be adopted by the Commission in accordance with the regulatory procedure with scrutiny referred to in Article 20(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 20(4). However, the designation “modified starch” listed in Annex II must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten,’; (c)the third subparagraph of paragraph 7 shall be replaced by the following: ‘The Community provisions referred to in this paragraph 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 20(3).’; (d)the third subparagraph of paragraph 11 shall be replaced by the following: ‘Without prejudice to the second subparagraph, Annex IIIa may be amended by the Commission, after an opinion has been obtained from the European Food Safety Authority issued on the basis of Article 29 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (⁵⁸). 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 20(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 20(4).

3.Article 7 shall be amended as follows: (a)paragraph 2(d) shall be replaced by the following: ‘(d)in the cases determined by the Commission; determination of such cases, being a measure designed to amend non-essential elements of this Directive by supplementing it, shall be carried out in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).’; (b)paragraph 3(d) shall be replaced by the following: ‘(d)in the cases determined by the Commission; determination of such cases, being a measure designed to amend non-essential elements of this Directive by supplementing it, shall be carried out in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).’; (c)the third sentence of paragraph 4 shall be replaced by the following: ‘Such provisions shall be adopted 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 20(3).’;

4.Article 8 shall be amended as follows: (a)the third subparagraph of paragraph 4 shall be replaced by the following: ‘This list may be supplemented by the Commission. That measure, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).’; (b)paragraph 6 shall be replaced by the following: ‘6.  The Community provisions referred to in paragraphs 1, second subparagraph, 2(b) and (d) and 5, second subparagraph, shall be adopted 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 20(3).’;

5.in Article 11(2), the third subparagraph shall be replaced by the following: ‘The Community provisions referred to in this paragraph shall be adopted 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 20(3).’;

6.in Article 12, the second paragraph shall be replaced by the following: ‘In the case of other beverages containing more than 1,2 % by volume of alcohol, these rules shall be laid down 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 20(3).’;

7.Article 16(1) shall be replaced by the following: ‘1.  Member States shall ensure that the sale is prohibited within their own territories of foodstuffs for which the particulars provided for in Article 3 and Article 4(2) do not appear in a language easily understood by the consumer, unless the consumer is in fact informed by means of other measures, determined as regards one or more labelling particulars. Determination of such measures, being a measure designed to amend non-essential elements of this Directive by supplementing it, shall be carried out in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).’;

8.Article 20 shall be amended as follows: (a)paragraph 3 shall be replaced by the following: ‘3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’; (b)the following paragraph shall be 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.’;

9.Article 21 shall be replaced by the following: ‘Article 21 The Commission shall adopt temporary measures, if these prove necessary in order to facilitate the application of this Directive. Temporary measures of general scope designed to amend non-essential elements of this Directive, including those supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in the provisions of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3). Other temporary measures may be adopted in accordance with the regulatory procedure referred to in Article 20(2).’.

5.7.   Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (⁵⁹)

As regards Directive 2001/37/EC, the Commission should be empowered in particular to adopt rules for the use of colour photographs or the illustrations on tobacco products and to adapt the provisions on the measurement methods and on the health warnings to scientific and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/37/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 2001/37/EC is hereby amended as follows:

1.the first subparagraph of Article 5(3) shall be replaced by the following: ‘3.  The rules for the use of colour photographs or other illustrations to depict and explain the health consequences of smoking shall be adopted by the Commission with a view to ensuring that internal market provisions are not undermined. 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 10(3).’;

2.Article 9 shall be replaced by the following: ‘Article 9 Adaptations

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

5.8.   Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (⁶⁰)

As regards Directive 2001/95/EC, the Commission should be empowered in particular to set out and adapt the principal rules and procedures of notification of serious risks from products. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/95/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.

On grounds of efficiency and in particular because the adequacy of the principal rules and procedures regarding notifications of serious risks from products is a precondition for the proper functioning of the rapid alert system, the time-limits for the regulatory procedure with scrutiny should be curtailed.

Accordingly, Directive 2001/95/EC is hereby amended as follows:

1.Article 4(1)(a) shall be replaced by the following: ‘(a)the requirements intended to ensure that products which conform to those standards satisfy the general safety requirement shall be determined 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 15(4);’;

2.the second subparagraph of Article 5(3) shall be replaced by the following: ‘The Commission shall adapt the specific requirements relating to the obligation to provide information laid down in Annex I. 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 15(5).’;

3.Article 12(3) shall be replaced by the following: ‘3.  Detailed procedures for RAPEX are set out in Annex II. They shall be adapted 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 15(5).’;

4.Article 15 shall be replaced by the following: ‘Article 15

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

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

5.9.   Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (⁶¹)

As regards Regulation (EC) No 178/2002, the Commission should be empowered in particular to adopt provisions relating to the number and names of the Scientific Panels, the rules of procedure for submitting a request for an opinion to the Authority and the criteria for inclusion of an institute on the list of competent organisations designated by the Member States. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 178/2002, 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 178/2002 is hereby amended as follows:

1.the second subparagraph of Article 28(4) shall be replaced by the following: ‘The number and names of the Scientific Panels may be adapted in the light of technical and scientific development by the Commission, at the Authority’s request. 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 58(3).’;

2.Article 29(6) shall be replaced by the following: ‘6.  The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority. Those rules shall specify in particular: (a)the procedure to be applied by the Authority to the requests referred to it; (b)the guidelines governing the scientific evaluation of substances, products or processes which are subject under Community legislation to a system of prior authorisation or entry on a positive list, in particular where Community legislation makes provision for, or authorises, a dossier to be presented for this purpose by the applicant. The measure referred to in point (a), 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 58(3). The guidelines referred to in point (b) shall be adopted in accordance with the regulatory procedure referred to in Article 58(2).’;

3.Article 36(3) shall be replaced by the following: ‘3.  The Commission, after consulting the Authority, shall lay down rules establishing the criteria for inclusion of an institute on the list of competent organisations designated by the Member States, arrangements for setting out harmonised quality requirements and the financial rules governing any financial support. 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 58(3). Other implementing rules for the application of paragraphs 1 and 2 shall be laid down by the Commission, after consulting the Authority, in accordance with the regulatory procedure referred to in Article 58(2).’;

4.paragraphs 2 and 3 of Article 58 shall be replaced by the following: ‘2.  Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

5.10.   Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (⁶²)

As regards Regulation (EC) No 1774/2002, the Commission should be empowered in particular to establish rules on the disposal, processing, importation/exportation and transformation of Category 1, 2 and 3 material of animal by-products, as well as rules on the placing on the market of animal by-products coming from territories subject to animal health restrictions and of organic fertilisers and soil improvers; to define the conditions for the importation from third countries of petfood and raw material for petfood production; and to define specific or alternative hygiene requirements laid down in the Annexes. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1774/2002, 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.

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of the rules regarding the placing on the market of animal by-products, or products deriving therefrom, coming from territories subject to animal health restrictions, for the adoption of alternative rules for specific situations regarding the placing on the market of animal by-products, or products deriving therefrom, coming from territories subject to animal health restrictions and for amendment of the Annexes.

Accordingly, Regulation (EC) No 1774/2002 is hereby amended as follows:

1.Article 3(2) shall be replaced by the following: ‘2.  However, Member States may regulate under national law the importation and placing on the market of products not referred to in Annexes VII and VIII, pending the adoption of a decision by the Commission. 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 33(3). Member States shall immediately inform the Commission of the use that they make of this possibility.’;

2.Article 4 shall be amended as follows: (a)paragraph 2(e) shall be replaced by the following: ‘(e)in the light of developments in scientific knowledge, disposed of by other means that are approved by the Commission after consultation of the appropriate scientific committee. 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 33(3). Those means may either supplement or replace those provided for in points (a) to (d) of this paragraph.’; (b)the first sentence of paragraph 4 shall be replaced by the following: ‘Category 1 material shall not be imported or exported except in accordance with this Regulation or with rules 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 33(3).’;

3.Article 5 shall be amended as follows: (a)paragraph 2 shall be amended as follows: (i)in point (c), point (i) shall be replaced by the following: ‘(i)in the case of resulting proteinaceous material, used as an organic fertiliser or soil improver in compliance with requirements, if any, laid down by the Commission after consultation of the appropriate scientific committee. 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 33(3),’; (ii)point (d) shall be replaced by the following: ‘(d)in the case of material of fish origin, ensiled or composted in compliance with 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 33(3);’; (iii)in point (e), point (iii) shall be replaced by the following: ‘(iii)transformed in a biogas plant or composted in accordance with rules 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 33(3);’; (iv)point (g) shall be replaced by the following: ‘(g)disposed of by other means, or used in other ways, in accordance with rules laid down by the Commission after consultation of the appropriate scientific committee. 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 33(3). Those means or ways may either supplement or replace those provided for in points (a) to (f) of this paragraph.’; (b)paragraph 4 shall be replaced by the following: ‘4.  Category 2 material shall not be placed on the market or exported except in accordance with this Regulation or with rules 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 33(3).’;

4.points (g), (h) and (i) of Article 6(2) shall be replaced by the following: ‘(g)in the case of catering waste referred to in paragraph 1(l), transformed in a biogas plant or composted in accordance with rules laid down by the Commission, or, pending the adoption of such rules, in accordance with national law. 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 33(3); (h)in the case of material of fish origin, ensiled or composted in accordance with rules 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 33(3); or (i)disposed of by other means, or used in other ways, in accordance with rules laid down by the Commission after consultation of the appropriate scientific committee; 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 33(3). Those means or ways may either supplement or replace those provided for in points (a) to (h).’;

5.Article 12(5) shall be replaced by the following: ‘5.  The requirements of paragraphs 2 and 3 may be amended by the Commission in the light of developments in scientific knowledge, after consultation of the appropriate scientific committee. 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 33(3).’;

6.Article 16(3) shall be amended as follows: (a)point (d) shall be replaced by the following: ‘(d)comply with the requirements laid down in Annexes VII and VIII, or with detailed rules to 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 33(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 33(4).’; (b)the first sentence of the second subparagraph shall be replaced by the following: ‘Conditions alternative to those set out in the first subparagraph may be laid down in specific situations by decisions 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 33(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 33(4).’;

7.Article 20(2) shall be replaced by the following: ‘2.  Member States shall ensure that organic fertilisers and soil improvers produced from processed products, other than those produced from manure and digestive tract content, are placed on the market or exported only if they meet requirements, if any, laid down by the Commission after consultation of the appropriate scientific committee. 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 33(3)’;

8.Article 22(2) shall be replaced by the following: ‘2.  The Commission shall establish rules concerning control measures. 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 33(3). Other rules for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 33(2). Derogations from paragraph 1(a) may be granted in relation to fish and fur animals, after consultation of the appropriate scientific committee. 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 33(3).’;

9.Article 23 shall be amended as follows: (a)paragraph 2(d) shall be replaced by the following: ‘(d)In addition, Member States may authorise the use, under the supervision of the competent authorities, of Category 1 material referred to in Article 4(1)(b)(ii) for the feeding of endangered or protected species of necrophagous birds in accordance with rules laid down by the Commission after consultation of the European Food Safety Authority. 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 33(3).’; (b)paragraph 5 shall be replaced by the following: ‘5.  Detailed rules concerning verification measures may be 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 33(3).’;

10.Article 25(3) shall be replaced by the following: ‘3.  The Commission may lay down rules concerning the frequency of checks and reference methods for microbiological analyses. 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 33(3). Any other detailed arrangements for implementing this Article may be laid down under the regulatory procedure referred to in Article 33(2).’;

11.Article 26(5) shall be replaced by the following: ‘5.  The Commission may lay down rules concerning the frequency of checks and reference methods for microbiological analyses. 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 33(3). Any other detailed arrangements for implementing this Article may be laid down under the regulatory procedure referred to in Article 33(2).’;

12.the second paragraph of Article 28 shall be replaced by the following: ‘However, the importation from third countries of petfood and raw material for petfood production, derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC, shall be permitted provided that such raw material is permanently marked and under specific conditions 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 33(3).’;

13.Article 32(1) shall be replaced by the following: ‘1.  After consultation of the appropriate scientific committee on any question that could have an impact on animal or public health, the Annexes may be amended or supplemented and any appropriate transitional measures may be adopted by the Commission. Transitional measures and measures amending or supplementing the Annexes, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, in particular further specifications of the requirements laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 33(4). Other transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 33(2).’;

14.Article 33 shall be replaced as follows: ‘Article 33 Committee procedure

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

15.in Annex III, Chapter II, Part B, point 11 shall be replaced by the following: ‘11.Waste water must be treated to ensure, as far as is reasonably practicable, that no pathogens remain. Specific requirements for the treatment of waste water from Category 1 and Category 2 intermediate plants may 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 33(3).’;

16.Annex V shall be amended as follows: (a)point 4 of Chapter II shall be replaced by the following: ‘4.Waste water originating in the unclean sector must be treated to ensure, as far as is reasonably practicable, that no pathogens remain. Specific requirements for the treatment of waste water from processing plants may 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 33(3).’; (b)point 5 of Chapter V shall be replaced by the following: ‘5.Validation procedures based on testing methods may 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 33(3).’;

17.Annex VI shall be amended as follows: (a)point 8 in Part C of Chapter I shall be replaced by the following: ‘8.Processed products derived from Category 1 or 2 material, with the exception of liquid products destined for biogas or composting plants, must be permanently marked, where technically possible with smell, using a system approved by the competent authority. Detailed rules for such marking may 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 33(3).’; (b)point 2(b) of Chapter III shall be replaced by the following: ‘(b)in a continuous process at 140 °C 2 bars (2 000 hPa) for eight minutes, or under equivalent conditions 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 33(3).’;

18.Annex VII shall be amended as follows: (a)point 13(b) in Part C of Chapter II shall be replaced by the following: ‘(b)reprocessed in a processing plant approved pursuant to this Regulation or decontaminated by a treatment authorised by the competent authority. A list of permitted treatments may be 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 33(3). The consignment must not be released until it has been treated, tested for salmonella by the competent authority in accordance with Chapter I, paragraph 10, and a negative result obtained.’; (b)Chapter V shall be amended as follows: (i)point 5 of Part A shall be replaced by the following: ‘5.Raw milk and colostrum must be produced under conditions offering adequate guarantees as regards animal health. Such conditions may be 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 33(3).’; (ii)point 3 of Part B shall be replaced by the following: ‘3.Where a risk of introduction of an exotic disease or any other risk to animal health is identified, additional conditions for the protection of animal health may be 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 33(3).’; (c)point 3(c) in Part B of Chapter VI shall be replaced by the following: ‘(c)an equivalent production process approved 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 33(3).’; (d)point 1 in Part A of Chapter VII shall be replaced by the following: ‘1.Dicalcium phosphate must be produced by a process that: (a)ensures that all Category 3 bone-material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at a minimum concentration of 4 % and a pH of less than 1,5) over a period of at least two days; (b)following the procedure provided for in point (a), applies a treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7; and (c)finally, air-dries the precipitate of dicalcium phosphate with inlet temperature of 65 °C to 325 °C and end temperature between 30 °C and 65 °C, or by an equivalent process approved 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 33(3).’; (e)point 1 in Part A of Chapter VIII shall be replaced by the following: ‘1.Tricalcium phosphate must be produced by a process that ensures: (a)that all Category 3 bone-material is finely crushed and degreased in counter-flow with hot water (bone chips less than 14 mm); (b)continuous cooking with steam at 145 °C during 30 minutes at 4 bars; (c)separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by centrifugation; and (d)granulation of the tricalcium phosphate after drying in a fluid bed with air at 200 °C; or by an equivalent production process approved 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 33(3).’;

19.Annex VIII shall be amended as follows: (a)point 2(e) in Part A of Chapter VI shall be replaced by the following: ‘(e)preserved by a process other than tanning 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 33(3).’; (b)point 4(a)(iii) in Part A of Chapter VII shall be replaced by the following: ‘(iii)preserved by a treatment other than tanning approved 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 33(3).’.

5.11.   Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (⁶³)