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

Type Regulation
Publication 2009-03-31
Last updated 2021-10-20
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 4
Reform history JSON API
    1. Article 13 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.’;
    1. Article 14 shall be deleted.

6.3.   Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials([^E0035])

As regards Directive 96/25/EC, the Commission should be empowered to draw up and amend the list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited and to amend the annex in the light of advances in scientific and technical knowledge. Since those measures are of general scope and are designed to amend non-essential elements of Directive 96/25/EC, 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 apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the amendment of the list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited.

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

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

    1. the second indent of Article 5(1)(g) shall be replaced by the following:
  • — - ‘— Community measures included on a list to be drawn up by the Commission. That measure, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3);’;
    1. Article 11 shall be replaced by the following: ‘Article 11
1.

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

2.

The list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited shall be drawn up by the Commission in order to ensure their compliance with Article 3. That measure, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).

3.

The list referred to in paragraph 2 shall be amended by the Commission in the light of advances in scientific and technical knowledge. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 13(5) with a view to adopting those measures.

4.

Amendments to be made to the Annex as a result of developments in scientific or technical knowledge shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(4).’;

    1. Article 13 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 paragraphs shall be added: ‘4. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The periods laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.
5.

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

6.4.   Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed([^E0036])

As regards Directive 2002/32/EC, the Commission should be empowered to amend Annexes I and II and adapt them in the light of developments in scientific and technical knowledge, and to lay down additional criteria for detoxification processes. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2002/32/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 time limits normally applicable for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adaptation of Annexes I and II in the light of developments in scientific and technical knowledge.

Accordingly, Directive 2002/32/EC is hereby amended as follows:

    1. the first subparagraph of Article 7(2) shall be replaced by the following: ‘2. An immediate decision shall be taken as to whether Annexes I and II should be amended. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 11(4).’;
    1. Article 8(1) and (2) shall be replaced by the following: ‘1. The Commission shall adapt Annexes I and II in the light of developments in scientific and technical knowledge. 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(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 11(4) with a view to adopting those amendments.
2.

Furthermore the Commission:

— shall periodically adopt consolidated versions of Annexes I and II incorporating any adaptations made pursuant to paragraph 1, in accordance with the regulatory procedure referred to in Article 11(2), — may define acceptability criteria for detoxification processes as a complement to the criteria provided for products intended for animal feed which have undergone such processes. 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 11(3).’;

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

The Commission shall be assisted by the Standing Committee for Feedingstuffs set up by Article 1 of Council Decision 70/372/EEC ([^E0037]).

2.

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

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

3.

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

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.

    1. Article 12 shall be deleted.

6.6.   Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents([^E0039])

As regards Directive 2003/99/EC, the Commission should be empowered to establish coordinated monitoring programmes concerning zoonoses and zoonotic agents. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2003/99/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 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 Annex I to Directive 2003/99/EC in order to add zoonoses and zoonotic agents to, or delete them from, the lists provided for therein.

Accordingly, Directive 2003/99/EC is hereby amended as follows:

    1. in Article 4, paragraph 4 shall be amended as follows:
  • (a) the introductory phrase shall be replaced by the following: ‘Annex I may be amended by the Commission to add zoonoses or zoonotic agents to, or delete them from, the lists therein, taking account in particular of the following criteria:’;
  • (b) the following subparagraph shall be added: ‘Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 12(4).’;
    1. Article 5(1) shall be replaced by the following: ‘1. If data collected through routine monitoring in accordance with Article 4 are not sufficient, coordinated monitoring programmes concerning one or more zoonoses and/or zoonotic agents may be established by the Commission, especially when specific needs are identified, to assess risks or to establish baseline values related to zoonoses or zoonotic agents at the level of Member States or at Community level. 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 12(3).’;
    1. Article 11 shall be replaced by the following: ‘Article 11 Amendments to the Annexes and transitional or implementing measures Annexes II, III and IV may be amended by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3). Transitional measures of general scope designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, 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 12(3). Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 12(2).’;
    1. Article 12 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.’

6.7.   Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs([^E0040])

As regards Regulation (EC) No 852/2004, the Commission should be empowered to adopt provisions relating to specific hygiene rules and to the approval of establishments, and to grant derogations from Annexes I and II subject to certain conditions. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 852/2004, 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 852/2004 is hereby amended as follows:

    1. Article 4(4) shall be replaced by the following: ‘4. The criteria, requirements and targets referred to in paragraph 3, and associated sampling and analysis methods 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 14(3).’;
    1. Article 6(3)(c) shall be replaced by the following:
  • ‘(c) by a decision adopted by the Commission. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).’;
    1. Article 12 shall be replaced by the following: ‘Article 12 Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, 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 14(3). Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 14(2).’;
    1. Article 13 shall be amended as follows:
  • (a) paragraph 1 shall be amended as follows:
  • (i) the introductory sentence shall be replaced by the following: ‘Annexes I and II may be adapted or updated by the Commission taking into account:’;
  • (ii) the following subparagraph shall be added: ‘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).’;
  • (b) paragraph 2 shall be replaced by the following: ‘2. Derogations from Annexes I and II may be granted by the Commission, in particular to facilitate the implementation of Article 5 for small businesses, taking into account the relevant risk factors, provided that such derogations do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).’;
    1. Article 14(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.’.

6.8.   Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin([^E0041])

As regards Regulation (EC) No 853/2004, the Commission should be empowered to adopt provisions relating to the general obligations of food business operators and to the special guarantees for placing food on the market in Sweden or Finland, and to allow derogations from the annexes subject to certain conditions. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 853/2004, 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 853/2004 is hereby amended as follows:

    1. in Article 3(2), the first sentence shall be replaced by the following: ‘Food business operators shall not use any substance other than potable water — or, when Regulation (EC) No 852/2004 or this Regulation permits its use, clean water — to remove surface contamination from products of animal origin, unless use of the substance has been 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 12(3).’;
    1. Article 8(3) shall be replaced by the following: ‘3. (a) The requirements of paragraphs 1 and 2 may be updated by the Commission, in particular to take account of changes in Member States’ control programmes or of the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004. 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 12(3). (b) In accordance with the regulatory procedure referred to in Article 12(2), the rules laid down in paragraph 2 of this Article in respect of any of the foodstuffs referred to in paragraph 1 of this Article may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned.’;
    1. Article 9 shall be replaced by the following: ‘Article 9 Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, 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 12(3). Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 12(2).’;
    1. Article 10 is hereby amended as follows:
  • (a) paragraph 1 shall be amended as follows:
  • (i) the introductory wording shall be replaced by the following: ‘Annexes II and III may be adapted or updated by the Commission taking into account:’;
  • (ii) the following subparagraph shall be added: ‘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 12(3).’;
  • (b) paragraph 2 shall be replaced by the following: ‘2. Exemptions from Annex II and III may be granted by the Commission, provided that they do not affect the achievement of the objectives of this Regulation. 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).’;
    1. the introductory wording of Article 11 shall be replaced by the following: ‘Without prejudice to the general application of Article 9 and Article 10(1), implementing measures may be laid down in accordance with the regulatory procedure referred to in Article 12(2), and amendments to Annex II or III, as measures designed to amend non-essential elements of this Regulation, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3):’;
    1. Article 12(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.’

6.9.   Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption([^E0042])

As regards Regulation (EC) No 854/2004, the Commission should be empowered to amend or adapt the annexes thereto and to adopt transitional measures, in particular further specifications of the requirements laid down in the provisions of that Regulation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 854/2004, 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 854/2004 is hereby amended as follows:

    1. Article 16 shall be replaced by the following: ‘Article 16 Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, 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 19(3). Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 19(2).’;
    1. Article 17(1) and (2) shall be replaced by the following: ‘1. Annexes I, II, III, IV, V and VI may be amended or supplemented by the Commission to take account of scientific and technical progress. 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 19(3).
2.

Exemptions from Annexes I, II, III, IV, V and VI may be granted by the Commission, provided that they do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).’;

    1. the introductory wording of Article 18 shall be replaced by the following: ‘Without prejudice to the general application of Article 16 and Article 17(1), implementing measures may be laid down in accordance with the regulatory procedure referred to in Article 19(2), and amendments to Annexes I, II, III, IV, V or VI, as measures designed to amend non-essential elements of this Regulation, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3), to specify:’;
    1. Article 19(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.’

6.10.   Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene([^E0043])

As regards Regulation (EC) No 183/2005, the Commission should be empowered to define the microbiological criteria and targets to be met by feed business operators, to adopt measures for the approval of establishments, to amend Annexes I, II and III, and to grant derogations from those annexes. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 183/2005, 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 183/2005 is hereby amended as follows:

    1. the second subparagraph of Article 5(3) shall be replaced by the following: ‘The criteria and targets referred to in points (a) and (b) shall 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 31(3).’;
    1. in Article 10, point (3) shall be replaced by the following: ‘(3) approval is required by a Regulation adopted by the Commission. This 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 31(3).’;
    1. Article 27 shall be replaced by the following: ‘Article 27 Amendments to Annexes I, II and III Annexes I, II and III may be amended to take account of:
  • (a) the development of codes of good practice;
  • (b) the experience gained from the implementation of HACCP-based systems pursuant to Article 6;
  • (c) technological developments;
  • (d) scientific advice, particularly new risk assessments;
  • (e) the setting of feed safety targets; and
  • (f) the development of requirements relating to specific operations. 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 31(3).’;
    1. Article 28 shall be replaced by the following: ‘Article 28 Derogations from Annexes I, II and III Derogations from Annexes I, II and III may be granted by the Commission for particular reasons, provided that such derogations do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 31(3).’;
    1. Article 31(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.’

7. ENERGY AND TRANSPORT

7.2.   Council Directive 97/70/EC of 11 December 1997 setting up a harmonised safety regime for fishing vessels of 24 metres in length and over([^E0045])

As regards Directive 97/70/EC, the Commission should be empowered to adopt provisions for the harmonised interpretation of provisions of the Annex to the Torremolinos Protocol and for the implementation of the Directive. The Commission should also be empowered to amend certain provisions of the Directive and of the annexes thereto in order to apply, for the purpose of the Directive, subsequent amendments to the Torremolinos Protocol which entered into force after the adoption of the Directive. Since those measures are of general scope and are designed to amend non-essential elements of Directive 97/70/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 97/70/EC is hereby amended as follows:

    1. in Article 4(4)(b), the words ‘in accordance with the procedure laid down in Article 9’ shall be replaced by the words ‘in accordance with the regulatory procedure referred to in Article 9(2).’;
    1. in Article 8, the first subparagraph shall be replaced by the following: ‘The following adaptations, 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):
  • (a) provisions may be adopted and incorporated for:
  • — a harmonised interpretation of those provisions of the Annex to the Torremolinos Protocol which have been left to the discretion of the administrations of individual contracting parties, as far as necessary to ensure their consistent implementation in the Community,
  • — the implementation of this Directive without broadening its scope,
  • (b) Articles 2, 3, 4, 6 and 7 of this Directive may be adapted and its Annexes may be amended in order to apply, for the purpose of this Directive, subsequent amendments to the Torremolinos Protocol which have entered into force after the adoption of this Directive.’;
    1. Article 9 shall be replaced by the following: ‘Article 9 Committee procedure
1.

The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council ([^E0046]).

2.

Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ([^E0047]) 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 two months.

3.

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

7.3.   Council Directive 1999/35/EC of 29 April 1999 on a system of mandatory surveys for the safe operation of regular ro-ro ferry and high-speed passenger craft services([^E0048])

As regards Directive 1999/35/EC, the Commission should be empowered to adapt the Annexes, definitions and references to Community instruments and instruments of the International Maritime Organisation (IMO) in order to bring them into line with Community or IMO measures which have subsequently entered into force. The Commission should also be empowered to amend the annexes in order to improve the regime established by the Directive. Since those measures are of general scope and are designed to amend non-essential elements of Directive 1999/35/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 1999/35/EC is hereby amended as follows:

    1. in Article 4(1)(d), last sentence, Article 11(6) and (8) and Article 13(3), second and last sentences, the words ‘the procedure laid down in Article 16’ shall be replaced by the words ‘the regulatory procedure referred to in Article 16(2).’;
    1. Article 16 shall be replaced by the following: ‘Article 16 Committee procedure
1.

The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council ([^E0049]).

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 two months.

3.

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

    1. Article 17 shall be replaced by the following: ‘Article 17 Amendment procedure The Annexes to this Directive, the definitions, the references to Community instruments and references to IMO instruments may be adapted to the extent necessary to bring them into line with Community or IMO measures which have entered into force, but without broadening the scope of this Directive. The Annexes may also be adapted when it is necessary to improve the arrangements established by this Directive, but without broadening its scope. 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 16(3). The amendments to the international instruments referred to in Article 2 may be excluded from the scope of this Directive pursuant to Article 5 of Regulation (EC) No 2099/2002.’

7.5.   Regulation (EC) No 782/2003 of the European Parliament and of the Council of 14 April 2003 on the prohibition of organotin compounds on ships([^E0052])

As regards Regulation (EC) No 782/2003, the Commission should be empowered to establish a harmonised survey and certification regime for certain ships, to take certain measures as regards ships sailing under the flag of a third State, to establish port State control procedures, and to amend certain references and annexes to take account of developments at international level, in particular in the IMO, or to improve the effectiveness of that Regulation in the light of experience. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 782/2003, 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 782/2003 is hereby amended as follows:

    1. Article 6 shall be amended as follows:
  • (a) in paragraph 1(b), the second subparagraph shall be replaced by the following: ‘If necessary, the Commission may establish a harmonised survey and certification regime for these ships. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 9(2).’;
  • (b) paragraph 3 shall be replaced by the following: ‘3. If the AFS-Convention has not entered into force by 1 January 2007, the Commission shall adopt appropriate measures in order to allow ships flying the flag of a third State to demonstrate their compliance with Article 5. 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 9(2).’;
    1. in Article 7, the second paragraph shall be replaced by the following: ‘If the AFS-Convention has not entered into force by 1 January 2007, the Commission shall establish appropriate procedures for these controls. 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 9(2).’;
    1. Article 8 shall be replaced by the following: ‘Article 8 In order to take account of developments at international level and in particular in the International Maritime Organisation (IMO), or to improve the effectiveness of this Regulation in the light of experience, the Commission may amend the references to the AFS-Convention, to the AFS-Certificate, to the AFS-Declaration and to the AFS-Statement of Compliance and the Annexes to this Regulation, including relevant IMO guidelines in relation to Article 11 of the AFS-Convention. 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 9(2).’;
    1. Article 9 shall be replaced by the following: ‘Article 9 Committee procedure
1.

The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council ([^E0053]).

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.

7.8.   Regulation (EC) No 725/2004 of the European Parliament and of the Council of 31 March 2004 on enhancing ship and port facility security([^E0056])

As regards Regulation (EC) No 725/2004, the Commission should be empowered to decide whether amendments to the Annexes, which concern certain special measures to enhance maritime security of the International Convention for the Safety of Life at Sea, and of the International Code for the security of ships and of port facilities, that apply automatically to international traffic should also apply to ships operating domestic services and the port facilities serving them. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 725/2004, 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.

Regulation (EC) No 725/2004 lays down security requirements and measures and is based on international instruments that are subject to amendment. Where, 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.

Accordingly, Regulation (EC) No 725/2004 is hereby amended as follows:

    1. Article 10(2) shall be replaced by the following: ‘2. The Commission shall decide on the integration of amendments to the international instruments referred to in Article 2 in respect of ships operating domestic services and the port facilities serving them to which this Regulation applies, in so far as they constitute a technical update of the provisions of the SOLAS Convention and the ISPS Code. 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(4); on imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 11(5). The procedure for checking conformity established in paragraph 5 of this Article shall not apply in these cases.’;
    1. Article 10(3) shall be replaced by the following: ‘3. The Commission may adopt provisions in order to define harmonised procedures for the application of the mandatory provisions of the ISPS Code, without broadening the scope of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 11(5).’;
    1. Article 11 shall be replaced by the following: ‘Article 11 Committee procedure
1.

The Commission shall be assisted by a committee.

2.

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

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

3.

Where reference is made to this paragraph, Articles 6 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The periods laid down in Article 6(b) and (c) respectively of Decision 1999/468/EC shall be set at one month.

4.

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

5.

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

7.9.   Regulation (EC) No 789/2004 of the European Parliament and of the Council of 21 April 2004 on the transfer of cargo and passenger ships between registers within the Community([^E0057])

As regards Regulation (EC) No 789/2004, the Commission should be empowered to amend certain definitions in order to take account of developments at international level, in particular in the International Maritime Organisation (IMO), and to improve the effectiveness of the Regulation in the light of experience and technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 789/2004, 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 789/2004 is hereby amended as follows:

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

The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) set up by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council ([^E0058]).

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 two months.

3.

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

    1. Article 9(1) shall be replaced by the following: ‘1. In order to take account of developments at international level, in particular in the International Maritime Organisation (IMO), and to improve the effectiveness of this Regulation in the light of experience and technical progress, the Commission may amend the definitions in Article 2 insofar as such amendments do not broaden the scope of the Regulation. 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 7(3).’

7.10.   Directive 2005/44/EC of the European Parliament and of the Council of 7 September 2005 on harmonised river information services (RIS) on inland waterways in the Community([^E0059])

As regards Directive 2005/44/EC, the Commission should be empowered to adapt the annexes to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2005/44/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 2005/44/EC is hereby amended as follows:

    1. Article 10 shall be replaced by the following: ‘Article 10 Amendment procedure Annexes I and II may be amended in the light of the experience gained from the application of this Directive and adapted 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 11(4).’;
    1. Article 11 shall be replaced by the following: ‘Article 11 Committee procedure
1.

The Commission shall be assisted by the Committee set up by Article 7 of Council Directive 91/672/EEC of 16 December 1991 on the reciprocal recognition of boatmasters’ certificates for the carriage of goods and passengers by inland waterway ([^E0060]).

2.

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

3.

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

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

4.

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

5.

The Commission shall regularly consult representatives of the sector.

7.11.   Directive 2005/65/EC of the European Parliament and of the Council of 26 October 2005 on enhancing port security([^E0061])

As regards Directive 2005/65/EC, the Commission should be empowered to adapt the Annexes thereto. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2005/65/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Directive 2005/65/EC lays down security requirements and measures and is based on international instruments that are subject to amendment. Where, 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 adaptation of its Annexes.

Accordingly, Articles 14 and 15 of Directive 2005/65/EC shall be replaced by the following:

‘Article 14

Adaptations

The Commission may adapt Annexes I to IV without broadening the scope 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 15(2).

On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 15(3).

Article 15

Committee procedure

1.

The Commission shall be assisted by the committee set up by Regulation (EC) No 725/2004.

2.

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

3.

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.’

Chronological index

  • (1)Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers
  • (2)Council Directive 79/373/EEC of 2 April 1979 on the circulation of compound feeding stuffs
  • (3)Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition
  • (4)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
  • (5)Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport
  • (6)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
  • (7)Council Regulation (EEC) No 3924/91 of 19 December 1991 on the establishment of a Community survey of industrial production
  • (8)Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses
  • (9)European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste
  • (10)Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk products
  • (11)Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials
  • (12)Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid
  • (13)Council Directive 97/70/EC of 11 December 1997 setting up a harmonised safety regime for fishing vessels of 24 metres in length and over
  • (14)Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels
  • (15)Council Directive 1999/35/EC of 29 April 1999 on a system of mandatory surveys for the safe operation of regular ro-ro ferry and high-speed passenger craft services
  • (16)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
  • (17)Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants
  • (18)Directive 2001/109/EC of the European Parliament and of the Council of 19 December 2001 concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain species of fruit trees
  • (19)Regulation (EC) No 417/2002 of the European Parliament and of the Council of 18 February 2002 on the accelerated phasing-in of double hull or equivalent design requirements for single hull oil tankers
  • (20)Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed
  • (21)Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics
  • (22)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
  • (23)Regulation (EC) No 782/2003 of the European Parliament and of the Council of 14 April 2003 on the prohibition of organotin compounds on ships
  • (24)Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movements of pet animals
  • (25)Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers
  • (26)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
  • (27)Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents
  • (28)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
  • (29)Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors
  • (30)Directive 2004/8/EC of the European Parliament and of the Council of 11 February 2004 on the promotion of cogeneration based on a useful heat demand in the internal energy market
  • (31)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)
  • (32)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)
  • (33)Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents
  • (34)Regulation (EC) No 725/2004 of the European Parliament and of the Council of 31 March 2004 on enhancing ship and port facility securit
  • (35)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
  • (36)Regulation (EC) No 789/2004 of the European Parliament and of the Council of 21 April 2004 on the transfer of cargo and passenger ships between registers within the Community
  • (37)Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids
  • (38)Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants
  • (39)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs
  • (40)Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin
  • (41)Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption
  • (42)Directive 2004/52/EC of the European Parliament and of the Council of 29 April 2004 on the interoperability of electronic road toll systems in the Community
  • (43)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
  • (44)Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene
  • (45)Directive 2005/44/EC of the European Parliament and of the Council of 7 September 2005 on harmonised river information services (RIS) on inland waterways in the Community
  • (46)Directive 2005/65/EC of the European Parliament and of the Council of 26 October 2005 on enhancing port security
  • (47)Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste

[^E0001]: () OJ L 163, 2.7.1996, p. 1.

[^E0002]: () OJ L 147, 9.6.1975, p. 40.

[^E0004]: () OJ L 162, 3.7.2000, p. 1.

[^E0005]: () OJ L 304, 21.11.2003, p. 1.

[^E0006]: () OJ L 50, 20.2.2004, p. 28.

[^E0007]: OJ 196, 16.8.1967, p. 1.’;

[^E0008]: () OJ L 50, 20.2.2004, p. 44.

[^E0009]: OJ 196, 16.8.1967, p. 1.’;

[^E0010]: () OJ L 47, 18.2.2004, p. 1.

[^E0011]: OJ L 22, 26.1.2005, p. 1.’

[^E0012]: () OJ L 104, 8.4.2004, p. 1.

[^E0013]: () OJ L 136, 30.4.2004, p. 1.

[^E0014]: () OJ L 378, 31.12.1982, p. 1.

[^E0015]: () OJ L 181, 4.7.1986, p. 6.

[^E0016]: () OJ L 365, 31.12.1994, p. 10.

[^E0018]: () OJ L 309, 27.11.2001, p. 22.

[^E0019]: () OJ L 275, 25.10.2003, p. 32.

[^E0021]: () OJ L 23, 26.1.2005, p. 3.

[^E0022]: () OJ L 190, 12.7.2006, p. 1.

[^E0023]: OJ L 377, 31.12.1991, p. 48.’;

[^E0024]: () OJ L 374, 31.12.1991, p. 1.

[^E0025]: OJ L 181, 28.6.1989, p. 47.’

[^E0026]: () OJ L 78, 28.3.1996, p. 27.

[^E0030]: () OJ L 66, 11.3.2003, p. 1.

[^E0031]: () OJ L 7, 13.1.2004, p. 1.

[^E0032]: () OJ L 142, 30.4.2004, p. 12.

[^E0033]: () OJ L 86, 6.4.1979, p. 30.

[^E0034]: () OJ L 213, 21.7.1982, p. 8.

[^E0035]: () OJ L 125, 23.5.1996, p. 35.

[^E0036]: () OJ L 140, 30.5.2002, p. 10.

[^E0037]: OJ L 170, 3.8.1970, p. 1.’;

[^E0039]: () OJ L 325, 12.12.2003, p. 31.

[^E0040]: () OJ L 139, 30.4.2004, p. 1.

[^E0041]: () OJ L 139, 30.4.2004, p. 55.

[^E0042]: () OJ L 139, 30.4.2004, p. 206.

[^E0043]: () OJ L 35, 8.2.2005, p. 1.

[^E0045]: () OJ L 34, 9.2.1998, p. 1.

[^E0046]: OJ L 324, 29.11.2002, p. 1.

[^E0047]: OJ L 184, 17.7.1999, p. 23.’

[^E0048]: () OJ L 138, 1.6.1999, p. 1.

[^E0049]: OJ L 324, 29.11.2002, p. 1.’;

[^E0052]: () OJ L 115, 9.5.2003, p. 1.

[^E0053]: OJ L 324, 29.11.2002, p. 1.’

[^E0056]: () OJ L 129, 29.4.2004, p. 6.

[^E0057]: () OJ L 138, 30.4.2004, p. 19.

[^E0058]: OJ L 324, 29.11.2002, p. 1.’;

[^E0059]: () OJ L 255, 30.9.2005, p. 152.

[^E0060]: OJ L 373, 31.12.1991, p. 29.’

[^E0061]: () OJ L 310, 25.11.2005, p. 28.

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