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

Type Regulation
Publication 2009-06-18
Last updated 2009-08-07
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 3
Reform history JSON API

As regards Directive 2002/98/EC, the Commission should be empowered in particular to adapt the technical requirements set out in Annexes I to IV to technical and scientific progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2002/98/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.

In the event that scientific and technical developments indicate that additional information should be provided to or obtained from donors, in order, for instance, to exclude donors presenting a health risk to others, an adaptation should be made without delay. Similarly, if scientific progress suggests new eligibility criteria concerning the suitability of blood and plasma donors, new deferral criteria should be added to the list immediately. 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 adaptation to scientific and technical progress of the technical requirements concerning information to be provided to or obtained from donors, as well as requirements related to the suitability of blood and plasma donors, set out in Annexes I to IV.

Accordingly, Directive 2002/98/EC is hereby amended as follows:

1.Article 28 shall be replaced by the following: ‘Article 28 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 referred to 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.’;

2.Article 29 shall be amended as follows: (a)the first paragraph shall be replaced by the following: ‘The adaptation of the technical requirements set out in Annexes I to IV to technical and scientific progress shall be decided 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 28(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 28(4) as regards technical requirements set out in Annexes III and IV.’; (b)the introductory wording in the second paragraph shall be replaced by the following: ‘The following technical requirements and their adaptation to technical and scientific progress shall be decided by the Commission:’; (c)the following paragraphs are added: ‘Technical requirements referred to in points (a) to (i) of the second paragraph, being 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 28(3). On imperative grounds of urgency the Commission may have recourse to the urgency procedure referred to in Article 28(4) as regards technical requirements referred to in points (b), (c),(d), (e), (f) and (g) of the second paragraph.’.

5.12.   Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (64)

As regards Regulation (EC) No 1831/2003, the Commission should be empowered in particular to establish, as a result of technological progress or scientific development, additional feed additive categories and functional groups, to adopt amendments to Annex III and to the general conditions of Annex IV to take technological progress and scientific development into account and to adopt amendments to Annex II. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1831/2003, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 1831/2003 is hereby amended as follows:

1.Article 3(5) shall be replaced by the following: ‘5.  Where necessary, as a result of technological progress or scientific development, the Commission may adapt the general conditions set out in Annex IV. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3).’;

2.Article 6(3) shall be replaced by the following: ‘3.  Where necessary, as a result of technological progress or scientific development, the Commission shall establish additional feed additive categories and functional groups. 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 22(3).’;

3.the second subparagraph of Article 7(5) shall be replaced by the following: ‘After the Authority has been consulted, further rules for the implementation of this Article may be established. Rules to allow for simplified provisions for the authorisation of additives which have been authorised for use in food shall be laid down 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 22(3). Other implementing rules may be adopted in accordance with the regulatory procedure referred to in Article 22(2). Those rules should, where appropriate, differentiate between requirements for feed additives in respect of food-producing animals and requirements in respect of other animals, in particular pets.’;

4.Article 16(6) shall be replaced by the following: ‘6.  The Commission may adopt amendments to Annex III to take technological progress and scientific development into account. 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 22(3).’;

5.the third paragraph of Article 21 shall be replaced by the following: ‘Detailed rules for implementing Annex II shall be adopted in accordance with the regulatory procedure referred to in Article 22(2). Annex II may be amended 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 22(3).’;

6.Article 22(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.’.

5.13.   Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (65)

As regards Regulation (EC) No 2065/2003, 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 Regulation (EC) No 2065/2003, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 2065/2003 is hereby amended as follows:

1.Article 17(3) shall be replaced by the following: ‘3.  If necessary, the Commission shall, after requesting scientific and technical assistance from the Authority, adopt quality criteria for validated analytical methods proposed in accordance with point 4 of Annex II, including substances to be measured. 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 19(3).’;

2.Article 18 shall be replaced by the following: ‘Article 18 Amendments

1.

Amendments to the Annexes shall be adopted by the Commission following a request to the Authority for scientific and/or technical assistance. 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 19(3).

2.

Amendments to the list referred to in Article 6(1) shall be adopted in accordance with the regulatory procedure referred to in Article 19(2) following a request to the Authority for scientific and/or technical assistance.’;

3.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.’.

5.14.   Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (66)

As regards Regulation (EC) No 2160/2003, the Commission should be empowered in particular to adopt Community targets for the reduction of the prevalence of zoonoses and zoonotic agents, specific control methods and specific rules concerning the criteria for the evaluation of the testing methods, and to lay down the responsibilities and tasks of the reference laboratories and the rules for the implementation of Community controls. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 2160/2003, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 2160/2003 is hereby amended as follows:

1.Article 4 shall be amended as follows: (a)the second subparagraph of paragraph 1 shall be replaced by the following: ‘The targets, and any amendments thereto, shall be established 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).’; (b)paragraph 6(a) shall be replaced by the following: ‘(a)Annex I may be amended by the Commission for the purposes listed in point (b), after taking account in particular of the criteria listed in point (c). 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 14(3).’; (c)paragraph 7 shall be replaced by the following: ‘7.  Annex III may be amended or supplemented 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 14(3).’;

2.Article 5(6) shall be replaced by the following: ‘6.  The requirements and minimum sampling rules laid down in Annex II may be amended, adapted or supplemented by the Commission, after taking account in particular of the criteria listed in Article 4(6)(c). 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 14(3).’;

3.Article 8(1) shall be amended as follows: (a)the introductory words shall be replaced by the following: ‘At the initiative of the Commission or at the request of a Member State:’; (b)the following subparagraph shall be added: ‘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.  Without prejudice to Article 5(6), specific rules concerning the setting by Member States of the criteria referred to in Article 5(5) and in paragraph 2 of this Article 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 14(3).’;

5.Article 10(5) shall be replaced by the following: ‘5.  The Member State of final destination may be authorised, in accordance with the regulatory procedure referred to in Article 14(2), to require for a transitional period that the results of the testing referred to in paragraph 4 of this Article fulfil the same criteria as those laid down under its national programme, in accordance with Article 5(5). The authorisation may be withdrawn and, without prejudice to Article 5(6), specific rules concerning such criteria 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 14(3).’;

6.Article 11 shall be amended as follows: (a)paragraph 2 shall be replaced by the following: ‘2.  The responsibilities and tasks of the Community reference laboratories, in particular with regard to coordination of their activities and those of the national reference laboratories, 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).’; (b)paragraph 4 shall be replaced by the following: ‘4.  Certain responsibilities and tasks of the national reference laboratories, in particular with regard to coordination of their activities and those of the relevant laboratories in the Member States designated under Article 12(1)(a), 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 14(3).’;

7.the third subparagraph of Article 12(3) shall be replaced by the following: ‘Where necessary, other methods for testing may be 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 14(3).’;

8.Article 13 shall be replaced by the following: ‘Article 13 Implementing and transitional measures Appropriate transitional or implementing measures, including the necessary amendments to the relevant health certificates, may be adopted by the Commission. Transitional measures of general scope designed to amend non-essential elements of this Regulation, including those supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in the provisions of 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).’;

9.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.’;

10.Article 17(2) shall be replaced by the following: ‘2.  Practical arrangements for the implementation of this Article, in particular those governing the procedure for cooperation with national competent authorities, shall be laid down under the regulatory procedure referred to in Article 14(2).’.

5.15.   Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (67)

As regards Directive 2004/23/EC, the Commission should be empowered in particular to establish traceability requirements for tissues and cells and the related procedures of enforcement as well as certain technical requirements regarding, inter alia, an accreditation system for tissue establishments and the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/32/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.

In the event that scientific and technical developments on selection criteria and laboratory tests for donors provide for new evidence of diseases transmissible through donation, prompt adaptation of Community legislation should follow consequently. 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 concerning the criteria for selection of the donor of tissues and/or cells and the laboratory tests required for donors.

Accordingly, Directive 2004/23/EC is hereby amended as follows:

1.Article 8 shall be amended as follows: (a)paragraph 5 shall be replaced by the following: ‘5.  The traceability requirements for tissues and cells, as well as for products and materials coming into contact with those tissues and cells and having an effect on their quality and safety, 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 29(3).’; (b)paragraph 6 shall be replaced by the following: ‘6.  The procedures for ensuring traceability at Community level shall be established 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 29(3).’;

2.Article 9(4) shall be replaced by the following: ‘4.  The procedures for verifying the equivalent standards of quality and safety in accordance with paragraph 1 shall be established 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 29(3).’;

3.Article 28 shall be amended as follows: (a)the introductory wording shall be replaced by the following: ‘The following technical requirements and their adaptation to scientific and technical progress shall be decided by the Commission:’; (b)the following paragraphs shall be added: ‘Technical requirements referred to in points (a) to (i), being 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 29(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 29(4) as regards technical requirements referred to in points (d) and (e) of this Article.’;

4.Article 29 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.’.

5.16.   Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (68)

As regards Regulation (EC) No 882/2004, the Commission should be empowered in particular to adopt implementing measures concerning methods of sampling and analysis, to lay down the conditions in which special treatment may take place, to update the minimum rates for any fees or charges, to determine the circumstances in which official certification is required, to amend and update the lists of Community reference laboratories, and to lay down the criteria for assessing the risk of products exported to the Community and specific import conditions. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 882/2004, 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 882/2004 is hereby amended as follows:

1.Article 11(4) shall be amended as follows: (a)the introductory wording shall be replaced by the following: ‘The following implementing measures may be taken by the Commission:’; (b)the following subparagraph shall be added: ‘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 62(4).’;

2.Article 20(2) shall be replaced by the following: ‘2.  The competent authority shall ensure that special treatment takes place in establishments under its control, or under the control of another Member State, and in accordance with 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 62(4). In the absence of such conditions, the special treatment shall take place in accordance with national rules.’;

3.the second subparagraph of Article 27(3) shall be replaced by the following: ‘The rates in Annex IV, Section B and Annex V, Section B shall be updated by the Commission at least every two years, in particular to take account of inflation. 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 62(4).’;

4.Article 30(1) shall be amended as follows: (a)the introductory wording shall be replaced by the following: ‘Without prejudice to requirements concerning official certification adopted for animal health or animal welfare purposes, requirements may be adopted by the Commission concerning:’; (b)the following subparagraphs are added: ‘The measures 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 62(4). The measures referred to in points (b) to (g) shall be adopted in accordance with the regulatory procedure referred to in Article 62(3).’;

5.Article 32 shall be amended as follows: (a)paragraph 5 shall be replaced by the following: ‘5.  Other Community reference laboratories relevant to the areas referred to in Article 1 may be included in Annex VII 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 62(4). In accordance with the same procedure, Annex VII may be updated.’; (b)paragraph 6 shall be replaced by the following: ‘6.  Additional responsibilities and tasks for Community reference laboratories 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 62(4).’;

6.Article 33(6) shall be replaced by the following: ‘6.  Additional responsibilities and tasks for national reference laboratories 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 62(4).’;

7.the second subparagraph of Article 46(3) shall be replaced by the following: ‘The criteria for determining risk for the purpose of the risk assessment referred to in point (a) shall be decided 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 62(4).’;

8.Article 48(1) shall be replaced by the following: ‘1.  To the extent that the conditions and detailed procedures to be respected when importing goods from third countries or their regions are not provided for by Community law and in particular by Regulation (EC) No 854/2004, they shall, if necessary, 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 62(4).’;

9.Article 62(4) shall be replaced by the following: ‘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.’;

10.Article 63 shall be replaced by the following: ‘Article 63 Implementing and transitional measures

1.

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

—any modification of the standards referred to in Article 12(2), —a definition of what feed is to be regarded as feed of animal origin for the purpose of this Regulation, and further specifications of the requirements laid down in the provisions of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 62(4). Other transitional and implementing measures necessary in order to ensure the uniform application of this Regulation may be laid down in accordance with the regulatory procedure referred to in Article 62(3). This applies in particular to: —the delegation of control tasks to control bodies referred to in Article 5, where those control bodies were already in operation before the entry into force of this Regulation, —non-compliance as referred to in Article 28 which gives rise to expense arising from additional official controls, —expenditure incurred pursuant to Article 54, —rules on microbiological, physical and/or chemical analysis in official controls, in particular in cases involving a suspicion of risk and including the surveillance of the safety of products imported from third countries,

2.

In order to take account of the specificity of Regulations (EEC) No 2092/91, (EEC) No 2081/92 and (EEC) No 2082/92, specific measures to be adopted by the Commission may provide for the necessary derogations from, and adjustments to, the rules laid down in 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 62(4).’;

11.Article 64 shall be replaced by the following: ‘Article 64 Amendment of Annexes and references to European standards The following 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 62(4): (1)the Annexes to this Regulation may be updated, except for Annex I, Annex IV and Annex V, without prejudice to Article 27(3), in particular in order to take account of administrative changes and scientific and/or technological progress; (2)the references to the European standards mentioned in this Regulation may be updated in the event that CEN amends those references.’.

5.17.   Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (69)

As regards Regulation (EC) No 1935/2004, the Commission should be empowered in particular to adopt specific measures for groups of materials and articles, Community authorisation of a substance, and the modification, suspension or revocation of such authorisation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1935/2004, 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.

In order to strengthen the competitiveness and innovation of the European industry, materials and articles intended to come into contact with food should be marketed as soon as possible once their safety has been established. On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of a list of substances authorised for use in the manufacturing of materials and articles; list(s) of authorised substances incorporated in active or intelligent food contact materials and articles, list(s) of active or intelligent materials and articles and, when necessary, special conditions of use for those substances and/or the materials and articles in which they are incorporated; purity standards; special conditions of use for certain substances and/or the materials and articles in which they are used; specific limits on the migration of certain constituents or groups of constituents into or on to food; amendments of existing specific directives on materials and articles; Community authorisations and the modification, suspension or revocation thereof.

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 specific measures regarding the modification, suspension or revocation of Community authorisations.

Accordingly, Regulation (EC) No 1935/2004 is hereby amended as follows:

1.Article 5 shall be amended as follows: (a)the first subparagraph of paragraph 1 shall be replaced by the following: ‘For the groups of materials and articles listed in Annex I and, where appropriate, combinations of those materials and articles or recycled materials and articles used in the manufacture of those materials and articles, specific measures may be adopted or amended by the Commission.’; (b)the following subparagraphs shall be added to paragraph 1: ‘The specific measures referred to in point (m) shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 23(2). The specific measures referred to in points (f), (g), (h), (i), (j), (k), (l) and (n), designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3). The specific measures referred to in points (a) to (e), designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(4).’; (c)paragraph 2 shall be replaced by the following: ‘2.  The Commission may amend the existing specific directives on materials and articles. Those measures, designed to amend the non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(4).’;

2.Article 11(3) shall be replaced by the following: ‘3.  Community authorisation in the form of specific measure, as referred to in paragraph 1, shall be adopted 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 23(4).’;

3.Article 12(6) shall be replaced by the following: ‘6.  A final specific measure on the modification, suspension or revocation of the authorisation shall be adopted 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 23(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 23(5).’;

4.Article 22 shall be replaced by the following: ‘Article 22 Amendments to Annexes I and II shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’;

5.Article 23 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 time-limits 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. ENERGY AND TRANSPORT

6.1.   Council Directive 96/98/EC of 20 December 1996 on marine equipment (70)

As regards Directive 96/98/EC, the Commission should be empowered in particular to adopt testing standards where international organisations fail or refuse to adopt them within a reasonable time, to transfer equipment from Annex A.2 to Annex A.1, and to authorise, in exceptional circumstances, the placing on board of technically innovative equipment. The Commission should also be empowered to apply, for the purposes of that Directive, subsequent amendments of international instruments, to update Annex A, to add the possibility of using certain modules for equipment listed in Annex A.1, to amend the columns for the conformity assessment modules, and to include standardisation organisations in the definition of ‘testing standards’ in Article 2. Since those measures are of general scope and are designed to amend non-essential elements of Directive 96/98/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.

Accordingly, Directive 96/98/EC is hereby amended as follows:

1.Article 7(5) and (6) shall be replaced by the following: ‘5.  Should the international organisations, including the IMO, fail or refuse to adopt appropriate testing standards for a specific item of equipment within a reasonable time, standards based on the work of the European standardisation organisations may be adopted. 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 18(3).

6.

When the testing standards referred to in paragraphs 1 or 5 are adopted or enter into force, as appropriate, for a specific item of equipment, that equipment may be transferred from Annex A.2 to Annex A.1. 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 18(3).

Article 5 shall apply to that equipment from the date of that transfer.’;

2.in Article 13(2), the first indent shall be replaced by the following: ‘—the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the testing standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 18(1) within two months if the Member State which has taken the decision intends to maintain it, and shall initiate the regulatory procedure referred to in Article 18(2).’;

3.Article 14(5) shall be replaced by the following: ‘5.  Equipment such as is referred to in paragraph 1 shall be added to Annex A.2. 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 18(3).’;

4.the first paragraph of Article 17 shall be replaced by the following: ‘This Directive may be amended in order: (a)to apply subsequent amendments of international instruments for the purposes of this Directive; (b)to update Annex A, both by introducing new equipment and by transferring equipment from Annex A.2 to Annex A.1 and vice versa; (c)to add the possibility of using modules B + C and module H for equipment listed in Annex A.1, and by amending the columns for the conformity assessment modules; (d)to include other standardisation organisations in the definition of “testing standards” in Article 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 18(3).’;

5.Article 18 shall be replaced by the following: ‘Article 18

1.

The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council (71).

2.

Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC (72) 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.

6.2.   Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) and amending the Regulations on maritime safety and the prevention of pollution from ships (73)

As regards Regulation (EC) No 2099/2002, the Commission should be empowered in particular to amend Article 2(2) in order to include a reference to the Community acts conferring implementing powers on COSS that have entered into force following the adoption of this Regulation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 2099/2002, 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 2099/2002 is hereby amended as follows:

1.Article 3 shall be replaced by the following: ‘Article 3 Establishment of a Committee

1.

The Commission shall be assisted by a Committee on Safe Seas and the Prevention of Pollution from Ships (hereinafter called COSS).

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, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

2.Article 7 shall be replaced by the following: ‘Article 7 Powers of COSS COSS shall exercise the powers conferred on it by virtue of the Community legislation in force. Article 2(2) may be amended in accordance with the regulatory procedure with scrutiny referred to in Article 3(3) in order to include a reference to the Community acts conferring implementing power on COSS that have entered into force following the adoption of this Regulation. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the procedure referred to in Article 3(3).’.

6.3.   Directive 2003/42/EC of the European Parliament and of the Council of 13 June 2003 on occurrence reporting in civil aviation (74)

As regards Directive 2003/42/EC, the Commission should be empowered in particular to amend the Annexes in order to expand upon, or change, the examples, to facilitate the exchange of information and to adopt measures for the dissemination to interested parties of the information. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2003/42/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2003/42/EC is hereby amended as follows:

1.Article 3(2) shall be replaced by the following: ‘2.  The Commission may decide to amend the Annexes in order to expand upon, or change, the examples. 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 10(3).’;

2.Article 7(2) shall be replaced by the following: ‘2.  Without prejudice to the public’s right of access to the Commission’s documents as laid down in Regulation (EC) No 1049/2001 of the European Parliament and the Council (75), the Commission shall adopt on its own initiative measures for the dissemination to interested parties of the information referred to in paragraph 1 and the associated conditions. Those measures, which may be general or individual, shall be based on the need: —to provide persons and organisations with the information they need to improve civil aviation safety, —to limit the dissemination of information to what is strictly required for the purpose of its users, in order to ensure appropriate confidentiality of that information, The individual measures shall be adopted in accordance with the regulatory procedure referred to in Article 10(2). The general 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). The decision to disseminate information under this paragraph shall be limited to what is strictly required for the purpose of its user, without prejudice to the provisions of Article 8.

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

1.

The Commission shall be assisted by the committee established by Article 12 of Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation (76).

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 provided for 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.

6.4.   Directive 2004/36/EC of the European Parliament and of the Council of 21 April 2004 on the safety of third-country aircraft using Community airports (77)

As regards Directive 2004/36/EC, the Commission should be empowered in particular to adopt measures for the dissemination to interested parties of the information obtained through ramp inspections conducted under the European Community (EC) SAFA Programme, and measures amending the Annexes to the Directive, laying down the elements of technical procedures for the conduct and reporting of SAFA ramp inspections. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/36/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 2004/36/EC is hereby amended as follows:

1.Article 6(3) shall be replaced by the following: ‘3.  Without prejudice to the public’s right of access to the Commission’s documents as laid down in Regulation (EC) No 1049/2001, the Commission shall adopt, on its own initiative, measures for the dissemination to interested parties of the information referred to in paragraph 1 and the associated conditions. Those measures, which may be general or individual, shall be based on the need: —to provide persons and organisations with the information they need to improve civil aviation safety, —to limit the dissemination of information to what is strictly required for the purposes of its users, in order to ensure appropriate confidentiality of that information, The individual measures shall be adopted in accordance with the advisory procedure referred to in Article 10(3). The general 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(4).’;

2.Article 8(2) shall be replaced by the following: ‘2.  On the basis of the information collected under paragraph 1, the Commission may (a)in accordance with the regulatory procedure referred to in Article 10(2), take any appropriate measures to facilitate the implementation of Articles 3, 4 and 5, such as: —define the format for the storage and dissemination of data, —create or support the appropriate bodies for managing or operating the tools necessary for the collection and exchange of information, (b)detail conditions for conducting ramp inspections, including systematic ones, and establish the list of information to be collected. 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(4).’;

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

1.

The Commission shall be assisted by the committee set up by Article 12 of Regulation (EEC) No 3922/91.

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, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.

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

5.

The Committee may furthermore be consulted by the Commission on any other matter concerning the application of this Directive.’;

4.Article 12 shall be replaced by the following: ‘Article 12 The Commission may amend the Annexes to 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 10(4).’.

6.5.   Regulation (EC) No 868/2004 of the European Parliament and of the Council of 21 April 2004 concerning protection against subsidisation and unfair pricing practices causing injury to Community air carriers in the supply of air services from countries not members of the European Community (78)

As regards Regulation (EC) No 868/2004, the Commission should be empowered in particular to develop a detailed methodology for determining the existence of unfair pricing practices. This methodology should cover, inter alia, the manner in which normal competitive pricing, actual costs and reasonable profit margins are to be assessed in the specific context of the aviation sector. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 868/2004 by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Regulation (EC) No 868/2004 is hereby amended as follows:

1.Article 5(3) shall be replaced by the following: ‘3.  The Commission shall develop a detailed methodology for determining the existence of unfair pricing practices. This methodology shall cover, inter alia, the manner in which normal competitive pricing, actual costs and reasonable profit margins are to be assessed in the specific context of the aviation sector. 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 15(4).’;

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

1.

The Commission shall be assisted by the Committee established by Article 11 of Council Regulation (EEC) No 2408/92 of 23 July 1992 on access for Community air carriers to intra-Community air routes (79).

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.

6.6.   Directive 2004/54/EC of the European Parliament and of the Council of 29 April 2004 on minimum safety requirements for tunnels in the Trans-European Road Network (80)

As regards Directive 2004/54/EC, the Commission should be empowered in particular to make the necessary amendments to adapt the Annexes to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/54/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/54/EC is hereby amended as follows:

1.Article 13(3) shall be replaced by the following: ‘3.  By 30 April 2009 the Commission shall publish a report on the practice followed in the Member States. Where necessary, it shall make recommendations for the adoption of a common harmonised risk analysis methodology in accordance with the regulatory procedure referred to in Article 17(2).’;

2.Article 16 shall be replaced by the following: ‘Article 16 Adaptation to technical progress The Commission shall adapt to technical progress the Annexes to 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 17(3).’;

3.Article 17 shall be replaced by the following: ‘Article 17 Committee procedure

1.

The Commission shall be assisted by a committee.

2.

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

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

3.

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

6.7.   Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 December 2005 on the establishment of a Community list of air carriers subject to an operating ban within the Community and on informing air transport passengers of the identity of the operating air carrier (81)

As regards Regulation (EC) No 2111/2005, the Commission should be empowered in particular to modify the common criteria for imposing an operating ban on an air carrier in order to take account of scientific and technical developments. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 2111/2005, 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.

On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the modification of the Annex setting out the common criteria for consideration of an operating ban for safety reasons at Community level.

Accordingly, Regulation (EC) No 2111/2005 is hereby amended as follows:

1.Article 3(2) shall be replaced by the following: ‘2.  The common criteria for imposing an operating ban on an air carrier, which shall be based on the relevant safety standards, are set out in the Annex (and are hereinafter referred to as the common criteria). The Commission may modify the Annex, in particular in order to take account of scientific and technical developments. 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 15(4).’;

2.Article 8(1) shall be replaced by the following: ‘1.  The Commission shall, where appropriate, adopt implementing measures in order to lay down detailed rules in respect of the procedures referred to in this Chapter. 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 15(4).’;

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

1.

The Commission shall be assisted by the Committee referred to in Article 12 of Regulation (EEC) No 3922/91 (hereinafter referred to as the Committee).

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 referred to 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 (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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

5.

The Commission may consult the Committee on any other matter concerning the application of this Regulation.’.

Chronological index

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

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

(3)Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonized indices of consumer prices.

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

(5)Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls.

(6)Council Directive 96/98/EC of 20 December 1996 on marine equipment.

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

(8)Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery.

(9)Council Regulation EC) No 577/98 of 9 March 1998 on the organisation of a labour force sample survey in the Community.

(10)Council Regulation (EC) No 1165/98 of 19 May 1998 concerning short-term statistics.

(11)Decision 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.

(12)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

(13)Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption.

(14)Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity.

(15)Council Regulation (EC) No 530/1999 of 9 March 1999 concerning structural statistics on earnings and on labour costs.

(16)Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.

(17)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.

(18)Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer.

(19)Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

(20)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.

(21)Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products.

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

(23)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.

(24)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.

(25)Regulation (EC) 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) and amending the Regulations on maritime safety and the prevention of pollution from ships.

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

(27)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.

(28)Regulation (EC) No 450/2003 of the European Parliament and of the Council of 27 February 2003 concerning the labour cost index.

(29)Directive 2003/42/EC of the European Parliament and of the Council of 13 June 2003 on occurrence reporting in civil aviation.

(30)Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition.

(31)Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods.

(32)Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents.

(33)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.

(34)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.

(35)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

(36)Directive 2004/36/EC of the European Parliament and of the Council of 21 April 2004 on the safety of third-country aircraft using Community airports.

(37)Regulation (EC) No 868/2004 of the European Parliament and of the Council of 21 April 2004 concerning protection against subsidisation and unfair pricing practices causing injury to Community air carriers in the supply of air services from countries not members of the European Community.

(38)Directive 2004/54/EC of the European Parliament and of the Council of 29 April 2004 on minimum safety requirements for tunnels in the Trans-European Road Network.

(39)Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

(40)Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food.

(41)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.

(42)Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 December 2005 on the establishment of a Community list of air carriers subject to an operating ban within the Community and on informing air transport passengers of the identity of the operating air carrier.

(43)Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register.

(44)Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality.

(45)Directive 2006/21/EC of the European Parliament and of the Council of 15 March 2006 on the management of waste from extractive industries.

(46)Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery.

(1) OJ C 224, 30.8.2008, p. 35.

(2) OJ C 117, 14.5.2008, p. 1.

(3) Opinion of the European Parliament of 16 December 2008 (not yet published in the Official Journal) and Council Decision of 28 May 2009.

(4) OJ L 184, 17.7.1999, p. 23.

(5) OJ L 200, 22.7.2006, p. 11.

(6) OJ C 255, 21.10.2006, p. 1.

(7) OJ L 59, 27.2.1998, p. 1.

(8) OJ L 331, 7.12.1998, p. 1.

(9) OJ L 184, 17.7.1999, p. 23.’;

(10) OJ L 91, 7.4.1999, p. 10.

(11) OJ L 18, 22.1.2000, p. 1.

(12) OJ L 311, 28.11.2001, p. 67.

(13) OJ L 184, 17.7.1999, p. 23.’.

(14) OJ L 121, 1.5.2001, p. 34.

(15) OJ L 311, 28.11.2001, p. 67.’

(16) OJ L 311, 28.11.2001, p. 1.

(17) OJ L 157, 9.6.2006, p. 24.

(18) OJ L 243, 24.9.1996, p. 31.

(19) OJ L 114, 27.4.2006, p. 9.’.

(20) OJ L 330, 5.12.1998, p. 32.

(21) OJ L 244, 29.9.2000, p. 1.

(22) OJ L 33, 4.2.2006, p. 1.

(23) OJ L 64, 4.3.2006, p. 37.

(24) OJ L 102, 11.4.2006, p. 15.

(25) OJ L 257, 27.10.1995, p. 1.

(26) Published by the United Nations, series F No 2, revision 3, table 6.1, amended by the OECD (DES/NI/86,9), Paris 1986.’;

(27) OJ L 181, 28.6.1989, p. 47.

(28) OJ L 184, 17.7.1999, p. 23.’;

(29) OJ L 77, 14.3.1998, p. 3.

(30) OJ L 181, 28.6.1989, p. 47.

(31) OJ L 184, 17.7.1999, p. 23.’.

(32) OJ L 162, 5.6.1998, p. 1.

(33) OJ L 181, 28.6.1989, p. 47.

(34) OJ L 184, 17.7.1999, p. 23.’;

(35) OJ L 63, 12.3.1999, p. 6.

(36) OJ L 181, 28.6.1989, p. 47.

(37) OJ L 184, 17.7.1999, p. 23.’;

(38) OJ L 69, 13.3.2003, p. 1.

(39) OJ L 181, 28.6.1989, p. 47.’;

(40) OJ L 255, 30.9.2005, p. 1.

(41) OJ L 181, 28.6.1989, p. 47.’.

(42) OJ L 340, 16.12.2002, p. 1.

(43) OJ L 185, 16.8.1971, p. 15.’.

(44) OJ L 134, 30.4.2004, p. 1.

(45) OJ L 185, 16.8.1971, p. 15.’;

(46) OJ L 134, 30.4.2004, p. 114.

(47) OJ L 185, 16.8.1971, p. 15.’;

(48) OJ L 37, 13.2.1993, p. 1.

(49) OJ L 291, 19.11.1969, p. 9.’;

(50) OJ L 184, 17.7.1999, p. 23.’;

(51) OJ L 237, 22.9.1993, p. 23.

(52) OJ L 125, 23.5.1996, p. 10.

(53) OJ L 31, 1.2.2002, p. 1.

(54) OJ L 184, 17.7.1999, p. 23.’.

(55) OJ L 43, 14.2.1997, p. 1.

(56) OJ L 268, 3.10.1998, p. 1.

(57) OJ L 109, 6.5.2000, p. 29.

(58) OJ L 31, 1.2.2002, p. 1.’;

(59) OJ L 194, 18.7.2001, p. 26.

(60) OJ L 11, 15.1.2002, p. 4.

(61) OJ L 31, 1.2.2002, p. 1.

(62) OJ L 273, 10.10.2002, p. 1.

(63) OJ L 33, 8.2.2003, p. 30.

(64) OJ L 268, 18.10.2003, p. 29.

(65) OJ L 309, 26.11.2003, p. 1.

(66) OJ L 325, 12.12.2003, p. 1.

(67) OJ L 102, 7.4.2004, p. 48.

(68) OJ L 165, 30.4.2004, p. 1.

(69) OJ L 338, 13.11.2004, p. 4.

(70) OJ L 46, 17.2.1997, p. 25.

(71) OJ L 324, 29.11.2002, p. 1.

(72) OJ L 184, 17.7.1999, p. 23.’.

(73) OJ L 324, 29.11.2002, p. 1.

(74) OJ L 167, 4.7.2003, p. 23.

(75) OJ L 145, 31.5.2001, p. 43.’;

(76) OJ L 373, 31.12.1991, p. 4.’.

(77) OJ L 143, 30.4.2004, p. 76.

(78) OJ L 162, 30.4.2004, p. 1.

(79) OJ L 240, 24.8.1992, p. 8.’.

(80) OJ L 167, 30.4.2004, p. 39.

(81) OJ L 344, 27.12.2005, p. 15.

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