OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the control of salmonella and other specified food-borne zoonotic agents AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the EC Treaty

2001/0177 (COD)

OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the control of salmonella and other specified food-borne zoonotic agents

1. Introduction

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendments proposed by the European Parliament at second reading.

The Regulation is one of the two proposals that form part of the "zoonoses package" adopted by the Commission on 1 August 2001, as COM(2001) 452 final:

- a Directive of the European Parliament and of the Council on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC [1] and repealing Council Directive 92/117/EEC [2]: 2001/0176 (COD) [3];

[1] OJ L 224, 18.8.1990, p. 19; Decision as last amended by Regulation (EC) No 806/2003 of the Council (OJ L 122, 16.5.2003, p. 1).

[2] OJ L 62, 15.3.1993, p. 38; Directive as last amended by Directive 1999/72/EC of the European Parliament and of the Council (OJ L 210, 10.8.1999, p. 12).

[3] OJ C 304 E, 30.10.2001, p. 250.

- a Regulation of the European Parliament and of the Council on the control of salmonella and other specified food-borne zoonotic agents: 2001/0177 (COD) [4].

[4] OJ C 304 E, 30.10.2001, p. 260.

The two proposals were handled simultaneously along the co-decision procedure, because of the links between the two texts. The new Directive repeals Directive 92/117/EEC and contains the financing provisions for both the new Directive and the new Regulation.

In second reading, the Parliament approved the common position on the Directive and therefore the present opinion does not cover the Directive.

As regards the Regulation, the fruitful discussions held between the three Institutions to prepare the second reading, led the European Parliament to approve at its Plenary session of 19 June 2003, 6 amendments that the Council stated it would be in a position to approve.

2. Background

- Adoption of the proposals by the Commission: 1 August 2001 [5]

[5] COM(2001) 452 final of 1.8.2001.

- Opinion of the European Economic and Social Committee on both proposals: 20 February 2002 [6]

[6] OJ C 94, 18.4.2002, p. 18.

- Opinion of the European Parliament at first reading on both proposals: 15 May 2002 [7]

[7] Opinion of the EP of 15 May 2002 (not yet published on the OJ).

- Date of adoption of both revised Commission proposals: 27 November 2002 [8]

[8] COM(2002) 684 final of 27.11.2002.

- Date of political agreement in Council on both proposals: 28 November 2002 (qualified majority with support the Commission)

- Date of adoption of the common positions on each proposal: 20 February 2003 [9]

[9] OJ C 90E, 15.4.2003, p. 9 and p. 25 respectively for the Directive (common position (EC) No 13/2003) and for the Regulation (common position (EC) No 14/2003).

- Adoption by Parliament of the Recommendation for a second reading : 19 June 2003

3. Purpose of the proposal

The purpose of the "zoonoses package" is to revise and replace Directive 92/117/EEC of the Council concerning measures for protection against specified zoonoses and specific zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications.

The Regulation on control of salmonella and other specified food-borne zoonotic agents provides for effective measures to be progressively implemented to control specified food-borne zoonotic agents, primarily in specified animal populations but possibly also at other stages of the food chain where appropriate, in order to reduce the risk these agents pose to public health. The primary aim is to control salmonella with public health significance in critical categories of animals. The objectives of the Regulation are to:

- progressively set Community targets for the reduction of the prevalence of specified zoonotic agents and implement related national control programmes;

- provide for a procedure by which the use of specific control measures may be subject to particular requirements or restrictions;

- provide for rules for trade and imports of live animals and hatching eggs to be set;

- set specific requirements concerning animal populations covered by control measures and, where appropriate, after transitional periods have elapsed.

4. Opinion of the Commission on the amendments by the European Parliament to the Common Position regarding the Regulation of the European Parliament and of the Council on the control of salmonella and other specified food-borne zoonotic agents (2001/0177 (COD))

4.1. Amendments accepted by the Commission

* Amendment 2 on the outcome of cost/benefit analyses to be provided by the Commission when defining Community targets is acceptable, as it avoids misinterpretation of the word "favourable" mentioned in the common position. The Commission clarified its intention in a declaration (see in Annex). The amendment does not hamper the principle of preliminary cost/benefit analyses when defining Community targets pursuant to the Regulation.

* Amendment 6 relating to Article 1, paragraph 1, is acceptable as it clarifies further the purpose of the Regulation and it is consistent with Article 1.2 (a).

* Amendment 7 on to the scope of the Community targets during transitional periods is acceptable. The first part of the amendment concerning the use of historical data to define salmonella serotypes composing the target on breeding flocks of Gallus gallus during the transitional period, provides more flexibility than the text in the common position to use available data in the most appropriate way. The Commission clarified its intention in a declaration (see Annex). The second part of the amendment can be accepted because it is consistent with the general principle established in Article 4, paragraph 4, to define targets on the basis of cost/benefit analyses.

* Amendments 8, 9 and 10 relating to Annex III on the specific criteria to determine salmonella serotypes with public health significance, are acceptable. Amendment 8 has a similar purpose as the first part of amendment 7. Amendment 9 makes reference to feed, which is consistent with the need to consider feed as a source of infection of animal populations. National control programmes have to cover the feed industry. Amendment 10 adds to the list of criteria, whether serotypes have a profile making them particularly hazardous for humans. The Commission can support that amendment.

4.2. Amendments rejected by the Commission

There are none.

5. Conclusions

Pursuant to Article 250 (2) of the Treaty, the Commission amends its proposal as set out above.

ANNEX

Commission declarations in the framework of the second reading on the proposal for a Regulation of the European Parliament and of the Council on the control of salmonella and other specified food-borne zoonotic agents

In relation to Article 4(4)(c):

The Commission declares that, in relation to Article 4(4)(c), it will take due account of the results of cost/benefit analyses and other legitimate factors. It will not propose targets that would lead to disproportionate costs in comparison to the expected benefits of Community action.

In relation to Article 4(5), subpara. 2

The Commission declares that, in relation to the use of data on human salmonellosis collected through EC monitoring systems to define salmonella serotypes with public health significance, it will take account both of historical data and of recent trends, as most appropriate to the circumstances.