# C_2008224EN.01008401.xml

| 30.8.2008 | EN | Official Journal of the European Union | C 224/84 |
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30.8.2008

EN

Official Journal of the European Union

C 224/84

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Opinion of the European Economic and Social Committee on the Proposal for a Council Directive simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC, and 2005/94/EC

COM(2008) 120 final — 2008/0046 (CNS)

(2008/C 224/19)

On 11 April 2008, the Council decided to consult the European Economic and Social Committee, under Article 37 of the Treaty establishing the European Community on the:

Proposal for a Council Directive simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC, and 2005/94/EC.

Proposal for a Council Directive simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC, and 2005/94/EC.

On 21 April 2008, the Bureau of the European Economic and Social Committee instructed the Section for Agriculture, Rural Development and the Environment to undertake the preparatory work.

In view of the urgency of the matter, the European Economic and Social Committee, at its 445th plenary session held on 28 and 29 May 2008 (meeting of 29 May), appointed Mr Nielsen as rapporteur-general and unanimously adopted the following opinion.

1.   Conclusions

| 1.1 | The EESC fully recognises the need identified by the Commission to harmonise and simplify procedures for listing and publishing information in the veterinary and zootechnical fields. Hence, the rules for the listing, update, transmission and publication of information should be amended as quickly as possible. |
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1.1

The EESC fully recognises the need identified by the Commission to harmonise and simplify procedures for listing and publishing information in the veterinary and zootechnical fields. Hence, the rules for the listing, update, transmission and publication of information should be amended as quickly as possible.

| 1.2 | Member States should continue to be responsible for compiling information and making it available to the other Member States and to the public at large. Harmonisation and simplification should be achieved through the regulatory procedure and, in the interests of clarity and consistency, this new procedure should also apply in the zootechnical field. |
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1.2

Member States should continue to be responsible for compiling information and making it available to the other Member States and to the public at large. Harmonisation and simplification should be achieved through the regulatory procedure and, in the interests of clarity and consistency, this new procedure should also apply in the zootechnical field.

| 1.3 | However, the Commission proposal is unnecessarily complicated and bureaucratic. It should be possible to secure the sought-after simplification and harmonisation more quickly and more easily by providing the Commission directly with the desired legal basis, including the remit to undertake the process of simplification and harmonisation in cooperation with the Member States using the regulatory procedure. In that way, the objective can be reached more quickly and more directly, thereby enabling the quickest possible application of the procedures for the listing, update, transmission and publication of information. Moreover, the information available on Member States' websites should be made more easily accessible and more readily understandable for all. |
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1.3

However, the Commission proposal is unnecessarily complicated and bureaucratic. It should be possible to secure the sought-after simplification and harmonisation more quickly and more easily by providing the Commission directly with the desired legal basis, including the remit to undertake the process of simplification and harmonisation in cooperation with the Member States using the regulatory procedure. In that way, the objective can be reached more quickly and more directly, thereby enabling the quickest possible application of the procedures for the listing, update, transmission and publication of information. Moreover, the information available on Member States' websites should be made more easily accessible and more readily understandable for all.

| 1.4 | This is all the more necessary given the overall desire that has been expressed for simpler, more readily accessible legislation in the EU as a whole, and not least the Commission's intention to draw up a common legislative programme in the veterinary field, in conjunction with the new Animal Health Strategy, which seeks to consolidate EU legislation in the veterinary and zootechnical fields. If the proposal is implemented as it stands, this consolidation of legal instruments into a common framework will necessitate a revisiting of the entire issue in just a few years' time and will again mean new and time-consuming changes in Member States' legislation and administrative practice. |
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1.4

This is all the more necessary given the overall desire that has been expressed for simpler, more readily accessible legislation in the EU as a whole, and not least the Commission's intention to draw up a common legislative programme in the veterinary field, in conjunction with the new Animal Health Strategy, which seeks to consolidate EU legislation in the veterinary and zootechnical fields. If the proposal is implemented as it stands, this consolidation of legal instruments into a common framework will necessitate a revisiting of the entire issue in just a few years' time and will again mean new and time-consuming changes in Member States' legislation and administrative practice.

| 1.5 | In this connection, there is also a need to specify as quickly as possible the procedures to be followed for the approval of — and the update of information on — assembly centres and the requirements to be met by the national reference laboratories. |
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1.5

In this connection, there is also a need to specify as quickly as possible the procedures to be followed for the approval of — and the update of information on — assembly centres and the requirements to be met by the national reference laboratories.

2.   Background

| 2.1 | Trade in live animals and breeding material in the EU requires approval and monitoring by the institutions, businesses, installations and associations concerned (referred to hereinafter as relevant bodies) (1). It is vital to maintain adequate security and avoid any risk of spreading contagious animal diseases. The relevant bodies therefore have to meet a range of conditions and must be approved by the Member States to conduct internal EU trade in live animals and breeding material, including, not least, genetic material from animals in the form of semen and embryos. |
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2.1

Trade in live animals and breeding material in the EU requires approval and monitoring by the institutions, businesses, installations and associations concerned (referred to hereinafter as relevant bodies) (1). It is vital to maintain adequate security and avoid any risk of spreading contagious animal diseases. The relevant bodies therefore have to meet a range of conditions and must be approved by the Member States to conduct internal EU trade in live animals and breeding material, including, not least, genetic material from animals in the form of semen and embryos.

relevant bodies

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| 2.2 | EU veterinary legislation has grown up over time through the successive adoption of a significant number of legal instruments. As a result, a number of different procedures are in place for Member State registration of the relevant bodies and for the listing, update, transmission and publication of information. This makes the practical use of the information difficult for the national authorities and for the stakeholder organisations and operators. In some cases, there is no legal basis for the reporting involved. |
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2.2

EU veterinary legislation has grown up over time through the successive adoption of a significant number of legal instruments. As a result, a number of different procedures are in place for Member State registration of the relevant bodies and for the listing, update, transmission and publication of information. This makes the practical use of the information difficult for the national authorities and for the stakeholder organisations and operators. In some cases, there is no legal basis for the reporting involved.

| 2.3 | The proposal seeks to harmonise and simplify the rules using the regulatory procedure (2), thus easing the administrative burden by putting in place more systematic, coherent and uniform rules for the registration, listing, update, transmission and publication of information. This formally requires the amendment of 20 directives and one decision. (3) In the interests of clarity and consistency, the Commission feels that this new procedure should also apply in the zootechnical field and to breeding associations approved for maintaining or establishing herd books, flock books or stud books in the Member States, and to trade in equidae intended for competitions and to participation in such competitions. |
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2.3

The proposal seeks to harmonise and simplify the rules using the regulatory procedure (2), thus easing the administrative burden by putting in place more systematic, coherent and uniform rules for the registration, listing, update, transmission and publication of information. This formally requires the amendment of 20 directives and one decision. (3) In the interests of clarity and consistency, the Commission feels that this new procedure should also apply in the zootechnical field and to breeding associations approved for maintaining or establishing herd books, flock books or stud books in the Member States, and to trade in equidae intended for competitions and to participation in such competitions.

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| 2.4 | Bodies in third countries also have to meet a range of conditions for the export of semen and embryos to the EU. These are monitored by the national authorities of the third country concerned and in line with Community veterinary inspections, where appropriate. In the case of concerns with regard to the information communicated by the third countries, safeguard measures are to be adopted in accordance with Directive 97/78/EC. For reasons of clarity and consistency, the Commission considers that the procedure should also apply to authorities in third countries approved for the purpose of keeping a herd book, a flock book or a stud book in accordance with Community zootechnical legislation. |
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2.4

Bodies in third countries also have to meet a range of conditions for the export of semen and embryos to the EU. These are monitored by the national authorities of the third country concerned and in line with Community veterinary inspections, where appropriate. In the case of concerns with regard to the information communicated by the third countries, safeguard measures are to be adopted in accordance with Directive 97/78/EC. For reasons of clarity and consistency, the Commission considers that the procedure should also apply to authorities in third countries approved for the purpose of keeping a herd book, a flock book or a stud book in accordance with Community zootechnical legislation.

| 2.5 | The Commission feels that, in contrast to the current position, the Member States should be responsible for drawing up and updating information on approved national reference laboratories and other approved laboratories. On the other hand, under the current proposal, the Commission will continue to be responsible for drawing up and publishing information on approved laboratories situated in third countries. Lastly, transitional measures are proposed to ensure continuity in the serological tests for rabies vaccines (4). |
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2.5

The Commission feels that, in contrast to the current position, the Member States should be responsible for drawing up and updating information on approved national reference laboratories and other approved laboratories. On the other hand, under the current proposal, the Commission will continue to be responsible for drawing up and publishing information on approved laboratories situated in third countries. Lastly, transitional measures are proposed to ensure continuity in the serological tests for rabies vaccines (4).

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3.   General comments

| 3.1 | EU veterinary and zootechnical legislation is exceptionally complex and comprehensive, not only because the provisions have been drawn up gradually to meet developments, but also because of the complex nature of the diseases involved and the need for reliable preventive action and monitoring. The outbreak and spread of infectious animal diseases may have a significant economic and social impact, and it is vital, therefore, to secure the optimum operation both of the legislation in place and of the relevant administrative procedures. There is also an increased global risk as a result of the constant population growth and pressure on livestock production, coupled with more trade and increasing international communication. Climate change too is leading to changes in the geographical distribution of diseases. |
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3.1

EU veterinary and zootechnical legislation is exceptionally complex and comprehensive, not only because the provisions have been drawn up gradually to meet developments, but also because of the complex nature of the diseases involved and the need for reliable preventive action and monitoring. The outbreak and spread of infectious animal diseases may have a significant economic and social impact, and it is vital, therefore, to secure the optimum operation both of the legislation in place and of the relevant administrative procedures. There is also an increased global risk as a result of the constant population growth and pressure on livestock production, coupled with more trade and increasing international communication. Climate change too is leading to changes in the geographical distribution of diseases.

| 3.2 | The EESC thus feels that there is a clear need to act without delay to simplify and harmonise the rules for the listing, update, transmission and publication of information. However, the EESC feels that the desired objective can be achieved more quickly and much more straightforwardly by removing the existing provisions on the procurement and publication of information from the relevant legislative instruments and replacing them with a single piece of legislation that gives the Commission the requisite legal basis and remit to start work on simplification and harmonisation as quickly as possible and to carry it through using the regulatory procedure. This has the same result without the need to wait for the time-consuming administrative implementation in Member States' legislation and administrative practice. |
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3.2

The EESC thus feels that there is a clear need to act without delay to simplify and harmonise the rules for the listing, update, transmission and publication of information. However, the EESC feels that the desired objective can be achieved more quickly and much more straightforwardly by removing the existing provisions on the procurement and publication of information from the relevant legislative instruments and replacing them with a single piece of legislation that gives the Commission the requisite legal basis and remit to start work on simplification and harmonisation as quickly as possible and to carry it through using the regulatory procedure. This has the same result without the need to wait for the time-consuming administrative implementation in Member States' legislation and administrative practice.

| 3.3 | The Commission's current proposal provides for the introduction of new provisions into each of the 21 legislative instruments, with repeated allusions to new rules, which in turn refer to the use of the regulatory procedure. This seems an unnecessarily complicated approach, whereby the procedural rules are first adopted through appropriate references in each of the 21 legislative instruments, followed by a delay while the necessary implementing provisions are adopted in the national legislation and administration of the 30 EEA countries. Only at the end of that process does the Commission have the requisite remit, and the real work of drawing up the common rules using the regulatory procedure can begin. |
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3.3

The Commission's current proposal provides for the introduction of new provisions into each of the 21 legislative instruments, with repeated allusions to new rules, which in turn refer to the use of the regulatory procedure. This seems an unnecessarily complicated approach, whereby the procedural rules are first adopted through appropriate references in each of the 21 legislative instruments, followed by a delay while the necessary implementing provisions are adopted in the national legislation and administration of the 30 EEA countries. Only at the end of that process does the Commission have the requisite remit, and the real work of drawing up the common rules using the regulatory procedure can begin.

| 3.4 | This matter is all the more important given the overall desire that has been expressed for simpler, more readily accessible legislation in the EU as a whole, and not least the Commission's proposal to draw up a common legislative programme in the veterinary field, in conjunction with the new Animal Health Strategy, which seeks to consolidate EU legislation in the veterinary and zootechnical fields (5). It would be quicker and more straightforward to replace the existing rules directly and give the Commission, through the adoption of a legal instrument to that effect, the remit it needs to begin work as quickly as possible without waiting for the introduction of amended rules as part of the national implementation of the 21 legislative instruments concerned, with the delays and administrative complications that would entail. |
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3.4

This matter is all the more important given the overall desire that has been expressed for simpler, more readily accessible legislation in the EU as a whole, and not least the Commission's proposal to draw up a common legislative programme in the veterinary field, in conjunction with the new Animal Health Strategy, which seeks to consolidate EU legislation in the veterinary and zootechnical fields (5). It would be quicker and more straightforward to replace the existing rules directly and give the Commission, through the adoption of a legal instrument to that effect, the remit it needs to begin work as quickly as possible without waiting for the introduction of amended rules as part of the national implementation of the 21 legislative instruments concerned, with the delays and administrative complications that would entail.

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| 3.5 | The EESC therefore feels that the Council and the Commission should seize the opportunity to make good use of the planned common legislative framework in this area. Otherwise, the provisions will have to be revised again in conjunction with the consolidation of the legislation, with the concomitant administrative complications that this will entail for the Member States, which will again have to revise their legislation and administrative practice. |
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3.5

The EESC therefore feels that the Council and the Commission should seize the opportunity to make good use of the planned common legislative framework in this area. Otherwise, the provisions will have to be revised again in conjunction with the consolidation of the legislation, with the concomitant administrative complications that this will entail for the Member States, which will again have to revise their legislation and administrative practice.

4.   Specific comments

| 4.1 | The Commission proposal repeatedly uses the term ‘listing’, which gives the impression that this is an agreed term. The main thrust of the proposal, however, relates to procedures for the listing, update, transmission and publication of the relevant information and the laying-down of a model form of this information using the regulatory process. |
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4.1

The Commission proposal repeatedly uses the term ‘listing’, which gives the impression that this is an agreed term. The main thrust of the proposal, however, relates to procedures for the listing, update, transmission and publication of the relevant information and the laying-down of a model form of this information using the regulatory process.

| 4.2 | To make the information on Member States' websites more easily accessible and more readily understandable, the Commission should, without delay, start developing the technical aspects and the model forms of the information concerned. It is also important to provide a clear link from the Commission's home page to the information compiled and updated by the Member States. Otherwise, there is a risk that Member States will continue to present the information in different ways, making it difficult for the authorities and other stakeholders to make use of it in practice. |
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4.2

To make the information on Member States' websites more easily accessible and more readily understandable, the Commission should, without delay, start developing the technical aspects and the model forms of the information concerned. It is also important to provide a clear link from the Commission's home page to the information compiled and updated by the Member States. Otherwise, there is a risk that Member States will continue to present the information in different ways, making it difficult for the authorities and other stakeholders to make use of it in practice.

| 4.3 | There is also a need to specify the procedures to be followed for the approval and update of information on approved assembly centres. Thus, uncertainty about compliance with the rules for the unloading of animals during long-distance transport is due to gaps in the information on useable assembly centres. The rules are frequently misleading as to the species and number of animals that can be accommodated in the assembly centres. |
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4.3

There is also a need to specify the procedures to be followed for the approval and update of information on approved assembly centres. Thus, uncertainty about compliance with the rules for the unloading of animals during long-distance transport is due to gaps in the information on useable assembly centres. The rules are frequently misleading as to the species and number of animals that can be accommodated in the assembly centres.

| 4.4 | No reason is given for the Commission's proposal to allow Member States to approve reference laboratories. This is probably due to a desire to reduce the Commission's workload and the expediency of obliging the Member States to shoulder this responsibility. However, it is necessary as soon as possible to specify the requirements to be met by the national reference laboratories, in the light, among other things, of international standards for laboratory facilities, quality assurance and methodology. |
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4.4

No reason is given for the Commission's proposal to allow Member States to approve reference laboratories. This is probably due to a desire to reduce the Commission's workload and the expediency of obliging the Member States to shoulder this responsibility. However, it is necessary as soon as possible to specify the requirements to be met by the national reference laboratories, in the light, among other things, of international standards for laboratory facilities, quality assurance and methodology.

Brussels, 29 May 2008

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

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(1)  These include:

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| — | state-run laboratories responsible for matters relating to serious contagious animal diseases (monitoring, test methods and preparedness, use of reagents, vaccine testing etc.); |
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state-run laboratories responsible for matters relating to serious contagious animal diseases (monitoring, test methods and preparedness, use of reagents, vaccine testing etc.);

| — | bovine and porcine semen collection centres, semen storage centres, sperm banks and embryo collection or production teams; |
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bovine and porcine semen collection centres, semen storage centres, sperm banks and embryo collection or production teams;

| — | breeding organisations and associations officially approved for maintaining or establishing herd books, flock books or stud books; |
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breeding organisations and associations officially approved for maintaining or establishing herd books, flock books or stud books;

| — | all kinds of approved assembly centres for bovine, porcine, caprine and ovine animals, poultry establishments; |
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all kinds of approved assembly centres for bovine, porcine, caprine and ovine animals, poultry establishments;

| — | approved dealers and registered premises used by dealers in connection with their business. |
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approved dealers and registered premises used by dealers in connection with their business.

(2)  Regulatory procedure under 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.

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(3)  Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2005/94/EC and Decision 2000/258/EC

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(4)  Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines, including which tests may replace the existing IF tests or national provisions.

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(5)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on a new Animal Health Strategy for the European Union (2007-2013) where ‘Prevention is better than cure’, COM(2007) 539 final.

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