Explanatory Memorandum to COM(2008)120 - Simplification of procedures of listing and publishing information in the veterinary and zootechnical fields

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The general objective of the Commission’s proposal is to harmonise and simplify the current procedures for updating and publishing information in the veterinary and zootechnical fields, such as lists of approved animal health establishments and breeding organisations in Member States and Third Countries and lists of certain national reference laboratories and other approved laboratories.

The Commission’s proposal aims at amending 20 Directives and one Decision , ensuring a simplified approach, which will lead to benefits in terms of reduced workload and administrative burdens to the competent authorities in the Member States, the farming industry and trade operators and the Commission.

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Animal health establishments approved for intra-Community trade in live animals and their products and information to be provided in the zootechnical field

Community legislation in the veterinary field lays down that assembly centres for bovine, porcine, caprine and ovine animals, dealers of those animals, poultry establishments, semen collection or storage centres and embryo collection or production teams and certain bodies, institutes and centres are to comply with certain conditions and must be officially approved by Member States for intra-Community trade of certain live animals and their products, and in particular animal genetic materials such as semen, ova and embryos.

Current Community legislation provides for different procedures with regard to registration, listing, update, transmission and publication of these animal health establishments. Differences in the procedure make the listing and the update however complicated and the practical use of these lists for the competent control services and the concerned operators very difficult.

Therefore the procedures should be harmonised and provide for more systematic, coherent and uniform rules with regard to the five key elements of the procedure, namely registration, listing, update, transmission and publication of the lists.

In addition, since it is for the Member States to control the conditions that must be fulfilled by the different animal health establishments in order to be listed, the responsibility for the drawing up of the lists should lay with the Member States, and not the Commission.

Member States should therefore draw-up and keep up-to-date lists of the animal health establishments concerned and make them available to the other Member States and to the public. In order to harmonise the model of those lists and the way to achieve a simple access to up-to-date lists for the Community, common criteria need to be introduced under the comitology procedure.

In the interests of clarity and consistency of Community rules, this new procedure should also apply in the zootechnical field, in particular to breeding associations approved for maintaining or establishing herd books, flock books or stud books in Member States and to information to be provided by Member States regarding equine competitions in accordance with Council Directive 90/428/EEC of 26 June 1990 on trade in equidae intended for competitions and laying down the conditions for participation therein.

Animal health establishments approved in third countries for imports of animal products into the Community and authorities approved in third countries for the purpose of keeping a herd book, a flock book or a studbook

Similarly to the rules applied to intra Community trade, imports of semen, ova and embryos are regulated in such a way that the establishments of origin in third countries are to fulfil certain conditions in order to minimise animal health risks. Accordingly, imports into Community of such genetic materials should only be authorised from semen collection or storage centres and embryo collection or production teams officially approved for export to the Community by the competent authorities of the third country concerned in accordance with Community requirements and following Community veterinary inspections, where appropriate. Depending on the type of genetic materials and on the species concerned, the current procedures for listing animal health establishments and updating the relevant lists are different, ranging from decisions adopted under a comitology procedure in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission  i to a simple consultation with Member States.

The co-existence of different procedures can lead to confusion and uncertainty amongst administrative officials in third countries, the farming industry and trade operators. Since it is for the third countries to check on the conditions that must be fulfilled by the different animal health establishments in order to be listed as approved for export to the Community in accordance with Community requirements, the current legal framework for the authorisation of those establishments should be harmonised and simplified, so that the responsibility for drawing up and updating the lists lies with the third countries and not the Commission. It is important to ensure that the level of animal health guarantees given by the third country concerned is not affected. The simplification measures are without prejudice to the right of the Commission to take safeguard measures if necessary.

The different existing procedures should therefore be replaced by a procedure under which the competent authorities of the third countries draw up, keep up-to-date the lists and communicate them to the Commission. The Commission should inform the Member States about these lists and makes them available to the public for information purposes. In the case of concerns with regard to the lists communicated by the third countries, adoption of safeguard measures is to be taken in accordance with Council Directive 97/78/EC.

For reasons of clarity and consistency, that procedure should also apply to authorities in third countries approved for the purpose of keeping a herd book, a flock book or a studbook in accordance with Community zootechnical legislation.

Laboratories

In the veterinary field, the Commission has the responsibility for setting up and updating the lists of approved national reference laboratories and other approved laboratories on the basis of information provided for by the Member States.

In accordance with existing Community legislation, amendments to those lists are made, following a request from a Member State and a decision adopted under a comitology procedure in accordance with Decision 1999/468/EC or by the Council on a proposal from the Commission.

However, amendments to such lists are often of purely formal nature, such as changes in the contact details of the laboratories in question.

The current practice has been to make only periodic updates of the lists of those laboratories to reduce the number of Commission decisions to be taken. However, this practice does not guarantee a rapid update of those lists. This could compromise the legal status of national reference laboratories and other approved laboratories. Since the Member States designate the national reference laboratories and provide all the necessary details and updates, the responsibility for the drawing up of the lists should lay with the Member States and not the Commission. The same should apply to other approved laboratories in the Member States.

Member States shall therefore draw-up and keep up-to-date the lists of national reference laboratories and other approved laboratories concerned and make them available to the other Member States and the public. In order to harmonise the model of those lists and the way to achieve a simple access to up-to-date lists for the Community, common criteria need to be introduced under the comitology procedure.

However, where the lists concern approved laboratories situated in third countries, the Commission should continue to be responsible for drawing up and publishing the lists of such laboratories.

The purpose of this proposal is:

– to harmonise and simplify the current procedures for updating and publishing lists of certain approved animal health establishments and breeding organisations in Member States and information to be provided by Member States regarding equine competition;

– to harmonise and simplify the current procedures for updating and publishing lists of certain approved animal health establishments and authorities approved for the purpose of keeping a herd book, a flock book or a studbook in third countries;

– to simplify the current procedures for updating and publishing lists of certain national reference laboratories and other approved laboratories.

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 should be amended accordingly.