Explanatory Memorandum to COM(2004)775 - Amendment of Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

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Regulation (EC) No 999/2001 of the European parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies i (TSE Regulation) provides measures targeting all animal and public health risks resulting from all animal TSE, and governing the entire chain of production and placing on the market of live animals and products of animal origin. This Regulation is applicable as of 1 July 2001.

It consolidated much of the previous legislation on BSE or TSE, including rules for the monitoring of TSE in bovine, ovine and caprine animals, removal of specified risk material and prohibitions concerning animal feeding. It also introduced new legislation for areas such as eradication of TSE and trade rules covering the domestic market, intra-community trade, import and export. Furthermore it provided for the procedure, criteria and categories for the classification of countries according to BSE status.

This proposal is an amendment to the TSE Regulation on various matters and in the light of new developments since the adoption of the Regulation.

1. determination of BSE status

Regulation (EC) No 1128/2003 of the European Parliament and of the Council amending the TSE Regulation as regards the extension of the period for transitional measures i extended the application of the transitional measures under Article 23 of the TSE Regulation by two years, until 30 June 2005.

Maintaining the present level of public health protection, the two-year extension of time was intended to allow the Commission to continue its attempts to reach an agreement at international level on the determination of BSE status of countries.

The World Organisation for Animal health (OIE) presented a proposal to simplify the current criteria for the categorisation of countries according to their BSE risk for discussion at the General Session in May 2004. Since the Members did not express major objections to the proposal, a proposal for possible adoption will be presented at the OIE General session in May 2005 at the earliest. The intention is to reduce the number of categories, possibly in a step-wise way. To avoid multiple amendments to the Articles of the TSE Regulation pending the final modifications to the number of categories, it is proposed to transfer references to individual categories from the Articles to the Annexes.

Furthermore, a Resolution was adopted at the OIE General Session in May 2003 according to which OIE will classify all countries into one or other of the defined categories. It may be assumed that OIE will not conclude the final categorisation of countries according to their BSE risk before 1 July 2005. Therefore it is proposed to prolong the period of application of the transitional measures. Therefore it is proposed to prolong the period of application of the transitional measures until 1 July 2007.

2. PREVENTION OF TSE

In its opinion of 6-7 March 2003, the Scientific Steering Committee (SSC) recommended to start a monitoring programme for TSEs in cervids. The TSE Regulation establishes a monitoring programme for BSE and scrapie. It is proposed to extend this provision to other TSEs, in particular in order to follow the SSC recommendation on cervids.

Commission Decision No. 2003/100/EC i introduced a harmonised breeding programme to select for resistance to TSEs in ovine animals as a transitional measure. It is proposed to introduce a permanent legal basis for the breeding programme in the TSE Regulation.

The TSE Regulation prohibits the feeding of certain processed animal proteins to certain animals, with a possibility to extend the prohibition or lay down derogations in Annex IV. In order to make comprehensive amendments to the Annex, it is proposed to make certain technical amendments to the present wording of the corresponding Articles in order to develop the structure of the Annex.

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 i establishes the rules for disposal of specified risk materials and animals infected by TSEs. It is proposed to replace the present rules in the TSE Regulation on the disposal of specified risk materials and animals infected by TSEs with a reference to Regulation (EC) No 1774/2002 laying down health rules concerning animal by-products not intended for human consumption.

New developments concerning specified risk materials have furthermore led to a need to make comprehensive amendments to the relevant Annex. It is proposed to make certain technical amendments to the present wording of the corresponding Articles in order to develop the structure of the Annex.

Although stunning by injection of gas into the cranial cavity is not authorised within the European Union, injection of gas may also occur after stunning. It is therefore proposed to revise the present provisions on slaughter methods with a view to prohibit gas injection into the cranial cavity in connection with stunning.

It is proposed to align the definition of mechanically recovered meat with the definition used in other Community legislation on food safety.

3. CONTROL AND ERADICATION OF TSES

In order to avoid that animals are moved from holdings where scrapie is officially suspected, it is proposed to lay down the same rules regarding movement restrictions as for bovine animals following the detection of a BSE suspect.

4. PLACING ON THE MARKET

To take account of possible emerging TSEs in other species it is proposed to introduce a possibility to extend the scope of the current provisions on the placing on the market and export of bovine, ovine and caprine animals, their semen, embryos and ova in order to cover other species.

The Scientific Steering Committee (SSC) opinion of 26 June 1998 indicates that certain restrictions regarding sourcing of raw material for the manufacture of di-calcium phosphate should be observed. It is proposed to remove di-calcium phosphate from the list of products which the Regulation currently specifies shall not be subject to restrictions on placing on the market.

Since no restrictions apply for milk for human consumption, the same derogation should apply for milk not intended for human consumption within the meaning of Regulation (EC) No 1774/2002. The list of products which shall not be subject to restrictions on placing on the market by the Regulation shall be modified accordingly.

5. CONTROLS

The TSE Regulation provides a legal basis for inspections by the Food and Veterinary Office (FVO) only within the Member States. Although Commission Decision 98/140/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries i provides a general legal basis for Community inspections in Third countries, it should be advisable to provide within the TSE Regulation such legal provisions. It is proposed to amend the Regulation to provide for such checks.

The proposal has no implications for the budget of the European Community.