S.L. 437.42 Art. 5Classification.

(1) The BSE status of the territory of Malta, a Member State, of a third country, or of one of their regions (hereinafter referred to as ''countries or regions'') may be determined only on the basis of the criteria set out in Schedule II, Chapter A, and the outcome of a risk analysis on the basis of all the potential factors for the appearance of bovine spongiform encephalopathy as defined in Schedule II, Chapter B, and their development over time. The territory of Malta, Member States and third countries wishing to be retained on the list of third countries approved for the export to the European Community of the live animals or of the products covered by these regulations, shall submit to the European Commission an application for their BSE status to be determined, accompanied by the relevant information on the criteria set out in Schedule II, Chapter A, and on the potential risk factors specified in Schedule II, Chapter B, and their development over time.

(2) A decision on each application, placing the territory of Malta, Member State or third country or region of the Member State or third country which submitted the application in one of the categories defined in Schedule II, Chapter C, shall be adopted, taking account of the criteria and potential risk factors set out in subregulation (1), in accordance with the procedure referred to in regulation 24(2). This decision shall be taken within six months of the submission of the application and of the relevant information referred to in subregulation (1). If the European Commission finds that the supporting evidence does not include the information laid down in Schedule II, Chapters A and B, it shall ask for additional information to be provided within a period to be specified. The final decision shall then be taken within six months of the submission of all information.

After the International Office of Epizootic Diseases (OIE) has established a procedure for the classification of countries by category and if it has placed the applicant country in one of those categories, a reassessment of the European Community categorisation of the country concerned in accordance with the first paragraph of this subregulation may be decided, if appropriate, in accordance with the procedure referred to in regulation 24(2).

(3) If the European Commission finds that the information submitted by a Member State or a third country pursuant to Schedule II, Chapters A and B, is insufficient or unclear, it may, in accordance with the procedure referred to in regulation 24(2), determine the BSE status of the territory of Malta, another Member State or third country concerned on the basis of a full risk analysis.

Such a risk analysis must include a conclusive statistical survey of the epidemiological situation regarding TSEs in the applicant Member State or third country, on the basis of the use, in a screening procedure, of rapid tests. The European Commission shall take into account the classification criteria used by the OIE. The rapid tests shall be approved for that purpose in accordance with the procedure referred to in regulation 24(2) and entered on a list set out in Schedule X, Chapter C, point 4. Such screening procedure may also be used by Member States or third countries which wish to have the classification they carried out on that basis approved by the European Commission in accordance with the procedure laid down in regulation 24(2). The cost of such screening procedure shall be borne by the Member State or third country concerned.

(4) The Veterinary Services shall notify the European Commission as soon as possible of any epidemiological evidence or other information which might lead to a change in BSE status, in particular the results of the monitoring programmes provided for in regulation 6.

(5) The retention of a third country on one of the lists provided for by European Community rules for the purpose of being allowed to export to the European Community live animals and products of animal origin for which these regulations provides specific rules shall be decided upon under the procedure laid down in regulation 24(2) and shall be made conditional in the light of the information available or where a TSE is presumed to be present on the information provided for in subregulation (1) being supplied. In the event of refusal to supply the said information within three months of the date of the European Commission’s request, the relevant European Community legislation provisions shall apply until this information has been submitted and evaluated in accordance with subregulations (2) or (3).

The eligibility of third countries to export to the European Community live animals, or products of animal origin for which these regulations provide specific rules, under conditions based on their category as established by the European Commission, shall be conditional upon their undertaking to notify the latter in writing as soon as possible of any epidemiological or other evidence which might lead to a change in BSE status.

(6) A decision may be taken, under the procedure laid down in regulation 24(2), to change the BSE classification of a Member State or third country, or of one of its regions, in accordance with the results of the checks provided for in regulation 21.

(7) The decisions referred to in subregulations (2), (3), (5) and

(6) shall be based on a risk assessment, taking into consideration the recommended criteria set out in Schedule II, Chapters A and B.

CHAPTER III PREVENTION OF TSE