18.6.2008 Official Journal of the European Union L 158/5 COMMISSION REGULATION (EC) No 553/2008 of 17 June 2008 amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to 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 (1), and in particular Article 23 thereof, Whereas: Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies in bovine, ovine and caprine animals and for eradication measures to be carried out following confirmation of a transmissible spongiform encephalopathy (TSE) in ovine and caprine animals. Annex VII to Regulation (EC) No 999/2001 lays down the eradication measures to be carried out following confirmation of an outbreak of TSE in ovine and caprine animals. Although TSE has been known to be present in ovine and caprine animals for over two hundred years, there is no evidence of any relationship between outbreaks of TSE in those animals and outbreaks of TSE in humans. Nevertheless, in 2000 the Commission introduced a comprehensive set of measures for the monitoring, prevention, control and eradication of TSE in ovine and caprine animals, on the basis of the limited scientific knowledge available at that time, and in order to ensure that sourcing from ovine and caprine animals’ materials is as safe as possible. Those measures are aimed at gathering as much data as possible on the prevalence of TSE other than bovine spongiform encephalopathy (BSE) in ovine and caprine animals, and on possible links with BSE and transmissi- bility to humans. The measures are also aimed at reducing as much as possible the occurrence of TSE. () O] L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 357/2008 (O] L 111, 23.4.2008, p. 3). (6) The measures include the removal of specified risk materials, an extensive active monitoring programme, measures applicable to flocks infected with TSE and voluntary breeding schemes to increase resistance to TSE in the ovine population. Since the introduction of such measures and with the information obtained from active surveillance programmes carried out in the Member States, no epidemiological link has ever been established between TSE, other than BSE, in ovine and caprine animals and TSE in humans. Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (%) provides that in specific circum- stances where, following an assessment of available infor- mation, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure a high level of health protection may be adopted, pending further scientific information for a more comprehensive risk assessment. It also stipulates that such measures must be proportionate and no more restrictive of trade than is required to achieve the high level of health protection sought, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures are to be reviewed within a reasonable period of time. On 8 March 2007 the European Food Safety Authority (EFSA) adopted an opinion on certain aspects related to the risk of TSE in ovine and caprine animals (*). In that opinion, EFSA concluded that ‘there is no evidence for an epidemiological or molecular link between classical and/or atypical scrapie and TSEs in humans. The BSE agent is the only TSE agent identified as zoonotic. However, in view of their diversity it is currently not possible to exclude transmissibility to humans of other animal TSE agents’. It also concluded that ‘current discri- minatory tests as described in the Community legislation to be used for discrimination between scrapie and BSE appear, up to now, to be reliable for the differentiation of BSE from classical and atypical scrapie. However, at the current stage of scientific knowledge, neither their diag- nostic sensitivity nor their specificity can be assumed to be perfect’. (®» OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 202/2008 (O] L 60, 5.3.2008, p. 17). (%) The EFSA Journal (2007), 466, 1-10.