Facilitations in the Regulation of Plant Protection Products Containing Baculoviruses

Abstract

Baculoviruses represent a family of double stranded DNA viruses that exclusively infect Arthropoda used in plant protection for control of insect pests in agriculture, horticulture and forestry. In the EU baculoviruses are regulated as microorganisms with data requirements laid down in the EU legislation. The OECD “Consensus document on information used in the assessment of environmental applications involving Baculoviruses” (2002) revised all publicly available information relevant for safety assessments of baculoviruses and concludes “the use of baculoviruses is safe”. Potential risks from baculovirus products are minimal and can occur only indirectly through product components other than the baculovirus itself. Based on the safety assessment of different baculoviruses, REBECA experts proposed a simplified procedure for the inclusion into Annex I (91/414/EEC). Baculoviruses shall be evaluated at species level and new isolates shall be included with a reduced data set that is presented. This proposal resulted in the “Guidance Document on the assessment of new isolates of baculovirus species already included in Annex I of Council Directive 91/414/EEC” (SANCO/0253/2008 rev. 2 from January 22, 2008).