EFSA Guidance Document on the risk assessment of plant protection products on bees
The European Food Safety Authority (EFSA) was asked by the European Commission (EC) to develop a Guidance Document on the risk assessment of plant protection products on bees. The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of plant protection products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific opinion on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) (EFSA Panel on Plant Protection Poducts and their Residues (PPR), 2012a) provided the scientific basis for the development of the Guidance Document. The process of the development of the Guidance Document follows the methodology of definition of specific protection goals (SPGs) as outlined in the scientific opinion of EFSA‘s Plant Protection Products and their Residues Panel (EFSA Panel on Plant Protection Products and their Residues (PPR), 2010). The Standing Committee on the Food Chain and Animal Health was consulted for the appropriate levels of protection (e.g. to make choices on the magnitude of effects, duration of effects and exposure percentiles). The Guidance Document suggests the implementation of a tiered risk assessment scheme with a simple and cost-effective first tier to more complex higher tier studies under field conditions. Each of the tiers will have to ensure that the appropriate level of protection is achieved. More detailed guidance on specific aspects of laboratory studies and higher tier risk assessments is given in the appendices. A need for test protocols for bumble bees and solitary bees was identified. Potential protocols are available in the published literature and first proposals are made in the appendices. It is important that fully validated test protocols are developed in future.