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Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

EFSA Journal 2013;11(7):3295 [268 pp.]. doi:10.2903/j.efsa.2013.3295
European Food Safety Authority Acknowledgment EFSA wishes to thank the members of the working group: Gérard Arnold, Jos Boesten, Mark Clook, Robert Luttik, Fabio Sgolastra, Jacoba Wassenberg and the hearing expert Jens Pistorius for the preparatory work on this scientific output and EFSA staff: Franz Streissl, Maria Arena, Csaba Szentes, Agnès Rortais and Olaf Mosbach-Schulz for the support provided to this scientific output. Contact pesticides.ppr@efsa.europa.eu
Type: Guidance of EFSA On request from: European Commission Question number: EFSA-Q-2011-00418 Approved: 27 June 2013 Published: 04 July 2013 Last updated: 04 July 2014. This version replaces the previous one/s. Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

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 Products and their Residues (PPR), 2012a) provided the scientific basis for the development of the Guidance Document. Specific Protection Goals were agreed in consultation with the Standing Committee on the Food Chain and Animal Health. The Guidance Document suggests 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.

© European Food Safety Authority, 2013

Summary

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 Products 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.

Keywords

honey bees, risk assessment, pesticides, Apis mellifera, Bombus, solitary bees

Corporate author: EFSA - European Food Safety Authority

Themes: Food technology and food safety, Environment - Ecology

ISBN number: 978-92-9199-557-8

Catalogue number: TM-01-13-440-EN-C

Link to EU-bookshop: Print on demand version

Price: € 9.00

Number of pages: 266

Order status: available