Sense and nonsense of the secondary metabolites data requirements in the EU for beneficial microbial control agents

TY - JOUR

T1 - Sense and nonsense of the secondary metabolites data requirements in the EU for beneficial microbial control agents

AU - Scheepmaker, Jacqueline W.A.

AU - Busschers, Marloes

AU - Sundh, Ingvar

AU - Eilenberg, Jørgen

AU - Butt, Tariq M.

PY - 2019/9

Y1 - 2019/9

N2 - Microbial control agents (MCAs) are promising for use in sustainable agriculture. Nevertheless, they face a major hurdle in the registration process of the European Union, one reason being unclear data requirements on metabolites. This review examines the EU regulatory perspective on metabolites of MCAs for plant protection and identifies some key issues and concerns. Current data requirements for secondary metabolites of micro-organisms are based on degradation products/metabolites of chemicals. We conclude that this has contributed strongly to the current confusion regarding how to best evaluate potential production of toxic substances by MCAs. We suggest that data requirements should be revised and/or need guidance fit for purpose, in order to give the EU-regulation for MCAs a stronger base in microbiological knowledge. We also suggest implementation of a basic hazard assessment. If this is passed without any concerns, the production of unknown, potentially toxic, substances does not need to be further investigated.

AB - Microbial control agents (MCAs) are promising for use in sustainable agriculture. Nevertheless, they face a major hurdle in the registration process of the European Union, one reason being unclear data requirements on metabolites. This review examines the EU regulatory perspective on metabolites of MCAs for plant protection and identifies some key issues and concerns. Current data requirements for secondary metabolites of micro-organisms are based on degradation products/metabolites of chemicals. We conclude that this has contributed strongly to the current confusion regarding how to best evaluate potential production of toxic substances by MCAs. We suggest that data requirements should be revised and/or need guidance fit for purpose, in order to give the EU-regulation for MCAs a stronger base in microbiological knowledge. We also suggest implementation of a basic hazard assessment. If this is passed without any concerns, the production of unknown, potentially toxic, substances does not need to be further investigated.

KW - Bioactives

KW - Biopesticides

KW - Data requirements

KW - Microbial control agents

KW - Microbial plant protection products

KW - Product registration

KW - Regulation

KW - Regulation (EC) No. 1107/2009

KW - Risk assessment

KW - Secondary metabolites

UR - http://www.scopus.com/inward/record.url?scp=85068623801&partnerID=8YFLogxK

U2 - 10.1016/j.biocontrol.2019.104005

DO - 10.1016/j.biocontrol.2019.104005

M3 - Comment/debate

AN - SCOPUS:85068623801

SN - 1049-9644

VL - 136

SP - 1

EP - 10

JO - Biological Control

JF - Biological Control

M1 - 104005

ER -