EFSA Scientific Report (2007) 122, 1-84, Conclusion on the peer review of 

diflufenican 

 

 

 

http://www.efsa.europa.eu

 

9 of 84 

 

S

PECIFIC 

C

ONCLUSIONS OF THE 

E

VALUATION

 

1. Identity, 

physical/chemical/technical properties and methods of 

analysis 

The minimum purity of diflufenican of both sources is 970 g/kg, which is meeting the requirements 

of the FAO specification AGP:CP/348

 

(462/TC/S/F (1997)) of minimum 945 g/kg.  

 

According to the equivalence assessment of the two technical materials, the RMS concluded that the 

Makhteshim Agan source can be considered comparable to the Bayer source, with minor differences 

in the levels of impurities. The minimum purity of the two sources was identical (Report on the 

Makhteshim Agan source, July 2005) The RMS stated that the minor differences in impurities which 

were identified were not considered to be toxicologically significant or were considered to be non-

relevant impurities which did not exceed the acceptable maximum increases as defined in the 

appropriate Guidance Document (Sanco/10597/2003 –rev. 7). However the expert meeting (PRAPeR 

21) found the proposed specifications unacceptable with regard to the supporting batch analysis and 

the experts of PRAPeR 24 considered that further information was required to confirm the 

toxicological relevance of the impurities in the technical material with respect to the batches tested in 

toxicology studies. 

Following the PRAPeR expert meetings the main data submitter, Bayer CropScience, have provided 

the information, including a revised technical specification, to address both these points, presented in 

addendum 4 to Vol. 4 (August 2007), however this has not been evaluated in detail by the RMS nor 

peer reviewed. The specification of the main data submitter is still open however it is not considered 

to be a critical area of concern. 

Since the specifications for the technical materials are not finalized, it is not possible to conclude on 

the equivalence of the Makhteshim Agan source and the equivalence has to be determined at MS 

level. 

 

The assessment of the data package revealed no issues that need to be included as critical areas of 

concern with respect to the identity, physical, chemical and technical properties of diflufenican or the 

respective formulation. 

 

The main data regarding the identity of diflufenican and its physical and chemical properties are 

given in appendix 1. 

 

Adequate analytical methods are available for the determination of diflufenican in the technical 

material and in the representative formulation as well as for the determination of the respective 

impurities in the technical material. 

Several methods have been developed for the analysis of diflufenican residues in plants based on 

extraction into acetonitrile followed by determination using GC-ECD. The applicability of the 

German multi-residue method DFG S19 with both GC-ECD and GC-MS has been demonstrated. For