The approval procedure for adjuvants
Applications for the approval of adjuvants according to § 42 of the Plant Protection Act must be submitted to the BVL. Please refer to the instructions (available only in German) on how to complete the application.
The application form can be downloaded here in pdf format or word format.
Attachment 1 is available here in pdf format or word format.
Attachment 2 is available here in pdf format or word format.
Three further authorities are involved in evaluation and assessment:
- the Federal Institute for Risk Assessment (BfR; regarding possible harmful effects on human and animal health)
- the Federal Environment Agency (UBA: regarding possible harmful effects on the environment)
- the Julius Kühn Institute (JKI; regarding other harmful effects)
The authorities check to see whether it can be assumed for definite that the adjuvant will cause no harmful effects. If the submitted information and documentation give rise to doubt, the BVL can demand further documentation and/or samples according to § 42 (3) of the Plant Protection Act.
Special requirements apply to adjuvants that are intended to be used in combination with insecticides. In this case, the applicant must provide studies with honey bees. Instructions for conducting representative studies with honey bees are available in pdf format (available only in German).
By law the application must be processed within four months. If the BVL demands further documentation and samples in order to pursue any doubts, the deadline for processing is extended.
The approval according to § 42 is granted for ten years (§ 42 (2) Plant Protection Act); it applies to the placing on the market but not to the deadline for using up stocks. The approval is published in the Federal Gazette.
The BVL charges fees for processing applications in accordance with the BMELBGebV.
Further information on adjuvants and a FAQ on the subject can be found here (available only in German).
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