Reasoned opinion on the modification of the existing MRLs for propyzamide in leaves, flowers and roots of herbal infusions


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(9):3378 [28 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
23 September 2013
Published in the EFSA Journal
25 September 2013
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, herewith referred to as the evaluating Member State (EMS), received an application from the Landesanstalt für Landwirtschaft Forsten und Gartenbau Sachsen-Anhalt to modify the existing MRLs for the propyzamide in herbal infusions. In order to accommodate for the intended use of propyzamide in Germany, the EMS proposed to raise the existing MRLs in leaves and flowers of herbal infusions to 0.4 mg/kg and in roots of herbal infusions to 0.15 mg/kg. According to EFSA, the residue data are sufficient to support the extrapolation of residue data on dried peppermint, lemon balm leaves, narrow leaf plantain and camomile flowers to the whole group of dried leaves and flowers of herbal infusions with a MRL proposal of 0.4 mg/kg. The submitted residue data on black snakeroot can be extrapolated to dried roots of herbal infusions with a MRL proposal of 0.02 mg/kg (the LOQ). The applicant has to confirm the applicability of the enforcement method to analyse propyzamide residues in dried herbs. A minor data gap was identified regarding the freezer storage stability of propyzamide in dry matrices. Based on the risk assessment results, EFSA concludes that the intended use of propyzamide on the crops under consideration and the use of dried plant parts (leaves, flowers and roots) in herbal infusions will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a public health concern.

Propyzamide, herbal infusions, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, benzamide herbicide, 3,5-dichlorobenzoic acid
Print on demand
Number of Pages