Proposed Maximum Residue Limit  PMRL2019- 36 
Fludioxonil  
(publié aussi en français)  27 November 2019 
T
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Proposed Maximum Residue Limit - PMRL2019 -36 
Page 1 Under the authority of the Pest Control Products Act , Health Canada’s Pest Management 
Regulatory Agency (PMRA) has concluded that the addition of new uses on dried shelled pea 
and bean (except soybean) – crop subgroup 6C to the product label of  Cyproflu Fungicide and 
Switch 62.5 WG Fungicide, containing tec hnical grade active ingredients fludioxonil and 
cyprodinil , is acceptable. The specific uses approved in Canada are detailed on the labels of 
Switch 62.5 WG Fungicide and Cyproflu Fungicide , Pest Control Products Act  Registration 
Numbers 28189 and 30185, respectively.  
The evaluation of this fludioxonil  application indicated that the end -use product has value and 
the human health and environmental risks associated with the new use are acceptable.  
Before registering a pesticide for food use in Canada, the PM RA must determine the quantity of 
residues that are likely to remain in or on the food when the pesticide is used according to label 
directions and that such residues will not be a concern to human health. This quantity is then 
legally established as a max imum residue limit (MRL). An MRL applies to the identified raw 
agricultural food commodity as well as to any processed food product that contains it, except 
where separate MRLs are specified for the raw agricultural commodity and a processed product 
made f rom it.  
Consultation on the proposed MRL for fludioxonil is being conducted via this document (see 
Next Steps). A summary of the field trial data used to support the proposed MRL can be found in 
Appendix I. MRL consultation for the other active ingredient, cyprodinil, present in Switch 62.5 
WG Fungicide and Cyproflu Fungicide is being conducted under a separate action.  
To comply with Canada’s international trade obligations, consultation on the proposed MRL is 
also being conducted int ernationally by notifying the World Trade Organization , as coordinated 
by the Canada’s Notification Author ity and Enquiry Point . 
The proposed MRL, to be added to the MRLs already established for fludioxonil , is as follows. 
Table 1  Proposed Maximum Residue Limit for Fludioxonil  
Common 
Name  Residue Definition  MRL 
(ppm)1 Food Commodity  
Fludioxonil  4-(2,2-difluoro -1,3-benzodioxol -4-
yl)-1H-pyrrole -3-carbonitrile  0.52 Dried shelled bean and pea 
(except soybean) (crop 
subgroup 6C)  
1 ppm = parts per million   
2 The 0.5 ppm MRL is proposed to be extended to all food commodities in crop subgroup 6C.  
MRLs are proposed for each commodity included in the listed crop groupings in accordance with 
the Residue Chemistry Crop Groups  webpage in the Pesticides section of the Canada.ca website.  
MRLs established in Canada may be found using the Max imum Residue Limit Database  on the 
Maximum R esidue Limits for Pesticides  webpage. The database allows users to search for 
established MRLs, regulated under the Pest Control Products Act , both for pesticides or for food 
commodities.    
 
Proposed Maximum Residue Limit - PMRL2019 -36 
Page 2 International Situation and Trade Implications  
MRLs may vary from on e country to another for a number of reasons, including differences in 
pesticide use patterns and the locations of the crop field trials used to generate residue chemistry 
data.  
Table 2 compares the MRL proposed for fludioxonil in Canada with corresponding  American 
tolerance and Codex MRLs.1 American tolerances are listed in  the Electronic Code of Federal 
Regulations , 40 CFR Part 180, by  pesticide. A listing of established Codex MRLs is available on 
the Codex Alimentarius Pesticide Index  webpage, by pesticide or commodity.  
Table 2  Comparison of the Canadian MRL, American Tolerance and Codex MRLs 
(where different)  
Food Commodity  Canadian MRL 
(ppm)  American Tolerance  
(ppm)  Codex MRL  
(ppm)  
Crop subgroup 6C  0.5 0.4 (dry beans)  0.5 (dry beans)  
0.07 (dry peas)  
 
Next Steps  
The PMRA invites the public to submit written comments on the proposed MRL for fludioxonil  
up to 75 days from the date of publication of this document. Please forward your comments to 
Publications (see the contact information on the cover page of this document). The PMRA will 
consider all comments received before making a final decision on the proposed MRL. Comments 
received will be addressed in a separate document linked to this PMRL. The established MRL 
will be legally in effect as of the date that it is entered into the Maximum Re sidue Limit 
Database .
                                                           
1  The Codex Alimentarius Commission  is an international organization under the auspices of the United 
Nations that develops international food standards, including MRLs.  Appendix I  
  
 
Proposed Maximum Residue Limit - PMRL2019 -36 
Page 3 Appendix I  
Summary of Field Trial Data Used to Support the Proposed Maximum Residue Limits  
Residue data for fludioxonil in dry pea were submitted to support the domestic use of Cyproflu 
Fungicide and Switch 62.5 WG Fungicide on crop s ubgroup 6C. In addition, previously 
reviewed residue data from field trials conducted on dry beans were reassessed in the framework 
of this petition  
Maximum Residue Limit(s)  
The recommendation for the maximum residue limit (MRL) for fludioxonil was based upon the 
submitted field trial data, and the guidance provided in the OECD MRL  Calculator . Table A1 
summarizes the res idue data used to calculate the proposed MRL for all commodities of crop 
subgroup 6C.  
Table A1  Summary of Field Trial Data Used to Support the MRL  
Commodity  Application 
Method/ Total 
Application Rate  
(g a.i./ha)1 Preharvest 
Interval 
(days)  Lowest 
Average F ield 
Trial Residues  
(ppm) Highest 
Average Field 
Trial Residues  
(ppm)  
Dry peas  Foliar application / 
734 6–7 0.02 0.17 
Dry beans  Foliar application / 
1000  5–8 0.02 0.29 
1 g a.i./ha = grams of active ingredient per hectare  
Following the review of all available data, the MRL as proposed in Table 1 is recommended to 
cover residues of fludioxonil. Residues of fludioxonil in these commodities at the proposed 
MRLs will not pose an unacceptable risk to any segment of the population, including infants, 
childr en, adults and seniors.