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Mandestrobin has been widely used in Canada as a fungicide for various foods. Canada’s Pest Management Regulatory Agency (PMRA) has notified the World Trade Organization (WTO) of its intention to implement MRLs for mandestrobin. Comments on the proposals should be sent to the PMRA by March 14, 2016, before a final decision is made. [1]

Mandestrobin is a new active substance of the strobilurin group registered by Sumitomo Chemical Company.  It is a fungicide to control sclerotinia on oilseed rape. To ensure its use is safe for consumption and does not pose a risk to human health, a risk assessment based on environmental and human exposure has been studied in many countries in order to find the safe level. Major adverse effects of mandestrobin observed by the Food Safety Commission of Japan (FSCJ) are hepatocellular hypertrophy and increased liver weights, and hypertrophy of thyroid follicular cells in rats. However, it does not show any neurotoxicity, carcinogenicity, reproductive toxicity or genotoxicity [2]. The sum of its two isomers in food commodities should comply with Japanese maximum residue limits (MRLs) [3]. Beyond Japan, the EU commission also studied the risk assessment and approved mandestrobin as active substance for plant production products in accordance with Regulation (EC) No. 1107/2009 [4].

Recently, the PMRA has received applications to register a technical grade of mandestrobin and its end-use products (S-2200 4 SC, S-2200 3.2 FS, S-2200 4 SC AG) in foods. The quantity of residue that is likely to remain in or on foods when the pesticide is used according to label direction without negative human impact has to be considered.  Consequently, the quantified safe level is then legally specified as an MRL. These legal MRLs should be used when testing for the residue in raw agricultural food commodities, as well as any processed food products that may contain it. To date, there is no international standard MRL issued by Codex for mandestrobin, in or on any commodity. Once the tolerance of this substance has been established by Canada, the PMRA is required to set its MRLs corresponding to Canadian tolerance [5]. Proposed Canadian MRLs in food commodities regarding PMRL 2016-03 are shown in Table 1.

Table 1 MRLs of Mandestrobin

Common Name Residue definition MRL (ppm)1 Food commodity
Mandestrobin 2-[(2,5-dimethylphenoxy)methyl]-α-methoxy-N-methylbenzeneacetaminde 7.0 Raisins
5.0 Small fruit vine climbing (Crop Subgroup 13-07F, except fuzzy kiwifruit)
3.0 Low growing berry (Crop Subgroup 13-07G, except cranberry)
0.5 Rapeseed (Crop Subgroup 20A)
0.02 Legume vegetables (succulent or dried) (Crop Group 6, except cowpea and field pea), corn (field, popcorn, sweet)

1ppm = part per million

What do the changes mean?

Canada’s proposed MRLs have the potential to affect agricultural producers and food manufacturers. The residue of mandestrobin in or on products destined for Canada must not exceed the proscribed MRLs. For support in complying with the food safety regulation, producers should seek professional advice.

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Amornpun Dajsiripun
Global Competence Support Centre Food Specialist
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