Consultation on Proposed Guidance for Residual Solvents in Technical Grade Active Ingredients

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The online consultation is now closed.

Pest Management Regulatory Agency
29 March 2023

In Health Canada's Guidance for developing datasets for conventional pest control product applications (updated February 2021), registrants and applicants are informed of the need to minimize the presence of impurities of toxicological concern (IOCs) in the manufacture of pest control products (DACO 2.13.4) in order to protect the health of Canadians and the environment.

To provide clarity on the data requirements, Health Canada's Pest Management Regulatory Agency (PMRA) has established generally acceptable limits for certain residual solvents of concern in technical grade active ingredient (TGAI) products. If a particular limit is not met, consultation with the PMRA will be required to determine whether it is acceptable; further supporting data may be requested. As described in the Guidance for developing datasets for conventional pest control product applications, the use of several of these solvents is to be avoided completely where possible, while others are to be limited.

PMRA established limits for residual solvents in TGAIs
Residual solvent Maximum PMRA general limit (ppm) Required limit of quantitation (LOQ) (ppm)
carbon tetrachloride --- (to be avoided) 1
1,2-dichloroethane --- (to be avoided) 1
benzene --- (to be avoided) 1
1,4-dioxane 4 1
chloroform 10 1
tetrahydrofuran 100 10
pyridine 200 100
hexane 290 100
dichloromethane 300 100
acetonitrile 410 100
N,N-dimethylformamide 500 100
N-methyl-2-pyrrolidone 530 100
chlorobenzene 600 100
cyclohexane 710 500
methylcyclohexane 1000 500
N,N-dimethylacetamide 1090 500
xylene 2170 1000
methanol 3000 1000
toluene 15000 1000

Next steps

Health Canada invites the public to submit written comments on the publication of limits for solvents of concern in the manufacture of technical grade pest control products for 30 days from the date of publication of this notice. Health Canada will consider all comments received before finalizing the guidance, anticipating that it will be updated as needed.

Please forward your comments to PMRA Publications, and include:

Please be sure to include the title of the consultation document on which you are commenting. Interested parties are encouraged to provide comments by 28 April 2023.

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