Consultation on Proposed Guidance for Residual Solvents in Technical Grade Active Ingredients
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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.
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:
- Your full name and organization;
- Your phone number; and,
- Your complete mailing address or email address.
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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