Impurity Cause for concern Source of impurity and level Maximum level in in source product e.g. TSMP Track 1 substance 10 ppm in TGAI 1 ppm Hexachlorobenzene [PMRA] 30-50 ppm in Formulant e.g. Arsenic Toxic heavy metal 1 ppm Mixture A IIIA 5.2.4 + 5 Analytical methods for the determination of impurities which are of toxicological, ecotoxicological or environmental concern in the formulation / Analytical methods for the determination of formulants or constituents of formulants in the product Not required by PMRA or EPA, except in certain scenarios such as the following: essential oils where the applicant may choose to analyse an impurity (e.g. methyl eugenol) in the end-use product rather than the technical product end-use products (e.g. dimethylamine formulations of 2,4-D) where the impurity of concern is introduced/increased during the formulation process active ingredients that degrade upon storage to more toxic substances REFERENCES RELIED ON Title Source Annex No., Company Report No. Data OECD Data GLP or GEP Status (where Protection Requirement relevant) Claimed No. Author(s) Year Published or not (Y/N) Owner IIIA, 1.4 Smith, A.B. 2013 Formulation: manufacturing process Y Company A Company A Company A Report No. 1 GLP: No Published: No IIIA, 1.9 Jones, C.D. 2014 Technical grade: Identity, Y Company A composition, and certified limits Company B Company B Report No. 1 GLP: No Published: No PMRA and EPA will generate their respective reference lists electronically.
Impurity Cause for concern Source of impurity and level in source Maximum level in product e.g. Hexachlorobenzene TSMP Track 1 substance [PMRA] 10 ppm in TGAI 1 ppm e.g. Arsenic Toxic heavy metal 30-50 ppm in Formulant Mixture A 1 ppm IIIA 5.2.4 + 5 Analytical methods for the determination of impurities which are of toxicological, ecotoxicological or environmental concern in the formulation / Analytical methods for the determination of formulants or constituents of formulants in the product Not required by PMRA or EPA, except in certain scenarios such as the following: essential oils where the applicant may choose to analyse an impurity (e.g. methyl eugenol) in the end-use product rather than the technical product end-use products (e.g. dimethylamine formulations of 2,4-D) where the impurity of concern is introduced/increased during the formulation process active ingredients that degrade upon storage to more toxic substances REFERENCES RELIED ON Annex No., OECD Data Requirement No. Author(s) Year Title Source Company Report No. GLP or GEP Status (where relevant) Published or not Data Protection Claimed (Y/N) Owner IIIA, 1.4 Smith, A.B. 2013 Formulation: manufacturing process Company A Company A Report No. 1 GLP: No Published: No Y Company A IIIA, 1.9 Jones, C.D. 2014 Technical grade: Identity, composition, and certified limits Company B Company B Report No. 1 GLP: No Published: No Y Company A PMRA and EPA will generate their respective reference lists electronically.