On 16 May 2016, the Canada Pest Management Regulatory Agency (PMRA) released the “Regulatory Directive DIR2016-02, Notification/Non-notification”. To simply certain minor changes to registered product, the PMRA has provided a notification/non-notification policy since 1994 and the industry and stakeholders can follow the notification or non-notification process without standard registration alteration formalities.
The Notification/Non-notification Policy has been revised for three times and this version replaces the “Regulatory Directive DIR2013-02, Notification/Non-notification”. Changes in this directive include:
Addition of a tank mix;
Changes to subsequent crops (addition or removal) and plant-back intervals (increase or removal);
Changes to application rate, application timing, application number or frequency, and Application method when based on a precedent with identical formulation;
Certain changes to precautionary statements;
Changes in source of starting materials that are not commodity chemicals;
Requirement of a label for repack/re-label notifications; and
Removal of trade label statement by non-notification.
The directive provides conditions of pesticide label and formulation/specification-related alteration applicable for notification/ non-notification and product changes beyond the scope will be made under standard registration alteration. The general circumstances are summarized as table below:
Item | Notification | Non-notification | New registration or registration alteration |
Label | |||
Address or regulatory email of registrant; Name and address of Canadian agent; Packaging and related statement*; Product name; Deleting a use; Removal of treated paper with food contact advisory statement; Product type List 1 adjuvant label disclosure Ozone-depleting adjuvant label disclosure Allergen label disclosure; "Refillable" container; Obsolete label information*; Rotational crops and plant-back interval*; Changes to application rate (increase or decrease), application timing, application number or frequency, or application method when based on a precedent*; Precautions*; | √(*criteria are met) |
|
|
Disposal of statements; First aid statement; Resistance management statement; Effects on treated objects or sites; | Using PMRA standard statements |
| Using non-standard statements and variations of standard statements |
Unlabeled tank mix; Buffer zone calculator reference; |
| Using PMRA standard statements | Changes to the standard statement |
Correction of typographical or print errors Label format Notice to user statement; Sybols or graphics(pictograms and drawings); Redundant label statement; Recycled packaging; Place of manufacture Consumer access information Price or price-related marketing text; Company history; “New” or “improved” formulation |
| √ |
|
Addition of tank mixes | Where currently labeled on tank mix partner and text is identical OR criteria are met (in other words, for tank mix not labeled on any product |
| Neither notification nor non-notification criteria are met or other tank mixes or variations in label text |
Marketing Text | Where text is clearly consistent with approved directions for use |
| Text that is not clearly supported by the approved directions for use, for example, duration of control claims |
Translation corrections | For text omission or errors | Typographical or print errors on marketplace label | General ”improvement” of translated text |
Net contents/container size | Notification Criteria are met | Non-notification criteria are met | Neither notification or non-notification criteria are met |
Formulation/Specification-Related | |||
Formulation process*; Nominal concentration of an adjuvant*; Certified limits of an adjuvant*; Supplier of an adjuvant*; Identity of an adjuvant/adjuvant substitution*; Formulator name or address*; Colorants*; Fragrances*; Source of TC for an end-use product*; Removal of a source of active ingredient*; Deletion of a formulation; Deletion of alternate adjuvant; Change in pH range*; Change in source of starting material that are not commodity chemicals; | √(*criteria are met) |
| √(*criteria are not met) |
Formulator name or address | For end-use products and manufacturing concentration that are not microbial pesticide control products |
| For all technical grade active ingredients and microbial end-use and manufacturing products |
Grantee conversion from minimal to nominal; | For end-use products and manufacturing concentrates where grantee for technical product used is normal |
| For technical products |
Change in source of starting material that are not commodity chemical |
| √(*criteria are met) | √(*criteria are not met) |
