Label Verification

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Valerie Robertson, Ph.D.
Director
Submission and Information Management Division Registration Directorate

• Label is defined as:
  • "Anything that conveys information that is required by the Pest Control Products Act or the regulations to accompany the product"
    • includes written, printed, or graphic matter on, or attached to the pesticide or device or any of its containers or wrappers
• Revised Pest Control Products Regulations [sections 22-29]
  • Requirements include those for:
    • the primary and secondary panels
    • a bilingual label (with limited exceptions)
    • legibility
  • Summarized in Label Requirements Checklist
• Revised Regulations -labelling revisions:
  • Notice to Buyer eliminated and liability aspect added to the Notice to User statement:
    • "...the user assumes the risk to persons or property that arises from any such [unapproved] use of the product"
  • Name, address, telephone no. to which public enquiries can be addressed must be found on the on primary panel
  • Product type no longer required in product name, but must be on primary panel
  • Registration statement may be abbreviated
• Labelling Requirements Checklist also lists other PMRA documents that affect labelling, including:
  • Re-evaluation Decision documents (RVD/RRD) and some interim decisions (REV)
  • DIR2006-02: Formulants Policy
  • DIR99-06: Resistance Management Statement
  • DIR2007-01: First Aid Labelling Statements
  • DIR96-04: Aerial Application
  • And others
• Bilingual labelling lexicon

Small Package Labelling

• Products with very small packages and labels:
  • In general:
    • May move to the lower portion of the secondary panel:
      • guarantee, preservative & allergen statements
      • name of the registrant
      • net contents
    • "Read the label" must remain on principal panel
  • PMRA will consider requirements for particularly small containers/labels on a case by case basis, e.g. sachets

Current Process

• Described in:
  • LPS2003-01 and LPS2003-02
• Steps:
  1. Applicant submits proposed label, E or F plain text version by attaching as DACO 1.1.2 in e-index with remaining documents
  2. PMRA reviews label, annotates any changes and sends annotated label to applicant
  3. Applicant translates the annotated label with changes incorporated and returns the corrected E and F versions in separate files
  4. PMRA verifies corrected label and, if acceptable, issues the approved label with registration certificate
  5. PMRA posts approved label (E & F) in Web Label Search Tool

Process Challenges

• Step 3:
  • PMRA changes not incorporated as requested; unapproved information added
  • Corrected label incorporates proposed re-evaluation changes (PACR/PRVD) before final re-evaluation decision (RRD/RVD)
  • Corrected label -translated version:
    • Missing sentences/paragraphs
    • Retranslate previously approved wording (amendment subs.)
    • French translation inconsistent with Re-evaluation decision document or other policies/guidelines

Process Improvements

• PMRA currently considering means to improve the efficiency of the label process, including:
  • Microsoft Word as the preferred format for submission of e-labels
  • Methodology for the applicant and the PMRA to flag label revisions, and for the applicant to identify other submissions in which the same wording had been approved
  • The stage for submitting the second language label version/file
  • The stage at which the label will be finalized