Formulants Policy

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Stephanie Smith
Senior Screening Officer
Formulants/Renewal Section
Submission and Information Management Division
Registration Directorate

Formulants Policy

• DIR2006-02
  • Categorization of formulants into 5 lists
  • Regulatory action required for certain formulants
  • Processes and timelines for addressing regulatory requirements

Formulants Categorization

• Formulants assigned to Lists based on level of concern for human health and environment:
  • List 1: significant concern
  • List 2: potentially of concern, high priority for reassessment
  • List 3: anything that doesn't fall under the other lists
  • List 4A: minimal concern
  • List 4B: minimal concern for a particular use
• PMRA List of Formulants (REG2007-04)

Regulatory Actions by List Number

• List 1:
  • Discontinuation of formulation, or
  • Substitution or Removal of List 1 from formulation, or
  • Data or Rationale to support continued use.
  • Disclosure labelling required (List of Formulants of Concern)
• List 2
  • High priority for assessment and reclassification to either list 1, 4A, or 4B.
• List 3
  • Assessment and reclassification to either list 1, 4A, or 4B.
• Lists 4A and 4B
  • None, unless proposed use of a 4B is beyond that of approved use.

Other Regulatory Actions Related to Formulants

• Submission of SPSF with all applications as of April 2005
  • Must use latest version of form available on website
• Proprietary formulants: MSDS/CSI required with application
  • PMRA needs to know 100% of the composition
• New formulants: data review required
• Formulant-related notifiable changes

Allergens

• Definition
  • Allergens that cause anaphylactic-type reactions
    • Milk, eggs, fish, crustaceans, shellfish, peanuts, soy, tree nuts or their shells, sesame seeds, wheat and derivatives of these substances containing proteins.
    • Sulphites
• Labelling
  • "Warning, contains the allergen (insert name of allergen)"
    • On same panel as guarantee, similar font and size
    • Allergen source must be included
      • "soya lecithin" or "soy"
      • "casein (milk)" or "milk"

Formulation Preservatives

• Definition
  • Substances added to pest control products to protect their formulations from degradation or denaturation by pests.
    • Formulation preservatives are by definition active ingredients (registered or not), but they do not contribute to the intended effect of the pest control product to which they are added.
• Types
  • Can be a single chemical or a component of a mixture
  • Examples:
    • Insecticides added to rodenticide baits to prevent feeding by insects
    • Antimicrobials added to pesticides to prevent microbial growth within the container
• Labelling
  • "Contains (insert name of the formulation preservative) at (insert percent w/w) % as a preservative"
    • on same panel as guarantee, similar font and size -Example: "Contains Malathion at 0.1% as a preservative"
• SPSF Disclosure
  • Identify preservatives in the "Purpose" box of SPSF (box 10).
  • List the guarantee of the preservative on the SPSF as for an active ingredient.

Registration of Preservatives

• Preservatives are generally subject to registration under PCPA.
  • As of May 31, 2006, new pesticides must use a registered preservative.
  • For pesticides currently using unregistered preservatives, pleaserefer to Section 6.3.3, page 32, of the Formulants Policy for detailed implementation timelines.
• But, registration may not be required if the preservative is already regulated as a food additive under the Food and Drugs Act.
• Letter of Confirmation of Source of Supply (LOC)
  • Must be submitted for all registered preservatives.
  • Refer to memo "Requirements and Expectations for Letters of Confirmation of Source of Supply" (April 13, 2006)

Multiple Formulations under the same Registration

• Acceptability criteria
  • Similar product chemistry
  • Same hazard classification
  • Same performance
  • Mechanism for identifying the formulation found within a specific container
• Formulations that should be on the same SPSF:
  • Alternate active sources with the same purity
  • Alternate formulants at the same amount
  • Alternate formulation sites of MAs and EPs
• Formulations that should be on separate SPSFs:
  • Active sources with different purities
  • Alternate formulants at different amounts
  • Alternate manufacturing sites of TGAIs
• Formulation Number and Version Number
  • The first time it is used, it should start at 1.1
  • Formulation number
    • Identifies individual formulations
    • Never more than one current formulation with the same formulation number
    • Registrants must determine the formulation number
  • Version number
    • New number assigned each time the formulation is revised.
    • Does not change for: Notifiable changes, Renewal, and Other submissions where the formulation is not revised (e.g. label amendments)

SPSF: Statement of Product Specification Form

New Registration: Formulation 1 - SPSF 1.1; Formulation 2 - SPSF 2.1

Amendment to add Formulation 3: Formulation 1 - SPSF 2.2; Formulation 2 - SPSF 2.1; Formulation 3 - SPSF 3.1

Amendment to replace formulants in Formulation 1 and Formulation 3: Formulation 1 - SPSF 1.2; Formulation 2 - SPSF 2.1; Formulation 3 - SPSF 3.2

Notification letter to remove a colorant from formulation 1: Formulation 1 - SPSF 1.2; Formulation 2 - SPSF 2.1; Formulation 3 - SPSF 3.2

Letter to discontinue formulation # 2: Formulation 1 - SPSF 1.2; Formulation 2 - Discontinued Formulation # no longer used; Formulation 3 - SPSF 3.2

Amended composition of formulation # 3: Formulation 1 - SPSF 1.2; Formulation 3 - SPSF 3.3

Renewal Submission: Formulation 1 - SPSF 1.2; Formulation 3 - SPSF 3.3

• Labelling
  • Text label
    • Must include all List 1 formulants, allergens and formulation preservatives from all formulations, even if they are only present in some of them.
  • Marketplace label
    • Must only include List 1 formulants, allergens and formulation preservatives found in the particular formulation being labelled for sale in the marketplace.

Conclusion

• Reminder
  • If a submission does not meet the requirements of the Formulants Policy, there will be a delay in the completion date.
    • Examples:
      • No CSI for unknown formulant
      • No LOC for registered preservative
      • Incorrect Formulation and Version Number
      • Older version of SPSF form used
      • More than one technical manufacturing site listed on the same TGAI spec form

Reference Material

• Formulants Policy and Implementation Guidance Document (DIR2006-02
• PMRA List of Formulants (REG2007-04)
• List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern (Canada Gazette, Part II, November 30, 2005)
• Requirements and Expectations for Letters of Confirmation of Source of Supply (Memo April 13, 2006)
• Transparency Requirements of the new Pest Control Products Act: New Requirements for Applications to Register or Amend a Pest Control Product (Memo June 1, 2006)