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RG-1 Regulatory guidance:
Chapter 2 - Data requirements for single ingredient approval and feed registration

2.4 Generic data requirements for safety evaluations of single ingredients

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In order to facilitate the health & safety assessments of single ingredients, the following list of data requirements has been developed to clarify section 2.3.

These requirements will apply to all single ingredients which are not already approved for use in Canada. It is expected that all manufacturers/registrants will be able to supply the information listed if applicable. In the event that a preliminary evaluation identifies concerns, more specific information may be requested.

Single ingredients already cleared may be subject to a similar assessment if any doubt as to their safety or improper use is suspected.

Please note that information is required of active ingredients, major metabolites, and any contaminants of concern.

  1. Identification and Use of the Product
    • Name
    • Other names (i.e. international feed name, chemical name, botanical name, etc.)
    • Suggested rates, timing, intervals of feeding, withdrawal times
    • Identification of species of intended use
    • Unit amount
    • Product Label and Material Safety Data Sheet (MSDS) for product or ingredients
    • Outline of manufacture
  2. Chemical Components Including Impurities
    • Chemical name and synonyms
    • Chemical formula (molecular and structural)
    • Chemical Abstract Service (CAS) Number
    • Concentrations in the finished product (% or ppm)
    • Criteria of chemical identity and purity
    • Estimated shelf life
  3. Method(s) of Analysis, Recovery and Detection Limit Data for the Analyses (per section 6.2)
  4. Physicochemical Data (if applicable)
    • Molecular weight
    • Physical state
    • Density/specific gravity
    • Refractory index
    • Melting point
    • Boiling point
    • Flash point
    • Auto-ignition temperature
    • Vapour pressure
    • Vapour density
    • pH
    • Solubility in water
    • Octanol-water partition coefficient
    • Solubility in other solvents
    • Incompatibility
    • Polymerization
  5. Pertinent Livestock Toxicity Data
  6. Livestock Metabolic Fate and Residue Studies
    • Metabolic fate studies, to include analytical methods for recovery and detection limits
    • Residue studies for the parent compound and its possible metabolites, to include analytical methods for recovery and detection limits
    • Excretion data
    • Suggested Maximum Residue Limit(s) or tolerance
  7. Mammalian Toxicological Data

    Typical minimum mammalian toxicology data requirements are bolded. The additional studies or data may be required of particular products or constituents if deemed necessary.

    • Routes of entry
    • Rate and degree of absorption
    • Estimation of exposure
    • Acute toxicity: acute median lethality, skin/eye irritation, skin sensitization, mutagenicity (with and without activation)
    • Short-term toxicity (e.g. 28-day study)
    • Teratogenicity
    • Carcinogenicity
    • Developmental toxicity
    • Reproductive toxicity
    • Epidemiological studies
    • Chemical interactions
  8. Environmental Fate and Effects
    • Vapour pressure and volatilization
    • Hydrolysis
    • Photodegradation
    • Solubility in water
    • Octanol-water partition coefficient
    • Adsorption-desorption
    • Leaching
    • Biotransformation in soil (aerobic/anaerobic)
    • Biotransformation in aquatic systems (aerobic/anaerobic)
    • Toxicity to wildlife
    • Toxicity to aquatic organisms
    • Toxicity to soil organisms

Note: If tissue residue levels above background are evident, the Food Directorate of Health and Welfare Canada may require a more extensive review before approval for use is granted.

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