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Registration Guidelines Updates

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Registration Guidelines Updates. Carmen Grindatti. Research Toxicologist. NSF International ... It is very helpful to NSF to have this information because it ... – PowerPoint PPT presentation

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Title: Registration Guidelines Updates


1
Registration Guidelines Updates
NSF Nonfood Compounds Steering Committee
MeetingOctober 24, 2006
  • Carmen Grindatti
  • Research Toxicologist
  • NSF International

2
Topics to be covered
  • Formulation submission requirements
  • D2 formulation requirements
  • F1 formulation requirements
  • Decharacterization options
  • L2 label requirements
  • Q category formulation requirements

3
Formulation submissions
  • Current Guidelines
  • Requirements complete chemical name, CAS number,
    supplier and regulatory reference.
  • Proposed Guidelines
  • Addition of trade name as an optional requirement.

4
Formulation submissions
  • Rationale
  • It is very helpful to NSF to have this
    information because it helps us to find
    ingredient information when CAS numbers were not
    provided.

5
Questions?
6
D2 Formulation Requirements
  • Current Guidelines
  • Require formulations to comply with 21 CFR
    178.1010 (FDA).
  • Proposed Guidelines
  • Require formulations to comply with 40 CFR
    180.940 (EPA).

7
D2 Formulation Requirements
  • Rationale
  • This change reflects the change in jurisdiction
    of these products.
  • These products are currently regulated by the EPA
    and not the FDA.

8
Questions?
9
F1 Formulation Requirements
  • Current Guidelines
  • The concentration of the synergist in contact or
    space sprays is limited to 5 when used as an
    aerosol.
  • Proposed Guidelines
  • All EPA registered formulations are acceptable.

10
F1 Formulation Requirements
  • Rationale
  • Per correspondence with the USDA, synergist
    levels greater than 5 were allowed when the EPA
    had approved the use level.

11
Questions?
12
Decharacterization Options
  • Current Guidelines
  • One decharacterization option is to use K2PO3.
  • Proposed Guidelines
  • Change K2PO3 to K2CO3.

13
Decharacterization Options
  • Rationale
  • This is a correction of a typo.

14
Questions?
15
L2 Label Requirements
  • Current Guidelines
  • Require that the lot or batch number appear on
    the product label.
  • Proposed Guidelines
  • This requirement has been removed.

16
L2 Label Requirements
  • Rationale
  • Originally intended to be a method by which the
    annual salmonella reports could be linked to the
    lot or batch tested.
  • NSF no longer requires the submission of annual
    salmonella reports.
  • Annual reporting was based on obsolete
    contamination issues in the early 70s, therefore
    follow-up is no longer necessary.

17
Questions?
18
Q Category Formulation Requirements
  • Current Guidelines
  • Require formulations to consist of appropriately
    regulated food additives or GRAS substances.
  • Proposed Guidelines
  • Require formulations to consist of substances
    regulated for any purpose as food additives in 21
    CFR 172-186.
  • Dyes and pigments regulated as color additives
    for use in food may also be acceptable.

19
Q Category Formulation Requirements
  • Rationale
  • FSIS website lists substances regulated under 21
    CFR 172 - 186, as well as color additives
    regulated for use in food, as being acceptable
    for use in shell egg products
  • FDA has indicated that an egg shell is an
    effective barrier to egg wash components,
    therefore these substances are not considered
    food additives.

20
Questions?
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