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Title Approval of 455-2i29r1 - Section 4.3.1 Exemptions
Description
Proposed revision to NSF/ANSI 455-2 – Good Manufacturing Practices for Dietary Supplements (455-2i29r1)

Section 4.3.1 in the NSF/ANSI 455-2 standard states a Food Hazard analysis is needed as per 21CFR117.130 however, there is an exemption for 21CFR117 for the manufacture of finished dietary supplements, registered establishments that are complying with Part 111 are exempt from the regulations relating to the Hazard Analysis and Preventive Controls (see 21CFR117.5e).
Ballot Options Ballot has closed
[ ] Affirmative
[ ] Negative
[ ] Abstain
Document for Approval 455-2i29r1 - Section 4.3.1 Exemptions - JC Memo & Ballot.pdf
Opening Date Thu, Jul 15 2021 6:00 pm Eastern Daylight Time
Closing Date Thu, Aug 5 2021 11:59 pm Eastern Daylight Time
Ballot has closed.

Referenced Items

Name Type Date Actions

07188: Approval of 455-2i29r1 - Section 4.3.1 Exemptions

Document (Archive)

2021-08-06

No Access

Blank Comment - TEMPLATE.docx

Document

2021-07-15

No Access

gmpDS-2021-19.pdf

Document

2021-07-15

No Access

- Voting Results

Voting Statistics

Number of votes cast (excluding abstentions) 10
Eligible members who have voted 10 of 13 76.923%
Eligible members who have not voted 3 of 13 23.077%

Voting Summary by Option

Options with highest number of votes are bold
Option # Votes % of Total
Affirmative 9 90%
Negative w/comment 1 10%
Abstain 0

Voting Summary by Interest Category

Interest CategoryAffirmativeNegative w/commentAbstainNot ReturnedTotal
Academia / NGO00000 (0%)
Distributor00000 (0%)
Emeritus00000 (0%)
Fabricator/Formulator00000 (0%)
General Interest00000 (0%)
Government00000 (0%)
Industry60006 (46.154%)
Ingredient Supplier00000 (0%)
Manufacturer00000 (0%)
Manufacturer Processes00000 (0%)
Medicine/Health00000 (0%)
Non-voting Liaison00000 (0%)
Other00000 (0%)
Other Industry00000 (0%)
Practitioner/Service Provider00000 (0%)
Product Certifier / Testing Lab00000 (0%)
Public Health / Regulatory20013 (23.077%)
Purchasers & Ecolabel Criteria Users00000 (0%)
Sustainability Advocate & Gov00000 (0%)
Trade Association00000 (0%)
User11024 (30.769%)
Water Utility00000 (0%)
Not Specified00000 (0%)
Total910313 (100%)