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21 CFR § 80.37 - Treatment of batch pending certification.

---
identifier: "/us/cfr/t21/s80.37"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 80.37 - Treatment of batch pending certification."
title_number: 21
title_name: "Food and Drugs"
section_number: "80.37"
section_name: "Treatment of batch pending certification."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "80"
part_name: "COLOR ADDITIVE CERTIFICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 371, 379e."
regulatory_source: "42 FR 15662, Mar. 22, 1977, unless otherwise noted."
cfr_part: "80"
---

# 80.37 Treatment of batch pending certification.

Immediately after the sample that is to accompany a request for certification of a batch of color additive is taken, the batch shall be:

(a) Stored in containers of such kind as to prevent change in composition.

(b) Held under the control of the person requesting certification until certified.

(c) Marked, by labeling or otherwise, in a manner such that there can be no question as to the identity of the batch and no question that it is not to be used until the requested certificate has been issued.