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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR1.1350]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart S - Additional Traceability Records for Certain Foods

Records of Critical Tracking Events

Sec. 1.1350 What records must I keep when I transform a food on the Food Traceability List?

(a) Except as specified in paragraphs (b) and (c) of this section, for each new traceability lot of food you produce through transformation, you must maintain records containing the following information and linking this information to the new traceability lot:

(1) For the food on the Food Traceability List used in transformation (if applicable), the following information:

(i) The traceability lot code for the food;

(ii) The product description for the food to which the traceability lot code applies; and

(iii) For each traceability lot used, the quantity and unit of measure of the food used from that lot.

(2) For the food produced through transformation, the following information:

(i) The new traceability lot code for the food;

(ii) The location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;

(iii) The date transformation was completed;

(iv) The product description for the food;

(v) The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds); and

(vi) The reference document type and reference document number for the transformation event.

(b) For each traceability lot produced through transformation of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List that was not initially packed prior to your transformation of the food, you must maintain records containing the information specified in § 1.1330(a) or (c), and, if the raw agricultural commodity is sprouts, the information specified in § 1.1330(b).

(c) Paragraphs (a) and (b) of this section do not apply to retail food establishments and restaurants with respect to foods they do not ship (e.g., foods they sell or send directly to consumers).

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