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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 Mar 22, 2024.

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 8]
[CITE: 21CFR1240.61]
 See Related Information on Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER L - REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION

PART 1240 -- CONTROL OF COMMUNICABLE DISEASES

Subpart D - Specific Administrative Decisions Regarding Interstate Shipments

Sec. 1240.61 Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption.

(a) No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized or is made from dairy ingredients (milk or milk products) that have all been pasteurized, except where alternative procedures to pasteurization are provided for by regulation, such as in part 133 of this chapter for curing of certain cheese varieties.

(b) Except as provided in paragraphs (c) and (d) of this section, the terms "pasteurization," "pasteurized," and similar terms shall mean the process of heating every particle of milk and milk product in properly designed and operated equipment to one of the temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time:

Temperature Time
145 deg.F (63 deg.C) 130 minutes.
161 deg.F (72 deg.C) 115 seconds.
191 deg.F (89 deg.C)1 second.

1 If the fat content of the milk product is 10 percent or more, or if it contains added sweeteners, the specified temperature shall be increased by 5 deg.F (3 deg.C).

Temperature Time
194 deg.F (90 deg.C)0.5 second.
201 deg.F (94 deg.C)0.1 second.
204 deg.F (96 deg.C)0.05 second.
212 deg.F (100 deg.C)0.01 second.

(c) Eggnog shall be heated to at least the following temperature and time specification:

Temperature Time
155 deg.F (69 deg.C)30 minutes.
175 deg.F (80 deg.C)25 seconds.
180 deg.F (83 deg.C)15 seconds.

(d) Neither paragraph (b) nor (c) of this section shall be construed as barring any other pasteurization process that has been recognized by the Food and Drug Administration to be equally efficient in the destruction of microbial organisms of public health significance.

[52 FR 29514, Aug. 10, 1987, as amended at 57 FR 57344, Dec. 4, 1992]

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