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573.460 Formaldehyde.

Home > Regulations > Food additives permitted in feed and drinking water of animals > 573.460 Formaldehyde.






[Code of Federal Regulations]

[Title 21, Volume 6]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR573.460]



[Page 516-517]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                          SERVICES (CONTINUED)

 

PART 573_FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS

--Table of Contents

 

                     Subpart B_Food Additive Listing

 

Sec.  573.460  Formaldehyde.



    The food additive formaldehyde may be safely used in the manufacture 

of animal feeds in accordance with the following conditions:

    (a) The additive is used, or intended for use, to improve the 

handling characteristics of fat by producing a dry, free-flowing 

product, as follows:

    (1) For animal fat in combination with certain oilseed meals, as a 

component of dry, nonpelletted feeds for beef and nonlactating dairy 

cattle.

    (i) An aqueous blend of soybean and sunflower meals in a ratio of 

3:1, respectively, is mixed with animal fat such that the oilseed meals 

and animal fat are in a ratio of 3:2. The feed ingredients are those 

defined by the ``Official Publication'' of the Association of American 

Feed Control Officials, Inc., 2003 ed., pp. 303, 308, and 309, which is 

incorporated by reference. The Director of the Office of the Federal 

Register approves this incorporation by reference in accordance with 5 

U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the 

Assistant Secretary-Treasurer, Association of American Feed Control 

Officials Inc., P.O. Box 478, Oxford, IN 47971, or you may examine a 

copy at the Division of Dockets Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or at 

the National Archives and Records Administration (NARA). For information 

on the availability of this material at NARA, call 202-741-6030, or go 

to: http://www.archives.gov/federal--register/code--of--federal--

regulations/ibr--locations.html.

    (ii) Formaldehyde (37 percent solution) is added to the mixture at a 

level of 4 percent of the dry matter weight of the oilseed meals and 

animal fat. This mixture, upon drying, contains not more than 1 percent 

formaldehyde and not more than 12 percent moisture.

    (iii) To assure the safe use of the additive, in addition to the 

other information required by the Federal Food, Drug, and Cosmetic Act 

(the act), the label and labeling of the dried mixture shall bear:

    (A) The name of the additive.

    (B) Adequate directions for use providing that the feed as consumed 

does not contain more than 25 percent of the mixture.

    (2) For soybean and canola seeds and/or meals to which there may be 

added vegetable oil as a component of dry, nonpelleted feeds for beef 

and dairy cattle, including lactating dairy cattle.

    (i) An aqueous blend of oilseed and/or meals, with or without added 

vegetable oil, in a ratio such that, on a dry matter basis, the final 

protein level will be 25 to 35 percent and the fat content will



[[Page 517]]



be 20 to 45 percent. The feed ingredients are those defined by the 

``Official Publication'' of the Association of American Feed Control 

Officials, Inc., 2003 ed., pp. 301, 307, 308, and 309, which is 

incorporated by reference. The Director of the Office of the Federal 

Register approves this incorporation by reference in accordance with 5 

U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the 

Assistant Secretary-Treasurer, Association of American Feed Control 

Officials Inc., P.O. Box 478, Oxford, IN 47971, or you may examine a 

copy at the Division of Dockets Management, Food and Drug 

Administration, 5630 Fishers lane, rm. 1061, Rockville, MD 20852, or at 

the National Archives and Records Administration (NARA). For information 

on the availability of this material at NARA, call 202-741-6030, or go 

to: http://www.archives.gov/federal--register/code--of--federal--

regulations/ibr--locations.html.

    (ii) Formaldehyde (37 percent solution) is added to the mixture at a 

level of 2.7 percent of the dry matter weight basis of the oilseeds and/

or meals and the vegetable oil. This mixture, upon drying, contains not 

more than 0.5 percent formaldehyde and not more than 12 percent 

moisture.

    (iii) To assure the safe use of the additive, in addition to the 

other information required by the act, the label and labeling of the 

dried mixture shall bear:

    (A) The name of the additive.

    (B) The statement, ``This supplement is not to exceed 12.5% of the 

total ration. Dietary calcium and magnesium levels should be considered 

when supplementing the diet with fat.''

    (C) The minimum and maximum levels of crude fat must be guaranteed 

and must be between -5 percent and +5 percent of the analyzed fat 

content for each batch.

    (b)(1) The food additive is formaldehyde (CAS No. 50-00-0; 37 

percent aqueous solution). It is used at a rate of 5.4 pounds (2.5 

kilograms) per ton of animal feed or feed ingredient. It is an 

antimicrobial agent used to maintain complete animal feeds or feed 

ingredients Salmonella negative for up to 21 days.

    (2) To assure safe use of the additive, in addition to the other 

information required by the Act, the label and labeling shall contain:

    (i) The name of the additive.

    (ii) A statement that formaldehyde solution which has been stored 

below 40 [deg]F or allowed to freeze should not be applied to complete 

animal feeds or feed ingredients.

    (iii) Adequate directions for use including a statement that 

formaldehyde should be uniformly sprayed on and thoroughly mixed into 

the complete animal feeds or feed ingredients and that the complete 

animal feeds or feed ingredients so treated shall be labeled as 

containing formaldehyde. The label must prominently display the 

statement: ``Treated with formaldehyde to maintain feed Salmonella 

negative. Use within 21 days.''

    (iv) The labeling for feed or feed ingredients to which formaldehyde 

has been added under the provisions of paragraph (b)(1) of this section 

is required to carry the following statement: ``Treated with 

formaldehyde to maintain feed Salmonella negative. Use within 21 days.''

    (3) To assure safe use of the additive, in addition to the other 

information required by the Act, the label and labeling shall contain:

    (i) Appropriate warnings and safety precautions concerning 

formaldehyde.

    (ii) Statements identifying formaldehyde as a poison with potentials 

for adverse respiratory effects.

    (iii) Information about emergency aid in case of accidental 

inhalation.

    (iv) Statements reflecting requirements of applicable sections of 

the Superfund Amendments and Reauthorization Act (SARA), and the 

Occupational Safety and Health Administration's (OSHA) human safety 

guidance regulations.

    (v) Contact address and phone number for reporting adverse reactions 

or to request a copy of the Materials Safety Data Sheet (MSDS).



[41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 

61 FR 15704, Apr. 9, 1996; 63 FR 53580, Oct. 6, 1998; 68 FR 65633, Nov. 

21, 2003]



[[Page 518]]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 573, Section 460


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