CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 2]

[CITE: 21CFR130.9]

TITLE 21--FOOD AND DRUGS

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

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 130 -- FOOD STANDARDS: GENERAL

Subpart A - General Provisions

Sec. 130.9 Sulfites in standardized food.

(a) Any standardized food that contains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in the finished food at a detectable concentration is misbranded unless the presence of the sulfiting agent or agents is declared on the label of the food. A detectable amount of sulfiting agent is 10 parts per million (ppm or mg/kg) or more of the sulfite in the finished food. The concentration of sulfite in the finished food will be determined using either:

(1) Determination of Sulfite in Food by Liquid Chromatography Tandem Mass Spectrometry; or

(2) AOAC Official Method 990.28.

(b) Any standardized food that, as a result of actions that are consistent with current good manufacturing practice, contains an indirectly added sulfiting agent that has no functional effect in the food and that would, in the absence of § 101.100(a)(4) of this chapter, be considered to be an incidental additive for purposes of § 130.8, conforms to the applicable definition and standard of identity if the presence of the sulfiting agent is declared on the label of the food.

(c) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration, Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and available from AOAC International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-3250. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html .

(1) AOAC Official Method 990.28, Sulfites in Foods, Optimized Monier-Williams Method, Section 47.3.43, Official Methods of Analysis, 21st edition, 2019.

(2) Determination of Sulfite in Food by Liquid Chromatography Tandem Mass Spectrometry: Collaborative Study, Katherine S. Carlos and Lowri S. De Jager; Journal of AOAC International, Vol. 100, No. 6, 2017, pp. 1785-1794.

[58 FR 2876, Jan. 6, 1993, as amended at 63 FR 14035, Mar. 24, 1998; 87 FR 2547, Jan. 18, 2022]