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U.S. Department of Health and Human Services

Inventory of Food Contact Substances Listed in 21 CFR
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β-carotene (Natural and Synthetic)

Permanently listed, exempt from certification

Consult the regulation(s) cited below to see if your substance is authorized for your intended use.
CAS Reg No or other ID code: 7235-40-7
Color: β-carotene (Natural and Synthetic)
Status: Permanently listed, exempt from certification
Use: Foods, Drugs, Cosmetics
Restrictions: Foods generally. Ingested drugs generally. Externally applied drugs including eye area use. Cosmetics generally including eye area use.
End Notes: 5, 6
21 CFR (color additives): 73.9573.109573.2095
Other regulations in 21 CFR: 101.9166.110184.110
Citations 1: 25 FR 9759Oct 12, 1960Provisional Regulation
Limitations 1: Provisional food and drug use.
Citations 2: 26 FR 7578Aug 16, 1961Provisional Regulation
Limitations 2: Provisional cosmetic use.
Citations 3: 28 FR 13488Dec 13, 1963Final Rule
29 FR 1615Jan 31, 1964Final Rule; confirmation of effective date
Limitations 3: Foods generally GMP.
Citations 4: 29 FR 3003Mar 5, 1964Final Rule
29 FR 5393Apr 22, 1964Final Rule; confirmation of effective date
Limitations 4: Ingested drugs generally GMP.
Citations 5: 42 FR 33722Jul 1, 1977Final Rule
42 FR 43620Aug 30, 1977Final Rule; confirmation of effective date
Limitations 5: External drugs and cosmetics including area of the eye.
E Number: E160a


* Definitions

  • CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number® for the substance or a numerical code (other ID) assigned by HFP to those substances that do not have a CAS Registry Number (977nnn-nn-n series).
  • Substance: The name of the additive as recognized by HFP.
  • 21 CFR: The Code of Federal Regulations, Title 21 is the preferred reference to determine the regulatory status of Indirect Food Additives. Substances whose names appear in 21 CFR, parts 175-178 are authorized for specified intended users and conditions of use as stated in the regulation. Note that substances may appear in more than one regulation, or several times in the same regulation.

Note that if a substance is mentioned in 21 CFR parts 175-178 and thus, is listed above, any other citations for the same substance in other sections of 21 CFR dealing with food additives (parts 1-199 inclusive) may also be cited.
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