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FDA Finalises Withdrawal of Food Colour Orange B, Proposes Withdrawing Citrus Red No. 2

The U.S. Food and Drug Administration (FDA) finalised the withdrawal of its authorisation for the petroleum-based food colour Orange B and proposed withdrawing the authorisation for Citrus Red No. 2, used to colour orange peels. The basis is abandonment, meaning industry no longer uses them, not a new safety determination.

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U.S. Food and Drug Administration
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NBS editors
FDA Finalises Withdrawal of Food Colour Orange B, Proposes Withdrawing Citrus Red No. 2

The U.S. Food and Drug Administration (FDA) announced regulatory actions on two colour additives for food. One is an order finalising the withdrawal of the authorisation for Orange B, which had been permitted for colouring sausage and frankfurter casings. The other is a proposal to withdraw the authorisation for Citrus Red No. 2, which has been permitted since 1959 for colouring the skins of mature oranges.

For Orange B, the FDA said it reviewed public comments on its earlier proposal to withdraw the authorisation and found no information that would change its conclusion that industry had abandoned that use. For Citrus Red No. 2, too, the FDA presented abandonment as its preliminary conclusion, and the comment period is 30 days (docket number FDA-2026-N-6304). The FDA will review the comments it receives before deciding whether to finalise the withdrawal.

How to read this

These actions are not based on a new scientific assessment that the two colours are harmful. They are housekeeping that removes authorisations no longer in use from the regulations. In the U.S. colour additive framework, 'abandonment' is one legal basis for withdrawing an authorisation, and it is a separate pathway from a safety re-evaluation. The FDA also said it is tracking, on a separate web page, commitments by manufacturers, distributors and industry groups to voluntarily replace petroleum-based colours. The actions can be seen as an extension of the ongoing push to reduce synthetic colours.

The Citrus Red No. 2 action is still only a proposal and has not been finalised. Also, this announcement contains no judgement on the safety of other synthetic colours, so whether any individual colour poses a hazard must be checked against its own scientific assessment.

Key points
  • Orange B: authorisation for food use finally withdrawn (use for colouring sausage casings)
  • Citrus Red No. 2: authorised in 1959; withdrawal proposed and comment period under way (FDA-2026-N-6304)
  • The basis is 'abandonment,' not a new finding of harm

Limitations The Citrus Red No. 2 action is only a proposal and is not final. These actions clean up authorisations based on abandonment, not on a safety re-evaluation, and contain no judgement on the safety of other colours.

Original research

  1. U.S. Food and Drug Administration · U.S. Food and Drug Administration (FDA). FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food. U.S. Food and Drug Administration.

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Copyright in the original research belongs to its publisher and authors.

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