WTO notification · SPS
United StatesUpdated: check whether it is now adopted or in force
Official title
Filing of Color Additive Petition From Center for Science in the Public Interest, et al. Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs; Petition for Rulemaking
The United States issued an addendum on 7 August 2026 to the earlier SPS notification G/SPS/N/USA/3368. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 24 February 2023. The comment period closed on 18 May 2023.
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Inorganic or mineral colouring matter, n.e.s. preparations based on inorganic or mineral colouring matter of a kind used for colouring any material or produce colorant preparations (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215); inorganic products of a kind used as luminophore
The comment period closed on 18 May 2023. You can still raise concerns about the measure with your country's WTO SPS enquiry point, quoting the document symbol G/SPS/N/USA/3368/Add.3; it can take them up with the United States.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/SPS/N/USA/3368/Add.3, 7 August 2026)
The latest notice extends the comment period.
Micro-Tracers, Inc. Response to Objections and Requests for a Public Hearing; Notification; Response to Objections and Denial of Public Hearing Requests; Removal of Administrative Stay
The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the effective date for the repeal and delisting of the color additive regulations is now lifted. This order that published in the Federal Register of 16 January 2025 (90 FR 4628) with effective dates of 15 January 2027, and 18 January 2028, was administratively stayed by the filing of objections under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(e)(2)) as of 18 February 2025. FDA lifts the administrative stay as of 5 August 2026. The effective dates of 15 January 2027, and 18 January 2028, for amendatory instruction 4, for the order published on 16 January 2025 (90 FR 4628), are confirmed.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/SPS/N/USA/3368/Add.3
Micro-Tracers, Inc. Response to Objections and Requests for a Public Hearing; Notification; Response to Objections and Denial of Public Hearing Requests; Removal of Administrative Stay
The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the effective date for the repeal and delisting of the color additive regulations is now lifted. This order that published in the Federal Register of 16 January 2025 (90 FR 4628) with effective dates of 15 January 2027, and 18 January 2028, was administratively stayed by the filing of objections under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(e)(2)) as of 18 February 2025. FDA lifts the administrative stay as of 5 August 2026. The effective dates of 15 January 2027, and 18 January 2028, for amendatory instruction 4, for the order published on 16 January 2025 (90 FR 4628), are confirmed.
AddendumG/SPS/N/USA/3368/Add.2
Color Additive Petition From Center for Science in the Public Interest, et al. Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs; Final Amendment; Order
The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations. DATES: This order is effective 15 January 2027, except for amendatory instruction 4, which is effective 18 January 2028. If any provisions are delayed or stayed by the filing of proper objections, FDA will publish such notification in the Federal Register. Submit either electronic or written objections and requests for a hearing on the order by 18 February 2025.
AddendumG/SPS/N/USA/3368/Add.1
Comment deadline: Closed on 18 May 2023
Filing of Color Additive Petition From Center for Science in the Public Interest, et al. Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the color additive petition for which we published a notice of filing in the Federal Register of 17 February 2023. In the notice, FDA requested comments on a filed color additive petition submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Regular notificationG/SPS/N/USA/3368
Comment deadline: Closed on 18 April 2023
Filing of Color Additive Petition From Center for Science in the Public Interest, et al. Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs; Petition for Rulemaking
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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