| At a Glance: The FDA has finalized the revocation of Orange B as a food color additive and proposed revoking Citrus Red No. 2, cite abandonment by the industry. Moving forward, the agency is working with manufacturers to phase out six additional synthetic dyes by 2027, following its recent revocation of FD&C Red No. 3. |
The FDA is issuing a final order revoking the authorized use of Orange Bas a color additive in food and is proposing to revoke the authorized use of Citrus Red No.2 as a color additive in food.
The U.S. Food and Drug Administration (FDA) recently announced two significant regulatory actions concerning petroleum-based food color additives:
- FDA has issued a Final Order revoking the authorization for Orange B as a food color additive.
- FDA has also published a Proposed Rule to revoke the authorization for Citrus Red No. 2 as a food color additive.
The proposal is open for a 30-day public comment period, with comments due by August 24, 2026.
According to FDA, the proposed revocation of Citrus Red No. 2 is based on the agency’s preliminary determination that the color additive has been abandoned by the food industry. Citrus Red No. 2 has been authorized since 1959 for use in coloring the peels of mature oranges.
FDA stated that it will continue to monitor the food industry’s transition to alternative coloring sources and ensure that regulatory requirements remain aligned with current manufacturing practices and public health objectives. FDA is now working closely with food manufacturers and industry associations to phase out six widely used notified synthetic color additives from the U.S. food supply by the end of 2027: FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Blue No. 2. Earlier this year, FDA also revoked the authorization for FD&C Red No. 3, further advancing its efforts to reduce the use of petroleum-based synthetic food dyes.
What CIRS Can Do for You
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.
The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:
- Health food registration and filing in China;
- Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
- U.S. GRAS, NDI, and CAP notifications;
- EU Novel Food, food additives, and food enzymes applications; and
- Application for new feed ingredients and feed additives in China, the U.S., and the EU.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
