New Food Color Additives Approval in China, the U.S. and EU: Regulatory Pathways and Requirements

At a Glance: When Is a New Food Color Application Required?

The key regulatory question in all three markets is therefore not simply whether the substance itself is known, but whether the specific substance, source or manufacturing process, specifications, intended technological function, food categories and use levels are covered by an existing authorisation.

China: NHC Approval for New Food Color Additives and Expanded Uses

The regulation of food colors in China is centered on the GB 2760-2024 National Food Safety Standard - Food additive usage standard, with the National Health Commission (NHC) responsible for standard development and updates, and market regulatory authorities overseeing enforcement. China classifies food colors into two distinct categories: natural pigments and synthetic pigments. GB 2760 explicitly lists permitted colorant varieties, their scope of use, maximum usage levels (or "quantum satis" as needed in production), and labeling requirements—all colors used must be clearly identified by their generic names in food ingredient lists, and any use beyond the prescribed scope or dosage is strictly prohibited.

Official reference: NHC – GB 2760-2024 and Related National Food Safety Standards

For a broader overview of the China application pathway, see REACH24H's China NHC New Food Additive Registration Service.

Core Regulations:

• Measures for the Administration of New Varieties of Food Additives

• Provisions on Application and Acceptance of New Varieties of Food Additives

Application Procedure:

• Submission of Dossier: Submit application materials to the National Health Commission (NHC).

• Technical Review: The China National Center for Food Safety Risk Assessment (CFSA) organizes expert evaluations on safety and technical necessity.

• Public Consultation: Following a favorable review, the application is released for public comment from the industry.

• Approval Announcement: The NHC issues a final official announcement for approval.

Key Requirements:

• Technical Necessity: It must be demonstrated that the food color serves an irreplaceable function in food processing (e.g., enhanced stability, broader color spectrum) and does not mask food spoilage.

• Toxicological Evaluation: Depending on the usage level and scope, a four-phase toxicological testing package is generally required, encompassing acute toxicity, genetic toxicity, subchronic toxicity, and teratogenicity/chronic toxicity studies.

• Specification Standards: The applicant must draft quality specification criteria for the food color  (analogous to GB standards), covering parameters such as purity, heavy metal residues, and microbiological limits.

United States: FDA Color Additive Petition (CAP)

Food colors additives in the U.S. are strictly regulated by the FDA, and all colors must be approved through the Color Additive Petition (CAP) pathway prior to marketing. Based on the level of post-market oversight, they are divided into two categories: "subject to batch certification," which primarily applies to petroleum-based synthetic colors and requires mandatory batch-by-batch certification during production; and "exempt from batch certification," which mainly covers natural and biologically derived colors and focuses on compliance with manufacturing practices and specification parameters. Notably, there is no "GRAS" pathway for colors in the U.S.—any new substance intended for use as a colorant must meet the FDA's explicit pre-market approval standards.

Of particular note, the FDA has been accelerating the phase-out of petroleum-based synthetic colors in recent years. In 2025, it revoked the authorization for FD&C Red No. 3 (Erythrosine) and plans to phase out eight additional products on a rolling basis: Citrus Red No. 2, Orange B, FD&C Red No. 40 (Allura Red), FD&C Yellow No. 5 (Tartrazine), FD&C Yellow No. 6 (Sunset Yellow), FD&C Blue No. 1 (Brilliant Blue), FD&C Blue No. 2 (Indigo Carmine), and FD&C Green No. 3 (Fast Green). Concurrently, the FDA is progressively lowering the entry barriers for natural colors, particularly those produced through bio-manufacturing, having already approved natural blue colorsderived from Huito fruit extract and butterfly pea flower aqueous extract. This has opened up substantial opportunities for bio-based colors, though the approval process still requires the submission of robust safety data and rigorous compliance review.

Official reference: FDA – Color Additive Petitions

Notably, there is no GRAS exemption for a substance when it is used as a color additive. A substance may have a GRAS conclusion for another food use but still require color additive approval when its intended function is to impart color.

For non-coloring food ingredient uses, see REACH24H's U.S. FDA GRAS for Food Ingredients.

Core Regulations:

• Section 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

• 21 CFR Part 71

Application Procedure:

• CAP Submission: The company submits a Color Additive Petition to the FDA.

• Scientific Review: The FDA's chemistry and toxicology divisions evaluate the physicochemical properties and safety profile.

• Regulation Issuance: Upon favorable review, the FDA publishes a final rule in the Federal Register and updates the listing in 21 CFR.

Key Requirements:

• Physicochemical Characterization: Stringent requirements for molecular structure, chemical composition, and impurity profiles (e.g., residual monomers, solvents) of the colorant.

• Exposure Assessment: Precise estimation of the maximum daily exposure to the colorant through dietary intake across different population groups.

• Environmental Assessment: The submission must include an Environmental Impact Assessment (EIA) evaluating the environmental impact of the colorant's production and use.

European Union: Food Colour Authorisation and EFSA Assessment

The regulation of foodcolors in the EU is overseen by the European Food Safety Authority (EFSA), which is responsible for safety assessments, while the European Commission establishes uniform admission standards and usage specifications. Member States implement these rules uniformly without any national exemptions. The EU incorporates food colors into a unified regulatory framework for food additives, and all permitted colors must be listed in the Codex on Food Additives (Regulation EC No 1333/2008), which clearly specifies their scope of use, maximum usage levels, and quality specifications. Both synthetic and natural colors must undergo EFSA safety assessment before market entry.

The core regulatory features of the EU are characterized by "stringent labeling requirements and natural orientation": as early as 2010, the EU mandated that food products containing any of the six synthetic colors—Tartrazine (E102), Quinoline Yellow (E104), Sunset Yellow (E110), Azorubine (E122), Ponceau 4R (E124), and Allura Red (E129)—must carry a warning label stating "may have an adverse effect on activity and attention in children." For natural colors, those classified as "coloring foodstuffs" (e.g., phycocyanin from spirulina) may be exempted from E-number labeling, aligning with the "clean label" trend. This regulatory approach has accordingly driven growing market demand in the EU for natural and bio-based colors; however, it is important to note that specific usage restrictions vary across different food categories.

Official reference: European Commission – Common Authorisation Procedure

Core Regulations:

• Regulation (EC) No 1331/2008 (Union Authorization Procedure)

• Regulation (EC) No 1333/2008 (Food Additives Regulation)

• Regulation (EU) No 231/2012 (Specifications for Food Additives)

Application Procedure:

• Application Submission: Submit the application online to the European Commission (EC).

• EFSA Assessment: Upon receipt of the mandate, the EFSA typically has 9 months (with possible clock-stop periods) to conduct a scientific assessment and issue an opinion.

• Commission Decision: If the assessment concludes that the colorant is safe, the European Commission and Member States vote for approval, and the colorant is added to Annex II of Regulation (EC) No 1333/2008.

Key Requirements:

• Tiered Toxicological Data: Strict adherence to EFSA's guidance on food additive evaluations, employing a tiered testing approach. If Tier 1 data indicates potential risks, additional in-depth reproductive or developmental toxicity studies are required.

• Nanomaterial Review: If the novel colorant involves nanostructures, it must additionally comply with the EU's exceptionally stringent safety assessment requirements for nanomaterials.

China vs. U.S. vs. EU: Key Differences for Food Color Applicants

Under the context of divergent global regulatory frameworks, precisely mastering the differences in approval pathways for natural, synthetic, and bio-based colors across China, the U.S., and the EU has become a core competency for food companies seeking to break down trade barriers and achieve compliant market access.

REACH24H Recommendation: Assess First, Then Invest

Under divergent global regulatory frameworks, understanding the approval pathway for natural, synthetic and bio-based food colors is an important part of market-access planning.

REACH24H recommends that companies adopt an “assess first, then invest” approach by evaluating regulatory status and data gaps before committing to a large testing program.

For bio-based or fermentation-derived colorants, particular attention may need to be given to the production microorganism or strain, manufacturing process and resulting impurity profile.

For multi-market projects, existing studies may potentially support more than one jurisdiction where the study design, test material and reporting quality meet the relevant authority's requirements. However, one identical dossier should not be assumed to be directly acceptable in all three markets.

Planning China, U.S. and EU Approval Together?

REACH24H can compare your existing technical and safety package against China, FDA and EU requirements before additional studies are commissioned.

How REACH24H Supports Food Color Approval Projects

REACH24H supports food color and ingredient companies throughout China, U.S. and EU market-access projects, with the scope tailored to the applicable regulatory pathway.

Regulatory Status and Pathway Assessment

We assess the colorant's identity, source, manufacturing process, specifications, intended function, food categories and use levels against applicable positive lists and approval conditions to determine whether:

• the intended use is already permitted;

• an expanded-use application may be available; or

• a full new-additive or new-color approval pathway is required.

Feasibility and Data-Gap Assessment

Before new testing begins, REACH24H can review available technical and safety evidence and identify gaps against the target authority's requirements.

This may cover:

• identity and characterisation;

• manufacturing information;

• specifications and impurities;

• analytical methods;

• intended-use data;

• technological necessity;

• dietary exposure;

• toxicological evidence;

• microbial or production-strain information where applicable; and

• jurisdiction-specific administrative requirements.

Testing and Study Strategy

Where additional evidence is needed, REACH24H can help develop a regulatory testing strategy and coordinate appropriate testing resources.

For multi-market projects, we can also assess where study designs may be aligned across jurisdictions to reduce unnecessary duplication, while recognising that final acceptability is determined by the competent authority.

Dossier Preparation and Application Support

Depending on the jurisdiction, support may include:

• China NHC dossier preparation and submission support;

• U.S. FDA Color Additive Petition preparation;

• FDA pre-petition consultation support;

• EU food additive dossier preparation;

• EFSA pre-submission and study-notification planning;

• EU application submission support;

• technical document review and localisation; and

• application project management.

Authority Questions and Supplementary Information

During review, REACH24H can support the applicant in analysing authority questions, coordinating additional technical evidence and preparing scientifically structured responses.

Post-Approval Compliance Support

Following approval, we can help companies understand the approved specifications, conditions of use, food categories, use levels and other restrictions relevant to subsequent commercialisation.

For broader food ingredient and market-access needs across multiple jurisdictions, see REACH24H's Global Food Compliance Service.

Start with the Regulatory Pathway Before You Start Testing

Developing a food color for China, the United States and the European Union can require substantial scientific and regulatory investment.

The most important early decision is therefore not how many tests to conduct, but which regulatory pathway applies in each market and which existing data can realistically support that pathway.

REACH24H can help food color manufacturers, ingredient suppliers, biotechnology companies and food brands assess their proposed colorant across China, the U.S. and EU, identify regulatory and data gaps, and develop a practical market-access strategy before significant testing or dossier investment begins.

Send us your colorant identity, source, manufacturing process, specifications, intended food categories, proposed use levels and available safety data. We can help determine whether your project involves an existing permitted use, an expanded-use application or a new food color approval pathway.

Related REACH24H Resources

• China NHC New Food Additive Registration Service

China regulatory status screening, data-gap assessment, dossier preparation and NHC application support.

• FDA's 2025 Approval of Three Food Colors Signals U.S. Shift Away from Petroleum-Based Synthetic Dyes

Review recent FDA approvals involving natural-source and alternative food colors.

• A Shift in the Food Colors Industry: Stricter Global Regulations and the Rise of Natural Alternatives

Explore regulatory developments and market trends affecting natural and synthetic food colors.

• REACH24H Successfully Assisted Enterprises in Obtaining Approval for “New Food Additive” in China

See an example of REACH24H's China new food additive project support.

• Global Food Compliance Service

Regulatory assessment and market-access support for food ingredients and products across multiple jurisdictions.