Regulatory Compliance for Natural Food Colors
US FDA 21 CFR, EU NATCOL, Canadian FDR references, and certification status for all seven Binmei natural food colors — with regulatory team contacts for country-specific documentation.
| Frameworks Covered: | US FDA, EU NATCOL, Canada FDR |
| Certifications: | Halal, Kosher, FSSC 22000 |
| Products: | 7 Binmei Natural Colors |
| Last Updated: | May 2026 |
Important Notice on Regulatory Information
The regulatory references in this chapter are provided as general guidance for product selection and initial evaluation. Specific country regulatory frameworks change over time, and individual product compliance depends on application context, dosage, and end-use category.
Before launching a product in any market, manufacturers should obtain current regulatory documentation (Certificate of Analysis, Letter of Compliance, country-specific clearance letters) from the Binmei regulatory team and confirm with their own regulatory affairs counsel. This chapter is technical reference material, not regulatory advice.
Regulatory Frameworks for Natural Food Colors
Natural food colors are regulated differently across major markets. The three primary frameworks Binmei customers most commonly reference are:
- US FDA — Title 21 Code of Federal Regulations (21 CFR) — The US framework distinguishes between "certified" color additives (synthetic dyes subject to batch certification) and "exempt-from-certification" color additives (most natural colors). Natural colors are listed under 21 CFR Part 73.
- European Union — NATCOL Code of Practice + EU Food Additive Regulations — The EU framework distinguishes between "colouring foods" (food ingredients with natural colouring properties, governed by NATCOL) and "food colour additives" (subject to E-number designation, e.g., E163 for anthocyanins).
- Canada — Food and Drug Regulations (CA FDR) — Canada's framework lists permitted food colours under Part B.16, with most natural colors appearing in List 3 of permitted colours.
Additional frameworks (Japan JAS, Australia/New Zealand FSANZ, Brazil ANVISA, China GB) follow similar logic and Binmei can provide country-specific compliance documentation on request.
US FDA: 21 CFR Compliance
US Food and Drug Administration
21 CFR Part 73 — Color Additives Exempt from Certification
The US FDA regulates color additives under Title 21 of the Code of Federal Regulations (21 CFR). Color additives are divided into two categories:
- 21 CFR Part 73 — Color Additives Exempt from Certification: Most natural colors, including those derived from fruits, vegetables, algae, and other natural sources. No batch-by-batch certification required.
- 21 CFR Part 74 — Color Additives Subject to Certification: Synthetic dyes (e.g., FD&C Red 40). Each batch requires FDA certification before commercial use.
All Binmei natural colors fall under 21 CFR Part 73 (exempt from certification). The specific sub-section within Part 73 varies by colorant.
21 CFR References by Product
Important: The 21 CFR section references below are verified per Binmei's official Product Performance Guide (2026-07). Customers requiring official compliance documentation should request current FDA Letter of Compliance from the Binmei regulatory team.
| Binmei Product | Colouring Principle | 21 CFR Reference | Notes |
|---|---|---|---|
| Spirulina Extract | Phycocyanin | 73.530 | "Spirulina Extract" — approved for use in candy, chewing gum, dietary supplements, decorative confections, drink mixes and powders, gelatins, puddings, dairy products (including yogurt), custards, sauces, condiments, ice creams, frozen desserts, and frostings. |
| Butterfly Pea Flower Extract | Anthocyanins | 73.260 | "Vegetable juice (color)" — FDA-approved 2021 for alcoholic and non-alcoholic RTD beverages, ice cream and frozen dairy desserts, candies, and liquid coffee creamers (dairy and plant-based). |
| Aronia Extract | Anthocyanins | 73.250 | "Fruit juice" color category. |
| Black Carrot Extract | Anthocyanins | 73.260 | "Anthocyanins" — vegetable juice color category. |
| Beet Extract | Betanin | 73.260 | "Beet Red" — vegetable juice color category. Also referenced under §73.40 (dehydrated beets) for specific applications. |
| Sea Buckthorn Extract | Carotenoids | 73.250 | "Fruit juice" color category. |
FDA Compliance Quick Notes
Letter of Compliance: Binmei provides FDA Letter of Compliance documentation upon request, identifying specific 21 CFR section, intended use category, and dosage guidance for each product.
Category restrictions: Some 21 CFR Part 73 colors have category-specific restrictions (e.g., "for use in non-meat applications only"). Verify category eligibility with the Binmei regulatory team before formulating.
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European Union: NATCOL + E-Number Framework
European Union Food Regulations
NATCOL Code of Practice + Food Additive Regulation (EC) 1333/2008
The EU regulates colored food ingredients under two distinct categories:
- Colouring Foods (NATCOL Code of Practice): Plant-derived ingredients with natural colouring properties, processed in ways that preserve their food character. Not classified as additives. No E-number assigned. Subject to NATCOL classification criteria.
- Food Colour Additives (EC 1333/2008): Extracted, purified, or chemically-defined colour compounds. Assigned E-numbers (e.g., E163 for Anthocyanins, E162 for Beetroot Red). Subject to additive labelling and dosage limits.
Most Binmei natural colors are eligible for classification as "colouring foods" under NATCOL when supplied in their standard form. Where customers require E-number designation (typically for downstream label declarations), specific extractions can be supplied that fall under the food additive framework.
EU References by Product
Important: EU classification depends on extraction method, processing, and labelling intent. [All entries marked for regulatory team review.] Customers should request a product-specific EU compliance letter from the Binmei regulatory team before EU market launch.
| Binmei Product | NATCOL Classification | EU E-Number (if applicable) | Notes |
|---|---|---|---|
| Spirulina Extract | "Spirulina Extract" [需法规核对] | Not assigned to a specific E-number | EU recognizes spirulina extract for use in specific applications under Regulation (EU) 231/2012. |
| Butterfly Pea Flower Extract | Subject to verification [需法规核对] | May reference E163 (anthocyanin) [需法规核对] | EU classification of butterfly pea is evolving; specific applications may require approval. |
| Aronia Extract | "Chokeberry" [需法规核对] | May reference E163 (anthocyanin) [需法规核对] | Fruit-derived colouring food classification. |
| Black Carrot Extract | "Carrot, black" [需法规核对] | May reference E163 (anthocyanin) [需法规核对] | Vegetable-derived colouring food classification commonly used. |
| Beet Extract | "Red beet" [需法规核对] | May reference E162 (Beetroot Red / Betanin) [需法规核对] | Beetroot color extract may be supplied as E162 additive. |
| Sea Buckthorn Extract | "Sea Buckthorn Extract" [需法规核对] | Not commonly assigned a specific E-number | Fruit juice colouring food classification. |
Canada: Food and Drug Regulations (CA FDR)
Health Canada
Food and Drug Regulations, Part B.16 — Food Additives
Health Canada regulates food colours under Part B.16 of the Food and Drug Regulations. Permitted colours are organized in Lists; most natural food colors appear in List 3 (Permitted Food Colours for Foods Other Than Those Set Out in Column 5 of List 1).
Canadian FDR References by Product
Important: Canadian compliance requires List 3 verification and category eligibility check. [All entries marked for regulatory team review.] Request product-specific Canadian compliance letter from the Binmei regulatory team.
| Binmei Product | CA FDR Reference | List Classification |
|---|---|---|
| Spirulina Extract | List 3 of Permitted Food Colours | "Spirulina Extract" |
| Butterfly Pea Flower Extract | Subject to verification [需法规核对] | Confirm current Canadian permitted status with regulatory team |
| Aronia Extract | List 3 of Permitted Food Colours | "Anthocyanins" |
| Black Carrot Extract | List 3 of Permitted Food Colours | "Anthocyanins" |
| Beet Extract | List 3 of Permitted Food Colours | Betanin/Beet Red classification [需法规核对] |
| Sea Buckthorn Extract | Subject to verification [需法规核对] | Confirm current Canadian permitted status with regulatory team |
Certifications and Facility Standards
Binmei manufactures natural colors under facilities certified to international food safety and religious dietary standards. Certificate availability varies by product and customer requirement.
FSSC 22000
Global food safety management certification.
Facility CertifiedHalal
Certified production for Halal-compliant markets.
AvailableKosher
Kosher certification for applicable products.
AvailableNon-GMO
Non-GMO statement available for applicable products. Spirulina Extract: Non-GMO certified.
Available (Spirulina Extract) / On Request (others)Organic
Organic-certified options available for select products. Spirulina Extract: Certified organic under both EU Organic and USDA NOP standards.
Available (Spirulina Extract) / On Request (others)ISO 9001
Quality management system certification.
Facility CertifiedCertification Status — Important Verification Note
Certificate status, scope, and validity periods change. The above is a general overview of facility and product certifications maintained by Binmei. For any product or market launch decision, request current certificate copies from the Binmei team, verify expiration dates, and confirm scope coverage for your specific product application. [Certification list to be confirmed and updated by the Binmei regulatory team before publishing.]
Labelling Considerations
Label declarations for natural food colors vary by market. The Binmei regulatory team can provide market-specific labelling guidance during product selection.
US Labelling
Natural colors under 21 CFR Part 73 are typically declared on US labels by their common name (e.g., "Beet juice color," "Spirulina extract (color)," "Anthocyanin (color)") or by their CFR-recognized name. Specific ingredient declaration depends on FDA guidance for each colorant.
EU Labelling
EU labelling differs based on the colouring foods vs. food colour additive classification:
- Colouring foods (NATCOL): Declared as the food ingredient name (e.g., "Black carrot concentrate," "Aronia berry extract"). No E-number declaration required.
- Food colour additives: Declared by the E-number with category name (e.g., "Colour: E163 (Anthocyanins)").
Canada Labelling
Canadian labelling typically follows the FDR Permitted Food Colours framework, with specific declaration based on the List classification and product category.
Other Markets
Country-specific labelling guidance for Japan, Australia/New Zealand, Brazil, China, and other markets is available from the Binmei regulatory team. Request a country-specific labelling memo with your product inquiry.
What to Request from the Binmei Regulatory Team
When evaluating Binmei products for a specific market launch, the typical documentation request includes:
- Certificate of Analysis (COA) — Batch-specific product specifications and test results
- Letter of Compliance (FDA / EU / Canada / Country-Specific) — Confirms regulatory framework compliance for the specific colorant in the target market
- Halal Certificate Copy — If required for the target market or customer specification
- Kosher Certificate Copy — If required for the target market or customer specification
- Non-GMO Statement — For products marketed with Non-GMO claims
- Allergen Statement — Confirms allergen status for label declarations
- Organic Certificate Copy — If supplying organic-certified version of the product
- Country-Specific Compliance Letter — Custom regulatory letter for non-standard markets
Documentation requests are processed by the Binmei regulatory team within 1-3 business days for standard requests. Country-specific compliance letters for complex markets may take 5-10 business days.