Mineral Ingredients Across Major Markets

Values as supplied for this product.
Identity
Product Code / SKU	Not yet confirmed
CAS Number	Not yet confirmed
Core specification
Assay / Purity	Not yet confirmed
Elemental Mineral Content	Not yet confirmed
Appearance	Not yet confirmed

Product → Form → Application → Market → Documents

GLOBAL REGULATORY MATRIX

Key Regulatory Frameworks by Market

Use this matrix as a starting point when evaluating mineral ingredients for food, supplement, nutrition and other B2B applications.

Market	Key Regulatory Framework	What Matters for Mineral Ingredients
EU	Food Supplements Directive 2002/46/EC	Mineral source and chemical form should be checked against the permitted framework for food supplements.
EU	Novel Food Regulation 2015/2283	New ingredients, certain new structures or production processes may require Novel Food assessment.
EU	Regulation 2023/915	Applicable maximum levels for contaminants should be considered for food and supplement applications.
EU / EEA	REACH	Chemical-substance obligations may depend on the substance, importer role, annual volume and applicable exemptions.
USA	DSHEA / FDA	Minerals are recognized as dietary ingredients; finished dietary supplements are not generally pre-approved by FDA.
USA	NDI	A dietary ingredient not marketed in the U.S. before October 15, 1994 may require assessment under the NDI framework.
USA	21 CFR Part 111	Specific CGMP requirements apply to dietary supplement manufacturing.
UK	Food Supplement Framework	Supplements are regulated as food; source, composition, labelling and claims need to meet applicable requirements.
Japan	CAA Food Function Frameworks	Requirements depend on food category, nutrient, intake and claims; specified minerals are covered under the Nutrient Function Food framework.
China	SAMR Health Food Raw Material Catalogue	Nutrient-supplement health foods use defined raw-material and technical frameworks.

The matrix identifies major frameworks, not a complete legal assessment for a specific product. Requirements should be checked against the exact ingredient form, application and destination market.

MARKET SNAPSHOT

Five Markets. Different Regulatory Focus.

European Union

Focus: Mineral Source · Chemical Form · Novel Food · REACH

For food supplements, the permitted mineral source and form should be checked under the applicable EU framework. New or less-established ingredients may require additional assessment.

Key Frameworks: Directive 2002/46/EC · Regulation (EU) 2015/2283 · Regulation (EU) 2023/915 · REACH

United States

Focus: Dietary Ingredient · NDI · CGMP

Minerals are recognized as dietary ingredients in the U.S. dietary supplement framework. New dietary ingredients may require FDA notification, while dietary supplement manufacturing is subject to applicable CGMP requirements.

Key Frameworks: DSHEA · FDA dietary supplement framework · NDI notification framework · 21 CFR Part 111

United Kingdom

Focus: Source · Composition · Labelling · Claims

In Great Britain, food supplements are regulated as food. Mineral sources, composition, labelling and nutrition or health claims should be assessed against applicable UK requirements.

Key Framework: UK food supplement framework

Japan

Focus: Food Category · Mineral Source · Intake · Claims

Japan uses different food-function frameworks depending on the finished product and claims. Specified minerals are included within the Nutrient Function Food framework.

Specified Minerals: Calcium · Iron · Zinc · Copper · Magnesium · Potassium

Key Framework: Consumer Affairs Agency food-function frameworks

China

Focus: Catalogue · Mineral Form · Intake · Function

China uses defined catalogues and technical requirements for health-food nutrient supplementation. The applicable raw-material status, form, intake and function should be checked for the intended product.

Relevant Minerals: Calcium · Magnesium · Iron · Zinc · Selenium · Copper · Potassium · Manganese

Key Framework: SAMR Health Food Raw Material Catalogue — Nutrient Supplements

EUROPEAN UNION

Food Supplements: The Mineral Form Matters

EU food supplement rules do not focus only on the mineral element. The specific mineral source and chemical form should be checked against the applicable permitted framework.

Check	Question
Mineral	Which mineral is supplied?
Source	What chemical source is used?
Form	Is the specific form permitted for the intended use?
Application	Is the finished product a food supplement or another category?
Intake	What daily amount is intended?
Documents	What evidence supports ingredient identity and specification?

Novel Food

New ingredient? New structure? New process? If an ingredient falls within the Novel Food framework, additional assessment may be required.

REACH

Food-supplement status and chemical regulatory status are separate questions. EU/EEA chemical-substance obligations may depend on substance identity, supply-chain role, annual volume and exemptions.

Bottom line: EU: Mineral → Form → Use → Novel Food → REACH → Finished Product

UNITED STATES

Dietary Ingredients: Check the U.S. Framework

In the United States, minerals can qualify as dietary ingredients for dietary supplement purposes. Assessment depends on the ingredient, its history of use, intended application and finished product.

Area	What to Check
Dietary Ingredient	Does the substance qualify as a dietary ingredient?
NDI	Was it marketed in the U.S. before October 15, 1994?
Safety	Are applicable safety requirements satisfied?
Manufacturing	Are applicable CGMP requirements met?
Label	Does the finished product meet applicable labelling requirements?

NDI

A dietary ingredient not marketed in the U.S. before October 15, 1994 may fall within the New Dietary Ingredient framework. Where notification is required, FDA states it is generally submitted at least 75 days before introduction into interstate commerce.

CGMP

Dietary supplement manufacturing is subject to FDA Current Good Manufacturing Practice requirements under 21 CFR Part 111.

Bottom line: USA: Dietary Ingredient → NDI → Safety → CGMP → Label

UNITED KINGDOM

Food Supplements Are Regulated as Food

In Great Britain, food supplements are regulated as food. Assessment should cover nutrient source, composition, labelling and nutrition or health claims of the finished product.

Area	What to Check
Source	Is the mineral source suitable?
Composition	Does the finished product meet applicable composition requirements?
Labelling	Does the supplement label meet UK requirements?
Claims	Are nutrition and health claims permitted and correctly presented?

Bottom line: UK: Source → Composition → Label → Claims → Finished Product

JAPAN

The Finished Food Category Matters

Japan applies different frameworks according to finished food category and claims. For mineral-containing products, source, intake level, labelling and claims should be assessed together.

Nutrient Function Food — specified minerals: Calcium · Iron · Zinc · Copper · Magnesium · Potassium

Bottom line: Japan: Source → Category → Intake → Label → Claims

CHINA

Health Food Uses a Defined Raw-Material Framework

China uses specific catalogues and technical requirements for health-food nutrient supplementation. The applicable raw-material status, mineral form, intake and permitted function should be checked for the intended product.

Nutrient-supplement mineral examples: Calcium · Magnesium · Iron · Zinc · Selenium · Copper · Potassium · Manganese

Area	What to Confirm
Raw Material	Is the source covered by the applicable framework?
Mineral	Which nutrient is supplied?
Form	Which chemical form is used?
Intake	What use level applies?
Function	What function is permitted?
Product	Which registration or filing pathway applies?

Bottom line: China: Raw Material → Form → Catalogue → Intake → Function → Finished Product

REGULATORY CHECK

Five Questions Before You Buy

Product — what exactly is the ingredient?

Product name · Chemical name · CAS · Formula · Mineral · Form · Elemental content
Form — what chemical form or ligand is supplied?

Do not treat salt, complex and chelate as interchangeable terms.
Application — where will it be used?

Dietary Supplement · Functional Food · Nutritional Product · Cosmetic · Pharmaceutical / Health Product
Market — where will the finished product be marketed?

EU · USA · UK · Japan · China · Other Market
Documents — what evidence does your regulatory team need?

Specification · COA · TDS · SDS · Certificates · Declarations · Batch Documents

DOCUMENTATION

Not Every Document Proves the Same Thing

Document	Main Purpose
Specification	Defines agreed product parameters and acceptance criteria.
COA	Reports test results covered for the product or batch it identifies.
TDS	Provides technical product information and typical use-related details.
SDS	Provides safety, handling, storage and hazard information as applicable.
Certificate	Provides evidence within the scope, standard, site and period stated.
Declaration	Provides a written statement covering a defined requirement or characteristic.
Batch Documents	Connects quality information to the actual batch supplied.

Important

A COA does not automatically prove molecular structure, regulatory authorization, true chelation or finished-product compliance.

IMPORTANT DISTINCTION

Ingredient Compliance Is Not Finished-Product Compliance

A mineral ingredient may meet a supplier specification while the finished product still requires a separate regulatory assessment.

Ingredient Level: Identity → Form → Specification → Testing → Documents

Finished Product Level: Application → Dose → Population → Label → Claims → Market Requirements

The regulatory status of an ingredient should not be separated from its intended use and finished-product context.

FROM INGREDIENT TO MARKET

A Practical Regulatory Path

01ProductWhat exactly is it?
02FormWhat chemical form or ligand?
03ApplicationWhere will it be used?
04MarketWhere will it be sold?
05DocumentsWhat evidence is available?
06Finished ProductWhat additional requirements apply?

REGULATORY SUPPORT

Start With the Product. Then Check the Market.

Santa Minerals provides product information and available supporting documents to help B2B customers conduct their technical and regulatory review.

We Can Provide

Product Identity: Core chemical and product information.
Specification: Agreed product parameters.
Technical Documents: Available TDS, SDS and product documentation.
Quality Documents: Representative and batch-related documents where applicable.
Samples: Material for customer evaluation.

Final regulatory assessment remains the responsibility of the importer, manufacturer and qualified regulatory team responsible for the finished product.

QUICK CHECK

Before Placing an Order

Product identity confirmed
Chemical form confirmed
Mineral content confirmed
Intended application confirmed
Destination market confirmed
Applicable regulatory framework identified
Specification reviewed
Required documents identified
Sample evaluated where required
Finished-product requirements checked

NEED REGULATORY DOCUMENTS?

Tell Us the Product and the Market

Send us the product, mineral form, application and destination market. We can provide the relevant product information and available supporting documents for your review.

Request product documents Contact us

Regulatory requirements may change. Always verify the current requirements applicable to the specific product, application and market. Regulatory information reviewed: September 2026.