Our Verdict: SAFE

Clay, Attapulgite

CAS12174-11-7

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Clay, Attapulgite — food additive

Clay, Attapulgite, also known as palygorskite (CAS: 12174-11-7), is a naturally occurring magnesium aluminum silicate clay mineral. In the food industry, it primarily functions as a processing aid, utilized for its adsorbent and filtration properties to clarify and purify various food products. As a processing aid, it is typically removed from the final food product.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Clay, Attapulgite?

Clay, Attapulgite, also chemically identified as palygorskite, is a naturally occurring hydrated magnesium aluminum silicate clay mineral. Its unique fibrous, chain-like, and porous structure distinguishes it from other plate-like clays such as bentonite or kaolin. This structure gives attapulgite excellent adsorbent and rheological properties. It is mined from natural deposits found in various parts of the world, including the United States, China, and Spain. After extraction, the clay typically undergoes processing steps such as drying, milling, and sometimes activation (e.g., acid treatment) to enhance its functional characteristics for specific applications. The refined attapulgite clay is insoluble in water and generally inert, meaning it does not react chemically with most substances under typical processing conditions. Its high surface area and porous nature make it effective at adsorbing various molecules, including color pigments, impurities, and undesirable substances.

Common Uses

In the food industry, attapulgite clay is exclusively utilized as a processing aid. A processing aid is a substance used during the processing of food that does not perform a technological function in the final food product and is not intentionally present in the final product at significant levels. Attapulgite's primary applications leverage its adsorbent and filtration capabilities:

* **Clarification and Decolorization:** It is commonly used in the refining of edible oils (such as vegetable oils) to remove impurities, phospholipids, and undesirable color pigments through adsorption. This process, often referred to as bleaching, improves the oil's stability, appearance, and quality.

* **Filtration Aid:** Attapulgite can be employed as a filter aid in the processing of various beverages, including fruit juices, wines, and beers. It helps to remove particulate matter, haze-forming compounds, and other suspended solids, leading to clearer final products.

* **Adsorption of Undesirable Compounds:** Beyond color and particulates, it can adsorb other specific impurities or contaminants present in raw food materials or intermediate products, contributing to the overall purification process.

* **Carrier for Catalysts:** In some food-related chemical processes, it might serve as an inert carrier for catalysts, which are then removed along with the clay.

Crucially, because attapulgite functions as a processing aid, it is designed to be substantially removed from the food during manufacturing steps (e.g., filtration, centrifugation) and is not intended to be a direct ingredient in the finished food product. Beyond food, attapulgite has diverse industrial applications, including as an adsorbent in cat litter, a rheological modifier in paints and drilling muds, and as an active ingredient in some pharmaceutical preparations (e.g., antidiarrheal medications).

Safety Assessment

The safety assessment of attapulgite clay as a processing aid focuses primarily on the potential for residual levels in the final food product and the inherent properties of the clay itself. Attapulgite is generally considered to be biologically inert and chemically stable. When ingested, studies on attapulgite used in pharmaceuticals (e.g., as an antidiarrheal) indicate that it is not absorbed from the gastrointestinal tract due to its insoluble nature and large particle size. Instead, it passes through the digestive system largely unchanged, acting as an adsorbent. This characteristic is a key factor in its safety profile for oral exposure.

For its use as a processing aid in food, the expectation is that residual levels in the final product are minimal and non-functional. The inertness of attapulgite means it is not expected to metabolize or interact significantly with biological systems at such trace levels. The U.S. Food and Drug Administration (FDA) tracks adverse events related to food additives, and for Clay, Attapulgite (CAS: 12174-11-7), there have been 0 reported adverse events and 0 recalls, suggesting a favorable safety record under regulated use. Regulatory bodies, when evaluating processing aids, typically consider the efficacy of their removal and the safety of any unavoidable residues. Given its established use in various industries and its inert nature, attapulgite is generally regarded as safe when used appropriately as a processing aid, with its primary function being to facilitate processing steps rather than to contribute to the final food's composition.

Regulatory Status

### United States (FDA)

In the United States, Clay, Attapulgite (CAS: 12174-11-7) is not specifically designated as Generally Recognized As Safe (GRAS) by the FDA for all food additive uses. However, its use as a processing aid is permitted under specific conditions or through a 'no objection' letter process, provided that it achieves its technical effect and is removed during processing such that any residual levels in the final food product are negligible, non-functional, and safe. The FDA's monitoring of food additives has recorded 0 adverse events and 0 recalls associated with Attapulgite, which indicates a history of safe use within regulatory guidelines as a processing aid.

### European Union (EFSA)

In the European Union, attapulgite is not listed as an approved food additive with an E-number. The use of processing aids is generally regulated by national authorities within the EU, or it might fall under broader regulations concerning food contact materials or general food law. While other clays, such as bentonite (E 558) and kaolin (E 559), are approved as food additives by the European Food Safety Authority (EFSA), attapulgite itself does not have a specific EU food additive approval. Its use as a processing aid would therefore depend on compliance with specific national regulations or general principles of good manufacturing practice, ensuring that it is adequately removed and presents no safety concerns at residual levels. EFSA has, however, evaluated attapulgite for other applications, such as in animal feed, indicating a familiarity with its properties and safety profile.

Key Studies

Research on attapulgite clay often focuses on its material properties and applications, particularly its adsorption capabilities. Studies evaluating its safety generally highlight its inertness and lack of absorption:

* **Toxicological Profiles:** While comprehensive, dedicated long-term toxicity studies specifically for attapulgite *as a food processing aid* in humans are not widely published, its safety is inferred from its extensive use in other applications, including pharmaceuticals. For instance, studies on attapulgite used as an antidiarrheal agent in humans and animals have consistently shown that it is not absorbed from the gastrointestinal tract, indicating a low systemic toxicity risk. These studies support its inert behavior upon oral ingestion.

* **Adsorption Efficacy and Removal:** Numerous industrial and academic studies have demonstrated attapulgite's effectiveness as an adsorbent in various matrices, including edible oils and beverages. These studies often focus on optimizing conditions for impurity removal (e.g., color, heavy metals) and demonstrating the efficiency of its subsequent removal from the processed product, ensuring minimal carry-over into the final food.

* **General Clay Safety:** The broader scientific understanding of other food-grade clays (like bentonite and kaolin), which share similar inert properties and have established safety profiles as food additives or processing aids, further supports the safe use of attapulgite when applied according to good manufacturing practices and regulatory requirements for processing aids.

Frequently Asked Questions

What is Clay, Attapulgite?

Clay, Attapulgite, also known as palygorskite (CAS: 12174-11-7), is a naturally occurring magnesium aluminum silicate clay mineral. In the food industry, it primarily functions as a processing aid, utilized for its adsorbent and filtration properties to clarify and purify various food products. As a processing aid, it is typically removed from the final food product.

Is Clay, Attapulgite safe?

Clay, Attapulgite is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Clay, Attapulgite banned in any country?

Clay, Attapulgite is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.