Food and Water Contact Applications

Earth Glass products are a mixture of naturally occurring inert, non-toxic, non-crystalline silicates and aluminosilicates of sodium, potassium, calcium, iron, and magnesium. Natural silicate materials, as a group, have a long global history of safe use in food packaging (both in plastics and paper goods), food processing, and as food additives and pharmaceutical ingredients. Information below addresses regulations pertaining to additives used in polymers intended for food contact in the United States, Canada, European Community, and Japan, as well as a summary of toxicologic tests conducted on 100% Earth Glass product powder (100 to 200 times the amount used in polymer processing).
Earth Glass products are safe for use in all plastic applications intended for food and water contact.

United States Food and Drug Administration (USFDA, FDA)

Earth Glass products are FDA Compliant with CFR Title 21 regulations for use in polymers intended for food contact. The component materials of Earth Glass products are Generally Recognized As Safe (GRAS) and can be used as food additives at loads of up to 2% in table salt, grated cheese, dry mixes, etc. Geologically and chemically, Earth Glass products are identical to material found in dental polishes, skin care products, and in food and beverage processing equipment. Earth Glass products are USP Class VI Compliant, the most restrictive class, for use in medical devices.

NSF Registration

NSF International, formerly National Sanitation Foundation, lists Earth Glass products as registered products in its “white book”, which is available on the internet at www.nsf.org/USDA. (A search function can be accessed on the top right side of this page.) NSF reviewed the chemical elemental composition, heavy metal assay results, and the toxicologic and biocompatibility tests performed on Earth Glass products prior to registering.

Canada

January, 2004, the Bureau of Chemical Safety of the Health Products and Food Branch of Health Canada issued a letter of no objection for the use of Earth Glass products in polymers intended for use for food contact. The letter was issued by the head of the Food Packaging Materials and Incidental Additives Section of the Chemical Health Hazard Assessment Division.

European Community

Current regulations authorize use of Earth Glass products in polymers for food and beverage contact in the European Community. A number of documents including the “Synoptic Document” (last updated July 25, 2003), lists “additives which can be used in the manufacture of plastics intended to come into contact with foodstuffs”. Our products are included under the headings of “Silicates, natural” and/or “Silicic Acid and Salts.” References are PM/REF 85600 and PM/REF 85680.

Japan

In September 2003, Earth Glass products were submitted and approved for inclusion on the “positive list” as a permitted additive to polymers intended for use in food contact applications. Generically, our materials were included already as being a “mixture of silicates of sodium, potassium, calcium, magnesium, aluminum, and iron”, previously approved materials for use in plastics intended for food contact in Japan.

Biocompatibility and Toxicology Testing

With the exception of the muscle implantation test performed using strips of polyethylene molded with a 50% Earth Glass product concentration, the following list of tests has been completed on 100% Earth Glass product powder (100 to 200 times the amount used in plastics processing). There is no possible worse case scenario. All results confirm the non-toxic, inert nature of Earth Glass products. These tests are in excess of what is required for USP (United States Pharmacopoeia) Class VI, the most stringent class of plastics intended for medical use, including implantation into the body.

  • Intracutaneous Reactivity Test
  • Acute Systemic Injection Test
  • Hemolysis (direct blood damage)
  • Pyrogen (fever) Study
  • Cytotoxicity Study (1XMEM)
  • Dermal Irritection Test (skin test)
  • BECAM Assay (eye test)
  • Ames Mutagenicity Test (genetic test)
  • Muscle Implantation Study

Toxicology testing protocols used in evaluating Earth Glass products were selected after consultation with the senior compliance officer of the Southern California office of the FDA, and a senior toxicologist at NAMSA in Irvine, California. NAMSA, an internationally credentialed and certified scientific testing organization, specializes in toxicologic and biocompatibility evaluations. Tests were conducted in accordance with ISO 10993 requirements and fully documented under Good Laboratory Practices (GLP) guidelines. GLP documented tests are the standard necessary to be accepted as valid in all markets and jurisdictions. A complete master-file is maintained at the headquarters office of Earth Glass.

Note: This information is presented in good faith. No warranty, expressed or implied, is given. Earth Glass assumes no obligation or liability in this document.

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