M-Cor Inc. trusted USA manufacturer logo
Compliance Documents

M-Cor Compliance Documents and Regulatory Statements

Request supplier-based compliance statements, material declarations, quality documents, and regulatory information for M-Cor sealing products.

M-Cor provides compliance documents by request so the correct statement can be matched to the product, material, application, order, and documentation requirement.

Direct public document-download links are intentionally not shown on this page. Instead, each available document is listed below. To request a document, use the contact button and include the document name in your message.

Request Compliance Documents Before Quoting or Ordering

Compliance requirements should be reviewed before the quote is finalized and before the order is placed.

Different materials, core compounds, jacket materials, specifications, applications, and documentation requirements may require different statements. Therefore, customers should state all compliance needs clearly, including FDA, USP Class VI, REACH, PFAS, TSCA, Prop 65, shelf life, country of origin, packaging, or quality-document requirements.

Important

Compliance documents are based on the current information available to M-Cor, including supplier-provided raw material certifications and statements. A compliance statement does not replace customer testing, application validation, or purchaser/end-user responsibility for final suitability.

Regulatory and Chemical Compliance Statements

The documents below are available by request. Direct PDF and DOCX links have been removed from the visible page.

📄

TSCA Compliance Statement

Statement related to TSCA compliance information for applicable M-Cor materials or products.

Request name: TSCA Compliance Statement

📄

REACH 247 Compliance Declaration

Declaration related to REACH compliance information and applicable restricted-substance review.

Request name: REACH 247 Compliance Declaration

📄

SVHC and POPS Certificate of Conformance

Certificate related to substances of very high concern and persistent organic pollutants.

Request name: SVHC and POPS Certificate of Conformance

📄

PFAS Compliance Statement

Statement related to PFAS compliance review for applicable M-Cor materials and products.

Request name: PFAS Compliance Statement

📄

California Prop 65 Statement

Statement related to California Proposition 65 compliance information and product review.

Request name: California Prop 65 Statement

📄

Bisphenol Statement

Statement related to bisphenol review for applicable M-Cor materials or products.

Request name: Bisphenol Statement

Material, Food-Contact, Animal-Origin, and Shelf-Life Statements

📄

FDA / USP VI Certificate

Information related to FDA and USP Class VI compliance for selected applicable materials.

Request name: FDA / USP VI Certificate

📄

NSF61 Compliance

Statement related to NSF61 compliance review for applicable product or material requirements.

Request name: NSF61 Compliance

📄

TSE-BSE Statement

Statement related to transmissible spongiform encephalopathy and bovine spongiform encephalopathy concerns.

Request name: TSE-BSE Statement

📄

ADI Free Statement

Statement related to animal-derived ingredient review for applicable M-Cor materials or products.

Request name: ADI Free Statement

📄

Non-GMO Statement

Statement related to non-GMO review for applicable M-Cor materials or products.

Request name: Non-GMO Statement

📄

Cobalt-Free Statement

Statement related to cobalt-free review for applicable M-Cor materials or products.

Request name: Cobalt-Free Statement

📄

Shelf Life Statement

Statement related to shelf-life expectations for applicable encapsulated O-rings and material components.

Request name: Shelf Life Statement

Supply Chain, Origin, Quality, Packaging, and Company Policy Documents

📄

Country of Origin

Statement related to country-of-origin information for applicable M-Cor products.

Request name: Country of Origin

📄

M-Cor QAA Document

Quality assurance agreement or quality-related document available by request.

Request name: M-Cor QAA Document

📄

M-Cor Code of Ethics / Conduct

Company policy document related to ethics, conduct, and business expectations.

Request name: M-Cor Code of Ethics / Conduct

📄

M-Cor Packing Statement

Statement related to packing practices and shipping documentation for applicable products.

Request name: M-Cor Packing Statement

📄

M-Cor Documents Policy

Policy document describing how M-Cor handles document requests and compliance information.

Request name: M-Cor Documents Policy

📄

Sustainability Code of Conduct

Company or supply-chain statement related to sustainability and conduct expectations.

Request name: Sustainability Code of Conduct

Compliance Background for ENCAP-O-SEAL® Encapsulated O-Rings

The following summary preserves important technical compliance information from the prior M-Cor compliance page while making the content easier to review on desktop and mobile devices.

FEP and PFA Encapsulation

The clear encapsulation of the M-Cor ENCAP-O-SEAL® Teflon® encapsulated O-ring is manufactured from FEP and PFA resins. The existing compliance statement identifies these as 100% virgin FEP or PFA resins and states that the resins are made from permissible ingredients under Part 177 of Title 21 of the Food and Drug Administration regulations, including 21 CFR 177.1550.

Food-Contact and USP Class VI Review

The FEP and PFA resins used for the encapsulation are identified as suitable for use as articles or components of articles intended for producing, manufacturing, processing, preparing, treating, packing, transporting, or holding food under applicable provisions. The prior compliance language also states that these resins are acceptable ingredients under USP Class VI.

FKM/FPM Core

The standard FKM/FPM core material is identified as M-Cor compound MCOR7228-75KV. Where applicable, the prior compliance page states that the FKM core material meets or exceeds AMS3216F, AMS D-2000 / SAE J-200, AMS 7280, AMS 7276, and former MIL-R-83248 specifications. The standard FKM core is not manufactured from FDA or USP Class VI allowable ingredients unless specified as a special-order option.

Silicone VMQ/MVQ Core

The standard silicone core material is identified as silicone compound MCOR-PS-2735. The prior compliance page states that this compound supersedes previous versions, exceeds ZZR specifications, and is manufactured from ingredients allowable under FDA Title 21 CFR 177.2600. It also states that the standard silicone core complies with USP Class VI protocols.

EPDM Core

The EPDM core material is identified as compound 75-81385, 75 durometer rubber. The prior compliance page states that this compound is manufactured from ingredients allowable under FDA Part 177, Title 21, Regulation 177.2600. It also states that the standard EPDM core has not been tested for compliance with USP Class VI protocols.

Special-Order Core Material Options

Special-order FKM/FPM core materials may be available using ingredients allowable under FDA Title 21 CFR 177.2600, USP Class VI, or both FDA and USP Class VI requirements. Minimum orders may apply. Customers should identify these requirements before quoting or ordering.

How to Request M-Cor Compliance Documents

Use the contact page to request the correct compliance document before the document becomes a purchasing, inspection, or customer-approval issue.

1

Identify the Document

Select the compliance statement, quality document, origin statement, or material document required for your application or customer file.

2

Send the Requirement

Use the contact page and include the document name, part number, material, application, end-use requirement, and customer specification.

3

Confirm Suitability

M-Cor can provide available documentation, but the purchaser and end user must independently verify suitability for the intended use.

Disclaimer

Compliance Disclaimer and Customer Responsibility

Compliance certificates, statements, and declarations are based solely on claims, certifications, documents, and information provided by M-Cor raw material supply vendors and other supply chain sources. They do not constitute an independent warranty, independent guarantee, or independent certification by M-Cor Inc.

M-Cor Inc. disclaims all warranties, express or implied, including any warranty of merchantability or fitness for a particular purpose. The information on this page is provided for informational purposes only and should not be construed as a recommendation by M-Cor for use of any product in a particular application.

The purchaser and end user must thoroughly and independently test the ENCAP-O-SEAL® product under actual end-use conditions and independently verify satisfactory performance, regulatory suitability, material compatibility, and application suitability before specifying or using the product.

Need a Compliance Document?

Request the document before quoting, ordering, approving, or specifying the seal. M-Cor can help identify the appropriate available compliance statement for the material, product, and requirement.

Loading…