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FDA, NSF & USDA Information
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SC:2156-01

EPON Resins, EPI-REZ Waterborne Resins, EPIKURE Curing Agents, HELOXY Modifiers, and CARDURA Products
Table of Contents 1 5 8

FDA Information

The Food and Drug Administration (FDA) regulations must be consulted to determine the suitability of substances for use in food contact applications. This bulletin was developed to assist Resolution Performance Products LLCs (RPPLLC) customers in selecting epoxy resins and curing agents which may be used in applications regulated by the FDA. Many RPPLLC products are candidates for inclusion in coatings and/or adhesive formulations intended for food contact applications. Since these formulations consist of multiple components, some of which may be reacted to form the finished product, the individual components and the finished product must be reviewed to determine FDA status. The purpose of this bulletin is to identify epoxy resins and curing agents which are permitted under sections 175.105 (Adhesives) and 175.300 (Resinous and polymeric coatings) of Title 21 Code of Federal Regulations (21 CFR). The responsibility for determining the overall compliance with applicable food additive regulations is with the company manufacturing the final product and/or the person placing that product in contact with food. The products listed in Tables 1-4 are permitted (i.e. cleared) for use in food contact applications under the provisions specified in 21 CFR 175.105 and 175.300. Please consult the specific regulatory section for any requirements or restrictions which may apply to your use of the product.

E P I KOT E

EPON

EPIKURE

EPI-REZ

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FDA Information (cont.)

Table 1/ EPON resins permitted for food contact applications

21 CFR 175.105 21 CFR 175.300

Product Name

MSDS #

EPON Resin 824 EPON Resin 825 EPON Resin 826 EPON Resin 828 EPON Resin 829 EPON Resin 829H EPON Resin 829P EPON Resin 830 EPON Resin 834 EPON Resin 836 EPON Resin 862 EPON Resin 1001F EPON Resin 1002F EPON Resin 1004F EPON Resin 1007F EPON Resin 1009F EPON Resin 2002 EPON Resin 2002-FC-10 EPON Resin 2003 EPON Resin 2004 EPON Resin 2005 EPON Resin DPS-2011 EPON Resin 2012 EPON Resin 2022 EPON Resin 2024 EPON Resin SU-2.5 EPON Resin SU-3 EPON Resin SU-8 EPON Resin 155 EPON Resin 160
1

1129 21 22 23 63 397 800261 25 26 27 800674 184 185 267 186 187 172 284 653 180 800665 800300 800588 696 300 1430 1429 1431 800624 1110

Yes Yes Yes Yes Yes1 Yes1 Yes1 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes1 Yes1 Yes1 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Direct use cannot be recommended due to the presence of added catalyst. However, the intended use is for the resin to be further reacted, i.e. advanced with BPA, which, depending on the reactant, is acceptable.

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FDA Information (cont.)

Table 2/ Epoxy resin dispersions permitted for food contact applications

21 CFR 175.105 Yes Yes Yes Yes 21 CFR 175.300 Yes Yes Yes No

Product Name EPI-REZ 3510-W-60 Waterborne Resin EPI-REZ 3515-W-60 Waterborne Resin EPI-REZ 3522-W-60 Waterborne Resin EPI-REZ WD-510 Waterborne Resin

MSDS # 1582 1585 1433 1428

Table 3/ EPON Resin solutions permitted for food contact applications

21 CFR 175.105 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 21 CFR 175.300 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Product Name EPON Resin 875-O-70 EPON Resin 876-Q-50 EPON Resin 8511-MY-65 EPON Resin 8521-MX-60 EPON Custom Solution CS-251 EPON Custom Solution CS-252 EPON Custom Solution CS-258 EPON Custom Solution CS-266 EPON Custom Solution CS-267 EPON Custom Solution CS-275 EPON Custom Solution CS-277 EPON Custom Solution CS-281 EPON Custom Solution CS-286 EPON Custom Solution CS-288 EPON Custom Solution CS-289 EPON Custom Solution CS-294 EPON Custom Solution CS-331 EPON Custom Solution CS-338 EPON Custom Solution CS-339 EPON Custom Solution CS-340 EPON Custom Solution CS-344 EPON Custom Solution CS-352

MSDS # 1419 1446 1426 1439 800337 800354 800538 800634 800652 800697 800700 800773 795 936 937 1045 1411 1378 1396 1409 1393 1421

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FDA Information (cont.)

Table 4/ Curing agents permitted for food contact applications1

21 CFR 175.105 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No Yes3 Yes3 Yes Yes Yes Yes Yes Yes Yes 21 CFR 175.300 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes2 Yes Yes Yes Yes Yes Yes Yes Yes No No No Yes

Product Name EPIKURE Curing Agent 3015 EPIKURE Curing Agent 3046 EPIKURE Curing Agent 3055 EPIKURE Curing Agent 3061 EPIKURE Curing Agent 3100-XY-60 EPIKURE Curing Agent 3115 EPIKURE Curing Agent 3115-E-73 EPIKURE Curing Agent 3115-X-70 EPIKURE Curing Agent 3125 EPIKURE Curing Agent 3140 EPIKURE Curing Agent 3155 EPIKURE Curing Agent 3211 EPIKURE Curing Agent3212 EPIKURE Curing Agent 3213 EPIKURE Curing Agent 3223 EPIKURE Curing Agent 3234 EPIKURE Curing Agent 3245 EPIKURE Curing Agent 3281 EPIKURE Curing Agent 3281-H-60 EPIKURE Curing Agent 3380 EPIKURE Curing Agent 3381 EPIKURE Curing Agent 3502 EPIKURE Curing Agent P-201
1

MSDS # 1510 1512 1506 1520 1517 79 1511 85 80 81 1580 3 61 800668 1616 1608 1621 1720 1662 1495 1494 15 800602

The above information may not be comprehensive of all EPIKURE Curing Agents which can be used in food additive applications. The FDA status given is based on the fact that ingredients of the curing agent (with the exception of the solvent(s)) are permitted under the referenced regulation. The assumption is made that any solvents present in the curing agent will be evaporated during the curing process. The cited regulations should be consulted to determine specific requirements applicable to the end product. 2 For use in can end cements at <1%. 3 For use in manufacture of polyamides only.

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FDA Information (cont.)

Resin Solutions and Custom Solutions

All standard resin solutions are deemed cleared for use in applications covered by 175.105 and 175.300 provided that all traces of solvent(s) are removed during the application and/or cure. The term standard resin means those resins which are listed as permitted in this technical bulletin. Examples include, but are not limited to, products containing various solvents and EPON Resins 828, 834, 836, 1001, 1002, 1004, 1007, 1009, etc. Resins and curing agents intended for the following end uses are NOT cleared for food contact applications under sections 175.105 and 175.300 of 21 CFR: electrical, brominated/ electrical (including solutions), composites, and pipe rehabilitation. In addition, the following RPPLLC product lines are NOT cleared for food contact applications according to these FDA regulations: all elastomer modified products, all EPONEX Resins, all EPON HPT Resins and Curing Agents, and all HELOXY Modifiers.

Products Not Recommended for Food Contact Applications

Regulation Status

The FDA regulations specified herein were in effect at the time of compilation of this bulletin and they are subject to change. No chemical should be used as or in a food, drug or cosmetic or in a product or process in which it might contact a food, drug or cosmetic until you have determined the safety and legality of its use. Questions and requests for information on RPPLLC products, including, if necessary, written qualified confirmation of FDA acceptability, should be directed to your RPPLLC Sales Representative or the nearest RPPLLC Sales Office.

National Sanitation Foundation (NSF) Standards Approval

The NSF Drinking Water Additives Program is responsible for the Certification of drinking water treatment chemicals and drinking water system components to ensure that these products do not contribute contaminants to drinking water that could cause adverse health effects. ANSI/NSF Standard 61: "Drinking Water System Components Health Effects" is the nationally recognized health effects standard for all devices, components and materials that contact drinking water. The NSF Certification Process In addition to NSF's responsibilities for the development and maintenance of Standards 60 and 61, NSF developed a certification program based on Standards 60 and 61 which includes unannounced factory audits, product testing, and evaluation of products and materials. The

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National Sanitation Foundation (NSF) Standards Approval (cont.)

manufacturer of epoxy coatings seeking certification should contact NSF (www.nsf.org) to receive an application packet containing forms including a Product Materials Information Form and a Toxicology Data Review Submission A (TDRS A) Form. All information disclosed to NSF is held in strict confidence. NSF toxicology staff first reviews the product/material information submitted by a manufacturer. Typically, additional material or ingredient information is required and this information is requested in order to determine all potential contaminants to drinking water. This is an important step, because to properly evaluate a product or material for health effects, complete information about the formulation and impurities associated with each of its ingredients must be known by the certifying agency. If more information is needed, a Toxicology Data Review Submission B (TDRS B) Form will be forwarded to the manufacturer, who should forward it to the supplier of the raw materials. The contact at Resolution Performance Products is: Product Safety and Compliance, P. O. Box 1380, Houston, TX 77251. If a supplier has previously submitted a TDRS B Form to NSF, they have the option of giving NSF permission to use that information for multiple applicants. The applicant will still have to go through the entire NSF certification process, however, it will be shortened because NSF will not have to wait for the supplier to submit all the information required in a TDRS B Form. They only need to wait for the supplier to sign and send in the permission form. Table 7 is a list of products for which Resolution Performance Products has already completed a TDRS B Form. Once NSF has received all information, a factory audit is then scheduled and performed by trained NSF auditors. During the audit, formulations and suppliers are verified, QA/QC records are audited, and the product/material is sampled for testing at NSF. The sampled product/material is tested according to the protocols outlined in each of the standards. Following laboratory testing, contaminant concentrations are "normalized" or converted to at-the-tap concentrations and compared to the standard's maximum allowable level (MALS). If the results are acceptable, NSF and the manufacturer enter into a contractual agreement and the product is certified and Listed by NSF. The NSF authorized formulations are retained at the product facilities. Deviations from the authorized formulation are not permitted without advance written notice to, and acceptance by, NSF. After the initial certification, production facilities are audited unannounced and certified products are tested and/or evaluated on a periodic basis (typically annually), to ensure continued compliance with the requirements of the standard, and that the manufacturer continues to operate in accordance with NSF's general and program specific certification policies.

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National Sanitation Foundation (NSF) Standards Approval (cont.)

Table 7/ Products for which TDRS B Form have been submitted

Base Chemicals Epichlorohydrin Epoxy Resins EPON Resin 1001-A-85 EPON Resin 1001-CX-75 EPON Resin 1001F EPON Resin 1001-T-75 EPON Resin 1001-X-75 EPON Resin 1001-X-75 EPON Resin 1002F EPON Resin 1009F EPON Resin 1031 EPON Resin 154 EPON Resin 2002 EPON Resin 2002-FC-10 EPON Resin 815C EPON Resin Custom Solution 283 EPI-REZ Resin 3522-W-60 EPI-REZ Resin 5522-WY-55 EPI-REZ Resin WD 510 Epoxy Research Resin RSW-2801 Epoxy Curing Agents EPIKURE Curing Agent 3010 EPIKURE Curing Agent 3025 EPIKURE Curing Agent 3055 EPIKURE Curing Agent 3072 EPIKURE Curing Agent 3100-XY-60 EPIKURE Curing Agent 3115-X-70 EPIKURE Curing Agent 3125 EPIKURE Curing Agent 3140 EPIKURE Curing Agent 3155 EPIKURE Curing Agent 3200 EPIKURE Curing Agent 3213 EPIKURE Curing Agent 3271 EPIKURE Curing Agent 3274 Modifiers HELOXY Modifier 505 HELOXY Modifier 68 Glycidyl Ester CARDURA E-10

EPON Resin 826 EPON Resin 828 EPON Resin 834-F-90 EPON Resin 834-X-80 EPON Resin 834-X-90 EPON Resin 836-A-85 EPON Resin 862 EPON Resin 871 EPON Resin 9210 EPON Resin 9215 EPON Resin 9220 EPON Resin 9230

EPIKURE Curing Agent 3281-H-60 EPIKURE Curing Agent 3290 EPIKURE Curing Agent 3380 EPIKURE Curing Agent 3382 EPIKURE Curing Agent 3501 EPIKURE Curing Agent 3502 EPIKURE Curing Agent 3503 EPIKURE Curing Agent 8290-Y-60 EPIKURE Curing Agent 8525 EPIKURE Curing Agent 9270 EPIKURE Curing Agent 9275 EPIKURE Curing Agent P-104 EPIKURE Curing Agent P-108

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USDA Compliance

The Food Safety & Inspection Service (FSIS) of the United States Department of Agriculture (USDA) consolidated the sanitation requirements of official meat and poultry establishments into a single part, and converted many of the highly prescriptive sanitation requirements into performance standards. Establishments can now use different and varying means to achieve the performance standards as long as the result is that the establishment prevents insanitary conditions that could lead to adulterated product. The FSIS has removed several Directives, including Directive 11,000.4 "Approval of Paints and Coatings Used in Official Establishments," and has replaced those Directives with FSIS Directive 11,000.1 "Sanitation Performance Standards," issued January 25, 2000. Directive 11,000.1 outlines the sanitation standards an establishment must meet to be in compliance. A copy of this Directive can be obtained from the FSIS websight (www.fsis.usda.gov).

Resolution Performance Products P.O. Box 4500 Houston, Texas 77210-4500 For product prices, availability, or order placement, call our toll-free customer service number at:

1.877.859.2800
For sales in North and South America outside the United States, call:

1.832.366.2365

For literature and technical assistance, visit our website at:

www.resins.com

SAFETY & HANDLING These products are capable of producing adverse health effects ranging from minor skin irritation to serious systemic effects. Exposure to these materials should be minimized and avoided, if feasible, through the observance of proper precautions, use of appropriate engineering controls and proper personal protective clothing and equipment, and adherence to proper handling procedures. None of these materials should be used, stored, or transported until the handling precautions and recommendations as stated in the Material Safety Data Sheet (MSDS) for these and all other products being used are understood by all persons who will work with them. Questions and requests for information on Resolution Performance Products LLC (RPPLLC) products should be directed to your RPPLLC sales representative, or the nearest RPPLLC sales office. Information and MSDSs on non-RPPLLC products should be obtained from the respective manufacturer. WARRANTY NOTHING CONTAINED HEREIN CONSTITUTES AN OFFER FOR THE SALE OF ANY PRODUCT. ALL PRODUCTS SUPPLIED BY RESOLUTION PERFORMANCE PRODUCTS LLC (RPPLLC) ARE SUBJECT TO THE TERMS AND CONDITIONS OF THE APPLICABLE SALES CONTRACT AND NOTHING CONTAINED HEREIN SHALL AMEND OR MODIFY ANY SUCH CONTRACT. SUBJECT TO THE FOREGOING, RPPLLC WARRANTS ONLY THAT ITS PRODUCTS WILL MEET SPECIFICATIONS SET FORTH IN THE APPLICABLE SALES CONTRACT. RPPLLC MAKES NO OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS OR THE RESULTS TO BE OBTAINED FROM THE USE THEREOF, OR WITH RESPECT TO ANY INFORMATION PROVIDED BY RPPLLC, INCLUDING WITHOUT LIMITATION THAT ANY PRODUCT WILL BE MERCHANTABLE OR FIT FOR ANY PARTICULAR PURPOSE OR THAT THE USE OF ANY PRODUCT OR INFORMATION PROVIDED BY RPPLLC WILL NOT INFRINGE ANY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS. ALL SUCH WARRANTIES ARE HEREBY DISCLAIMED AND EXCLUDED.

2001 Resolution Performance Products LLC. All rights reserved. Printed in the U.S.A.

SC:2156-01 10/01

E P I KOT E

EPON

EPIKURE

EPI-REZ

H E LOX Y

C A R D U R A

V E O VA