Adcote 812/Coreactant 9L10 February 2008 Page 1 of 7Adcote 812/Coreactant 9L10 February 2008 Page 2 of 7



### FDA Status

Adcote 812/Coreactant 9L10, after removal of volatiles during normal use in a coating/drying & curing operation, will conform to the requirements of the indicated United States Food and Drug Administration Regulations, subject to all other p rovisions of the regulations. Compliance with 21 CFR 177.1390 is affirmed based on migration studies, see below notes.

Adcote 812/Coreactant 9L10:

21 CFR 175.105 , Adhesives: Adcote 812/Coreactant 9L10 combination compositionally complies.

21 CFR 177.13 90 , Laminate structures for use at temperatures of 250°F and above: Affirmed as compliant based upon migration studies. Adcote 812 & Coreactant 9L10, when used at the recommended mix ratio, with a maximum dry coating weight of 2.4 lb/ream, cured at 120° F for 10 days, and using a food contact layer of cast polypropylene with a minimum thickness of 3 mils, may be used with no limitations as to temperatures or food

- types. Adcote 812 & Coreactant 9L10, when used at the recommended mix ratio, with a maximum dry coating weight of 2.4 lb/ream, cured at 120°F for 4 days, and using a 1 mil food contact layer heat sealable film, may be used at all temperatures with only aqueous and acidic food types (Types I,
II, IVB, VIB & VIIB as defined in 21 CFR 176.170, para graph (c) Table 1).

21 CFR 177.1395 , Laminate structures for use at temperatures between 120°F and 250°F: Adcote 812/Coreactant 9L10 must be used in a manner consistent with compliance with

restrictions listed above for 177.1390.

Safety, Handling and S torage

 Store in cool, dry, well ventilated area away from heat and ignition sources. Keep container tightly

closed.

 Hot organic chemical vapors can suddenly and without warning combust when mixed with air. Ignition can occur at typical elevated temperat ure process conditions. Please evaluate such processes to assure safe handling conditions.

 Support and ground containers before opening, dispensing, mixing, pouring or emptying. Open with

non

- sparking tools. If container is warm, open bung slowly to rel ease the internal pressure.

 Wash thoroughly after handling. Wash contaminated goggles, face shield, and gloves. Professionally launder contaminated clothing before re

- use.

 ATTENTION! Container can be hazardous when empty. Follow label warnings even aft er container is empty. Do no use heat, sparks, open flames, torches or cigarettes on or near empty containers. Do not reuse empty container without professional cleaning.

 Refer to Material Safety Data Sheet for more information.

Coreactant 9L10 is mois ture sensitive. Containers should not remain open for an extended period of

time.Adcote 812/Coreactant 9L10 February 2008 Page 3 of 7

ADCOTE is a registered trademark of Rohm and Haas Company These suggestions and data are based on informat ion we believe to be reliable. They are offered in good faith, but without guarantee, as conditions and method of use of our products are beyond our control. We recommend that the prospective user determine the su itability of our materials and suggestion s before adopting them on a commercial scale.

Suggestions for uses of our products or the inclusion of descriptive material from patents and the citation of specific paten ts in this publication should not be understood as recommending the use of our produ cts in violation of any patent or as permission or license to use any patents of the Rohm and Haas Company.

Visit us at http://www.rohmhaas.com/adhesivesSealants Address after April 2002: Midwe st Technology Center, 2531 Technology Drive, Suite 301, Elgin, IL 60124Adcote 812/Coreactant 9L10 February 2008 Page 4 of 7



# Rohm and Haas Food and Drug Opinion

Name: ADCOTE(TM) 812



## Regulation Complies 

## Opinion

Date Limitations

21CFR175.105 L 03/06/2002 ▪ SOLVENT MUST BE COMPLETELY EVAPORATED DURI NG

DRYING AND CURING.

21CFR177.1390 L 12/30/2004 ▪ Compositional compliance with 21 CFR 177.1390 requires the use of another component that is listed in the same paragraph of 21 CFR 177.1390. In other words, a component listed in (c)(2)(v) may

NOT be use d with a component listed in (c)(2)(vi), unless migration studies have affirmed the combination to be in compliance with the FDA regulations. This requirement for use of components in the same section of 21 CFR 177.1390 applies to the use of this material in compliance with 21 CFR 177.1395 as well.

▪ COMPOSITIONALLY COMPLIANT WITH FOOD CONTACT

NOTIFICATION 123 The combination of Adcote 812 and

Coreactant 9L10 are limited for use as an adhesive for laminate constructions for all food types, except those containing more than 8% alcohol. May be used o nly for construction of retort pouches intended for use at a maximum temperature of 135°C (275°F). Must meet the test specifications in 21CFR177.1390 (c)(3)(i)(b)(2) and (c)(3)(ii).

Paragraph (c)(2)(vi)(a)

21CFR177.1390 A 02/08/2008 ▪ The combination of Adcote 812 and Coreactant 9L10, when used at a ratio of 100:7.3, at 2.74 pounds per ream (4.5 g per meter), and cured for five days at 115F (46C), may be used as an adhesive layer in multilaminate food packaging materials with aqueous and acidic food type s provided that the adhesive layer is separated from food by a 2 mil (50 micron) polypropylene film (or equivalent or better barrier properties) in compliance with the Federal Food, Drug, and

Cosmetic Act.

21CFR177.1390 A 12/30/2004 ▪ The combination of Adcote 812 and Coreactant 9L10, used at a ratio of 100:8, at a maximum of 4 g/m2 (2.4 lb/ream), cured at 49°C (120°F) for 10 days, and has as a food contact layer 75 micron (3 mil) of cast polypropylene, may be used with no limitations as to temperature or food

- types in compliance with the United States Federal Food, Drug, and Cosmetic Act. The combination of Adcote 812 and Coreactant 9L10, used at a ratio of 100:8, at a maximum of 4 g/m2 (2.4 lb/ream), cured at 49°C (120°F) for 4 days, and has a 25 micron (1 mil) food contact layer, may be used at all temperatures with aqueous and acidic food types in compliance with the United States Federal Food, Drug, and Cosmetic Act.

21CFR177.1390 A 02/08/2008 ▪ The combination of Adcote 812 and CR 842D, when used at a ratio of 100:7.15, at 2.8 pounds per ream (4.6 g per meter), and cured for five days at 115F (46C), may be used as an adhesive layer in multilaminate food packaging materials with aqueous and acid ic food types provided that the adhesive layer is separated from food by a 2 mil (50 micron) polypropylene film (or equivalent or better barrier properties) in compliance with the United States Federal Food, Drug, and Cosmetic Act.

21CFR177.1395 L 12/30/2 004 ▪ In accordance with the limitations as described under

21CFR177.1390 above.



### Legend:

L Yes, this product is cleared with limitations noted

N No, this product is not cleared

Y Yes, this product is cleared.

A Affirmed as compliant based on migration st udies.Adcote 812/Coreactant 9L10 February 2008 Page 5 of 7



### Regulations:

21CFR175.105 Adhesives

21CFR177.1390 Laminate structures for use at temperatures of 250F and above

21CFR177.1390 Laminate structures for use at temperatures of 250F and above

21CFR177.1390 Laminate structures for use at tempe ratures of 250F and above

21CFR177.1390 Laminate structures for use at temperatures of 250F and above

21CFR177.1395 Laminate structures for use at temperatures between 120F and 250F



### Disclaimer: This information relates specifically to this prod uct. We believe this information to be accurate and

reliable as of this date. We recommend that our customers make their own determination on the suitability of this product for their particular application. We cannot guarantee that the indirect food additives/food

- contact status of this product will remain unchanged indefinitely; therefore we recommend that you periodically verify its status.Adcote 812/Coreactant 9L10 February 2008 Page 6 of 7



# Rohm and Haas Food and Drug Opinion

Name: COREACTANT 9L10



## Regulat ion Complies 

## Opinion

Date Limitations

21CFR175.105 Y 05/12/2004

21CFR177.1390 L 08/16/2005 ▪ SOLVENT MUST BE COMPLETELY EVAPORATED DURING

DRYING AND CURING.

▪ PROVIDED THAT IT IS NO MORE THAN 14% OF THE WEIGHT

OF THE CURED ADHESIVE.

▪ Compositional comp liance with 21 CFR 177.1390 requires the use of another component that is listed in the same paragraph of 21 CFR 177.1390. In other words, a component listed in (c)(2)(v) may NOT be used with a component listed in (c)(2)(vi), unless migration

studies have affirmed the combination to be in compliance with the FDA regulations. This requirement for use of components in the same section of 21 CFR 177.1390 applies to the use of this material in compliance with 21 CFR 177.1395 as well.

Paragraph (c)(2)(v)(c)

21CFR177.1390 A 02/08/2008 ▪ Adcote 76X159 and COREACTANT 9L10, used at a ratio of 100:8, at 2.9 lb/ream, and cured for 8 days at 120F and 3 days at room temperature, may be used as an adhesive layer in multilaminate food packaging materials with aqueous f ood types with a food contact layer of at least 3 mil cast polypropylene under all conditions of use in full compliance with the Federal Food, Drug and Cosmetic

Act.

21CFR177.1390 A 02/08/2008 ▪ The combination of Adcote 812 and COREACTANT 9L10, when

used at a ratio of 100:7.3, at 2.74 pounds per ream (4.5 g per meter), and cured for five days at 115F (46C), may be used as an adhesive layer in multilaminate food packaging materials with aqueous and acidic food types provided that the adhesive layer is

sepa rated from food by a 2 mil (50 micron) polypropylene film (or equivalent or better barrier properties) in compliance with the Federal Food, Drug, and Cosmetic Act.

21CFR177.1390 A 02/08/2008 ▪ The combination of Adcote 812 and COREACTANT 9L10, used at a ratio of 100:8, at a maximum of 4 g/m2 (2.4 lb/ream), cured at 49°C (120°F) for 10 days, and has as a food contact layer 75 micron (3 mil) of cast polypropylene, may be used with no limitations as to temperature or food

- types in compliance with the United States Federal Food, Drug, and Cosmetic Act. The combination of Adcote 812 and COREACTANT 9L10, used at a ratio of 100:8, at a maximum of 4 g/m2 (2.4 lb/ream), cured at 49°C (120°F) for 4 days, and has a 25 micron (1 mil) food contact layer, may be used at all temperatures with aqueous and acidic food types in compliance with the United States Federal Food, Drug, and Cosmetic Act.

21CFR177.1390 A 02/08/2008 ▪ The combination of Adcote 842 and C OREACTANT 9L10, when used in a ratio of 100:8.0 and cured for seven days at 115F (46C), may be used as an adhesive layer in multilaminate food packaging materials under high temperature, heat

- sterilized (e.g., over 212F (100C)) and less severe conditions, with all food types provided that the adhesive layer is separated from food by a 3 mil (76 micron) polypropylene layer (or equivalent or better barrier properties) in compliance with the Federal Food, Drug, and Cosmetic Act.

21CFR177.1395 L 08/16/2005 ▪ I n accordance with the limitations as described under

21CFR177.1390 above.Adcote 812/Coreactant 9L10 February 2008 Page 7 of 7



### Legend:

L Yes, this product is cleared with limitations noted

N No, this product is not cleared

Y Yes, this product is cleared.

A Affirmed as compliant based on migration stu dies.



### Regulations:

21CFR175.105 Adhesives

21CFR177.1390 Laminate structures for use at temperatures of 250F and above

21CFR177.1390 Laminate structures for use at temperatures of 250F and above

21CFR177.1390 Laminate structures for use at tempera tures of 250F and above

21CFR177.1390 Laminate structures for use at temperatures of 250F and above

21CFR177.1390 Laminate structures for use at temperatures of 250F and above

21CFR177.1395 Laminate structures for use at temperatures between 120F and 250F



### Disclaimer:
This information relates specifically to this product. We believe this information to be accurate and

reliable as of this date. We recommend that our customers make their own determination on the suitability of this product for their particular application. We cannot guarantee that the indirect food additives/food

- contact status of this product will remain unchanged indefinitely; therefore we recommend that you periodically verify its status.