NOTICE REGARDING FOOD SAFE RESIN SYSTEMS

This formulation is in accordance with CFR Title 21, Part 175.300 and 175.105 for direct and indirect food contact as a resinous adhesive or coatings.

For Coatings Applications 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=175.300

 For Adhesives Application

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=175.105

Proper care must be taken to ensure all usage instructions such as accuracy of mix ratio proportioning, component mixing to a homogeneous state and established curing schedule must be observed. Please make sure to review all published usage instructions and processing information posted on this item page. Proportioning the resin and curing agent by weight must be observed to achieve an accurate mix ratio and reduce the likelihood of improper proportioning.

The FDA CFR Title 21 175.300 (coatings applications) only provides a list of raw materials and chemical compounds that can be utilized for the formulation of the MAX CLR and similar resin system for the same purpose. We validate the efficacy of the MAX CLR formulation by performing our internal laboratory extractable and leachable studies and deem its suitable performance.

The user should thoroughly test any proposed use of this product and independently conclude satisfactory performance in the application. Likewise, if the manner in which this product is used requires government approval or clearance, the user must obtain and validate said approval.

Parameters Of Consideration For Food Contact Coatings Per
Title 21 FDA CFR 175.105

This product and its composition are in compliance with Title 21 FDA CFR 175.105

This product and its composition is in compliance with title 21 FDA CFR 175.xxx. This confirmation is limited to the use of this product in the above food contact applications and does not apply to any use in drug, medical device, cosmetic products or packaging. It is the responsibility of the drug, medical device, or cosmetic manufacturer to establish all materail use complies with any related government regulations.

The product may be used based on the “no-migration”-principle, i.e. if FDA – recognized migration modeling or studies show no detectable migration (transfer of substance to food) in a particular application, the product can be used legally. However, final legal compliance needs to be verified by the producer of the final article under consideration of the final application and the conditions of use of the product.

IMPORTANT GUIDELINES FOR FOOD CONTACT APPLICATIONS

For food contact applications, MAX CLR A/B must be fully cured to ensure no chemical leaching can occur when foodstuffs' come in contact with the cured resin system. Any uncured chemical compounds from the improperly prepared MAX CLR may be extracted and cause cross-contamination or leaching during food contact. Please review the following and to avoid any curing problems.

• Check for resin crystallization. During the colder season, the MAX CLR resin component or PART A may crystallize and must be heat-process to fully polymerize the resin system. Inspect the PART A bottle for any turbidity or any solid mass that typically forms on the bottom of the bottle. Please view the following video on heat-processing the PART A or resin component.

• Weigh or measure the components accurately at a 2:1 mix ratio. Any off-ratio excess of either the resin or curing agent in the mixture can cause poor cure and can cause chemical leaching that can transfer to the food or beverage. Use a digital scale and weigh each component for best results, for example, a 200-grams of MAX CLR PART A will require 100 grams of MAX CLR PART B. Careful accuracy must be observed when proportioning the resin & curing agent to ensure the proper cured performance of the MAX CLR A/B resin system. This digital scale is available on eBay for purchase.

• Mix the components thoroughly. Any unmixed component from poor mixing will result in poor polymerization and can be extracted and cross-contaminated the food stuff. Please view the following mixing demonstration below.

• Allow the applied resin to fully cure for a minimum of 48 hours at 75°F before exposing the coating to any food or beverage. A short heat post cure at 150°F for 60 to 90 minutes will ensure the resin is fully cured. Rinse the cured coating with warm water and mild detergent before allowing any food contact. If an oven is not available, an infrared heat lamp will work well for heat curing.