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Regulatory Guidelines for Adhesives in Food Packaging

Posted on 10/26/2017 9:22:06 AM By Deb Bhattacharjee
  

Adhesives, though used in a small amount (about 1 wt% of the overall package), offer a very important function to the overall food packaging functions, esp. maintaining overall integrity of the package from manufacturing to transportation and in actual use conditions.

Adhesives compositions incorporating a variety of polymer chemistries are designed to impart adhesion requirements specific to different end use applications like general, medium and high performance. In general, adhesives are applied in between two polymer film layers in multilayer structures such that it is not in direct contact with the food. The polymers have varying degrees of barrier properties to small molecules like oxygen, carbon dioxide and water vapor as well as to entities of different medium size molecular weights in actual use conditions depending on the solubility parameter and morphology of the polymer backbone.

Adhesives manufacturers collaborate with raw material suppliers and FDA ensuring all food compliance requirements are met. While specific attention is given to well-known possible migrants, several established test protocols are followed to search for any other potential migrants as new chemistries are developed for improved performance.

The following can be used as general guidelines for food law compliance in packaging applications:

In North America the Food and Drug Administration’s Title 21 Code of Federal Regulation parts 175.105 (covers the use of adhesives for indirect food contact), 177.1390 and 177.1395

In USA, follow:

-21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings

Three parts are relevant:

-- 21 CFR 175.105: Adhesives – For use at any temperature in food containment up to 121°F (50 °C)

-- 21 CFR 177.1395: Laminate Structures for use at temperatures between 120°F and 250°F (50 – 121 °C)

-- 21 CFR 177.1390: Laminate Structures for use at temperatures of 250°F and above (121+ °C)

-Commission Regulation EU No 10/2011 (on plastic materials & articles intended to come into contact with food)

-German BfR (Budesamt fuer Risikobewertung) Regulation XXI (commodities based on natural and synthetic rubber)

There are excellent, comprehensive reviews and references in this subject matter. A few recent articles are listed below.

References:

“FDA Regulations of Adhesives in Food Packaging”, posted by Adhesives and Sealants Council, June 23, 2015 

“FDA Regulation of Adhesives in Food Packaging”, by George G. Misko, Esq., Food Safety, June/July issue, 2015

“Determining the regulatory status of components of a food contact material”, Last Updated: 06/03/2015, U.S. Food and Drug Administration 

“Food Legislation Status of Adhesives used in the Manufacture of Materials and Articles intended to come into Contact with Food”, version March, 2016, Compiled and revised by the Technical Committee Paper and Packaging Adhesives (TKPV) of the Industrieverband Klebstoffe e.V. (German Adhesives Association), Düsseldorf, Germany:  www.klebstoffe.com