FDA 175.105 Adhesives: Glues for Indirect Food Contact

 

What is FDA 21 CFR 175.105?

 

Regulation 21 CFR 175.105 refers specifically to Title 21, Chapter I, Subchapter B, Part 175, Subpart B "Adhesives" from the Food and Drug Administration (FDA).

The FDA is a federal agency responsible for protecting public health by regulating various types of products, including food, drugs, biologics, medical devices, cosmetics, veterinary products, tobacco products, and more. 21 CFR 175.105 focuses specifically on indirect food contact adhesives in food packaging. It includes criteria regarding formulation as well as how these adhesives should be used in food packaging to meet the proper safety standards.

 

Indirect Food Contact Adhesives Explained

Let's break this down a bit more by taking a step back. To start, we should note how the FDA defines a related term. A food additive is "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food."¹

There are three types of food additives, including direct, secondary direct, and indirect. They can pertain to substances used in various steps in the production process, including the manufacturing, preparation, processing, packing, transporting, and holding of food. Food packaging and its components (like adhesives) are considered indirect food additives that do not come into direct contact with the food itself. These indirect food contact adhesives must meet the FDA 21 CFR 175.105 regulations for adhesives.

Examples of applications where FDA indirect food contact adhesives are needed include:

Between layers of laminated food packaging

For labels that go on food jars or bottles

To bond agents in cartons or flexible film wraps

 

175.105 Adhesive Regulations for Food Packaging Manufacturers

The burden of compliance for FDA 175.105 adhesive regulations typically falls on the packaging manufacturer instead of the adhesive manufacturer.

Simplifying FDA regulation 21 CFR 175.105, adhesives can safely be used in the packaging, transporting, or holding of food if they meet the following conditions:

1. The adhesive is prepared from one or more approved substances.

2a. The adhesive is separated from the food by a functional barrier.

2b. OR The amount of adhesive that comes in contact with the packaged food cannot exceed the limits of the FDA's Current Good Manufacturing Practices (CGMPs). (There are different requirements regarding dry goods versus fatty and aqueous foods.)

3. The finished adhesive container must include a label that reads, "food-packaging adhesive."²

Along with safe use, there are also very specific, technical requirements regarding the formulation of these FDA-compliant glues for indirect food contact. In simpler terms, optional substances used in the formulation of FDA 175.105 adhesives may include some of the following:

Substances generally recognized as safe for use in food or food packaging

Substances with prior sanction or approval that are used according to the specific conditions outlined by those sanctions or approvals

Flavoring substances permitted for use in food so long as they are volatilized from the adhesives during the packaging fabrication process

Color additives approved for use in food

Substances approved by other regulations in the Food for Human Consumption subchapter so long as they meet any specific regulations outlined for them²

These are just a simplified and summarized version of the FDA 175.105 Adhesives section. Regulations can also change, and substances are subject to limitations. To ensure you remain compliant, reference the current FDA 21 CFR 175.105 adhesive regulations at the Code of Federal Regulations. It is also important to note that pressure-sensitive adhesives for indirect food contact have a separate subset of regulations under 175.125.

 

See What We Suggest

 

Feeling a little lost? That is okay. At Good Adhesive, we carry various food-safe glues (and even some food-grade tapes) that meet the FDA indirect food contact regulations for adhesives. To help you determine the best option for you, our team shares a few notable products that may be worth investigating and testing with your application.

 

General Purpose Packaging Applications

 

 

For a general-purpose FDA 175.105 adhesive, the YD-5158/5159 hot melt adhesive is a good option to try for various packaging applications, especially for case and carton sealing. It can be applied at a standard temperature and has great thermal stability to reduce adhesive charring and related maintenance problems. The low odor formulation also creates a better environment for workers.

 

Suitable for quick bonding YD-5313

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Polyolefin Packaging Glue YD-5100/5289

 

For more product information, please contact us.