Ask Dr. Dave: How can we get our adhesives approved for food/beverage or medical applications?
Dave Dunn's July 2014 column.
Question: How can we get our adhesives approved for food applications, contact with drinking water, or medical applications?
Answer: Food packaging is an industry that involves special requirements. Most adhesives in food packaging applications only come into indirect contact with food (they are separated by a barrier layer). However, in some applications, such as labels on fruit and heat-sealable lids, the adhesive does come in direct contact, and all packaging adhesives must meet strict regulations. You need to read the U.S. Food and Drug Administration (FDA) section of the Code of Federal Regulations (21 CFR 175.105 - Adhesives) to see the requirements.
If you want to use your adhesives to bond medical devices, you must remember that adhesives are not approved by the FDA; only the final assembled device needs approval. However, adhesive manufacturers routinely get their products tested for biocompatibility as a marketing tool to increase consumer trust in the product. Adhesives used in the medical industry are tested to the USP Class VI or ISO 10993 toxicological classification requirements. This essentially means that the products have been tested by an independent laboratory to verify that they are non-toxic and biologically inert in the cured state.
For adhesives that will be in contact with potable water, your product must be certified to the NSF/ANSI Standard 61. This standard involves a toxicological evaluation of the ingredients in the product and immersion of the applied product in test waters, which are analyzed for possible extraction of toxic ingredients. Six test laboratories are accredited by ANSI to carry out this testing. Potable water and medical approvals can be time consuming and expensive but can often give you a real competitive advantage.