In the United States, the Food and Drug Administration (referred to as the US FDA) is the governmental agency in the U.S. that regulates food contact substances, materials, and articles. All existing regulations are published in the Code of Federal Regulations (also commonly referred to as the CFR). More specifically, Title 21 CFR parts 170-199 regulations are applicable to food additives. In the first podcast of the series, our experts discuss the general requirements outlined in these regulations.
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In the United States, the Food and Drug Administration (referred to as the US FDA) is the governmental agency in the U.S. that regulates food contact substances, materials, and articles. All existing regulations are published in the Code of Federal Regulations (also commonly referred to as the CFR). More specifically, Title 21 CFR parts 170-199 regulations are applicable to food additives. In the first podcast of the series, our experts discuss the general requirements outlined in these regulations.
Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
00 :15 à 00 :46
Speaker 1
Hey, everyone! Welcome to the Assurance in Action podcast. More specifically, welcome to the first episode in our special podcast series about U.S. regulations on food contact materials and articles. This is going to be a 3-part series and we are very excited to bring it to you.
My name is Tommy Savarese. I am a food contact compliance manager[TI1] [AI2] here at Intertek, and today I am sitting with Ashli Span, food contact regulatory project manager, who is going to help us dig into this very intriguing topic.
00 :46 à 00 :50
Speaker 2
Thank you, Tommy. Happy to be here!
00 :50 à 00 :59
Speaker 1
So, to get started, Ashli, how are food contact materials and articles regulated in the U.S. and who’s in charge of overseeing this?
00 :59 à 01 :34
Speaker 2
Yes, so the Food and Drug Administration (or U.S. FDA) is the governmental agency in the U.S. that regulates food contact substances, materials, and articles. All existing regulations are published in the Code of Federal Regulations (also commonly referred to as the CFR). More specifically, the regulations in Title 21 CFR parts 170-199 are applicable to food additives.
01:34 à 01 :47
Speaker 1
Ok, so food additives are listed in 21 CFR. But if I’m asking about food contact materials or articles, not additives, why would regulations that pertain to food additives be relevant?
01:47 à 02:15
Speaker 2
Yes, Tommy, I can see why that may be a bit confusing. As you pointed out, the FDA looks at food contact materials or articles from the perspective of additives to food. These additives can be direct or indirect. Similarly, food contact materials can be considered direct or indirect. So let me explain a little further.
02:15 à 02:17
Speaker 1
Please do.
02:17 à 02:47
Speaker 2
So, there are food additives, or substances that become part of the food.
A direct food additive is a substance that is intentionally added to the food, for example a sweetener or preservative. Then, there are indirect food additives. These are substances that unintentionally become part of the food, often by way of migration from a food contact material.
02:47 à 02:50
Speaker 1
Ok, I think that makes sense so far.
02:50 à 04 :15
Speaker 2
Perfect. So, then there are food contact materials or articles. As I mentioned, food contact materials can also be direct or indirect. A direct food contact material is a material that directly contacts the food—sounds obvious, right? Many people believe that a material or component that is not intended to contact food would not fall under the food contact regulations—but that is not entirely true. Even food contact materials that are separated from the food by the direct food contact material are subject to the regulations as well.
An example of this could be a candy box. The nonprinted side of the paperboard is the direct food contact material on the inside of the box, but the ink printed on the outside of the package, or even the adhesives used on the seams of the box, would be considered indirect food contact materials. And just to be clear, each of the components (paperboard, ink, and adhesive) would be considered “food contact materials” where the final box would be considered the “food contact article.”
04 :15 à 04 :32
Speaker 1
Wait... so you’re saying that even an outside layer needs to be regulated? It seems unlikely that anything that’s not a food contact layer would become a “food additive,” right? I’m not adding anything into the food, and my product isn’t even being made at the same facility as the food.
04:32 à 05:05
Speaker 2
Actually Tommy, this is a common misconception. Substances from a food contact material, whether by direct or indirect food contact, can migrate into the food. That substance then becomes an additive, and therefore, becomes subject to FDA regulation.
So, one way you can visualize this: have you ever bought those artificially colored flowers and put them in a vase of water?
05:05 à 05:10
Speaker 1
Yeah, I know what you’re talking about—those flowers that have the extra-vibrant petals from dye coloring?
05:10 à 05:47
Speaker 2
Yes, exactly. You can think of the flower as the food contact material and the water as the food. After a day or so, the water starts to have the same tint as the colored flowers. This isn’t because you added the dye directly to the water, like a direct food additive. But by virtue of being in contact with the flower, or, the food contact material, the dye has now become part of the water, or the food, as well, and is now considered an indirect food additive.
05:47 à 06:02
Speaker 1
Ok, right, I can see the logic now. Thank you.
So, in the example of the candy box, all of the food contact materials would be subject to FDA regulation, per 21 CFR, as indirect food additives, whether they are direct or indirect.
06:02 à 06:04
Speaker 2
Exactly.
06:04 à 06:09
Speaker 1
Ok great—so how do I go about making sure that these materials are compliant?
06:09 à 08:03
Speaker 2
Wholistically speaking, food contact compliance consists of 3 main components or requirements that need to be met. These include the framework regulation, any applicable specific material regulations, and good manufacturing practices, or GMP for short.
The framework regulation specifies that food contact materials cannot endanger human health, change the composition of the food, or effect the organoleptic properties—meaning sensory aspects like taste, smell, and sight—of the food.
Then there are specific material regulations that govern the use of the different food contact materials; for example, regulations for paper and paperboard, polyolefins, and so on. These can include material regulations at the federal, national, and state level. The regulations include positive lists of materials that are approved by government agencies, limitations for use on specific substances where applicable, and set forth any of the requirements for testing. Actually, one of the biggest misconceptions is that compliant test results equate to food contact compliance, but testing is only one piece of the compliance requirement.
Then, finally, GMP or good manufacturing practices are required to ensure that there are quality systems and manufacturing processes in place to avoid contamination during manufacturing of food contact articles or substances. GMP also ensures that the material or article is only used at the level necessary to achieve its technical function, and that it’s of suitable purity for food contact.
08:03 à 08:08
Speaker 1
Hold on, so are you saying that I need to be compliant with multiple regulations?
08:08 à 08:36
Speaker 2
Yes, kind of. A good place to start is the framework regulation, or 21 CFR Section 174.5 which has the general provisions applicable to indirect food additives. If you meet the applicable requirements of the specific material regulations and good manufacturing practices, this would also demonstrate compliance with the framework regulation.
08:36 à 08:51
Speaker 1
Got it. So, the framework is kind of like the foundation that lays out the requirements. I think all of us may be thinking that determining whether a material or article is compliant can get pretty complicated. How would you typically go about evaluating a product?
08:51 à 09:34
Speaker 2
First, we would determine what the type of material is, or in the case of a food contact article, the materials of each of the individual components. Once we identify all of the applicable regulations, we would evaluate each of the components against their respective regulations to ensure compositional compliance and perform any required testing. To put it simply, once we can determine that the material or article is compositionally compliant, that it has passed any compliance testing, and that good manufacturing practices have been followed in its production, we are able to claim its compliance with U.S. FDA food contact regulations.
09:34 à 09:45
Speaker 1
Ok, so you made that sound simple. Maybe we can walk through an example, like the candy box you previously mentioned, so I can make sure I understand.
09:45 à 11:42
Speaker 2
Absolutely, lets break it into phases. The first would be the regulatory compliance review to determine the regulatory status of each of the components or materials in the candy box—the paperboard, the ink, and the adhesive.
First, we need to obtain all the required product and regulatory information such as the intended end use of the product, including food contact time, food contact temperatures, the types of food it will come into contact with, and whether the material is a single‑ or repeat-use article.
In the candy box example, we might assume that it would be in contact with dry solids that have surfaces containing free fat or oil, at room temperature, for up to 6 months, for a single-use application. These uses are important to know when reviewing the components, because we need to ensure that each of the food contact materials are regulated for the specific intended end use of the article, or candy box.
Secondly, we would need the component or formulation information, depending on the material. If the individual food contact materials already have FDA food contact compliance, then we need to review the compliance documentation from each of the individual suppliers to ensure that the statements are sufficient and support the intended end use of the product being evaluated. If the components do not have current regulatory compliance, then we need to obtain the formulations of the individual components from the suppliers and review them against the applicable regulations.
In addition, we may need to review other information as well depending on the article, such as a description of the manufacturing processes or procedures. For products like the candy box, we would need to review the loading and lay-down rates of the printed ink on the outside of the packaging[TI3] .
11:42 à 11:51
Speaker 1
Ok, so let’s say the candy box manufacturer has supplied all of this information and it is determined that each of the components are regulated for the intended end use. Now what?
11:51 à 12:33
Speaker 2
Then we would move onto phase 2, where we perform compliance testing. Based on the applicable regulations for each of the components, the final article may be required to demonstrate that it passes any of the limitations set forth by the material regulation. So for the candy box example, the paperboard would be subject to 21 CFR 176.170 extraction testing. However, the ink may be subject to further toxicological assessments or calculations, and even further testing to determine if it is being used at an acceptable safe level for its intended end use.
12:33 à 12:46
Speaker 1
Got it. So for the sake of this example, if all of the components are regulated for their intended end use, and the testing has shown compliant results, I can now say my candy box is food contact–compliant? Is that right?
12:46 à 12:54
Speaker 2
Yes, as long as there are also good manufacturing practices in place, that is correct.
12:54 à 13:02
Speaker 1
Ok, so what if something is or isn’t regulated but not for its intended end use? What options would I have there?
13:02 à 13:15
Speaker 2
That is a great question Tommy, but I think that may have to be the start of our next episode.
13:15 à 13:32
Speaker 1
Definitely, I think I have enough to think about for today. Thank you for all the insight on U.S. FDA food contact compliance so far—we will pick this back up later. I think we all have lots to think about. Thank you all for your time. Thank you, Ashli.
13:32 à 13:37
Speaker 2
Yes, thank you Tommy—looking forward to it. Thank you all for listening.
maybe I should just say I'm the host? [TI1] [TI1]
I think your title is good here. It may be better than just "host" so if they're paying attention it would be another person that they could contact for any inquiries or information. [AI2] [AI2]