Food Contact Industry- Part 3/3: FDA Food Contact regulations

Listen to the 3rd episode of our Assurance in Action podcast series dedicated Food Contact Materials and Articles Regulations in the United States. Navigating the regulatory landscape for food contact substances in the U.S. is crucial. The FDA, or the Food and Drug Administration, oversees these regulations, with guidelines found in the Code of Federal Regulations (Title 21 CFR parts 170-199). Join our experts in the latest podcast episode as they delve into the intricacies of state-level regulations for food contact materials and articles. Stay informed and stay compliant! To learn more about the regulation, stream our podcast now.

Speakers:

• Thomas Savarese- Compliance Manager, Intertek Assuris
• Ashli Span- Project Manager, MBA, Intertek Assuris

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Transcript

00:16 --> 00:50 
Speaker 1 

Hey, everyone! Welcome back to the Assurance in Action podcast. My name is Ashli Span, food contact regulatory project manager here at Intertek. This is our third episode looking at food contact regulations in the U.S., and we’re doing things a little differently this time. As you can see, I’m going to be the host today, and we’re going to put the spotlight on Tommy Savarese, food contact compliance manager, who will be educating us about Food Contact Regulations at the state level. 

00:50 --> 00:54 
Speaker 2 

Thanks Ashli. I’m looking forward to sitting in your seat this time and having this discussion.   

00:54 --> 01:17 
Speaker 1 

Yeah, I think I could get used to this change.  

So, our last two episodes really focused on how the US FDA regulates food contact materials and articles at the federal level. But I think the point we want to drive home today is that you can’t overlook local regulations, right? 

01:17 --> 01:35 
Speaker 2 

Yeah, that’s right Ashli. The FDA doesn’t prevent local governments from instituting their own regulations or restrictions. So, manufacturers really need to be aware of what local governments are putting into place. And there has been a lot of activity in this area recently as we’ll talk about today.  

01:35 --> 01:51 
Speaker 1 

Well, we’re ready to get going. Let’s start with this…are there any regulations that states are putting into place that are similar in nature or part of a sort of coordinated effort among multiple states? 

01:51 --> 02:58 
Speaker 2 

Actually, yes. For decades, dozens of states have put restrictions on the amount of lead, mercury, cadmium, and hexavalent chromium allowed in packaging material. Many of our listeners may recall at some point testing for these metals to meet “CONEG requirements.” In the 70s, governors of the northeastern states Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island and Vermont created the Coalition of Northeastern Governors (or CONEG). This organization developed the model legislation to reduce the levels of these four heavy metals, which many states adopted in some form. 

In the 90s CONEG established The Toxics in Packaging Clearinghouse (or TPCH) to carry on this task with an aim to reduce the presence of harmful substances in packaging and packaging components. So, it is more common now to seek compliance with TPCH requirements. And with updated model legislation put into place as recently as 2021, states are paying attention to the TPCH and how they can adopt new measures.  

02:58 --> 03:11 
Speaker 1 

So, you refer to TPCH having “model legislation.” Is this sort of like a template for states to use when they craft their own regulations? 

03:11 --> 03:13 
Speaker 2 

Exactly.  

03:13 --> 03:23 
Speaker 1 

Great. So, what’s included in the 2021 TPCH update, and are states taking steps to be in line with it? 

03:23 --> 04:22 
Speaker 2 

Well, the 2021 model legislation still has the limitation on incidental presence of the four heavy metals we discussed. The sum cannot exceed 100ppm or 0.01%. And you can’t use them intentionally. 

As for the new stuff…  

There is a prohibition on intentional use of per- and polyfluorinated substances (known as PFAS), and on intentional use of phthalates 

There is now a limitation on incidental presence of phthalates (100ppm or 0.01%), 

And a limitation on incidental presence of PFAS (Not Detectable) 

The legislation now also outlines processes and criteria for identifying and regulating additional chemicals of high concern  

And yes, there are plenty of examples of states taking action to address PFAS and phthalates. But no state has amended its current toxics in packaging law to add the updated model legislation language in its entirety. Some states have adopted certain provisions but not all. 

04:22 --> 04:34 
Speaker 1 

Interesting. Maybe we can talk a little more about the substances that were added to the TPCH: the phthalates and PFAS. 

04:34 --> 05:21 
Speaker 2 

Sure. Well let’s start with phthalates. The TPCH defines phthalates as all members of the class of organic chemicals that are esters of phthalic acid and that contain 2 carbon chains located in the ortho position. 

Phthalates are used as Plasticizers that aid in making plastic soft and less brittle (commonly PVC) and as components of adhesives, lubricants, and sealants. 

This brings up a good opportunity to point out where the US federal government and states start to diverge. The FDA currently allows 9 phthalates in food contact applications, whereas the TPCH model legislation prohibits intentional use and limits incidental presence of any phthalate. The state of Maine has a regulation in effect right now that mimics this requirement.  

05:21 --> 05:27 
Speaker 1 

Thanks Tommy. So, what can you tell us about PFAS? 

05:27 --> 07:40 
Speaker 2 

Well, I’m sure by now most people have heard about PFAS in the news or online and how they don’t break down easily, persisting in the environment. They are group of man-made chemicals that really became popular to use because of their effectiveness in resisting grease, oil, water, and heat. There are thousands of PFAS with varying chemical structures and chemical and physical properties.  

As with phthalates, the federal government and local governments differ with regard to PFAS. Many state regulations define them as fluorinated organic chemicals containing at least one fully fluorinated carbon atom. The EPA’s working definition is that they are chemicals with at least two adjacent carbon atoms, where one carbon atom is fully fluorinated and the other is at least partially fluorinated. 

Some PFAS are authorized by the FDA for limited use in cookware, food packaging, and food processing equipment. However, there have been recent actions taken after safety concerns had been raised. Long Chain or C8 compounds authorized by FCNs, or Food Contact Notifications, were phased out. Additionally, the FDA amended 21 CFR 176.170   to remove certain long chain PFAS. Then, in 2020, the FDA phased out some short-chain PFAS that were authorized via multiple FCNs with cooperation from manufacturers.  

At the state level, we’ve seen a big push to regulate PFAS. Most are focused on prohibiting the intentional use of PFAS, but it may depend on the application and product. Some states may regulate PFAS in fiber-based food contact materials, others in pizza boxes, some in cookware. It really depends on the state.  

Some of the states that our listeners should take a look at are: 

• Vermont 

• Connecticut 

• Washington State 

• Maine 

• New York 

• Colorado 

• California 

• Rhode Island 

• Hawaii 

• Maryland 

• Minnesota 

But this isn’t a comprehensive list by any means.  

I also don’t want to forget about bisphenol A, commonly known as BPA. The FDA does not allow BPA to be used in infant sippy cups, but some states go beyond this. For instance, Vermont, Connecticut and Washington prohibit BPA in reusable sports bottles.  

07:40 --> 07:50 
Speaker 1 

So, it sounds like a lot of the states have the same kind of idea, but they could be unique in the way they write their legislation.  

07:50 --> 07:58 
Speaker 2 

Yes, I would recommend researching each state’s specific requirements, as a blanket approach could end up causing you to miss something.  

07:58 --> 08:09 
Speaker 1 

Seems like a good idea! Well, let’s give that a shot now. How about California? That would seem like a good place to start.  

08:09 --> 09:27 
Speaker 2 

Yes sure. Well California follows the TPCH limitations for metals we discussed earlier. But in addition, they have what’s known as AB 1200. Article 1 of this regulation says that plant-based food packaging cannot have any intentionally added PFAS, and the regulation limits non-intentional PFAS to 100ppm as measured in Total Organic Fluorine (or TOF).  

Article 2 says that Cookware that contains one or more intentionally added chemicals present on the “designated list” in the handle of the product or in any product surface must meet disclosure requirements. This “Designated List” is a list of chemicals, which is published on the Department of Toxic Substances Control’s internet website, that exhibit a hazard trait or an environmental or toxicological endpoint that meets the criteria specified in regulations adopted by the Department of Toxic Substances Control in California. 

Of course, California also has Proposition 65 (or Prop 65) which has labeling requirements for a huge list of chemicals based on their exposure to consumers. Many people don’t realize that the key to this regulation is exposure levels. The presence of a chemical on prop 65 isn’t necessarily the end of the world.  

09:27 --> 09:35 
Speaker 1 

That’s a lot of good stuff, Tommy. California sounds like they have a lot, but what about another state?  

09:35 --> 10:08 
Speaker 2 

Well, I won’t get into too many details, but I would say that Maine and Washington are two states that really have been marching forward with these types of restrictions. One Interesting thing to share is that Maine’s definition of food packaging includes plastic disposable gloves used in commercial or institutional food service. Maine also now has the authority to identify “chemicals of high concern.” These can be elevated to priority food contact chemicals which will trigger reporting requirements for their presence and intentional use. 

10:08 --> 10:20 
Speaker 1 

Interesting. With so many newer regulations in place, I’m sure that our listeners might need some assistance with navigating everything. What can Intertek to do help? 

10:20 --> 10:51 
Speaker 2 

That’s a great question! 

Well, we have a great team of toxicologists that have unbelievable expertise in performing Proposition 65 Assessments. They can assess exposure levels and even develop safe harbor levels as part of the assessment.  

We also have a great network of Intertek labs that can conduct testing to support compliance with those regulatory limitations we discussed. Phthalates, PFAS, Total Fluorine, BPA, TPCH metals. We can offer all of this to our customers with great turnaround times.  

10:51 --> 10:58 
Speaker 1 

Well that’s great news. It sounds like our listeners would be able get any help they need from your team.  

10:58 --> 11:13 
Speaker 2 

Yeah they sure can. And if they want to learn more, they can visit www.intertek.com/assuris/food-contact/ or contact us at 561-989-7294.  

11:13 --> 11:46 
Speaker 1 

I’m sure they’ll take you up on that offer, Tommy! 

Well, I hope all of you enjoyed this episode and the whole 3-part Assurance in Action podcast series on food contact regulations in the US. Don’t worry If you missed one of the episodes—if you did, you can easily download it from our website. Tommy thanks for providing us with your insight today. You definitely raised the bar even higher from what I did! 

11:46 --> 11:55 
Speaker 2 

Haha. Thanks Ashli, that means a lot. It was a pleasure and I hope we helped some folks with this series. And I hope we get a chance to do another one in the future.  

11:55 --> 12:01 
Speaker 1 

Yeah, me too. Thanks again everyone for listening. Have a wonderful day.