A Half-Baked Explanation on Regulatory Compliance for Compounded Resins

The other day, I was in our “Town Center” – a room which serves as a kitchen and lunchroom here at M. Holland. I was about to start eating my lunch when a co-worker friend of mine walked in.

“Chocolate cake for lunch, Chris? That’s so unhealthy.”

I looked up and frowned at him. “Don’t judge me, Bill. It’s already been a busy day for me, and I deserve a treat.”

“Oh – speaking of busy, I’m still waiting for you to send me the regulatory documents on that compounded resin that I asked for this morning.”

“I can’t do anything with that until I get documentation from the additive provider.”

A confused look came over Bill’s face. “Why do you need that? The resin should be fine, shouldn’t it?” This was going to require some education – as well as a practical demonstration.

“Bill, I’ll tell you what… I will give you this slice of cake, on one condition. You need to remove the egg that is in it.”

He stood there for a moment, trying to figure out if I was tricking him. “Remove the egg from the cake? You can’t do that!”

“Aha! Exactly!”

“I don’t understand.”

“You see, Bill, chocolate cake contains many different ingredients – flour, water, sugar, butter, salt, egg, chocolate, and so on. But when you mix those ingredients together, and you throw them into an oven for a set amount of time, there are chemical changes going on inside the pan. So, when you take the cake out of the oven, you know that all of those ingredients are in there, like the egg, but it’s an entirely different product.

“The same can be said for when you add anything to a thermoplastic resin. While you might not be changing the organoleptic properties of the base resin, you could be introducing something which might not be compliant with a specific regulation. So, if you have a resin which you know is FDA compliant, and you add a colorant to it, you need to make sure that colorant is also FDA compliant. If it’s not, then the final product will not be compliant either.”

Bill thought for a minute, then smiled. “Hey, that makes a lot of sense! Thanks, man!”

I reached out to shake his hand – and, in the process, my arm accidentally hit the plate, sending it and the cake tumbling to the floor, landing with a sickening plop.

We looked down at the mess; finally, I spoke. “Well, Bill, you know what they call that in the world of plastics, right?”

“No, what?”

I smiled. “Wide-spec.”

Christopher Thelen is M. Holland’s Regulatory Specialist, responsible for obtaining, supplying and maintaining a database of documents covering numerous regulatory issues (e.g., CONEG, FDA, UL, NSF) for clients, as well as technical data sheets and MSDS. He has been with M. Holland for over 20 years.