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7 Believe It or Not Facts About Manual EU PCN Submissions
Safety

7 Believe It or Not Facts About Manual EU PCN Submissions

By Jeff Tengwall November 16, 2020

Pretty much anywhere you go these days you’ll see a bottle of hand sanitizer on the counter or hanging from the wall. In the age of COVID-19, it’s just so commonplace.

And while we’ve all been paying a lot more attention to cleaning and sanitizing, do we know everything about the chemicals we’re using?

Hand sanitizers, for example, often contain either ethanol or isopropyl alcohol, and consumers would be wise to steer clear of hand sanitizers containing methanol. While ethanol and isopropyl alcohol are safe for consumer use, that doesn’t mean there aren’t concerns.

Trying to keep up with these requirements is no easy task, and, believe it or not, manual entry might not be the best strategy. We’ll explain why.

Here Are 7 Believe It or Not Facts About Manual EU PCN Submissions

1.  Data Requirements: The EU PCN requires 17 different sections of information for each submission. Yes, we said SEVENTEEN! Apologies to Robert Ripley, but there’s more data required for a PCN notification than there would be if you authored a Safety Data Sheet (SDS). Just being able to gather all that information can be difficult. First, you have to identify where the information is, then you have to make sure it’s up to date. You also have to ensure the information is formatted appropriately for the dossier. Believe us; it’s a lot.

2.  That’s Not Acceptable: Perhaps not as surprising as the fact that Ripley’s recently paid $81,000-plus for a tuft of Abraham Lincoln’s hair is the fact that ECHA wants its PCN data in a certain format. So gathering all the data is not enough. Also, since there are many member states that speak different languages, the data must be translated appropriately. It’s not one-size-fits-all, so doing all that extra translation work can get quite . Oh, did we mention that each time the regulation changes and each time you potentially sell that product into a new market, you have to go through and fill out the dossier? We’re just being honest, Abe—and Abigail for that matter.

3.  Time, Time, Time: Earlier this year Aaron Yoder ran a mile in under six minutes. Not bad, but nothing to write home about in the world of competitive running, right? Well, what if we told you that he ran the mile backward and set a Guinness World Record in the process? Well, that’s odd, you might say. So, too, is the position a company would be in if it had to enter in all those records manually. Not being able to get the right information entered expeditiously, keeping in mind that each of those submissions have their own language requirements, could potentially take tens of thousands of hours depending how many products a company produces and how many European countries it distributes it in. A manual process might not be the equivalent of running backward, but it probably equates to running in place.

4.  How Unique: It might surprise you to learn that Salvador Dali, the famed Spanish surrealist, once had a unique pet: an anteater. It might also surprise you to learn that each formula ID must have a Unique Formula Identifier (UFI) number that must be attached to packaging as part of the EU PCN requirements. Basically, the UFI connects the substance in the product to the dossier, and any time there’s any type of update, you guessed it, the UFI has to be updated as well. Being able to do so is an artform for sure, and not an abstract one at that.

5.  Mistakes Matter: Not to rub salt on an old wound, but, believe it or not, there was a third co-founder of Apple named Ronald Wayne. Haven’t heard that name before? Well, you’re not the only one. You see, Wayne sold his 10% share in the company for $800. Since Apple’s market cap is about $2 trillion now, you probably guessed this was in the early days of the company. The point is: People make mistakes, and the more data you enter into any system, the more likely it is that you’ll make a mistake. And mistakes have consequences in the EU PCN as they could lead to regulatory penalties depending on the rules from a particular member state.

6.  Consistency Matters: Consistency matters. Some famous brands have inconsistencies in their logos—the “L’s” in Kellogg’s are not quite the same nor are the “C’s” in Coca-Cola, but you probably never really noticed. They just work! For the EU PCN, consistency definitely does matter. If you’re submitting data that conflicts potentially with your SDS information, that could lead to problems. Consistency between the source content used to author SDSs and build a PCN is critical. Without ensuring alignment of your regulatory content, there’s a potential that a poison center is not going to have the appropriate information to properly assist people who call for help if they are exposed to a certain chemical substance. Definitely not good—or safe.

7.  Seeking Security: We all know how valuable intellectual property is. We also know that hacking and cybersecurity are uber-important areas that companies must address. Of course, not many people are that concerned that someone might hack into their toothbrush, but smart toothbrushes were one of the things listed on a 2017 CNBC report related to odd tech that was ripe for hacking. For the PCN, by using secure software that keeps your data all in one place, you’re not moving data around from system to system nor are you exposing said data to different data enterers unnecessarily. From start to finish, it’s important that the data reside and be transmitted from one place so it doesn’t have to be re-keyed into another system or translated to work in another system. In other words, don’t just brush this off.

Believe it or not—and we’re sure you believe it—products tend to have many substances in them, and having to manually submit every one of them into the European Chemicals Agency (ECHA) submission portal would be a costly and time-consuming process. That’s why an automated system-to-system solution is so important to ensure not only compliance but also competitive advantage.

“Some estimates have shown that a single manual submission can take hours of continuous effort,” explained John Falk, president of Opesus, a solution and consulting company that partners with Sphera. “And if you haven’t attempted a manual submission, we wholeheartedly encourage you to do so and give it a try, so you understand the amount of effort and complexity behind it.”

If you don’t believe it, like Falk said, give it a try!

James Tehrani contributed to this post.

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