For this Vitafoods Insights podcast episode, Maja Oresnik, Science & Research Director at PharmaLinea, joined us to discuss regulatory updates formulators should know about. 

Tune in to hear more about: 

• Regulatory updates from European Food Safety Authority (EFSA) from a formulator's perspective 
• How these regulatory changes affect the nutraceutical industry players and the key barriers the industry should be aware of
• the lack of clarity in this system makes formulating difficult
• What supplements formulators can do to stay on top of these changes 

Guest: Maja Oresnik, who's Science & Research Director at PharmaLinea

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Podcast transcript:

Welcome to the Vitafoods Insights Podcast. Join us as we explore the latest science and innovation, helping the global health and nutrition industry, connect, develop and progress. Today's host is Natalia Franca Rocha.

Hello and welcome to the Vitafoods insights Podcast. I'm Natalia Franca Rocha Harsha, Senior Content Producer at Vitafoods. Today we will be talking about regulatory updates formulators should know about and I'm delighted to be joined by Maja Oresnik, who's Science & Research Director at PharmaLinea. Thanks for joining me today, Maja.

Hi Natalia, thank you for inviting.

EFSA, the European Food Safety Authority, has a body of policies and laws to ensure safety around nutrition offerings, including food supplements regulated as food. But the requirements are becoming stricter, and bilberry, red yeast rice, ALA, and berberine have all recently changed – so as a formulator, can you share with our listeners what these latest changes are?

Yeah, sure. It depends a little bit case by case. But we all know in general that EFSA is doing their best to ensure safety of the consumers. And this can be now seen also in practice. We have feeling that more article eight procedures are in place that are related to the main supplement Regulatory Act. And this article is assessing the potential harmful effects of ingredients that are used in the supplements or in food for that fact. Probably the most known case would be the example the limitation that has been set for the usage of monacolin recently in the food supplements. And since inclusion of monacolin k from red yeast rice, granted business operators a rare chance of the usage of health claims, and they need confirming the contribution of the maintenance of normal blood cholesterol levels. This has been really a popular ingredient in the last couple of years in the cardiovascular shield. And we can in this case, expect notable disruption in the market as a consequence of this regulatory change. I think that now it's really important to offer clients and effective as well as safe alternative. And actually the formulators would have to be careful here. And some of the ingredients that have been gaining popularity in the meantime, are actually facing the same procedure as it was for the reduced price. And good case here is Berberine ingredient that also can be in a long term a big question number.

Thanks for sharing more about these case examples. It's definitely of interest to the industry to offer consumers with effective and safety as well. So, how do these regulatory changes affect the nutraceutical industry players? For example, are there any key barriers or questions that could be helpful to the industry to be aware of?

I would just say that the industry needs to remain vigilant and be aware of the potential changes before they actually come into the practice. Decisions are, on the European level at least are usually not done overnight. So it's helpful to follow the draft opinions, consultation processes, and so on, likewise, it will also be beneficial if you have partners that watch out for you and have a reliable supply chains. When regulatory updates affect many players at once, then established relationship can be crucial for prompt response to the coming change. And good example here would be probably everybody knows the ban of the Tanium oxide in recent years where the whole industry had to react at once and then delaying the supply critical. So just be ready and be vigilant for the reaction.

Nice. And can you speak more about the lack of clarity in this system that makes formulating difficult as well?

If you're talking on the European level, we have the unified legislation in the area of the whole union. While in theory these ideas of course good, but when asked it as in the practice, there are still many cases where decision if a certain ingredient can be placed on the market differs from one member state to another. This is true especially when we talk about the ingredients that are coming from herbal materials. And we can see various interpretations, different understanding about the suitable usage of the raw materials, what it means if it goes through any processing and so on. Another example in this field would be the normal food catalogue that we also know and usually work with is often used as the reference catalogue is more or less an online platform where entries can change daily as it's operated through, let's say member states procedures and so on. There are no tracking options. So which means that the again, it can put formulators in awkward position. And it's really important that you have a system in place, how you follow the changes and so on. Another important point here would be that the notion that market doesn't always really reflect the legal situation. So if something on the market, and we can quickly make a wrong conclusion that the EVC similar cases already present on the market that is also in line with the legal requirements, and that you can also put similar products on the market, because when we checked the legal procedures, we could have also problems here.

This catalogue, online platform that you mentioned, that goes through daily changes. And the inability of tracking those definitely sounds like a great challenge for the industry. You also mentioned other things as well as the importance of being vigilant and the legal aspects, and also the ability to fast react to everything. So, what else can supplements formulators do to stay on top of these changes?

I would say maybe a bit cliche, but good knowledge here really goes a long way. Formulating hugely is not an easy task is there are many things that you need to take into account. On one hand, you're for sure need to know how the ingredients work, what would make sense, what would work together, where the synergies and so on, you need to understand the quality issues. And you also then need to focus on the regulatory framework on the market for sure where you're operating in in the markets are different. And there's even more to address if you're using the same formulations on the all markets. So understanding that this is a live process and that flexibility is required for sure can be helpful. On the other hand, it usually requires a great team and also team effort and partnership outside of the organisation. Because for sure it's easier to work and tackle regulatory questions, if also other partners in the supply chain understand the importance of properly addressing them.

Thank you so much, Maya, for sharing all of your great insights with us today. We've covered a lot of good information for our listeners, especially for formulators out there. So, thank you for covering those and also for going to the examples that you shared. And before we end the show, do you have any final thoughts that you'd like to share with our listeners?

First, thank you for the podcasts from my side. I would just say that we as a company for sure think that more harmonisation among the member states will come into the future, because this will then in the end, simplify the procedures and if everybody has a common understanding for sure this would be beneficial. But on the other hand, we also understand that this will be a rocky road and a lot of changes will have to be done throughout the procedure. But a lot will be going on also in the future for sure and go through be able to follow it vigilantly as said.

That's great way of ending the show. We'll certainly keep up with all these changes and look forward to seeing the harmonizations and collaborations in the industry taking place. Thank you so much again for joining us today, Maya.

Thank you.

Thank you also to our listeners for tuning in. And if you're interested in learning more about PharmaLinea or EFSA, make sure to check the hyperlinks available in the show notes. Thank you again and see you next time.

Thank you for tuning in. And don't forget to check the show notes that will allow you to link to the information discussed in today's podcast, as well as any sponsorship opportunities. Be sure to stay tuned, subscribe and even suggest to a friend