FPP Amsterdam 2024 Speaker Spotlight: Ida Søndergaard, Regulatory Affairs Manager, Solar Foods

A highly experienced regulatory affairs specialist, Ida Søndergaard – one of +100 speakers at The Future of Protein Production Amsterdam on 23/24 October 2024 – discusses the complex path to approval for novel proteins and shares the lessons learned from Solar Foods’ regulatory achievements

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At The Future of Protein Production Amsterdam on 23/24 October 2024, Regulatory Affairs Manager, Ida Søndergaard, at Finnish novel protein firm, Solar Foods, will be giving a presentation on the company’s pioneering journey through the regulatory landscape in various different markets so far.

Our regulations conference sessions are always among the most popular and well-attended segments of our events: it’s no surprise that people who aren’t as far ahead in the process as Solar Foods want to discover how they can learn from the wisdom of those further along the path. Sharing a hint of her presentation subject matter, Søndergaard says, “I’ll cover the challenges Solar Foods encountered and the key lessons we learned while navigating the regulatory landscapes of Singapore, the EU, and the UK. I’ll also share the strategies and adaptive measures we used to stay on top of the ever-evolving regulations in these regions. If time permits, I may also touch on our regulatory experiences in the USA.”

That last experience has been one of Solar Foods most significant stories thus far. In early September 2024, the firm announced it had obtained self-affirmed GRAS status for its Solein product in the USA. And Søndergaard notes that this is just the start of a fast-moving process.

“The next steps for Solein’s commercialization in the USA involve registering our production facility, Factory 01, with the FDA,” she reveals. “This requires meeting specific food safety plan requirements and fulfilling any other applicable regulations. Once registered, we will be able to start exporting food from Factory 01 to the USA, with sales expected to begin by the end of this year. After that, we will aim to achieve the notified GRAS status with the aim of receiving a ‘No Questions Letter’ by the end of 2026.”

A lot of valuable knowledge isn’t explicitly stated in the regulations – it’s something you learn through experience; and their experience will make a significant difference

This impressive progress in the USA comes hot on the heels of successes elsewhere, including securing regulatory approval in Singapore back in 2022. But Søndergaard reports that she’s also currently working on markets a little closer to home. “We’re focusing on securing approval for Solein in the EU and UK markets,” she confirms. “We’ll be working through their regulatory processes and addressing any questions from EFSA and FSA. These projects are crucial for Solein’s global expansion, and we’ll keep pushing forward with both projects.”

Expert advice

Søndergaard often gets asked what advice she has for others who are only just beginning their regulatory journey. Her answer to this can be summarized simply: bring in the experts! “Having both internal and external experts on board is crucial,” she states. “A lot of valuable knowledge isn’t explicitly stated in the regulations – it’s something you learn through experience; and their experience will make a significant difference. Another piece of advice is to be prepared for the unexpected. No matter how strong your team is, there will always be surprises in the regulatory process that you can’t predict. So, to avoid disappointment, it’s important to leave some buffer in your timelines for those unknowns.”

But experts don’t come cheap. What about startups that simply don’t have the budget to bring on more staff? “Hiring experts can indeed be costly,” Søndergaard acknowledges. “If bringing an internal expert on board isn’t an option, my advice would be to ensure you have a strong project manager internally and partner with a well-established consultancy firm. Although that can also be pricey, it will ultimately save you time and money by providing up-to-date insights into the regulatory landscape and helping you avoid costly mistakes.”

Global outlook

In terms of tackling regulatory issues at a geographical level, one piece of advice often given is that startups should aim for approvals in the toughest markets first, on the basis that if you can secure approvals for notoriously difficult markets, all others that follow will be easier. But, says Søndergaard, it’s not quite that straightforward.

“It can be challenging to generalize, as the difficulty often depends on the specifics of each market and your strategy,” she continues. “For instance, launching an innovative product in a market without established regulations for new foods can be challenging due to the lack of clear guidelines. Conversely, markets with well-defined but complex regulatory processes can also be demanding because of their detailed requirements.” She also points out that, “Additionally, the suitability of your product in different markets and your overall strategy will play a significant role in determining which approach might be more effective.”

Ida will be giving her presentation, Global Regulatory Insights: Solar Foods' experience in various markets, on 24 October 2024 at The Future of Protein Production Amsterdam. Book your place today to hear another 100 speakers, network with +400 industry leaders, and visit the exhibition stands of more than 40 participating companies