Don’t let regulatory surprises derail your product launch

By Dr. René Floris, NIZO’s Chief Innovation Officer and Dr. Marjon Wells-Bennik, NIZO’s Principal Scientist for Food Safety.

Launching an innovative food product or ingredient to market takes a major investment. But that investment is at risk if you don’t have the right supporting data available. So, how do you know what information you need? The answer lies in fully understanding your product, its characteristics and potential applications.

The rules and regulations around launching food products and ingredients vary from market to market. But one general rule holds true: at some point, you will need to prove your product meets various requirements, typically related to food safety, quality and nutrition. To do that, you need to compile a dossier of information based on the results of a series of tests. The dossier will then need to be assessed and approved – which itself takes time, effort and money.

Know your route from the start

What information and tests go into that dossier depends heavily on what your product is and how it will be used. Anything considered a novel food will need a very different series of tests, typically with a bigger emphasis on safety, to a product based on familiar ingredients. Similarly, a bulk protein requires more data to substantiate its nutritional value, safety, bioavailability and digestibility than an enzyme used purely as an additive.

Target audience also plays a role. For example, infant formulas or medical food products face more stringent safety and nutrition requirements than products for general consumption.

“The secret to a smooth, timely launch lies in understanding ahead of time which regulatory requirements apply to your product,” says Marjon Wells-Bennick, Principal Scientist for Food Safety at NIZO.  “Realizing later in the process that you need to consider different requirements can lead to long, costly delays as you refocus or restart your dossier building program.”

Novel or not?

The first question to ask yourself is whether your product or ingredient is a novel food or not.

“This isn’t always as straightforward as it may seem,” Marjon explains. “If you are using an innovative production technique like precision fermentation, that’s clearly a novel food. But, in some cases, a minor change to a familiar food – even just sterilising it in a new way such as using UV light – could also lead to it being considered novel.”

Understand the true potential of your product

The next step is to understand your products full potential in the marketplace. Again, this can be a more complicated question than it first appears. It is not unusual for a new ingredient to be developed with one (type of) application in mind only to find, later in development, that it could also be used in other, perhaps higher-value, applications. This is great news for your bottom line but could mean you have to consider a completely different testing program. At the very least, you may need additional shelf-life studies to prove stability in these new applications.

The best way to avoid such late surprises is to map out the technical, functional, sensory and commercial characteristics of your product or ingredient. This will help you identify all its potential opportunities and, hence, the right program for building its dossier of information.

For example, you may be planning to produce an enzyme by precision fermentation, perhaps with target applications as an additive. However, it may also have potential as a bulk protein. Depending on its gelling, hydration and foaming properties as well as its impact on flavour and mouthfeel, it could have applications in meat, cheese or yoghurt analogues, plant-based beverages or frozen desserts. Meanwhile, understanding its production costs could help you decide whether to target mass-market or premium applications. All of which could have a big impact on the testing choices you make.

“Fully mapping out the characteristics of a new product requires a wide range of expertise and equipment, and most food manufacturers won’t have that all in house. NIZO does, and can apply it in comprehensive benchmarking analyses, while our understanding of food production can help determine how downstream processing will influence an ingredient’s final characteristics in application,” adds Marjon.

Putting it to the test

Once you know how, where, and by whom your product will be used, you can start to plan out the type of information that needs to be in your dossier, perhaps with the help of a third-party consultant. Common areas of information that need to be considered include:

• Composition
• Production processes
• Toxicological data
• Bioavailability and digestibility
• Allergenic potential
• GMO status
• Stability and shelf life

Many of these tests and assays are standardized and available from multiple lab services providers. Others are more specialized and must be tailored to the product, its production process and its planned use,”

For example, products and ingredients produced via precision fermentation must be proven to be free of recombinant DNA, which requires quantitative polymerase chain reaction (qPCR). Similarly, assessing the digestibility and bioavailability of new protein ingredients is be done through in-vitro digestion models and the calculated Digestible Indispensable Amino Acid Score (DIAAS). Such assessments require specific equipment and know-how to ensure regulatory-compliant and meaningful results.

“For regulatory-compliant and meaningful results, such assessments require specific equipment and analytics expertise as well as comprehensive understanding of food processing and the end application,” Marjon advises. “This is another area where NIZO’s unique blend of experts can really add value for manufacturers.”

Proving production

Another important part of the dossier is to show that your new product or ingredient can be manufactured consistently. This involves producing multiple batches in a food-grade facility and assessing them for quality, safety and composition throughout shelf life.

“Manufacturers usually don’t want to interrupt production of existing products to trial production of potential new ones, so finding production capacity for test batches can be a challenge,” says Marjon. “NIZO’s pilot plant offers an excellent solution. Not only does it have extensive facilities that can be tailored to most food production processes, but you have food production and analysis experts on-site if any unexpected issues arise.”

Ready to launch

The launch of a new food product or ingredient can be a huge opportunity. But it takes foresight and planning to deliver on that opportunity. By fully understanding your product, its technical, functional and nutritional characteristics, and its potential applications, you can plot a smooth route through testing and data gathering to protect your investment and launch on schedule.

This article has also been published on Food Navigator – read more here.