One example of a company that is making strides globally is ReMilk, a startup that produces animal-free milk proteins. ReMilk has recently achieved regulatory approval from Singapore Food Agency (SFA) and has been designated as Generally Recognized As Safe (GRAS) by the Food and Drug Administration (FDA), enabling sales of its animal-free protein in both Singapore and the United States.
Nevertheless, navigating the novel food regulatory frameworks remains a daunting challenge for many companies in the alternative protein space. The complexity and variability of these regulations, combined with the lack of clear guidance and harmonization across jurisdictions, can create significant barriers to entry, investment, and innovation.
As the leading alternative protein consultancy, we have extensive experience in guiding companies through regulatory processes. In this article, we provide three expert recommendations that have been proven to be effective in successfully launching novel food products.
We also explore some key considerations that will guide your journey toward approval, preventing any regulatory surprises and ensuring a seamless regulatory process.
Local regulations and processes such as novel food and GMO definitions, food safety studies requirements, cultural and religious requirements, data confidentiality, and the experience of authorities can all impact the regulatory approval process for novel foods, so it's important to choose your target country wisely.
Additionally, it is worth noting that some countries may fully or partially recognize dossiers from other territories, which could impact the decision-making process.
We’ll take a closer look at some of the key factors that may influence your decision when choosing a country for a product launch:
Approval may be unpredictable or practically impossible to obtain if the target country does not have an already developed regulatory framework for novel foods. This is because the relevant authorities may lack the necessary expertise or resources to evaluate the safety and efficacy of these new food products.
When developing a product strategy, it is important to be aware of the regulatory aspects of the specific product types. If a country has specific requirements for your product type, it means that they know how to assess its safety, can specify required studies, and, as a result, the process will likely be faster and more predictable. In the US and Singapore, for example, it’s much easier to gain regulatory approval for lab-grown meat as opposed to in the EU.
There may also be variations in the regulatory requirements for different types of alternative proteins within the same country. For example, in the US, cultivated meat is regulated by the FDA, while plant-based meat substitutes are regulated by the USDA.
Similarly, microbial proteins may be subject to different regulatory requirements; in some cases, these products may be regulated as "food additives" or "dietary supplements".
Countries should be able to offer data confidentiality to protect all information relating to your intellectual property, manufacturing process, and product specifications. Holder-specific authorizations are preferable since they ensure that companies wishing to sell the same products would need to submit their own applications and go through the same approval process.
In some cases, obtaining exclusive market access can be a valuable tool for companies hoping to establish a foothold in a particular market. This can provide time to build brand recognition and market share before facing competition from other companies.
A short regulatory timeline can help a company bring its product to market more quickly and start generating revenue sooner, as well as reduce costs associated with regulatory compliance.
For novel foods, the length of this process can vary depending on the product type and country. Generally, timelines are the longest for EU novel food regulation and shortest in Singapore. Still, it’s important to note that a shorter regulatory timeline does not necessarily mean that the requirements are less rigorous. What’s more, while it may be possible to get approval quickly in some developing countries, a company would need to be aware of local risks.
The EU framework is a complex and lengthy approval process that prioritizes exhaustive consumer protection over efficiency. The lack of clear guidance and pre-submission advice makes it difficult for applicants to determine which studies they should perform. Submitting an incomplete dossier can lead to clock stops being issued, which request further information from the applicant and can prolong the overall regulatory process.
Several of the bioprinted meat and precision fermentation-derived products that have been approved in the US and Singapore are yet to achieve approval in the EU (such as ReMilk’s dairy protein, Every’s egg whites, and Good Meat’s chicken).
On the other hand, the EU provides good market exclusivity and data protection mechanisms, as well as specific data requirements for plant-based, fermentation, and cultivated meat products.
Since novel foods are not specifically defined, there is no novel food regulation in the US. Nevertheless, they can be treated as new ingredients or additives and are therefore authorized through one of two major pathways:
Genetically modified foods follow similar pre-market pathways, with the addition of authorization of GM plants under the Coordinated Framework for the Regulation of Biotechnology through a consultation process (Plant Biotechnology Consultation pathway).
Each of these pathways provides specific, detailed guidance documents, albeit without distinctive data requirements for product types. For cultivated meat products, a framework is currently under development and, although ready to receive applications, is yet to publish specific guidance.
Clear and effective communication between applicants and local authorities can help to identify potential issues or misunderstandings, which can be addressed and resolved before they become significant obstacles to the application process. Wherever possible, therefore, it’s prudent for companies to engage with local authorities early on.
To streamline the process and ensure a successful application, applicants should take advantage of pre-submission advice services. If an applicant has concerns about the content or structure of their dossier or proposed safety studies, they can reach out to authorities for guidance.
As mentioned above, companies should gather relevant dossier structures, checklists, and data requirements if a country provides guidance documents specific to product type. This will ensure that applicants only provide the necessary data, expediting the approval process for both parties.
If possible, it's also recommended that applicants submit a draft dossier for review to identify any potential problems, receive targeted feedback, and optimize their application before submitting the final dossier for evaluation.
Companies developing novel food products need to be aware of the regulatory landscape and ensure that their products are safe and comply with all relevant regulations. Genetically modified (GM) foods are subject to stricter regulatory scrutiny than conventional foods and companies should also carefully consider the regulatory complexities related to launching products in countries requiring religious certifications.
The recent legal battle brought against the FDA for approving Impossible Foods’ use of precision fermentation-derived heme demonstrates the importance of this step. Fortunately, the court ruling stated that the FDA had “substantial evidence” to deem the novel food ingredient safe to eat. If Impossible Foods has been less stringent with the regulatory process and the subsequent court ruling had been less positive, it could have dealt a significant blow to the company.
This is usually the case if the product contains 1% or more rDNA, but this may vary from country to country. If it is considered GM, more studies will need to be carried out and the entire process will take much longer.
For example, it took Impossible Foods 4 years to gain approval for their heme protein, whereas approval for Perfect Day’s recombinantly produced B-lactoglobulin only took 10 months, demonstrating how much a GM product can slow down the approval process.
What’s more, GM products require specific labeling, which can significantly impact consumer acceptance. Exporting to countries with differing GM regulations may also be prohibited.
Obtaining religious certification, such as halal or kosher, not only ensures that a company's products meet religious dietary requirements but can also increase the potential customer base.
For certain countries, such as the United Arab Emirates and Saudi Arabia, obtaining halal certification is mandatory to be able to sell your product in that market. It is also important to engage with religious bodies early on and understand the requirements that need to be met.
Planning ahead and being prepared can help you speed up the approval process and increase your chances of success. However, different countries have different regulations when it comes to approving novel food products, so it's important to consider factors such as the existence of a novel food framework, the speed of the regulatory process, and the availability of specific guidance resources. You may also wish to take data confidentiality and exclusivity opportunities into account.
Engaging with local authorities by taking advantage of pre-submission advice services and draft submission opportunities is recommended. Finally, it’s important to be aware of and strictly comply with regulations related to religious certifications and GM, which can have an impact on your product formulation if you're looking to sell in certain countries.
By taking these considerations into account, you'll be able to navigate the regulatory hurdles more smoothly and increase your chances of gaining approval for your products.
Want to learn more?
For support with launching your new alt protein product and navigating the novel food regulatory space, reach out to us at Bright Green Partners. We’ll help you develop the optimal strategy and ensure no regulatory surprises along the journey.