Christian Dammann, PhD, Chief Operating Officer (COO) of Bluu Seafood and VP at Cellular Agriculture Europe, is an internationally renowned expert in cellular agriculture and cultivated fish development as well as a former co-founder of BlueNalu. Bluu Seafood is one of the first cultivated seafood innovators in the European sphere and appointed Christian as its inaugural COO in 2021.
Christian focuses on process development, scaling-up, and – most crucially – regulatory affairs at Bluu Seafood so we talked with him about the present and future of both the company and the sector.
Plant-based alternatives for meat and some seafood can now be found in many supermarkets around the world. However, only one cultivated product, chicken, is available and only in Singapore. Cultivated seafood is not yet available to consumers at large. Why is that?
Cultivated seafood products are made from fish cells that are cultivated in specialized facilities. This cultivation process often called “Cellular Agriculture”, is very similar to growing yeast for beer, or making yogurt. However, Cellular Agriculture is considered a novel process for food production. Therefore, it requires a longer regulatory process than products that only contain common plant ingredients.
It is also important to keep in mind that the cultivated seafood and meat industry is very young indeed. Our company Bluu Seafood was founded only two years ago, while the oldest company in the industry is seven years old.
When will we see the first cultivated seafood products on the market?
We will likely see the first cultivated seafood products on the market in either the US or Singapore, the latter having by far the shortest official approval timeline at about 12 months. The official approval process in the US takes about 18 months. It is generally expected that the first approval for a cultivated seafood product will be given within the next nine months. Shortly after that, the approved product will probably enter a test market with limited amounts at first. By 2025 cultivated seafood can be expected to appear in supermarkets.
In the European Union, it will take at least two years for approval of a novel food item. As more than 20 countries are involved, with different political and economic priorities, the process is more complex and can take more time. In this market, it may be 2026 until we see products broadly available in stores.
Will it be difficult to obtain regulatory approval for Bluu Seafood’s products?
No, I do not expect any major difficulties. There are several reasons for this: First, Bluu’s cultivation process does not involve genetic modifications or other cell transformations. We isolate the fish cells, provide them with nutrients that they would also receive in a living fish and let them grow. That is all. Other ingredients we may use in addition to fish cells in our products are known materials from plants or algae that are common in other foods. Bluu products do not contain artificial colorants or flavors. So, we keep it simple and clean.
Second, the regulatory authorities in Singapore and the US have taken a collaborative approach in dealing with applications for cultivated products. Both SFA and FDA encourage an open discussion and are very open about the requirements for a complete dossier. The processes are indeed very stringent and demand extensive experiments, analytics, and documentation. However, as an applicant we know exactly what is expected and, therefore, can provide all required data.
Third, Bluu has a staff well experienced in regulatory affairs. We already work with officials, consultants, and law firms in their respective geographies. Therefore, Bluu will be able to submit high-quality dossiers that meet all requirements from the start.
If you could make a wish, what would you ask of regulators?
The whole industry and consumers, too, would benefit from faster and better-defined approval processes. How smoothly the approval process goes largely depends on clear guidelines, well-defined standards and detailed information shared even before handing in a dossier. I would wish for a high level of collaboration between the respective authorities and the applicants.
For the EU, I would love to see a complete list of specific studies that need to be conducted to prove product safety. With this, it is important to include the types of essays, the extent of studies, types of data, the parameters that need to be measured, and the level of detail. Providing proof of product safety for Bluu’s products, in general, is not a problem, but we need help with determining what data authorities exactly require. Of course, I would also welcome individual support from the EU Member States such as Germany.
How do geographies differ and how does this influence Bluu’s go-to-market strategy?
Regulatory approval is essential in any market and Bluu wants to get the product into the hands of consumers as fast as possible. For this reason, Singapore and the US are currently our main targets for a first product launch since they have the fastest timelines and the best-defined application processes. Approval in these countries would also provide important precedents which could be advantageous for later applications in the EU.
Asia is of course of great interest for Bluu due to its size with China being the largest seafood market in the world. In China, as in Japan the approval process is not yet fully defined. But both countries are working on new legislation that will regulate novel food. Bluu has established collaborations with Chinese partners to be prepared for regulatory applications as soon as the new guidelines are in force.
Nevertheless, Bluu is a European company, and we prepare to become the market leader for cultivated seafood here on the continent. Therefore, we are actively participating at all levels in the current discussions about novel food regulatory guidelines for the EU and the UK. The UK is an interesting case that we are following very closely. As of now, the EU regulations are still being applied but the government has announced significant changes to the novel food approval process.
What can Bluu do to ensure fair and efficient regulatory processes?
The most important work is to educate and inform regulatory authorities, politicians, consumers, and the public about cultivated products. Bluu has co-founded “Cellular Agriculture Europe”, the industry association of cellular agriculture companies in Europe and Israel. Cellular Agriculture Europe is a coalition of companies committed to playing a part in building a sustainable future. The association is a registered EFSA Stakeholder and appointed to DG SANTE’s new Advisory Group on sustainable food systems. Members of Cellular Agriculture Europe participate as speakers in conferences, meetings, and discussion groups about regulatory affairs and food safety. In addition, the association provides input and opinions on requests from EFSA and other international organizations.
In parallel, Bluu works on establishing good relations with German authorities and politicians. We speak openly about the processes of cultivated fish, the opportunities for the environment and the economy, and explain the industry’s need for clear regulatory guidelines. Bluu recognizes that the support of national Governments is very important in the effort to formulate regulatory guidelines for the EU.