Early commitment to internationally recognized third-party certification ensures premium quality product beyond domestic regulatory requirements, raising standard across cell-cultured foods globally

BlueNalu, a leading innovative food company developing a variety of seafood products directly from fish cells, announced today its framework designed to achieve a premier standard of food safety, quality, and traceability for its cell-cultured seafood production. The company has committed to pursuing third-party certification recognized by the international Global Food Safety Initiative (GFSI), such as the Safe Quality Food (SQF) or similar programs, as a means to demonstrate the highest possible standards for its safe and trusted cell-cultured seafood products.

GFSI certification programs are voluntary and recognized internationally by leading retailers and foodservice operators for setting standards that go beyond domestic government regulations. The programs follow a globally consistent standard for the demonstration of safety and quality and are validated by independent third-party audits.

“BlueNalu aims to be a globally leading cell-cultured seafood producer, recognized for the highest caliber of safety, quality, and traceability,” said Lou Cooperhouse, president & CEO of BlueNalu. “Food quality and safety are core values at BlueNalu and it is especially important that we not only meet regulatory requirements, but also establish the highest standards to achieve trusted third-party certification. We are pleased to announce BlueNalu’s commitment to GFSI certification standards for our cell-cultured seafood.”

Leading these initiatives at BlueNalu is Noreen Hobayan, MSc, PCQI, its director of quality assurance and regulatory affairs, who has over 25 years of diversified experience in worldwide quality systems, standards, and regulations for the food, pharmaceutical, and medical device industries. Noreen has established a robust quality systems framework for BlueNalu and over 100 procedures and policies designed to ensure product safety and supply chain transparency to prepare the company for both FDA regulatory inspection and third-party certification.

“It’s imperative that we create a culture of food safety and put comprehensive systems in place to enable traceability of our supply chain. We’re committed to laying the groundwork early for a scalable, top-tier food safety and quality management system that we intend to replicate globally in markets that we enter,” said Hobayan. “By pursuing the highest caliber of safety, quality and traceability in our food production processes, we hope our commitment and leadership raises the industry standard for other companies in our category.”

To aid in preparation for market entry and regulatory compliance, BlueNalu evaluated a number of top quality management solutions and selected TraceGains, a global leader in compliance, quality, and innovation software for food, beverage, and supplement companies. Their highly configurable system will streamline and strengthen BlueNalu’s regulatory compliance, allowing for quality control and safety data collection and review in a comprehensive electronic database while providing real-time insight into plant floor and quality operations. The adoption of TraceGains also represents BlueNalu’s shift from pharmaceutical-grade to food-grade sourcing of food-safe components – an important step towards cost reduction that the company anticipates will help it achieve price parity for its cell-cultured seafood products.

Elements of BlueNalu’s current quality systems framework include the following:

• Food Safety Culture: BlueNalu has expanded its Quality Assurance department and is fostering a strong food safety culture through structured trainings and assessments with measurable objectives and progressive goals.

• Quality Assurance Systems: BlueNalu has developed a robust quality assurance system based on GFSI benchmarking requirements. The programs include strong supplier quality management, validation master planning, prerequisite programs, and a comprehensive food safety plan combined with a seafood Hazard Analysis and Critical Control Point (HACCP) plan.

• Advanced Quality Control: The company is developing state of the art methods to verify the quality and safety of cell-cultured seafood. Testing will include traditional test methods as well as novel techniques to continuously evaluate the materials, processes and final product to ensure conformance to specifications, bioprocess control, and food safety.

• Tools and Analytics: Our documentation and traceability policies are designed to ensure materials, equipment and processes meet the highest possible standard. To facilitate compliance with regulatory and third-party certification requirements, BlueNalu will implement sophisticated software systems, including TraceGains, to monitor supplier performance, track and trend process data, manage documentation and training, and drive continuous improvement.

• Certifications and Claims: The company plans to pursue premier third-party certifications, like SQF, that are voluntary and recognized internationally by GFSI. The company also expects to seek additional third-party certifications to verify claims related to safety, sustainability and health.

The company plans to launch its cell-cultured mahi mahi, bluefin tuna and other species through small-scale market testing that will be produced at its nearly 40,000 sq. ft. pilot-scale food production facility in San Diego, and plans to break ground on its first large-scale, regional production facility in the next few years. Both the pilot-scale and large-scale production facilities will meet Good Manufacturing Practices (GMP) guidelines and comply with domestic regulatory requirements for food production, enabling process optimization and product commercialization.

To learn more about BlueNalu, please visit www.BlueNalu.com.

About BlueNalu

BlueNalu's mission is to develop great-tasting, healthy, safe and trusted cell-cultured seafood products that support the sustainability and diversity of our ocean. With their culinary-centric approach and leading cell-culture technologists, BlueNalu is developing a wide array of great tasting seafood products from a variety of species to meet consumer demand. Their cell-cultured technology will result in seafood that is 100% yield with the same health benefits and performance as conventional seafood but without genetic modification and without environmental contaminants, while providing a consistent, predictable, and traceable supply-chain year-round. BlueNalu is aligned with the United Nations’ Sustainable Development Goals, a blueprint to achieve a better and more sustainable future for our planet. The company began its operations in 2018 and is based in San Diego, California.

Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, statements related to the development and commercialization of BlueNalu’s products, the launching of BlueNalu’s products publicly, the type and characteristics of products that BlueNalu will produce, BlueNalu’s ability to receive regulatory approvals and build partnerships and BlueNalu’s ability to achieve a premier standard of food safety, quality, and traceability for its cell-cultured seafood production. These forward-looking statements are based on BlueNalu’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, risks that BlueNalu’s actual future financial and operating results may differ from its expectations or goals, BlueNalu’s ability to commercialize and successfully launch its products, risks relating to BlueNalu’s ability to successfully implement its business strategies, competition, including potential generic competition, the ability to protect intellectual property and defend patents, regulatory obligations and oversight, including any changes in the legal and regulatory environment in which BlueNalu operates among others. BlueNalu undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.

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BlueNalu announced today its framework to achieve a premier standard of food safety, quality and traceability for its cell-cultured seafood production, including its commitment to pursue internationally recognized, third-party GFSI certification.