Business Wire

c-LEcta: European Dossiers Submitted for Approval of New Enzymes in the Food Industry

Share

c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, has submitted dossiers for two newly developed enzymes in the food sector. The evaluation by EFSA (European Food Safety Agency) and the EU Commission is based on the harmonized EU approval procedure for food improvement agents (food enzymes, food additives and food flavors). The enzyme dossiers submitted by c-LEcta for products in the target market of the food industry complement the company’s offering to its customers, who thus no longer have to worry separately about approvals for the use of the enzymes.

The two dossiers were submitted as part of an exclusive collaboration with an industry partner in the food sector for two food enzymes. Both enzymes are used to produce a natural sugar, for example, that can replace lactose, which has recently become unpopular with consumers, in industrially processed foods. With the help of the c-LEcta enzymes and the process developed by the cooperation partner, this sugar can be extracted from readily available sugar beets on a large scale.

“This is a typical case of enzymes making something entirely new and valuable possible. We are proud of this and, in cooperation with our partner, we are safeguarding this development result for the future. Thanks to our expertise in both new product development and regulatory matters, we can also provide our partners and customers with comprehensive support at this point,” explained Paula Pescador, responsible for enzyme dossiers at c-LEcta.

As part of the implementation of the FIAP (Food Improvement Agents Package), a new approval procedure was introduced for enzymes used in the production of food. This is intended to create a harmonized regulatory system for food enzymes throughout the European Union. Following evaluation by the European Food Safety Authority (EFSA), the EU Commission will draw up a positive list of enzymes approved in the EU for use in the food industry in the future. So-called enzyme dossiers have to be submitted for inclusion in this list, demonstrating the safety and technical necessity of the enzymes. The first publication of the new list is planned for 2023. From that date on, food manufacturers will only be allowed to use the enzymes listed. To provide customers with planning security, c-LEcta is therefore ensuring the necessary submission of enzyme dossiers so that the enzymes can already be included in the list when it is first published.

“The EU enzyme approval is of course a new process that everyone in the industry has to get used to. However, for us at c-LEcta, this is not a problem thanks to our in-house expertise and flexibility. On the other hand, the European positive list also offers us a simplification for the approval of new products for the food industry. Of course, we will continue to handle this in such a way that we submit these dossiers for all our products for the food industry. For us, this is a natural part of the service we provide to our customers,” concluded Dr. Marc Struhalla, founder and CEO of c-LEcta.

About c-LEcta

c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the food and pharma industries. The company is based in Leipzig, Germany, and has established itself as a leading player in the realization of high-value biotech products, either in the form of in-house developments or in close cooperation with industry. The company currently employs more than 100 people.

c-LEcta delivers cost-efficient and sustainable production processes which open new markets and allow for better penetration of existing markets. The company is characterized by fast and efficient development of best-in-class biotech solutions and a rapid and successful market introduction and commercialization of the resulting products. This enables c-LEcta to leverage the unique potential of its core technologies. c-LEcta has a proven track record of more than ten successfully commercialized high-value industrial biotech products.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

cometis AG
Matthias Kunz
Phone: +49 (0) 611 - 205855 – 64
Fax: +49 (0) 611 - 205855 – 66
Email: kunz@cometis.de

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma26.11.2025 13:00:00 EET | Press release

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. “Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window,” said Lai Wang, Ph.D., Global Head of R&D at BeOne. “That pace reflects both the strength of the data and the urgency of the need for patients with R/R MCL. With rapid, deep, and durable responses and a manageable safety profile, sonrotoclax is emerging as a potential best-in-class BCL2 inhibitor, alongside our two other transformative hematology assets – BTK inhibitor BRUKINSA, and investigational BTK degrader BGB-16

Modon Holding Announces a Strategic Investment in Wellington Lifestyle Partners, Expanding Its Global Portfolio in Luxury Lifestyle Destination Development26.11.2025 12:15:00 EET | Press release

Abu Dhabi-based Modon Holding P.S.C (“Modon”) today announced a strategic investment in Wellington Lifestyle Partners (“WLP”), joining a consortium of existing investors in the company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251125937208/en/ Aerial shot of Wellington International (Photo: AETOSWire) Modon’s investment will support the long-term development of Wellington International equestrian showgrounds and deliver a landmark ultra-luxury real estate development featuring high-end residences, a boutique hotel, a commercial marketplace and a championship golf course located in Wellington, Florida – a global icon of equestrian sport. This investment marks Modon’s first direct investment in an equestrian led development in the United States, complementing its existing global portfolio, and reinforcing its strategy to partner with leading international organisations in expanding its presence across ultra-luxury destin

Epassi Announces Leadership Transition26.11.2025 12:00:00 EET | Press release

Epassi Group, a European leader in digital employee benefits technology, today announced that Nickyl Raithatha will join as Chief Executive Officer. Nickyl will assume the role in 2026. Pekka Rantala, who has served as CEO since September 2019, will remain on the Board as Non-Executive Chair. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126015983/en/ Pekka Rantala and Nickyl Raithatha Over the past six years, Epassi Group has evolved from a Nordic success story into one of Europe’s leading SaaS employee benefits and wellbeing platforms. The company has expanded both its geographic footprint as well as its product portfolio, driven by a powerful combination of strong organic growth and strategic acquisitions, with backing from TA Associates and Warburg Pincus. Today it has a presence in ten countries and a team of 1,000 people. With net revenue expected to exceed €200 million in 2025, Epassi is redefining employee engage

Enerin raises €15 million Series A to industrialise modular high-temperature heat pumps for global industry26.11.2025 11:00:00 EET | Press release

Enerin, a technology leader in high-temperature heat pumps, has raised €15 million (NOK 180 million) in a Series A led by Climentum Capital, The Footprint Firm, Johnson Controls and Move Energy, with participation from PSV Hafnium and Momentum. “This investment marks our shift from pioneering to full industrialisation, bringing proven high-temperature technology from Norway to industries worldwide,” said Arne Høeg, Founder and CEO of Enerin. “Industrial companies are ready to decarbonise high-temperature heat, but the mass market has lacked simple, profitable solutions that fit everyday operations.” Replacing fossil-fuelled industrial boilers — responsible for nearly 20% of global CO₂ emissions — remains one of the toughest challenges in the energy transition, largely because conventional heat pumps can’t cope with the sector’s highly variable process conditions and high temperatures. Enerin’s modular, flexible and standardised system removes such barriers by adapting automatically to

IQM to Invest Over €40 Million to Expand Finland Production Facility, Accelerate Innovation and Fuel Growth26.11.2025 10:49:00 EET | Press release

IQM Quantum Computers, a global leader in superconducting quantum computers, today announced over €40 million investment to expand its state-of-the-art production facility in Finland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126943986/en/ This strategic expansion will accelerate the development, fabrication and testing of advanced quantum processing units and the assembly of quantum computers, paving the way for scalable, error-corrected quantum systems that will power the next era of computing. The expansion aligns with the company’s recent Series B fundraise of over $300 million. The facility, which will spread over 8,000 square meters, will expand the company’s cleanroom area quantum data centre. It will also double its assembly line capacity, enabling to produce over 30 full-stack quantum computers per year, helping to meet the growing demand for its systems and support research innovation and development activi

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye