News from the BioCity Campus

c-LEcta: European dossiers submitted for the approval of new enzymes in the food industry

c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, has submitted the dossiers for two newly developed enzymes in the food sector. The assessment by the EFSA (European Food Safety Agency) and the EU Commission is based on the harmonized EU approval procedure for "Food Improvement Agents" (food enzymes, additives and flavors). The enzyme dossiers submitted by c-LEcta for products in the target market of the food industry complement c-LEcta's range of services for customer companies, who no longer have to worry about approvals for the use of the enzymes separately.

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

Paula Pescador, responsible for the enzyme dossiers at c-LEcta: "This is a typical case for enzymes that make something completely new and valuable possible. We are proud of this and, in cooperation with our partner, secure this development result for the future. Thanks to our existing competence both in the development of new products and in questions of approval, we can also provide our partners and customers with comprehensive support in this area.”

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 aims to create a harmonized regulatory system for food enzymes across the European Union. After evaluation by the European Food Safety Authority EFSA, the EU Commission is to draw up a positive list of the enzymes approved in the EU for the food industry. In order to be included in this list, so-called enzyme dossiers must be submitted, which demonstrate the safety and technical necessity of the enzymes. The first publication of the new list is planned for 2023. From this point on, food manufacturers may only use the enzymes listed there. In order to offer customers planning security, c-LEcta takes care of the necessary submission of the enzyme dossiers so that the enzymes can be included in the list as soon as they are first published.

dr Marc Struhalla, Founder and CEO of c-LEcta, comments: “Obviously, EU enzyme approval is a new process that everyone in the industry will have to get used to. For us at c-LEcta, however, this is not a problem thanks to our in-house expertise and flexibility. Conversely, 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 do this in the future by submitting 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.” 

About c-LEcta

c-LEcta is a global biotechnology company with technology leadership in the areas of enzyme engineering and bioprocess development for regulated markets such as the food and pharmaceutical industries. The company, based in Leipzig, has established itself as a leading supplier of high-quality biotechnological products, be it in-house developments or in close cooperation with industry. c-LEcta currently employs more than 100 people.

c-LEcta delivers cost-efficient and sustainable production processes that open up new markets and enable better penetration of existing markets. The company excels at rapidly and efficiently developing best-in-class biotech solutions and successfully bringing to market and commercializing the resulting products. This allows c-LEcta to develop the unique potential of its core technologies. c-LEcta already has more than ten successfully marketed, high-quality, industrial biotech products.

Source: Press release c-LEcta GmbH from May 26.05.2021th, XNUMX


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