LOGOLOGOLOGOLOGO
  • About us
    • What we do
    • Who we are
      • Governance
      • Staff
      • Vacancies
  • Members
    • EuropaBio Members
    • About Membership
  • How we work
    • Healthcare Biotechnology Council
      • Patient BioForum
      • Study – Impact of the EU’s General Pharmaceutical Legislation
    • Industrial Biotechnology Council
      • EFIB
      • Microorganisms
    • National Associations Council
    • SME Platform
    • Biomanufacturing Platform
      • Biotechnology in our Lives
  • Activities
    • 25 Years of Innovation
    • The EU Biotech Act
    • European Biotech Week
    • EU Projects
      • PRIMED Project
      • APROVALS Project
  • News & Events
    • News
    • Events
  • Library
Become a member
✕

Recombinant DNA in fermentation products is of no regulatory relevance

13/07/2022
OTHER
Recombinant DNA in fermentation products is of no regulatory relevance

(Alexandra Lensch, Elke Duwenig, Hans-Georg Dederer, Sirpa O. K¨arenlampi, Ren´e Custers, Agnes Borg, Markus Wyss)

ABSTRACT

A large variety of fermentation products are used in food and feed production, but also in other industries, and many of these products are produced with genetically modified microorganisms (GMMs).

In food and feed production, prominent examples are amino acids, vitamins, food and feed enzymes, colorants, non-caloric sweeteners, human milk oligosaccharides, or vegan alternatives of dairy, egg and meat products.

From a regulatory perspective, fermentation products are typically produced under containment. This means that premises, equipment and work processes need to be designed to prevent or at least minimize release of GMMs into the environment. The fermentation products themselves should not contain any live cells of the GMM.

Over the past years, there have been concerning developments, particularly in the European Union, stipulating that also absence of recombinant DNA might be interpreted as a regulatory requirement for fermentation products produced with GMMs.

In this paper, we attempt to place these developments into the historical context, sketch the potential negative repercussions for the food and feed industries, elaborate on the safety of recombinant DNA, and postulate that recombinant DNA should remain an integral part of the safety assessment of fermentation products but should not be misconstrued as a criterion for regulatory classification of products of biotechnology.

Read the full article below.

Recombinant DNA in fermentation products is of no regulatory relevance


Download
2022_07_IB_Article_rDNA-in-fermentation-products-is-of-no-regulatory-relevanceDownload
Share
Alexandra Simionca
Alexandra Simionca

Related posts

22/05/2025

Adisseo joins EuropaBio: Feeding Animals Sustainably Around the World


Read more
21/05/2025

Ensuring Biotech Integration in the Single Market


Read more
08/04/2025

EFIB 2025 Brussels Statement


Read more

Important links

  • Adisseo joins EuropaBio: Feeding Animals Sustainably Around the World
  • Ensuring Biotech Integration in the Single Market

Categories in our Newsroom

EBIO-white

EuropaBio represents corporate and associate members across sectors, plus national and regional biotechnology associations which, in turn, represent over 5000 biotech companies, 4600 out of them are SMEs.

Contact us

Extra links

Members
Staff
Privacy policy
Legal & cookies
Events
Newsroom

Become a member

Media pack

© 2025 Europabio. All Rights Reserved. Designed by EYAS
Become a member

Algal Omega 3

Algal Omega-3 is an innovative feed product for aquaculture. It reduces the impact on climate change by 30-40% compared to fish oil and saves 60 tons of wild fish for every ton of Algal Omega-3 used.

Cheese

Cheese is a vegetarian product thanks to biotechnology. Biotechnology is also essential to produce lactose- or cholesterol-free cheese, as well as alternative proteins.

Clothes

Clothes made from alternative fibres produced by microorganisms can be 8x stronger than steel, 100% recyclable, biodegradable and replace fossil-fuel based or resource-intensive textiles.

Vitamin B2

The biomanufacturing of Vitamin B2 led to the reduction of 75% of fossil raw materials and 50% operating costs, compared to the chemical process. Vitamin B2 is used in the food, feed or healthcare sectors.

Detergents

Enzymes and biosurfactancts are alternative ingredients that improve the performance of detergents, while leading to water and energy savings and reductions in CO2 emissions and water toxicity.

Insulin

Insulin is one of the most widely known biopharmaceutical. Biotechnology revolutionised its manufacturing process and led to the development of new types of insulin through r-DNA technology.