Foundation for Europe's innovative strength

Uniform rules for biotechnology are intended to speed up approvals and promote innovation.

With the EU Biotech Act, the European Union is paving the way for a strong, innovation-friendly biotechnology ecosystem. Biotechnology is no longer a niche technology, but a key to progress in health, sustainable industry, agriculture, nutrition and the environment – from enzymatic recycling to the conversion of waste materials into valuable materials.

The EU Biotech Act is more than just a legislative reform: it is a strategic pillar for Europe's technological sovereignty, economic competitiveness and the implementation of key initiatives such as the Green Deal, the Bioeconomy Strategy and the European Health Union.

What makes the EU Biotech Act so important?

• It creates a coherent legal framework for all biotechnology applications.
• It harmonises fragmented regulations and speeds up approvals.
• It combines high safety standards with innovation-friendliness

The German Association of Biotechnology Industries (DIB) expressly supports this initiative. Europe needs scientifically sound, technology neutral regulation in order to unlock the full potential of biotechnology for health, sustainability and competitiveness.

Our proposal

A two-stage model with

• horizontal principles (e.g. scientific assessment, data reuse)
• vertical gateway solutions that implement these principles in all sectors – from pharmaceuticals to agriculture.

This will create a flexible, innovation-friendly framework for the future of biotechnology.

The complete position paper is available for download on this website.

The proposal for the EU BioTech Act is based on the understanding that biotechnology is a platform technology. For more details, see the biotech letter "The evolution of biotechnology: from niche to platform" .