The initiative follows the first Biotech Act and takes a broader approach, focusing on the regulatory and market conditions needed to support biotechnology across the EU. Its objectives include addressing regulatory fragmentation, reducing administrative burdens and facilitating the development and market uptake of innovative biotechnology and bio-based products.
Although Biotech Act II is not specifically aimed at cosmetics or nutraceuticals, its development could be relevant to these sectors as they increasingly adopt biotechnology-derived ingredients and manufacturing processes.
What is the EU Biotech Act II?
Biotech Act II is being developed as part of the European Commission’s broader strategy for industrial competitiveness, the bioeconomy and the transition to more sustainable production models.
One of the issues identified by the Commission is the complexity and fragmentation of the current regulatory environment. Companies developing biotechnology products may encounter different requirements, terminology and regulatory pathways, creating additional administrative burdens and making it more difficult to scale innovative technologies across the EU Single Market.
The initiative is therefore expected to explore ways to improve regulatory predictability, market access and the deployment of biotechnology, while maintaining existing standards for health, safety and environmental protection.
Where does the initiative stand?
The Commission launched a Call for Evidence for an impact assessment on May 13, 2026. The consultation period closed on June 10, 2026, providing stakeholders with an opportunity to comment on the problems and potential policy approaches under consideration.
The Commission has not yet finalized the legislative framework. The content of the future initiative remains subject to change, and the current indicative timetable points to the publication of a legislative proposal in Q4 2026.
For companies, this means that there are not yet specific new compliance obligations arising from Biotech Act II.
Why could it matter to cosmetics and nutraceuticals?
The potential relevance to these sectors comes from the growing use of biotechnology to produce ingredients and raw materials.
Fermentation, biocatalysis and other biotechnology processes are already used to manufacture substances such as vitamins, amino acids, peptides, postbiotics and certain active ingredients. At the same time, manufacturers are exploring alternative bio-based feedstocks and new production technologies.
If Biotech Act II succeeds in reducing regulatory fragmentation and facilitating market access, these developments could indirectly benefit companies developing biotechnology-derived ingredients for cosmetics and nutraceuticals.
However, it is important to distinguish between potential sector impacts and measures actually proposed for cosmetics or nutraceuticals. The initiative is currently focused on industrial biotechnology and biomanufacturing and does not establish new cosmetic or nutraceutical ingredient requirements at this stage.
What should ingredient manufacturers consider?
Companies working with biotechnology-derived ingredients can already strengthen areas that are likely to remain important regardless of the final legislative outcome.
Traceability and characterization should be addressed from the beginning of ingredient development, with appropriate control of the manufacturing process and characterization of the finished ingredient.
Safety and compliance documentation should also be robust, particularly where production involves genetically modified microorganisms or other technologies requiring specific regulatory assessment.
Finally, companies should consider the intended market and regulatory pathway early in development. The same biotechnology-derived ingredient may be subject to different requirements depending on whether it is ultimately used in a cosmetic, nutraceutical, pharmaceutical or other product.
