The European Commission is continuing the development of the Biotech Act II, a legislative initiative aimed at strengthening the European Union’s competitiveness in the fields of industrial biotechnology and biomanufacturing.

To foster the biotechnology industry and the bioeconomy in Europe, the Biotech Act II promotes a strategic framework designed to simplify market access for innovative products derived from biotechnological processes.

Announced in the European Commission’s 2026 Work Programme, the Biotech Act II follows the Biotech Act of 2025, expanding its scope. While the first initiative was primarily focused on healthcare applications, the second initiative is positioned within the broader context of EU policies on bioeconomy, industrial transition and technological competitiveness.

The public consultation launched by the European Commission in May 2026 closed on 10 June 2026. Feedback gathered through the Call for Evidence and stakeholder engagement indicates that the main challenge lies not in the absence of legislation, but rather in its complexity and fragmentation.

The Commission is currently assessing options to simplify administrative procedures while maintaining existing health and environmental protection standards. Further details are expected with the publication of the legislative proposal in the coming months.

Potential implications for the cosmetics and nutraceutical sectors

Developments under the Biotech Act II could also have indirect implications for sectors such as cosmetics and nutraceuticals, which are becoming increasingly influenced by advances in biotech technologies and the growing availability of new sources of raw materials. Indeed, the biotechnological production of ingredients such as vitamins, amino acids, peptides, postbiotics and active ingredients through fermentation or biocatalysis is already a well-established reality. Future developments are expected to include a broader range of these ingredients, the use of alternative bio-based raw materials, greater supply chain resilience and the evolution of EU criteria relating to sustainability and industrial innovation.

At present, the main interest for the cosmetics and nutraceutical sectors lies in the opportunities offered by innovation in raw materials and manufacturing processes, while any specific regulatory implications are expected to emerge only during the subsequent stages of the legislative process.

Companies developing biotechnological ingredients can already focus on several key strategic aspects:

• Traceability and characterisation: optimisation of manufacturing process control and thorough characterisation of the final ingredient.
• Safety and compliance: robust safety documentation and appropriate management of aspects related to the use of genetically modified microorganisms (GMMs).
• Market strategy: monitoring the evolution of regulatory interpretations across the different application sectors.

Integrating these considerations from the earliest stages of product development can facilitate subsequent compliance activities and market access.

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SOURCE:

• European Commission – Biotech Act II – Call for Evidence: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17394-Biotech-Act-II_en