Switzerland Drafts New Law on NBTs

On April 2, 2025, Switzerland's Federal Council released a proposal for the Breeding Technologies Act (BTA) to ease restrictions on plants developed through new genomic techniques such as CRISPR. The bill also aims to strengthen Switzerland's position as a hub for agricultural innovation and cultivation.

Under the current law, these plants are treated identically to those developed through conventional genetic engineering. They are subject to the strict provisions of the Genetic Engineering Act (GEA), including the ongoing moratorium on cultivation in Switzerland. The new proposal marks a shift in the country's regulatory landscape and introduces a risk-based authorization system that will reflect the potential of new breeding technologies (NBTs) and the need for appropriate safeguards.

The Draft BTA proposes to regulate plants developed through NBTs and applies to all relevant sectors, including agriculture, forestry, and horticulture. The proposed BTA outlines a simplified, three-step process for handling plants from NBTs. First, closed-system handling in controlled environments like labs or greenhouses is required for initial research and risk assessment, with containment measures and either notification or authorization depending on the plant's risk. Second, release trials in controlled outdoor settings, requiring authorization, are necessary to move to field application, but only if essential data cannot be obtained in a closed system. Lastly, market authorization is needed for commercialization (sale, exchange, or import), demanding proof of tangible benefits to agriculture, the environment, or consumers, supported by comparative data from release trials against the original unmodified plant.

The draft BTA aims to simplify the authorization process for plants developed through NBTs compared to the existing GEA, proposing two main procedures based on current knowledge. Comparability-based authorization offers a streamlined route, waiving the complex environmental risk assessment if the new plant's biological properties and genetic modifications are comparable to an already authorized plant. This is a significant simplification. A full environmental assessment is required when no comparable plant exists, involving a standard authorization process with a comprehensive evaluation of potential risks to humans, animals, and the environment. Plants deemed safe through this full assessment, along with relevant data, would be made public to ensure legal certainty and transparency.

The draft BTA would require clear labeling of plants developed through NBTs once they are placed on the market. Labels must state that the product is "from new breeding technologies" or "from new genomic processes." The draft BTA must first undergo a full legislative process. It has now entered a consultation period until July 8, 2025 to allow stakeholders to provide their support or concerns.

For more details, read the article in Lexology.