Biocides 2026: what changes in data protection and how it affects your company

Key data

If your company manufactures, distributes or applies for authorization of biocidal products in Europe, Regulation (EU) 2026/1165 changes the rules of the game regarding technical data protection. The regulation, published on 26 May 2026, amends Regulation (EU) No 528/2012 and applies throughout the European Economic Area.

The change is relevant both for those who invest in innovation and want to protect their studies and for those who seek to market equivalent products based on existing data. In both cases, business strategy must be reviewed.

What does this regulation establish?

Regulation (EU) 2026/1165 introduces a specific amendment to Regulation 528/2012, which is the framework regulation governing the marketing and use of biocides in the European Union. The change focuses on a specific aspect: the data protection periods that companies submit during authorization procedures for their products.

When a company applies for authorization of a biocide, it must submit technical studies, tests and scientific documentation demonstrating the efficacy and safety of the product. This data represents a significant investment. The previous regulation already contemplated a protection period to prevent competitors from using that same data to obtain their own authorizations without assuming the cost of generating it.

With the new regulation, that protection period is extended. The stated objective is to encourage innovation in the biocides sector, ensuring that companies recover their investment before third parties can benefit from their work.

Economic and operational impact

The impact of this regulation occurs in two opposite directions depending on the company profile:

For manufacturers and innovators: The extension of protection periods strengthens temporary exclusivity over submitted technical information. This means more time without direct competition based on their own data, which can translate into greater return on investment in R&D and testing. It is a measure that favors the competitive position of those who invest in developing new biocides or obtaining authorizations with their own data.

For generic or similar product manufacturers: The scenario becomes more complex. Until now, once the original protection period expired, it was possible to reference existing data to obtain authorizations for equivalent products at lower cost. With the new extended periods, that window is delayed. There are two options: wait longer or assume the cost of generating your own studies and tests, which involves significant additional investment.

For distributors: The impact is indirect but real. The availability of generic products in the market may be delayed, which affects the breadth of the available catalog and negotiating margins with manufacturers in a dominant position.

Who does it affect?

• Manufacturers of biocidal products who have submitted or will submit technical data in authorization procedures in the EU or the EEA.
• Distributors of biocides whose catalog includes products whose authorization depends on protected data.
• Applicants for authorization of new biocidal products, both for national markets and for the European mutual recognition procedure.
• Manufacturers of generic or similar products planning to market biocides equivalent to already authorized products, based on existing data.
• Regulatory and R&D departments of chemical and industrial hygiene companies with activity in the EEA.

Practical example

A Spanish manufacturer of a biocidal disinfectant invested in recent years in efficacy and toxicology studies to obtain authorization for its product under Regulation 528/2012. That data was protected during the original period established in that regulation.

A competitor wanting to launch an equivalent product to the market could reference that data once the original period expired, thus avoiding the cost of generating its own tests. With the entry into force of Regulation (EU) 2026/1165, that period is extended for certain data, forcing the competitor to recalculate its strategy: either wait longer before being able to access that data, or assume the investment of generating its own studies to request its own authorization independently.

For the original manufacturer, this change means a longer exclusivity window over its technical information, which strengthens its market position during that additional period.

What should companies do now?

1. Review the portfolio of current authorizations and identify which technical data is currently under protection and when it was due to expire under the original Regulation 528/2012, to assess the impact of the extension.
2. If you are an innovative manufacturer, update your data protection strategy: the extension strengthens your competitive position and may justify delaying licensing agreements or reviewing terms with distributors.
3. If you plan to launch a generic or similar product, recalculate market entry timelines and evaluate whether it is more profitable to generate your own data or adjust the launch schedule to the new extended protection period.
4. Consult with your regulatory team or specialist advisor in biocides to determine which specific data is affected by the extension and to what extent it modifies ongoing authorization procedures.
5. Monitor the entry into force date, which has not been specified in the publication of 26 May 2026, to adapt operational and product planning timelines accordingly.