Extension of data protection for active substances under the Biocidal Products Regulation

The European Commission has put forward a proposal to amend Regulation (EU) No 528/2012 in order to address the expiration of data protection for active substances scheduled for 31 December 2025. This proposal is a direct consequence of the repeated delays affecting the review of active substances included in the regulatory assessment programme.

The aim is to strike an appropriate balance between data protection and regulatory simplification, while continuing to ensure a high level of protection for human health, animal health and the environment.

Regulatory context and delays in the review programme

The review programme for biocidal active substances was launched in 2000 and was originally expected to be completed by 2010.

However, due to persistent structural delays, its completion has now been postponed until 31 December 2030.

These delays are mainly attributable to limited resources within national competent authorities, as well as the need to generate additional data, including studies required under the scientific criteria for endocrine disruptors.

Challenges linked to the expiration of data protection

Under the current legal framework, data protection for existing active substances under review would expire on 31 December 2025. As a result, regulatory data could become accessible before the review process has been finalised.

According to the EU, this situation would jeopardise significant investments made in regulatory studies, particularly data generated since 2018, such as studies addressing endocrine-disrupting properties. Moreover, the lack of protection would encourage so-called “free-riding”, allowing third parties to rely on data owned by others without providing compensation.

Proposal to extend protection until 2030

The Commission’s proposal provides for an extension of data protection until 31 December 2030 for all active substances and product-type combinations that were still under review on 7 June 2018.

The extension applies to the entire data package contained in the dossier and is not limited to specific endpoints, such as endocrine disruption.

A temporary protection gap is anticipated between 1 January 2026 and the entry into force of the amended regulation. During this period, data owners would be entitled to seek financial compensation from suppliers that have benefited from the absence of protection.

Implications for the sector and competition

The proposed extension is intended to safeguard data owners by allowing them to recover investments made in complex and costly regulatory studies. According to the EU, it also aims to support fair competition and prevent unfair market practices within the biocides sector. Nevertheless, the measure may lead to increased costs for alternative suppliers, who may need to negotiate letters of access or pay compensation.

Do you need support to comply with the Biocidal Products Regulation? Nordiik can support you throughout the regulatory process — contact us.

Source: EU