Extending Protection for Biocide Research Data Until 2030

What the document is about
The European Commission proposes to change Regulation (EU) No 528/2012, which governs the approval of biocidal products. The change concerns the period during which data submitted by companies for the review of existing biocidal active substances are protected from use by others.

The problem being addressed

• The review programme for existing biocidal active substances has been repeatedly delayed (originally due in 2010, now extended to 31 Dec 2030).
• Because of these delays, many data sets were still under review on 7 June 2018.
• Article 95(5) of the Regulation set a hard stop: all data protection for those substances would end on 31 Dec 2025.
• If protection ends, other companies could use the data without paying, undermining the investment made by the original data owners and discouraging future research.

How the problem is being solved

• The proposal extends the data‑protection period for all data related to substances that were still under review on 7 June 2018 until 31 Dec 2030.
• During the interim (1 Jan 2026 – 31 Dec 2030) the data will not be protected, but owners can claim compensation from any supplier who used the data during that period.
• The amendment also changes Article 60(1) to allow protection to be re‑established after the 2025 expiry.

What changes as a result of this document

1. Article 60(1) – the second sub‑paragraph is replaced to say that once a protection period has expired it normally cannot start again.
2. Article 95(5) – a new sub‑paragraph is added:

• All data protection periods for substances not approved by 7 June 2018 end on 31 Dec 2030.
• Owners may seek compensation for the period 1 Jan 2026 – 31 Dec 2030 from any supplier who benefited from the lack of protection.

3. The Regulation will enter into force 20 days after publication in the Official Journal.

Other important information

• The change is part of a broader “Simplification Omnibus Package” aimed at reducing regulatory burdens while keeping high safety standards.
• No additional costs are expected for the Commission or EU agencies.
• The Commission will monitor implementation and will conduct a full evaluation of Regulation 528/2012 in 2026‑2027.
• The proposal is based on stakeholder consultations, impact assessments, and the need to balance the interests of data owners with those of alternative suppliers and product authors.
• The amendment keeps the overall goal of Regulation 528/2012 – safe and efficient approval of biocidal products – unchanged while adjusting the data‑protection timeline to reflect the actual review schedule.