EUROPEAN COMMISSION
Strasbourg, 16 December 2025
COM(2025) 1020 final
2025/0408(COD)
Simplification Omnibus Package
EXPLANATORY MEMORANDUM
1. Context of the proposal
The proposal is part of the cross‑cutting legislative simplification package announced in the European Commission’s Vision for Agriculture and Food. The aim is to reduce unnecessary regulatory burdens while maintaining high standards for food and feed safety, human and animal health, and the environment. It responds to requests from stakeholders and Member States for faster and clearer regulatory procedures.
The initiative seeks to modify Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, in order to address concerns expressed by Member‑State competent authorities and economic operators about the expiry of protection of certain data on 31 December 2025 (Article 95(5) of that Regulation).
The review programme of existing biocidal active substances set out in Article 89 of Regulation (EU) No 528/2012 has suffered major delays. Initiated on 14 May 2000 under Directive 98/8/EC, it was first extended to 14 May 2009, then to 14 May 2014, to 31 December 2024, and most recently to 31 December 2030.
Delays are due to lack of resources in Member‑State authorities, quality issues in initial applications, complex technical questions, evolution of technical guidance, and adoption of new scientific criteria for endocrine‑disrupting properties (Commission Delegated Regulation (EU) 2017/2100).
Article 95(5) currently foresees that on 31 December 2025 protection expires for all data submitted for existing active substance/product‑type combinations whose decision on inclusion in Annex I to Directive 98/8/EC was not taken before 1 September 2013 and which are still under examination after 31 December 2025. The protection period was set to expire ten years after mandatory listing of active substance suppliers (Article 95 list) which took effect on 1 September 2015.
Stakeholders have raised concerns that, given the delays, the expiry of all data protection needs to be reconsidered. An Implementation Dialogue on 15 July 2025 highlighted the need to extend protection for data generated since 7 June 2018 (date of application of the scientific criteria for endocrine disruption). The proposal therefore seeks to extend protection to balance the interests of review‑programme participants and alternative suppliers.
2. Legal basis, subsidiarity and proportionality
- Legal basis: Article 114 TFEU.
- Subsidiarity: The amendment concerns a provision of a Regulation already adopted at EU level; only EU‑level action can modify Article 95(5).
- Proportionality: The amendment only changes the specific provision on data‑protection expiry and does not introduce additional obligations.
3. Results of ex‑post evaluations, stakeholder consultations and impact assessments
The proposal is accompanied by a Commission Staff Working Document summarising the positive impacts of the amendment, based on evidence gathered during the Call for evidence and previous analyses.
Stakeholder consultations revealed divergent views: some industry actors and Member‑State authorities call for extending protection for data generated since 7 June 2018 (or until the end of the review programme), while others warn that longer protection could reduce competition and increase costs.
No full impact assessment is deemed necessary; the proposed measures are technical, have no viable alternatives, and do not alter core policy objectives. The estimated cost of preparing an application for an active substance ranges from €3 million to €5 million. Extending protection provides legal certainty and the possibility of compensation for data owners, supporting innovation and the robustness of the review programme.
4. Budgetary implications
The initiative will not entail additional costs for the Commission or any regulatory agency.
5. Other elements
- Implementation and monitoring: The Commission will monitor implementation and evaluate the amendment in line with better‑regulation principles.
- Specific provision details: The cut‑off date for protection of data related to active substances still under review on 1 September 2013 should be reconsidered. The extension will apply to all data for active substance/product‑type combinations for which a decision on approval had not been adopted by 7 June 2018. The protection period will be extended until 31 December 2030, corresponding to a maximum of 11.5 years for data generated since that date.
- Transitional period: From 1 January 2026 until the new Regulation enters into force, the concerned data will not be protected; the amendment provides a derogation allowing protection to restart.
- Compensation: Data owners may claim compensation from substance or product suppliers who benefit from the temporary lack of protection.
Legislative text
Article 1 – Amendments to Regulation (EU) No 528/2012
- In Article 60(1), the second sub‑paragraph is replaced by:
“Without prejudice to Article 95(5), second sub‑paragraph, protection periods under this Article, which have expired, shall not start to run again.” - In Article 95(5), the following sub‑paragraph is added:
“By way of derogation from the first sub‑paragraph, all data‑protection periods for active substance/product‑type combinations for which a decision on the approval has not been adopted in accordance with Article 89(1), third sub‑paragraph, by 7 June 2018, shall end on 31 December 2030. Data owners may claim compensation for access to their data for the period starting from 1 January 2026 until the date of entry into force of this Regulation, from a substance supplier or product supplier having benefitted from the absence of protection and having been included in the list referred to in paragraph 1 during that period.”
Article 2 – Entry into force
This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union and shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg,
For the European Parliament For the Council
The President The President