The Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025

Published: Tue 25th Nov 25

The Regulations amended cross-references within Article 95 of the GB Biocidal Products Regulation and extended the data protection end date for certain active substance/product-type combinations to 31 December 2030.

The Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025, made by the Secretary of State with the consent of the Scottish and Welsh Ministers, modify Article 95 of the GB Biocidal Products Regulation by updating cross-references to previous EU regulations and significantly extending the data protection expiration date to 31 December 2030 for specific active substance/product-type combinations where approval decisions are still pending.

Arguments For

Ensures continued regulatory alignment and procedural consistency by updating cross-references within the retained EU law concerning biocidal product evaluation.
Extends the data protection period for certain active substance/product-type combinations (listed in Annex II to Regulation (EU) No 1062/2014) until December 31, 2030, providing greater certainty for market participants and allowing more time for regulatory decisions to be made by both UK and former EU bodies.
Allows the process of substance approval under the UK framework to continue without undue pressure on data submission timelines related to older, unresolved applications.

Arguments Against

Prolongs transitional arrangements concerning data access and protection, potentially delaying the full implementation of dynamic post-Brexit regulatory frameworks for biocides.
The five-year extension of the data protection deadline (from 2025 to 2030) may indicate administrative delays or complexity in finalizing evaluations for these specific substance/product-type combinations.
Modifies existing UK retained law, requiring businesses reliant on these specific active substances to track amendments to data protection expiry dates.

The Secretary of State makes these Regulations in exercise of the powers conferred by Articles 83A(2) and 89(2)(b) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products1.

In accordance with Article 89(4) of that Regulation, these Regulations are made with the consent of the Scottish Ministers and the Welsh Ministers2.

The Secretary of State created these Regulations by using powers granted under Article 83A(2) and 89(2)(b) of Regulation (EU) No 528/2012, which governs the rules for making biocidal products available on the market and their use.

These statutory rules were made with the formal agreement of both the Scottish Ministers and the Welsh Ministers, as required by Article 89(4) of the referenced EU Regulation.

Citation, commencement, extent and interpretation

(1)

These Regulations may be cited as the Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025 and come into force on 30th December 2025.

(2)

These Regulations extend to England and Wales and Scotland.

(3)

In these Regulations, “the GB Biocidal Products Regulation” means Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

The official short title for these legislative rules is the Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025, and they became legally active on December 30, 2025.

These Regulations apply across the jurisdictions of England, Wales, and Scotland.

For clarity within the text, 'the GB Biocidal Products Regulation' is explicitly defined as Regulation (EU) No 528/2012, which covers how biocidal products are placed on the market and used.

Amendments to Article 95 of the GB Biocidal Products Regulation

The intro text states: Article 95 of the GB Biocidal Products Regulation (transitional measures concerning access to the active substance dossier) is amended as follows—

(a)

in paragraph 3, for “Regulation (EC) No 1451/2007” substitute “Regulation (EU) No 1062/2014”3;

(b)

for paragraph 5, substitute—

“5.
By way of derogation from Article 60, all data protection periods for active substance/product-type combinations listed in Annex II to Regulation (EU) No 1062/2014, but for which no decision as to whether the active substance/product-type combination is approved4 has been issued by—
(a)
the Secretary of State, under this Regulation, or
(b)
before IP completion day, the Commission, under Regulation (EU) No 528/20125,
shall end on 31 December 2030.”.

This regulation modifies Article 95 of the GB Biocidal Products Regulation, which deals with the rules for accessing technical data on active substances.

Sub-paragraph (a) updates a reference in paragraph 3 by replacing Regulation (EC) No 1451/2007 with a reference to Regulation (EU) No 1062/2014.

Sub-paragraph (b) completely substitutes paragraph 5.

The new text establishes that, despite Article 60, the data protection period ends on December 31, 2030, for specific active substance/product-type combinations listed in Annex II of Regulation (EU) No 1062/2014, provided that a decision on their approval has not yet been made by either the Secretary of State (under the current UK regulation) or the European Commission (under the previous Regulation (EU) No 528/2012) before the UK's departure from the EU (IP completion day).

View Source