Date: 2025-09-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2025/1846 of 11 September 2025 cancelling the Union authorisation for the single biocidal product Nordkalk QL 0-0,1 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council and repealing Commission Implementing Regulation (EU) 2024/1478
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
Commission Implementing Regulation (EU) 2025/1846 cancels the Union authorisation for the single biocidal product Nordkalk QL 00,1, previously granted to Nordkalk AB under Implementing Regulation (EU) 2024/1478. This decision follows a request from Nordkalk AB to discontinue production for commercial reasons. The regulation sets deadlines for the cessation of market availability and use of existing stocks, with Implementing Regulation (EU) 2024/1478 being repealed.
**Key Points / Main Content:**
* **Cancellation of Authorisation:**
* The Union authorisation for Nordkalk QL 00,1 (authorisation number EU00293590000) is cancelled.
* **Repeal of Previous Regulation:**
* Commission Implementing Regulation (EU) 2024/1478 is repealed.
* **Deadlines for Market Availability and Use:**
* Nordkalk QL 00,1 shall no longer be made available on the market from March 31, 2026.
* Existing stocks of Nordkalk QL 00,1 shall no longer be used from September 27, 2026.
* **Entry Into Force:**
* This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Impact Analysis:**
* **Nordkalk AB:**
* *Impact:* The company's Union authorisation for Nordkalk QL 00,1 is cancelled, preventing further production and sale under the previous authorisation.
* *Action Required:* Cease making Nordkalk QL 00,1 available on the market by March 31, 2026.
* **Distributors/Suppliers:**
* *Impact:* Distributors and suppliers of Nordkalk QL 00,1 must cease making the product available on the market.
* *Action Required:* Stop offering Nordkalk QL 00,1 for sale by March 31, 2026.
* **End Users:**
* *Impact:* End users of Nordkalk QL 00,1 must discontinue their use of existing stocks.
* *Action Required:* Cease using existing stocks of Nordkalk QL 00,1 by September 27, 2026.
* **Member States:**
* *Impact:* Member states must ensure compliance with this regulation within their jurisdiction.
* *Action Required:* Enforce the deadlines for market availability and use of existing stocks.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Parliament: The parliamentary body of the European Union.
Council of the European Union: A component of the EU legislative branch in which ministers from each national government meet to adopt laws and coordinate policies.
Commission Implementing Regulation (EU) 2024/1478: A regulation granting a Union authorisation for the single biocidal product Nordkalk QL 00,1.
Nordkalk AB: The authorisation holder for the biocidal product Nordkalk QL 00,1 that requested cancellation of the Union authorisation.
Nordkalk QL 00,1: A single biocidal product for which the Union authorization is being cancelled.
European Chemicals Agency: An agency of the European Union that manages the registration, evaluation, authorisation and restriction of chemicals.
Official Journal EN
of the European Union L series
2025/1846 12.9.2025
COMMISSION IMPLEMENTING REGULATION(EU) 2025/1846
of 11 September 2025
cancelling the Union authorisation for the single biocidal product ‘Nordkalk QL 0-0,1’ in accordance
with Regulation (EU) No 528/2012 of the European Parliament and of the Council and repealing
Commission Implementing Regulation (EU) 2024/1478
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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(1), and in particular Article 49 thereof,
Whereas:
(1) On 29 May 2024, Commission Implementing Regulation (EU) 2024/1478(2)granted a Union authorisation with the
authorisation number EU-0029359-0000 to the authorisation holder Nordkalk AB for the making available on the
market and use of the same single biocidal product ‘Nordkalk QL 0-0,1’ in accordance with Article 44(5), first
subparagraph, of Regulation (EU) No 528/2012.
(2) On 15 May 2025, Nordkalk AB submitted a request to cancel that Union authorisation to the European Chemicals
Agency (‘the Agency’) in accordance with Article 49 of Regulation (EU) No 528/2012. The request was recorded
under case number BC-MD105909-40 in the Register for Biocidal Products.
(3) On 28 May 2025, Nordkalk AB submitted a reasoning for the request for cancellation, providing that it had decided
to discontinue the production of ‘Nordkalk QL 0-0,1’ based on commercial considerations.
(4) On 3 June 2025, the Agency forwarded the request to the Commission.
(5) It is therefore appropriate to cancel the Union authorisation for the single biocidal product ‘Nordkalk QL 0-0,1’ at the
request of the authorisation holder and consequently to repeal Implementing Regulation (EU) 2024/1478.
(6) It is also appropriate to grant a period of grace for the making available on the market and the use of the existing
stocks in accordance with Article 52 of Regulation (EU) No 528/2012,
HAS ADOPTED THIS REGULATION:
Article 1
The Union authorisation for the single biocidal product ‘Nordkalk QL 0-0,1’ granted by Implementing Regulation
(EU) 2024/1478 to Nordkalk AB with the authorisation number EU-0029359-0000 is cancelled.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2024/1478 of 29 May 2024 granting a Union authorisation for the single biocidal
product ‘Nordkalk QL 0-0,1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L,
2024/1478, 30.5.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1478/oj).
.
ELI: http://data.europa.eu/eli/reg_impl/2025/1846/oj 1/2EN
OJ L, 12.9.2025
Article 2
Implementing Regulation (EU) 2024/1478 is repealed.
Article 3
The biocidal product ‘Nordkalk QL 0-0,1’ shall no longer be made available on the market from 31 March 2026 and
existing stocks of such biocidal product shall no longer be used from 27 September 2026.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 September 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/reg_impl/2025/1846/oj