Date: 2025-09-17Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1813 of 11 September 2025 not granting a Union authorisation for the biocidal product family VEOLIA WATER TECHNOLOGIES CMIT/MIT biocidal product family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2025) 6102)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Decision EU 2025/1813, dated 11 September 2025, denies Union authorisation for the biocidal product family VEOLIA WATER TECHNOLOGIES CMIT/MIT, product types 6, 11, 12 and 13, due to the applicant's failure to provide a letter of access to reference product family data, despite repeated requests. The application was initially submitted on 30 June 2017. The Commission requested the applicant to provide the letter of access to the reference product family data on 2 December 2024.
Key Points / Main Content:
* **Application and Scope:**
* The decision concerns the biocidal product family VEOLIA WATER TECHNOLOGIES CMIT/MIT, covering product types 6, 11, 12, and 13.
* The application for Union authorisation was submitted on 30 June 2017 and recorded under case number BCMG03294144.
* **Reason for Denial:**
* The primary reason for denying authorisation is the applicant's failure to provide a letter of access to data supporting the authorisation of the related reference product family (LANXESS CMIT/MIT biocidal product family).
* The Agency concluded that the application was incomplete as it did not contain the required elements set out in Article 2, point c, of Implementing Regulation EU No 414/2013.
* **Communication and Deadlines:**
* The Agency requested additional information, including the letter of access, on multiple occasions.
* The Commission also requested the applicant to provide the letter of access on 2 December 2024 and set a deadline of 31 March 2025.
* A final opportunity to provide the document was given with a deadline of 23 April 2025, but the applicant failed to comply.
* **Decision:**
* A Union authorisation is not granted to VEOLIA WATER SOLUTIONS TECHNOLOGIES SUPPORT for the biocidal product family VEOLIA WATER TECHNOLOGIES CMIT/MIT.
Impact Analysis:
* **VEOLIA WATER SOLUTIONS TECHNOLOGIES SUPPORT:**
* *Impact:* The company is directly affected as its application for Union authorisation of the VEOLIA WATER TECHNOLOGIES CMIT/MIT biocidal product family has been denied. They cannot make the product available on the market or use it within the Union under the applied authorisation.
* *Action Required:* VEOLIA WATER SOLUTIONS TECHNOLOGIES SUPPORT cannot proceed with the commercialisation of the product as a biocidal product family under the scope of the denied application. They would need to address the missing letter of access and reapply, or consider alternative strategies.
* **European Chemicals Agency (ECHA):**
* *Impact:* ECHA's opinion and assessment were central to the decision-making process. The decision validates ECHA's role in evaluating applications for biocidal product authorisation.
* *Action Required:* No direct action is required, but ECHA should document and consider this case in future application assessments to ensure consistent application of regulations.
Key Entities Referenced
Regulation (EU) No 528/2012: Regulation concerning the making available on the market and use of biocidal products.
VEOLIA WATER TECHNOLOGIES CMITMIT biocidal product family: The biocidal product family for which Union authorization was denied.
Commission Implementing Regulation (EU) No 414/2013: Regulation specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012.
European Chemicals Agency (ECHA): The agency that evaluated the application for Union authorisation.
VEOLIA WATER SOLUTIONS TECHNOLOGIES SUPPORT: The applicant for the Union authorisation of the biocidal product family.
Official Journal EN
of the European Union L series
2025/1813 17.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1813
of 11 September 2025
not granting a Union authorisation for the biocidal product family ‘VEOLIA WATER
TECHNOLOGIES CMIT/MIT biocidal product family’ in accordance with Regulation (EU)
No 528/2012 of the European Parliament and of the Council
(notified under document C(2025) 6102)
(Only the French text is authentic)
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 44(5), first subparagraph,
thereof,
Whereas:
(1) On 30 June 2017, VEOLIA WATER SOLUTIONS & TECHNOLOGIES SUPPORT (the ‘applicant’) submitted an
application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU)
No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013(2)for Union authorisation
of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013. That
biocidal product family was named ‘VEOLIA WATER TECHNOLOGIES CMIT/MIT biocidal product family’, of
product-types 6, 11, 12 and 13, as described in Annex V to Regulation (EU) No 528/2012. The application was
recorded under case number BC-MG032941-44 in the Register for Biocidal Products. The application also indicated
the case number of the related reference product family ‘LANXESS CMIT/MIT biocidal product family’, later
authorised by Commission Implementing Regulation (EU) 2024/2750(3), with authorisation number
EU-0031652-0000.
(2) The biocidal product family ‘VEOLIA WATER TECHNOLOGIES CMIT/MIT biocidal product family’
contains CMIT/MIT (3:1) as the active substance, included in the Union list of approved active substances referred to
in Article 9(2) of Regulation (EU) No 528/2012 for product-types 6, 11, 12 and 13.
(3) Following its acceptance by the Agency, the validation of the application was initiated on 24 July 2017.
(4) On 22 August 2017, 27 October 2017 and 30 October 2017, the Agency requested the following additional
information from the applicant(4):
(a) a revision of the Summary of Product Characteristics (‘SPC’) to include all non-active substances and to align
their ranges in accordance with those in the related reference product family;
(b) a modification concerning the indication of the change in the ‘Name of the biocidal product’ in the supporting
document of the application;
(c) a modification concerning the indication of the change in the ‘Name of the authorisation holder’ in the
supporting document of the application;
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same
biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125,
7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).
(3) Commission Implementing Regulation (EU) 2024/2750 of 25 October 2024 granting a Union authorisation for the biocidal product
family ‘LANXESS CMIT/MIT biocidal product family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament
and of the Council (OJ L, 2024/2750, 28.10.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2750/oj).
(4) Communications R4BP: UBP-C-1264624-26-00/F, UBP-C-1276879-04-00/F, UBP-C-1277314-24-00/F.
ELI: http://data.europa.eu/eli/dec_impl/2025/1813/oj 1/3EN
OJ L, 17.9.2025
(d) a modification concerning the indication of a new manufacturer of the biocidal product in the supporting
document of the application;
(e) a modification concerning the indication of the removal of a certain meta or use in the supporting document
of the application.
That information was provided by the applicant on 7 September 2017, 27 October 2017 and 21 October 2017. The
application was validated on 12 December 2017.
(5) Following the adoption of the Biocidal Products Committee (‘BPC’) opinion on 13 September 2023(5)of the related
reference product family, including the draft SPC, the applicant was requested to submit a revised version of the SPC
of the same biocidal product family that was aligned with the SPC of the related reference product family (‘aligned
SPC’) and a letter of access to the data supporting the authorisation of the related reference product family (‘reference
product family data’).
(6) The applicant provided the aligned SPC. However, despite the Agency’s repeated requests(6), the applicant did not
provide the letter of access to the reference product family data.
(7) In the absence of the letter of access to the reference product family data, the application does not contain the
elements required under Article 2, point (c), of Implementing Regulation (EU) No 414/2013.
(8) On 19 July 2024, the Agency submitted to the Commission its opinion(7) on the application for the Union
authorisation of the same biocidal product family ‘VEOLIA WATER TECHNOLOGIES CMIT/MIT biocidal product
family’.
(9) The opinion concludes that the same biocidal product family ‘VEOLIA WATER TECHNOLOGIES CMIT/MIT biocidal
product family’ should not be authorised since the application is incomplete as it does not contain the required
elements set out in Article 2, point (c), of Implementing Regulation (EU) No 414/2013.
(10) The Agency therefore proposes not to authorise the same biocidal product family ‘VEOLIA WATER
TECHNOLOGIES CMIT/MIT biocidal product family’.
(11) On 2 December 2024, the Commission requested the applicant to provide the letter of access to the reference
product family data(8). Since the applicant had provided the letter of access to data required for inclusion of the
active substance in Annex I to Directive 98/8/EC of the European Parliament and of the Council(9)or in the Union
list for approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012, the Commission held
a meeting with the applicant on 21 February 2025 to clarify which document needed to be provided and set a
deadline of 31 March 2025 for submitting the correct document.
(12) On 3 April 2025, the applicant informed the Agencyof its intention to provide the letter of access to the reference
product family data within a few days(10).
(13) Since on 14 April 2025 the letter of access to the reference product family data was still not submitted, the
Commission gave the applicant another opportunity to provide the document by 23 April 2025(11). However, the
applicant neither submitted the required document nor provided any reply.
(5) European Chemicals Agency opinion of 13 September 2023 on the Union authorisation of ‘LANXESS CMIT/MIT biocidal product
family’, https://echa.europa.eu/opinions-on-union-authorisation.
(6) Requests of 8 May 2024 (Communication R4BP: UBP-C-1719869-96-00/F), 24 May 2024 (Communication R4BP: UBP-C-
1734865-08-00/F) and 1 July 2024 (Communication R4BP: UBP-C-1748247-07-00/F).
(7) European Chemicals Agency opinion of 19 July 2024 on the application for Union authorisation of the same biocidal product family
VEOLIA WATER TECHNOLOGIES CMIT/MIT, https://echa.europa.eu/opinions-on-applications-for-union-authorisation.
(8) Commission Communication R4BP: UBP-C-1783879-99-00/F.
(9) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1, ELI: http://data.europa.eu/eli/dir/1998/8/oj).
(10) Applicant Communication R4BP: UBP-C-1814340-22-00/F.
(11) Commission Communication R4BP: UBP-C-1816386-04-00/F.
2/3 ELI: http://data.europa.eu/eli/dec_impl/2025/1813/ojEN
OJ L, 17.9.2025
(14) The Commission concurs with the opinion of the Agency that, in the absence of the letter of access to the reference
product family data, the application does not fulfil the requirements set out in Article 2, point (c), of Implementing
Regulation (EU) No 414/2013. Therefore, the Commission considers it appropriate not to grant a Union
authorisation for ‘VEOLIA WATER TECHNOLOGIES CMIT/MIT biocidal product family’.
(15) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
A Union authorisation is not granted to VEOLIA WATER SOLUTIONS & TECHNOLOGIES SUPPORT for the making
available on the market and use of the same biocidal product family ‘VEOLIA WATER TECHNOLOGIES CMIT/MIT
biocidal product family’.
Article 2
This Decision is addressed to VEOLIA WATER SOLUTIONS & TECHNOLOGIES SUPPORT, 1 place Montgolfier, 94410
Saint-Maurice, FRANCE.
Done at Brussels, 11 September 2025.
For the Commission
Olivér VÁRHELYI
Member of the Commission
ELI: http://data.europa.eu/eli/dec_impl/2025/1813/oj 3/3