Date: 2025-09-17Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1805 of 11 September 2025 not granting a Union authorisation for the biocidal product family ODYSSEE ENVIRONNEMENT 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) 6103)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2025/1805, dated 11 September 2025, denies Union authorisation for the ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family. The decision follows an application by ODYSSEE Environnement submitted on 11 September 2017. The European Chemicals Agency (the Agency) recommended against authorisation, citing incomplete data and discrepancies.
Key Points / Main Content:
Application Details:
* On 11 September 2017, ODYSSEE Environnement applied for Union authorisation of the ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family (product-type 11).
* The application referenced the LANXESS CMIT/MIT biocidal product family as a related reference product family.
* The active substance in the product family is CMIT/MIT 3:1.
* The application was validated on 11 December 2017 after additional information was provided by the applicant on 16 November 2017.
Reasons for Denial:
* The Agency requested an aligned Summary of Product Characteristics (SPC) and a letter of access to the data supporting the authorisation of the related reference product family, but the applicant failed to provide these despite repeated requests.
* The Agency concluded that differences between the ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family and the reference product family could not be assessed without the aligned SPC.
* The Agency determined that the application was incomplete, lacking elements required under Article 2(c) of Implementing Regulation EU No 414/2013 due to the missing letter of access.
Decision:
* A Union authorisation is not granted to ODYSSEE Environnement for the ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family.
Impact Analysis:
ODYSSEE Environnement:
* Impact: The company is denied Union authorisation to make available on the market and use the ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family.
* Action Required: ODYSSEE Environnement cannot market or use the biocidal product family within the Union based on this application.
Key Entities Referenced
Regulation EU No 528/2012: Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
ODYSSEE ENVIRONNEMENT CMITMIT biocidal product family: The biocidal product family for which Union authorization was denied.
European Chemicals Agency (ECHA): The agency that assessed the application for Union authorisation and provided an opinion to the Commission.
Commission Implementing Regulation EU No 414/2013: Specifies procedure for authorization of same biocidal products in accordance with Regulation EU No 528/2012.
ODYSSEE Environnement: The applicant company for the biocidal product authorization.
Official Journal EN
of the European Union L series
2025/1805 17.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1805
of 11 September 2025
not granting a Union authorisation for the biocidal product family ‘ODYSSEE
ENVIRONNEMENT 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) 6103)
(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 11 September 2017, ODYSSEE Environnement 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, named ‘ODYSSEE
ENVIRONNEMENT CMIT/MIT biocidal product family’, of product-type 11, as described in Annex V to Regulation
(EU) No 528/2012. The application was recorded under case number BC-HR033845-20 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 ‘ODYSSEE ENVIRONNEMENT 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-type 11.
(3) Following its acceptance by the Agency, the validation of the application was initiated on 21 October 2017.
(4) On 27 October 2017, the Agency requested the following additional information from the applicant(4):
(a) a modification concerning the indication of the change in the ‘Name of the authorisation holder’ in the
supporting document of the application;
(b) a modification concerning the indication of a new formulator of the biocidal product in the supporting
document of the application;
(c) proof that the biocidal product composition and the formulating process remained unchanged;
(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) Communication R4BP: UBP-C-1276876-07-00/F.
ELI: http://data.europa.eu/eli/dec_impl/2025/1805/oj 1/3EN
OJ L, 17.9.2025
(d) 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 16 November 2017. The application was validated on
11 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 Summary of Product Characteristics (‘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) Despite the Agency’s repeated requests(6), the applicant did not provide the aligned SPC nor the letter of access to the
reference product family data.
(7) In the absence of the aligned SPC for the same biocidal product family, the Agency is unable to determine whether the
proposed differences between the same biocidal product family and the related reference product family are limited to
information that can be the subject of an administrative change in accordance with Commission Implementing
Regulation (EU) No 354/2013(7).
(8) 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.
(9) On 19 July 2024, the Agency submitted to the Commission its opinion(8) on the application for the Union
authorisation of the same biocidal product family ‘ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family’.
(10) The opinion concludes that the same biocidal product family ‘ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal
product family’ should not be authorised since the differences between the same biocidal product family and the
related reference product family cannot be assessed in the absence of the aligned SPC and 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.
(11) The Agency therefore proposes not to authorise the same biocidal product family ‘ODYSSEE
ENVIRONNEMENT CMIT/MIT biocidal product family’.
(12) On 12 February 2025, the Commission gave ODYSSEE Environnement the opportunity to provide the aligned SPC
and the letter of access to the reference product data via the Register for Biocidal Products platform (R4BP)(9). The
Commission also indicated its availability to discuss the dossier in a meeting. A deadline of 28 February 2025 was
set for a response. However, the applicant neither submitted the required documents nor provided any reply.
(13) The Commission concurs with the opinion of the Agency that, in the absence of the aligned SPC for the same biocidal
product family, it is not possible to determine whether the biocidal product for which authorisation is sought,
qualifies as ‘same product’ as referred to in Article 1 of Implementing Regulation (EU) No 414/2013. The
Commission also agrees with the Agency’s conclusion that the application does not fulfil the requirements set out in
Article 2, point (c), of that Implementing Regulation. Therefore, the Commission considers it appropriate to not grant
a Union authorisation for ‘ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family’.
(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 6 February 2024 (Communication R4BP: UBP-C-1712837-18-00/F), 29 February 2024 (Communication R4BP: UBP-C-
1717202-25-00/F), 13 March 2024 (Communication R4BP: UBP-C-1719822-11-00/F) and 8 May 2024 (Communication R4BP:
UBP-C-1284638-18-00/F).
(7) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance
with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.
eu/eli/reg_impl/2013/354/oj).
(8) European Chemicals Agency opinion of 19 July 2024 on the Union authorisation of ‘ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal
product family’, https://echa.europa.eu/opinions-on-union-authorisation.
(9) Commission Communication R4BP: UBP-C-1802072-22-00/F.
2/3 ELI: http://data.europa.eu/eli/dec_impl/2025/1805/ojEN
OJ L, 17.9.2025
(14) 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 ODYSSEE Environnement for the making available on the market and use of the
same biocidal product family ‘ODYSSEE ENVIRONNEMENT CMIT/MIT biocidal product family’.
Article 2
This Decision is addressed to ODYSSEE Environnement, Zone Artisanale Belle-Croix, 72510 Requeil, FRANCE.
Done at Brussels, 11 September 2025.
For the Commission
Olivér VÁRHELYI
Member of the Commission
ELI: http://data.europa.eu/eli/dec_impl/2025/1805/oj 3/3