Date: 2026-05-26Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2026/1109 of 22 May 2026 postponing the expiry date of the approval of glutaraldehyde for use in biocidal products of product-types 2, 3, 4, 6, 11 and 12 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Decision (EU) 2026/1109 postpones the expiry date of the approval for glutaraldehyde in biocidal products of product-types 2, 3, 4, 6, 11, and 12. Due to delays in the (eco)toxicological evaluation by the competent authority, the current expiry date of 30 September 2026 is extended to 31 March 2029. This extension provides sufficient time for the European Chemicals Agency and the Commission to complete the renewal assessment process.
**Key Points / Main Content**
**Postponement of Expiry Date**
* The approval of glutaraldehyde for use in biocidal product-types 2, 3, 4, 6, 11, and 12 is officially postponed to 31 March 2029.
* During this extension period, the substance remains approved subject to the conditions originally set out in Implementing Regulation (EU) 2015/1759.
* The decision enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Evaluation Progress and Delays**
* Renewal applications for the substance were submitted on 25 and 26 March 2025.
* The evaluating competent authority of Finland determined that a full evaluation of the applications was necessary.
* A delay in the assessment was reported on 20 February 2026, specifically regarding the assessment of (eco)toxicological properties.
* The evaluating authority expects to submit the renewal assessment report to the European Chemicals Agency in the third quarter of 2027.
**Regulatory Timeline**
* The European Chemicals Agency (ECHA) must prepare and submit its opinion to the Commission within 270 days of receiving the evaluation recommendation.
* The extension is granted because the delay is beyond the control of the applicants, preventing the approval from expiring before a renewal decision is reached.
**Impact Analysis**
**Stakeholder: Applicants for Renewal**
**Impact**
Applicants are protected from the expiration of their active substance approval while the regulatory review is ongoing. This ensures their products can remain on the market during the evaluation period.
**Action Required**
Applicants must ensure continued compliance with the existing conditions set out in the Annex to Implementing Regulation (EU) 2015/1759.
**Stakeholder: Evaluating Competent Authority (Finland)**
**Impact**
The authority is granted an extended timeframe to resolve technical delays related to the assessment of complex (eco)toxicological data.
**Action Required**
The authority must perform the full evaluation and aims to submit the renewal assessment report to the Agency by the third quarter of 2027.
**Stakeholder: European Chemicals Agency (ECHA)**
**Impact**
The Agency’s timeline for preparing a formal opinion is shifted according to the new submission date of the assessment report.
**Action Required**
ECHA must prepare and submit its opinion on the renewal to the Commission within 270 days of receiving the evaluating authority’s recommendation.
Key Entities Referenced
Regulation (EU) No 528/2012: The primary European Union regulation concerning the making available on the market and use of biocidal products, providing the legal basis for approval renewals.
European Chemicals Agency: The regulatory body responsible for preparing and submitting opinions to the European Commission regarding the renewal of active substance approvals.
Commission Implementing Regulation (EU) 2015/1759: The specific regulation that originally approved glutaraldehyde as an active substance and established its usage conditions.
Evaluating competent authority of Finland: The designated national body responsible for conducting the full evaluation of the renewal applications for glutaraldehyde.
Official Journal EN
of the European Union L series
2026/1109 26.5.2026
COMMISSION IMPLEMENTING DECISION(EU) 2026/1109
of 22 May 2026
postponing the expiry date of the approval of glutaraldehyde for use in biocidal products of product-
types 2, 3, 4, 6, 11 and 12 in accordance with Regulation (EU) No 528/2012 of the European
Parliament and of the Council
(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 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Glutaraldehyde was approved as an active substance for use in biocidal products of product-types 2, 3, 4, 6, 11
and 12 by Commission Implementing Regulation (EU) 2015/1759(2)subject to the conditions set out in the Annex
to that Regulation.
(2) The approval of glutaraldehyde for use in biocidal products of product-types 2, 3, 4, 6, 11 and 12 (‘the approval’) is to
expire on 30 September 2026. On 25 and 26 March 2025, applications were submitted in accordance with
Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of glutaraldehyde for use in biocidal
products of product-types 2, 3, 4, 6, 11 and 12 (‘the applications’).
(3) On 1 July 2025, the evaluating competent authority of Finland informed the Commission that it had decided,
pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications was necessary.
Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the
application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out
the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is
suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of
the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals
Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the
active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) On 20 February 2026, the evaluating competent authority informed the Commission that the evaluation is delayed.
That delay is linked to the assessment of data related with the (eco)toxicological properties of glutaraldehyde. The
evaluating competent authority expects to submit the renewal assessment report to the Agency in the third quarter
of 2027.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2015/1759 of 28 September 2015 approving glutaraldehyde as an existing active
substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12 (OJ L 257, 2.10.2015, p. 19, ELI: http://data.europa.eu/
eli/reg_impl/2015/1759/oj).
ELI: http://data.europa.eu/eli/dec_impl/2026/1109/oj 1/2EN
OJ L, 26.5.2026
(7) Consequently, for reasons beyond the control of the applicants, the approval is likely to expire before a decision has
been taken on its renewal. It is therefore appropriate to postpone the expiry date of the approval for a period of time
sufficient to enable the examination of the applications. Taking into account the expected finalisation of the
evaluation by the evaluating competent authority, the time-limit for preparation and submission by the Agency of its
opinions and the time needed for the Commission to decide whether to renew the approval of glutaraldehyde for use
in biocidal products of product-types 2, 3, 4, 6, 11 and 12, the expiry date should be postponed to 31 March 2029.
(8) After the postponement of the expiry date of the approval, glutaraldehyde remains approved for use in biocidal
products of product-types 2, 3, 4, 6, 11 and 12 subject to the conditions set out in the Annex to Implementing
Regulation (EU) 2015/1759,
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of glutaraldehyde for use in biocidal products of product-types 2, 3, 4, 6, 11 and 12 set out
in the Annex to Implementing Regulation (EU) 2015/1759, is postponed to 31 March 2029.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
Done at Brussels, 22 May 2026.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/dec_impl/2026/1109/oj