Date: 2026-05-26Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2026/1103 of 22 May 2026 postponing the expiry date of the approval of PHMB (1415; 4.7) for use in biocidal products of product-types 2 and 4 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**
This Commission Implementing Decision postpones the expiry date of the approval for PHMB (1415; 4.7) for biocidal product-types 2 and 4 from 31 October 2026 to 30 April 2029. The extension is required due to delays in the evaluation process regarding complex technical data, ensuring the substance remains approved while the renewal application is reviewed. The evaluating competent authority expects to submit its renewal assessment report by the third quarter of 2028.
**Key Points / Main Content**
**Substance Approval and Renewal Status**
* **Active Substance:** PHMB (1415; 4.7) is currently approved for use in biocidal products of product-types 2 and 4.
* **Renewal Application:** Applications for the renewal of this approval were submitted on 25 April 2025.
* **Regulatory Basis:** The decision is made in accordance with Article 14(5) of Regulation (EU) No 528/2012.
**Evaluation Progress and Delays**
* **Mandatory Evaluation:** The evaluating competent authority of France determined that a full evaluation of the applications was necessary.
* **Cause of Delay:** Progress is delayed due to the assessment of complex data, specifically 5-batch analysis, developmental neurotoxicity, and endocrine-disrupting properties.
* **Revised Timeline:** The evaluating authority expects to submit the renewal assessment report to the European Chemicals Agency (ECHA) in the third quarter of 2028.
**Postponement Provisions**
* **New Expiry Date:** The approval expiry date is officially postponed to 30 April 2029.
* **Continued Compliance:** During the extension period, PHMB (1415; 4.7) remains approved subject to the conditions originally set out in Implementing Regulation (EU) 2018/613.
* **Entry into Force:** This decision enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Impact Analysis**
**Evaluating Competent Authority (France)**
**Impact**
The authority is granted an extended timeframe to complete a full and complex safety evaluation that was otherwise impossible to finish before the original expiry.
**Action Required**
The authority must continue its assessment and aims to submit the final renewal assessment report to ECHA by Q3 2028.
**Applicants / Manufacturers of PHMB (1415; 4.7)**
**Impact**
Manufacturers can legally keep their products on the market for an additional period, as the expiry of the active substance approval has been deferred for reasons beyond their control.
**Action Required**
Applicants must continue to comply with the existing conditions of the current approval and may be required to provide additional data as requested by the evaluating authority during the ongoing assessment.
**European Chemicals Agency (ECHA)**
**Impact**
ECHA’s timeline for preparing its opinion is shifted to align with the delayed submission of the assessment report.
**Action Required**
Upon receipt of the recommendation from the French authority, ECHA must prepare and submit its opinion on the renewal to the Commission within 270 days.
**European Commission**
**Impact**
The Commission secures the necessary time to review ECHA’s eventual opinion and make a final decision on the renewal of the substance.
**Action Required**
The Commission must monitor the progress of the evaluation to ensure a decision is reached before the new deadline of 30 April 2029.
Key Entities Referenced
Regulation (EU) No 528/2012: The primary legislative framework of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Chemicals Agency: The regulatory body responsible for preparing and submitting opinions on the renewal of active substance approvals to the European Commission.
Evaluating competent authority of France: The national authority responsible for conducting the full evaluation of applications for the renewal of PHMB (1415; 4.7) approval.
Commission Implementing Regulation (EU) 2018/613: The specific regulation that originally approved PHMB (1415; 4.7) as an active substance, the expiry of which is postponed by this decision.
Standing Committee on Biocidal Products: The advisory committee consulted by the European Commission regarding the postponement of the active substance approval expiry date.
Official Journal EN
of the European Union L series
2026/1103 26.5.2026
COMMISSION IMPLEMENTING DECISION(EU) 2026/1103
of 22 May 2026
postponing the expiry date of the approval of PHMB (1415; 4.7) for use in biocidal products of
product-types 2 and 4 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) PHMB (1415; 4.7) was approved as an active substance for use in biocidal products of product-types 2 and 4 by
Commission Implementing Regulation (EU) 2018/613(2) subject to the conditions set out in the Annex to that
Regulation.
(2) The approval of PHMB (1415; 4.7) for use in biocidal products of product-types 2 and 4 (‘the approval’) is to expire
on 31 October 2026. On 25 April 2025, applications were submitted in accordance with Article 13(1) of
Regulation (EU) No 528/2012 for the renewal of the approval of PHMB (1415; 4.7) for use in biocidal products of
product-types 2 and 4 (‘the applications’).
(3) On 10 July 2025, the evaluating competent authority of France 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 23 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 5-batch analysis, developmental neurotoxicity and the
endocrine-disrupting properties of PHMB (1415; 4.7). The evaluating competent authority expects to submit the
renewal assessment report to the Agency in the third quarter of 2028.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance
for use in biocidal products of product-types 2 and 4 (OJ L 102, 23.4.2018, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2018/613/oj).
ELI: http://data.europa.eu/eli/dec_impl/2026/1103/oj 1/2EN
OJ L, 26.5.2026
(7) Consequently, for reasons beyond the control of the applicant, 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 PHMB (1415; 4.7) for
use in biocidal products of product-types 2 and 4, the expiry date should be postponed to 30 April 2029.
(8) After the postponement of the expiry date of the approval, PHMB (1415; 4.7) remains approved for use in biocidal
products of product-types 2 and 4 subject to the conditions set out in the Annex to Implementing Regulation
(EU) 2018/613,
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of PHMB (1415; 4.7) for use in biocidal products of product-types 2 and 4 set out in the
Annex to Implementing Regulation (EU) 2018/613 is postponed to 30 April 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/2026/1103/oj