The European Commission has adopted measures to extend the approval period for three active substances used in biocidal products, for which the renewal procedures are not expected to be completed before their current approval periods expire.
Approval of Folpet, Granulated Copper, and 2-Methylisothiazol-3(2H)-one (MIT)
The substances in question are as follows:
- Folpet : PT9, Protective products for fibers, leather, rubber, and polymerized materials
- New expiration date : March 31, 2029
- 2-methylisothiazol-3(2H)-one (MIT) : PT13, Protective products for working fluids or cutting fluids
- New expiration date : March 31, 2029
- Granulated Copper : PT8, Wood Preservatives
- New expiration date : July 31, 2029
These extensions were granted because the delays in the renewal procedures are considered to be beyond the applicants’ control.
The three implementing decisions were published in the Official Journal of the European Union on September 28, 2026, and will take effect 20 days after their publication.
What are the uses of these active substances?
Use of the active substance Folpet
For folpet used as a preservative in materials such as fibers, leather, rubber, and polymerized materials (PT9), Switzerland, as the competent authority responsible for the evaluation, requires additional time to review the data pertaining, in particular, to risks to human health and the environment, efficacy, analytical methods, and the physicochemical properties of the substance.
The authority currently plans to submit its recommendation to ECHA in early 2028. It should be noted that this extension applies exclusively to PT9: the approval of folpet for PT7 (film protection products) expired on September 30, 2026, as no application for renewal was submitted for this use.
Use of the active substance 2-methylisothiazol-3(2H)-one (MIT)
For MIT, used to protect fluids employed in metal processing and other industrial processes (PT13), the renewal process has been delayed due to the evaluation of data regarding the substance’s developmental neurotoxicity.
Slovenia plans to submit its renewal evaluation report to ECHA in the third quarter of 2028.
Use of the active substance granulated copper
Regarding granulated copper used in wood preservatives (PT8), France has indicated that it is unlikely to be able to submit the renewal assessment to ECHA before mid-2028.
Extension of the Expiration Date for the Approval of Active Substances
These three decisions, published in the Official Journal of the European Union on September 28, 2026, are part of the mechanism provided for in Article 14(5) of the BPR (Biocidal Products Regulation), which allows for the extension of an approval’s expiration date when the renewal procedure cannot be completed on time for reasons beyond the applicant’s control.
These extensions were granted because the delays in the renewal procedures are considered to be beyond the applicants’ control, thereby allowing the existing approval to remain in effect while the renewal procedure continues.
For the companies concerned, these extensions ensure the continuity of existing approvals, without prejudging the outcome of the ongoing renewal procedures. The previously established conditions of approval remain applicable. It therefore remains essential to follow the conclusions of the ongoing evaluations, which may result in new conditions of use, restrictions, or decisions not to renew.
EcoMundo supports you in managing your biocidal products
We offer regulatory solutions and comprehensive support for all types of products.
- Product Regulatory Assessment
- Transitional Measures
- Product Authorizations, SAME Dossiers & Mutual Recognition
- Post-Authorization Monitoring
Contact us for a free, no-obligation consultation.
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The European Commission has adopted measures to extend the approval period for three active substances used in biocidal products, for which the renewal procedures are not expected to be completed before their current approval periods expire.
Approval of Folpet, Granulated Copper, and 2-Methylisothiazol-3(2H)-one (MIT)
The substances in question are as follows:
- Folpet : PT9, Protective products for fibers, leather, rubber, and polymerized materials
- New expiration date : March 31, 2029
- 2-methylisothiazol-3(2H)-one (MIT) : PT13, Protective products for working fluids or cutting fluids
- New expiration date : March 31, 2029
- Granulated Copper : PT8, Wood Preservatives
- New expiration date : July 31, 2029
These extensions were granted because the delays in the renewal procedures are considered to be beyond the applicants’ control.
The three implementing decisions were published in the Official Journal of the European Union on September 28, 2026, and will take effect 20 days after their publication.
What are the uses of these active substances?
Use of the active substance Folpet
For folpet used as a preservative in materials such as fibers, leather, rubber, and polymerized materials (PT9), Switzerland, as the competent authority responsible for the evaluation, requires additional time to review the data pertaining, in particular, to risks to human health and the environment, efficacy, analytical methods, and the physicochemical properties of the substance.
The authority currently plans to submit its recommendation to ECHA in early 2028. It should be noted that this extension applies exclusively to PT9: the approval of folpet for PT7 (film protection products) expired on September 30, 2026, as no application for renewal was submitted for this use.
Use of the active substance 2-methylisothiazol-3(2H)-one (MIT)
For MIT, used to protect fluids employed in metal processing and other industrial processes (PT13), the renewal process has been delayed due to the evaluation of data regarding the substance’s developmental neurotoxicity.
Slovenia plans to submit its renewal evaluation report to ECHA in the third quarter of 2028.
Use of the active substance granulated copper
Regarding granulated copper used in wood preservatives (PT8), France has indicated that it is unlikely to be able to submit the renewal assessment to ECHA before mid-2028.
Extension of the Expiration Date for the Approval of Active Substances
These three decisions, published in the Official Journal of the European Union on September 28, 2026, are part of the mechanism provided for in Article 14(5) of the BPR (Biocidal Products Regulation), which allows for the extension of an approval’s expiration date when the renewal procedure cannot be completed on time for reasons beyond the applicant’s control.
These extensions were granted because the delays in the renewal procedures are considered to be beyond the applicants’ control, thereby allowing the existing approval to remain in effect while the renewal procedure continues.
For the companies concerned, these extensions ensure the continuity of existing approvals, without prejudging the outcome of the ongoing renewal procedures. The previously established conditions of approval remain applicable. It therefore remains essential to follow the conclusions of the ongoing evaluations, which may result in new conditions of use, restrictions, or decisions not to renew.
EcoMundo supports you in managing your biocidal products
We offer regulatory solutions and comprehensive support for all types of products.
- Product Regulatory Assessment
- Transitional Measures
- Product Authorizations, SAME Dossiers & Mutual Recognition
- Post-Authorization Monitoring
Contact us for a free, no-obligation consultation.
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