PHMB Biocides Extension Types 2 and 4: What Manufacturers Must Do

Key data

Manufacturers and distributors of biocides using PHMB (1415; 4.7) in their formulations can continue to market their products without interruption. Commission Implementing Decision (EU) 2026/1103, published on 26 May 2026 and in force since 22 May, delays the expiration date of the approval of this substance for product types 2 and 4, under Regulation (EU) No 528/2012.

The reason is technical and regulatory: the evaluation process for the renewal of PHMB approval has not been completed on time. Without this extension, products containing this substance would have had to be withdrawn from the market, creating a regulatory gap with direct impact on the supply chain for industrial, health and food disinfectants.

What does this regulation establish?

The decision exclusively delays the expiration date of the approval of PHMB (1415; 4.7) as an active biocidal substance. It does not modify any use conditions, any authorization requirements or any technical parameters of products already on the market.

The two product types affected are:

• Type 2: Disinfectants for private use and in the public health sector.
• Type 4: Disinfectants for surfaces in contact with food and feed.

The legal framework of reference remains Regulation (EU) No 528/2012, which regulates the marketing and use of biocides in the European Union. The extension is justified by the need to complete the evaluation and renewal process without creating market discontinuities.

What companies affected must do is update their product authorizations in accordance with the new deadlines established by this decision.

Economic and operational impact

For companies in the sector, this extension has an immediate positive effect: it eliminates the risk of having to withdraw products from the market before the PHMB renewal evaluation is completed. This means there is no interruption in the production, distribution or sale of the affected biocides.

However, the extension is neither indefinite nor automatic. Companies must act to maintain their regulatory position:

• Update product authorizations in accordance with the new deadlines established by the decision.
• Monitor the progress of the PHMB approval renewal process, as its conclusion could lead to new conditions or restrictions.
• Review whether their current formulations fully comply with the conditions of authorization in force, which have not changed.

The main operational cost is administrative: management of authorization updates and regulatory monitoring. No new fees, penalties or additional economic requirements have been established in this decision.

Who does it affect?

• Biocide manufacturers using PHMB (1415; 4.7) in type 2 or type 4 formulations.
• Distributors of biocidal products with PHMB in the public health, private use or food industry markets.
• Professional users of PHMB disinfectants in health care settings, industrial cleaning or food and feed production facilities.
• Regulatory and compliance managers in chemical and industrial hygiene companies that manage biocide authorizations with competent authorities.

Practical example

A Spanish manufacturer of disinfectants for surfaces in contact with food (type 4) using PHMB (1415; 4.7) as the active substance in its formulation was waiting for the European Commission to conclude the renewal evaluation of this substance.

Without Commission Implementing Decision (EU) 2026/1103, upon reaching the original expiration date of the approval, the manufacturer would have had to withdraw that product from the market or reformulate it with another active substance, with the cost and time that entails.

Thanks to the extension, the manufacturer can continue to market the product with its current formulation. Its immediate obligation is to update the product authorization in accordance with the new deadlines and keep abreast of the final outcome of the PHMB renewal evaluation, which will determine the definitive long-term conditions of use.

What should companies do now?

1. Identify affected products: Review your own biocide catalog or distributed products containing PHMB (1415; 4.7) in product types 2 and 4.
2. Update product authorizations: Process the update of authorizations in accordance with the new deadlines established by Commission Implementing Decision (EU) 2026/1103 with the competent authority.
3. Verify compliance with current conditions: Confirm that current formulations fully comply with the authorization conditions in force, which have not been modified by this decision.
4. Establish regulatory monitoring: Monitor the progress of the PHMB renewal evaluation process in the EU, as its conclusion may generate new obligations or restrictions.
5. Inform the distribution chain: Communicate to distributors and professional customers that products remain compliant and that there are no changes in use conditions.