#32026R0488Commission Implementing Regulation (EU) 2026/488 amending Union authorisation of SatPax® 70/30 IPA biocidal product
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This regulation extends the shelf life of the single biocidal product SatPax® 70/30 IPA from 2 years to 3 years. The product is a ready-to-use pre-saturated wipe containing 64.7% propan-2-ol (isopropyl alcohol) used for disinfecting hard surfaces in cleanrooms and controlled manufacturing environments. The European Chemicals Agency assessed the minor change application submitted by CSI-Ireland and confirmed that all safety and efficacy conditions under Regulation (EU) No 528/2012 remain fulfilled. The entire Annex containing the Summary of Product Characteristics has been replaced to incorporate the new 3-year shelf life along with minor editorial and formatting updates.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Shelf life of SatPax® 70/30 IPA extended from 2 years to 3 years
- Complete replacement of the Annex containing the Summary of Product Characteristics
- Minor editorial and layout updates due to Register format change in February 2024
+ 3 more changes with Pro
Obligations
What this law requires
CSI-Ireland must ensure SatPax® 70/30 IPA product shelf life is updated from 2 years to 3 years in all marketing, labeling, and product documentation
CSI-Ireland must comply with all conditions specified in Article 19 of Regulation (EU) No 528/2012 for continued market authorization of SatPax® 70/30 IPA
All manufacturers (Berkshire International Ltd and subcontractors) must ensure the product maintains safety and efficacy standards as assessed by the European Chemicals Agency with the new 3-year shelf life
CSI-Ireland must use the updated Summary of Product Characteristics as provided in the Annex to this Regulation for all commercial and regulatory communications regarding SatPax® 70/30 IPA
All EU Member States must recognize and enforce the Union authorisation EU-0032869-0000 for SatPax® 70/30 IPA with the amended 3-year shelf life as of the regulation's entry into force