Health

#32026R0367Commission Implementing Regulation (EU) 2026/367 amending Union authorisation of the biocidal product family 'PAL IPA PRODUCT FAMILY'

🇪🇺European Union··Other·Low Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This regulation updates the existing Union authorisation for the PAL IPA Product Family, a biocidal wipe product containing 62.9% propan-2-ol (isopropyl alcohol). It approves administrative changes including the addition of new trade names and an update to the manufacturer's address. The product is authorised for professional disinfection against bacteria, mycobacteria, and yeast on hard surfaces in cleanrooms, pharmaceutical, healthcare, and food preparation areas. The core summary of product characteristics remains largely unchanged except for these administrative updates and minor editorial formatting improvements. The authorisation runs until 30 November 2029.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Addition of multiple new trade names including Sirafan Alco Wipes, Alcodes GF maxi wipes, Medipal Alcohol Disinfectant Wipes, Pal Tech Precision 70% IPA Wipes, and Pal TX IPA Surface Disinfectant Wipes
  • Update to the address of the manufacturing location and manufacturer
  • Replacement of the entire Annex to Implementing Regulation (EU) 2019/2030 with a revised summary of product characteristics

+ 3 more changes with Pro

Obligations

What this law requires

high

Maintain Union authorisation number EU-0020463-0000 for the PAL IPA Product Family biocidal product until expiry date of 30 November 2029

Pal Hygiene Products Limited (authorisation holder)
licensing
high

Ensure the biocidal product is used only for professional disinfection against bacteria, mycobacteria, and yeast on hard surfaces in cleanrooms, pharmaceutical, healthcare, and food preparation areas

Pal Hygiene Products Limited and all users of the product
operational
high

Maintain the active substance composition of propan-2-ol (isopropyl alcohol) at 62.9% (w/w) as specified in the authorisation

Pal Hygiene Products Limited (authorisation holder) and manufacturer Pal International Limited
operational
medium

Notify the European Chemicals Agency of any further administrative changes to the Union authorisation in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013

Pal Hygiene Products Limited (authorisation holder)
reporting
high

Ensure manufacturing takes place at the registered manufacturing site: Unit 3 Mountpark, Victoria Road, Ellistown LE67 1FA Coalville, Leicestershire, United Kingdom

Pal International Limited (manufacturer)
operational

Affected Parties

Pal Hygiene Products LimitedManufacturers and distributors of PAL IPA biocidal wipes+2 more…

Tags

biocidal products,disinfectant wipes,isopropyl alcohol