The European Commission has adopted Implementing Regulation (EU) 2024/2679 on 15 October 2024, amending the Union authorisation for the Contec IPA biocidal product family. The regulation introduces administrative and minor changes to the original authorisation, enhancing clarity and usability for disinfectants used in key industries, including biotechnology and food production.
Changes to the Contec IPA Product Family Authorisation
The European Commission has approved changes to the Union authorisation of the Contec IPA product family, originally granted in 2019 under authorisation number EU-0020460-0000. These changes, detailed in Regulation (EU) 2024/2679, affect the authorisation’s administrative framework and introduce minor modifications to the product's usage parameters.
The Contec IPA product family consists of disinfectants primarily used in biotechnology, medical device manufacturing, and the food industry. The products within this family are designed to combat bacteria, mycobacteria, and yeast on hard, non-porous surfaces in cleanrooms and critical life science environments.
Key Amendments
The approved changes include:
- New Trade Name and Manufacturing Additions: The addition of a trade name to the product family and updates to the list of manufacturers for both the active substance (propan-2-ol) and the biocidal products. These updates reflect the growing demand for the product across the EU.
- Modification of Pack Sizes: An extension of the pack size range was introduced, providing more flexibility for users across various industries. The updated pack sizes are expected to improve ease of use and storage.
Detailed Assessment by ECHA
The European Chemicals Agency (ECHA) evaluated these proposed changes under case numbers BC-QS069138-06 and BC-LM074066-29. ECHA concluded that the additions, including the new trade name and updated manufacturer information, fall under administrative changes as defined by Regulation (EU) No 528/2012. These updates do not compromise the biocidal product's safety, efficacy, or compliance with EU standards.
One proposed change—removing the carrier material information from Section 6 of meta SPC 2—was initially rejected by ECHA. However, the European Commission later clarified that while information on the carrier must remain in place, some details regarding the substance content could be removed.
Implications for Industry
With the approval of these amendments, industries relying on high-standard disinfection processes, such as pharmaceutical manufacturing, healthcare, and food preparation, can benefit from enhanced regulatory clarity and improved product specifications. The flexibility in pack sizes and the broader range of authorised manufacturers further ensures reliable access to these critical disinfectants.
