REACH – Applications for authorisation AFA018-02 OPEO

Closes 1 Dec 2022

Opened 6 Oct 2022

Overview

Public consultation on alternatives

Reference: AFA018-02

Applicant: Siemens Healthcare Diagnostics Products GmbH

Application type: Initial

Substance name: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated,

  • 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
    • EC Number: -
    • CAS Number: 9002-93-1
  • 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
    • EC Number: -
    • CAS Number: 9036-19-5

Proposed use: Use of IVD wash solutions on diagnostic analyser systems by professional users

Broad information on use applied for (conditions of use and function): Octylphenolethoxylates (OPE) are used as detergents in wash solutions to serve a specific analyser system.

Conditions of use: The supplied solution is diluted by the customer under laboratory conditions and connected with the platform to clean and flush the internal parts in a full automatic application. After use OPE-containing solutions are discharged to the sewage and communal STP.

IVD wash solutions are used with every IVD kit on an analyser system to clean and flush the internal parts which have come into contact with the IVD kit reagents and/or patient sample as part of the liquid-handling operation, to prevent contamination between patient tests.

An IVD wash solution is specifically designed to be compatible with all of the IVD kits run on that analyser system and must be compatible with each one, providing no interference with any kit’s function;

Their technical function is to maintain a clean status between single measurements on the analyser system, which is vital for the accuracy of testing as any impurities carried over from one sample or reagent to another can affect the diagnostic result.

List of descriptors:

  • Sector of end use (SU): 20 
  • Product category (PC): 21 - Laboratory chemicals 
  • Environmental release category (ERC): 8a
  • Process category (PROC): 5 – Mixing or blending in batch processes
  • Process category (PROC): 8a - Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
  • Process category (PROC): 8b - Transfer of substance or mixture (charging and discharging) at dedicated facilities 
  • Process category (PROC): 21 - Low energy manipulation of substances bound in materials and/or articles   
  • Article category related to subsequent service life (AC): N/A
  • Technical Function: Surfactant 

Annual tonnage used:  <1 tonne per year

Review period requested: 4 years

How to submit comments

Provide some basic information on possible alternative(s) in the online survey below but more detailed information should be provided in document(s) prepared using the commenting templates in the related section below. A “public version” should always be completed and will be published after the consultation has closed. If you want to include confidential information in your submission, please additionally complete a “confidential version” and submit both versions as attachments.

The consultation lasts for 8 weeks (unless otherwise specified) and closes at 23:59 London time (BST).

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  • Applications for authorisation

Interests

  • Registration, Evaluation, Authorisation & restriction of CHemicals (REACH)