REACH – Applications for authorisation AFA005-01 – OPEO

Overview

Public consultation on alternatives

Reference: AFA005-01

Applicant: Abbott Laboratories Limited

Application type: Initial

Substance name: Annex 14, entry 42 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues] (4-tert-OPnEO)

• 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
  • EC Number: 618-344-0
  • CAS Number: 9002-93-1
• 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
  • EC Number: 618-541-1
  • CAS Number: 9036-19-5

Proposed use: Professional use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surfactant in the final use of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems

Broad information on use applied for (conditions of use and function): 

The Applicant's IVD reagents and test kits are used by professional clinical technicians in hospitals, medical laboratories, research institutions and blood bank facilities worldwide. These IVD reagents and test kits are intended exclusively for use in conjunction with ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems to test patient samples for clinical diagnosis and monitoring disease. 4-tert-OPnEO plays a key role in the optimal functioning of immunoassay and clinical chemistry IVDs.

4-tert-OPnEO acts as an effective surfactant functioning within the IVD by reducing nonspecific interactions, preventing protein binding on surfaces, preventing aggregation of proteins or microparticles, promoting solubility and stabilising proteins allowing their detection. The final product performance attributes that are influenced by these functions include accuracy, precision, sensitivity, specificity of the IVD tests and shelf-life stability of the reagents.

Key substance properties required for the technical function include: surfactant classification (non-ionic); Hydrophile-Lipophile Balance (HLB); surface tension; and cloud point.

The Applicant has identified a potentially suitable alternative and is in the process of verifying the technical feasibility of the selected alternative before they proceed with the subsequent phases of substitution. As a result, the Applicant cannot conclude that a suitable and available alternative has been definitively identified. The process of establishing technical feasibility for any given product involves a complex multi-step IVD manufacturing process. Due to physical capacity constraints within the laboratories and manufacturing facilities it is not possible to run technical feasibility studies on the approximately 200 IVD products in parallel. Moreover, studies have shown that the primary alternative is not technically feasible in some product applications, thus additional studies with secondary alternatives are required on a case-by-case basis.  Considering the need for the completion of internal validation of the alternatives within a large range of approximately 200 IVD products, the lengthy global regulatory approval timeframes combined with conversion periods for the Applicant’s customers, the Applicant is requesting a 5.5-year review period (until 4-Jan-2028) under UK REACH to coincide with the substitution plan established under EU REACH.

List of descriptors:

• Sector of end use (SU): 20
• Environmental release category (ERC): 8a
• Process category (PROC): 0 Other: Use in IVD instruments with controlled exposures
• Product category (PC): 21
• Article category related to subsequent service life (AC): N/A
• Technical Function: Surfactant

Annual tonnage used: <1

Review period requested: 5.5 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).