REACH - Applications for authorisation AFA067-01 - OPEO

Overview

Public consultation on alternatives

Reference: AFA067-01

Applicant: Abbott Laboratories Limited    

Application Type: Review Report

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)

Proposed Use: Professional use 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 Authorisation Holder’s IVD reagents and test kits are used by professional clinical technicians in hospitals, medical laboratories, research institutions and blood bank facilities worldwide. The IVD reagents and test kits are intended exclusively for use in conjunction with ARCHITECT and Alinity 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 Authorisation Holder has identified a potentially suitable alternative and has already substituted 4-tert-OPnEO in a number of their assays. The remaining assays are in various phases of substitution, and, while the selected alternative is proving suitable in most of those, it cannot be considered suitable until substitution is complete.

The process of establishing technical feasibility for any given product involves a complex multi-step IVD manufacturing process. Due to a number of factors beyond the Authorisation Holder’s control, substitution of the products sold in the GB market cannot be completed within the current review period.

Considering the need for the completion of internal verification of the alternatives within a large range of IVD products, significant developments in the global regulatory approval landscape, combined with conversion periods for the Authorisation Holder’s customers, the Authorisation Holder is requesting an extension to the review period for additional 5 years (until 4-Jan-2033) under UK REACH to match the substitution plan which aligns with the granted review period under EU REACH, and is considered the most efficient and economical option.

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: < 0.1 tonnes/year

Review Period Requested: 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).