REACH – Applications for authorisation AFA014-01 – OPnEO/NPnEO

Closes 4 Oct 2022

Opened 9 Aug 2022

Overview

Public consultation on alternatives

Reference: AFA014-01

Applicant: Roche Diagnostics Limited

Application type: Initial

Substance name:

  1. 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (Octylphenolethoxylates, OPnEO)
  2. 4-Nonylphenol, branched and linear, ethoxylated (Nonylphenolethoxylates, NPnEO)

Proposed use: Use of OPnEO and NPnEO in 10 in vitro diagnostic (IVD) assays used for example in Clinical Chemistry (CC) and Drug Monitoring (DM) products

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

Octyl- and/or Nonylphenol ethoxylates are used in IVD kits due to their surface-active properties and are usually used as an auxiliary chemical in one or several liquid reagents used for each assay. Both substances may fulfil different functions during the performance of the assay. Typical functions are increasing solubilisation of reagents, cell lysis, protein stabilisation and as wetting agent. As already completed substitutions of OPnEO and NPnEO and experiences in the development of new products have shown, other surfactants can in principle be used to replace OPnEO and NPnEO in IVD assays.

Specific performance requirements of the IVD assays are decisive for the assessment whether a specific alternative surfactant is suitable for replacement in a specific IVD assay or not. IVD products are highly regulated. Therefore, several steps are required to accomplish substitution which focus on performance of the IVD assay. Several alternative substances have been identified and are further assessed for their technical suitability.

List of descriptors:

  • Sector of end use (SU): 20
  • Product category: PC0: Other – IVD assays
  • Environmental release category (ERC): 8a
  • Process category (PROC): 15
  • Article category related to subsequent service life (AC): N/A
  • Technical Function: Surfactant

Annual tonnage used: 

  • OPnEO: maximum 48.65 kg/a, NPnEO: maximum 0.39 kg/a

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).

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Audiences

  • Applications for authorisation

Interests

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