REACH – Applications for authorisation AFA007-01 – OPEO/NPEO

Overview

Public consultation on alternatives

Reference: AFA007-01

Applicant: IDEXX Laboratories Limited

Application type: Initial

Substance name:

1. 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
2. Annex 14, entry 43 - 4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof] (4-NPnEO)
   • 4-Nonylphenol, branched and linear, ethoxylated
     • EC Number: 500-024-6
     • CAS Number: 9016-45-9

Proposed use: Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and use of 4-Nonylphenol, branched and linear, ethoxylated in in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions

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

This application for authorisation covers the downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO) and 4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO) in in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions. The downstream use takes place in the UK by IDEXX’s customers, which are veterinary clinics, reference laboratories, universities, governmental laboratories or private livestock and milk laboratories. The concentration of 4-tert-OPnEO and/or 4-NPnEO in the concerned solutions is between 0.1 % to 5 % (w/w).

The IVD veterinary products covered by this use are produced outside the UK. They are used to screen for and detect various antigens, antibodies or proteins that are markers for disease or pregnancy in livestock and pets.

List of descriptors:

• Sector of end use (SU): 1, 20, 24
• Environmental release category (ERC): 8a
• Process category (PROC): 1, 15, 28
• Product category (PC): 21
• Article category related to subsequent service life (AC): N/A
• Technical Function: Surfactant

Annual tonnage used: 

• Between 0.00548 and 0.0117 tonnes/year of 4-tert-OPnEO
• Between 0.001 and 0.0021 tonnes/year of 4-NPnEO

Review period requested: 12 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).