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Avis adoptés et consultations antérieures sur des demandes d’autorisation

Avis adoptés et consultations antérieures sur des demandes d’autorisation

 

This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

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Substance Details

Name
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
42
Use name
Use of OPE as detergent in the production of bead components for in-vitro diagnostic kits for an immunoassay platform
Broad information on use applied for (conditions of use and function)
Octylphenolethoxylates (OPE), under the trade name Triton X-100, are used at one site in the United Kingdom as a detergent and a stabiliser in the preparation of bead components for in-vitro diagnostic kits (IVD kits) for a specific immunoassay platform. The final IVD kits are used on analysers by hospitals, commercial laboratories and research centres to perform vital diagnoses of specific diseases and conditions in patient samples.

The manufacture of beads is undertaken in batch mode in a dedicated installation through three consecutive steps:
- Buffer formulation: Buffer solutions for use in either bead washing or bead coating are prepared by weighting OPE and other buffer ingredients and mixing it in a vessel.
- Bead washing and coating: Beads are washed and coated in the pre-prepared buffer solutions in a closed process.
- Bead drying: Beads undergo drying before being inserted into the final IVD kits. OPE is not present during this step and the dry beads produced are also OPE-free.

After use the OPE containing solutions will be collected and disposed of as hazardous waste. Rinse and cleaning solutions are collected together with other waste waters and transported to a waste water treatment plant.

The function of OPE in the beads achieving their required performance characteristics can be grouped into the following two categories:
- During bead washing, the surfactant action of OPE is exploited to remove impurities from the bead surface.
- During bead coating, OPE acts as a stabiliser for specific critical raw materials which are to be successfully deposited from aqueous buffers onto bead surfaces.

Annual tonnage used: < 0.05 tonnes
Review period requested: 9 years
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 0 – Other: Manufacture of medical and dental instruments and supplies (NACE code C32.5)
Environmental release category (ERC): 4
Process category (PROC): 3, 4, 5, 8a, 21
Product category (PC): 21
Article category related to subsequent service life (AC): n/a
Technical Function: Surfactant
Summary table of RMMs and OCs (non confidential)
Section 9 and 10 of the CSR (original and updated, if available) (non confidential)
Analysis of Alternatives (non confidential report)
Substitution Plan (non confidential summary)
Socio-Economic Analysis (non confidential report)
Joint Analysis of Alternatives and Socio-Economic Analysis (non confidential report)
Explanatory note
Additional information
ID
0173-01
Applicant(s)
Siemens Healthcare Diagnostics Products Ltd
Application type
Initial
Status
Opinions adopted
Other consultations on the same/ similar use
Comments submitted to date
No comments received
Response to comments by applicant
Responses to RAC and SEAC requests by Applicant(s) (non confidential)
Compiled RAC and SEAC opinions
Minority positions
Adopted commission decision (OJ summary)
Authorisation decision

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