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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 in formulation of IVD-kit reagents
Broad information on use applied for (conditions of use and function)

Octylphenolethoxylates (OPE) are used as detergents in formulation of IVD-kit reagents for use #4. These reagents are needed to analyse human diagnostic samples in dedicated laboratory analyser systems in the healthcare sector.

OPEs have to contribute to fulfil two main parameters in the IVD kits:

- Specificity (the potential of the kit to detect a certain protein with a high accuracy) and

- Sensitivity (the degree to which a test does detect a target protein)

Conditions of use: The formulation of the kit reagents is performed batch-wise in a dedicated installation. OPE stock solution is transferred to a vessel, diluted and mixed with other ingredients. From the mixing vessel the buffer is transported via closed pipes to a dedicated IVD filling line. OPE containing rinse water will be collected and disposed of as hazardous waste.

Annual tonnage used: 0.001-0.01 tonnes

Review period requested: 12 years

Use applied for number in application for authorisation
2
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): n/a
Environmental release category (ERC): 2
Process category (PROC): 3, 5, 8a, 9, 15, 21, 28
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
0154-02
Applicant(s)
Siemens Healthcare Diagnostics Products GmbH
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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