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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

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
CAS Number
Entry Nr in Annex XIV
Use name
Use of IVD-kit reagents on diagnostic analyser systems
Broad information on use applied for (conditions of use and function)

Octylphenolethoxylates (OPE) are used as detergents in IVD-kits.

Conditions of use: To perform an assay for a specific disease or condition, the customer is essentially running a ‘ready to use’ IVD-kit on a compatible analyser system. After use OPE-containing solutions are discharged to the sewage and communal STP.

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)
  • Stability (IVD kits are required to have a long shelf-life)

Annual tonnage used: <1 tonne

Review period requested: 20 years

Use applied for number in application for authorisation
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 20
Environmental release category (ERC): 8a
Process category (PROC): 8b, 15, 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
Siemens Healthcare Diagnostics Products GmbH
Application type
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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