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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 isolation of protein from recombinant cell cultures for the production of IVD-kits (protein cell extraction)
Broad information on use applied for (conditions of use and function)

Use of OPE in isolation of protein from recombinant cell cultures for the production of IVD kit components (protein cell extraction). These components are needed to formulate reagents that are necessary to analyse diagnostic samples in dedicated laboratory instruments (analyser) in the healthcare sector. There are two proteins in the scope of this use.

Octylphenolethoxylates (OPE) are used as a processing aid and component in the extraction of proteins from cell cultures that are needed in the production of commercial IVD-kit reagents.

There are 3 main functions of OPE within this use:

- To ensure a high level of cell membrane permeabilisation during the cell disruption process. This increases the efficiency of the physical cell breaking process which results in an increased protein yield.

- To act as a non-ionic detergent, which solubilises lipophilic membrane proteins in the presence of cell membrane fragments and thereby increases accessibility and reactivity of the isolated protein; and

- To stabilise lipophilic membrane proteins in an aqueous solution to avoid aggregation and disintegration.

Conditions of use: The protein purification process is performed batch-wise in a dedicated laboratory. An aqueous cell lysis solution is mixed and applied to cells. The resulting raw extract is, in the case of one protein, forwarded to another Siemens Healthineers legal entity for further processing, and the other protein is subjected to a purification column. The OPE-containing solution, once passed through the column, will be collected as hazardous waste leaving behind an OPE-free protein that can be used in further production processes, which do not involve OPE.

Annual tonnage used: 0.001-0.01 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, 5, 8a, 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
0154-01
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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