Adopted opinions and previous consultations on applications for authorisation

Adopted opinions and previous consultations on applications for authorisation

Adopted opinions and previous consultations on applications for authorisation

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. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid. 

 

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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
Industrial use, as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology.
Broad information on use applied for (conditions of use and function)
4-tert-OPnEO is used as a surfactant during the purification processes for the preparation of antigens, which will in turn be included into vitro diagnostic (IVD) reagents. The IVD kits are used to diagnose infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology. The substance is not present any more in the IVD kits.
The purification processes are performed in biochemistry/biotechnology and biology laboratories and can be divided into two phases: the buffer preparation (including weighing and dilution) and the buffer application. The function of the substance, which is used in concentrations up to 10 % in aqueous buffers, is identified by the applicant as lysis of cells, lysis of cell paste, removal of contaminants (washing) and prevention from antigens unfolding, crystallisation or precipitation (storage).
The action of the 4-tert-OPnEO-buffer is aimed: to disrupt the bacterial wall cell; to remove possible contaminants bound to the protein of interest; to maintain, in solution, the purified proteins; to lyses of the eukaryote cell membranes. 4-tert-OPnEO-buffer is critical to allow the extraction of the cell proteins; to make available the protein of interest; to avoid aggregation and/or precipitation phenomena of proteins; to extract proteins from the cell nucleus.
Customers, mainly hospitals and laboratories, require the assays to be sensitive, specific, reproducible and stable over the shelf life. An alternative surfactant has to be:
- mild, non-ionic, thus it does not denature the tertiary structure of antigens and does not affect the immunological performance, in terms of sensitivity, specificity, reproducibility and stability
- selective towards contaminants to solubilise during and after lysis
- stable under operative conditions and removable from the sample without causing side-effects on the antigens, such as denaturation, aggregation or precipitation, in order to allow the following process steps. For instance, only traces of surfactants are compatible with column chromatography that is run for the purification of antigens.
Technical function: the specific function of 4-tert-OPnEO is surfactant.
Annual tonnage used: <10kg
Review period requested: 12 years
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): SU 0: Other: preparation of antigens which will be in turn included into IVDs
Environmental release category (ERC): 2, 4
Process category (PROC): 5, 9, 15
Product category (PC): 0: buffer
Article category related to subsequent service life (AC): n/a
Technical Function: Surfactant
Summary table of RMMs and OCs (non confidential)
Chemical Safety Report (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
0181-01
Applicant(s)
DiaSorin Italia S.p.A [name of applicant in the original application: DiaSorin S.p.A. updated due to a notified legal entity change]
Application type
Initial
Status
Commission decided
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)
Link
Authorisation decision
Link

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