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Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

 

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
Industrial use of 4-tert-OPnEO for its wetting detergent properties in the production of buffers, reagents and gel supports allowing the dissolution, the dilution and the good spreading of substrates and reagents, necessary to optimize the functioning and the sensitivity of gel electrophoresis in vitro diagnostic tests.
Broad information on use applied for (conditions of use and function)
Substance function and performances expected for final products Under use-1, 4-tert-OPnEO is used industrially for its wetting properties necessary for the dissolution, the dilution and the good spreading of substrates and reagents in the different components of the in vitro diagnostic kits.

The following type of products are concerned by use 1:
-Dyes and colouring bases allowing a good reading of separated proteins;
-Strip buffers ensuring contact and thus migration between the gel and electrodes;
-Fixing solutions immobilizing the proteins in the gel at the expected migration level and as described in the corresponding kit leaflet;
-Antiserum diluents, optimizing the spreading of antiserum in the gel medium. Antiserum solutions contain immunoglobulins directed against human Ig G, conjugated to an enzyme. In the context of the immunofixation process of interest, the sample Ig G binds antiserum Ig;
-Substrate solvents, ensuring a better distribution of the substrate on the gel and thus a better separation of proteins;
-Coated plastic support produced by REXOR for SEBIA

The main functional properties sought after with 4-tert-OPnEO include:
-Optimization of the molecules’ migration by solubilization and stabilisation of proteins in order to improve test sensitivity and reproducibility,
-Medium wettability conditions required for support- dependant reactions and optimization of the test sensitivity,
-Continuity between electrophoresis elements and solutions in view of increasing test sensitivity and reproducibility.

Key elements of the conditions of use
-The commercialized in vitro testing kits concerned by use-1 involve 4-tert-OPnEO-containing mixtures in concentration of less than 5 % (w/w).
-In this purpose, a solution containing 4-tert-OPnEO in a concentration of 50 g/L is supplied by SEBIA to the subcontractor REXOR manufacturing one of the references concerned by this use. This product (plastic support coated with 4-tert-OPnEO solution) is employed as the basis of all the gel electrophoresis references manufactured by the Applicant.
-Waste collection:
1) In REXOR’s facilities, all the liquid and soiled solid waste generated during the coating process at the subcontractor’s site are taken in charge by approved processing systems. Only extremely low releases arise from a second step of washing of the equipment of the coating line.
2) In SEBIA facilities, liquid effluents are collected and concentrated on-site using an evapo- concentrator and/or osmo-films. The only potential extremely low releases arise from washing of non-disposable glassware. Soiled solid wastes are collected in dedicated containers and disposed of by a certified company
-According to the requirements regulating medical diagnostic devices, the change of detergent, as for any other raw material, will have regulatory impacts. At European level, any imported in vitro diagnostic medical device placed on the market or in use must have a CE marking. This CE marking may be affixed to an in vitro diagnostic medical device only if it complies with the essential requirements and has been subjected to the evaluation procedures applicable to it. If production under use-1 doesn’t comply with the regulation and the level of performance associated to it, it can no longer be commercialized in the European Union.

Annual tonnage used: 101 kg
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): 20, 24
Environmental release category (ERC): 2, 3
Process category (PROC): 0, 5, 9, 15
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
0141-01
Applicant(s)
SEBIA
Application type
Initial
Status
Opinions adopted
Other consultations on the same/ similar use
Comments submitted to date
Download
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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