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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-Nonylphenol, branched and linear, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
43
Use name
Industrial use of 4-NPnEO for its detergent properties in the production of buffers and reagents in view of ensuring the positioning of specific proteins necessary for the interpretation of gel electrophoresis in vitro diagnostic tests results based on the determination of isoenzymes.
Broad information on use applied for (conditions of use and function)
Substance function and performances expected for final products
4-NPnEO is used industrially for its isolating properties of specific proteins needed for the interpretation of in vitro diagnostic test results based on protein separation. The following products are concerned by this use:
  • Gel buffers integrated in agarose gels. After formulation, these buffer solutions are mixed with agarose gels, thus forming casting solutions that will be applied to the plastic electrophoresis support;
  • Substrate solutions: by adding the detergent to the substrate solution, the solubilization of the substrate is ensured, allowing a better mixing with the chromogen and during its deposit, a good distribution of the resulting chromogenic substrate on the gel.

The main functional properties sought-after with 4-NPnEO include:
  • Optimizing the solubilisation and the migration of proteins of clinical interest, resulting thus in the improvement of the test sensitivity
  • Stabilising enzymes and their substrate in view of increasing the test sensitivity and reproducibility performances
  • Separating and immobilizing isoenzymes that disrupt the interpretation of results and decrease the test specificity

Key elements of the conditions of use
  • The commercialized in vitro testing kits present 4-NPnEO -containing mixtures in concentration less than 5 % (w/w).
  • Products concerned by this use represent around 1% of the global Company’s turnover, but SEBIA has a near-monopoly of in this assays area.
  • Under this use, 4-NPnEO is used as the commercial Nonidet™P-40 in the production of electrophoresis gel assays.
  • Between 2015 and 2018, around 1.31 kg of 4-NPnEO were consumed by SEBIA per year in the context of the production of these gel supports. The maximum quantity of 4-NPnEO used in SEBIA’s facilities could reach 2 kg in 2022. The increase of 4-tert-OPnEO quantities is linked to SEBIA business model based on an economical growth value calculated on the basis of investments and current developments of the company. In this context, at less than this growth value, the viability of the company would no longer be ensured. For this reason, consumption, until substitution, will continue to follow this minimum growth rate.
  • All liquid effluents potentially containing 4-NPnEO are concentrated on-site (evapo-concentrator and/or osmo-films) and contaminated solid wastes are collected and incinerated by a certified provider. The only potential extremely low releases arise from washing of non-disposable glassware.
  • 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 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: 2 kg
Review period requested: 7 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
Process category (PROC): 0, 5, 8b, 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
0142-01
Applicant(s)
SEBIA
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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