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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-Nonylphenol, branched and linear, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
43
Use name
Professional use as a surfactant in an onboard solution (Detergent B) as an accessory to In-Vitro Diagnostic Devices (IVDs) to wash the reagent probes, the mixers and the reaction cuvettes between tests to prevent interference with the test result on ARCHITECT and Alinity automated analyser systems.
Broad information on use applied for (conditions of use and function)
4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO) is used as a constituent of a wash solution (Detergent B) that is intended to be used as an accessory to an In-Vitro Diagnostic Device (IVD). The wash solution is used on-board the Applicant’s ARCHITECT and Alinity clinical chemistry diagnostic instrument systems. The instrument systems are fully automated analysers operated by trained professionals typically in clinical laboratories, hospitals, or blood banking facilities to test patients’ samples for diagnosing and monitoring a wide variety of diseases as well as other health indicators.
IVDs must be evaluated for assay to assay carryover and assess potential interference with sample results. The wash solution containing 4-NPnEO is a system cleaning solution used to wash reagent probes, mixers and cuvettes between specific tests. It is used during system operation when additional probe or cuvette washes may be required to mitigate carryover assay-to-assay interference.
The technical function of 4-NPnEO in this solution is as a surfactant and wetting agent that reduces nonspecific interactions and prevents protein binding on surfaces.
Key substance properties of 4-tert-OPnEO that allow Detergent B to function according to requirements include: surfactant classification (non-ionic): Hydrophile-Lipophile Balance (HLB); and cloud point.
While the Applicant’s substitution timeline indicates that implementation of the alternative at the non-EU Third Party Manufacturer may be possible prior to the Sunset Date, a two-year review period is requested to allow bridging activities at the downstream user sites and to mitigate against any unexpected technical problems with remaining verification and/or implementation activities that might occur after the latest application date. In addition, some time is required for downstream users to complete any conversion studies needed to evaluate carryover mitigation that may be required per individual laboratory procedures, and to deplete any remaining inventory of existing Detergent B.
Annual tonnage used: 0.03-0.3 tonnes/year
Review period requested: 2 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
Environmental release category (ERC): 8a
Process category (PROC): 5, 0: Other: Use in IVD Instruments with controlled exposures
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
0182-01
Applicant(s)
Abbott Diagnostics 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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