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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. 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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
CAS Number
Entry Nr in Annex XIV
Use name
Use as a lysing agent for red blood cells in blood analysis diagnostic device.
Broad information on use applied for (conditions of use and function)
The use of 4-tert-OPnEO relates to the production of lysing bags contained in disposable cartridges which are used in two diagnostic devices: GEM® PREMIER 4000 and GEM® PREMIER 5000. These two types of instruments are used in different clinical settings (laboratories, intensive care units, operating rooms, and emergency departments) to measure and to report concentrations of critical analytes in blood (e.g., pressure of oxygen and carbon dioxide as well as haemoglobin and haemoglobin fractions through CO-Oximetry).
The GEM analyser is comprised of an instrument housing a disposable cartridge (PAK) which contains all the components required to perform whole blood-gas analysis. Bags containing the solutions needed for analyses, including 4-tert-OPnEO, are filled, sealed and inserted into the cartridge at the manufacturing facility. The cartridge contains a waste-bag collecting the mixture of blood sample, 4-tert-OP-nEO and other reagents after the analyses. Thus, during operation, the cartridge is a closed system containing all solutions needed for the analysis as well as the waste from the analysis. There are no releases from the instrument or the PAK during use. The waste bag has a ventilation system with a membrane that allows exchange of gasses with the outside air. Liquids cannot pass the membrane. This is to prevent gasses from the waste to build up a pressure in the waste bag. After use, the cartridges are discarded in containers for infectious waste. The infectious waste containers are labelled according to the EU directive on transport of dangerous goods (EU 2008). The containers are collected by authorized waste companies. The end treatment is by incineration.

The applicant of this application for authorization is an Italian company (based in Milan) that imports into the EEA the disposable cartridges manufactured in Bedford (MA, USA) containing lysing bags that are manufactured in Orangeburg (NY, USA). The applicant is the sole importer into the EEA of the in-scope products for this application for authorization.

4-tert-OP-nEO is used as a lysing agent to rupture the cell membranes of the red blood cells in a whole blood sample. The blood measurement algorithms of the GEM Premier analyzers require complete and fast lysis (1 to 2 seconds) for accurate measurements and reporting results in 45 seconds to diagnose and treat critically ill patients.

Annual tonnage used: 6 tonnes
Review period requested: 12 years
Use applied for number in application for authorisation
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 20
Environmental release category (ERC): 9a
Process category (PROC): 15
Product category (PC): 21
Article category related to subsequent service life (AC): No
Technical Function: Lysing agent
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
Instrumentation Laboratory SpA
Application type
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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