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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

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
CAS Number
Entry Nr in Annex XIV
Use name
Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA.
Broad information on use applied for (conditions of use and function)

Octyl- and / or Nonylphenolethoxylates (OPnEO and / or NPnEO) are used in IVD kits due to their surface-active properties and are usually used as an auxiliary chemical in one or several liquid reagents used for each assay.

Substances may fulfil different functions during the performance of the assay. Typical technical functions of OPnEO and / or NPnEO are: increasing solubilisation and stabilisation of reagents; lysis of blood cells and lipid membranes; reduction of carryover effect from one sample to the following one; reduction of matrix interferences; decrease of assay imprecision; wetting agents.

The exposure scenarios in this application cover the usage of the IVD assays in laboratories, hospitals, blood banks or at ambulatory points of care. The scenarios also include the generation of waste and handling of such waste.

Regarding risk management measures applied and relevant for the environmental hazard of the substances, it should be noted that solid waste is typically advised to be collected and disposed of ‘as if it was hazardous waste’. No release to air is expected due to low volatility of the substances.

As already completed substitutions of OPnEO and NPnEO and experiences in the development of new products have shown, other surfactants can in principle be used to replace OPnEO and NPnEO in IVD assays.

Specific performance requirements of the IVD assays are decisive for the assessment whether a specific alternative surfactant is suitable for replacement in a specific IVD assay or not. IVD products are highly regulated in countries world-wide. Therefore, several steps are required to accomplish substitution which focus on performance of the IVD assay.

Several alternative substances have been identified and are further assessed for their technical suitability.

Annual tonnage used: OPnEO: maximum 646.3 kg/a, NPnEO: maximum 54.8 kg/a

Review period requested: 7 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): 8a
Process category (PROC): 15
Product category (PC): 0: Other: IVD assays
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
Roche Diagnostics GmbH
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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