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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-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
42
Use name
Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of 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 the formulation of IVD assays as well as filling of the assays, where they are introduced as an auxiliary chemical in one or several liquid reagents.

Both substances fulfil their function in the final product, i.e. 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 reported in this application cover the formulation and filling of reagents for IVD assays at the production sites of Mannheim and Penzberg and the formulation of test strips at the site of Mannheim.

The activities performed at these sites typically include storage, weighing, transfer of raw materials to a blend tank, transfer of bulk reagents / solutions to intermediate containers, filling of small flasks or application on strips, maintenance and cleaning of equipment.

Regarding risk management measures applied and relevant for the environmental hazard of the substances, it should be noted that surplus, used buffers and solid waste are collected and incinerated. Wastewater is sent to a municipal STP (in Mannheim) or to an on-site industrial STP (in Penzberg). 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 1326 kg/a. NPnEO: maximum 217.4 kg/a

Review period requested: 7 years

Use applied for number in application for authorisation
2
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 20, 0: Other: IVD assays
Environmental release category (ERC): 2
Process category (PROC): 5, 8a, 8b, 9, 13, 15, 21
Product category (PC): 0: Other: Surfactant
Article category related to subsequent service life (AC): n/a
Technical Function: Other: In final product: surfactant. No technical function during formulation and filling
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
0171-01
Applicant(s)
Roche 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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