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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
Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA)
Broad information on use applied for (conditions of use and function)

Octyl- and Nonylphenolethoxylates (OPnEO / NPnEO) are used in the production of proteins and in a conjugation process of latex beads (use in processes) due to their surface-active properties. The proteins and latex beads are applied as components of or for production of components of IVD assays, research products, quality control reagents and other products for analytical applications (use in downstream applications).

Typical functions of OPnEO / NPnEO in the protein production processes are increasing solubilisation of reagents, cell lysis, extraction and protein stabilisation. In the bead conjugation process, OPnEO stabilizes the beads in solution and increases the washing efficiency.

The exposure scenarios in this application cover the Use of OPnEO / NPnEO as processing aid for the production of proteins and the use as processing aid for the production of MDx enzymes in the production sites of Mannheim and Penzberg, as well as the use as processing aid for the conjugation of latex beads in Mannheim.

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.

Other surfactants can in principle be used to replace OPnEO and NPnEO in the processes. Requirements to make an alternative suitable for a specific process involve the function of the alternative in the process, but also performance requirements in a range of downstream products, including highly regulated IVD assays.

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

Annual tonnage used: OPnEO: maximum 107.6 kg/a, NPnEO: maximum 2.3 kg/a

Review period requested: 7 years

Use applied for number in application for authorisation
4
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 20, 0: Other: IVD assays and other non- IVD products
Environmental release category (ERC): 4
Process category (PROC): 5, 8a, 8b, 9, 15
Product category (PC): 0: Other: Surfactant
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
0171-06
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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