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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
The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of one biopharmaceutical protein, a biosimilar product, used to prevent infection and neutropenic fevers.
Broad information on use applied for (conditions of use and function)
Triton X-100 is used in the manufacture of a biopharmaceutical protein, which is used for the manufacture of one biosimilar product used to prevent infection and neutropenic fevers. The use takes place at one site in Croatia.

The function of Triton X-100 is the removal of biological contaminants, namely residual E. coli host cell proteins and DNA, from the biopharmaceutical protein produced during "upstream" manufacture. The solubilisation of these contaminants is due to the amphipathic character of Triton X-100, i.e. its molecules having both hydrophilic and hydrophobic parts.

Triton X-100 is used in accordance with the use conditions set out in the CSR:
- Triton X-100 is stored in a locked and bunded cabinet prior to being used in the preparation of a solution that will be used in the upstream process (0.1% Triton X-100 w/w).
- Once prepared, the solution is stored in a closed disposable bag in the cold storage area before being transported to the production area.
- The Triton X-100 containing solution is mixed with the intermediate product before being piped into a homogeniser where the Triton X-100 performs the function outlined above.
- Once this step has been completed, the solution is piped to a centrifuge where the Triton X-100 containing waste stream is separated from the intermediate product and stored in a segregated special waste container.
- The biopharmaceutical protein is further purified from the intermediate product via several chromatography and ultrafiltration steps in the downstream process.
- Aqueous process waste that has the potential to contain Triton X-100 is segregated as hazardous waste and sent off site for incineration using specialist waste contractors.
- Triton X-100 is only present in aqueous waste streams generated by Hospira Zagreb. There are no other routes of Triton X-100 exposure to the environment.

Annual tonnage used: < 0.01 tonnes
Review period requested: 12 years
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 9, 20 Environmental release category (ERC): 4 Process category (PROC): 1, 8b, 28 Product category (PC): 29 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
0174-01
Applicant(s)
Hospira Zagreb d.o.o., a Pfizer company
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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