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- Adopted opinions and previous consultations on applications for authorisation
Adopted opinions and previous consultations on applications for authorisation
Adopted opinions and previous consultations on applications for authorisation
Adopted opinions and previous consultations on applications for authorisation
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
Related links
| 0157-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Merck Biodevelopment SAS Fujifilm Diosynth Biotechnologies (UK) Ltd - [Application void as of 01/01/2021] |
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies | Commission decided | Details |
| 0156-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Sanofi Pasteur | Use of Octoxynol-9 for virus splitting and inactivation step in the manufacturing of influenza vaccines | Commission decided | Details |
| 0155-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Kedrion S.p.A | Use of 4-tert-OPnEO as Triton X-100 as detergent for virus inactivation in the manufacturing process of the human plasma-derived medicinal products Plasmagrade/Plasmasafe and Resusix, as well as Plasminogen (pre-commercialization name) and any subsequent commercialization brand | Commission decided | Details |
| 0154-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of IVD-wash solutions on diagnostic analyser systems | Commission decided | Details |
| 0154-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of IVD-kit reagents on diagnostic analyser systems | Commission decided | Details |
| 0154-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in formulation of IVD- wash solutions | Commission decided | Details |
| 0154-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in formulation of IVD-kit reagents | Commission decided | Details |
| 0154-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in isolation of protein from recombinant cell cultures for the production of IVD-kits (protein cell extraction) | Commission decided | Details |
| 0153-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | BILBAINA DE ALQUITRANES, S.A. | Use of AO for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0153-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |