Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
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There are currently no ongoing consultations.
| 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 |
| 0180-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application | Commission decided | Details |
| 0180-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent property in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles | Commission decided | Details |
| 0180-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Commission decided | Details |
| 0180-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications | Commission decided | Details |
| 0180-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Bio-Rad | Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Commission decided | Details |
| 0204-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Biokit S.A. | Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | Commission decided | Details |
| 0204-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Biokit S.A. | Professional use of 4-tert-OPnEO as a detergent during the final use of latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | Commission decided | Details |
| 0145-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB). | Commission decided | Details |
| 0145-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population. | Commission decided | Details |
| 0143-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent to control the level of non-specific reactions in the formulation of in vitro reagents for clinical and industrial in vitro testing immunoassays. | Commission decided | Details |
| 0143-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its detergent properties, used for the extraction of biological material which is further formulated and intended for clinical and industrial in vitro testing applications. | Commission decided | Details |
| 0143-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of reagents for molecular clinical and industrial in vitro preparative and testing applications. | Commission decided | Details |
| 0179-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, consisting in the filling of 4-tert-OPnEO-containing solutions into specific single-use ampoules to be included in clinical and industrial in vitro testing applications as part of the BioFire and BioFire Next Gen FA products. | Commission decided | Details |
| 0349-01 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, used for the extraction of biological material which is further formulated and coated on articles intended for clinical and industrial in vitro testing applications | Opinions adopted | Details |
| 0298-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Bjerringbro Fornikling A/S | Electroplating (by a job plater) of metal substrates using chromium trioxide to achieve functional surfaces | Opinions adopted | Details |
| 0138-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim RCV GmbH & Co KG |
Use of 4-tert-OPnEO in a washing buffer to purify biological APIs (active pharmaceutical ingredients) during the production of Palivizumab and Moxetumomab pasudotox-tdfk. | Commission decided | Details |
| 0247-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Boehringer Ingelheim RCV GmbH & Co KG | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification of lipidated OspA protein subsequently used for manufacturing of Lyme disease vaccine candidate. | Commission decided | Details |
| 0118-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Boeing Distribution Deutschland GmbH [name of applicant
in the original application: Aviall Services Inc updated due to a notified change of corporate name]; Finalin GmbH |
Use of pentazinc chromate octahydroxide in wash primer, fuel tank primer and aluminized primer for the purpose of corrosion protection in aeronautic applications | Commission decided | Details |
| 0118-01 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Boeing Distribution Deutschland GmbH [name of applicant
in the original application: Aviall Services Inc updated due to a notified change of corporate name]; Finalin GmbH |
Formulation of mixture | Commission decided | Details |
| 0338-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Chromate rinsing after phosphating using chromium trioxide in aerospace and defence industry and its supply chains | Opinions adopted | Details |
| 0343-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Pre-treatments: Deoxidising, pickling, etching and/or desmutting using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinions adopted | Details |
| 0345-02 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinions adopted | Details |
| 0335-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Anodising using chromium trioxide in aerospace and defence industry and its supply chains | Opinions adopted | Details |
| 0339-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Electroplating using chromium trioxide in aerospace and defence industry and its supply chains | Opinions adopted | Details |