Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
| 0094-01 | Initial | 2,2'-dichloro-4,4'-methylenedianiline (MOCA) | 202-918-9 | 101-14-4 | REACHLaw Ltd in its legal capacity as Only Representative of Suzhou Xiangyuan Special Fine Chemical Co., Ltd | Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production | Withdrawn | Details |
| 0225-01 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for custom-made rollers with high reliability requirements for steel and aluminium sectors. | Commission decided | Details |
| 0225-02 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for heavy-duty rollers, tensioner pads and spring blocks with high reliability requirements for offshore energy and renewables sectors. | Commission decided | Details |
| 0007-02 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Roxel (UK Rocket Motors) Ltd | Industrial use of DBP in manufacture of solid propellants and motor charges for rockets and tactical missiles | Authorisation expired | Details |
| 0005-03 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. | Industrial use of DBP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Authorisation expired | Details |
| 0126-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | AVX NI [application transferred from: "AVX Limited" due to a notified legal entity change] | Industrial use in the manufacture of ceramic sheets for the production of multi-layer ceramic capacitors. | Commission decided | Details |
| 0005-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. | Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride | Commission decided | Details |
| 0006-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Sasol-Huntsman GmbH & Co. KG | Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride | Commission decided | Details |
| 0005-02 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. |
Use of DBP in propellants Formulation: Industrial use of DBP as a burning rate surface moderant, plasticiser and/or coolant in the formulation of nitrocellulose-based propellant grains. Use at industrial site: Industrial use of DBP-containing propellant grains in manufacture of ammunition for military and civilian uses, and pyrocartridges for aircraft ejection seat safety systems [includes propellants for police force ammunition and excludes propellants intended for manual, private reloading of ammunition cartridges by civilian users, i.e., licensed individual sports shooters and hunters. No direct consumer use of DBP or its mixtures is covered by this Use.] |
Commission decided | Details |
| 0007-03 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Roxel (UK Rocket Motors) Ltd | Industrial use of DBP within a specialty paint in manufacture of motors for rockets and tactical missiles | Authorisation expired | Details |
| 0026-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Richard Geiss GmbH | Use of tricholoroethylene in formulation | Commission decided | Details |
| 0025-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Chimcomplex S.A. Borzesti | Industrial use of trichloroethylene (TCE) as a solvent as a degreasing agent in closed systems | Authorisation expired | Details |
| 0243-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | DOMO Caproleuna GmbH | Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil | Commission decided | Details |
| 0129-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | SPOLANA s.r.o. [name of applicant in the original application: SPOLANA a.s. updated due to a notified change of corporate name] | Use as an extraction solvent in caprolactam production | Commission decided | Details |
| 0014-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Vlisco Netherlands BV | Use of trichloroethylene as a solvent in a process to recover and purify resin from process water | Commission decided | Details |
| 0208-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production | Commission decided | Details |
| 0024-03 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Use of tricholoroethylene in packaging | Commission decided | Details |
| 0014-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Vlisco Netherlands BV | Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth | Commission decided | Details |
| 0242-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as extraction solvent in the manufacture of polyethylene separators for lead-acid batteries | Opinions adopted | Details |
| 0019-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Parker Hannifin Manufacturing Netherlands (Filtration & Separation) BV | Use of trichloroethylene (TCE) as a process solvent for the manufacturing of modules containing hollow fibre gas separation membranes | Commission decided | Details |
| 0022-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SPOLANA a.s. | Use as an extraction solvent in caprolactam production | Commission decided | Details |
| 0018-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ROQUETTE Frères | Use of trichloroethylene as a processing aid in the biotransformation of starch to obtain betacyclodextrin | Commission decided | Details |
| 0026-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Richard Geiss GmbH | Use of tricholoroethylene in packaging | Commission decided | Details |
| 0021-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Grupa Azoty S.A. | Industrial use as a process chemical in caprolactam purification | Commission decided | Details |
| 0016-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as degreasing solvent in the manufacture of polyethylene separators for lead-acid batteries | Commission decided | Details |
| 0020-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | DOMO Caproleuna GmbH | Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil | Commission decided | Details |
| 0024-04 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Use of tricholoroethylene in formulation | Commission decided | Details |
| 0024-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Use Of Trichloroethylene in Industrial Parts Cleaning by Vapour Degreasing in Closed Systems where specific requirements (system of use-parameters) exist | Authorisation expired | Details |
| 0227-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | ROQUETTE Frères | Use as a processing aid in the biotransformation of starch to obtain betacyclodextrin | Commission decided | Details |
| 0017-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ENTEK International Limited – [Decision discontinued as of 01/01/2021] | Trichloroethylene as an extraction solvent for removal of process oil and formation of the porous structure in polyethylene based separators used in lead-acid batteries | Discontinued as of 01 January 2021 | Details |
| 0027-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | RAG Aktiengesellschaft, RAG Anthrazit Ibbenbüren GmbH | Use of Tricholoroethylene-containing vulcanising and bonding agents for endless connections and repair of chloroprene rubber coated conveyor belts in underground hard coal mining | Authorisation expired | Details |
| 0024-05 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Use of Trichloroethylene as Extraction Solvent for Bitumen in Asphalt Analysis | Commission decided | Details |
| 0023-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | A.L.P.A.-AZIENDA LAVORAZIONE PRODOTTI AUSILIARI S.P.A.; CAFFARO INDUSTRIE S.P.A | Use of trichloroethylene as solvent in the synthesis of vulcanization accelerating agents for fluoroelastomers | Commission decided | Details |
| 0024-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Industrial use as process chemical (enclosed systems) in Alcantara Material production | Commission decided | Details |
| 0361-01 | Initial | tetraethyllead | 201-075-4 | 78-00-2 | Trafigura Ventures V.B.V. | Blending of TEL in Avgas formulations | Opinion development | Details |
| 0353-01 | Initial | Tetraethyllead | 201-075-4 | 78-00-2 | Shell Nederland Raffinaderij B.V. | Use of tetraethyl lead in the formulation of aviation fuel | Opinion development | Details |
| 0362-01 | Initial | tetraethyllead | 201-075-4 | 78-00-2 | Warter Fuels Spółka Akcyjna | FUEL FORMULATION WITH ADDED TETRAETHYL LEAD | Opinion development | Details |
| 0139-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Ortho-Clinical Diagnostics - [Application void as of 01/01/2021] | Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) for use in the manufacture of in vitro diagnostic VITROS® products used for infectious disease screening, endocrinology, and oncology testing. | Application void as of 01 January 2021 | Details |
| 0140-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO in view of controlling the amount of non-specific reactions in the production of in-vitro diagnostic reagents (STA® - Liatest® D-Di assays). | Commission decided | Details |
| 0169-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Janssen Vaccines & Prevention BV Janssen Biologics B.V. |
4-tert-Octylphenol ethoxylate is used as a lysing agent for the permeabilization of the host cell membrane to release adenovirus particles used for the manufacture of vaccines. Its use allows the selective elimination of enveloped adventitious viruses and is compatible with the chemicals needed to control the host cell DNA precipitation in the next process step. | Commission decided | Details |
| 0206-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Phadia GmbH; Thermo Fisher Scientific Baltics UAB | Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB | Commission decided | Details |
| 0161-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Vetter Pharma-Fertigung GmbH & Co. KG | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company. | Commission decided | Details |
| 0167-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Abbott Ireland Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] Abbott Diagnostics GmbH |
Professional use as a surfactant in the final use of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. | Commission decided | Details |
| 0187-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | AGC Biologics A/S | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as detergent for the inactivation of viruses in the production of therapeutic proteins using mammalian cell hosts in projects where processes have been approved by the authorities (GMP compliant) | Commission decided | Details |
| 0200-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | QIAGEN GmbH | Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing | Commission decided | Details |
| 0141-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests. | Commission decided | Details |
| 0163-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Wallac Oy | Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments | Commission decided | Details |
| 0197-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | MERCK MILLIPORE LIMITED | Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes). | Commission decided | Details |
| 0188-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Wallac Oy | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (as Triton X-100) in the assay buffer of the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity | Commission decided | Details |
| 0206-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Phadia GmbH; B∙R∙A∙H∙M∙S GmbH | Coating Thyroid Stimulating Hormone Receptor onto articles used as components of IVD reagent systems at B∙R∙A∙H∙M∙S GmbH and Phadia GmbH | Commission decided | Details |