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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
| 0060-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane | Commission decided | Details |
| 0110-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Bayer AG [application transferred from original applicant: Bayer Pharma AG, due to a notified legal entity change] | Use as an industrial solvent in the manufacture of the high-grade pure final intermediate of Iopromide, the Active Pharmaceutical Ingredient for the X-ray contrast medium Ultravist® | Commission decided | Details |
| 0077-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Eli Lilly Kinsale Limited [application transferred from original Applicant: Eli Lilly S.A. - Irish Branch due to a notified legal entity change] | Industrial use as a reaction medium and a solvating agent in mediating subsequent chemical transformation reactions leading to the manufacture of an Active Pharmaceutical Ingredient, Raloxifene Hydrochloride | Commission decided | Details |
| 0108-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | ORGAPHARM | Use as an process solvent in the manufacture of an Active Pharmaceutical Ingredient: Nefopam hydrochloride | Commission decided | Details |
| 0223-01 | Review report | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins. | Commission decided | Details |
| 0224-01 | Review report | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | EURENCO | Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives. | Commission decided | Details |
| 0083-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | EURENCO | Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives | Commission decided | Details |
| 0079-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins | Commission decided | Details |
| 0120-01 | Initial | 1,2-dichloroethane (EDC) | 203-458-1 | 107-06-2 | Microbeads AS | Industrial use as a swelling agent during the sulfonation reaction of crosslinked polystyrene beads in the manufacture of ion exchange resins for purification of radioactive waste | Commission decided | Details |
| 0078-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
|
Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins | Commission decided | Details |
| 0072-06 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Souriau sas; TE UK Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). | Commission decided | Details |
| 0040-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
CAFFARO BRESCIA S.r.l | Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorite | Commission decided | Details |
| 0041-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Akzo Nobel Pulp and Performance Chemicals AB Akzo Nobel Pulp and Performance Chemicals Oy Akzo Nobel Pulp and Performance Chemicals S.A.S. |
Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide. | Commission decided | Details |
| 0137-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
SOCIETA' CHIMICA BUSSI S.P.A. | Use of sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacturing of sodium chlorite. | Commission decided | Details |
| 0072-07 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Souriau sas “Amphenol Limited – [Decision discontinued as of 01/01/2021] AMPHENOL SOCAPEX |
Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. | Commission decided | Details |
| 0043-02 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Brenntag Chemicals Distribution (Ireland) Ltd [application transferred from original Applicant: Brenntag UK Ltd due to a notified legal entity change] Henkel AG & Co. KGaA AD International BV |
Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites and sealings of anodic films | Commission decided | Details |
| 0343-02 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Pre-treatments: Deoxidising, pickling, etching and/or desmutting using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0327-03 | Initital | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O | Chemical conversion coating using chromium trioxide, sodium dichromate and/or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0332-03 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0345-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0304-01 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Acciaierie d'Italia S.p.A. | Use of Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0342-03 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0211-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Tata Steel IJmuiden BV; Tata Steel UK Ltd - [Application void as of 01/01/2021] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0340-02 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Inorganic finish stripping using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0301-02 | initial | Sodium dichromate | 234-190-3 | 10588-01-9 | LIBERTY GALATI SA [application transferred from original Applicant: "Liberty Liège Dudelange (BE)” due to a notified legal entity change] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0311-01 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Liebherr-Aerospace Lindenberg GmbH | Industrial use of sodium dichromate for the sealing after anodizing of aluminium alloys and passivation of metallic coatings of actuation and landing gear system parts for the aviation industry that meet the airworthiness certification requirements | Opinions adopted | Details |
| 0341-04 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Formulation of mixtures with soluble Cr(VI) compounds for use in aerospace and defence industry and its supply chains for surface treatments | Opinion development | Details |
| 0334-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0337-04 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Chemical conversion coating using chromium trioxide, sodium dichromate, potassium dichromate and/or dichromium tris(chromate) in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0336-02 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O; AD International BV; Brenntag Chemicals Distribution (Ireland) Ltd | Anodise sealing using chromium trioxide, potassium dichromate, sodium chromate and/or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0355-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Airbus Helicopters Technik GmbH | Surface treatment of metals (such as aluminium, steel, zinc, magnesium, titanium, alloys), composites and sealings of anodic films, in the production of transmissions for helicopters and in maintenance of helicopters. | Opinions adopted | Details |
| 0274-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0124-01 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 |
H&R Ölwerke Schindler GmbH; H&R Chemisch-Pharmazeutische Spezialitäten GmbH |
Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems, applied for the dewaxing and deoiling process steps of petroleum raffinate. | Commission decided | Details |
| 0356-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | AD International BV | Use of SDC in formulation of mixtures intended for supply for authorised uses | Opinion development | Details |
| 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 |
| 0246-01 | Initial | 2,2'-dichloro-4,4'-methylenedianiline (MOCA) | 202-918-9 | 101-14-4 | Courbis Synthèse Annovi S.r.l.; Dansk Elastomer A/S; Durlast S.r.l.; Pieffe S.r.l.; Policart S.r.l.; R.B.M. Italia S.r.l.; Tecnocaucho S.A.; Tegea S.r.l.; Optibelt Urethane Belting Ltd.; Productos Salinas S.A.; V.M. SPA | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of hot cast polyurethane products | Commission decided | 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 |
| 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 |