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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
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| 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Chemical Co., Ltd | Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production | Withdrawn | Details |
| 0167-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott Ireland | Professional use of system solutions (Pre-Trigger and Trigger) in the final use of the In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. | Withdrawn | Details |
| 0182-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Abbott Diagnostics GmbH | Professional use as a surfactant in an onboard solution (Detergent B) as an accessory to In-Vitro Diagnostic Devices (IVDs) to wash the reagent probes, the mixers and the reaction cuvettes between tests to prevent interference with the test result on ARCHITECT and Alinity automated analyser systems. | Withdrawn | Details |
| 0230-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Safran Landing Systems; SOCIETE DE TRAITEMENTS ELECTROLYTIQUES NORMALISES S.T.E.N. | Industrial use of 4-NPnEO as non-reactive surfactant in the sealing product in sulfuric acid anodization process of aluminium alloy parts of aircraft landing gears | Withdrawn | Details |
| 0122-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. |
Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Withdrawn | Details |
| 0122-02 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. |
Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrials workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. | Withdrawn | Details |
| 0002-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | Details |
| 0004-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | Details |
| 0004-03 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use of DEHP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Withdrawn | Details |
| 0003-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0002-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0003-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | Details |
| 0004-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0299-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | 9036-19-5 | MeiraGTx Ireland Designated Activity Company | Use of 4-tert-OPnEO as a manufacturing aid in the production of gene therapies | Opinions adopted | Details |
| 0164-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Swedish Orphan Biovitrum | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in manufacture of biopharmaceuticals by Swedish Orphan Biovitrum AB. | Opinions adopted | Details |
| 0202-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Merckle-GmbH-Ulm | The use of 4-OPnEO as an emulsifier in a silicone oil emulsion for siliconization of pre-filled syringes in a medicinal product | Opinions adopted | Details |
| 0317-01 | Initial | Acids generated from chromium trioxide and their oligomers | - | - | Micron srl | Dilution of chromic acid solution at concentrations lower than 0.1% for the use in passivation baths | Opinions adopted | Details |
| 0123-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Plastic Planet srl | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Opinions adopted | Details |
| 0123-02 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Plastic Planet srl | Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrial workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. | Opinions adopted | Details |
| 0278-01 | Review report | Bis(2-methoxyethyl) ether | 203-924-4 | 111-96-6 | PMC ISOCHEM | Use as a process solvent in one step of manufacturing of an active pharmaceutical ingredient used in an anti-protozoal drug | Opinions adopted | Details |
| 0235-01 | Initial | Chromic acid | 231-801-5 | 7738-94-5 | Neoperl GmbH | The use of chromic acid in the functional electroplating of brass-made sanitary articles with the specific purpose of obtaining a final Cr(0) coating that provides a surface with high durability and chemical resistance. | Opinions adopted | Details |
| 0264-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | CRISTINA SRL A SOCIO UNICO | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications. | Opinions adopted | Details |
| 0297-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Acciaierie d'Italia S.p.A. | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) | Opinions adopted | Details |
| 0252-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Eastern Europe Sp. z o.o. | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Eastern Europe Sp. z o.o. in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0274-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |