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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. 

 

 
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. Opinion development
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. Opinion development
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Formulation of recycled soft PVC containing DEHP in compounds and dry-blends Withdrawn
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
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
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
0229-01 Review report Chromium trioxide 215-607-8 1333-82-0 Volta Energy Solutions Hungary Kft Industrial formulation of a chromium trioxide solution below 0.1% w/w concentration for the passivation of copper foil used in the manufacture of Lithium Ion Batteries (LiB) for motorised vehicles Opinion development
0222-01 Review report Sodium dichromate 234-190-3
7789-12-0
10588-01-9
Gruppo Colle.S.r.l. Use of Sodium dichromate as mordant in wool dyeing with dark colours. Opinion development
0208-01 Review report Trichloroethylene 201-167-4 79-01-6 Blue Cube Germany Assets GmbH & Co. KG Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production Opinions adopted
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
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 Opinion development
0078-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2
  • Specialty Electronic Materials Italy srl [name of lead applicant in the original application: DOW ITALIA S.R.L. updated due to a notified legal entity change]
  • DSP S.A.S. [name of co-applicant in the original application: Dow France SAS updated due to a notified legal entity change]
Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins Commission decided
0081-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 GRUPA LOTOS S.A. Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes. Commission decided
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
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
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
0080-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 H&R Ölwerke Schindler GmbH
H&R Chemisch-Pharmazeutische Spezialitäten GmbH
Industrial use as a solvent and anti-solvent of the feedstock and intermediate product streams in the combined de-waxing and de-oiling of refining of petroleum vacuum distillates for the production of base oils and hard paraffin waxes Commission decided
0111-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 OLON Spa The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient for epirubicin. Commission decided
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
0079-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Lanxess Deutschland GmbH Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange and chelating resins Commission decided
0082-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name] Industrial use of 1,2-dichloroethane as an emulsifying solvent in the manufacture of porous particles for beaded chromatography and cell culture media. Commission decided
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
0109-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Akzo Nobel Chemicals SpA The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant Commission decided
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
0029-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Laboratoires Expanscience Use as process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients Commission decided
0076-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 BASF plc - [Decision discontinued as of 01/01/2021; application transferred from original Applicant: BASF SE due to a notified legal entity change] Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) Discontinued as of 01 January 2021
0107-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 emp Biotech GmbH Use as a solvent in manufacture of polymeric particles for pharmaceutical and research purification processes Commission decided
0108-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 ORGAPHARM Use as a process solvent in the manufacture of an Active Pharmaceutical Ingredient: Flecainide acetate Commission decided
0111-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 OLON Spa The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient prednisolone steaglate. Commission decided
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
0076-01 Initial 1,2-dichloroethane (EDC) 203-458-1 107-06-2 BASF SE Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) Commission decided
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 Opinions adopted
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. Opinion development
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. Opinion development
0200-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L. Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Opinions adopted
0200-07 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing Opinions adopted
0205-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Becton Dickinson Distribution Center NV Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)) as a processing aid in imported Diagnostics Opinion development
0160-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®). Opinions adopted
0166-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Rousselot bvba Use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated as a surfactant in the manufacturing of low endotoxin gelatin Opinions adopted
0167-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. Opinions adopted
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. Opinions adopted
0190-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Teva Baltics UAB The use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated (TritonX-100) as a nonionic surfactant for bacteria cells disruption and washing of inclusion bodies in Biological Drug Substance manufacturing process Opinions adopted
0195-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - RSI ChemRep Europe Ltd (O002) OR for OraSure Technologies Inc Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as surfactant in in –vitro diagnostic device developer solution. Opinion development
0196-01 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 (syringes and cartridges) used as primary packaging material for 44 medicinal products of several pharmaceutical companies listed in the confidential Appendix 1 to the AoA. These products cover several therapeutic areas, and approx. 40 % of them are listed on the WHO Model List of Essential Medicines (EML). Opinions adopted
0197-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - MERCK MILLIPORE LIMITED Downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as component of mixed cellulose ester membranes. Opinions adopted
0198-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Pfizer Ireland Pharmaceuticals The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals - Viral Inactivation and associated processes. Opinion development
0199-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Sanquin Reagents B.V. Use of Triton™ X-100 (4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated) in formulation of components for IVD kits. Opinions adopted
0201-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A. Industrial use as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs Opinion development
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 Opinions adopted
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 Opinions adopted



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