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Antagna yttranden och tidigare samråd om tillståndsansökningar

Antagna yttranden och tidigare samråd om tillståndsansökningar

 

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. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

 
0082-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 GE Healthcare Bio-Sciences AB 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
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
0110-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Bayer Pharma AG 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
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
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
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
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
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
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
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
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
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
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
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
0126-01 Initial Dibutyl phthalate (DBP) 201-557-4 84-74-2 AVX Limited Industrial use in the manufacture of ceramic sheets for the production of multi-layer ceramic capacitors. Commission decided
0024-02 Initial Trichloroethylene 201-167-4 79-01-6 Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] Industrial use as process chemical (enclosed systems) in Alcantara Material production Commission decided
0024-03 Initial Trichloroethylene 201-167-4 79-01-6 Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] Use of tricholoroethylene in packaging Commission decided
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
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
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
0024-04 Initial Trichloroethylene 201-167-4 79-01-6 Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] Use of tricholoroethylene in formulation Commission decided
0026-01 Initial Trichloroethylene 201-167-4 79-01-6 Richard Geiss GmbH Use of tricholoroethylene in formulation Commission decided
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
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
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
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
0024-05 Initial Trichloroethylene 201-167-4 79-01-6 Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] Use of Trichloroethylene as Extraction Solvent for Bitumen in Asphalt Analysis Commission decided
0017-01 Initial Trichloroethylene 201-167-4 79-01-6 ENTEK International Limited 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 Commission decided
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
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
0022-01 Initial Trichloroethylene 201-167-4 79-01-6 SPOLANA a.s. Use as an extraction solvent in caprolactam production Commission decided
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 Opinions adopted
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 Commission decided
0026-02 Initial Trichloroethylene 201-167-4 79-01-6 Richard Geiss GmbH Use of tricholoroethylene in packaging Commission decided
0024-01 Initial Trichloroethylene 201-167-4 79-01-6 Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH 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 Commission decided
0141-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - SEBIA Industrial use of 4-tert-OPnEO for its detergent properties in the production of electrophoresis gels in view of ensuring the positioning of specific proteins necessary for the interpretation of results of gel electrophoresis in vitro diagnostic tests. Opinion development
0157-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Merck Biodevelopment SAS
FUJIFILM Diosynth Biotechnologies UK Limited
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies Opinion development
0186-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc. In-process production use of OPnEO as a washing buffer used in the coating of in vitro diagnostic immunoassay particles. Opinion development
0186-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.;
Immunotech S.R.O.;
Immunotech S.A.S.
Formulation of OPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. Opinion development
0186-06 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.;
Immunotech S.R.O;
Immunotech S.A.S.;
Beckman Coulter S.A.S.;
Beckman Coulter Česká republika s.r.o.;
Beckman Coulter UK Ltd;
Beckman Coulter S.L.U;
Beckman Coulter SPA Italy;
BC Distribution B.V
Downstream use of OPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development. Opinion development
0184-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Lilly France S.A.S.; Eli Lilly Italia S.p.A. Industrial formulation (dilution) of a silicone solution containing 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and its subsequent use as a lubricant in the manufacture of medicinal product delivery devices Opinion development
0167-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland
Abbott GmbH & Co. KG
Industrial use as a surfactant in the formulation of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Opinion development
0156-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Sanofi Pasteur Use of Octoxynol-9 for virus splitting and inactivation step in the manufacturing of influenza vaccines Opinion development
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. Opinion development
0139-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in two in vitro diagnostic VITROS® products used by professional diagnostic laboratories to detect antibodies to human hepatitis A virus and IgG antibodies to rubella virus. Opinions adopted
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. Opinion development
0181-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - DiaSorin S.p.A. Industrial use, as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology. Opinion development
0178-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Baxter AG; Baxalta Belgium Manufacturing SA Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (as a detergent) for virus inactivation via S/D (Solvent/Detergent) treatment in recombinant and plasma-derived medicinal products. Opinion development
0171-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinion development
0189-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Lonza Biologics Porriño, SL.; Lonza Biologics, plc. Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures Opinion development



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