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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

 

There are currently no ongoing consultations.
 
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
0173-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products Ltd - [Application void as of 01/01/2021] Use of OPE as detergent in the production of bead components for in-vitro diagnostic kits for an immunoassay platform Application void as of 01 January 2021
0146-01 Initial Chromium trioxide 215-607-8 1333-82-0 Tata Steel UK Ltd - [Application void as of 01/01/2021] The use of Chromium (VI) Trioxide for the manufacture of Electrolytic Chromium/Chromium oxide Coated Steel (ECCS) Application void as of 01 January 2021
0007-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Roxel (UK Rocket Motors) Ltd Industrial use of DEHP in manufacture of solid propellants and motor charges for rockets and tactical missiles Authorisation expired
0008-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles Authorisation expired
0008-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl Formulation of recycled soft PVC containing DEHP in compounds and dry-blends Authorisation expired
0015-01 Initial Diarsenic trioxide 215-481-4 1327-53-3 Yara France Industrial use of diarsenic trioxide as a processing aid to activate the absorption and desorption of carbon dioxide by potassium carbonate from synthesis gas formed in the production of ammonia 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
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
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
0013-02 Initial Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane
221-695-9
247-148-4
3194-55-6
25637-99-4
134237-50-6
134237-51-7
134237-52-8
INEOS Styrenics Netherlands BV
INEOS Styrenics Ribecourt SAS
INEOS Styrenics Wingles SAS
Synthos Dwory 7 spółka z ograniczoną odpowiedzialnością spółka komandytowo-akcyjna.
Synthos Kralupy a.s.
StyroChem Finland Oy
Monotez SA
RP Compounds GmbH
Synbra Technology bv
Sunpor Kunststoff GmbH
Dunastyr Polystyrene Manufacturing C. Co. Ltd
Versalis SpA
Unipol Holland bv
Manufacture of flame retarded expanded polystyrene (EPS) articles for use in building applications Authorisation expired
0013-01 Initial Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane
221-695-9
247-148-4
3194-55-6
25637-99-4
134237-50-6
134237-51-7
134237-52-8
INEOS Styrenics Netherlands BV
INEOS Styrenics Ribecourt SAS
INEOS Styrenics Wingles SAS
Synthos Dwory 7 spółka z ograniczoną odpowiedzialnością spółka komandytowo-akcyjna.
Synthos Kralupy a.s.
StyroChem Finland Oy
Monotez SA
RP Compounds GmbH
Synbra Technology bv
Sunpor Kunststoff GmbH
Dunastyr Polystyrene Manufacturing C. Co. Ltd
Versalis SpA
Unipol Holland bv
Formulation of flame retarded expanded polystyrene (EPS) to solid unexpanded pellets using hexabromocyclododecane as the flame retardant additive (for onward use in building applications) Authorisation expired
0012-06 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking Authorisation expired
0012-12 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking Authorisation expired
0012-11 Initial Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking Authorisation expired
0012-05 Initial Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking Authorisation expired
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
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 Authorisation expired
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
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
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
0081-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 LOTOS Asfalt Sp. z o.o. [name of applicant in the original application: GRUPA LOTOS S.A. updated due to a notified legal entity change] 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
0168-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Diagnostics GmbH Professional use as a surfactant, in wash buffer components used in conjunction with Fluorescence In Situ Hybridisation (FISH) test kits and/or their Laboratory Developed Test (LDT) equivalents, in clinical diagnostic use for medical analysis of human tissue and blood samples to identify characteristic genetic abnormalities related to specific disease conditions. Commission decided
0162-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Novo Nordisk A/S Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as a solvent/detergent agent for virus inactivation in the manufacture of pharmaceutical products used in the treatment of rare bleeding disorders. Commission decided
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. Commission decided
0145-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - BioMarin International Limited Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB). Commission decided
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
0145-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - BioMarin International Limited Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population. Commission decided
0159-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Nuova Ompi S.r.l. unipersonale Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for one specific medicinal product (NeoRecormon®) of one pharmaceutical company. Commission decided
0139-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics France [application transferred from: “Ortho-Clinical Diagnostics” due to a notified legal entity change]. 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. Commission decided
0073-01 Initial Ammonium dichromate 232-143-1 7789-09-5 Veco B.V. Use of ammonium dichromate as photosensitive component in a polyvinyl alcohol photolithographic lacquer system for the manufacturing of mandrels which are used in nickel electroforming processes. Commission decided
0049-01 Initial Ammonium dichromate 232-143-1 7789-09-5 Micrometal GmbH The use of Ammonium dichromate (ADC) as a photosensitizer for production of micro components Commission decided
0059-01 Initial Arsenic acid 231-901-9 7778-39-4 CIRCUIT FOIL LUXEMBOURG SARL Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of Printed Circuit Board Commission decided



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