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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
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 Withdrawn
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in the sealing product in sulfuric acid anodization process of aluminium alloy parts of aircraft landing gears Withdrawn
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 Withdrawn
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
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
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
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
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
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
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
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
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. Opinions adopted
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. Opinions adopted
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 Opinions adopted
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
0225-01 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. 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. Opinions adopted
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
0239-01 initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Prionics Lelystad B.V Use as component of buffer solutions to produce antigens (Cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and in-process and final Quality Control of antigens intended for use as veterinary and human health laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications Opinions adopted
0247-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Boehringer Ingelheim RCV GmbH & Co KG Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification of lipidated OspA protein subsequently used for manufacturing of Lyme disease vaccine candidate. Opinions adopted
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
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
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 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. Opinions adopted
0248-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - FYSOL SAS [name of applicant in the original application: OCV Chambéry France S.A.S. updated due to a notified legal entity change] Mixing by the Applicant of a NPnEO-containing epoxy resin, resulting in mixtures containing < 0.1% w/w of NPnEO for the manufacture of glass fiber articles for critical composite helicopter parts, that is exempt from authorisation under REACH Art. 56(6)(a) Opinions adopted
0206-02 Initial 4-Nonylphenol, branched and linear, 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
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
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
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
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
0275-01 Initial Chromium trioxide 215-607-8 1333-82-0 SICROM S.r.l. Functional chrome plating of hydraulic cylinders and swivel joints using chromium trioxide Opinions adopted
0095-03 Initial Chromium trioxide 215-607-8 1333-82-0 REGARTIS s.r.o. in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” [application transferred from: “REACHLaw” in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” due to a notified legal entity change] Functional chrome plating with decorative character Opinions adopted
0257-01 Initial Chromium trioxide 215-607-8 1333-82-0 QUALIPAC Aurillac; Etablissements R.GRAINDORGE Industrial use of chromium trioxide for the etching of polypropylene (PP) substrates, as a pre-treatment step of the electroplating process, for the luxury sector and other applications Opinions adopted
0294-01 Initial Chromium trioxide 215-607-8 1333-82-0 Kludi GmbH & Co. KG; Kludi-Armaturen Austria Ges.m.b.H. Functional chrome plating with decorative character of metal and plastic substrates for sanitary applications Opinions adopted
0132-01 Initial Chromium trioxide 215-607-8 1333-82-0 KEUCO GmbH & Co KG 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
0241-01 Initial Chromium trioxide 215-607-8 1333-82-0 Gessi S.p.A.
San Marco Rubinetteria S.r.l.
Use of chromium trioxide for electroplating of metal substrates with the purpose of creating a long-lasting high durability surface with bright look for kitchen and bathroom sanitaryware (functional plating with decorative character) Opinions adopted
0258-01 Initial Chromium trioxide 215-607-8 1333-82-0 Heinrich Schulte Söhne GmbH & Co. KG; Schulte Hartchrom GmbH Chromium trioxide-based functional chrome plating of large components and small components with complex geometries and/or requiring special approval procedures for their application in demanding sectors such as medical, aerospace, defence and mining industry Opinions adopted
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
0255-01 Initial Chromium trioxide 215-607-8 1333-82-0 Chrom - Mueller Metallveredelung GmbH Industrial use of chromium trioxide for high ratio aspects inside hard chromium coating of firearms barrel bores subject to thermal, mechanical and chemical stresses, in order to provide wear resistance properties, as well as low friction coefficient, hardness, resistance to corrosion and gas erosion properties. Opinions adopted
0255-03 Initial Chromium trioxide 215-607-8 1333-82-0 Chrom - Mueller Metallveredelung GmbH Industrial use of chromium trioxide in the hard chromium coating of complex outer and inner surfaces of firearms auxiliary parts requiring a customised and selective coating technique and subject to thermal, mechanical and chemical stresses, in order to provide wear resistance and barrier properties, as well as post-processing capability and resistance to hot combustion gas erosion. Opinions adopted
0234-02 Initial Chromium trioxide 215-607-8 1333-82-0 Maschinenfabrik Kaspar Walter GmbH & Co KG Chromium trioxide-based functional chrome plating of cylinders used in the rotogravure printing and embossing industry. Opinions adopted
0262-01 Initial Chromium trioxide 215-607-8 1333-82-0 Cromoplastica C.M.C. S.r.l. Use of chromium trioxide for etching of plastic substrates as a key pre-treatment step for creating an electrically conductive surface to enable electroplating Opinions adopted
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
0212-01 Initial Chromium trioxide 215-607-8 1333-82-0 LARS Chemie, spol. s r.o.
CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U.
Industrial use of chromium trioxide for the etching, pre-treatment step in the electroplating process of functional chrome plating with decorative character Opinions adopted
0221-01 Initial Chromium trioxide 215-607-8 1333-82-0 U. S. Steel Košice, s.r.o. Use of Chromium (VI) Trioxide for Passivation of Electrolytic Tinplate (ETP). Opinions adopted
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
0253-01 Initial Chromium trioxide 215-607-8 1333-82-0 GEA Westfalia Separator Group GmbH Chromium trioxide-based functional chrome plating of machine components for centrifugal separator and decanter centrifuges Opinions adopted
0244-02 Initial Chromium trioxide 215-607-8 1333-82-0 CROMAPLAST S.p.A. Industrial use of CrO3 in the chrome plating of automotive plastic components Opinions adopted
0267-01 Initial Chromium trioxide 215-607-8 1333-82-0 SPGPrints B.V. Use of Cr(VI) in an integrated process to create a hard surface with selective adhesion properties on mandrels used to manufacture screens for Rotary Screen Printing (RSP) for textile and other (printing) applications Opinions adopted