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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

 

 
0175-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Merck KGaA Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (technical grade) as raw material for the manufacturing of GMP Triton® X-100 Emprove® Expert according to IPEC standards Opinions adopted
0174-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Hospira Zagreb d.o.o., a Pfizer company The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of one biopharmaceutical protein, a biosimilar product, used to prevent infection and neutropenic fevers. Opinions adopted
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
0172-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 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 emulsifiers containing nonylphenols ethoxylated for the manufacture of chromatography resins used by the biopharmaceutical industry, food & beverage sector and academia Opinions adopted
0171-06 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) Opinions adopted
0171-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) Opinions adopted
0171-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinions adopted
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. Opinions adopted
0171-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinions adopted
0171-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinions adopted
0170-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Octapharma AB Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as component of a chromatography column regeneration solution during the manufacture of a recombinant-derived Factor VIII Opinions adopted
0170-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Octapharma AB
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H
Octapharma S.A.S.
Octapharma Produktionsgesellschaft Deutschland mbH
Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as detergent for a virus inactivation step (solvent/detergent treatment) during the manufacture of plasma-derived and recombinant medicinal products Opinions adopted
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. Opinions adopted
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. Opinions adopted
0167-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] Industrial use as a surfactant in the extraction and purification of antigens for incorporation into In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM 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
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
0167-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland
Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name]
Abbott Diagnostics GmbH
Professional use as a surfactant in the final use of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Opinions adopted
0167-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland
Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name]
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. 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
0165-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Eli Lilly Kinsale Limited Industrial use of a 4-tert-octylphenol ethoxylate compound, as a patient safety viral inactivation reagent in the manufacture of human medicines produced from biological systems 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
0163-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments Opinions adopted
0163-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) into enhancement solutions and DELFIA standard and maintenance solutions used in In Vitro Diagnostic assays and RUO products as well as maintenance of instruments as a critical ingredient for detection process while measuring europium (or other lanthanide) content of the assay solution Opinions adopted
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. Opinions adopted
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. Opinions adopted
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
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. Opinions adopted
0158-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Swords Laboratories Industrial use of the substance as a surfactant in the purification of the biopharmaceutical drug Orencia, used for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis and Adult Psoriatic Arthritis Opinions adopted
0157-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Merck Biodevelopment SAS
Fujifilm Diosynth Biotechnologies (UK) Ltd - [Application void as of 01/01/2021]
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 Opinions adopted
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 Opinions adopted
0155-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Kedrion S.p.A Use of 4-tert-OPnEO as Triton X-100 as detergent for virus inactivation in the manufacturing process of the human plasma-derived medicinal products Plasmagrade/Plasmasafe and Resusix, as well as Plasminogen (pre-commercialization name) and any subsequent commercialization brand Opinions adopted
0154-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of IVD-wash solutions on diagnostic analyser systems Opinions adopted
0154-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of IVD-kit reagents on diagnostic analyser systems 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
0154-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of OPE in formulation of IVD-kit reagents Opinions adopted
0154-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of OPE in isolation of protein from recombinant cell cultures for the production of IVD-kits (protein cell extraction) Opinions adopted
0153-02 Initial Anthracene oil 292-602-7 90640-80-5 BILBAINA DE ALQUITRANES, S.A. Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0153-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 BILBAINA DE ALQUITRANES, S.A. Use of CTPht for manufacture of formulations for various industrial uses Opinions adopted
0152-02 Initial Anthracene oil 292-602-7 90640-80-5 Rain Carbon bvba Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0152-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 Rain Carbon bvba Use of CTPht for manufacture of formulations for various industrial uses Opinions adopted
0151-02 Initial Anthracene oil 292-602-7 90640-80-5 Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0151-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] Use of CTPht for manufacture of formulations for various industrial uses Opinions adopted
0150-02 Initial Anthracene oil 292-602-7 90640-80-5 Koppers Denmark ApS Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0150-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 Koppers Denmark ApS Use of CTPht for manufacture of formulations for various industrial uses Opinions adopted
0149-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 Industrial Quimica del Nalon, S.A. Use of CTPht for manufacture of formulations for various industrial uses Opinions adopted
0148-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 DEZA a.s. Use of CTPht as a binder in the manufacture of clay targets Opinions adopted
0147-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 BILBAINA DE ALQUITRANES, S.A. Use of CTPht as a binder in the manufacture of clay targets Opinions adopted
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
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. Opinions adopted
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). Opinions adopted
0144-01 Initial Pitch, coal tar, high-temp 266-028-2 65996-93-2 ArianeGroup SAS Industrial use of pitch, coal tar, high temp. as precursor of carbon matrix in the manufacturing of thermally and thermo-mechanically highly loaded carbon/carbon parts including nozzle throats and other critical carbon-carbon composite parts, resistant to very harsh erosion conditions, and very high temperature ranges, dedicated to high-performance civilian and military aerospace launchers. Commission decided
0143-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - bioMérieux SA Industrial use of 4-tert-OPnEO for its detergent properties, used for the extraction of biological material which is further formulated and intended for clinical and industrial in vitro testing applications. Opinions adopted
0143-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - bioMérieux SA Industrial use of 4-tert-OPnEO for its non-ionic detergent to control the level of non-specific reactions in the formulation of in vitro reagents for clinical and industrial in vitro testing immunoassays. Opinions adopted
0143-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - bioMérieux SA Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of reagents for molecular clinical and industrial in vitro preparative and testing applications. Opinions adopted
0142-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - SEBIA Industrial use of 4-NPnEO for its detergent properties in the production of buffers and reagents in view of ensuring the positioning of specific proteins necessary for the interpretation of gel electrophoresis in vitro diagnostic tests results based on the determination of isoenzymes. Opinions adopted
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. Opinions adopted
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. Opinions adopted
0141-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - SEBIA Industrial use of 4-tert-OPnEO for its wetting detergent properties in the production of buffers, reagents and gel supports allowing the dissolution, the dilution and the good spreading of substrates and reagents, necessary to optimize the functioning and the sensitivity of gel electrophoresis in vitro diagnostic tests. Opinions adopted
0140-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - DIAGNOSTICA STAGO Industrial use of 4-tert-OPnEO in view of controlling the amount of non-specific reactions in the production of in-vitro diagnostic reagents (STA® - Liatest® D-Di assays). Opinions adopted
0140-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - DIAGNOSTICA STAGO Industrial use of 4-tert-OPnEO for its detergent properties in the process of cell lysing for the production of in-vitro diagnostic reagents (Asserachrom® HPIA, Asserachrom® HPIA–IgG and Asserachrom® PF4 and STA®-Néoplastine® R15 assays). Opinions adopted
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. Opinions adopted
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
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. Opinions adopted
0137-01 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
SOCIETA' CHIMICA BUSSI S.P.A. Use of sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacturing of sodium chlorite. Commission decided
0136-01 Initial Sodium chromate 231-889-5 7775-11-3 Ariston Thermo SpA Use of sodium chromate as an anticorrosion agent of the carbon steel in sealed circuit of gas absorption appliances up to 0.70% by weight (as Cr6+) in the refrigerant solution Opinions adopted
0135-01 Initial Chromium trioxide 215-607-8 1333-82-0 Thyssenkrupp Electrical Steel GmbH;
Thyssenkrupp Electrical
Steel UGO S.A.S.
Surface treatment for the manufacture of grain-oriented electrical steel used in magnetic circuits of electric devices, in particular magnetic cores of high-performance transformers Opinions adopted
0134-02 Initial Chromium trioxide 215-607-8 1333-82-0 ThyssenKrupp Rasselstein GmbH Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) Commission decided
0134-01 Initial Chromium trioxide 215-607-8 1333-82-0 ThyssenKrupp Rasselstein GmbH Use of Chromium (VI) Trioxide for Passivation of tinplated steel (ETP) Commission decided
0133-02 Initial Chromium trioxide 215-607-8 1333-82-0 Ideal Standard - Vidima AD Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes Opinions adopted
0133-01 Iitital Chromium trioxide 215-607-8 1333-82-0 Ideal Standard - Vidima AD;
Ideal Standard Produktions-GmbH;
Jado Iberia-Produtos Metalurgicos Sociedade Unipessoal LDA (withdrawn)
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
0132-02 Initial Chromium trioxide 215-607-8 1333-82-0 KEUCO GmbH & Co KG Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes 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
0131-01 Initial Chromium trioxide 215-607-8 1333-82-0 Schell GmbH & Co. KG Armaturentechnologie Functional chrome plating with decorative character for sanitary applications Opinions adopted
0130-01 Initial Chromium trioxide 215-607-8 1333-82-0 Dornbracht AG & Co. KG [name of applicant in the original application: Aloys F. Dornbracht GmbH & Co.KG updated due to a notified change of corporate name] Functional chrome plating with decorative character for sanitary applications 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
0128-01 Initial Chromium trioxide 215-607-8 1333-82-0 Doosan Electro-Materials
Luxembourg SARL
Volta Energy Solutions Hungary Kft [name of applicant in the original application: Doosan Energy Solution Kft updated due to a notified corporate name change]
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 Commission decided
0127-01 Initial Chromium trioxide 215-607-8 1333-82-0 MAHLE Ventiltrieb GmbH
MAHLE Polska Sp. z o.o.
Use of chromium trioxide in functional chrome plating of valves used in engines of light gasoline and diesel vehicles and in heavy duty diesel combustion engines 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
0125-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 N.V. Ajinomoto OmniChem S.A. Use of diglyme as a solvent for the synthesis of the anti-HIV active pharmaceutical ingredient (API) dapivirine. Commission decided
0124-01 Initial Sodium dichromate 234-190-3 10588-01-9 H&R Ölwerke Schindler GmbH;
H&R Chemisch-Pharmazeutische Spezialitäten GmbH
Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems, applied for the dewaxing and deoiling process steps of petroleum raffinate. Commission decided
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
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
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
0121-02 Initial Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Ramboll Belgium BVBA [application transferred from: “Indestructible Paint Ltd.” due to a notified legal entity change] Use of pentazinc chromate octahydroxide in stoved epoxy primer for corrosion protection of aircraft engine components in aerospace and aeroderivative applications Commission decided
0121-01 Initial Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Indestructible Paint Ltd. Formulation of mixtures 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
0119-01 Initial Chromium trioxide 215-607-8 1333-82-0 ZF Friedrichshafen AG Functional chrome plating of piston rods for automotive and rail applications Commission decided
0118-02 Initial Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name];
Finalin GmbH
Use of pentazinc chromate octahydroxide in wash primer, fuel tank primer and aluminized primer for the purpose of corrosion protection in aeronautic applications Commission decided
0118-01 Initial Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name];
Finalin GmbH
Formulation of mixture Commission decided
0117-01 Initial Strontium chromate 232-142-6 7789-06-2 HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change];
PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative]
Cytec Engineered Materials GmbH in its legal capacity as OR of Cytec Industries Inc. [application transferred from original Applicant: “Cytec Engineered Materials Ltd. in its legal capacity as Only Representative of Cytec Industries Inc.” due to a notified change of Only Representative]
Use of strontium chromate in primers applied by aerospace and defence companies and their associated supply chains Commission decided
0116-01 Initial Dichromium tris(chromate) 246-356-2 24613-89-6 HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change] Use of dichromium tris(chromate) for chemical conversion coating applications by aerospace and defence companies and their associated supply chains Commission decided
0115-04 Initial Sodium chromate 231-889-5 7775-11-3 Saes Getters S.p.A. Use of alkali metal dispensers containing sodium chromate for production of photocathodes. Commission decided
0115-03 Initial Potassium chromate 232-140-5 7789-00-6 Saes Getters S.p.A. Use of alkali metal dispensers containing potassium chromate for production of photocathodes. Commission decided
0115-02 Initial Sodium chromate 231-889-5 7775-11-3 Saes Getters S.p.A. Use of sodium chromate in the fabrication of alkali metal dispensers for production of photocathodes. Commission decided
0115-01 Initial Potassium chromate 232-140-5 7789-00-6 Saes Getters S.p.A. Use of potassium chromate in the fabrication of alkali metal dispensers for production of photocathodes. Commission decided
0114–02 Initial Chromium trioxide 215-607-8 1333-82-0 Hansgrohe SE The use of chromium trioxide for a pre-treatment step (etching) in the electroplating process Commission decided
0114–01 Initial Chromium trioxide 215-607-8 1333-82-0 Hansgrohe SE The use of chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional plating with decorative character) Commission decided
0113-01 Initial 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 Commission decided



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