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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
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| 0201-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A.; Delpharm Biotech | Industrial use in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary In Vitro Diagnostic devices (IVDs) used for detecting certain diseases in pets and farm animals | Opinions adopted | |
| 0201-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A.; Delpharm Biotech | Industrial use as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary In Vitro Diagnostic devices (IVDs) for detecting infectious disease in farm animals | Opinions adopted | |
| 0201-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A. | Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary In Vitro Diagnostic devices (IVDs) including one SERELISA, six ProFLOK, six WITNESS and five VetScan. The use is carried out by professional users in diagnostic laboratories and veterinary clinics to detect certain diseases in pets and farm animals | 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 | Opinions adopted | |
| 0100-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ZF Luftfahrttechnik GmbH | Functional chrome plating | Commission decided | |
| 0100-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ZF Luftfahrttechnik GmbH | Surface treatment for applications in the aeronautics and aerospace industries (unrelated to Functional chrome plating or Functional chrome plating with decorative character) | Commission decided | |
| 0101-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ZF Luftfahrttechnik GmbH | Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films | 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 | |
| 0193-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Yposkesi | Use of 4-tert-OPnEO for its non-ionic detergent properties for the cell membrane lysis and viral clearance during the development and manufacturing of viral vectors in medicinal products dedicated to human use (Investigational and Authorized Advanced Therapy Medicinal Product). | Opinions adopted | |
| 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 | |
| 0188-02 | 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 the assay buffer of the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity | 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 | |
| 0188-01 | 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) for use in the assay buffer for the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity | 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 | |
| 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 | Opinions adopted | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 0271-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Villeroy & Boch Gustavsberg AB FM Mattsson Mora Group AB | The use of chromium trioxide for electroplating of metal substrates with the purpose to create a long-lasting high durability surface with bright look for kitchen and bathroom sanitary ware | Opinion development | |
| 0216-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega GmbH & Co. KG. [name of applicant in the original application: Viega Supply Chain GmbH & Co. KG updated due to a notified corporate name change] | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinions adopted | |
| 0216-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega GmbH & Co. KG. [name of applicant in the original application: Viega Supply Chain GmbH & Co. KG updated due to a notified corporate name change] | Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright silvery appearance for sanitary applications | 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. | Commission decided | |
| 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 | |
| 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 | |
| 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 | |
| 0221-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
U. S. Steel Košice, s.r.o. | Use of Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP). | Opinions adopted | |
| 0074-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
TOTAL RAFFINERIE MITTELDEUTSCHLAND GMBH |
Use of sodium dichromate as a corrosion inhibitor in an ammonia absorption deep cooling system of a methanol synthesis plant. | Commission decided | |
| 0069-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Topocrom GmbH | TOPOCROM functional chrome plating in closed reactor systems for the establishment of adjustable hemispherical surface structures. | Commission decided | |
| 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 | |
| 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 | Commission decided | |
| 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 | |
| 0250-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Ibérica | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Ibérica S.A in the functional chrome plating of shock absorber rods. | Opinion development | |
| 0251-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Europe BVBA | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Europe BVBA in the functional chrome plating of shock absorber rods. | Opinion development | |
| 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. | Opinion development | |
| 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 | |
| 0211-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tata Steel IJmuiden BV; Tata Steel UK Ltd - [Application void as of 01/01/2021] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | |
| 0211-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Tata Steel IJmuiden BV; Tata Steel UK Ltd - [Application void as of 01/01/2021] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | |
| 0158-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Swords Laboratories Unlimited Company [name of applicant in the original application: Swords Laboratories updated due to a notified corporate name change] | 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 | |
| 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 | |
| 0213-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Steel Color S.p.A. | Use of chromium trioxide as colouring and hardening agent for stainless steel plates | Opinions adopted | |
| 0259-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ST s.r.l. | Use 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 electroplating with decorative character) | Opinion development | |
| 0220-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SRG Global Ibi, S.L. | Functional chrome plating with decorative character for transportation applications. | Opinions adopted | |
| 0220-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SRG Global Ibi, S.L. | Chromium trioxide-based etching as pre-treatment step for electroplating of plastics for transportation 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 | |
| 0022-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SPOLANA a.s. | Use as an extraction solvent in caprolactam production | Commission decided | |
| 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 | Opinion development | |
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