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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
0201-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change] 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. Commission decided Details
0201-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change] 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 Commission decided Details
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 Commission decided Details
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 Commission decided Details
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 Details
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). Commission decided Details
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 Details
0300-01 Initial Chromium trioxide 215-607-8 1333-82-0 WEBER-HYDRAULIK GMBH Chromium trioxide-based functional chrome plating of solid and hollow piston rods for hydraulic applications Opinions adopted Details
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 Commission decided Details
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 Commission decided Details
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 Commission decided Details
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 Commission decided Details
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 Details
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 Details
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 Details
0307-01 Initial Chromium trioxide 215-607-8 1333-82-0 VINZIA F.lli S.p.A. Industrial use of chromium trioxide for functional chrome plating with the decorative character of brass or stainless-steel drain components for the tap industry to provide thickness, corrosion resistance Opinions adopted Details
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 Details
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 Details
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 Details
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 Details
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 Opinions adopted Details
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 Commission decided Details
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 Commission decided Details
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 Details
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). Commission decided Details
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 Details
0295-01 Initial Chromium trioxide 215-607-8 1333-82-0 Ugitech Saint-Etienne Industrial use of chromium trioxide for the functional chrome plating of stainless-steel bars, mainly designed to be cylinder rods, used in aggressive and corrosive environments in diverse sectors such as transportation Opinions adopted Details
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). Commission decided Details
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). Commission decided Details
0351-01 Initial Potassium dichromate 231-906-6 7778-50-9 TURDUS TESTERS OF CAPACITY Industrial use of a potassium dichromate-based mixture for the manufacture of single-use chemical breathalysers Opinion development Details
0074-01 Initial Sodium dichromate 234-190-3
7789-12-0
10588-01-9
TotalEnergies Raffinerie Mitteldeutschland GmbH [name of the applicant in the original application: TOTAL RAFFINERIE MITTELDEUTSCHLAND GMBH updated due to a change of corporate name] Use of sodium dichromate as a corrosion inhibitor in an ammonia absorption deep cooling system of a methanol synthesis plant. Commission decided Details
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 Details
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 Details
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 Details
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 Details
0302-01 Initial Chromium trioxide 215-607-8 1333-82-0 Thoma Metallveredelung GmbH Functional chrome plating for hydraulic applications, other cylindrical components and further industrial applications Opinion development Details
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 Commission decided Details
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. Opinions adopted Details
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. Opinions adopted Details
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 Details
0324-01 Initial Chromium trioxide 215-607-8 1333-82-0 Tecnofiniture S.r.l. Industrial use of chromium trioxide for the hard-chrome plating of a wide variety of items with large dimensions and complex geometries used in energy generation and supply, off-shore oil and gas extraction and manufacturing industries. Opinions adopted Details
0280-02 Initial Chromium trioxide 215-607-8 1333-82-0 TECNOCROM INDUSTRIAL, S.A.;ALLION ESPAÑOLA S.A.; CROMADO INDUSTRIAL SARRASIN S.L.; CROMECAL, S.L. ; Talleres Acro, S. L. [name of the applicant in the original application: Talleres Acro, S.A. updated due to a change of corporate name]; DUROKROM, SL; IkanKronitek, S.L.; CROMO DURO ANFER S.A.; GIROCLAD, SL; OVIDICROM S.L.; RECTIFICADOS DELVAL S.A; REQUEL S.L.; Talleres Durocrom S. L.; TALLERES GUMILA, S.L. Functional chrome plating of parts with complex surface geometry and requiring the use of an auxiliary anode Opinions adopted Details
0280-01 Initial Chromium trioxide 215-607-8 1333-82-0 TECNOCROM INDUSTRIAL, S.A.;ALLION ESPAÑOLA S.A.; CROMADO INDUSTRIAL SARRASIN S.L.; CROMECAL, S.L. ; Talleres Acro, S. L. [name of the applicant in the original application: Talleres Acro, S.A. updated due to a change of corporate name]; DUROKROM, SL; IkanKronitek, S.L.; CROMO DURO ANFER S.A.; GIROCLAD, SL; OVIDICROM S.L.; RECTIFICADOS DELVAL S.A; REQUEL S.L.; Talleres Durocrom S. L.; TALLERES GUMILA, S.L. Functional chrome plating of parts with at least one axis of symmetry and simple surface geometry Opinions adopted Details
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 Details
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 Details
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 Details
0293-01 Initial Chromium trioxide 215-607-8 1333-82-0 Talleres Aykrom, S.A. Industrial use of Chromium Trioxide in functional chrome plating of metallic pieces required in different industrial sectors such as corrugated rolls to meet hardness, wear resistance, corrosion resistance, good surface condition, low friction coefficient and coating adhesion requirements Opinions adopted Details
0178-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Takeda Manufacturing Austria AG [name of the applicant in the original application: Baxter AG updated due to a change of corporate name]; 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. Commission decided Details
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 Commission decided Details
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 Details