Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
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. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.
| 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). | Opinion development | |
| 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). | Opinion development | |
| 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 | |
| 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 | |
| 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 | |
| 0216-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega Supply Chain GmbH & Co KG | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinion development | |
| 0216-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega Supply Chain GmbH & Co KG | Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright silvery appearance for sanitary applications | Opinion development | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 0163-01 | 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 | |
| 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 | |
| 0116-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | Wesco Aircraft EMEA, LTD. | Use of dichromium tris(chromate) for chemical conversion coating applications by aerospace and defence companies and their associated supply chains | Commission decided | |
| 0096-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Wesco Aircraft EMEA, LTD. [application transferred from original Applicant: Haas Group International SCM Ltd due to a notified legal entity change] | Use of chromium trioxide for chemical conversion and slurry coating applications by aerospace companies and their suppliers | Commission decided | |
| 0098-01 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Wesco Aircraft EMEA, LTD. [application transferred from original Applicant: Haas Group International SCM Ltd due to a notified legal entity change] | Use of potassium dichromate for sealing after anodizing applications by aerospace companies and their suppliers | Commission decided | |
| 0097-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Wesco Aircraft EMEA, LTD. [application transferred from original Applicant: Haas Group International SCM Ltd due to a notified legal entity change] | Use of sodium dichromate for sealing after anodizing applications by aerospace companies and their suppliers | Commission decided | |
| 0117-01 | Initial | Strontium chromate | 232-142-6 | 7789-06-2 |
Wesco Aircraft EMEA, LTD.; 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 Ltd. in its legal capacity as Only Representative of Cytec Industries Inc. | Use of strontium chromate in primers applied by aerospace and defence companies and their associated supply chains | Commission decided | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | Opinion development | |
| 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 | Opinion development | |
| 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 | Opinion development | |
| 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 | Opinion development | |
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