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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
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
Related links
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. | Commission decided | Details |
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. | Commission decided | Details |
0350-01 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc.; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. | Repackaging hardener formulations containing OPE as a surfactant in a concentration above 0.1%, to be used within two-part polysulphide sealants by Airbus and their associated supply chains | Opinion development | Details |
0349-01 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, used for the extraction of biological material which is further formulated and coated on articles intended for clinical and industrial in vitro testing applications | Opinion development | Details |
0350-02 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc.; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. | Mixing, by Airbus, and their associated supply chains, including the Applicant, of base polysulfide sealant components with OPE-containing hardener, resulting in mixtures containing < 0.1% w/w of OPE for Aerospace and Defence uses that are exempt from authorisation under REACH Art. 56(6)(a) | Opinion development | Details |
0348-02 | Review report | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Chemetall GmbH | Mixing, by Aerospace Companies and their associated supply chains, including the Applicant, of base polysulfide sealant components with NPE-containing hardener, resulting in mixtures containing < 0.1% w/w of NPE for Aerospace uses that are exempt from authorisation under REACH Art. 56(6)(a). | Opinion development | Details |
0348-01 | Review report | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Chemetall GmbH | The formulation of a hardener component containing NPE within Aerospace two-part polysulfide sealants. | Opinion development | Details |
0358-01 | Review report | Arsenic acid | 231-901-9 | 7778-39-4 | CIRCUIT FOIL LUXEMBOURG SARL | Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of printed circuit board. | Opinion development | Details |
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 | 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 |
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 | Details |
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 | Details |
0354-02 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Airbus Helicopters Technik GmbH | Surface treatment (as corrosion inhibitor, no connection with functional chrome plating) in the manufacture of helicopter transmissions and the maintenance of helicopters. | Opinion development | 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 |
0336-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7) | Anodise sealing using chromium trioxide, potassium dichromate, sodium chromate and/or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0345-02 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0341-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Chemservice GmbH - (B1P7) | Formulation of mixtures with soluble Cr(VI) compounds for use in aerospace and defence industry and its supply chains for surface treatments | Opinion development | Details |
0340-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Chemservice GmbH - (B1P7) | Inorganic finish stripping using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0338-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Chromate rinsing after phosphating using chromium trioxide in aerospace and defence industry and its supply chains | Opinion development | Details |
0359-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | CIRCUIT FOIL LUXEMBOURG SARL | Industrial use of chromium trioxide for the treatment of copper foil used in the manufacture of printed circuit board. | Opinion development | Details |
0354-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Airbus Helicopters Technik GmbH | Use as a surface hardener (functional chrome plating) in the manufacture of helicopter transmissions and the maintenance of helicopters. | Opinion development | Details |
0337-02 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | HAAS GROUP INTERNATIONAL SP. Z.O.O; CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Chemservice GmbH - (B1P7); Boeing Distribution Deutschland GmbH | Chemical conversion coating using chromium trioxide, sodium dichromate, potassium dichromate and/or dichromium tris(chromate) in aerospace and defence industry and its supply chains | Opinion development | Details |
0342-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Chemservice GmbH - (B1P7) | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0343-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Pre-treatments: Deoxidising, pickling, etching and/or desmutting using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0335-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Anodising using chromium trioxide in aerospace and defence industry and its supply chains | Opinion development | Details |
0344-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | HAAS GROUP INTERNATIONAL SP. Z.O.O; CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Chemservice GmbH - (B1P7); Boeing Distribution Deutschland GmbH | Slurry coating using chromium trioxide in aerospace and defence industry and its supply chains | Opinion development | Details |
0339-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Electroplating using chromium trioxide in aerospace and defence industry and its supply chains | Opinion development | Details |
0337-01 | Review report | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | HAAS GROUP INTERNATIONAL SP. Z.O.O; Henkel Global Supply Chain B.V. | Chemical conversion coating using chromium trioxide, sodium dichromate, potassium dichromate and/or dichromium tris(chromate) in aerospace and defence industry and its supply chains | Opinion development | Details |
0342-02 | Review report | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag Chemicals Distribution (Ireland) Ltd | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0357-01 | Review report | potassium dichromate | 231-906-6 | 7778-50-9 | LYNRED | Industrial use of potassium dichromate-based mixtures during the step of final etching of CZT layers during the production of opto-electronic components gathering a readout and an infrared detecting circuit with the MCT technology. | Opinion development | Details |
0336-04 | Review report | Potassium dichromate | 231-906-6 | 7778-50-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O; Brenntag Chemicals Distribution (Ireland) Ltd | Anodise sealing using chromium trioxide, potassium dichromate, sodium chromate and/or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0337-03 | Review report | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag Chemicals Distribution (Ireland) Ltd | Chemical conversion coating using chromium trioxide, sodium dichromate, potassium dichromate and/or dichromium tris(chromate) in aerospace and defence industry and its supply chains | Opinion development | Details |
0341-02 | Review report | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag Chemicals Distribution (Ireland) Ltd | Formulation of mixtures with soluble Cr(VI) compounds for use in aerospace and defence industry and its supply chains for surface treatments | Opinion development | Details |
0341-03 | Review report | Sodium chromate | 231-889-5 | 7775-11-3 | Boeing Distribution Deutschland GmbH; HAAS GROUP INTERNATIONAL SP. Z.O.O | Formulation of mixtures with soluble Cr(VI) compounds for use in aerospace and defence industry and its supply chains for surface treatments | Opinion development | Details |
0336-03 | Review report | Sodium chromate | 231-889-5 | 7775-11-3 | HAAS GROUP INTERNATIONAL SP. Z.O.O; Boeing Distribution Deutschland GmbH | Anodise sealing using chromium trioxide, potassium dichromate, sodium chromate and/or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0341-04 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Formulation of mixtures with soluble Cr(VI) compounds for use in aerospace and defence industry and its supply chains for surface treatments | Opinion development | Details |
0337-04 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Chemical conversion coating using chromium trioxide, sodium dichromate, potassium dichromate and/or dichromium tris(chromate) in aerospace and defence industry and its supply chains | Opinion development | Details |
0222-01 | Review report | 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 with dark colours. | Commission decided | Details |
0343-02 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Pre-treatments: Deoxidising, pickling, etching and/or desmutting using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0356-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | AD International BV | Use of SDC in formulation of mixtures intended for supply for authorised uses | Opinion development | Details |
0342-03 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0355-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Airbus Helicopters Technik GmbH | Surface treatment of metals (such as aluminium, steel, zinc, magnesium, titanium, alloys), composites and sealings of anodic films, in the production of transmissions for helicopters and in maintenance of helicopters. | Opinions adopted | Details |
0345-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0340-02 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Inorganic finish stripping using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0336-02 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O; AD International BV; Brenntag Chemicals Distribution (Ireland) Ltd | Anodise sealing using chromium trioxide, potassium dichromate, sodium chromate and/or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0227-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | ROQUETTE Frères | Use as a processing aid in the biotransformation of starch to obtain betacyclodextrin | Commission decided | Details |
0242-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as extraction solvent in the manufacture of polyethylene separators for lead-acid batteries | Opinions adopted | Details |
0208-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production | Commission decided | Details |
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 | Details |
0243-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | DOMO Caproleuna GmbH | Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil | Commission decided | Details |
0327-03 | Initital | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O | Chemical conversion coating using chromium trioxide, sodium dichromate and/or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
0108-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | ORGAPHARM | Use as an process solvent in the manufacture of an Active Pharmaceutical Ingredient: Nefopam hydrochloride | Commission decided | Details |
0029-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Laboratoires Expanscience | Use as process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients | Commission decided | Details |
0109-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Akzo Nobel Chemicals SpA | The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant | Commission decided | Details |
0083-01 | Initial | 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 | Commission decided | Details |
0079-01 | Initial | 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 | Commission decided | Details |
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 | Details |
0082-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | 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 1,2-dichloroethane as an emulsifying solvent in the manufacture of porous particles for beaded chromatography and cell culture media. | Commission decided | Details |
0080-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
H&R Ölwerke Schindler GmbH
H&R Chemisch-Pharmazeutische Spezialitäten GmbH |
Industrial use as a solvent and anti-solvent of the feedstock and intermediate product streams in the combined de-waxing and de-oiling of refining of petroleum vacuum distillates for the production of base oils and hard paraffin waxes | Commission decided | Details |
0077-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Eli Lilly Kinsale Limited [application transferred from original Applicant: Eli Lilly S.A. - Irish Branch due to a notified legal entity change] | Industrial use as a reaction medium and a solvating agent in mediating subsequent chemical transformation reactions leading to the manufacture of an Active Pharmaceutical Ingredient, Raloxifene Hydrochloride | Commission decided | Details |
0110-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Bayer AG [application transferred from original applicant: Bayer Pharma AG, due to a notified legal entity change] | Use as an industrial solvent in the manufacture of the high-grade pure final intermediate of Iopromide, the Active Pharmaceutical Ingredient for the X-ray contrast medium Ultravist® | Commission decided | Details |
0060-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane | Commission decided | Details |
0111-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | OLON Spa | The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient prednisolone steaglate. | Commission decided | Details |
0111-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | OLON Spa | The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient for epirubicin. | Commission decided | Details |
0076-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF plc - [Decision discontinued as of 01/01/2021; application transferred from original Applicant: BASF SE due to a notified legal entity change] | Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) | Discontinued as of 01 January 2021 | Details |
0078-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
|
Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins | Commission decided | Details |
0079-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange and chelating resins | Commission decided | Details |
0107-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | emp Biotech GmbH | Use as a solvent in manufacture of polymeric particles for pharmaceutical and research purification processes | Commission decided | Details |
0108-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | ORGAPHARM | Use as a process solvent in the manufacture of an Active Pharmaceutical Ingredient: Flecainide acetate | Commission decided | Details |
0081-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Rafineria Gdańska Sp. z o.o. [name of applicant in the original application: GRUPA LOTOS S.A. updated due to a notified legal entity change] | Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes. | Commission decided | Details |
0076-01 | Initial | 1,2-dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) | Commission decided | Details |
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 | Commission decided | Details |
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 | Withdrawn | Details |
0360-03 | Initial | 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate | 239-622-4 | 15571-58-1 | Galata Chemicals GmbH; REAGENS SPA; PMC Vlissingen Netherlands B.V. | Industrial manufacture of PVC articles through extrusion, injection, calendering and coating using mixtures containing DOTE as stabilizer | Opinion development | Details |
0360-02 | Initial | 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate | 239-622-4 | 15571-58-1 | Galata Chemicals GmbH; REAGENS SPA; PMC Vlissingen Netherlands B.V. | Formulation of PVC dry mixtures (granules and pellets) containing DOTE | Opinion development | Details |
0360-01 | Initial | 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate | 239-622-4 | 15571-58-1 | Galata Chemicals GmbH; REAGENS SPA | Formulation of liquid mixtures containing DOTE | Opinion development | Details |
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. | Commission decided | Details |
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. | Commission decided | Details |
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. | Commission decided | Details |
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 | Commission decided | Details |
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 | 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 |
0197-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | MERCK MILLIPORE LIMITED | Downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as component of mixed cellulose ester membranes. | Commission decided | Details |
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. | Commission decided | Details |
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. | Commission decided | Details |
0187-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
AGC Biologics A/S; AGC Biologics GmbH |
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as a detergent during the purification process of recombinant biopharmaceuticals derived from microbial expression hosts in projects where processes have been approved by the authorities (GMP compliant) | Commission decided | Details |
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). | Commission decided | Details |
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 | Commission decided | 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 |
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 |
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 | Details |
0184-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Lilly France S.A.S.; Eli Lilly Italia S.p.A. | Industrial formulation (dilution) of a silicone solution containing 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and its subsequent use as a lubricant in the manufacture of medicinal product delivery devices | Commission decided | Details |
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. | Commission decided | Details |
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 | Commission decided | Details |
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 | Details |
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). | Commission decided | Details |
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. | Commission decided | Details |
0180-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications | Commission decided | Details |
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. | Commission decided | Details |