Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
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
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
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
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
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
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
0341-03 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
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
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
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
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
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
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
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
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
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
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 Commission decided 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
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
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
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
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
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
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
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
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
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
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
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
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
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
0109-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Nouryon Chemicals SPA [name of the applicant in the original application: Akzo Nobel Chemicals SpA updated due to a change of corporate name] The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant 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
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
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
0078-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2
  • Specialty Electronic Materials Italy srl [name of lead applicant in the original application: DOW ITALIA S.R.L. updated due to a notified legal entity change]
  • DSP S.A.S. [name of co-applicant in the original application: Dow France SAS updated due to a notified legal entity change]
Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins 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
0360-02 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
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
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
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
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. Commission decided Details
0204-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Biokit S.A. Professional use of 4-tert-OPnEO as a detergent during the final use of latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. Commission decided Details
0180-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Bio-Rad Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application 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
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 Commission decided Details
0185-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX Montpellier SAS Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as detergent in the technical manufacturing of in vitro diagnostic veterinary ELISA Plate tests (plate coating) to prevent the non-specific binding of unwanted macromolecules Commission decided Details
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. Commission decided Details
0176-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - LFB BIOMEDICAMENTS Use as virus inactivation into the manufacture process of plasma-derived immunoglobulins. Commission decided Details
0183-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - DIAGAST Industrial use of 4-tert-OPnEO for its amphiphilic, surfactant and non-haemolytic properties, to create controlled hydrophilic spots on porous hydrophobic membranes (solid form) for in vitro diagnostic kits for blood testing via antigen/antibody reaction in the following product ranges: ABTest Card®, ABD PAD® and M-TRAP® cartridges for the ONYX® system. Commission decided Details
0195-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - RSI ChemRep Europe Ltd (O002) OR for OraSure Technologies Inc Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as surfactant in in –vitro diagnostic device developer solution. Commission decided Details
0186-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.;
Immunotech S.R.O.;
Immunotech S.A.S.
Formulation of OPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. Commission decided Details
0200-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L. Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Commission decided Details
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. 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
0299-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - 9036-19-5 MeiraGTx Ireland Designated Activity Company Use of 4-tert-OPnEO as a manufacturing aid in the production of gene therapies Opinions adopted Details
0186-06 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.
Immunotech S.R.O
Immunotech S.A.S.
Beckman Coulter France S.A.S.
Beckman Coulter Česká republika s.r.o.
Beckman Coulter UK - [Application void as of 01/01/2021]
Beckman Coulter S.L.U
Beckman Coulter SPA Italy;
BC Distribution B.V
Downstream use of OPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development. Commission decided 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
0226-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - LETI Pharma, S.L.U. [name of applicant in the original application: Laboratorios LETI, S.L.U. updated due to a notified change of corporate name] Use of 4-tert-OPnEO in aqueous buffers during the manufacturing process of the active pharmaceutical ingredient (Protein Q) of the veterinary vaccine LetiFend® 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
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