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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. The table below will be updated at a later stage.

 

 
0012-06 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking Authorisation expired
0012-10 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Industrial use of solid or liquid colour premixes and pre-compounds containing pigment to colour plastic or plasticised articles for non-consumer use Commission decided
0012-12 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking Authorisation expired
0012-02 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer use Commission decided
0012-04 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.) Commission decided
0012-08 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Distribution and mixing pigment powder in an industrial environment into liquid or solid premix to colour plastic/plasticised articles for non consumer use Commission decided
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
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
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
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
0002-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 ARKEMA FRANCE Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Withdrawn
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
0004-03 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 DEZA a.s. Industrial use of DEHP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements Pending decision
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
0007-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Roxel (UK Rocket Motors) Ltd Industrial use of DEHP in manufacture of solid propellants and motor charges for rockets and tactical missiles Authorisation expired
0001-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Rolls-Royce plc – [Decision discontinued as of 01/01/2021] The processing of a stop-off formulation containing DEHP during the diffusion bonding and manufacture of aero engine fan blades. Discontinued as of 01 January 2021
0002-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 ARKEMA FRANCE Formulation of DEHP in compounds, dry-blends and Plastisol formulations Withdrawn
0004-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 DEZA a.s. Formulation of DEHP in compounds, dry-blends and Plastisol formulations Pending decision
0004-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 DEZA a.s. Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Pending decision
0003-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. Formulation of DEHP in compounds, dry-blends and Plastisol formulations Withdrawn
0003-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Withdrawn
0047-01 Initial Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 PPG Industries (UK) Ltd
Finalin GmbH
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]
PPG Coatings SA
Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
Formulation of Mixtures Commission decided
0047-02 Initial Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 PPG Industries (UK) Ltd
Finalin GmbH
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]
PPG Coatings SA
Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
Use of potassium hydroxyoctaoxodizincatedichromate in paints, in primer, sealants, and coatings (including as wash primers) Commission decided
0089-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 PMC ISOCHEM [application transferred from original Applicant: ISOCHEM due to a notified legal entity change] Use of diglyme as a process solvent in one step of the manufacturing of an Active Pharmaceutical Ingredient used in an anti-protozoal drug Commission decided
0088-02 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (downstream user processes). Opinions adopted
0091-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Merck KGaA Industrial use of diglyme as solvent in the manufacturing process of cryptand intermediates for further conversion into cryptand 221 and cryptand 222 Commission decided
0217-02 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (downstream user processes) Opinion development
0125-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 N.V. Ajinomoto OmniChem S.A. Use of diglyme as a solvent for the synthesis of the anti-HIV active pharmaceutical ingredient (API) dapivirine. Commission decided
0088-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (in-house processes). Opinions adopted
0217-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (in-house processes) Opinion development
0087-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 MAFLON S.P.A. Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity. Commission decided
0061-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Novartis Ringaskiddy Limited Use of diglyme as solvent in the manufacturing process of an intermediate for further conversion into a pharmaceutical compound used in medicinal products for treatment of respiratory diseases Commission decided
0086-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Bracco Imaging s.p.a Use of bis(2-methoxyethyl) ether (diglyme) as a processing aid in the purification of 5-amino-2,4,6-triiodoisophthalic acid dichloride (EC 417- 220-1; CAS 37441-29-5) by precipitation Commission decided
0085-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Life Technologies AS Use of diglyme as a process chemical in the manufacture of Dynabeads. Commission decided
0084-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Roche Diagnostics GmbH Use of diglyme as a process chemical in the manufacture of one specific type of Dynabeads® used in immunodiagnostic assays (in vitro diagnostic) Commission decided
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
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. Opinion development
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
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
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
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
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
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
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
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
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
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
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
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
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. Opinion development
0081-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 GRUPA LOTOS S.A. 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
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
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
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
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
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
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
0040-01 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
CAFFARO BRESCIA S.r.l Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorite Commission decided
0137-01 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
SOCIETA' CHIMICA BUSSI S.P.A. Use of sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacturing of sodium chlorite. Commission decided
0072-07 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Souriau sas
“Amphenol Limited – [Decision discontinued as of 01/01/2021]
AMPHENOL SOCAPEX
Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. Commission decided
0043-02 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Brenntag UK Ltd
Henkel AG & Co. KGaA
AD International BV
Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites and sealings of anodic films Commission decided
0072-06 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Souriau sas;
TE UK Ltd – [Decision discontinued as of 01/01/2021]
Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). Commission decided
0041-01 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Akzo Nobel Pulp and Performance Chemicals AB
Akzo Nobel Pulp and Performance Chemicals Oy
Akzo Nobel Pulp and Performance Chemicals S.A.S.
Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide. Commission decided
0124-01 Initial Sodium dichromate 234-190-3 10588-01-9 H&R Ölwerke Schindler GmbH;
H&R Chemisch-Pharmazeutische Spezialitäten GmbH
Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems, applied for the dewaxing and deoiling process steps of petroleum raffinate. Commission decided
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
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 Opinions adopted
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. Opinion development
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. Opinion development
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
0156-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Sanofi Pasteur Use of Octoxynol-9 for virus splitting and inactivation step in the manufacturing of influenza vaccines Opinions adopted
0167-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland
Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name]
Industrial use as a surfactant in the formulation of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Opinions adopted
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). Opinions adopted
0198-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Pfizer Ireland Pharmaceuticals The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals – Post-Production Cleaning. Opinion development
0169-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Janssen Vaccines & Prevention BV
Janssen Biologics B.V.
4-tert-Octylphenol ethoxylate is used as a lysing agent for the permeabilization of the host cell membrane to release adenovirus particles used for the manufacture of vaccines. Its use allows the selective elimination of enveloped adventitious viruses and is compatible with the chemicals needed to control the host cell DNA precipitation in the next process step. Opinions adopted
0164-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Swedish Orphan Biovitrum The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in manufacture of biopharmaceuticals by Swedish Orphan Biovitrum AB. Opinions adopted
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. Opinions adopted
0186-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.
Immunotech S.R.O.
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 clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays. Opinions adopted
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. Opinions adopted
0187-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - AGC Biologics A/S Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as detergent for the inactivation of viruses in the production of therapeutic proteins using mammalian cell hosts in projects where processes have been approved by the authorities (GMP compliant) Opinions adopted
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 Opinions adopted
0158-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Swords Laboratories Industrial use of the substance as a surfactant in the purification of the biopharmaceutical drug Orencia, used for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis and Adult Psoriatic Arthritis Opinions adopted
0154-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of OPE in formulation of IVD-kit reagents Opinions adopted
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® Opinion development
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. Opinions adopted
0159-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Nuova Ompi S.r.l. unipersonale Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for one specific medicinal product (NeoRecormon®) of one pharmaceutical company. Opinions adopted
0139-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics France [application transferred from: “Ortho-Clinical Diagnostics” due to a notified legal entity change]. Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in two in vitro diagnostic VITROS® products used by professional diagnostic laboratories to detect antibodies to human hepatitis A virus and IgG antibodies to rubella virus. 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
0179-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - bioMérieux SA Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, consisting in the filling of 4-tert-OPnEO-containing solutions into specific single-use ampoules to be included in clinical and industrial in vitro testing applications as part of the BioFire and BioFire Next Gen FA products. Opinions adopted
0141-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - SEBIA Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests. Opinions adopted
0175-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Merck KGaA Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (technical grade) as raw material for the manufacturing of GMP Triton® X-100 Emprove® Expert according to IPEC standards Opinions adopted
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 Opinions adopted
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 Opinions adopted
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
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
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. Opinions adopted
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 Opinions adopted
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. Opinion development
0145-02 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 Gene Therapy products for the treatment of rare conditions in the human population. Opinions adopted
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). Opinions adopted
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. Opinions adopted



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