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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
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There are currently no ongoing consultations.
| 0199-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Sanquin Reagents B.V. | Use of Triton™ X-100 (4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated) in formulation of components for IVD kits. | Commission decided | Details |
| 0027-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | RAG Aktiengesellschaft, RAG Anthrazit Ibbenbüren GmbH | Use of Tricholoroethylene-containing vulcanising and bonding agents for endless connections and repair of chloroprene rubber coated conveyor belts in underground hard coal mining | Authorisation expired | Details |
| 0026-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Richard Geiss GmbH | Use of tricholoroethylene in packaging | Commission decided | Details |
| 0024-03 | Initial | 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] | Use of tricholoroethylene in packaging | Commission decided | Details |
| 0024-04 | Initial | 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] | Use of tricholoroethylene in formulation | Commission decided | Details |
| 0026-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Richard Geiss GmbH | Use of tricholoroethylene in formulation | Commission decided | Details |
| 0024-01 | Initial | 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] | Use Of Trichloroethylene in Industrial Parts Cleaning by Vapour Degreasing in Closed Systems where specific requirements (system of use-parameters) exist | Authorisation expired | Details |
| 0023-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | A.L.P.A.-AZIENDA LAVORAZIONE PRODOTTI AUSILIARI S.P.A.; CAFFARO INDUSTRIE S.P.A | Use of trichloroethylene as solvent in the synthesis of vulcanization accelerating agents for fluoroelastomers | Commission decided | Details |
| 0024-05 | Initial | 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] | Use of Trichloroethylene as Extraction Solvent for Bitumen in Asphalt Analysis | Commission decided | Details |
| 0014-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Vlisco Netherlands BV | Use of trichloroethylene as a solvent in a process to recover and purify resin from process water | Commission decided | Details |
| 0014-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Vlisco Netherlands BV | Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth | Commission decided | Details |
| 0018-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ROQUETTE Frères | Use of trichloroethylene as a processing aid in the biotransformation of starch to obtain betacyclodextrin | Commission decided | Details |
| 0019-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Parker Hannifin Manufacturing Netherlands (Filtration & Separation) BV | Use of trichloroethylene (TCE) as a process solvent for the manufacturing of modules containing hollow fibre gas separation membranes | Commission decided | Details |
| 0353-01 | Initial | Tetraethyllead | 201-075-4 | 78-00-2 | Shell Nederland Raffinaderij B.V. | Use of tetraethyl lead in the formulation of aviation fuel | Opinion development | Details |
| 0117-01 | Initial | Strontium chromate | 232-142-6 | 7789-06-2 |
HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change]; PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative] Cytec Engineered Materials GmbH in its legal capacity as OR of Cytec Industries Inc. [application transferred from original Applicant: “Cytec Engineered Materials Ltd. in its legal capacity as Only Representative of Cytec Industries Inc.” due to a notified change of Only Representative] |
Use of strontium chromate in primers applied by aerospace and defence companies and their associated supply chains | Commission decided | Details |
| 0112-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
HAPOC GmbH & Co KG | Use of sodium dichromate in molten bath form to modify surfaces, especially by blackening, of delicate medical products, specifically micro-surgical instruments | Commission decided | Details |
| 0063-03 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Gentrochema BV | Use of Sodium dichromate for the electrolytic passivation of tin plated steel for the packaging industry. | Commission decided | Details |
| 0043-03 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Brenntag Chemicals Distribution (Ireland) Ltd [application transferred from original Applicant: Brenntag UK Ltd due to a notified legal entity change] Henkel AG & Co. KGaA AD International BV |
Use of Sodium dichromate for the electrolytic passivation of tin plated steel for the packaging industry | Commission decided | Details |
| 0101-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Airbus Helicopters Technik GmbH [name of applicant in the original application: “ZF Luftfahrttechnik GmbH” updated due to a notified corporate name change] | Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films | Commission decided | Details |
| 0063-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Gentrochema 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 | Details |
| 0043-02 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Brenntag Chemicals Distribution (Ireland) Ltd [application transferred from original Applicant: Brenntag UK Ltd due to a notified legal entity change] 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 | Details |
| 0097-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD” due to a notified legal entity change. Previously application transferred from original applicant: Haas Group International SCM Ltd due to a notified legal entity change] | Use of sodium dichromate for sealing after anodizing applications by aerospace companies and their suppliers | Commission decided | Details |
| 0221-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
U. S. Steel Košice, s.r.o. | Use of Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP). | Commission decided | Details |
| 0304-01 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Acciaierie d'Italia S.p.A. | Use of Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | 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 |
| 0113-01 | Initial | 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 | Commission decided | Details |
| 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 | Details |
| 0042-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ARLANXEO Netherlands B.V. [application transferred from original Applicant: Lanxess Elastomers B.V. due to a notified legal entity change] | Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems | Commission decided | Details |
| 0236-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Robur S.p.A | Use of sodium dichromate as an anticorrosion agent of the carbon steel in sealed circuit of gas absorption appliances up to 1.05% w/w (corresponding to 0.42% w/w as Cr VI) in the refrigerant solution | Opinions adopted | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 0035-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ARKEMA FRANCE | 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 or sodium chlorite | Commission decided | Details |
| 0036-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ELECTROQUÍMICA DE HERNANI, S.A. |
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 or sodium chlorite | Commission decided | Details |
| 0037-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Ercros SA | 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 or sodium chlorite | Commission decided | Details |
| 0039-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
HyChem – Química Sustentável, S.A [name of applicant in the original application: "SOLVAY PORTUGAL - PRODUTOS QUIMICOS S.A. " updated due to a notified corporate name change] | 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 or sodium chlorite | Commission decided | Details |
| 0038-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Kemira Chemicals Oy | 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 or sodium chlorite | Commission decided | Details |
| 0041-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Akzo Nobel Pulp and Performance Chemicals AB |
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 potassium chlorate. | Commission decided | Details |
| 0105-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ILARIO ORMEZZANO - SAI s.r.l. [name of applicant in the original application: Ilario Ormezzano Sai Spa updated due to a notified name change] | Use of Sodium Dichromate as a mordant in the dyeing of wool as sliver and/or yarn with dark colours in industrial settings | Opinions adopted | Details |
| 0074-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
TotalEnergies Raffinerie Mitteldeutschland GmbH [name of the applicant in the original application: TOTAL RAFFINERIE MITTELDEUTSCHLAND GMBH updated due to a change of corporate name] | Use of sodium dichromate as a corrosion inhibitor in an ammonia absorption deep cooling system of a methanol synthesis plant. | Commission decided | Details |
| 0075-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Jacobs Douwe Egberts DE GmbH Dr. Otto Suwelack Nachf. GmbH & Co. KG Européenne de Lyophilisation S.A. |
Use of sodium dichromate as a corrosion inhibitor in ammonia absorption deep cooling systems as applied in the industrial production of freeze dried products such as coffee, herbs, spices and comparable products. | Commission decided | Details |
| 0115-02 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Saes Getters S.p.A. | Use of sodium chromate in the fabrication of alkali metal dispensers for production of photocathodes. | Commission decided | Details |
| 0099-02 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
|
Use of sodium chromate for sealing after anodizing, chemical conversion coating, pickling and etching applications by aerospace companies and their suppliers | Commission decided | Details |
| 0136-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Ariston Thermo SpA | Use of sodium chromate as an anticorrosion agent of the carbon steel in sealed circuit of gas absorption appliances up to 0.70% by weight (as Cr6+) in the refrigerant solution | Commission decided | 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 |
| 0047-02 | Initial | Potassium hydroxyoctaoxodizincatedichromate | 234-329-8 | 11103-86-9 | PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - OR23 [application transferred from original Applicant: “PPG Industries (UK) Ltd” due to a notified change of Only Representative]; 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 Deutschland GmbH [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 | Details |
| 0062-02 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Gentrochema BV | Use of potassium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films. | Commission decided | Details |
| 0044-02 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag Chemicals Distribution (Ireland) Ltd [application transferred from original Applicant: Brenntag UK Ltd due to a notified legal entity change] | Use of potassium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films | Commission decided | Details |
| 0098-01 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD” due to a notified legal entity change. Previously application transferred from original applicant: Haas Group International SCM Ltd due to a notified legal entity change] | Use of potassium dichromate for sealing after anodizing applications by aerospace companies and their suppliers | Commission decided | Details |
| 0115-01 | Initial | Potassium chromate | 232-140-5 | 7789-00-6 | Saes Getters S.p.A. | Use of potassium chromate in the fabrication of alkali metal dispensers for production of photocathodes. | Commission decided | Details |
| 0118-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Boeing Distribution Deutschland GmbH [name of applicant
in the original application: Aviall Services Inc updated due to a notified change of corporate name]; Finalin GmbH |
Use of pentazinc chromate octahydroxide in wash primer, fuel tank primer and aluminized primer for the purpose of corrosion protection in aeronautic applications | Commission decided | Details |
| 0121-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | Ramboll Belgium BVBA [application transferred from: “Indestructible Paint Ltd.” due to a notified legal entity change] | Use of pentazinc chromate octahydroxide in stoved epoxy primer for corrosion protection of aircraft engine components in aerospace and aeroderivative applications | Commission decided | Details |
| 0154-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in isolation of protein from recombinant cell cultures for the production of IVD-kits (protein cell extraction) | Commission decided | Details |
| 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 | Commission decided | Details |
| 0154-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in formulation of IVD- wash solutions | Commission decided | Details |
| 0173-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products Ltd - [Application void as of 01/01/2021] | Use of OPE as detergent in the production of bead components for in-vitro diagnostic kits for an immunoassay platform | Application void as of 01 January 2021 | Details |
| 0161-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Vetter Pharma-Fertigung GmbH & Co. KG | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company. | Commission decided | Details |
| 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. | Commission decided | Details |
| 0160-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®). | Commission decided | Details |
| 0196-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Vetter Pharma-Fertigung GmbH & Co. KG | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers (syringes and cartridges) used as primary packaging material for 44 medicinal products of several pharmaceutical companies listed in the confidential Appendix 1 to the AoA. These products cover several therapeutic areas, and approx. 40 % of them are listed on the WHO Model List of Essential Medicines (EML). | Commission decided | Details |
| 0171-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) | Commission decided | Details |
| 0171-06 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) | Commission decided | Details |
| 0171-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | Commission decided | Details |
| 0171-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | Commission decided | Details |
| 0171-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | Commission decided | Details |
| 0171-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | Commission decided | Details |
| 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 | Commission decided | Details |
| 0154-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of IVD-wash solutions on diagnostic analyser systems | 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 |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 0232-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | Monroe Czechia s.r.o. | Use of dichromium tris(chromate) in a post-treatment step of the autodeposition coating process of shock absorbers for automotive vehicles. | Opinions adopted | Details |
| 0045-02 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 |
Henkel AG & Co. KGaA Henkel Global Supply Chain B.V. |
Use of dichromium tris(chromate) for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films. | Commission decided | Details |
| 0116-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change] | Use of dichromium tris(chromate) for chemical conversion coating applications by aerospace and defence companies and their associated supply chains | Commission decided | Details |
| 0009-01 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Boliden Kokkola Oy | Use of diarsenic trioxide in the purification of metal impurities from the leaching solution in the zinc electrowinning process | Commission decided | Details |
| 0352-02 | Initial | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd | Use of DEHP-containing plastics for immediate packaging of medicinal products | Opinion development | Details |
| 0352-03 | Initial | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd | Use of DEHP-based mixtures as a lubricating/sealing agent for the insertion of port closures into empty bags and assembly/connection of parts, that are used in immediate packaging of medicines | Opinion development | Details |
| 0005-02 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. |
Use of DBP in propellants Formulation: Industrial use of DBP as a burning rate surface moderant, plasticiser and/or coolant in the formulation of nitrocellulose-based propellant grains. Use at industrial site: Industrial use of DBP-containing propellant grains in manufacture of ammunition for military and civilian uses, and pyrocartridges for aircraft ejection seat safety systems [includes propellants for police force ammunition and excludes propellants intended for manual, private reloading of ammunition cartridges by civilian users, i.e., licensed individual sports shooters and hunters. No direct consumer use of DBP or its mixtures is covered by this Use.] |
Commission decided | Details |
| 0005-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. | Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride | Commission decided | Details |
| 0006-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Sasol-Huntsman GmbH & Co. KG | Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride | Commission decided | Details |
| 0151-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0150-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Koppers Denmark ApS | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0152-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Rain Carbon bvba | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0153-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0149-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Industrial Quimica del Nalon, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0147-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht as a binder in the manufacture of clay targets | Commission decided | Details |
| 0148-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | DEZA a.s. | Use of CTPht as a binder in the manufacture of clay targets | Commission decided | Details |
| 0267-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SPGPrints B.V. | Use of Cr(VI) in an integrated process to create a hard surface with selective adhesion properties on mandrels used to manufacture screens for Rotary Screen Printing (RSP) for textile and other (printing) applications | Opinions adopted | Details |
| 0092-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of plastic, with or without current flow | Opinions adopted | Details |
| 0064-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of Chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category III. | Opinions adopted | Details |
| 0064-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category II. | Opinions adopted | Details |
| 0064-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of Chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category I. | Opinions adopted | Details |
| 0093-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of brass, bronze, copper and other copper alloys for medical engineering, aviation and automation products | Commission decided | Details |
| 0127-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
MAHLE Ventiltrieb GmbH
MAHLE Polska Sp. z o.o. |
Use of chromium trioxide in functional chrome plating of valves used in engines of light gasoline and diesel vehicles and in heavy duty diesel combustion engines | Commission decided | Details |
| 0067-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Abloy Oy | Use of chromium trioxide in electroplating of mechanical and electromechanical cylinders, cam- and padlocks, electromechanical lock cases and architectural hardware. | Commission decided | Details |
| 0064-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in dissolved and solid form to produce aqueous solutions of any composition for industrial application. | Opinions adopted | Details |
| 0033-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Oy Kromatek Ab; Kova-Kromi Oy; CrTe-Plating Oy; Saizeri Plating Oy; Turun Kovakromi Oy; Veljekset Wallenius Oy; Pirkan Kovakromaus Oy | Use of chromium trioxide in Cr(VI) based functional plating | Commission decided | Details |
| 0102-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Clariant Produkte (Deutschland) GmbH | Use of chromium trioxide in a catalyst for the dehydrogenation of propane to propene | Commission decided | Details |
| 0305-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Meoni e Bartoletti S.p.A. | Use of Chromium Trioxide for the hard-chrome plating of hydraulic and pneumatic cylinders for various applications, and inner tubes of motorbike front suspension for the automotive industry. | Opinion development | Details |
| 0262-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Cromoplastica C.M.C. S.r.l. | Use of chromium trioxide for etching of plastic substrates as a key pre-treatment step for creating an electrically conductive surface to enable electroplating | Opinions adopted | Details |
| 0262-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Cromoplastica C.M.C. S.r.l. | Use of chromium trioxide for electroplating of plastic substrates to achieve a protective and durable surface with a silvery finish | Opinions adopted | Details |
| 0320-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Fratelli Creola S.r.l. | Use of chromium trioxide for electroplating of metal substrates with the purpose to creating a long-lasting high durability surface with bright (shiny) or matte look for sanitary and industrial applications | Opinion development | Details |
| 0241-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Gessi S.p.A. San Marco Rubinetteria S.r.l. |
Use of chromium trioxide for electroplating of metal substrates with the purpose of creating a long-lasting high durability surface with bright look for kitchen and bathroom sanitaryware (functional plating with decorative character) | Opinions adopted | Details |
| 0231-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Kesseboehmer Beschlagsysteme GmbH&Co.KG | Use of chromium trioxide for decorative/functional application in the furniture, sanitary and automotive sector. | Opinions adopted | Details |
| 0096-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD” due to a notified legal entity change. Previously application transferred from original applicant: Haas Group International SCM Ltd due to a notified legal entity change] | Use of chromium trioxide for chemical conversion and slurry coating applications by aerospace companies and their suppliers | Commission decided | Details |
| 0213-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Steel Color S.p.A. | Use of chromium trioxide as colouring and hardening agent for stainless steel plates | Commission decided | Details |
| 0056-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Rimex Metals (UK) Ltd – [Decision discontinued as of 01/01/2021] | Use of chromium trioxide as an oxidising and hardening agent in the manufacture of coloured stainless steel | Discontinued as of 01 January 2021 | Details |
| 0134-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ThyssenKrupp Rasselstein GmbH | Use of Chromium (VI) Trioxide for Passivation of tinplated steel (ETP) | Commission decided | Details |
| 0221-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | U. S. Steel Košice, s.r.o. | Use of Chromium (VI) Trioxide for Passivation of Electrolytic Tinplate (ETP). | Commission decided | Details |
| 0274-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS); also known as Tin Free Steel (TFS) | Opinions adopted | Details |
| 0134-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ThyssenKrupp Rasselstein GmbH | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) | Commission decided | Details |
| 0297-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Acciaierie d'Italia S.p.A. | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) | Opinions adopted | Details |
| 0274-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0301-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | LIBERTY GALATI SA [application transferred from original Applicant: "Liberty Liège Dudelange (BE)” due to a notified legal entity change] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0211-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tata Steel IJmuiden BV; Tata Steel UK Ltd - [Application void as of 01/01/2021] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0301-02 | initial | Sodium dichromate | 234-190-3 | 10588-01-9 | LIBERTY GALATI SA [application transferred from original Applicant: "Liberty Liège Dudelange (BE)” due to a notified legal entity change] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0274-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0211-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Tata Steel IJmuiden BV; Tata Steel UK Ltd - [Application void as of 01/01/2021] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 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 | Details |
| 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 | Details |
| 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). | Commission decided | Details |
| 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) | Commission decided | Details |
| 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). | Commission decided | Details |
| 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) | Commission decided | Details |
| 0153-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | BILBAINA DE ALQUITRANES, S.A. | Use of AO for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0151-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] | Use of AO for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0150-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | Koppers Denmark ApS | Use of AO for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0152-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | Rain Carbon bvba | Use of AO for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0073-01 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 | Veco B.V. | Use of ammonium dichromate as photosensitive component in a polyvinyl alcohol photolithographic lacquer system for the manufacturing of mandrels which are used in nickel electroforming processes. | Commission decided | Details |
| 0115-04 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Saes Getters S.p.A. | Use of alkali metal dispensers containing sodium chromate for production of photocathodes. | Commission decided | Details |
| 0115-03 | Initial | Potassium chromate | 232-140-5 | 7789-00-6 | Saes Getters S.p.A. | Use of alkali metal dispensers containing potassium chromate for production of photocathodes. | 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 |
| 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 |
| 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 |
| 0155-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Kedrion S.p.A | Use of 4-tert-OPnEO as Triton X-100 as detergent for virus inactivation in the manufacturing process of the human plasma-derived medicinal products Plasmagrade/Plasmasafe and Resusix, as well as Plasminogen (pre-commercialization name) and any subsequent commercialization brand | 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 |
| 0185-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | IDEXX B.V. [name of the applicant in the original application: “IDEXX EUROPE B.V.” updated due to a notified corporate name change] | Use of 4-Nonylphenol, branched and linear, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions | Commission decided | Details |
| 0185-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
IDEXX B.V. [name of the applicant in the original application: “IDEXX EUROPE B.V.” updated due to a notified corporate name change] IDEXX Montpellier SAS |
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions | Commission decided | Details |
| 0189-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Lonza Biologics Porriño, SL. Lonza Biologics, plc. - [Application void as of 01/01/2021] |
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures | Commission decided | Details |
| 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) | 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 |
| 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 |
| 0157-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Merck Biodevelopment SAS Fujifilm Diosynth Biotechnologies (UK) Ltd - [Application void as of 01/01/2021] |
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies | 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 |
| 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 | Commission decided | Details |
| 0188-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Wallac Oy | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (as Triton X-100) in the assay buffer of the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity | Commission decided | Details |
| 0205-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Becton Dickinson Distribution Center NV | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)) as a processing aid in imported Diagnostics | 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 |
| 0177-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Rentschler Biopharma SE | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated in a washing buffer applied during a purification step in the manufacture of the monoclonal antibody Dinutuximab beta | 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 |
| 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 |
| 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 |
| 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. | Commission decided | Details |
| 0163-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Wallac Oy | Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments | Commission decided | Details |
| 0178-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Takeda Manufacturing Austria AG [name of the applicant in the original application: Baxter AG updated due to a change of corporate name]; Baxalta Belgium Manufacturing SA | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (as a detergent) for virus inactivation via S/D (Solvent/Detergent) treatment in recombinant and plasma-derived medicinal products. | Commission decided | Details |
| 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 |
| 0259-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MT METAL TECH S.r.l. [application transferred from “ST SRL” due to a notified legal entity change] | Use for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (functional electroplating with decorative character) | Opinions adopted | Details |
| 0237-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Carlo Nobili SPA Rubinetterie | Use at industrial site electroplating of different types of substrates to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Opinions adopted | 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 |
| 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 |
| 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 |
| 0239-02 | Initial | 4-Nonylphenol, branched and linear, 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 |
| 0206-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Phadia GmbH; Thermo Fisher Scientific Baltics UAB | Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB | Commission decided | Details |
| 0206-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Phadia GmbH; Thermo Fisher Scientific Baltics UAB | Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB | 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 |
| 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 |
| 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 |
| 0022-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SPOLANA a.s. | Use as an extraction solvent in caprolactam 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 0194-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Instrumentation Laboratory SpA | Use as a lysing agent for red blood cells in blood analysis diagnostic device. | 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 |
| 0016-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as degreasing solvent in the manufacture of polyethylene separators for lead-acid batteries | Commission decided | Details |
| 0017-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ENTEK International Limited – [Decision discontinued as of 01/01/2021] | Trichloroethylene as an extraction solvent for removal of process oil and formation of the porous structure in polyethylene based separators used in lead-acid batteries | Discontinued as of 01 January 2021 | Details |
| 0363-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Ramboll Belgium BVBA (Indestructible Paints) | Treatment of components used in industrial gas turbines and associated components using slurry coating products containing chromium trioxide to enhance corrosion resistance, chemical resistance, high temperature oxidation resistance, adhesion to components which produce a smooth finish and enhance the technical performance of turbines. | Opinion development | Details |
| 0069-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Topocrom GmbH | TOPOCROM functional chrome plating in closed reactor systems for the establishment of adjustable hemispherical surface structures. | Commission decided | Details |
| 0031-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Boliden Mineral AB | The use of sodium dichromate in copper/lead separation in concentrators handling complex sulphide ores | Commission decided | Details |
| 0104-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Borealis Plastomers B.V. | The use of sodium dichromate as in-situ corrosion inhibitor in a closed water/ammonia absorption cooling system | Commission decided | Details |
| 0030-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
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The use of sodium chromate as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0.75% by weight (Cr6+) in the cooling solution | Commission decided | Details |
| 0210-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the selective etching of multi-component (2K/3K) plastic articles. | Opinions adopted | Details |
| 0210-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the functional electroplating of single-component (1K) and multi-component (2K/3K) plastic articles with the specific aim of obtaining a final Cr(0) coating with high durability and chemical resistance while preserving the lightweight nature of the plastic component. | Opinions adopted | Details |
| 0210-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the etching of single-component (1K) plastic articles. | Opinions adopted | Details |
| 0103-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Euro Cryospace France | The use of chromium trioxide for the surface preparation of aluminium alloy cryogenic tanks used in the Ariane 5 launcher | Commission decided | Details |
| 0271-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Villeroy & Boch Gustavsberg AB FM Mattsson Mora Group AB | The use of chromium trioxide for electroplating of metal substrates with the purpose to create a long-lasting high durability surface with bright look for kitchen and bathroom sanitary ware | Opinions adopted | Details |
| 0114–01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional plating with decorative character) | Commission decided | Details |
| 0034-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | The use of Chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional electroplating with decorative character) | Commission decided | Details |
| 0114–02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide for a pre-treatment step (etching) in the electroplating process | Commission decided | Details |
| 0034-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | The use of Chromium Trioxide for a pre-treatment step (etching) in the electroplating process | Commission decided | Details |
| 0250-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Ibérica | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Ibérica S.A in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0251-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Europe BVBA | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Europe BVBA in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0252-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Eastern Europe Sp. z o.o. | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Eastern Europe Sp. z o.o. in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0249-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Monroe Czechia s.r.o. | The use of Chromium Trioxide (EC 215-607-8) by Monroe Czechia s.r.o. in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0228-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Eaton S.R.L; Eaton Automotive Systems sp.zoo | The use of Chromium Trioxide (EC 215-607-8) by Eaton Vehicle Group (Eaton) across two legal entities in the functional chrome plating of engine valves and valve actuation (“lash adjusters”) | Commission decided | Details |