Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.
On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid.
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There are currently no ongoing consultations.
| 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 |
| 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 |
| 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 |
| 0171-05 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 0154-01 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |