Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid. 

 

There are currently no ongoing consultations.
 
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
  • Boeing Distribution Deutschland GmbH [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
  • 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 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
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
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
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
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
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
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
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
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
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
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
0024-01 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
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
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
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
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