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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
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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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| 0004-03 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use of DEHP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Withdrawn | Details |
| 0007-03 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Roxel (UK Rocket Motors) Ltd | Industrial use of DBP within a specialty paint in manufacture of motors for rockets and tactical missiles | Authorisation expired | Details |
| 0007-02 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Roxel (UK Rocket Motors) Ltd | Industrial use of DBP in manufacture of solid propellants and motor charges for rockets and tactical missiles | Authorisation expired | Details |
| 0005-03 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. | Industrial use of DBP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Authorisation expired | Details |
| 0244-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | CROMAPLAST S.p.A. | Industrial use of CrO3 in the pre-treatment (etch) in the chrome plating process of automotive plastic components | Opinions adopted | Details |
| 0244-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | CROMAPLAST S.p.A. | Industrial use of CrO3 in the chrome plating of automotive plastic components | Opinions adopted | Details |
| 0209-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Safran Aircraft Engines | Industrial use of chromium trioxide-based mixtures for the surface treatment of legacy spare parts of military aircraft engines, including safety-critical parts whose failure endangers airworthiness | Commission decided | Details |
| 0218-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | DOURECA - Produtos Plásticos, Lda. | Industrial use of chromium trioxide to create a long-lasting and high durability chromium decorative surface on plastic substrates in the electroplating process for automotive applications. | Opinions adopted | Details |
| 0070-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
FN HERSTAL S.A. MANROY ENGINEERING LTD – [Decision discontinued as of 01/01/2021] |
Industrial use of chromium trioxide in the hard chromium coating of military small- and medium-caliber firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide hardness, heat resistance and thermal barrier properties, as well as corrosion resistance, adhesion and low friction properties | Commission decided | Details |
| 0255-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Chrom - Mueller Metallveredelung GmbH | Industrial use of chromium trioxide in the hard chromium coating of complex outer surfaces of firearm auxiliary parts subject to mechanical, chemical and thermal stress in order to provide optimized sliding properties as well as heat, corrosion and wear resistance properties. | Opinions adopted | Details |
| 0255-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Chrom - Mueller Metallveredelung GmbH | Industrial use of chromium trioxide in the hard chromium coating of complex outer and inner surfaces of firearms auxiliary parts requiring a customised and selective coating technique and subject to thermal, mechanical and chemical stresses, in order to provide wear resistance and barrier properties, as well as post-processing capability and resistance to hot combustion gas erosion. | Opinions adopted | Details |
| 0070-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
FN HERSTAL S.A. BROWNING VIANA, FABRICA DE ARMAS E ARTIGOS DE DESPORTO SA |
Industrial use of chromium trioxide in the hard chromium coating of civilian firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide a low friction coefficient as well as heat, corrosion and wear resistance properties. | Commission decided | Details |
| 0293-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Talleres Aykrom, S.A. | Industrial use of Chromium Trioxide in functional chrome plating of metallic pieces required in different industrial sectors such as corrugated rolls to meet hardness, wear resistance, corrosion resistance, good surface condition, low friction coefficient and coating adhesion requirements | Opinions adopted | Details |
| 0359-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | CIRCUIT FOIL LUXEMBOURG SARL | Industrial use of chromium trioxide for the treatment of copper foil used in the manufacture of printed circuit board. | Opinion development | Details |
| 0058-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | CIRCUIT FOIL LUXEMBOURG SARL | Industrial use of chromium trioxide for the treatment of copper foil used in the manufacture of Printed Circuit Board | Commission decided | Details |
| 0315-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Egal srl | Industrial use of chromium trioxide for the pre-treatment step (etching) in the electroplating process of small sized plastic items for various sectors | Opinion development | Details |
| 0291-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | BELLONI S.a.s. DI BELLONI ADRIANO & C. | Industrial use of chromium trioxide for the plating of coffee machine parts in contact with water and food | Opinions adopted | Details |
| 0309-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Cromatura Staff Srl | Industrial use of chromium trioxide for the plating of brass valves destined for applications involving industrial and technical fluids and brass fittings for oxygen cylinders | Opinions adopted | Details |
| 0324-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tecnofiniture S.r.l. | Industrial use of chromium trioxide for the hard-chrome plating of a wide variety of items with large dimensions and complex geometries used in energy generation and supply, off-shore oil and gas extraction and manufacturing industries. | Opinions adopted | Details |
| 0287-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Bacrom S.L. | Industrial use of chromium trioxide for the hard plating of various end-products made of steel for the industry manufacturers to provide hardness, corrosion resistance, low friction coefficient, good surface roughness, thickness, and excellent surface condition | Opinions adopted | Details |
| 0281-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ELECTRO-DUROCROM.S.L | Industrial use of chromium trioxide for the hard chromium plating of moulds, dies and custom-made finished parts on any metal base, in order to provide hardness, wear resistance, corrosion resistance, demoulding properties, low friction ratio, for the manufacture of high-quality metal parts in several sectors as automotive, pharmaceutical, food and packaging industries | Opinions adopted | Details |
| 0263-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Orelec | Industrial use of chromium trioxide for the hard chrome plating of injection moulds in order to provide hardness, wear resistance and good demoulding properties, critical for the manufacture of high-quality plastic parts. | Opinions adopted | Details |
| 0292-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Artech SRL | Industrial use of chromium trioxide for the functional chrome plating with decorative character of steel tubes and plates incorporated in machines for the agri-food industry, leisure, household furniture and automotive industries | Opinions adopted | Details |
| 0290-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Fir Italia S.p.A. | Industrial use of chromium trioxide for the functional chrome plating with decorative character of items for the hydrosanitary sector | Opinions adopted | Details |
| 0318-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Sirio Galv S.R.L | Industrial use of Chromium Trioxide for the functional chrome plating with decorative character for different applications. | Commission decided | Details |
| 0212-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. |
Industrial use of chromium trioxide for the functional chrome plating with decorative character for automotive and sanitary industry | Opinions adopted | Details |
| 0295-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Ugitech Saint-Etienne | Industrial use of chromium trioxide for the functional chrome plating of stainless-steel bars, mainly designed to be cylinder rods, used in aggressive and corrosive environments in diverse sectors such as transportation | Opinions adopted | Details |
| 0313-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | BWI Poland Technologies Sp. z. o.o | Industrial use of chromium trioxide for the functional chrome plating of shock absorber rods and strut rods, cylinders and reservoir tubes mounted on passive or semi-active dampers for automotive applications | Opinions adopted | Details |
| 0321-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | LMC S.r.l. | Industrial use of Chromium Trioxide for the functional chrome plating of food slicer’s circular blades. | Opinion development | Details |
| 0212-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. |
Industrial use of chromium trioxide for the etching, pre-treatment step in the electroplating process of functional chrome plating with decorative character | Opinions adopted | Details |
| 0257-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | QUALIPAC Aurillac; Etablissements R.GRAINDORGE | Industrial use of chromium trioxide for the etching of polypropylene (PP) substrates, as a pre-treatment step of the electroplating process, for the luxury sector and other applications | Opinions adopted | Details |
| 0260-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Sarrel Sarreliber - Transformação de Plásticos e Metais, S.A | Industrial use of chromium trioxide for the etching of plastics materials, as a pre-treatment step of the electroplating process, for automotive applications mostly | Opinions adopted | Details |
| 0254-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RATIER-FIGEAC | Industrial use of chromium trioxide for the chromic acid anodizing of aluminium spars as critical surface preparation phase for bonding with aircraft safety critical propeller blades to secure reliable bonding performance and enhance spars corrosion resistance | Opinions adopted | Details |
| 0285-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Liebherr-Aerospace Lindenberg GmbH | Industrial use of chromium trioxide for surface treatment of aluminium alloys for applications in the aerospace industries unrelated to functional chrome plating | Opinions adopted | Details |
| 0312-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Metalplast sas; CO.BE. sas di Colombo Nadia e Flavia | Industrial use of chromium trioxide for plating on plastic materials to create a long-lasting high durability chromium decorative surface in the electroplating process for various applications. | Opinion development | Details |
| 0255-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Chrom - Mueller Metallveredelung GmbH | Industrial use of chromium trioxide for high ratio aspects inside hard chromium coating of firearms barrel bores subject to thermal, mechanical and chemical stresses, in order to provide wear resistance properties, as well as low friction coefficient, hardness, resistance to corrosion and gas erosion properties. | Opinions adopted | Details |
| 0346-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Safran Landing Systems; TSM; REVETEMENT DE CHROME DUR; SOCIETE TECHNIQUE D'ETUDES ET DE GESTION; SABENA TECHNICS BOD; OMA S.P.A.; Metal Sud s.r.l; Safran Landing Systems Services; Compañia Española de Sistemas Aeronauticos, (C.E.S.A.), S.A.U.; Aerostar S.A. | Industrial use of chromium trioxide for hard chrome plating to provide key functional properties such as wear resistance (...) in the manufacturing of landing and braking system parts for aeronautical applications exclusively supplied by Safran Landing Systems without technical limitations with the identified alternative. | Opinion development | Details |
| 0346-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Safran Landing Systems; TSM; REVETEMENT DE CHROME DUR; SOCIETE TECHNIQUE D'ETUDES ET DE GESTION; SABENA TECHNICS BOD; OMA S.P.A.; Metal Sud s.r.l; Safran Landing Systems Services; Compañia Española de Sistemas Aeronauticos, (C.E.S.A.), S.A.U.; Aerostar S.A. | Industrial use of chromium trioxide for hard chrome plating in the manufacturing and the repairing of landing gear parts exclusively supplied by Safran Landing Systems and for which there is not yet potential alternatives identified as part of the substitution process. | Opinion development | Details |
| 0307-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | VINZIA F.lli S.p.A. | Industrial use of chromium trioxide for functional chrome plating with the decorative character of brass or stainless-steel drain components for the tap industry to provide thickness, corrosion resistance | Opinions adopted | Details |
| 0279-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | GalvanoPlus Srl | Industrial use of chromium trioxide for functional chrome plating with decorative character of sanitary equipment | Opinions adopted | Details |
| 0306-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | GALVANICA PASOTTI THEA S.R.L.; CHINO COLOR S.r.l. | Industrial use of chromium trioxide for functional chrome plating with decorative character of items for the sanitary, hydro-sanitary, taps, household industries, and various other applications (such as handles/locks, pneumatic elements and electrical connection). | Opinions adopted | Details |
| 0322-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal Belgium NV/SA | Industrial use of chromium trioxide for functional chrome plating of work rolls for use in the production of flat metal products | Opinions adopted | Details |
| 0254-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RATIER-FIGEAC | Industrial use of chromium trioxide for functional chrome plating of aircraft safety critical steel ball screws used in airplane's actuators, to decrease friction ratio, and enhance wear, corrosion, and endurance resistance, enabling targeted service life | Opinions adopted | Details |
| 0285-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Liebherr-Aerospace Lindenberg GmbH | Industrial use of chromium trioxide for functional chrome plating of actuation and landing gear systems for the aviation industry. | Opinions adopted | Details |
| 0358-01 | Review report | Arsenic acid | 231-901-9 | 7778-39-4 | CIRCUIT FOIL LUXEMBOURG SARL | Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of printed circuit board. | Opinion development | Details |
| 0059-01 | Initial | Arsenic acid | 231-901-9 | 7778-39-4 | CIRCUIT FOIL LUXEMBOURG SARL | Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of Printed Circuit Board | Commission decided | Details |
| 0090-02 | Initial | Formaldehyde, oligomeric reaction products with aniline | 500-036-1 | 25214-70-4 | Polynt Composites France | Industrial use of an epoxy resin hardener containing technical MDA aimed at immobilising spent ion exchange resins in a high containment matrix | Commission decided | Details |
| 0106-01 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 |
BAE Systems (Operations) Limited – [Decision discontinued as of 01/01/2021] Qioptiq Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of Ammonium Dichromate in the process of manufacturing holographic combiners for diffractive head-up displays intended to be used in military aircrafts | Discontinued as of 01 January 2021 | Details |
| 0106-02 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 | Display Technologies Limited - [Decision discontinued as of 01/01/2021] | Industrial use of Ammonium Dichromate in the process of manufacturing Cathode Ray Tubes for head up displays intended to be used in military and civilian aircrafts | Discontinued as of 01 January 2021 | Details |
| 0351-01 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | TURDUS TESTERS OF CAPACITY | Industrial use of a potassium dichromate-based mixture for the manufacture of single-use chemical breathalysers | Opinion development | Details |
| 0057-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Nexter Mechanics | Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament steels parts which are thermomechanically stressed and in contact with oxidizing gas at high temperature, so as to ensure a thermal barrier with high melting point, resistance to wear and oxidation associated with weapons as well as resistance to impact and atmospheric corrosion. | Commission decided | Details |
| 0057-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Nexter Mechanics | Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament parts in order to ensure surface hardness, resistance to atmospheric corrosion, abrasive wear resistance and friction coefficient for parts in relative movement. | Commission decided | Details |
| 0057-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Nexter Mechanics | Industrial use of a mixture of chromium trioxide for the black colour hard chromium plating of exterior surface of steel weapon barrel designed for military use, to ensure, during the whole gun barrel service life, stealth, erosion, corrosion and high temperature resistances in the condition of uses. | Commission decided | Details |
| 0072-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Souriau sas “Amphenol Limited – [Decision discontinued as of 01/01/2021] AMPHENOL SOCAPEX ITT Cannon GmbH TE UK Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. | Commission decided | Details |
| 0072-05 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Connecteurs Electriques Deutsch | Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. | Commission decided | Details |
| 0072-07 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Souriau sas “Amphenol Limited – [Decision discontinued as of 01/01/2021] AMPHENOL SOCAPEX |
Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. | Commission decided | Details |
| 0072-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Souriau sas “Amphenol Limited – [Decision discontinued as of 01/01/2021] AMPHENOL SOCAPEX ITT Cannon GmbH Connecteurs Electriques Deutsch TE UK Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). | Commission decided | Details |
| 0072-04 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 |
Connecteurs Electriques Deutsch TE UK Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). | Commission decided | Details |
| 0072-06 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Souriau sas; TE UK Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). | Commission decided | Details |
| 0219-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Husqvarna AB | Industrial use of a mixture containing Chromium Trioxide in functional chrome plating of the saw chain cutter links in order to meet stay sharp and durability requirements for use with chainsaws. | Commission decided | Details |
| 0072-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Souriau sas | Industrial use of a mixture containing chromium trioxide for the etching of composite connectors used by industries subject to harsh environments, to mainly ensure adhesive deposit to meet the requirements of international standards. | Commission decided | Details |
| 0065-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Safran Aircraft Engines [name of applicant in the original application: SNECMA updated due to a notified change of corporate name] | Industrial use of a chromium trioxide based surface treatment mixture applied on safety-critical rotating components of commercial and military aircraft engines, whose failure endangers airworthiness | Commission decided | Details |
| 0165-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Eli Lilly Kinsale Limited | Industrial use of a 4-tert-octylphenol ethoxylate compound, as a patient safety viral inactivation reagent in the manufacture of human medicines produced from biological systems | Commission decided | Details |
| 0200-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | QIAGEN GmbH | Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing | Commission decided | Details |
| 0200-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | QIAGEN GmbH | Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing | Commission decided | Details |
| 0140-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO in view of controlling the amount of non-specific reactions in the production of in-vitro diagnostic reagents (STA® - Liatest® D-Di assays). | Commission decided | Details |
| 0141-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its wetting detergent properties in the production of buffers, reagents and gel supports allowing the dissolution, the dilution and the good spreading of substrates and reagents, necessary to optimize the functioning and the sensitivity of gel electrophoresis in vitro diagnostic tests. | Commission decided | Details |
| 0143-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent to control the level of non-specific reactions in the formulation of in vitro reagents for clinical and industrial in vitro testing immunoassays. | Commission decided | Details |
| 0180-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent property in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles | Commission decided | Details |
| 0349-01 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, used for the extraction of biological material which is further formulated and coated on articles intended for clinical and industrial in vitro testing applications | Opinion development | Details |
| 0179-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, consisting in the filling of 4-tert-OPnEO-containing solutions into specific single-use ampoules to be included in clinical and industrial in vitro testing applications as part of the BioFire and BioFire Next Gen FA products. | Commission decided | Details |
| 0180-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Commission decided | Details |
| 0143-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of reagents for molecular clinical and industrial in vitro preparative and testing applications. | Commission decided | Details |
| 0143-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its detergent properties, used for the extraction of biological material which is further formulated and intended for clinical and industrial in vitro testing applications. | Commission decided | Details |
| 0180-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications | Commission decided | Details |
| 0141-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests. | Commission decided | Details |
| 0141-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its detergent properties in the production of electrophoresis gels in view of ensuring the positioning of specific proteins necessary for the interpretation of results of gel electrophoresis in vitro diagnostic tests. | Commission decided | Details |
| 0140-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO for its detergent properties in the process of cell lysing for the production of in-vitro diagnostic reagents (Asserachrom® HPIA, Asserachrom® HPIA–IgG and Asserachrom® PF4 and STA®-Néoplastine® R15 assays). | Commission decided | Details |
| 0183-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGAST | Industrial use of 4-tert-OPnEO for its amphiphilic, surfactant and non-haemolytic properties, to create controlled hydrophilic spots on porous hydrophobic membranes (solid form) for in vitro diagnostic kits for blood testing via antigen/antibody reaction in the following product ranges: ABTest Card®, ABD PAD® and M-TRAP® cartridges for the ONYX® system. | Commission decided | Details |
| 0204-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Biokit S.A. | Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | Commission decided | Details |
| 0180-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Bio-Rad | Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Commission decided | Details |
| 0142-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | SEBIA | Industrial use of 4-NPnEO for its detergent properties in the production of buffers and reagents in view of ensuring the positioning of specific proteins necessary for the interpretation of gel electrophoresis in vitro diagnostic tests results based on the determination of isoenzymes. | Commission decided | Details |
| 0230-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Safran Landing Systems; SOCIETE DE TRAITEMENTS ELECTROLYTIQUES NORMALISES S.T.E.N. | Industrial use of 4-NPnEO as non-reactive surfactant in the sealing product in sulfuric acid anodization process of aluminium alloy parts of aircraft landing gears | Withdrawn | Details |
| 0197-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | MERCK MILLIPORE LIMITED | Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes). | Commission decided | Details |
| 0240-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Alexion Pharma International Operations Unlimited Company | Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation in the manufacture Andexanet alfa for treatment of adult patients treated with a direct factor Xa (FXa) inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding | Commission decided | Details |
| 0246-01 | Initial | 2,2'-dichloro-4,4'-methylenedianiline (MOCA) | 202-918-9 | 101-14-4 | Courbis Synthèse Annovi S.r.l.; Dansk Elastomer A/S; Durlast S.r.l.; Pieffe S.r.l.; Policart S.r.l.; R.B.M. Italia S.r.l.; Tecnocaucho S.A.; Tegea S.r.l.; Optibelt Urethane Belting Ltd.; Productos Salinas S.A.; V.M. SPA | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of hot cast polyurethane products | Commission decided | Details |
| 0225-02 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for heavy-duty rollers, tensioner pads and spring blocks with high reliability requirements for offshore energy and renewables sectors. | Commission decided | Details |
| 0225-01 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for custom-made rollers with high reliability requirements for steel and aluminium sectors. | Commission decided | Details |
| 0082-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name] | Industrial use of 1,2-dichloroethane as an emulsifying solvent in the manufacture of porous particles for beaded chromatography and cell culture media. | Commission decided | Details |
| 0224-01 | Review report | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | EURENCO | Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives. | Commission decided | Details |
| 0083-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | EURENCO | Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives | Commission decided | Details |
| 0004-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0002-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0003-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0201-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change] | Industrial use in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary In Vitro Diagnostic devices (IVDs) used for detecting certain diseases in pets and farm animals | Commission decided | Details |
| 0076-01 | Initial | 1,2-dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) | Commission decided | Details |
| 0076-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF plc - [Decision discontinued as of 01/01/2021; application transferred from original Applicant: BASF SE due to a notified legal entity change] | Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) | Discontinued as of 01 January 2021 | Details |
| 0024-02 | 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] | Industrial use as process chemical (enclosed systems) in Alcantara Material production | Commission decided | Details |
| 0191-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Sekisui S-lec BV Roermond | Industrial use as polymer additive in the manufacture of interlayer polymer films for laminated safety glass | Commission decided | Details |
| 0243-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | DOMO Caproleuna GmbH | Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil | Commission decided | Details |