22 May 2019, ECHA proposed to add 18 substances to the authorization list of REACH annex XIV, which is currently under public consultation. The deadline for comment is July 17, 2019.

The information of 18 substances to be included in the authorization list is as follows:

Substance Name

CAS Number

EC Number

Use Name

Chromium trioxide

1333-82-0

215-607-8

Surface treatment for the manufacture of grain-oriented electrical steel used in magnetic circuits of electric devices, in particular magnetic cores of high-performance transformers

Sodium chromate

7775-11-3

231-889-5

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

Sodium dichromate

10588-01-9

7789-12-0

 

234-190-3

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

-

 -

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) for use in the manufacture of in vitro diagnostic VITROS® products used for infectious disease screening, endocrinology, and oncology testing.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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).

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

         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).

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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.

4-Nonylphenol, branched and linear, ethoxylated

 -

 -

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

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.

Pitch, coal tar, high-temp

65996-93-2

266-028-2

Industrial use of pitch, coal tar, high temp. as precursor of carbon matrix in the manufacturing of thermally and thermo-mechanically highly loaded carbon/carbon parts including nozzle throats and other critical carbon-carbon composite parts, resistant to very harsh erosion conditions, and very high temperature ranges, dedicated to high-performance civilian and military aerospace launchers.

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB).

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

 -

 -

Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population.

C&K Testing reminds enterprises to pay attention to the revising of REACH annex XIV to prevent the subsequent risk.



|Further Information:

Consultation on 18 Substances Proposed for Authorization List

|Our service:

REACH Regulation

REACH Annex XIV Authorization List