On June 13, 2023, the European Commission (EC) published in the Official Journal of the European Union (EU) several authorization decisions concerning uses of 4-tert-OPnEO and 4-NPnEO, Substances of Very High Concern (SVHC). The authorizations concern QIAGEN, STAT-Dx Life and QIAGEN Distribution.
4-tert-OPnEO is used in a variety of industrial and medical applications as a lysing agent, emulsifier and surfactant. For example, it is used to siliconized glass containers and inactivate viral biological proteins in the manufacture of biopharmaceuticals.
To date, there are no proven alternatives to these substances for these specific uses, particularly in the in vitro diagnostics sector. Insofar as the benefits of using these substances still outweigh the associated risks, the EC has authorized these uses until the substitution of substances of very high concern has been implemented.
On November 9, 2021, the EC had already granted authorization for 11 uses of 4-tert-OPnEO.
Ethoxylated (1,1,3,3-tetra methylbutyl) phenol, known as 4-tert-OPnEO, and ethoxylated, branched and linear 4-nonylphenol, also known as 4-NPnEO, are endocrine disruptors. They present environmental risks. They have therefore been added to Annex XIV (authorization list) of REACH (Registration, Evaluation and Authorization of Chemicals) to limit their use. When a substance is added to the Annex XIV list, it can no longer be marketed and used in the EU, unless the user obtains authorization for one or more uses under the REACH regulation.
Contact our experts free of charge and without obligation!
EcoMundo's experts can help you keep abreast of changes in the regulations governing your substances, audit your sites and design your authorization dossiers.
With a 100% success rate in the dossiers our teams have submitted, our experts can assure you of regulatory compliance for all your substances.
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On June 13, 2023, the European Commission (EC) published in the Official Journal of the European Union (EU) several authorization decisions concerning uses of 4-tert-OPnEO and 4-NPnEO, Substances of Very High Concern (SVHC). The authorizations concern QIAGEN, STAT-Dx Life and QIAGEN Distribution.
4-tert-OPnEO is used in a variety of industrial and medical applications as a lysing agent, emulsifier and surfactant. For example, it is used to siliconized glass containers and inactivate viral biological proteins in the manufacture of biopharmaceuticals.
To date, there are no proven alternatives to these substances for these specific uses, particularly in the in vitro diagnostics sector. Insofar as the benefits of using these substances still outweigh the associated risks, the EC has authorized these uses until the substitution of substances of very high concern has been implemented.
On November 9, 2021, the EC had already granted authorization for 11 uses of 4-tert-OPnEO.
Ethoxylated (1,1,3,3-tetra methylbutyl) phenol, known as 4-tert-OPnEO, and ethoxylated, branched and linear 4-nonylphenol, also known as 4-NPnEO, are endocrine disruptors. They present environmental risks. They have therefore been added to Annex XIV (authorization list) of REACH (Registration, Evaluation and Authorization of Chemicals) to limit their use. When a substance is added to the Annex XIV list, it can no longer be marketed and used in the EU, unless the user obtains authorization for one or more uses under the REACH regulation.
Contact our experts free of charge and without obligation!
EcoMundo's experts can help you keep abreast of changes in the regulations governing your substances, audit your sites and design your authorization dossiers.
With a 100% success rate in the dossiers our teams have submitted, our experts can assure you of regulatory compliance for all your substances.
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