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.
What uses are concerned?
Review period expiry date: January 4, 2031
- REACH/23/17/0 and REACH/23/17/1 : Formulation and filling of buffer solutions containing 4-tert-OPnEO for the manufacture and use of in vitro diagnostic and life science kits in the following product groups: sample preparation, PCR and sequencing.
- REACH/23/17/2 : Formulation and filling of buffer solutions containing 4-NPnEO for the manufacture and use of in vitro diagnostic and life science kits in the following product groups: sample preparation, PCR and sequencing.
- REACH/23/17/3 : Industrial use of 4-tert-OPnEO in biomaterial purification and blocking of non-specific binding for use in in vitro diagnostic and life science kits from the sample preparation, PCR and sequencing product groups.
- REACH/23/17/4 : Industrial use of 4-NPnEO in biomaterial purification and non-specific binding blocking for use in in vitro diagnostic and life science kits from the sample preparation, PCR and sequencing product groups.
- REACH/23/17/5, REACH/23/17/6 and REACH/23/17/7 : Professional downstream use of 4-tert-OPnEO in biomaterial purification and non-specific binding blocking for use in in vitro diagnostic and life science kits with regulatory impact of product groups: sample preparation, PCR, sequencing and immunoassays.
- REACH/23/17/8 and REACH/23/17/9 : Professional downstream use of 4-NPnEO in biomaterial purification and non-specific binding blocking for use in in vitro diagnostic and life science kits with regulatory impact of product groups: sample preparation, PCR, sequencing.
Review period expiry date: January 4, 2026
- REACH/23/17/10 and REACH/23/17/11 : Professional downstream use of 4-tert-OPnEO in biomaterial purification and non-specific binding blocking for life science kits without regulatory impact of product groups: sample preparation, PCR and sequencing.
- REACH/23/17/12 and REACH/23/17/13 : Professional downstream use of 4-NPnEO in biomaterial purification and non-specific binding blocking for life science kits with no regulatory impact on product groups: sample preparation, PCR and sequencing.
What are the reasons for this decision?
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.
Why were 4-tert-OPnEO and 4-NPnEO included on the authorization list?
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.
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