Commercial use of Triton X-100 at risk after January 4, 2021

Companies intending to use Triton X-100 in commercial production after January 4, 2021 may find their use of the product to be illegal within the EEA and suppliers unwilling to sell to them.

Triton X-100 is a detergent commonly used in the biotechnology sector for laboratory activities such as cell lysis (to extract proteins) or to increase permeability of cell membranes. It is likely that many biotechnology start-ups use this detergent and have incorporated it as part of their product development process. The continued use of this detergent may now be at risk due to an upcoming REACH authorisation deadline.

Risks from REACH authorisation

The key ingredient of Triton X-100, 2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol, is on the REACH authorisation list. This means that the compound cannot be used or sold within the European Union after its sunset date of January 4, 2021 unless an authorisation has been granted by the European Commission or an exemption applies.

If manufacturers or importers of the compound did not make an application before the latest application date of July 4, 2019, there is a risk that the European Commission will not grant an authorisation before the sunset date. Therefore, commercial production using Triton X-100 and other products containing the compound after 4 January 4, 2021 will have to cease until an authorisation is granted.

Act now to stay on the market

If you intend to import or use Triton X-100 or similar detergents in the EU after the sunset date, on its own or in products, it is important to develop a compliance strategy. Several courses of action can be taken to maintain compliance with the REACH regulation and to mitigate risks to your business continuity.

TSG can help

TSG’s REACH regulatory consultants have many years’ experience working in the chemical industry and can guide chemical companies through every aspect of their REACH obligations. Our REACH services include:

• Registration service
• Support through the evaluation process
• Support authorisation applications
• Advise on use of restricted substances
• Only Representative (OR) service
• Compliance assessment and training