Nonylphenol & Octylphenol

Ethoxylated Nonylphenol (NPnEO) & Octylphenol (OPnEO)

These substances are surfactants, which is why they have long been used in detergents, emulsifiers, dryers and dispersants. However, due to their endocrine disrupting properties and their overall persistence in the environment, many uses - and more particularly of ethoxylated nonylphenols - were banned in Europe as early as 2003, i.e. before the official adoption of the REACH Regulation.

The endocrine disruptor character also justifies the entry of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (commonly known as OPnEO or Octylphenols ethoxylated) and 4-nonylphenol, branched and linear, ethoxylated (commonly known as NPnEO or Nonylphenols ethoxylated) into the REACH authorisation process.
In particular, ECHA has identified, on the basis of the data available in the registration dossiers, a significant number of uses necessary for various major industrial sectors (mining, textiles, paint, energy, chemicals).

However, these substances (most often known by trade names such as "Triton" or "Nonidet") are also widely used in the manufacture of in vitro diagnostic (IVD) reagents for hospitals and medical laboratories because of their cell lysis properties.

Approximately 100 applications for authorisation were submitted, representing the vast majority of the authorisation needs for these two substances.

In addition, the needs for the management of the COVID epidemic have justified a postponement of the sunset date for ethoxylated octylphenols until December 2023, which implies a submission of dossiers before mid-2022.

Ethoxylated octylphenols are, in fact, currently used for the production of in vitro diagnostic kits. Thus, it cannot be excluded that this group of substances is used for the development and production of active ingredients and assay products to combat COVID-19 (vaccines, in vitro diagnostic kits, etc.), as the European Commission points out in its decision extending the deadline for the submission of applications and the sunset date.

There is therefore an urgent need to cover all authorisation requirements in the fight against COVID-19. R2A brings its experience on OPnEO and NPnEO files and is able to provide its members with quick and relevant advice on the best way to obtain an authorisation in this respect.