4-tert-OPnEO Authorised for Use as an Emulsifier in a Silicone Oil Emulsion

Key Decision Details

Substance Name: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)

Holder of Authorisation: Merckle GmbH, Germany

Authorisation Number: REACH/23/30/0

Authorised Use: The substance is approved for use as an emulsifier in a silicone oil emulsion. This application is vital for the siliconisation of pre-filled syringes in medicinal products.

Date of Expiry of Review Period: 4 January 2028

Decision Rationale

In alignment with Article 60(4) of Regulation (EC) No 1907/2006, the decision to grant authorisation to Merckle GmbH for the use of 4-tert-OPnEO was primarily influenced by a balanced consideration of socio-economic benefits against the risks posed to human health and the environment. The European Commission concluded that the benefits of using this substance significantly outweigh the potential risks. Moreover, it was determined that there are no suitable alternative substances or technologies available that could replace 4-tert-OPnEO in its specific industrial application.

Implications for Stakeholders

This decision highlights the European Commission’s approach to regulating chemical substances under the REACH framework (Registration, Evaluation, Authorisation and Restriction of Chemicals). It underscores the importance of evaluating chemicals not only on the basis of their potential risks but also considering their socio-economic utility.

The decision by the European Commission serves as a reminder of the intricate balance between ensuring safety and enabling technological and industrial progress. It also exemplifies the dynamic nature of chemical legislation, where decisions are made based on a comprehensive evaluation of various factors, including health, environmental impact, and socio-economic benefits.