The European Commission has made a crucial decision regarding the authorisation for the use of a specific chemical substance. The decision, documented as C(2023) 8566 and dated 15th December 2023, focuses on the substance 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO). This substance is particularly noted for its industrial applications.
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.
