The European Commission has released its decisions on the authorisation for the market placement and use of certain substances listed in Annex XIV to Regulation (EC) No 1907/2006. This regulation, which forms the backbone of the European Union's chemical management policy, is commonly known as REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals). The recent decisions, published under the reference C/2023/1425, mark a crucial step in balancing the socio-economic benefits of these chemicals against the potential risks to human health and the environment.
Decision Overview
One of the key decisions (C(2023) 8143) made on December 1, 2023, concerns two substances:
- 4-(1,1,3,3-Tetramethylbutyl)phenol, Ethoxylated (4-tert-OPnEO)
- 4-Nonylphenol, Branched and Linear, Ethoxylated (4-NPnEO)
Both these substances are authorised for use in buffer solutions for antigen production and quality control in both veterinary and human health laboratory settings.
Authorisation Details
Holder of Authorisation: Prionics Lelystad B.V., based in Lelystad, Flevoland, the Netherlands.
Authorisation Numbers: REACH/23/34/0 and REACH/23/34/1.
Authorised Use: Both 4-tert-OPnEO and 4-NPnEO are authorised as components in buffer solutions. These solutions are essential in antigen production processes like cell extraction, cell lysis, and the coating of biological antigens. They are also pivotal in the inactivation of microorganisms that produce targeted antigens and solvent exchange. Furthermore, they are used in the in-process and final quality control of antigens intended for scientific research and development, as well as in vitro diagnostic applications in both veterinary and human health sectors.
Date of Expiry of Review Period: 4 January 2033.
Rationale Behind the Decision
The European Commission's decision to grant these authorisations aligns with Article 60(4) of the REACH Regulation. This article mandates that authorisations can be granted if the socio-economic benefits of using the substance outweigh the risks posed to human health and the environment. Moreover, it necessitates that there should be no suitable alternative substances or technologies available.
This decision underscores the importance of continuous evaluation and monitoring of chemical substances used in critical industries like healthcare and research. Stakeholders, especially those in the pharmaceutical and biotechnological sectors, must ensure compliance with the specific conditions under which these authorisations are granted. They should also stay informed about potential alternatives as they become available, in line with the evolving landscape of chemicals legislation.
