The Health and Safety Executive (HSE) received an application for authorization of two substances from Roche Diagnostics Switzerland. From 9 August 2022, HSE has asked for public comments on the scientific and technological information on alternatives or processes of these two substances. The deadline for comments is 4 October 4, 2022.
These two substances are:
- 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (Octylphenolethoxylates, OPnEO)
- 4-Nonylphenol, branched and linear, ethoxylated (Nonylphenolethoxylates, NPnEO)
Intended uses: Used in 10 vitro diagnostic (IVD) assays for clinical chemistry and drug monitoring products.
Extensive information on uses: OPnEO and NPnEO can be used in IVD kits due to their surface-active properties. Other surfactants can in principle be used to replace OPnEO and NPnEO in IVD assays based on experiences. Several steps are required to accomplish substitution considering its specific performance. Currently, several alternative substances have been identified and are further assessed for their technical suitability.
Roche Diagnostics has applied for the authorization to the end of 2027, seeking to gain sufficient time to accomplish the evaluation of alternatives.
Moreover, the Department for Environment, Food and Rural Affairs (referred to as Defra) extends the deadline for collecting public comments on persistent organic pollutants (POPs) from August 12 to August 19, 2022. It is conducting a review of statutory exemptions for permitted uses of POPs in the following:
- Decabromodiphenyl ether (decaBDE)
- Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds
- Perfluorooctane sulfonic acid (PFOS), its salts and its derivatives
- Short chain chlorinated paraffins (SCCPs)
Defra is inviting industries to provide information on the uses of these POPs to understand specific exemptions as part of the review. Information can be provided by industries as follows:
- Names of enterprises, names and information of contact;
- Do enterprises use POPs in the manufacturing processes?
- What is the purpose of manufacturing or using POPs?
- Which specific exemption is being used?
- What is the estimated amount of POPs produced or used?
- What is the reason for not using alternatives of POPs?
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