Substance Evaluation Support for BPA-PO CoRAP
The Regulatory Challenge
In 2015, the European Chemicals Agency (ECHA) took the decision for the Evaluation Pursuant to Article 46(1) of Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation) for the following substance:
4,4’-propane-2,2-diyldiphenol, polymer with 2-methyloxirane
CAS Number: 37353-75-6
EC No 500-097-4
The substance is also referred to as BPA 1 – 4.5 P0, BPA-PO and Propoxylated Bisphenol A.
The initial grounds for concern for the unknown or variable composition (UVCB) that triggered the Evaluation is that it is a suspected Carcinogenic, Mutagenic, Reprotoxic (CMR) substance with high aggregated tonnage (1,000–10,000 tonnes p.a.) and a wide dispersive use.
Our Solution
As Only Representative (OR) for the Lead Registrant and some of the joint registrants for the substance under evaluation, Yordas became the lead for this evaluation. Yordas investigated the repeated-dose and reproductive toxicity of BPA-PO, updated and submitted the IUCLID and CSR on behalf of the registrants. Upon completion of testing, Yordas updated and submitted the IUCLID and CSR on behalf of the registrants.
The project was made challenging due to the substance being a UVCB, commercially available as various grades. Available experimental data generated on different grades of the substance indicated they could be expected to display different properties, especially in regards to their potential endocrine-disrupting properties. Identifying the most relevant grade for each endpoint – i.e. the grade expected to represent the worst-case scenario – proved to be a critical part of the project.
Benefits for the Client
Yordas managed all the requirements of the Community Rolling Action Plan (CoRAP), including engagement with the Authorities, review and comments of draft decision. The evaluation was completed in May 2020 concluding that the information available is sufficient to address the concern(s) raised in the CoRAP for the time being. Consequently, the substance evaluation process under the REACH Regulation for this substance was concluded.