EU Risk Assessments are one element in the EU's Existing Substances Regulation to evaluate and control risks of chemical substances, one of the pre-cursors to REACH. They are widely recognised as the world's most rigorous scientific assessment of a substance's safety in existence today.
In the Risk Assessment Report on BPA published in June 2008, the European Commission concluded that products made from BPA, such as polycarbonate plastic and epoxy resins, are safe for consumers and the environment when used as intended.
For the BPA Risk Assessment, independent scientific experts from the EU Members States considered several hundreds of studies that appeared during recent years, among them both small exploratory studies that do not follow established protocols, as well as comprehensive, statistically-robust studies following accepted international protocols and standards, such as the Good Laboratory Practice Directive. Overall, the studies also covered all potentially affected age groups of consumers including babies and small children.
This BPA Risk Assessment conclusion is consistent with conclusions of the scientific assessments of other regulatory bodies including the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare.
The BPA Risk Assessment was the basis for the BPA dossier registration under REACH. This dossier is currently being re-evaluated by the European Chemicals Agency. The comprehensive substance re-evaluation under REACH is currently in the final phase; it is led by the German risk assessment authorities. The purpose of the evaluation is to identify any potential risks from all relevant uses of BPA for consumers, workers and the environment by assessing all relevant new data and information that has become available since the previous assessment. The result may be the conclusion of “risk adequately controlled” by currently applied risk management measures, or proposals for further measures. The authority´s conclusions are expected to become available in 2016.
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