Potential ban on silicone substances in EU “inconsistent with sound science”
WASHINGTON (April 3, 2020) – Members of the Global Silicones Council (GSC) oppose the European Union’s (EU) recent draft recommendation to prioritize three essential silicone substances,
D4, D5, and D6 for authorization. If a substance is subject to authorization under the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, some uses will be banned in the EU unless explicit permission from the government is granted.
“The EU recommendation to prioritize D4, D5, and D6 for authorization is inconsistent with sound science and out of step with regulatory outcomes for the substances in Australia and Canada,” said Karluss Thomas, Executive Director of the GSC. “To date, regulatory authorities on three continents, including North America, Europe, and Australia, have evaluated the risk associated with D4, D5, and D6. Two of those regulatory evaluations, and the associated risk management measures identified for the substances, have been remarkably similar, with the EU being the notable outlier. It is noteworthy that outside of the EU no regulatory authority has imposed any restriction on the use of these substances in commerce, nor have they considered adopting such restrictive measures as requiring permission from the government to use these substances. D4, D5, and D6 are widely considered safe for human health and the environment when used as intended.”
It is noteworthy that outside of the EU no regulatory authority has imposed any restriction on the use of these substances in commerce.
To ban some uses of the substances in the EU would also pose practical challenges for the use of the substances in global supply chains that would likely create barriers to trade and complicate the effective implementation of risk-based science policy in regions that are developing chemicals management systems.
“The EU proposal to prioritize D4, D5, and D6 for authorization is an unfortunate consequence of a flawed regulatory evaluation for these silicone substances,” said Thomas. “The EU’s assessment of these silicone substances did not consider all available evidence and ignored technical input from leading academic experts. Similar to the regulatory restrictions and the substance of very high concern (SVHC) designation imposed on the substances in the EU, authorization of D4, D5, and D6 would not provide any meaningful environmental benefit and would needlessly jeopardize innovation and economic growth.”