ECHA: Siloxanes D4, D5, and D6 Classified as SVHC

The Member State Committee (MSC) of the ECHA has approved the classification of siloxanes D4, D5, and D6 as substances of very high concern (SVHC). The German Environmental Ministry submitted the required reports (Annex XV Report on D4 and Annex XV Report on D5: Annex XV – Identification of D4 and D5 as SVHC in March of this year. The ECHA submitted the Report on D6.

The experts in the MSC rated D4 as persistent, bioaccumulative (it accumulates in the food chain), and toxic (PBT), but they assigned only persistent and bioaccumulative (vPvB) properties to D5 and D6. Nevertheless, D5 and D6 can also be classified as PBT when both substances show D4 impurities in a concentration equal to or greater than 0.1% by weight.

The EU has had its eye on the three siloxanes for some time. REACH (EU) 2018/35 has been in effect since January 10, meaning that wash-off cosmetics products may not be marketed after January 31, 2020 if they contain siloxanes D4 and D5 in a concentration of 0.1 % or higher by weight. The regulation is based on an initiative of Great Britain that had recommended restrictions as early as 2015.

Industry has criticized the decision of the MSC. Pierre Germain, the general secretary of the CES-Silicones Europe organization, accused the MSC of not having considered all the available scientific data and facts in its decision. He also noted that the amounts found in the environment were very small. Germain and other critics base their arguments on a current U.S. study that indicates no environmental dangers whatsoever from D4.

On April 2, representatives of European and U.S. silicon industry associations began a legal action against current U.S. study the EU Commission. See: Official Journal of the European Union Volume 61, 11 June 2018, (Case T-226/18) (2018/C 200/57). They argue that the criteria for SVHC defined in Annex XIII of REACH regulation are inappropriate to describe the properties of siloxanes correctly.

Silicone compounds D4 (cyclotetrasiloxane), D5 (cyclopentasiloxane), and D6 (cyclohexasiloxane) are often found in personal care products and flow into the environment along with waste water. They are also important source materials for certain silicones and are often found as residues in finished products.

Do you have any questions about the legal compliance of your products? We’re happy to help. Please contact us at reach@kft.de.

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