New REACH restrictions on D4, D5, and D6 apply to medical devices and IVDs

On 17 May 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/1328 amending REACH regarding the use of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6).

REACH is Regulation (EC) 1907/2006 on the registration, evaluation, authorization, and restriction of chemicals. REACH aims at protecting human health and the environment from harmful substances. At the same time, it promotes competitiveness and innovation within the European Union.

D4, D5, and D6 (cyclic siloxanes) are used in a wide range of products to create silicone materials (polymers). In medical devices and IVDs, they are used, among others, as coating for hypodermic needles, in hydrogel contact lenses, insulin pumps, and prosthetic devices. Nevertheless, these silicones pose risks to the environment when present in products and devices as they end up being released into the aquatic and atmospheric compartments. Regulation (EU) 2024/1328 aims at minimizing such risks.

Restrictions and exceptions

According to the new restrictions, D4, D5, and D6 can be used up to a maximum concentration of 0,1% in products and devices for the EU market. For medical devices and IVDs, the European Commission granted a 7-year transition period for the industry to comply with the new concentration limit. Hence, medical devices and IVDs manufacturers have time until 6 June 2031 to adapt to these restrictions.

Furthermore, the Regulation provides that the restriction on D5 and D6 will not apply to medical devices for the treatment and care of scars and wounds, and for the prevention of wounds, and the care of stoma. The restrictions will also not apply to mixtures containing cyclic siloxanes as residues from silicone polymers in the following cases:

• Mixtures containing D4, D5, or D6 up to 0,2% by weight of the respective substance for use in medical devices and IVDs;
• Mixtures containing D5 up to 0,3% by weight or D6 up to 1% by weight for use in medical devices for dental impression.

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