REACH amendment: EU Bans D4, D5, D6 to enhance safety and environmental protection
22 May 2024 --- The Official Journal of the European Union publication bans the use of cosmetic silicones octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) in wash-off and leave-on products.
The restrictions add to those already imposed by REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) on rinse-off cosmetic products containing D4 and D5.
Regulation 2024/1328 applies across industries — including beauty and personal care — and amends the REACH Regulation.
Added restriction
In personal care, the three silicones are known to deliver smoothness to the skin and hair by adding a protective film.
Restrictions apply to cosmetics from 6 June 2027.However, the Cosmetics Regulation has prohibited D4 entirely since 2018. Since 2020, D5 in rinse-off cosmetics has been restricted to a maximum concentration of 0.1%.
From 6 June 2027, the use of D5 and D6 in concentrations over 0.1% will be banned in all cosmetic products, including leave-on products.
Environmental and health hazards
The European Chemicals Agency (ECHA) warned the three silicones were detected in human plasma, abdominal fat and breast milk.
The agency flagged D4, D5 and D6 as substances of very high concern in 2018 due to their “very persistent and very bioaccumulative” characteristics. It was determined that D4 is persistent, bioaccumulative and toxic (PBT).
D5 and D6 were also identified as having PBT properties when they contained 0.1% or more by weight of D4.
Furthermore, ECHA’s Risk Assessment Committee confirmed that D4, D5 and D6 had environmental consequences in 2019 when present in consumer and professional products released into the environment.
The Cosmetics Regulation has prohibited D4 since 2018.In 2020, ECHA’s Socio-Economic Assessment Committee’s (SEAC) opinion suggested an EU-wide action on D4, D5 and D6 use. Following that, the EU Commission concluded that exposure was an “unacceptable risk” and supported an EU-wide measure.
Global concern
Last year, the EU proposed a global restriction on D4, D5 and D6 as persistent organic pollutants in the Stockholm Convention. The Stockholm Convention aims to protect human health and the environment.
In its proposal, ECHA flagged that D4, D5 and D6 could be considered to meet the screening criteria in Annex D of the Stockholm Convention for persistence, bioaccumulation, long-range transport and adverse effects.
“D4, D5 and D6 do not occur naturally in the environment. They are released to the environment mainly as a result of their presence as intentional constituents or impurities in a very wide variety of consumer products and as residual impurities in silicone polymers,” reads the proposal.
“Globally, the occurrence and distribution of D4, D5 and D6 are shown for humans, wildlife and the environment. Detections include measurements in the Arctic and Antarctica.” The proposal underscored that these silicones are toxic to aquatic organisms, and D5 is toxic to terrestrial organisms such as plants.
By Venya Patel
