EU Procedures & Regulations
Cyclosiloxanes
Ongoing procedures
Proposal:
Authorisation requirement
(D4, D5, D6)
On 14 April 2021, the European Chemicals Agency recommended for the European Commission to add D4, D5 and D6 to the Authorisation list because they are hazardous, produced in high volumes and widely used. The European Commission is yet to decide if it will follow the recommendation.
The silicone industry considers the authorisation of D4, D5, and D6 to be unnecessary, aligning with the European authorities’ own conclusion that restriction, rather than authorisation, is the most appropriate measure to regulate their use and placing on the market.
Silicones Europe remains committed to supporting regulatory processes grounded in rigorous scientific assessment and aligned with Europe’s green, digital, and circular economy objectives.
Existing regulation
REACH Restriction (D4, D5, D6) Consumer and Professional Use
In May 2024, having considered ECHA RAC’s and SEAC’s opinions, the European Commission adopted an extension to the existing restriction on the placing on the market of D4 and D5 in wash-off cosmetic products, as to include D4, D5, D6 in leave-on cosmetic products as well. The expanded restriction entered into force on 6 June 2024.
CLH classification (D4)
In 2022, the CLP Regulation categorised D4 as very toxic to aquatic life with long lasting effects and as suspected of damaging fertility. The rules apply since 1 March 2022.
Wash-off personal care products restriction (D4,D5)
Following a proposal made by the United Kingdom, the European Chemicals Agency (ECHA)’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) agreed to restrict the use of D4 and D5 in wash-off personal care products in a concentration equal to or greater than 0.1% by weight of either substance. The restriction entered into force on 1 February 2020.
SVHC (D4, D5, D6)
In 2018, ECHA’s Member State Committee (MSC) agreed that D4, D5 and D6 should be included on the Candidate List of SVHC as substances that are very persistent, very bioaccumulative (vPvB). It also concluded that D4 meets the criteria for persistent, bioaccumulative and toxic (PBT) substances, and that D5 and D6 meet the same criteria if they contain more than 0.1% of D4.
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