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 position is that the D4, D5 and D6 authorisation is an unnecessary and unjustified regulatory step. European authorities have themselves acknowledged that the restriction route, and not authorisation, is the most appropriate measure to regulate the use and placing on the market of the substances.
Proposal:
POP NOMINATION
(D4, D5, D6)
The European Commission is currently considering proposing that the European Union nominate cyclic siloxanes D4, D5, D6 for listing in Annex B of the Stockholm Convention on Persistent Organic Pollutants (POPs). For a chemical substance to be classified as a POP, it needs to meet the Long-Range Environmental Transport (LRET) criterion. In other words, evidence needs to be presented that a substance can travel long distances from where it was originally released, even across continents and oceans, and can accumulate in a pristine environment very far away from any release points (e. g. production sites and municipal wastewater treatment plants). At present, a consensus has not been reached within the scientific community regarding the potential for long-range transport and the deposition of these substances in remote locations.
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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