Ongoing procedures


REACH Restriction proposal
(D4, D5, D6)

EU regulators are currently considering a consumer and professional use restriction proposal for the placing on the Consumer and Professional markets of D4, D5 and D6 as substances, as constituents of other substances, or in mixtures in a concentration equal to or greater than 0.1% w/w of each substance, as well as a solvent for the dry cleaning of textiles, leather and fur.

The restriction would only apply to products on the European market.

The industry, in its contribution to the public consultation, sought further clarity to the derogation for industrial uses and proposed to extend derogations to essential consumer and professional applications:
dental impression and reproduction materials
personalised prosthetic devices e.g., limbs and hands
materials used for prototyping, including 3D printing

Following the proposal made by ECHA, its Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) agreed that the proposed restriction is the most appropriate Union-wide measure. The proposal is, indicatively, set to be discussed in the June 2023 REACH committee meetings. After a positive vote, the proposal will be submitted to the Council of the European Union and the European Parliament for scrutiny.


In response to stakeholder input, ECHA proposed derogations for certain uses or for increased allowable concentrations for some uses of silicones including dental impression materials and medical devices for scar and wound management and stoma care. Intermediate use for D4, D5, D6 is out of scope of the proposed restriction.


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.

Existing regulation

1st Mar 2022

CLH classification (D4)

1st Mar 2022

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.

1st Feb 2020

Wash-off personal care products restriction (D4,D5)

1st Feb 2020

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.


    Keep up to date to by subscribing to our mailing list
    Media/press Governments and Regulators Silicones manufacturers Silicones Users NGOs Academics Other
    Accept terms & Conditions: