Cyclomethicone (D4, D5, D6) Proposed EU REACH Restrictions

New EU REACH restrictions on cosmetic use are expected imminently

February 3, 2021

On 11 January 2019, the European Chemicals Agency (ECHA) proposed a restriction under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation on the use of Cyclotetrasiloxane (D4), Cyclopentasiloxane (D5), and Cyclohexasiloxane (D6) in leave-on cosmetic products at a maximum concentration of 0.1% due to concerns over their persistence in the environment. The ECHA committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) have delivered a joint opinion supporting the restriction. This proposal is now under consideration by the European Commission and is likely to result in a REACH restriction. RAC and SEAC’s joint opinion proposes the following:

Cyclotetrasiloxane (D4), Cyclopentasiloxane (D5), and Cyclohexasiloxane (D6) shall not be placed on the market:

As substance
b)    As constituents of other substances (except polymers) or in mixtures in a concentration equal to or greater than 0.1% w/w of each substance.

The restriction will come into force at least 5 years after publication in the official journal for leave-on cosmetics and 2 years after publication for rinse-off cosmetic products (D6 only, D4/D5 already restricted in rinse-off). The publication of the restriction is expected imminently. The restriction will not automatically apply in the UK due to the introduction of UK REACH on 1 January 2021, as there will now be a separate process for restrictions in the UK.

How Exponent Can Help

Exponent’s international team of experts in EU chemical regulation offers complete guidance to assist companies whose substances or ingredients are under scrutiny to ensure regulatory compliance and to represent their interests. We can help manufacturers and retailers of cosmetics and consumer chemical products by advising in advance of upcoming ingredient restrictions through monitoring regulatory processes within REACH. We can also review alternative ingredients to assess potential problems.