10 January 2018, the Official Journal of the European Union releases Directive (EU) 2018/35, amending Annex XVII to REACH Regulation as regards octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in cosmetic products.


This directive adds the following entry in Annex XVII to REACH Regulation:

Name of the Substance

Conditions of Restriction

70. Octamethylcyclotetrasiloxane (D4)

      CAS No 556-67-2

      EC No 209-136-7

      Decamethylcyclopentasiloxane (D5)

      CAS No 541-02-6

      EC No 208-764-9

1. Shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, after 31 January 2020.

2. For the purposes of this entry,“wash-off cosmetic products”means cosmetic products as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009 that, under normal conditions of use, are washed off with water after application.

On 17 April 2015, the United Kingdom submitted to the European Chemicals Agency a dossier, proposing to restrict octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in cosmetic products that are washed off in normal conditions of use to adress the risk to the environment posed by the use of D4 and D5 when discharged into waste water.

On 22 April 2015, the Member State Committee adopted an opinion that both D4 and D5 fulfill the identification of very persistent (VP) and very bioaccumulative (VB) substances.

On 10 March 2016, the Agency's Risk Assessment Committee (RAC) adopted the opinion that D4 meets the criteria for the identification of a persistent, bioaccumulative and toxic (PBT) substance and a vPvB substance and that D5 fulfils the criteria for the identification of a vPvB substance. RAC confirmed that the hazard properties of D4 and D5 give rise to specific concerns for the environment when present in cosmetic products that are used or disposed with water.

This Regulation is applicable in all Member States and effective from 31 January, 2018.

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