The European Commission has published Regulation (EC) 2018/35 to restrict the use of Octamethylcyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5) in “wash-off cosmetic products” as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009.

SAFEGUARDS | Cosmetics, Personal Care & Household NO. 012/18

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The European Commission published Regulation (EU) 2018/35 on January 10, 2018 to restrict the use of Octamethylcyclotetrasiloxane (D4 with CAS No. 556-67-2) and Decamethylcyclopentasiloxane (D5 with CAS No. 541-02-6) in wash-off cosmetic products as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009. The regulation shall enter into force on twentieth day following that of its publication in the Official Journal of the European Union.

D4 and D5 are respectively identified by the Agency’s Risk Assessment Committee as a persistent, bioaccumulative and toxic (PBT) substance and a very persistent and very bioaccumulative (vPvB) substance under the criteria in Annex XVIII to Regulation (EC) No. 1907/2006, which may give rise to environmental concern when cosmetic products containing D4 or D5 are disposed with water. Also, considering that D4 and D5 evaporate over time after application; while the environmental risk in these products has not been assessed, the Commission addresses the risks by setting a restriction limit on intended usage of D4 and D5 in wash-off cosmetic products only.

D4 and D5 are restricted with a maximum concentration not exceeding 0.1% by weight of either substance in wash-off cosmetic products. The new restriction applies from February 1, 2020.

Timeline for compliance:

  • From January 31, 2020, only cosmetic products which comply with the Regulation shall be placed on the Union market

Reference Source:

  1. COMMISSION REGULATION (EU) 2018/35 of 10 January 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’) [1]

  2. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products [2]

Next step:

The industry is advised to check and confirm if existing wash-off cosmetic products which are already on market contain D4 and/or D5 in their formulation. Wash-off cosmetic products containing D4 and/or D5 shall be phased out in the above-mentioned period or shall be replaced by other ingredients which provide similar function.

For enquiries, please contact:

Queenie TSE
Consumer and Retail
Cosmetics, Personal Care and Household (CPCH)
Senior Technical Service Executive
t: +852 2765 3672 (ext 1672)

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