Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) restricted in the EU

Recently many ingredients have been restricted in cosmetic products, among others: Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4). Both of them are silicones, and they are used to protect the skin and to retain moisture.

Major changes

In 2015, the Scientific Committee of Consumers Safety (SCCS) stated that the level of Cyclotetrasiloxane (D4) as an impurity of Cyclopentasiloxane (D5), should be kept as low as possible, due to the toxicity potential of D4.

At the beginning of 2017 the European Commission (EC) proposed to ban Cyclotetrasiloxane (D4) and Cyclopentasiloxane (D5) in rinse-off cosmetic products, with 0.1% or more of either substance. This ban, when officially published, is going to cover products such as shampoos, conditioners, shower gels, etc.

The European Chemicals Agency (ECHA) plans to go even further and to extend the restriction to leave on personal care products intended to remain on the skin. This proposal is currently in public consultation.

Why are these ingredients being restricted?

Cyclotetrasiloxane (D4) is toxic to human reproduction system and it accumulates in the environment with unpredictable long-term effects. Cyclopentasiloxane (D5) can also be harmful to the environment.

The major problem is  the purity of the silicone – or the lack of it. The harmful Cyclotetrasiloxane (D4) is a common case of impurity for Cyclopentasiloxane (D5) and it is very difficult to differentiate between them.

What do the Manufacturers need to do?

  • Make sure that the raw materials supplier provides you with Cyclopentasiloxane (D5) with the highest purity (99%) and that it does not contain  Cyclotetrasiloxane (D4)
  • As a precautionary measure – plan to reformulate rinse-off cosmetic products with Cyclopentasiloxane by decreasing the amount until up to 0,1%, or by replacing it with another type of silicone

Restrictions on cosmetic ingredients In the EU

Cosmetic ingredients are constantly under watch by the Scientific Committee for Consumer Safety (SCCS) and Competent Authorities. The aim is to assess their safety and establish restrictions for the protection of human health. Silicones have been on the spot recently. Currently the attention has turned towards one of the most widely used types – Cyclopentasiloxane. Cosmetics manufacturers and their Responsible Persons should closely follow the updates from the SCCS and keep track of the amendments to the relevant Regulations to take the right decisions to ensure compliance of their products on the EU market.

If you wish to know more about restricted ingredients in the EU market, do not hesitate to contact us. Obelis Experts, having 30 years of experience with EU Regulations, will gladly verify your products and ensure their EU compliance.

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