Restrictions on Personal Care, Consumer and Professional Products

‘Wash-off’ restriction:

The EU adopted a restriction on the use of D4 and D5 in wash-off cosmetic products under REACH in May 2017.

The scope of the restriction is limited to wash-off cosmetic products with D4 or D5 concentrations equal to or greater than 0.1% by weight of each of these substances. All companies that place products that are within the restriction scope on the European market (including those substances imported to the European market) were required to comply with the requirements set forth in this restriction by January 31, 2020.

In response to this restriction, the silicones industry set up a large-scale Wastewater Treatment Plant (WWTP) monitoring program to help assess the effectiveness of this restriction in reducing D4 and D5 down-the-drain emissions. Monitoring results indicate that D4 and D5 wastewater treatment plant influent concentrations are well below the baseline levels predicted, and in the case of D4, already consistent with the predicted post-restriction concentrations. These concentrations are lower than expected and suggest that the restriction was unnecessary.

‘Leave-on’ restriction proposal:

In April 2017, the European Commission announced its intention to add wash-off uses of D6 use in personal care products to the prior restriction, and assess the need for a further restriction of D4, D5 and D6 in leave-on personal care products and other consumer/professional uses (e.g. dry cleaning, waxes and polishes, washing and cleaning products).

EU regulators are currently considering a REACH restriction proposal on D4, D5 and D6 in leave-on and personal care applications as well as consumer and professional applications. In response to additional information provided by industry during the Public Consultations , the European Chemicals Agency (ECHA) has proposed exemptions to the restriction for certain industrial and consumer and professional use applications of D4, D5, and D6, including sealants, protective coatings, dental impressions and prosthetic devices. The silicone industry also succeeded in obtaining a 5-year transition period in which to implement the leave-on restriction for personal care products. The adopted proposal is expected to be published in the Official Journal in 2021.

In 2018, the GSC filed a legal challenge against the European Commission’s decision to restrict the use of D4, and D5 based on their PBT/vPvB status. The silicones industry lodged this case because it believes that the decision to categorize these substances as PBT/vPvB and vPvB respectively is not supported by the available scientific evidence. Oral hearings were held by the court in September 2020. A ruling is expected sometime in 2021.

Substances of Very High Concern

The silicones industry believes that D4, D5, and D6 as SVHCs, ECHA do not meet the criteria of vPvB and PBT substances.

Draft Authorization Proposal

ECHA has identified D4, D5, and D6 in its draft recommendation as potential candidates for an authorization requirement.

Cosmetics and Siloxanes

Learn about Annex II of the EU Cosmetics Regulation.