Additional regulatory action for D4 & D5 is premature and not necessary
Brussels, 10 February 2017 – The REACH restriction concerning the use of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in wash-off personal care products is targeted and proportionate. CES member companies are committed to its success.
The European Commission’s request to prepare a restriction proposal concerning the use of D4 and D5 in leave-on cosmetic and other consumer and professional products not covered in the earlier restriction proposal is premature and not required in the recent conclusions reached by the Committees of the European Chemicals Agency (ECHA)1.
Commenting on the European’s Commission request, CES-Silicones Europe Secretary General Dr. Pierre Germain said, “We believe discussions on the need for additional regulatory action are premature and not required by the recent conclusions reached by the Committees of the European Chemicals Agency (ECHA)2.”
He added, “The UK authorities conducted an in-depth review and analysis of all available Risk Management Options (RMOA), and concluded that a targeted restriction in wash-off personal care products should be implemented.” The relevant ECHA committees (RAC/ SEAC) endorsed this proposal.
ECHA’s Committees agreed to target wash-off personal care products
In their final opinion3 in June 2016, ECHA’s Risk Assessment (RAC) and Socio Economic Assessment (SEAC) Committees agreed with the UK’s proposal to restrict D4 and D5 only when used in wash-off personal care products as the main source of emissions to the aquatic environment. This conclusion was reached after an in-depth assessment that included effectiveness and proportionality of the measure. Direct uses and releases of D4 and D5 are already targeted: when considering releases to surface water from all sources, wash-off personal care products account for 93% of aquatic emissions.
Environmental monitoring to assess the REACH restriction’s effectiveness in reducing emissions to the environment should be conducted before any new measure is proposed.
ECHA’s Committees in June 2016 agreed on a stepwise approach, i.e. restricting the use of D4 and D5 in wash-off personal care products whilst undertaking environmental monitoring activities to check the effectiveness of this restriction. The outcome of the environmental monitoring should help provide sufficient information to assess whether extending the scope of the restriction is necessary.
Actual uses and benefits of D5
A total restriction of D5 in all leave-on products would have a strong economic impact, since there is no drop-in solution with similar properties as D5. D5 is tasteless, odourless, and colourless; it has high skin compatibility and low chemical reactivity with other ingredients4. Thanks to its unique benefits D5 contributes to a large share of product innovation.
About cyclosiloxanes D4 and D5: D4 and D5 are cyclosiloxanes, basic members of the broad family of silicone materials. D4 and D5 are two cyclosiloxanes in commercial production and their use has been proven safe for human health and the environment. D4 and D5 are used as intermediates for the manufacture of silicone polymers.
About CES – Silicones Europe: We are a non-profit trade organisation representing all major producers of silicones, silanes and siloxanes in Europe. CES is a sector group of the European Chemical Industry Council (CEFIC), which is both the forum and voice of the European chemicals industry. We provide health, safety and environmental information and are dedicated to the principles of Responsible Care.
1 RAC and SEAC opinion on Annex XV restriction report https://echa.europa.eu/documents/10162/7209f47e-58a0-4fa7-9890-11366f5aa4e9
2 RAC and SEAC opinion on Annex XV restriction report https://echa.europa.eu/documents/10162/7209f47e-58a0-4fa7-989011366f5aa4e9
4 UK Annex XV restriction report https://echa.europa.eu/documents/10162/9a53a4d9-a641-4b7b-ad58-8fec6cf26229