ECHA committees should take into account recent monitoring data during their upcoming evaluation of D4, D5 and D6

Proposed REACH restriction concerning the use of three siloxanes is an opportunity to consider new findings

On 30 January, the European Chemicals Agency (ECHA) published a proposal (page 31, section 2.2) for a restriction of direct uses of siloxanes D41, D52 and D63 in consumer and professional products.

Commenting on the publication of the restriction proposal, CES-Silicones Europe Secretary General Dr. Pierre Germain said, “recent monitoring data clearly show that amounts of D4 and D5 in wastewater are lower than previously predicted. We strongly urge regulators to take this into account before proceeding with further restrictions.”

He added, “we are concerned about the potential impacts an additional restriction could have on the use of silicone polymers in existing sustainable solutions and future technologies.”

The silicones industry appreciates that with this restriction, ECHA has provided the opportunity to give more input to address uncertainties and has already proposed a number of specific derogations. It is essential that the outcome of this restriction is proportionate and takes into consideration the most recent scientific findings.

Silicones enable future technology and sustainable solutions

Silicone polymers rely on D4, D5 and D6 as building blocks (monomers) for their manufacturing. Silicone materials are widely used and provide unique benefits because of their durable, safe and highly effective mechanical, optical and thermal properties. Critical applications of strategic importance to the EU include construction, transportation, lighting, alternative energy, electronics and medical uses.

A 0.1% limit across sectors would significantly impact polymers and make it difficult for our downstream users to supply the same high standards of safety, durability and sustainability. The silicones industry worries that the new restriction proposal could have unintended consequences resulting in a net negative result for the environment, considering, for example, that the use of silicone polymers reduces the carbon footprint of countless other sectors.

Environmental monitoring results should be taken into account

In their final opinion 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 when used in wash-off personal care products as the main source of emissions to the aquatic environment. They agreed that monitoring activities would help check the effectiveness of this restriction. CES – Silicones Europe has commissioned a third party to monitor the concentrations and mass loadings of D4 and D5 in Waste Water Treatment Plant (WWTP) influent (before it is treated). The first results show that levels of D4 and D5 from domestic uses are already below predicted post-wash-off-restriction levels for D4, and much lower than expected for D5. These results indicate that the wash-off restriction is already effectively addressing environmental emissions of D4 and D5. For D6, a monitoring programme will start in 2019.

Restriction decisions should be made based on the best-available evidence

CES – Silicones Europe has committed to a wide range of activities in order to evaluate the substances we use in the production of silicones. We have for example developed a set of analytical methods4 to measure residual levels of D4, D5 and D6, as well as a comprehensive toolbox for minimising environmental emissions.

We remain committed to working with ECHA and other stakeholders throughout the restriction process to ensure that any future decisions are based on the most recent and robust scientific and socio-economic evidence, and do not endanger development or use of innovative silicone polymer technologies. We will also be sending further information to our downstream users to assist them in assessing the potential impact of the restriction for them.

In the context of the current restriction proposal, the silicones industry would encourage ECHA’s committees to continue to focus on emissions to the aquatic environment as the principal source of environmental exposure to D4, D5 and D6. We are confident that, on this basis, a proportionate decision can be made based on the best-available scientific and socioeconomic evidence.

About cyclosiloxanes D4, D5 and D6: D4, D5 and D6 are cyclosiloxanes, basic members of the broad family of silicone materials. These are the three main cyclosiloxanes in commercial production and their use has been proven safe for human health and the environment.

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 on silicones and are dedicated to the principles of Responsible Care.

For more information:
CES Manager, Evelyne Frauman // Email: efr@cefic.be // www.silicones.eu // @SiliconesEU

1 octamethylcyclotetrasiloxane
2 decamethylcyclopentasiloxane
3 dodecamethylcyclohexasiloxane
4 Quantification of residual amounts of cyclic volatile methyl siloxanes in 1) fully formulated personal care products 2) silicone elastomers 3) silicone fluids

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The Global Silicones Council (GSC) is a not-for-profit, international organization representing companies that produce and sell silicone products around the world. The GSC brings together all the major global manufactures via the three Regional Silicone Industry Associations in North America (Silicones Environmental, Health, and Safety Center – SEHSC), Europe (Silicones Europe – CES), and Japan (Silicones Industry Association of Japan – SIAJ) and encourages their cooperation and collaboration.

The GSC’s objective is to promote the safe use and stewardship of silicones globally. To accomplish its mission, the GSC undertakes the following activities:

• Monitor the environmental, health, and safety activities of the three Regional Silicones Industry Associations (RSIAs) and coordinate such activities on a global basis.
• Proactively promote industry communication with regulatory bodies around the world and with international environmental, health, and safety organizations, such as the World Health Organization, the Organization of Economic Cooperation and Development, and the United Nations.
• Through the RSIAs, identify and anticipate opportunities to enhance environmental, health, and safety research relating to silicones and engage in global projects to communicate the industry’s product stewardship commitment.
• Through the RSIAs, sponsor projects to improve the public’s understanding of the benefits and safety of silicones.