EU proposal to nominate D4 under the Stockholm Convention is inconsistent with ECHA recommendations
Brussels 8 April 2016 – Following the publication of the European Commission’s proposal to nominate octamethylcyclotetrasiloxane (D4) for potential listing in Annex A, B and/or C of the Stockholm Convention on Persistent Organic Pollutants, we call on EU authorities to ensure consistency with the ongoing EU regulatory process and apply proportionality before nominating D4.
The European Commission is proposing a nomination in parallel to the ongoing assessment by the European Chemicals Agency (ECHA) of the United Kingdom’s proposal for a REACH restriction of D4 (and D5); the scope of which is limited to “ personal - care products that are washed off in normal use conditions ” .
The nomination proposal is inconsistent with the conclusions drawn by the UK and the recommendations of ECHA’s Committees, all of which state that a limited scope restriction is adequate to address the risk identified by the UK. In addition, it effectively bypasses the Risk Assessment Committee’s opinion that the effectiveness of the restriction should be proven additional environmental monitoring. The Committees also note that sediment in the aquatic environment is the only environmental compartment of concern.
“ According to the E CHA Committees, the proposed restriction on wash - off personal care products by the UK represents a targeted, efficient and EU - harmonised approach to reducing emissions in the aquatic environment . We are committed to its successful implementation ” said Dr. Pierre Germain, Secretary General of CES – Silicones Europe.
Regulatory authorities have concluded D4 should not be considered as a POP
The UK Annex XV dossier investigates the long-range transport (LRT) potential of D4 and concludes that this is not of concern; “ once in the atmosphere, they can be transported long distances, and have been detected in remote regions. However, they are expected to remain in the atmosphere until degraded and their potential for deposition to surface water an d land is generally very low. ”
D4 meets the present PBT and vPvB criteria of the REACH Regulation. However the current numerical criteria for bioaccumulation, established decades ago, do not accurately predict the behaviour of silicone chemistry. D4 does not behave as a conventional PBT1 or vPvB2, as demonstrated by the absence of its biomagnification in the environment, and is safe in its intended uses.
A POP nomination would have disproportionate and unjustified implications
In its final opinion adopted on 10th March, the Risk Assessment Committee of ECHA concluded that the REACH restriction in wash-off personal-care products is an appropriate measure to manage D4. An assessment shared by the Socio-Economic Assessment Committee, whose draft opinion is currently under public consultation and which states: “SEAC agrees with the line of argumentation by the Dossier Submitter with regard to POPs [and other measures…] being less effective and more costly ways of reducing aquatic emission . ”
In its current draft, the EU mandate for a POP nomination would have wider, disproportionate and unjustified implications that go beyond the direct use of D4 in the applications of concern, as identified by REACH. Notably, this would have considerable negative impact on uses of silicone polymers for which D4 is an essential building block. These silicone polymers are vital in sectors such as automotive, construction and healthcare as well as environmental technologies such as energyefficient lighting, wind turbines and solar panels.
About cyclosiloxanes D4: D4 is a cyclosiloxane, a basic member of the broad family of silicone materials. D4 is one of the cyclosiloxanes in commercial production and its 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, visit www.silicones.eu and follow us on Twitter @siliconesEU
Contact: Dr. Pierre Germain, CES – Silicones Europe Secretary General, email@example.com, +32.2.436.94.55.
1 persistent, bioaccumulative and toxic substance (as per REACH regulation)
2 very persistent, very bioaccumulative