The EU is the only jurisdiction in the world that has imposed restrictions on the use of silicone materials in commerce. These restrictions are the direct result of the EU’s precautionary approach for assessing the environmental risks associated with chemicals in commerce that meet overly rigid laboratory criteria and the EU’s failure to consider the unique properties of silicone substances or exposure in its evaluation of these substances.
European Union Siloxane Evaluations
In Europe, siloxanes are assessed and regulated under the chemicals regulation framework known as REACH. Cyclosiloxanes have come under scrutiny because of a suspicion that some of them may be PBT (Persistent, Bioaccumulative, Toxic) or vPvB (very Persistent, very Bioaccumulative). However, the European criteria for assessing whether a substance is PBT or vPvB do not allow for accurate evaluation of the unique physico-chemical properties and hybrid chemical nature of siloxanes. In fact, many leading scientific experts believe that current regulations define PBT in terms of overly rigid laboratory criteria that are based on the state of the science in the late 1970s and early 1980s, and do not reflect what is observed in the environment.
Learn about “Wash-Off” and “Leave-On” restrictions.
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.