"As a trade association representing the silicone industry in Europe, CES worked with REACHCentrum to set up the Reconsile Consortium for silicone manufacturers and importers. The Reconsile Consortium is responsible for around 260 substances for all of the registration phases and registered 43 substances in Phase One. Phase One of REACH required manufactured and/or imported substances of 1,000 tonnes per year or more to be registered by December 2010.
The 260 substances is a huge number compared to most REACH Consortia and one which reflects the diversity of silicone chemistry. Many of these substances are also used in cosmetics applications, either directly like cyclic or volatile silicones or indirectly as intermediates, like the silanes used for manufacturing various polymers or to bring functionality to dimethicone. About 18 per cent of silicones’ total production goes into personal care applications.
Huge investment in silicone safety will be used for REACH
Over the years more than €35m euro has been spent by the silicone industry on research into silicones’ safety, as the industry has a long history of studying the properties of substances for worker and consumer protection. All this data is being shared with the regulators, in the three phases of REACH stretching to 2018 and beyond and in other regulatory dialogues elsewhere in the world.
Although the Phase One substances have been registered, this Phase is not yet completed as the European Chemicals Agency ECHA still has to evaluate the files submitted by Consortia members and work with producers to address any gaps where additional testing may be required. By end-2012 we expect that ECHA should have decided what additional testing is needed.
Phase One of REACH required substances of 1,000 tonnes or more to be registered. Not all of the 43 substances registered by Reconsile in Phase One will be treated the same. ECHA makes a distinction depending on how the substances are used. If they are used in applications where there is widespread exposure to humans and the environment, then more data can be requested. For intermediates with limited interaction with the end-user, the dossier is more limited. Given the wealth of information available on all silicones, Reconsile provided full dossiers for all categories.
Some silicones are difficult to classify
Not all silicones are covered by REACH, for example dimethicone is classed as a polymer and polymers are not covered by REACH. However, the starting materials to make dimethicone, such as various functional silanes and D4 and D5 are covered under REACH.
The safety of dimethicone and other siloxanes is assessed under the Cosmetics Directive. A favourable opinion on the use of D4 and D5 in personal care applications was recently published by the European Commission Expert Committee Scientific Committee for Consumer Safety (SCCS).
A huge amount of work went into the REACH Registration process on all sides and both industry and ECHA have learned a lot. The silicone industry has invested massively in human resources to fulfill its obligations under REACH.
Advice for Phase Two: Action now!
Our advice to manufacturers of substances covered by Phase Two who have no experience of registration through SIEFs (Substance Identification Exchange Fora) or Consortia to date is that they should take action immediately.
There is no time to lose asREACH is a long and complicated process. If a dossier is not submitted to ECHA on time, substances risk being taken off the market. Companies must be prepared to invest the right resources – both financial and human resources – into this process.
Using an established service provider and consortium means companies do not need to go it alone and can learn from the experience of others. For silicones, the CES members have taken the necessary steps to ensure that downstream users in the cosmetics and other industries can still enjoy the benefits of silicones."