Silicones, Silanes, Siloxanes and REACH
What is the purpose of this site?
The recently enacted REACH legislation places obligations on all companies working with chemical substances. This site is an initiative of the European Silicones Centre (CES) to assist the silicone industry, including downstream users.
What is CES?
CES is a trade association with no commercial purpose and represents major European producers of silicones, silanes and siloxanes. It was created in 1984.
The main objectives of CES are in particular to:
- Maintain an up to date technical understanding by identifying and managing health, environmental and safety research and risk assessment and relevant communication programmes;
- Encourage the safe and proper use of silicones by developing and publishing appropriate technical information;
- Encourage implementation of the principles of the national "Responsible Care" programmes.
- Provide information to stakeholders on the benefits of silicones to people in terms of quality of life and safety.
CES is a sector group of Cefic, the Council of European Chemical Industry Federations.
For more information about CES, visit its website www.silicones.eu.
How is CES organised for REACH?
REACH is the regulation (EC) N° 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. It establishes a European Chemical Agency (EChA), it amends Directive 1999/45/EC and it repeals Council Regulation (EEC) N° 793/93 and Commission Regulation (EC) N° 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
A summary of REACH and of its implications can be found here.
CES is composed of several standing committees and task forces, managed by staff provided by Cefic. Governance is ensured by a Steering Committee composed of senior executives of member companies and of the Committee Chairs. Experts delegated by the member companies participate in the activities of the committees.
CES has set up a REACH Task Force to develop and implement a REACH compliance strategy. One of its responsibilities is to prepare the formation of a consortium of manufacturers, importers, data owners and downstream users of silanes and siloxanes open to non-CES members that will help meet future registrants meet their Substance Information Exchange Forum (SIEF) obligations and make joint submissions.
What are SIEFs and what is their role with consortia?
A SIEF, or a Substance Information Exchange Forum, will be defined for each substance pre-registered between June and December 2008. REACH does not provide details on how SIEFs should operate. Since CES has identified at least 200 silanes and siloxanes that will potentially be preregistered and as many SIEFs, CES has identified a need to create a single consortium that will offer to coordinate the work done in the respective SIEFs. Participation of a SIEF member in a consortium is voluntary. Conditions for membership of a consortium should be by law, fair and non-discriminatory.
What does CES Expect of EU Manufacturers, Importers and Downstream Users of silicones, silanes or siloxanes?
CES recommends that EU Manufacturers, Importers, or M/I, (represented by their "Only Representative"), Downstream Users (D/U) and Data Owners do the following:
- Understand the legislation and its guidance and determine if they have have need to pre-register the production, importation or use of silicones, silanes or siloxanes (the pre-registration period will begin on 1 June 2008 and will end on 1 December 2008);
- Determine from the information given in this site if they are likely to belong to a SIEF jointly with a CES member;
- Decide whether they will wait for the publication by the European Chemical Agency (EChA) or whether they prefer to contact CES proactively to declare their interest in joining the Silicones, Silanes and Siloxanes REACH Registration Consortium.
Downstream Users are encouraged to contact their suppliers for any additional information.
Downstream Users should be aware that REACH has created several obligations and rights with respect to the substances they use. One of these obligations is to provide substance use exposure information to be included in the registration dossier, if the use is also to be registered. Cefic recommends to the extent possible that the definition and standardization of exposure scenarios be coordinated by downstream users with their respective trade associations. Should these trade associations identify within their industry exposure scenarios linked to the use of silanes and siloxanes, they should also contact CES.
What are the benefits for M/I and D/U in informing CES of their intent to pre-register silicones, silanes and siloxanes or their uses?
There are several important reasons for M/I to inform CES of their intent to pre-register and subsequently, to possibly register substances belonging to the categories of silicones, silanes and siloxanes, or their uses, including:
- The time allocated by the Regulation for the organisation of the consortia and its relationship with the respective SIEF is very short; by proactively notifying CES of their interest, non-CES member companies will benefit from better preparation;
- If M/I, DU or Data Owners have physico-chemical, toxicological or ecotoxicological data on silicones, silanes and siloxanes, these data can be more readily incorporated into the existing database of studies lowering the overall cost by allowing an earlier decision not to undertake additional testing, thereby avoiding animal testing whenever possible and in accordance with guidelines;
- Begin work as soon as possible to establish "sameness" of the substances added to the SIEF (see RIP 3.10 for details).
What about Confidentiality?
CES staff is prepared to address questions concerning the confidentiality of information provided by any third party expressing an interest in joining a silicones, silanes and siloxanes REACH registration consortium.
When will CES Set Up a Consortium?
It is expected that a consortium will be set up before June 2008.
What CES will not do
CES will not provide "helpdesk" services to non-members to help them understand their obligations under the REACH Regulation. The role of CES is strictly limited to facilitating the formation of a consortium of future SIEF members with an interest in siloxanes or silanes. Cefic, national chemical industry trade federations, EChA and the national authorities have set up several websites and contacts to help parties concerned understand their respective obligations.
For more information on REACH, visit the following websites:
