Cyclosiloxanes - Information Center

Regulation

Europe

Europe

REACH is the EU’s Regulation on Registration, Evaluation and Authorisation of Chemicals, adopted in 2006. When it entered into force in June 2007, REACH replaced more than 40 earlier pieces of legislation and introduced some of the most important changes to the EU’s management of chemicals in 30 years.

Following an assessment of the two cyclosiloxanes D4 and D5, the Member States Committee of the European Chemicals Agency (ECHA) concluded that D4 and D5 are vPvB (very Persistent very Bioaccumulative substances) under the REACH regulation. The proposal of the United Kingdom to restrict the use of D4 and D5 in rinse-off personal care products under REACH will be analysed by ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC). ECHA launched a public consultation encouraging stakeholders to provide information that would assist RAC and SEAC’s opinions, the adoption of which would in all likelihood take place early 2016. The proposed restrictions have not yet been finalized nor approved and may be further amended based on information provided in response to the public consultation. On the basis of the RAC and SEAC opinions, the European Commission will decide whether it is justified to amend Annex XV of REACH. CES - Silicones Europe will continue to work with regulatory authorities and provide all the necessary information regarding the safety of D4 and D5 for human health and the environment in their intended uses.

Over 50 years of research on D4 and D5 demonstrates that these substances are safe for human health and the environment when used as intended and the silicones industry is at the forefront of research and leading the way in ensuring that the different uses of D4 and D5 are valuable and safe. Visit the Safety Section for more studies and useful links related to cyclosiloxanes.

Members of CES - Silicones Europe, a trade association representing all major silicone producers in Europe, have contracted ReachCentrum SPRL, a REACH services provider, to manage a consortium, Reconsile, and implement a REACH compliance strategy for the silicone industry in Europe. More information about Reconsile REACH consortium.

Reconsile members successfully registered 43 substances produced or imported in volumes greater than 1000 tons/year before the 30 November 2010 deadline and 68 substances of 100 tons/year before the 1 June 2013 deadline.

The consortium is now working on the remaining substances that must be registered in the next phase of REACH, with a deadline in 2018. For more information on REACH, visit the following websites:

In addition to REACH, many of the products in which silicones are used are regulated by sector specific regulations.

The silicones industry in Europe

CES - Silicones Europe is a non-profit trade organisation representing all major producers of silicones in Europe. We provide information on silicones from a health, safety and environmental perspective.

North America

North America

The North American silicones industry is regulated by a patchwork of national and state laws, instead of a single regulatory structure. This requires the silicones industry to engage with a range of government agencies in Canada and at the federal and state level in the United States to provide data from monitoring studies and additional research on D4, D5, and D6. In addition, part of that agency cooperation includes informing the authorities of the many benefits associated with D4, D5, and D6 and the socio-economic consequences of unwarranted or inappropriate regulation of the substances as “PBT’s?. 

In 2006, the Canadian government announced its comprehensive strategy for managing chemicals, the Chemicals Management Plan, as a way to gather information on approximately 4,000 of the 23,000 materials in commerce in Canada. Several silicone materials were included in this program. Since then, the Silicones Environmental, Health, and Safety Center (SEHSC) has worked diligently with both Environment Canada and Health Canada on the safety evaluation of D4, D5, and D6. None of the three substances are subject to use restrictions in Canada, and an independent panel of experts known as the D5 Board of Review found that D5 presents no danger to the environment. SEHSC also supplied Health Canada with a host of scientific information for an examination of the potential human health impact of D4, D5, and D6. In 2008, Health Canada determined that they are “not entering the environment in a [way] that may constitute a danger in Canada to human life or health.?

Since 2012, SEHSC has worked with the U.S. Environmental Protection Agency on a monitoring program to better understand D4’s behavior in the environment.

Under an agreement with the EPA – known as an Enforceable Consent Agreement – the industry will monitor a total of 14 industrial and wastewater treatment sites and will provide this environmental data to EPA for any future D4 risk assessment. SEHSC is also cooperating with the EPA to provide health and safety data for the agency’s Integrated Risk Information System (IRIS) assessment of D4. EPA’s IRIS assessment is expected to begin in 2014.The industry is also conducting a global human health risk assessment that will be submitted for publication in 2014 to demonstrate that D4 and D5 pose no risk to human health. 

The silicones industry in North America

Operating as a sector group of the American Chemistry Council, the Silicones Environmental, Health, and Safety Center (SEHSC) promotes the safe use of silicones through product stewardship, outreach and environmental, health and safety research.

SEHSC is managed in the Chemical Products and Technology Division (CPTD) of the American Chemistry Council, which provides technical and management services, issue management activities, specialized advocacy, research, education, communication and evaluation services to a core group of more than 50 sector and product groups.

SEHSC's members represent over 90 percent of silicone chemical manufacturing capacity in North America.

Japan

Japan

Japan’s Ministry of Economy, Trade, and Industry (METI) oversees the Chemical Substance Control Law (CSCL) that was enacted in 1973 and was most recently amended in 2009 extending the scope of the law to address persistent, bioaccumulative, and toxic substances, “PBTs?. METI was created by merging the Ministry of International Trade and Industry with various other ministries in the 2001 Central Government Reform.

In 2007, D4 was added to the assessment program of existing chemical substances by the Chemical Substances Control Law. In 2010, D5 and D6 were also added to the list. By May 2012, their biodegradation and bioaccumulation tests had been conducted. Additional evaluation and review are currently underway.

The silicones industry in Japan

The Silicone Industry Association of Japan (SIAJ), is a trade organization representing silicone producers in Japan. SIAJ’s main mission is to provide information about silicones to industries, consumers and society as a whole. The association fosters product stewardship programmes for the sustainable growth of the silicone industry. 

SIAJ also exchanges information and sponsors environmental, health, and safety initiatives through its cooperation with regional silicones industry associations, SEHSC and CES.