Regulatory

There is nothing more important to us than the safety of our products. Over 50 years of scientific research have been dedicated to assessing the safety of silicones relative to workers, consumers, the environment and manufacturing processes.

The results of this continuous research and testing demonstrate that silicones are safe in their diverse and important applications, which contribute enormously to comfort, safety and enjoyment in our daily lives – read more about the uses and benefits of silicones.

Committed to the responsible use of silicones, the industry continues to evaluate the science behind the materials through several rigorous research programmes. Research methods include computer modelling, laboratory testing, environmental monitoring and other approaches. Below is an overview of European chemicals legislation and how it impacts the silicone industry.

CES continues to work with regulatory authorities and provide all the necessary information regarding the safety of D4, D5 and D6 for human health and the environment in their intended uses.

CES member companies communicate to their customers documentation such as data sheets and safety data sheets to ensure that they are informed about the properties of the raw material they purchase and help them to comply with the applicable regulations. In addition, the silicones industry is committed to good product stewardship, and to continuously improving the ways in which we produce and use silicones. Please consult our commitments and responsibilities section for more information. 

Regulations in Europe

There are no restrictions on the use of silicone polymers, anywhere in the world. Numerous regulations in the EU and its member countries as well as international conventions ensure that chemicals and the products they are used in are safe for consumers and workers. 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.

CES members have contracted ReachCentrum SPRL, a REACH services provider, to manage the consortium Reconsile and implement a REACH compliance strategy for the silicone industry in Europe. Reconsile members successfully registered all relevant silicone substances before the 2018 registration deadline.

For more information on international regulations, please visit the Global Silicones Council’s website.

Regulations on silicone substances under REACH

Some substances used in the production of silicones are restricted in a very specific use (wash-off personal care products such as shampoos and shower gels).

Following a proposal made by the United Kingdom, the European Chemicals Agency (ECHA)’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) agreed to restrict the use of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in wash-off personal care products under REACH. The restriction stipulates that D4 and D5 “shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0.1% by weight of either substance”. The restriction was published in the European Commission’s official journal in January 2018 and will enter into force in the first quarter of 2020.

Currently, there are no restrictions on uses other than wash-off personal care products, for any silicone substances anywhere in the world.

In 2017, the European Commission proposed to initiate a restriction on uses of D4 and D5 in leave-on cosmetic products and other consumer and professional uses, and proposed to extend the scope of the “wash-off restriction” to include dodecamethylcyclohexasiloxane (D6). If ECHA considers it has sufficient data for a restriction proposal, a proposal would be expected in January 2019.

In 2018, ECHA’s Member State Committee (MSC) agreed that D4, D5 and D6 should be included on the Candidate List of Substances of Very High Concern (SVHC) according to the criteria set out in REACH article 57 (e), as substances that are very persistent, very bioaccumulative (vPvB). It further concluded that D4 meets the criteria for persistent, bioaccumulative and toxic (PBT) substances, and that D5 and D6 meet the same criteria if they contain more than 0.1% of D4.

CES believes that in designating D4, D5, and D6 as SVHCs, ECHA did not consider the full range of relevant evidence that demonstrates these materials do not behave as vPvB and PBT substances.  The PBT/vPvB SVHC criteria were intended only for carbon-based organic chemical substances.  However, siloxanes and silicones are Si-based substances with an inorganic backbone. The criteria were not intended for inorganic substances and do not appropriately predict their environmental behaviour.

ECHA relied primarily on laboratory models and the strict regulatory screening criterial and failed to consider newer, more accurate real-world data that shows that siloxanes do not pose a risk to the environment.  Consequently, there is no underlying scientific justification for the SVHC listing. Relevant studies and real-world data can be found in our science section.

The SVHC decision does not restrict the use of D4, D5 and D6. It only carries a legal obligation to provide additional information. Suppliers of articles containing D4, D5, or D6 above 0.1% must provide information to the recipients of the article to allow the safe use of the article and notify ECHA (if total ≥ 1 T/y). Relevant Safety Data Sheets (SDS) are in the process of being updated, and CES is currently working on an Emissions Management Toolkit to provide the value chain with additional guidance.

Product regulations

All sensitive applications that silicones are used in are thoroughly regulated by specific sectoral legislation to ensure their safety. This includes food contact materials, medical applications and cosmetics.

Cosmetic products are regulated in the EU by the Cosmetics Regulation (EC 1223/2009), which places strong safety requirements on cosmetic products and requires the preparation of a special product safety report prior to placing a cosmetic product on the market.

The regulatory authorities in the EU are supported by scientific committees, which provide advice on specific substances used in cosmetic products. In 2010, the Scientific Committee for Consumer Safety (SCCS) concluded that cyclomethicone, the silicone mixture used in personal care products, does not pose a risk to human health when used in cosmetics. It further concluded in 2016 that D5 in cosmetic products is safe at the reported concentrations, except for use in hair styling aerosols and sun care spray products.

In Europe, all food contact materials are regulated by the Food Contact Framework Regulation (EC 1935/2004). This regulation provides the basis for securing a high level of protection of human health for all articles and materials intended to come into contact with food (directly or indirectly). Article 3 of this regulation provides general but essential requirements for such food contact materials: they may not transfer substances to food which change the composition, endanger human health and/or change the taste and smell of food. Specific migration limits have been set for certain substances.

To help consumers and the value chain understand how to best work with silicones in food contact, CES – Silicones Europe has developed a set of “dos and don’ts” for food contact materials, in several languages.

Silicone rubbers are also subject to national provisions, such as the “French Arrêté of 25 November 1992” and the “Recommendation XV. Silicone” by the German Institute for Risk Assessment.

Silicone materials can be manufactured and used for a wide range of different applications and must meet high quality standards. The manufacturing of materials for medical applications is particularly strictly regulated, in Europe as well as in other regions of the world.

The EU updated its Medical Device Regulation in 2017, replacing all existing directives.