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.
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.
REACH restriction proposal
EU regulators are currently considering a REACH restriction proposal for the placing on the Consumer and Professional markets of D4, D5 and D6 as substances, as constituents of other substances, or in mixtures in a concentration equal to or greater than 0.1% w/w of each substance, as well as a solvent for the dry cleaning of textiles, leather and fur. The restriction would only apply to products on the European market.
Given the lack of clarity in some of the restricted uses and the lack of benefit the restriction would have for the environment, the silicone industry actively engaged in the restriction process to ensure that essential consumer applications are not harmed.
The industry, in its contribution to the public consultation, sought further clarity to the derogation for industrial uses and proposed to extend derogations to essential consumer and professional applications such as dental impression and dental reproduction materials or personalised prosthetic devices e.g. limbs and hands, as well as applications which are important to industrial innovation such as materials used for prototyping, including 3D printing.
In response to stakeholder input, ECHA subsequently proposed derogations for uses or for increased allowable concentrations for some uses including dental impression materials and medical devices for scar and wound management and stoma care.
The industry would also like to highlight that other regions like Australia and Canada have taken different regulatory approaches and reached conclusions of no significant risk and no necessary restrictions for these substances. Currently, there are no restrictions on any uses for any silicone substances anywhere in the world outside of Europe.
Therefore, the silicone industry believes that this restriction is unnecessary and disproportionate. This is demonstrated by the legal action undertaken by the industry.
Authorisation proposal for D4, D5, D6
D4, D5 and D6 have been added to the Candidate List under REACH. Following standard required REACH procedures, a consultation was launched as a next step to gather input on whether or not these substances should be prioritised for authorisation. CES provided significant information and comments to the public consultation and encouraged its value chain to similarly participate in order to ensure that the European Chemicals Agency (ECHA) and the European Commission had the most current and complete information to inform their decision-making processes. The public consultation period closed on 5 June 2020.
As a next step following the consultations, the Member State Committee (MSC) will develop its opinion on the draft 10th recommendation of substances to be included in Annex XIV which includes D4, D5 and D6. Once the MSC has drafted its opinion it will be put to a vote. The adopted MSC opinion and the consultation results will then be assessed by ECHA when finalising its recommendation. The final recommendation will then be submitted to the Commission. It is then for the Commission to decide whether the prioritised substances will be included in Annex XIV.
There is significant overlap with the pre-existing wash-off personal care restriction and the on-going draft restriction proposal on consumer and professional uses of D4, D5, D6. As mentioned previously, other regions like Australia and Canada have taken different regulatory approaches and reached conclusions of no significant risk and no necessary restrictions for these substances.
Therefore, the silicone industry believes that authorisation is unnecessary and disproportionate. This is demonstrated by the legal action undertaken by the industry with regards to other regulatory restrictions and nominations found to be unjustified.
Key European policy decision makers believe that the restriction route, and not authorisation, is the most appropriate measure to regulate the use and placing on the market of D4, D5 and D6.
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 and entered into force on 1st February 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). The draft restriction proposal was announced in January 2019 and the 6-month public consultation period was initiated 2 March 2019. CES submitted extensive comments and provided significant data to the public consultation, which was closed in September 2019.
The joint ECHA Risk Assessment Committee (RAC)/Socio-economic Assessment Committee (SEAC) draft opinion was published on 5 December 2019. It concluded that the restriction proposed on D4, D5 and D6 is the most appropriate Union-wide measure to address the identified risks, as concluded by RAC.
On 16 March 2020, following a public consultation period, during which CES submitted comments, ECHA announced that SEAC has adopted its final opinion supporting ECHA’s proposal to restrict the placing on the market of D4, D5 and D6 as substances, as constituents of other substances, or in mixtures in a concentration equal to or greater than 0.1 % weight by weight of each substance. The joint RAC/SEAC final opinion has not yet been made publicly available.
The EU Commission should prepare its legislative proposal between May and August 2020. Should the Council and the European Parliament not oppose the proposal, the restriction will be adopted. Based on usual timelines, we expect it to be published in the Official Journal in late 2020.
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 or hybrid organic-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 exceeds 1 T/y). Relevant Safety Data Sheets (SDS) have been updated, and CES has developed an Emissions Management Toolkit that provides the value chain with additional guidance.
In January 2017, the European Chemicals Agency (ECHA) published a proposal to reclassify D4 from Aquatic Chronic Category 4 (H413) to Aquatic Chronic Category 1 (H410) under the Regulation on the classification, labelling and packaging of substances and mixtures (CLP).
The RAC opinion adopted on 9 March 2018, concluded that following the criteria for long-term (chronic) hazard, D4 warrants classification as Aquatic Chronic 1 (H410) with an M-factor of 10 (not rapidly degradable and chronic toxicity in range of 0.01 < NOEC ≤ 0.001). CES believes that this classification does not reflect the real-world behaviour of D4 in the environment. The hazard that is the basis for this classification derives from studies conducted under unrealistic laboratory conditions that cannot be replicated in the environment.
On November 4, 2019, the World Trade Organization (WTO) circulated a draft regulation from the European Union announcing its intention to revise the CLP regulation. The change is anticipated to be part of the 15th adaptation to technical progress (ATP) of the CLP Regulation, to be published in the course of 2020.
The anticipated deadline for compliance with the new classification is the end of January 2022.
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.