When chemical substances are involved in the production of silicone products, complying with regulations is not only your legal obligation but also the foundation for building trust with your consumers. And the most comprehensive regulation in this regard is the REACH regulation of the European Union.
This article will explain to you the specific contents of REACH regulation in the silicone industry and its significance in the silicone industry.
What is REACH Compliance?
REACH stands for Registration, Evaluation, Authorisation and Restriction of chemicals. The regulation came into effect officially on June 1, 2007, stipulating that companies must identify and manage the risks associated with the substances they produce and sell within the EU.
If you adhere to this standard, it means that your company needs to register the chemical substances, provide safety data, and comply with certain restrictions on harmful chemical substances.
This is the most comprehensive chemical control regulation within the EU system, covering a wide range of industries including mining, textiles, light industry, and mechanical and electrical engineering. Silicone products containing substances of very high concern (SVHC) or other restricted chemicals fall under REACH control.
Key Components of REACH
Registration: If your annual production volume or import quantity exceeds 1 ton, you must truthfully provide detailed information about the chemicals, including their physical properties, application scope, and safe disposal methods.
Evaluation: The regulatory authorities will verify the authenticity of the submitted data and comprehensively assess all potential risks associated with the substances.
Authorisation: Before the high-risk substances are put into use, you need to apply for and obtain the approval qualifications in advance.
Restriction: The regulations have clear restrictive provisions, strictly controlling and even prohibiting the use of highly hazardous chemical substances.
Why Do Silicone Products Need REACH Compliance?
Product Safety
Silicone has a wide range of applications. You can make various products such as medical equipment, kitchen utensils, and personal care items using silicone. Therefore, it is very important to strictly control the product ingredients and eliminate any harmful substances residues for the safety of your customers.
When your silicone products have completed the REACH compliance, it can prove that the materials you use are safe and non-toxic, enhancing the influence and brand reputation of your products.
Environmental Protection
During the production process of silicone products, various chemical substances will be involved. Whether it is the emissions during the production or the disposal after use, if these substances are not handled properly, they may cause irreversible harm to the soil, water bodies and air, and damage the surrounding ecological environment.
And if you strictly follow REACH, you can standardize the selection of chemical substances and control the usage amount, thereby reducing the pollution of harmful chemical substances to the environment.
It can help you effectively prevent the leakage of harmful substances, safeguarding the ecological balance. At the same time, it can enhance the environmental reputation of your products and demonstrate the social responsibility of your company.
Market Access
You comply with the EU REACH regulations not only to fulfill compliance obligations, but also as a core necessity for expanding overseas markets. As the EU is a popular export market, if your silicone products do not meet the REACH standards, they will not be legally available for sale and circulation in most parts of Europe.
Moreover, the EU attaches great importance to product health and safety issues, so the requirements are quite strict. Obtaining a REACH test report means that your silicone products contain very few harmful chemicals. This is beneficial for you to smoothly achieve the long-term expansion of orders and business.
company Reputation
Adhering to the strict REACH compliance standards can help you establish a good image of a responsible and high-quality silicone company. This fully demonstrates your high regard for human health, product safety and environmental protection.
It can not only deepen customers’ trust and recognition of your silicone brand, but also win the full trust of investors, steadily improving the overall reputation and industry prestige of the company.
Innovation and Sustainability
If all companies comply with the REACH compliance requirements, it will drive innovation and upgrading in the entire silicone industry. To avoid restricted substances, you will actively research and adopt safer and more environmentally friendly alternative raw materials and production methods.
This not only conforms to the global trend of sustainable development, but also aligns with the current market trend where consumers prefer safe and environmentally friendly products. It helps you achieve the upgrade of silicone products and promote green and long-term development.
Key Controlled Substances Related to Silicone in REACH
Substance of Very High Concern (SVHC)
As of 2025, the list of SVHCs under the REACH Regulation contains over 240 substances. If the weight percentage of any SVHC substance in your silicone material exceeds 0.1%, you must fulfill the official notification obligation.
When producing silicone products, you should pay special attention to checking several high-risk sources, including residual vulcanizing agents, various coloring pigments, processing additives and filler materials, as well as impurity components generated during the production process. For specific substances, you can refer to the following table:
| Heavy Metals | Organic Compounds |
| Lead (Pb) | Phthalates (Plasticizers) |
| Cadmium (Cd) | Flame retardants: Polybrominated biphenyls (PBB) and Polybrominated diphenyl ethers (PBDE) |
| Mercury (Hg) | Shortchain chlorinated paraffins (SCCP) |
| Hexavalent chromium (Cr⁶⁺) | Polycyclic aromatic hydrocarbons (PAHs) |
| Nickel release (Compliant with EN 1811) | Formaldehyde, Bisphenol A (BPA) |
By carefully controlling the quality of raw materials and conducting thorough component screening, you can effectively avoid SVHC risks and ensure full compliance with EU export regulations.
Annex XVII Controlled Substances
The substances subject to control under REACH Appendix XVII are those chemicals that are either prohibited or subject to limited use. The restriction applies to all products placed on the EU market, including imported articles, not just raw silicone.
On May 17, 2024, the European Union issued an amendment (EU) 2024/1328, which will come into effect on June 6, 2026. Due to the strict restrictions imposed on three siloxane substances, this amendment has the greatest impact on the silicone industry. For details, you can refer to the table below:
| Substance | Full Name | General Limit Values |
| D4 | Octamethylcyclotetrasiloxane | Prohibited from being placed on the market or used at concentrations ≥ 1% |
| D5 | Decamethylcyclopentasiloxane | Prohibited from being placed on the market or used at concentrations ≥ 1% |
| D6 | Dodecamethylcyclohexasiloxane | Prohibited from being placed on the market or used at concentrations ≥ 1% |
If you still plan to produce silicone products, you must be vigilant about the residual cyclic siloxanes in the products to avoid compliance risks when exporting to the EU. The following methods can be used to optimize the production process:
- Select low-residue raw materials
- Optimize the vulcanization process to reduce impurities
- Carry out product testing properly
FAQ
How Often Is the SVHC List Updated? Do Reports Expire?
The SVHC list is updated approximately every six months, so the validity period of the test report is not permanent. You can conduct a comprehensive screening before mass production or update the test annually.
What Are the Consequences If Specific Hazardous Substances Exceed 0.1% in Silicone Products?
If the content of high concern substances (SVHC) in your silicone products exceeds the limit of 0.1%, the EU distributors have the right to refuse to accept the goods. Moreover, when entering the EU Amazon platform, the platform’s review process will require you to provide additional compliance proof materials.
What Other Regulations Besides REACH Should I Note for Silicone Products Exported to the EU?
Because REACH is a basic compliance requirement, it does not cover all compliance aspects. Different market segments have different thresholds. For instance, in the food industry, one needs to pass the EU 10/2011 and (EC) 1935/2004 tests; in the medical industry, one needs to pass the ISO 10993 series of tests, and so on.
Do Different Curing Systems of Silicone Affect REACH Compliance?
Yes. If your silicone products are not fully vulcanized, the risk of D4/D5/D6 residues significantly increases. Peroxide vulcanized silicone may produce benzene derivatives, tert-butanol, etc., and has a higher SVHC risk; while platinum vulcanized silicone has no decomposition products and produces fewer residues, and has a lower SVHC risk.
Is REACH Compliance Required If Silicone Products Are Not Exported to the EU?
No. Because REACH is an EU regulation and is only applicable in the EU and the European Economic Area (EEA) regions. If your silicone products do not enter these countries at all, there is no need to obtain a REACH test report.
Final Thoughts
Legensilico is a professional silicone manufacturer in China, capable of providing you with compliant silicone products and customized services. If you are interested in our silicone products, please contact us. Our team will discuss your compliance requirements.
