Silicone Material Product Compliance Certification Test

Silicone materials and their products need to meet various international, regional, and industry certification requirements across different sectors and applications, depending on their intended use (such as food contact, medical, electronics, etc.).

Types of Certifications：

1. ROHS certification:

The Restriction of Hazardous Substances Directive is a mandatory certification by the European Union to limit harmful substances in electrical and electronic products, aiming to reduce the environmental and health hazards posed by these products.

The RoHS certification limits the presence of the following 6 hazardous substances in electrical and electronic products (4 additional substances were added in 2015, making it a total of 10, but it is commonly still referred to as "RoHS 6" or "RoHS 10"):

- Lead (Pb): ≤ 0.1%

- Mercury (Hg): ≤ 0.1%

- Cadmium (Cd): ≤ 0.01% (strictly limited)

- Hexavalent Chromium (Cr⁶⁺): ≤ 0.1%

- Polybrominated Biphenyls (PBB): ≤ 0.1%

- Polybrominated Diphenyl Ethers (PBDE): ≤ 0.1%

The 4 additional substances (RoHS 2.0):

- Bis(2-ethylhexyl) phthalate (DEHP),

- Butyl benzyl phthalate (BBP),

- Dibutyl phthalate (DBP),

- Diisobutyl phthalate (DIBP).

RoHS certification reports are typically updated annually.

2. REACH Certification:

The Registration, Evaluation, Authorization, and Restriction of Chemicals is an EU regulation for managing chemicals, applicable to all products entering the EU market (including electronics, toys, textiles, furniture, etc.).

REACH is the core regulation for chemical management in the EU, and companies must monitor the SVHC list to ensure compliance and avoid recalls or fines.

REACH has tested 247 Substances of Very High Concern (SVHC) as of now and may also test other potential SVHCs.

The SVHC candidate list is typically updated twice a year.

3. FDA Certification:

The Food and Drug Administration (FDA) is responsible for regulating food, drugs, medical devices, cosmetics, radiation products, and more to ensure their safety and efficacy. FDA certification does not refer to a traditional “certificate” but rather means that the product complies with FDA regulations, and the process of registration, filing, or review has been completed.

Food-grade silicone FDA certification must meet FDA 21 CFR 177.2600 standards.

FDA test reports do not have a fixed validity period, but formula changes require updates.

4. LFGB Certification:

The Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch is the German "Food, Consumer Goods, and Feed Law," regulating materials and products that come into contact with food (such as tableware, cookware, packaging, etc.).

LFGB certification is one of the strictest food-contact material regulations within the EU, particularly for silicone, plastic, stainless steel, and other materials.

LFGB certification mainly focuses on chemical migration (VOCs) and sensory tests.

LFGB reports do not have a fixed validity period, but formula changes require updates.

5. NSF Certification:

The National Sanitation Foundation is a leading public health and safety certification organization in the U.S., focusing on the safety and performance evaluation of products such as food, drinking water, and medical devices.

NSF certification is widely recognized worldwide, particularly in the fields of food-contact materials, water purification equipment, and foodservice utensils.

Food-grade silicone NSF certification must meet NSF 51 standards.

NSF certification is valid for one year and requires an annual factory audit and product sampling to maintain validity.

6. ISO 10993:

ISO 10993 (Biocompatibility Testing) is a series of standards developed by the International Organization for Standardization (ISO) to assess the biocompatibility of medical devices that come into contact with the human body. This standard is widely applied to medical equipment, implants, in vitro diagnostic products, and more, ensuring no harmful reactions occur during use.

Silicone materials or products' biocompatibility testing typically includes:

- ISO 10993-5: In vitro cytotoxicity testing

- iso 10993-10: Skin sensitization testing

- ISO 10993-11: Pyrogen testing

ISO 10993 reports do not have a fixed validity period, but formula changes require updates.

7. USP Class VI:

United States Pharmacopeia (USP) sets biocompatibility testing standards for medical devices and drug packaging materials, primarily used to assess the safety of materials for medical applications.

USP Class VI is the most stringent testing level in USP <88> (Biological Reactivity Tests, In Vivo) and includes the following three animal tests:

- Acute systemic toxicity test

- Intracutaneous reactivity test

- Implantation test (7-day observation)

USP Class VI test reports do not have a fixed validity period, but formula changes require updates.

8. UL certification:

Underwriters Laboratories provides product safety certification, one of the most widely recognized safety standards globally, covering various fields, including electrical and electronic equipment, building materials, batteries, medical devices, etc.

Silicone raw materials are typically tested according to UL 94 standards for flammability, with the following levels:

- HB (low flammability)

- V-0/V-1/V-2 (vertical burning test, V-0 being the best)

- 5VA/5VB (more stringent flammability requirements)

Silicone wires and cables are generally tested according to UL 758 and UL 1581 standards, covering tests such as:

1) Electrical performance testing

2) Mechanical performance testing

3) Thermal performance testing

4) Combustion performance testing

5) Other tests

Flammability ratings include:

- FT2 (horizontal burning test)

- FT1 (vertical burning test)

- VW-1 (vertical burning test with an additional test compared to FT1)

- FT4 (vertical burning test)

- FT6 (horizontal burning and smoke emission test)

UL certification has no fixed validity period, but requires annual factory audits and product sampling to maintain validity.

9. MSDS:

Material Safety Data Sheet, now called SDS (Safety Data Sheet), is a document that details the hazardous properties, safety handling guidelines, and emergency measures for chemicals or products. It follows the globally harmonized GHS (Globally Harmonized System of Classification and Labeling of Chemicals) standards to ensure information is standardized.

According to the GHS standards, the SDS must include 16 sections:

1) Identification

2) Hazard identification

3) Composition/information on ingredients

4) First-aid measures

5) Firefighting measures

6) Accidental release measures

7) Handling and storage

8) Exposure control/personal protection

9) Physical and chemical properties

10) Stability and reactivity

11) Toxicological information

12) Ecological information

13) Disposal considerations

14) Transport information

15) Regulatory information

16) Other information

MSDS is typically updated every five years.