Clients often ask whether our silicone raw materials and products can pass specific certifications or tests. So, what certifications or standards exist for silicone raw materials?
Food-grade silicone is not silicone intended for consumption but is safe to come into contact with food without harming humans. Many chemicals contain small, unstable molecules that can dissolve into edible oils and be ingested, making them unsuitable for food contact. Food-grade silicone, on the other hand, is tested to ensure it does not release harmful substances when in contact with food. The U.S. FDA and the EU LFGB are primary certifications for food-grade testing.
In Taiwan, products generally adhere to U.S. FDA standards. For products intended for the European market, compliance with the EU’s LFGB standards is required. Other certifications include ROHS, REACH, Halogen, NSF, MSDS, PAHS, and UL Yellow Card. Renowned certification bodies include SGS, TUV, and CE. Below are commonly used testing standards for silicone raw materials:
1. Food and Drug Administration (FDA)
The FDA (Food and Drug Administration) is the United States’ authoritative body for regulating food and drug safety. It ensures that materials in contact with food meet safety standards. The FDA consists of professionals like doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians, working together to promote and protect public health.
FDA-certified food, drugs, cosmetics, and medical devices are recognized as safe and effective for human use. Its regulations apply to products produced or imported into the U.S. FDA standards are also trusted internationally, with nearly 100 countries adopting its materials and technologies for clinical applications.
Food-Contact Materials in CFR Title 21
FDA regulations for food-contact materials are described in Title 21 of the Code of Federal Regulations (CFR), specifically in parts 174–178:
- Part 174: Indirect Food Additives: General Provisions
- Part 175: Adhesives and Components of Coatings
- Part 176: Paper and Paperboard Components
- Part 177: Polymers
- Part 178: Adjuvants, Production Aids, and Sanitizers
FDA Certification Process for Food-Grade Materials:
- Consultation: The applicant provides product details or descriptions.
- Quotation: Engineers assess the product to determine necessary tests and provide a quote.
- Application: Fill out a test application form and submit samples.
- Testing: Conduct tests based on applicable FDA standards.
- Report: Provide the FDA certification report upon test completion.
2. Lebensmittel- und Futtermittelgesetzbuch (LFGB)
The LFGB (Lebensmittel- und Futtermittelgesetzbuch) is a German certification standard also recognized across the EU. It is based on the “Food, Tobacco Products, Cosmetics, and Other Commodities Management Act,” which regulates food and related products’ safety. Products complying with LFGB standards can be sold in Germany and the EU.
Why Is LFGB Widely Accepted in the EU?
Although LFGB is specific to Germany, it is highly respected across the EU. Many customers prefer LFGB certification over general EU food contact standards. Products certified under LFGB are eligible for the “knife and fork” symbol, signifying compliance with German and EU safety regulations.
LFGB Testing Scope:
- Sensory testing (odor and taste transfer)
- 10% ethanol extraction
- 3% acetic acid extraction
- Water extraction
- Peroxide value test
- Organic tin compounds test
- Volatile organic compounds (VOM) test
- PAHs (AfPS GS 2014:01 PAK)
LFGB Certification Process:
- Fill out a testing application form.
- The testing body evaluates and provides a quote.
- Confirm the quote and make payment.
- Submit samples to the testing body.
- The testing body performs tests as requested.
- A compliance report is issued if the tests are passed.
3. Restriction of Hazardous Substances (RoHS)
RoHS (Restriction of Hazardous Substances) is a mandatory EU standard regulating the use of hazardous substances in electronic and electrical equipment. Implemented in 2006, it aims to protect human health and the environment by reducing harmful materials such as lead, mercury, cadmium, hexavalent chromium, PBBs, and PBDEs in products.
RoHS restricts these substances to specific levels, e.g., cadmium content must not exceed 100 ppm, while other restricted materials must not exceed 1,000 ppm.
4. Registration, Evaluation, Authorisation, and Restriction of Chemicals in the European Union (REACH)
The REACH regulation stands for the Registration, Evaluation, Authorisation, and Restriction of Chemicals in the European Union. REACH is a comprehensive law ensuring the safe entry and use of chemicals in the EU market. Its goals include protecting human health and environmental safety, maintaining and enhancing the competitive position of the EU chemical industry, improving companies’ innovative capabilities, and achieving sustainable development. The European Parliament and the European Council passed the regulation on December 13 and 18, 2006, respectively, and it officially came into effect on June 1, 2007.
REACH is based on a precautionary principle: any chemical substance whose properties and risks are unknown is considered harmful until proven safe through experiments and risk analysis. The regulation mandates that all chemicals imported into or produced within the EU must undergo comprehensive procedures such as registration, evaluation, authorization, and restriction to ensure environmental and human safety. The regulation mainly involves these four processes. Every product must have a registration file detailing its chemical composition, the manufacturer’s use, and a toxicity assessment report. The European Chemicals Agency manages this information, evaluating each file. If a chemical is found to pose risks to human health or the environment, stricter measures may be taken, including banning or restricting its use.
REACH differs significantly from RoHS in scope, covering a broader range of substances. It currently includes 168 tests and has become a cornerstone of chemical management since its implementation on June 1, 2007. The law emphasizes the idea that society should not introduce new materials, products, or technologies without understanding their potential hazard
5. Halogen
Halogens typically refer to substances like fluorine, chlorine, bromine, and iodine. They are widely used in applications such as flame retardants, flux agents, refrigerants, solvents, organic chemical raw materials, pesticides, bleaches, and wool degreasers due to their unique properties, including flame resistance, solubility, and high reactivity. However, organic halogen compounds are toxic, potentially carcinogenic, and have a low biodegradability rate, leading to their accumulation in ecosystems. Some volatile organic halogen compounds also severely damage the ozone layer, posing significant risks to the environment and human health. As a result, many halogen compounds are classified as hazardous and are restricted or banned worldwide.
Halogen testing mainly includes assessments for heavy metals, halogens, ultraviolet content, phenols, lead levels, phthalates, dimethyl fumarate, azo compounds, PFOA, formaldehyde, benzene, TVOC, radon, aflatoxins, plasticizers, pesticide residues, food additive content, ELV, atomic content, volatile organic compounds, polycyclic aromatic hydrocarbons, fluorescent agents, and standards such as ROHS/REACH/SVHC/POSH/WEEE. Products that use halogens often include flame retardants like polybrominated biphenyls (PBB), PBDE, HBCD, tribromophenol, and short-chain chlorinated paraffins, as well as refrigerants and insulation materials such as chlorofluorocarbons (CFCs), hydrochlorofluorocarbons (HCFCs), and hydrofluorocarbons (HFCs).
6.NSF
NSF (National Sanitation Foundation) is an independent, nonprofit organization focusing on the effects of water, food, air, and environmental factors on public health. NSF develops standards and testing methodologies and is widely regarded as the benchmark in drinking water certification. Testing conducted by NSF is rigorous and precise, and reports certified by NSF are recognized by other certification bodies without requiring retesting.
NSF certification is approved by numerous organizations, including the American National Standards Institute (ANSI) and the Occupational Safety and Health Administration (OSHA). It also serves as a designated collaborator of the World Health Organization (WHO) in food and drinking water safety. Products certified by NSF can display the NSF mark, indicating compliance with stringent standards in areas such as material safety, manufacturing processes, and functionality.
Applicable Products:
- Commercial food processing equipment
- Water supply systems piping and fittings
- Water purification equipment
- Drinking water chemical treatment agents
- Bottled water
- Swimming pools and bath water quality equipment
- Microbiological testing equipment
- Wastewater treatment and recovery systems
Products with the NSF mark ensure the following:
- Effective impurity removal as per the product’s specifications.
- Non-contamination of water by-product materials during treatment.
- Compliance with design and production standards.
- Absence of structural or functional defects.
- Accurate representation of verification standards in advertising and labeling.
7. Material Safety Data Sheet (MSDS)
MSDS (Material Safety Data Sheet) is a chemical safety document, also known as a material safety coefficient sheet, chemical safety technical data sheet, or chemical safety data sheet. MSDS is a comprehensive legal document that chemical manufacturers or sellers must provide to customers by law, detailing the characteristics of chemicals. It includes information on the physical and chemical properties of chemicals (e.g., pH value, flash point, flammability, reactivity), combustion and explosion performance, health hazards (e.g., carcinogenicity, teratogenicity), safe handling and storage, spill response, first aid measures, and related regulations, covering 16 specific items.
MSDS certification is also called SDS certification (Safety Data Sheet) or SDS form in Europe. At the same time, in countries such as the United States, Canada, Australia, and many parts of Asia, it is referred to as MSDS (Material Safety Data Sheet). The purpose and content of both technical documents are essentially the same and are typically required by carriers during transportation and logistics.
MSDS summarizes a chemical’s hazards to human health and the environment, along with information on safe handling, storage, and usage. As a service to users, manufacturers are expected to provide MSDS along with their chemical products, allowing users to understand the associated risks and take preventive measures, thereby reducing occupational hazards and preventing chemical accidents.
Countries like the United States, Japan, and EU member states have widely implemented MSDS systems, mandating that manufacturers of hazardous chemicals provide MSDS when selling, transporting, or exporting their products. Globally, whether for domestic or international trade, sellers must provide descriptive legal documents for their products. Since chemical management and trade regulations differ across countries—and even states within the U.S., often changing monthly—providing inaccurate or incomplete MSDS can result in legal liability. The quality of MSDS preparation is a key indicator of a company’s strength, reputation, and management level.
8.PAHs
Polycyclic Aromatic Hydrocarbons (PAHs) are organic compounds containing two or more benzene rings. PAHs include over 150 compounds such as naphthalene, anthracene, phenanthrene, and pyrene. The full English term is polycyclic aromatic hydrocarbon (PAHs for short). Some PAHs also contain nitrogen, sulfur, or cyclopentane. Many carcinogenic PAHs consist of four to six fused rings.
The International Agency for Research on Cancer (IARC) listed 94 compounds carcinogenic to experimental animals in 1976, 15 of which are PAHs. Benzo[a]pyrene, the first identified environmental chemical carcinogen, serves as a representative PAH due to its strong carcinogenicity, accounting for 1%–20% of all carcinogenic PAHs.
Sources of PAH Pollution
PAHs originate from both natural and human sources. Natural sources include volcanic eruptions, forest fires, and biological synthesis. Human sources encompass the incomplete combustion or thermal decomposition under reducing conditions of materials such as coal, oil, natural gas, wood, paper, and other hydrocarbons.
PAHs can also be found in foods, primarily resulting from processes such as smoking, grilling, or charring, where dripping fats can generate benzo[a]pyrene. Storage in contaminated packaging or contact with impure solvents can also introduce PAHs. Environmental contamination from air, water, or soil can lead to PAHs polluting crops, fruits, and vegetables.
PAHs are common in crude oil, creosote, tar, dyes, plastics, rubber, lubricants, rust inhibitors, release agents, gasoline additives, electrolytic capacitors, mineral oils, asphalt, pesticides, charcoal, fungicides, mosquito repellents, and other chemicals.
In electronics and electrical manufacturing, PAHs are often introduced as plastic additives. For example, release agents used during plastic molding may contain PAHs.
PAHs and Their Impact on Humans and the Environment
PAHs primarily harm the respiratory system and skin. Long-term exposure can lead to acute or chronic health issues, including photodermatitis, acne-like dermatitis, folliculitis, and warty growth. PAHs deposited on plant leaves can clog stomata, causing discoloration, wilting, curling, and eventual shedding, adversely affecting plant growth and fruiting. For instance, PAH-contaminated soybean leaves may turn red, shed prematurely, and produce small or no pods. The carcinogenic effects of PAHs on animals have also been confirmed through experiments, showing systemic reactions and accelerated death in animals exposed to sunlight in conjunction with PAHs.
PAH detection mainly focuses on hydrocarbons generated by the incomplete combustion of coal, petroleum, wood, tobacco, and other organic compounds. PAHs are significant environmental and food pollutants, with over 200 identified compounds, many of which are carcinogenic.
PAH Testing Scope:
- Consumer electronics and electrical products
- Rubber and plastic products, automotive plastic and rubber parts
- Food packaging materials, toys, container materials
- Other materials
9.UL Yellow Card
The UL Yellow Card refers to flame retardant ratings certified by UL (Underwriters Laboratories). UL94 is a flammability standard for plastics published by UL. It includes 12 flame retardant ratings: HB, V-0, V-1, V-2, 5VA, 5VB, VTM-0, VTM-1, VTM-2, HBF, HF-1, and HF-2.
The UL94 flammability standard is widely used to evaluate a material’s ability to extinguish after ignition. Ratings are based on burn rate, combustion time, drip resistance, and whether flaming droplets ignite cotton. Ratings must include thickness specifications for the material, as UL grades alone are insufficient without corresponding thickness data.
UL94 Flame Retardant Ratings (From Lowest to Highest):
- HB: The lowest UL94 rating. For samples 3–13 mm thick, the burn rate must be less than 40 mm/min. For samples under 3 mm, the burn rate must be less than 70 mm/min or extinguished before the 100 mm mark.
- V-2: After two 10-second flame tests, any residual flame must be extinguished within 60 seconds. Flaming particles may ignite cotton.
- V-1: Same as V-2, but flaming particles must not ignite cotton.
- V-0: After two 10-second flame tests, any residual flame must be extinguished within 30 seconds. Flaming particles must not ignite cotton.
- 5VB: After five 5-second flame tests, residual flames must be extinguished within 60 seconds. Flaming particles must not ignite cotton, but block samples may burn through.
- 5VA: The highest rating. After five 5-second flame tests, residual flames must be extinguished within 30 seconds. Flaming particles must not ignite cotton, and block samples must not burn through.
Flammability difficulty increases in the order: 5VA > 5VB > V-0 > V-1 > V-2 > HB.
