Regarding the safety of our products, Kingwills™ is proud to announce that Hypak™ has passed SGS testing: it complies with the European Union standards RoHS and REACH, the US California Proposition 65, and the US FDA 21 CFR. This means that Hypak™ materials do not contain / exceed all restricted substances of the above four international standards, which can prove its safety for human use, non-hazardous for the environment and beneficial for sustainable development.
SGS, established in 1878, is an internationally recognized authority in testing, inspection, and certification. It has more than 2,600 branches and laboratories worldwide, providing services across all industries. In China, SGS is also the first third-party joint venture inspection organization to obtain recognition from the China National Accreditation Service for Conformity Assessment (CNAS) for ISO 17020, and its laboratory has been recognized by many authoritative institutions.
The background, purpose, composition requirements and test results of these four international standards are as follows and can be used for reference by various industries:
The full name of REACH is Registration, Evaluation, Authorization, and Restriction of Chemicals, which is a regulation of the European Union for precautionary management of all chemicals entering its market. REACH requires that all imported and manufactured chemicals in Europe must go through comprehensive procedures such as registration, evaluation, authorization, and restriction to better and more easily identify the composition of chemicals to ensure the safety of the environment and the human body.
REACH covers a wide range of areas and has higher requirements for product composition restrictions Hypak™ has passed testing for over 200 substance components, which can prove that it has no potential harm to the human body and the environment.
RoHS is a mandatory standard formulated by the European Union. Its full name is Restriction of Hazardous Substances. This standard is mainly used to standardize electronic and electrical products' materials and process standards to make them more conducive to human health and environmental protection.
The standard requires testing for lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers (PBBs and PBDEs). The test results can prove that Hypak™ meets the requirements for the detection of these six toxic and harmful heavy metals, which will not cause toxicity and disease in humans due to these substances.
US California Proposition 65, officially known as the "1986 Safe Drinking Water and Toxic Enforcement Act," aims to protect California residents and drinking water sources by ensuring that water sources do not contain substances known to cause cancer, birth defects, or other reproductive harm. It requires honest notification to residents when such substances are present.
The designation applies to both natural and synthetic chemicals. Hypak™ has been tested to meet the chemical composition criteria outlined in this regulation and is free of lead, chromium, formaldehyde, carcinogenicity and reproductive toxicity.
The FDA (US Food and Drug Administration), is responsible for regulating food, drugs, and medical devices in the United States. CFR 21 is the federal regulation 21, which is the legal standard for food and drug regulations in the United States. Depending on the product, there are corresponding regulations. Products that have passed these standards can be safely used.
After testing, Hypak™ meets the FDA 21CFR 177.1520 standard and can be used for packaging, labeling, and other sterile purposes in food, drugs, and medical devices.
In various industries, product safety and sustainability have become global trends. By passing SGS testing and complying with the above four international standards, Hypak™ will play an important role as a raw material in many fields, helping to achieve more innovative product design and realizing a healthier and greener future life.