A great many products exported to the U.S. are required to process FDA certification and EPA certification before entering the U.S. market. Then what do you know about FDA certification and EPA certification? As a leading product safety and regulatory consulting firm, CIRS Group is now able to provide the U.S. FDA certification and EPA certification services to help clients remove the technical barriers to trade and successfully enter the US market.
What is US FDA Certification?
The U.S. Food and Drug Administration (FDA) is one of the executive agencies of the U.S. government under the Department of Health and Human Services (DHHS). As a scientific management agency, the FDA's responsibility is to ensure the safety of food (including food additives), food contact materials (containing additives), medical devices, radioactive products and pharmaceuticals produced or imported in the United States. The above products must be registered or certified by the FDA before they can be sold in the US.
According to the product category, the US FDA certification can be divided into the following categories:
- Food Facility Registration;
- Food Contact Substance Notification (FCN);
- Food contact materials FDA testing;
- Medical device FDA registration and exemption application;
- Laser products FDA registration;
- Voluntary Cosmetics Registration Program (VCRP);
- Drug FDA registration;
What is US EPA certification?
EPA, the U.S. Environmental Protection Agency, is the competent authority for the management of industrial chemicals and pesticides. All industrial chemicals, including pesticides, pesticide adjuvants, fungicides, disinfectants, and pesticide devices sold in or exported to the United States fall under the control of the US EPA and must be registered with the EPA before they can be legally sold in the U.S.
- General Industrial Chemicals: Primarily regulated by the Toxic Substances Control Act (TSCA). Based on the regulation and supervision circumstances of substances, companies need to submit a new chemical substance pre-production notification (PMN) and a significant new use notification (SNUN) to the EPA, or provide a TSCA compliance or exemption statement before entering the US market;
- Pesticides, antimicrobials and disinfectants: Mainly regulated by the Federal Insecticides, Fungicides and Rodenticides Act (FIFRA), enterprises and factories must register with the EPA in accordance with the FIFRA directive before they can register their pesticides.
- Pesticide adjuvants: The adjuvants are used in the production of pesticide formulations. Each component in the adjuvant mixture must get approved with EPA, and the approved adjuvants will be added into the list of approved adjuvants. For adjuvants listed in the approved list, companies can make an application about adding their trade names into EPA's adjuvant database.
- Pesticide equipments: For pesticide equipments that use physical methods (such as UV, ozone or electromagnetic radiation) to achieve specific functions such as disinfection, sterilization, insect repellent, and mosquito control, enterprises and factories only need to carry out EPA registration to ensure that their product labels and packaging comply with relevant regulations. Common products include electric mosquito swatters, ultraviolet disinfection equipment, sound generators, insect traps, ozone generators, animal glue traps, water treatment equipment, air treatment equipment, and equipment that produces pesticides (such as chlorine dioxide generators) vibrator.
- U.S. FDA and EPA certification consulting and training
- U.S. FDA and EPA certification
- U.S. FDA and EPA related testing
CIRS has owned a wholly-owned subsidiary in the United States and is able to provide EPA and FDA certification. Besides, C&K Testing, subsidiary of CIRS Group in China, has been accredited by the China National Accreditation Service for Conformity Assessment (CNAS) and China Metrology Accreditation (CMA) and can carry out certification-related testing according to global standards.
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