Technical Enzyme Regulations

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In the US, enzymes for use in technical applications, for example cleaning enzymes, are regulated under the Toxic Substance Control Act (TSCA), which is administered by the US Environmental Protection Agency (EPA). Compliant enzymes can be found on the TSCA inventory.  Enzyme manufacturers should ensure that the enzyme, the enzyme production microorganism and all formulation ingredients are in compliance with TSCA.  Ingredients used in the formulation of these enzyme products must also be listed on the inventory.  The Federal Hazardous Substance Act requires precautionary labeling on containers of hazardous household products to help consumers safely store and use those products and to provide them with safety information in case of accidental exposure. Additionally, the Consumer Product Safety Commission (CPSC), as authorized under the Consumer Product Safety Act (CPSA), develops safety standards and pursues recalls for products that present unreasonable or substantial risks of injury or death to consumers. Also, the CPSC, pursuant to the Poison Prevention Packaging Act (PPPA), oversees the requirements for household substances to be packaged in child-resistant packaging.

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In Canada, cleaning products containing enzymes are regulated under the Consumer Chemicals and Containers Regulations (CCCR) by Health Canada which establishes classification criteria, labeling, and packaging requirements for chemical products used by consumers. In addition, technical enzymes are regulated under the Canadian Environmental Protection Agency (EPA), which is jointly administered by Environment and Climate Change Canada (ECCC) and Health Canada (HC).

map of south americaIn Brazil, the “Agencia Nacional de Vigilancia Sanitaria” (ANVISA) is the regulatory body that oversees the registration of enzymatic detergent products.  Relevant regulations in Mexico focus on consumer protection, packaging and labeling. In Mexico the National Chamber of the Industry of Oils, Fats, Soaps and Detergents (CANAJAD) oversees the manufacturers of these products.