Explore the Enzyme Ecosystem

Regulators Government agencies that authorise medicines, devices, chemicals or food ingredients and inspect the organisations that make them.
Regulators Government agencies that authorise medicines, devices, chemicals or food ingredients and inspect the organisations that make them.

Organizations to Explore
US Food and Drug Administration Evaluates US food additive petitions and GRAS notices for enzyme preparations. Its enzyme guidance describes chemical and technological information used in that review. The checked guidance was revised in July 2010 and states that its recommendations are nonbinding. It does not cover every safety question or establish approval of every preparation with the same enzyme name. Geography: United States.
Health Canada Assesses food enzyme safety and permits specified uses and sources in foods sold in Canada. Its food enzyme page points readers to the List of Permitted Food Enzymes. The checked explanation dates from May 2017; the current list and the exact preparation’s conditions must be checked before making a product-specific claim. Geography: Canada.
European Commission, DG SANTE Sets the EU food enzyme framework with Member States and acts on scientific assessments. EFSA’s May 2026 procedure distinguishes its safety opinion from a possible authorization by the Commission and Member States. It also says the EU enzyme list has not yet been established and national rules still apply. Do not present a positive EFSA opinion as blanket permission to sell or use an enzyme. Geography: European Union; national rules remain relevant.

Sources
Health Canada official evidence Read the source for scope and details.
European Food Safety Authority official evidence Read the source for scope and details.
US Food and Drug Administration official evidence Read the source for scope and details.
US Food and Drug Administration official evidence Read the source for scope and details.
European Commission, DG SANTE official evidence Read the source for scope and details.
European Commission, Directorate-General for Health and Food Safety official page Read the source for scope and details.
European Food Safety Authority official page Read the source for scope and details.
US Food and Drug Administration official page Read the source for scope and details.
Health Canada official page Read the source for scope and details.

Regulators