Personnel (leaders specifically trained in
courses required by FSMA and proficient in
food quality and safety controls)
• Is it Recognized Globally? – To ensure a par-
ticular certification scheme meets all applicable
standards and regulations, manufacturers should
ensure it is accepted by the GFSI, the European
Cooperation for Accreditation (EA) or other
accreditation bodies located in regions where the
product may be imported/sold. In general, if a
certification is accepted by EA, most accreditation
bodies will likely accept it.
c-GMP’s (Current Good Manufacturing
Prior to FSMA, provided the framework for U.S. food safety regulation, enforced
by the FDA under 21 CFR and other agencies around the world. If a product is
manufactured to meet c-GMP's, it may also indicate that it meets all minimum
regulatory requirements for that region (but not necessarily in all regions).
Certified/Accredited to Meet… Indicates a manufacturer has met the standards of a 3rd party certification program.
The scheme, not the facility or products, are certified. A manufacturer's full portfolio
is not necessarily covered by the certified scheme, and the scheme generally needs
to be re-certified periodically.
Codex (Alimentarius) A set of globally recognized food product and process standards developed by the
UN and WHO. Defines a HACCP system and guidelines for its application, utilized by
some certification schemes such as BRC.
FCC (Food Chemicals Codex) A set of globally recognized standards for food ingredient quality and purity,
FD&C Act (U.S. Food, Drug, and Cosmetic) Passed in 1938, gave the FDA authority to oversee the safety of food additives such
including flavors. Contains specifications for "food grade" ingredients. A product
label indicating a product is FCC indicates that the product meets the FCC
specifications, but does not guarantee that the product has been tested or certified
to meet the standard.
as flavors. Products (especially colorants) labeled FD&C must be batch tested to
ensure they meet FCC specifications.
Food-Grade Indicates that a product that is fit for human consumption, though not with respect
to any particular regulation. Evaluate whether a food-grade ingredient and supplier
meets all requirements for the intended application, such as FCC specifications, FDA
registration, and 21 CFR restrictions.
FSMA (U.S. Food Safety Modernization Act) Indicates a manufacturer meets all FDA rules, but does not necessarily mean that a
GFSI (Global Food Safety Initiative) Provides globally recognized food safety benchmarks. Recognizes schemes that
manufacturer has a certified food safety scheme or that it has been audited. Does
not replace c-GMP's, but rather works with them for comprehensive coverage of
products and practices. International food/ingredient manufacturers whose products
may be distributed in the U.S. must also comply.
meet current benchmarks for HACCP, a food safety management system, and good
practices for manufacturing and distribution. Examples of GFSI-recognized schemes
include BRC, FSSC 22000, IFS, and SQF.
GRAS (Generally Recognized As Safe) Indicates that experts consider a particular chemistry safe for human consumption.
Does not indicate if a particular product is safe or meets specifications.
HACCP (Hazard Analysis and Critical
A plan to identify and manage risks to food safety, mandated by the U.S. FDA
and USDA/FSIS for juice and seafood processors. Primary focus is raw materials,
products, and processes.
HARPC (Hazard Analysis and Risk-Based
FSMA-provisioned plan to identify and manage risks to food safety. Does not apply
to HACCP- or USDA-regulated facilities. Designed to be more comprehensive than
HACCP, requiring a detailed recall strategy and re-analysis every three years or
when new products or equipment are added.
PRP's (Pre-Requisite Programs) Integrate hazard control and c-GMP's for a holistic food safety program.
Incorporated into regulations.
T- 1. Glossary of Key Food Safety Terms