| United States | FDA food facility registration | Mandatory where applicable | Confirm that the manufacturing facility is registered with the U.S. Food and Drug Administration when required for an animal-food facility under the Federal Food, Drug, and Cosmetic Act. | Verify the registered facility address, product activity, and registration status before approving production. | Registration information and renewal requirements should be checked against 21 CFR Part 1, Subpart H. |
| United States | Preventive controls for animal food | Mandatory where applicable | Request a written food-safety plan prepared and overseen by a qualified individual, including hazard analysis, preventive controls, monitoring, corrective actions, and verification. | Hazards should address Salmonella, Listeria monocytogenes, pathogenic Escherichia coli where relevant, foreign material, allergens, and process contamination. | Review the supplier’s food-safety plan and records under 21 CFR Part 507. |
| United States | Import compliance and FSVP | Mandatory for applicable importers | The U.S. importer should maintain a Foreign Supplier Verification Program covering supplier approval, hazard evaluation, verification activities, corrective actions, and records. | Use a risk-based verification plan for each ingredient and finished product, especially animal-derived ingredients and products without a validated kill step. | Reference 21 CFR Part 1, Subpart L. |
| United States | HACCP system | Recommended | Request a HACCP plan showing the seven Codex HACCP principles, process flow, hazard analysis, critical limits, monitoring, corrective actions, verification, and recordkeeping. | Do not treat freeze-drying alone as a validated pathogen-reduction step; require scientific validation or a documented preventive-control strategy. | Compare the plan with the Codex General Principles of Food Hygiene, CXC 1-1969. |
| European Union | Animal-by-product controls | Mandatory where applicable | Confirm that the operator and establishment meet applicable animal-by-product requirements, including sourcing, categorization, handling, traceability, and approved processing activities. | Raw animal materials should have documented category, origin, supplier approval, transport conditions, and batch traceability. | Review applicability of Regulation (EC) No 1069/2009 and Commission Regulation (EU) No 142/2011. |
| European Union | Feed hygiene and HACCP principles | Mandatory for feed operators | Request documented hygiene procedures, hazard analysis, prerequisite programs, traceability, and a HACCP-based system appropriate to the operator’s activities. | Controls should cover receiving, raw-material storage, grinding or mixing, freeze-drying, packaging, environmental hygiene, and dispatch. | Reference Regulation (EC) No 183/2005. |
| European Union | Feed labeling and traceability | Mandatory | Check the product label, composition, additives, analytical constituents, batch identification, net quantity, storage instructions, and responsible operator information for the destination market. | Ensure the label does not imply that “raw” or “freeze-dried” means pathogen-free unless the claim is scientifically substantiated. | Use Regulation (EC) No 767/2009 as the principal feed-marketing reference. |
| Canada | Feed import and preventive controls | Mandatory where applicable | Confirm that the Canadian importer has assessed import eligibility and that the foreign supplier can provide preventive-control, traceability, product specification, and complaint records. | Maintain lot-level records for animal ingredients, finished-product testing, packaging, shipping temperature, and recall capability. | Consult the Canadian Food Inspection Agency feed requirements. |
| Australia and New Zealand | Imported pet-food and biosecurity review | Mandatory where applicable | Obtain import-permit, biosecurity, ingredient, manufacturing-process, and official-document requirements before shipment; requirements vary by product composition and origin. | Animal-origin ingredients and processing conditions should be disclosed accurately for import-risk assessment. | Verify current conditions through Australia’s BICON and pet-food import guidance. |
| All global markets | ISO 22000 food-safety management system | Expected by many buyers | Request a current certificate issued by an accredited certification body, showing the legal entity, manufacturing site, scope, product category, standard version, issue date, expiry date, and certificate status. | The certification scope should explicitly include pet food, animal feed, or the actual freeze-dried raw product activity rather than an unrelated operation. | Check certificate validity with the issuing certification body and accreditation framework; reference ISO 22000:2018. |
| All global markets | HACCP certification or audited HACCP plan | Expected | Request either an independently audited HACCP certification or a complete HACCP plan supported by audit reports, prerequisite programs, sanitation records, and verification evidence. | Critical control points should be supported by measurable limits and documented actions for deviations, rather than relying only on end-product testing. | Use Codex CXC 1-1969 as the internationally recognized HACCP framework. |
| All global markets | Pathogen control and product testing | Recommended | Request a written sampling plan, test methods, laboratory qualifications, test frequency, specifications, certificates of analysis, and documented release criteria. | Testing should be risk-based and may include Salmonella, Listeria monocytogenes, Enterobacteriaceae, total aerobic count, moisture, water activity, and relevant nutritional parameters. | Confirm that methods are fit for purpose and laboratories operate under a recognized quality system; test results should identify product lot, sample date, method, and result. |
| All global markets | Water activity and moisture control | Recommended | Require batch records showing validated freeze-drying parameters and finished-product moisture and water-activity results against an approved specification. | Low water activity can limit microbial growth but does not by itself prove pathogen elimination; packaging must protect the product from moisture uptake. | Review calibration records for water-activity and moisture instruments, test results by lot, packaging-barrier specifications, and stability data. |
| All global markets | Environmental monitoring and sanitation | Recommended | Request a sanitation master schedule, cleaning validation or verification records, zoning plan, personnel hygiene controls, and environmental-monitoring trend reports. | Use risk-based monitoring of food-contact and non-food-contact areas, with documented root-cause analysis and corrective action for positive findings. | Verify sanitation and environmental records during an on-site audit or qualified remote audit; trend data should cover a defined period rather than a single test. |
| All global markets | Traceability and recall readiness | Core buyer requirement | Require one-step-back and one-step-forward traceability for ingredients, packaging, processing, finished goods, customers, and shipment lots. | The supplier should demonstrate a mock recall, lot coding, retention-sample policy, complaint investigation, and documented disposition of affected product. | Request the latest mock-recall report and verify that the supplier can identify affected lots and distribution records within its documented target time. |
| All global markets | Supplier approval scorecard | Recommended | Use a documented qualification score covering legal compliance, food-safety certification, audit performance, testing, traceability, capacity, complaints, and corrective-action closure. | A preferred supplier should provide complete records, pass a risk-based audit, disclose subcontractors, and demonstrate consistent lot performance before commercial approval. | Reassess at least annually and whenever there is a major process change, serious complaint, failed test, regulatory alert, ownership change, or significant audit finding. |