| 1 | Regulatory and material-compliance review | Reviews packaging composition, intended food contact, use conditions, and available supplier documentation against target-market requirements. | US: applicable FDA food-contact provisions in 21 CFR. EU: Regulation (EC) No 1935/2004 and, where applicable, Regulation (EC) No 2023/2006 and material-specific measures such as Regulation (EU) No 10/2011 for plastics. | Requirements map, document-gap list, and recommended testing plan. |
| 2 | Overall migration testing | Measures the total amount of substances that migrate from applicable plastic materials into specified food simulants under selected contact conditions. | EU plastic food-contact rules include an overall migration limit of 10 mg/dm², or 60 mg/kg of food or simulant in the specified circumstances; the test protocol must match intended use. | Test report listing simulants, time-temperature conditions, results, and applicable limit assessment. |
| 3 | Specific migration testing | Quantifies selected substances that have substance-specific migration limits or other restrictions, using suitable analytical methods. | EU: applicable restrictions in Regulation (EU) No 10/2011 for plastics. US: applicable authorizations and limitations in the relevant 21 CFR provisions or other applicable FDA regulatory pathways. | Analyte-specific results, method details, and comparison with identified restrictions. |
| 4 | Non-intentionally added substance (NIAS) screening | Uses analytical screening to identify and assess substances that may arise from impurities, reaction products, or degradation; follow-up assessment is risk-based. | EU: considered within the general safety and risk-assessment framework of Regulation (EC) No 1935/2004 and applicable material rules. Testing scope is not a standalone legal certification. | Screening report with identified signals, limitations, and recommended toxicological or confirmatory follow-up. |
| 5 | Sensory and organoleptic assessment | Checks whether packaging imparts undesirable taste or odour to food or a suitable test medium under defined conditions. | EU: Regulation (EC) No 1935/2004 requires food-contact materials not to transfer constituents in quantities that endanger health or bring about an unacceptable change in food composition or organoleptic characteristics. | Assessment results with sample conditioning, test conditions, and sensory observations. |
| 6 | Heavy metals and elemental analysis | Tests for selected elements in packaging or migration extracts where indicated by material composition, inks, coatings, pigments, or customer specifications. | Requirements vary by material and market; results should be evaluated against applicable legal restrictions and relevant specifications rather than a single universal limit. | Element-by-element results, reporting limits, and the specified assessment criteria. |
| 7 | Paper, board, and recycled-fibre assessment | Reviews composition and intended use; may include testing for selected contaminants or migration, especially where recycled fibre or functional barriers are involved. | US: 21 CFR Part 176 contains provisions for paper and paperboard components. EU: framework Regulation (EC) No 1935/2004 applies; national measures may also be relevant because EU-wide harmonized rules do not cover every paper and board material. | Material review, test results where applicable, and a clear statement of assumptions and limitations. |
| 8 | Coatings, adhesives, and printing-ink assessment | Examines formulation information and potential transfer from coatings, adhesives, or inks, including transfer through the substrate or from the non-food-contact side where relevant. | US: provisions may include applicable sections of 21 CFR Parts 175 and 178. EU: framework and GMP rules apply; requirements depend on the component, construction, and intended conditions of use. | Component-level review, targeted migration or transfer test results, and identified data gaps. |
| 9 | Packaging integrity and physical inspection | Checks dimensions, visual defects, seal strength, leakage, and other performance characteristics specified for the package and distribution conditions. | Supports quality, product protection, and good manufacturing practice; these checks do not by themselves establish chemical food-contact compliance. | Inspection record with sampling details, acceptance criteria, and measured results. |
| 10 | Documentation, traceability, and change-control review | Checks declarations, specifications, test reports, batch traceability, supplier controls, and procedures for evaluating changes in materials or manufacturing. | EU: Regulation (EC) No 1935/2004 includes traceability requirements; Regulation (EC) No 2023/2006 sets GMP requirements. EU plastics may require supporting documentation under Regulation (EU) No 10/2011. | Document checklist, traceability findings, and change-control recommendations. |