Legal Compliance for Packaging Materials
Aligned with FSSC 22000 Requirements
Requirement Overview
FSSC 22000 requires that organizations ensure all packaging materials used in food and consumer product supply chains comply with applicable legal and regulatory requirements in the countries of manufacture, distribution, and use. This includes requirements relating to substances used in manufacturing, food contact safety, labeling, chemical restrictions, and environmental considerations.
A documented process must be in place to verify that materials meet relevant legal requirements and that supporting evidence is maintained. Failure to ensure compliance can result in regulatory penalties, product recalls, or customer complaints—particularly for food-contact and consumer-facing packaging.
Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3
Requirement Overview
BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.
Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”
Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.
Key Compliance Objectives
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✓ Verify all packaging materials meet legal and safety standards
✓ Maintain declarations of compliance from raw material suppliers
✓ Monitor regulatory updates for target markets
✓ Keep evidence of assessments, certifications, and approvals
Step-by-Step Compliance Implementation
1. Identify Applicable Regulatory Requirements
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Applicable regulations may include:
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• Food contact safety regulations (e.g., EU Regulation 10/2011, FDA 21 CFR)
• Chemical restrictions (e.g., REACH, Prop 65, SVHC)
• Environmental claims or labeling laws
• Heavy metal or migration limits for inks, adhesives, plastics
Evidence to Maintain:
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• Legal register of applicable packaging regulations
• Risk assessments by market/country
• Client or product-specific requirements summary
- • Food contact safety regulations (e.g., EU Regulation 10/2011, FDA 21 CFR) • Chemical restrictions (e.g., REACH, Prop 65, SVHC) • Environmental claims or labeling laws • Heavy metal or migration limits for inks, adhesives, plastics
- • Legal register of applicable packaging regulations • Risk assessments by market/country • Client or product-specific requirements summary
2. Obtain and Review Compliance Documentation
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Required documents from suppliers may include:
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• Declarations of compliance (DoC)
• Material safety data sheets (MSDS)
• Analytical test reports (e.g., migration, heavy metal content)
• Certificates for recyclability, compostability, or sustainability
Evidence to Maintain:
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• Signed DoCs from material and component suppliers
• Validated laboratory reports and test certificates
• Supplier approval files including compliance documentation
- • Declarations of compliance (DoC) • Material safety data sheets (MSDS) • Analytical test reports (e.g., migration, heavy metal content) • Certificates for recyclability, compostability, or sustainability
- • Signed DoCs from material and component suppliers • Validated laboratory reports and test certificates • Supplier approval files including compliance documentation
3. Establish a Legal Compliance Procedure
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The procedure must outline:
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• How regulatory requirements are identified and updated
• How supplier documentation is requested, reviewed, and approved
• Who is responsible for maintaining compliance and updating clients
Evidence to Maintain:
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• Documented legal compliance SOP
• Compliance approval workflow or checklist
• Training records for responsible personnel
- • How regulatory requirements are identified and updated • How supplier documentation is requested, reviewed, and approved • Who is responsible for maintaining compliance and updating clients
- • Documented legal compliance SOP • Compliance approval workflow or checklist • Training records for responsible personnel
4. Verify Ongoing Compliance and Regulatory Changes
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Verification actions include:
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• Review compliance certificates annually or with each change
• Monitor regulatory changes in each market of use
• Audit suppliers for ongoing conformance
Evidence to Maintain:
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• Annual regulatory review log
• Supplier re-evaluation or requalification records
• Documentation updates following law changes
- • Review compliance certificates annually or with each change • Monitor regulatory changes in each market of use • Audit suppliers for ongoing conformance
- • Annual regulatory review log • Supplier re-evaluation or requalification records • Documentation updates following law changes
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Missing or outdated declarations of compliance | Request and archive valid supplier documentation annually |
| No documented legal compliance procedure | Develop and implement an SOP for legal compliance |
| Lack of regulatory awareness for export markets | Maintain a country-specific regulatory checklist |
| Incomplete review of multi-component materials | Obtain compliance evidence for all subcomponents (e.g., inks, adhesives) |