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200Module 7 of 8

Food-Contact Materials & Migration

EU 1935/2004 and FDA regs for food-contact safety: inks, adhesives, coatings, and declarations.

8 minutes

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Lesson Video

Food-Contact Materials & Migration

Module Content

1) Executive Summary

The 7 most important things to know

Framework vs specific measures. EU requires compliance with Reg. (EC) 1935/2004 and GMP Reg. (EC) 2023/2006 for all FCMs; only some materials (e.g., plastics 10/2011, recycled plastics 2022/1616, active & intelligent) have EU-wide specific measures. Printing inks and adhesives have no harmonised EU measure; rely on framework, GMP, national rules, and industry GMPs (EuPIA, FEICA).
Declarations/documentation are not optional. A Declaration of Compliance (DoC) is mandatory where a specific EU measure requires it (e.g., plastics 10/2011). For non-harmonised components (inks/adhesives/coatings), adequate upstream information must flow B2B per Commission Union Guidance so downstream articles can comply.
Migration drives risk. EU plastics set an overall migration limit (OML) of 10 mg/dm² and substance-specific SMLs; testing conditions and food simulants are specified in 10/2011 Annexes. NIAS must be assessed.
US approach is ingredient-based. FDA regulates indirect additives by positive lists in 21 CFR Parts 174–178; new uses proceed via FCN or TOR (21 CFR 170.39). General GMP for indirect additives is at 21 CFR 174.5.
Adhesives and functional barriers. In the US, 21 CFR 175.105 generally requires adhesives be behind a functional barrier (or limited-contact use); 21 CFR 175.125 allows defined PSA uses as a food-contact surface for limited foods.
Coatings differ by region. US 21 CFR 175.300 governs many resinous/polymeric coatings; EU 1895/2005 restricts epoxy derivatives (BADGE/BFDGE/NOGE), and 2018/213 addresses BPA in varnishes/coatings.
Swiss printing inks are the reference list. Swiss FDHA Ordinance Annex 10 provides positive lists for packaging inks with SML/ND entries; widely used as a benchmark where the EU lacks harmonisation.

Action starters for design & sourcing

Require DoCs for plastics and adequate information for all non-plastic intermediates (inks/adhesives/coatings) tied to intended use (food type, time/temperature, area/ratio).
Specify EuPIA/FEICA GMP in RFQs and supplier quality agreements; demand curing/retort validation if applicable.
In the US, map each component to 21 CFR clearances or FCN/TOR/GRAS; document limits (food types, time/temperature).

Key risks (next 12–24 months)

Swiss Annex 10 updates affecting ink raw-material eligibility/limits.
EU FCM reform work may add horizontal rules; monitor consultations.
GB market surveillance on documentation completeness (DoC/adequate information).

2) Definitions & Concepts

FCM: Food-contact material/article—materials intended to contact food or reasonably expected to.
DoC: Declaration of Compliance—formal statement of compliance (mandatory under specific EU measures like plastics 10/2011).
GMP: Good Manufacturing Practice—EU 2023/2006 applies to all FCM manufacturing stages.
OML/SML: Overall migration limit and specific migration limits.
NIAS: Non-intentionally added substances—impurities/reaction products requiring risk assessment.
FCN/TOR/GRAS (US): FDA clearance routes—Food Contact Notification; Threshold of Regulation; Generally Recognized as Safe.
Functional barrier: Layer(s) preventing migration from components behind it into food.

Concept map (bullet diagram)

Safety requirement (1935/2004) → GMP (2023/2006) → Specific measures (10/2011 plastics; 1895/2005 epoxy; 450/2009 A&I; 2022/1616 recycled) → Testing (Annexes, simulants) → Documentation (DoC/Adequate Information) → Market surveillance.

3) Standards, Regulations, and Governance

3.1 European Union (EU)

Framework & GMP: Reg. (EC) 1935/2004 (safety, labeling, traceability, Article 16 DoC), Reg. (EC) 2023/2006 (GMP; printing-inks annex principle that non-food-contact prints must not transfer).
Plastics (binding): Reg. (EU) 10/2011—Union list, OML/SMLs, simulants, Annex IV DoC, Annex V migration testing.
Recycled plastics: Reg. (EU) 2022/1616—authorization/oversight of recycling processes.
Coatings (selected): Reg. (EC) 1895/2005 (epoxy derivatives), 2018/213 (BPA in varnishes/coatings).
Active & intelligent: Reg. (EC) 450/2009 defines functional barrier and authorization elements.
Printing inks & adhesives: No harmonised EU-level measure; rely on 1935/2004 + 2023/2006, Commission Union Guidance for information flow, and industry GMPs (EuPIA, FEICA).

3.2 Switzerland (reference for inks)

FDHA Ordinance (SR 817.023.21) Annex 10 positive lists for packaging inks (binders, colorants, solvents, photoinitiators) with SML/ND; updates effective 2024–2025. Frequently used as a spec benchmark.

3.3 United States (FDA)

Structure via 21 CFR Parts 174–178; 174.5 general GMP.
Adhesives 175.105 (functional barrier) and 175.125 (PSA direct contact for limited foods).
Coatings 175.300 (resinous/polymeric systems; extractives limits).
Clearance via FCN or TOR (170.39) where criteria met.
Letters of guaranty commonly used (21 CFR 7.13) though not statutory DoCs.

3.4 United Kingdom (GB)

Retained/assimilated EU law: 1935/2004, 2023/2006, and GB version of 10/2011; FSA oversees authorisations.

3.5 What differs by region (inks/adhesives/coatings)

Topic	EU	Switzerland	US (FDA)	UK (GB)
Printing inks	No harmonised measure; use framework+GMP; EuPIA GMP widely used.	Annex 10 positive lists with SML/ND; DoC required for inks/printed materials.	No ink-specific reg; components must be cleared under 174–178, FCN or TOR.	Retains EU approach (assimilated plastics; framework/GMP).
Adhesives	No EU list; rely on FEICA GMP and risk assessment.	Covered by general ordinance.	175.105/175.125 define conditions; functional barrier central.	Same as EU/assimilated.
Coatings	EU restrictions on epoxy derivatives (1895/2005); BPA varnish rules (2018/213).	General ordinance.	175.300 systems/limits.	Retained as per EU measures where applicable.

4) Evidence Base & Benchmarks

4.1 EU plastics testing & limits (10/2011)

OML: 10 mg/dm²; SMLs per substance; infant applications may have additional conditions.
Simulants: A (10% EtOH), B (3% acetic), C (20% EtOH), D1 (50% EtOH), D2 (fat/oil), E (Tenax for dry).
DoC content: identity, date, compliance confirmation, substances with SML/OML, dual-use additives, test conditions; integrate adequate information from non-plastic intermediates per Commission Union Guidance.

4.2 US adhesives/coatings conditions (selected)

175.105: Adhesives behind functional barrier or trace seam/edge contact within GMP; composition from listed substances.
175.125: Pressure-sensitive adhesives may be direct food-contact for limited foods when conditions are met.
175.300: Resin systems, extractives limits, and conditions of use.
TOR (170.39): Exposure ≤0.5 ppb with criteria may exempt a substance.

4.3 Industry GMPs

EuPIA Guideline (2023): raw-material selection, set-off/migration control, curing, hygiene/QA.
FEICA GMP (2015): HACCP-based controls for packaging adhesives; interface with EU GMP 2023/2006.

Evidence gap: robust migration datasets for modern UV photoinitiators/oligomers across laminates; propose ring trials aligned to Annex V.

5) Design & Production Implications

Rules of thumb (with sources)

Print on the non-food-contact side; prevent set-off; verify curing and retort resistance per EuPIA.
In US applications, place adhesives behind functional barriers unless 175.105/175.125 conditions are met.
For coatings, confirm regulatory route (EU epoxy/BPA rules; US 175.300) and SML-driven composition limits.
Plastics DoC + test data must reflect food type and worst-case time/temperature per Annex V; update on formulation/process change.

Material/format trade-offs (qualitative)

Solvent vs water vs UV inks: curing depth and set-off risk differ; follow EuPIA guidance.
Reactive adhesives (PU) vs hot-melts: potential NIAS (e.g., aromatic amines) vs performance; rely on supplier data + migration testing.

Manufacturing note

Set-off migration from printed outer to food-contact side when reels/sheets are stacked is a recurring failure mode—design lay-downs and curing to prevent it. Prefer evidence-based “food packaging compliant” over generic “low migration”.

6) Sustainability & Compliance Considerations

Recycled plastics: EU 2022/1616 imposes controls on recycling processes; DoC should reflect recycled content and controls.
Recyclability & inks/adhesives/coatings: Dark/metallic inks, cross-linked coatings, and aggressive PSAs can hinder sortability/deinking; align with local DfR guidance.
Claims risk: Avoid unqualified “food safe” claims; instead state basis of compliance (e.g., “complies with 10/2011 for intended use X at Y °C / Z h; tested per Annex V”).

7) Workflow & Tooling

7.1 Print-ready / pre-press FCM checklist

Confirm intended use (food type, max time/temperature, contact mode, area/ratio).
Obtain ink/adhesive/coating compositions and adequate information (NIAS statements, curing windows, residuals).
Ensure GMP and hygiene controls at converter (ink kitchen segregation, set-off prevention).
For plastics: verify DoC completeness (Annex IV fields), migration test reports/OML/SMLs, dual-use additives.

7.2 Decision tree – choose an adhesive route (EU/US)

Will adhesive contact food? If yes/uncertain (US) → check 175.125 applicability; else require functional barrier per 175.105.
EU: Apply GMP 2023/2006, FEICA GMP, and risk assessment (migration modelling/testing).
Build adequate information package linking to the laminate’s plastics DoC.

7.3 Calculator blueprints (to-be)

Area/ratio → mg/kg conversion for OML/SML checks (use 6 dm²/kg default; adjust for small packs).
TOR screening: estimate worst-case migration vs 0.5 ppb; if ≤ threshold and criteria met, consider 170.39 pathway.

7.4 Template specs

EU Plastics DoC (Annex IV fields) and Non-plastic “adequate information” cover sheet for inks/adhesives/coatings (identity, intended use, SML drivers, NIAS assessment, curing/retort validation).
US Letter of Guaranty (21 CFR 7.13 suggested forms) referencing applicable 21 CFR clearances/FCNs/TORs.

8) Category-Specific Guidance

Beauty (high alcohols, oils): Prioritise resistant varnishes and well-cured inks; verify high-ethanol simulant conditions (D1/D2 as applicable) and SML drivers.

Food (acid/fatty/salty): Match simulants A/B/C/D1/D2; for retort/oven, confirm heat-set inks or validated UV systems and post-cure; epoxy restrictions if can-coated.

Beverage (carbonated, hot-fill): Stress-test coatings/adhesives at use time/temperature; include CO₂ pressure, tunnel pasteurisation, and condensation set-off risks in trials.

9) Case Studies (Problem → Approach → Result)

9.1 EU laminate pouch – aromatic foods (adhesive behind barrier)

Problem: Migration risk from adhesive in PET/ink/adhesive/PE laminate.

Approach: FEICA GMP; ensure adhesive is behind functional barrier (outer PET + PE); require plastics DoC per 10/2011; migration tested per Annex V in D2 and isooctane.

Result: OML < 10 mg/dm²; SMLs met; NIAS assessed via screening + TTC.

9.2 US PSA label on fresh produce

Problem: Retail labels contacting raw fruits/vegetables.

Approach: Select PSA cleared under 21 CFR 175.125; document substrate, food type, and time/temperature; supplier letter of guaranty citing 175.125 and any colorant clearances.

Result: Regulatory fit without a barrier; QA includes peel-transfer checks.

9.3 Swiss-spec outer print for EU export

Problem: Customer requests “compliant ink” proof.

Approach: Restrict ink raw materials to Annex 10 positive list; provide ink DoC plus converter statement integrated into plastics DoC; validate set-off control per EuPIA.

Result: Clear, list-based justification accepted across EU markets despite lack of EU ink measure.

10) Common Pitfalls & Red Flags

Using “low-migration” as a compliance claim without data; prefer evidence-backed wording.
Missing dual-use additives and test conditions in DoCs.
Set-off during winding/stacking; inadequate curing windows.
US RFQs lacking explicit 21 CFR/FCN/TOR mapping per component and intended use.
Assuming GB = EU without checking assimilated references and local enforcement expectations.

15) References

Primary: EU 1935/2004, 2023/2006, 10/2011 (+ Union Guidance), 1895/2005, 2018/213; EU 450/2009; EU 2022/1616; Swiss FDHA SR 817.023.21 Annex 10; FDA 21 CFR Parts 174–178, 170.39, 7.13. Secondary: EuPIA Guideline (2023), FEICA GMP (2015), EFSA overviews, Intergraf printer guidance.

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