In Q3 2025, three separate shipments of iron oxide pigments intended for food contact materials were detained at Rotterdam port. The issue was not heavy metal content, not missing certificates, not incorrect labeling. The issue was migration test data — specifically, migration data generated under outdated temperature conditions that no longer matched the revised regulation.
The detentions were not anomalies. They were the first visible signs of a regulatory shift that had been quietly implemented months earlier. Many exporters missed the changes. Some are still missing them.
This article examines the latest revisions to EU Regulation (EU) 10/2011 — the cornerstone of food contact material compliance in Europe — and explains exactly what iron oxide pigment exporters need to change in their testing protocols, documentation packages, and compliance strategies.
(EU) No 10/2011 is the European Union's regulation on plastic materials and articles intended to come into contact with food. It establishes:
Why iron oxide exporters must care: When your pigment is incorporated into plastic food packaging — PET bottles, polypropylene containers, LDPE films, or any plastic that touches food — the finished material must comply with (EU) 10/2011. Your pigment is part of that compliance chain.
Iron oxides are listed in Annex I of (EU) 10/2011 under FCM substance No. 13440 (Iron oxides, hydroxides and hydrates). This listing requires compliance with the regulation's purity and migration requirements.
The most recent significant amendments to (EU) 10/2011 came through Commission Regulation (EU) 2023/2007 (effective August 1, 2024) and subsequent corrigenda. For iron oxide pigment exporters, four changes matter most:
What changed: The regulation refined which food simulants must be used for specific food categories. For acidic foods (pH < 4.5), 3% acetic acid remains the primary simulant. However, for foods containing both acid and fat (e.g., tomato sauce with oil), testing must now be conducted with both 3% acetic acid AND 95% ethanol or Tenax.
Impact on iron oxide exporters: If your pigment is used in packaging for acidic-fatty foods, you now need two migration tests where previously one might have sufficed. Single-simulant testing is no longer sufficient for multi-component foods.
What changed: The "worst-case" temperature for long-term storage testing was clarified. Previously, 40°C for 10 days was standard for ambient storage. The new regulation explicitly requires 60°C for 10 days for materials intended for hot-filled or tropical-storage conditions.
Impact on iron oxide exporters: Migration data generated at 40°C may no longer be accepted for products destined for warm climates or hot-fill applications. Exporters serving Southern Europe, Middle East, or Africa markets should re-test at 60°C.
What changed: The regulation strengthened requirements for assessing NIAS — substances present in the final food contact material that were not intentionally added but may form during processing (e.g., degradation products, reaction by-products).
Impact on iron oxide exporters: While iron oxides themselves are stable, surface treatments or processing aids used during pigment manufacturing could generate NIAS. Exporters must now provide more detailed information about all substances used in pigment production, not just the final pigment composition.
What changed: The required content of the DoC was expanded. DoCs must now include:
Impact on iron oxide exporters: Your existing DoC template is likely outdated. Simply referencing "complies with (EU) 10/2011" is no longer sufficient. You must provide specific testing condition details.
Before the revision: Many pigment suppliers conducted migration testing at 40°C for 10 days using only one simulant (typically 3% acetic acid for acidic foods or 95% ethanol for fatty foods).
After the revision: Depending on your customer's end use, you may need:
| End-Use Application | Simulants Required | Temperature/Time |
|---|---|---|
| Acidic beverage (soft drink) | 3% acetic acid | 40°C for 10 days |
| Fatty food (chocolate) | 95% ethanol OR Tenax | 40°C for 10 days |
| Acidic-fatty food (tomato sauce) | 3% acetic acid + 95% ethanol | 60°C for 10 days |
| Hot-filled (coffee, tea) | 3% acetic acid or 95% ethanol | 60°C for 10 days or 100°C for 2 hours |
| Infant food | 3% acetic acid (plus stricter SMLs) | 60°C for 10 days |
Critical warning: Your existing migration test reports — even if only 12 months old — may be rejected if they were generated under outdated conditions.
For iron oxide pigments, lead migration is the single most common failure in (EU) 10/2011 compliance. Under the revision, enforcement has tightened.
What the regulation requires: Lead is not intentionally added to food-grade iron oxides. However, it may be present as a trace impurity. The ALARA principle (As Low As Reasonably Achievable) applies. For most food contact applications, customs authorities expect lead migration below 0.5 mg/kg — and increasingly, below detection limits (typically < 0.05 mg/kg).
What changed: Customs authorities are now scrutinizing lead migration data more rigorously. A "pass" statement is no longer sufficient. Numerical results with detection limits are required.
Based on recent detention data, these documentation gaps are now fatal:
Action 1: Audit your existing migration test reports against the new requirements. For each report, ask: was the pigment tested at 40°C or 60°C? Were all relevant simulants tested? Is the laboratory ISO 17025 accredited?
Action 2: Update your Declaration of Compliance (DoC) template. Your new DoC must include specific reference to (EU) 10/2011 amendments, list of all simulants and conditions used, and a NIAS assessment statement.
Action 3: Contact your testing laboratory to schedule updated migration testing under the new conditions. Budget for additional testing if your pigments serve multiple end-use categories.
Action 4: Develop a tiered testing strategy. Work with your customers to understand their actual end-use applications, then test only for relevant conditions.
Action 5: Build a library of migration data by pigment grade and application. A single "representative" test report for all products is no longer defensible.
Action 6: Train your customer-facing teams on the new requirements. Your sales and technical support staff must be able to explain which test data applies to which application.
When evaluating iron oxide pigment suppliers for EU food contact applications, ask these specific questions:
Name: MIKE DAI
Mobile：0086-15657131533
Tel：0086-15657131533
Whatsapp：8615657131533
Email：mike31888@vip.126.com 、hangyan@hangyantech.com
Add：河南辉县市孟庄镇郭村
