Migration Testing and Declarations of Compliance for Food Contact Materials, with NIAS

Categories: FSMS
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About Course

A lidding film lot leaves the plant before its adhesive has cured. Your customer in the Netherlands then asks for its migration data. Can you show it was compliant on the day it was filled?

This course teaches you to answer with evidence a customer auditor or an EU competent authority will accept, working from Regulation (EU) No 10/2011 as amended by Regulation (EU) 2025/351.

What will you be able to do?

  • Plan a migration test for a real pack: simulants, time and temperature, the overall migration (OM) test and the worst case variant.
  • Correct a laboratory result in the right order, then apply the 2025 measurement uncertainty rule before you call it a pass or a fail.
  • Approve, approve with conditions or reject a supplier declaration of compliance against all eleven points of Annex IV, with an owner and a date for every action.
  • Assess non-intentionally added substances (NIAS) from screen to TTC or Cramer class threshold, and record the conclusion.

Is it for you? Packaging technologists, QA and technical managers who sign declarations, and laboratory staff who order or report migration tests at South African converters, brand owners and exporters of food contact packaging. It is an Advanced course. You need to know your packaging materials. No other course is required first.

What do you get? 32 lessons in seven modules, 31 case activities with model answers, and a knowledge check and game per module. The course tool builds your test plan, runs the declaration review checklist, keeps a NIAS log and a decision record, and exports all four to Excel.

Will it work for your site? Every activity can be completed on Mzansi Pack, a fictional Gauteng converter making lidding film, pouches and trays, and the assignment can use your own pack instead. No site access is needed.

How long, and how are you assessed? 12 hours, self-paced online. A timed, proctored final of 30 questions from a bank of 62, and a practical assignment marked from your tool export. Pass mark 70 percent, three attempts at each assessment, feedback after every failed attempt. Your QR-verified certificate is released when every assessment is passed and your course review is submitted.

Is it worth R2 950? No VAT is charged. Weigh it against one repeat migration test, or one export lot held at the customer while you look for evidence that should already be on file.

What Will You Learn?

  • Choose a defensible migration test plan for a pack
  • Approve or reject a declaration of compliance with reasons
  • Assess NIAS using screening, identification and a TTC or Cramer class exposure approach, and record the conclusion
  • Correct a laboratory migration result and apply the 2025/351 measurement uncertainty rule

Course Content

Module 1: Module 1: Overall and specific migration explained (plastics, with notes on paper, board and coatings)
The safety rule behind every food contact pack, the overall and specific migration limits in Regulation (EU) No 10/2011 as amended, the Annex II limits for metals and primary aromatic amines, multi-layers and functional barriers, and what applies to paper, board, inks and coatings.

  • Why every food contact pack comes back to migration
  • Overall migration: the inertness check
  • Specific migration: SMLs, group limits and not detectable
  • Multi-layers, functional barriers, inks and adhesives
  • Paper, board and coatings: when there is no EU specific measure
  • Module 1 knowledge check
  • Overall or specific?

Module 2: Module 2: Simulants, test conditions and worst case selection
How Annex III assigns food simulants, how Annex V turns worst foreseeable use into specific and overall migration test conditions, how to pick the worst case product, specimen and surface to volume ratio, when screening is enough, and how the US approach differs.

Module 3: Module 3: Reading a laboratory migration report
What a migration report must contain, the corrections in Annex V (surface to volume, D2 and E reduction factors, fat reduction factor and the cap of 5), the measurement uncertainty decision rule introduced by Regulation (EU) 2025/351, and the red flags that mean a report does not yet prove compliance.

Module 4: Module 4: Declarations of compliance: what a valid one contains
The legal basis of the declaration of compliance, who issues one at each stage, every point of Annex IV of Regulation (EU) No 10/2011 as amended, the 2025/351 changes and transitional dates, a structured review method with defect grades, and how to write your own declaration for a converted product.

Module 5: Module 5: Supporting documents and dual use additives
What supporting documents must contain under Article 16 of Regulation (EU) No 10/2011 as replaced by 2025/351, how to build and keep a compliance file with GMP records and change control, dual use additives and Article 11(3), and adequate information and set-off control for inks, adhesives and coatings.

Module 6: Module 6: NIAS: screening, identification and risk assessment
Non-intentionally added substances under Regulation (EU) No 10/2011 as amended by 2025/351, including the new Article 3a on purity. Planning a screen, grading identification, estimating exposure with the regulation’s conventions, applying EFSA’s TTC approach and Cramer classes, and recording and acting on the conclusion.

Module 7: Module 7: Workshop: approve or reject three realistic packaging submissions
Three Mzansi Pack submissions reviewed end to end with one method: a new PP sheet supplier for meat trays, the lidding film after an adhesive change, and a snack pouch extended to new foods. Each ends in a graded, recorded decision.

Assignment, final assessment and course review
Your practical assignment on your own site or on Mzansi Pack, then the final assessment. Your certificate is released when every assessment is passed and your course review is submitted.

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