2026 marks a watershed year for Food Contact Material (FCM) compliance in the European Union. The new plastics regulation is now in force, and the requirements on Non-Intentionally Added Substances (NIAS) and on the purity of starting substances have become legally binding. Since 16 September 2026, plastic articles produced under the old rules can no longer be placed on the EU market for the first time. RASFF data point in the same direction.

Executive Summary

  • 78 RASFF notifications against FCM in Jan–Jul 2026, with 41 cases of China-origin products (>50%). The vast majority of violations — primary aromatic amines, mineral oils, formaldehyde, BPS — fall under the NIAS category.
  • Regulation (EU) 2025/351 entered into force on 16 March 2025; since 16 September 2026 all new plastic articles placed on the EU market must be accompanied by an updated Declaration of Compliance (DoC) under Article 15 of Regulation (EU) No 10/2011 (as amended).
  • Regulation (EU) 2024/3190 prohibits BPA and other hazardous bisphenols (including BPS) in food contact materials, repealing the former 0.05 mg/kg migration limit. Switching to BPS is not a workaround.
  • Recycled plastics are now in scope of Regulation (EU) 2022/1616, with new DoC P/DoC C and an electronic registration system for recyclers.
  • A typical NIAS program uses (i) non-target screening by LC-QTOF/MS or GC-MS full scan, (ii) targeted quantification of priority substances, and (iii) a toxicological risk assessment under Article 19 of Regulation (EU) No 10/2011.

1. EU RASFF Notification Data

NIAS — Non-Intentionally Added Substances — refer to substances that are absent from the recipe but are present in the material and may migrate into food. They can originate from impurities in raw materials, degradation products, neighbouring layers, or recycled feedstock.

According to information released by China's Ministry of Commerce in August 2026, the EU RASFF system recorded 78 non-compliant FCM notifications between January and July 2026, of which 41 involved products of Chinese origin — more than half of the total. Breaking the violations down — primary aromatic amines, mineral oils, formaldehyde, BPS — almost all of them fall under the NIAS category.

2. Typical Cases

Landmark case

NIAS substance and outcome

ITX in baby milk (Europe, 2005–2006)

UV-ink photoinitiator ITX migrated into liquid baby milk; roughly one million litres recalled; Switzerland subsequently introduced dedicated printing-ink rules.

4-MBP in breakfast cereals (Germany, 2009)

Ink transferred from the printed outer face into cereals via set-off; 10 RASFF notifications were issued that year.

Bamboo-fibre melamine tableware (NL/BE/LU, 2021)

Formaldehyde up to 17.7 mg/kg (limit 15) and melamine 5.6 mg/kg (limit 2.5); bamboo powder was unauthorised; the three Member States imposed sales bans.

Black nylon kitchenware PAAs (China → EU, ongoing)

Aniline and 4,4'-MDA derived from azo pigments and thermal breakdown, capped at 0.01 mg/kg; cases were still being notified in 2026.

Mineral oils MOSH/MOAH (Germany set a limit in 2016)

Mineral oils from recycled board and inks migrated via the gas phase into dry foods; EU-level progress is summarised in Section 3.

3. Key Dates

Date

Event and significance

16 March 2025

Regulation (EU) 2025/351 entered into force, bringing NIAS and starting-substance purity requirements into law.

20 July 2026

Default transition period under Regulation (EU) 2024/3190 expired: single-use and repeat-use articles containing BPA can no longer be first placed on the EU market.

16 September 2026 (now in effect)

Plastic articles produced under the old rules can no longer be placed on the EU market for the first time. Export batches must be accompanied by an updated DoC under Article 15 of Regulation (EU) No 10/2011 (as amended by (EU) 2025/351), which now includes NIAS information.

~30 September 2026 (expected)

Amending act to Regulation (EU) 2022/1616: new DoC P/DoC C, recyclers move to a non-public electronic register; transition period 3–6 months.

~October 2026 (expected)

MOAH limit regulation expected to be adopted, applying from 1 January 2027, with later dates (2028/2030) for certain food categories.

20 January 2028

Extended transition period for certain single-use categories (fruit and vegetables, fishery products, exterior metal coatings) and for repeat-use professional food production equipment under Regulation (EU) 2024/3190.

Regulation (EU) 2024/3190 entered into force on 20 January 2025. It repeals the 0.05 mg/kg migration limit for BPA under the previous rules. Except for the limited derogations set out in Annex II, it prohibits the use of BPA and other hazardous bisphenols/bisphenol derivatives in food contact materials (BPS is also controlled if it qualifies as a hazardous bisphenol, but is not named separately). The detection limit is 1 μg/kg. For single-use final articles, the transition period generally ends on 20 July 2026; two categories of single-use articles — those used for preserving fruits/vegetables and fishery products, and those with BPA-based coating applied only to the exterior metal surface — are extended to 20 January 2028. Substituting with a structurally similar bisphenol does not circumvent the ban.

4. NIAS Requirements

NIAS has no positive list to reference, but the responsibility it carries is no smaller for that. Article 3 of Regulation (EC) No 1935/2004 requires that materials must not endanger health, change food composition, or deteriorate organoleptic properties. Article 19 of Regulation (EU) No 10/2011 places the risk-assessment obligation squarely on the business operator. What to test and what to control must be justified by your own evidence.

There are three typical origins of NIAS:

  • Impurities and degradation products carried in by raw materials — monomers, catalyst residues, PET oligomers such as BHET, etc.
  • Migration from neighbouring layers — ink photoinitiators such as ITX, adhesive curing agents and their cleavage products.
  • Recycled feedstock and processing aids — non-food-grade residues, mineral oils, mould-release agents.

5. What to Test, and How

A common misconception is to treat an overall-migration report and a heavy-metal screen as the full NIAS package. What your customers actually want to know is: what is the substance, how toxic is it, and what is the exposure level.

Step

What is tested

Instruments typically used

① Non-target screening

All unknown substances in the migration simulant, without pre-defined targets.

LC-QTOF/MS, GC-MS full scan

② Targeted quantification

Hits from the screening plus recurring priorities: PAAs, MOSH/MOAH, photoinitiators, oligomers, BPA/BPS, formaldehyde.

LC-MS/MS, HPLC, GC-MS/MS

③ Risk assessment

Exposure evaluation using TTC/NOAEL or compliance with regulatory limits.

Per Article 19 of Regulation (EU) No 10/2011

Step 3 delivers a written conclusion: a screening report plus a risk-assessment report, together with the supporting documents for the updated Declaration of Compliance (DoC).

6. Which Businesses Should Act First

  • Plastic resin and additive manufacturers are directly in scope of Regulation (EU) 2025/351.
  • Flexible laminate and printed packaging producers should pay particular attention to neighbour-layer transfer.
  • Recycled plastics producers fall within the core supervisory scope of Regulation (EU) 2022/1616.
  • Nylon/PA kitchenware and melamine tableware are recurring subjects of PAA and formaldehyde notifications.
  • Paper articles and recycled paperboard carry their main risks from mineral oils.

Whenever your EU customer asks for a NIAS assessment or an updated DoC, this step is unavoidable.

Common project scope: additives and their degradation/cleavage products (colorants, antioxidants, plasticisers, photoinitiators, etc.), process solvents, mineral oils MOSH/MOAH.

7. Why Choose CIRS Testing for NIAS Testing and Toxicological Risk Assessment

  • CIRS Testing is the laboratory of the CIRS Group. We hold CMA and CNAS accreditation, and our reports are widely accepted by EU customers.
  • LC-MS/MS, GC-MS/MS, ICP-MS and other key instruments are operated in our own laboratories.
  • Our regulatory team continuously monitors developments across the relevant EU FCM framework, including Regulation (EU) No 10/2011 on plastic materials and articles; Regulation (EU) 2022/1616 on recycled plastic materials and articles; Regulation (EC) No 2023/2006 on Good Manufacturing Practice for materials and articles intended to come into contact with food; and Regulation (EU) 2025/351, which consolidates and amends the above.
  • We have served more than 30,000 exporting businesses, and every screening result is reviewed by our technical staff.
  • A team of 30+ toxicologists from China, the United States, Europe and the United Kingdom supports toxicological risk assessment of NIAS and preparation of the DoC.

8. Frequently Asked Questions

Q1. Is NIAS testing mandatory? What should be tested?

No single regulation literally says “NIAS testing is mandatory”. However, the general safety obligation under Article 3 of Regulation (EC) No 1935/2004, the assessment duty under Article 19 of Regulation (EU) No 10/2011, the new requirements introduced by Regulation (EU) 2025/351, and the written evidence demanded by customer audits add up to something indistinguishable from a mandate in practice.

Q2. If the recipe uses recycled material, what should we watch for?

Recycled plastic is one of the main sources of NIAS, because non-food-grade residues and cross-contamination from earlier use are carried into the new product. The DoC and registration requirements are changing with Regulation (EU) 2022/1616 (see Section 3 for timing). We recommend reviewing your supply-chain documentation now, and running a NIAS screen in parallel.

Conclusion

For food contact materials exported to the European Union, NIAS is no longer optional. It is usually not flagged by routine testing, but it does appear on RASFF notification lists. CIRS Testing can support your compliance journey end-to-end — from non-target screening and targeted quantification to toxicological risk assessment and updated DoC documentation.

About CIRS Testing

CIRS Testing is the testing laboratory of CIRS Group, headquartered in Hangzhou, China. We provide testing, inspection, and certification services for food contact materials, toys and children's products, cosmetics, textiles, electronics, and many other consumer-product categories. Our reports are widely accepted by regulatory authorities and brand customers across the EU, North America, Asia-Pacific, and the Middle East.

Contact Us

CIRS TESTING | A member of CIRS Group | CMA & CNAS dual-accredited laboratory

Email: test@cirs-group.com | Hotline: +86 571-87206587 | Website: www.cirs-testing.com

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Note: This article is for informational purposes only and does not constitute legal advice.