EU Food Contact Materials: EFSA Update
The European Food Safety Authority (EFSA) has identified melamine as potentially requiring reassessment following a screening of substances of very high concern (SVHCs) authorized for use in plastic food contact materials. Additional evidence on male reproductive toxicity prompted the finding.
The technical report, first published on September 18, 2026, identifies a scientific priority for possible follow-up. It does not itself amend food contact authorizations or migration limits. For manufacturers of melamine tableware, EU importers and brand owners, the immediate task is to review existing compliance evidence and track any subsequent assessment or legislative action.
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Explore the screening findings, market requirements and recommended evidence reviews.
What Did EFSA Find in Its SVHC Screening?
In its technical report on SVHCs in plastic food contact materials, EFSA compared the SVHC Candidate List with the Union list under Regulation (EU) No 10/2011. The exercise used an April 15, 2026 snapshot containing 253 Candidate List entries.
EFSA identified 23 substances appearing on both lists and applied a two-step screening process:
Exclude substances that did not warrant further prioritization. Sixteen substances met criteria concerning relevance to oral exposure, existing restrictions, negligible expected exposure or regulatory measures.
Review the remaining substances against additional evidence. EFSA compared previous safety assessments with information available through EFSA and European Chemicals Agency (ECHA) databases.
Seven substances proceeded to detailed consideration: melamine, N-methylpyrrolidone, boric acid, sodium tetraborate, two di-n-octyltin compounds, and 2,2′-methylenebis(4-methyl-6-tert-butylphenol). Available information did not challenge the previous assessments or Union-list restrictions for six of them. Melamine was the only substance identified as potentially requiring reassessment.
Why Is Melamine Under Consideration?
EFSA's 2010 opinion on melamine in food and feed established a tolerable daily intake (TDI) of 0.2 mg/kg body weight per day, primarily on the basis of urinary tract toxicity. The TDI is a health-based guidance value for daily intake; it is distinct from a legal migration limit for a food contact material.
The EU subsequently set a specific migration limit (SML) of 2.5 mg/kg food for melamine. An SML limits the amount of a substance permitted to migrate from a material or article into food.
The 2026 screening identified additional animal studies on male reproductive toxicity with reference points below the one used in 2010. Despite study limitations and uncertainties, EFSA considered that this evidence could support a lower TDI and potentially a recommendation to reduce the SML. A reassessment could initially focus on reproductive toxicity.
EFSA also states that identifying a need for reassessment does not necessarily mean that current use poses a risk to human health. Any revised scientific conclusion and any change to binding requirements would need to be assessed through the relevant subsequent processes.
Does SVHC Status Automatically Ban Food Contact Use?
Inclusion on the SVHC Candidate List does not automatically withdraw a substance's authorization for food contact use.
SVHC identification addresses hazardous properties. A food contact safety assessment also considers the intended use, migration into food and consumer exposure. These are related but distinct regulatory questions.
Businesses should therefore check the applicable food contact conditions and assess relevant REACH requirements separately. Authorization under one framework should not be treated as evidence that every requirement under the other has been met.
How Do EU, US and Chinese Requirements Differ?
Melamine has authorized food contact applications in all three markets, but the permitted uses and compliance criteria differ.
| Market | Authorized applications and key compliance considerations |
|---|---|
| European Union | Melamine is authorized as a monomer, additive or polymer production aid in plastics, subject to applicable conditions. The SML is 2.5 mg/kg food. |
| United States | Requirements depend on the applicable provision for the resin, coating or other food contact use. Composition, use conditions and finished-article extractives requirements must be checked. There is no single melamine migration limit equivalent to the EU SML across these applications. |
| China | Authorized applications include use as an additive in polypropylene (PP) and polyoxymethylene (POM), as well as melamine resin applications. Applicable requirements include an SML of 2.5 mg/kg, with 1 mg/kg for articles specifically intended for infants and young children. |
For a broader comparison of authorization routes and documentation, see REACH24H's guide to EU, US and ASEAN food contact materials compliance. A compliance conclusion for one destination market should be checked against the rules and intended use in each additional market.
What Should Manufacturers, Importers and Brand Owners Review?
REACH24H recommends a focused review for businesses supplying melamine-based tableware or other affected food contact articles to the EU:
Map affected products and suppliers. Identify where melamine is used and connect substance information to the relevant material specifications and finished articles.
Check whether migration evidence supports the intended use. Review the food types, contact time, temperature and repeated-use conditions covered by existing data. Determine whether additional evidence is needed for the actual application.
Review supply-chain documentation. Check that the Declaration of Compliance and supporting information correspond to the material, use conditions and applicable restrictions.
Track the next regulatory trigger. Monitor further EFSA work and any European Commission proposal affecting authorization conditions or migration limits. If binding requirements change, assess the implications for formulations, manufacturing processes, migration data and documentation against the adopted text and its application dates.
These are preparation steps recommended by REACH24H. The screening report itself does not introduce a new retesting deadline or establish that existing authorizations or limits will necessarily change.
How REACH24H Can Help
REACH24H's EU food contact materials compliance services include:
Regulatory compliance analysis;
Declaration of Compliance preparation and review;
Laboratory selection and testing supervision.
Discuss Your EU Food Contact Compliance Evidence
To discuss how your product composition, intended uses and existing documentation align with applicable EU requirements, contact REACH24H.
Recommended Reading
How to Navigate EU, US and ASEAN Food Contact Materials Regulations
Understanding the EU Declaration of Compliance for Food Contact Materials
