EU Regulation 2026/2412: New Authorisations, Migration Limits & Food Contact Compliance

Introduction

Food contact materials (FCMs) play an essential role in food manufacturing, processing, packaging, storage and transportation. However, chemical substances used in packaging materials can migrate into food under certain conditions, potentially affecting consumer safety, food composition, taste, odour and overall product quality.

To strengthen the regulatory framework governing plastic food-contact materials, the European Commission adopted Commission Regulation (EU) 2026/2412 of 28 October 2026, amending Annex I to Regulation (EU) No 10/2011.

The amendment introduces four new entries into the Union List of authorised substances used in the manufacture of plastic materials and articles intended to come into contact with food. These authorisations include specific conditions relating to polymer applications, permitted concentrations, food categories, contact conditions and migration limits.

For food packaging manufacturers, polymer producers, converters, food businesses and testing laboratories, the update highlights the importance of reviewing material composition, migration performance, technical documentation and compliance declarations.

The regulation is particularly relevant to businesses developing or using specialised plastic materials, including polyether ether ketone (PEEK), polylactic acid (PLA) and polyamide-based materials.

Understanding EU Food Contact Material Regulations

The regulatory framework

The EU framework for food contact materials is primarily established under Regulation (EC) No 1935/2004, which requires that materials and articles intended to come into contact with food are manufactured so that they do not transfer their constituents into food in quantities that could:

Endanger human health.
Bring about an unacceptable change in the composition of food.
Deteriorate the organoleptic characteristics of food, including taste and odour.

For plastic food-contact materials, these general principles are supported by Commission Regulation (EU) No 10/2011.

The regulation establishes a Union List of authorised substances that may be intentionally used in the manufacture of plastic food-contact materials, together with applicable restrictions and specifications.

Why the Union List matters

Annex I of Regulation (EU) No 10/2011 contains the Union List of authorised substances, including relevant monomers, additives and other starting substances.

A substance being listed does not mean that it can be used without restrictions. Its authorisation may specify:

Permitted polymer or material applications.
Maximum concentration in the finished material.
Specific migration limits (SMLs).
Permitted food categories.
Temperature and duration of contact.
Additional restrictions or verification requirements.

Manufacturers must assess the complete authorisation entry rather than relying solely on the presence of a substance in the Union List.

EU Regulation 2026/2412: What Has Changed?

Overview of the amendment

Commission Regulation (EU) 2026/2412 amends Annex I of Regulation (EU) No 10/2011 by introducing four new authorised substance entries.

The new entries are associated with the following FCM substance numbers:

FCM substance number	Substance	Main application
1086	Chopped carbon fibres from carbonised polyacrylonitrile	Filler and reinforcement in PEEK and specified PLA applications
1087	Nano-precipitated calcium carbonate, uncoated	Plastic food-contact material applications, subject to restrictions
1088	Poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters	Additive in specified PLA materials
1090	Mixture of 1,9-nonanediamine (NMDA) and 2-methyl-1,8-octanediamine (MODA)	Co-monomer for polyamide production

The authorisations are based on scientific assessments by the European Food Safety Authority (EFSA). Each entry includes conditions intended to ensure that the substance can be used safely under its specified conditions.

New authorisation: Chopped carbon fibres (FCM No. 1086)

Chopped carbon fibres produced from carbonised polyacrylonitrile have been authorised for use as filler and reinforcement materials in plastic food-contact applications.

The authorisation specifies:

The carbon fibres must have a minimum carbon content of 95% by weight.
Their dimensions must be outside the nanoscale in every dimension, with a diameter greater than 100 nm.
Use is permitted at up to 40% by weight in polyether ether ketone (PEEK) polymer.

The authorisation also addresses use in PLA-based materials under more restricted conditions, with a maximum concentration of 15% by weight and a specific migration limit of 0.05 mg/kg food. The permitted PLA application is limited to specified food categories and contact conditions.

This authorisation is relevant to manufacturers developing reinforced plastic materials for specialised food-contact applications.

New authorisation: Nano-precipitated calcium carbonate (FCM No. 1087)

The amendment introduces an entry for uncoated nano-precipitated calcium carbonate.

An important restriction is that this substance must not be used in the manufacture of materials and articles intended to come into contact with infant formula. The regulation also identifies a potential risk of exceeding the overall migration limit when the material is in contact with acidic foods. Manufacturers using this substance should therefore evaluate its intended application, food-contact conditions and migration behaviour rather than treating the authorisation as unrestricted approval.

New authorisation: Poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters (FCM No. 1088)

This substance is authorised as an additive in specified PLA-based materials.

The key conditions include:

Maximum use level of 15% by weight.
Use only in PLA materials without starch or other additives performing a similar function that could increase migration.
Specific migration limit of 0.05 mg/kg food.
Contact duration of up to 10 days.
Contact temperature of up to 40°C.
Permitted contact with specified food categories, including certain waters, fresh or chilled fruits, fresh or chilled vegetables and vinegar.

The regulation also highlights a potential risk of exceeding the specific migration limit when the material is tested with food simulants other than simulant B.

This makes the selection of appropriate food simulants and migration-test conditions particularly important for manufacturers using this additive.

New authorisation: NMDA and MODA mixture (FCM No. 1090)

The mixture of 1,9-nonanediamine (NMDA) and 2-methyl-1,8-octanediamine (MODA) is authorised for use as a co-monomer with terephthalic acid in the manufacture of polyamide materials and articles.

The main restrictions include:

Combined migration of NMDA and MODA must not exceed 0.05 mg/kg food.
Migration of the relevant fraction of substances below 1,000 Da, consisting of NMDA- and MODA-related substances, must not exceed 5 mg/kg food.
The authorisation does not permit use in materials and articles intended to contact infant formula or breast milk.

The migration assessment must therefore consider both the combined migration of the two diamines and the specified low-molecular-weight fraction.

Migration Limits: What Manufacturers Need to Understand

Migration testing is a central component of plastic food-contact compliance. It evaluates the transfer of substances from packaging materials into food or an appropriate food simulant under defined contact conditions.

Regulation (EU) 2026/2412 introduces or specifies migration-related conditions for particular newly authorised substances. These should be distinguished from the general migration limits already established under Regulation (EU) No 10/2011.

Overall Migration Limit (OML)

The Overall Migration Limit (OML) controls the total quantity of substances that can migrate from a plastic material into food.

Under the existing EU plastic FCM framework, the general OML is:

Measurement basis	Overall migration limit
Per kilogram of food or food simulant	60 mg/kg
Per surface area of material	10 mg/dm²

For plastic materials and articles intended for contact with food for infants and young children, the applicable OML is expressed as 60 mg/kg of food.

The OML is a general measure of total migration. It does not replace the need to assess individual substances against their specific migration limits.

Specific Migration Limit (SML)

The Specific Migration Limit (SML) controls the migration of an individual substance or a defined group of substances into food.

The 2026 amendment includes specific migration requirements for certain newly authorised substances.

Substance / application	Migration requirement
Carbon fibres in specified PLA applications (FCM 1086)	0.05 mg/kg
Poly(2-hydroxypropanoic acid), n-octyl/n-decyl esters (FCM 1088)	0.05 mg/kg
Combined NMDA and MODA migration (FCM 1090)	0.05 mg/kg
Specified NMDA/MODA-related fraction below 1,000 Da (FCM 1090)	5 mg/kg

These limits apply to the relevant authorised uses and must be interpreted alongside the restrictions in the regulation.

For FCM 1087, the amendment identifies a potential overall migration concern for acidic food contact. It does not establish a new universal SML for this substance.

Why both OML and SML testing are important

A material may meet the overall migration requirement but still exceed the specific migration limit for an individual substance.

Conversely, demonstrating that selected substances comply with their SMLs does not automatically establish compliance with the overall migration requirement. A suitable compliance programme should therefore identify which migration assessments are required for the material’s composition and intended conditions of use.

Food Simulants and Migration Testing Conditions

Understanding food simulants

Food simulants are used to represent different food types during migration testing. They provide a standardised approach for evaluating the potential transfer of substances from food-contact materials.

Common simulants include:

Food simulant	Typical application
Simulant A – 10% ethanol	Aqueous foods
Simulant B – 3% acetic acid	Acidic foods
Simulant C – 20% ethanol	Alcohol-containing foods
Simulant D1 – 50% ethanol	Fat-containing foods
Simulant D2 – Vegetable oil	Fatty foods
Simulant E – Tenax	Dry foods

The applicable simulant depends on the food category and the regulatory testing provisions. A material may require more than one simulant to represent its intended use.

Time and temperature conditions

Migration testing must reflect the foreseeable conditions of use, including:

Duration of food contact.
Storage temperature.
Hot-fill or heat-treatment conditions.
Refrigerated or frozen storage.
Repeated-use conditions, where relevant.
Maximum intended shelf life.

For the specified PLA applications covered by the new FCM 1088 authorisation, the conditions are limited to contact at up to 40°C for up to 10 days.

Testing under conditions that do not represent the intended application may produce results that are unsuitable for a compliance assessment.

Special consideration for acidic foods

The amendment identifies a potential overall migration concern for nano-precipitated calcium carbonate when used in contact with acidic foods.

For the specified PLA additive application, it also identifies a risk of exceeding the SML when using simulants other than simulant B. These provisions reinforce the need to select food simulants according to the specific material authorisation and intended food-contact conditions.

Analytical Techniques for Food Contact Migration Testing

Reliable migration assessment requires analytical methods that are suitable for the target substance, expected concentration and food simulant.

Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

ICP-MS can support elemental analysis of migration solutions where inorganic elements or metal-related contaminants are relevant.

It offers high sensitivity and multi-element capability, making it useful for investigating selected elemental constituents released from food-contact materials.

Gas Chromatography–Mass Spectrometry (GC-MS)

GC-MS can be used for suitable volatile and semi-volatile organic compounds that may migrate from packaging materials.

Its application depends on the chemical properties of the target substance, sample preparation and method performance.

Liquid Chromatography–Mass Spectrometry (LC-MS)

LC-MS and LC-MS/MS can support the analysis of selected non-volatile, polar or thermally sensitive organic compounds.

These techniques may be relevant for specific additives, degradation products and other substances where the analytical method is appropriately developed and validated.

High-Performance Liquid Chromatography (HPLC)

HPLC can be used for the separation and quantification of suitable organic compounds in migration solutions.

The selection of detector and chromatographic conditions depends on the target substance and required analytical sensitivity.

Analytical method performance

For regulatory migration testing, method selection should consider:

Target substance and relevant chemical form.
Required SML or reporting threshold.
Method limit of quantification (LOQ).
Specificity and selectivity.
Recovery and precision.
Matrix effects from food simulants.
Calibration and quality-control procedures.
Measurement uncertainty and applicable decision rules.

The method must be capable of reliably measuring the substance at concentrations relevant to the applicable migration requirement. A generic migration screening method should not automatically be considered sufficient for every newly authorised substance.

What Does Regulation 2026/2412 Mean for Food Packaging Manufacturers?

Review of raw materials and formulations

Manufacturers should identify whether the newly listed substances are used in their plastic formulations, additives, polymer blends or intermediate materials.

The review should cover supplier specifications, material composition, intended polymer application and restrictions associated with each FCM number.

Verification of intended conditions of use

Authorisation is conditional. Manufacturers should check whether the intended food category, temperature, contact duration and material composition fall within the permitted conditions.

A substance authorised for one polymer application or food category should not automatically be assumed suitable for another.

Migration testing and technical verification

Where a newly authorised substance is used, the manufacturer should determine the applicable migration requirements and establish an appropriate testing strategy.

This may involve overall migration testing, specific migration testing or additional verification of low-molecular-weight substances, depending on the relevant authorisation.

Declaration of Compliance (DoC)

The Declaration of Compliance should accurately reflect the composition and regulatory status of the material, including relevant restrictions and conditions of use.

Supporting documentation should provide the technical basis for the compliance assessment and be available to competent authorities when required.

Good Manufacturing Practice (GMP)

Commission Regulation (EC) No 2023/2006 requires food-contact materials to be manufactured under appropriate Good Manufacturing Practice.

Manufacturers should maintain documented quality assurance and quality control systems, including controls over raw materials, production conditions, process changes and finished-material verification.

Practical Compliance Checklist for Exporters and Manufacturers

Businesses supplying plastic food-contact materials to the EU should consider the following actions:

How Eureka Supports Food Contact Material Testing

Eureka supports food businesses, packaging manufacturers and material suppliers with analytical testing services intended to assist food-contact compliance and quality assurance programmes.

Depending on the applicable testing scope and method availability, support may include:

The appropriate testing plan depends on the material type, target substances, food-contact application, applicable migration limits and required analytical performance. Customers should confirm method availability, sample specifications and intended conditions of use before sample submission.

Conclusion

Commission Regulation (EU) 2026/2412 introduces four new entries into the Union List of authorised substances under Regulation (EU) No 10/2011. The amendment covers specialised materials and additives, including chopped carbon fibres, nano-precipitated calcium carbonate, a PLA additive and an NMDA/MODA mixture for polyamide production.

Although these authorisations expand the substances permitted for specific plastic food-contact applications, they are subject to defined conditions, including polymer restrictions, food-contact limitations and migration requirements.

For manufacturers and exporters, the key compliance priority is to evaluate the complete authorisation conditions rather than considering substance approval in isolation. Appropriate migration testing, supplier verification, formulation controls and updated technical documentation remain essential to demonstrating compliance with EU food-contact requirements.

A structured approach to food-contact material assessment can help businesses identify potential migration risks, strengthen packaging safety and support access to the European market.

Frequently Asked Questions (FAQ)

1. What is Commission Regulation (EU) 2026/2412?

It is an amendment to Annex I of Regulation (EU) No 10/2011, introducing four new authorised substance entries for plastic food-contact materials.

2. When was Regulation 2026/2412 adopted?

It was adopted on 28 October 2026 and published in the Official Journal on 29 October 2026.

3. Which substances are newly authorised?

The amendment covers chopped carbon fibres from carbonised polyacrylonitrile, nano-precipitated calcium carbonate, poly(2-hydroxypropanoic acid) n-octyl/n-decyl esters, and a mixture of NMDA and MODA.

4. Does the regulation introduce a new overall migration limit for all packaging?

No. It introduces substance-specific authorisations and conditions. The existing general OML requirements under Regulation (EU) No 10/2011 continue to apply.

5. What is the overall migration limit for plastic food-contact materials?

The general OML is 10 mg/dm² of contact surface or 60 mg/kg of food or food simulant, subject to the applicable provisions.

6. What is the specific migration limit for the authorised PLA additive FCM No. 1088?

Its SML is 0.05 mg/kg food, subject to the specified material composition and contact conditions.

7. Are NMDA and MODA subject to migration restrictions?

Yes. Their combined migration must not exceed 0.05 mg/kg food. The specified NMDA/MODA-related fraction below 1,000 Da must not exceed 5 mg/kg food.

8. Can nano-precipitated calcium carbonate be used in packaging for infant formula?

No. The new authorisation for FCM No. 1087 specifically prohibits its use in materials and articles intended to contact infant formula.

9. Why are food simulants used in migration testing?

Simulants represent different food categories and allow standardised evaluation of the transfer of substances from packaging into food.

10. Is overall migration testing sufficient to establish full compliance?

No. Specific migration testing and additional checks may also be required depending on the substance, material composition and intended conditions of use.

11. What is a Declaration of Compliance (DoC)?

It is a document communicating the compliance status and relevant conditions of use of plastic food-contact materials through the supply chain, supported by appropriate technical documentation.

12. Which regulations govern EU plastic food-contact materials?

The principal framework includes Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011 and Commission Regulation (EC) No 2023/2006 on Good Manufacturing Practice.

Official References

Commission Regulation (EU) 2026/2412 amending Annex I to Regulation (EU) No 10/2011
Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food
Commission Regulation (EC) No 2023/2006 on Good Manufacturing Practice for materials and articles intended to come into contact with food
European Food Safety Authority (EFSA) — Scientific Opinions on Food Contact Materials
European Commission — Food Contact Materials: Legislation and Authorisation Framework