EU Regulation 10/2011 on Plastic Food Contact Materials

Commission Regulation (EU) No 10/2011 on plastic food contact materials is the EU rulebook that controls which chemicals may go into plastics that touch food, how much of those chemicals may transfer into the food, and what documentation must follow the product through the supply chain. It sits under the broader Framework Regulation (EC) No 1935/2004 but narrows the focus to one material family: plastics and the substances used to make them. If you manufacture, import, convert, or fill plastic packaging placed on the EU market, this regulation sets the substance list you can draw from, the migration limits you have to meet, the tests that prove you meet them, and the Declaration of Compliance you must issue.

What the Regulation Applies To

The rules apply to materials and articles made entirely of plastic — bottles, yogurt cups, cling films, trays — and to the plastic layers inside multi-material structures. If a beverage carton has a plastic inner lining or a metal lid has a plastic gasket, the plastic layers still have to meet every requirement here, even though the paper, foil, or metal around them does not.¹

Several material categories fall outside the scope because they need different chemistry and different testing: ion exchange resins, natural and synthetic rubber, silicones, and coatings and varnishes. Those have their own regulatory tracks. A “material” is the raw plastic before shaping; an “article” is the finished product ready for use. Both are covered, but the compliance obligations attach at different points in the chain.

Multi-Material Multi-Layer Products

For products that combine plastic with other materials, the regulation treats each plastic layer as if it were a standalone plastic article. The business operator placing the finished product on the market must issue a Declaration of Compliance covering the plastic layers; there is no obligation under Regulation 10/2011 to address the non-plastic layers in that declaration. Safety of the finished multi-material article as a whole is handled by the Framework Regulation.² Plastic layers not yet incorporated into a finished article are treated as “intermediate materials” and carry their own declaration obligations before they move down the chain.

The Union List of Authorized Substances

The regulation runs on a positive list. Annex I — the Union List — sets out every substance that may be intentionally used to make the plastic layers of food contact materials. If a substance is not on the list, you cannot use it.³ The list covers four categories: monomers and other starting substances, additives (colorants excluded), polymer production aids (solvents excluded), and macromolecules obtained from microbial fermentation.⁴

Each entry carries a unique reference number, a substance name, and often specific restrictions: a maximum concentration in the finished plastic, a migration limit into food, or limits on which foods the substance may contact. The Commission amends the list periodically to add substances or tighten existing entries, so the version you relied on last year is not necessarily the one that applies now.

Some additives on the list are also authorized as food additives or flavorings under separate regulations. These “dual-use” substances must not migrate at levels that would produce a technical effect in the food itself, and they must respect whichever limit is stricter — the Union List value or the food additive value.⁵ Missing the second framework is a common source of non-compliance.

Migration Limits: How Much Can Transfer Into Food

The regulation sets two kinds of limits.

The Overall Migration Limit

The overall migration limit (OML) caps the total mass of substances that may migrate from a plastic article into food at 10 milligrams per square decimeter of surface area. Below that threshold, the material is considered inert enough for food contact.⁶

For packaging intended for infants and young children, the same limit is expressed as 60 mg per kilogram of food rather than per surface area. For a standard-sized cubic container holding one kilogram of food the two expressions come out the same, but for small jars and pouches — where the plastic surface is large relative to the food volume — tying the limit to food weight gives infant packaging significantly tighter protection.⁷

Specific Migration Limits

Individual substances of higher toxicity carry specific migration limits (SMLs) set substance by substance and listed alongside the entry in Annex I. SMLs are often measured in fractions of a milligram per kilogram of food, well below the overall limit. A plastic article must comply with the OML and every applicable SML; passing one does not excuse failing the other.

How Migration Is Tested

Migration is measured against standardized liquids called food simulants, each meant to represent a class of food. Annex III assigns six of them:⁸

Simulant A (10% ethanol) for water-based, non-acidic foods.
Simulant B (3% acetic acid) for acidic foods with pH below 4.5, such as fruit juices or pickled vegetables.
Simulant C (20% ethanol) for alcoholic foods up to 20% alcohol and foods with significant organic content.
Simulant D1 (50% ethanol) for alcoholic foods above 20% and oil-in-water emulsions such as mayonnaise.
Simulant D2 (vegetable oil) for fatty foods with free fats at the surface.
Simulant E (modified polyphenylene oxide) for dry foods such as flour or sugar.

Where testing with vegetable oil is not technically feasible, 95% ethanol or isooctane can substitute for simulant D2.⁹

Annex V then prescribes standard time and temperature combinations for overall migration testing, coded OM1 through OM7. The chosen condition must reflect the worst foreseeable use of the article:¹⁰

OM1: 10 days at 20 °C
OM2: 10 days at 40 °C
OM3: 2 hours at 70 °C
OM4: 1 hour at 100 °C (or reflux)
OM5: 2 hours at 100 °C (or reflux), alternatively 1 hour at 121 °C
OM6: 4 hours at 100 °C (or reflux)
OM7: 2 hours at 175 °C

A refrigerated salad tub is tested under OM1 or OM2; a microwave-ready meal tray faces OM5 or higher. Choosing a condition that does not represent the actual worst-case use is one of the quickest ways to invalidate an otherwise thorough compliance package.

Functional Barriers

Not every layer inside a multi-layer plastic has to use only Union-listed substances. If a plastic layer is separated from the food by a functional barrier that prevents migration, the layer behind the barrier can contain non-listed substances, provided:¹¹

The substance is not classified as mutagenic, carcinogenic, or toxic to reproduction under CLP Regulation (EC) No 1272/2008.
The substance is not in nanoform.
Migration into food or simulant is not detectable at a limit of detection of 0.01 mg/kg.

Vinyl chloride monomer is an exception; even behind a functional barrier it must comply with its Annex I restrictions. Where the functional barrier is used, the Declaration of Compliance must confirm that the Article 13 conditions are met, and if the manufacturer cannot verify the CMR status of substances behind the barrier, their chemical identity must be disclosed to downstream users.

Non-Intentionally Added Substances

Manufacturing produces chemicals that nobody put in on purpose: reaction byproducts, degradation products, trace impurities in raw materials. These non-intentionally added substances (NIAS) are not on the Union List but can still migrate, and Article 19 makes the manufacturer responsible for assessing their safety.

The regulation does not prescribe a single method. In practice, NIAS assessment starts by identifying what is likely present given the process chemistry, estimating exposure from migration data or worst-case calculations, and evaluating toxicity. Where substance-specific toxicological data is not available, the Threshold of Toxicological Concern concept can be used as a screening tool: substances are classified by molecular structure and compared against thresholds for their category. Because there is no fixed methodology, the strength of a NIAS assessment lies in how well it is documented, and that documentation becomes part of the file authorities may request.

The Declaration of Compliance

Every plastic food contact material or article requires a written Declaration of Compliance at all marketing stages except retail. A DoC is also required for intermediate products and for the raw substances used to make them.¹² The content follows Annex IV and must cover:¹³

Name and address of the operator issuing the declaration, plus the manufacturer or importer if different.
A clear identification of the material or article by name, batch, or other identifier that allows traceability.
An explicit statement of compliance with Regulation 10/2011 and the relevant provisions of Regulation (EC) No 1935/2004.
Information on any substances with restrictions or specifications, sufficient for downstream operators to verify compliance.
Disclosure, where applicable, of substances that also function as food additives or flavorings.
The conditions of use: the food types the material may contact, the maximum time and temperature of contact, and the surface-to-volume ratio for which compliance was verified.
Where a functional barrier is used, confirmation that the Article 13 requirements are met.

An incomplete or inaccurate DoC is one of the most common issues found during inspections, and it is usually the first document an authority will ask for.

Supporting Documentation

Behind the DoC sits a technical file. It does not travel down the chain with the product, but must be produced to competent authorities on request at any stage of manufacture or marketing, including retail.¹ It should include:

Declarations of Compliance received from upstream suppliers.
OML and SML test results from in-house or contracted laboratories.
Full formulation details, including intentionally added substances and identified NIAS.
Confirmation that every intentionally added substance appears on the Union List and meets its purity criteria.
The NIAS risk assessment and its supporting reasoning.
Quality control records covering procedures used in manufacture.

Digital records are acceptable as long as they can be produced readily. The regulation does not fix a retention period, but records should be kept for as long as the product is in production and for a reasonable period afterward, since national authorities can and do ask for historical documentation during investigations.

The Bisphenol A Ban and the July 2026 Deadline

Commission Regulation (EU) 2024/3190 prohibits the use of Bisphenol A, its salts, and other bisphenols or bisphenol derivatives classified as mutagenic, carcinogenic, toxic to reproduction, or endocrine disrupting. The ban reaches beyond plastics to adhesives, rubbers, ion exchange resins, printing inks, silicones, and varnishes used in food contact materials.¹⁴

The prohibition took effect on 20 January 2025. A transitional provision allows food contact articles manufactured with BPA before that date, whether single-use or repeat-use, to remain on the market until 20 July 2026.¹⁵ After that date, any BPA-containing food contact article on the EU market is in breach regardless of when it was made. Existing stock has to clear before then.

Recycled Plastic Sits Under a Separate Regulation

Recycled plastic in food contact use is governed by Commission Regulation (EU) 2022/1616, which runs alongside Regulation 10/2011 rather than replacing it. The added concern is contamination from the previous use of the plastic waste, which the recycling process must remove.¹⁶

At present, only two recycling technologies are established as suitable: mechanical PET recycling and recycling from a closed and controlled product chain. Mechanical PET processes need individual authorization. Recyclers, facilities, and installations register in a Union register established under Article 24. The recycled material still has to meet every substance and migration requirement of Regulation 10/2011; the recycling rules are added on top.

Enforcement Across Member States

Enforcement is uneven. A European Commission audit covering 2017–2018 found that national systems existed but were often not equipped to identify compliance failures, and even when non-compliance was detected, penalties were frequently not applied.¹⁷ The audit reported that no visited member state had withdrawn food from the market because of non-compliant packaging, even in cases of clear migration exceedances or missing declarations. Proving that a non-compliant material makes the food itself “unsafe,” which some national frameworks require before enforcement, is technically difficult; validated methods do not exist for every substance, and inspector training in food contact chemistry is limited.

The most common issues flagged in the EU Rapid Alert System for Food and Feed involve migration of primary aromatic amines and heavy metals from plastic food contact materials, with most notifications originating from official border controls and market surveillance. The uneven enforcement picture does not reduce the legal obligation, and businesses relying on lax enforcement rather than real compliance are taking a bet that gets riskier as analytical methods and regulatory capacity improve.

1
European Commission. Union Guidance on Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food
2
European Commission. Legislation – Food Safety
3
EUR-Lex. Commission Regulation (EU) No 10/2011 of 14 January 2011 on Plastic Materials and Articles Intended to Come into Contact with Food – Article 5
4
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Chapter II
5
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Chapter II, Article 11
6
EUR-Lex. Commission Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food
7
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Recitals 25 and 26
8
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Annex III
9
EUR-Lex. Commission Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food – Annex V
10
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Annex V, Chapter 3
11
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Article 13
12
EUR-Lex. Commission Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food – Article 15
13
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Annex IV
14
EUR-Lex. Commission Regulation (EU) 2024/3190
15
EUR-Lex. Commission Regulation (EU) 2024/3190 – Articles 11 and 12
16
European Commission. Plastic Recycling – Food Safety
17
European Commission. Overview Report: Official Controls over Food Contact Materials in EU Member States