PIM - Regulation (EU) No 10/2011

What PIM is and why it matters

The Plastics Implementation Measure (PIM) — formally Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food — is the EU’s dedicated rulebook for plastic food-contact materials, and if you make, import or sell plastic packaging, containers or kitchenware that touches food, it applies to you. PIM is a specific measure that sits underneath the broader food-contact materials (FCM) framework: where the FCM Framework Regulation (EC) No 1935/2004 sets the general principle that materials must not transfer their constituents into food in quantities that endanger health, change food composition or alter taste and smell, PIM turns that principle into concrete, testable rules for the single most common food-contact material — plastic.

PIM matters because it is detailed and prescriptive in a way the general framework is not. It defines exactly which chemical substances may be used to make food-contact plastics, sets numerical limits on how much may migrate into food, and prescribes how that migration must be tested. For a manufacturer or brand owner, PIM is the regulation that determines whether a plastic tray, bottle, film or lid can lawfully be placed on the EU market, and it is the regulation against which enforcement laboratories will test your product.

📄 Official text: Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food — on EUR-Lex →

Who PIM applies to

PIM applies across the supply chain for plastic food-contact materials, and the duties follow your role:

Manufacturers of plastics and finished articles — anyone producing plastic materials, articles or intermediate products (such as resins, masterbatches, films or finished packaging) intended to contact food. They carry the core duty to use only authorised substances and to respect the migration limits.
Converters and downstream processors — businesses that take intermediate plastic materials and turn them into finished food-contact articles. They rely on, and must pass on, compliance information through the chain.
Importers — businesses bringing plastic food-contact materials or articles into the EU from outside the Union. They must ensure imported products meet PIM just as if they were made in the EU.
Suppliers of substances and additives — those supplying the monomers, additives and other starting materials must provide the information that lets downstream users prove compliance.

PIM covers materials and articles made exclusively of plastics, plastic multi-layer materials, and the plastic layers in multi-material multi-layer constructions. It does not, on its own, cover ion-exchange resins, rubbers and silicones, or printing inks, adhesives and coatings, which fall under the wider FCM framework or other rules.

Key dates and timeline

2011 — Regulation (EU) No 10/2011 was adopted, consolidating and replacing the earlier patchwork of directives that had governed plastic food-contact materials, and establishing the single Union list of authorised substances.
The Regulation has been amended many times since adoption through a series of implementing amendments that update the Union list, add or revise specific migration limits, and refine the testing rules. Because it is a living instrument, the authorised substances and limits in force are those of the current consolidated version, not the original 2011 text.
As a directly applicable EU regulation, PIM applies uniformly in all Member States without national transposition, which removes the divergence that existed under the old directive-based system.

Core requirements

The Union list of authorised substances

At the heart of PIM is the Union list — a positive list of the monomers, other starting substances, additives and polymer production aids that are authorised for use in making food-contact plastics. The principle is restrictive: only substances on the Union list may deliberately be used to manufacture the plastic layers, and each entry can carry its own restrictions and specifications. New substances are added only after a safety evaluation by the European Food Safety Authority (EFSA). For a manufacturer this means the formulation of your plastic must be built from listed substances, and any substance you rely on must be checked against its specific entry and conditions of use.

The overall migration limit (OML)

PIM sets an overall migration limit of 10 mg of total constituents released per dm² of food-contact surface area (10 mg/dm²). This is an inertness ceiling: it caps the total quantity of non-volatile substances that may transfer from the plastic into food or a food simulant, regardless of which substances they are. The OML protects against excessive transfer of material as a whole, separate from the safety of any single chemical.

Specific migration limits (SMLs)

Alongside the overall limit, PIM assigns specific migration limits (SMLs) to individual substances. An SML is the maximum permitted amount of a particular substance that may migrate into food, expressed typically in mg per kg of food, and is set on the basis of that substance’s toxicological profile. Some substances also carry restrictions such as a maximum quantity in the material itself, or a group limit shared across related substances. Compliance therefore has two layers: the material must respect the global OML and, at the same time, every restricted substance must stay within its own SML.

Migration testing with food simulants

Because real foods are too variable to test directly, PIM prescribes migration testing using food simulants — standardised liquids that stand in for categories of food, such as aqueous, acidic, alcoholic and fatty foods. The Regulation sets out which simulants to use, and the time-and-temperature test conditions that represent the foreseeable worst-case contact (for example chilled storage, room-temperature use, hot-fill or high-temperature applications). The results are compared against the OML and the relevant SMLs to demonstrate the article complies under its intended and foreseeable conditions of use.

The Declaration of Compliance and supporting documentation

PIM requires that plastic materials and articles (other than at the retail stage) be accompanied by a written Declaration of Compliance (DoC). The DoC is the formal statement, passed along the supply chain, confirming the material meets PIM and the FCM framework. It must identify the business, the material or article, the substances subject to restrictions, and the conditions of use for which the material is suitable. Behind the DoC sits supporting documentation — test results, migration data and reasoning — which is not normally published but must be made available to enforcement authorities on request. Each actor in the chain relies on the DoC received from upstream and issues its own to downstream customers.

Obligations by role

Plastic and article manufacturers — use only Union-list substances, respect the OML and SMLs, carry out or commission migration testing, and issue a Declaration of Compliance with supporting documentation.
Converters and downstream processors — verify the DoCs received cover their intended use, ensure their processing does not break compliance, and pass on accurate compliance information.
Importers — confirm imported plastic materials meet PIM and the FCM framework, and ensure a valid DoC and supporting documentation exist.
Substance and additive suppliers — supply listed substances and provide the data downstream users need to demonstrate migration compliance.

Enforcement

PIM is enforced through national market surveillance and official food controls. In Denmark, the Danish Veterinary and Food Administration (Fødevarestyrelsen) is the competent authority for food-contact materials, including plastics, and can take samples, require migration testing in official laboratories, and demand the Declaration of Compliance and supporting documentation.

Where a plastic article exceeds the overall or a specific migration limit, uses a non-authorised substance, or lacks proper documentation, authorities can stop sales, require withdrawal or recall, and act against the responsible operators. Non-compliant food-contact materials can also be shared EU-wide through the rapid alert system for food and feed (RASFF), so a problem found in one Member State can quickly trigger checks across the Union. The practical reality for a brand is that a single failed migration test can take a product off shelves in multiple markets at once.

Getting compliant

Confirm your material falls under PIM (plastic layers) and identify which other FCM rules also apply.
Build your formulation only from substances on the Union list and check each entry’s restrictions and specifications.
Identify every substance subject to an SML or group restriction in your material.
Run migration testing with the correct food simulants and worst-case time-and-temperature conditions for the intended use.
Verify results against the 10 mg/dm² overall migration limit and all relevant specific migration limits.
Issue a Declaration of Compliance to your customers and keep the supporting documentation ready for authorities.
Collect and check the DoCs you receive from your own suppliers before relying on their materials.

How Conphora helps

Conphora monitors PIM and maps your plastic food-contact products against its requirements, flagging where a substance falls outside the Union list, where migration data or limits need attention, and where a Declaration of Compliance or its supporting documentation is missing. The platform helps you generate and keep the right documentation, and alerts you when the Union list or migration rules are amended so your compliance stays current.

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Sources and further reading

This guide is for general information and is not legal advice.

Last updated: 12 June 2026