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EU 10/2011 for plastic containers: what it requires

Regulation (EU) 10/2011 is the rulebook for plastic materials that touch food in the European Union. For a container buyer it comes down to three things: approved substances, migration limits proven by testing, and a declaration of compliance for the finished item from the plant that made it.

EU 10/2011 for plastic containers: what it requires - Compliance and claims

Where 10/2011 sits in EU law

EU food contact law has two layers. Regulation (EC) 1935/2004 is the framework that applies to every material intended to touch food: plastics, paper, metal, glass, wood. It requires that materials do not transfer constituents to food in quantities that could endanger health, change the composition of the food unacceptably or spoil its taste and odour, and it requires traceability through the supply chain. Below the framework, specific measures cover individual materials. Regulation (EU) 10/2011 is the specific measure for plastics, and it is the one that governs PP takeout boxes, PET fruit boxes, PP storage containers and plastic lids.

Two practical points follow. First, paper boxes, bamboo and wooden parts are under the framework regulation but not under 10/2011, so their evidence looks different. Second, the Single-Use Plastics Directive 2019/904 is a separate law about which products may be placed on the market at all, not about food contact safety. A PP cutlery kit can meet 10/2011 and still be banned from the EU market under the SUPD.

The three core requirements

Authorised substances

10/2011 contains a Union list of monomers, additives and other starting substances that may be used to make plastic food contact materials, with restrictions on some of them. Resin producers design their food contact grades around this list. That is why the resin producer's declaration is the first document in the chain: it states that the grade is made from listed substances and names any restrictions the converter must respect.

Migration limits

Finished plastic items must not transfer their constituents to food above set limits. The overall migration limit is 10 mg per square decimetre of contact surface, or 60 mg per kg of food simulant, and covers everything that migrates. Specific migration limits apply to individual listed substances. Compliance is shown by testing the finished item, or a representative item, in food simulants under time and temperature conditions that match the intended use.

Declaration of compliance

Each business in the chain issues a written declaration of compliance for what it supplies. The resin producer declares the resin; the plant that molds or thermoforms the container declares the finished item. The declaration names the item, the materials, the regulations, the substances with restrictions and the conditions of use, such as food types, maximum temperature and contact time.

Simulants and test conditions

Migration tests use food simulants in place of real food. The lab chooses simulants that represent the foods the container will hold, aqueous, acidic, alcoholic or fatty, and runs them for a time and temperature that represent the use, for example long term chilled storage or a short hot fill. A box tested only with an aqueous simulant at room temperature tells you little about curry delivered hot. That is why the desk writes the intended foods and temperatures on the specification before the test is ordered.

EU documents for a plastic container program
DocumentIssued byWhat it coversWhat it does not cover
Resin declaration of complianceResin producerThe grade, listed substances, restrictionsThe finished container
Item declaration of complianceConverting partner plant, per projectThe finished base, lid or insert, conditions of useOther models or other materials
Migration test reportThird-party lab, issued to plant or brandOverall and specific migration for stated conditionsConditions not tested
LFGB 30 and 31 reportThird-party labGerman test basis, often with BfR recommendationsIt is not a certification mark

Germany, LFGB and BfR

German buyers and some EU retailers ask for LFGB test reports under sections 30 and 31 of the German food and feed code, often combined with checks against BfR recommendations for materials not fully covered by EU measures. These reports are useful evidence and many partner plants can arrange them through a lab. They are reports for a tested item, not a certificate, so the accurate wording is tested to LFGB 30 and 31 per report, never certified.

The intermediate material trap

The most common gap in EU files is a resin declaration presented as if it covered the box. Under 10/2011 the resin is an intermediate material: the converter adds colorants, masterbatch, slip agents and heat, and its own process can change what migrates. A black base PP box and a clear PP box from the same resin can test differently. The finished item needs its own declaration from the plant, and that declaration should rest on migration testing of the finished item or of a representative item from the same material and process.

Changes that reopen the file

A declaration describes one item made one way. Several changes that look small on a purchase order can take a container outside the evidence on file: a new color or masterbatch, a switch of resin grade or resin producer, a printed lid with inks on the food side, a move from clear to black base, a different partner plant or a new use such as hot fill where the item was assessed for chilled storage only. The desk treats each of these as a trigger to ask the plant for an updated declaration and, where the conditions change, a fresh migration test on the new sample. Recycled content is a separate question again; if a program wants it in a food contact part, raise it at the start so the desk can check what the partner plant can document, as set out in recycled content in containers.

How the desk runs an EU file

  1. Specify each part, material, color, foods, maximum temperature and contact time.
  2. Collect the resin declaration for each grade used.
  3. Request the item declaration from the partner plant for each finished part.
  4. Order migration tests at a third-party lab for the conditions of use, on the approved sample.
  5. Check that declaration, test report, specification and labels all match.
  6. File the documents with the lot so repeat orders stay traceable.

Documents are issued to partner plants or to your brand per project and verified by the desk; the desk does not hold certificates. For a legal reading of a specific product, confirm with your test lab or counsel. The compliance guide and testing and inspection pages describe the tests, the migration testing note goes deeper into simulants, and lab time is planned into the sample stage on MOQ and lead time. Send your parts list through the quote form.

Questions buyers ask

Q01Does EU 10/2011 apply to paper boxes?

No. 10/2011 covers plastic materials and articles. Paper and board fall under the framework Regulation (EC) 1935/2004 and national measures. A paper box with a plastic window has two parts with different evidence, and both are listed in the file.

Q02What is the overall migration limit under 10/2011?

10 mg per square decimetre of food contact surface, or 60 mg per kg of food simulant. Specific migration limits apply in addition for listed substances. Both are shown by testing the finished item under conditions that match its use.

Q03Is an LFGB report the same as an EU certificate?

No. An LFGB 30 and 31 report is a test report for a specific item under the German test basis. It is strong evidence, but it is not a certification, and the EU declaration of compliance for the finished item is still required.

Q04Can the resin declaration be used for my container?

Only as the first document in the chain. The resin is an intermediate material; the partner plant that makes the container issues the item declaration, ideally backed by migration testing of the finished item in its color and material.

Send the lines you need, target size or capacity, material, the quantity per item and your market. The desk replies in writing with matched plants, a cut sheet, food contact documents and the reference MOQ.

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