# Food Contact Compliance for Plastic Cups: FDA, EU 10/2011 & Buyer Document Checklist A B2B guide to plastic cup food-contact compliance for U.S. and EU orders, covering FDA regulatory basis, EU 10/2011, migration limits, food simulants, DoC scope, printing set-off and buyer document verification. ## Why Food-Contact Compliance Must Be Defined Before the Order A compliance document is useful only when its regulatory basis, article identity, intended use and current scope match the order. For U.S. orders, buyers need to understand the FDA basis that applies to the substances used in the food-contact material and their conditions of use. For EU plastic articles, the review normally starts with Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011 and the related Declaration of Compliance and supporting documentation. A resin letter, finished-article migration evidence and a supplier declaration are different records. One should not be treated as a substitute for all the others. ### 30-Second Food Contact Compliance Audit - U.S.: Do not ask only for an “FDA certificate.” Identify the applicable basis—such as a 21 CFR provision, GRAS basis, prior sanction, TOR exemption or effective FCN—and verify intended-use limits. - EU: Map the exact plastic article to the current EU 10/2011 requirements, the DoC and appropriate supporting documentation. Migration evidence is one possible part of that support, not a universal stand-alone certificate. - Scope: Raw-material evidence does not automatically cover the finished cup, lid, ink system or every SKU made from the resin. - Printed cups: Treat printing as an additional compliance review because GMP controls transfer through the substrate and set-off from the printed surface. Start with the destination market, exact finished article, material and intended food-contact conditions. If material selection is not final, use the [PET vs PLA buyer selection guide](/blog/pet-vs-pla-cups-differences-applications-buyer-selection-guide/) first. ## FDA vs EU 10/2011: Which Framework Applies to the Order? “FDA compliant” and “EU compliant” are not interchangeable labels. The U.S. system evaluates the regulatory status of the individual substances that make up the food-contact material. The EU system combines a framework regulation with specific measures for plastics, business-to-business declarations and supporting compliance documentation. Buyer question U.S. order EU plastic article Buyer action Where does the review start? Regulatory status of each substance/component expected to migrate because of intended use. Regulation (EC) No 1935/2004 plus Regulation (EU) No 10/2011 for plastics and applicable GMP requirements. Ask for the regulatory basis, not only a document title. Do use conditions matter? Yes. Authorizations can be limited by food type and conditions of use. Yes. DoC specifications and migration verification depend on food type, contact time and temperature. Describe the real beverage and contact conditions before document review. Is one certificate enough? No universal FDA plastic-cup certificate replaces the component authorization review. No. The DoC and supporting file must be read for the identified article and use scope. Match evidence to the article actually being purchased. Does supplier identity matter? It can. An FCN is effective for the manufacturer/supplier, substance and conditions identified in that notification. The DoC identifies the issuing operator and the operator manufacturing or importing the material/article. Check supply-chain identity where the legal basis makes it relevant. ### Why “FDA Certificate” Is the Wrong Starting Question FDA states that the regulatory status of a food-contact material is dictated by the status of the individual substances that comprise the article. Those substances may rely on a regulation in 21 CFR, GRAS status, a prior sanction, a Threshold of Regulation exemption or an effective Food Contact Substance Notification. If a supplier sends a PDF called “FDA Certificate,” the buyer still needs to identify which of those bases it relies on and whether the limitations match the intended use. ## Raw Material, Finished Cup and Document Scope Are Not the Same Thing Procurement teams should separate material-level evidence, finished-article evidence and business declarations before deciding whether the file supports the order. Evidence type What it can support What it does not automatically establish Raw resin / component document Identity or regulatory information for the stated resin, additive or supplied component. Every finished cup SKU, lid, print system or changed formulation made from it. Supplier declaration The supplier's stated basis, article identity and scope. Independent laboratory verification of every migration condition. Finished-article migration report The tested sample under the stated simulants, contact time, temperature and analytical scope. Other sizes, materials or configurations not represented by the tested sample. EU Declaration of Compliance The identified material/article and the compliance information required by Annex IV. Articles or uses outside the declaration's identification and stated conditions. Compostability certificate / listing The products and scheme covered by the compostability assessment. Food-contact compliance under FDA or EU food-contact rules. EU 10/2011 requires the DoC to permit easy identification of the material or article. Buyers should therefore map the declared article to the exact commercial SKU used on the PO. Closures require the same discipline. A cup document should not be treated as lid evidence unless the documentation scope identifies the closure or clearly supports it. Physical compatibility is a separate issue covered in the [cup and lid compatibility guide](/blog/how-to-match-pet-and-pla-cups-with-the-correct-lids-a-buyer-s-compatibility-guide/). ![Compliance evidence mapped from plastic resin and components to finished cup, lid and printed cup configuration](/images/blog/food-contact-compliance-for-plastic-cups-fda-eu-10-2011-buyer-document-checklist/inline-01.webp) ## EU DoC, Migration Limits, Food Simulants and Supporting Evidence Under the current consolidated EU 10/2011 text, a written Declaration of Compliance is required at marketing stages other than retail for plastic materials and articles and relevant intermediate products/substances. Annex IV requires information such as the issuing business operator, the manufacturer or importer, article identity, declaration date, relevant compliance confirmation and specifications for use. Article 16 requires supporting documentation that can include test conditions and results, calculations, modelling, other analysis and safety reasoning. ### Overall and Specific Migration Are Different Controls The general overall migration limit for plastic materials and articles in Article 12 is 10 mg/dm² of food-contact surface . The separate 60 mg/kg expression is a derogation for plastic materials and articles intended to contact food for infants and young children; it is not a second general OML option for ordinary cold-drink cups. Specific migration limits are substance-specific and are expressed in mg/kg in Annex I. ### Food Simulants Must Match the Intended Food Annex III lists A as 10% ethanol, B as 3% acetic acid, C as 20% ethanol, D1 as 50% ethanol, D2 as qualifying vegetable oil, and E as poly(2,6-diphenyl-p-phenylene oxide) for dry-food testing. Selection depends on food category and the migration question, so the buyer should verify that the simulant and test conditions represent the intended use. ### Three Quantitative Points Buyers Should Read Correctly - 10 mg/dm²: the general EU 10/2011 overall migration limit for plastic materials and articles. - 60 mg/kg: a special Article 12 limit for articles intended for food for infants and young children, not the normal alternative expression for every cup. - Time and temperature: migration verification is based on foreseeable use. The current Annex V uses defined test selections; buyers should compare the report's conditions with the real application rather than accepting “passed migration” without context. ## Printed Plastic Cups: Ink Set-Off, PAA and Finished-Configuration Review Printing adds a compliance layer because the approved finished article now includes an ink system and a stacking pattern. Regulation (EC) No 2023/2006 requires printing inks on the non-food-contact side to be formulated and applied so that substances are not transferred to the food-contact side through the substrate or by set-off at levels that would make the food non-compliant. The same GMP regulation requires printed materials to be handled and stored to control that transfer, and the printed surface must not directly contact food. For nested cups, the outside of one cup can contact the food-contact side of the next cup. That is the set-off mechanism to control. The regulation does not require one universally named “set-off migration certificate” for every printed plastic cup; supporting evidence should match the ink system, article design, substances and intended use. ### PAA Is Not a Universal Printed-Cup Test The current EU 10/2011 text contains specific restrictions for primary aromatic amines in plastic materials and articles. For listed PAAs without another migration limit, the regulation sets a 0.002 mg/kg detection limit for each individual PAA; for other PAAs without an SML, the sum is limited to 0.01 mg/kg. Those numbers are real regulatory controls, but they should not be turned into a blanket claim that every printed cup requires the same PAA test panel. Relevance depends on the actual substances and compliance assessment. For custom orders, keep artwork approval and regulatory review connected but separate. The [custom cup printing approval workflow](/blog/custom-cup-printing-guide-artwork-colors-print-area-sample-approval/) controls the production file; the food-contact review controls whether the finished configuration has appropriate evidence for the destination market. ## How Buyers Should Verify FDA-Related Evidence and Supplier Claims For U.S. orders, work from the exact material and intended use back to the authorization basis. FDA guidance uses conditions of use such as C for hot fill or pasteurization above 150°F (66°C), E for room-temperature filling and storage with no thermal treatment, and F for refrigerated storage. Do not assign a condition merely because a catalog calls the product a “cold cup.” - Identify the exact article. Match the evidence to the quoted [PET cold cup](/pet-cups/) or [PLA cup](/pla-cups/) configuration. - Identify the legal basis. Check the cited 21 CFR provision, GRAS basis, prior sanction, TOR exemption or effective FCN. - Read limitations. Match food type, contact temperature and other conditions to the actual use. - Check supply-chain identity where relevant. An FCN is effective for the identified manufacturer/supplier, substance and conditions. - Connect component evidence to the finished article. Confirm that the actual production specification uses the covered material and record anything that cannot be traced. ### Real Audit Failure: A Genuine File With the Wrong Scope A raw-resin FDA or EU document can be authentic and still be insufficient for a finished printed cup. The importer, auditor or competent authority may be unable to connect it to the article under review. Close the gap by linking the material basis to the finished specification and adding the DoC, migration/supporting evidence or print-related documentation the configuration requires. ## Buyer Document Checklist Before RFQ, Sampling and PO Approval Do not wait until a container is ready to discover that the compliance file cannot be mapped to the PO. EU 10/2011 requires supporting documents to be available to competent authorities on request, and EU GMP requires relevant manufacturing and quality-control documentation to be maintained. Buyer-side traceability should therefore be built into the order file from the beginning. - Confirm the destination market before requesting food-contact documents. - Lock the exact cup SKU, material, lid and printed/plain configuration being purchased. - Define intended food or beverage type, contact time and contact temperature before reviewing migration or FDA-use conditions. - For U.S. orders, identify the actual FDA regulatory basis and check supplier/manufacturer identity where an FCN is relied on. - For EU plastic articles, map the current DoC to the article identity and review the supporting evidence relevant to the intended use. - Check the report's food simulant, time, temperature and analytical scope before treating a migration result as relevant. - For printed cups, confirm that the compliance review addresses the finished print configuration and GMP set-off risk where applicable. - Freeze the document version with the product specification, and reopen the review after substantial composition/production changes, new relevant regulatory information, or an article/supplier change. The [plastic cup sourcing and document approval workflow](/blog/how-to-source-disposable-plastic-cups-from-china-supplier-samples-qc-order-approval/) shows where this review sits inside sampling and PO approval. For PLA, keep it separate from the [PLA certification scope and validity](/blog/pla-cup-certifications-explained-bpi-astm-d6400-en-13432-for-buyers/) review. ![Plastic cup compliance audit workflow from destination market and exact SKU to regulatory basis and buyer approval](/images/blog/food-contact-compliance-for-plastic-cups-fda-eu-10-2011-buyer-document-checklist/inline-02.webp) ## Final Recommendation Do not approve a plastic cup order because a supplier sent a folder labelled “FDA,” “EU” or “food grade.” Lock the destination market, exact finished article, material, lid, printed/plain configuration and intended contact conditions first. Then map each document to the regulatory basis or requirement it supports, the article it identifies, the use conditions it covers and the supplier or manufacturer identity where relevant. For U.S. orders, verify the applicable FDA basis and the limitations attached to that basis. For EU plastic articles, review the current Regulation (EU) No 10/2011 text, the DoC, relevant migration limits and the supporting evidence behind the declaration. For printed cups, add GMP set-off and finished-configuration review instead of assuming a plain-resin file covers the printed article. Final regulatory applicability requires human review for the specific destination market and product configuration. Before commercial release, resolve any gap where the evidence cannot be mapped to the actual article, intended use, current revision or supply chain. ## Frequently Asked Questions ### Does FDA issue a certificate for plastic cups? There is no single FDA “plastic cup certificate” that replaces a regulatory-status review. Food-contact substances may rely on a 21 CFR regulation, GRAS status, prior sanction, TOR exemption, effective FCN or another applicable basis. Buyers should identify the legal basis and its intended-use limitations rather than relying on the title of a supplier PDF. ### What is the EU 10/2011 overall migration limit for plastic food-contact articles? The general overall migration limit in Article 12 is 10 mg/dm² of food-contact surface. The 60 mg/kg expression is a specific derogation for materials and articles intended to contact food for infants and young children; it should not be presented as the normal alternative limit for ordinary cold-drink cups. ### Is an EU Declaration of Compliance the same as a migration test report? No. The DoC is a structured business declaration identifying the material/article and relevant compliance information. A migration report records testing for a stated sample and stated conditions. Article 16 supporting documentation can include testing, calculations, modelling, other analysis and safety reasoning, so a laboratory report is one form of support rather than the DoC itself. ### Does a raw-resin food-contact document cover the finished plastic cup? Not automatically. A resin document can support the identity or regulatory status of the stated material, but the finished article can include additional substances, processing conditions, lids and printing. The buyer needs a documented compliance chain that connects the material evidence to the exact finished article and intended use. ### Do printed plastic cups always need PAA and set-off test reports? No universal rule requires the same named PAA or set-off report for every printed cup. EU GMP requires control of transfer from non-food-contact printing inks through the substrate or by set-off, while EU 10/2011 contains PAA restrictions for plastic materials and articles. The appropriate testing and supporting evidence should be selected from the actual substances, article design, intended use and compliance risk. ## References - [U.S. FDA — Food Ingredient & Packaging Terms: Food Contact Substance, Material and Article](https://www.fda.gov/food/food-ingredients-packaging/food-ingredient-packaging-terms) - [U.S. FDA — Determining the Regulatory Status of Components of a Food Contact Material](https://www.fda.gov/food/packaging-food-contact-substances-fcs/determining-regulatory-status-components-food-contact-material) - [U.S. FDA — Inventory of Food Contact Substances Listed in 21 CFR](https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-food-contact-substances-listed-21-cfr) - [U.S. FDA — Inventory of Effective Food Contact Substance Notifications](https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-effective-food-contact-substance-fcs-notifications) - [U.S. FDA — Food Types & Conditions of Use for Food Contact Substances](https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances) - [EUR-Lex — Consolidated Regulation (EC) No 1935/2004 on Food-Contact Materials and Articles](https://eur-lex.europa.eu/eli/reg/2004/1935/2021-03-27/eng) - [EUR-Lex — Consolidated Regulation (EU) No 10/2011 on Plastic Food-Contact Materials and Articles, 14 July 2026](https://eur-lex.europa.eu/eli/reg/2011/10/2026-07-14/eng) - [EUR-Lex — Consolidated Regulation (EC) No 2023/2006 on Good Manufacturing Practice, including printing-ink set-off controls](https://eur-lex.europa.eu/eli/reg/2006/2023/2025-03-16/eng)