--- title: "FCM — Food Contact Materials Framework Regulation" description: "The Food Contact Materials Framework Regulation requires food contact materials and articles to be made under good manufacturing practice so they do not endanger health or change the food, with labelling, traceability and declaration-of-compliance duties for business operators. It has applied since 3 December 2004; the transparency amendment of Regulation (EU) 2019/1381 since 27 March 2021." type: "guide" url: "https://www.conphora.com/regulations/fcm/" markdown: "https://www.conphora.com/regulations/fcm.md" locale: "en" language: "en" published: "2004-12-03" updated: "2026-09-16" author: "Conphora compliance team" publisher: "Conphora" reference: "Regulation (EC) No 1935/2004" celex: "32004R1935" source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R1935" tags: ["FCM", "Food & Cosmetics"] license: "Free to quote with attribution and a link to the page" --- # FCM — Food Contact Materials Framework Regulation The Food Contact Materials Framework Regulation requires food contact materials and articles to be made under good manufacturing practice so they do not endanger health or change the food, with labelling, traceability and declaration-of-compliance duties for business operators. It has applied since 3 December 2004; the transparency amendment of Regulation (EU) 2019/1381 since 27 March 2021. ## Key facts - **Official title:** Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC - **Reference:** Regulation (EC) No 1935/2004 - **CELEX:** 32004R1935 - **Act type:** Regulation - **In force:** 2004-12-03 - **Applies from:** 2004-12-03 - **Enforced by:** Member States carry out official controls to enforce the regulation under the Union rules on official food and feed controls; Article 24(3) still cites Regulation (EC) No 882/2004, which Regulation (EU) 2017/625 repealed with effect from 14 December 2019; the reference is read as a reference to Regulation (EU) 2017/625 (its Article 146), which the bisphenol A regulation also cites for the selection of test methods (Article 9(1)), with the EU reference laboratory for food contact materials and national reference laboratories supporting the analytical work. In Denmark, Fødevarestyrelsen (the Danish Veterinary and Food Administration) administers the rules: executive order nr. 681 of 25 May 2020 on food contact materials was issued by Fødevarestyrelsen under the Danish food act (lov om fødevarer, sections 25, 25 a, 49 and 60) and has been in force since 1 July 2020 (§ 25); it makes Fødevarestyrelsen the authority to be notified of withdrawals (§ 7), and businesses that manufacture, import or wholesale food contact materials must register with it. The toolkit is the marketing prohibition for non-compliant materials, the operator's duty to withdraw non-compliant materials, notify Fødevarestyrelsen and inform consumers, temporary national suspension or restriction of a specific measure on health grounds, and national sanctions that must be effective, proportionate and dissuasive, which in Denmark are fines and up to two years' imprisonment for intentional or grossly negligent infringements that harm or endanger health or seek an economic gain. - **Category:** Food & Cosmetics ## Who it applies to **Covered by the act:** Materials and articles, including active and intelligent materials and articles, which in their finished state are intended to be brought into contact with food, are already in contact with food and were intended for that purpose, or can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use; Packaging, containers, bottles, kitchenware, cutlery, tableware, coatings, inks, adhesives and food processing, filling and vending equipment, whatever the material; The 17 material groups of Annex I that may be covered by specific measures: active and intelligent materials, adhesives, ceramics, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and board, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes and wood; Every business at any stage of manufacture, processing and distribution of materials and articles, and the business operators responsible for meeting the requirements within the business under their control; Materials and articles placed on the market in the Union, meaning held for sale, offered for sale or transferred, whether free of charge or not **Derived and downstream products:** Where a specific measure exists for a material group, its rules apply on top of the framework: Regulation (EU) No 10/2011 for plastics, Regulation (EU) 2022/1616 for recycled plastic, Regulation (EC) No 450/2009 for active and intelligent materials, Directive 84/500/EEC for ceramics, Directive 2007/42/EC for regenerated cellulose film, Regulation (EC) No 1895/2005 for epoxy derivatives and Regulation (EU) 2024/3190 for bisphenol A (Art. 5 and Annex I); Where no specific measure exists, the framework still applies in full and Member States may maintain or adopt national provisions, including national declaration-of-compliance rules; in Denmark executive order nr. 681 of 25 May 2020 requires a declaration of compliance for every food contact material and sets lead and cadmium limits for ceramics, enamel and glass and a PFAS ban for paper and board (Art. 6 and Art. 16(2)); Good manufacturing practice under Regulation (EC) No 2023/2006 applies to all sectors and all stages of manufacture, processing and distribution, up to but excluding the production of starting substances, with detailed rules for printing inks applied to the non-food-contact side (Regulation (EC) No 2023/2006, Art. 2 and Annex); Active materials may change the composition or organoleptic characteristics of food only in compliance with the Union or national provisions applicable to food, and released substances are treated as food ingredients; active and intelligent materials must not mislead consumers and must be labelled as active or intelligent (Art. 4); Substances not yet on a Union list adopted under a specific measure must be authorised through an EFSA-assessed application submitted to a national competent authority (Art. 8 to Art. 12) **Roles under the act:** - **Business operator (any stage of manufacture, processing or distribution)** — The natural or legal persons responsible for ensuring that the requirements of the regulation are met within the business under their control; a business is any undertaking, whether for profit or not and whether public or private, carrying out any activity related to any stage of manufacture, processing and distribution of materials and articles, which includes converters and printers and the food businesses that fill or use the materials. - **Manufacturer or processor responsible for placing on the market** — The manufacturer or processor established within the Union whose name or trade name and address must appear on the material or article; it manufactures under good manufacturing practice, issues the declaration of compliance where a specific measure requires one and holds the supporting documentation. - **Importer or seller responsible for placing on the market in the Union** — The seller established within the Union that is responsible for placing materials or articles from outside the Union on the market and whose name and address must accompany them; the specific measures on ceramics and plastics make the importer responsible for keeping the supporting documentation available to the authorities, and the Danish order treats the importer like the producer for withdrawal and notification. - **Distributor, wholesaler or retailer** — A business at the distribution stage, including retail trade, that holds materials and articles for sale or transfers them; it must pass on the labelling information in a language purchasers understand, display it at the retail stage and be able to identify its suppliers and customers. ## Key dates - 2004-10-27: Regulation (EC) No 1935/2004 adopted by the European Parliament and the Council in Strasbourg - 2004-11-13: Publication in OJ L 338 of 13 November 2004 - 2004-12-03: Entry into force on the twentieth day after publication; Directives 80/590/EEC and 89/109/EEC repealed; materials lawfully placed on the market before this date may be marketed until stocks are exhausted - 2005-05-13: Deadline for Member States to communicate their rules on sanctions to the Commission - 2006-01-01: Regulation (EC) No 1895/2005 applies: migration limits for the epoxy derivatives BADGE, BFDGE and NOGE in plastics, surface coatings and adhesives - 2006-10-27: Article 17 on traceability applies: systems to identify the businesses from which and to which materials, articles and substances were supplied - 2007-07-20: Directive 2007/42/EC in force: the codified specific directive on regenerated cellulose film, replacing Directive 93/10/EEC - 2008-08-01: Regulation (EC) No 2023/2006 on good manufacturing practice applies to all sectors and all stages of manufacture, processing and distribution of food contact materials - 2009-08-07: Regulation (EC) No 596/2009 in force: specific measures, Union authorisations and Annex amendments move to the regulatory procedure with scrutiny (Articles 5, 11(3), 12(6), 22 and 23) - 2009-12-19: Regulation (EC) No 450/2009 on active and intelligent materials: the labelling and declaration-of-compliance provisions of Article 4(f), Article 11(1) and (2) and Chapter IV apply - 2011-05-01: Regulation (EU) No 10/2011 on plastic materials and articles applies: Union list of authorised substances, migration limits, declaration of compliance and supporting documents - 2020-07-01: Danish executive order nr. 681 of 25 May 2020 on food contact materials in force, replacing order nr. 1248 of 30 October 2018; it bans PFAS in paper and board, sets lead and cadmium limits for ceramics, enamel and glass, requires a declaration of compliance for all food contact materials and penalises the EU articles - 2020-09-23: Regulation (EU) 2020/1245 amending and correcting the plastics regulation in force; plastics complying with the previous rules and first placed on the market before 23 March 2021 could still be placed on the market until 23 September 2022 - 2021-03-27: Regulation (EU) 2019/1381 applies: EFSA publishes authorisation applications and supporting information, and the confidentiality rules of Articles 19 and 20 follow Regulation (EC) No 178/2002 - 2022-10-10: Regulation (EU) 2022/1616 on recycled plastic materials and articles in force, replacing Regulation (EC) No 282/2008; Article 6(3)(c) and Article 13(2) apply from 10 October 2024 - 2025-01-20: Regulation (EU) 2024/3190 in force: bisphenol A banned in adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact, Regulation (EU) 2018/213 repealed, BPA and bisphenol S removed from the plastics Union list - 2025-03-16: Regulation (EU) 2025/351 in force: amendments to the plastics regulation, the recycled-plastic regulation and the GMP annex on quality control, reprocessing of plastic by-products and repeat-use articles - 2025-12-16: Intermediate plastic products and substances first placed on the market after this date that do not yet comply with Regulation (EU) 2025/351 must say so in their declaration of compliance - 2026-02-23: Regulation (EU) 2026/245 (new substances in Annex I to the plastics regulation) and Regulation (EU) 2026/250 (corrections to the bisphenol A regulation, including the transitional dates) in force - 2026-07-20: End of the general bisphenol A transition: single-use and repeat-use final food contact articles made with BPA under the old rules may be first placed on the market until this date; single-use articles may then be filled and sealed for 12 months - 2026-09-16: End of the Regulation (EU) 2025/351 transition: plastics complying with the previous rules and first placed on the market before this date may continue to be placed on the market until stocks are exhausted - 2027-07-20: Repeat-use BPA articles first placed on the market under the general transition may remain on the market until this date - 2028-01-20: End of the extended bisphenol A transition for single-use articles preserving fruit, vegetables or fishery products, single-use articles with a BPA coating only on the exterior metal surface, and repeat-use professional food production equipment - 2029-01-20: Repeat-use professional food production equipment made with BPA and first placed on the market under the extended transition may remain on the market until this date ## What you must do ### Business operator (any stage of manufacture, processing or distribution) - Manufacture materials and articles in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food or deteriorate its organoleptic characteristics, and never mislead consumers through labelling, advertising or presentation. - Run an effective, documented quality assurance system proportionate to the size of the business, select starting materials against pre-established specifications, work to pre-established instructions, maintain a quality control system that monitors GMP and corrects failures without delay, and keep documentation on specifications, formulae, processing and quality control results available to the authorities. - Run an effective, documented quality assurance system proportionate to the size of the business, select starting materials against pre-established specifications, work to pre-established instructions, and maintain a quality control system that monitors GMP and corrects failures without delay. - Keep documentation on specifications, formulae, processing and quality control results, and make it available to the competent authorities on request. - Have systems and procedures in place to identify the businesses from which and to which materials, articles and, where appropriate, the substances used in their manufacture were supplied, make that information available to the competent authorities on demand, and make sure the materials placed on the market are identifiable by labelling or documentation. - Have systems and procedures in place to identify the businesses from which and to which materials, articles and, where appropriate, the substances used in their manufacture were supplied, and make that information available to the competent authorities on demand. - Make sure the materials and articles you place on the market are identifiable by labelling or documentation that ensures their traceability. - Where a specific measure applies, accompany the materials and articles with a written declaration of compliance and hold appropriate documentation demonstrating compliance, to be made available to the competent authorities on demand; in Denmark every food contact material must be accompanied by a declaration of compliance, which may be published on the producer's or importer's website if the next operators in the chain are informed. - Where a specific measure applies, accompany the materials and articles with a written declaration of compliance; in Denmark every food contact material must be accompanied by one, which may be published on the producer's or importer's website if the next operators in the chain are informed. - Hold appropriate documentation demonstrating compliance with the specific measure and make it available to the competent authorities on demand. - Comply with any condition or restriction attached to the authorisation of a substance you use, and immediately inform the Commission of any new scientific or technical information that might affect the safety assessment of an authorised substance. - Comply with any condition or restriction attached to the authorisation of a substance you use. - Immediately inform the Commission of any new scientific or technical information that might affect the safety assessment of an authorised substance you use. - For active and intelligent materials, ensure that changes to the food comply with the food rules, that released substances are authorised as food ingredients, that the materials do not mask spoilage or give misleading information, and that they are labelled to identify non-edible parts and as active or intelligent. - For active and intelligent materials, ensure that changes to the food comply with the food rules, that released substances are authorised as food ingredients, and that the materials do not mask spoilage or give misleading information about the condition of the food. - Label active and intelligent materials and articles so that non-edible parts can be identified and so that they are identified as active or intelligent. - Stop using bisphenol A in the manufacture of adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact, respect the transitional deadlines of 20 July 2026 and 20 January 2028, and accompany those materials with a declaration of compliance containing the Annex III information. - Stop using bisphenol A in the manufacture of adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact, respecting the transitional deadlines of 20 July 2026 and 20 January 2028. - Accompany materials and articles covered by the bisphenol regulation with a declaration of compliance containing the Annex III information. - If you are a food business that imports, manufactures or packs food, use only food contact materials that meet the general requirements and only for the purposes for which they are intended, and obtain the declaration of compliance from your supplier. ### Manufacturer or processor responsible for placing on the market - Label materials and articles not yet in contact with food with the words for food contact, a specific indication of use such as coffee machine, wine bottle or soup spoon, or the glass-and-fork symbol of Annex II, unless the article is clearly intended for food contact by its characteristics, and add special instructions for safe and appropriate use where necessary. - Put your name or trade name and address or registered office, as the manufacturer, processor or seller established in the Union responsible for placing on the market, on the material, its packaging, a label or the accompanying documents, together with the labelling or identification that ensures traceability, and make all labelling conspicuous, clearly legible and indelible. - Put your name or trade name and address or registered office, as the manufacturer, processor or seller established in the Union responsible for placing on the market, on the material, its packaging, a label or the accompanying documents, conspicuously, clearly legibly and indelibly. - Label or otherwise identify the materials and articles so that they can be traced. - For active materials, give information on the permitted uses and the name and quantity of the substances released by the active component so that food businesses can comply with the food rules, including food labelling. - Use the for-food-contact information only on materials and articles that comply with the general requirements and with the specific measures or, in their absence, the applicable national provisions. - For plastics, issue the written declaration of compliance with the Annex IV information for materials, articles, intermediate products and substances at every stage other than retail, renew it when composition or production changes alter migration or when new scientific data appears, and hold supporting documents with test conditions and results, calculations and modelling, including evidence of compliance with the Article 8 purity and composition rules, and let authorities take samples. - For plastics, issue the written declaration of compliance with the Annex IV information for materials, articles, intermediate products and substances at every marketing stage other than retail, and renew it when changes in composition or production alter migration or when new scientific data appears. - Hold the supporting documents for the plastics declaration, with test conditions and results, calculations and modelling, including evidence of compliance with the Article 8 purity and composition rules, make them available to the authorities on request and let them take samples. - For ceramics, issue the written declaration of compliance with the Annex III information up to and including the retail stage and hold the analysis results, test conditions and laboratory details demonstrating compliance with the lead and cadmium limits. - For ceramics, issue the written declaration of compliance with the Annex III information so that it accompanies the articles up to and including the retail stage. - For ceramics, hold the analysis results, test conditions and laboratory details demonstrating compliance with the lead and cadmium limits, and make them available to the authorities on request. - Where printing inks are applied to the non-food-contact side, formulate, apply, handle and store the printed materials so that substances are not transferred to the food-contact side through the substrate or by set-off in the stack or reel, and never let printed surfaces touch food. - If you consider or have reason to believe that materials you produced do not meet the food-safety requirements and are no longer under your control, withdraw them from the market, notify Fødevarestyrelsen immediately and, where they have reached consumers, inform consumers effectively and precisely. ### Importer or seller responsible for placing on the market in the Union - Place on the Union market only materials and articles that comply with the general requirements, the applicable specific measures and, in their absence, the national provisions of the Member State of marketing; in Denmark non-compliant food contact materials may not be marketed. - As the seller established in the Union responsible for placing on the market, put your name or trade name and address or registered office on the material, its packaging, a label or the accompanying documents. - Obtain the written declaration of compliance from the non-EU manufacturer where a specific measure requires one, keep the supporting documentation available for the competent authorities, and for ceramics hold the migration test results, test conditions and laboratory details yourself. - Obtain the written declaration of compliance from the non-EU manufacturer where a specific measure requires one. - Keep the supporting documentation for the declaration available for the competent authorities, and for ceramics hold the migration test results, test conditions and laboratory details yourself. - Keep traceability records identifying the businesses from which you sourced and to which you supplied materials, articles and substances, and hand them to the authorities on demand. - In Denmark, register the import of food contact materials with Fødevarestyrelsen through the food-business start-up form unless your imports stay at or below 1 000 units and DKK 50 000 a year, and withdraw and notify Fødevarestyrelsen when imported materials fail the food-safety requirements. - In Denmark, register the import of food contact materials with Fødevarestyrelsen through the food-business start-up form unless your imports stay at or below 1 000 units and DKK 50 000 a year. - In Denmark, withdraw imported food contact materials that fail the food-safety requirements and notify Fødevarestyrelsen. - Check that bisphenol A articles you import fall within the transitional windows: general first placing on the market until 20 July 2026, fruit, vegetable and fishery packaging, exterior-coated single-use articles and professional equipment until 20 January 2028, and that they carry the Annex III declaration. ### Distributor, wholesaler or retailer - Do not sell at retail materials and articles whose for-food-contact indication, instructions for use and active-material information are not given in a language easily understood by purchasers; in Denmark the labelling must be in Danish or a language that differs from Danish only in insignificant spelling. - At the retail stage, display the required information on the materials or their packaging, on labels affixed to them, or on a clearly visible notice in their immediate vicinity, using the notice for the name and address only where a label cannot be affixed for technical reasons. - At the wholesale stage, pass the labelling information on in the accompanying documents, on the labels or packaging or on the materials themselves, and pass on the declaration of compliance where a specific measure requires it. - Keep systems and procedures to identify your suppliers and your business customers and make that information available to the competent authorities on demand. - In Denmark, register wholesale of food contact materials with Fødevarestyrelsen unless the activity stays at or below 1 000 units and DKK 50 000 a year, and cooperate in withdrawals of materials that fail the food-safety requirements. - In Denmark, register wholesale of food contact materials with Fødevarestyrelsen unless the activity stays at or below 1 000 units and DKK 50 000 a year. - In Denmark, cooperate in withdrawals of food contact materials that fail the food-safety requirements. ## Requirements Each duty above as an identified requirement (38); ids are permanent and shared with the compliance engine. ### evidence - `fcm-op-manufacture-materials-articles` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — Manufacture materials and articles in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food or deteriorate its organoleptic characteristics, and never mislead consumers through labelling, advertising or presentation. [Art. 3] - `fcm-op-accompany-declaration-compliance` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — Where a specific measure applies, accompany the materials and articles with a written declaration of compliance; in Denmark every food contact material must be accompanied by one, which may be published on the producer's or importer's website if the next operators in the chain are informed. [Art. 16(1); https://www.retsinformation.dk/eli/lta/2020/681 · § 15] - `fcm-op-comply-authorisation-conditions` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — Comply with any condition or restriction attached to the authorisation of a substance you use. [Art. 11(4)] - `fcm-op-ensure-active-intelligent-safety` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — For active and intelligent materials, ensure that changes to the food comply with the food rules, that released substances are authorised as food ingredients, and that the materials do not mask spoilage or give misleading information about the condition of the food. [Art. 4(1) to Art. 4(4)] - `fcm-op-phase-out-bisphenol-a` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — Stop using bisphenol A in the manufacture of adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact, respecting the transitional deadlines of 20 July 2026 and 20 January 2028. [Art. 1(2), Art. 3, Art. 8 and Art. 11; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0250 · Art. 1] - `fcm-op-accompany-bpa-declaration` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — Accompany materials and articles covered by the bisphenol regulation with a declaration of compliance containing the Annex III information. [Art. 12] - `fcm-mfr-issue-plastics-declaration` (Manufacturer or processor responsible for placing on the market, product, before-market) — For plastics, issue the written declaration of compliance with the Annex IV information for materials, articles, intermediate products and substances at every marketing stage other than retail, and renew it when changes in composition or production alter migration or when new scientific data appears. [Art. 15] - `fcm-mfr-issue-ceramics-declaration` (Manufacturer or processor responsible for placing on the market, product, before-market) — For ceramics, issue the written declaration of compliance with the Annex III information so that it accompanies the articles up to and including the retail stage. [Art. 2a(1)] - `fcm-imp-obtain-declaration-compliance` (Importer or seller responsible for placing on the market in the Union, product, before-market) — Obtain the written declaration of compliance from the non-EU manufacturer where a specific measure requires one. [Art. 16(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R0010-20260714 · Art. 16(1)] ### data - `fcm-mfr-give-information-permitted` (Manufacturer or processor responsible for placing on the market, product, before-market) — For active materials, give information on the permitted uses and the name and quantity of the substances released by the active component so that food businesses can comply with the food rules, including food labelling. [Art. 15(1)(e)] - `fcm-dist-wholesale-stage-pass` (Distributor, wholesaler or retailer, product, before-market) — At the wholesale stage, pass the labelling information on in the accompanying documents, on the labels or packaging or on the materials themselves, and pass on the declaration of compliance where a specific measure requires it. [Art. 15(8) and Art. 16(1)] ### mark - `fcm-op-label-traceability` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — Make sure the materials and articles you place on the market are identifiable by labelling or documentation that ensures their traceability. [Art. 17(3)] - `fcm-op-label-active-intelligent` (Business operator (any stage of manufacture, processing or distribution), product, before-market) — Label active and intelligent materials and articles so that non-edible parts can be identified and so that they are identified as active or intelligent. [Art. 4(5) and Art. 4(6)] - `fcm-mfr-label-materials-articles` (Manufacturer or processor responsible for placing on the market, product, before-market) — Label materials and articles not yet in contact with food with the words for food contact, a specific indication of use such as coffee machine, wine bottle or soup spoon, or the glass-and-fork symbol of Annex II, unless the article is clearly intended for food contact by its characteristics, and add special instructions for safe and appropriate use where necessary. [Art. 15(1)(a), Art. 15(1)(b) and Art. 15(2)] - `fcm-mfr-mark-name-address` (Manufacturer or processor responsible for placing on the market, product, before-market) — Put your name or trade name and address or registered office, as the manufacturer, processor or seller established in the Union responsible for placing on the market, on the material, its packaging, a label or the accompanying documents, conspicuously, clearly legibly and indelibly. [Art. 15(1)(c), Art. 15(3) and Art. 15(8)] - `fcm-mfr-label-traceability` (Manufacturer or processor responsible for placing on the market, product, before-market) — Label or otherwise identify the materials and articles so that they can be traced. [Art. 15(1)(d)] - `fcm-mfr-use-for-food-contact-information` (Manufacturer or processor responsible for placing on the market, product-market, before-market) — Use the for-food-contact information only on materials and articles that comply with the general requirements and with the specific measures or, in their absence, the applicable national provisions. [Art. 15(9)] - `fcm-imp-seller-established-union` (Importer or seller responsible for placing on the market in the Union, product, before-market) — As the seller established in the Union responsible for placing on the market, put your name or trade name and address or registered office on the material, its packaging, a label or the accompanying documents. [Art. 15(1)(c) and Art. 15(8)] - `fcm-dist-retail-stage-display` (Distributor, wholesaler or retailer, product, before-market) — At the retail stage, display the required information on the materials or their packaging, on labels affixed to them, or on a clearly visible notice in their immediate vicinity, using the notice for the name and address only where a label cannot be affixed for technical reasons. [Art. 15(7)] ### procedure - `fcm-mfr-formulate-apply-handle` (Manufacturer or processor responsible for placing on the market, product, before-market) — Where printing inks are applied to the non-food-contact side, formulate, apply, handle and store the printed materials so that substances are not transferred to the food-contact side through the substrate or by set-off in the stack or reel, and never let printed surfaces touch food. [Annex, points 1 to 3] ### submission - `fcm-op-inform-commission-new-data` (Business operator (any stage of manufacture, processing or distribution), product, on-event) — Immediately inform the Commission of any new scientific or technical information that might affect the safety assessment of an authorised substance you use. [Art. 11(5)] - `fcm-mfr-withdraw-them-market` (Manufacturer or processor responsible for placing on the market, product, on-event) — If you consider or have reason to believe that materials you produced do not meet the food-safety requirements and are no longer under your control, withdraw them from the market, notify Fødevarestyrelsen immediately and, where they have reached consumers, inform consumers effectively and precisely. [§ 7] - `fcm-imp-register-import-denmark` (Importer or seller responsible for placing on the market in the Union, company, before-market) — In Denmark, register the import of food contact materials with Fødevarestyrelsen through the food-business start-up form unless your imports stay at or below 1 000 units and DKK 50 000 a year. [§ 7] - `fcm-imp-withdraw-notify-denmark` (Importer or seller responsible for placing on the market in the Union, product, on-event) — In Denmark, withdraw imported food contact materials that fail the food-safety requirements and notify Fødevarestyrelsen. [§ 7] - `fcm-dist-register-wholesale-denmark` (Distributor, wholesaler or retailer, company, before-market) — In Denmark, register wholesale of food contact materials with Fødevarestyrelsen unless the activity stays at or below 1 000 units and DKK 50 000 a year. [§ 7] - `fcm-dist-cooperate-withdrawals-denmark` (Distributor, wholesaler or retailer, product, on-event) — In Denmark, cooperate in withdrawals of food contact materials that fail the food-safety requirements. [§ 7] ### verification - `fcm-imp-place-union-market` (Importer or seller responsible for placing on the market in the Union, product-market, before-market) — Place on the Union market only materials and articles that comply with the general requirements, the applicable specific measures and, in their absence, the national provisions of the Member State of marketing; in Denmark non-compliant food contact materials may not be marketed. [Art. 3, Art. 5, Art. 6 and Art. 15(9); https://www.retsinformation.dk/eli/lta/2020/681 · § 6(1)] - `fcm-imp-check-bisphenol-articles` (Importer or seller responsible for placing on the market in the Union, product, before-market) — Check that bisphenol A articles you import fall within the transitional windows: general first placing on the market until 20 July 2026, fruit, vegetable and fishery packaging, exterior-coated single-use articles and professional equipment until 20 January 2028, and that they carry the Annex III declaration. [Art. 8, Art. 11 and Art. 12; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0250 · Art. 1, points (4) and (5)] - `fcm-dist-sell-retail-materials` (Distributor, wholesaler or retailer, product-market, before-market) — Do not sell at retail materials and articles whose for-food-contact indication, instructions for use and active-material information are not given in a language easily understood by purchasers; in Denmark the labelling must be in Danish or a language that differs from Danish only in insignificant spelling. [Art. 15(4) and Art. 15(5); https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/maerkning] ### standing - `fcm-op-apply-good-manufacturing-practice` (Business operator (any stage of manufacture, processing or distribution), company, ongoing) — Run an effective, documented quality assurance system proportionate to the size of the business, select starting materials against pre-established specifications, work to pre-established instructions, and maintain a quality control system that monitors GMP and corrects failures without delay. [Art. 4, Art. 5 and Art. 6] - `fcm-op-keep-gmp-documentation` (Business operator (any stage of manufacture, processing or distribution), company, ongoing) — Keep documentation on specifications, formulae, processing and quality control results, and make it available to the competent authorities on request. [Art. 7] - `fcm-op-keep-traceability-systems` (Business operator (any stage of manufacture, processing or distribution), company, ongoing) — Have systems and procedures in place to identify the businesses from which and to which materials, articles and, where appropriate, the substances used in their manufacture were supplied, and make that information available to the competent authorities on demand. [Art. 17(2)] - `fcm-op-hold-supporting-documentation` (Business operator (any stage of manufacture, processing or distribution), product, ongoing) — Hold appropriate documentation demonstrating compliance with the specific measure and make it available to the competent authorities on demand. [Art. 16(1)] - `fcm-mfr-hold-plastics-supporting-documents` (Manufacturer or processor responsible for placing on the market, product, ongoing) — Hold the supporting documents for the plastics declaration, with test conditions and results, calculations and modelling, including evidence of compliance with the Article 8 purity and composition rules, make them available to the authorities on request and let them take samples. [Art. 16] - `fcm-mfr-hold-ceramics-test-documentation` (Manufacturer or processor responsible for placing on the market, product, ongoing) — For ceramics, hold the analysis results, test conditions and laboratory details demonstrating compliance with the lead and cadmium limits, and make them available to the authorities on request. [Art. 2a(2)] - `fcm-imp-keep-supporting-documentation` (Importer or seller responsible for placing on the market in the Union, product, ongoing) — Keep the supporting documentation for the declaration available for the competent authorities, and for ceramics hold the migration test results, test conditions and laboratory details yourself. [Art. 16(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(2)] - `fcm-imp-keep-traceability-records` (Importer or seller responsible for placing on the market in the Union, company, ongoing) — Keep traceability records identifying the businesses from which you sourced and to which you supplied materials, articles and substances, and hand them to the authorities on demand. [Art. 17(2)] - `fcm-dist-keep-systems-procedures` (Distributor, wholesaler or retailer, company, ongoing) — Keep systems and procedures to identify your suppliers and your business customers and make that information available to the competent authorities on demand. [Art. 17(2)] ## Penalties Member States lay down the rules on sanctions for infringements of the regulation and take all measures necessary to ensure they are implemented; the sanctions must be effective, proportionate and dissuasive. Member States enforce the regulation through official controls under the Union rules on official food and feed controls, and a Member State that has detailed grounds for concluding that a material endangers human health although it complies with a specific measure may temporarily suspend or restrict the provisions in question on its territory pending a Union decision. In Denmark, executive order nr. 681 of 25 May 2020 prohibits the marketing of non-compliant food contact materials and their use by food businesses, obliges the producer or importer to withdraw non-compliant materials, notify Fødevarestyrelsen and inform consumers, and punishes with a fine infringements of Articles 3, 4(1) and (3) to (6), 11(5), 15 and 17 of the regulation, Articles 4 to 7 of the GMP regulation, the epoxy, active-and-intelligent and plastics regulations, the former recycled-plastic regulation (EC) No 282/2008 and the former bisphenol A regulation (EU) 2018/213 (§§ 21 and 24 still cite those repealed acts; the order has not yet been updated to Regulations (EU) 2022/1616 and 2024/3190) and the national rules on PFAS in paper and board, lead and cadmium and the declaration of compliance; the penalty rises to imprisonment of up to two years where the infringement was intentional or grossly negligent and harmed or endangered health or sought an economic gain, and companies can be held criminally liable. ## Checklist 1. Confirm the product is a material or article intended for, already in or reasonably expected to come into contact with food in its finished state, and that it is not an antique, an edible covering or fixed water supply equipment (Article 1). 2. Assign each product to its Annex I material group and list the specific measures that apply: Regulation (EU) No 10/2011 for plastics, Regulation (EU) 2022/1616 for recycled plastic, Regulation (EC) No 450/2009 for active and intelligent materials, Directive 84/500/EEC for ceramics, Directive 2007/42/EC for regenerated cellulose, Regulation (EC) No 1895/2005 for epoxy derivatives and Regulation (EU) 2024/3190 for bisphenol A (Article 5). 3. Demonstrate the Article 3 general requirement with migration testing, modelling or other evidence, applying the positive lists and migration limits of the relevant specific measure and, for Denmark, the national lead, cadmium and PFAS rules. 4. Implement good manufacturing practice under Regulation (EC) No 2023/2006: a documented quality assurance system, a quality control system, records of specifications, formulae and processing, and set-off controls for printed materials. 5. Remove bisphenol A from adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings, and plan the transition around 20 July 2026 and 20 January 2028 (Regulation (EU) 2024/3190, Articles 3, 11 and 12). 6. Issue or obtain the written declaration of compliance with the content required by the specific measure, hold the supporting documentation, and renew the declaration when composition, process or science changes (Article 16; Regulation (EU) No 10/2011, Articles 15 and 16). 7. Label the product with the for-food-contact wording, use indication or glass-and-fork symbol, instructions for safe use, the responsible operator's name and address, traceability identification and, for active materials, the released substances, in the language of the market (Article 15). 8. Set up one-step-up, one-step-down traceability records for materials, articles and substances and be able to hand them to the authority on demand (Article 17). 9. In Denmark, register the manufacture, import or wholesale of food contact materials with Fødevarestyrelsen unless you stay at or below 1 000 units and DKK 50 000 a year, and keep a withdrawal and notification procedure ready (executive order nr. 681 of 25 May 2020, § 7). ## Questions ### When did Regulation (EC) No 1935/2004 start to apply? It entered into force on 3 December 2004, the twentieth day after publication in the Official Journal of 13 November 2004, and as a regulation it applies directly in all Member States without transposition. Materials and articles lawfully placed on the market before 3 December 2004 could be marketed until stocks were exhausted, and the traceability duties of Article 17 applied from 27 October 2006. The transparency amendment of Regulation (EU) 2019/1381 applies from 27 March 2021. ### Which products count as food contact materials? Any material or article, including active and intelligent ones, which in its finished state is intended to be brought into contact with food, is already in contact with food and was intended for that purpose, or can reasonably be expected to come into contact with food or transfer its constituents to food under normal or foreseeable use. Annex I names 17 material groups that may get specific measures: active and intelligent materials, adhesives, ceramics, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and board, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes and wood. Antiques, coverings that form part of the food and fixed water supply equipment are excluded. ### Do I need a declaration of compliance for every food contact material? Under the framework, a written declaration of compliance is mandatory where a specific measure requires it: the plastics regulation requires one at every stage other than retail, the ceramics directive up to and including retail, the bisphenol A regulation for the seven material groups it covers, and the active-and-intelligent regulation for those materials. Where no specific measure exists, Member States may keep national declaration rules, and Denmark requires a declaration of compliance for all food contact materials, with the background documentation available on request. In every case appropriate documentation demonstrating compliance must be available to the competent authorities on demand. ### When must the glass-and-fork symbol be used? Materials and articles not yet in contact with food must carry the words for food contact, a specific indication of use such as coffee machine, wine bottle or soup spoon, or the glass-and-fork symbol of Annex II, in a language easily understood by purchasers. The indication is not obligatory for articles that are clearly intended for food contact by their characteristics. The information must be conspicuous, clearly legible and indelible, and may only be used on materials that actually comply with the regulation and the applicable specific or national measures. ### Is bisphenol A banned in food packaging, and from when? Yes. Regulation (EU) 2024/3190, in force since 20 January 2025, prohibits the use of bisphenol A in the manufacture of adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact and the placing on the market of materials made with it, except for the applications listed in its Annex II, and it also bans other bisphenols with a harmonised classification as carcinogenic, mutagenic, toxic to reproduction or endocrine disrupting unless authorised. Single-use and repeat-use final articles made under the old rules may be first placed on the market until 20 July 2026; packaging for fruit, vegetables and fishery products, single-use articles coated with BPA only on the exterior metal surface and professional food production equipment get until 20 January 2028. Repeat-use articles may remain on the market until 20 July 2027 or, for professional equipment, 20 January 2029, as corrected by Regulation (EU) 2026/250. ### What does good manufacturing practice require for food contact materials? Regulation (EC) No 2023/2006, applicable since 1 August 2008, requires every business operator at every stage of manufacture, processing and distribution, except the production of starting substances, to run an effective and documented quality assurance system adapted to the size of the business, to select starting materials against specifications, to work to pre-established instructions, to maintain a quality control system that monitors GMP and corrects failures, and to keep documentation on specifications, formulae, processing and quality control results for the authorities. Its annex adds detailed rules for printing inks on the non-food-contact side: no transfer to the food-contact side through the substrate or by set-off, and no contact between printed surfaces and food. ### How is a new substance authorised for food contact materials? Where a specific measure contains a list of authorised substances, anyone seeking to add a substance applies to the competent authority of a Member State with a technical dossier following EFSA's guidelines; the authority acknowledges receipt within 14 days and informs EFSA, which makes the application public and delivers an opinion within six months, extendable by six months. The Commission then authorises the substance by adopting or amending a specific measure, and no substance is authorised unless it is adequately demonstrated that the final material meets Article 3 and, where relevant, Article 4. In Denmark the competent authority for food contact materials is Fødevarestyrelsen. ### Is the framework regulation being revised? Not yet in law. The Commission states that it is working towards revised EU legislation on food contact materials to address the challenges identified in its evaluation of the current rules, that it aims to consult stakeholders further and to develop an impact assessment and an eventual legislative proposal, but no proposal has been adopted, so Regulation (EC) No 1935/2004 as consolidated on 27 March 2021 remains the applicable law. ## What changed - 2028-01-20 (applies): **Extended bisphenol A transition ends** — Single-use articles preserving fruit, vegetables or fishery products, single-use articles with a BPA varnish or coating only on the exterior metal surface, and repeat-use professional food production equipment made with BPA may no longer be first placed on the market; single-use articles may be filled and sealed for a further 12 months and professional equipment may remain on the market until 20 January 2029. - 2026-09-16 (applies): **Regulation (EU) 2025/351 transition for plastics ends** — Plastic materials and articles complying with the plastics regulation as it stood before 16 March 2025 may be first placed on the market only until this date; those already placed on the market may be sold until stocks are exhausted. - 2026-09-11 (guidance): **Guide rewritten from the consolidated text and the specific measures** — The body was rewritten from the consolidated text of 27 March 2021, the GMP, plastics, recycled-plastic, bisphenol A, active-and-intelligent, epoxy, regenerated-cellulose and ceramics measures and the Danish executive order; the earlier text's vague timeline was replaced by sourced dates, the Danish registration, declaration and penalty rules were added, and the corrected bisphenol A transitional dates were included. - 2026-07-20 (applies): **General bisphenol A transition ends** — Single-use and repeat-use final food contact articles manufactured using BPA under the previous rules may no longer be first placed on the market, except the categories with the extended deadline of 20 January 2028; single-use articles may be filled and sealed for 12 months and repeat-use articles may remain on the market until 20 July 2027. - 2026-02-23 (amendment): **Regulations (EU) 2026/245 and 2026/250 in force** — Regulation (EU) 2026/245 of 2 February 2026 amends Annex I to the plastics regulation to authorise or change the conditions of use of several substances, and Regulation (EU) 2026/250 of the same date corrects the bisphenol A regulation: Article 3 now refers to BPA without its salts and covers placing on the market in the derogation, Article 11 refers to first placing on the market, and Article 12(3) sets 20 July 2027 for repeat-use articles under the general transition next to 20 January 2029 for professional equipment. - 2025-03-16 (amendment): **Regulation (EU) 2025/351 in force: plastics, recycled plastic and GMP updated** — The Commission regulation of 21 February 2025 amends the plastics regulation, replaces Article 4(2) of the recycled-plastic regulation (EU) 2022/1616 and amends the GMP annex on reprocessing of plastic by-products and quality control; plastics compliant with the previous rules may be first placed on the market until 16 September 2026, and from 16 December 2025 non-compliant intermediate products must say so in their declaration of compliance. - 2025-01-20 (amendment): **Regulation (EU) 2024/3190 in force: bisphenol A banned** — The Commission regulation of 19 December 2024, published on 31 December 2024, prohibits BPA in adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact, bans other hazardous bisphenols unless authorised, requires a declaration of compliance with the Annex III information, deletes BPA and bisphenol S from the plastics Union list and repeals Regulation (EU) 2018/213, with transitional periods to 20 July 2026 and 20 January 2028. - 2022-10-10 (amendment): **Regulation (EU) 2022/1616 on recycled plastic in force** — The Commission regulation of 15 September 2022 lays down the rules for placing on the market plastic food contact materials containing recycled plastic, for developing and operating recycling technologies, processes and installations, and for the use of recycled plastic in contact with food, replacing Regulation (EC) No 282/2008; Article 6(3)(c) and Article 13(2) apply from 10 October 2024. - 2021-03-27 (applies): **Transparency rules of Regulation (EU) 2019/1381 apply** — From this date EFSA makes authorisation applications, supporting information and its opinions public under Articles 38 to 39e of Regulation (EC) No 178/2002 and assesses confidentiality requests under the new Article 20; applications submitted before this date stay under the previous rules. - 2020-09-23 (amendment): **Regulation (EU) 2020/1245 amends and corrects the plastics regulation** — The Commission regulation of 2 September 2020 amends and corrects Regulation (EU) No 10/2011; plastics complying with the previous rules and first placed on the market before 23 March 2021 could be placed on the market until 23 September 2022 and remain on the market until stocks were exhausted. - 2020-07-01 (guidance): **Danish executive order nr. 681 of 25 May 2020 in force** — Fødevarestyrelsen's order on food contact materials and penalties for infringements of the related EU acts replaces order nr. 1248 of 30 October 2018: it bans PFAS in paper and board unless a functional barrier prevents migration, keeps national lead and cadmium limits for ceramics, enamelled articles and glassware, requires a declaration of compliance for all food contact materials and penalises infringements of the EU articles with fines and up to two years' imprisonment. - 2019-09-26 (amendment): **Regulation (EU) 2019/1381 in force: transparency of the EU risk assessment** — The regulation of 20 June 2019, published in OJ L 231 on 6 September 2019, replaces Article 9(1)(c) and 9(2), Article 19(1) and Article 20 on public access and confidentiality in the authorisation procedure; the amendments apply from 27 March 2021. - 2011-05-01 (applies): **Plastics regulation (EU) No 10/2011 applies** — The Commission regulation of 14 January 2011 establishes the specific requirements for plastic food contact materials: the Union list of authorised monomers, additives and other substances, specific and overall migration limits, the declaration of compliance and supporting documents; certain provisions applied from 31 December 2012 and 31 December 2015. - 2009-12-19 (applies): **Labelling and declaration rules for active and intelligent materials apply** — Regulation (EC) No 450/2009 of 29 May 2009, in force since 19 June 2009, applies its labelling, declaration-of-compliance and supporting-documentation provisions from this date; the composition rules of Article 4(e) and Article 5 apply from the date of application of the Union list. - 2009-08-07 (amendment): **Regulation (EC) No 596/2009 in force: comitology adaptation** — The regulation of 18 June 2009, published in OJ L 188 on 18 July 2009, adapts Articles 5, 11(3), 12(6), 22 and 23 so that specific measures, Union authorisations and Annex amendments are adopted under the regulatory procedure with scrutiny. - 2008-08-01 (applies): **Good manufacturing practice regulation applies** — Regulation (EC) No 2023/2006 of 22 December 2006 applies to all sectors and all stages of manufacture, processing and distribution of food contact materials, requiring a quality assurance system, a quality control system and documentation, with detailed rules for printing inks. - 2006-10-27 (applies): **Traceability duties of Article 17 apply** — From this date business operators must have systems and procedures to identify the businesses from which and to which materials, articles and substances were supplied and make the information available to the authorities on demand. - 2004-12-03 (in-force): **Regulation (EC) No 1935/2004 enters into force** — Adopted on 27 October 2004 and published in OJ L 338 on 13 November 2004, the regulation entered into force on the twentieth day after publication and repealed Directives 80/590/EEC and 89/109/EEC; materials lawfully placed on the market before this date could be marketed until stocks were exhausted. ## FCM in plain terms The Food Contact Materials Framework Regulation, formally Regulation (EC) No 1935/2004, is the EU's umbrella law for anything that touches food: packaging, bottles, cans, kitchen utensils, tableware, coatings, inks, adhesives and processing equipment. Its purpose is the functioning of the internal market for these materials while securing a high level of protection of human health and consumer interests (Art. 1(1)). It applies to materials and articles, including active and intelligent ones, which in their finished state are intended to be brought into contact with food, are already in contact with food and were intended for that purpose, or can reasonably be expected to come into contact with food or transfer their constituents to it under normal or foreseeable use (Art. 1(2)). As a regulation it has applied directly in every Member State since 3 December 2004, when it replaced Directives 80/590/EEC and 89/109/EEC (Art. 26 and Art. 28). It works in two layers: a general requirement, labelling, traceability and declaration rules that apply to every material, and specific measures that the Commission adopts for the 17 material groups in Annex I (Art. 5). Where no specific measure exists, Member States may keep or adopt national provisions (Art. 6). > **Official text** > Read the regulation on EUR-Lex: [Regulation (EC) No 1935/2004 (CELEX 32004R1935)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R1935), or the [consolidated text of 27 March 2021](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327) that includes the comitology adaptation of Regulation (EC) No 596/2009 and the transparency amendment of Regulation (EU) 2019/1381. ## Scope The regulation covers the finished material or article, not the raw chemical: a film, a jar, a lid, a conveyor belt or a coffee machine that is meant to meet food, is already in contact with it, or can reasonably be expected to be (Art. 1(2)). Three things are excluded: materials and articles supplied as antiques, covering or coating materials such as cheese rinds, prepared-meat coverings or fruit coatings that form part of the food and may be eaten with it, and fixed public or private water supply equipment (Art. 1(3)). Annex I lists the 17 groups of materials and articles that may be covered by specific measures: active and intelligent materials and articles, adhesives, ceramics, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and board, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes and wood (Annex I). Specific measures may also cover combinations of these materials and recycled materials used in their manufacture (Art. 5(1)). The duties fall on business operators, the natural or legal persons responsible for ensuring that the requirements are met within the business under their control, and a business is any undertaking at any stage of manufacture, processing and distribution (Art. 2(2)(c) and (d)). Placing on the market means holding materials for sale, offering them for sale or transferring them, whether free of charge or not (Art. 2(1)(b)). Active materials are those designed to extend shelf-life or maintain or improve the condition of packaged food by releasing or absorbing substances, and intelligent materials are those that monitor the condition of the food or its surroundings (Art. 2(2)(a) and (b)). ## What you must do ### The general requirement and good manufacturing practice Materials and articles must be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food or deteriorate its organoleptic characteristics, and their labelling, advertising and presentation must not mislead consumers (Art. 3). Good manufacturing practice is defined in Regulation (EC) No 2023/2006, which has applied since 1 August 2008 to all sectors and all stages of manufacture, processing and distribution, up to but excluding the production of starting substances (Regulation (EC) No 2023/2006, Art. 2 and Art. 8). Every business operator must run an effective and documented quality assurance system adapted to the size of the business, select starting materials against pre-established specifications, follow pre-established instructions, maintain a quality control system that monitors GMP and corrects failures without delay, and keep documentation on specifications, formulae, processing and quality control results available to the authorities (Regulation (EC) No 2023/2006, Art. 4 to Art. 7). Its annex adds detailed rules for printing inks applied to the non-food-contact side: no transfer to the food-contact side through the substrate or by set-off in the stack or reel, and no direct contact between printed surfaces and food (Regulation (EC) No 2023/2006, Annex). ### Active and intelligent materials Active materials may change the composition or organoleptic characteristics of food only in compliance with the Union or national provisions applicable to food, and the substances deliberately released are considered ingredients; active materials must not mask spoilage or otherwise mislead consumers, intelligent materials must not give misleading information about the condition of the food, and both must be labelled to identify non-edible parts and to indicate that they are active or intelligent (Art. 4). Regulation (EC) No 450/2009 lays down the specific requirements for their marketing, with the labelling and declaration provisions applying since 19 December 2009 (Regulation (EC) No 450/2009, Art. 1, Art. 2 and Art. 14). ### Specific measures per material For the Annex I groups the Commission adopts specific measures that may contain lists of authorised substances, purity standards, conditions of use, specific and overall migration limits, rules on oral contact, compliance checking, sampling and analysis, traceability, labelling and a public register (Art. 5(1)). The measures in force are: - **Plastics.** Regulation (EU) No 10/2011, applicable since 1 May 2011, covers materials consisting exclusively of plastics, plastic multi-layers, printed or coated plastics, plastic gaskets in caps and closures and plastic layers in multi-material multi-layers, but not ion-exchange resins, rubber or silicones; it sets the Union list of authorised substances, migration limits, a mandatory declaration of compliance at every stage other than retail and supporting documents for the authorities (Regulation (EU) No 10/2011, Art. 1, Art. 2, Art. 15, Art. 16 and Art. 23). The latest amendments are Regulation (EU) 2025/351, in force since 16 March 2025 with a transition for compliant plastics first placed on the market before 16 September 2026, and Regulation (EU) 2026/245, in force since 23 February 2026, which adds substances to Annex I (Regulation (EU) 2025/351, Art. 4 and Art. 5; Regulation (EU) 2026/245, Art. 1 and Art. 2). - **Recycled plastic.** Regulation (EU) 2022/1616, in force since 10 October 2022, governs plastic food contact materials containing plastic originating from waste, the recycling technologies, processes and installations, and the use of recycled plastic in contact with food, replacing Regulation (EC) No 282/2008 (Regulation (EU) 2022/1616, Art. 1 and Art. 33). - **Bisphenol A.** Regulation (EU) 2024/3190, in force since 20 January 2025, prohibits the use of BPA in the manufacture of adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings and the placing on the market of materials made with it, bans other hazardous bisphenols unless authorised, requires a declaration of compliance with the Annex III information and repeals Regulation (EU) 2018/213 (Regulation (EU) 2024/3190, Art. 1, Art. 3, Art. 5, Art. 8, Art. 13 and Art. 14). Articles made under the old rules may be first placed on the market until 20 July 2026, or until 20 January 2028 for packaging preserving fruit, vegetables or fishery products, single-use articles coated with BPA only on the exterior metal surface and professional food production equipment; repeat-use articles may remain on the market until 20 July 2027 or, for professional equipment, 20 January 2029, as corrected by Regulation (EU) 2026/250 (Regulation (EU) 2024/3190, Art. 11 and Art. 12; Regulation (EU) 2026/250, Art. 1). - **Epoxy derivatives.** Regulation (EC) No 1895/2005, applicable since 1 January 2006, limits the migration of BADGE, BFDGE and NOGE from plastics, surface coatings and adhesives, except heavy-duty coatings in tanks above 10 000 litres (Regulation (EC) No 1895/2005, Art. 1, Art. 2 and Art. 8). - **Ceramics.** Directive 84/500/EEC, as amended by Directive 2005/31/EC, limits the lead and cadmium released by ceramic articles to 0,8 mg/dm² and 0,07 mg/dm² for flat and shallow articles, 4,0 mg/l and 0,3 mg/l for other fillable articles and 1,5 mg/l and 0,1 mg/l for cookware and vessels above three litres, and requires a written declaration of compliance up to and including the retail stage (Directive 84/500/EEC, Art. 2(4) and Art. 2a). - **Regenerated cellulose film.** Directive 2007/42/EC, in force since 20 July 2007, lists the substances permitted in uncoated and cellulose-coated film and subjects plastic-coated film to the plastics rules; synthetic casings of regenerated cellulose are outside it (Directive 2007/42/EC, Art. 1, Art. 2 and Art. 8). ### Authorisation of substances Where a specific measure contains a list of authorised substances, a substance not yet listed needs an authorisation: the application goes to the competent authority of a Member State with a technical dossier following EFSA's guidelines, the authority acknowledges receipt within 14 days and passes the file to EFSA, which publishes the application and gives its opinion within six months, extendable by a further six months, and the Commission authorises the substance by adopting a specific measure (Art. 8 to Art. 11). No substance is authorised unless it is adequately demonstrated that the final material meets Article 3 and, where relevant, Article 4 (Art. 8(2)). Since 27 March 2021, under Regulation (EU) 2019/1381, EFSA makes the application, supporting information and its opinion public and assesses confidentiality requests, which may additionally cover starting substances, mixture composition, manufacturing methods, impurities, migration test results and trademarks (Art. 9, Art. 19 and Art. 20). Operators using an authorised substance must respect its conditions and immediately inform the Commission of new scientific or technical information affecting its safety (Art. 11(4) and (5)). ### Labelling Materials and articles not yet in contact with food must be accompanied by the words for food contact, a specific indication of use such as coffee machine, wine bottle or soup spoon, or the glass-and-fork symbol of Annex II; by special instructions for safe and appropriate use where necessary; by the name or trade name and address or registered office of the manufacturer, processor or seller responsible for placing on the market established in the Union; by labelling or identification ensuring traceability; and, for active materials, by information on the permitted uses and the substances released (Art. 15(1)). The for-food-contact indication is not obligatory for articles that are clearly intended for food contact by their characteristics (Art. 15(2)). The information must be conspicuous, clearly legible and indelible, retail trade is prohibited if the use, instruction and active-material information is not in a language easily understood by purchasers, and Member States may require their official languages (Art. 15(3) to (6)). At retail the information goes on the article, its packaging, a label or a nearby notice; at other stages it may go in the accompanying documents (Art. 15(7) and (8)). Only compliant materials may carry the for-food-contact information (Art. 15(9)). ### Declaration of compliance and traceability The specific measures require the materials they cover to be accompanied by a written declaration stating that they comply with the rules applicable to them, and appropriate documentation demonstrating compliance must be available to the competent authorities on demand; where no specific measure exists, Member States may keep national declaration rules (Art. 16). Traceability must be ensured at all stages to facilitate control, the recall of defective products, consumer information and the attribution of responsibility: business operators must have systems to identify the businesses from which and to which materials, articles and substances were supplied, hand that information to the authorities on demand, and make the materials identifiable by labelling or documentation (Art. 17). ### Obligations by role Every business operator carries the general requirement, GMP, traceability and, where a specific measure applies, the declaration and documentation duties (Art. 3, Art. 16 and Art. 17). The manufacturer, processor or seller responsible for placing on the market is the operator whose name and address appear on the material and who issues the declaration of compliance (Art. 15(1)(c) and Art. 16(1)). Importers are the sellers established in the Union responsible for placing materials from outside the Union on the market; the ceramics and plastics measures make them keep the supporting documentation available (Directive 84/500/EEC, Art. 2a(2); Regulation (EU) No 10/2011, Art. 16(1)). Distributors and retailers must respect the language rules, display the information at retail and keep their traceability records (Art. 15(4), Art. 15(7) and Art. 17(2)). ## Enforcement and penalties Member States enforce the regulation through official controls under the Union rules on official food and feed controls, with the EU reference laboratory for food contact materials and the national reference laboratories supporting the analytical work (Art. 24); Article 24(3) still cites Regulation (EC) No 882/2004, which Regulation (EU) 2017/625 repealed with effect from 14 December 2019; the reference is read as a reference to Regulation (EU) 2017/625 (its Article 146), which the bisphenol A regulation also cites for the selection of test methods (Article 9(1)). A Member State with detailed grounds for concluding that a material endangers health although it complies with a specific measure may temporarily suspend or restrict the provisions in question pending a Union decision (Art. 18). Sanctions are national and must be effective, proportionate and dissuasive (Art. 25). In Denmark, Fødevarestyrelsen (the Danish Veterinary and Food Administration) administers the rules: executive order nr. 681 of 25 May 2020 on food contact materials was issued by Fødevarestyrelsen under the Danish food act (lov om fødevarer, sections 25, 25 a, 49 and 60) and has been in force since 1 July 2020 (§ 25); it makes Fødevarestyrelsen the authority to be notified of withdrawals (§ 7), and businesses that manufacture, import or wholesale food contact materials must register with it. The order prohibits the marketing of non-compliant materials and their use by food businesses (§ 6), obliges the producer or importer to withdraw non-compliant materials, notify Fødevarestyrelsen immediately and inform consumers (§ 7), bans PFAS in paper and board unless a functional barrier prevents migration (§ 8), sets lead and cadmium limits for ceramics, enamelled articles and glassware (§ 14) and requires a declaration of compliance for every food contact material, which may be published on the producer's or importer's website (§ 15). Infringements of Articles 3, 4, 11(5), 15 and 17 of the regulation, of Articles 4 to 7 of the GMP regulation, the epoxy, active-and-intelligent and plastics regulations, the former recycled-plastic regulation (EC) No 282/2008 and the former bisphenol A regulation (EU) 2018/213 (§§ 21 and 24 still cite those repealed acts; the order has not yet been updated to Regulations (EU) 2022/1616 and 2024/3190) and of the national rules on PFAS in paper and board, lead and cadmium and the declaration of compliance are punished with fines, rising to imprisonment of up to two years where the infringement was intentional or grossly negligent and harmed or endangered health or sought an economic gain, and companies can be held liable (§§ 17 to 24). The registration duty does not apply where the activity stays at or below 1 000 units and DKK 50 000 a year (Fødevarestyrelsen, registrering). Denmark notified a draft replacement order with lower lead and cadmium limits to the Commission on 17 July 2025 (TRIS 2025/0387/DK); until it is adopted and published, order nr. 681 of 25 May 2020 remains the applicable Danish law. ## What is changing The Commission states that it is working towards revised EU legislation on food contact materials to address the challenges identified in its evaluation of the current rules, with further stakeholder consultation and an impact assessment before an eventual legislative proposal; no proposal has been adopted (European Commission, revision of EU rules). The moving parts today are the specific measures: the bisphenol A transition ends on 20 July 2026 and 20 January 2028, the Regulation (EU) 2025/351 transition for plastics ends on 16 September 2026, and the plastics Union list is amended regularly, most recently by Regulation (EU) 2026/245. ## How Conphora helps Conphora monitors the framework regulation and the specific measures beneath it, maps your products to the right Annex I group and measure, and flags gaps in the declaration of compliance, GMP documentation, labelling and traceability before they become enforcement problems. The platform helps you build and keep the declarations and supporting documentation, tracks the bisphenol A and plastics transition dates, and alerts you when a Union list or a Danish order changes. [See how Conphora works](/how-it-works) · [See plans and pricing](/pricing) ## Sources - [Regulation (EC) No 1935/2004 on food contact materials, consolidated text of 27 March 2021 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327) - [Regulation (EC) No 1935/2004 as published in OJ L 338, 13 November 2004 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R1935) - [Document information, dates and relationships for CELEX 32004R1935 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32004R1935) - [Regulation (EC) No 596/2009 adapting instruments to the regulatory procedure with scrutiny, Part Four (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R0596) - [Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1381) - [Commission Regulation (EC) No 2023/2006 on good manufacturing practice (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023) - [Commission Regulation (EU) No 10/2011 on plastic materials and articles, consolidated text of 14 July 2026 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R0010-20260714) - [Commission Regulation (EU) 2024/3190 on bisphenol A and other bisphenols (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R3190) - [Commission Regulation (EU) 2026/250 correcting Regulation (EU) 2024/3190 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0250) - [Commission Regulation (EU) 2022/1616 on recycled plastic materials and articles (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R1616) - [Commission Regulation (EU) 2025/351 amending the plastics, recycled-plastic and GMP regulations (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0351) - [Commission Regulation (EU) 2026/245 amending Annex I to the plastics regulation (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0245) - [Commission Regulation (EU) 2020/1245 amending and correcting the plastics regulation (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R1245) - [Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R0450) - [Commission Regulation (EC) No 1895/2005 on epoxy derivatives (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005R1895) - [Commission Directive 2007/42/EC on regenerated cellulose film (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32007L0042) - [Council Directive 84/500/EEC on ceramic articles, consolidated text of 20 May 2005 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520) - [Food contact materials (European Commission, DG SANTE)](https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials_en) - [Food contact materials: legislation (European Commission, DG SANTE)](https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/legislation_en) - [Revision of EU rules on food contact materials (European Commission, DG SANTE)](https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/revision-eu-rules_en) - [TRIS notification 2025/0387/DK, draft Danish order on food contact materials (European Commission)](https://technical-regulation-information-system.ec.europa.eu/en/notification/27084) - [Bekendtgørelse nr. 681 af 25. maj 2020 om fødevarekontaktmaterialer (Retsinformation)](https://www.retsinformation.dk/eli/lta/2020/681) - [Fødevarekontaktmaterialer, lovstof (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/lovstof/foedevarekontaktmaterialer-lovstof) - [Registrering af FKM-virksomheder (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/registrering) - [Dokumentation for fødevarekontaktmaterialer (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/dokumentation) - [Mærkning af fødevarekontaktmaterialer (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/maerkning) *This guide is for general information and is not legal advice.* ## Sources - [Regulation (EC) No 1935/2004 on food contact materials, consolidated text of 27 March 2021 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327) - [Regulation (EC) No 1935/2004 as published in OJ L 338, 13 November 2004 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R1935) - [Document information, dates and relationships for CELEX 32004R1935 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32004R1935) - [Regulation (EC) No 596/2009 adapting instruments to the regulatory procedure with scrutiny, Part Four (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R0596) - [Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1381) - [Commission Regulation (EC) No 2023/2006 on good manufacturing practice for food contact materials (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023) - [Commission Regulation (EU) No 10/2011 on plastic materials and articles, consolidated text of 14 July 2026 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R0010-20260714) - [Commission Regulation (EU) 2024/3190 on bisphenol A and other bisphenols in food contact materials (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R3190) - [Commission Regulation (EU) 2026/250 correcting Regulation (EU) 2024/3190 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0250) - [Commission Regulation (EU) 2022/1616 on recycled plastic materials and articles (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R1616) - [Commission Regulation (EU) 2025/351 amending the plastics, recycled-plastic and GMP regulations (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0351) - [Commission Regulation (EU) 2026/245 amending Annex I to the plastics regulation (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0245) - [Commission Regulation (EU) 2020/1245 amending and correcting the plastics regulation (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R1245) - [Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R0450) - [Commission Regulation (EC) No 1895/2005 on epoxy derivatives in food contact materials (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005R1895) - [Commission Directive 2007/42/EC on regenerated cellulose film (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32007L0042) - [Council Directive 84/500/EEC on ceramic articles, consolidated text of 20 May 2005 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520) - [Food contact materials (European Commission, DG SANTE)](https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials_en) - [Food contact materials: legislation (European Commission, DG SANTE)](https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/legislation_en) - [Revision of EU rules on food contact materials (European Commission, DG SANTE)](https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/revision-eu-rules_en) - [TRIS notification 2025/0387/DK, draft Danish order on food contact materials with lower lead and cadmium limits (European Commission)](https://technical-regulation-information-system.ec.europa.eu/en/notification/27084) - [Bekendtgørelse nr. 681 af 25. maj 2020 om fødevarekontaktmaterialer og om straffebestemmelser for overtrædelse af relaterede EU-retsakter (Retsinformation)](https://www.retsinformation.dk/eli/lta/2020/681) - [Fødevarekontaktmaterialer, lovstof (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/lovstof/foedevarekontaktmaterialer-lovstof) - [Registrering af FKM-virksomheder (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/registrering) - [Dokumentation for fødevarekontaktmaterialer (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/dokumentation) - [Mærkning af fødevarekontaktmaterialer (Fødevarestyrelsen)](https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/maerkning) _Reviewed 2026-09-24 by Conphora compliance team_