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PIM Food & Cosmetics 13 min Changing in the next 12 months

PIM: Plastics Regulation (Regulation (EU) No 10/2011), explained

The Plastics Regulation limits plastic food-contact materials to Union-listed substances within migration limits and requires every business operator except retailers to pass on a written declaration of compliance. It has applied since 1 May 2011; the consolidated version of 14 July 2026 carries the bisphenol A ban and the 2025 revision, whose transition ends on 16 September 2026.

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Reviewed 24 September 2026 by Conphora compliance team · Next review 13 March 2027 · Not legal advice

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Who it applies to

Covered by the act

  • Materials and articles, and parts of them, consisting exclusively of plastics, placed on the EU market and intended to come into contact with food, already in contact with food, or which can reasonably be expected to come into contact with food
  • Plastic multi-layer materials and articles held together by adhesives or by other means, and materials and articles of either kind that are printed and/or covered by a coating
  • Plastic layers or plastic coatings that form gaskets in caps and closures, where the cap or closure is made up of two or more layers of different types of material
  • Plastic layers in multi-material multi-layer materials and articles, such as the plastic layers of a beverage carton or a coated metal or paper laminate
  • The substances used to make them: monomers and other starting substances, additives, polymer production aids and macromolecules obtained from microbial fermentation, plus the products from intermediate stages of manufacture
  • The business operators along the chain, from substance and intermediate suppliers through manufacturers, importers and distributors, each of whom must issue or pass on the written declaration of compliance at every marketing stage other than retail

Derived and downstream products

  • Ion exchange resins, rubber and silicones are excluded from the regulation because they are intended to be covered by other specific measures, and the regulation is without prejudice to Union or national provisions on the substances used to make adhesives, coatings and printing inks applied on or incorporated in plastic materials and articles, even though a printed or coated plastic article is itself in scope (Art. 2(1)(c), Art. 2(2) and Art. 2(3))
  • Plastic materials and articles may only be placed on the market if they also satisfy Article 3 of Regulation (EC) No 1935/2004 on safety, Article 15 on labelling and Article 17 on traceability, are manufactured under the good manufacturing practice of Regulation (EC) No 2023/2006, meet Chapters II, III and IV of this regulation and, where they fall within its scope, Regulation (EU) 2022/1616 on recycled plastic (Art. 4)
  • Only substances on the Union list in Annex I may be used, but Article 6 carves out polymer production aids, colorants and solvents subject to national law, salts of listed acids, phenols and alcohols within the Annex II limits, mixtures of authorised substances, polymeric additives and pre-polymers, non-intentionally added substances, aids to polymerisation and certain product-type 4 biocides, and Article 19 requires a risk assessment on internationally recognised scientific principles for those substances (Art. 5, Art. 6 and Art. 19)
  • A plastic layer that is not in direct contact with food and is separated from it by a functional barrier may be made with substances not on the Union list, provided they do not migrate above the detection limit, are not classified as mutagenic, carcinogenic or toxic to reproduction under Regulation (EC) No 1272/2008 and are not in nanoform; the vinyl chloride monomer restriction always applies and the final article must still meet the overall and specific migration limits (Art. 13 and Art. 14)
  • Substances in nanoform may only be used if they are explicitly authorised and mentioned in the specifications in Annex I (Art. 9(2))
  • Since 20 January 2025 bisphenol A and other hazardous bisphenols and bisphenol derivatives may only be used in plastic food contact materials in accordance with Regulation (EU) 2024/3190, whose Annex II leaves just two applications: liquid epoxy resins on self-supporting articles above 1 000 litres, and polysulfone filtration membrane assemblies, both with no detectable migration and mandatory cleaning and flushing before first food contact (Art. 6(6); Regulation (EU) 2024/3190, Art. 3 and Annex II)
  • Article 12(2) sets a separate overall migration limit of 60 mg per kg of food simulant for materials intended to contact food for infants and young children and still names Commission Directives 2006/141/EC and 2006/125/EC. Directive 2006/141/EC was repealed by Article 20(4) of Regulation (EU) No 609/2013 read with Article 21 of Delegated Regulation (EU) 2016/127, with effect from 22 February 2020, and it continued to apply only until 21 February 2022 to infant formula and follow-on formula manufactured from protein hydrolysates; infant formula and follow-on formula are now defined by Delegated Regulation (EU) 2016/127. Directive 2006/125/EC on processed cereal-based foods and baby foods remains in force, because the delegated act that will replace it under Article 11(1) of Regulation (EU) No 609/2013 has not been adopted. Article 17(2), as amended in 2025, already refers to Regulation (EU) No 609/2013, so the Article 12(2) cross-reference is read against the successor acts
  • The regulation imposes no company-size threshold: a micro business making food contact plastic carries the same compositional, migration and documentation duties as a multinational, and only the voluntary reporting on alternatives to bisphenols under Regulation (EU) 2024/3190 is lighter for micro, small and medium-sized enterprises

Roles under the act

Manufacturer of plastic materials, articles and intermediate products

Business operator that manufactures plastic materials and articles intended to come into contact with food, or products from intermediate stages of their manufacture such as resins, compounds, masterbatches, sheet and film. It issues the written declaration of compliance, must keep the documentation demonstrating compliance including documentation on the degree of purity and composition of the substances used, and must let competent authorities take samples during official controls.

Source · Art. 15(1), Art. 15(2), Art. 16(1), Art. 16(3) and Art. 16(4)
Supplier of substances and starting materials

Business operator that supplies the substances intended for the manufacture of plastic food contact materials, that is the monomers and other starting substances, additives, polymer production aids and macromolecules obtained from microbial fermentation. A written declaration of compliance must be available for those substances as well, and the composition of the substance must be known to its manufacturer.

Source · Art. 5(2), Art. 8(1), Art. 15(1) and Art. 16(1)
Importer

Business that brings plastic food contact materials, articles, intermediate products or substances into the Union market from a third country. In Denmark the importer carries the same duty as the producer to withdraw material that fails the food safety requirements, notify Fødevarestyrelsen immediately and inform consumers, and must register the import of food contact materials with Fødevarestyrelsen unless the activity stays at or below 1 000 units and a turnover of DKK 50 000 a year.

Source · § 7Source
Distributor, wholesaler or retailer

Business that makes plastic food contact materials available on the market without manufacturing or importing them. The written declaration of compliance must be available at every marketing stage other than the retail stage, and in Denmark wholesale of food contact materials must be registered with Fødevarestyrelsen unless the activity stays at or below 1 000 units and a turnover of DKK 50 000 a year.

Source · Art. 15(1)Source · § 15Source
Food business using plastic food contact materials

Food business that uses plastic materials and articles when handling food. The Plastics Regulation does not address it: it is not an addressee of the Union list, the migration limits or the declaration duty. The Danish duty is narrower than the role: under executive order nr. 681 of 25 May 2020 a business that imports, manufactures and/or packs food may not use food contact materials that fail the general requirements of Regulation (EC) No 1935/2004 and the rules made under it, and must make sure it uses them only for the purposes for which they are intended. Other food businesses are reached through the general safety and own-check rules rather than through this provision.

Source · § 6, stk. 2Source

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Does PIM apply to your product?

Three questions, a first answer from the regulation’s own scope rules. No account needed.

The rules behind this check
  1. Ion exchange resins used in food production, such as water and juice treatment resins, Rubber and elastomer food contact materials, such as rubber seals, hoses and teats, Silicone food contact materials, such as baking moulds, spatulas, tubing and gaskets · any · any Not in scope Article 2(2) excludes ion exchange resins, rubber and silicones from the Plastics Regulation because they are intended to be covered by other specific measures. They remain fully subject to the framework Regulation (EC) No 1935/2004, to good manufacturing practice under Regulation (EC) No 2023/2006 and, since 20 January 2025, to the bisphenol A prohibition of Regulation (EU) 2024/3190, which lists rubbers, ion-exchange resins and silicones among the material groups it covers, and in Denmark to executive order nr. 681 of 25 May 2020. Source · Art. 2(2)Source · Art. 1(2)Source · § 1 and § 6
  2. Adhesives, coatings, varnishes and printing inks as such, applied on or incorporated in a plastic material or article · any · any It depends A plastic material or article that is printed and/or covered by a coating is itself within scope under Article 2(1)(c), and the finished article must meet the overall and specific migration limits. The substances used to make the adhesive, coating or printing ink are not regulated by this regulation: Article 2(3), as replaced in 2025, states that the regulation is without prejudice to Union or national provisions applicable to those substances, and the good manufacturing practice regulation adds rules for printing inks applied to the non-food-contact side. Since 20 January 2025 adhesives, printing inks and varnishes and coatings are within the scope of the bisphenol A regulation in their own right. Source · Art. 2(1)(c) and Art. 2(3)Source · Annex, section ASource · Art. 1(2)
  3. Food contact materials manufactured using bisphenol A, another hazardous bisphenol or a hazardous bisphenol derivative · any · any It depends Since 20 January 2025 the use of bisphenol A and its salts, and of other bisphenols and bisphenol derivatives classified as category 1A or 1B mutagenic, carcinogenic or toxic to reproduction or category 1 endocrine disrupting, is prohibited in the manufacture of food contact materials, as is placing such materials on the market; only the two applications in Annex II to Regulation (EU) 2024/3190 remain, both with no detectable migration. Material made under the earlier rules could be placed on the market until 20 July 2026, until 20 January 2028 for single-use articles preserving fruit, vegetables or fishery products, for articles whose BPA coating is only on the exterior metal surface and for repeat-use professional food production equipment, and repeat-use articles first placed on the market under those transitions may remain on the market until 20 January 2029. Single-use articles placed on the market under those transitions may still be filled with food and sealed for 12 months after the applicable transitional period expires, and the packaged food may be placed on the market until stocks are exhausted. The transitions cover final food contact articles only: intermediate food contact materials, which are intended to undergo further processing before they become part of a final article, have no transitional period at all. A material made with another bisphenol must contain no residual BPA at all. Source · Art. 3, Art. 4, Art. 5, Art. 11, Art. 12 and Annex II
  4. any · Food business using plastic food contact materials · any It depends A food business is not an addressee of the Union list, the migration limits or the declaration duty, but it may only use compliant material. In Denmark a business that imports, manufactures or packs food may not use food contact materials that fail the general requirements and must use them only for their intended purpose, and Fødevarestyrelsen expects the food business to obtain the declaration of compliance from its supplier as part of its own-check system and to respect the conditions of use it states, such as the food types, the contact time and temperature and the surface-to-volume ratio for which compliance was verified. Source · § 6, stk. 2 and § 15SourceSource · Annex IV, point 8
  5. Materials and articles made exclusively of plastic, such as film, trays, pots, bottles, crates, tubing, kitchenware and food processing parts, Plastic multi-layer materials and articles, where two or more plastic layers are held together by adhesives or other means, Plastic materials and articles that are printed and/or covered by a coating or varnish, Plastic layers or plastic coatings forming gaskets in caps and closures on jars, bottles and cans, Final plastic food contact articles intended for repeated use, such as reusable containers, bottles, tableware and processing equipment parts · Manufacturer of plastic materials, articles and intermediate products, Supplier of substances and starting materials, Importer, Distributor, wholesaler or retailer · any In scope These are the core categories of Article 2(1). The material may only be made from substances on the Union list in Annex I or covered by an Article 6 derogation, must be of a high degree of purity, must meet the Annex I restrictions and specifications, the Annex II limits for the 24 listed elements and ammonium and the primary aromatic amines rule, must not exceed any specific migration limit or the overall migration limit of 10 mg per square decimetre, and must be manufactured under good manufacturing practice. A written declaration of compliance with the Annex IV information must be available at every marketing stage other than retail, backed by supporting documentation. Repeat-use articles must additionally be designed so that migration does not increase over successive use cycles and must carry instructions, a description of observable deterioration and, where relevant, a warning. There is no company-size threshold. Source · Art. 2(1), Art. 4, Art. 5, Art. 8, Art. 9, Art. 10, Art. 11, Art. 12, Art. 14a, Art. 15, Art. 16 and Annexes I, II and IV
  6. Plastic layers inside multi-material multi-layer materials, such as beverage cartons, coated board and plastic-coated metal or aluminium laminates · Manufacturer of plastic materials, articles and intermediate products, Supplier of substances and starting materials, Importer, Distributor, wholesaler or retailer · any It depends The composition of each plastic layer of a multi-material multi-layer material must comply with the regulation, and the plastic layers must always meet the vinyl chloride monomer restriction in Annex I. A plastic layer not in direct contact with food and separated from it by a functional barrier may be made with substances not on the Union list, provided they do not migrate detectably, are not classified as mutagenic, carcinogenic or toxic to reproduction and are not in nanoform. Since the 2025 revision the specific and overall migration limits of Articles 11 and 12 apply to the whole article when the surface layer in contact with food is a material within the scope of this regulation; where that surface layer is not, national law may set the limits instead, and the declaration of compliance must confirm compliance with the functional barrier provisions. Source · Art. 2(1)(e), Art. 14(1) to Art. 14(6) and Annex IV, point 9
  7. Plastic materials and articles containing recycled plastic from a recycling process under Regulation (EU) 2022/1616 · Manufacturer of plastic materials, articles and intermediate products, Supplier of substances and starting materials, Importer, Distributor, wholesaler or retailer · any In scope Plastic materials and articles that fall within the scope of Regulation (EU) 2022/1616 on recycled plastic must comply with it as well, under Article 4(f) added in 2025. In the other direction, Article 4(2) of Regulation (EU) 2022/1616, as replaced by Regulation (EU) 2025/351, applies Chapters II and III and Chapter V of the Plastics Regulation to recycled plastic materials and articles, with the single exception that Article 8(1) does not apply to contaminants in the input and output of decontamination processes, whose quality and purity are governed by the recycled-plastic regulation instead. Source · Art. 4(f)Source · Art. 2
  8. Plastic containing reprocessed off-cuts, scraps and similar by-products from your own or another manufacturing operation · Manufacturer of plastic materials, articles and intermediate products, Supplier of substances and starting materials · any In scope Since the 2025 revision plastic materials and articles may contain reprocessed plastic only if it is a by-product within the meaning of Article 5 of Directive 2008/98/EC, is collected and used in accordance with section C of the Annex to the good manufacturing practice regulation, originates from off-cuts and scraps that themselves meet Chapter II or whose constituents have been risk-assessed under Article 19, contains no functional barrier layer, and does not carry substances in amounts that would exceed a migration limit or otherwise breach Article 3 of Regulation (EC) No 1935/2004. A batch of material intended for reprocessing must be accompanied by a declaration confirming compliance with Article 10(1) and 10(2) and, as appropriate, its composition and reprocessing instructions. Source · Art. 3, point (20), Art. 10(2) and Annex IV, point 10Source · Annex II, point 3
  9. any · any · any It depends Whether the regulation applies turns on whether the material is a plastic within the meaning of Article 3, which of the five categories of Article 2(1) it falls into, whether it is one of the three excluded material groups, whether a functional barrier separates the layer from the food, and which role in the chain you hold. Company size never changes the answer. Source · Art. 1, Art. 2, Art. 3 and Art. 4

Key dates

  1. Regulation (EU) No 10/2011 enters into force, on the twentieth day after its publication in OJ L 12 of 15 January 2011 Source · Art. 23
  2. The regulation applies; Directives 80/766/EEC, 81/432/EEC and 2002/72/EC are repealed and references to them are read against the correlation tables in Annex VI; materials and articles lawfully placed on the market before this date could still be placed on the market until 31 December 2012 Source · Art. 21, Art. 22(5) and Art. 23
  3. The prohibition on bisphenol A in polycarbonate infant feeding bottles introduced by Implementing Regulation (EU) No 321/2011 applies to placing on the market and importation into the Union, after applying to manufacture from 1 May 2011 Source · Art. 1 and Art. 2
  4. Article 5 starts to apply to additives other than plasticisers in the plastic layers and coatings of caps and closures, and to additives used in glass fibre sizing for glass-fibre-reinforced plastics; until this date the glass fibre sizing additives not listed in Annex I had to comply with the risk assessment provisions of Article 19 Source · Art. 22(4) and Art. 23
  5. The supporting documents required by Article 16 must be based on the migration testing rules of Article 18, ending the option of relying on the basic rules in the Annex to Directive 82/711/EEC Source · Art. 22(2) and Art. 22(3)
  6. Regulation (EU) 2020/1245 in force: the derogation in Article 6(3)(a) is rewritten to cover all salts of the substances marked in Table 1 of Annex II, Annex II is restructured as a single list of migration limits for 24 elements and ammonium including the four lanthanides, and Annexes I, IV and V are amended Source · Art. 1 and Art. 3
  7. End of the transition under Regulation (EU) 2020/1245: materials and articles first placed on the market before 23 March 2021 under the earlier rules could be placed on the market until this date and remain on the market until stocks are exhausted Source · Art. 2
  8. Regulation (EU) 2023/1442 in force: new total specific migration limits for the phthalates, the authorisations of untreated wood flour and fibres (FCM No 96) and salicylic acid (FCM No 121) revoked, and several new substances authorised Source · Art. 1 and Art. 3
  9. Regulation (EU) 2023/1627 in force, authorising bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH, FCM No 1079) as a plasticiser in PVC in contact with foods assigned simulants A and B at room temperature or below Source · Art. 1, Art. 2 and Annex
  10. Regulation (EU) 2024/3190 applies: bisphenol A and hazardous bisphenols and bisphenol derivatives are prohibited in food contact materials, the entries for FCM No 151 and FCM No 154 are deleted from Table 1 of Annex I, Article 6(6) is added to the Plastics Regulation and Regulation (EU) 2018/213 is repealed Source · Art. 3, Art. 10, Art. 13 and Art. 14
  11. End of the transition under Regulation (EU) 2023/1442: plastic materials and articles first placed on the market before this date under the earlier rules may remain on the market until stocks are exhausted, while salicylic acid and untreated wood flour or fibres may continue only under a valid application filed before 1 August 2024 Source · Art. 2
  12. Regulation (EU) 2025/351 in force: the definitions of additive, reprocessing of plastic and UVCB substance, the new Article 3a on a high degree of purity, the rewritten Articles 8, 10 and 16, the new labelling Article 14a and the alignment with the recycled-plastic and good-manufacturing-practice regulations start to apply Source · Art. 1, Art. 2, Art. 3 and Art. 5
  13. From this date the declaration of compliance of an intermediate product or substance that complies with the earlier rules but not with Regulation (EU) 2025/351 must say so, and must state that it may only be used for plastic materials and articles placed on the market before 16 September 2026 Source · Art. 4(2)
  14. Regulation (EU) 2026/245 in force, authorising six further additives and monomers in Annex I and renaming FCM No 768 Source · Art. 1, Art. 2 and Annex
  15. Regulation (EU) 2026/1380 in force, correcting the Estonian language version of Article 8(1); the other language versions, including English, are not affected. This is the date of the current consolidated text Source · recital 2, Art. 1 and Art. 2
  16. End of the main bisphenol A transition: single-use final food contact articles made with BPA under the earlier rules may no longer be placed on the market, and repeat-use final articles may no longer be first placed on the market, after this date Source · Art. 11(1) and Art. 12(1)
  17. End of the transition under Regulation (EU) 2025/351: plastic materials and articles first placed on the market before this date under the earlier rules may continue to be placed on the market until stocks are exhausted; everything first placed on the market later must meet the 2025 text Source · Art. 4(1)
  18. End of the extended bisphenol A transition for single-use articles preserving fruit, vegetables or fishery products and for articles whose BPA varnish or coating is only on the exterior metal surface, and for repeat-use articles used as professional food production equipment Source · Art. 11(2) and Art. 12(2)
  19. Last date on which repeat-use final food contact articles made with bisphenol A and first placed on the market under the transitional provisions may remain on the market Source · Art. 12(3)

What you must do

Obligations by role

Manufacturer of plastic materials, articles and intermediate products9
  • Use only substances included in the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids in Table 1 of Annex I, or substances covered by an Article 6 derogation, and use a substance in nanoform only where Annex I explicitly authorises it and says so in the specifications. Art. 5(1), Art. 6 and Art. 9(2)
  • Ensure every substance that may be present in the final plastic is of a high degree of purity and of a technical quality suitable for the intended and foreseeable use, with its composition known to the substance manufacturer; a substance qualifies as pure where its constituents correspond to its identity and any non-intentionally added substances meet one of the four conditions of Article 3a, the strictest of which is a foreseeable migration at or below 0,00015 mg/kg food. Art. 3a and Art. 8
  • Respect the restrictions and specifications in column 10 of Table 1 of Annex I, the group restrictions of Table 2, the detailed specifications of point 4 of Annex I and the Annex II limits: the migration limits for the 24 listed elements and ammonium, from aluminium at 1 mg/kg and nickel at 0,02 mg/kg to lead, mercury and arsenic, which must not be detectable, and the rule that primary aromatic amines without their own limit must not be detectable at 0,002 mg/kg each, with the sum of unlisted ones not exceeding 0,01 mg/kg. Art. 9(1), Art. 10(1) and Annex II, points 1 and 2
  • Keep the finished material within the overall migration limit of 10 mg of total constituents released per square decimetre of food contact surface, or 60 mg per kg of food simulant for material intended for food for infants and young children, and within every applicable specific migration limit, expressed in mg per kg of food using the real surface-to-volume ratio in actual or foreseen use and the derogations of Article 17 for small, very large or awkwardly shaped articles and for closures. Art. 11, Art. 12 and Art. 17
  • Demonstrate compliance by migration testing under Article 18: food simulants A, B, C, D1, D2 and E assigned to the food categories in Annex III, the test time and temperature selected from Tables 1 and 2 of Chapter 2 of Annex V for specific migration, one of the eight standardised tests OM0 to OM7 for overall migration, ten days at 60 degrees Celsius for long-term storage at room temperature or below, and an analytical method meeting Article 34 of Regulation (EU) 2017/625; results in food prevail over results in simulant, which prevail over screening results. Art. 18, Annex III and Annex V, Chapters 2 and 3
  • Manufacture under the good manufacturing practice of Regulation (EC) No 2023/2006 with a documented quality assurance system, a quality control system and documentation of specifications, formulae, processing and quality control results; if you reprocess off-cuts and scraps, meet the Article 10(2) conditions and the separate collection, containment, batch and traceability rules of section C of its Annex. Art. 4, Art. 5, Art. 6 and Art. 7Art. 4(d) and Art. 10(2)
  • Issue a written declaration of compliance at every marketing stage other than retail with the eleven items of Annex IV, including the identity of the issuer and of the manufacturer or importer, the identity of the material, the date, the confirmation of compliance with this regulation and with Articles 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004, the information downstream users need on restricted substances and non-intentionally added substances, the specifications of use covering food types, time and temperature and the highest surface-to-volume ratio verified, and the functional barrier, reprocessing and waste-derived substance confirmations; renew it when the composition or production changes materially or new scientific data appears. Art. 15 and Annex IV
  • Keep the supporting documentation demonstrating compliance, including test conditions and results, calculations, modelling, other analyses and the reasoning, and documentation on the composition and purity of the substances used, available to the competent authorities on request, and allow them to take samples during official controls. Art. 16(1) to Art. 16(4)
  • For repeat-use articles, supply users with instructions that slow deterioration, a description of observable changes and a warning where damage or foreseeable misuse would increase migration; give consumers instructions of use where Annex I restricts the food types, contact conditions or heating. Art. 14a
Supplier of substances and starting materials5
  • Make a written declaration of compliance available for the substances intended for the manufacture of plastic food contact materials and for products from intermediate stages of manufacture, at every marketing stage other than retail, containing the Annex IV information and allowing easy identification of what it covers. Art. 15(1) to Art. 15(3) and Annex IV
  • At intermediate stages, state in the declaration the identification and amount of the substances contained in the intermediate material that are subject to restrictions or specifications in Annex II, and of substances for which genotoxicity has not been ruled out that originate from an intentional use and could foreseeably give rise to an individual migration above 0,00015 mg/kg food from the final article. Annex IV, point 6
  • Know the composition of the substance you supply, keep it to a high degree of purity and of a technical quality suitable for the intended and foreseeable use, and make the documentation on composition and degree of purity available to the competent authorities on request; a UVCB substance named after a natural multi-constituent material may be supplied as obtained from its natural origin only if it contains nothing outside that identity and meets any Annex I specification. Art. 8(1), Art. 8(2) and Art. 16(1)
  • Where an intermediate product or substance first placed on the market after 16 December 2025 complies with the earlier text but not with Regulation (EU) 2025/351, say so in its declaration of compliance and state that it may only be used to make plastic materials and articles placed on the market before 16 September 2026. Art. 4(2)
  • For bisphenols and bisphenol derivatives intended to be used as monomers or other starting substances, supply the separate declaration of compliance required by the bisphenol A regulation, listing every bisphenol or bisphenol derivative used and confirming compliance with that regulation and with Articles 3, 15 and 17 of Regulation (EC) No 1935/2004. Art. 8 and Annex III
Importer8
  • Place plastic food contact materials on the Union market only if they satisfy Article 3 of Regulation (EC) No 1935/2004, the labelling and traceability articles, good manufacturing practice and Chapters II, III and IV of the Plastics Regulation, and if they fall within its scope, Regulation (EU) 2022/1616 on recycled plastic; imported material is judged by exactly the same rules as material made in the Union. Art. 4Art. 3, Art. 15 and Art. 17
  • Obtain and hold the written declaration of compliance for everything you import other than at retail stage; in Denmark all food contact materials must be accompanied by a declaration of compliance meeting Annex 5 of the executive order. Art. 15 and Annex IV§ 15
  • Check that the declaration's specifications of use cover the food types, contact times and temperatures and the surface-to-volume ratio your customers will apply. Annex IV, point 8
  • Be able to produce the supporting documentation behind the declaration of compliance to Fødevarestyrelsen on request. Art. 16
  • Verify that nothing you import is manufactured using bisphenol A or another hazardous bisphenol or bisphenol derivative outside the two Annex II applications, that any transitional article is still within its period, and that material made with another bisphenol contains no residual BPA; hold the separate bisphenol declaration of compliance. Art. 3, Art. 4, Art. 8, Art. 11 and Art. 12
  • Register the import of food contact materials with Fødevarestyrelsen through the food business start-up form unless the activity stays at or below 1 000 units and a turnover of DKK 50 000 a year, remembering that the rules apply whether or not you have to register. Source
  • If you assume or have reason to believe that material you imported fails the food safety requirements and is no longer under your control, withdraw it from the market, notify Fødevarestyrelsen immediately and, where it has reached consumers, inform them effectively and precisely about why the product is withdrawn, recalling it from consumers where necessary. § 7
  • Make sure the material carries the framework regulation's labelling, the words for food contact or an equivalent indication, the special instructions for safe use, the name and address of the responsible business established in the Union and the traceability identification, and that consumer articles made with substances whose Annex I restrictions concern specific foods, contact time or temperature or heating are supplied with instructions of use. Art. 15(1) and Art. 17Art. 14a(2)
Distributor, wholesaler or retailer6
  • Do not market plastic food contact materials that fail the general requirements of Regulation (EC) No 1935/2004 and the rules made under it, which in Denmark is a separate offence under the executive order regardless of where in the chain the defect arose. § 6, stk. 1Art. 3
  • Pass the written declaration of compliance on to the next link in the chain at every marketing stage other than retail; in Denmark the duty is met if the declarations are published on the producer's or importer's website and the next link is informed of that. Art. 15(1)§ 15, stk. 1 and stk. 2
  • Keep systems and procedures that identify the businesses from which and to which you were supplied, and make that information available to the competent authorities on demand, so that a defective batch can be traced and recalled. Art. 17
  • At the retail stage, display the words for food contact or an equivalent indication, the special instructions for safe use and, for active materials, the required information, on the article, its packaging, a label or a clearly visible notice, in a language easily understood by purchasers. Art. 15(4), Art. 15(5) and Art. 15(7)
  • Cooperate in withdrawals: where material you distributed fails the food safety requirements, the producer or importer must withdraw it, notify Fødevarestyrelsen and inform consumers, and you must be able to say who supplied you and whom you supplied. § 7Art. 17(2)
  • Register wholesale of food contact materials with Fødevarestyrelsen unless the activity stays at or below 1 000 units and a turnover of DKK 50 000 a year. Source

PIM in plain terms

The Plastics Regulation, formally Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, is the EU’s detailed rulebook for the most common food contact material there is. It is a specific measure within the meaning of Article 5 of the framework Regulation (EC) No 1935/2004 (Art. 1(1)), which means it turns the framework’s general safety principle into concrete, testable rules: which substances may be used, how much of them may end up in the food, and how that is proven. The framework regulation still applies alongside it, and is covered in the separate Food Contact Materials guide.

The regulation applies to five categories of material placed on the EU market: articles made exclusively of plastic; plastic multi-layer materials held together by adhesives or other means; either of those when printed and/or covered by a coating; plastic layers or coatings forming gaskets in caps and closures; and plastic layers in multi-material multi-layer materials such as beverage cartons (Art. 2(1)). It covers them when they are intended to come into contact with food, are already in contact with it, or can reasonably be expected to come into contact with it (Art. 1(2)). Three material groups are left out because other specific measures are meant to cover them: ion exchange resins, rubber and silicones (Art. 2(2)). The regulation is also without prejudice to the Union or national rules on the substances used to make adhesives, coatings and printing inks applied on or incorporated in plastics (Art. 2(3)), a wording replaced in 2025 — but the printed or coated plastic article itself is squarely in scope.

The regulation entered into force on 4 February 2011 and has applied since 1 May 2011, when it repealed Directives 80/766/EEC, 81/432/EEC and 2002/72/EC (Art. 21 and Art. 23). It has been amended 21 times since, and the text that matters is the consolidated version, currently the one dated 14 July 2026. The twelve corrigenda recorded for the regulation concern language versions other than English — the most recent, published on 10 August 2026, corrects the Italian version — and the most recent amendment, Regulation (EU) 2026/1380, corrects only the Estonian text.

📄 Official text: Regulation (EU) No 10/2011, consolidated version of 14 July 2026 — on EUR-Lex →

Scope

“Plastic” means a polymer to which additives or other substances may have been added and which can function as the main structural component of the final material or article; “polymer” covers macromolecules obtained by polymerisation, by chemical modification of natural or synthetic macromolecules, or by microbial fermentation (Art. 3, points (2) and (3)). That definition is what decides scope, not the commercial description of the product.

Plastic material may only be placed on the market if it satisfies Article 3 of the framework regulation on safety under intended and foreseeable use, the framework’s labelling and traceability articles, the good manufacturing practice of Regulation (EC) No 2023/2006, the compositional and declaration requirements of Chapters II, III and IV of this regulation and, where it falls within their scope, the recycled-plastic rules of Regulation (EU) 2022/1616 (Art. 4). None of those conditions has a company-size threshold: a micro converter carries the same duties as a multinational.

Two boundaries matter in practice. The first is the functional barrier: a plastic layer that is not in direct contact with food and is separated from it by a barrier ensuring compliance may be made with substances outside the Union list, provided they do not migrate detectably, are not classified as mutagenic, carcinogenic or toxic to reproduction under Regulation (EC) No 1272/2008 and are not in nanoform; the vinyl chloride monomer restriction always applies and the finished article must still meet the migration limits (Art. 13 and Art. 14). The second is the multi-material multi-layer article. Each plastic layer’s composition must comply, and since the 2025 revision the migration limits of Articles 11 and 12 apply to the whole article when the layer in contact with food is a material within the scope of this regulation; where it is not, national law may set the limits instead (Art. 14(4) and Art. 14(6)).

What you must do

The Union list and the derogations

Only substances included in the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids in Table 1 of Annex I may be used to manufacture plastic food contact materials (Art. 5(1)). Each entry carries its own restrictions and specifications in column 10, may belong to a group restriction in Table 2, and may be subject to detailed specifications in point 4 of Annex I (Art. 9(1)). A substance in nanoform may only be used where Annex I explicitly authorises it and says so in the specifications (Art. 9(2)). The list is amended through the authorisation procedure of Articles 8 to 12 of the framework regulation, which runs on EFSA opinions.

Article 6 then carves out what does not need to be on the list: polymer production aids, colorants and solvents, which are subject to national law; all salts of the authorised acids, phenols and alcohols marked in Table 1 of Annex II, within the limits of that table; mixtures of authorised substances without chemical reaction; polymeric additives of at least 1 000 Da and pre-polymers whose monomers are listed; non-intentionally added substances and aids to polymerisation, which may be present without authorisation; and certain product-type 4 biocides authorised under Regulation (EU) No 528/2012. Anything relying on those derogations still has to comply with Article 3 of the framework regulation, assessed on internationally recognised scientific principles of risk assessment (Art. 19).

Purity, restrictions and the Annex II limits

Since the 2025 revision, substances used in the manufacture of plastic that may be present in the final material, including those made from waste, must be of a high degree of purity and of a technical quality suitable for the intended and foreseeable use, and their composition must be known to the substance manufacturer (Art. 8(1)). Article 3a defines that purity: all constituents correspond to the substance’s identity, and any non-intentionally added substances meet one of four conditions, the most demanding of which is a documented conclusion that they cannot be present at a level giving rise to an individual migration above 0,00015 mg/kg food.

Annex II adds restrictions on the finished material. Point 1 sets migration limits for 24 entries, 23 elements plus ammonium: aluminium and barium at 1 mg/kg, antimony at 0,04, cobalt and the four lanthanides europium, gadolinium, lanthanum and terbium at 0,05, copper and zinc at 5, iron at 48, lithium and manganese at 0,6, nickel at 0,02, cadmium not detectable with a specified limit of detection of 0,002, and arsenic, lead and mercury not detectable. Chromium is also set at not detectable, applying a detection limit of 0,01 mg/kg for total chromium, but a limit of 3,6 mg/kg of food applies instead where the operator that placed the material on the market can prove from pre-existing documentary evidence that hexavalent chromium is neither used nor formed at any point in the production process. Ammonium, calcium, magnesium, potassium and sodium have no numeric limit but remain subject to Articles 11(3) and 12. Point 2 requires primary aromatic amines listed in entry 43 of Appendix 8 to Annex XVII of the REACH Regulation, and without their own limit in Annex I, not to be detectable at 0,002 mg/kg each; unlisted primary aromatic amines without a specific limit are assessed under Article 19 and their sum must not exceed 0,01 mg/kg.

Migration limits

Two limits work together. The overall migration limit caps total transfer: a plastic material must not transfer its constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per square decimetre of food contact surface, and for material intended to contact food for infants and young children the limit is 60 milligrams per kilogram of food simulant (Art. 12). Specific migration limits cap named substances, expressed in milligrams per kilogram of food (Art. 11(1)), and total specific migration limits cap groups. The phthalate limits set in 2023 are the best known: 0,6 mg/kg for the sum of DBP, DIBP, BBP and DEHP expressed as DEHP equivalents using the equation DBP times 5 plus DIBP times 4 plus BBP times 0,1 plus DEHP times 1; 1,8 mg/kg for DINP and DIDP together; and 60 mg/kg for the sum of the listed plasticisers (Annex I, Table 2, group restrictions 36, 26 and 32).

Where no migration of a substance is permitted, compliance is established with a method that can confirm absence above a specified limit of detection, and unless a specific limit has been set, a detection limit of 0,01 mg/kg applies (Art. 11(4)). Additives that are also authorised food additives or flavourings must not migrate in quantities having a technical effect in the final food and must respect the food-additive restrictions as well (Art. 11(3)).

Migration testing, simulants and conditions

Specific migration values are expressed in mg/kg using the real surface-to-volume ratio in actual or foreseen use; a ratio of at least 6 dm² per kg of food may be used for containers below 500 ml or above 10 litres, for shapes where the ratio cannot be estimated, and for sheets and films not yet in contact with food, but not for material for food for infants and young children. For caps, gaskets and stoppers the value is expressed using the actual content of the container where the intended use is known, and per article where it is not (Art. 17).

Annex III assigns six food simulants: ethanol 10 % (A), acetic acid 3 % (B), ethanol 20 % (C), ethanol 50 % (D1), vegetable oil with less than 1 % unsaponifiable matter (D2) and poly(2,6-diphenyl-p-phenylene oxide) (E). A, B and C stand in for hydrophilic foods, D1 and D2 for lipophilic foods and E for dry foods, and Table 2 assigns them per food category. Material intended for all food types is tested with A, B and D2 (Annex V, Chapter 2, point 2.1.2).

For specific migration, the contact time is selected from Table 1 of Chapter 2 of Annex V, from five minutes up to ten days, and the temperature from Table 2, from 5 to 225 degrees Celsius, each representing the worst foreseeable conditions of use. Contact longer than 30 days at room temperature or below is tested in accelerated conditions for a maximum of ten days at 60 degrees; hot-fill only articles are tested for two hours at 70 degrees. For overall migration, Chapter 3 sets eight standardised tests, OM0 to OM7, from 30 minutes at 40 degrees for short cold contact to two hours at 175 degrees for high-temperature fatty applications. For a single-use article the overall migration is analysed once, at the end of the prescribed contact time; for an article intended for repeated use the test is carried out three times on a single sample with a fresh portion of simulant each time, compliance is judged on the third result, and each result must be no higher than the one before it. Results obtained in food prevail over results in simulant, which prevail over screening results, and correction factors from point 3 of Annex III and Chapter 4 of Annex V are applied before comparing with the limit (Art. 18).

Recycled and reprocessed plastic

Plastic materials and articles within the scope of Regulation (EU) 2022/1616 must comply with it as well (Art. 4(f)), and that regulation in turn applies Chapters II, III and V of the Plastics Regulation to recycled plastic, with the single exception that Article 8(1) does not apply to contaminants in the input and output of decontamination processes. Reprocessing is separate and newer: Article 10(2) allows plastic to contain reprocessed off-cuts, scraps and similar by-products only where they are a by-product under Article 5 of Directive 2008/98/EC, are collected and used under section C of the Annex to the good manufacturing practice regulation, come from material meeting Chapter II or risk-assessed under Article 19, contain no functional barrier layer, and carry no substance in an amount that would exceed a migration limit or breach Article 3 of the framework regulation.

Bisphenol A since 2025

Since 20 January 2025 the Plastics Regulation defers to Regulation (EU) 2024/3190 on bisphenol A: BPA and other hazardous bisphenols and bisphenol derivatives may only be used in plastic food contact materials in accordance with that regulation (Art. 6(6)), and the Annex I entries for FCM No 151 and FCM No 154 have been deleted. The 2024 regulation prohibits the use of BPA and its salts in adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact and the placing on the market of material made with them, leaving only two applications in its Annex II, both requiring that migration not be detectable and that the article be cleaned and flushed before first food contact. Material made under the earlier rules could be placed on the market until 20 July 2026, and in defined cases until 20 January 2028, with repeat-use articles allowed to remain on the market until 20 January 2029 at the latest.

Declaration of compliance, documentation and labelling

At every marketing stage other than retail, a written declaration must be available for plastic materials and articles, for products from intermediate stages of manufacture and for the substances intended to make them (Art. 15(1)). It carries the eleven items of Annex IV, including the specifications of use — the food types, the time and temperature of treatment and storage, and the highest food contact surface area to volume ratio for which compliance was verified — and must be renewed when substantial changes in composition or production change migration, or when new scientific data appears (Art. 15(3)). Behind it sits the supporting documentation: the conditions and results of testing, calculations including modelling, other analyses and the reasoning demonstrating compliance, plus documentation on the composition and degree of purity of the substances used, made available to competent authorities on request, who may also take samples during official controls (Art. 16).

The 2025 revision added Article 14a. The operator placing a repeat-use final article on the market must give users instructions designed to slow deterioration, a description of observable changes indicating deterioration, and a warning where specific damage or foreseeable misuse would increase migration. Where a substance’s Annex I restrictions concern specific foods, contact time or temperature, or heating conditions such as oven or microwave use, the article must reach the consumer with instructions of use that mention those restrictions.

Obligations by role

The regulation addresses “business operators” rather than the manufacturer, importer and distributor triad of the New Legislative Framework, and the practical division of duties follows the chain: substance and intermediate suppliers issue declarations that let the next stage calculate compliance; converters and article manufacturers hold the migration data and the technical documentation; importers answer for imported material exactly as if they had made it; distributors pass declarations on and keep traceability; and food businesses must not use non-compliant material. The obligations block in this guide’s data sets out each role’s duties with the article behind them.

Food contact materials in Denmark

Fødevarestyrelsen is the competent authority. Executive order nr. 681 of 25 May 2020 on food contact materials and penalties for infringements of the related EU acts, in force since 1 July 2020, prohibits the marketing of non-compliant food contact materials (§ 6, stk. 1) and their use by businesses that import, manufacture or pack food (§ 6, stk. 2); obliges the business, producer or importer to withdraw material that fails the food safety requirements, notify Fødevarestyrelsen immediately and inform consumers effectively and precisely, recalling from consumers where necessary (§ 7); and requires every food contact material to be accompanied by a declaration of compliance meeting its Annex 5, which may be published on the producer’s or importer’s website provided the next link in the chain is informed (§ 15). Businesses that import, manufacture or wholesale food contact materials must register with Fødevarestyrelsen unless the activity stays at or below 1 000 units and a turnover of DKK 50 000 a year, and the rules apply whether or not registration is required.

One detail is worth knowing: the order’s penalty chapter still reflects the law as it stood in 2020. That chapter consists of § 17 on the order’s own rules and §§ 18 to 24, one section per EU act: the framework regulation (§ 18), good manufacturing practice (§ 19), the epoxy derivatives regulation (§ 20), the recycled plastic regulation (§ 21), active and intelligent materials (§ 22), the Plastics Regulation (§ 23) and the bisphenol A regulation (§ 24). Two of those point at acts that no longer exist: § 21 punishes infringements of Regulation (EC) No 282/2008, repealed by Article 30 of Regulation (EU) 2022/1616, and § 24 punishes infringements of Regulation (EU) 2018/213, repealed by Article 13 of Regulation (EU) 2024/3190 with effect from 20 January 2025. No section of the order refers to Regulation (EU) 2024/3190 or to Regulation (EU) 2022/1616, and the thirteen entries of § 23 do not include Article 3a on purity, Article 6(6) on bisphenols or Article 14a on labelling, all of which were added to the Plastics Regulation after 2020. That is the position under the order as in force on 17 September 2026; a replacement order was notified to the Commission on 17 July 2025 (TRIS 2025/0387/DK) and its draft penalty section does cover Regulation (EU) 2024/3190 and Regulation (EU) 2022/1616, but it had not been issued at the time of writing. The EU obligations apply directly regardless; it is the Danish fine provision that has not caught up.

Enforcement and penalties

The Plastics Regulation has no penalty article of its own. Article 25 of the framework regulation requires effective, proportionate and dissuasive national sanctions, and Article 24 requires official controls under the Union rules on official food and feed controls. Article 24(3) of the framework regulation and Article 11(4) of the Plastics Regulation both still cite Regulation (EC) No 882/2004, which Regulation (EU) 2017/625 repealed with effect from 14 December 2019 and whose references are construed as references to Regulation (EU) 2017/625. The newer provisions work directly from the current regime — the overall migration test for repeat-use articles in Chapter 3 of Annex V and Article 9 of the bisphenol A regulation require analytical methods meeting Article 34 of Regulation (EU) 2017/625 — while the corresponding rule for single-use articles in Annex V still points at Article 11 of Regulation (EC) No 882/2004 and is read the same way. A Member State with detailed grounds to conclude that a material endangers human health although it complies may temporarily suspend or restrict the provisions on its territory under the safeguard clause (framework regulation, Art. 18).

In Denmark, § 23 of executive order nr. 681 punishes with a fine the infringement of Articles 4, 5, 6(3), 8, 9, 10, 11, 12, 13, 14(1), 14(3) and 14(5), 15, 16 and 17 of Regulation (EU) No 10/2011 — placing on the market, the Union list, the salts and mixtures derogation, the general and specific requirements on substances, the composition rules, both migration limits, the multi-layer rules, the declaration of compliance, the supporting documents and the expression of test results. The penalty rises to imprisonment of up to 2 years where the infringement was intentional or grossly negligent and harmed or endangered health or obtained or sought an economic advantage, and legal persons can be held criminally liable. Parallel provisions punish infringements of the framework regulation (§ 18), the good manufacturing practice regulation (§ 19) and the national rules on PFAS in paper and board, lead and cadmium and the declaration of compliance (§ 17).

What is changing

Two clocks are running. The 2025 revision applies in full to everything first placed on the market from 16 September 2026; material placed on the market before that date under the earlier text may continue to be placed on the market until stocks are exhausted, and since 16 December 2025 the declaration of compliance of a non-conforming intermediate product or substance has had to say so and state that it may only be used for material placed on the market before 16 September 2026 (Regulation (EU) 2025/351, Art. 4). The bisphenol A clock runs beyond that: 20 July 2026 for most transitional stock, 20 January 2028 for single-use articles preserving fruit, vegetables or fishery products, for articles whose BPA coating is only on the exterior metal surface and for repeat-use professional food production equipment, and 20 January 2029 as the last day repeat-use articles first placed on the market under those transitions may remain on the market. EFSA is due to publish, before 20 January 2027, the scientific output specifying what an application to authorise a hazardous bisphenol for a specific application must contain (Regulation (EU) 2024/3190, Art. 6(4)).

The Union list itself keeps moving: the 2026 amendment added six substances, and the Commission publishes the list of specific measures and the consolidated text on its food contact materials pages.

How Conphora helps

Conphora monitors the Plastics Regulation, its amending acts and the Union list, and maps your plastic food contact products against the categories of Article 2(1), the authorised substances and their restrictions, the overall and specific migration limits and the simulant and test conditions your intended use requires. The platform flags where a formulation relies on a substance that has lost its authorisation, where a declaration of compliance is missing an Annex IV item or a specification of use, where bisphenol transitional stock is running out of time, and where a supplier’s declaration no longer covers the conditions your customers apply. It keeps the documentation and the Danish registration and withdrawal procedures in one place, and alerts you when the Union list, a migration limit or the Danish executive order changes.

See how Conphora works · See plans and pricing

Sources

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

Penalties

Enforced by Member States enforce the regulation through official food controls. Article 24(1) of the framework Regulation (EC) No 1935/2004 requires official controls under the Union rules on official food and feed controls, and Article 11(4) of the Plastics Regulation still cites Regulation (EC) No 882/2004, which Regulation (EU) 2017/625 repealed with effect from 14 December 2019 and whose references are construed as references to Regulation (EU) 2017/625; the newer provisions of the Plastics Regulation, Annex V and the bisphenol A regulation already select analytical methods under Article 34 of Regulation (EU) 2017/625, with the EU reference laboratory for food contact materials and the national reference laboratories supporting the analytical work. In Denmark the competent authority is Fødevarestyrelsen (the Danish Veterinary and Food Administration) under executive order nr. 681 of 25 May 2020 on food contact materials and penalties for infringements of the related EU acts, issued under the Danish food act; businesses that manufacture, import or wholesale food contact materials must register with Fødevarestyrelsen unless the activity stays at or below 1 000 units and a turnover of DKK 50 000 a year. The toolkit is the prohibition on marketing non-compliant materials and on their use by food businesses, the producer's or importer's duty to withdraw non-compliant material, notify Fødevarestyrelsen immediately and inform consumers, sampling and migration testing in official laboratories, the framework regulation's safeguard measure allowing a Member State to suspend or restrict a specific measure on health grounds, and national penalties that must be effective, proportionate and dissuasive, which in Denmark are fines rising to imprisonment of up to 2 years for intentional or grossly negligent infringements that harm or endanger health or seek an economic gain.

The Plastics Regulation contains no penalty article of its own. Article 25 of the framework Regulation (EC) No 1935/2004 requires Member States to lay down rules on sanctions applicable to infringements of that regulation and to take all measures necessary to ensure that they are implemented, and the sanctions must be effective, proportionate and dissuasive; because the Plastics Regulation is a specific measure adopted under Article 5 of the framework regulation, Member States sanction infringements of it in the same national instrument. Enforcement runs through official food controls under Article 24 of the framework regulation, carried out under Regulation (EU) 2017/625, which replaced Regulation (EC) No 882/2004 from 14 December 2019, and a Member State that has detailed grounds for concluding that a material endangers human health although it complies with the specific measure may temporarily suspend or restrict the provisions on its territory under the safeguard clause. 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, requires the producer or importer to withdraw non-compliant material, notify Fødevarestyrelsen immediately and inform consumers, and in § 23 punishes with a fine the infringement of Articles 4, 5, 6(3), 8, 9, 10, 11, 12, 13, 14(1), 14(3) and 14(5), 15, 16 and 17 of Regulation (EU) No 10/2011, that is the placing-on-the-market conditions, the Union list and its derogations, the general and specific requirements on substances, the composition rules, the specific and overall migration limits, the multi-layer rules, the declaration of compliance, the supporting documents and the expression of test results. The list has thirteen entries and was written in 2020: it does not reach Article 3a on a high degree of purity, Article 6(6) on bisphenols or Article 14a on labelling, all of which were added to the Plastics Regulation later, so those provisions are not themselves backed by the Danish fine provision even though they apply directly. The fine rises to imprisonment of up to 2 years where the infringement was committed intentionally or by gross negligence and health was harmed or endangered or an economic advantage was obtained or sought, and companies can be held criminally liable under chapter 5 of the Danish criminal code. The order was issued by Fødevarestyrelsen under sections 25, 25 a, 49(1) and 60(3) of the Danish food act and the delegation in section 7(3) of executive order nr. 596 of 7 May 2020 on Fødevarestyrelsen's tasks and powers, which is what carries the fine provisions. Its § 17 punishes infringements of the order's own §§ 6 to 12 and §§ 14 to 15 — the marketing and use prohibitions, PFAS in paper and board, surface biocides, vinyl chloride, regenerated cellulose film, lead and cadmium in ceramics, enamelled articles and glassware, and the declaration of compliance — and parallel provisions punish infringements of the framework regulation (§ 18), the good manufacturing practice regulation (§ 19), the epoxy derivatives regulation (§ 20) and the active and intelligent materials regulation (§ 22).

Source · Art. 18, Art. 24 and Art. 25Source · Art. 146Source · § 6, § 7, § 17, § 18, § 19 and § 23

What changed

Entry into force, amendments and Compliance Radar entries for PIM, newest first.

  1. Guidance

    Guide rebuilt on the SPEC-62 model from the consolidated regulation

    The guide was rewritten from the consolidated text of 14 July 2026, the amending acts, the framework and good manufacturing practice regulations, the bisphenol A regulation and the Danish executive order nr. 681 of 25 May 2020. The earlier text described PIM as the Plastics Implementation Measure and gave only the overall migration limit and a general account of the Union list; it is corrected to the Plastics Regulation, with the five categories of Article 2(1), the three excluded material groups, the Article 6 derogations, the Annex II element and primary aromatic amine limits, the phthalate group limits, the named food simulants and the standardised test conditions, the functional barrier rules, the reprocessing and recycled-plastic conditions, the 2025 purity and labelling provisions and the eleven items of the declaration of compliance. The earlier statement that printing inks, adhesives and coatings fall outside the regulation is corrected to Article 2(1)(c) and Article 2(3), and the Danish enforcement basis and penalty provision are now sourced.

    Source · Art. 2, Art. 5, Art. 6, Art. 10 to Art. 18 and Annexes I to VSource · § 6, § 7, § 15 and § 23
  2. Amendment

    Regulation (EU) 2026/1380 in force, correcting the Estonian language version

    The Estonian version of Article 8(1) contained an error as regards the degree of purity. The correcting regulation states that the other language versions are not affected, so the English text is unchanged; 14 July 2026 is the date of the current consolidated version.

    Source · recital 1, recital 2 and Art. 2
  3. Amendment

    Regulation (EU) 2026/245 adds six substances to the Union list

    Annex I is amended to authorise FCM No 1084, 1089, 1092, 1093, 1094 and 1096 on the basis of EFSA opinions adopted in 2024, each with its own use level, polymer, food and temperature restrictions, and FCM No 768 is renamed and loses its note on verification of compliance. No transitional period applies.

    Source · recitals 2 to 15, Art. 1 and Art. 2
  4. Amendment

    Regulation (EU) 2025/351, the 2025 revision, enters into force

    New definitions of additive, reprocessing of plastic and UVCB substance; the new Article 3a on a high degree of purity; rewritten Articles 8, 10 and 16; the new labelling Article 14a; migration limits extended to multi-material multi-layer articles whose food contact surface layer is in scope; a cross-reference to the recycled-plastic regulation in Article 4(f); and a new section C on the reprocessing of plastics in the good manufacturing practice regulation. Non-conforming intermediate products must be flagged in their declaration from 16 December 2025 and the transition for plastic materials and articles ends on 16 September 2026.

    Source · Art. 1, Art. 2, Art. 3, Art. 4 and Art. 5
  5. Applies

    The bisphenol A prohibition applies and Regulation (EU) 2018/213 is repealed

    Regulation (EU) 2024/3190 prohibits the use of bisphenol A and of hazardous bisphenols and bisphenol derivatives in 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 them, leaving only the two Annex II applications. The Annex I entries for FCM No 151 and FCM No 154 are deleted, Article 6(6) is added to the Plastics Regulation, and the transitional periods run to 20 July 2026, 20 January 2028 and 20 January 2029.

    Source · Art. 3, Art. 10, Art. 11, Art. 12, Art. 13 and Art. 14
  6. Amendment

    Regulation (EU) 2023/1627 authorises DEHCH as a PVC plasticiser

    Bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM No 1079) is added to Annex I for use at up to 25 % w/w in PVC in contact with foods assigned simulants A and B at room temperature or below, with a specific migration limit of 0,05 mg/kg.

    Source · recital 2, Art. 1, Art. 2 and Annex
  7. Amendment

    Regulation (EU) 2023/1442 tightens the phthalate limits and revokes two authorisations

    A new total specific migration limit of 0,6 mg/kg applies to the sum of DBP, DIBP, BBP and DEHP expressed as DEHP equivalents, alongside the retained total of 1,8 mg/kg for DINP and DIDP and 60 mg/kg for the sum of the listed plasticisers, all with a 20 % allocation factor. The authorisations of untreated wood flour and fibres (FCM No 96) and salicylic acid (FCM No 121) are revoked, and further substances are authorised. The transition for plastic materials and articles ended on 1 February 2025.

    Source · recitals 3 to 12 and 24, Art. 1, Art. 2 and Art. 3
  8. Amendment

    Regulation (EU) 2020/1245 restructures Annex II and the salts derogation

    Article 6(3)(a) is rewritten to cover all salts of the substances marked in Table 1 of Annex II, and Annex II becomes a single table of migration limits for 24 entries, 23 elements plus ammonium, adding europium, gadolinium, lanthanum and terbium with a combined limit of 0,05 mg/kg and an evidence requirement on their dissociated ionic form. The transition ended on 23 September 2022.

    Source · recitals 3 and 4, Art. 1, Art. 2 and Art. 3
  9. Amendment

    Regulation (EU) 2016/1416 revises the definitions, the migration rules and the annexes

    The hot-fill definition is added, the definition of non-fatty foods is corrected, the salts derogation is clarified, the generic specific migration limit in Article 11(2) is deleted, the detection-limit rules are consolidated into Article 11(4) with a default of 0,01 mg/kg, the mg per square decimetre option for closures is removed, and Annexes III, IV and V on food simulants, the declaration of compliance and compliance testing are rewritten.

    Source · recitals 3 to 8 and Art. 1
  10. Applies

    Regulation (EU) No 10/2011 applies and replaces the plastics directives

    The regulation applies from 1 May 2011 and repeals Directives 80/766/EEC, 81/432/EEC and 2002/72/EC with effect from the same date, with references read against the correlation tables in Annex VI. Material lawfully placed on the market before that date could still be placed on the market until 31 December 2012, and the supporting documents could rely on the old testing rules of Directive 82/711/EEC until 31 December 2015.

    Source · Art. 21, Art. 22 and Art. 23
  11. In force

    Regulation (EU) No 10/2011 enters into force

    Adopted on 14 January 2011 as a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004 and published in OJ L 12 on 15 January 2011, the regulation entered into force on the twentieth day after publication and consolidated the earlier plastics directives into a single directly applicable act with one Union list.

    Source · Art. 1(1) and Art. 23

Tools and training

What Conphora offers for PIM.

Start from the problem

We sell a product for babies or small children

Baby and childcare products: when toy rules apply, the GPSR check for vulnerable users, food contact limits for infants, and baby monitors under the RED.

Regulation guides → Product validation

Our product touches food

Food contact rules for kitchenware and containers: the safety duty of Regulation 1935/2004, plastics under Regulation 10/2011, declarations, labels.

Regulation guides → Product validation

Our plastic kitchen product has no declaration of compliance

When plastic food contact goods arrive without a declaration of compliance: what Annex IV requires, the BPA ban and dates, tests, your own declaration.

Documentation generator → Regulation guides

We sell bamboo-melamine tableware

Bamboo-melamine cups and plates: why the plant filler is the issue under the plastics rules, formaldehyde and melamine limits, and China import checks.

Regulation guides → Knowledge & insights

Questions people ask about PIM

Which products does Regulation (EU) No 10/2011 apply to?

Five categories placed on the EU market: materials and articles and parts of them consisting exclusively of plastics; plastic multi-layer materials held together by adhesives or other means; either of those when printed and/or covered by a coating; plastic layers or coatings forming gaskets in caps and closures; and plastic layers in multi-material multi-layer materials such as beverage cartons. It covers them when they are intended to come into contact with food, are already in contact with food, or can reasonably be expected to come into contact with food. Three material groups are excluded because other specific measures are meant to cover them: ion exchange resins, rubber and silicones. The regulation is also without prejudice to the rules on substances used in adhesives, coatings and printing inks applied on or incorporated in plastics, although the printed or coated plastic article itself remains in scope.

Source · Art. 1(2), Art. 2(1), Art. 2(2) and Art. 2(3)
What is the overall migration limit and what is a specific migration limit?

The overall migration limit is an inertness ceiling: a plastic material or article must not transfer its constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per square decimetre of food contact surface. For material intended to contact food for infants and young children the limit is expressed differently, at 60 milligrams of total constituents per kilogram of food simulant. A specific migration limit is the maximum amount of one named substance that may be released into food or simulant, set in column 8 of Table 1 of Annex I and expressed in milligrams per kilogram of food; Table 2 adds total limits for groups of substances, for example 0,6 mg/kg for the sum of DBP, DIBP, BBP and DEHP expressed as DEHP equivalents, 1,8 mg/kg for DINP and DIDP together and 60 mg/kg for the sum of the listed plasticisers. Annex II adds limits for 24 further entries, 23 elements plus ammonium, and for primary aromatic amines. A material must satisfy the overall limit and every applicable specific and group limit at the same time.

Source · Art. 3, points (11), (13) and (14), Art. 11, Art. 12, Annex I, Table 2, group restrictions 26, 32 and 36, and Annex II
Is bisphenol A still allowed in plastic food contact materials?

No, apart from two narrow applications. Since 20 January 2025 Regulation (EU) 2024/3190 prohibits the use of bisphenol A and its salts in the manufacture of adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings for food contact, and prohibits placing materials made with them on the Union market; the entries for FCM No 151 and FCM No 154 were deleted from Annex I to the Plastics Regulation and Article 6(6) now says BPA may only be used in accordance with that regulation. Its Annex II leaves BPA as a monomer or starting substance for liquid epoxy resins applied to self-supporting food contact articles with a capacity above 1 000 litres, and for polysulfone filtration membrane assemblies, in both cases with no detectable migration and with cleaning and flushing before first food contact. Other hazardous bisphenols and bisphenol derivatives are prohibited on the same terms unless authorised, and a material made with another bisphenol may contain no residual BPA at all. Transitional stock could be placed on the market until 20 July 2026, in defined cases until 20 January 2028, and repeat-use articles first placed on the market under those transitions may remain on the market until 20 January 2029.

Source · Art. 1(2), Art. 3, Art. 4, Art. 5, Art. 10, Art. 11, Art. 12 and Annex IISource · Art. 6(6)
What must a declaration of compliance for plastic food contact material contain?

Annex IV lists eleven items: the identity and address of the operator issuing it; the identity and address of the operator that manufactures or imports the material, article, intermediate product or substance; the identity of what the declaration covers; the date; the confirmation that it meets this regulation and Articles 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004; adequate information on substances subject to restrictions or specifications in Annexes I and II, including non-intentionally added substances that could cause non-compliance, with identification and amounts at intermediate stages; information on substances restricted in food; the specifications of use, namely the types of food, the time and temperature of treatment and storage, and the highest food contact surface area to volume ratio for which compliance has been verified; the functional barrier confirmation for multi-layer materials; the confirmation and composition details for a batch of material intended for reprocessing; and the confirmation that substances manufactured from waste meet Article 8(1). The declaration is required at every marketing stage other than retail, must allow easy identification of what it covers, and must be renewed when substantial changes in composition or production change the migration or when new scientific data appears. In Denmark all food contact materials must be accompanied by a declaration of compliance meeting Annex 5 of executive order nr. 681 of 25 May 2020, which may be published on the producer's or importer's website provided the next link in the chain is informed.

Source · Art. 15 and Annex IVSource · § 15
Which food simulants and test conditions must I use?

Annex III assigns six simulants: ethanol 10 % as simulant A, acetic acid 3 % as B, ethanol 20 % as C, ethanol 50 % as D1, any vegetable oil with less than 1 % unsaponifiable matter as D2, and poly(2,6-diphenyl-p-phenylene oxide) as E. A, B and C stand in for hydrophilic foods, with B for foods below pH 4,5 and C for alcoholic foods up to 20 % and more lipophilic foods; D1 and D2 stand in for lipophilic foods, D1 for alcoholic foods above 20 % and oil-in-water emulsions and D2 for foods with free fat at the surface; E is for dry foods. Table 2 of Annex III assigns the simulants per food category, and material intended for all food types is tested with A, B and D2. For specific migration the test time and temperature are selected from Tables 1 and 2 of Chapter 2 of Annex V, running from five minutes to ten days and from 5 to 225 degrees Celsius, with ten days at 60 degrees standing in for storage longer than 30 days at room temperature or below and a two-hour test at 70 degrees for hot-fill only. For overall migration Chapter 3 of Annex V sets eight standardised tests, OM0 to OM7, from 30 minutes at 40 degrees to two hours at 175 degrees, with substitute tests OM8 and OM9 where OM7 cannot be run in simulant D2. A single-use article is analysed once at the end of the prescribed contact time; an article intended for repeated use is tested three times on a single sample with a fresh portion of simulant each time, compliance is established on the third result, and the migration must not rise from one test to the next.

Source · Art. 18, Annex III, points 1 to 3, and Annex V, Chapter 2, points 2.1.2 to 2.1.4, and Chapter 3
Can I use recycled or reprocessed plastic in food contact articles?

Yes, on conditions. Recycled plastic is governed by Regulation (EU) 2022/1616, which the Plastics Regulation now cross-refers to in Article 4(f); in the other direction Article 4(2) of that regulation, as replaced in 2025, applies Chapters II and III and Chapter V of the Plastics Regulation to recycled plastic materials and articles, except that Article 8(1) does not apply to contaminants in the input and output of decontamination processes. Reprocessing your own or another manufacturer's off-cuts and scraps is separate: since the 2025 revision Article 10(2) allows reprocessed plastic only if it is a by-product within the meaning of Article 5 of Directive 2008/98/EC, is collected and used under section C of the Annex to the good manufacturing practice regulation, comes from off-cuts and scraps that themselves meet Chapter II or whose constituents have been risk-assessed under Article 19, contains no functional barrier layer, and carries no substance in an amount that would exceed a migration limit or otherwise breach Article 3 of the framework regulation. A batch intended for reprocessing must be declared as compliant and, as appropriate, described with its composition and reprocessing instructions.

Source · Art. 4(f), Art. 10(2) and Annex IV, point 10Source · Art. 2 and Annex II, point 3
What changed with Regulation (EU) 2025/351 and by when must I comply?

It is the largest revision since 2016. It redefines additive, adds definitions of reprocessing of plastic and of UVCB substance, introduces Article 3a defining a high degree of purity with four alternative conditions for non-intentionally added substances, replaces Article 8 on general requirements for substances and Article 10 with general composition rules covering the Annex II restrictions, reprocessed plastic and the design of repeat-use articles, extends the migration limits of Articles 11 and 12 to multi-material multi-layer articles whose food contact surface layer is within scope, adds the labelling Article 14a on instructions for repeat-use articles and consumer instructions of use, rewrites Article 16 on supporting documents and sampling, and adds Article 4(f) tying the regulation to the recycled-plastic rules. It also adds section C on reprocessing to the good manufacturing practice regulation. It entered into force on 16 March 2025. From 16 December 2025 the declaration of compliance of a non-conforming intermediate product or substance must say so and state that it may only be used for material placed on the market before 16 September 2026, and plastic materials and articles first placed on the market before 16 September 2026 under the earlier rules may continue to be placed on the market until stocks are exhausted.

Source · Art. 1, Art. 2, Art. 3, Art. 4 and Art. 5
Who enforces the Plastics Regulation in Denmark and what are the penalties?

Fødevarestyrelsen, the Danish Veterinary and Food Administration, is the competent authority for food contact materials, and enforcement runs through official food controls. Executive order nr. 681 of 25 May 2020 on food contact materials and penalties for infringements of the related EU acts prohibits the marketing of non-compliant food contact materials and their use by food businesses, requires the producer or importer to withdraw non-compliant material, notify Fødevarestyrelsen immediately and inform consumers, and requires a declaration of compliance for every food contact material. Its § 23 punishes with a fine the infringement of Articles 4, 5, 6(3), 8 to 13, 14(1), 14(3) and 14(5), and 15 to 17 of Regulation (EU) No 10/2011; the penalty rises to imprisonment of up to 2 years where the infringement was intentional or grossly negligent and harmed or endangered health or sought an economic advantage, and legal persons can be held criminally liable. Businesses that manufacture, import or wholesale food contact materials must register with Fødevarestyrelsen unless the activity stays at or below 1 000 units and a turnover of DKK 50 000 a year.

Source · § 6, § 7, § 15 and § 23SourceSource

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Sources

  1. Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, consolidated text of 14 July 2026 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R0010-20260714
  2. Regulation (EU) No 10/2011 as published in OJ L 12, 15 January 2011 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011R0010
  3. Document information, dates, amendments and corrigenda for CELEX 32011R0010 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32011R0010
  4. Regulation (EC) No 1935/2004, the food contact materials framework regulation, consolidated (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327
  5. Regulation (EC) No 2023/2006 on good manufacturing practice for food contact materials, consolidated (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R2023-20250316
  6. Regulation (EU) 2024/3190 on bisphenol A and other hazardous bisphenols in food contact materials (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R3190
  7. Regulation (EU) 2025/351, the 2025 revision of the Plastics Regulation (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0351
  8. Regulation (EU) 2023/1442, the phthalate and Union list revision (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1442
  9. Regulation (EU) 2023/1627 authorising DEHCH, FCM No 1079 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1627
  10. Regulation (EU) 2020/1245 restructuring Annex II and the salts derogation (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R1245
  11. Regulation (EU) 2016/1416, the 2016 revision of the definitions, migration rules and annexes (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R1416
  12. Regulation (EU) 2026/245 amending Annex I as regards several substances (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0245
  13. Regulation (EU) 2026/1380 correcting the Estonian language version (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1380
  14. Regulation (EU) 2022/1616 on recycled plastic materials and articles (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R1616
  15. Regulation (EU) 2017/625 on official controls, which replaced Regulation (EC) No 882/2004 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0625
  16. Food contact materials, legislation (European Commission) https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/legislation_en
  17. Food contact materials (European Commission) https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials_en
  18. Plastic recycling for food contact (European Commission) https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/plastic-recycling_en
  19. 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
  20. Fødevarekontaktmaterialer, lovstof (Fødevarestyrelsen) https://foedevarestyrelsen.dk/lovstof/foedevarekontaktmaterialer-lovstof
  21. Dokumentation for fødevarekontaktmaterialer (Fødevarestyrelsen) https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/dokumentation
  22. Registrering af FKM-virksomheder (Fødevarestyrelsen) https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/registrering

About this guide

Reviewed by
Conphora compliance team, Compliance editors, Conphora
Reviewed
24 September 2026
Next review
13 March 2027

Written from the official text on EUR-Lex and the Commission’s guidance, with a source for every fact. It is not legal advice.

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Conphora (2026). PIM: Plastics Regulation (Regulation (EU) No 10/2011), explained. Retrieved 13 October 2026 from https://www.conphora.com/regulations/pim/
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