{
  "type": "problem",
  "slug": "food-contact-product",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/food-contact-product/",
  "markdown": "https://www.conphora.com/solutions/problem/food-contact-product.md",
  "title": "Our product touches food",
  "description": "Food contact rules for kitchenware and containers: the safety duty of Regulation 1935/2004, plastics under Regulation 10/2011, declarations, labels.",
  "answer": "Materials and articles intended to come into contact with food, or that can reasonably be expected to, fall under Regulation (EC) No 1935/2004: they must not transfer constituents that endanger health or change the food. Plastics also follow Regulation (EU) No 10/2011, with migration limits and a written declaration of compliance. Map every material that touches food, collect declarations and label the product for food contact.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "FCM",
    "PIM"
  ],
  "path": [
    "regulation-library",
    "product-validation"
  ],
  "trigger": "A kitchen tool, container, bottle, lunch box, appliance part or tableware item is developed or sourced, and a buyer asks for food contact documentation",
  "keep": null,
  "why": [
    {
      "text": "Regulation (EC) No 1935/2004 is the framework for everything that touches food. It applies to 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 (Article 1(2)). Antiques, covering or coating materials that form part of the food and may be eaten with it, such as those covering cheese rinds, and fixed water supply equipment are outside it (Article 1(3)).",
      "sources": [
        1
      ]
    },
    {
      "text": "The core duty is short. 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 taste and smell (Article 3(1)). Their labelling, advertising and presentation must not mislead consumers (Article 3(2)). The detailed good manufacturing practice rules are in Regulation (EC) No 2023/2006: a documented quality assurance system, pre-established specifications and documentation, at all stages of manufacture, processing and distribution up to but excluding the production of starting substances (Articles 2, 4, 5 and 7).",
      "sources": [
        1,
        3
      ]
    },
    {
      "text": "Specific measures add detail per material. Annex I lists 17 groups that may be covered, including plastics, ceramics, glass, metals and alloys, paper and board, rubbers, silicones, printing inks, varnishes and coatings, and wood (Article 5 and Annex I). Specific measures must require that the materials they cover are accompanied by a written declaration that they comply with the applicable rules, with appropriate documentation available to demonstrate it (Article 16(1)); where there is no specific measure, Member States may keep or adopt national rules on declarations (Article 16(2)).",
      "sources": [
        1
      ]
    },
    {
      "text": "For plastics, the specific measure is Regulation (EU) No 10/2011, which applies from 1 May 2011 (Article 23). It covers materials and articles consisting exclusively of plastics, plastic multi-layers, printed or coated plastics, and plastic layers in caps, closures and multi-material articles, but not ion exchange resins, rubber or silicones (Article 2). Plastics may not release more than 10 mg of constituents per dm2 of food contact surface, or 60 mg per kg of food simulant for food for infants and young children as defined by Directives 2006/141/EC and 2006/125/EC (Article 12), and substances in the Union list are held to the specific migration limits in Annex I (Article 11(1)). Regulation (EU) 2023/1442 removed untreated wood flour and fibres from the Union list, and Regulation (EU) 2025/351 added Article 14a on instructions and warnings for repeat-use articles. The written declaration of compliance must be available at marketing stages other than retail, contain the information in Annex IV and be renewed when changes affect migration (Article 15), with supporting documents available to authorities on request (Article 16). Since 20 January 2025, Regulation (EU) 2024/3190 prohibits the use of bisphenol A in food contact plastics, varnishes and coatings, rubbers, silicones, adhesives, printing inks and ion-exchange resins, and the placing on the market of materials made with it, except for uses listed in its Annex II (Articles 1 and 3); articles made under the old rules could be first placed on the market only until 20 July 2026, with later dates for a few listed uses (Articles 11 and 12).",
      "sources": [
        2,
        4
      ]
    },
    {
      "text": "The product also has to say what it is. Articles not yet in contact with food when placed on the market carry the words \"for food contact\", a specific indication of use or the symbol in Annex II, special instructions for safe use where necessary, the name and address of the business responsible established in the EU, and identification that ensures traceability (Article 15(1)). The indication is not needed for articles clearly intended for food (Article 15(2)), and at retail the information must be in a language easily understood by purchasers (Article 15(4)). Business operators keep systems that identify who supplied them and whom they supplied (Article 17(2)).",
      "sources": [
        1
      ]
    }
  ],
  "steps": [
    {
      "name": "Map every material that touches food",
      "text": "List each part that is in contact with food, or can reasonably be expected to be under normal or foreseeable use: body, lid, seal, coating, handle insert, printed surface. Note the material of each part, because the specific rules are set per material group."
    },
    {
      "name": "Find the specific rules for each material",
      "text": "Regulation (EC) No 1935/2004 lists 17 material groups that may get specific measures, from plastics and ceramics to silicones, rubbers, metals and wood. Plastics have Regulation (EU) No 10/2011; silicone and rubber are expressly outside it. Bisphenol A is banned across several groups by Regulation (EU) 2024/3190. Check what applies to each material group you found.",
      "item": "regulation-library"
    },
    {
      "name": "Get a declaration of compliance for plastic parts",
      "text": "Ask the supplier for a written declaration of compliance with the content of Annex IV of Regulation (EU) No 10/2011: who issues it, the material, the date, confirmation of compliance, information on restricted substances, and the conditions of use it covers, such as food types, time, temperature and surface-to-volume ratio.",
      "item": "product-validation"
    },
    {
      "name": "Keep the supporting test documentation",
      "text": "Behind each declaration there must be documentation showing compliance: the conditions and results of migration testing, calculations or other analysis. Check that the tested conditions match the way your product is used, such as hot filling, microwave use or contact with fatty food."
    },
    {
      "name": "Label for food contact and make it traceable",
      "text": "Unless the article is clearly intended for food, mark it 'for food contact', with a specific use such as 'soup spoon', or with the glass-and-fork symbol. Add special instructions for safe use where needed, the name and address of the business responsible, and identification that allows traceability."
    }
  ],
  "documents": [
    {
      "name": "Declarations of compliance for each plastic part, with the content of Annex IV",
      "from": "The supplier of the plastic material or article",
      "ground": "Regulation (EU) No 10/2011 Article 15 and Annex IV; Regulation (EC) No 1935/2004 Article 16(1)"
    },
    {
      "name": "Supporting documents: migration test conditions and results, calculations or other evidence",
      "from": "The business operator, from the supplier or a laboratory",
      "ground": "Regulation (EU) No 10/2011 Article 16"
    },
    {
      "name": "Records identifying the businesses you bought from and sold to",
      "from": "Your own systems",
      "ground": "Regulation (EC) No 1935/2004 Article 17(2)"
    }
  ],
  "risks": [
    {
      "title": "Retail sale is prohibited without understandable labelling",
      "text": "Retail trade in food contact materials is prohibited if the food contact indication, the safe-use instructions and, for active materials, the use information are not given in a language easily understood by purchasers (Regulation (EC) No 1935/2004 Article 15(4)).",
      "source": 1
    },
    {
      "title": "Authorities can ask for the evidence",
      "text": "Documentation demonstrating compliance must be made available to the competent authorities on demand (Regulation (EC) No 1935/2004 Article 16(1); Regulation (EU) No 10/2011 Article 16(1)), and traceability information must be provided on demand too (Regulation (EC) No 1935/2004 Article 17(2)).",
      "source": 2
    },
    {
      "title": "A declaration goes stale when production changes",
      "text": "The declaration of compliance must be renewed when substantial changes in composition or production change the migration, or when new scientific data becomes available (Regulation (EU) No 10/2011 Article 15(3)).",
      "source": 2
    }
  ],
  "faq": [
    {
      "q": "Does a coffee mug need the glass-and-fork symbol?",
      "a": "The food contact indication is not obligatory for articles that, because of their characteristics, are clearly intended to come into contact with food (Regulation (EC) No 1935/2004 Article 15(2)). The other labelling particulars still apply."
    },
    {
      "q": "Do shops need the declaration of compliance?",
      "a": "For plastics, the written declaration must be available at the marketing stages other than retail (Regulation (EU) No 10/2011 Article 15(1)). At retail the labelling rules of Regulation (EC) No 1935/2004 Article 15 apply."
    },
    {
      "q": "Is our silicone baking mat covered by the plastics regulation?",
      "a": "No. Regulation (EU) No 10/2011 does not apply to ion exchange resins, rubber or silicones (Article 2(2)). The general requirements of Regulation (EC) No 1935/2004 still apply to them (Articles 1 and 3)."
    },
    {
      "q": "What is the general migration limit for plastics?",
      "a": "Plastic materials must not transfer more than 10 mg of total constituents per dm2 of food contact surface (Regulation (EU) No 10/2011 Article 12(1)). Substances in the Union list are also held to the specific migration limits set for them in Annex I (Article 11(1)); the former generic limit of 60 mg per kg for substances without their own limit was deleted in 2016."
    },
    {
      "q": "We sell antique tableware. Does this apply?",
      "a": "No. Regulation (EC) No 1935/2004 does not apply to materials and articles supplied as antiques (Article 1(3)(a))."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food (consolidated text of 27 March 2021)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (consolidated text of 14 July 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R0010-20260714",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2024/3190 on the use of bisphenol A and other bisphenols in food contact materials (consolidated text of 23 February 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R3190-20260223",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "childcare-product",
    "which-regulations-apply",
    "product-change-recheck",
    "language-requirements",
    "new-eu-country"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-05",
  "notice": "General information, not legal advice."
}