{
  "type": "problem",
  "slug": "plastic-food-contact",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/plastic-food-contact/",
  "markdown": "https://www.conphora.com/solutions/problem/plastic-food-contact.md",
  "title": "Our plastic kitchen product has no declaration of compliance",
  "description": "When plastic food contact goods arrive without a declaration of compliance: what Annex IV requires, the BPA ban and dates, tests, your own declaration.",
  "answer": "Plastic food contact materials must carry a written declaration of compliance at every marketing stage before retail (Regulation (EU) No 10/2011 Article 15), with the content of Annex IV and supporting test evidence. Without it you cannot sell to retailers. Ask the supplier for a complete declaration, check BPA under Regulation (EU) 2024/3190, test where evidence is missing, and only then issue your own.",
  "theme": {
    "id": "chemicals-materials",
    "label": "Chemicals and materials"
  },
  "roles": [
    {
      "id": "importer",
      "label": "Importer"
    },
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    }
  ],
  "regulations": [
    "PIM",
    "FCM"
  ],
  "path": [
    "documentation-generator",
    "regulation-library"
  ],
  "trigger": "Goods are in the warehouse or on order, and a retailer or an authority asks for the declaration of compliance the supplier never sent",
  "keep": null,
  "why": [
    {
      "text": "Plastic articles that touch food sit under two layers of law. The framework, Regulation (EC) No 1935/2004, requires materials to be manufactured so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities that could endanger health or change the food (Article 3(1)). Where a specific measure exists, materials covered by it must be accompanied by a written declaration that they comply with the rules, and appropriate documentation must be available to the authorities on demand (Article 16(1)). Business operators must be able to identify who supplied them and whom they supplied (Article 17(2)).",
      "sources": [
        1
      ]
    },
    {
      "text": "For plastics, the specific measure is Regulation (EU) No 10/2011. Only the substances in the Union list in Annex I may be used in their manufacture (Article 5(1)), with derogations for some production aids, colorants and solvents under national law (Article 6(1) and (2)). At the marketing stages other than retail, a written declaration of compliance must be available for the plastic materials and articles, for products from intermediate stages and for the substances used (Article 15(1)). The business operator issues it with the information in Annex IV (Article 15(2)), it must allow easy identification of what it covers, and it is renewed when composition or production changes alter migration (Article 15(3)).",
      "sources": [
        2
      ]
    },
    {
      "text": "Annex IV lists what a buyer should see: the identity and address of the issuer and of the manufacturer or importer, the identity of the material or article, the date, confirmation of compliance, information on restricted substances and non-intentionally added substances, information on substances with limits in food, and the specifications of use, such as food types, time and temperature of contact and the highest surface-to-volume ratio for which compliance was verified. The declaration rests on supporting documents with the conditions and results of testing, calculations or other analysis, made available to the authorities on request (Article 16).",
      "sources": [
        2
      ]
    },
    {
      "text": "Bisphenol A has its own rules since Regulation (EU) 2024/3190. The use of BPA in the manufacture of food contact plastics and other listed materials, and the placing on the market of articles manufactured using BPA, is prohibited, subject to the derogations in Annex II (Articles 1(2) and 3). Articles made with another bisphenol must not contain residual BPA (Article 4). The Regulation entered into force on 20 January 2025, the twentieth day after its publication on 31 December 2024 (Article 14). Repeat-use articles made with BPA that complied with the earlier rules could be first placed on the market until 20 July 2026 and may remain on the market until 20 July 2027, with later dates for professional food production equipment (Article 12, as amended by Regulation (EU) 2026/250). The articles covered must be accompanied by a declaration of compliance at every marketing stage other than retail (Article 8(1)). Regulation (EU) No 10/2011 points to that Regulation for BPA (Article 6(6)).",
      "sources": [
        3,
        2
      ]
    }
  ],
  "steps": [
    {
      "name": "Hold the goods at the business stage",
      "text": "The declaration is required at every marketing stage other than retail. Until you have one, do not deliver the goods to retailers or other businesses. Note batch, supplier and order, so the later declaration can be matched to exactly these goods."
    },
    {
      "name": "Ask the supplier for a complete declaration",
      "text": "Send the supplier the Annex IV list: who issues it and who manufactures or imports, what material or article, the date, confirmation of compliance, information on substances with restrictions or specifications, and the conditions of use tested: food types, time and temperature, and surface-to-volume ratio.",
      "item": "regulation-library"
    },
    {
      "name": "Check for bisphenol A",
      "text": "Under Regulation (EU) 2024/3190, in force since 20 January 2025, BPA may not be used to make plastic food contact articles, except under the derogations in its Annex II. Repeat-use articles made with BPA could be first placed on the market until 20 July 2026 and may remain on the market until 20 July 2027. Ask the supplier in writing about BPA and other bisphenols."
    },
    {
      "name": "Get the evidence behind the declaration",
      "text": "A declaration must rest on documentation: conditions and results of migration testing, calculations or other analysis. If the supplier has none, order migration tests on samples from your batch, under the conditions your customers will use the product, such as hot food or the dishwasher."
    },
    {
      "name": "Issue your own declaration only on that basis",
      "text": "As the business operator placing the goods on the market, you can issue the declaration yourself once the evidence supports it. Keep it with the test reports and your supplier and customer records, and renew it when the composition or production changes.",
      "item": "documentation-generator"
    }
  ],
  "documents": [
    {
      "name": "Declaration of compliance with the Annex IV content",
      "from": "The supplier, or your own business on documented evidence",
      "ground": "Regulation (EU) No 10/2011 Article 15 and Annex IV"
    },
    {
      "name": "Supporting documents: migration test conditions and results",
      "from": "The supplier or a laboratory",
      "ground": "Regulation (EU) No 10/2011 Article 16"
    },
    {
      "name": "Written confirmation on BPA and other bisphenols",
      "from": "The supplier",
      "ground": "Regulation (EU) 2024/3190 Articles 3, 5 and 8"
    }
  ],
  "risks": [
    {
      "title": "No declaration, no sale to businesses",
      "text": "At the marketing stages other than retail, a written declaration of compliance must be available for plastic materials and articles (Regulation (EU) No 10/2011 Article 15(1)); the framework regulation requires materials under specific measures to be accompanied by it (Regulation (EC) No 1935/2004 Article 16(1)).",
      "source": 1
    },
    {
      "title": "BPA-made articles are now prohibited",
      "text": "The use of BPA in the manufacture of food contact materials and articles, and placing on the market articles manufactured using BPA, is prohibited, subject to Annex II (Regulation (EU) 2024/3190 Article 3).",
      "source": 3
    },
    {
      "title": "Authorities can ask for the evidence",
      "text": "Documentation demonstrating compliance must be made available to the competent authorities on request (Regulation (EU) No 10/2011 Article 16(1); Regulation (EC) No 1935/2004 Article 16(1)).",
      "source": 2
    }
  ],
  "faq": [
    {
      "q": "Does the shop selling to consumers need the declaration?",
      "a": "The declaration is required at marketing stages other than retail (Regulation (EU) No 10/2011 Article 15(1)). Retail sales follow the labelling rules of Regulation (EC) No 1935/2004, but the retailer's supplier must hold the declaration."
    },
    {
      "q": "Can a declaration from the raw material supplier replace one for our product?",
      "a": "It helps, but it is not enough. Declarations are needed for intermediate products and substances as well as for the final material or article (Regulation (EU) No 10/2011 Article 15(1)), and each must identify what it covers (Article 15(3))."
    },
    {
      "q": "The supplier sent a test report but no declaration. Is that enough?",
      "a": "No. The test report is supporting documentation (Article 16). The declaration is a separate written statement with the Annex IV content, issued by a business operator (Article 15(2))."
    },
    {
      "q": "Which substances may be used in the plastic?",
      "a": "Only the substances in the Union list in Annex I, with derogations for some production aids, colorants and solvents under national law (Regulation (EU) No 10/2011 Articles 5(1) and 6(1)–(2))."
    },
    {
      "q": "Do repeat-use kitchen articles need extra information?",
      "a": "Yes, under the version of Regulation (EU) No 10/2011 amended by Regulation (EU) 2025/351. The operator gives users instructions that slow deterioration, a description of observable signs of deterioration and a warning on damage or misuse that increases migration (Article 14a(1)). Articles complying with the earlier rules and first placed on the market before 16 September 2026 may be sold until stocks run out (Regulation (EU) 2025/351 Article 4(1))."
    },
    {
      "q": "When must the declaration be renewed?",
      "a": "When substantial changes in composition or production change migration, or when new scientific data becomes available (Regulation (EU) No 10/2011 Article 15(3))."
    }
  ],
  "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 (EU) 2024/3190 on 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"
    },
    {
      "title": "Commission Regulation (EU) 2025/351 amending Regulation (EU) No 10/2011",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0351",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "food-contact-product",
    "bamboo-melamine",
    "supplier-material-data",
    "customs-stopped-goods",
    "documents-scattered"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-04",
  "notice": "General information, not legal advice."
}