{
  "type": "problem",
  "slug": "phthalates-toys",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/phthalates-toys/",
  "markdown": "https://www.conphora.com/solutions/problem/phthalates-toys.md",
  "title": "Our plastic toy was flagged for phthalates",
  "description": "A phthalate finding in a toy: the REACH limits per plasticised material, the corrective duties under the toy directive, recalls and root cause.",
  "answer": "Phthalates in toys are restricted by REACH Annex XVII: DEHP, DBP, BBP and DIBP may not reach 0.1 % of the plasticised material, and DINP, DIDP and DNOP may not exceed it in toys children can put in their mouth. The toy safety directive requires toys to meet these restrictions. Get the finding in writing, stop sales, take corrective action, inform authorities of any risk and fix the material.",
  "theme": {
    "id": "chemicals-materials",
    "label": "Chemicals and materials"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "TSD",
    "REACH"
  ],
  "path": [
    "regulation-library",
    "recall-manager"
  ],
  "trigger": "A laboratory, a retailer's test, a customs check or a market surveillance authority finds phthalates above the limit in a soft plastic part of a toy",
  "keep": null,
  "why": [
    {
      "text": "The phthalate limits for toys sit in REACH, Regulation (EC) No 1907/2006. Entry 51 of Annex XVII restricts DEHP, DBP, BBP and DIBP: they shall not be placed on the market in toys or childcare articles, individually or in any combination, at 0.1 % or more by weight of the plasticised material (point 2). Entry 52 restricts DINP, DIDP and DNOP in toys and childcare articles that can be placed in the mouth by children, at concentrations greater than 0.1 % of the plasticised material. A substance in an article restricted in Annex XVII shall not be placed on the market unless it complies with the restriction (Article 67(1)).",
      "sources": [
        1
      ]
    },
    {
      "text": "The limit is measured in the right place. Plasticised material means PVC, PVDC, polyvinyl acetate and polyurethanes, any other polymer including foams and rubber except silicone rubber and natural latex coatings, surface coatings, non-slip coatings, finishes, decals, printed designs, adhesives, sealants, paints and inks (entry 51, point 5(a)). A childcare article is any product intended to facilitate sleep, relaxation, hygiene, feeding or sucking (point 5(c)).",
      "sources": [
        1
      ]
    },
    {
      "text": "The toy safety directive brings these restrictions into the toy's conformity. Directive 2009/48/EC requires toys to comply with Union legislation on restrictions for certain substances and mixtures (Annex II, Part III, point 1), and bans substances classified as carcinogenic, mutagenic or toxic for reproduction in categories 1A, 1B or 2 in toys, their components and micro-structurally distinct parts, subject to the derogations in points 4 and 5 (point 3).",
      "sources": [
        2
      ]
    },
    {
      "text": "A phthalate finding therefore starts the corrective duties of the directive. A manufacturer who has reason to believe a toy is not in conformity must immediately take the corrective measures necessary to bring it into conformity, withdraw it or recall it if appropriate, and where the toy presents a risk, immediately inform the competent national authorities of the Member States where it was made available (Article 4(8)). Importers have the same duty (Article 6(7)), may only place compliant toys on the market (Article 6(1)) and must not place a toy they believe is not in conformity (Article 6(2)). Manufacturers keep series production in conformity and take changes in design or characteristics into account (Article 4(4)).",
      "sources": [
        2
      ]
    },
    {
      "text": "The rules are about to move to a regulation. Regulation (EU) 2025/2509 repeals Directive 2009/48/EC with effect from 1 August 2030 (Article 56) and applies from that date, while Articles 28 to 44 and 49 to 55 apply from 1 January 2026 (Article 59). Toys placed on the market in conformity with the directive before 1 August 2030 may continue to be made available (Article 57(1)). From that date its Annex II, Part III prohibits substances with certain harmonised classifications (including CMR category 1A, 1B or 2 and endocrine disruptors for human health), the intentional use of PFAS and the bisphenols listed in its Appendix, while materials that comply with a substance-specific toy restriction in REACH Annex XVII are excluded from those bans for that substance unless the Appendix sets a stricter rule (points 4 to 9). The Regulation, published on 12 December 2025, does not name phthalates, so entries 51 and 52 remain the reference for them.",
      "sources": [
        3
      ]
    }
  ],
  "steps": [
    {
      "name": "Get the finding in writing",
      "text": "Ask for the test report: which phthalate, which part, which concentration, which method and which batch. The limits apply to the plasticised material, such as PVC, polymer foams, coatings, decals, adhesives or inks, so you need to know exactly which material failed."
    },
    {
      "name": "Compare it with the right entry",
      "text": "DEHP, DBP, BBP and DIBP: below 0.1 % by weight of the plasticised material, alone or combined, in any toy. DINP, DIDP and DNOP: not more than 0.1 % in toys that children can place in their mouth. A result above the limit means the toy does not conform.",
      "item": "regulation-library"
    },
    {
      "name": "Stop sales and decide on corrective action",
      "text": "Stop placing the batch on the market. Bring it into conformity, withdraw it or recall it, as appropriate. Where the toy presents a risk, inform the competent authorities of every Member State where you made it available, with details of the non-compliance and the measures taken.",
      "item": "recall-manager"
    },
    {
      "name": "Trace the batch and the root cause",
      "text": "Identify which shipments and customers received the batch, using the type, batch or serial number on the toy or packaging. Ask the supplier which plasticiser was used and why. A change of compound or sub-supplier is the usual cause; get it in writing."
    },
    {
      "name": "Clear the corrected product before it ships",
      "text": "Test the corrected material before the next production, update the technical documentation and make sure series production stays in conformity. Check the other chemical requirements of the toy directive at the same time, such as the ban on CMR substances in toys and their components, subject to its derogations."
    }
  ],
  "documents": [
    {
      "name": "The test report with part, material, phthalate, concentration and batch",
      "from": "The laboratory or the authority",
      "ground": "Regulation (EC) No 1907/2006 Annex XVII entries 51 and 52"
    },
    {
      "name": "Record of corrective measures and the information sent to authorities",
      "from": "The manufacturer or importer",
      "ground": "Directive 2009/48/EC Article 4(8) and Article 6(7)"
    },
    {
      "name": "Test report for the corrected material and the updated technical file",
      "from": "The manufacturer, with a laboratory",
      "ground": "Directive 2009/48/EC Article 4(2) and (4)"
    }
  ],
  "risks": [
    {
      "title": "Restricted substances may not be placed on the market",
      "text": "A substance in an article for which Annex XVII contains a restriction shall not be placed on the market unless it complies with the conditions of that restriction (Regulation (EC) No 1907/2006 Article 67(1)).",
      "source": 1
    },
    {
      "title": "Corrective action is a duty, not a choice",
      "text": "Manufacturers and importers who have reason to believe a toy is not in conformity must immediately take the corrective measures necessary, withdraw or recall it if appropriate, and where the toy presents a risk, immediately inform the competent national authorities (Directive 2009/48/EC Articles 4(8) and 6(7)).",
      "source": 2
    },
    {
      "title": "The toy directive includes the chemical restrictions",
      "text": "Toys shall comply with the relevant Community legislation on restrictions for certain substances and mixtures (Directive 2009/48/EC Annex II, Part III, point 1).",
      "source": 2
    }
  ],
  "faq": [
    {
      "q": "Does the 0.1 % apply to the whole toy?",
      "a": "No. It applies by weight of the plasticised material (REACH Annex XVII entry 51, points 1 and 2). Plasticised material includes PVC, polyurethanes, other polymers including foams and rubber, surface coatings, decals, printed designs, adhesives, sealants, paints and inks, but not silicone rubber or natural latex coatings (point 5(a))."
    },
    {
      "q": "Which phthalates are covered in toys?",
      "a": "DEHP, DBP, BBP and DIBP in all toys and childcare articles (REACH Annex XVII entry 51), and DINP, DIDP and DNOP in toys and childcare articles that can be placed in the mouth by children (entry 52)."
    },
    {
      "q": "We are an importer. Is this our problem or the factory's?",
      "a": "Yours as well. Importers may only place compliant toys on the market and must take corrective measures and inform authorities where a toy they placed presents a risk (Directive 2009/48/EC Article 6(1) and (7))."
    },
    {
      "q": "Does the new Toy Safety Regulation change this?",
      "a": "Regulation (EU) 2025/2509 repeals Directive 2009/48/EC with effect from 1 August 2030 and applies from that date, with some articles from 1 January 2026 (Articles 56 and 59). Toys placed on the market in conformity with the directive before 1 August 2030 may still be made available (Article 57(1)). Its Annex II, Part III bans further substance groups in toys, including intentionally used PFAS, and keeps REACH Annex XVII toy restrictions for the substances they cover unless its Appendix is stricter (points 4 to 9)."
    },
    {
      "q": "Is a childcare product covered too?",
      "a": "Yes. Entries 51 and 52 cover childcare articles: any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children (REACH Annex XVII entry 51, point 5(c), and entry 52, point 4)."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EC) No 1907/2006 (REACH), Annex XVII (consolidated text of 22 June 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1907-20260622",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2009/48/EC on the safety of toys (consolidated text of 29 August 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009L0048-20260829",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2025/2509 on the safety of toys and repealing Directive 2009/48/EC",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R2509",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "toy-or-not",
    "warning-texts-toys",
    "childcare-product",
    "withdrawal-or-recall",
    "test-purchase-failed",
    "product-on-safety-gate"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-04",
  "notice": "General information, not legal advice."
}