{
  "type": "problem",
  "slug": "childcare-product",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/childcare-product/",
  "markdown": "https://www.conphora.com/solutions/problem/childcare-product.md",
  "title": "We sell a product for babies or small children",
  "description": "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.",
  "answer": "Products for babies and small children are rarely covered by one act. Toys follow Directive 2009/48/EC; soothers and most childcare articles fall under the General Product Safety Regulation, which requires the risk analysis to consider children as vulnerable users. Plastic feeding items meet a stricter migration limit, and radio baby monitors that process personal data meet the RED privacy requirement.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "GPSR",
    "TSD",
    "PIM",
    "RED"
  ],
  "path": [
    "regulation-library",
    "product-validation"
  ],
  "trigger": "A range of baby or childcare products, such as soothers, feeding bottles, bibs, carriers, cot accessories, toys or baby monitors, is being launched or sourced",
  "keep": "GPSR technical documentation for 10 years after the product is placed on the market (GPSR Article 9(3))",
  "why": [
    {
      "text": "Products for babies and small children sit where several acts meet. The General Product Safety Regulation (GPSR) covers consumer products insofar as no specific Union rules with the same objective regulate their safety (Article 2(1)). That makes it the main act for most childcare articles that are not toys. The Toy Safety Directive covers products for play by children under 14 (Article 2(1)), but its Annex I takes babies' soothers out of the toy definition (point 16). The Commission's guidelines name furniture and childcare articles as products the GPSR applies to fully (Commission Notice C/2025/6233, section 2.2).",
      "sources": [
        1,
        2,
        8
      ]
    },
    {
      "text": "The GPSR asks more of an assessment when children are the users. Among the aspects to take into account are the labelling regarding age suitability for children and any warnings (Article 6(1)(d)), the categories of consumers using the product, in particular vulnerable consumers such as children (Article 6(1)(e)), and products that are likely to be used by children or resemble something appealing to them (Article 6(1)(f)(ii)). The manufacturer carries out an internal risk analysis and draws up technical documentation before placing the product on the market (Article 9(2)) and keeps it for 10 years (Article 9(3)).",
      "sources": [
        1
      ]
    },
    {
      "text": "Standards carry much of the practical weight. A product is presumed to meet the general safety requirement for the risks covered by European standards whose references are published in the Official Journal (Article 7(1)(a)). Without such standards, the assessment draws on other elements such as international standards, Commission guidelines, the state of the art and reasonable consumer expectations (Article 8(1)). The presumption does not stop authorities from acting where there is evidence that the product is dangerous anyway (Article 7(3)).",
      "sources": [
        1
      ]
    },
    {
      "text": "Feeding products bring in food contact rules. Plastic materials and articles must not release more than 10 mg of total constituents per dm2 of food contact surface, but for food intended for infants and young children, as defined by Directives 2006/141/EC and 2006/125/EC, the limit is 60 mg per kg of food simulant (Regulation (EU) No 10/2011 Article 12). 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). At marketing stages other than retail, a written declaration of compliance with the content of Annex IV must be available (Article 15), and supporting documentation is made available to the authorities on request (Article 16).",
      "sources": [
        3,
        7
      ]
    },
    {
      "text": "Toys and radio products for this age group have their own extras. Toys that might be dangerous for children under 36 months carry a warning such as \"Not suitable for children under 36 months\" with a brief indication of the hazard (Directive 2009/48/EC Annex V Part B point 1). Radio equipment designed or intended exclusively for childcare that can process personal, traffic or location data must meet the personal data and privacy requirement of the Radio Equipment Directive (Delegated Regulation (EU) 2022/30 Article 1(2)(b)), applicable since 1 August 2025 (Article 3) and repealed with effect from 11 December 2027 (Delegated Regulation (EU) 2026/339 Article 1). The Toy Safety Directive is replaced by Regulation (EU) 2025/2509 from 1 August 2030, which keeps soothers out of the toy definition (Annex I Part II point 16).",
      "sources": [
        2,
        4,
        5,
        6
      ]
    }
  ],
  "steps": [
    {
      "name": "Sort each product by the acts that apply",
      "text": "Decide per product whether it is a toy, a childcare article under the GPSR, a material in contact with food, radio equipment, or several at once. A baby monitor can be radio equipment and a childcare product; a teething toy can be a toy and touch the mouth. Note every act per product before you look at standards."
    },
    {
      "name": "Write the risk analysis with the child as the user",
      "text": "The GPSR asks the assessment to take into account vulnerable consumers such as children, the labelling on age suitability, and how the product will foreseeably be used. Describe the youngest user, how the child handles the product and what the carer is expected to do.",
      "item": "product-validation"
    },
    {
      "name": "Find the European standards and other references",
      "text": "A product that conforms to European standards whose references are published in the Official Journal under Regulation (EU) No 1025/2012 is presumed safe for the risks those standards cover. Where there are none, the GPSR lists other elements to use, such as international standards, Commission guidelines and the state of the art.",
      "item": "regulation-library"
    },
    {
      "name": "Check food contact for feeding items",
      "text": "Plastic items for food intended for infants and young children must not release more than 60 mg of constituents per kg of food simulant. Bisphenol A may not be used in food contact plastics, coatings and similar materials. Ask the supplier for the written declaration of compliance with the content of Annex IV of Regulation (EU) No 10/2011, and keep the supporting test documentation available."
    },
    {
      "name": "Check radio equipment and its privacy requirement",
      "text": "Radio equipment designed or intended exclusively for childcare that can process personal, traffic or location data must meet the personal data and privacy requirement of the Radio Equipment Directive from 1 August 2025 until Delegated Regulation (EU) 2022/30 is repealed on 11 December 2027, whether or not it connects to the internet."
    },
    {
      "name": "Set age labels and warnings",
      "text": "Where the risk analysis calls for it, give age suitability and safe-use information on the product or packaging; the GPSR counts that labelling among the aspects of safety. For toys that might be dangerous for children under 36 months, use the warning Annex V of the Toy Safety Directive sets out, with a short indication of the specific hazard."
    }
  ],
  "documents": [
    {
      "name": "The GPSR risk analysis and technical documentation for each non-toy product",
      "from": "The manufacturer",
      "ground": "GPSR Articles 6(1) and 9(2)–(3)"
    },
    {
      "name": "Declarations of compliance for plastic food contact parts, 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"
    },
    {
      "name": "For toys: the safety assessment and conformity assessment record",
      "from": "The manufacturer",
      "ground": "Directive 2009/48/EC Articles 18 and 19"
    }
  ],
  "risks": [
    {
      "title": "A dangerous product triggers immediate corrective measures",
      "text": "A manufacturer that considers or has reason to believe that a product it placed on the market is dangerous must immediately take corrective measures, including withdrawal or recall where appropriate, inform consumers and notify the authorities through the Safety Business Gateway (GPSR Article 9(8)).",
      "source": 1
    },
    {
      "title": "Meeting a standard does not end the discussion",
      "text": "The presumption of conformity from European standards does not prevent market surveillance authorities from taking measures where there is evidence that the product is dangerous anyway (GPSR Article 7(3)).",
      "source": 1
    },
    {
      "title": "Food contact documents are checked on request",
      "text": "Business operators must make appropriate documentation demonstrating compliance of plastic materials and articles available to the national competent authorities on request (Regulation (EU) No 10/2011 Article 16(1)).",
      "source": 3
    }
  ],
  "faq": [
    {
      "q": "Is a soother a toy?",
      "a": "No. Babies' soothers are listed among the products not considered toys (Directive 2009/48/EC Annex I point 16; Regulation (EU) 2025/2509 Annex I Part II point 16). Their safety falls under the General Product Safety Regulation."
    },
    {
      "q": "Are European standards for childcare articles mandatory?",
      "a": "The GPSR does not make them mandatory, but conformity with European standards whose references are published in the Official Journal gives a presumption of safety for the risks they cover (Article 7(1)(a))."
    },
    {
      "q": "Does our baby monitor fall under the cybersecurity rules?",
      "a": "Radio equipment designed or intended exclusively for childcare must meet the RED privacy requirement if it can process personal, traffic or location data (Delegated Regulation (EU) 2022/30 Article 1(2)(b)). If it also communicates over the internet, the network requirement applies too (Article 1(1)). Both apply until the delegated regulation is repealed on 11 December 2027 (Delegated Regulation (EU) 2026/339 Article 1)."
    },
    {
      "q": "Are the migration limits stricter for baby food containers?",
      "a": "Yes. Plastic materials for food intended for infants and young children, as defined by Directives 2006/141/EC and 2006/125/EC, must not transfer more than 60 mg of total constituents per kg of food simulant, instead of the general 10 mg per dm2 (Regulation (EU) No 10/2011 Article 12). Bisphenol A is banned in their manufacture (Regulation (EU) 2024/3190 Article 3)."
    },
    {
      "q": "When does a toy need the under-36-months warning?",
      "a": "Toys that might be dangerous for children under 36 months bear a warning such as 'Not suitable for children under 36 months', with a brief indication of the hazard; it does not apply to toys manifestly unsuitable for that age (Directive 2009/48/EC Annex V Part B point 1)."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EU) 2023/988 on general product safety (consolidated text of 29 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R0988-20260529",
      "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) 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": "Delegated Regulation (EU) 2022/30 on the application of Article 3(3)(d), (e) and (f) of Directive 2014/53/EU (consolidated text of 27 October 2023)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02022R0030-20231027",
      "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"
    },
    {
      "title": "Delegated Regulation (EU) 2026/339 repealing Delegated Regulation (EU) 2022/30",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0339",
      "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"
    },
    {
      "title": "Commission Notice — Guidelines on the application of the EU general product safety legislative framework by businesses (C/2025/6233)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/eli/C/2025/6233/oj",
      "accessed": "2026-10-05"
    }
  ],
  "related": [
    "toy-or-not",
    "warning-texts-toys",
    "food-contact-product",
    "radio-cybersecurity",
    "which-regulations-apply"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-05",
  "notice": "General information, not legal advice."
}