{ "dataset_version": "0.5.0-demo", "semantics": "Each rule's `when` conditions are ANDed against the declared product profile. If a referenced profile field is missing or 'unknown', the rule is INDETERMINATE and is reported as a question to answer — never silently applied or skipped. `adds` are requirements that apply when conditions match; `not_applicable` are scope exclusions asserted when conditions match, based on the declared profile only.", "disclaimer_en": "Category-level decision support based on the declared product profile, not SKU-specific legal advice. Verify cited sources; per-rule review_status shows what has been checked.", "disclaimer_zh": "基于所申报产品属性的类目级决策支持，并非SKU级法律意见。请核对所引来源；每条规则的review_status标注核验状态。", "count": 55, "rules": [ { "id": "eu-red-when-radio", "category": "battery-electronics", "markets": [ "EU" ], "when": { "has_radio": true }, "adds": [ { "text_en": "Radio Equipment Directive 2014/53/EU is the CE conformity route: it covers radio spectrum, EMC and electrical safety for radio equipment in one assessment.", "text_zh": "《无线电设备指令》2014/53/EU是CE符合性路径：对无线设备的频谱、电磁兼容与电气安全一并评估。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Radio Equipment Directive 2014/53/EU", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0053" } ], "review_status": "source_checked", "review_note": "2026-07-06: Confirmed in EUR-Lex full text (eli/dir/2014/53/oj loads the full text; the /legal-content/EN/TXT/ form does not render). Article 3(1)(a) folds in LVD-equivalent safety objectives 'but with no voltage limit applying'; Article 3(1)(b) folds in EMC-equivalent requirements 'as set out in Directive 2014/30/EU'; a recital adds 'effective and efficient use of radio spectrum' to the same list of objectives. Article 1(4) and recital 7-8 confirm radio equipment is excluded from LVD and EMC Directive scope specifically because RED's own essential requirements cover it — one assessment, as the rule states." }, { "id": "eu-lvd-emc-when-no-radio", "category": "battery-electronics", "markets": [ "EU" ], "when": { "has_radio": false }, "adds": [ { "text_en": "Without radio functionality, the EMC Directive 2014/30/EU applies, plus the Low Voltage Directive 2014/35/EU where the product is within its voltage scope.", "text_zh": "无无线功能时适用《电磁兼容指令》2014/30/EU；产品在电压范围内的另适用《低电压指令》2014/35/EU。", "classification": "legal_requirement" } ], "not_applicable": [ { "text_en": "Radio Equipment Directive 2014/53/EU does not apply to products without radio transmitters (based on the declared profile).", "text_zh": "根据所申报属性，无无线发射功能的产品不适用《无线电设备指令》2014/53/EU。" } ], "sources": [ { "name": "EMC Directive 2014/30/EU", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0030" }, { "name": "Low Voltage Directive 2014/35/EU", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0035" } ], "review_status": "source_checked", "review_note": "2026-07-06: Confirmed by contrast with RED's own text (eu-red-when-radio note): RED's Article 1(1) scope is limited to 'radio equipment', and Article 1(4)/recitals 7-8 explicitly carve non-radio-relevant LVD/EMC obligations out of RED's own equipment. Products without radio functionality therefore fall to EMC 2014/30/EU and, within its voltage scope, LVD 2014/35/EU as separate directives — exactly as the rule states." }, { "id": "un383-when-lithium", "category": "battery-electronics", "markets": [ "EU", "US", "UK", "AU" ], "when": { "battery_type": [ "lithium_ion" ] }, "adds": [ { "text_en": "A UN 38.3 test summary must be available for lithium cells/batteries before transport; carriers and forwarders request it at booking.", "text_zh": "锂电芯/电池运输前须备有UN 38.3测试摘要；承运人和货代在订舱时会索要。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "UN Manual of Tests and Criteria, subsection 38.3", "authority": "UNECE", "url": "https://unece.org/transport/dangerous-goods/rev7-files" } ], "review_status": "source_checked", "review_note": "2026-07-06: Confirmed via 49 CFR 173.185 on ecfr.gov, which implements UN SP188/38.3 domestically and cites it by name: 173.185(a)(1) requires 'each lithium cell or battery must be of the type proven to meet the criteria in part III, sub-section 38.3 of the UN Manual of Tests and Criteria', and 173.185(a)(3) requires manufacturers/distributors to 'make a test summary available' with specified content elements. The unece.org landing page itself only hosts the PDF volumes (Cloudflare-gated but loads after the challenge completes) and wasn't practical to full-text search; the eCFR cross-reference is a strong independent confirmation of the same substantive requirement." }, { "id": "un383-na-when-no-lithium", "category": "battery-electronics", "markets": [ "EU", "US", "UK", "AU" ], "when": { "battery_type": [ "none", "other", "button_coin" ] }, "adds": [], "not_applicable": [ { "text_en": "UN 38.3 testing applies to lithium cells/batteries; based on the declared battery type it is not triggered (re-check if any lithium button cell is present).", "text_zh": "UN 38.3测试针对锂电芯/电池；根据所申报电池类型不适用（如含锂纽扣电池请重新核对）。" } ], "sources": [ { "name": "UN Manual of Tests and Criteria, subsection 38.3", "authority": "UNECE", "url": "https://unece.org/transport/dangerous-goods/rev7-files" } ], "review_status": "source_checked", "review_note": "2026-07-06: Mirror of un383-when-lithium — the 38.3 trigger is lithium cells/batteries specifically (confirmed via 49 CFR 173.185(a)(1) on ecfr.gov), so non-lithium battery types (button/coin, other) are correctly excluded here." }, { "id": "eu-battery-passport-scope", "category": "battery-electronics", "markets": [ "EU" ], "when": { "has_battery": true }, "adds": [], "not_applicable": [ { "text_en": "The EU battery passport (Art. 77, from 18 February 2027) is not triggered by portable batteries in consumer electronics — its scope is LMT batteries, industrial batteries above 2 kWh, and EV batteries.", "text_zh": "欧盟电池护照（第77条，2027年2月18日起）不因消费电子中的便携式电池而触发——其范围为LMT电池、2千瓦时以上的工业电池和电动汽车电池。" } ], "sources": [ { "name": "Regulation (EU) 2023/1542, Art. 77", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2023/1542/oj" }, { "name": "EUR-Lex legislative summary of 2023/1542", "authority": "European Union", "url": "https://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX:32023R1542" } ], "review_status": "source_checked", "review_note": "2026-07-05: Art. 77(1) confirmed word-for-word in the EUR-Lex full text — 18 February 2027, LMT/industrial >2 kWh/EV scope (see changelog 0.7.0). Portable exclusion follows from that scope enumeration." }, { "id": "eu-removability-when-battery", "category": "battery-electronics", "markets": [ "EU" ], "when": { "has_battery": true }, "adds": [ { "text_en": "From 18 February 2027, portable batteries in appliances must be removable and replaceable by the end user (Art. 11) — a product-design obligation worth checking now for products still on sale then.", "text_zh": "自2027年2月18日起，器具中的便携式电池须可由最终用户拆卸更换（第11条）——届时仍在售的产品现在就应核对该设计义务。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Regulation (EU) 2023/1542, Art. 11", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2023/1542/oj" } ], "review_status": "source_checked", "review_note": "2026-07-05: Date confirmed in the EUR-Lex full text — Art. 96(2)(a): 'Article 11 shall apply from 18 February 2027' (see changelog 0.7.0)." }, { "id": "us-fcc-certification-when-radio", "category": "battery-electronics", "markets": [ "US" ], "when": { "has_radio": true }, "adds": [ { "text_en": "Intentional radiators (Bluetooth/Wi-Fi) require FCC certification through a Telecommunication Certification Body, resulting in an FCC ID on the device.", "text_zh": "有意辐射设备（蓝牙/Wi-Fi）须经电信认证机构(TCB)完成FCC认证，设备须标注FCC ID。", "classification": "legal_requirement" } ], "not_applicable": [ { "text_en": "The self-declaration SDoC route alone is not sufficient for intentional radiators.", "text_zh": "对有意辐射设备，仅走SDoC自我声明路径并不足够。" } ], "sources": [ { "name": "FCC Part 15 equipment authorization", "authority": "Federal Communications Commission", "url": "https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15" } ], "review_status": "partially_checked", "review_note": "2026-07-05: FCC authorization-route conditionality was reviewed in the 0.2.0 editorial pass of the battery-electronics-us record; ecfr.gov blocks automated re-checks." }, { "id": "us-fcc-sdoc-when-no-radio", "category": "battery-electronics", "markets": [ "US" ], "when": { "has_radio": false }, "adds": [ { "text_en": "Digital devices without radio functionality follow the FCC Supplier's Declaration of Conformity (SDoC), which requires a US-based responsible party.", "text_zh": "无无线功能的数字设备走FCC供应商符合性声明(SDoC)路径，须有美国境内责任方。", "classification": "legal_requirement" } ], "not_applicable": [ { "text_en": "TCB certification and an FCC ID are not required for unintentional radiators (based on the declared profile).", "text_zh": "根据所申报属性，非有意辐射设备无需TCB认证和FCC ID。" } ], "sources": [ { "name": "FCC Part 15 equipment authorization", "authority": "Federal Communications Commission", "url": "https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15" } ], "review_status": "partially_checked", "review_note": "2026-07-05: SDoC US-responsible-party requirement reviewed in the 0.2.0 editorial pass; ecfr.gov blocks automated re-checks." }, { "id": "us-dot-when-lithium", "category": "battery-electronics", "markets": [ "US" ], "when": { "battery_type": [ "lithium_ion" ] }, "adds": [ { "text_en": "US domestic transport of lithium batteries follows DOT/PHMSA rules at 49 CFR 173.185, in addition to the UN 38.3 test summary.", "text_zh": "锂电池在美国境内运输须遵守DOT/PHMSA的49 CFR 173.185规则，UN 38.3测试摘要另行适用。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "49 CFR 173.185 lithium batteries", "authority": "US Department of Transportation", "url": "https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-E/section-173.185" } ], "review_status": "source_checked", "review_note": "2026-07-06: Confirmed directly on ecfr.gov (loads fine; get_page_text only grabs the nav sidebar here, so full text was pulled via in-page JS). Section title is exactly 'Lithium cells and batteries'; 173.185(a)(1) cites UN 38.3 by name for classification, and 173.185(a)(3) adds the manufacturer/distributor test-summary requirement. Confirms both halves of the rule's claim (DOT/PHMSA rule + UN 38.3 test summary)." }, { "id": "uk-radio-regs-when-radio", "category": "battery-electronics", "markets": [ "UK" ], "when": { "has_radio": true }, "adds": [ { "text_en": "The Radio Equipment Regulations 2017 are the GB conformity route for radio products; UKCA or CE marking is accepted.", "text_zh": "《2017年无线电设备条例》是无线产品的大不列颠符合性路径；UKCA或CE标志均可接受。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Radio Equipment Regulations 2017", "authority": "OPSS / Ofcom", "url": "https://www.legislation.gov.uk/uksi/2017/1206/contents" } ], "review_status": "partially_checked", "review_note": "2026-07-05: Instrument and UKCA/CE acceptance reviewed in the 0.2.0 editorial pass of the battery-electronics-uk record." }, { "id": "uk-plug-when-charger", "category": "battery-electronics", "markets": [ "UK" ], "when": { "includes_mains_charger": true }, "adds": [ { "text_en": "A supplied mains charger for the UK must have a BS 1363 (UK three-pin) plug under the Plugs and Sockets etc. (Safety) Regulations 1994 — shipping EU two-pin plugs with a travel adaptor is a known enforcement trigger.", "text_zh": "随附英国市场的市电充电器须符合《1994年插头插座（安全）条例》，使用BS 1363英式三脚插头——附欧规两脚插头加转换头是已知的执法触发点。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Plugs and Sockets etc. (Safety) Regulations 1994", "authority": "OPSS", "url": "https://www.legislation.gov.uk/uksi/1994/1768/contents" } ], "review_status": "source_checked", "review_note": "2026-07-06: Confirmed via the full legislation text (browser JS-execution was blocked on this domain; fetched successfully instead). Regulation 12(1) requires appliances to be fitted with a 'standard plug' (three rectangular pins to BS 1363) complying with regulations 6(2) and 8. Regulation 12(2)'s only alternative route is a non-UK plug (IEC 884-1) fitted with a notified-body-approved conversion plug that 'encloses the fitted non-UK plug and can only be removed by the use of a tool' — a loose travel adaptor bought separately does not meet this, confirming the pitfall about shipping EU two-pin plugs with a generic travel adaptor." }, { "id": "au-button-batteries-when-coin", "category": "battery-electronics", "markets": [ "AU" ], "when": { "battery_type": [ "button_coin" ] }, "adds": [ { "text_en": "Australia's mandatory button/coin battery standards apply: secure battery compartments, child-resistant packaging and warnings — they cover all consumer goods with button/coin batteries, not only toys.", "text_zh": "澳大利亚纽扣电池强制标准适用：电池仓须牢固、包装须防儿童开启并附警示——覆盖所有含纽扣电池的消费品，不限于玩具。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Button and coin battery mandatory standards", "authority": "ACCC", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/button-and-coin-batteries" } ], "review_status": "source_checked", "review_note": "2026-07-05: Scope (all consumer goods with button/coin batteries) confirmed directly against the ACCC mandatory-standard page." }, { "id": "au-eess-when-charger", "category": "battery-electronics", "markets": [ "AU" ], "when": { "includes_mains_charger": true }, "adds": [ { "text_en": "A supplied mains charger is in-scope electrical equipment: EESS registration applies by risk level, and plug-pack chargers are commonly classified high-risk (Level 3) requiring certification before the RCM is applied.", "text_zh": "随附市电充电器属范围内电气设备：须按风险等级完成EESS注册，插墙式充电器通常被列为高风险(Level 3)，加贴RCM前须先取得认证。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Electrical Equipment Safety System (EESS)", "authority": "State electrical safety regulators", "url": "https://www.eess.gov.au/" } ], "review_status": "partially_checked", "review_note": "2026-07-06: Confirmed the general mechanics directly on eess.gov.au: in-scope equipment is defined by voltage band (50-1000V AC RMS / 120-1500V ripple-free DC) plus household/personal marketing; three risk levels exist; Level 3 (high risk) specifically requires a valid Certificate of Conformity from a recognised certifier issued before EESS registration, plus the RCM — matching the rule's 'certification before the RCM is applied' claim. Could not independently confirm the specific claim that 'plug-pack chargers are commonly classified high-risk (Level 3)': that requires checking the current AS/NZS 4417.2-based equipment list PDF, which is too large to search in full through available tools this pass. Leaving as partially_checked rather than overclaiming that one detail." }, { "id": "eu-toy-red-when-connected", "category": "toys", "markets": [ "EU" ], "when": { "has_radio": true }, "adds": [ { "text_en": "A connected toy that intentionally transmits or receives radio waves must be assessed under the Radio Equipment Directive as well as the applicable toy-safety rules; the EU declaration of conformity must cover every applicable Union act.", "text_zh": "有意发射或接收无线电波的联网玩具除适用玩具安全规则外，还须按《无线电设备指令》评估；欧盟符合性声明须涵盖所有适用的欧盟法规。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Radio Equipment Directive 2014/53/EU, Articles 2, 10 and 18", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2014/53/oj/eng" }, { "name": "Toy Safety Directive 2009/48/EC", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2009/48/oj/eng" } ], "review_status": "source_checked", "review_note": "2026-07-06: RED definition of radio equipment, conformity assessment and single-declaration rule checked against Articles 2, 10 and 18; toy obligations remain separately applicable." }, { "id": "eu-toy-small-parts-under-three", "category": "toys", "markets": [ "EU" ], "when": { "age_group": "under_3", "accessible_small_parts": true }, "adds": [ { "text_en": "A toy intended for children under 36 months must not have components or detachable parts small enough to be swallowed or inhaled. Accessible small parts are a launch-blocking design and testing issue, not something cured by a warning.", "text_zh": "供36个月以下儿童使用的玩具，其部件或可拆卸部件不得小到可能被吞咽或吸入。可触及小部件属于阻止上市的设计与测试问题，不能仅靠警示语解决。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Toy Safety Directive 2009/48/EC, Annex II Part I(4)(d)", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2009/48/oj/eng" } ], "review_status": "source_checked", "review_note": "2026-07-06: Under-36-month small-part rule checked directly against Annex II Part I(4)(d)." }, { "id": "eu-toy-small-parts-age-warning", "category": "toys", "markets": [ "EU" ], "when": { "age_group": "3_to_13", "accessible_small_parts": true }, "adds": [ { "text_en": "If small parts make the toy dangerous for children under 36 months, the prescribed age warning and the specific hazard must be visible before purchase, including online; the warning must not contradict the toy's intended use.", "text_zh": "如小部件会对36个月以下儿童造成危险，规定的年龄警示及具体危险须在购买前（包括线上）清晰可见；警示不得与玩具的预期用途相矛盾。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Toy Safety Directive 2009/48/EC, Article 11 and Annex V", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2009/48/oj/eng" } ], "review_status": "source_checked", "review_note": "2026-07-06: Warning placement, online visibility and under-36-month wording checked against Article 11 and Annex V." }, { "id": "eu-toy-unsecured-battery-compartment", "category": "toys", "markets": [ "EU" ], "when": { "has_battery": true, "battery_compartment_security": "unsecured" }, "adds": [ { "text_en": "An unsecured battery compartment creates foreseeable electrical, ingestion and choking hazards. Stop the launch, redesign the closure, then repeat the applicable mechanical and electrical-toy tests.", "text_zh": "未可靠固定的电池仓会造成可预见的电气、误吞与窒息风险。应暂停上市、重新设计闭合结构，并重新进行适用的机械与电动玩具测试。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Toy Safety Directive 2009/48/EC, Article 10 and Annex II", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2009/48/oj/eng" }, { "name": "European Commission harmonised standards for toy safety", "authority": "European Commission", "url": "https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/toy-safety_en" } ], "review_status": "partially_checked", "review_note": "2026-07-06: The Directive's foreseeable-use, choking and electrical-hazard duties were checked. The exact closure/test method depends on the current applicable harmonised standard and product design, so this is a compliance measure rather than a universal two-action claim." }, { "id": "eu-toy-lithium-transport", "category": "toys", "markets": [ "EU" ], "when": { "battery_type": "lithium_ion" }, "adds": [ { "text_en": "A UN 38.3 lithium cell or battery test summary must be available for the transport configuration before shipment.", "text_zh": "装运前须针对运输配置备有UN 38.3锂电芯或电池测试摘要。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "UN Manual of Tests and Criteria, subsection 38.3.5", "authority": "UNECE", "url": "https://unece.org/DAM/trans/danger/publi/manual/Rev.6/ST-SG-AC10-11-Rev6-Amend1e.pdf" } ], "review_status": "source_checked", "review_note": "2026-07-06: Subsection 38.3.5 checked for the requirement that the lithium cell or battery test summary be made available." }, { "id": "eu-toy-chemical-assessment-incomplete", "category": "toys", "markets": [ "EU" ], "when": { "toy_chemical_assessment_complete": false }, "adds": [ { "text_en": "Before placing the toy on the market, complete the safety assessment covering chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to them.", "text_zh": "玩具上市前须完成安全评估，覆盖化学、物理、机械、电气、易燃性、卫生和放射性危害及其潜在暴露。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Toy Safety Directive 2009/48/EC, Article 18", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2009/48/oj/eng" } ], "review_status": "source_checked", "review_note": "2026-07-06: Safety-assessment hazard categories and timing checked directly against Article 18." }, { "id": "eu-toy-german-warning-copy", "category": "toys", "markets": [ "EU" ], "when": { "eu_destination": "DE" }, "adds": [ { "text_en": "Prepare German-language warnings and safety instructions for the Germany launch, and verify the final wording against the applicable German implementation and product-specific hazards.", "text_zh": "德国首发应准备德语警示与安全说明，并按德国实施要求及产品具体危险核对最终措辞。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Toy Safety Directive 2009/48/EC, Articles 4(7) and 11(3)", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2009/48/oj/eng" } ], "review_status": "partially_checked", "review_note": "2026-07-06: The Directive's member-state-language rule was checked. Germany-specific implementation wording remains to be reviewed before this rule can be source_checked." }, { "id": "us-toy-small-parts-ban-under3", "category": "toys", "markets": [ "US" ], "when": { "age_group": "under_3", "accessible_small_parts": true }, "adds": [ { "text_en": "For toys intended for children under 36 months, small parts are banned outright (not just warned about) under the 16 CFR part 1501 small-parts test method — this is stricter than the general 3-13 age band, which only requires a warning.", "text_zh": "供36个月以下儿童使用的玩具，小部件依16 CFR part 1501小部件测试方法被直接禁止（而非仅需警示）——比3至13岁段仅需警示的要求更严格。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "16 CFR part 1501, Small parts regulation", "authority": "US Consumer Product Safety Commission (CPSC)", "url": "https://www.ecfr.gov/current/title-16/chapter-II/subchapter-C/part-1501" } ], "review_status": "source_checked", "review_note": "2026-07-06: 16 CFR 1501's under-36-months small-parts ban was already checked against the toys-us requirements record (source_checked, last_verified 2026-07-05); this rule restates it in attribute-conditional form. Not re-fetched this pass." }, { "id": "us-toy-small-parts-warning-3to13", "category": "toys", "markets": [ "US" ], "when": { "age_group": "3_to_13", "accessible_small_parts": true }, "adds": [ { "text_en": "For toys intended for children aged 3 to 13 with accessible small parts, a choking hazard warning is required under 16 CFR 1500.19 — the part is not banned, but the warning is mandatory and must appear before purchase.", "text_zh": "供3至13岁儿童使用、含可触及小部件的玩具，须依16 CFR 1500.19标注窒息危险警示——部件本身不禁止，但警示为强制要求且须在购买前可见。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "16 CFR 1500.19, Small parts choking hazard labeling", "authority": "US Consumer Product Safety Commission (CPSC)", "url": "https://www.ecfr.gov/current/title-16/chapter-II/subchapter-B/part-1500/section-1500.19" } ], "review_status": "source_checked", "review_note": "2026-07-06: 16 CFR 1500.19 warning requirement was already checked against the toys-us requirements record (source_checked, last_verified 2026-07-05); this rule restates it in attribute-conditional form. Not re-fetched this pass." }, { "id": "us-toy-radio-fcc-when-connected", "category": "toys", "markets": [ "US" ], "when": { "has_radio": true }, "adds": [ { "text_en": "A connected toy with Bluetooth/Wi-Fi or another intentional radio transmitter needs FCC equipment authorization (TCB certification, FCC ID) in addition to CPSC toy-safety testing — the same intentional-radiator route that applies to battery-electronics products.", "text_zh": "含蓝牙/Wi-Fi或其他有意无线电发射功能的联网玩具，除CPSC玩具安全测试外还须完成FCC设备授权（TCB认证、FCC ID）——与带电电子产品适用的有意辐射设备路径相同。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "FCC Part 15 equipment authorization", "authority": "Federal Communications Commission", "url": "https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15" } ], "review_status": "partially_checked", "review_note": "2026-07-06: Mirrors the us-fcc-certification-when-radio rule already used for battery-electronics; the intentional-radiator/TCB requirement itself was reviewed in the 0.2.0 editorial pass, but the toy-specific interaction with CPSC's ASTM F963 electronics/radio provisions has not been independently re-checked." }, { "id": "us-toy-lithium-un383", "category": "toys", "markets": [ "US" ], "when": { "battery_type": "lithium_ion" }, "adds": [ { "text_en": "A lithium battery inside or supplied with the toy needs a UN 38.3 test summary before transport, plus compliance with US domestic DOT/PHMSA rules at 49 CFR 173.185 for any US-leg shipping.", "text_zh": "玩具内置或随附的锂电池运输前须备有UN 38.3测试摘要，美国境内运输段还须遵守DOT/PHMSA的49 CFR 173.185规则。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "49 CFR 173.185 lithium batteries", "authority": "US Department of Transportation", "url": "https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-E/section-173.185" } ], "review_status": "source_checked", "review_note": "2026-07-06: 49 CFR 173.185 (citing UN 38.3 by name at 173.185(a)(1) and requiring a test summary at 173.185(a)(3)) was directly confirmed on ecfr.gov this pass — see us-dot-when-lithium in this same file for the battery-electronics version of this check." }, { "id": "us-toy-cbp-efiling-cpc", "category": "toys", "markets": [ "US" ], "when": { "age_group": "under_3" }, "adds": [ { "text_en": "Starting July 8, 2026, importers must eFile certificates of compliance (including the toy's Children's Product Certificate) with US Customs and Border Protection via a Partner Government Agency Message Set, in addition to keeping the CPC available on request.", "text_zh": "自2026年7月8日起，进口商须通过PGA消息集向美国海关电子申报符合性证书（含玩具的儿童产品证书CPC），并仍须应要求提供CPC备查。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Children's Product Certificate — CBP eFiling requirement", "authority": "CPSC / US Customs and Border Protection (CBP)", "url": "https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Childrens-Product-Certificate" } ], "review_status": "partially_checked", "review_note": "2026-07-06: The July 8, 2026 CBP eFiling requirement was confirmed directly on cpsc.gov (see toys-us requirements record, last_verified 2026-07-05) and applies to children's products broadly, not only the under-3 age band; the age_group:under_3 condition here is a placeholder trigger reusing an existing profile field rather than a precisely-scoped condition, since this system has no general 'is_childrens_product' field. Flagging the approximation rather than overclaiming precision." }, { "id": "uk-toy-radio-when-connected", "category": "toys", "markets": [ "UK" ], "when": { "has_radio": true }, "adds": [ { "text_en": "A connected toy with a radio transmitter needs conformity with the Radio Equipment Regulations 2017 (the GB radio route) in addition to the Toys (Safety) Regulations 2011; UKCA or CE marking is accepted for both.", "text_zh": "含无线发射功能的联网玩具除《2011年玩具（安全）条例》外，还须符合《2017年无线电设备条例》（大不列颠无线电路径）；UKCA或CE标志均可接受。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Radio Equipment Regulations 2017", "authority": "OPSS / Ofcom", "url": "https://www.legislation.gov.uk/uksi/2017/1206/contents" }, { "name": "Toys (Safety) Regulations 2011", "authority": "UK Office for Product Safety and Standards (OPSS)", "url": "https://www.legislation.gov.uk/uksi/2011/1881/contents" } ], "review_status": "partially_checked", "review_note": "2026-07-06: Mirrors the uk-radio-regs-when-radio rule already used for battery-electronics (instrument and UKCA/CE acceptance reviewed in the 0.2.0 editorial pass); the toy-specific dual-regulation interaction has not been independently re-checked this pass." }, { "id": "uk-toy-lithium-un383", "category": "toys", "markets": [ "UK" ], "when": { "battery_type": "lithium_ion" }, "adds": [ { "text_en": "A lithium battery inside or supplied with the toy needs a UN 38.3 test summary available before transport; UK carriers and forwarders request it at booking the same way EU/US carriers do.", "text_zh": "玩具内置或随附的锂电池运输前须备有UN 38.3测试摘要；英国承运人和货代订舱时同样会索要。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "UN Manual of Tests and Criteria, subsection 38.3", "authority": "UNECE", "url": "https://unece.org/transport/dangerous-goods/rev7-files" } ], "review_status": "source_checked", "review_note": "2026-07-06: UN 38.3's substantive test-summary requirement was confirmed this pass via 49 CFR 173.185 on ecfr.gov (see un383-when-lithium in this same file); the requirement is transport-mode rather than market-specific, so the same underlying check applies here." }, { "id": "uk-toy-small-parts-under3", "category": "toys", "markets": [ "UK" ], "when": { "age_group": "under_3", "accessible_small_parts": true }, "adds": [ { "text_en": "For toys intended for children under 36 months, accessible small parts are a design-and-test issue under BS EN 71-1 (harmonised with EU EN 71-1) as applied through the Toys (Safety) Regulations 2011 — not something a warning label alone can cure.", "text_zh": "供36个月以下儿童使用的玩具，可触及小部件依《2011年玩具（安全）条例》所援引的BS EN 71-1（与欧盟EN 71-1协调）属设计与测试问题——不能仅靠警示标签解决。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Toys (Safety) Regulations 2011", "authority": "UK Office for Product Safety and Standards (OPSS)", "url": "https://www.legislation.gov.uk/uksi/2011/1881/contents" } ], "review_status": "partially_checked", "review_note": "2026-07-06: Mirrors the EU under-36-months small-part rule (eu-toy-small-parts-under-three, checked against Directive 2009/48/EC Annex II Part I(4)(d)) on the basis that BS EN 71-1 is harmonised with EU EN 71-1 and the toys-uk requirements record confirms BS EN 71 harmonisation; the GB instrument's own text has not been independently re-read this pass." }, { "id": "uk-toy-battery-compartment-unsecured", "category": "toys", "markets": [ "UK" ], "when": { "has_battery": true, "battery_compartment_security": "unsecured" }, "adds": [ { "text_en": "An unsecured battery compartment is a foreseeable electrical, ingestion and choking hazard under the Toys (Safety) Regulations 2011 — stop the launch, redesign the closure, and retest against BS EN 71-1 and, for electric toys, BS EN 62115.", "text_zh": "未可靠固定的电池仓依《2011年玩具（安全）条例》构成可预见的电气、误吞与窒息风险——应暂停上市、重新设计闭合结构，并依BS EN 71-1及（电动玩具适用的）BS EN 62115复测。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Toys (Safety) Regulations 2011", "authority": "UK Office for Product Safety and Standards (OPSS)", "url": "https://www.legislation.gov.uk/uksi/2011/1881/contents" } ], "review_status": "partially_checked", "review_note": "2026-07-06: Mirrors the EU unsecured-battery-compartment rule (eu-toy-unsecured-battery-compartment); the GB instrument's own hazard-duty text has not been independently re-read this pass, so this is flagged rather than claimed as fully source_checked." }, { "id": "au-toy-mechanical-standard-under3", "category": "toys", "markets": [ "AU" ], "when": { "age_group": "under_3" }, "adds": [ { "text_en": "Toys for children up to 36 months old must meet the ACCC mandatory standard, based on sections of AS/NZS ISO 8124.1:2023 (with ISO 8124-1:2022, EN 71-1:2014+A1:2018 and ASTM F963-17 accepted as alternatives) — this is a mandatory, not voluntary, standard specific to this age band.", "text_zh": "面向36个月以下儿童的玩具须符合ACCC强制标准，该标准基于AS/NZS ISO 8124.1:2023部分条款（ISO 8124-1:2022、EN 71-1:2014+A1:2018及ASTM F963-17可作为替代标准）——这是针对该年龄段的强制（非自愿）标准。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Consumer Goods (Toys for Children up to 36 months) Safety Standard", "authority": "Australian Competition and Consumer Commission (ACCC)", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/toys-for-children-up-to-and-including-36-months-of-age" } ], "review_status": "source_checked", "review_note": "2026-07-06: The accepted-standards list (AS/NZS ISO 8124.1:2023 with ISO 8124-1/EN 71-1/ASTM F963-17 alternatives) was already checked directly against the ACCC mandatory-standard page for the toys-au requirements record (source_checked, last_verified 2026-07-05); this rule restates it in attribute-conditional form." }, { "id": "au-toy-button-battery-secure-compartment-under3", "category": "toys", "markets": [ "AU" ], "when": { "battery_type": "button_coin", "age_group": "under_3" }, "adds": [ { "text_en": "Beyond the general button/coin battery mandatory standard covering all consumer goods, toys for children up to 36 months have an additional requirement: the battery compartment must be secured so it can only be opened with a tool.", "text_zh": "在覆盖所有消费品的纽扣/硬币电池通用强制标准之外，供36个月以下儿童使用的玩具另需满足：电池仓须做到只能用工具才能打开。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Consumer Goods (Toys for Children up to 36 months) Safety Standard", "authority": "Australian Competition and Consumer Commission (ACCC)", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/toys-for-children-up-to-and-including-36-months-of-age" }, { "name": "Button and coin battery mandatory standards", "authority": "ACCC", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/button-and-coin-batteries" } ], "review_status": "source_checked", "review_note": "2026-07-06: The tool-required battery-compartment requirement for toys up to 36 months was already checked directly against the ACCC page for the toys-au requirements record (source_checked, last_verified 2026-07-05); this rule restates it in attribute-conditional form." }, { "id": "au-toy-electric-toy-standard", "category": "toys", "markets": [ "AU" ], "when": { "has_battery": true }, "adds": [ { "text_en": "Electric toys (battery-powered or mains-powered) must meet AS/NZS 62115:2018 in addition to the general mechanical/physical toy standard.", "text_zh": "电动玩具（电池供电或市电供电）除一般机械/物理玩具标准外，还须符合AS/NZS 62115:2018。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "AS/NZS 62115:2018 Electric toys", "authority": "Standards Australia", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/toys-for-children-up-to-and-including-36-months-of-age" } ], "review_status": "partially_checked", "review_note": "2026-07-06: AS/NZS 62115:2018's applicability to electric toys was already confirmed against the ACCC page for the toys-au requirements record. The 'has_battery: true' condition is used here as a proxy for 'electrically operated toy' since this system has no separate is_electric_toy field — mains-powered but battery-less toys (rare in this product set) would be missed by this condition. Flagging the approximation rather than overclaiming precision." }, { "id": "au-toy-battery-compartment-unsecured", "category": "toys", "markets": [ "AU" ], "when": { "has_battery": true, "battery_compartment_security": "unsecured" }, "adds": [ { "text_en": "An unsecured battery compartment on a toy creates a foreseeable choking, ingestion and electrical hazard under the general Australian Consumer Law safety obligations — stop the launch, redesign the closure, and retest against AS/NZS ISO 8124.1 and, for electric toys, AS/NZS 62115.", "text_zh": "玩具电池仓未可靠固定，依《澳大利亚消费者法》一般安全义务构成可预见的窒息、误吞与电气风险——应暂停上市、重新设计闭合结构，并依AS/NZS ISO 8124.1及（电动玩具适用的）AS/NZS 62115复测。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Consumer Goods (Toys for Children up to 36 months) Safety Standard", "authority": "Australian Competition and Consumer Commission (ACCC)", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/toys-for-children-up-to-and-including-36-months-of-age" } ], "review_status": "partially_checked", "review_note": "2026-07-06: Mirrors the EU/UK unsecured-battery-compartment rules; the general Australian Consumer Law safety-obligation framing (as opposed to a single named mandatory-standard clause) has not been independently re-checked this pass against a specific ACL provision." }, { "id": "cosmetics-therapeutic-claims-stop", "category": "cosmetics", "markets": [ "EU", "US", "UK", "AU" ], "when": { "claims_therapeutic": true }, "adds": [ { "text_en": "Therapeutic, disease-prevention or body-function claims are a launch-blocking classification issue: do not treat the SKU as an ordinary cosmetic until the medicines/drug/therapeutic-goods route is checked for the destination market.", "text_zh": "治疗、预防疾病或影响身体功能的宣称属于阻止上市的分类问题：在核对目标市场药品/治疗用品路径前，不应按普通化妆品处理该SKU。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "EU cosmetic products regulation and claims requirements", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2009/1223/oj" }, { "name": "FDA cosmetics and drugs classification guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap" }, { "name": "Australian industrial chemicals/cosmetics import guidance", "authority": "AICIS", "url": "https://www.industrialchemicals.gov.au/business/getting-started-cosmetics" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates the source-checked pitfall and classification claims in the cosmetics EU/US/UK/AU requirement records: therapeutic or drug-like claims can move a product out of ordinary cosmetic treatment and into medicinal/drug/therapeutic-goods pathways. This cross-market rule deliberately stops at classification triage rather than naming one universal approval route." }, { "id": "cosmetics-non-therapeutic-ordinary-route", "category": "cosmetics", "markets": [ "EU", "US", "UK", "AU" ], "when": { "claims_therapeutic": false }, "adds": [], "not_applicable": [ { "text_en": "Based on the declared profile, the special medicines/drug/therapeutic-goods route is not triggered by product claims alone; still re-check ingredients, SPF/sunscreen status and market-specific cosmetic duties.", "text_zh": "根据所申报属性，仅从产品宣称看，药品/治疗用品特殊路径未被触发；仍须核对成分、防晒/SPF状态及各市场化妆品义务。" } ], "sources": [ { "name": "EU Cosmetic Products Regulation (EC) No 1223/2009", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2009/1223/oj" }, { "name": "FDA cosmetics and drugs classification guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap" } ], "review_status": "source_checked", "review_note": "2026-07-07: Negative-scope counterpart to cosmetics-therapeutic-claims-stop. The exclusion is conditional only on declared claims; it does not exclude other triggers such as active ingredients, sunscreen/SPF treatment or destination-specific product type rules." }, { "id": "eu-uk-cosmetics-formula-not-reviewed", "category": "cosmetics", "markets": [ "EU", "UK" ], "when": { "ingredients_reviewed": false }, "adds": [ { "text_en": "Before EU/UK launch, complete the formula review against prohibited/restricted substances and feed it into the cosmetic safety report and Product Information File; an unreviewed formula is not ready for expert sign-off.", "text_zh": "欧盟/英国上市前须完成配方禁限用成分审核，并纳入化妆品安全报告和产品信息档案；未审核配方不能进入专家签核。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "EU Cosmetic Products Regulation (EC) No 1223/2009", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2009/1223/oj" }, { "name": "UK cosmetic products notification and responsible person guidance", "authority": "UK Office for Product Safety and Standards", "url": "https://www.gov.uk/guidance/submit-a-cosmetic-product-notification" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates source-checked cosmetics-eu and cosmetics-uk records covering formula restriction checks, safety report/PIF-style evidence and notification/responsible-person preparation." }, { "id": "eu-uk-cosmetics-responsible-person-when-seller", "category": "cosmetics", "markets": [ "EU", "UK" ], "when": { "supply_chain_role": "marketplace_seller" }, "adds": [ { "text_en": "A marketplace seller placing cosmetics in the EU/UK flow needs a named local Responsible Person before the product is placed on the market; their details must align with the safety file and notification.", "text_zh": "平台卖家将化妆品投放欧盟/英国市场前，需要指定当地责任人；责任人资料须与安全档案和通报信息一致。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "EU Cosmetic Products Regulation (EC) No 1223/2009", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2009/1223/oj" }, { "name": "UK submit a cosmetic product notification", "authority": "UK Office for Product Safety and Standards", "url": "https://www.gov.uk/guidance/submit-a-cosmetic-product-notification" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates the source-checked local-presence claims in cosmetics-eu and cosmetics-uk. The rule uses marketplace_seller as a practical high-risk trigger for cross-border sellers; manufacturer/importer roles can also carry responsibility depending on the transaction structure." }, { "id": "us-cosmetics-sunscreen-drug-route", "category": "cosmetics", "markets": [ "US" ], "when": { "is_sunscreen": true }, "adds": [ { "text_en": "In the US, sunscreen/SPF positioning can move the SKU into the OTC drug route rather than ordinary cosmetic-only treatment; check the drug facts, active ingredients and listing obligations before launch.", "text_zh": "在美国，防晒/SPF定位可能使SKU进入OTC药品路径，而非仅按普通化妆品处理；上市前须核对药品事实标签、活性成分和列名义务。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "FDA sunscreen products guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-sun" }, { "name": "FDA cosmetics and drugs classification guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates the source-checked US cosmetics record's sunscreen/SPF pitfall: sunscreen claims are not ordinary cosmetic-only treatment in the US." }, { "id": "au-cosmetics-sunscreen-therapeutic-goods-check", "category": "cosmetics", "markets": [ "AU" ], "when": { "is_sunscreen": true }, "adds": [ { "text_en": "In Australia, sunscreen/SPF positioning requires a separate sunscreen/therapeutic-goods classification check before treating the product as a normal cosmetic import.", "text_zh": "在澳大利亚，防晒/SPF定位须先进行防晒/治疗用品分类核对，不能直接按普通化妆品进口处理。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "AICIS cosmetics guidance", "authority": "Australian Industrial Chemicals Introduction Scheme", "url": "https://www.industrialchemicals.gov.au/business/getting-started-cosmetics" }, { "name": "TGA sunscreens regulatory guidance", "authority": "Therapeutic Goods Administration", "url": "https://www.tga.gov.au/products/sunscreens" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates the source-checked AU cosmetics record's sunscreen/SPF pitfall: sunscreen products can require treatment outside ordinary cosmetic import handling." }, { "id": "us-au-cosmetics-formula-not-reviewed", "category": "cosmetics", "markets": [ "US", "AU" ], "when": { "ingredients_reviewed": false }, "adds": [ { "text_en": "Complete an ingredient/formula screen before launch: the US and Australia both require checking that cosmetic ingredients and claims fit the permitted cosmetic pathway, even where there is no EU-style CPSR.", "text_zh": "上市前须完成成分/配方筛查：美国与澳大利亚均需核对成分和宣称是否落入允许的化妆品路径，即使没有欧盟式CPSR。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "FDA cosmetics laws and regulations", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations" }, { "name": "AICIS getting started with cosmetics", "authority": "Australian Industrial Chemicals Introduction Scheme", "url": "https://www.industrialchemicals.gov.au/business/getting-started-cosmetics" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates source-checked cosmetics-us and cosmetics-au ingredient/formula screening claims. It is framed as a compliance measure because exact filings depend on ingredient status and business role." }, { "id": "eu-uk-food-contact-plastic-hot-use", "category": "food-contact", "markets": [ "EU", "UK" ], "when": { "food_contact_material": "plastic", "contact_temperature": [ "hot_fill", "cooking_reheating" ] }, "adds": [ { "text_en": "Plastic food-contact goods intended for hot fill, cooking or reheating need migration evidence for the actual use conditions and a declaration of compliance before EU/UK launch.", "text_zh": "拟用于热灌装、烹饪或复热的塑料食品接触产品，在欧盟/英国上市前须按实际使用条件准备迁移测试证据和符合性声明。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Regulation (EU) No 10/2011 on plastic food contact materials", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2011/10/oj" }, { "name": "UK food contact materials guidance", "authority": "Food Standards Agency", "url": "https://www.food.gov.uk/business-guidance/food-contact-materials-regulations" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates source-checked food-contact-eu and food-contact-uk records for plastic FCM, migration evidence and declaration/documentation duties; the hot-use trigger narrows the rule to higher-risk actual-use conditions." }, { "id": "eu-uk-food-contact-doc-needed", "category": "food-contact", "markets": [ "EU", "UK" ], "when": { "food_contact_material": [ "plastic", "multi_material" ] }, "adds": [ { "text_en": "For plastic or multi-material food-contact goods, prepare the declaration of compliance, supplier declarations and traceability file; missing upstream composition data blocks meaningful migration review.", "text_zh": "塑料或多材料食品接触产品须准备符合性声明、供应商声明与追溯档案；缺少上游组成资料会阻碍迁移评估。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "EU food contact materials framework regulation", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2004/1935/oj" }, { "name": "Regulation (EU) No 10/2011 on plastic food contact materials", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2011/10/oj" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates source-checked food-contact-eu/uk records covering declaration, traceability and supplier evidence. Multi-material goods are included as a conservative trigger because plastic layers/components may be present." }, { "id": "us-food-contact-fda-status-needed", "category": "food-contact", "markets": [ "US" ], "when": { "food_contact_material": [ "plastic", "silicone_rubber", "multi_material" ] }, "adds": [ { "text_en": "For US food-contact goods, document the FDA status or clearance basis for each food-contact substance and match it to the intended food type, temperature and duration of use.", "text_zh": "美国食品接触产品须记录每种食品接触物质的FDA状态或许可依据，并与预期食品类型、温度和接触时间匹配。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "FDA food contact substances inventory and notifications", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-contact-substances-fcs" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates the source-checked food-contact-us record's FDA-status/use-condition requirement. The material condition targets common synthetic food-contact materials where substance status is usually the gating question." }, { "id": "us-food-contact-hot-use-migration", "category": "food-contact", "markets": [ "US" ], "when": { "contact_temperature": [ "hot_fill", "cooking_reheating" ] }, "adds": [ { "text_en": "Hot-fill, cooking or reheating uses require use-condition-specific migration/extractives evidence; ambient-use evidence should not be reused without a technical justification.", "text_zh": "热灌装、烹饪或复热用途需要按使用条件准备迁移/浸提证据；不能在没有技术理由的情况下复用常温用途证据。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "FDA chemistry recommendations for food contact notifications", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/chemistry-recommendations-food-contact-notifications" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates source-checked food-contact-us testing/use-condition claims. Framed as a compliance measure because the exact protocol depends on material, food type and contact duration." }, { "id": "au-food-contact-material-suitability", "category": "food-contact", "markets": [ "AU" ], "when": { "food_contact_material": [ "plastic", "silicone_rubber", "multi_material" ] }, "adds": [ { "text_en": "For Australia, prepare material-suitability and chemical-migration evidence for the intended food-contact use; the current AU record is only partially checked, so escalate source review before relying on it for launch decisions.", "text_zh": "澳大利亚食品接触产品须按预期用途准备材料适用性和化学迁移证据；当前澳大利亚记录仅部分核验，上市决策前应升级来源复核。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "FSANZ food packaging and food contact materials", "authority": "Food Standards Australia New Zealand", "url": "https://www.foodstandards.gov.au/business/packaging" } ], "review_status": "partially_checked", "review_note": "2026-07-07: Mirrors the partially_checked food-contact-au requirement record. This rule intentionally carries partial confidence and tells agents to escalate source review before launch decisions." }, { "id": "food-contact-repeated-use-retaining-evidence", "category": "food-contact", "markets": [ "EU", "US", "UK", "AU" ], "when": { "repeated_use": "repeated_use" }, "adds": [ { "text_en": "Repeated-use food-contact goods need evidence that covers repeated exposure, cleaning and foreseeable wear; a single-use packaging file is not enough unless the lab or assessor justifies equivalence.", "text_zh": "重复使用食品接触产品的证据须覆盖重复接触、清洗和可预见磨损；一次性包装证据不足以直接替代，除非实验室或评估方说明等同性。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "EU framework regulation for food contact materials", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2004/1935/oj" }, { "name": "FDA food contact substances guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-contact-substances-fcs" } ], "review_status": "partially_checked", "review_note": "2026-07-07: Cross-market practical rule derived from source-checked EU/US records plus partially_checked AU coverage. Exact repeat-use simulation conditions depend heavily on material and standard, so this remains partially_checked." }, { "id": "cosmetics-non-therapeutic-claim-substantiation", "category": "cosmetics", "markets": [ "EU", "US", "UK", "AU" ], "when": { "claims_therapeutic": false }, "adds": [ { "text_en": "Even without therapeutic claims, cosmetic benefit claims still need substantiation and must not mislead consumers or imply an unapproved medicinal/drug/therapeutic function.", "text_zh": "即使没有治疗性宣称，化妆品功效宣称仍须有支持依据，且不得误导消费者或暗示未经批准的药品/治疗功能。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "EU common criteria for cosmetic claims", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2013/655/oj" }, { "name": "FDA cosmetics labeling claims guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates source-checked claim-substantiation and label/pitfall claims in the cosmetics records. This rule is positive even when therapeutic claims are false because ordinary cosmetic claims still require support and truthful presentation." }, { "id": "us-cosmetics-manufacturer-importer-mocra", "category": "cosmetics", "markets": [ "US" ], "when": { "supply_chain_role": [ "manufacturer", "importer" ] }, "adds": [ { "text_en": "US manufacturers/importers should check MoCRA facility registration, product listing, adverse-event and safety-substantiation duties before launch; the exact duty depends on business role and exemptions.", "text_zh": "美国制造商/进口商上市前应核对MoCRA设施注册、产品列名、不良事件和安全支持义务；具体义务取决于业务角色和豁免。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "FDA Modernization of Cosmetics Regulation Act (MoCRA)", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates the source-checked cosmetics-us record's facility registration/product listing/adverse-event/safety-substantiation claims. Role-specific exemptions are intentionally not collapsed into a universal mandate." }, { "id": "au-cosmetics-importer-aicis-check", "category": "cosmetics", "markets": [ "AU" ], "when": { "supply_chain_role": [ "importer", "marketplace_seller" ] }, "adds": [ { "text_en": "An Australian importer or cross-border marketplace seller should check AICIS industrial-chemical introduction obligations for the ingredients before treating the product as ready for sale.", "text_zh": "澳大利亚进口商或跨境平台卖家在销售前，应核对产品成分是否触发AICIS工业化学品引入义务。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "AICIS getting started with cosmetics", "authority": "Australian Industrial Chemicals Introduction Scheme", "url": "https://www.industrialchemicals.gov.au/business/getting-started-cosmetics" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates the source-checked cosmetics-au record's AICIS ingredient/introduction pathway. The marketplace_seller trigger is a conservative cross-border seller proxy; local role still needs factual confirmation." }, { "id": "cosmetics-sunscreen-na-when-no-spf", "category": "cosmetics", "markets": [ "US", "AU" ], "when": { "is_sunscreen": false }, "adds": [], "not_applicable": [ { "text_en": "Based on the declared profile, sunscreen/SPF-specific drug or therapeutic-goods treatment is not triggered by SPF positioning alone; re-check if the label, listing or marketing later adds sun-protection claims.", "text_zh": "根据所申报属性，仅从SPF/防晒定位看，未触发防晒药品或治疗用品路径；如标签、上架信息或营销后续加入防晒宣称须重新核对。" } ], "sources": [ { "name": "FDA sunscreen products guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-sun" }, { "name": "TGA sunscreens regulatory guidance", "authority": "Therapeutic Goods Administration", "url": "https://www.tga.gov.au/products/sunscreens" } ], "review_status": "source_checked", "review_note": "2026-07-07: Negative-scope counterpart to the US/AU sunscreen rules. It excludes the sunscreen-specific trigger only, not other drug/therapeutic classification triggers." }, { "id": "eu-uk-food-contact-ceramic-glass-migration", "category": "food-contact", "markets": [ "EU", "UK" ], "when": { "food_contact_material": "ceramic_glass" }, "adds": [ { "text_en": "Ceramic or glass food-contact goods need material-specific migration/leaching evidence and label/use instructions that match the final article, not a generic plastic FCM file.", "text_zh": "陶瓷或玻璃食品接触产品需要与材料和最终成品匹配的迁移/溶出证据及标签/使用说明，不能使用通用塑料FCM文件替代。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "EU food contact materials framework regulation", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2004/1935/oj" }, { "name": "UK food contact materials guidance", "authority": "Food Standards Agency", "url": "https://www.food.gov.uk/business-guidance/food-contact-materials-regulations" } ], "review_status": "source_checked", "review_note": "2026-07-07: Restates source-checked EU/UK food-contact material-specific testing and labelling claims. Exact ceramic/glass limits depend on the applicable measure and product facts, so this rule keeps the claim at evidence-routing level." }, { "id": "food-contact-paper-board-composition-review", "category": "food-contact", "markets": [ "EU", "US", "UK", "AU" ], "when": { "food_contact_material": "paper_board" }, "adds": [ { "text_en": "Paper/board food-contact goods need composition, coating/ink/adhesive and intended-use review; do not assume paper is low-risk if coatings or recycled content contact food.", "text_zh": "纸/纸板食品接触产品须审核组成、涂层/油墨/胶黏剂及预期用途；如涂层或再生成分接触食品，不应假定纸材低风险。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "EU framework regulation for food contact materials", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2004/1935/oj" }, { "name": "FDA food contact substances guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-contact-substances-fcs" }, { "name": "FSANZ food packaging and food contact materials", "authority": "Food Standards Australia New Zealand", "url": "https://www.foodstandards.gov.au/business/packaging" } ], "review_status": "partially_checked", "review_note": "2026-07-07: Cross-market material-routing rule derived from food-contact records. Paper/board specifics vary heavily by coating, ink and recycled content; kept as partially_checked compliance routing rather than a universal legal conclusion." }, { "id": "food-contact-metal-material-release-review", "category": "food-contact", "markets": [ "EU", "US", "UK", "AU" ], "when": { "food_contact_material": "metal" }, "adds": [ { "text_en": "Metal food-contact goods need alloy/coating and corrosion or metal-release review matched to the intended food and temperature; supplier material declarations alone are not enough for launch readiness.", "text_zh": "金属食品接触产品须按预期食品和温度审核合金/涂层、腐蚀或金属释放风险；仅有供应商材料声明不足以证明上市准备度。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "EU framework regulation for food contact materials", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2004/1935/oj" }, { "name": "FDA food contact substances guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-contact-substances-fcs" } ], "review_status": "partially_checked", "review_note": "2026-07-07: Cross-market material-routing rule derived from the general FCM safety and substance-status records. Metal-specific test pathways depend on alloy/coating and use condition, so this remains partially_checked." }, { "id": "food-contact-ambient-single-use-scope", "category": "food-contact", "markets": [ "EU", "US", "UK", "AU" ], "when": { "contact_temperature": "ambient", "repeated_use": "single_use" }, "adds": [], "not_applicable": [ { "text_en": "Based on the declared profile, hot-use and repeated-use evidence triggers are not raised; still check material composition, food type, contact duration and destination-specific declaration/labelling duties.", "text_zh": "根据所申报属性，未触发热用途和重复使用证据路径；仍须核对材料组成、食品类型、接触时间以及目标市场声明/标签义务。" } ], "sources": [ { "name": "EU framework regulation for food contact materials", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2004/1935/oj" }, { "name": "FDA food contact substances guidance", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-contact-substances-fcs" } ], "review_status": "partially_checked", "review_note": "2026-07-07: Negative-scope rule for two declared attributes only. It deliberately does not exclude material-specific, food-type or destination documentation duties." }, { "id": "au-food-contact-hot-use-escalation", "category": "food-contact", "markets": [ "AU" ], "when": { "contact_temperature": [ "hot_fill", "cooking_reheating" ] }, "adds": [ { "text_en": "For Australia, hot-fill, cooking or reheating use should be escalated for material- and temperature-specific review because AU food-contact coverage is currently partially checked in this dataset.", "text_zh": "澳大利亚热灌装、烹饪或复热用途应升级进行材料与温度专项复核，因为本数据集中澳大利亚食品接触覆盖当前为部分核验。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "FSANZ food packaging and food contact materials", "authority": "Food Standards Australia New Zealand", "url": "https://www.foodstandards.gov.au/business/packaging" } ], "review_status": "partially_checked", "review_note": "2026-07-07: AU hot-use escalation rule tied to the partially_checked food-contact-au record; it tells agents to route the case to source review rather than treating AU coverage as fully verified." } ] }