{ "dataset_version": "0.10.0-beta", "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": 70, "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": "source_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. 2026-07-11: Fetched ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15 directly in a browser (the earlier block was on automated curl/bash access, not browser fetches). Section 15.201(b): 'all intentional radiators operating under the provisions of this part shall be certified by the Telecommunication Certification Bodies pursuant to the procedures in subpart J of part 2 of this chapter prior to marketing.' Section 15.201(a) limits the SDoC route to a narrow carve-out (carrier current systems and a few named low-power device classes), confirming both the 'adds' claim (TCB certification, FCC ID) and the 'not_applicable' claim (SDoC alone is not sufficient) for ordinary Bluetooth/Wi-Fi devices." }, { "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": "source_checked", "review_note": "2026-07-05: SDoC US-responsible-party requirement reviewed in the 0.2.0 editorial pass. 2026-07-11: Confirmed directly on ecfr.gov: Section 15.101 sets out the SDoC procedure (subpart J of part 2) for unintentional radiators, and 47 CFR 2.909/2.1077 (also fetched) define the 'responsible party' concept and require that the party responsible for compliance 'must be located in the United States' — matching both halves of this rule's claim." }, { "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": "source_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. 2026-07-11: Confirmed against legislation.gov.uk's current (revised) text of the RER 2017 — regs 10/44/44A show the GB route now runs on 'UK marking' (CE marking is the separate Northern Ireland route) — and against gov.uk's 'Placing UKCA or CE marked products on the market in Great Britain' guidance, which states plainly that 'the UK continues to recognise the CE marking, alongside or in place of the UKCA marking, for the Great Britain market under The Product Safety and Metrology (Amendment) Regulations 2024,' and lists the Radio Equipment Regulations 2017 in its Self Declaration of Conformity table. Both UKCA and CE remain accepted routes for GB radio equipment; the rule's claim holds." }, { "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": "source_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. 2026-07-11: Closed the remaining gap. The v4.3 in-scope equipment/risk-level PDF (eess.gov.au) lists 'Power supply or charger' (class specification incl. AS/NZS 61558.2.6/.2.16, AS/NZS 60335.2.29 for battery chargers) as an in-scope class, and EESS Information Bulletin #21-030 (Power supply / battery charger standards, Aug 2023) states directly: 'The power supply is a level 3 power supply in EESS – AS/NZS 4417.2', and its point 16 confirms the same class covers items marketed as 'wall charger, AC adaptor etc.' This confirms the 'plug-pack chargers are commonly classified high-risk (Level 3)' claim." }, { "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 under the toy safety requirements. Stop the launch and redesign the closure before relying on the evidence package.", "text_zh": "未可靠固定的电池仓会造成玩具安全要求下可预见的电气、误吞与窒息风险。应暂停上市并重新设计闭合结构，然后再依赖证据包。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Toy Safety Directive 2009/48/EC, Annex II Part I point 4 and Part IV points 2 and 4", "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": "source_checked", "review_note": "2026-07-16: Scoped to the directly verified legal duties only. Directive 2009/48/EC Annex II Part I point 4 covers choking, swallowing and inhalation hazards, while Part IV points 2 and 4 cover electrical insulation and foreseeable-fault protection. Specific tool-access or harmonised-standard test methods remain separate reviewer/lab evidence questions." }, { "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. Under Germany's 2. ProdSV (the national implementation of the Toy Safety Directive), warning and safety information must be drafted in German (§ 11(5)), must begin with the word \"Achtung\" (§ 11(3)), and age-restriction/purchase-relevant warnings under Annex V must be shown on the packaging or otherwise clearly visible before purchase, including online (§ 11(4)).", "text_zh": "德国首发应准备德语警示与安全说明。根据德国《2. ProdSV》（玩具安全指令的国内实施法规），警示与安全说明必须以德语撰写（第11条第5款），须以\"Achtung\"（注意）一词开头（第11条第3款），且附件V规定的与购买决定相关的年龄限制等警示须在包装上标明或在购买前以其他方式清晰可见，网购同样适用（第11条第4款）。", "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" }, { "name": "2. ProdSV (Verordnung über die Sicherheit von Spielzeug) § 11 - Warnhinweise", "authority": "Bundesministerium der Justiz (Germany)", "url": "https://www.gesetze-im-internet.de/gpsgv_2/__11.html" } ], "review_status": "source_checked", "review_note": "2026-07-16: Located and read Germany's national implementing regulation for the Toy Safety Directive, 2. ProdSV (Zweite Verordnung zum Produktsicherheitsgesetz). § 11(5) directly reads 'Warn- und Sicherheitshinweise sind in deutscher Sprache abzufassen' (warning and safety notices must be drafted in German), § 11(3) requires warnings to begin with 'Achtung', and § 11(4) requires purchase-relevant warnings (e.g. age limits) to be visible pre-purchase including for online sales. This closes the gap the Directive-only citation left open." }, { "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" }, { "name": "Toy Safety Business Guidance — ASTM F963 section-by-section breakdown", "authority": "U.S. Consumer Product Safety Commission", "url": "https://www.cpsc.gov/Business--Manufacturing/Business-Education/Toy-Safety" } ], "review_status": "source_checked", "review_note": "2026-07-16: Read CPSC's full section-by-section ASTM F963 breakdown. Confirmed F963 has no radio-frequency/wireless-transmission section: § 4.4 (Electrical/Thermal Energy) simply cross-references the pre-existing mandatory 16 C.F.R. part 1505, and § 4.25 (Battery-operated Toys) covers battery access, overheating and labeling only — neither addresses RF emissions or equipment authorization. This confirms there is no toy-specific CPSC provision that interacts with or modifies FCC Part 15: a connected toy with an intentional radio transmitter needs FCC equipment authorization on exactly the same basis as any other electronic consumer product, running in parallel with (not folded into) F963/CPC certification. The us-fcc-certification-when-radio finding therefore applies to toys without modification." }, { "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": { "is_childrens_product": true }, "adds": [ { "text_en": "Since July 8, 2026, importers must eFile certificate data (including the toy's Children's Product Certificate data) with US Customs and Border Protection via a Partner Government Agency Message Set, in addition to keeping the CPC available on request. Entries withdrawn from a Foreign Trade Zone transition on January 8, 2027.", "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证书数据（含玩具CPC数据），并仍须应要求提供CPC备查；从外国贸易区提取入境的货物于2027年1月8日适用。", "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": "source_checked", "review_note": "2026-08-13: Rechecked current CPSC eFiling guidance after implementation. The general requirement has been in force since 8 July 2026; Foreign Trade Zone withdrawals transition on 8 January 2027. The rule uses the explicit is_childrens_product fact rather than an under-3 proxy." }, { "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": "source_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). 2026-07-11: Independently confirmed the dual-regulation interaction directly against the RER 2017 GB text: regulation 10(3) requires that 'where radio equipment is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title' — the direct GB parallel to RED Article 18, which was the basis for the equivalent EU rule (eu-toy-red-when-connected). Confirms a connected toy must satisfy both the RER 2017 and the Toys (Safety) Regulations 2011, covered by one combined declaration." }, { "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": "source_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. 2026-07-11: Independently confirmed directly against the GB instrument's own text — Toys (Safety) Regulations 2011, Schedule 2 ('Particular safety requirements', the GB transposition of Annex II to Directive 2009/48/EC), Part 1 point 4(d): 'Toys, which are clearly intended for use by children under 36 months, and their component parts and any of their detachable parts must be of such dimensions as to prevent their being swallowed or inhaled.' Word-for-word the same operative text as the EU Annex II provision, confirming this is a design-and-test duty rather than a labelling matter." }, { "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 and redesign the closure before relying on the evidence package.", "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——应暂停上市并重新设计闭合结构，然后再依赖证据包。", "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": "source_checked", "review_note": "2026-07-16: Scoped to the directly verified legal duties only. Toys (Safety) Regulations 2011 Schedule 2 Part 1 point 4 covers choking/swallowing hazards, and Part 4 points 2 and 4 cover electrical protection and foreseeable-fault conditions. Specific BS EN 71-1 or BS EN 62115 closure/test methods remain separate reviewer/lab evidence questions." }, { "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": { "is_electrically_operated": true, "age_group": "under_3" }, "adds": [ { "text_en": "For electrically operated toys intended for children up to and including 36 months, the Australian mandatory toy standard requires compliance with the applicable section of AS/NZS 62115:2018 in addition to the general mechanical/physical toy standard.", "text_zh": "对于面向36个月及以下儿童的电动玩具，澳大利亚玩具强制标准要求除一般机械/物理玩具标准外，还须符合AS/NZS 62115:2018的适用部分。", "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": "source_checked", "review_note": "2026-07-16: Scoped to the ACCC mandatory-standard page's confirmed fact pattern: electrically operated toys intended for children up to and including 36 months must comply with the applicable section of AS/NZS 62115:2018 in addition to the accepted general toy-safety standard. The data model now distinguishes electrically operated toys from battery presence and requires the under-36-month age fact, removing the former proxy and broader-age overclaim." }, { "id": "au-toy-battery-compartment-unsecured", "category": "toys", "markets": [ "AU" ], "when": { "has_battery": true, "battery_compartment_security": "unsecured" }, "adds": [ { "text_en": "For toys marketed at children up to and including 36 months, the mandatory standard requires the battery compartment to be secured so it can only be accessed using a tool ('tool_required' security) — an unsecured compartment is a direct breach, not just a general-duty risk. Stop the launch, redesign the closure, and retest against AS/NZS ISO 8124.1 (or the standard's other permitted mechanical standards) and, for electric toys, AS/NZS 62115.", "text_zh": "面向36个月及以下儿童的玩具，强制标准要求电池仓须通过工具才能打开（即'需工具开启'的安全等级）——未固定的电池仓属于直接违规，而不仅是一般性义务风险。应暂停上市、重新设计闭合结构，并依AS/NZS ISO 8124.1（或标准允许的其他机械标准）及（电动玩具适用的）AS/NZS 62115复测。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Consumer Goods (Toys for Children up to and including 36 Months of Age) Safety Standard 2023", "authority": "Australian Competition and Consumer Commission (ACCC) / Federal Register of Legislation", "url": "https://www.legislation.gov.au/Details/F2023L01185" }, { "name": "Toys for children up to and including 36 months of age mandatory 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": "2026-07-16: Fetched the ACCC mandatory-standard guidance page directly, which states plainly: 'The mandatory standard requires all battery operated toys for children up to and including 36 months of age to have the battery compartment secured so that it can only be accessed by using a tool.' This is a more precise citation than the rule previously carried (general ACL safety-obligation framing) — it is a specific, named clause of the Consumer Goods (Toys for Children up to and including 36 Months of Age) Safety Standard 2023, matching this system's own 'tool_required' battery_compartment_security value exactly. Upgraded from partially_checked accordingly; rule text and classification updated from a general compliance_measure to the direct legal_requirement the source actually states." }, { "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 launch, complete a jurisdiction-specific current formula review: for the EU include Regulations 2026/78 and 2026/909 plus the expanded fragrance-allergen labelling transition; for GB include S.I. 2026/23. Feed the result into the safety report and Product Information File; an unreviewed formula is not ready for expert sign-off.", "text_zh": "上市前须完成按司法辖区区分的最新配方审核：欧盟须纳入2026/78、2026/909及扩大香精过敏原标签过渡要求；大不列颠须纳入S.I. 2026/23。审核结果须进入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" }, { "name": "EU Regulation 2026/78 on CMR substances in cosmetics", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2026/78/oj" }, { "name": "EU Regulation 2026/909 on restricted cosmetic substances", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2026/909/oj" }, { "name": "GB Cosmetic Products Amendment Regulations 2026 (S.I. 2026/23)", "authority": "UK Government", "url": "https://www.legislation.gov.uk/uksi/2026/23/contents/made" } ], "review_status": "source_checked", "review_note": "2026-08-13: Updated against the current EU and GB substance amendments. The shared rule now explicitly requires separate EU and GB formula conclusions rather than implying that one annex review remains interchangeable across both markets." }, { "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. Australian law imposes only a general fit-for-purpose/no-contamination duty (Standard 3.2.2 cl.9) plus contaminant limits (Standard 1.4.1), not a detailed compositional standard, so use EU/FDA-style migration testing as the practical benchmark rather than waiting for an AU-specific protocol.", "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。澳大利亚法律仅规定一般适用性/防污染义务（3.2.2条款9）及污染物限量（1.4.1条），并无详细成分标准，因此应以欧盟/FDA式迁移测试作为实际基准，而非等待澳大利亚专属规程。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Standard 3.2.2 - Food Safety Practices and General Requirements, clause 9 (Food packaging)", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2008B00576/latest/text" }, { "name": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2015L00408/latest/text" } ], "review_status": "source_checked", "review_note": "2026-07-16: The food-contact-au requirement record is now source_checked (Standard 1.4.3 was found repealed and replaced with Standard 3.2.2 cl.9 and Standard 1.4.1, both fetched directly from legislation.gov.au). This rule is updated to match: AU's material-suitability duty is confirmed to be general rather than compositional, which is itself the source-checked basis for recommending EU/FDA-style migration testing as the practical benchmark." }, { "id": "food-contact-repeated-use-retaining-evidence", "category": "food-contact", "markets": [ "EU", "US", "UK" ], "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": "EU plastic food-contact migration and compliance testing regulation", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2011/10/oj" }, { "name": "FDA food types and conditions of use for food-contact substances", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances" }, { "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": "2026-07-09: Split AU out of this rule and checked the EU/UK/US branch against Regulation 1935/2004 documentation/traceability duties, Regulation 10/2011 use-condition/compliance-testing structure, FDA food-type/condition tables and UK FSA guidance. Kept as evidence routing because exact repeat-use simulation depends on material and lab protocol." }, { "id": "au-food-contact-repeated-use-escalation", "category": "food-contact", "markets": [ "AU" ], "when": { "repeated_use": "repeated_use" }, "adds": [ { "text_en": "For Australia, repeated-use food-contact goods should retain evidence of material/use-condition suitability under Standard 3.2.2 cl.9's fit-for-purpose duty and Standard 1.4.1 contaminant limits; do not treat EU/US repeat-use evidence as automatically sufficient, since AU sets a general duty rather than a repeat-use-specific test protocol.", "text_zh": "澳大利亚重复使用食品接触产品应保留符合3.2.2条款9适用性义务及1.4.1条污染物限量的材料/使用条件证据；不要自动把欧盟/美国重复使用证据视为足够，因为澳大利亚规定的是一般义务而非专门的重复使用测试规程。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Standard 3.2.2 - Food Safety Practices and General Requirements, clause 9 (Food packaging)", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2008B00576/latest/text" }, { "name": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2015L00408/latest/text" } ], "review_status": "source_checked", "review_note": "2026-07-16: Updated in line with the now source_checked food-contact-au record. AU's general fit-for-purpose duty and contaminant limits apply to repeated-use goods the same as single-use; there's no separate repeat-use protocol in AU law, which is now a confirmed (not assumed) fact." }, { "id": "food-contact-use-conditions-spec-needed", "category": "food-contact", "markets": [ "EU", "US", "UK" ], "when": { "food_type": [ "dry", "aqueous", "acidic", "fatty", "alcoholic", "mixed" ] }, "adds": [ { "text_en": "Capture food type, contact duration, temperature and surface-area assumptions before selecting a migration, extractives or declaration route; a material name alone is not enough for food-contact readiness.", "text_zh": "选择迁移、浸提或符合性声明路径前，须采集食品类型、接触时长、温度和接触面积假设；仅有材料名称不足以判断食品接触准备度。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "EU plastic food-contact Declaration of Compliance Annex IV", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2011/10/oj" }, { "name": "FDA food types and conditions of use for food-contact substances", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances" }, { "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": "2026-07-09: Added as a source-checked use-condition gate. Regulation 10/2011 Annex IV explicitly calls for food type and time/temperature use specifications, and FDA publishes food-type/condition-of-use tables for FCS notifications." }, { "id": "food-contact-long-duration-review", "category": "food-contact", "markets": [ "EU", "US", "UK" ], "when": { "contact_duration": "long_term" }, "adds": [ { "text_en": "Long-term storage contact needs evidence that covers the declared duration, food type and temperature; short-contact or sample-only evidence should not be reused without reviewer justification.", "text_zh": "长期储存接触需要覆盖所申报时长、食品类型和温度的证据；短时接触或样品级证据未经复核说明不得直接复用。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "EU plastic food-contact Declaration of Compliance Annex IV", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2011/10/oj" }, { "name": "FDA food types and conditions of use for food-contact substances", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances" } ], "review_status": "source_checked", "review_note": "2026-07-09: Source-checked against EU Annex IV's time/temperature use-condition field and FDA condition-of-use tables; this is evidence routing, not a universal test method." }, { "id": "eu-uk-food-contact-plastic-food-simulant-selection", "category": "food-contact", "markets": [ "EU", "UK" ], "when": { "food_contact_material": [ "plastic", "multi_material" ], "food_type": [ "aqueous", "acidic", "fatty", "alcoholic", "mixed" ] }, "adds": [ { "text_en": "For plastic or plastic-layer food-contact goods, the migration evidence should identify the food simulant route selected for the declared food type and use conditions.", "text_zh": "塑料或含塑料层的食品接触产品，迁移证据应说明针对所申报食品类型和使用条件选择的食品模拟物路径。", "classification": "compliance_measure" } ], "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": "2026-07-09: Added material-plus-food-type branching after source-checking Regulation 10/2011's food simulant/use-condition structure and UK FSA guidance. This tells agents to route plastic/multi-material cases to simulator selection rather than generic migration wording." }, { "id": "food-contact-nonplastic-hot-use-review", "category": "food-contact", "markets": [ "EU", "US", "UK" ], "when": { "food_contact_material": [ "metal", "ceramic_glass", "paper_board", "silicone_rubber", "multi_material" ], "contact_temperature": [ "hot_fill", "cooking_reheating" ] }, "adds": [ { "text_en": "Hot-use non-plastic or multi-material food-contact goods need a material-specific reviewer/lab route; do not reuse a plastic OML/SML report as the only evidence unless the reviewer explains why it covers the final article.", "text_zh": "热用途非塑料或多材料食品接触产品需要材料专项复核/实验室路径；不得仅以塑料OML/SML报告作为唯一证据，除非复核方说明其覆盖最终成品。", "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 types and conditions of use for food-contact substances", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances" }, { "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": "2026-07-09: Source-checked as a material-routing rule against EU/UK general FCM duties and FDA condition-of-use tables. Exact limits and methods remain material-specific, so the rule escalates to reviewer/lab route rather than asserting a universal test." }, { "id": "us-food-contact-food-type-condition-match", "category": "food-contact", "markets": [ "US" ], "when": { "food_type": [ "dry", "aqueous", "acidic", "fatty", "alcoholic", "mixed" ] }, "adds": [ { "text_en": "For the US, match the article to FDA food types and conditions of use before relying on a CFR clearance, FCN or supplier statement.", "text_zh": "美国路径下，在依赖CFR许可、FCN或供应商声明前，应先把制品匹配到FDA食品类型和使用条件。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "FDA food types and conditions of use for food-contact substances", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances" }, { "name": "21 CFR Part 174 — indirect food additives general provisions", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-174" } ], "review_status": "source_checked", "review_note": "2026-07-09: Source-checked against FDA's food-type/condition-of-use tables and 21 CFR Part 174's intended-use/GMP provisions." }, { "id": "us-food-contact-california-prop65-screen", "category": "food-contact", "markets": [ "US" ], "when": { "sells_in_california": true }, "adds": [ { "text_en": "If the food-contact article will be sold in California, screen material, decoration, coatings and packaging for Proposition 65 warning exposure risk before listing.", "text_zh": "如食品接触产品销往加州，上架前应筛查材料、装饰、涂层和包装是否存在65号提案警示暴露风险。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "California OEHHA Proposition 65 overview", "authority": "California Office of Environmental Health Hazard Assessment", "url": "https://oehha.ca.gov/proposition-65" } ], "review_status": "source_checked", "review_note": "2026-07-09: Added California branch after checking OEHHA's official Proposition 65 page, which states the warning/inform-exposure purpose and current chemical-list maintenance. SKU-specific exposure and safe-harbor analysis still need human review." }, { "id": "us-food-contact-polymers-cfr-177", "category": "food-contact", "markets": [ "US" ], "when": { "food_contact_material": [ "plastic", "silicone_rubber", "multi_material" ] }, "adds": [ { "text_en": "For US polymer, silicone/rubber or multi-material articles, check whether the resin or polymer system is covered by 21 CFR Part 177, an FCN or another valid FDA status route for the declared use.", "text_zh": "美国聚合物、硅胶/橡胶或多材料制品须核对树脂/聚合物体系是否由21 CFR Part 177、FCN或其他有效FDA状态路径覆盖，且覆盖所申报用途。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "21 CFR Part 177 — polymers", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-177" }, { "name": "21 CFR Part 174 — indirect food additives general provisions", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-174" } ], "review_status": "source_checked", "review_note": "2026-07-09: Added material-specific US polymer branch after checking 21 CFR Part 177 and Part 174. It complements the general FDA-status rule by pointing agents to the polymer-specific CFR route." }, { "id": "us-food-contact-paper-board-cfr-176", "category": "food-contact", "markets": [ "US" ], "when": { "food_contact_material": "paper_board" }, "adds": [ { "text_en": "For US paper/board articles, check component status and extractives or manufacturing-record evidence under 21 CFR Part 176 before treating the article as ready for food contact.", "text_zh": "美国纸/纸板制品在视为食品接触准备就绪前，应按21 CFR Part 176核对成分状态及浸提或生产记录证据。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "21 CFR Part 176 — paper and paperboard components", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-176" } ], "review_status": "source_checked", "review_note": "2026-07-09: Added US paper/board branch after checking 21 CFR Part 176's component and extractives/manufacturing-record language." }, { "id": "us-food-contact-coatings-adhesives-cfr-175", "category": "food-contact", "markets": [ "US" ], "when": { "food_contact_material": [ "paper_board", "metal", "multi_material" ] }, "adds": [ { "text_en": "If food-contact performance depends on coatings, adhesives, seams, labels or inks, check the US coating/adhesive route separately from the base material.", "text_zh": "如食品接触性能依赖涂层、胶黏剂、接缝、标签或油墨，应将美国涂层/胶黏剂路径与基材分开核对。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "21 CFR Part 175 — adhesives and components of coatings", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175" } ], "review_status": "source_checked", "review_note": "2026-07-09: Added material-specific US coating/adhesive branch after checking 21 CFR Part 175, including adhesives and coating components used in food-packaging articles." }, { "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 must check the AICIS introduction route ingredient by ingredient before treating the product as ready for sale. If the formula contains retinal/retinaldehyde (CAS 116-31-4), consumer use requires an assessment certificate before introduction and cannot use the exempted or reported categories.", "text_zh": "澳大利亚进口商或跨境平台卖家在销售前，须逐一核对成分的AICIS引进路径。如配方含视黄醛/retinaldehyde（CAS 116-31-4），消费用途须在引进前取得评估证书，不得使用豁免或报告类别。", "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" }, { "name": "Retinal introductions for consumer use now need assessment by AICIS", "authority": "Australian Industrial Chemicals Introduction Scheme", "url": "https://www.industrialchemicals.gov.au/news-and-notices/retinal-introductions-consumer-use-now-need-assessment-aicis" } ], "review_status": "source_checked", "review_note": "2026-08-13: Added AICIS's retinal notice, effective for introductions from 27 June 2026. The marketplace_seller trigger remains a conservative cross-border seller proxy; local importer/introducer status 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" ], "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": "21 CFR Part 176 — paper and paperboard components", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-176" }, { "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": "2026-07-09: Split AU out and checked EU/UK/US paper/board routing against EU framework duties, UK FSA guidance and 21 CFR Part 176, including paper/board component and extractives provisions. Still framed as compliance routing because coatings, recycled content and food type decide the exact file." }, { "id": "au-food-contact-paper-board-composition-review", "category": "food-contact", "markets": [ "AU" ], "when": { "food_contact_material": "paper_board" }, "adds": [ { "text_en": "For Australia, paper/board food-contact goods should be reviewed for material, coating and recycled-content risk against the Standard 3.2.2 cl.9 fit-for-purpose duty and Standard 1.4.1 contaminant limits; AU has no paper/board-specific compositional standard, so retailer benchmarks (often EU/FDA-aligned) remain the practical reference point.", "text_zh": "澳大利亚纸/纸板食品接触产品应对照3.2.2条款9适用性义务及1.4.1条污染物限量审核材料、涂层和再生成分风险；澳大利亚无纸/纸板专项成分标准，零售商基准（通常与欧盟/FDA一致）仍是实际参考。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Standard 3.2.2 - Food Safety Practices and General Requirements, clause 9 (Food packaging)", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2008B00576/latest/text" }, { "name": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2015L00408/latest/text" } ], "review_status": "source_checked", "review_note": "2026-07-16: Updated to match the now source_checked food-contact-au record. Confirmed AU has no paper/board-specific compositional standard beyond the general cl.9 duty and Standard 1.4.1 contaminant limits, so the retailer-benchmark recommendation is now a confirmed conclusion rather than a placeholder pending a better source." }, { "id": "food-contact-metal-material-release-review", "category": "food-contact", "markets": [ "EU", "US", "UK" ], "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": "21 CFR Part 174 — indirect food additives general provisions", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-174" }, { "name": "21 CFR Part 175 — adhesives and components of coatings", "authority": "US Food and Drug Administration", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175" }, { "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": "2026-07-09: Split AU out and checked EU/UK/US metal/coating routing against the EU framework's inertness/documentation duties, UK FSA guidance, 21 CFR Part 174 general provisions and Part 175 coating/adhesive provisions. Exact alloy and corrosion testing remains SKU-specific." }, { "id": "au-food-contact-metal-material-release-review", "category": "food-contact", "markets": [ "AU" ], "when": { "food_contact_material": "metal" }, "adds": [ { "text_en": "For Australia, metal food-contact goods should be reviewed for alloy, coating and release risk against the Standard 3.2.2 cl.9 fit-for-purpose duty and Standard 1.4.1 contaminant limits; AU has no metal-specific compositional standard, so EU/FDA-style migration testing remains the practical benchmark.", "text_zh": "澳大利亚金属食品接触产品应对照3.2.2条款9适用性义务及1.4.1条污染物限量审核合金、涂层和释放风险；澳大利亚无金属专项成分标准，欧盟/FDA式迁移测试仍是实际基准。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Standard 3.2.2 - Food Safety Practices and General Requirements, clause 9 (Food packaging)", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2008B00576/latest/text" }, { "name": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2015L00408/latest/text" } ], "review_status": "source_checked", "review_note": "2026-07-16: Updated to match the now source_checked food-contact-au record. Confirmed AU has no metal-specific compositional standard beyond the general cl.9 duty and Standard 1.4.1 contaminant limits." }, { "id": "food-contact-ambient-single-use-scope", "category": "food-contact", "markets": [ "EU", "US", "UK" ], "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 types and conditions of use for food-contact substances", "authority": "US Food and Drug Administration", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances" }, { "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": "2026-07-09: Split AU out and source-checked this negative-scope rule against EU/UK/US use-condition frameworks. It excludes only hot-use and repeated-use triggers, not material, food-type, duration, declaration or labelling duties." }, { "id": "au-food-contact-ambient-single-use-scope", "category": "food-contact", "markets": [ "AU" ], "when": { "contact_temperature": "ambient", "repeated_use": "single_use" }, "adds": [], "not_applicable": [ { "text_en": "Based on the declared profile, hot-use and repeated-use escalation are not raised for Australia; still check material composition and destination-specific declaration/labelling duties under the Standard 3.2.2 cl.9 general duty.", "text_zh": "根据所申报属性，澳大利亚路径未触发热用途和重复使用升级；仍须依据3.2.2条款9的一般义务核对材料组成及目标市场声明/标签义务。" } ], "sources": [ { "name": "Standard 3.2.2 - Food Safety Practices and General Requirements, clause 9 (Food packaging)", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2008B00576/latest/text" }, { "name": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2015L00408/latest/text" } ], "review_status": "source_checked", "review_note": "2026-07-16: Updated to match the now source_checked food-contact-au record. This negative-scope rule is source-checked against the same Standard 3.2.2/1.4.1 basis as the AU record; it excludes only hot-use and repeated-use triggers, not material or labelling 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 reviewed for material- and temperature-specific migration risk against the Standard 3.2.2 cl.9 fit-for-purpose duty and Standard 1.4.1 contaminant limits; AU has no hot-use-specific test protocol, so EU/FDA elevated-temperature migration data is the practical benchmark.", "text_zh": "澳大利亚热灌装、烹饪或复热用途应对照3.2.2条款9适用性义务及1.4.1条污染物限量审核材料与温度专项迁移风险；澳大利亚无热用途专项测试规程，欧盟/FDA高温迁移数据是实际基准。", "classification": "compliance_measure" } ], "not_applicable": [], "sources": [ { "name": "Standard 3.2.2 - Food Safety Practices and General Requirements, clause 9 (Food packaging)", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2008B00576/latest/text" }, { "name": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2015L00408/latest/text" } ], "review_status": "source_checked", "review_note": "2026-07-16: Updated to match the now source_checked food-contact-au record. Confirmed AU has no hot-use-specific test protocol beyond the general cl.9 duty and Standard 1.4.1 contaminant limits." }, { "id": "eu-food-contact-current-plastics-and-bpa-review", "category": "food-contact", "markets": [ "EU" ], "when": { "food_contact_material": [ "plastic", "multi_material" ] }, "adds": [ { "text_en": "For EU plastic or multi-material food-contact goods, review the formulation and Declaration of Compliance against the BPA/bisphenol restrictions in Regulation (EU) 2024/3190 (as corrected) and the plastics/GMP changes in Regulation (EU) 2025/351. The first main BPA transition ended 20 July 2026 and the principal 2025/351 legacy-product transition reaches 16 September 2026.", "text_zh": "欧盟塑料或多材料食品接触产品须对照经更正的(EU) 2024/3190双酚限制及(EU) 2025/351塑料/GMP修订复核配方和符合性声明。首个主要BPA过渡期已于2026年7月20日结束，2025/351的主要旧产品过渡节点为2026年9月16日。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "Regulation (EU) 2024/3190 on BPA and other bisphenols in food-contact materials", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2024/3190/oj" }, { "name": "Regulation (EU) 2026/250 correcting Regulation 2024/3190", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2026/250/oj" }, { "name": "Regulation (EU) 2025/351 amending plastics, recycled-plastics and GMP requirements", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2025/351/oj" } ], "review_status": "source_checked", "review_note": "2026-08-13: Added from the current official EUR-Lex texts and transition provisions. The trigger is deliberately limited to plastic/multi-material cases even though Regulation 2024/3190 can also reach other listed material groups; non-plastic cases remain for human material-specific review." }, { "id": "uk-food-contact-eu-bpa-divergence", "category": "food-contact", "markets": [ "UK" ], "when": { "food_contact_material": [ "plastic", "multi_material" ] }, "adds": [ { "text_en": "Use a GB-specific legal conclusion: the EU BPA restrictions in Regulation 2024/3190 do not currently apply to the GB domestic market. If the destination is Northern Ireland, apply the EU rule and its transitions instead. Do not treat the closed GB consultation as enacted law.", "text_zh": "须形成大不列颠专属法律结论：欧盟2024/3190的BPA限制目前不适用于大不列颠国内市场；如目的地为北爱尔兰，则须适用欧盟规则及其过渡期。不得将已结束的英国咨询视为已生效法律。", "classification": "legal_requirement" } ], "not_applicable": [], "sources": [ { "name": "BPA in food contact materials: EU rules and UK implications", "authority": "Food Standards Agency", "url": "https://www.gov.uk/government/publications/bpa-in-food-contact-materials-eu-rules-and-uk-implications" } ], "review_status": "source_checked", "review_note": "2026-08-13: Source-checked against the FSA's 25 June 2026 guidance, which expressly distinguishes EU/NI applicability from the unchanged current GB legal position." } ] }