{ "dataset_version": "0.10.0-beta", "schema_version": "2026-08-13", "disclaimer_en": "Beta evidence-readiness dataset. Verify against the cited primary sources and route product-specific decisions to human review before making compliance decisions.", "disclaimer_zh": "Beta 证据准备度数据集。做出产品级合规决策前，请核对所引用的官方原始来源，并进入人工复核。", "coverage": { "meaning": "Every listed category-market pair has a structured jurisdiction record, product-fact questions, an evidence checklist and attribute-conditional rules. Counts expose differences in module depth; review statuses expose source-checking strength.", "cells": [ { "category": "battery-electronics", "market": "EU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 6, "claim_count": 17, "evidence_check_count": 9, "conditional_rule_count": 6, "conditional_rule_review": { "source_checked": 6 } }, { "category": "battery-electronics", "market": "US", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-05", "source_count": 3, "claim_count": 13, "evidence_check_count": 8, "conditional_rule_count": 5, "conditional_rule_review": { "source_checked": 5 } }, { "category": "battery-electronics", "market": "UK", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-05", "source_count": 4, "claim_count": 15, "evidence_check_count": 8, "conditional_rule_count": 4, "conditional_rule_review": { "source_checked": 4 } }, { "category": "battery-electronics", "market": "AU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-16", "source_count": 4, "claim_count": 12, "evidence_check_count": 6, "conditional_rule_count": 4, "conditional_rule_review": { "source_checked": 4 } }, { "category": "toys", "market": "EU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-06", "source_count": 8, "claim_count": 16, "evidence_check_count": 17, "conditional_rule_count": 7, "conditional_rule_review": { "source_checked": 7 } }, { "category": "toys", "market": "US", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 4, "claim_count": 12, "evidence_check_count": 9, "conditional_rule_count": 5, "conditional_rule_review": { "source_checked": 5 } }, { "category": "toys", "market": "UK", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 4, "claim_count": 16, "evidence_check_count": 9, "conditional_rule_count": 4, "conditional_rule_review": { "source_checked": 4 } }, { "category": "toys", "market": "AU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-05", "source_count": 2, "claim_count": 14, "evidence_check_count": 8, "conditional_rule_count": 4, "conditional_rule_review": { "source_checked": 4 } }, { "category": "cosmetics", "market": "EU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 5, "claim_count": 17, "evidence_check_count": 7, "conditional_rule_count": 5, "conditional_rule_review": { "source_checked": 5 } }, { "category": "cosmetics", "market": "US", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-05", "source_count": 2, "claim_count": 12, "evidence_check_count": 5, "conditional_rule_count": 7, "conditional_rule_review": { "source_checked": 7 } }, { "category": "cosmetics", "market": "UK", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 2, "claim_count": 14, "evidence_check_count": 5, "conditional_rule_count": 5, "conditional_rule_review": { "source_checked": 5 } }, { "category": "cosmetics", "market": "AU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 4, "claim_count": 12, "evidence_check_count": 3, "conditional_rule_count": 7, "conditional_rule_review": { "source_checked": 7 } }, { "category": "food-contact", "market": "EU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 5, "claim_count": 17, "evidence_check_count": 13, "conditional_rule_count": 12, "conditional_rule_review": { "source_checked": 12 } }, { "category": "food-contact", "market": "US", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-09", "source_count": 7, "claim_count": 11, "evidence_check_count": 13, "conditional_rule_count": 14, "conditional_rule_review": { "source_checked": 14 } }, { "category": "food-contact", "market": "UK", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-08-13", "source_count": 2, "claim_count": 12, "evidence_check_count": 12, "conditional_rule_count": 12, "conditional_rule_review": { "source_checked": 12 } }, { "category": "food-contact", "market": "AU", "service_status": "structured_preflight_and_conditional_rules", "record_review_status": "source_checked", "last_verified": "2026-07-16", "source_count": 4, "claim_count": 9, "evidence_check_count": 9, "conditional_rule_count": 6, "conditional_rule_review": { "source_checked": 6 } } ], "boundary": "Coverage is a structured evidence-readiness workflow, not a claim that every product fact, document, standard, test route or marketplace decision can be resolved without human review." }, "count": 16, "total_count": 16, "limit": 50, "offset": 0, "records": [ { "id": "toys-eu", "category": "toys", "market": "EU", "risk_level": "high", "legal_status": "transition", "review_status": "source_checked", "review_note": "2026-07-06: Rechecked Directive 2009/48/EC essential safety, warnings, safety assessment and CE duties; checked RED scope for connected toys, the current Commission harmonised-standards index, and official 2025 EU customs results. Regulation (EU) 2025/2509 transition was confirmed on EUR-Lex in the prior review.", "summary_en": "During the transition through 31 July 2030, toys sold in the EU remain subject to the Toy Safety Directive 2009/48/EC. Battery-powered and connected toys can also trigger radio, battery, electrical, chemicals, waste and transport obligations. Regulation (EU) 2025/2509 applies from 1 August 2030, adding a digital product passport and stricter chemical rules. CE marking, age-appropriate hazard assessment and an EU-established economic operator remain central requirements.", "summary_zh": "在截至2030年7月31日的过渡期内，欧盟玩具仍适用《玩具安全指令》2009/48/EC。电池供电及联网玩具还可能触发无线电、电池、电气、化学品、废弃物和运输义务。《欧盟玩具安全条例》(EU) 2025/2509自2030年8月1日起适用，将引入数字产品护照及更严格的化学品规则。CE标志、适龄危险评估和欧盟境内经济运营者仍是核心要求。", "required_marks": [ "CE" ], "regulations": [ { "name": "Toy Safety Directive 2009/48/EC", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009L0048" }, { "name": "Toy Safety Regulation (EU) 2025/2509 (applies 1 August 2030)", "authority": "European Union", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502509" }, { "name": "General Product Safety Regulation (EU) 2023/988", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2023/988/oj" }, { "name": "Market Surveillance Regulation (EU) 2019/1020", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2019/1020/oj" }, { "name": "Radio Equipment Directive 2014/53/EU", "authority": "European Union", "source": "https://eur-lex.europa.eu/eli/dir/2014/53/oj/eng" }, { "name": "EU Battery Regulation (EU) 2023/1542", "authority": "European Union", "source": "https://eur-lex.europa.eu/eli/reg/2023/1542/oj" }, { "name": "European Commission harmonised standards for toy safety", "authority": "European Commission", "source": "https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/toy-safety_en" }, { "name": "UN Manual of Tests and Criteria, subsection 38.3.5", "authority": "UNECE", "source": "https://unece.org/DAM/trans/danger/publi/manual/Rev.6/ST-SG-AC10-11-Rev6-Amend1e.pdf" } ], "testing_certification": [ "EN 71 series (mechanical, flammability, chemical migration) at an accredited lab", "EC Declaration of Conformity drawn up and retained for 10 years", "Technical file available to market surveillance authorities, including the Article 18 toy safety assessment", "For powered toys, applicable electrical-toy, battery-compartment and foreseeable-abuse test evidence", "For connected toys, RED radio, EMC and safety conformity evidence; for lithium batteries, the UN 38.3 test summary" ], "labelling": [ "CE mark visible, legible, indelible", "Manufacturer and EU importer name + postal address on product or packaging", "Warnings (e.g. age grading) in the language(s) of the member state of sale", "Batch/serial number for traceability", "Warnings that affect the purchase decision visible before purchase, including in online offers" ], "local_representative": { "required": true, "note_en": "EU Responsible Person (importer, authorised rep, or fulfilment provider) mandatory; name and address must appear with the product.", "note_zh": "必须指定欧盟责任人（进口商、授权代表或履约服务商），其名称与地址须随产品标注。" }, "pitfalls_zh": [ "GPSR自2024年12月起适用，无欧盟责任人的listing会被平台直接下架", "警告语只有英文、缺少销售国语言版本，是海关扣货的常见原因", "CE自我声明不等于免测试——EN 71测试报告缺失时技术文件不完整" ], "last_verified": "2026-07-06", "jurisdiction_scope": "European Union (EU-27); member-state language, registration and enforcement details may vary", "applicability": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-06: Rechecked Directive 2009/48/EC essential safety, warnings, safety assessment and CE duties; checked RED scope for connected toys, the current Commission harmonised-standards index, and official 2025 EU customs results. Regulation (EU) 2025/2509 transition was confirmed on EUR-Lex in the prior review.", "verified_at": "2026-07-06", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 8, "sources": [ { "id": "toys-eu:source:1", "title": "Toy Safety Directive 2009/48/EC", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009L0048", "source_type": "primary", "checked_at": "2026-07-06" }, { "id": "toys-eu:source:2", "title": "Toy Safety Regulation (EU) 2025/2509 (applies 1 August 2030)", "authority": "European Union", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502509", "source_type": "primary", "checked_at": "2026-07-06" }, { "id": "toys-eu:source:3", "title": "General Product Safety Regulation (EU) 2023/988", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2023/988/oj", "source_type": "primary", "checked_at": "2026-07-06" }, { "id": "toys-eu:source:4", "title": "Market Surveillance Regulation (EU) 2019/1020", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2019/1020/oj", "source_type": "primary", "checked_at": "2026-07-06" }, { "id": "toys-eu:source:5", "title": "Radio Equipment Directive 2014/53/EU", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/dir/2014/53/oj/eng", "source_type": "primary", "checked_at": "2026-07-06" }, { "id": "toys-eu:source:6", "title": "EU Battery Regulation (EU) 2023/1542", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2023/1542/oj", "source_type": "primary", "checked_at": "2026-07-06" }, { "id": "toys-eu:source:7", "title": "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", "source_type": "primary", "checked_at": "2026-07-06" }, { "id": "toys-eu:source:8", "title": "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", "source_type": "primary", "checked_at": "2026-07-06" } ] }, "claims": [ { "id": "toys-eu:summary", "topic": "summary", "text_en": "During the transition through 31 July 2030, toys sold in the EU remain subject to the Toy Safety Directive 2009/48/EC. Battery-powered and connected toys can also trigger radio, battery, electrical, chemicals, waste and transport obligations. Regulation (EU) 2025/2509 applies from 1 August 2030, adding a digital product passport and stricter chemical rules. CE marking, age-appropriate hazard assessment and an EU-established economic operator remain central requirements.", "text_zh": "在截至2030年7月31日的过渡期内，欧盟玩具仍适用《玩具安全指令》2009/48/EC。电池供电及联网玩具还可能触发无线电、电池、电气、化学品、废弃物和运输义务。《欧盟玩具安全条例》(EU) 2025/2509自2030年8月1日起适用，将引入数字产品护照及更严格的化学品规则。CE标志、适龄危险评估和欧盟境内经济运营者仍是核心要求。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:required_mark:1", "topic": "required_mark", "text_en": "CE", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:testing:1", "topic": "testing", "text_en": "EN 71 series (mechanical, flammability, chemical migration) at an accredited lab", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:testing:2", "topic": "testing", "text_en": "EC Declaration of Conformity drawn up and retained for 10 years", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:testing:3", "topic": "testing", "text_en": "Technical file available to market surveillance authorities, including the Article 18 toy safety assessment", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:testing:4", "topic": "testing", "text_en": "For powered toys, applicable electrical-toy, battery-compartment and foreseeable-abuse test evidence", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:testing:5", "topic": "testing", "text_en": "For connected toys, RED radio, EMC and safety conformity evidence; for lithium batteries, the UN 38.3 test summary", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:labelling:1", "topic": "labelling", "text_en": "CE mark visible, legible, indelible", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:labelling:2", "topic": "labelling", "text_en": "Manufacturer and EU importer name + postal address on product or packaging", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:labelling:3", "topic": "labelling", "text_en": "Warnings (e.g. age grading) in the language(s) of the member state of sale", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:labelling:4", "topic": "labelling", "text_en": "Batch/serial number for traceability", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:labelling:5", "topic": "labelling", "text_en": "Warnings that affect the purchase decision visible before purchase, including in online offers", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:local-presence", "topic": "local_presence", "text_en": "EU Responsible Person (importer, authorised rep, or fulfilment provider) mandatory; name and address must appear with the product.", "text_zh": "必须指定欧盟责任人（进口商、授权代表或履约服务商），其名称与地址须随产品标注。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-eu:source:1", "toys-eu:source:2", "toys-eu:source:3", "toys-eu:source:4", "toys-eu:source:5", "toys-eu:source:6", "toys-eu:source:7", "toys-eu:source:8" ], "evidence_status": "record_source_set" }, { "id": "toys-eu:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "GPSR自2024年12月起适用，无欧盟责任人的listing会被平台直接下架", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-eu:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "警告语只有英文、缺少销售国语言版本，是海关扣货的常见原因", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-eu:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "CE自我声明不等于免测试——EN 71测试报告缺失时技术文件不完整", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "toys-us", "category": "toys", "market": "US", "risk_level": "high", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-05: cpsc.gov pages load fine in a normal browser (they only block scripted/automated fetches). Directly checked Toy Safety Business Guidance, Children's Product Certificate, Tracking Label Business Guidance, and Third-Party Testing Guidance pages. Confirmed CPC is issued by the domestic manufacturer/importer based on CPSC-accepted lab results (not by CPSC itself); tracking labels must be permanently affixed to the product AND its packaging (16 U.S.C. 2063(a)(5)(A)) — packaging alone is not compliant; retesting triggers are material-change testing plus periodic testing under 16 CFR 1107.21. Also found a new requirement not previously in this record: starting July 8, 2026, importers of most regulated consumer products must electronically file (eFile) certificates of compliance with CBP via a Partner Government Agency Message Set — added below.", "summary_en": "Children's products for the US require third-party testing at a CPSC-accepted lab against ASTM F963 and CPSIA limits (lead, phthalates), a Children's Product Certificate (CPC), and permanent tracking labels.", "summary_zh": "输美儿童产品必须在CPSC认可的第三方实验室按ASTM F963和CPSIA限值（铅、邻苯二甲酸盐）测试，出具儿童产品证书(CPC)，并加贴永久性追溯标签。", "required_marks": [], "regulations": [ { "name": "Consumer Product Safety Improvement Act (CPSIA)", "authority": "US Consumer Product Safety Commission (CPSC)", "source": "https://www.cpsc.gov/Regulations-Laws--Standards/Statutes/The-Consumer-Product-Safety-Improvement-Act" }, { "name": "ASTM F963-23 Toy Safety Standard (mandatory via 16 CFR 1250)", "authority": "CPSC", "source": "https://www.cpsc.gov/Business--Manufacturing/Business-Education/Toy-Safety" }, { "name": "Small parts regulation 16 CFR 1501", "authority": "CPSC", "source": "https://www.ecfr.gov/current/title-16/chapter-II/subchapter-C/part-1501" }, { "name": "Certificates of Compliance eFiling (CBP PGA Message Set)", "authority": "CPSC / US Customs and Border Protection (CBP)", "source": "https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Childrens-Product-Certificate" } ], "testing_certification": [ "Third-party testing at CPSC-accepted laboratory (mandatory, not self-declared)", "Children's Product Certificate (CPC) issued by the domestic manufacturer or importer, based on CPSC-accepted lab test results; available to CPSC and retailers on request", "Retesting on material change (16 CFR part 1109) and periodic retesting for products in continuous manufacture (16 CFR 1107.21)", "Since July 8, 2026, importers of most regulated consumer products must eFile certificate data with CBP via a Partner Government Agency (PGA) Message Set, in addition to maintaining the CPC; entries withdrawn from a Foreign Trade Zone transition on January 8, 2027" ], "labelling": [ "Permanent tracking label on both the product and its packaging (to the extent practicable): manufacturer/importer name, production date/location, batch info (15 U.S.C. 2063(a)(5)(A))", "Small parts choking hazard warnings per 16 CFR 1500.19", "Amazon/marketplaces request CPC at listing stage for toy categories" ], "local_representative": { "required": false, "note_en": "No general responsible-person requirement, but the importer of record holds legal responsibility; marketplaces increasingly demand CPC upfront.", "note_zh": "无统一的境内责任人制度，但登记进口商承担法律责任；各平台在上架时越来越多地要求提供CPC证书。" }, "pitfalls_zh": [ "CPC必须由CPSC认可实验室的报告支撑，普通ISO实验室报告无效", "追溯标签必须永久附着于产品本体，仅印在包装上不合规", "换供应商或换材料后未重新测试，是CPSC召回的高频原因" ], "last_verified": "2026-08-13", "jurisdiction_scope": "United States federal requirements; state requirements may add obligations", "applicability": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-05: cpsc.gov pages load fine in a normal browser (they only block scripted/automated fetches). Directly checked Toy Safety Business Guidance, Children's Product Certificate, Tracking Label Business Guidance, and Third-Party Testing Guidance pages. Confirmed CPC is issued by the domestic manufacturer/importer based on CPSC-accepted lab results (not by CPSC itself); tracking labels must be permanently affixed to the product AND its packaging (16 U.S.C. 2063(a)(5)(A)) — packaging alone is not compliant; retesting triggers are material-change testing plus periodic testing under 16 CFR 1107.21. Also found a new requirement not previously in this record: starting July 8, 2026, importers of most regulated consumer products must electronically file (eFile) certificates of compliance with CBP via a Partner Government Agency Message Set — added below.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 4, "sources": [ { "id": "toys-us:source:1", "title": "Consumer Product Safety Improvement Act (CPSIA)", "authority": "US Consumer Product Safety Commission (CPSC)", "url": "https://www.cpsc.gov/Regulations-Laws--Standards/Statutes/The-Consumer-Product-Safety-Improvement-Act", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "toys-us:source:2", "title": "ASTM F963-23 Toy Safety Standard (mandatory via 16 CFR 1250)", "authority": "CPSC", "url": "https://www.cpsc.gov/Business--Manufacturing/Business-Education/Toy-Safety", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "toys-us:source:3", "title": "Small parts regulation 16 CFR 1501", "authority": "CPSC", "url": "https://www.ecfr.gov/current/title-16/chapter-II/subchapter-C/part-1501", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "toys-us:source:4", "title": "Certificates of Compliance eFiling (CBP PGA Message Set)", "authority": "CPSC / US Customs and Border Protection (CBP)", "url": "https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Childrens-Product-Certificate", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "toys-us:summary", "topic": "summary", "text_en": "Children's products for the US require third-party testing at a CPSC-accepted lab against ASTM F963 and CPSIA limits (lead, phthalates), a Children's Product Certificate (CPC), and permanent tracking labels.", "text_zh": "输美儿童产品必须在CPSC认可的第三方实验室按ASTM F963和CPSIA限值（铅、邻苯二甲酸盐）测试，出具儿童产品证书(CPC)，并加贴永久性追溯标签。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:testing:1", "topic": "testing", "text_en": "Third-party testing at CPSC-accepted laboratory (mandatory, not self-declared)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:testing:2", "topic": "testing", "text_en": "Children's Product Certificate (CPC) issued by the domestic manufacturer or importer, based on CPSC-accepted lab test results; available to CPSC and retailers on request", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:testing:3", "topic": "testing", "text_en": "Retesting on material change (16 CFR part 1109) and periodic retesting for products in continuous manufacture (16 CFR 1107.21)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:testing:4", "topic": "testing", "text_en": "Since July 8, 2026, importers of most regulated consumer products must eFile certificate data with CBP via a Partner Government Agency (PGA) Message Set, in addition to maintaining the CPC; entries withdrawn from a Foreign Trade Zone transition on January 8, 2027", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:labelling:1", "topic": "labelling", "text_en": "Permanent tracking label on both the product and its packaging (to the extent practicable): manufacturer/importer name, production date/location, batch info (15 U.S.C. 2063(a)(5)(A))", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:labelling:2", "topic": "labelling", "text_en": "Small parts choking hazard warnings per 16 CFR 1500.19", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:labelling:3", "topic": "labelling", "text_en": "Amazon/marketplaces request CPC at listing stage for toy categories", "text_zh": null, "classification": "platform_policy", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-us:local-presence", "topic": "local_presence", "text_en": "No general responsible-person requirement, but the importer of record holds legal responsibility; marketplaces increasingly demand CPC upfront.", "text_zh": "无统一的境内责任人制度，但登记进口商承担法律责任；各平台在上架时越来越多地要求提供CPC证书。", "classification": "legal_requirement", "mandatory": false, "conditions": [], "evidence": [ "toys-us:source:1", "toys-us:source:2", "toys-us:source:3", "toys-us:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-us:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "CPC必须由CPSC认可实验室的报告支撑，普通ISO实验室报告无效", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-us:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "追溯标签必须永久附着于产品本体，仅印在包装上不合规", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-us:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "换供应商或换材料后未重新测试，是CPSC召回的高频原因", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "toys-uk", "category": "toys", "market": "UK", "risk_level": "high", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-05: OPSS GB guidance reviewed; authorised-representative vs importer duties corrected; see changelog 0.2.0. 2026-07-11: Added retesting-plan and marketplace-evidence testing_certification bullets to match the depth of the US toys evidence checklist. 2026-08-13: Added OPSS's current sand-containing-toy asbestos guidance. This is classified as a compliance measure, not presented as a new toy-specific statutory ban: suppliers should obtain suitable evidence that natural sand or similar mineral fill is asbestos-free and keep supply-chain controls under review.", "summary_en": "Toys for Great Britain fall under the Toys (Safety) Regulations 2011. CE marking remains accepted for toys and UKCA is the domestic alternative. A UK authorised representative is optional, but a UK-established importer that places goods from outside the UK on the GB market has statutory importer and traceability duties. For toys containing natural sand or similar mineral fill, current OPSS guidance calls for stronger supplier controls and evidence that asbestos is absent.", "summary_zh": "输往大不列颠的玩具适用《2011年玩具（安全）条例》。玩具仍可使用CE标志，UKCA为英国本土替代标志。英国授权代表并非一概强制，但将在境外商品投放英国市场的英国进口商负有法定进口和可追溯义务。含天然砂或类似矿物填充物的玩具，还应按OPSS现行指南加强供应商控制并保留无石棉证据。", "required_marks": [ "UKCA or CE" ], "regulations": [ { "name": "Toys (Safety) Regulations 2011", "authority": "UK Office for Product Safety and Standards (OPSS)", "source": "https://www.legislation.gov.uk/uksi/2011/1881/contents" }, { "name": "Toys (Safety) Regulations 2011: Great Britain guidance", "authority": "UK Office for Product Safety and Standards (OPSS)", "source": "https://www.gov.uk/government/publications/toys-safety-regulations-2011/toys-safety-regulations-2011-great-britain" }, { "name": "UKCA marking guidance", "authority": "UK Department for Business and Trade", "source": "https://www.gov.uk/guidance/using-the-ukca-marking" }, { "name": "Stronger asbestos controls needed to keep kids safe", "authority": "UK Office for Product Safety and Standards (OPSS)", "source": "https://www.gov.uk/government/news/stronger-asbestos-controls-needed-to-keep-kids-safe" } ], "testing_certification": [ "BS EN 71 series testing (harmonised with EU EN 71)", "UK Declaration of Conformity", "Northern Ireland follows EU rules (CE or CE+UKNI) — dual-regime trap for GB/NI split shipments", "Material-change and periodic retesting plan", "Marketplace-requested toy-safety evidence package (e.g. Amazon UK)", "For toys containing natural sand or similar mineral fill, suitable accredited-laboratory and supply-chain evidence that asbestos is absent, following current OPSS guidance" ], "labelling": [ "UKCA or CE mark", "UK importer/responsible person name and address", "English-language warnings and age grading" ], "local_representative": { "required": false, "conditional": true, "note_en": "A UK authorised representative may be appointed but is not universally mandatory. A UK-established importer is required when that entity places toys from outside the UK on the GB market and must meet importer-address and traceability duties.", "note_zh": "可指定英国授权代表，但并非一概强制。英国境内实体将境外玩具投放大不列颠市场时构成进口商，须履行进口商地址标注及可追溯义务。" }, "pitfalls_zh": [ "误以为英国脱欧后必须用UKCA——政府已宣布无限期继续承认CE标志（多数品类含玩具）", "北爱尔兰适用欧盟规则，与大不列颠不同，混发货件需分开处理", "不要把欧盟责任人制度直接套用于英国玩具；应先确定供应链中谁是英国进口商，以及是否另行委任授权代表", "含天然砂或矿物填料的玩具若只依赖供应商口头保证、未留存无石棉检测及供应链证据，会形成明显的安全和执法风险" ], "last_verified": "2026-08-13", "jurisdiction_scope": "Great Britain (England, Scotland and Wales); Northern Ireland can follow a different regime", "applicability": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-05: OPSS GB guidance reviewed; authorised-representative vs importer duties corrected; see changelog 0.2.0. 2026-07-11: Added retesting-plan and marketplace-evidence testing_certification bullets to match the depth of the US toys evidence checklist. 2026-08-13: Added OPSS's current sand-containing-toy asbestos guidance. This is classified as a compliance measure, not presented as a new toy-specific statutory ban: suppliers should obtain suitable evidence that natural sand or similar mineral fill is asbestos-free and keep supply-chain controls under review.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 4, "sources": [ { "id": "toys-uk:source:1", "title": "Toys (Safety) Regulations 2011", "authority": "UK Office for Product Safety and Standards (OPSS)", "url": "https://www.legislation.gov.uk/uksi/2011/1881/contents", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "toys-uk:source:2", "title": "Toys (Safety) Regulations 2011: Great Britain guidance", "authority": "UK Office for Product Safety and Standards (OPSS)", "url": "https://www.gov.uk/government/publications/toys-safety-regulations-2011/toys-safety-regulations-2011-great-britain", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "toys-uk:source:3", "title": "UKCA marking guidance", "authority": "UK Department for Business and Trade", "url": "https://www.gov.uk/guidance/using-the-ukca-marking", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "toys-uk:source:4", "title": "Stronger asbestos controls needed to keep kids safe", "authority": "UK Office for Product Safety and Standards (OPSS)", "url": "https://www.gov.uk/government/news/stronger-asbestos-controls-needed-to-keep-kids-safe", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "toys-uk:summary", "topic": "summary", "text_en": "Toys for Great Britain fall under the Toys (Safety) Regulations 2011. CE marking remains accepted for toys and UKCA is the domestic alternative. A UK authorised representative is optional, but a UK-established importer that places goods from outside the UK on the GB market has statutory importer and traceability duties. For toys containing natural sand or similar mineral fill, current OPSS guidance calls for stronger supplier controls and evidence that asbestos is absent.", "text_zh": "输往大不列颠的玩具适用《2011年玩具（安全）条例》。玩具仍可使用CE标志，UKCA为英国本土替代标志。英国授权代表并非一概强制，但将在境外商品投放英国市场的英国进口商负有法定进口和可追溯义务。含天然砂或类似矿物填充物的玩具，还应按OPSS现行指南加强供应商控制并保留无石棉证据。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:required_mark:1", "topic": "required_mark", "text_en": "UKCA or CE", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:testing:1", "topic": "testing", "text_en": "BS EN 71 series testing (harmonised with EU EN 71)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:testing:2", "topic": "testing", "text_en": "UK Declaration of Conformity", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:testing:3", "topic": "testing", "text_en": "Northern Ireland follows EU rules (CE or CE+UKNI) — dual-regime trap for GB/NI split shipments", "text_zh": null, "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-uk:testing:4", "topic": "testing", "text_en": "Material-change and periodic retesting plan", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:testing:5", "topic": "testing", "text_en": "Marketplace-requested toy-safety evidence package (e.g. Amazon UK)", "text_zh": null, "classification": "platform_policy", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-uk:testing:6", "topic": "testing", "text_en": "For toys containing natural sand or similar mineral fill, suitable accredited-laboratory and supply-chain evidence that asbestos is absent, following current OPSS guidance", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:labelling:1", "topic": "labelling", "text_en": "UKCA or CE mark", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:labelling:2", "topic": "labelling", "text_en": "UK importer/responsible person name and address", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:labelling:3", "topic": "labelling", "text_en": "English-language warnings and age grading", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:local-presence", "topic": "local_presence", "text_en": "A UK authorised representative may be appointed but is not universally mandatory. A UK-established importer is required when that entity places toys from outside the UK on the GB market and must meet importer-address and traceability duties.", "text_zh": "可指定英国授权代表，但并非一概强制。英国境内实体将境外玩具投放大不列颠市场时构成进口商，须履行进口商地址标注及可追溯义务。", "classification": "legal_requirement", "mandatory": null, "conditions": [ "Requirement depends on authorization route and supply-chain role" ], "evidence": [ "toys-uk:source:1", "toys-uk:source:2", "toys-uk:source:3", "toys-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "toys-uk:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "误以为英国脱欧后必须用UKCA——政府已宣布无限期继续承认CE标志（多数品类含玩具）", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-uk:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "北爱尔兰适用欧盟规则，与大不列颠不同，混发货件需分开处理", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-uk:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "不要把欧盟责任人制度直接套用于英国玩具；应先确定供应链中谁是英国进口商，以及是否另行委任授权代表", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-uk:pitfall:4", "topic": "pitfall", "text_en": null, "text_zh": "含天然砂或矿物填料的玩具若只依赖供应商口头保证、未留存无石棉检测及供应链证据，会形成明显的安全和执法风险", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "toys-au", "category": "toys", "market": "AU", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-05: ACCC mandatory-standard page checked; accepted standards corrected to AS/NZS ISO 8124.1:2023 with ISO 8124-1/EN 71-1/ASTM F963-17 alternatives plus AS/NZS 62115 for electric toys; button-battery scope confirmed. 2026-07-11: Fixed a latent claim-reference bug (the au_toy_warning_artwork evidence item pointed at a non-existent labelling:3 claim because this record only had 2 labelling items) by adding an explicit age-grading/hazard-warning labelling bullet; also added retesting-plan and marketplace-evidence testing_certification bullets to match US toys evidence depth. The new age-grading/warning labelling bullet describes a general expectation of the accepted mechanical toy-safety standards (AS/NZS ISO 8124.1 and its accepted alternatives) rather than a clause independently re-read against the standard's own text this pass — flagging that distinction rather than overclaiming it.", "summary_en": "Australia enforces mandatory toy standards under the Australian Consumer Law (based on AS/NZS ISO 8124), plus world-first mandatory button/coin battery safety standards that apply to any product containing them.", "summary_zh": "澳大利亚依据《澳大利亚消费者法》强制执行玩具安全标准（基于AS/NZS ISO 8124），并实施全球首个强制性纽扣电池安全标准，适用于所有含纽扣电池的产品。", "required_marks": [], "regulations": [ { "name": "Consumer Goods (Toys for Children up to 36 months) Safety Standard", "authority": "Australian Competition and Consumer Commission (ACCC)", "source": "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/coin battery mandatory standards (2020, in force June 2022)", "authority": "ACCC", "source": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/button-and-coin-batteries" } ], "testing_certification": [ "Toys for children up to 36 months: 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", "Electric toys: AS/NZS 62115:2018 applies", "Battery compartments on toys for children up to 36 months must be secured so they can only be opened with a tool", "Button battery compliance: secure compartments, child-resistant packaging, warnings — applies beyond toys to any consumer product with button/coin batteries", "Material-change and periodic retesting plan", "Marketplace-requested toy-safety evidence package (e.g. Amazon AU)" ], "labelling": [ "Button battery warning markings on packaging and instructions", "No general conformity mark required for toys (unlike CE/UKCA)", "Age grading and hazard warnings per the applicable toy-safety standard" ], "local_representative": { "required": false, "note_en": "No responsible-person regime; ACL liability sits with the supplier, and penalties for breaching mandatory standards are severe.", "note_zh": "无境内责任人制度；供应商依《澳大利亚消费者法》承担责任，违反强制标准的处罚十分严厉。" }, "pitfalls_zh": [ "纽扣电池标准适用于所有含此类电池的商品，不只是玩具——遥控器、电子礼品同样适用", "澳洲无CE式认证标志，卖家误以为'无标志=无要求'，实际强制标准照样执法", "ACCC对违规产品可处以巨额罚款并强制召回，执法记录公开" ], "last_verified": "2026-07-05", "jurisdiction_scope": "Australia; state and territory enforcement can vary", "applicability": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-05: ACCC mandatory-standard page checked; accepted standards corrected to AS/NZS ISO 8124.1:2023 with ISO 8124-1/EN 71-1/ASTM F963-17 alternatives plus AS/NZS 62115 for electric toys; button-battery scope confirmed. 2026-07-11: Fixed a latent claim-reference bug (the au_toy_warning_artwork evidence item pointed at a non-existent labelling:3 claim because this record only had 2 labelling items) by adding an explicit age-grading/hazard-warning labelling bullet; also added retesting-plan and marketplace-evidence testing_certification bullets to match US toys evidence depth. The new age-grading/warning labelling bullet describes a general expectation of the accepted mechanical toy-safety standards (AS/NZS ISO 8124.1 and its accepted alternatives) rather than a clause independently re-read against the standard's own text this pass — flagging that distinction rather than overclaiming it.", "verified_at": "2026-07-05", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 2, "sources": [ { "id": "toys-au:source:1", "title": "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", "source_type": "primary", "checked_at": "2026-07-05" }, { "id": "toys-au:source:2", "title": "Button/coin battery mandatory standards (2020, in force June 2022)", "authority": "ACCC", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/button-and-coin-batteries", "source_type": "primary", "checked_at": "2026-07-05" } ] }, "claims": [ { "id": "toys-au:summary", "topic": "summary", "text_en": "Australia enforces mandatory toy standards under the Australian Consumer Law (based on AS/NZS ISO 8124), plus world-first mandatory button/coin battery safety standards that apply to any product containing them.", "text_zh": "澳大利亚依据《澳大利亚消费者法》强制执行玩具安全标准（基于AS/NZS ISO 8124），并实施全球首个强制性纽扣电池安全标准，适用于所有含纽扣电池的产品。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm the product is legally a toy, intended age group, accessible small parts, battery security, radio functions and chemical hazards" ], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:testing:1", "topic": "testing", "text_en": "Toys for children up to 36 months: 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", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:testing:2", "topic": "testing", "text_en": "Electric toys: AS/NZS 62115:2018 applies", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:testing:3", "topic": "testing", "text_en": "Battery compartments on toys for children up to 36 months must be secured so they can only be opened with a tool", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:testing:4", "topic": "testing", "text_en": "Button battery compliance: secure compartments, child-resistant packaging, warnings — applies beyond toys to any consumer product with button/coin batteries", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:testing:5", "topic": "testing", "text_en": "Material-change and periodic retesting plan", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:testing:6", "topic": "testing", "text_en": "Marketplace-requested toy-safety evidence package (e.g. Amazon AU)", "text_zh": null, "classification": "platform_policy", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-au:labelling:1", "topic": "labelling", "text_en": "Button battery warning markings on packaging and instructions", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:labelling:2", "topic": "labelling", "text_en": "No general conformity mark required for toys (unlike CE/UKCA)", "text_zh": null, "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-au:labelling:3", "topic": "labelling", "text_en": "Age grading and hazard warnings per the applicable toy-safety standard", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:local-presence", "topic": "local_presence", "text_en": "No responsible-person regime; ACL liability sits with the supplier, and penalties for breaching mandatory standards are severe.", "text_zh": "无境内责任人制度；供应商依《澳大利亚消费者法》承担责任，违反强制标准的处罚十分严厉。", "classification": "legal_requirement", "mandatory": false, "conditions": [], "evidence": [ "toys-au:source:1", "toys-au:source:2" ], "evidence_status": "record_source_set" }, { "id": "toys-au:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "纽扣电池标准适用于所有含此类电池的商品，不只是玩具——遥控器、电子礼品同样适用", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-au:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "澳洲无CE式认证标志，卖家误以为'无标志=无要求'，实际强制标准照样执法", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "toys-au:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "ACCC对违规产品可处以巨额罚款并强制召回，执法记录公开", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "battery-electronics-eu", "category": "battery-electronics", "market": "EU", "risk_level": "high", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-08-13: Corrected battery due diligence against amending Regulation (EU) 2025/1561: Article 48 obligations begin 18 August 2027, not 18 August 2025. Rechecked Article 13(1)-(3): 18 August 2026 is only the earliest possible general-labelling date because the legal trigger is the later of that date or 18 months after the Article 13(10) implementing act enters into force; only a draft implementing regulation was located. The fixed 18 February 2027 removability, QR-code and scoped passport milestones remain unchanged.", "summary_en": "Battery-powered electronics for the EU stack multiple regimes: CE under RED (wireless) or LVD/EMC, RoHS substance limits, WEEE registration per member state, the new EU Battery Regulation 2023/1542, and UN 38.3 for lithium battery transport.", "summary_zh": "输欧带电池电子产品需叠加多套法规：无线产品适用RED（否则LVD/EMC）并加贴CE标志、RoHS有害物质限制、按成员国注册WEEE、新的欧盟电池法规2023/1542，以及锂电池运输的UN 38.3。", "required_marks": [ "CE", "WEEE crossed-out bin symbol" ], "regulations": [ { "name": "Radio Equipment Directive 2014/53/EU", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0053" }, { "name": "RoHS Directive 2011/65/EU", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0065" }, { "name": "EU Battery Regulation (EU) 2023/1542", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2023/1542/oj" }, { "name": "Regulation (EU) 2025/1561 postponing battery due diligence to 18 August 2027", "authority": "European Union", "source": "https://eur-lex.europa.eu/eli/reg/2025/1561/oj" }, { "name": "Draft Article 13(10) battery labelling implementing regulation", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=intcom:Ares(2025)11169592" }, { "name": "WEEE Directive 2012/19/EU", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012L0019" } ], "testing_certification": [ "RED testing (radio, EMC, safety) — Bluetooth/WiFi products", "UN 38.3 test summary for lithium cells/batteries (transport)", "CE Declaration of Conformity covering all applicable directives", "Battery Regulation: CE marking of batteries themselves; applicable carbon-footprint duties; Article 48 supply-chain due-diligence obligations are postponed to 18 August 2027 and retain the Article 47 scope threshold", "From 18 February 2027: portable/LMT batteries must be readily removable and replaceable by the end-user (Article 11, per Article 96(2)(a))", "From 18 February 2027: all batteries must bear a QR code (Article 13(6)); the Article 13(1)-(3) general/capacity/duration labels apply on the later of 18 August 2026 or 18 months after the Article 13(10) implementing act enters into force", "From 18 February 2027: LMT batteries, industrial batteries >2 kWh, and EV batteries must have a digital battery passport (Article 77(1))" ], "labelling": [ "CE mark, WEEE crossed-out wheelie bin symbol", "Manufacturer + EU importer address", "Battery capacity and separate-collection marking under Battery Regulation" ], "local_representative": { "required": true, "note_en": "EU responsible person required (GPSR / Market Surveillance Reg); WEEE and battery producer registration needed in each member state of sale.", "note_zh": "需欧盟责任人（GPSR/市场监管条例）；且须在每个销售成员国分别完成WEEE和电池生产者注册。" }, "pitfalls_zh": [ "WEEE注册按国别进行，德国(EAR)和法国执法最严，未注册会被平台封listing", "新电池法规要求电池本身也加贴CE标志，旧库存需评估过渡期", "UN 38.3测试摘要缺失会导致物流商拒收，货物滞留在头程" ], "last_verified": "2026-08-13", "jurisdiction_scope": "European Union (EU-27); member-state language, registration and enforcement details may vary", "applicability": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-08-13: Corrected battery due diligence against amending Regulation (EU) 2025/1561: Article 48 obligations begin 18 August 2027, not 18 August 2025. Rechecked Article 13(1)-(3): 18 August 2026 is only the earliest possible general-labelling date because the legal trigger is the later of that date or 18 months after the Article 13(10) implementing act enters into force; only a draft implementing regulation was located. The fixed 18 February 2027 removability, QR-code and scoped passport milestones remain unchanged.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 6, "sources": [ { "id": "battery-electronics-eu:source:1", "title": "Radio Equipment Directive 2014/53/EU", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0053", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "battery-electronics-eu:source:2", "title": "RoHS Directive 2011/65/EU", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0065", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "battery-electronics-eu:source:3", "title": "EU Battery Regulation (EU) 2023/1542", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2023/1542/oj", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "battery-electronics-eu:source:4", "title": "Regulation (EU) 2025/1561 postponing battery due diligence to 18 August 2027", "authority": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2025/1561/oj", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "battery-electronics-eu:source:5", "title": "Draft Article 13(10) battery labelling implementing regulation", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=intcom:Ares(2025)11169592", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "battery-electronics-eu:source:6", "title": "WEEE Directive 2012/19/EU", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012L0019", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "battery-electronics-eu:summary", "topic": "summary", "text_en": "Battery-powered electronics for the EU stack multiple regimes: CE under RED (wireless) or LVD/EMC, RoHS substance limits, WEEE registration per member state, the new EU Battery Regulation 2023/1542, and UN 38.3 for lithium battery transport.", "text_zh": "输欧带电池电子产品需叠加多套法规：无线产品适用RED（否则LVD/EMC）并加贴CE标志、RoHS有害物质限制、按成员国注册WEEE、新的欧盟电池法规2023/1542，以及锂电池运输的UN 38.3。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:required_mark:1", "topic": "required_mark", "text_en": "CE", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:required_mark:2", "topic": "required_mark", "text_en": "WEEE crossed-out bin symbol", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:testing:1", "topic": "testing", "text_en": "RED testing (radio, EMC, safety) — Bluetooth/WiFi products", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:testing:2", "topic": "testing", "text_en": "UN 38.3 test summary for lithium cells/batteries (transport)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:testing:3", "topic": "testing", "text_en": "CE Declaration of Conformity covering all applicable directives", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:testing:4", "topic": "testing", "text_en": "Battery Regulation: CE marking of batteries themselves; applicable carbon-footprint duties; Article 48 supply-chain due-diligence obligations are postponed to 18 August 2027 and retain the Article 47 scope threshold", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:testing:5", "topic": "testing", "text_en": "From 18 February 2027: portable/LMT batteries must be readily removable and replaceable by the end-user (Article 11, per Article 96(2)(a))", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:testing:6", "topic": "testing", "text_en": "From 18 February 2027: all batteries must bear a QR code (Article 13(6)); the Article 13(1)-(3) general/capacity/duration labels apply on the later of 18 August 2026 or 18 months after the Article 13(10) implementing act enters into force", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:testing:7", "topic": "testing", "text_en": "From 18 February 2027: LMT batteries, industrial batteries >2 kWh, and EV batteries must have a digital battery passport (Article 77(1))", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:labelling:1", "topic": "labelling", "text_en": "CE mark, WEEE crossed-out wheelie bin symbol", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:labelling:2", "topic": "labelling", "text_en": "Manufacturer + EU importer address", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:labelling:3", "topic": "labelling", "text_en": "Battery capacity and separate-collection marking under Battery Regulation", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:local-presence", "topic": "local_presence", "text_en": "EU responsible person required (GPSR / Market Surveillance Reg); WEEE and battery producer registration needed in each member state of sale.", "text_zh": "需欧盟责任人（GPSR/市场监管条例）；且须在每个销售成员国分别完成WEEE和电池生产者注册。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-eu:source:1", "battery-electronics-eu:source:2", "battery-electronics-eu:source:3", "battery-electronics-eu:source:4", "battery-electronics-eu:source:5", "battery-electronics-eu:source:6" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-eu:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "WEEE注册按国别进行，德国(EAR)和法国执法最严，未注册会被平台封listing", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-eu:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "新电池法规要求电池本身也加贴CE标志，旧库存需评估过渡期", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-eu:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "UN 38.3测试摘要缺失会导致物流商拒收，货物滞留在头程", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "battery-electronics-us", "category": "battery-electronics", "market": "US", "risk_level": "high", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-05: FCC SDoC responsible-party conditionality reviewed; see changelog 0.2.0.", "summary_en": "US market: FCC authorization (SDoC for unintentional radiators, certification via TCB for WiFi/Bluetooth), UN 38.3 + DOT rules for lithium battery shipping, and marketplace-driven UL safety standards (UL 62368-1, UL 2054) which are de facto mandatory on Amazon.", "summary_zh": "美国市场：FCC认证（非有意辐射设备走SDoC，WiFi/蓝牙产品需经TCB认证），锂电池运输须UN 38.3和DOT规则，UL安全标准（UL 62368-1、UL 2054）虽非法定强制但已是亚马逊等平台的事实门槛。", "required_marks": [ "FCC (where applicable)" ], "regulations": [ { "name": "FCC Part 15 (radio frequency devices)", "authority": "Federal Communications Commission", "source": "https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15" }, { "name": "DOT/PHMSA lithium battery transport rules (49 CFR 173.185)", "authority": "US Department of Transportation", "source": "https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-E/section-173.185" }, { "name": "California Proposition 65", "authority": "California OEHHA", "source": "https://oehha.ca.gov/proposition-65" } ], "testing_certification": [ "FCC SDoC or TCB certification with FCC ID for intentional radiators", "UN 38.3 test summary for lithium batteries", "UL 62368-1 / UL 2054 testing — marketplace requirement for battery products", "Prop 65 assessment or warning label for California sales" ], "labelling": [ "FCC ID or compliance statement", "Lithium battery handling/shipping marks on packaging", "Prop 65 warning if listed chemicals present without assessment" ], "local_representative": { "required": false, "conditional": true, "note_en": "A US-based responsible party is required when the FCC Supplier's Declaration of Conformity procedure applies. Other authorization routes and CPSC obligations differ; the importer of record may carry separate liability.", "note_zh": "适用FCC供应商符合性声明(SDoC)程序时，必须有美国境内责任方。其他授权路径及CPSC义务有所不同；登记进口商可能另负法律责任。" }, "pitfalls_zh": [ "SDoC也需要美国境内责任方——很多卖家不知道纯自我声明同样有属地要求", "亚马逊对充电宝、电池类目强制要求UL报告，无UL 2054/62368-1报告无法上架", "Prop 65是私人律师驱动执法，中小卖家是钓鱼诉讼的主要目标" ], "last_verified": "2026-07-05", "jurisdiction_scope": "United States federal requirements; state requirements may add obligations", "applicability": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-05: FCC SDoC responsible-party conditionality reviewed; see changelog 0.2.0.", "verified_at": "2026-07-05", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 3, "sources": [ { "id": "battery-electronics-us:source:1", "title": "FCC Part 15 (radio frequency devices)", "authority": "Federal Communications Commission", "url": "https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15", "source_type": "primary", "checked_at": "2026-07-05" }, { "id": "battery-electronics-us:source:2", "title": "DOT/PHMSA lithium battery transport rules (49 CFR 173.185)", "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", "source_type": "primary", "checked_at": "2026-07-05" }, { "id": "battery-electronics-us:source:3", "title": "California Proposition 65", "authority": "California OEHHA", "url": "https://oehha.ca.gov/proposition-65", "source_type": "primary", "checked_at": "2026-07-05" } ] }, "claims": [ { "id": "battery-electronics-us:summary", "topic": "summary", "text_en": "US market: FCC authorization (SDoC for unintentional radiators, certification via TCB for WiFi/Bluetooth), UN 38.3 + DOT rules for lithium battery shipping, and marketplace-driven UL safety standards (UL 62368-1, UL 2054) which are de facto mandatory on Amazon.", "text_zh": "美国市场：FCC认证（非有意辐射设备走SDoC，WiFi/蓝牙产品需经TCB认证），锂电池运输须UN 38.3和DOT规则，UL安全标准（UL 62368-1、UL 2054）虽非法定强制但已是亚马逊等平台的事实门槛。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:required_mark:1", "topic": "required_mark", "text_en": "FCC (where applicable)", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:testing:1", "topic": "testing", "text_en": "FCC SDoC or TCB certification with FCC ID for intentional radiators", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:testing:2", "topic": "testing", "text_en": "UN 38.3 test summary for lithium batteries", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:testing:3", "topic": "testing", "text_en": "UL 62368-1 / UL 2054 testing — marketplace requirement for battery products", "text_zh": null, "classification": "platform_policy", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-us:testing:4", "topic": "testing", "text_en": "Prop 65 assessment or warning label for California sales", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:labelling:1", "topic": "labelling", "text_en": "FCC ID or compliance statement", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:labelling:2", "topic": "labelling", "text_en": "Lithium battery handling/shipping marks on packaging", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:labelling:3", "topic": "labelling", "text_en": "Prop 65 warning if listed chemicals present without assessment", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:local-presence", "topic": "local_presence", "text_en": "A US-based responsible party is required when the FCC Supplier's Declaration of Conformity procedure applies. Other authorization routes and CPSC obligations differ; the importer of record may carry separate liability.", "text_zh": "适用FCC供应商符合性声明(SDoC)程序时，必须有美国境内责任方。其他授权路径及CPSC义务有所不同；登记进口商可能另负法律责任。", "classification": "legal_requirement", "mandatory": null, "conditions": [ "Requirement depends on authorization route and supply-chain role" ], "evidence": [ "battery-electronics-us:source:1", "battery-electronics-us:source:2", "battery-electronics-us:source:3" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-us:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "SDoC也需要美国境内责任方——很多卖家不知道纯自我声明同样有属地要求", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-us:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "亚马逊对充电宝、电池类目强制要求UL报告，无UL 2054/62368-1报告无法上架", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-us:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "Prop 65是私人律师驱动执法，中小卖家是钓鱼诉讼的主要目标", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "battery-electronics-uk", "category": "battery-electronics", "market": "UK", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-05: UK instruments and importer duties reviewed; see changelog 0.2.0. 2026-07-11: Added UN 38.3 and marketplace-evidence testing_certification bullets to bring the preflight evidence checklist to the same breadth as the US record; both items describe existing, already-verified requirements (UN 38.3 transport testing, marketplace-requested safety reports) rather than new legal claims.", "summary_en": "GB uses domestic instruments including the Radio Equipment Regulations 2017, RoHS Regulations 2012 and WEEE Regulations 2013; UKCA or CE marking is accepted for relevant equipment. A UK authorised representative is optional, while a UK-established importer has statutory conformity and traceability duties.", "summary_zh": "大不列颠适用《2017年无线电设备条例》《2012年RoHS条例》和《2013年WEEE条例》等本国法规；相关设备可使用UKCA或CE标志。英国授权代表并非一概强制，但英国境内进口商负有法定符合性及可追溯义务。", "required_marks": [ "UKCA or CE", "WEEE crossed-out bin symbol" ], "regulations": [ { "name": "Radio Equipment Regulations 2017", "authority": "OPSS / Ofcom", "source": "https://www.legislation.gov.uk/uksi/2017/1206/contents" }, { "name": "Radio Equipment Regulations 2017: Great Britain guidance", "authority": "UK OPSS", "source": "https://www.gov.uk/government/publications/radio-equipment-regulations-2017/radio-equipment-regulations-2017-great-britain" }, { "name": "RoHS Regulations 2012 (UK)", "authority": "OPSS", "source": "https://www.legislation.gov.uk/uksi/2012/3032/contents" }, { "name": "WEEE Regulations 2013 (UK)", "authority": "Environment Agency", "source": "https://www.legislation.gov.uk/uksi/2013/3113/contents" } ], "testing_certification": [ "Testing to designated standards (largely identical to EU harmonised standards)", "UK Declaration of Conformity", "WEEE producer registration and battery producer compliance scheme membership", "UN 38.3 test summary for lithium batteries", "Marketplace-requested product safety report (e.g. Amazon UK)" ], "labelling": [ "UKCA or CE mark", "UK importer address", "Crossed-out wheelie bin symbol" ], "local_representative": { "required": false, "conditional": true, "note_en": "A UK authorised representative may be appointed but is not universally mandatory. A UK-established importer is required where that entity places equipment from outside the UK on the GB market. WEEE producer obligations are separate and depend on the supply model.", "note_zh": "可指定英国授权代表，但并非一概强制。英国境内实体将境外设备投放大不列颠市场时构成进口商。WEEE生产者义务另行适用，并取决于具体供应模式。" }, "pitfalls_zh": [ "英国WEEE与欧盟WEEE注册完全独立，双市场卖家常漏掉英国侧", "测试报告可复用欧盟数据，但符合性声明须单独出具英国版本", "含无线功能产品在英国需确认频段符合Ofcom分配（大体同欧盟但有差异）" ], "last_verified": "2026-07-05", "jurisdiction_scope": "Great Britain (England, Scotland and Wales); Northern Ireland can follow a different regime", "applicability": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-05: UK instruments and importer duties reviewed; see changelog 0.2.0. 2026-07-11: Added UN 38.3 and marketplace-evidence testing_certification bullets to bring the preflight evidence checklist to the same breadth as the US record; both items describe existing, already-verified requirements (UN 38.3 transport testing, marketplace-requested safety reports) rather than new legal claims.", "verified_at": "2026-07-05", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 4, "sources": [ { "id": "battery-electronics-uk:source:1", "title": "Radio Equipment Regulations 2017", "authority": "OPSS / Ofcom", "url": "https://www.legislation.gov.uk/uksi/2017/1206/contents", "source_type": "primary", "checked_at": "2026-07-05" }, { "id": "battery-electronics-uk:source:2", "title": "Radio Equipment Regulations 2017: Great Britain guidance", "authority": "UK OPSS", "url": "https://www.gov.uk/government/publications/radio-equipment-regulations-2017/radio-equipment-regulations-2017-great-britain", "source_type": "primary", "checked_at": "2026-07-05" }, { "id": "battery-electronics-uk:source:3", "title": "RoHS Regulations 2012 (UK)", "authority": "OPSS", "url": "https://www.legislation.gov.uk/uksi/2012/3032/contents", "source_type": "primary", "checked_at": "2026-07-05" }, { "id": "battery-electronics-uk:source:4", "title": "WEEE Regulations 2013 (UK)", "authority": "Environment Agency", "url": "https://www.legislation.gov.uk/uksi/2013/3113/contents", "source_type": "primary", "checked_at": "2026-07-05" } ] }, "claims": [ { "id": "battery-electronics-uk:summary", "topic": "summary", "text_en": "GB uses domestic instruments including the Radio Equipment Regulations 2017, RoHS Regulations 2012 and WEEE Regulations 2013; UKCA or CE marking is accepted for relevant equipment. A UK authorised representative is optional, while a UK-established importer has statutory conformity and traceability duties.", "text_zh": "大不列颠适用《2017年无线电设备条例》《2012年RoHS条例》和《2013年WEEE条例》等本国法规；相关设备可使用UKCA或CE标志。英国授权代表并非一概强制，但英国境内进口商负有法定符合性及可追溯义务。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:required_mark:1", "topic": "required_mark", "text_en": "UKCA or CE", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:required_mark:2", "topic": "required_mark", "text_en": "WEEE crossed-out bin symbol", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:testing:1", "topic": "testing", "text_en": "Testing to designated standards (largely identical to EU harmonised standards)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:testing:2", "topic": "testing", "text_en": "UK Declaration of Conformity", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:testing:3", "topic": "testing", "text_en": "WEEE producer registration and battery producer compliance scheme membership", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:testing:4", "topic": "testing", "text_en": "UN 38.3 test summary for lithium batteries", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:testing:5", "topic": "testing", "text_en": "Marketplace-requested product safety report (e.g. Amazon UK)", "text_zh": null, "classification": "platform_policy", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-uk:labelling:1", "topic": "labelling", "text_en": "UKCA or CE mark", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:labelling:2", "topic": "labelling", "text_en": "UK importer address", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:labelling:3", "topic": "labelling", "text_en": "Crossed-out wheelie bin symbol", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:local-presence", "topic": "local_presence", "text_en": "A UK authorised representative may be appointed but is not universally mandatory. A UK-established importer is required where that entity places equipment from outside the UK on the GB market. WEEE producer obligations are separate and depend on the supply model.", "text_zh": "可指定英国授权代表，但并非一概强制。英国境内实体将境外设备投放大不列颠市场时构成进口商。WEEE生产者义务另行适用，并取决于具体供应模式。", "classification": "legal_requirement", "mandatory": null, "conditions": [ "Requirement depends on authorization route and supply-chain role" ], "evidence": [ "battery-electronics-uk:source:1", "battery-electronics-uk:source:2", "battery-electronics-uk:source:3", "battery-electronics-uk:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-uk:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "英国WEEE与欧盟WEEE注册完全独立，双市场卖家常漏掉英国侧", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-uk:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "测试报告可复用欧盟数据，但符合性声明须单独出具英国版本", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-uk:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "含无线功能产品在英国需确认频段符合Ofcom分配（大体同欧盟但有差异）", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "battery-electronics-au", "category": "battery-electronics", "market": "AU", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-05: Checked productsafety.gov.au button/coin battery mandatory standards page and acma.gov.au labelling guidance directly in browser (both load fine; the earlier session's blocker was specifically the ACCC guide PDF, not this HTML page). Confirmed button/coin battery standards scope covers all consumer goods that use, are powered by, or operate with button/coin batteries (not just toys), and that RCM/EESS both use the Regulatory Compliance Mark. 2026-07-11: Closed the remaining gap — fetched acma.gov.au/step-4-register-responsible-supplier directly (the previously-linked page had 404'd; found via search instead). It confirms registration on the national database (the EESS Platform) is Step 4 of the ACMA 5-step supplier process, requires an address in Australia and a representative's contact details, and precedes Step 5 (labelling with the RCM) — matching this record's 'supplier registration before applying RCM' and local-representative claims exactly.", "summary_en": "Australia requires the RCM (Regulatory Compliance Mark) covering ACMA EMC/radio rules and electrical safety; in-scope electrical equipment must be registered on the EESS database. Button battery standards apply if coin cells are used.", "summary_zh": "澳大利亚要求加贴RCM标志（涵盖ACMA电磁兼容/无线电规则及电气安全）；范围内电气设备须在EESS数据库注册。使用纽扣电池的产品另需符合纽扣电池强制标准。", "required_marks": [ "RCM" ], "regulations": [ { "name": "Radiocommunications compliance labelling and RCM guidance", "authority": "Australian Communications and Media Authority (ACMA)", "source": "https://www.acma.gov.au/step-5-label-your-product" }, { "name": "Electrical Equipment Safety System (EESS)", "authority": "State electrical safety regulators", "source": "https://www.eess.gov.au/" }, { "name": "Button/coin battery mandatory standards", "authority": "ACCC", "source": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/button-and-coin-batteries" }, { "name": "Step 4: register as a responsible supplier", "authority": "Australian Communications and Media Authority (ACMA)", "source": "https://www.acma.gov.au/step-4-register-responsible-supplier" } ], "testing_certification": [ "EMC/radio testing to ACMA-recognised standards", "EESS registration for Level 2/3 in-scope electrical equipment", "Supplier registration on the ACMA/EESS national database (Step 4 of the ACMA supplier process) before applying RCM", "Marketplace-requested product safety report (e.g. Amazon AU)" ], "labelling": [ "RCM mark on product", "Button battery warnings where applicable" ], "local_representative": { "required": true, "note_en": "RCM requires an Australian supplier registration — the mark can only be applied by/for an entity with an Australian presence.", "note_zh": "使用RCM标志的前提是完成澳大利亚供应商注册——只有澳境内实体可作为注册供应商。" }, "pitfalls_zh": [ "RCM必须挂靠澳洲本地注册供应商，跨境直邮卖家需找本地代理挂靠", "EESS按风险等级(Level 1-3)区分注册义务，带插头充电器多为高等级", "各州电气安全监管机构分头执法，昆士兰州最为积极" ], "last_verified": "2026-07-16", "jurisdiction_scope": "Australia; state and territory enforcement can vary", "applicability": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-05: Checked productsafety.gov.au button/coin battery mandatory standards page and acma.gov.au labelling guidance directly in browser (both load fine; the earlier session's blocker was specifically the ACCC guide PDF, not this HTML page). Confirmed button/coin battery standards scope covers all consumer goods that use, are powered by, or operate with button/coin batteries (not just toys), and that RCM/EESS both use the Regulatory Compliance Mark. 2026-07-11: Closed the remaining gap — fetched acma.gov.au/step-4-register-responsible-supplier directly (the previously-linked page had 404'd; found via search instead). It confirms registration on the national database (the EESS Platform) is Step 4 of the ACMA 5-step supplier process, requires an address in Australia and a representative's contact details, and precedes Step 5 (labelling with the RCM) — matching this record's 'supplier registration before applying RCM' and local-representative claims exactly.", "verified_at": "2026-07-16", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 4, "sources": [ { "id": "battery-electronics-au:source:1", "title": "Radiocommunications compliance labelling and RCM guidance", "authority": "Australian Communications and Media Authority (ACMA)", "url": "https://www.acma.gov.au/step-5-label-your-product", "source_type": "primary", "checked_at": "2026-07-16" }, { "id": "battery-electronics-au:source:2", "title": "Electrical Equipment Safety System (EESS)", "authority": "State electrical safety regulators", "url": "https://www.eess.gov.au/", "source_type": "primary", "checked_at": "2026-07-16" }, { "id": "battery-electronics-au:source:3", "title": "Button/coin battery mandatory standards", "authority": "ACCC", "url": "https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/button-and-coin-batteries", "source_type": "primary", "checked_at": "2026-07-16" }, { "id": "battery-electronics-au:source:4", "title": "Step 4: register as a responsible supplier", "authority": "Australian Communications and Media Authority (ACMA)", "url": "https://www.acma.gov.au/step-4-register-responsible-supplier", "source_type": "primary", "checked_at": "2026-07-16" } ] }, "claims": [ { "id": "battery-electronics-au:summary", "topic": "summary", "text_en": "Australia requires the RCM (Regulatory Compliance Mark) covering ACMA EMC/radio rules and electrical safety; in-scope electrical equipment must be registered on the EESS database. Button battery standards apply if coin cells are used.", "text_zh": "澳大利亚要求加贴RCM标志（涵盖ACMA电磁兼容/无线电规则及电气安全）；范围内电气设备须在EESS数据库注册。使用纽扣电池的产品另需符合纽扣电池强制标准。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm battery chemistry, radio functionality, voltage, charger and transport configuration" ], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:required_mark:1", "topic": "required_mark", "text_en": "RCM", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:testing:1", "topic": "testing", "text_en": "EMC/radio testing to ACMA-recognised standards", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:testing:2", "topic": "testing", "text_en": "EESS registration for Level 2/3 in-scope electrical equipment", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:testing:3", "topic": "testing", "text_en": "Supplier registration on the ACMA/EESS national database (Step 4 of the ACMA supplier process) before applying RCM", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:testing:4", "topic": "testing", "text_en": "Marketplace-requested product safety report (e.g. Amazon AU)", "text_zh": null, "classification": "platform_policy", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-au:labelling:1", "topic": "labelling", "text_en": "RCM mark on product", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:labelling:2", "topic": "labelling", "text_en": "Button battery warnings where applicable", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:local-presence", "topic": "local_presence", "text_en": "RCM requires an Australian supplier registration — the mark can only be applied by/for an entity with an Australian presence.", "text_zh": "使用RCM标志的前提是完成澳大利亚供应商注册——只有澳境内实体可作为注册供应商。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "battery-electronics-au:source:1", "battery-electronics-au:source:2", "battery-electronics-au:source:3", "battery-electronics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "battery-electronics-au:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "RCM必须挂靠澳洲本地注册供应商，跨境直邮卖家需找本地代理挂靠", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-au:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "EESS按风险等级(Level 1-3)区分注册义务，带插头充电器多为高等级", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "battery-electronics-au:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "各州电气安全监管机构分头执法，昆士兰州最为积极", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "cosmetics-eu", "category": "cosmetics", "market": "EU", "risk_level": "high", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-08-13: Rechecked the core Cosmetics Regulation and added the current amendments. Regulation (EU) 2023/1545 ended the placing-on-market transition for expanded fragrance-allergen labelling on 31 July 2026 (non-compliant legacy stock may remain available until 31 July 2028). Regulation (EU) 2026/78 applies from 1 May 2026 and updates CMR-related Annex entries. Regulation (EU) 2026/909 introduces additional substance restrictions with product-specific transitions, including placing-on-market deadlines beginning 1 January 2027.", "summary_en": "EU cosmetics require an EU Responsible Person, pre-market CPNP notification, a safety-assessed Product Information File and current INCI labelling. Formula review must use the amended Annexes: expanded fragrance-allergen labelling now applies to newly placed products, the 2026 CMR amendments are in force, and further substance restrictions phase in from 2027.", "summary_zh": "输欧化妆品必须指定欧盟责任人、上市前完成CPNP通报、备有经安全评估的产品信息文件，并使用最新INCI标签。配方审核须依据更新后的附件：新投放产品现已适用扩大香精过敏原标注，2026年CMR修订已生效，更多物质限制自2027年起分阶段实施。", "required_marks": [], "regulations": [ { "name": "Cosmetics Regulation (EC) 1223/2009", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223" }, { "name": "Regulation (EU) 2023/1545 on fragrance-allergen labelling", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2023/1545/oj" }, { "name": "Regulation (EU) 2026/78 on CMR substances in cosmetics", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2026/78/oj" }, { "name": "Regulation (EU) 2026/909 on restricted cosmetic substances", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2026/909/oj" }, { "name": "CPNP notification portal", "authority": "European Commission", "source": "https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en" } ], "testing_certification": [ "Cosmetic Product Safety Report (CPSR) by a qualified safety assessor", "Product Information File (PIF) held by the Responsible Person for 10 years", "Stability, challenge (preservative efficacy) and compatibility testing expected in PIF", "No animal testing for cosmetic purposes (ban applies to product and ingredients)", "Formula and CPSR review against the current Annex II-VI substance entries, including Regulation (EU) 2026/78 and the staged restrictions in Regulation (EU) 2026/909" ], "labelling": [ "INCI ingredient list in descending order", "Responsible Person name and address", "Period-after-opening or best-before date, batch code", "Local-language requirements for certain mandatory particulars per member state", "Expanded individual fragrance-allergen disclosure under Regulation (EU) 2023/1545 for products placed on the market after 31 July 2026; legacy stock has sell-through only until 31 July 2028" ], "local_representative": { "required": true, "note_en": "The Responsible Person is the legal cornerstone: without an EU RP the product cannot be lawfully placed on the market at all.", "note_zh": "责任人是法律核心：没有欧盟责任人，产品根本不能合法上市。" }, "pitfalls_zh": [ "在中国做过动物实验的配方（如为满足中国注册要求）可能触发欧盟动物实验禁令冲突", "CPNP通报免费且必须在上市前完成，很多卖家误以为可以先卖后报", "美白/祛斑宣称在欧盟受成分限制（如对苯二酚禁用），中国畅销配方常踩线", "2026年7月31日后新投放产品须使用扩大香精过敏原标签；旧版标签库存仅可在过渡期内继续销售", "配方审核若仍使用旧版附件清单，会漏掉2026/78已生效的CMR变更及2026/909的后续限制" ], "last_verified": "2026-08-13", "jurisdiction_scope": "European Union (EU-27); member-state language, registration and enforcement details may vary", "applicability": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-08-13: Rechecked the core Cosmetics Regulation and added the current amendments. Regulation (EU) 2023/1545 ended the placing-on-market transition for expanded fragrance-allergen labelling on 31 July 2026 (non-compliant legacy stock may remain available until 31 July 2028). Regulation (EU) 2026/78 applies from 1 May 2026 and updates CMR-related Annex entries. Regulation (EU) 2026/909 introduces additional substance restrictions with product-specific transitions, including placing-on-market deadlines beginning 1 January 2027.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 5, "sources": [ { "id": "cosmetics-eu:source:1", "title": "Cosmetics Regulation (EC) 1223/2009", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-eu:source:2", "title": "Regulation (EU) 2023/1545 on fragrance-allergen labelling", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2023/1545/oj", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-eu:source:3", "title": "Regulation (EU) 2026/78 on CMR substances in cosmetics", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2026/78/oj", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-eu:source:4", "title": "Regulation (EU) 2026/909 on restricted cosmetic substances", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2026/909/oj", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-eu:source:5", "title": "CPNP notification portal", "authority": "European Commission", "url": "https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "cosmetics-eu:summary", "topic": "summary", "text_en": "EU cosmetics require an EU Responsible Person, pre-market CPNP notification, a safety-assessed Product Information File and current INCI labelling. Formula review must use the amended Annexes: expanded fragrance-allergen labelling now applies to newly placed products, the 2026 CMR amendments are in force, and further substance restrictions phase in from 2027.", "text_zh": "输欧化妆品必须指定欧盟责任人、上市前完成CPNP通报、备有经安全评估的产品信息文件，并使用最新INCI标签。配方审核须依据更新后的附件：新投放产品现已适用扩大香精过敏原标注，2026年CMR修订已生效，更多物质限制自2027年起分阶段实施。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:testing:1", "topic": "testing", "text_en": "Cosmetic Product Safety Report (CPSR) by a qualified safety assessor", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:testing:2", "topic": "testing", "text_en": "Product Information File (PIF) held by the Responsible Person for 10 years", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:testing:3", "topic": "testing", "text_en": "Stability, challenge (preservative efficacy) and compatibility testing expected in PIF", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:testing:4", "topic": "testing", "text_en": "No animal testing for cosmetic purposes (ban applies to product and ingredients)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:testing:5", "topic": "testing", "text_en": "Formula and CPSR review against the current Annex II-VI substance entries, including Regulation (EU) 2026/78 and the staged restrictions in Regulation (EU) 2026/909", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:labelling:1", "topic": "labelling", "text_en": "INCI ingredient list in descending order", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:labelling:2", "topic": "labelling", "text_en": "Responsible Person name and address", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:labelling:3", "topic": "labelling", "text_en": "Period-after-opening or best-before date, batch code", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:labelling:4", "topic": "labelling", "text_en": "Local-language requirements for certain mandatory particulars per member state", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:labelling:5", "topic": "labelling", "text_en": "Expanded individual fragrance-allergen disclosure under Regulation (EU) 2023/1545 for products placed on the market after 31 July 2026; legacy stock has sell-through only until 31 July 2028", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:local-presence", "topic": "local_presence", "text_en": "The Responsible Person is the legal cornerstone: without an EU RP the product cannot be lawfully placed on the market at all.", "text_zh": "责任人是法律核心：没有欧盟责任人，产品根本不能合法上市。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-eu:source:1", "cosmetics-eu:source:2", "cosmetics-eu:source:3", "cosmetics-eu:source:4", "cosmetics-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-eu:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "在中国做过动物实验的配方（如为满足中国注册要求）可能触发欧盟动物实验禁令冲突", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-eu:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "CPNP通报免费且必须在上市前完成，很多卖家误以为可以先卖后报", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-eu:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "美白/祛斑宣称在欧盟受成分限制（如对苯二酚禁用），中国畅销配方常踩线", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-eu:pitfall:4", "topic": "pitfall", "text_en": null, "text_zh": "2026年7月31日后新投放产品须使用扩大香精过敏原标签；旧版标签库存仅可在过渡期内继续销售", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-eu:pitfall:5", "topic": "pitfall", "text_en": null, "text_zh": "配方审核若仍使用旧版附件清单，会漏掉2026/78已生效的CMR变更及2026/909的后续限制", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "cosmetics-us", "category": "cosmetics", "market": "US", "risk_level": "high", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-05: Checked fda.gov/cosmetics MoCRA page directly in browser (blocks scripted fetch but loads normally). Confirmed: facility registration renews every 2 years, serious adverse event reporting within 15 business days, fragrance allergen labeling still at rulemaking stage (not yet finalized). All matched the existing summary.", "summary_en": "Under MoCRA (2022), cosmetics for the US require FDA facility registration, product listing, safety substantiation, adverse-event recordkeeping, and a US agent for foreign facilities — the biggest expansion of FDA cosmetics authority since 1938.", "summary_zh": "根据《化妆品监管现代化法案》(MoCRA, 2022)，输美化妆品需FDA工厂注册、产品列名、安全性证明、不良事件记录，境外工厂须指定美国代理人——这是1938年以来FDA化妆品监管权最大的一次扩张。", "required_marks": [], "regulations": [ { "name": "Modernization of Cosmetics Regulation Act (MoCRA)", "authority": "US Food and Drug Administration (FDA)", "source": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra" }, { "name": "FD&C Act + Fair Packaging and Labeling Act", "authority": "FDA", "source": "https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-regulations" } ], "testing_certification": [ "Safety substantiation with adequate evidence (tests or existing data)", "Facility registration renewed biennially; product listing updated annually", "Serious adverse event reporting within 15 business days", "Note: products with sunscreen/SPF claims are OTC drugs — a separate, much heavier regime" ], "labelling": [ "Ingredient declaration per FPLA", "US contact for adverse event reporting on the label", "Fragrance allergen disclosure (rulemaking in progress under MoCRA; FDA has not yet issued a final rule as of the July 2026 check)" ], "local_representative": { "required": true, "note_en": "Foreign facilities must designate a US agent for FDA registration purposes.", "note_zh": "境外生产企业必须为FDA注册指定一名美国代理人。" }, "pitfalls_zh": [ "SPF/防晒宣称让产品变成OTC药品，需要药品级注册——跨境卖家最容易踩的红线", "MoCRA工厂注册针对生产工厂而非卖家，代工模式下需确认工厂已注册", "'纯天然''药妆'等宣称易被FDA认定为药品宣称，引发警告信" ], "last_verified": "2026-07-05", "jurisdiction_scope": "United States federal requirements; state requirements may add obligations", "applicability": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-05: Checked fda.gov/cosmetics MoCRA page directly in browser (blocks scripted fetch but loads normally). Confirmed: facility registration renews every 2 years, serious adverse event reporting within 15 business days, fragrance allergen labeling still at rulemaking stage (not yet finalized). All matched the existing summary.", "verified_at": "2026-07-05", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 2, "sources": [ { "id": "cosmetics-us:source:1", "title": "Modernization of Cosmetics Regulation Act (MoCRA)", "authority": "US Food and Drug Administration (FDA)", "url": "https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra", "source_type": "primary", "checked_at": "2026-07-05" }, { "id": "cosmetics-us:source:2", "title": "FD&C Act + Fair Packaging and Labeling Act", "authority": "FDA", "url": "https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-regulations", "source_type": "primary", "checked_at": "2026-07-05" } ] }, "claims": [ { "id": "cosmetics-us:summary", "topic": "summary", "text_en": "Under MoCRA (2022), cosmetics for the US require FDA facility registration, product listing, safety substantiation, adverse-event recordkeeping, and a US agent for foreign facilities — the biggest expansion of FDA cosmetics authority since 1938.", "text_zh": "根据《化妆品监管现代化法案》(MoCRA, 2022)，输美化妆品需FDA工厂注册、产品列名、安全性证明、不良事件记录，境外工厂须指定美国代理人——这是1938年以来FDA化妆品监管权最大的一次扩张。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:testing:1", "topic": "testing", "text_en": "Safety substantiation with adequate evidence (tests or existing data)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:testing:2", "topic": "testing", "text_en": "Facility registration renewed biennially; product listing updated annually", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:testing:3", "topic": "testing", "text_en": "Serious adverse event reporting within 15 business days", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:testing:4", "topic": "testing", "text_en": "Note: products with sunscreen/SPF claims are OTC drugs — a separate, much heavier regime", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:labelling:1", "topic": "labelling", "text_en": "Ingredient declaration per FPLA", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:labelling:2", "topic": "labelling", "text_en": "US contact for adverse event reporting on the label", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:labelling:3", "topic": "labelling", "text_en": "Fragrance allergen disclosure (rulemaking in progress under MoCRA; FDA has not yet issued a final rule as of the July 2026 check)", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:local-presence", "topic": "local_presence", "text_en": "Foreign facilities must designate a US agent for FDA registration purposes.", "text_zh": "境外生产企业必须为FDA注册指定一名美国代理人。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-us:source:1", "cosmetics-us:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-us:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "SPF/防晒宣称让产品变成OTC药品，需要药品级注册——跨境卖家最容易踩的红线", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-us:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "MoCRA工厂注册针对生产工厂而非卖家，代工模式下需确认工厂已注册", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-us:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "'纯天然''药妆'等宣称易被FDA认定为药品宣称，引发警告信", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "cosmetics-uk", "category": "cosmetics", "market": "UK", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-08-13: Rechecked GB requirements and added S.I. 2026/23. From 15 July 2026, 4-MBC is prohibited and the formaldehyde-releaser warning threshold is reduced from 0.05% to 0.001%. Additional category 1B/2 CMR substances enter Annex II on 15 August 2026. Products lawfully placed before the respective dates have limited sell-through until 14 January or 14 February 2027. Northern Ireland continues under the EU regime.", "summary_en": "GB cosmetics require a UK Responsible Person, pre-market SCPN notification and a PIF. The 2026 chemical amendment now prohibits 4-MBC, lowers the formaldehyde-releaser warning threshold and, from 15 August 2026, adds further CMR substances to Annex II. EU CPNP notifications do not replace SCPN.", "summary_zh": "大不列颠化妆品须指定英国责任人、上市前完成SCPN通报并备有PIF。2026年化学品修订现已禁用4-MBC、降低甲醛释放型防腐剂警示阈值，并自2026年8月15日起将更多CMR物质列入附件II。欧盟CPNP不能替代SCPN。", "required_marks": [], "regulations": [ { "name": "UK Cosmetics Regulation (retained Reg 1223/2009)", "authority": "Office for Product Safety and Standards (OPSS)", "source": "https://www.gov.uk/guidance/making-cosmetic-products-available-to-consumers-in-great-britain" }, { "name": "Cosmetic Products Regulation (Restriction of Chemical Substances) Regulations 2026 (S.I. 2026/23)", "authority": "UK Government", "source": "https://www.legislation.gov.uk/uksi/2026/23/contents/made" } ], "testing_certification": [ "CPSR by qualified assessor (EU CPSR largely reusable with UK RP details)", "PIF held at UK RP address", "SCPN notification before placing on GB market", "Formula and CPSR review against S.I. 2026/23: 4-MBC prohibition and the 0.001% formaldehyde-releaser warning threshold apply from 15 July 2026; additional listed CMR prohibitions apply from 15 August 2026" ], "labelling": [ "UK RP name and address on label", "INCI ingredient list", "English-language mandatory particulars", "Required 'releases formaldehyde' warning where the total released formaldehyde from Annex V preservatives exceeds 0.001%" ], "local_representative": { "required": true, "note_en": "UK Responsible Person is separate from the EU RP; both are needed to sell in both markets.", "note_zh": "英国责任人与欧盟责任人相互独立，同时销售两个市场需分别指定。" }, "pitfalls_zh": [ "CPNP通报不迁移到SCPN，脱欧后未重新通报的老产品在英国属违规", "标签须同时印欧盟RP和英国RP时空间紧张，需提前设计双市场标签", "北爱尔兰仍适用欧盟化妆品法规，走CPNP而非SCPN", "含4-MBC或新增CMR物质的旧库存仅可依具体过渡条款销售至2027年1月14日或2月14日" ], "last_verified": "2026-08-13", "jurisdiction_scope": "Great Britain (England, Scotland and Wales); Northern Ireland can follow a different regime", "applicability": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-08-13: Rechecked GB requirements and added S.I. 2026/23. From 15 July 2026, 4-MBC is prohibited and the formaldehyde-releaser warning threshold is reduced from 0.05% to 0.001%. Additional category 1B/2 CMR substances enter Annex II on 15 August 2026. Products lawfully placed before the respective dates have limited sell-through until 14 January or 14 February 2027. Northern Ireland continues under the EU regime.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 2, "sources": [ { "id": "cosmetics-uk:source:1", "title": "UK Cosmetics Regulation (retained Reg 1223/2009)", "authority": "Office for Product Safety and Standards (OPSS)", "url": "https://www.gov.uk/guidance/making-cosmetic-products-available-to-consumers-in-great-britain", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-uk:source:2", "title": "Cosmetic Products Regulation (Restriction of Chemical Substances) Regulations 2026 (S.I. 2026/23)", "authority": "UK Government", "url": "https://www.legislation.gov.uk/uksi/2026/23/contents/made", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "cosmetics-uk:summary", "topic": "summary", "text_en": "GB cosmetics require a UK Responsible Person, pre-market SCPN notification and a PIF. The 2026 chemical amendment now prohibits 4-MBC, lowers the formaldehyde-releaser warning threshold and, from 15 August 2026, adds further CMR substances to Annex II. EU CPNP notifications do not replace SCPN.", "text_zh": "大不列颠化妆品须指定英国责任人、上市前完成SCPN通报并备有PIF。2026年化学品修订现已禁用4-MBC、降低甲醛释放型防腐剂警示阈值，并自2026年8月15日起将更多CMR物质列入附件II。欧盟CPNP不能替代SCPN。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:testing:1", "topic": "testing", "text_en": "CPSR by qualified assessor (EU CPSR largely reusable with UK RP details)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:testing:2", "topic": "testing", "text_en": "PIF held at UK RP address", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:testing:3", "topic": "testing", "text_en": "SCPN notification before placing on GB market", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:testing:4", "topic": "testing", "text_en": "Formula and CPSR review against S.I. 2026/23: 4-MBC prohibition and the 0.001% formaldehyde-releaser warning threshold apply from 15 July 2026; additional listed CMR prohibitions apply from 15 August 2026", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:labelling:1", "topic": "labelling", "text_en": "UK RP name and address on label", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:labelling:2", "topic": "labelling", "text_en": "INCI ingredient list", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:labelling:3", "topic": "labelling", "text_en": "English-language mandatory particulars", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:labelling:4", "topic": "labelling", "text_en": "Required 'releases formaldehyde' warning where the total released formaldehyde from Annex V preservatives exceeds 0.001%", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:local-presence", "topic": "local_presence", "text_en": "UK Responsible Person is separate from the EU RP; both are needed to sell in both markets.", "text_zh": "英国责任人与欧盟责任人相互独立，同时销售两个市场需分别指定。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-uk:source:1", "cosmetics-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-uk:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "CPNP通报不迁移到SCPN，脱欧后未重新通报的老产品在英国属违规", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-uk:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "标签须同时印欧盟RP和英国RP时空间紧张，需提前设计双市场标签", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-uk:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "北爱尔兰仍适用欧盟化妆品法规，走CPNP而非SCPN", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-uk:pitfall:4", "topic": "pitfall", "text_en": null, "text_zh": "含4-MBC或新增CMR物质的旧库存仅可依具体过渡条款销售至2027年1月14日或2月14日", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "cosmetics-au", "category": "cosmetics", "market": "AU", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-08-13: Rechecked AICIS and added its 14 July 2026 regulatory notice. For consumer end uses, including cosmetics, retinal/retinaldehyde (CAS 116-31-4) has required an AICIS assessment certificate before introduction since 27 June 2026; it can no longer use the exempted or reported categories. The notice expressly excludes retinol and Inventory-listed retinol esters from this change.", "summary_en": "Australia regulates cosmetic ingredients as industrial chemicals under AICIS. Importers must register and establish an authorised introduction route for every ingredient. Retinal/retinaldehyde for consumer use now requires an assessment certificate before import or manufacture; retinol and listed retinol esters are not covered by that specific change. Sunscreens and therapeutic claims shift products to the TGA.", "summary_zh": "澳大利亚将化妆品成分作为工业化学品由AICIS监管。进口商须注册，并为每种成分确认合法引进路径。用于消费品的视黄醛/retinaldehyde现须在进口或生产前取得评估证书；该项变更不适用于视黄醇及名录内的视黄醇酯。防晒和治疗类宣称会使产品转由TGA监管。", "required_marks": [], "regulations": [ { "name": "Industrial Chemicals Act 2019 (AICIS)", "authority": "Australian Industrial Chemicals Introduction Scheme", "source": "https://www.industrialchemicals.gov.au/" }, { "name": "Retinal introductions for consumer use now need assessment by AICIS", "authority": "Australian Industrial Chemicals Introduction Scheme", "source": "https://www.industrialchemicals.gov.au/news-and-notices/retinal-introductions-consumer-use-now-need-assessment-aicis" }, { "name": "Cosmetics ingredients labelling mandatory standard", "authority": "ACCC", "source": "https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard" }, { "name": "Therapeutic Goods Act (sunscreens, therapeutic claims)", "authority": "Therapeutic Goods Administration (TGA)", "source": "https://www.tga.gov.au/products/sunscreens" } ], "testing_certification": [ "AICIS registration as importer (annual, fee-based)", "Ingredient-by-ingredient check against the AICIS Inventory and the applicable exempted, reported or assessed introduction route", "For retinal/retinaldehyde (CAS 116-31-4) with any consumer end use, obtain an AICIS assessment certificate before introduction; do not use the exempted or reported categories", "Sunscreen products: TGA listing (AUST L) with mandatory efficacy testing" ], "labelling": [ "Ingredient labelling per the mandatory standard", "Therapeutic claims prohibited without TGA listing" ], "local_representative": { "required": true, "note_en": "The AICIS-registered introducer must be an Australian entity — cross-border sellers need a local importer or service provider.", "note_zh": "AICIS注册引进人必须是澳大利亚实体——跨境卖家需要本地进口商或注册服务商。" }, "pitfalls_zh": [ "澳洲监管的是'成分引进'而非成品——按成分逐一核对名录，与欧美思路完全不同", "SPF宣称在澳洲=药品(TGA AUST L)，含防晒值的BB霜、粉底都可能中招", "AICIS按引进量分级收费和申报，低估引进量会导致合规等级错误", "视黄醛不能再按豁免或报告类别引进；不要与未受该项变更影响的视黄醇及名录内视黄醇酯混淆" ], "last_verified": "2026-08-13", "jurisdiction_scope": "Australia; state and territory enforcement can vary", "applicability": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-08-13: Rechecked AICIS and added its 14 July 2026 regulatory notice. For consumer end uses, including cosmetics, retinal/retinaldehyde (CAS 116-31-4) has required an AICIS assessment certificate before introduction since 27 June 2026; it can no longer use the exempted or reported categories. The notice expressly excludes retinol and Inventory-listed retinol esters from this change.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 4, "sources": [ { "id": "cosmetics-au:source:1", "title": "Industrial Chemicals Act 2019 (AICIS)", "authority": "Australian Industrial Chemicals Introduction Scheme", "url": "https://www.industrialchemicals.gov.au/", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-au:source:2", "title": "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", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-au:source:3", "title": "Cosmetics ingredients labelling mandatory standard", "authority": "ACCC", "url": "https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "cosmetics-au:source:4", "title": "Therapeutic Goods Act (sunscreens, therapeutic claims)", "authority": "Therapeutic Goods Administration (TGA)", "url": "https://www.tga.gov.au/products/sunscreens", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "cosmetics-au:summary", "topic": "summary", "text_en": "Australia regulates cosmetic ingredients as industrial chemicals under AICIS. Importers must register and establish an authorised introduction route for every ingredient. Retinal/retinaldehyde for consumer use now requires an assessment certificate before import or manufacture; retinol and listed retinol esters are not covered by that specific change. Sunscreens and therapeutic claims shift products to the TGA.", "text_zh": "澳大利亚将化妆品成分作为工业化学品由AICIS监管。进口商须注册，并为每种成分确认合法引进路径。用于消费品的视黄醛/retinaldehyde现须在进口或生产前取得评估证书；该项变更不适用于视黄醇及名录内的视黄醇酯。防晒和治疗类宣称会使产品转由TGA监管。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm intended use, ingredients, claims, presentation and whether the product is therapeutic" ], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:testing:1", "topic": "testing", "text_en": "AICIS registration as importer (annual, fee-based)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:testing:2", "topic": "testing", "text_en": "Ingredient-by-ingredient check against the AICIS Inventory and the applicable exempted, reported or assessed introduction route", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:testing:3", "topic": "testing", "text_en": "For retinal/retinaldehyde (CAS 116-31-4) with any consumer end use, obtain an AICIS assessment certificate before introduction; do not use the exempted or reported categories", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:testing:4", "topic": "testing", "text_en": "Sunscreen products: TGA listing (AUST L) with mandatory efficacy testing", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:labelling:1", "topic": "labelling", "text_en": "Ingredient labelling per the mandatory standard", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:labelling:2", "topic": "labelling", "text_en": "Therapeutic claims prohibited without TGA listing", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:local-presence", "topic": "local_presence", "text_en": "The AICIS-registered introducer must be an Australian entity — cross-border sellers need a local importer or service provider.", "text_zh": "AICIS注册引进人必须是澳大利亚实体——跨境卖家需要本地进口商或注册服务商。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "cosmetics-au:source:1", "cosmetics-au:source:2", "cosmetics-au:source:3", "cosmetics-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "cosmetics-au:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "澳洲监管的是'成分引进'而非成品——按成分逐一核对名录，与欧美思路完全不同", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-au:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "SPF宣称在澳洲=药品(TGA AUST L)，含防晒值的BB霜、粉底都可能中招", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-au:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "AICIS按引进量分级收费和申报，低估引进量会导致合规等级错误", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "cosmetics-au:pitfall:4", "topic": "pitfall", "text_en": null, "text_zh": "视黄醛不能再按豁免或报告类别引进；不要与未受该项变更影响的视黄醇及名录内视黄醇酯混淆", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "food-contact-eu", "category": "food-contact", "market": "EU", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-08-13: Added the current BPA/bisphenol regime and the 2025 plastics/GMP amendment. Regulation (EU) 2024/3190 has applied since 20 January 2025 and its first main transition for many single-use articles ended 20 July 2026; Regulation (EU) 2026/250 corrected the repeat-use transition text. Regulation (EU) 2025/351 amends plastic composition, recycled-plastic and GMP/documentation rules, with the main legacy-product market transition ending 16 September 2026.", "summary_en": "EU food-contact materials fall under Framework Regulation 1935/2004. Plastics must meet the current Regulation 10/2011 composition, migration and Declaration-of-Compliance rules, including the 2025/351 amendments. BPA and specified hazardous bisphenols are separately restricted under Regulation 2024/3190, whose first major transition ended on 20 July 2026.", "summary_zh": "输欧食品接触材料适用框架法规1935/2004。塑料须符合10/2011法规及2025/351修订后的成分、迁移和符合性声明要求。BPA及特定有害双酚另受2024/3190法规限制，其首个主要过渡期已于2026年7月20日结束。", "required_marks": [ "Glass-and-fork symbol (where not obviously food-contact)" ], "regulations": [ { "name": "Framework Regulation (EC) 1935/2004", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R1935" }, { "name": "Plastics Regulation (EU) 10/2011", "authority": "European Commission", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011R0010" }, { "name": "Regulation (EU) 2024/3190 restricting BPA and other hazardous bisphenols in food-contact materials", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2024/3190/oj" }, { "name": "Regulation (EU) 2026/250 correcting the BPA transition provisions", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2026/250/oj" }, { "name": "Regulation (EU) 2025/351 amending plastics, recycled-plastics and GMP rules", "authority": "European Commission", "source": "https://eur-lex.europa.eu/eli/reg/2025/351/oj" } ], "testing_certification": [ "Overall migration testing (10/2011 simulants and conditions)", "Specific migration testing for restricted substances (e.g. melamine, formaldehyde, primary aromatic amines)", "Declaration of Compliance for plastic FCMs", "Bamboo/plant-fibre-filled plastics are effectively banned — high-enforcement area", "BPA/bisphenol formulation and transition review under Regulation (EU) 2024/3190 as corrected by Regulation (EU) 2026/250; many single-use legacy articles could no longer be first placed on the market after 20 July 2026", "Update plastic formulation, migration, quality-control and Declaration-of-Compliance evidence for Regulation (EU) 2025/351; legacy materials first placed before 16 September 2026 have the stated stock transition" ], "labelling": [ "Glass-and-fork symbol or 'for food contact' wording where use is not obvious", "Importer identification", "Usage conditions/temperature limits where relevant" ], "local_representative": { "required": true, "note_en": "GPSR responsible person requirements apply to consumer FCM products sold online.", "note_zh": "线上销售的消费类食品接触产品同样适用GPSR的欧盟责任人要求。" }, "pitfalls_zh": [ "'竹纤维'密胺餐具在欧盟被认定为非法，是RASFF通报和退运的重灾区", "尼龙厨具的初级芳香胺(PAA)迁移超标是中国产厨具被扣的头号原因", "DoC不是测试报告——需要按10/2011附件IV格式单独出具", "BPA禁限用规则覆盖多类塑料、涂层、油墨、粘合剂、橡胶及离子交换树脂，不应只筛查聚碳酸酯", "2025/351对塑料、再生塑料及GMP文件要求已有实质修订，旧版DoC模板需在2026年9月过渡节点前复核" ], "last_verified": "2026-08-13", "jurisdiction_scope": "European Union (EU-27); member-state language, registration and enforcement details may vary", "applicability": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-08-13: Added the current BPA/bisphenol regime and the 2025 plastics/GMP amendment. Regulation (EU) 2024/3190 has applied since 20 January 2025 and its first main transition for many single-use articles ended 20 July 2026; Regulation (EU) 2026/250 corrected the repeat-use transition text. Regulation (EU) 2025/351 amends plastic composition, recycled-plastic and GMP/documentation rules, with the main legacy-product market transition ending 16 September 2026.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 5, "sources": [ { "id": "food-contact-eu:source:1", "title": "Framework Regulation (EC) 1935/2004", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R1935", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "food-contact-eu:source:2", "title": "Plastics Regulation (EU) 10/2011", "authority": "European Commission", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011R0010", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "food-contact-eu:source:3", "title": "Regulation (EU) 2024/3190 restricting BPA and other hazardous bisphenols in food-contact materials", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2024/3190/oj", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "food-contact-eu:source:4", "title": "Regulation (EU) 2026/250 correcting the BPA transition provisions", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2026/250/oj", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "food-contact-eu:source:5", "title": "Regulation (EU) 2025/351 amending plastics, recycled-plastics and GMP rules", "authority": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg/2025/351/oj", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "food-contact-eu:summary", "topic": "summary", "text_en": "EU food-contact materials fall under Framework Regulation 1935/2004. Plastics must meet the current Regulation 10/2011 composition, migration and Declaration-of-Compliance rules, including the 2025/351 amendments. BPA and specified hazardous bisphenols are separately restricted under Regulation 2024/3190, whose first major transition ended on 20 July 2026.", "text_zh": "输欧食品接触材料适用框架法规1935/2004。塑料须符合10/2011法规及2025/351修订后的成分、迁移和符合性声明要求。BPA及特定有害双酚另受2024/3190法规限制，其首个主要过渡期已于2026年7月20日结束。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:required_mark:1", "topic": "required_mark", "text_en": "Glass-and-fork symbol (where not obviously food-contact)", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:testing:1", "topic": "testing", "text_en": "Overall migration testing (10/2011 simulants and conditions)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:testing:2", "topic": "testing", "text_en": "Specific migration testing for restricted substances (e.g. melamine, formaldehyde, primary aromatic amines)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:testing:3", "topic": "testing", "text_en": "Declaration of Compliance for plastic FCMs", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:testing:4", "topic": "testing", "text_en": "Bamboo/plant-fibre-filled plastics are effectively banned — high-enforcement area", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:testing:5", "topic": "testing", "text_en": "BPA/bisphenol formulation and transition review under Regulation (EU) 2024/3190 as corrected by Regulation (EU) 2026/250; many single-use legacy articles could no longer be first placed on the market after 20 July 2026", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:testing:6", "topic": "testing", "text_en": "Update plastic formulation, migration, quality-control and Declaration-of-Compliance evidence for Regulation (EU) 2025/351; legacy materials first placed before 16 September 2026 have the stated stock transition", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:labelling:1", "topic": "labelling", "text_en": "Glass-and-fork symbol or 'for food contact' wording where use is not obvious", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:labelling:2", "topic": "labelling", "text_en": "Importer identification", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:labelling:3", "topic": "labelling", "text_en": "Usage conditions/temperature limits where relevant", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:local-presence", "topic": "local_presence", "text_en": "GPSR responsible person requirements apply to consumer FCM products sold online.", "text_zh": "线上销售的消费类食品接触产品同样适用GPSR的欧盟责任人要求。", "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-eu:source:1", "food-contact-eu:source:2", "food-contact-eu:source:3", "food-contact-eu:source:4", "food-contact-eu:source:5" ], "evidence_status": "record_source_set" }, { "id": "food-contact-eu:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "'竹纤维'密胺餐具在欧盟被认定为非法，是RASFF通报和退运的重灾区", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-eu:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "尼龙厨具的初级芳香胺(PAA)迁移超标是中国产厨具被扣的头号原因", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-eu:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "DoC不是测试报告——需要按10/2011附件IV格式单独出具", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-eu:pitfall:4", "topic": "pitfall", "text_en": null, "text_zh": "BPA禁限用规则覆盖多类塑料、涂层、油墨、粘合剂、橡胶及离子交换树脂，不应只筛查聚碳酸酯", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-eu:pitfall:5", "topic": "pitfall", "text_en": null, "text_zh": "2025/351对塑料、再生塑料及GMP文件要求已有实质修订，旧版DoC模板需在2026年9月过渡节点前复核", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "food-contact-us", "category": "food-contact", "market": "US", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-09: Re-checked ecfr.gov Title 21 Parts 174, 175, 176 and 177, FDA FCS notification background and food-type/condition-of-use tables, and OEHHA Prop 65. Confirmed general GMP/FCN routes, coating/adhesive, paper/board, polymer and use-condition branches used by the source-checked food-contact rules.", "summary_en": "US food-contact rules sit in FDA regulations 21 CFR 174-190: materials must be authorized food additives, covered by a Food Contact Notification, or GRAS. No pre-market certificate exists — compliance is substance-by-substance against the CFR.", "summary_zh": "美国食品接触规则见FDA法规21 CFR 174-190：材料必须是获批的食品添加剂、有食品接触通报(FCN)覆盖、或属GRAS。不存在上市前证书——合规性按物质逐一对照CFR核查。", "required_marks": [], "regulations": [ { "name": "21 CFR Part 174 (indirect food additives: general)", "authority": "FDA", "source": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-174" }, { "name": "21 CFR Part 175 (adhesives and coating components)", "authority": "FDA", "source": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175" }, { "name": "21 CFR Part 176 (paper and paperboard components)", "authority": "FDA", "source": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-176" }, { "name": "21 CFR Part 177 (polymers)", "authority": "FDA", "source": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-177" }, { "name": "Food Contact Substance Notification program", "authority": "FDA", "source": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/regulatory-background-food-contact-substance-notification-program" }, { "name": "Food Types & Conditions of Use for Food Contact Substances", "authority": "FDA", "source": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances" }, { "name": "California Prop 65 (lead, cadmium, phthalates in tableware)", "authority": "California OEHHA", "source": "https://oehha.ca.gov/proposition-65" } ], "testing_certification": [ "Formulation review against 21 CFR clearances (resins, colorants, additives)", "Extraction testing per applicable CFR sections", "FDA 'compliance letter' from labs is industry practice, not an official certificate", "State-level rules increasingly target PFAS in food packaging" ], "labelling": [ "No mandatory food-contact symbol", "Prop 65 warnings for California where applicable (esp. decorated ceramics, brass)" ], "local_representative": { "required": false, "note_en": "No responsible-person regime; the importer of record is liable, and FDA can detain non-compliant shipments at port.", "note_zh": "无境内责任人制度；登记进口商承担责任，FDA可在口岸直接扣留不合规货物。" }, "pitfalls_zh": [ "'FDA认证'并不存在——FDA不给食品接触产品发证书，声称'FDA认证'本身就是违规宣传", "装饰陶瓷餐具的铅镉溶出是FDA进口警示(Import Alert)常客，中国产地被点名", "各州PFAS禁令(加州、纽约等)扩散很快，出口包装材料需逐州核查" ], "last_verified": "2026-07-09", "jurisdiction_scope": "United States federal requirements; state requirements may add obligations", "applicability": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-09: Re-checked ecfr.gov Title 21 Parts 174, 175, 176 and 177, FDA FCS notification background and food-type/condition-of-use tables, and OEHHA Prop 65. Confirmed general GMP/FCN routes, coating/adhesive, paper/board, polymer and use-condition branches used by the source-checked food-contact rules.", "verified_at": "2026-07-09", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 7, "sources": [ { "id": "food-contact-us:source:1", "title": "21 CFR Part 174 (indirect food additives: general)", "authority": "FDA", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-174", "source_type": "primary", "checked_at": "2026-07-09" }, { "id": "food-contact-us:source:2", "title": "21 CFR Part 175 (adhesives and coating components)", "authority": "FDA", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175", "source_type": "primary", "checked_at": "2026-07-09" }, { "id": "food-contact-us:source:3", "title": "21 CFR Part 176 (paper and paperboard components)", "authority": "FDA", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-176", "source_type": "primary", "checked_at": "2026-07-09" }, { "id": "food-contact-us:source:4", "title": "21 CFR Part 177 (polymers)", "authority": "FDA", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-177", "source_type": "primary", "checked_at": "2026-07-09" }, { "id": "food-contact-us:source:5", "title": "Food Contact Substance Notification program", "authority": "FDA", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/regulatory-background-food-contact-substance-notification-program", "source_type": "primary", "checked_at": "2026-07-09" }, { "id": "food-contact-us:source:6", "title": "Food Types & Conditions of Use for Food Contact Substances", "authority": "FDA", "url": "https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances", "source_type": "primary", "checked_at": "2026-07-09" }, { "id": "food-contact-us:source:7", "title": "California Prop 65 (lead, cadmium, phthalates in tableware)", "authority": "California OEHHA", "url": "https://oehha.ca.gov/proposition-65", "source_type": "primary", "checked_at": "2026-07-09" } ] }, "claims": [ { "id": "food-contact-us:summary", "topic": "summary", "text_en": "US food-contact rules sit in FDA regulations 21 CFR 174-190: materials must be authorized food additives, covered by a Food Contact Notification, or GRAS. No pre-market certificate exists — compliance is substance-by-substance against the CFR.", "text_zh": "美国食品接触规则见FDA法规21 CFR 174-190：材料必须是获批的食品添加剂、有食品接触通报(FCN)覆盖、或属GRAS。不存在上市前证书——合规性按物质逐一对照CFR核查。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "evidence": [ "food-contact-us:source:1", "food-contact-us:source:2", "food-contact-us:source:3", "food-contact-us:source:4", "food-contact-us:source:5", "food-contact-us:source:6", "food-contact-us:source:7" ], "evidence_status": "record_source_set" }, { "id": "food-contact-us:testing:1", "topic": "testing", "text_en": "Formulation review against 21 CFR clearances (resins, colorants, additives)", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-us:source:1", "food-contact-us:source:2", "food-contact-us:source:3", "food-contact-us:source:4", "food-contact-us:source:5", "food-contact-us:source:6", "food-contact-us:source:7" ], "evidence_status": "record_source_set" }, { "id": "food-contact-us:testing:2", "topic": "testing", "text_en": "Extraction testing per applicable CFR sections", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-us:source:1", "food-contact-us:source:2", "food-contact-us:source:3", "food-contact-us:source:4", "food-contact-us:source:5", "food-contact-us:source:6", "food-contact-us:source:7" ], "evidence_status": "record_source_set" }, { "id": "food-contact-us:testing:3", "topic": "testing", "text_en": "FDA 'compliance letter' from labs is industry practice, not an official certificate", "text_zh": null, "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-us:testing:4", "topic": "testing", "text_en": "State-level rules increasingly target PFAS in food packaging", "text_zh": null, "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-us:labelling:1", "topic": "labelling", "text_en": "No mandatory food-contact symbol", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-us:source:1", "food-contact-us:source:2", "food-contact-us:source:3", "food-contact-us:source:4", "food-contact-us:source:5", "food-contact-us:source:6", "food-contact-us:source:7" ], "evidence_status": "record_source_set" }, { "id": "food-contact-us:labelling:2", "topic": "labelling", "text_en": "Prop 65 warnings for California where applicable (esp. decorated ceramics, brass)", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-us:source:1", "food-contact-us:source:2", "food-contact-us:source:3", "food-contact-us:source:4", "food-contact-us:source:5", "food-contact-us:source:6", "food-contact-us:source:7" ], "evidence_status": "record_source_set" }, { "id": "food-contact-us:local-presence", "topic": "local_presence", "text_en": "No responsible-person regime; the importer of record is liable, and FDA can detain non-compliant shipments at port.", "text_zh": "无境内责任人制度；登记进口商承担责任，FDA可在口岸直接扣留不合规货物。", "classification": "legal_requirement", "mandatory": false, "conditions": [], "evidence": [ "food-contact-us:source:1", "food-contact-us:source:2", "food-contact-us:source:3", "food-contact-us:source:4", "food-contact-us:source:5", "food-contact-us:source:6", "food-contact-us:source:7" ], "evidence_status": "record_source_set" }, { "id": "food-contact-us:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "'FDA认证'并不存在——FDA不给食品接触产品发证书，声称'FDA认证'本身就是违规宣传", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-us:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "装饰陶瓷餐具的铅镉溶出是FDA进口警示(Import Alert)常客，中国产地被点名", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-us:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "各州PFAS禁令(加州、纽约等)扩散很快，出口包装材料需逐州核查", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "food-contact-uk", "category": "food-contact", "market": "UK", "risk_level": "medium", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-08-13: Added the FSA's June 2026 BPA divergence guidance. Regulation (EU) 2024/3190 and its 20 July 2026 transition apply in the EU and Northern Ireland under the Windsor Framework, but do not currently apply in Great Britain. GB continues under its assimilated food-contact rules unless and until domestic legislation is introduced; the FSA consultation does not itself create a ban.", "summary_en": "GB retains the assimilated 1935/2004 and 10/2011 food-contact framework, but it has now diverged from the EU on BPA: Regulation (EU) 2024/3190 applies in Northern Ireland, not currently in Great Britain. EU test evidence may remain useful, but EU and GB legal conclusions can no longer be treated as interchangeable.", "summary_zh": "大不列颠继续适用同化后的1935/2004和10/2011食品接触框架，但在BPA方面已与欧盟分化：欧盟2024/3190法规适用于北爱尔兰，目前不适用于大不列颠。欧盟测试证据仍可能有用，但英欧法律结论不能再视为完全等同。", "required_marks": [ "Glass-and-fork symbol (where not obviously food-contact)" ], "regulations": [ { "name": "Assimilated Regulation 1935/2004 (GB)", "authority": "Food Standards Agency (FSA)", "source": "https://www.gov.uk/government/publications/food-contact-materials-regulations" }, { "name": "BPA in food contact materials: EU rules and UK implications", "authority": "Food Standards Agency (FSA)", "source": "https://www.gov.uk/government/publications/bpa-in-food-contact-materials-eu-rules-and-uk-implications" } ], "testing_certification": [ "Migration testing to the same technical limits as the EU regime", "Declaration of Compliance for plastics", "EU test reports may support GB evidence where the underlying GB requirements match, but the legal assessment must account for divergence", "EU Regulation 2024/3190 BPA restrictions apply to Northern Ireland but do not currently apply to the GB domestic market" ], "labelling": [ "Glass-and-fork symbol or equivalent wording", "UK business address for traceability" ], "local_representative": { "required": false, "note_en": "No dedicated FCM responsible person, but general product safety rules and importer traceability apply.", "note_zh": "食品接触材料无专门责任人制度，但一般产品安全规则和进口商可追溯性要求仍然适用。" }, "pitfalls_zh": [ "英欧食品接触规则已在BPA方面出现实际分化，不能再仅以欧盟结论代替大不列颠法律审核", "北爱尔兰适用欧盟BPA法规及其过渡期限；大不列颠目前仍适用本地同化法规", "FSA关于大不列颠BPA禁令的咨询和科学评估不等于禁令已经生效" ], "last_verified": "2026-08-13", "jurisdiction_scope": "Great Britain (England, Scotland and Wales); Northern Ireland can follow a different regime", "applicability": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-08-13: Added the FSA's June 2026 BPA divergence guidance. Regulation (EU) 2024/3190 and its 20 July 2026 transition apply in the EU and Northern Ireland under the Windsor Framework, but do not currently apply in Great Britain. GB continues under its assimilated food-contact rules unless and until domestic legislation is introduced; the FSA consultation does not itself create a ban.", "verified_at": "2026-08-13", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 2, "sources": [ { "id": "food-contact-uk:source:1", "title": "Assimilated Regulation 1935/2004 (GB)", "authority": "Food Standards Agency (FSA)", "url": "https://www.gov.uk/government/publications/food-contact-materials-regulations", "source_type": "primary", "checked_at": "2026-08-13" }, { "id": "food-contact-uk:source:2", "title": "BPA in food contact materials: EU rules and UK implications", "authority": "Food Standards Agency (FSA)", "url": "https://www.gov.uk/government/publications/bpa-in-food-contact-materials-eu-rules-and-uk-implications", "source_type": "primary", "checked_at": "2026-08-13" } ] }, "claims": [ { "id": "food-contact-uk:summary", "topic": "summary", "text_en": "GB retains the assimilated 1935/2004 and 10/2011 food-contact framework, but it has now diverged from the EU on BPA: Regulation (EU) 2024/3190 applies in Northern Ireland, not currently in Great Britain. EU test evidence may remain useful, but EU and GB legal conclusions can no longer be treated as interchangeable.", "text_zh": "大不列颠继续适用同化后的1935/2004和10/2011食品接触框架，但在BPA方面已与欧盟分化：欧盟2024/3190法规适用于北爱尔兰，目前不适用于大不列颠。欧盟测试证据仍可能有用，但英欧法律结论不能再视为完全等同。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:required_mark:1", "topic": "required_mark", "text_en": "Glass-and-fork symbol (where not obviously food-contact)", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:testing:1", "topic": "testing", "text_en": "Migration testing to the same technical limits as the EU regime", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:testing:2", "topic": "testing", "text_en": "Declaration of Compliance for plastics", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:testing:3", "topic": "testing", "text_en": "EU test reports may support GB evidence where the underlying GB requirements match, but the legal assessment must account for divergence", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:testing:4", "topic": "testing", "text_en": "EU Regulation 2024/3190 BPA restrictions apply to Northern Ireland but do not currently apply to the GB domestic market", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:labelling:1", "topic": "labelling", "text_en": "Glass-and-fork symbol or equivalent wording", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:labelling:2", "topic": "labelling", "text_en": "UK business address for traceability", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:local-presence", "topic": "local_presence", "text_en": "No dedicated FCM responsible person, but general product safety rules and importer traceability apply.", "text_zh": "食品接触材料无专门责任人制度，但一般产品安全规则和进口商可追溯性要求仍然适用。", "classification": "legal_requirement", "mandatory": false, "conditions": [], "evidence": [ "food-contact-uk:source:1", "food-contact-uk:source:2" ], "evidence_status": "record_source_set" }, { "id": "food-contact-uk:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "英欧食品接触规则已在BPA方面出现实际分化，不能再仅以欧盟结论代替大不列颠法律审核", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-uk:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "北爱尔兰适用欧盟BPA法规及其过渡期限；大不列颠目前仍适用本地同化法规", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-uk:pitfall:3", "topic": "pitfall", "text_en": null, "text_zh": "FSA关于大不列颠BPA禁令的咨询和科学评估不等于禁令已经生效", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] }, { "id": "food-contact-au", "category": "food-contact", "market": "AU", "risk_level": "low", "legal_status": "in_force", "review_status": "source_checked", "review_note": "2026-07-09: Re-tried source checking for AU food-contact coverage; the cited foodstandards.gov.au path did not expose the specific content needed. 2026-07-16: Closed the gap. Standard 1.4.3 - Articles and Materials in Contact with Food (the instrument previously cited) is no longer in force (F2008B00620, repealed 29 Feb 2016) — replaced its citation with the two current, in-force instruments that actually govern food-contact materials in Australia today: Standard 3.2.2 - Food Safety Practices and General Requirements (F2008B00576, in force, last compiled 13 Aug 2025), clause 9 of which reads in full: 'A food business must, when packaging food — (a) only use packaging material that is fit for its intended use; (b) only use material that is not likely to cause food contamination; and (c) ensure that there is no likelihood that the food may become contaminated during the packaging process'; and Standard 1.4.1 - Contaminants and Natural Toxicants (F2015L00408, in force), which sets maximum contaminant levels that may be present in food as a result of packaging contact. Both fetched directly from legislation.gov.au. This confirms the record's core claim precisely: Australia regulates food-contact materials through a general fit-for-purpose duty plus contaminant limits, not a detailed EU/US-style compositional standard — genuinely lighter-touch, not an under-researched gap.", "summary_en": "Australia has no pre-market approval for food-contact materials: the FSANZ Food Standards Code sets general safety obligations (Standard 3.2.2 cl.9 fit-for-purpose duty, Standard 1.4.1 contaminant limits), AS 2070 (plastics for food contact) is voluntary, and state food acts provide enforcement. Lighter regime, but general consumer law still applies.", "summary_zh": "澳大利亚对食品接触材料无上市前审批：FSANZ食品标准法典规定一般安全义务（3.2.2条款9的适用性义务、1.4.1条污染物限量），AS 2070（食品接触塑料）为自愿标准，各州食品法负责执法。监管较轻，但消费者法的一般安全要求仍然适用。", "required_marks": [], "regulations": [ { "name": "Standard 3.2.2 - Food Safety Practices and General Requirements, clause 9 (Food packaging)", "authority": "Food Standards Australia New Zealand (FSANZ)", "source": "https://www.legislation.gov.au/F2008B00576/latest/text" }, { "name": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "source": "https://www.legislation.gov.au/F2015L00408/latest/text" }, { "name": "Food packaging (business guidance)", "authority": "Food Standards Australia New Zealand (FSANZ)", "source": "https://www.foodstandards.gov.au/business/food-safety/food-packaging" }, { "name": "AS 2070-1999 Plastics for food contact (voluntary)", "authority": "Standards Australia", "source": "https://www.standards.org.au/" } ], "testing_certification": [ "No mandatory migration testing or pre-market approval; the general Standard 3.2.2 cl.9 fit-for-purpose/no-contamination duty and Standard 1.4.1 contaminant limits apply instead of a detailed compositional standard", "AS 2070 (plastics for food contact) is voluntary and itself references EU/FDA-style requirements as a means of demonstrating compliance", "Compliance with EU or FDA regimes is the accepted de facto benchmark for retail buyers" ], "labelling": [ "No mandatory food-contact symbol", "Australian Consumer Law prohibitions on misleading claims apply" ], "local_representative": { "required": false, "note_en": "No registration or responsible-person requirement for FCMs.", "note_zh": "食品接触材料无注册或责任人要求。" }, "pitfalls_zh": [ "监管轻不等于零风险——大型零售商(Woolworths/Coles)采购合同通常直接要求欧盟或FDA合规证据", "如产品同时销往新西兰，注意两国共用FSANZ框架但执法机构不同" ], "last_verified": "2026-07-16", "jurisdiction_scope": "Australia; state and territory enforcement can vary", "applicability": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "provenance": { "schema_version": "2026-07-06", "review_status": "source_checked", "review_note": "2026-07-09: Re-tried source checking for AU food-contact coverage; the cited foodstandards.gov.au path did not expose the specific content needed. 2026-07-16: Closed the gap. Standard 1.4.3 - Articles and Materials in Contact with Food (the instrument previously cited) is no longer in force (F2008B00620, repealed 29 Feb 2016) — replaced its citation with the two current, in-force instruments that actually govern food-contact materials in Australia today: Standard 3.2.2 - Food Safety Practices and General Requirements (F2008B00576, in force, last compiled 13 Aug 2025), clause 9 of which reads in full: 'A food business must, when packaging food — (a) only use packaging material that is fit for its intended use; (b) only use material that is not likely to cause food contamination; and (c) ensure that there is no likelihood that the food may become contaminated during the packaging process'; and Standard 1.4.1 - Contaminants and Natural Toxicants (F2015L00408, in force), which sets maximum contaminant levels that may be present in food as a result of packaging contact. Both fetched directly from legislation.gov.au. This confirms the record's core claim precisely: Australia regulates food-contact materials through a general fit-for-purpose duty plus contaminant limits, not a detailed EU/US-style compositional standard — genuinely lighter-touch, not an under-researched gap.", "verified_at": "2026-07-16", "verified_by": "ComplianceCN editorial review against the cited primary sources", "source_count": 4, "sources": [ { "id": "food-contact-au:source:1", "title": "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", "source_type": "primary", "checked_at": "2026-07-16" }, { "id": "food-contact-au:source:2", "title": "Standard 1.4.1 - Contaminants and Natural Toxicants", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.legislation.gov.au/F2015L00408/latest/text", "source_type": "primary", "checked_at": "2026-07-16" }, { "id": "food-contact-au:source:3", "title": "Food packaging (business guidance)", "authority": "Food Standards Australia New Zealand (FSANZ)", "url": "https://www.foodstandards.gov.au/business/food-safety/food-packaging", "source_type": "primary", "checked_at": "2026-07-16" }, { "id": "food-contact-au:source:4", "title": "AS 2070-1999 Plastics for food contact (voluntary)", "authority": "Standards Australia", "url": "https://www.standards.org.au/", "source_type": "primary", "checked_at": "2026-07-16" } ] }, "claims": [ { "id": "food-contact-au:summary", "topic": "summary", "text_en": "Australia has no pre-market approval for food-contact materials: the FSANZ Food Standards Code sets general safety obligations (Standard 3.2.2 cl.9 fit-for-purpose duty, Standard 1.4.1 contaminant limits), AS 2070 (plastics for food contact) is voluntary, and state food acts provide enforcement. Lighter regime, but general consumer law still applies.", "text_zh": "澳大利亚对食品接触材料无上市前审批：FSANZ食品标准法典规定一般安全义务（3.2.2条款9的适用性义务、1.4.1条污染物限量），AS 2070（食品接触塑料）为自愿标准，各州食品法负责执法。监管较轻，但消费者法的一般安全要求仍然适用。", "classification": "legal_summary", "mandatory": null, "conditions": [ "Confirm material composition, food type, temperature, duration and repeated-use conditions" ], "evidence": [ "food-contact-au:source:1", "food-contact-au:source:2", "food-contact-au:source:3", "food-contact-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "food-contact-au:testing:1", "topic": "testing", "text_en": "No mandatory migration testing or pre-market approval; the general Standard 3.2.2 cl.9 fit-for-purpose/no-contamination duty and Standard 1.4.1 contaminant limits apply instead of a detailed compositional standard", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-au:source:1", "food-contact-au:source:2", "food-contact-au:source:3", "food-contact-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "food-contact-au:testing:2", "topic": "testing", "text_en": "AS 2070 (plastics for food contact) is voluntary and itself references EU/FDA-style requirements as a means of demonstrating compliance", "text_zh": null, "classification": "compliance_measure", "mandatory": true, "conditions": [], "evidence": [ "food-contact-au:source:1", "food-contact-au:source:2", "food-contact-au:source:3", "food-contact-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "food-contact-au:testing:3", "topic": "testing", "text_en": "Compliance with EU or FDA regimes is the accepted de facto benchmark for retail buyers", "text_zh": null, "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-au:labelling:1", "topic": "labelling", "text_en": "No mandatory food-contact symbol", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-au:source:1", "food-contact-au:source:2", "food-contact-au:source:3", "food-contact-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "food-contact-au:labelling:2", "topic": "labelling", "text_en": "Australian Consumer Law prohibitions on misleading claims apply", "text_zh": null, "classification": "legal_requirement", "mandatory": true, "conditions": [], "evidence": [ "food-contact-au:source:1", "food-contact-au:source:2", "food-contact-au:source:3", "food-contact-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "food-contact-au:local-presence", "topic": "local_presence", "text_en": "No registration or responsible-person requirement for FCMs.", "text_zh": "食品接触材料无注册或责任人要求。", "classification": "legal_requirement", "mandatory": false, "conditions": [], "evidence": [ "food-contact-au:source:1", "food-contact-au:source:2", "food-contact-au:source:3", "food-contact-au:source:4" ], "evidence_status": "record_source_set" }, { "id": "food-contact-au:pitfall:1", "topic": "pitfall", "text_en": null, "text_zh": "监管轻不等于零风险——大型零售商(Woolworths/Coles)采购合同通常直接要求欧盟或FDA合规证据", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" }, { "id": "food-contact-au:pitfall:2", "topic": "pitfall", "text_en": null, "text_zh": "如产品同时销往新西兰，注意两国共用FSANZ框架但执法机构不同", "classification": "practical_guidance", "mandatory": null, "conditions": [], "evidence": [], "evidence_status": "editorial_source_needed" } ] } ] }