I. Core Regulatory Framework and Implementation Mechanism
- Registration
1–10 tonnes/year: physicochemical properties and toxicological data must be submitted;
≥10 tonnes/year: a Chemical Safety Report (CSR) including exposure scenarios and risk assessment must be additionally submitted.
Scope: chemical substances produced or imported at ≥1 tonne per year (including substances on their own, in mixtures, or intentionally released from articles) must be registered with the European Chemicals Agency (ECHA).
Data Requirements:
Joint Registration:同一物质的生产商 / 进口商需联合提交数据，遵循 “一个物质，一次注册” 原则，降低重复测试成本.
- Evaluation
Dossier Evaluation: ECHA verifies the completeness of registration data. In 2021, 240 compliance check decisions were issued for 2,500 dossiers covering 258 substances.
Substance Evaluation: member states evaluate substance risks. In 2021, further regulatory action was initiated for 30 substances.
- Authorization
针对高风险物质（如 CMR、PBT、vPvB），企业需申请授权方可使用.截至 2025 年，SVHC（高关注物质）清单已更新至250 entries, with newly added substances including reproductive toxicants and vPvB substanceschinawto.mofcom.gov.cn.
- Restriction
对特定物质的生产、使用或销售设定条件.例如，2025 年 6 月新增对 N,N - 二甲基乙酰胺（DMAC）和 1 - 乙基 - 2 - 吡咯烷酮（NEP）的限制，要求企业在安全数据表中明确工人暴露限值（DNEL），并采取风险管理措施Shandong Provincial Department of Commerce.
II. Major 2025 Amendments and Industry Impact
- Registration Validity Period and Data Updates
Registration validity is uniformly set at10 years; registration numbers that are not updated or are non-compliant will be revokedSichuan Provincial Department of Commerce.
1-10 吨 / 年的简化注册需升级为全Data Requirements，聚合物需先通报再评估是否需注册.
- Strengthened Nanomaterial Control
The 2022 EU nanomaterial definition is adopted, requiring disclosure of characterization information such as particle size and surface properties, and strengthening downstream user notification obligations.
传统测试方法可能不适用，企业需依赖替代方法（如计算机模拟）评估风险.
- Supply Chain Digitalization and Enforcement Upgrade
Importers must submit Safety Data Sheets (SDS) at customs clearance; the ECHA system automatically verifies registration/authorization numbers.
Member states will establish unified enforcement standards; non-compliant enterprises may face product detention, fines, or market bans.
III. Corporate Compliance Strategies and Challenges
1. Dynamic SVHC List Tracking and Response
Notification Obligation: when SVHC content in an article exceeds 0.1% and annual export volume exceeds 1 tonne, notification must be made within 6 months of the substance’s inclusion on the listchinawto.mofcom.gov.cn.
Supply Chain Management:企业需建立成分数据库，确保下游客户及时获取 SVHC 信息.例如，含 SVHC 的产品需在 SCIP 数据库通报后才可投放市场chinawto.mofcom.gov.cn.
2. Registration and Joint Submission Optimization
Joint Registration联盟:5 家以上企业可节省 70% 测试费用，建议选择数据完整的领头注册人（LR）合作.
Data Mutual Recognition:中国 GLP 实验室出具的降解性数据可直接引用，降低测试成本.
3. Nanomaterial Registration Challenges
Characterization and Risk Assessment: parameters such as nanoparticle morphology and dispersibility must be clearly defined; traditional toxicological testing may not be applicable.
Additional National Requirements: countries such as France and Belgium require separate nanomaterial declarations; national regulations must be monitored.
4. Dual Compliance Pressure: REACH and CBAM
出口欧盟的碳密集型产品（如钢铁、铝）需同时满足 REACH 化学品管控和 CBAM（碳边境调节机制）的碳排放申报要求.例如，2026 年起，铝材出口商需为每吨产品支付约 595 欧元的碳成本.
IV. Recommendations for Chinese Enterprises
- Supply Chain Due Diligence
实施三级审核:验证 SDS 生态信息完整性、抽查原料检测报告、对高风险供应商进行现场审计.
建立产品成分树状图，明确各层级供应商的 REACH 合规责任.
- Technology Upgrades and Alternative Solutions
优先使用非 SVHC 替代物质，例如在锂电池生产中避免使用含 LiPF6 的电解质.
投资低碳技术，降低 CBAM 成本，同时优化化学品使用以符合 REACH 要求.
- Policy and Tool Application
利用 ECHA 的 IUCLID 6.8 系统提交数字化卷宗，避免 PDF 格式被拒.
关注 ECHA 纠纷解决机制，通过仲裁解决数据共享争议.
V. Typical Cases and Enforcement Trends
Non-Compliance Case:2025 年 6 月，某中国企业因儿童服装拉绳设计不符合 REACH 限制条款被欧盟召回.
Compliance Practice:某化工企业通过Joint Registration将测试成本降低 60%，并采用纳米钝化技术使 UPVC 圆棒耐腐蚀性提升 27%，同时通过 FDA 认证进入高端市场.