2026-09
巴西Brazil
重点品种审查Priority Review
草甘膦新登记被法院临时叫停 90 天Court suspends new glyphosate registrations for 90 days
巴西利亚第七劳动法院于 2026-09-04 就草甘膦公共民事诉讼作出临时裁定，自裁定日起 90 天内暂停核发以草甘膦及其衍生物为基础的除草剂新登记、新授权、相同产品登记、用途扩展及基于等同性的登记。现有登记未被取消，但新进入者窗口短期关闭。On 2026-09-04 the 7th Labor Court of Brasília issued an interim ruling in a glyphosate public civil action, suspending for 90 days the granting of new registrations, authorizations, me-too products, use extensions and equivalence-based registrations for glyphosate and its derivatives. Existing registrations are unaffected, but the entry window is briefly closed.
- 现有登记不受影响，仅新申请受限。Existing registrations unaffected; only new filings restricted.
- 等同性(TE)路径的新登记同样在暂停范围。TE-based new registrations are also within the suspension scope.
2026-07
巴西Brazil
登记趋势Trend
登记"进""出"同步：五年批 3344 项、一年撤 158 项Approvals and withdrawals in parallel: 3,344 approved in 5 yrs, 158 cancelled in 1 yr
公开统计显示，巴西近五年批准登记 3344 项、一年内取消 158 项。MAPA 已暂停 97 项登记，草铵膦、莠去津、虫螨腈等 6 种原药被纳入审查；草甘膦与 2,4-D 的文件审查与样品补交要求导致 97 项暂停（33 项已恢复，64 项仍暂停）。Public statistics show Brazil approved 3,344 registrations over five years and cancelled 158 in one year. MAPA suspended 97 registrations; six active ingredients including glufosinate, atrazine and chlorfenapyr were flagged for review; glyphosate and 2,4-D documentation/sample requirements left 64 of 97 suspensions still active.
- 审查趋严，资料完整性与样品一致性更关键。Scrutiny tightens; dossier completeness and sample consistency matter more.
2026-06
巴西Brazil
审批流程Process
农药统一登记系统 Sispa 正式上线Unified registration system Sispa goes live
巴西于 2026-06-08 正式上线农药统一登记系统（Sispa），由农业畜牧部（MAPA）协调，整合 MAPA、国家卫生监督局（ANVISA）与环境部（IBAMA）三部门审批流程，实现 100% 无纸化，并支持企业实时追踪在三部门的审批进度。On 2026-06-08 Brazil launched Sispa, a unified pesticide registration system coordinated by MAPA, integrating the review workflows of MAPA, ANVISA and IBAMA into a single paperless portal with real-time progress tracking across all three federal authorities.
- 三部门审批壁垒打通，流程更透明。Silos between the three authorities are broken; process more transparent.
- 统一电子入口，材料提交与查询集中化。Single electronic entry for filing and status queries.
2026-05
阿根廷Argentina
标签规范Labeling
SENASA 全面修订农药标签，接轨 GHS 第 9 修订版SENASA overhauls pesticide labeling, aligning with GHS Rev.9
阿根廷国家农业食品卫生与质量局（SENASA）于 2026-04-24 发布第 373/2026 号决议，对农药标签要求实施全面修订，核心举措是引入联合国《全球化学品统一分类和标签制度》（GHS，第 9 修订版）。决议次日生效，并废止沿用十余年的第 367/2014 号决议。On 2026-04-24 Argentina's SENASA issued Resolution 373/2026, comprehensively revising pesticide labeling by adopting the UN Globally Harmonized System (GHS, Rev.9). It took effect the next day, repealing the decade-old Resolution 367/2014.
- 标签须按 GHS Rev.9 重新设计。Labels must be redesigned to GHS Rev.9.
- 同步更新 SDS 与分类逻辑。SDS and classification logic must be updated in tandem.
2026
欧盟EU
数据保护Data Protection
法规 (EU) 2026/747 延长部分数据保护期Regulation (EU) 2026/747 extends some data-protection periods
欧盟通过 (EU) 2026/747，延长了部分有效成分、安全剂与增效剂的数据保护期。这将直接影响后续 Me-Too 产品引用数据的时机与授权信（LoA）策略，企业需重新评估进入窗口。The EU adopted (EU) 2026/747, extending data-protection periods for certain active substances, safeners and synergists. This directly affects the timing of me-too data citation and Letter-of-Access (LoA) strategy; firms should reassess entry windows.
- Me-Too 引用须待保护期届满或取得 LoA。Me-too citation must wait for expiry or obtain an LoA.
2026
欧盟EU
法规修订Reform
1107/2009 配套修订与"化学品共同数据平台"落地1107/2009 follow-up revisions and the Common Data Platform land
欧盟推进 (EC) 1107/2009 配套的数据要求法规（283/2013、284/2013）与统一原则（546/2011）修订，并启动公众咨询。同时，(EU) 2025/2455 化学品共同数据平台（"One Substance, One Assessment"）于 2026 年落地，由 ECHA 牵头，推动"一种物质、一次评估"的数字化协同。The EU is revising the data-requirement regulations (283/2013, 284/2013) and uniform principles (546/2011) under 1107/2009, with a public consultation. Meanwhile (EU) 2025/2455 — the Chemicals Common Data Platform ("One Substance, One Assessment"), led by ECHA — lands in 2026, enabling digital coordination of substance assessments.
- 数据要求与评估原则可能调整，需持续跟踪。Data requirements and assessment principles may shift; keep monitoring.
2026
美国US
入境合规Import Compliance
EPA 与海关联合执法：注册号匹配成入境关键EPA–Customs enforcement: registration-number match is key at border
美国 EPA 与海关边境保护局（CBP）联合执法中，产品编码与 EPA 注册号匹配错误是常见的拒绝入境原因。出口商须在制单环节双重核对。此外，FIFRA 框架下的再评审（Registration Review）要求对每项已注册品种每 15 年回顾一次，是维持市场准入的必经程序。In EPA–CBP joint enforcement, mismatches between product codes and EPA registration numbers are a common cause of import refusal; exporters must double-check documentation. Under FIFRA, Registration Review re-examines every registered product every 15 years — a mandatory step to retain market access.
- 标签上的 EPA 注册号须与报关信息完全一致。The EPA registration number on the label must exactly match customs filings.
- 再评审是维持在美登记的前提。Registration Review is a precondition to keeping US registrations.
2026
美国US
流程优化Process
EPA 优化登记流程并推进生物农药EPA streamlines registration and advances biopesticides
EPA 于 2025 年 10 月发布优化农药登记流程的报告，并持续推动生物农药新登记。同时，濒危物种保护计划（ESPP）对标签缓冲带与施用限制提出更高要求，影响新登记标签设计。EPA released a report in Oct 2025 to optimize pesticide registration workflows and continues to advance new biopesticide registrations. The Endangered Species Protection Program (ESPP) raises label buffer and application-restriction requirements, affecting new-registration label design.
- 生物农药是美区登记提速的重点方向。Biopesticides are a priority lane for faster US registration.
2026
英国UK
制度体系Regime
脱欧后 GB 独立登记体系由 HSE/CRD 负责Post-Brexit GB regime run independently by HSE/CRD
英国脱欧后，大不列颠（GB）农药登记由 HSE 化学品监管司（CRD）独立负责，与欧盟体系不再互通。HSE 设有数据保护期，引用欧盟原有数据需重新评估合规性与可接纳性；北爱尔兰仍沿用法域安排，需分别对待。After Brexit, Great Britain's pesticide registration is run independently by HSE's Chemicals Regulation Division (CRD), no longer interoperable with the EU. HSE sets its own data-protection periods; citing legacy EU data requires re-assessing admissibility. Northern Ireland follows a separate arrangement and must be handled distinctly.
- 英欧数据不互通，需单独递交与评估。UK–EU data are not shared; separate filing and assessment needed.
2026
智利 / 阿根廷Chile / Argentina
体系改革Reform
智利推进登记现代化，阿根廷 SENASA 统筹Chile modernizes registration; Argentina coordinated by SENASA
智利推进农药登记体系现代化改革，借鉴美国与欧盟以风险为基础的原则，由农业与畜牧业局（SAG）主管。阿根廷则由 SENASA 统筹国家级登记，并与各省协同；两国均在提升审查效率与透明度。Chile is modernizing its pesticide registration system, borrowing risk-based principles from the US and EU, under the Agricultural and Livestock Service (SAG). Argentina coordinates national registration via SENASA with provincial alignment; both countries are improving review efficiency and transparency.
- 南美西语市场规则向国际惯例靠拢。Spanish-speaking South American rules converge toward international practice.
2025-11
巴西Brazil
生物投入品Biocontrol
巴西生物投入品"新法落地"，登记路径大改Brazil's new biocontrol law lands, reshaping registration paths
巴西生物投入品新法落地，登记路径大幅调整，由 MAPA、ANVISA、IBAMA 联合评审。新框架为生物农药与生物投入品企业带来进入机遇，也要求既有合规体系相应重构。Brazil's new biocontrol/bioinput law has landed, substantially changing registration pathways via joint MAPA/ANVISA/IBAMA review. The framework opens opportunities for biocontrol firms while requiring existing compliance setups to be reconfigured.
- 生物农药在巴西迎来更清晰的登记通道。Biopesticides gain a clearer registration channel in Brazil.
2025-06
英国UK
可持续使用Sustainable Use
英国发布十年来首份农药国家行动计划UK launches its first National Action Plan on Pesticides in a decade
2025-03-21，英国政府发布十年来首份《农药国家行动计划》，提出更可持续的农药使用框架，在保护人类健康与环境的同时保障长期粮食生产。四个组成政府将协同支持农户与种植者落实减量、替代与风险管理措施。On 2025-03-21 the UK government launched its first National Action Plan on Pesticides in a decade, setting a more sustainable-use framework that protects health and environment while supporting long-term food production. The four UK governments will jointly support farmers on reduction, substitution and risk management.
- 可持续使用与减量成为政策主轴。Sustainable use and reduction become the policy axis.
2025-06
阿根廷Argentina
标签规范Labeling
阿根廷将 GHS 引入植物卫生产品标签Argentina incorporates GHS into crop-protection product labels
2025 年，阿根廷 SENASA 推进将联合国 GHS 体系引入农用植物卫生产品（农药）标签与分类，统一危险沟通语言，为后续第 373/2026 号决议的全面修订奠定基线。In 2025 SENASA advanced the adoption of the UN GHS into crop-protection product labels and classification, unifying hazard communication and laying the baseline for the later comprehensive Revision 373/2026.
- 危险沟通向国际通行体系对齐。Hazard communication aligns with the international standard.
2025
英国UK
化学品管理Chemicals
UK-REACH 年度评估活动报告发布UK-REACH annual assessment activity report published
HSE 发布 2024 年度 UK-REACH 评估活动报告，强调对注册卷宗质量与测试提案的审查，以确保人类健康与环境安全。与欧盟 REACH 类似，评估涵盖完整性评估与物质评估，直接影响在英化学品（含农药相关物质）的合规预期。HSE published its 2024 UK-REACH assessment activity report, emphasizing dossier-quality and testing-proposal review to safeguard health and environment. Like EU REACH, it covers completeness and substance evaluation, shaping compliance expectations for chemicals (including pesticide-related substances) in Great Britain.
- 卷宗质量与数据完整性被重点审查。Dossier quality and data integrity are under the spotlight.
2024-12
巴西Brazil
毒理评估Toxicology
ANVISA 以 RDC 950/2024 将 Flora 自动评估制度化ANVISA institutionalizes Flora auto-assessment via RDC 950/2024
2024 年 12 月，巴西国家卫生监督局（ANVISA）发布 RDC No. 950/2024 号决议，将 Flora 自动毒理学评估系统制度化，旨在加快评估流程；但系统会在规定时限内未达标时自动拒绝申请。后续 RDC No. 1,005/2025 显示，Flora 运行后已有 92 项申请被拒，涉及 31 家企业。In Dec 2024 ANVISA issued RDC No. 950/2024, institutionalizing the Flora automatic toxicology assessment system to speed up reviews — but it auto-rejects applications that miss deadlines or requirements. Follow-up RDC No. 1,005/2025 shows 92 applications from 31 companies were rejected under Flora.
- 申报须严格满足时限，否则自动驳回。Filings must meet deadlines strictly or face auto-rejection.
2024-08
美国US
濒危物种Endangered Species
EPA 敲定首份《除草剂方案》保护 900+ 濒危物种EPA finalizes first Herbicide Strategy, protecting 900+ species
2024-08-20，美国 EPA 发布《除草剂方案》（Herbicide Strategy）终稿，针对常规除草剂，通过早期缓释与缓冲等措施降低对 900 多种联邦濒危/受威胁物种及其关键栖息地的暴露。该方案适用于新活性物质登记与再评审，并衔接《濒危物种法》（ESA）义务。On 2024-08-20 EPA finalized its Herbicide Strategy, applying early mitigations (buffers, etc.) to cut exposure of 900+ federally listed endangered/threatened species and critical habitats to conventional herbicides. It applies to new-active registrations and registration reviews and fulfills ESA obligations.
- 新登记标签须体现缓冲带等缓解措施。New labels must reflect buffer and mitigation measures.
- 继 2023 年草案后正式落地。Finalized after the 2023 draft consultation.
2024
美国US
PFAS 关注PFAS
美国加强对农药中 PFAS"永久化学品"的审视US tightens scrutiny of PFAS "forever chemicals" in pesticides
2024 年，美国围绕 PFAS（全氟/多氟烷基物质）的关注持续升温：国会提出逐步淘汰非必要 PFAS 用途的提案，EPA 亦加强对含 PFAS 农药成分与包装的审视，要求企业在配方与供应链环节提前排查。In 2024 US attention to PFAS intensified: Congress proposed phasing out non-essential PFAS uses, and EPA heightened scrutiny of PFAS in pesticide ingredients and packaging, prompting companies to screen formulations and supply chains early.
- 配方与包装需排查 PFAS 来源。Screen formulations and packaging for PFAS sources.
2024
欧盟EU
可持续使用Sustainable Use
欧盟撤回《农药可持续使用法规》(SUR) 提案EU withdraws the Sustainable Use of Pesticides Regulation (SUR)
在广泛争议后，欧盟委员会撤回了拟将化学农药使用与风险削减 50% 的《农药可持续使用法规》(SUR) 提案。2025 年 2 月，农业事务专员明确表态"农药削减目标不再列入议程"，意味着欧盟转向以创新与自愿为主的减药路径。After broad controversy, the Commission withdrew the SUR proposal that would have cut chemical pesticide use and risk by 50%. In Feb 2025 the Agriculture Commissioner stated the reduction target is "off the table", shifting the EU toward innovation- and voluntariness-led reduction.
- 强制削减路径让位于技术与自愿措施。Mandatory cuts give way to technology and voluntary measures.
2024-01
欧盟EU
残留限量MRL
欧盟更新多项农药最大残留限量(MRL)EU updates multiple pesticide MRLs
2024 年欧盟持续修订 (EC) No 396/2005 下的农药最大残留限量，例如 (EU) 2024/376（2024-01-24）对茚虫威（indoxacarb）等在特定作物上的 MRL 作出修订。出口企业须同步核查目标作物残留标准，避免通关受阻。Throughout 2024 the EU amended MRLs under (EC) No 396/2005 — e.g., (EU) 2024/376 (2024-01-24) revised indoxacarb limits on certain commodities. Exporters must re-check residue standards per crop to avoid border issues.
- MRL 频繁调整，须建立动态核查机制。MRLs shift often; keep a dynamic checking mechanism.
2024-05
巴西Brazil
生物制品Biocontrol
ANVISA 出台 RDC 876/2024 规范生物制品上市后变更ANVISA issues RDC 876/2024 on biocontrol post-market changes
由 2023 年的决议草案（No. 1207）演变而来，ANVISA 于 2024-05-28 发布 RDC No. 876/2024，明确生物制品（生物投入品）上市后注册变更与注销市场注册的条款，优化修改协议流程与分析，为生物农药合规铺路。Evolving from the 2023 draft (No. 1207), ANVISA published RDC No. 876/2024 on 2024-05-28, setting post-market change and cancellation rules for biocontrol products and streamlining amendment protocols — paving the way for biopesticide compliance.
- 生物制品变更有了明确法规路径。Biocontrol changes gain a clear regulatory path.
2023-03
欧盟EU
再评审细则Renewal
欧盟 (EU) 2023/574 明确再评审实施细则EU (EU) 2023/574 sets detailed renewal rules
2023-03-13，欧盟发布委员会实施法规 (EU) 2023/574，就 (EC) 1107/2009 下活性成分批准到期再评审的程序作出详细规定，包括申请人须识别拟提交的新数据并证明其必要性，提升了再评审的可预期性。On 2023-03-13 the EU adopted Commission Implementing Regulation (EU) 2023/574, detailing the renewal procedure for expired active-substance approvals under 1107/2009 — including the applicant's duty to identify and justify new data — improving predictability of renewals.
- 再评审需主动识别并论证新数据。Renewals require proactively identifying and justifying new data.
2023
美国US
濒危物种Endangered Species
EPA 发布《除草剂方案》草案并启动公众评议EPA releases Herbicide Strategy draft for public comment
为履行《濒危物种法》(ESA) 义务，EPA 于 2023 年发布《除草剂方案》草案并进入公众评议，提出以缓冲带、施用限制等早期缓解措施降低对濒危物种的暴露，最终于 2024 年 8 月敲定。To meet Endangered Species Act (ESA) obligations, EPA released the Herbicide Strategy draft in 2023 for public comment, proposing early mitigations such as buffers and application limits to reduce exposure; it was finalized in Aug 2024.
- ESA 合规成为美区登记核心变量。ESA compliance becomes a core variable for US registration.
2023-10
巴西Brazil
生物制品Biocontrol
巴西启动生物制品变更规则修订（草案）Brazil opens biocontrol change-rule revision (draft)
2023-10-02，巴西就生物制品（生物投入品）上市后注册变更与注销市场注册的条款发布第 1207 号决议草案（经 G/TBT/N/BRA/1505 通报），旨在优化 ANVISA 的修改协议流程与分析，后于 2024 年落地为 RDC 876/2024。On 2023-10-02 Brazil issued draft Resolution No. 1207 (notified as G/TBT/N/BRA/1505) on post-market change and cancellation rules for biocontrol products, aiming to optimize ANVISA's amendment protocols; it landed as RDC 876/2024 in 2024.
- 生物农药监管框架早期信号。An early signal of the biocontrol regulatory framework.
2023
欧盟 / 英国EU / UK
战略框架Strategy
绿色新政与"从农场到餐桌"持续重塑农药使用框架Green Deal and "Farm to Fork" keep reshaping the pesticide framework
自 2020 年欧盟绿色新政与"从农场到餐桌"战略提出削减化学农药目标以来，相关讨论在 2023 年持续主导监管议程（尽管后续 SUR 于 2024 撤回）。英国脱欧后同步构建独立的 GB 农药战略与 UK-REACH 体系，形成与欧盟既相关又分野的监管格局。Since the 2020 Green Deal and Farm-to-Fork target to cut chemical pesticides, the debate dominated the 2023 regulatory agenda (though SUR was later withdrawn in 2024). Post-Brexit, the UK built its own GB pesticide strategy and UK-REACH, creating a regime both linked to and diverging from the EU.
- 长期政策导向偏向低风险与生物方案。Long-term policy tilts toward low-risk and biological solutions.