关键时间点：2027 年 1 月 20 日，没有缓冲期

The Hard Date: 20 January 2027, With No Grace Period

新机械法规 (EU) 2023/1230 于 2023 年 6 月 14 日公布、6 月 29 日刊登于欧盟官方公报，经 42 个月过渡期后，自 2027 年 1 月 20 日起全面适用，同时废止沿用近 20 年的机械指令 2006/42/EC。需要特别注意的是：过渡期在 2027 年 1 月 19 日结束，之后并不存在「两套规则并行、可择一适用」的窗口。自适用日起投放欧盟市场的机械，CE 标识与合格声明只能依据 2023/1230 作出；依据 2006/42/EC 出具的符合性声明对新产品不再有效。法规形式的改变本身也很重要——「Regulation」在 27 个成员国直接、统一适用，不再经各国转化，各市场解释不一致的空间被压缩。

Regulation (EU) 2023/1230 was published on 14 June 2023 and appeared in the Official Journal on 29 June 2023. After a 42-month transition it applies in full from 20 January 2027, repealing Machinery Directive 2006/42/EC. The critical point: the transition ends on 19 January 2027 and there is no window in which both instruments may be applied at the manufacturer's choice. From the date of application, CE marking and declarations of conformity for machinery placed on the EU market can only be made under 2023/1230, and declarations issued under 2006/42/EC are no longer valid for new products. The change of legal form matters too — a Regulation applies directly and identically across all 27 Member States without national transposition, removing much of the divergence in interpretation.

对清洁设备意味着什么：先确认自己在不在范围内

What It Means for Cleaning Equipment: Confirm Your Scope First

新法规适用于机械、相关产品（可更换设备、安全部件、起重附件、链条绳索与吊带、可拆卸机械传动装置）以及不完整机械。排除项包括航空产品、机动车、两轮/三轮车与四轮摩托车、农林拖拉机，以及家用电器和普通办公设备。商用与工业清洁设备——驾驶式与手推式洗地机、扫地机、工业吸尘器、高压清洗机、自主清洁机器人——属于机械范畴，需要按新法规重做符合性评估路径。已在欧盟市场流通的存量机器不因此自动失效，但新投放的产品必须合规，这就是为什么整改要在 2026 年内完成，而不是等到 2027 年 1 月。

The Regulation covers machinery, related products (interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices) and partly completed machinery. Excluded are aeronautical products, motor vehicles, two- and three-wheelers and quadricycles, agricultural and forestry tractors, plus household appliances for domestic use and ordinary office machines. Commercial and industrial cleaning equipment — ride-on and walk-behind scrubbers, sweepers, industrial vacuums, pressure washers and autonomous cleaning robots — falls squarely within machinery and must be reassessed under the new route. Units already on the EU market are not invalidated, but anything newly placed on the market must comply, which is why remediation belongs in 2026 rather than January 2027.

约 90% 内容不变，真正变的是数字化那一块

About 90% Unchanged — The Real Shift Is Digital

认证机构的普遍判断是：新法规约 90% 的条文与原指令一致，许多要求只是描述得更细。真正的新增集中在数字化与互联：Annex III 的基本健康与安全要求（EHSR）经过修订扩充，新增了人工智能、网络安全、人机协作、设备联网（IoT）、软件更新影响以及功能安全（含软件）的相关条款，核心目的是防止第三方通过数字基础设施攻击机器的安全功能。这对清洁行业不是抽象条款：带远程车队管理、OTA 升级、云端调度的洗地机与清洁机器人，正好落在这些新要求上。这也是继 EN/IEC 60335-2-72（工业与商用地面处理机）与 IEC 63327（自主式地面清洁机）之后，产品合规栈上新增的一层。

Notified bodies broadly agree that roughly 90% of the Regulation mirrors the Directive, with many requirements simply described in more detail. The genuine additions cluster around digitalisation and connectivity: the essential health and safety requirements in Annex III have been revised and extended to cover artificial intelligence, cybersecurity, human-robot collaboration, internet-connected devices, the impact of software updates and functional safety including software, with the aim of preventing third-party attacks on machine safety via digital infrastructure. For cleaning equipment this is concrete, not theoretical: scrubbers and robots with fleet telematics, over-the-air updates and cloud scheduling land directly on these clauses — a new layer on top of EN/IEC 60335-2-72 for industrial and commercial floor treatment machines and IEC 63327 for autonomous floor cleaners.

网络安全首次成为强制性 EHSR

Cybersecurity Becomes a Mandatory EHSR for the First Time

这是欧盟机械立法史上第一次把网络安全写进基本健康与安全要求。凡设计为具备数字连接能力的机械，必须能够抵御可能危及安全功能的意外或未授权访问——一台联网但未做防护设计的机器，在法律上即为不合规。同样，当基于 AI 的系统承担安全相关功能（例如控制保护装置或实现自主运行）时，制造商必须证明这些系统在其预期运行范围内行为可靠、可预测。风险评估的边界也随之扩展：必须覆盖软件的完整生命周期，包括更新、修改与随时间发生的性能退化所带来的后果。对采用机器学习且具备自演化能力的机械，符合性评估程序更严格，并需公告机构介入。此外，若产品同时落入欧盟 AI 法案或 NIS2 指令范围，还会叠加相应义务。

For the first time in EU machinery law, cybersecurity is an explicit essential health and safety requirement. Machinery designed with digital connectivity must be protected against unintended or unauthorised access capable of compromising safety functions; a connected machine not designed to resist such access is non-compliant. Equally, where AI-based systems perform safety-relevant functions — controlling protective devices or enabling autonomous operation — the manufacturer must demonstrate reliable, predictable behaviour across the intended operational envelope. Risk assessment now spans the full software lifecycle, including the consequences of updates, modifications and degradation over time. Machines with self-evolving machine-learning systems face more rigorous conformity assessment with mandatory notified body involvement. Where the product also falls under the EU AI Act or the NIS2 Directive, those obligations stack on top.

Annex I 取代 Annex IV：高风险机械的评估路径变了

Annex I Replaces Annex IV: A New High-Risk Framework

原指令 Annex IV 的高风险机械清单被移入新法规 Annex I，并拆成两部分。Part A：无论是否完整适用协调标准，都必须由公告机构进行第三方评估，涵盖六类特定机械，包括木工机械、压力机、注塑/压塑机等。Part B：沿用原 Annex IV 的逻辑——除非制造商完整适用覆盖全部适用 EHSR 的协调标准，否则需公告机构介入。常规清洁设备通常不落在这两类清单中，可走自我评估（内部生产控制）路径，但前提是技术文件与风险评估必须按新法规重做，且能证明所依据的协调标准仍然有效。欧盟委员会正在编制新法规下的协调标准清单，制造商应持续跟踪自己产品线所引用标准的更新状态。若产品集成了落入 Annex I 的部件或具备自演化 AI 功能，则需尽早预约公告机构——2026 年的评估档期已相当紧张。

The former Annex IV high-risk catalogue moves into Annex I of the Regulation and splits in two. Part A requires mandatory third-party assessment by a notified body regardless of whether harmonised standards are applied, covering six specific categories including woodworking machines, pressing machines and injection or compression moulding machines. Part B mirrors the old Annex IV logic: notified body involvement is required unless the manufacturer fully applies a relevant harmonised standard covering all applicable EHSRs. Conventional cleaning machines generally sit outside both lists and can use self-assessment via internal production control — provided the technical file and risk assessment are rebuilt to the new Regulation and the standards relied upon remain valid. The Commission is compiling the harmonised standards list under the new Regulation, so track the status of the standards your product line cites. If your machine integrates Annex I components or self-evolving AI, book notified body capacity early; 2026 slots are already competitive.

数字说明书：QR 码、永久链接与 10 年可用性

Digital Instructions: QR Codes, Permanent Links, Ten Years of Availability

欧盟机械立法首次允许使用说明与欧盟符合性声明以纯数字形式提供，这对出口商是实打实的成本利好，但门槛并不低。数字说明书须通过机器上标注的 QR 码或 URL 访问，自产品投放市场起至少保持 10 年可用，且随时可下载、可打印。仅仅把 PDF 传到服务器并不够：需要结构化的系统，具备永久 URL、版本管理与访问留痕，以便在检查时回答「交付当天随机的是哪一版说明书」。实践中的坑在于 QR 码是刻在机身上的物理标识，一旦服务器迁移或公司域名变更，静态指向就会失效且无法远程修正，因此应使用可后台改指向的动态 QR 方案。合格声明也需可验证其真实性与未被篡改。对中国出口商而言，这意味着说明书交付方式要从「纸质随机 + 邮件发 PDF」升级为受控的文档发布流程。

For the first time, instructions for use and the EU Declaration of Conformity may be supplied in digital form only — a genuine cost saving for exporters, but not a low bar. Digital instructions must be reachable via a QR code or URL marked on the machine, remain available for at least 10 years after the product is placed on the market, and be downloadable and printable at any time. Uploading a PDF to a server is not enough: a structured system is needed with permanent URLs, certified versioning and an audit trail, so that an inspector's question — which version of the instructions accompanied this machine on the delivery date — can be answered. The practical trap is that the QR code is a physical mark on the frame: if the server migrates or the company domain changes, a static target breaks and cannot be corrected remotely, so use a dynamic QR scheme whose destination is managed centrally. The declaration must also be verifiable as authentic and unaltered.

「实质性改装」重新定义：售后与软件更新的责任转移

Substantial Modification Redefined: Liability Moves With Software

新法规明确了「实质性改装」的边界：任何制造商未预见的物理或数字干预——包括改变安全功能的软件更新——都会把制造商责任转移给实施该改装的一方。举例来说，若终端用户或服务商自行刷写固件、修改了急停逻辑，实施方即在法律上承担制造商义务：需重新做风险评估、编制新的技术文件，若涉及安全功能，还需重新走符合性程序。对清洁设备厂商与其海外经销网络来说，这条直接影响售后策略：远程升级权限如何管理、经销商能否自行改参数、改装件（不同刷盘、加装吸水扒、更换电池系统）的边界在哪，都需要在合同与服务手册中写清楚。

The Regulation sharpens the definition of substantial modification: any physical or digital intervention not foreseen by the manufacturer — including a software update that alters safety functions — transfers manufacturer responsibilities to the party carrying it out. If an end user or service provider flashes firmware that changes emergency-stop logic, that party assumes manufacturer obligations: a new risk assessment, a new technical file and, where safety functions are affected, a fresh conformity procedure. For cleaning equipment makers and their overseas dealer networks this reshapes after-sales policy. Who holds remote update rights, whether dealers may change parameters, and where the boundary lies for retrofits — different pad drives, added squeegees, replacement battery systems — must be spelled out in contracts and service manuals.

制造商、进口商与经销商的分工准备清单

Preparation Checklist by Role

制造商：① 盘点产品组合，判断是否落入 Annex I Part A/B；② 更新风险评估，纳入网络安全、AI 行为与软件生命周期；③ 按新的技术文件结构重编档案；④ 建立数字说明书发布系统（永久 URL + 版本留痕）；⑤ 若需公告机构，尽早预约档期；⑥ 内部培训覆盖新 EHSR。进口商与经销商：售前核查文件完整性、核对 CE 标识与（数字）合格声明的有效性，并留存合规证据。对中国供应商而言，务实的做法是在 2026 年内完成一轮 CE 档案审计，把仍引用 2006/42/EC 的声明与说明书全部换版，避免 2027 年 1 月出现「货到港但声明无效」的清关风险。ApexClean（常州永乐环境工程有限公司）在洗地机、扫地机与工业吸尘器方向持有 CE、ISO9001 体系文件，支持 OEM/ODM 与出口文件配套，可配合客户按新法规时间表推进档案更新。

Manufacturers: 1) audit the portfolio against Annex I Parts A and B; 2) update risk assessments to include cybersecurity, AI behaviour and software lifecycle; 3) restructure technical files to the new format; 4) stand up a digital instructions platform with permanent URLs and version history; 5) book notified body capacity early if required; 6) train internal teams on the new EHSRs. Importers and distributors: verify documentation before sale, check the CE marking and the validity of the (digital) declaration, and retain evidence of conformity. For Chinese suppliers the pragmatic move is a full CE file audit during 2026, replacing every declaration and manual that still cites 2006/42/EC, so that no shipment arrives in January 2027 with an invalid declaration. ApexClean (Changzhou Yongle Environmental Engineering Co., Ltd.) holds CE and ISO 9001 documentation for scrubbers, sweepers and industrial vacuums, supports OEM/ODM and export documentation, and can align file updates to the new regulatory timetable.