EU Machinery Regulation (EU) 2023/1230 — Modernising Machinery Safety and Market Access

Regulation (EU) 2023/1230, adopted by the European Parliament and the Council on 14 June 2023, establishes a harmonised legal framework governing the safety of machinery and related products placed on the European Union market. The Regulation replaces Directive 2006/42/EC and repeals Directive 73/361/EEC, introducing directly applicable requirements across all EU Member States.

The Regulation aims to ensure a high level of protection for the health and safety of persons while supporting the free movement of machinery within the EU internal market.

Legal Nature and Objectives

As an EU Regulation, Regulation 2023/1230 applies uniformly across all Member States without the need for national transposition. It sets out essential health and safety requirements, conformity assessment procedures, and obligations for economic operators involved in the manufacture, import and distribution of machinery.

The Regulation reflects technological developments and modern manufacturing practices, ensuring that safety rules remain effective and relevant.

Scope of Application

The Regulation applies to the following products:

• Machinery

• Interchangeable equipment

• Safety components

• Lifting accessories

• Chains, ropes and webbing

• Removable mechanical transmission devices

• Partly completed machinery

Certain products are excluded from scope, including:

• Fairground and amusement park equipment

• Machinery designed specifically for military or law-enforcement purposes

• Vehicles and vehicle components already regulated under specific EU legislation

• Means of transport by air, rail or water, except machinery installed on them

• Machinery for nuclear installations where safety risks are involved

• Machinery designed for temporary laboratory research use

Definitions and Clarifications

The Regulation provides updated and precise definitions for key concepts, including “machinery”, “safety component”, “safety function”, “placing on the market”, “manufacturer”, and “substantial modification”. These definitions are intended to ensure consistent interpretation and enforcement throughout the EU.

Essential Health and Safety Requirements

Manufacturers must ensure that machinery is designed and constructed in accordance with the essential health and safety requirements set out in the Regulation. These requirements apply throughout the product lifecycle, including foreseeable misuse.

Before placing machinery on the market or putting it into service, manufacturers must:

• Conduct a conformity assessment

• Prepare complete technical documentation

• Draw up an EU declaration of conformity

• Affix the CE marking

For certain categories of high-risk machinery, third-party conformity assessment by a notified body is required.

Obligations of Economic Operators

Manufacturers are responsible for:

• Ensuring compliance with essential safety requirements

• Maintaining technical documentation

• Providing clear and comprehensible instructions for use

• Making the EU declaration of conformity available, including in digital form

• Retaining documentation for at least ten years

• Taking corrective action and informing authorities if non-compliance or safety risks are identified

Importers must verify that machinery placed on the EU market complies with the Regulation, bears the CE marking, and is accompanied by the required documentation.

Distributors must act with due care and ensure that machinery remains compliant while under their responsibility.

Market Surveillance and Free Movement

Member States must not restrict the placing on the market or putting into service of compliant machinery. Machinery that does not yet comply may be displayed at trade fairs or exhibitions only if clearly marked as non-compliant and not offered for sale until conformity is achieved.

Member States may impose requirements related to installation and use, provided these do not conflict with the Regulation’s provisions.

Notified Bodies and Conformity Assessment

The Regulation establishes rules for the designation, notification and oversight of conformity assessment bodies. Member States notify competent bodies to the European Commission, which maintains a central list of notified bodies authorised to carry out conformity assessments under the Regulation.

Entry into Force and Transitional Period

The Regulation entered into force twenty days after its publication in the Official Journal of the European Union. Most substantive requirements apply from 20 January 2027, allowing a transition period for manufacturers and other economic operators.

During the transition period, machinery may continue to be placed on the market in accordance with Directive 2006/42/EC.