REGULATION (EU) 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 14 June 2023
on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
Article 2
Scope
Article 3
Definitions
Article 4
Free movement
Article 5
Protection of persons during installation or use of machinery or related products
Article 6
Categories of machinery and related products listed in Annex I subject to relevant conformity assessment procedures
Article 7
Safety components
Article 8
Essential health and safety requirements for products within the scope of this Regulation
Article 9
Specific Union harmonisation legislation
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS
Article 10
Obligations of manufacturers of machinery and related products
Article 11
Obligations of manufacturers of partly completed machinery
Article 12
Authorised representatives
Article 13
Obligations of importers of machinery and related products
Article 14
Obligations of importers of partly completed machinery
Article 15
Obligations of distributors of machinery and related products
Article 16
Obligations of distributors of partly completed machinery
Article 17
Cases in which obligations of manufacturers apply to importers and distributors
Article 18
Other cases in which obligations of manufacturers apply
Article 19
Identification of economic operators
CHAPTER III
CONFORMITY OF PRODUCTS WITHIN THE SCOPE OF THIS REGULATION
Article 20
Presumption of conformity of products within the scope of this Regulation
Article 21
EU declaration of conformity of machinery and related products
Article 22
EU declaration of incorporation of partly completed machinery
Article 23
General principles of the CE marking
Article 24
Rules for affixing the CE marking to machinery and related products
CHAPTER IV
CONFORMITY ASSESSMENT
Article 25
Conformity assessment procedures for machinery and related products
CHAPTER V
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 26
Notification
Article 27
Notifying authorities
Article 28
Requirements relating to notifying authorities
Article 29
Information obligation of notifying authorities
Article 30
Requirements relating to notified bodies
Article 31
Presumption of conformity of notified bodies
Article 32
Use of subcontractors and subsidiaries by notified bodies
Article 33
Application for notification
Article 34
Notification procedure
Article 35
Identification numbers and lists of notified bodies
Article 36
Changes to notifications
Article 37
Challenge of the competence of notified bodies
Article 38
Operational obligations of notified bodies
Article 39
Appeals against decisions of notified bodies
Article 40
Information obligation of notified bodies
Article 41
Exchange of experience
Article 42
Coordination of notified bodies
CHAPTER VI
UNION MARKET SURVEILLANCE AND UNION SAFEGUARD PROCEDURES
Article 43
Procedure at national level for dealing with products within the scope of this Regulation presenting a risk
Article 44
Union safeguard procedure
Article 45
Compliant products within the scope of this Regulation which present a risk
Article 46
Formal non-compliance
CHAPTER VII
DELEGATED POWERS AND COMMITTEE PROCEDURE
Article 47
Exercise of the delegation
Article 48
Committee procedure
CHAPTER VIII
CONFIDENTIALITY AND PENALTIES
Article 49
Confidentiality
Article 50
Penalties
CHAPTER IX
TRANSITIONAL AND FINAL PROVISIONS
Article 51
Repeals
Article 52
Transitional provisions
Article 53
Evaluation and review
Article 54
Entry into force and application
ANNEX I
CATEGORIES OF MACHINERY OR RELATED PRODUCTS TO WHICH ONE OF THE PROCEDURES REFERRED TO IN ARTICLE 25(2) AND (3) SHALL BE APPLIED
PART A
PART B
ANNEX II
INDICATIVE LIST OF SAFETY COMPONENTS
ANNEX III
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF MACHINERY OR RELATED PRODUCTS
PART A
Definitions
PART B
General principles
1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
1.1.
General remarks
1.1.1.
Applicability
1.1.2.
Principles of safety integration
1.1.3.
Materials and products
1.1.4.
Lighting
1.1.5.
Design of machinery or a related product to facilitate its handling
1.1.6.
Ergonomics
1.1.7.
Operating positions
1.1.8.
Seating
1.1.9.
Protection against corruption
1.2.
Control systems
1.2.1.
Safety and reliability of control systems
1.2.2.
Control devices
1.2.3.
Starting
1.2.4.
Stopping
1.2.4.1.
Normal stop
1.2.4.2.
Operational stop
1.2.4.3.
Emergency stop
1.2.4.4.
Assembly of machinery or related products
1.2.5.
Selection of control or operating modes
1.2.6.
Failure of the power supply or communication network connection
1.3.
Protection against mechanical risks
1.3.1.
Risk of loss of stability
1.3.2.
Risk of break-up during operation
1.3.3.
Risks due to falling or ejected objects
1.3.4.
Risks due to surfaces, edges or angles
1.3.5.
Risks related to a combined machinery or related product
1.3.6.
Risks related to variations in operating conditions
1.3.7.
Risks related to moving parts
1.3.8.
Choice of protection against risks arising from moving parts
1.3.8.1.
Moving transmission parts
1.3.8.2.
Moving parts involved in the process
1.3.9.
Risks of uncontrolled movements
1.4.
Required characteristics of guards and protective devices
1.4.1.
General requirements
1.4.2.
Special requirements for guards
1.4.2.1.
Fixed guards
1.4.2.2.
Interlocking movable guards
1.4.2.3.
Adjustable guards restricting access
1.4.3.
Special requirements for protective devices
1.5.
Risks due to other causes
1.5.1.
Electricity supply
1.5.2.
Static electricity
1.5.3.
Energy supply other than electricity
1.5.4.
Errors of fitting
1.5.5.
Extreme temperatures
1.5.6.
Fire
1.5.7.
Explosion
1.5.8.
Noise
1.5.9.
Vibrations
1.5.10.
Radiation
1.5.11.
External radiation
1.5.12.
Laser radiation
1.5.13.
Emissions of hazardous materials and substances
1.5.14.
Risk of being trapped in a machine
1.5.15.
Risk of slipping, tripping or falling
1.5.16.
Lightning
1.6.
Maintenance
1.6.1.
Machinery or related product maintenance
1.6.2.
Access to operating positions and servicing points
1.6.3.
Isolation of energy sources
1.6.4.
Operator intervention
1.6.5.
Cleaning of internal parts
1.7.
Information
1.7.1.
Information and warnings on the machinery or related product
1.7.1.1.
Information and information devices
1.7.1.2.
Warning devices
1.7.2.
Warning of residual risks
1.7.3.
Marking of machinery or related products
1.7.4.
Instructions for use
1.7.4.1.
General principles for the drafting of instructions for use
1.7.4.2.
Contents of the instructions for use
1.7.5.
Sales literature
2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY AND RELATED PRODUCTS
2.1.
Machinery and related products for foodstuffs and machinery and related products for cosmetics or pharmaceutical products
2.1.1.
General
2.1.2.
Instructions for use
2.2.
Portable hand-held or hand-guided machinery or related products
2.2.1.
General
2.2.1.1.
Instructions for use
2.2.2.
Portable fixing and other impact machinery or related products
2.2.2.1.
General
2.2.2.2.
Instructions for use
2.3.
Machinery or related products for working wood and material with similar physical characteristics
2.4.
Machinery or related products for plant protection products application
2.4.2.
General
2.4.3.
Controls and monitoring
2.4.4.
Filling and emptying
2.4.5.
Application of plant protection products
2.4.5.1.
Application rate
2.4.5.2.
Distribution, deposition and drift of plant protection products
2.4.5.3.
Tests
2.4.5.4.
Losses during stoppage
2.4.6.
Maintenance
2.4.6.1.
Cleaning
2.4.6.2.
Servicing
2.4.7.
Inspections
2.4.8.
Marking of nozzles, strainers and filters
2.4.9.
Indication of the plant protection product in use
2.4.10.
Instructions for use
3. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET RISKS DUE TO THE MOBILITY OF MACHINERY OR RELATED PRODUCTS
3.1.
General
3.2.
Work positions
3.2.1.
Driving position
3.2.2.
Seating
3.2.3.
Positions for other persons
3.2.4.
Supervisory function
3.3.
Control systems
3.3.1.
Control devices
3.3.2.
Starting/moving
3.3.3.
Travelling function
3.3.4.
Movement of pedestrian-controlled machinery
3.3.5.
Control circuit failure
3.4.
Protection against mechanical risks
3.4.1.
Uncontrolled movements
3.4.2.
Moving transmission parts
3.4.3.
Roll-over and tip-over
3.4.4.
Falling objects
3.4.5.
Means of access
3.4.6.
Towing devices
3.4.7.
Transmission of power between self-propelled machinery (or a tractor) and recipient machinery
3.5.
Protection against other risks
3.5.1.
Batteries
3.5.2.
Fire
3.5.3.
Emissions of hazardous substances
3.5.4.
Risk of contact with live overhead power lines
3.6.
Information and indications
3.6.1.
Signs, signals and warnings
3.6.2.
Marking
3.6.3.
Instructions for use
3.6.3.1.
Vibrations
3.6.3.2.
Multiple uses
3.6.3.3.
Autonomous mobile machinery or related products
4. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET RISKS DUE TO LIFTING OPERATIONS
4.1.
General
4.1.2.
Protection against mechanical risks
4.1.2.1.
Risks due to lack of stability
4.1.2.2.
Machinery or related products running on guide rails and rail tracks
4.1.2.3.
Mechanical strength
4.1.2.4.
Pulleys, drums, wheels, ropes and chains
4.1.2.5.
Lifting accessories and their components
4.1.2.6.
Control of movements
4.1.2.7.
Movements of loads during handling
4.1.2.8.
Machinery serving fixed landings
4.1.2.8.1. Movements of the carrier
4.1.2.8.2. Access to the carrier
4.1.2.8.3. Risks due to contact with the moving carrier
4.1.2.8.4. Risk due to the load falling off the carrier
4.1.2.8.5. Landings
4.1.3.
Fitness for purpose
4.2.
Requirements for machinery or related products whose power source is other than manual effort
4.2.1.
Control of movements
4.2.2.
Loading control
4.2.3.
Installations guided by ropes
4.3.
Information and markings
4.3.1.
Chains, ropes and webbing
4.3.2.
Lifting accessories
4.3.3.
Lifting machinery or related products
4.4.
Instructions for use
4.4.1.
Lifting accessories
4.4.2.
Lifting machinery or related products
5. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY OR RELATED PRODUCTS INTENDED FOR UNDERGROUND WORK
5.1.
Risks due to lack of stability
5.2.
Movement
5.3.
Control devices
5.4.
Stopping
5.5.
Fire
5.6.
Exhaust emissions
6. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY OR RELATED PRODUCTS PRESENTING PARTICULAR RISKS DUE TO THE LIFTING OF PERSONS
6.1.
General
6.1.1.
Mechanical strength
6.1.2.
Loading control for machinery or related products moved by power other than human strength
6.2.
Control devices
6.3.
Risks to persons in or on the carrier
6.3.1.
Risks due to movements of the carrier
6.3.2.
Risk of persons falling from the carrier
6.3.3.
Risk due to objects falling on the carrier
6.4.
Machinery or related products serving fixed landings
6.4.1.
Risks to persons in or on the carrier
6.4.2.
Controls at landings
6.4.3.
Access to the carrier
6.5.
Markings
ANNEX IV
Technical documentation
PART A
Technical documentation for machinery and related products
PART B
Technical documentation for partly completed machinery
ANNEX V
EU DECLARATION OF CONFORMITY AND EU DECLARATION OF INCORPORATION
PART A
EU declaration of conformity of machinery and related products No …
(1)
PART B
EU declaration of incorporation of partly completed machinery No …
(2)
ANNEX VI
INTERNAL PRODUCTION CONTROL
(Module A)
2. Technical documentation
3. Manufacturing
4. CE marking and EU declaration of conformity
5. Authorised representative
ANNEX VII
EU TYPE-EXAMINATION
(Module B)
3. Application for EU type-examination
4. EU type-examination
5. Evaluation report
6. EU type-examination certificate
7. Review of the EU type-examination certificate
ANNEX VIII
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
(Module C)
2. Manufacturing
3. CE marking and EU declaration of conformity
4. Authorised representative
ANNEX IX
CONFORMITY BASED ON FULL QUALITY ASSURANCE
(Module H)
2. Manufacturing
3. Quality system
4. Surveillance under the responsibility of the notified body
5. CE marking and EU declaration of conformity
8. Authorised representative
ANNEX X
CONFORMITY BASED ON UNIT VERIFICATION
(Module G)
2. Technical documentation
3. Manufacturing
4. Verification
5. CE marking and EU declaration of conformity
6. Authorised representative
ANNEX XI
ASSEMBLY INSTRUCTIONS FOR PARTLY COMPLETED MACHINERY
ANNEX XII
CORRELATION TABLE
Directive 2006/42/EC |
This Regulation |
Article 1 |
Article 2 |
Article 2 |
Article 3 |
Article 3 |
Article 9 |
Article 4 (1) and (2) |
Article 8 |
Article 4 (3) and (4) |
— |
Article 5 |
Articles 10 and 11 |
Article 6 |
Article 4 |
Article 7 |
Article 20 (1) |
Article 8 (1) |
Articles 6 (1) and 7 (1) |
Article 8 (2) |
— |
Article 9 |
— |
Article 10 |
Article 44 (3) |
Article 11 |
Articles 43, 44 and 45 |
Article 12 |
Article 25 |
Article 13 |
Article 11 |
Article 14 (and Annex XI) |
Article 26 to Article 42 |
Article 15 |
Article 5 |
Article 16 |
Articles 23 and 24 |
Article 17 |
Article 46 |
Article 18 |
Article 49 |
Article 19 |
— |
Article 20 |
— |
Article 21 |
Article 53 |
Article 21 a |
Article 47 |
Article 22 |
Article 48 |
Article 23 |
Article 50 |
Article 24 |
— |
Article 25 |
Article 51 |
Article 26 |
— |
Article 27 |
— |
Article 28 |
Article 54 (first paragraph) |
Article 29 |
Article 54 (second and third paragraphs) |
Annex I - General principles and Section 1.1.1 (Definitions) |
Annex III – Part A (Definitions) and Part B (General principles) |
Annex I, Sections 1.1.2 - 1.1.8. |
Annex III, Chapter 1 |
Annex I, Section 2 |
Annex III, Chapter 2 |
Annex I, Section 3 |
Annex III, Chapter 3 |
Annex I, Section 4 |
Annex III, Chapter 4 |
Annex I, Section 5 |
Annex III, Chapter 5 |
Annex I, Section 6 |
Annex III, Chapter 6 |
Annex II, Parts A and B |
Annex V, Parts A and B |
Annex III |
— |
Annex IV |
Annex I |
Annex V |
Annex II |
Annex VI |
Annex XI |
Annex VII, Parts A and B |
Annex IV, Parts A and B |
Annex VIII, when read in conjunction with Article 12 (3) (a) |
Annex VI |
Annex VIII (Point 3), when read in conjunction with Article 12 (3) (b) |
Annex VIII |
Annex IX |
Annex VII |
Annex X |
Annex IX |
Annex XI |
Article 30 |