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)

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

This Regulation lays down health and safety requirements for the design and construction of machinery, related products and partly completed machinery to allow them to be made available on the market or put into service while ensuring a high level of protection of the health and safety of persons, in particular consumers and professional users, and, where appropriate, of domestic animals and property, and, where applicable, of the environment. It also establishes rules on the free movement of products within the scope of this Regulation in the Union.

Article 2

Scope

This Regulation applies to machinery and the following related products:

(a) interchangeable equipment;

(b) safety components;

(c) lifting accessories;

(d) chains, ropes and webbing;

(e) removable mechanical transmission devices.

This Regulation also applies to partly completed machinery.

For the purposes of this Regulation, machinery, the related products listed in the first subparagraph and partly completed machinery shall together be referred to as ‘products within the scope of this Regulation’.

This Regulation does not apply to:

(a) safety components that are intended to be used as spare parts to replace identical components and are supplied by the manufacturer of the original machinery, related product or partly completed machinery;

(b) specific equipment for use in fairgrounds or amusement parks;

(c) machinery and related products specially designed for use within or used in a nuclear installation and whose conformity with this Regulation may undermine the nuclear safety of that installation;

(d) weapons, including firearms;

(e) means of transport by air, on water and on rail networks except for machinery mounted on those means of transport;

(f) aeronautical products, parts and equipment that fall within the scope of Regulation (EU) 2018/1139 of the European Parliament and of the Council (¹) and the definition of machinery under this Regulation, insofar as Regulation (EU) 2018/1139 covers the relevant essential health and safety requirements set out in this Regulation;

(g) motor vehicles and their trailers, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, which fall within the scope of Regulation (EU) 2018/858, except for machinery mounted on those vehicles;

(h) two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that fall within the scope of Regulation (EU) No 168/2013, except for machinery mounted on those vehicles;

(i) agricultural and forestry tractors, as well as systems, components, separate technical units, parts and equipment designed and constructed for such tractors, that fall within the scope of Regulation (EU) No 167/2013, except for machinery mounted on those tractors;

(j) motor vehicles exclusively intended for competition;

(k) seagoing vessels and mobile offshore units and machinery installed on board such vessels or units;

(l) machinery or related products specially designed and constructed for military or police purposes;

(m) machinery or related products specially designed and constructed for research purposes for temporary use in laboratories;

(n) mine winding gear;

(o) machinery or related products intended to move performers during artistic performances;

(p) the following electrical and electronic products, insofar as they fall within the scope of Directive 2014/35/EU or of Directive 2014/53/EU: (i) household appliances intended for domestic use which are not electrically operated furniture; (ii) audio and video equipment; (iii) information technology equipment; (iv) ordinary office machinery, except additive printing machinery for producing three-dimensional products; (v) low-voltage switchgear and control gear; (vi) electric motors;

(q) the following high-voltage electrical products: (i) switchgear and control gear; (ii) transformers.

Article 3

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘machinery’ means: (a) an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application; (b) an assembly referred to in point (a), missing only the components to connect it on site or to sources of energy and motion; (c) an assembly referred to points (a) and (b), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure; (d) assemblies of machinery referred to in points (a), (b) and (c), or of partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole; (e) an assembly of linked parts or components, at least one of which moves, and which are joined together, intended for lifting loads and whose only power source is directly applied human effort; (f) an assembly as referred to in points (a) to (e) missing only the uploading of the software intended for the specific application foreseen by the manufacturer;

(2) ‘interchangeable equipment’ means a device which, after the putting into service of machinery or an agricultural or forestry tractor, is assembled with that machinery or agricultural or forestry tractor by the operator in order to change its function or to attribute a new function to it, provided that the device is not a tool;

(3) ‘safety component’ means a physical or digital component, including software, of a product within the scope of this Regulation, which is designed or intended to fulfil a safety function and which is independently placed on the market, the failure or malfunction of which endanger the safety of persons, but which is not necessary in order for that product to function or for which normal components may be substituted in order for that product to function;

(4) ‘safety function’ means a function that serves to fulfil a protective measure designed to eliminate, or, if that is not possible, to reduce, a risk, which, if it fails, could result in an increase of that risk;

(5) ‘lifting accessory’ means a component or equipment, not attached to the lifting machinery, which enables the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market, including slings and their components;

(6) ‘chains’ means chains designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;

(7) ‘ropes’ means ropes designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;

(8) ‘webbing’ means webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;

(9) ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and other machinery or related products by joining them at the first fixed bearing; when it is placed on the market with a guard, the device and the guard are to be regarded as one item;

(10) ‘partly completed machinery’ means an assembly which is not yet machinery as it cannot in itself perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming machinery;

(11) ‘making available on the market’ means any supply of a product within the scope of this Regulation for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(12) ‘placing on the market’ means the first making available of a product within the scope of this Regulation on the Union market;

(13) ‘putting into service’ means the first use, for its intended purpose, in the Union, of machinery or related products;

(14) ‘essential health and safety requirements’ means the mandatory provisions, set out in Annex III, relating to the design and construction of products within the scope of this Regulation to ensure a high level of protection of the health and safety of persons, and, where appropriate, domestic animals and property, and, where applicable, of the environment;

(15) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

(16) ‘substantial modification’ means a modification of machinery or a related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, and which affects the safety of that machinery or related product, by creating a new hazard, or by increasing an existing risk, which requires: (a) the addition of guards or protective devices to that machinery or related product the processing of which necessitates the modification of the existing safety control system; or (b) the adoption of additional protective measures to ensure the stability or mechanical strength of that machinery or related product;

(17) ‘instructions for use’ means the information, provided by the manufacturer when the machinery or related product is placed on the market or put into service, to inform the user of the machinery or related product, of the intended and proper use of that machinery or related product, as well as information on any precautions to be taken when using or installing the machinery or related product, including information on the safety aspects, and on how to keep that machinery or related product safe, and to ensure that it remains fit for purpose during its entire lifetime;

(18) ‘manufacturer’ means any natural or legal person who: (a) manufactures products within the scope of this Regulation or who has those products designed or manufactured, and markets those products under its name or trademark; or (b) manufactures products within the scope of this Regulation, and puts those products into service for its own use;

(19) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks;

(20) ‘importer’ means any natural or legal person established within the Union who places a product within the scope of this Regulation from a third country on the Union market;

(21) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product within the scope of this Regulation available on the market;

(22) ‘economic operator’ means the manufacturer, the authorised representative, the importer or the distributor;

(23) ‘technical specifications’ means a document that prescribes technical requirements to be fulfilled by products within the scope of this Regulation;

(24) ‘harmonised standard’ means a harmonised standard as defined in Article 2, point 1, point (c), of Regulation (EU) No 1025/2012;

(25) ‘CE marking’ means a marking by which the manufacturer indicates that machinery or a related product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

(26) ‘accreditation’ means accreditation as defined in Article 2, point (10), of Regulation (EC) No 765/2008;

(27) ‘national accreditation body’ means a national accreditation body as defined in Article 2, point (11), of Regulation (EC) No 765/2008;

(28) ‘conformity assessment’ means the process for demonstrating whether the applicable essential health and safety requirements in this Regulation relating to machinery or related products have been fulfilled;

(29) ‘conformity assessment body’ means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;

(30) ‘notified body’ means a conformity assessment body notified in accordance with this Regulation;

(31) ‘market surveillance authority’ means a ‘market surveillance authority’ as defined in Article 3, point (4), of Regulation (EU) 2019/1020;

(32) ‘recall’ means any measure aimed at achieving the return of a product within the scope of this Regulation that has already been made available to a user;

(33) ‘withdrawal’ means, for a product, any measure aimed at preventing a product within the scope of this Regulation that is in the supply chain from being made available on the market;

(34) ‘lifetime’ means the period from the moment that machinery or a related product is placed on the market or put into service until the moment that it is discarded, including the effective time when the machinery or related product is capable of being used and the phases of transport, assembly, dismantling, disabling, scrapping or other physical or digital modifications foreseen by the manufacturer;

(35) ‘source code’ means the currently installed version of the software of a product within the scope of this Regulation, written in a programming language so that it is unambiguous and understandable to humans;

(36) ‘professional user’ means a natural person who uses or operates machinery or a related product in the course of his or her professional activity or work.

Article 4

Free movement

During demonstrations, adequate measures shall be taken to ensure the protection of persons.

Article 5

Protection of persons during installation or use of machinery or related products

Member States may lay down requirements to ensure that persons, including workers, are protected when installing or using machinery or related products, provided that such rules do not allow for the modification of machinery or a related product in a way that is not compatible with this Regulation.

Article 6

Categories of machinery and related products listed in Annex I subject to relevant conformity assessment procedures

In determining the probability and severity of harm, the following criteria shall, where relevant, be taken into account:

(a) the nature of the hazard inherent to the function of the category of machinery or related product, taking into account the intended use and any reasonably foreseeable misuse;

(b) the severity of harm which a person would suffer, including the degree of reversibility of that harm;

(c) the number of persons potentially affected by the harm;

(d) the frequency and the duration of the exposure to the hazard that a person would be exposed to in the course of the intended use or any reasonably foreseeable misuse of the category of machinery or related product;

(e) the possibilities of avoiding or limiting harm;

(f) in the case of safety components, the likelihood of serious consequences for the safety of the persons exposed to harm in the event of their failure.

When conducting the assessment referred in paragraph 4, the Commission shall consider the following elements:

(a) indications of harm that have been caused in the past by machinery or related products which have been used for their intended use or following any reasonably foreseeable misuse;

(b) information about safety defects detected in the course of market surveillance, and material possibly available in the information systems administered by the Commission;

(c) information about known accidents and serious ‘close calls’, including the characteristics of those accidents or ‘close calls’;

(d) data on accidents or damage to health caused by the machinery or related product for at least the preceding four years. In particular, information obtained, inter alia, from the Information and Communication System on Market Surveillance (ICSMS), safeguard clauses, Safety Gate Rapid Alert System, the European Injury Database (EU-IDB), Eurostat’s European Statistics on Accidents at Work (ESAW) and the Machinery Administrative Cooperation Group (AdCo).

In addition to points (a) to (d) of this paragraph, the Commission shall take into account any other information available that is relevant to the assessment referred to in paragraph 4.

A category of machinery or related product shall be included in Annex I, Part A, if, according to the assessment referred to in paragraph 4, and taking into account the available information, including the data referred to in paragraph 5, it presents a serious inherent potential risk, and one or more of the following conditions is fulfilled:

(a) there is a lack of harmonised standards or common specifications covering the relevant essential health and safety requirements;

(b) residual risks exist, including those which, according to the manufacturer, could be reduced by particular training or personal protective equipment, and the data and information referred to in paragraph 5, demonstrate the recurrence of similar serious or fatal accidents or damage to health in connection with those residual risks;

(c) data and information exist which according to the Commission demonstrate recurring wrongful application of the relevant harmonised standards or common specifications and for which the market surveillance activities that were carried out have not led to major improvements of the market situation, in a reasonable period;

(d) there is a degree of uncertainty in the existing risk assessment methods related to new categories of machinery or technologies.

Any other category of machinery or related product that, according to that assessment, presents a serious inherent potential risk but does not fulfil one or more of the conditions in points (a) to (d) shall be included in Annex I, Part B.

The Commission shall conduct the assessment referred to in paragraph 4 immediately after being informed by a Member State.

After making that assessment, the Commission may initiate the procedure laid down in paragraph 2.

When adopting those implementing acts, the Commission shall issue guidance to Member States on the collection and transmission of comparable, high-quality data and information.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

The first such implementing act shall be adopted not later than  20 July 2024.

Article 7

Safety components

Article 8

Essential health and safety requirements for products within the scope of this Regulation

Machinery or related products shall only be made available on the market or put into service if, where properly installed and maintained and used for their intended use or under conditions which can reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III.

Partly completed machinery shall only be made available on the market if it meets the relevant essential health and safety requirements set out in Annex III.

Article 9

Specific Union harmonisation legislation

Where, for a certain product within the scope of this Regulation, the risks addressed by the essential health and safety requirements set out in Annex III are wholly or partly covered by Union harmonisation legislation that is more specific than this Regulation, this Regulation shall not apply to that product to the extent that that specific Union legislation covers such risks.

CHAPTER II

OBLIGATIONS OF ECONOMIC OPERATORS

Article 10

Obligations of manufacturers of machinery and related products

Where compliance of machinery or a related product with the essential health and safety requirements laid down in Annex III has been demonstrated by that conformity assessment procedure, manufacturers shall draw up the EU declaration of conformity in accordance with Article 21 and affix the CE marking in accordance with Article 24.

When deemed appropriate with regard to the risks presented by machinery or related products, manufacturers shall, in order to protect the health and safety of users, carry out sample testing of machinery or related products made available on the market and investigate their results. If necessary, manufacturers shall keep a register of complaints, of non-conforming machinery or related products and machinery or related product recalls, and shall keep distributors informed of any such monitoring.

When the instructions for use are provided in digital format, the manufacturer shall:

(a) mark on the machinery or related product, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital instructions;

(b) present them in a format that makes it possible for the user to print and download the instructions for use and save them on an electronic device so that he or she can access them at all times, in particular during a breakdown of the machinery or related product; this requirement also applies where the instructions for use are embedded in the software of the machinery or related product;

(c) make them accessible online during the expected lifetime of the machinery or related product and for at least 10 years after the placing on the market of the machinery or related product.

However, at the request of the user at the time of the purchase, the manufacturer shall provide the instructions for use in paper format free of charge within one month.

In the case of machinery or a related product intended for non-professional users or that can, under reasonably foreseeable conditions, be used by non-professional users, even if not intended for them, the manufacturer shall provide, in paper format, the safety information that is essential for putting the machinery or related product into service and for using it in a safe way.

The instructions for use, the safety information and the information set out in Annex III shall be in a language which can be easily understood by users, as determined by the Member State concerned, and shall be clear, understandable and legible.

Digital EU declarations of conformity shall be made accessible online for the expected lifetime of the machinery or related product and in any event for at least 10 years after the placing on the market or the putting into service of the machinery or related product.

Article 11

Obligations of manufacturers of partly completed machinery

Where compliance of partly completed machinery with the relevant essential health and safety requirements set out in Annex III has been demonstrated in the technical documentation set out in Annex IV, Part B, manufacturers shall draw up the EU declaration of incorporation in accordance with Article 22.

The assembly instructions may be provided by the manufacturer in digital format.

When the assembly instructions are provided in digital format, the manufacturer shall:

(a) mark on the partly completed machinery, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital assembly instructions;

(b) present them in a format that makes it possible for the person who incorporates the partly completed machinery to print and download the assembly instructions and save them on an electronic device so that he or she can access them at all times, in particular during a breakdown of the partly completed machinery; this requirement also applies where the assembly instructions are embedded in the software of the partly completed machinery;

(c) make them accessible online for at least 10 years after the placing on the market of the partly completed machinery.

However, at the request of the person who incorporates the partly completed machinery at the time of purchase, the manufacturer shall provide the assembly instructions in paper format free of charge within one month.

The assembly instructions shall be in a language which can be easily understood by the person who incorporates the partly completed machinery, as determined by the Member State concerned, and shall be clear, understandable, and legible.

Digital EU declarations of incorporation shall be made accessible online for at least 10 years after the placing on the market of the partly completed machinery.

Article 12

Authorised representatives

The obligations laid down in Article 10(1) and Article 11(1) and the obligation to draw up the technical documentation set out in Annex IV shall not form part of the authorised representative’s mandate.

An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) keep the technical documentation and the EU declaration of conformity of machinery and related products or the EU declaration of incorporation of partly completed machinery at the disposal of the national market surveillance authorities for at least 10 years after the product has been placed on the market;

(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the product within the scope of this Regulation, either in paper or digital format;

(c) cooperate with the competent national authorities, at their request, on any actions taken to eliminate the risks presented by a product within the scope of this Regulation covered by the authorised representative’s mandate.

Article 13

Obligations of importers of machinery and related products

Where an importer considers or has reason to believe that machinery or a related product is not in conformity with this Regulation, the importer shall not place it on the market until it has been brought into conformity. Furthermore, where the machinery or related product presents a risk to the health and safety of persons and, where appropriate, domestic animals and property, and, where applicable, to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

Where relevant, the source code or the programming logic included in the technical documentation shall, upon a reasoned request, be made available to the competent national authorities, if that source code or programming logic is necessary in order for them to be able to check compliance with the essential health and safety requirements set out in Annex III.

Article 14

Obligations of importers of partly completed machinery

Where an importer considers or has reason to believe that partly completed machinery is not in conformity with this Regulation, the importer shall not place it on the market until it has been brought into conformity. Furthermore, where the partly completed machinery presents a risk as regards the relevant essential health and safety requirements, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

Article 15

Obligations of distributors of machinery and related products

Before making machinery or a related product available on the market, distributors shall verify that:

(a) the machinery or related product bears the CE marking;

(b) the machinery or related product is accompanied by the EU declaration of conformity referred to in Article 10(8);

(c) the machinery or related product is accompanied by the instructions for use and the information referred to in Article 10(7), and that they are in a language which can be easily understood by users, as determined by the Member State in which the machinery or related product is to be made available on the market;

(d) the manufacturer and the importer have complied with the requirements referred to in Article 10(5) and (6) and Article 13(3) respectively.

Article 16

Obligations of distributors of partly completed machinery

Before making partly completed machinery available on the market, distributors shall verify that:

(a) the partly completed machinery is accompanied by the EU declaration of incorporation referred to in Article 11(8);

(b) the partly completed machinery is accompanied by the assembly instructions referred to in Article 11(7), and that they are in a language which can be easily understood by the person who incorporates the partly completed machinery as determined by the Member State in which the partly completed machinery is to be made available on the market;

(c) the manufacturer and the importer have complied with the requirements referred to in Article 11(5) and (6) and Article 14(3) respectively.

Article 17

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered to be a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer set out in Articles 10 and 11, where that importer or distributor places a product within the scope of this Regulation on the market under its name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements might be affected.

Article 18

Other cases in which obligations of manufacturers apply

A natural or legal person that carries out a substantial modification of machinery or a related product shall be considered to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 10 for that machinery or related product or, if the substantial modification has an impact on the safety of only machinery or a related product that is part of an assembly of machinery, for that affected machinery or related product, as demonstrated in the risk assessment.

The person who carries out the substantial modification shall in particular, but without prejudice to other obligations set out in Article 10, ensure and declare on its sole responsibility that the machinery or related product concerned is in conformity with the applicable requirements of this Regulation and shall apply the relevant conformity assessment procedure as provided in Article 25 (2), (3) and (4) of this Regulation.

A non-professional user who carries out a substantial modification to his or her machinery or related product, for his or her own use, shall not be considered to be a manufacturer for the purposes of this Regulation and shall not be subject to the obligations on the manufacturer set out in Article 10.

Article 19

Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

(a) any economic operator who has supplied them with a product within the scope of this Regulation;

(b) any economic operator to whom they have supplied a product within the scope of this Regulation.

CHAPTER III

CONFORMITY OF PRODUCTS WITHIN THE SCOPE OF THIS REGULATION

Article 20

Presumption of conformity of products within the scope of this Regulation

Those implementing acts shall only be adopted where the following conditions are fulfilled:

(a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements set out in Annex III and: (i) the request has not been accepted; or (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or (iii) the harmonised standards do not comply with the request; and

(b) no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex III has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

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

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 24

Rules for affixing the CE marking to machinery and related products

The identification number of that notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or the manufacturer’s authorised representative.

CHAPTER IV

CONFORMITY ASSESSMENT

Article 25

Conformity assessment procedures for machinery and related products

Where the category of machinery or related product is listed in Annex I, Part A, the manufacturer or the natural or legal person referred to in Article 18 shall apply one of the following procedures:

(a) EU type-examination (module B) set out in Annex VII, followed by conformity to type based on internal production control (module C) set out in Annex VIII;

(b) conformity based on full quality assurance (module H) set out in Annex IX;

(c) conformity based on unit verification (module G) set out in Annex X.

Where the category of machinery or related product is listed in Annex I, Part B, the manufacturer or the natural or legal person referred to in Article 18 shall apply one of the following procedures:

(a) internal production control (module A) set out in Annex VI;

(b) EU type-examination (module B) set out in Annex VII, followed by conformity to type based on internal production control (module C) set out in Annex VIII;

(c) conformity based on full quality assurance (module H) set out in Annex IX;

(d) conformity based on unit verification (module G) set out in Annex X.

If a manufacturer applies the internal production control procedure referred to in point (a), it shall design and construct the machinery or related product in accordance with the harmonised standards or common specifications specific to that category of machinery or related product covering all the relevant essential health and safety requirements.

Where the category of machinery or related product is listed in Annex I, Part B, and the machinery or related product was not designed and constructed in accordance with the harmonised standards or common specifications specific to that category of machinery or related product covering all the relevant essential health and safety requirements for that category of machinery or related product, the manufacturer, including a natural or legal person referred to in Article 18, shall apply one of the procedures referred to in points (b), (c) or (d) of this paragraph.

CHAPTER V

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 26

Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks in accordance with this Regulation.

Article 27

Notifying authorities

Article 28

Requirements relating to notifying authorities

Article 29

Information obligation of notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 30

Requirements relating to notified bodies

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacture, provision, assembly, use or maintenance of machinery or related products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a conformity assessment body.

A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, import, distribution, manufacture, marketing, installation, use or maintenance of the machinery or related products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

A conformity assessment body shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.

At all times, and for each conformity assessment procedure and each kind of machinery or related products for which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;

(c) appropriate policies and procedures to distinguish between tasks that it carries out as a notified body and other activities;

(d) procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the machinery or related product technology in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c) appropriate knowledge and understanding of the essential health and safety requirements set out in Annex III, of the applicable harmonised standards and common specifications referred to in Article 20, and of the relevant provisions of Union harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and reports demonstrating that conformity assessments have been carried out.

The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not depend on the number of conformity assessments carried out or on the results of those assessments.

Article 31

Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 30 insofar as the applicable harmonised standards cover those requirements.

Article 32

Use of subcontractors and subsidiaries by notified bodies

Article 33

Application for notification

Article 34

Notification procedure

The notification referred to in paragraph 2 shall include the following:

(a) full details of the conformity assessment activities to be performed;

(b) an indication of the conformity assessment module or modules and the kinds or categories of machinery or related products concerned;

(c) the relevant attestation of competence.

Only such a body shall be considered a notified body for the purposes of this Regulation.

Article 35

Identification numbers and lists of notified bodies

It shall assign a single such number even where the body is notified under several Union acts.

The Commission shall ensure that the list is kept up to date.

Article 36

Changes to notifications

Article 37

Challenge of the competence of notified bodies

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 48(2).

Article 38

Operational obligations of notified bodies

In so doing, the notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the machinery or related product with the requirements of this Regulation.

Where corrective actions are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any approval decisions, as appropriate.

Article 39

Appeals against decisions of notified bodies

A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.

Article 40

Information obligation of notified bodies

A notified body shall inform the notifying authority of the following:

(a) any refusal, restriction, suspension or withdrawal of an EU type-examination certificate, quality system approval decision or unit verification certificate;

(b) any circumstances affecting the scope of, or the conditions for, its notification;

(c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activities;

(d) on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting.

Article 41

Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.

Article 42

Coordination of notified bodies

The Commission shall ensure the establishment and good functioning of appropriate coordination and cooperation between bodies notified under this Regulation in the form of a sectoral group of notified bodies.

Notified bodies shall participate in the work of that group, directly or by means of designated representatives.

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

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product within the scope of this Regulation does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action, as provided for in Article 16(3) of Regulation (EU) 2019/1020, to bring the non-compliance to an end or to eliminate hazards or, if that is not possible, minimise the risk specified by the market surveillance authorities within a reasonable period which is commensurate with the nature of the risk referred to in the first subparagraph.

The market surveillance authorities shall inform the relevant notified body accordingly.

The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product within the scope of this Regulation, the origin of that product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:

(a) the failure of the product to meet the requirements relating to the essential health and safety requirements set out in Annex III;

(b) shortcomings in the harmonised standards referred to in Article 20(1);

(c) shortcomings in the common specifications referred to in Article 20(6).

Article 44

Union safeguard procedure

On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not.

The Commission shall address its decision to all Member States and shall without delay communicate it to them and to the relevant economic operator or operators.

If the national measure is considered to be unjustified, the Member State concerned shall withdraw that measure.

Article 45

Compliant products within the scope of this Regulation which present a risk

On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not and, where necessary, order appropriate measures.

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 48(3).

On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 48(4).

Article 46

Formal non-compliance

Without prejudice to Article 43, where a Member State makes one of the following findings with regard to machinery or a related product, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 24 of this Regulation;

(b) the CE marking has not been affixed;

(c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 24(3) or has not been affixed;

(d) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;

(e) the technical documentation is either not available or not complete;

(f) the information referred to in Article 10(6) or Article 13(3) is absent, false or incomplete;

(g) any other administrative requirement provided for in Article 10 or Article 13 is not fulfilled.

Without prejudice to Article 43, where a Member State makes one of the following findings with regard to partly completed machinery, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the EU declaration of incorporation has not been drawn up or has not been drawn up correctly;

(b) the technical documentation is either not available or not complete;

(c) the information referred to in Article 11(5) or Article 14(3) is absent, false or incomplete;

(d) any other administrative requirement provided for in Article 11 or Article 14 is not fulfilled.

CHAPTER VII

DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 47

Exercise of the delegation

Article 48

Committee procedure

Where the committee delivers no opinion regarding the draft implementing act referred to in Article 20(3), Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

The committee may furthermore examine any other matter concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

CHAPTER VIII

CONFIDENTIALITY AND PENALTIES

Article 49

Confidentiality

All parties shall respect the confidentiality of the following information and data obtained in carrying out their tasks in accordance with this Regulation:

(a) personal data;

(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless disclosure is in the public interest.

Article 50

Penalties

CHAPTER IX

TRANSITIONAL AND FINAL PROVISIONS

Article 51

Repeals

References to the repealed Directive 73/361/EEC shall be construed as references to this Regulation.

References to the repealed Directive 2006/42/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XII.

Article 52

Transitional provisions

Article 53

Evaluation and review

Taking account of technical progress and practical experience gained in Member States as indicated in Article 6, the Commission shall in its report include an evaluation on the following aspects of this Regulation:

(a) the essential health and safety requirements set out in Annex III;

(b) the conformity assessment procedure applicable to machinery or related products listed in Annex I.

Where appropriate, the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.

The Commission shall include in its reports the following:

(a) a summary of data and information provided by Member States in accordance with Article 6(5) during the reporting period;

(b) an assessment of the list of categories of machinery or related products in Annex I in view of the criteria set out in Article 6(4).

In the reports, the Commission shall assess the appropriateness and availability of data and information provided by Member States, including its sufficiency and suitability for the purposes of making comparisons, identifying any shortcomings, necessary to ensure effective functioning and enforcement of Article 6.

Article 54

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from  20 January 2027.

However, the following Articles shall apply from the following dates:

(a) Articles 26 to 42 from  20 January 2024;

(b) Article 50(1) from  20 October 2026;

(c) Article 6(7) and Articles 48 and 52 from  19 July 2023;

(d) Article 6(2) to (6), (8) and (11) and Articles 47 and 53(3) from  20 July 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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

Categories of machinery or related products to which a procedure referred to in Article 25(2) shall be applied:

PART B

Categories of machinery or related products to which one of the procedures referred to in Article 25(3) shall be applied:

1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed; 1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage; 1.3. sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading; 1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.

4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece; 4.2. sawing machinery with blade(s) assembled on a carriage with reciprocating motion.

12.1. locomotives and brake-vans; 12.2. hydraulic-powered roof supports.

ANNEX II

INDICATIVE LIST OF SAFETY COMPONENTS

1.Guards for removable mechanical transmission devices.

2.Protective devices designed to detect the presence of persons.

3.Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 of Annex I, Part B.

4.Logic units to ensure safety functions.

5.Valves with additional means for failure detection intended for the control of dangerous movements of machinery.

6.Extraction systems for machinery emissions.

7.Guards and protective devices designed to protect persons against moving parts involved in the process of the machinery.

8.Monitoring devices for loading and movement control in lifting machinery.

9.Restraint systems to keep persons in their seats.

10.Emergency stop devices.

11.Discharging systems to prevent the build-up of potentially dangerous electrostatic charges.

12.Energy limiters and relief devices referred to in sections 1.5.7, 3.4.7 and 4.1.2.6 of Annex III.

13.Systems and devices to reduce the emission of noise and vibrations.

14.Roll-over protective structures (ROPS).

15.Falling-object protective structures (FOPS).

16.Two-hand control devices.

17.The following components for machinery designed for lifting and/or lowering persons between different landings:

(a) devices for locking landing doors;

(b) devices to prevent the load-carrying unit from falling or unchecked upwards movement;

(c) overspeed limitation devices;

(d) energy-accumulating shock absorbers, non-linear or with damping of the return movement;

(e) energy-dissipating shock absorbers;

(f) safety devices fitted to jacks of hydraulic power circuits and used to prevent falls;

(g) safety switches containing electronic components.

18.Software ensuring safety functions.

19.Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.

20.Filtration systems intended to be integrated into machinery cabins in order to protect operators or other persons against hazardous materials and substances, includingplant protection products, and filters for such filtration systems.

ANNEX III

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF MACHINERY OR RELATED PRODUCTS

PART A

Definitions

For the purposes of this Annex, the following definitions apply:

(a) ‘hazard’ means a potential source of injury or damage to health;

(b) ‘danger zone’ means any zone within and/or around machinery or a related product in which a person is subject to a risk to his or her health or safety;

(c) ‘exposed person’ means any person wholly or partially in a danger zone;

(d) ‘operator’ means the person or persons installing, operating, adjusting, maintaining, cleaning, repairing or moving machinery or a related product;

(e) ‘risk’ means a combination of the probability and the degree of an injury or damage to health that can arise in a hazardous situation;

(f) ‘guard’ means a part of machinery or a related product used specifically to provide protection by means of a physical barrier;

(g) ‘protective device’ means a device (other than a guard) which reduces the risk, either alone or in conjunction with a guard;

(h) ‘intended use’ means the use of machinery or a related product in accordance with the information provided in the instructions for use;

(i) ‘reasonably foreseeable misuse’ means the use of machinery or a related product in a way not intended in the instructions for use, but which may result from readily predictable human behaviour.

PART B

General principles

1.The manufacturer of machinery or a related product shall ensure that a risk assessment is carried out in order to determine the essential health and safety requirements which apply to the machinery or related product. The machinery or related product shall then be designed and constructed to eliminate hazards or, if that is not possible, to minimise all relevant risks, taking into account the results of the risk assessment.

By the iterative process of risk assessment and risk reduction referred to in the first subparagraph, the manufacturer shall:

(a) determine the limits of the machinery or related product, which include the intended use and any reasonably foreseeable misuse thereof;

(b) identify the hazards that may be generated by the machinery or related product and the associated hazardous situations;

(c) estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence;

(d) evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Regulation;

(e) eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).

The risk assessment and risk reduction shall include hazards that might arise during the lifecycle of the machinery or related product that are foreseeable at the time of placing the machinery or related product on the market as an intended evolution of its fully or partially self-evolving behaviour or logic as a result of the machinery or related product designed to operate with varying levels of autonomy. The risk assessment and risk reduction shall include risks resulting from interactions between machinery in order to achieve the same end that are arranged and controlled so that they function as an integral whole, thus forming machinery as defined in Article 3, point 1, point (d).

2.The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery or related product in question when it is used under the conditions foreseen by the manufacturer or in foreseeable abnormal situations. However, the principles of safety integration established in section 1.1.2 and the obligations concerning marking of machinery or related products referred to in section 1.7.3, and instructions for use referred to in section 1.7.4 apply in all cases.

3.The essential health and safety requirements laid down in this Annex are mandatory; however, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery or related product shall, as far as possible, be designed and constructed with the purpose of approaching those objectives.

4.This Annex is organised into six chapters. The first chapter is of general scope and applicable to all machinery or related products. The other chapters refer to certain sorts of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the relevant essential health and safety requirements. When machinery or a related product is being designed, the requirements of the first chapter and the requirements of one or more of the other chapters shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles. Essential health and safety requirements for the protection of the environment are applicable only to the machinery or related products referred to in section 2.4.

5.These general principles shall apply to the risk assessment carried out by the manufacturer of partly completed machinery.

The obligations laid down by the essential health and safety requirements are applicable to partly completed machinery insofar as those requirements are relevant.

The relevant requirements in relation to partly completed machinery do not cover the requirements that can only be fulfilled at the time of the incorporation of the partly completed machinery. However, the principles of safety integration established in section 1.1.2 are applicable in all cases.

(a) Machinery or related products shall be designed and constructed so that they are fit for their function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof. The aim of protective measures shall be to eliminate any risk throughout the foreseeable lifetime of the machinery or related product including the phases of transport, assembly, dismantling, disabling and scrapping.

(b) In selecting the most appropriate methods, the manufacturer shall apply the following principles, in the order given: (i) eliminate hazards or, if that is not possible, minimise risks (inherently safe machinery or related product design and construction); (ii) take the necessary protective measures in relation to risks that cannot be eliminated; (iii) inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.

(c) When designing and constructing machinery or a related product and when drafting the instructions for use, the manufacturer shall envisage not only the intended use of the machinery or related product but also any reasonably foreseeable misuse thereof. The machinery or related product shall be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions for use shall draw the user’s attention to ways – which experience has shown might occur – in which the machinery or related product should not be used.

(d) Machinery or related products shall be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.

(e) Machinery or related products shall be designed and constructed in such a way that it is possible for the user, where applicable, to test the safety functions. The machinery or related product shall be supplied with all the special equipment and accessories, and where appropriate, with the description of specific functional test procedures, essential to enable it to be tested, adjusted, maintained and used safely.

The materials used to construct machinery or related products, or products used or created during its use, shall not endanger the health and safety of persons. In particular, where fluids are used, machinery or related products shall be designed and constructed to prevent risks due to filling, use, recovery or draining.

Machinery or related products shall be supplied with integral lighting suitable for the operations concerned, where the absence thereof is likely to cause a risk despite ambient lighting of normal intensity.

Machinery or related products shall be designed and constructed so that there is no area of shadow likely to cause nuisance, that there is no irritating dazzle and that there are no dangerous stroboscopic effects on moving parts due to the lighting.

Internal parts requiring frequent inspection and adjustment, and maintenance areas shall be provided with appropriate lighting.

Machinery or a related product or each component part thereof, shall:

(a) be capable of being handled and transported safely;

(b) be packaged or designed so that it can be stored safely and without damage.

During the transportation of the machinery or related product or its component parts, there shall be no possibility of sudden movements or of hazards due to instability as long as the machinery or related product or its component parts are handled in accordance with the instructions.

Where the weight, size or shape of machinery or a related product or its various component parts prevents it or them from being moved by hand, the machinery or related product or each component part shall:

(a) either be fitted with attachments for lifting gear; or

(b) be designed so that it can be fitted with such attachments; or

(c) be shaped in such a way that standard lifting gear can easily be attached.

Where machinery or a related product or one of its component parts is to be moved by hand, it shall either:

(a) be easily moveable; or

(b) be equipped for picking up and moving safely.

Special arrangements shall be made for the handling of tools and/or machinery or related product parts, which, even if lightweight, could be hazardous.

Under the intended conditions of use, the discomfort, fatigue and physical and psychological stress faced by the operator shall be eliminated or reduced to the minimum possible, taking into account at least, the following ergonomic principles:

(a) allowing for the variability of the operator’s physical dimensions, strength and stamina;

(b) avoiding the need for demanding work postures or movements and manual force exertions that exceed the operator’s capacity;

(c) providing enough space for movements of the parts of the operator’s body;

(d) avoiding a machine-determined work rate;

(e) avoiding monitoring that requires lengthy concentration;

(f) adapting the human-machine interface to the foreseeable characteristics of the operators, including with respect to machinery or a related product with intended fully or partially self-evolving behaviour or logic that is designed to operate with varying levels of autonomy;

(g) where relevant, adapting machinery or a related product with intended fully or partially self-evolving behaviour or logic that is designed to operate with varying levels of autonomy to respond to people adequately and appropriately (such as verbally through words and non-verbally through gestures, facial expressions or body movement) and to communicate its planned actions (such as what it is going to do and why) to operators in a comprehensible manner.

The operating position shall be designed and constructed in such a way as to avoid any risk due to exhaust gases or lack of oxygen.

If the machinery or related product is intended to be used in a hazardous environment presenting risks to the health and safety of the operator or if the machinery or related product itself gives rise to a hazardous environment, adequate means shall be provided to ensure that the operator has good working conditions and is protected against any foreseeable hazards.

Where appropriate, the operating position shall be fitted with an adequate cabin designed, constructed or equipped to fulfil the above requirements. The exit shall allow rapid evacuation. Moreover, when applicable, an emergency exit shall be provided in a direction which is different from the usual exit.

Where appropriate and where the working conditions so permit, work stations constituting an integral part of the machinery or related product shall be designed for the installation of seats.

If the operator is intended to sit during operation and the operating position is an integral part of the machinery or related product, the seat shall be provided with the machinery or related product.

The operator’s seat shall enable him or her to maintain a stable position. Furthermore, the seat and its distance from the control devices shall be capable of being adapted to the operator.

If the machinery or related product is subject to vibrations, the seat shall be designed and constructed in such a way as to reduce the vibrations transmitted to the operator to the lowest level that is reasonably possible. The seat mountings shall withstand all stresses to which they can be subjected. Where there is no floor beneath the feet of the operator, footrests covered with a slip-resistant material shall be provided.

The machinery or related product shall be designed and constructed so that the connection to it of another device, via any feature of the connected device itself or via any remote device that communicates with the machinery or related product does not lead to a hazardous situation.

A hardware component transmitting signal or data, relevant for connection or access to software that is critical for the compliance of the machinery or related product with the relevant essential health and safety requirements shall be designed so that it is adequately protected against accidental or intentional corruption. The machinery or related product shall collect evidence of a legitimate or illegitimate intervention in that hardware component, when relevant for connection or access to software that is critical for the compliance of the machinery or related product.

Software and data that are critical for the compliance of the machinery or related product with the relevant essential health and safety requirements shall be identified as such and shall be adequately protected against accidental or intentional corruption.

The machinery or related product shall identify the software installed on it that is necessary for it to operate safely, and shall be able to provide that information at all times in an easily accessible form.

The machinery or related product shall collect evidence of a legitimate or illegitimate intervention in the software or a modification of the software installed on the machinery or related product or its configuration.

Control systems shall be designed and constructed in such a way as to prevent hazardous situations from arising.

Control systems shall be designed and constructed in such a way that:

(a) they can withstand, where appropriate to the circumstances and the risks, the intended operating stresses and intended and unintended external influences, including reasonably foreseeable malicious attempts from third parties leading to a hazardous situation;

(b) a fault in the hardware or the logic of the control system shall not lead to hazardous situations;

(c) errors in the control system logic shall not lead to hazardous situations;

(d) the limits of the safety functions are to be established as part of the risk assessment performed by the manufacturer and no modifications are allowed to the settings or rules generated by the machinery or related product or by operators, including during the machinery or related product learning phase, where such modifications could lead to hazardous situations;

(e) reasonably foreseeable human errors during operation shall not lead to hazardous situations;

(f) the tracing log of the data generated in relation to an intervention and of the versions of safety software uploaded after the machinery or related product has been placed on the market or put into service is enabled for five years after such upload, exclusively to demonstrate the conformity of the machinery or related product with this Annex further to a reasoned request from a competent national authority.

Control systems of machinery or related products with fully or partially self-evolving behaviour or logic that are designed to operate with varying levels of autonomy shall be designed and constructed in such a way that:

(a) they shall not cause the machinery or related product to perform actions beyond its defined task and movement space;

(b) recording of data on the safety related decision-making process for software based safety systems ensuring safety function including safety components, after the machinery or related product has been placed on the market or put into service, is enabled and that such data is retained for one year after its collection, exclusively to demonstrate the conformity of the machinery or related product with this Annex further to a reasoned request from a competent national authority;

(c) it shall be possible at all times to correct the machinery or related product in order to maintain its inherent safety.

Particular attention shall be given to the following points:

(a) the machinery or related product shall not start unexpectedly;

(b) the parameters of the machinery or related product shall not change in an uncontrolled way, where such change could lead to hazardous situations;

(c) modifications to the settings or rules, generated by the machinery or related product or by operators, including during the machinery or related product learning phase, shall be prevented, where such modifications could lead to hazardous situations;

(d) the machinery or related product shall not be prevented from stopping if the stop command has already been given;

(e) no moving part of the machinery or related product or piece held by the machinery or related product shall fall or be ejected;

(f) automatic or manual stopping of the moving parts, whatever they may be, shall be unimpeded;

(g) the protective devices shall remain fully effective or give a stop command;

(h) the safety-related parts of the control system shall apply in a coherent way to the whole of an assembly of machinery or related products or partly completed machinery, or a combination thereof.

For wireless control, a failure of the communication or connection or a faulty connection shall not lead to a hazardous situation.

Control devices shall be:

(a) clearly visible and identifiable, using pictograms where appropriate;

(b) positioned in such a way as to be safely operated without hesitation or loss of time and without ambiguity;

(c) designed in such a way that the movement of the control device is consistent with its effect;

(d) located outside the danger zones, except where necessary for certain control devices such as an emergency stop or a teach pendant;

(e) positioned in such a way that their operation cannot cause additional risk;

(f) designed or protected in such a way that the desired effect, where a hazard is involved, can only be achieved by a deliberate action;

(g) made in such a way as to withstand foreseeable forces, paying particular attention to emergency stop devices liable to be subjected to considerable forces.

Where a control device is designed and constructed to perform several different actions, namely, where there is no one-to-one correspondence, the action to be performed shall be clearly displayed and subject to confirmation, where necessary.

Control devices shall be so arranged that their layout, travel and resistance to operation are compatible with the action to be performed, taking account of ergonomic principles.

Machinery or related products shall be fitted with indicators as required for safe operation. The operator shall be able to read them from the control position.

From each control position, the operator shall be able to ensure that no one is in the danger zones, or the control system shall be designed and constructed in such a way that starting is prevented while someone is in the danger zone.

If neither of these possibilities is applicable, before the machinery or related product starts, an acoustic and/or visual warning signal shall be given. The exposed persons shall have time to leave the danger zone or prevent the machinery starting up.

If necessary, means shall be provided to ensure that the machinery or related product can be controlled only from control positions located in one or more predetermined zones or locations.

Where there is more than one control position, the control system shall be designed in such a way that the use of one of them precludes the use of the others, except for stop controls and emergency stops.

When the machinery or related product has two or more operating positions, each position shall be provided with all the required control devices without the operators hindering or putting each other into a hazardous situation.

It shall be possible to start the machinery or related product only by voluntary actuation of a control device provided for the purpose.

The same requirement applies:

(a) when restarting the machinery or related product after a stoppage, whatever the cause;

(b) when effecting a significant change in the operating conditions.

However, the restarting of the machinery or related product or a change in operating conditions may be effected by voluntary actuation of a device other than the control device provided for the purpose, on condition that this does not lead to a hazardous situation.

For the machinery or related product functioning in automatic mode, the starting of the machinery or related product, restarting after a stoppage, or a change in operating conditions may be possible without intervention, provided this does not lead to a hazardous situation.

Where the machinery or related product has several starting control devices and the operators can therefore put each other in danger, additional devices shall be fitted to rule out such risks. If safety requires that starting and/or stopping shall be performed in a specific sequence, there shall be devices that ensure that these operations are performed in the correct order.

The machinery or related product shall be fitted with a control device whereby the machinery can be brought safely to a complete stop.

Each workstation shall be fitted with a control device to stop some or all of the functions of the machinery or related product, depending on the existing hazards, so that the machinery or related product is rendered safe.

The machinery or related product’s stop control shall have priority over the start controls.

Once the machinery or related product or its hazardous functions have stopped, the energy supply to the actuators concerned shall be cut off.

Where, for operational reasons, a stop control that does not cut off the energy supply to the actuators is required, the stop condition shall be monitored and maintained.

The machinery or related product shall be fitted with one or more emergency stop devices to enable actual or impending danger to be averted.

The following exceptions apply:

(a) the machinery or related product in which an emergency stop device would not lessen the risk, either because it would not reduce the stopping time or because it would not enable the special measures required to deal with the risk to be taken;

(b) portable hand-held or hand-guided machinery or related products.

The device shall:

(a) have clearly identifiable, clearly visible and quickly accessible control devices;

(b) stop the hazardous process as quickly as possible, without creating additional risks;

(c) where necessary, trigger or permit the triggering of certain safeguard movements.

Once active operation of the emergency stop device has ceased following a stop command, that command shall be sustained by engagement of the emergency stop device until that engagement is specifically overridden; it shall not be possible to engage the device without triggering a stop command; it shall be possible to disengage the device only by an appropriate operation, and disengaging the device shall not restart the machinery or related product but only permit restarting.

The emergency stop function shall be available and operational at all times, regardless of the operating mode.

Emergency stop devices shall be a backup to other safeguarding measures and not a substitute for them.

In the case of machinery or a related product or parts of machinery or a related product designed to work together, the machinery or a related product shall be designed and constructed in such a way that the stop controls, including the emergency stop devices, can stop not only the machinery or related product itself but also all related equipment, if its continued operation may be dangerous.

The control or operating mode selected shall override all other control or operating modes, with the exception of the emergency stop.

If the machinery or related product has been designed and constructed to allow its use in several control or operating modes requiring different protective measures and/or work procedures, it shall be fitted with a mode selector, which can be locked in each position. Each position of the selector shall be clearly identifiable and shall correspond to a single operating or control mode.

The selector may be replaced by another selection method, which restricts the use of certain functions of the machinery or related product to certain categories of operator.

If, for certain operations, the machinery or related product shall be able to operate with a guard displaced or removed and/or a protective device disabled, the control or operating mode selector shall simultaneously:

(a) disable all other control or operating modes;

(b) permit operation of hazardous functions only by control devices requiring sustained action;

(c) permit the operation of hazardous functions only in reduced risk conditions while preventing hazards from linked sequences;

(d) prevent any operation of hazardous functions by voluntary or involuntary action on the machinery’s or related product’s sensors.

If these four conditions cannot be fulfilled simultaneously, the control or operating mode selector shall activate other protective measures designed and constructed to ensure a safe intervention zone.

In addition, the operator shall be able to control the operation of the parts he or she is working on from the adjustment point.

The interruption, the re-establishment after an interruption or the fluctuation in whatever manner of the power supply or communication network connection to the machinery or related product shall not lead to hazardous situations.

Particular attention shall be given to the following:

(a) the machinery or related product shall not start unexpectedly;

(b) the parameters of the machinery shall not change in an uncontrolled way when such change can lead to hazardous situations;

(c) the machinery or related product shall not be prevented from stopping if the stop command has already been given;

(d) no moving part of the machinery or related product or piece held by the machinery or related product shall fall or be ejected;

(e) automatic or manual stopping of the moving parts, whatever they may be, shall be unimpeded;

(f) the protective devices shall remain fully effective or give a stop command.

The machinery or related product and its components and fittings shall be stable enough to avoid overturning, falling or uncontrolled movements during transportation, assembly, dismantling and any other action involving the machinery or related product.

If the shape of the machinery or related product itself or its intended installation does not offer sufficient stability, appropriate means of anchorage shall be incorporated and indicated in the instructions for use.

The various parts of machinery or related products and their linkages shall be able to withstand the stresses to which they are subject when used.

The durability of the materials used shall be adequate for the nature of the working environment foreseen by the manufacturer, in particular as regards the phenomena of fatigue, ageing, corrosion and abrasion.

The instructions for use shall indicate the type and frequency of inspections and maintenance required for safety reasons. They shall, where appropriate, indicate the parts subject to wear and the criteria for replacement.

Where a risk of rupture or disintegration remains despite the measures taken, the parts concerned shall be mounted, positioned or guarded in such a way that any fragments will be contained, preventing hazardous situations.

Both rigid and flexible pipes carrying fluids, particularly those under high pressure, shall be able to withstand the foreseen internal and external stresses and shall be firmly attached or protected to ensure that no risk is presented by a rupture.

Where the material to be processed is fed to the tool automatically, the following conditions shall be fulfilled to avoid risks to persons:

(a) when the work piece comes into contact with the tool, the latter shall have attained its normal working condition;

(b) when the tool starts and/or stops (intentionally or accidentally), the feed movement and the tool movement shall be coordinated.

Precautions shall be taken to prevent risks from falling or ejected objects.

Insofar as their purpose allows, accessible parts of the machinery or a related product shall have no sharp edges, no sharp angles and no rough surfaces likely to cause injury.

Where the machinery or related product is intended to carry out several different operations with manual removal of the piece between each operation (combined machinery or related product), it shall be designed and constructed in such a way as to enable each element to be used separately without the other elements constituting a risk for exposed persons.

For this purpose, it shall be possible to start and stop separately any elements that are not protected.

Where the machinery or related product performs operations under different conditions of use, it shall be designed and constructed in such a way that selection and adjustment of these conditions can be carried out safely and reliably.

The moving parts of the machinery or related product shall be designed and constructed in such a way as to prevent risks of contact which could lead to accidents or shall, where risks persist, be fitted with guards or protective devices.

All necessary steps shall be taken to prevent accidental blockage of moving parts. In cases where, despite the precautions taken, a blockage is likely to occur, the necessary specific protective devices and tools shall, when appropriate, be provided to enable the equipment to be safely unblocked.

The instructions for use and, where possible, a sign on the machinery or related product shall identify these specific protective devices and how they are to be used.

The prevention of risks of contact leading to hazardous situations and the psychological stress that may be caused by the interaction with the machinery shall be adapted to:

(a) human-machine coexistence in a shared space without direct collaboration;

(b) human-machine interaction.

Guards or protective devices designed to protect against risks arising from moving parts shall be selected on the basis of the type of risk. The following guidelines shall be used to help to make the choice.

Guards designed to protect persons against the hazards generated by moving transmission parts shall be:

(a) either fixed guards as referred to in section 1.4.2.1; or

(b) interlocking movable guards as referred to in section 1.4.2.2.

Interlocking movable guards shall be used where frequent access is envisaged.

Guards or protective devices designed to protect persons against the hazards generated by moving parts involved in the process shall be:

(a) either fixed guards as referred to in section 1.4.2.1; or