Definition of machinery as provided by Directive 2006/42/EC (art. 2 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;
• an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion;
• an assembly referred to in the first and second indents, 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;
• assemblies of machinery referred to in the first, second and third indents or partly completed machinery which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;
• 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.

Machinery and equipment excluded from the scope of Directive 2006/42/EC (art. 1.2)

• safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;
• specific equipment for use in fairgrounds and/or amusement parks;
• machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
• weapons, including firearms;
• the following means of transport:

–    agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,

–    motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, with the exclusion of machinery mounted on these vehicles,

–    vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles, with the exclusion of machinery mounted on these vehicles,

–    motor vehicles exclusively intended for competition, and

–    eans of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;

• seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;
• machinery specially designed and constructed for military or police purposes;
• machinery specially designed and constructed for research purposes for temporary use in laboratories;
• mine winding gear;
• machinery intended to move performers during artistic performances;
• electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive  2006/95/EC, formerly 73/23/EEC, on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits:

–     household appliances intended for domestic use;

–     audio and video equipment;

–     information technology equipment;

–     ordinary office machinery;

–     low-voltage switchgear and control gear;

–     electric motors;

–     the following types of high-voltage electrical equipment: switch gear and control gear, and transformers.

Definition of interchangeable equipment as provided by Directive 2006/42/EC (art. 2 b)

“Interchangeable equipment” means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool.

Definition of safety components as provided by Directive 2006/42/EC (art. 2 c)

„Safety component” means a component:

-          which serves to fulfil a safety function,

-          which is independently placed on the market,

-          the failure and/or malfunction of which endangers the safety of persons, and

-          which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.

An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8.1 a.

Safety components wymienione w zał. V do Directive 2006/42/WE

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 items 9, 10 and 11 of Annex IV.
4. Logic units to ensure safety functions.
5. Valves with additional means for failure detection intended for the control of dangerous movements on machinery.
6. Extraction systems for machinery emissions.
7. Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery.
8. Monitoring devices for loading and movement control in lifting machinery.
9. Restraint systems to keep persons on 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 I.
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. Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list:

(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,

1.                                                               i.      non-linear, or
2.                                                             ii.      with damping of the return movement;

(e)    energy-dissipating shock absorbers;

(f)    safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls;

(g)   electric safety devices in the form of safety switches containing electronic components.

Definition of lifting accessory as provided by Directive 2006/42/EC (art. 2 d)

“Lifting accessory” means a component or equipment not attached to the lifting machinery, allowing 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; slings and their components are also regarded as lifting accessories.

Definition of chains, ropes and webbing as provided by Directive 2006/42/EC (art. 2 e)

„Chains, ropes and webbing” means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories.

Definition of removable mechanical transmission device as provided by Directive 2006/42/EC (art. 2 f)

„Removable mechanical transmission device” means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product.

Definition of partly completed machinery wg Directive 2006/42/EC (art. 2 g)

It means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.

List of annexes to Directive 2006/42/EC

Annex I – essential health and safety requirements relating to the the design and construction of machinery, including: general principles, essential health and safety requirements, supplementary essential health and safety requirements for certain categories of machinery (foodstuffs machinery and machinery for cosmetics or pharmaceutical products, portable hand-held and/or hand-guided machinery, machinery for working wood and material with similar physical characteristics) *), supplementary essential health and safety requirements to offset hazards due to the mobility of machinery, supplementary essential health and safety requirements to offset hazards due to lifting operations, supplementary essential health and safety requirements for machinery intended for underground work, supplementary essential health and safety requirements for machinery presenting particular hazards due to the lifting of persons;

Annex  II – Declarations (EC declaration of conformity of the machinery, declaration of incorporation of partly completed machinery);

Annex  III – CE marking;

Annex  IV – Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must be applied (machinery considered particularly dangerous and protective equipment essential for safety);

Annex  V – Indicative list of the safety components referred to in Article 2(c);

Annex  VI – Assembly instructions for partly completed machinery;

Annex  VII – Technical file for machinery and relevant technical documentation for partly completed machinery;

Annex  VIII – Assessment of conformity with internal checks on the manufacture of machinery;

Annex  IX – EC type-examination;

Annex  X – Full quality assurance;

Annex  XI – Minimum criteria to be taken into account by Member States for the notification of bodies

Annex  XII – Correlation table (of regulations of Directives 98/37/EC and 2006/42/EC);

^*) under the amendment in Directive 2009/127/EC the essentials requirements include pesticide machinery

Types of harmonised standards

Standards type A: (basic) – define the basic notions in machinery safety, set out general issues and principles for designing (construction) concerning all machinery types included in the Directive;

Standards type B: (problem) – refer to specific safety issues, common for several machinery types or safety components used in them. There are two subcategories: B1 – particular aspects of safety, e.g., safety distances, noise, temperatures, etc.) and B2 – safety components (np. two-hand control devices, blocking devices, pressure- or electric-sensitive devices, etc.);

Standards type C: (detailed) – set out detailed safety requirements related to particular types or groups of machinery;

Cases for application of specific conformity assessment procedures for machinery
set out in Directive 2006/42/EC(art. 12)

Case 1: Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII;

Case 2: Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonised standards referred to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII;

(b) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

(c) the full quality assurance procedure provided for in Annex X.

Case 3: Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonized standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonised standards do not cover all the relevant essential health and safety requirements or if no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

(b) the full quality assurance procedure provided for in Annex X.

Categories of machinery listed in Annex IV to Directive 2006/42/EC,
referred to in cases 2 and 3

1. Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:

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.

2. Hand-fed surface planing machinery for woodworking.

3. Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.

4. Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:

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.

5. Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.

6. Hand-fed tenoning machinery with several tool holders for woodworking.

7. Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.

8. Portable chainsaws for woodworking.

9. Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.

10. Injection or compression plastics-moulding machinery with manual loading or unloading.

11. Injection or compression rubber-moulding machinery with manual loading or unloading.

12. Machinery for underground working of the following types:

12.1. locomotives and brake-vans;

12.2. hydraulic-powered roof supports.

13. Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.

14. Removable mechanical transmission devices including their guards.

15. Guards for removable mechanical transmission devices.

16. Vehicle servicing lifts.

17. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres.

18. Portable cartridge-operated fixing and other impact machinery.

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

20. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11.

21. Logic units to ensure safety functions.

22. Roll-over protective structures (ROPS).

23. Falling-object protective structures (FOPS).

Procedure for assessment of conformity with internal checks on the manufacture of machinery as set out in Annex VIII to Directive 2006/42/EC (for cases 1, 2a)

1. It is a procedure by which the manufacturer or his authorised representative, who carries out the obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant requirements of this Directive.
2. For each representative type of the series in question, the manufacturer or his authorised representative shall draw up the technical file referred to in Annex VII, part A.
3. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the requirements of this Directive.

EC type-examination as provided by Annex IX to Directive 2006/42/EC (for cases 2b, 3a)

EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (hereafter named the type) satisfies the provisions of this Directive.

1. The manufacturer or his authorised representative must, for each type, draw up the technical file referred to in Annex VII, part A.

2. For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorized representative to a notified body of his choice.

The application shall include:

— the name and address of the manufacturer and, where appropriate, his authorised representative,

— a written declaration that the application has not been submitted to another notified body,

— the technical file.

Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test programme so requires.

3. The notified body shall:

3.1. examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of the standards referred to in Article 7(2), and those elements whose design is not based on the relevant provisions of those standards;

3.2. carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements of this Directive, where the standards referred to in Article 7(2) were not applied;

3.3. where harmonised standards referred to in Article 7(2) were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied;

3.4. agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out.

4. If the type satisfies the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and his authorized representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject. The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate.

5. If the type does not satisfy the provisions of this Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the Member State which notified it. An appeal procedure must be available.

6. The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type. The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type.

7. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. On reasoned request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the notified body.

8. Files and correspondence referring to the EC type-examination procedures shall be written in the official Community language(s) of the Member State where the notified body is established or in any other official Community language acceptable to the notified body.

9. Validity of the EC type-examination certificate

9.1. The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid.

9.2. The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.

9.3. The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years. If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years. The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate.

9.4. In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned

Full quality assurance procedure provided for in Annex X to Directive 2006/42/EC (for the cases 2c, 3b)

The Annex describes the conformity assessment of machinery referred to in Annex IV, manufactured using a full quality assurance system, and the procedure whereby a notified body assesses and approves the quality system and monitors its application.

1. The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as specified in point 2, and shall be subject to the surveillance referred to in point 3.

2. Quality system

2.1. The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.

The application shall contain:

— the name and address of the manufacturer and, where appropriate, his authorised representative,

— the places of design, manufacture, inspection, testing and storage of the machinery,

— the technical file described in Annex VII, Part A, for one model of each category of machinery referred to in Annex IV which he intends to manufacture,

— the documentation on the quality system,

— a written declaration that the application has not been submitted to another notified body.

2.2. The quality system must ensure conformity of the machinery with the provisions of this Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans,

manuals and records. It must contain, in particular, an adequate description of:

— the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery,

— the technical design specifications, including standards that will be applied and, where the standards referred to in Article 7(2) are not applied in full, the means that will be used to ensure that the essential health and safety requirements of this Directive are fulfilled,

— the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by this Directive,

— the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

— the inspections and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

— the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications of the personnel concerned,

— the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system.

2.3. The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2. The elements of the quality system which conform to the relevant harmonised standard shall be presumed to conform to the corresponding requirements referred to in point 2.2. The team of auditors must have at least one member who is experienced in the assessment of the technology of the machinery. The assessment procedure shall include an inspection to be carried out at the manufacturer's premises. During the assessment, the team of auditors shall carry out a review of the technical files referred to in point 2.1, second paragraph, third indent to ensure their compliance with the relevant health and safety requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. An appeal procedure must be available.

2.4. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective. The manufacturer or his authorised representative shall inform the notified body which approved the quality system of any planned change to it. The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in point 2.2, or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3. Surveillance under the responsibility of the notified body

3.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

3.2. The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:

— the documentation concerning the quality system,

— the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc.,

— the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

3.3. The notified body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report. The frequency of the periodic audits shall be such that a full reassessment is carried out every three years.

3.4. Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system:

— the results of previous surveillance visits,

— the need to monitor remedial measures,

— where appropriate, special conditions attaching to approval of the system,

— significant modifications in the organisation of the manufacturing process, measures or techniques. On the occasion of such visits, the notified body may, if necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if a test was carried out, with a test report.

4. The manufacturer or his authorised representative shall keep available for the national authorities, for a period of ten years from the last date of manufacture:

— the documentation referred to in point 2.1,

— the decisions and reports of the notified body referred to in point 2.4, third and fourth subparagraphs, and in points 3.3 and 3.4..