Comparison of Legal Requirements: The Machinery Directive vs. the Machinery Regulation
1.7.4.2. Contents of the instructions (for use)
Changes
The requirements are expanded to include digital access to documentation, rescue information, and detailed information on the release of hazardous substances.
- Requirement amended: "EC Declaration of Conformity..." is replaced by "EU Declaration of Conformity, or the internet address or machine-readable code where access to the EU Declaration of Conformity can be obtained, in accordance with Article 10.8."
Article 10.8
8. Manufacturers shall ensure that the machine or the related product is accompanied by an EU Declaration of Conformity in accordance with Section A of Annex V, or, alternatively, manufacturers shall indicate in the instructions for use and the information
set out in Annex III the web address or machine-readable code where access to the EU Declaration of Conformity can be obtained.
Digital EU Declarations of Conformity shall be made available online throughout the expected lifetime of the machine or related product and, in any case, for at least ten years after the machine or related product has been placed on the market or
put into service.
- New requirement: the possibility to provide the EU Declaration via an "internet address or machine-readable code"
- Requirement amended: reference to "harmonised standards" is expanded to "harmonised standards or common specifications adopted by the Commission in accordance with Article 20.3"
Article 20.3
3. The Commission may adopt implementing acts establishing common specifications covering technical requirements that provide a means of complying with the essential health and safety requirements set out in Annex III for products that
fall within the scope of this Regulation.
Such implementing acts may be adopted only if the following conditions are met:
a) the Commission has, in accordance with Article 10(1) of Regulation (EU) No 1025/2012, requested one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements in
Annex III, and
i) the request has not been accepted, or
ii) the harmonised standards requested 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.
These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48.3.
- Requirement amended: "community-specific directives" is replaced by "specific Union legal acts"
- New requirement: "Information on the necessary precautions, devices and aids for the immediate and safe rescue of persons."
- New requirement: "If the design of the machine or related product allows the release of hazardous substances ... the characteristics of the collection, filtration or discharge device..."
- New requirement: "i) The flow rate of the release of hazardous materials and substances..."
- New requirement: "ii) The concentration of hazardous materials or substances around the machine or related product..."
- New requirement: "iii) The effectiveness of the collection or filtration device and the conditions to be observed to maintain its effectiveness over time."
Proposed measures
Ensure that references to the EC Declaration of Conformity are updated to the EU Declaration of Conformity in:
instructions for use
technical documentation
internal templates
Introduce the option to provide the EU Declaration digitally via:
web address
machine-readable code (e.g. QR code)
Verify that the digital EU Declaration is:
available online
available for the entire lifetime
available for at least 10 years
Ensure that internal processes handle both:
physical EU Declaration of Conformity
digital access to the EU Declaration of Conformity
Update references from:
”harmonised standards”
to: ”harmonised standards or common specifications”
Ensure that the documentation clearly states:
which standards are used
or which common specifications are applied
Update all references from:
”Community-specific directives”
to: ”specific Union legal acts”
Verify that no outdated legal references remain in:
instructions for use
technical documentation
specifications
Ensure that the instructions for use contain information on:
measures for the immediate and safe rescue of persons
Verify that this information covers:
equipment
aids
practical implementation
Determine whether the machine can emit hazardous substances
If so, ensure that the instructions for use contain:
characteristics of collection, filtration or drainage systems
Verify that the following are specified:
emission flow rate
concentration of hazardous substances
efficiency of protective systems
Ensure that conditions for maintaining function over time are documented
Ensure that measurement data for emissions (e.g. noise and substances) are:
verified
documented
traceable
Update instructions for use so that they cover:
machines
related products
Ensure that terminology usage is consistent throughout all documentation
Machinery Directive statutory text
1.7.4.2. Contents of the instructions
Each instruction manual must contain, where applicable, at least the following information:
(a) the business name and full address of the manufacturer and of his authorised representative;
(b) the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3);
(c) the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;
(d) a general description of the machinery;
(e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;
(f) a description of the workstation(s) likely to be occupied by operators;
(g) a description of the intended use of the machinery;
(h) warnings concerning ways in which the machinery must not be used that experience has shown might occur;
(i) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;
(j) instructions relating to installation and assembly for reducing noise or vibration;
(k) instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;
(l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
(m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
(n) the essential characteristics of tools which may be fitted to the machinery;
(o) the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
(p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;
(q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;
(r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;
(s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
(t) the specifications of the spare parts to be used, when these affect the health and safety of operators;
(u) the following information on airborne noise emissions:
— the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,
— the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa),
— the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).
These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.
In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated.
Where the harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described.
Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 metre from the surface of the machinery and at a height of 1,6 metres from the floor or access platform. The position and value of the maximum sound pressure must be indicated.
Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;
(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.
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Machinery Regulation legal text
1.7.4.2. Contents of the instructions for use
Instructions for use shall contain, where applicable, at least the following information:
(a) the business name and full address of the manufacturer and, where applicable, of its authorised representative;
(b) the designation of the machinery or related product as marked on the machinery or related product itself, except for the serial number (see section 1.7.3);
(c) the EU declaration of conformity, or the internet address or machine readable code, where the EU declaration of conformity can be accessed, in accordance with Article 10(8);
(d) a general description of the machinery or related product;
(e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery or related product and for checking its correct functioning;
(f) a description of the workstation(s) likely to be occupied by operators;
(g) a description of the intended use of the machinery or related product;
(h) warnings concerning the ways in which the machinery or related product must not be used that experience has shown might occur;
(i) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery or related product is to be mounted;
(j) instructions relating to installation and assembly for reducing noise or vibration;
(k) instructions for the putting into service and use of the machinery or related product and, if necessary, instructions for the training of operators;
(l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
(m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
(n) the essential characteristics of tools, which may be fitted to the machinery or related product;
(o) the conditions in which the machinery or related product meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
(p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery or related product and of its various parts where these are regularly to be transported separately;
(q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;
(r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed taking account of the design and the use of the machinery or related product;
(s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
(t) the specifications of the spare parts to be used, when these affect the health and safety of operators;
(u) the following information on airborne noise emissions:
(i) the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB (A); where this level does not exceed 70 dB (A), this fact shall be indicated;
(ii) the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa);
(iii) the A-weighted sound power level emitted by the machinery or related product, where the A-weighted emission sound pressure level at workstations exceeds 80 dB (A).
These values shall be either those actually measured for the machinery or related product in question or those established on the basis of measurements taken for technically comparable machinery or for a technically comparable related product, which is representative of the machinery or related product to be produced.
In the case of very large machinery or a related product, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery or related product may be indicated.
Where the harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) cannot be applied, sound levels shall be measured using the most appropriate method for the machinery or related product.
Whenever sound emission values are indicated, the uncertainties surrounding these values shall be specified. The operating conditions of the machinery or related product during measurement and the measuring methods used shall be described.
Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels shall be measured at a distance of 1 m from the surface of the machinery or related product and at a height of 1,6 m from the floor or access platform. The position and value of the maximum sound pressure shall be indicated.
With respect to noise reduction machinery or related products, the instructions for use shall specify, where appropriate, how to correctly assemble and install that equipment (see also section 1.7.4.2(1), point (j)).
Where specific Union legal acts lay down other requirements for the measurement of sound pressure levels or sound power levels, those legal acts shall be applied and the corresponding provisions of this section shall not apply;
(v) information on the necessary precautions, devices and means for the immediate and gentle rescue of persons;
(w) where machinery or related products are likely to emit non-ionising radiation, which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons;
(x) where the design of machinery or related products allows emissions of hazardous substances from the machinery or related product, the characteristics of the capturing, filtration or discharge device if such device is not provided with the machinery or related product, and any of the following:
(i) the flow rate for the emission of hazardous materials and substances from the machinery or related product;
(ii) the concentration of hazardous materials or substances around the machinery or related product coming from the machinery or related product or from materials or substances used with the machinery or related product;
(iii) the effectiveness of the capturing or filtration device and the conditions to be observed to maintain its effectiveness over time.
The values referred to in the first subparagraph shall either be actually measured for the machinery or related product in question or established based on measurements in respect of technically comparable machinery or a technically comparable related product, which is representative of the state of the art.
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