The EU Commission has revised the guidelines for the Machinery Directive and published the new version 2.1 on July 19, 2017.
Update: Meanwhile a new version 2.2 of the guide has beed published. You can find more on this here.
Note: The guide was not only changed in the areas mentioned in the preface. Changes have also been made in other parts of the guide! Please also note the hint in the introduction to the guide: “It should be stressed that only the Machinery Directive and the texts implementing its provisions into national law are legally binding.”
The new guideline contains a brief summary of the most important changes in its foreword:
Guide
Title
New comments (excerpt)
§ 38
Assemblies of machinery
§ 39
In order to decide whether the (new) entire system has to be subjected to a conformity assessment procedure again by installing a new machine in a system, the creation of a risk assessment is now explicitly required.
The section also contains information on the possibility of dispensing with a new CE marking in the event of new risks if the existing protective devices are sufficient.
§ 42
Comprehensive explanations including examples for the definition of safety components.
§ 46
In many places in version 2.1 of the guide, it is pointed out that incomplete machines may have to carry a CE mark if this is required by other guidelines (e.g. ATEX-RL), although the machine directive does not provide for a CE mark for partly completed machines.
§ 53
Agricultural and forestry tractors
§ 55
Two- and three-wheeled road vehicles
§ 57
Explanations of the scope of the machine directive regarding drones
§ 64
Household appliances intended for domestic use
Notes on electrically operated furniture.
§ 69
Demarcations between low voltage-, machine- and ATEX guidelines.
§ 74
The legal and contractual forms of placing on the market
Additional comments regarding the handover of machines to sales outlets belonging to the manufacturer and the offering of products on the Internet.
§ 81
Other persons who may be considered as manufacturers
§ 86
The definition of „putting into service”
Clarifications as to when the commissioning takes place in different cases (import, self-construction, installation at the customer).
In particular, it is pointed out that the test operation during setup does not correspond to commissioning. During this time, however, the national occupational safety regulations must be observed.
§ 88
New in Guide 2.1: Essential health and safety requirements
Explanations of the basic safety and health requirements added by Directive 2009/127/EC (machines for applying pesticides).
In particular, that the protection goals of the Machinery Directive affect not only people, but also pets and farm animals, things and if applicable, the environment.
§§ 90-92
§ 90: Specific EU legislation that apply instead of the Machinery Directive to machinery that is in their scope
§ 91: Specific EU legislation that may apply to machinery instead of the Machinery Directive for specific hazards
§ 92: EU legislation that may apply to machinery, in addition to the Machinery Directive, for hazards they cover more specifically than the Machinery Directive
Update of the recently published guidelines as well as the associated explanations.
In particular, Section 90 now lists the Low Voltage Directive (LVD) with corresponding comments.
§ 93
§ 98
§ 100
If products pose a serious and immediate risk, the market surveillance authorities can contact the other people in the supply chain and the users if the manufacturer cannot be reached.
Note that the RAPEX system is also used for products in the scope of the machine directive.
§ 102
Controls at the external borders of the EU
§ 105
§ 107
Free movement of machinery and party completed machinery
§ 110
The presumption of conformity conferred by the CE marking and the EC Declaration of Conformity
Additional information that the presumption of conformity is only limited to those essential health and safety requirements (EHSR) that are covered by the harmonized standard.
Note that a risk assessment must also be carried out for the EHSR covered by harmonized standards: "The manufacturer will need to carry out a risk assessment and compliance procedure for the risk areas associated to the relevant essential health and safety requirements."
Additional information on the application of standards for machines according to Annex IV of the MD.
§ 111
The classification of machinery standards
§ 114
Publication of the references of harmonized standards for machinery
§ 118
Measures to deal with unsafe machinery presenting similar risks
Article 11 (3) of the Machinery Directive has been extended by Directive 2009/127/ EC. The EHSR relate not only to people, but also to pets, things and, in the case of pesticide application machines, to the environment.
Similar changes can be found e.g. also in sections 122, 125 and 143.
§ 119
Formal objections to harmonised standards
§ 121
The outcome of a formal objection
Additional explanations for the application of standards, which were published in the Official Journal with a warning.
Furthermore, § 121 explains that the sole procedure of internal production control, taking into account harmonized standards for Annex IV machines, can only be used if the applied standard triggers a comprehensive presumption of conformity.
§ 123
The safeguard procedure
Note that the safeguard clause procedure only affects machines with CE marking that do not meet the requirements of the Machinery Directive. Section 123 contains comments on how national authorities should handle machines that do not have a CE-mark and may not meet the requirements of the Machinery Directive.
In addition, § 123 contains a note that decision 768/2008 created a uniform safeguard clause procedure for CE guidelines. However, that of the Machinery Directive has not yet been adapted to this uniform procedure and must therefore be applied until the Machinery Directive is revised and adapted.
§ 129
The explanations on the three prerequisites so that the procedure in accordance with Article 12 (3) can be applied have been expanded in two points.
Exceptions regarding safety components have been added. Furthermore, special attention is now paid to the fact that some harmonized standards do not meet all EHSR. Manufacturers are therefore obliged to check this in accordance with the information in the Official Journal or Annex Z of the standards
§ 159
Risk assessment and harmonised standards
As an additional note, the guide recommends that the risk assessment should begin by reviewing Appendix Z of a harmonized C-standard to verify that the standard covers all EHSRs.
§ 161
The explanations now deal more closely with the question of when economic considerations may be included in the selection of measures to reduce risk. In Addition to consider the total costs, the new guide now explains that the possible severity of an injury must also be taken into account:
„For example, the cost of compliance will be more relevant for the risk of minor fully recoverable injuries, but to reduce the risk of a fatal injury the cost "barrier" will be extremelyhigh,whenanadequatetechnicalsolutionthatalreadyexistsis not applied, for risks leading to a fatal injury.“
§ 162
Harmonised standards and the state of the art
§ 174
The 3-step method
The importance of the 3-step method is now emphasized even more:
„This hierarchy of measures explained below is a one of the most important requirements of the Directive.“
§ 181
Ergonomic principles
A reference to a special guideline regarding ergonomics has been included.
§ 182
Operating positions in hazardous environments
The risk of electrical shock from overhead lines near the work area of agricultural spray machinery has been added to the examples of hazards.
In addition, the section contains explanations of control stands that are integrated in a building and the control elements.
§ 190
§ 202
Emergency stop devices
§ 204
Mode selection
The last paragraph (necessity of an operating mode in which normal protective devices are deactivated and one of the four requirements of the Machinery Directive, Annex I, 1.2.5, cannot be met) has been expanded to include the following:
"Such a safe zone may be limited by active optoelectronic protective devices. However, the use of easily defeateable devices, such as a pressure sensitive operator mat are not suitable."
§ 216
General requirements for guards and protective devices
With regard to the mechanical strength of mechanical protective devices, the comment was added that in particular the case must be provided that an operator climbs or falls on a protective device.
§ 218
The goal of the demand for fasteners that can only be solved by tools was specified in such a way that protective devices should only be solved by a conscious action that takes time and considerations ("needing some thought and time").
In addition, the section was expanded to include detailed information that parts of buildings (e.g. walls) can be used to block access to dangerous areas. The manufacturer's obligations are listed, which it must fulfill if parts of the building are used as part of the safety package.
§ 222
§ 236
Exemplary situations have been added to the section.
§ 246
The official languages of the EU
§ 250
Marking of Machinery
Additional note: Although the Machinery Directive does not provide specific labeling on partly completed machines, it would be good practice to label even partly completed machines for identification purposes in order to ensure the connection with the declaration of incorporation and the assembly instructions.
In addition, at the end of § 250, notes were added which indicate the date of the labeling in connection with imports of machines from other EU countries. describe in connection with significant changes.
§ 254
Chapter 2.4.8 was given for the list of additional requirements for the operating instructions. (In chapter 2.4 - Machines for applying pesticides).
Note: Chapter 2.4.10 of Annex I of the Machinery Directive, which deals with additional requirements for the operating instructions for pesticide application machines, is not mentioned in the guide (at this point). This chapter should also be observed when creating operating instructions, if applicable. See § 290.
§ 262
§ 268
The essential characteristics of tools
Examples, for tools as well as negative examples.
§ 269
§ 275
Note that it is not intended that sales documents are inspected or examined by notified bodies unless these are part of the technical documents.
§ 276
§ 277
§ 279
§ 281
§§ 282-290
Explanations to the new chapter 2.4 (machines for applying pesticides) from Annex I of the MD.
§ 294
Extending explanations of the foreseeable operating conditions, which include the presence of pedestrians or other machines. Particular attention is also drawn to the risk of children present.
Note that the use of special sensors does not replace the requirement of a direct, or if not possible, indirect view.
§ 301
§ 306
§ 315
§ 317
§ 320
§ 328
Additional information has been added which explains lifting operations at a low angle of inclination.
In addition, the following is pointed out regarding the applicability of Part 4 of Annex I of the Machinery Directive to earth-moving machinery:
"However, earth moving machinery that is also designed and equipped for lifting unit loads is subject to the requirements of Part 4 of Annex I, such machinery designed for use in general construction work can be expected to be used for lifting unit loads (e.g. pipes and other equipment), and this should be taken into account."
§ 344
For machines that (also) transport people, the provisions of Part 4 also apply to those from Part 6 of Annex I to the Machinery Directive.
This is also pointed out in § 368.
§ 361
§ 382
With regard to the requirements for the original declarations of conformity, the new guide explains:
"These language versions must bear the words 'Declaration of conformity' (in the language of each version). The manufacturer may provide 'Declarations of conformity' in one or more languages."
Acc. the translations: "The translations must bear the words 'Translation of the original Declaration of Conformity’ (in the language of each version) and must be accompanied by original Declaration of Conformity"
§ 383
Several additional explanations have been included in § 383:
§ 388
§ 389
The information that the list from Annex V is an indicative list has been reworded. It is also emphasized that all components that meet the definition of Article 2 (c) are safety components in the sense of the Machinery Directive.
The explanations were supplemented by the note that certain filter systems are safety components in the sense of the Machinery Directive.
§ 390
The example in the fourth paragraph has been revised:
New: "For example, the manufacturer of a drive systems with its engine to be incorporated into mobile machinery may provide the manual for the engine."
In addition, it was added that the manufacturer of the partly completed machine only has to provide the assembly instructions if he does not declare that he has complied with point 1.7.4 from Annex I of the Machinery Directive. The assembly instructions must nevertheless contain the information that the manufacturer of the entire machine needs to create the operating instructions.
§ 411
Safety fences as safety component under the Machinery Directive
2006/42/EC
§ 412
Classification of equipment used for lifting loads with lifting machinery
§ 413
§ 414
Guards for drilling machines
§ 415
Manually loaded trucks for the collection of household refuse
incorporating a compression mechanism
§ 416
Interchangeable equipment for lifting persons and equipment used with
machinery designed for lifting goods for the purpose of lifting person
Posted on: 21.08.2017
Johannes Windeler-Frick, MSc ETH Managing Director of IBF Solutions AG, the Swiss subsidiary of IBF in Zürich. Johannes is a trainer for both the Machinery Directive (MD) as well as the Low Voltage Directive (LVD). He studied electrical engineering at ETH Zürich with a specialization in energy systems.
Email: johannes.windeler-frick@ibf-solutions.com | www.ibf-solutions.com
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