Dipl.-Ing. Wolfgang Grassberger MBA
DI W. Grassberger
Consultant for Electrical Engineering
Certified Machine Safety Expert – CMSE®
UL Manufacturer Technical Representative – MTR
Safety Consultant
CE-Marking of Industrial Machines
European Machinery Directive was first published in 1989. Its first edition contained only 32 pages. It was meant to tear down trade barrieres within the common European market while providing for adequate safety.
This directive has been revised several times over the past decades. The current edition is from 2006/43/EG, some 14 years ago. It shall be re-issued as a European Regulation in approx. 2024.
Having passed a conformity assessment, a machine is marked with the CE sign. It states conformity with essential safety and health requirements of all applicable European Directives and Regulations (such as e.g. contained in Appendix I of Machinery Directive), on the date of commissioning, i.e. at the date of hand-over from manufacturer to end user.
OEMs may assess and declare conformity of most machines at their own responsibility, without consultation from external (notified) bodies. For dangerous machines listed by Annex IV, such as e.g. wood-working machines with automatic feeding, harmonised standards must fully be observed.
An OEM must compile a complete Technical File, comprising among other documents: Description, assembly drawing, risk assessment, operations manual.
Performing a comprehensive risk assessment is the most strenuous part of this process. It should be carried out well before design. Where inherently safe solutions cannot be obtained, guards must reduce risk of injury to an acceptable level.
An OEM's executive officer may eventuelly assert conformity by signing resp. declaration, pertaining to Machinery Directive and other applicable directives, regulations, and standards.
May I offer my vast experience with conformity assessment: I can diligently assist and propose practical concepts for safe design and guarding.
Conformance Assessment Procedures for Machines
In order to finally affix a type plate bearing the CE-mark on a machine, it must first be assessed in relation to essential safety and health requriements of the European Machinery Directive. Contrary to other equipement such as for medical use, this process is very straightforward for industrial machines. In most cases the OEM may investigate, and declare conformity, under their own responsibility. This is where I contribute my experience in various industries.
There are but a few exceptions, where type approval from a notified body, such as one of the four TÜV organisations, mut be applied for. Annex IV of Machinery Directive lists a couple of special machines, among them circular saws, woodworking planers, portable chain saws, presses, lifts for vehicles or for persons, removable mechanical transmisions. However even these more hazardous machines may be declared in conformance with esssential safety requirements by applying certain harmonized standards.
Machinery Directive regulates as follows:
| Annex IV | Annex IV of Machinery Directive lists machines with elevated hazards. |
| Harmonised Standards | OEM may declare conformity under their own responsiblity even for Annex IV listed machines, provided all essential safety requirements have been met through Harmonised Standards (see article 12, paragraphs 3 and 4). |
| Full Quality Assessment | OEM implements and maintains a full quality assessment program as required by Annex X, comprising design, manufacture, and validation. This program is audited in regular intervals by a notified body (e.g. TÜV). |
| EC Type Approval | A notified body inspects a specimen and its technical file against essential safety requriements (see Annex IX). |
| Technical File | OEM compiles a Technical File for conformity assessment. This file contains among other, drawings, circuit diagrams, P&IDs, descriptions, risk assessment (see Annex VII part A). |
| Internal Checks | OEM inspects each machine assembled for accordance with its Technical File, and validates its safety (see Annex VIII paragraph 3). |
| Declaration of Conformity | OEM issues and signs an EC Declaration of Conformity according to Annex II A. |
| CE-Mark | CE-mark is typically placed on machine's type plate. |
Ziviltechniker in Austria
Ziviltechniker have been entitled by the Austrian-Hungarian empire in 1913 to assist public administration in surveying. In Austria they are regarded as persons of public reliance and have the right to establish deeds with evidential value (§292 Zivilprozessordnung – ZPO).
Both Engineering Consultants and architects are Ziviltechniker.
Prerequisites are a relevant academic study, practical experience, an exam and an oath. The exam covers the resp. area of expertise, public administration, business administration, and code of professional conduct.
In general, engineering consultants handle planing, assessing, supervision, and fiduciary taks. Moreover they conduct measurements, draft expertises, and represent their clients before authorities.
As a Ziviltechniker I have to abide by strict confidentiality and code of conduct.
As a consultant for electrical engineering I offer my expert knowledge and practical experience in the area of machine and plant design, precisely on all their safety aspects. I am not entitled to commercial execution and therefore free from conflict of interest.
On the one hand, European law on safety of machinery aims to enable free trade within the Union, by defining a maximum safety standard. On the other hand, such regulation provides for a minimum standard on occupational safety. Persuant to these overall aims, first agreed upon in the Contract of Rome, both original equipment manufactuers/importers of machinery, and employers have the following obligations:
OEMs and Importers
Each machine designed, or imported into the European Community, must comply with essential safety and health requirements put forth in Annex I of Machinery Directive 2006/42/EC, as well as with those of all other applicable directives and regulation. Drawing on my qualification and experience in machine design I offer my assistance in obtaining cost-effective and practical implementation of these safety standards.
Employers (End-Users of Machinery)
As an employer you are obliged to provide for safe work places. Based on my experience in the area of machine safety, I offer first-time and recurring safety validation of all manufacturing equipment. I am able to represent your best interests in sourcing, commissioning, and acceptance testing of new machines, vis-a-vis your suppliers and OEMs.
Implementation of European Directives for OEMs in Austria
Directives are indirect European legal instruments, subject to national adoption by member states. Provided a machine complies with these national regulations, it may freely be put on the entire European market.
Even when you design and construct a machine for exclusive use in your own factories, it must still comply with essential safety requirements for OEMs, as documented in a Technical File and asserted by your resp. EC Declaration of Conformity.
As an exception to other directives, Annex I to MD puts forth many obligatory details, albeit in language far from everyday use. Nevertheless I recommend these few pages to each designer as an introduction to the subject. The same may be said for ATEX and Pressure Equipment Directives.
Unfortunately all other directives listed below contain nothing but a few general safety targets, from which no hint whatsoever can be obtained towards practical implementation. Resp. standards must be consulted for guidance.
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
Verordnung des Bundesministers für Wirtschaft und Arbeit über die Sicherheit von Maschinen und von Sicherheitsbauteilen für Maschinen (Maschinen-Sicherheitsverordnung 2010 – MSV 2010)
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
Verordnung des Bundesministers für Wissenschaft, Forschung und Wirtschaft über elektrische Betriebsmittel zur Verwendung innerhalb bestimmter Spannungsgrenzen (Niederspannungsgeräteverordnung 2015 – NspGV 2015)
Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)
Verordnung des Bundesministers für Wissenschaft , Forschung und Wirtschaft über elektromagnetsiche Verträglichkeit (Elektromagnetische Verträglichkeitsverordnung 2015 – EMVV 2015)
irective 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC
Bundesgesetz über die Marktüberwachung von Funkanlagen (Funkanlagen-Marktüberwachungs-Gesetz – FMaG 2016)
Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)
Verordnung des Bundesministers für Wissenschaft, Forschung und Wirtschaft über Geräte und Schutzsysteme zur bestimmungsgemäßen Verwendung in explosionsgefährdeten Bereichen (Explosionsschutzverordnung 2015 – ExSV 2015)
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment
Verordnung des Bundesministers für Wissenschaft, Forschung und Wirtschaft über Druckgeräte (Druckgeräteverordnung - DGVO)
Implementation of European Law for Employers in Austria
European Counsil has implemented a framework directive on occupational safety, persuant to article 137 on social welfare in Contract of Rome.
Its minimum safety requirements have been implemented in Austria by the ArbeitnehmerInnenschutzgesetz.
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work
Bundesgesetz über Sicherheit und Gesundheitsschutz bei der Arbeit (ArbeitnehmerInnenschutzgesetz - ASchG)
Under the umbrella of the framework directive, some 20 single directives have been issued on occupational safety. A few are named below.
These European Directives have mostly been implemented as national regulations in Austria.
Council Directive 89/654/EEC of 30 November 1989 concerning the minimum safety and health requirements for the workplace (first individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC)
Verordnung der Bundesministerin für Arbeit, Gesundheit und Soziales, mit der Anforderungen an Arbeitsstätten und an Gebäuden auf Baustellen festgelegt und die Bauarbeiterschutzverordnung geändert wird (Arbeitsstättenverordnung – AStV)
Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Verordnung des Bundesministers für Wirtschaft und Arbeit über den Schutz der ArbeitnehmerInnen bei der Benutzung von Arbeitsmitteln (Arbeitsmittelverordnung - AM-VO) und mit der die Bauarbeiterschutzverordnung geändert wird
Council Directive 90/269/EEC of 29 May 1990 on the minimum health and safety requirements for the manual handling of loads where there is a risk particularly of back injury to workers (fourth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)
§64 des Bundesgesetzes über die Sicherheit und Gesundheitsschutz bei der Arbeit (ArbeitnehmerInnenschutzgesetz - ASchG)
Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)
Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Verordnung des Bundesministers für Wirtschaft und Arbeit über den Schutz der Arbeitnehmer/innen vor explosionsfähigen Atmosphären und mit der die Bauarbeiterschutzverordnung und die Arbeitsmittel-Verordnung geändert werden (Verordnung explosionsfähige Atmosphären – VEXAT)
Directive 2002/44/EC of the European Parliament and of the Council of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (sixteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) - Joint Statement by the European Parliament and the Council
17th Individual DirectiveDirective 2003/10/EC of the European Parliament and of the Council of 6 February 2003 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) (Seventeenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Verordnung über den Schutz der Arbeitnehmer/innen vor der Gefährdung durch Lärm und Vibrationen (Verordnung Lärm und Vibrationen – VOLV)
Directive 2006/25/EC of the European Parliament and of the Council of 5 April 2006 on the minimum health and safety requirements regarding the exposure of workers to risks arising from physical agents (artificial optical radiation) (19th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Verordnung über den Schutz der Arbeitnehmer/innen vor der Einwirkung durch optische Strahlung (Verordnung optische Strahlung – VOPST)
Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC
Verordnung des Bundesministers für Arbeit, Soziales und Konsumentenschutz über den Schutz der Arbeitnehmer/innen vor der Einwirkung durch elektromagnetische Felder (Verordnung elektromagnetische Felder – VEMF)