Overview of the European Machinery Directive

Michael Loerzer, President GLOBALNORM group

Austin
7 9 October 2013

Texas
http://www.psessymposium.org/ 1

Author, presenter
President
Globalnorm GmbH Globalconformity GmbH

Expertise, memberships
TK Regulatory Affairs, Spectaris Member of the IEEE Product Safety Engineering Society, USA Chairman Product Conformity Topic Group of the ANP German Committee of Standards Users (DIN ANP TGP)
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AGENDA
Placing on the market and operation of machinery Introduction in the Machinery Directive 2006/42/EC Main changes between 98/37/EC and 2006/42/EC New scope and definitions Specific directives and their application (e. g. ATEX Directive 94/9/EC) for machinery New procedure for partly completed machinery Conformity assessment procedure for machinery

INTRODUCTION

Machinery Directive
European legislation for machine safety Adresses manufacturers and/or importers
Paper machine Christmas tree stands

Current version
The new version of the Machinery Directive (MD) 2006/42/EC is mandatory since 2009-12-29 Changed/amended regulations:
Article 1 Scope Article 2 Definitions Article 5 Placing on the market and putting into service Article 7 Presumption of conformity and harmonized standards Article 12 Procedures for assessing the conformity of machinery Article 13 Procedure for partly completed machinery
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Application of the EU machinery guide

Published is the 2nd edition (June 2010)
the citations the recitals the articles

Recommendations for the application of the guide

dont read the whole guide for each article (red-lined text frames) you will find interpretations and guidance

Link to guide
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KAN Report 40
Commission for Occupational Health and Safety and Standardization (KAN) Publication of a report which shows the regulatory changes between 98/37/EC and 2006/42/EC (redlined) English, french and german www.kan.de No interpretation of the Directive

SCOPE AND EXCLUSIONS

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Scope (article 1 section 1)

Added products are
chains, ropes and webbing partly completed machinery

Wide range of products

It is necessary to read Art. 1 together with Art. 2 (definitions), Art. 3 (specific directives) and Art. 24 (amendment of Lift Directive), to understand the whole field of application of the new directive.
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Compliance requirements
Machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing and removable mechanical transmission devices Partly completed machinery

Specific defintions in article 2 Conformity assessment procedure (article 12): Fulfillment of annex I with risk assessment, technical file, EU declaration of conformity, CE marking

Article 2 (g): 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

Procedure (article 13): Fulfillment of annex I with risk assessment, technical file, declaration of incorporation
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Excluded EEE (article 1 section 2 (k))

This new sub clause defines the borderline between the new machinery directive and the Low Voltage Directive (now known as 2006/95/EC - LVD). This products within 501000 VAC and/or 751500 V are excluded from the MD

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Specific directives (article 3)

Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives.
See EU guide 90, 91 and 92
90 Specific Directives that apply instead of the Machinery Directive to machinery that is in their scope 91 Specific Directives that may apply to machinery instead of the Machinery Directive for specific hazards 92 Directives that may apply to machinery, in addition to the Machinery Directive, for hazards not covered by the Machinery Directive
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Specific regulations instead of the MD

Reference with respect to 90 Directive 2009/48/EC On the safety of toys Directive 89/686/EEC on personal protective equipment (PPED) Directive 93/42/EEC as amended by Directive 2007/47/EC on medical devices (MDD) Directive 95/16/EC on lifts (LD) Directive 2000/9/EC on cableway installations designed to carry persons

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Application of regulations with specific hazards instead of the MD

Reference with respect to 91 Directive 94/9/EC on equipment and protective systems intended for use in potentially explosive atmospheres (ATEX Directive) Directive 84/500/EEC on ceramic articles to come into contact with foodstuffs Directive 2009/105/EC on simple pressure vessels

Directive 2009/142/EC on appliances burning gaseous fuels Directive 97/23/EC on pressure equipment

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Application of regulations with specific hazards in addition to the MD

Reference with respect to 92 Directive 89/106/EC on construction products (CPD) New: Regulation (EU) 305/2011 laying down harmonized conditions for the marketing of construction products and repealing Council Directive 89/106/EEC Directive 97/68/EC as amended by Directives 2002/88/EC43 and 2004/26/EC on the emission of gaseous and particulate pollutants from internal combustion engines to be installed in nonroad mobile machinery (NRMMD)

Directive 1999/5/EC on radio and telecommunications terminal equipment (R&TTED) New RoHS Directive 2011/65/EU
Directive 2004/108/EC on electromagnetic compatibility (EMCD) Directive 2009/125/EC establishing a framework for the setting of ecodesign requirements for energy-related products

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Example 1
Electrical machinery No fixed installation Applicable regulations
EMCD 2004/108/EC with partly application of harmonized standards (EMC assessment) MD 2006/42/EC with applicable C-Standard

Sample of an EU declaration of conformity

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DEFINITIONS

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Art. 2 (a) Machinery 5 definitions

1. 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 It is the definition of machinery stricto sensu. That is the reason that some christmas tree stands shall be CE marked under the MD (power of a spring) Legal: no minimum claim limits!
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(a2) and (a3) definition

2. an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion 3. 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 Even prior to fitting or installation, these assemblies are already machinery according to the new directive
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Examples
(a2): only the power sources or interfaces are missing
brake test stand, test stand for motorcycles wood splitter for tractors

(a3): machinery which is ready-to-install

Cranes on trains Hydraulic platforms on trucks

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(a4) definiton
4. assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole Machine installation The Federal Ministry of Labour and Social Affairs has published a specific guidance note (2011-05) which was integrated in the EU Guide
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Assessment
Production process is given? Only an EU DoC and CE marking of each single machinery and/or declaration of incorporation of each single partly completed machiney is required Safety-related connection?

Assembly of machinery

EU DoC, CE marking (Art. 12)

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(a5) definition
5. 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 No regulatory changes

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Definition of a manufacturer
manufacturer means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer
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Substantial modifications
Operators are modifying machines during the lifetime Key questions: is that a substantial modification? If yes, the modified machine falls under the scope of the MD!!!
The Federal Ministry of Labour and Social Affairs has published a national guidance note for the market surveillance authorities and all stakeholders Operator Manufacturer Performance of a risk assessment is mandatory!
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COMPLIANCE REQUIREMENTS

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Placing on the market: machinery

a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I; b) ensure that the technical file referred to in Annex VII, part A is available c) provide, in particular, the necessary information, such as instructions EN 82079-1 d) carry out the appropriate procedures for assessing conformity in accordance with Article 12 e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery; f) affix the CE marking in accordance with Article 16
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Conformity assessment
Start

Machinery isnt listed in Annex IV?

no

Standards applied with all relevant ESH? Art. 12 (3) yes

no Art. 12 (4)

Art. 12 (2)

yes Procedure 1

Procedure 1 , 2 OR 3

Procedure 2 OR 3

End

Procedure 1
Internal production control (Annex VIII)

Procedure 2
EU type-examination (Annex IX) and no. 3 of Annex VIII

Procedure 3
Full quality assurance (Annex X)

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Placing on the market: partly completed machinery

Before placing partly completed machinery on the market, the manufacturer or his authorised representative shall ensure that the procedure referred to in Article 13 has been completed

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Partly completed machinery

a) the relevant technical documentation described in Annex VII, part B is prepared;
Including risk assessment (EN ISO 12100)

b) assembly instructions described in Annex VI are prepared; c) a declaration of incorporation described in Annex II, part 1, Section B has been drawn up
See sample

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CONCLUSIONS

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Conclusions
The new MD includes some new regulatory requirements in detail The most machine manufacturers in the EU have problems with the technical documentation including the risk assessment Some operators have no knowledge with respect to the MD if they modify the machine substantial! Also many operators dont know that the construction of machinery for ist own use is also within the the scope of the MD!
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Abbreviations
CE EEE EU DoC MD Conformit Europenne, meaning "European Conformity" Electrical and an eletronic equipment EU declaration of conformity Machinery Directive 2006/42/EC

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Contact
Thank you very much for your participation and attention Feel free to contact me if you have any questions
Michael Loerzer, President GLOBALNORM, Regulatory Affairs Specialist Michael.loerzer@globalnorm.de Phone: +49 30 3229027-51 Website http://www.globalnorm.de/en.html

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