risk assessment 2006/42/ec

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Guide to application of the Machinery Directive 2006/42/EC

Aims Directive 2006/42/EC contains provisions for machinery products that are placed on the market. The Directive aims at harmonising the health and safety requirements guaranteeing a high level of protection for EU workers and citizens, while ensuring the free circulation of machinery on the EU market. The purpose of the  Guide to application of the Machinery Directive 2006/42/EC (edition 2.2) is to provide explanations on the content of Directive 2006/42/EC in order to facilitate a uniform application throughout the EU. It is addressed to all of the parties involved in applying the Machinery Directive, including machinery manufacturers, importers and distributors, Notified Bodies, OSH and consumer protection agencies and officials of the relevant national administrations and market surveillance authorities.

Contents The comprehensive guide provides explanations for every item of the Directive: citations, recitals, articles and annexes. Each part starts with the text from the Directive, presented in boxed red italic type, followed by a comment section. From an OSH perspective, the explanations in the sections on  Annex I Essential health and safety requirements relating to the design and construction of machinery  are particularly interesting. These sections provide information on aspects such as machine guarding, noise emissions, vibration, etc. Guidance on the ergonomic requirements is available in a complementary document . 

Publication details Published by: European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Publication date: October 2019 Number of pages: 465 pp.

• Mechatronics and Motion Control
• Machine Safety

Risk Assessment Documentation & the new European Machinery Directive 2006/42/EC

The European Machinery Directive 2006/42/EC clearly calls out the requirements for the “Technical File”. Per this new Directive companies should consider that the risk assessment is required compliance documentation. This requirement is specifically detailed in the General Principles section of Annex I. In the earlier Directive there was always a need to access the hazards, but now the complete assessment process in included. Additionally, Annex VII of the new Directive also requires the entire risk assessment as part of the “Technical File”. In my opinion, machine builders need to realize that compliance to the new Directive includes documenting their risk assessment procedure.

I bring this out because over the last ten years there have been plenty of discussions about the new risk assessment requirements as machine safety vaulted to the top of considerations around the world. Wasn’t it back in the late 1990’s when the robotics world here in the U.S. declared that all robots will be supplied with risk assessments as part of their documentation from 1999 going forward? Throughout the next ten years I can personally count over a dozen machine standards that have included normative requirements for risk assessments as they completed their 3 to 5 year update cycles. Many standards now require that the risk assessment be initiated during the design stage and that it’s a “living” document for the life cycle of the machine.

With all this said, it seems that there is still confusion on one hand as to what is really required by regulation and on the other hand as to what will actually be supplied in the documentation. Yes, a dichotomy seems to live on! What are the possible drivers for suppliers of engineering or machinery to possibly not fully embrace supplying the risk assessment details? Do they consider some of the details to be proprietary? Is it that they don’t fully understand the risk assessment process? Is it an added expense which impacts narrow profit margins? Maybe it’s because they’ve made this machine for several years and there’s never been a serious hazard based incident? Or do some feel that this information slightly opens the liability door openly acknowledging that their machine might include a hazard?

I believe that all of these considerations (and more) play a role in the dichotomy discussion and that most of these perspectives have some basis on the issue of residual risk . Daily if not weekly I’m reminded that the awareness of residual risk is not openly acknowledged by machine builders. The fact that residual risk for any hazard will never reach zero – is in itself an acknowledged intellectual fact. But, it’s like the word “ safety ” in the 1970’s and 80’s which was feared if it appeared in print. We’ve advanced too far today to still hang onto old behaviors. I suggest that we learn from history to actively and smartly embrace these new requirements and carve out new pathways for sustainability.

     Are you a laggard or have I updated your mind?

Submit your ideas, experiences, or challenges in the comments section below.

Related articles:

Machine Safety & Residual Risk

Machine Safety and “reasonably foreseeable misuse”

Machinery Directive 2006/42/EC & EN ISO 13849-1; 2006 – with comments

Contact: www.jbtitus.com for “Solutions for Machine Safety”.

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Machinery Directive (MD)

Machinery Directive 2006/42/EC (MD) Evaluation and Testing

F2 Labs can perform the evaluation and testing required by the Machinery Directive at our facility or yours. We have assisted with the certification of thousands of products for compliance to the European Directives, including the Machinery Directive. The scope of the Machinery Directive 2006/42/EC is indicated in Article 1:

• interchangeable equipment
• safety components
• lifting accessories
• chains, ropes & webbing
• removable mechanical transmission devices
• partly completed machinery

The Machinery Directive is a European law and requires that equipment within its scope is compliant with the applicable technical requirements listed in Annex I. These technical requirements are called the Essential Health and Safety Requirements (EHSR’s).

The first step in compliance with Annex I is to perform a Risk Assessment on the equipment to determine which of the Annex I EHSR’s are applicable to the equipment, and therefore must be met. The process at that point is to prove and document, point-by-point, how the equipment is compliant with the selected EHSR’s or to determine which of the harmonized EN standards are applicable to the equipment, and then to apply those portions of the applicable harmonized standards to the applicable EHSR’s.

This means you have the choice to prove, technically, the compliance of each applicable EHSR or to apply the applicable portion of an applicable harmonized EN standard. The most practical method is to evaluate and test using harmonized EN standards because compliance with these confers the “presumption of conformity,” which is defined in Article 7 of the Machinery Directive. This is what we do and if there is a risk that is not covered by a harmonized EN standard we will address this specifically and technically.

EN ISO 12100:2010 is the sole harmonized Machinery Directive standard for risk assessment for non-explosive atmosphere equipment and is the first step mentioned above. F2 Labs can perform an evaluation on your equipment to EN ISO 12100:2010 and other harmonized EN standards that may apply.

There are three types or classes of EN standards as pertains to the Machinery Directive:

• A-type standards – cover principles common to all machinery; an example is EN ISO 12100:2010
• B-type standards – address specific aspects of machinery safety and safeguards
• C-type standards – product specific. If your product falls under the scope of a C-type EN standard then that standard is applicable

Once your machine has been evaluated, tested (if required), and made compliant the next step is to complete and sign the EC declaration of conformity. This is a one-page document that lists the machine, and specific details about it, plus the EN standards used to evaluate it and the applicable Directives to which you are claiming conformity for the machine. The EC declaration of conformity must accompany each machine sent to the EU and you must retain a copy of each one for ten years. The document must be matched to a specific machine: i.e., serial number. We can prepare the EC declaration of conformity for you.

You are also required to be able to quickly assemble a Technical File that contains the information needed to prove conformity to any Directives that apply to the machine. This file is used by the European authorities to assess the compliance of the machine but you should not send it with your machine to Europe. The requirement is detailed in Annex VII of the Machinery Directive and your customer does not have a right to this file unless you have previously agreed to it. This requirement extends ten years past the date you ship the machine to Europe. We can help you with this and we can securely store it for you also

The Machinery Directive also requires that your EC declaration of conformity lists an address on community soil (the EU) to which the authorities may write in order to make a formal request for the Technical File. This is a responsibility that an Authorized EU Contact may legally assume for you. We offer that service as well.

Please call or email us to discuss your European CE Mark project. We have helped many machinery manufacturers with this process.

Helpful Links:

• Directive 2006/42/EC (PDF)
• Machinery Directive 2006/42/EC Guide (PDF)
• Application guide: ergonomic health and safety requirements
• Directive 2009/127/EC, machinery for pesticide application
• Regulation (EU) No. 167/2013 for the market surveillance of agricultural and forestry vehicles
• Changes to Machinery Directive Blog Article

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Risk assessment according Machinery Directive 2006/42/EC

4S carries out a written risk assessment for your machine. A risk assessment is a legal requirement according Machinery Directive 2006/42/EC and has to be conducted by every manufacturer of a machine. According Annex I of the directive:

The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

You might even become a manufacturer of a “new” machine when modifying your machinery in a scope which is not the intended use. When building partly completed machinery you also have to carry out a risk assessment.

The international standard EN ISO 12100 Safety of machinery – General principles for design – Risk assessment and risk reduction will be the basis of the risk assessment carried out by 4S. This standard is harmonized according Machinery Directive 2006/42/EC which means simplified: When you fulfill the requirements of the standard you also meet the requirements of the directive. You ar insecure if you are a manufacturer of machinery or partly completed machinery and have to carry out a risk assessment?

CONTACT 4S . 4S supports you to clarify your legal requirements when building or modifying machinery.

cemarking.net

Your Definitive Guide to CE Marking

Machinery Directive 2006/42/EC: Your Definitive Guide

The Machinery Directive, what is it and how does it impact your business? How is it related to CE marking and European Union’s product certification rules? In this Definitive Guide to the Machinery Directive 2006/42/EC, you will find the answers to these questions and more. You will learn why there is a Machinery Directive, to whom it concerns, what it is all about, and how to achieve CE compliance for machinery.

Table of contents

What is the machinery directive 2006/42/ec, why did the european union adopt a regulation for machinery, which products are covered by the machinery directive, which products are exempted from the machinery directive, how to comply with the machinery directive (2006/42/ec), what if the machinery does not comply, do you need ce marking for machinery, other articles that may interest you:.

The Machinery Directive is a European Union directive concerning machinery and certain parts of machinery: mandatory specifications in health and safety are combined with voluntary harmonized standards.  The Machinery Directive applies to machinery as well as interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices, and partly completed machinery.

Directive 2006/42/EC is all about safety. Safety of machinery, but also the safety of related products are regulated.  It provides the requirements that products must comply with. The potential for the machinery to create hazardous situations must be minimized, or -even better- eliminated. It also lays out the procedures how to assess conformity.

The aim of the Machinery Directive is to harmonize essential health and safety requirements for machinery between all member states of the European Union. Common rules allow for the removal of trade restrictions, and the free movement of machinery within the EU market. At the same time, the requirements guarantee a high level of protection for European workers and European citizens. Safe machinery and fair competition, that’s the purpose.

The directive applies to the following types of products:

• Interchangeable equipment
• Safety components
• Lifting accessories
• Removable mechanical transmission devices
• Ropes, webbing and chains and
• Partly completed machinery.

Let’s look into each of these in more detail:

• ‘Machinery’ is defined as an assembly of linked parts or components of which at least one moves and joined together for a specific application, fitted with a drive system other than directly applied human or animal effort. A conveyor belt, for example, is a machine in its own right. Applications with only directly applied human power may be machinery if intended for lifting and lowering loads, for example, a pulley is a machinery.
• ‘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.
• A ‘safety component’ means a component: which serves to fulfill 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 link to an external website, which may be updated in accordance with Article 8(1)(a)
• A ‘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.
• ‘Chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories.
• ‘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.
• ‘Partly completed machinery’ means it is an assembly that 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 the Directive applies.

Some types of machinery and equipment are exempted from Directive 2006/42/EC. Typically, this is because these are covered by other, specific EU regulations. Currently outside of the scope of the directive are the following types of equipment:

• Equipment used explicitly in fairgrounds and/or amusement parks.
• Weapons, with the inclusion of firearms.
• Means of transport, such as forestry and agricultural tractors; motor vehicles and trailers covered by Council Directive 70/156/EEC; vehicles covered by Directive 2002/24/EC; vehicles meant for competing; air/water/rail means of transport, excluding any machinery mounted on them.
• Any military and police machinery.
• Any research machinery for temporary use in labs.
• Mind winding gear.
• Machinery equipment intended to move performers during artistic performances.
• High-voltage equipment, such as switch and control gears, and transformers.
• Safety components used as spare parts for replacing identical components in the original machinery.
• Machinery equipment for nuclear purposes that, in the event of failure, can emit radioactivity.
• Mobile offshore units and seagoing vessels, and any machinery mounted on them.
• Electrical and electronic equipment, such as ordinary office machinery, electric motors, audio, and video equipment, domestic household appliances, information technology equipment, and, low-voltage switch and control gears.

Who is responsible for compliance with the Machinery Directive?

The following persons or companies are responsible for compliance of machinery with the Machinery Directive:

• Machine builders.
• Assemblers of machine parts or installations.
• Manufacturers of special-purpose tools, skids and rigs.
• Machinery importers located in the EU.
• Machinery distributors or dealers that buy from the EU-based manufacturer or importer have the obligation to verify that the conformity assessment was performed and that the necessary documentation and information is available.

The compliance process of any machinery should include the following steps, performed by the manufacturer:

• Determine the applicable essential health and safety requirements from the directive and from related harmonised standards.
• Conformity assessment: ensure that the product satisfies all essential health and safety requirements applicable to it.
• Compile the set of technical documentation proving the machinery’s compliance with the requirements into a Technical File .
• Draw up an EU Declaration of Conformity and ensure that it accompanies the product.
• Affix the CE marking to the product.
• Take steps to ensure the machinery remains in compliance, even after modifications and after amendments of the regulations and standards.

However, the process described above can be a bit different when it comes to partly completed machinery. In such a case, the manufacturer needs to:

• Prepare all technical documentation described in Annex VII, Part B of the Directive and ensure compliance by doing the conformity assessment
• Prepare assembly instructions as defined in Annex VI of the Directive.
• Draw up a Declaration of Incorporation as stated in Annex II, part 1, section B .
• Ensure that the assembly instructions and the Declaration of Incorporation accompany the partly completed machinery. The CE marking may not be affixed to partly complted machinery.

There are basically two ways for manufacturers to perform the conformity assessment.

The Machinery Directive (2006/42/EC) offers two ways to perform conformity assessment: ‘self-certification’ or ‘self-declaration’ versus third party certification. Read this linked article to learn more about how for most products CE marking self-certification is allowed.

1. Internal Production Control or CE marking self-certification: the manufacturer performs the conformity assessment and documents the assessment in his own right.

When putting machinery on the EU market, manufacturers must guarantee that a risk assessment is carried out. The purpose of the risk assessment is to determine all the necessary health and safety requirements applicable to the machinery. Afterward, the design and construction of the machine must follow the results of the risk assessment.

Usually, what the manufacturers need to do in regards to the risk assessment is:

• To determine the limits of the machinery when used.
• To make sure all hazards, which the machinery can generate, are identified and considered, along with all associated hazardous situations.
• To estimate all possible health risks and their probability of occurrence.
• To evaluate all the identified risks and determine if risk reduction is needed.
• To eliminate all recognized hazards and reduce all risks associated with them.

2. Involvement of a Notified Body: For higher risk machinery (listed in Annex IV to the Machinery Directive, as seen in the paragraph above), for which no European harmonized standards are available, or for which the manufacturer did not apply these standards, the manufacturer is required to involve a third-party certification body, or so-called ‘Notified Body’.  This is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is required.

The following machines are listed in Annex IV of the Machinery Directive, and this means that for these machines it is mandatory to involve a Notified Body in the conformity assessment if the manufacturer has not used (all) European harmonised standards:

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. Thickeners 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 meters.

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).

If machinery does not comply with the requirements of the Machinery Directive (2006/42/EC), or any other EU directive or regulation that applies to it, it may not be made available in the market. Compliance is checked and enforced by market surveillance authorities of the EU Member States. (In other words, there is not a European Union agency or organisation that checks CE conformity.)

In the event of discovering non-compliant machinery placed on the EU market, the Member State can take immediate actions to:

• Withdraw such products from the market.
• Prohibit the placing on the EU market and/or putting into service of such machinery.
• Restrict the free movement of such equipment.

Consequently, the Member State will inform the European Commission and the other Member States of its actions, stating the motives for its decision, which could be related to:

• Failure to comply with the essential requirements of the Machinery Directive 2006/42/EC.
• Improper application of the harmonized standards.
• Shortcomings in the harmonized standards themselves.
• Significant safety risks, despite compliance with the requirements and standards.

Then, after it is notified about the problem, the European Commission will consult with the parties concerned, inform all other member States and take appropriate measures according to what is stated in the Directive 2006/42/EC.

Are you making available machinery, safety components, interchangeable equipment or any other products covered by Directive 2006/42/EC in the EU market? In that case, your product may need to comply with the CE rules. Hopefully, this article has provided you with the guidance to get started.

We also invite you to read some other articles that may be of interest to you:

• What are the costs of CE marking?
• Which countries require the CE marking?
• What are the benefits of CE marking?
• Do your products need CE marking?
• Can you do CE self-certification?
• Who is responsible for CE marking?
• Technical File
• EU Declaration of Conformity

We understand that the requirements can be complex. The process is daunting and rather intimidating, considering that all your efforts may be in vain if you don’t get it right. We will be happy to help. We offer consulting and coaching solutions and can tailor our services to your specific needs.

Reach out to us by phone, or simply fill out the form at https://cemarking.net/start/ to ensure we have the information we need to provide you with a fitting offer. Our team looks forward to assisting you.

• Machinery Directive – 2006/42/EC
• Low Voltage Directive – 2014/35/EU
• EMC Directive – 2014/30/EU
• Medical Devices Directive – 93/42/EEC
• Personal Protective Equipment Directive – 89/686/EEC
• Construction Products Regulation – Regulation (EU) No 305/2011
• Pressure Equipment Directive – 97/23/EC
• REACH – Regulation (EC) No 1907/2006
• RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
• Waste Electrical and Electronic Equipment Directive – 2012/19/EU
• ATEX Directive – 2014/34/EU
• Toy Directive – 2009/48/EC
• R&TTE Directive – 1999/5/EC
• Recreational Craft Directive – 94/25/EC
• Active Implantable Medical Devices Directive – 90/385/EEC
• Explosive for Civil Use Directive – 93/15/EEC
• Noise Emission in the Environment Directive – 2000/14/EC
• Gas Appliances Directive – 2009/142/EC
• Lifts Directive – 1995/16/EC
• Pyrotechnic Directive – 2007/23/EC
• Measuring Instruments Directive – 2004/22/EC
• What is CE marking?
• What does the CE mark mean? What do the initials CE stand for?
• How do you benefit from CE marking? ?
• In which countries is the CE marking required?
• What does CE certification cost?
• Do our products automatically qualify for the CE mark when they are UL/CSA approved?
• Who should undertake CE marking?
• Notified Bodies: What Are They? What Is Their Role
• What is the CE marking process?
• What files / documentation must I keep?
• How and where must the CE mark appear?
• Other Posts About CE Marking

• Welcome to "industry-finder." web site
• Council Resolution of 7 May 1985 on a new approach
• Evaluation of Directive 2006/42/EC on Machinery - Final Report
• New blue guide on the implementation of EU product rules 2016
• CE marking and machines
• The new blue guide dated 04/2014
• Machinery new regulation framework
• History of the Machinery Directive 2006/42/EC
• Whereas of machinery directive 2006/42/EC
• Article 1 of machinery directive 2006/42/EC - Scope
• Article 2 of machinery directive 2006/42/EC - Definitions
• Article 3 : Specific Directives of machinery directive 2006/42/EC
• Article 4 : Market surveillance of machinery directive 2006/42/EC
• Article 5 : Placing on the market and putting into service - machinery directive 2006/42/EC
• Article 6 : Freedom of movement - machinery directive 2006/42/EC
• Article 7 : Presumption of conformity and harmonised standards - machinery directive 2006/42/EC
• Article 8 : Specific measures - machinery directive 2006/42/EC
• Article 9 : Specific measures to deal with potentially hazardous machinery - machinery directive 2006/42/EC
• Article 10 : Procedure for disputing a harmonised standard - machinery directive 2006/42/EC
• Article 11 : Safeguard clause - machinery directive 2006/42/EC
• Article 12 : Procedures for assessing the conformity of machinery - machinery directive 2006/42/EC
• Article 13 : Procedure for partly completed machinery - 2006/42/EC
• Article 14 : Notified bodies - machinery directive 2006/42/EC
• Article 15 : Installation and use of machinery - machinery directive 2006/42/EC
• Article 16 : CE marking - machinery directive 2006/42/EC
• Article 17 : Non-conformity of marking - machinery directive 2006/42/EC
• Article 18 : Confidentiality - machinery directive 2006/42/EC
• Article 19 : Cooperation between Member States - machinery directive 2006/42/EC
• Article 20 : Legal remedies - machinery directive 2006/42/EC
• Article 21 : Dissemination of information - machinery directive 2006/42/EC
• Article 22 : Committee - machinery directive 2006/42/EC
• Article 23 : Penalties - machinery directive 2006/42/EC
• Article 24 : Amendment of Directive 95/16/EC - machinery directive 2006/42/EC
• Article 25 : Repeal - machinery directive 2006/42/EC
• Article 26 : Transposition - machinery directive 2006/42/EC
• Article 27 : Derogation - machinery directive 2006/42/EC
• Article 28 : Entry into force - machinery directive 2006/42/EC
• Article 29 : Addressees - machinery directive 2006/42/EC
• GENERAL PRINCIPLES of annex 1 of machinery directive 2006/42/EC
• 1 ESSENTIAL HEALTH AND SAFETY REQUIREMENTS of annex 1 - definitions - machinery directive 2006/42/EC
• Article 1.1.2. Principles of safety integration of annex 1 machinery directive 2006/42/EC
• Article 1.1.3. Materials and products annex 1 machinery directive 2006/42/EC
• Article 1.1.4. Lighting - annex 1 machinery directive 2006/42/EC
• Article 1.1.5. Design of machinery to facilitate its handling - annex 1 machinery directive 2006/42/EC
• Article 1.1.6. Ergonomics - annex 1 machinery directive 2006/42/EC
• Article 1.1.7. Operating positions - annex 1 machinery directive 2006/42/EC
• Article 1.1.8. Seating - annex 1 machinery directive 2006/42/EC
• Article 1.2.1. Safety and reliability of control systems - annex 1 of machinery directive 2006/42/EC
• Article 1.2.2. Control devices - annex 1 of machinery directive 2006/42/EC
• Article 1.2.3. Starting - annex 1 of machinery directive 2006/42/EC
• Article 1.2.4. Stopping - annex 1 of machinery directive 2006/42/EC
• Article 1.2.4.4. Assembly of machinery - Annex 1 of machinery directive 2006/42/EC
• Article 1.2.5. Selection of control or operating modes - annex 1 of machinery directive 2006/42/EC
• Article 1.2.6. Failure of the power supply - annex 1 of machinery directive 2006/42/EC
• Article 1.3. PROTECTION AGAINST MECHANICAL HAZARDS - annex 1 of machinery directive 2006/42/EC
• Article 1.4. REQUIRED CHARACTERISTICS OF GUARDS AND PROTECTIVE DEVICES - annex 1 of machinery directive 2006/42/EC
• Article 1.5. RISKS DUE TO OTHER HAZARDS - annex 1 of machinery directive 2006/42/EC
• Article 1.6. MAINTENANCE - annex 1 of machinery directive 2006/42/EC
• Article 1.7. INFORMATION - annex 1 of machinery directive 2006/42/EC
• Article 2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS - annex 1 machinery directive 2006/42/EC
• Article 3. SUPPLEMENTARY ESSENTIAL HEALTH TO THE MOBILITY OF MACHINERY - annex 1 machinery directive 2006/42/EC
• Article 4. SUPPLEMENTARY REQUIREMENTS TO OFFSET HAZARDS DUE TO LIFTING OPERATIONS of machinery directive 2006/42/EC
• Article 5. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR UNDERGROUND WORK of machinery directive 2006/42/EC
• Article 6. SUPPLEMENTARY REQUIREMENTS - HAZARDS DUE TO THE LIFTING OF PERSONS of machinery directive 2006/42/EC
• Annex II : Declarations of CONFORMITY OF THE MACHINERY, DECLARATION OF INCORPORATION - machinery directive 2006/42/EC
• Annex III of machinery directive 2006/42/EC - CE marking
• Annex IV of machinery directive 2006/42/EC
• Annex V of machinery directive 2006/42/EC
• Annex VI of machinery directive 2006/42/EC
• Annex VII - Technical file for machinery - machinery directive 2006/42/EC
• Annex VIII - Assessment of conformity of machinery directive 2006/42/EC
• Annex IX of machinery directive 2006/42/EC - EC type-examination
• Annex X of machinery directive 2006/42/EC - Full quality assurance
• Annex XI of machinery directive 2006/42/EC - Minimum criteria for the notification of bodies
• Annex XII of machinery directive 2006/42/EC - Correlation table between machinery directive 2006/42/CE and MD 1998/37/CE
• considerings of machinery directive 1998/37/CE
• articles of 1998/37/EC machinery directive
• Annex I of 1998/37/CE machinery directive
• Annex II of 1998/37/EC machinery directive
• Annex III of machinery directive 1998/37/CE
• Annex IV of machine directive 1998/37/EC
• Annex V of machines directive 1998/37/CE
• Annex VI of machines directive 1998/37/EC
• Annex VII of machines directive 1998/37/EC
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• Annex IX of machinery directive 1998/37/CE
• whereas of machinery directive machines 1989/392/EEC
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• Annex I of machinery directive 1989/392/EEC
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• Annex IV of machinery directive 1989/392/EEC
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• Annexe VII of machinery directive 1989/392/EEC
• DIRECTIVE 1991/368/EEC amending Directive 89/392/EEC
• DIRECTIVE 93/44/EEC amending Directive 89/392/EEC
• DIRECTIVE 93/68/EEC amending Directives 89/392/EEC (machinery)
• Whereas of ATEX 94/9/CE directive
• article 1 ATEX 94/9/EC directive
• article 2 ATEX 94/9/EC directive
• article 3 ATEX 94/9/EC directive
• article 4 : ATEX 94/9/EC directive
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• article 7 : ATEX 94/9/EC directive
• article 8 ATEX 94/9/EC directive
• article 9 : ATEX 94/9/EC directive
• article 10 : ATEX 94/9/EC directive
• article 11 : ATEX 94/9/EC directive
• article 12 : ATEX 94/9/EC directive
• article 13 : ATEX 94/9/EC directive
• article 14 : ATEX 94/9/EC directive
• article 15 : ATEX 94/9/EC directive
• article 16 : ATEX 94/9/EC directive
• ANNEX I of ATEX 94/9/EC directive : CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES
• ANNEX II of ATEX 94/9/EC : directive ESSENTIAL HEALTH AND SAFETY REQUIREMENTS -EHSR
• ANNEX III of ATEX 94/9/EC directive : MODULE EC-TYPE EXAMINATION
• ANNEX IV of ATEX 94/9/EC directive : MODULE PRODUCTION QUALITY ASSURANCE
• ANNEX V of ATEX 94/9/EC directive : MODULE PRODUCT VERIFICATION
• ANNEX VI of ATEX 94/9/EC directive : MODULE CONFORMITY TO TYPE
• ANNEX VII of ATEX 94/9/EC directive : MODULE PRODUCT QUALITY ASSURANCE
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• ANNEX IX of ATEX 94/9/EC directive : MODULE UNIT VERIFICATION
• ANNEX X of ATEX 94/9/EC directive : CE Marking - Content of the EC declaration of conformity
• ANNEX XI of ATEX 94/9/EC directive: NOTIFICATION OF BODIES
• Whereas of ATEX 99/92/EC directive
• Articles of ATEX 99/92/EC directive
• Annex 1 of ATEX 99/92/EC directive
• Annex 2 of ATEX 99/92/EC directive
• Annex 3 of ATEX 99/92/EC directive
• whereas of 2014/34/UE ATEX directive
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• Annex 1 of ATEX 2014/34/UE directive
• Annex 2 of the ATEX 2014/34/UE directive
• Annex 3 of ATEX 2014/34/UE directive
• Annex 4 of ATEX 2014/34/UE directive
• Annex 5 of ATEX 2014/34/UE directive
• Annex 6 of ATEX 2014/34/UE directive
• Annex 7 of ATEX 94/9/EC directive
• Annex 8 of the ATEX 2014/34/UE directive
• Annex 9 of the ATEX 2014/34/UE directive
• Annex 10 of ATEX 2014/34/UE directive
• Annex 11 of ATEX 2014/34/UE directive
• Annex 12 of the ATEX 2014/34/UE directive
• EN 13980 2002 standard
• EN ISO/CEI 80079-34:2011-09
• IECEx Quality System Requirements for Manufacturers - OD 005
• New ATEX directive
• RASE european project
• European regulation for machines - standardization for machines - harmonized standards
• EN ISO 12100 - Décembre 2010
• EN ISO 12100-1 - January 2004
• EN ISO 12100-1:2003/A1
• EN ISO 12100-2 November 2003
• EN ISO 12100-2:2003/A1
• EN ISO 14121-1 September 2007
• ISO/TR 14121-2 - 2007
• EN 50205:2002 standard - Relays with forcibly guided (mechanically linked) contacts
• ISO 11161:2007
• ISO 13849-1:2006
• ISO 13849-2:2012
• ISO 13850:2006 - Safety of machinery -- Emergency stop -- Principles for design
• ISO 13851:2002 - Safety of machinery -- Two-hand control devices -- Functional aspects and design principles
• ISO 13854:1996 Safety of machinery - Minimum gaps to avoid crushing of parts of the human body
• ISO 13855:2010 - Safety of machinery -- Positioning of safeguards with respect to the approach speeds of parts of the human body
• ISO 13856-1:2013 Safety of machinery -- Pressure-sensitive protective devices -- Part 1: General principles
• ISO 13856-2:2013 - Safety of machinery -- Pressure-sensitive protective devices -- Part 2: General principles for design testing
• ISO 13856-3:2013 Safety of machinery -- Pressure-sensitive protective devices - Part 3: General principles for design
• ISO 13857:2008 Safety of machinery -- Safety distances to prevent hazard zones
• ISO 14118:2000 - Safety of machinery -- Prevention of unexpected start-up
• ISO 14119:2013- Interlocking devices associated with guards
• ISO 14120:2002 - Guards -- General requirements for the design and construction
• ISO 14122-1:2001 - Permanent means of access to machinery
• ISO 14122-2:2001 - Permanent means of access to machinery
• ISO 14122-4:2004 - Permanent means of access to machinery
• ISO 14123-1:1998 - Reduction of risks to health from hazardous substances emitted by machinery
• ISO 14123-2:1998 - Reduction of risks to health from hazardous substances emitted by machinery
• ISO 14159:2002 - Hygiene requirements for the design of machinery
• ISO 19353:2005 -- Fire prevention and protection
• ISO/AWI 17305 - Safety of machinery - Safety functions of control systems
• ISO/DTR 22100-2 - Safety of machinery -- Part 2: How ISO 12100 relates to ISO 13849-1
• ISO/TR 14121-2:2012 - Risk assessment - Part 2: Practical guidance
• ISO/TR 18569:2004 - Guidelines for the understanding and use of safety of machinery standards
• ISO/TR 23849:2010 - Guidance on the application of ISO 13849-1 and IEC 62061 in the design of safety-related control systems
• STABILITY DATES FOR Machinery STANDARDS
• Publication of harmonised standards for machinery directive 2006/42/EC - 9.3.2018
• Harmonized standard list - machinery directive 2006/42/EC - 9.6.2017
• Harmonized standards for machinery - OJ C 2016/C173/01 of 15/05/2016
• Harmonized standards for machinery -OJ C 2016/C14/102 of 15/01/2016
• Harmonized standards for machinery - corrigendum OJ C 2015/C 087/03 of 13/03/2015
• harmonized standards for machinery - OJ C 2015/C 054/01 of 13/02/2015
• Guide to application of the machinery directive 2006/42/CE - July 2017 - citations-recitals
• Guide to application of the machinery directive 2006/42/CE - July 2017 - the articles of MD
• Guide to application of machinery directive - 1-2 : The citations
• Guide to application of machinery directive - § 3 to § 31 The Recitals
• Guide to application of machinery directive - § 32 to § 156 - The Articles
• Guide to application of machinery directive - § 157 to § 381 - Annex I
• Guide to application of machinery directive - § 382 to § 386 - ANNEX II Declarations
• Guide to application of machinery directive - § 387 - ANNEX III CE marking
• RFU 0.100 status of RFU
• Notified bodies under the machinery directive 2006/42/CE
• IEC 60079-0
• GUIDANCE DOCUMENT ON THE ATEX DIRECTIVE TRANSITION FROM 94/9/EC TO 2014/34/EU
• Harmonized standard list for ATEX 2014/34/UE - 12-10-2018
• Harmonized standard list for ATEX 2014/34/UE - 15.6.2018
• Harmonized standard list for ATEX 2014/34/UE - 12-07-2019
• Harmonized standard list for ATEX 2014/34/UE - 9.6.2017
• Harmonized standards list ATEX 2014/34/UE directive - OJ C 126 - 08/04/2016
• application guide of 2014/34/EU directive - preambule, citations and recitals
• Guide to application of the ATEX 2014/34/UE directive - THE ARTICLES OF THE ATEX DIRECTIVE
• Guide to application of the ATEX 2014/34/UE directive - ANNEX I CLASSIFICATION INTO CATEGORIES
• Guide to application of the ATEX 2014/34/UE directive - ANNEX II ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
• Guide to application of the ATEX 2014/34/UE directive - ANNEX III MODULE B: EU-TYPE EXAMINATION
• Guide to application of the ATEX 2014/34/UE directive - ANNEX IV MODULE D: CONFORMITY TO TYPE
• Guide to application of machinery directive - § 388 - ANNEX IV machinery and mandatory certification
• Guide to application of the ATEX 2014/34/UE directive - ANNEX V MODULE F: CONFORMITY TO TYPE
• Alignment of ten technical harmonisation directives - Decision No 768/2008/EC
• 1 INTRODUCTION of ATEX 94/9/EC guidelines 4th edition
• 2 OBJECTIVE OF THE ATEX DIRECTIVE 94/9/EC - ATEX 94/9/EC guidelines 4th edition
• 3 GENERAL CONCEPTS of ATEX 94/9/EC directive ATEX 94/9/EC guidelines 4th edition
• 4 IN WHICH CASES DOES DIRECTIVE 94/9/EC APPLY - ATEX 94/9/EC guidelines 4th edition
• 5 EQUIPMENT NOT IN THE SCOPE OF DIRECTIVE 94/9/EC - ATEX 94/9/EC guidelines 4th edition
• 6 APPLICATION OF DIRECTIVE 94/9/EC ALONGSIDE OTHERS THAT MAY APPLY - ATEX 94/9/EC guidelines 4th edition
• 7 USED, REPAIRED OR MODIFIED PRODUCTS AND SPARE PARTS - ATEX 94/9/EC guidelines 4th edition
• 8 CONFORMITY ASSESSMENT PROCEDURES - ATEX 94/9/EC guidelines 4th edition
• 9 NOTIFIED BODIES - ATEX 94/9/EC guidelines 4th edition
• 10 DOCUMENTS OF CONFORMITY - ATEX 94/9/EC guidelines 4th edition
• 11 MARKING - CE marking -ATEX 94/9/EC guidelines 4th edition
• 12 SAFEGUARD CLAUSE AND PROCEDURE - ATEX 94/9/EC guidelines 4th edition
• ​13 EUROPEAN HARMONISED STANDARDS - ATEX 94/9/EC guidelines 4th edition
• 14 USEFUL WEBSITES - ATEX 94/9/EC guidelines 4th edition
• ANNEX I: SPECIFIC MARKING OF EXPLOSION PROTECTION - ATEX 94/9/EC guidelines 4th edition
• ANNEX II: BORDERLINE LIST - ATEX PRODUCTS - ATEX 94/9/EC guidelines 4th edition
• Harmonized standards list ATEX 94/9/EC directive - OJ C 126 - 08/04/2016
• Harmonized standards list ATEX 94/9/EC - OJ C 335 - 09/10/2015
• Harmonized standards list ATEX 94/9/EC - OJ-C 445-02 - 12/12/2014
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• Harmonized standards list ATEX 94/9/EC - OJ-C 319 05/11/2013
• European regulation for ATEX 94/9/EC ATEX directive
• § 1 The citations - application guide 2nd edition of the ATEX 2014/34/EU directive
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General principles of annex 1 of machinery directive 2006/42/ec.

The text in RED color is the amended or added text in comparison with the former 98/37/EC machinery directive

GENERAL PRINCIPLES

1. The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

Comment: risk assesment

The four principles of safety must be applied in the order as defined. This is the assessment process and risk reduction defined in EN 12100-1.

The ESSENTIAL HEALTH AND SAFETY REQUIREMENTS   (EHSR) of Annex 1 of the Directive are based four general principles:

• The first principle relates to the risk assessment (formerly risk analysis in the previous directive) as a basic principle to identify hazards and assess risks associated with the machine so as to apply the EHSR that relates to the machine
• Other general principles (numbered 2, 3 and 4, below) are essential and must be taken into account to satisfy the EHSR in the design and construction of the machine.

The EHSR are only applicable when there is a hazard for the machine. The list of dangers is the subject of all the chapters of Annex I of the Directive. During hazard identification, the machine builder must take into account ALL phases of machine life (transport, implementation, operation, maintenance, ...).

This risk assessment process is an iterative process in which each risk reduction  measure must be evaluated in order to measure its contribution to the overall risk reduction . An other objective is to ensure that this measure does not generate any new risk.

At the risk analysis level, that must be performed by the manufacturer or its agent or an other entity acting on its behalf. In all cases, the manufacturer remains responsible for the completeness and extent of the risk analysis and the implementation of the necessary measures to reduce risks during the phases of design and building of the machine. The results of this risk analysis are components of the construction file ("technical file")

Les quatre principes de sécurité doivent s’appliquer dans l’ordre. Il s’agit du processus d’évaluation et de réduction des risques mentionné dans la norme EN 12100-1.

Les exigences essentielles de sécurité et de santé (EESS) de l’annexe 1 de la directive ont pour base 4 principes généraux :

• Le premier principe concerne à l’évaluation des risques (anciennement analyse de risque dans la précédente directive) comme principe de base pour identifier les dangers et évaluer les risques en rapport avec la machine de façon a appliquer les EESS qui se rapportent à la machine
• Les autres principes généraux (numérotés 2, 3 et 4 –ci-après) sont essentiels et doivent être pris en compte de façon à satisfaire les EESS lors de la conception et de la construction de la machine.

Les EESS sont applicables uniquement lorsque le danger existe pour la machine en question. La liste des dangers fait l’objet de tous les chapitres de l’annexe I de la directive. Lors de l’identification des dangers, il faut tenir compte de TOUTES les phases de vie de la machine (transport, mise en œuvre, utilisation, maintenance, …).

Ce processus d’évaluation des risques est un processus itératif, dans lequel chaque mesure de réduction du risque doit être évaluée dans le but de mesurer sa contribution à la réduction du risque global. Elle a également pour but de s’assurer que cette mesure ne génère pas de nouveau risque.

Au niveau de l’analyse de risques, cette dernière doit être réalisée par le fabricant ou de son mandataire ou par une autre entité agissant en son nom. Dans tous les cas, le fabricant reste responsable de la complétude et de l’étendue de cette analyse de risques et de la mise en place des mesures nécessaires de réduction de risques lors des phases de conception et de construction de la machine. Les résultats de cette analyse de risque sont des éléments constitutifs du dossier de construction (« technical file »)

Comment 3: Risk assessment and C-type standards

The risk analysis is to be done, however, if a type C standard exists, then the requirements of this C-standard covers partially or completely all risks of the machine.   In this case, the risk analysis can be simplified.

Original Comment  3: Evaluation des risques et normes de type C

L’analyse de risque est à faire, toutefois dans le cas ou une une norme de type C existe, alors les exigences de cette norme couvrent partiellement ou totalement l’ensemble des risques de la machine. Dans ce cas, cette analyse de risque peut être simplifiée.

By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall:

- determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof,

- identify the hazards that can be generated by the machinery and the associated hazardous situations,

- estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence,

- evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive,

- eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).

2. The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the manufacturer  or his authorised representative or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 apply.

foreseeable abnormal situations must also be considered.

Original Comment:

Les situations anormales prévisibles doivent également être considérées.

3. The essential health and safety requirements laid down in this Annex are mandatory; However, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.

4. This Annex is organised in several parts. The first one has a general scope and is applicable to all kinds of machinery. The other parts refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the relevant essential requirements. When machinery is being designed, the requirements of the general part and the requirements of one or more of the other parts shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles.

This last safety principle insists once again on the need to perform a risk assessment, and then to comply with the essential health &  safety requirements that apply to all machines and are defined in the general part of annex (Chapter 1) and to meet the specific requirements set out in Annex 1 (Chapters 2 to 6) for other specific machines.

Ce dernier principe de sécurité insiste une fois encore sur la nécessite de réaliser une évaluation des risques, puis de satisfaire les exigences essentielles de sécurité et de santé générales qui s’appliquent à toutes les machines et définies dans la partie générale de l’annexe 1 (chapitre 1) puis de satisfaire les exigences particulières définies à l’annexe 1 (chapitres 2 à 6) pour les autres machines spécifiques.

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New Machinery Directive Guide 2006/42/EC (6th Ed)

Introduction

The new Machinery Directive 2006/42/EC became applicable on 29 December 2009, superseding the Machinery Directive 98/37/EC.  While the two are broadly similar, there are significant differences that affect machine builders, those performing final assembly and CE marking of machinery, and those placing imported machinery on the market in the European Economic Area (EEA), Switzerland and Turkey.

This guide highlights differences between the new and old Directives and provides information that will aid compliance with the new requirements.  However, it remains the reader’s responsibility to ensure compliance with the requirements of the Directive.

Since 29 December 2009 Directive 2006/42/EC has regulated the placing on the market, and the putting into service, of machinery in the EEA, replacing the existing Directive 98/37/EC.  This recasting of the Machinery Directive, which is a comprehensive amendment, is intended to extend the scope, improve clarity, remove some of the acknowledged flaws that existed in the old Directive, provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery, especially prototype and bespoke machinery, and introduce provisions for market surveillance.

National Governments are required to implement the Directive through their own legislation; the UK Government has done this by introducing new Machinery Regulations.

This is not the first time that the Machinery Directive has undergone changes.  It was originally known as Directive 89/392/EEC, then it was amended by Directives 91/386/EEC and 93/68/EEC.  Directive 98/37/EC was created to consolidate the original Directive and its amendments.

In 2001 the European Commission proposed to amend Directive 98/37/EC and, following protracted negotiations, an agreed text was published in late 2005.

Directive 2006/42/EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive.

National Governments had until 29 June 2008 to transpose the Directive into their domestic legislation.  Here in the UK, Statutory Instrument 2008/1597  The Supply of Machinery (Safety) Regulations  2008 came into force on 29 December 2009 in accordance with the Directive.  The new Regulations replace the Supply of Machinery (Safety) Regulations 1992, as well as the 1994 and 2005 amendments.

CEN (the European standards organisation) had until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive, though this task was not completed on time.

On 29 December 2009 the new Directive became applicable and the old Directive was repealed.  There was no transition period except for cartridge-operated fixing and other impact machinery, which were previously excluded from the machinery Directive; for these there was a transition period until 29 June 2011.

General Overview

Changes to the scope of the Directive, and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 95/16/EC, mean that construction site hoists are now included, and lifts with a travel speed no greater than 0.15m/s are excluded from the Lifts Directive; these are now subject to the Machinery Directive instead.

Cartridge-operated fixing and other impact machinery are no longer excluded from the machinery Directive.

Whereas the old Directive stated that the Low-Voltage Directive (LVD 73/23/EEC) should be applied in situations where the risks are mainly electrical, Article 1 of the new Machinery Directive identifies specific types of equipment to which the LVD (now 2006/95/EC) should be applied.  Note, however, that the essential health and safety requirements of the LVD have become part of the Machinery directive requirements for electrical equipment.

As with other ‘New Approach’ EU Directives, the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA – which consists of the EU Member States and Iceland, Norway and Liechtenstein – plus Switzerland and Turkey have harmonised their laws with the new Machinery Directive.

Partly Completed Machinery

Whereas the old Directive referred to ‘machinery which cannot function independently’, the new Directive introduces – and more clearly explains – the concept of ‘partly completed machinery.’ Under the new Directive, a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation, assembly instructions and declaration of incorporation.  Note that authorities can perform market surveillance on partly completed machinery, though Article 11 is not applicable, this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service.

Essential Health and Safety Requirements

At the heart of the Directive are the essential health and safety requirements (EHSRs) and these have been clarified and placed in a more logical order.  Because of the inclusion of the construction site hoists and slow-moving lifts in the revised scope, there are new EHSRs relating to risks associated with lifts serving fixed landings.

The list of standards harmonised to the Machinery Directive 2006/42/EC was first published in the Official Journal on 8 September 2009, though a revised list and additional amendments have been published more recently (see Further information).

It was agreed in the EU Machinery Working Group that prior to 29 December 2009 if a product complied with both Directive the Declaration of Conformity could reference both Directive but should state that 98/37/EC applied until 28 December 2009 and 2006/42/EC applied after that date.

Fixed Guards

Something that will affect virtually all machine builders is the change to the way fixed guards must be fastened to the machine.  Fixings can no longer b loose; the new Directive states that they must remain attached to either the guards or machinery when the guards are removed.  

Conformity Assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed in Annex IV).  If machinery is designed in accordance with the relevant harmonised standards, the new Directive gives manufactures the option to self-certify machinery, thereby avoiding the requirement to deposit the technical file with a Notified Body.  For other Annex IV machinery, manufactures can either request EC type-examination by a Notified Body or have a Notified body approve a full quality assurance system covering design, manufacture, final inspection and testing.

There are changes relating to the Technical File and Declaration of Conformity, and a new Declaration of Incorporation for partly completed machinery.

Market Surveillance

The new Directive is more explicit about the duties of the Member States to organise market surveillance (enforcement).  Obligations include co-operation between the market surveillance authorities and respect for confidentiality and transparency.  In addition, the new Directive draws on material in the General Product Safety Directive, enabling the European Commission to adopt a decision, after consultation of the Machinery Committee, to prohibit or restrict the placing on the market of a category of machines presenting risks to health and safety due to shortcomings in the relevant harmonised standard(s) or by virtue of their technical characteristics, or to make such machinery subject to special conditions.  

Certification

Manufacturers that have obtained CE type-examination certificates for their machinery under the old Directive need to request a review of the certification by the Notified Body, as new certificates, issued in accordance with the new Directive, need to be in place for machinery placed on the market after 29 December 2009.

For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued), manufacturers now need to apply one of the procedures from Article 12(3) and (4) of the new Directive, as the old route to certification no longer exists in the new Directive.

Detailed Analysis

(5) Construction site hoists intended for lifting persons and persons and goods are now included. (6) Portable cartridge-operated fixing and other cartridge-operated impact machinery designed for industrial or technical purposes (which had been excluded from the original Machinery Directive by the amending Directive 91/368/EEC) is reintroduced into the scope of Machinery Directive 2006/42/EC.   (9) Provides for the legal framework within which market surveillance (enforcement) can proceed harmoniously. 

Article 1 – Scope

1(1) The scope is now: (a) machinery (b) interchangeable equipment (c) safety components (d) lifting accessories (e) chains, ropes and webbing (f) removable mechanical transmission devices (g) partly completed machinery

1(2) Exclusions The new Directive changes the location of the exclusion relating to machinery for which the only power source is directly applied human effort.  Hence although the exclusion is absent from 1(2), such machines are in fact still excluded unless they are used for lifting.  See article 2(a) below.

Medical devices are no longer specifically excluded, as the general exclusion for machinery types that are covered by more specific Directives applies.  In this case such machinery would normally be covered by the Medical Devices Directive.  93/42/EEC, though Article 3 of the M5 version (which became applicable from 21 March 2010) states that where a relevant hazard exists then the machinery shall also meet the essential health and safety requirements in annex I of the Machinery Directive if they are more specific to the machinery than those in the Medical Devices Directive.

The new Directive excludes ‘weapons, including firearms’, whereas the old Directive excluded ‘firearms.’ Crossbows and similar weapons are therefore now excluded.

There is a clearer definition of the means of transport excluded.

Machinery specially designed and constructed for research purposes for temporary use in laboratories is excluded, but note the word ‘temporary.’

The following are new excluded, as they are covered by the Low-Voltage Directive:

• Household appliances intended for domestic use
• Audio and video equipment
• Information technology equipment
• Ordinary office machinery
• Low-voltage switchgear and control gear
• Electric motors

In addition, high-voltage switchgear, control gear and transformers are excluded. 

Article 2 – Definitions

In comparison with the old Directive, formal definitions are provided for many more terms.

2(a) The definition of ‘machinery’ refers to a ‘drive system other than directly applied human or animal effort.’ Machinery may therefore be powered by natural sources of energy such as wind or water power.  Furthermore, machinery can be powered by manual effort that is not directly applied but stored (e.g by means of a spring, raised weight, or hydraulic or pneumatic accumulator) so that the machinery can function after the manual effort has ceased.  The fourth indent of 2(a) makes it clear that assemblies of machinery may include partly completed machinery.   Note that there is now a harmonised standard for assemblies of machinery (EN ISO 11161:2007+A1:2000,  Safety of machinery.  Integrated manufacturing systems.  Basic requirements ) whereas no such standard was harmonised to the old Directive.

“The problem is that end users are often unaware that they are responsible for CE marking assemblies of machinery.”

2(c) There is now a clearer definition of ‘safety component’ within the body of the Directive, plus there is now an indicative list of safety components in annex V.  Note that the definition of a safety component could be interpreted very broadly to include a wide variety of standard machine components that fulfil a safety function; conversely, safety components that are manufactured by the machinery manufacturer for use on the machinery are  not  subject to the Machinery Directive as such (though these components must enable the machinery to comply with the essential health and safety requirements.)

2(g) ‘Partly completed machinery’ is defined.  However, although this point states that a drive system is partly completed machinery, there is no definition for ‘drive system.’ An internal combustion engine placed on the market for fitting to machinery would count as partly completed machinery whereas most electric motors would not (because they are covered by the Low Voltage Directive).

2(h) Machinery is considered as placed on the market when it is made available in the Community for the first time.  While the Machinery Directive does not generally apply to used or second-hand machinery, it does if that machinery is placed on the market or put into service for the first time in the Community having first been made available for distribution or use outside the Community.

2(j) ‘Authorised representative’ is defined as ‘any natural or legal person established in the community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with the Directive.’

“Someone within Europe who can be contacted and, if necessary, made liable should an incident occur.”

Article 5 – Placing on the market and putting into service

1(f) This states that the CE mark must be affixed.  Note that this applies to the products listed int he scope, which includes the safety components listed in Annex V.  But although partly completed machinery is included in the scope, it is not CE marked (see clause 2 of Article 5).  

Article 12 – Procedures for assessing the conformity of machinery

There are some significant changes with respect to conformity assessment.  First, there is no longer an option to submit a technical file to a notified body for verification and certification of adequacy.  Second, there is a new quality assurance procedure, which is described in Annex X. 

Article 13 – Procedure for partly complete machinery

This new Article explains what a manufacturer of partly completed machinery or his authorised representative must do before the partly completed machinery is placed on the market. 

Article 24 – Amend of Directive 95/16/EC

This new Article amends the Lifts Directive, defines ‘lift’ and ‘carrier’ and makes it far easier to identify which Directive should be applied. 

Article 27 – Derogation

This new Article provides for a transition period until 29 JUne 2011 for portable cartridge operated fixing and other impact machinery.  However, Member States can choose whether or not to apply the derogation, so manufacturers should check the local regulations before placing such machinery on the market if it does not yet comply with the new Machinery Directive.  

Annex I – Essential Health and Safety Requirements Relating to the Design and Construction of Machinery

Note that the Annex title no longer refers to ‘safety components’ but, for the purposes of this Annex, safety components are included because they are specified in the definition for ‘machinery’ given in Article 2.

General principles  The comparable section in the old Machinery Directive (‘Preliminary observations’) stated that the manufacture ‘is under an obligation to assess the hazards’ whereas the new Directive states that the manufacturer or his representative’ must ensure that a risk assessment is carried out.’ It then goes on to outline the steps that shall be taken in a risk assessment and risk reduction process.

“Machine builders will therefore need to ensure that they have documented their risk assessment procedure.”

Paragraph 3 (which is virtually identical to paragraph 2 in the old Directive) states: ‘The essential health and safety requirements laid down in this Annex are mandatory; However, taking into account the state of the art, it may not be possible to meet the objectives set by them.  In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.’  Some commentators have suggested that ‘as far as possible’ might be interpreted as a loophole’ to enable machinery designed under the old Directive to remain on the market under the new Directive.  Anyone considering taking this approach should think carefully about whether a failure to meet the essential health and safety requirements is really justifiable taking account of the state of the art, and the consequences of a market surveillance authority taking action to have the machinery removed from the market.

When considering the state of the art, machine builders should remember that Recital 14 states that they can take account of economic requirements.  Machine builders are therefore not expected to implement safety measures that are prohibitively expensive.

Chapter 1 – Essential Health and Safety Requirements

1.1.1 Definitions  The new EHSRs (Essential Health and Safety Requirements) contains nine definitions compared with three in the old EHSRs.  In particular, paragraph (f) now defines a ‘guard’ as ‘a part of the machinery used specifically to provide protection by means of a physical barrier.  Note, however, that this definition differs from that int he harmonised standard EN 953 ( Safety of machinery.  Guards.  General requirements for the design and construction of fixed and movable guards ).  Moreover, interpreting the term ‘specifically’ from the Directive in order to relax the requirements relating to parts of the machine such as weatherproof covers and chutes would be incorrect, as they often provide protection, if only as a secondary function.

1.1.2(a) Principles of safety integration  This section refers to the ‘foreseeable lifetime’ and includes within this the phases of ‘transport, assembly, dismantling, disabling and scrapping.’ In comparison, the old Directive mentioned only assembly and dismantling.

1.1.6 Ergonomics  This new section states that ‘discomfort, fatigue and physical and psychological stress faced by the operator must be reduced to the minimum possible.’

“In addition, ergonomics should be addressed under many of the other essential health and safety requirements.”

1.1.7 Operating positions and 1.1.8 Seating  These new sections cover these safety-related requirements for operators.

1.2 Control systems  This section has changes as outlined below.

1.2.1 Safety and reliability of control systems  This section has been expanded.  Note that the requirements in this section apply to  all  parts of a control system (not just parts of the safety-related control system) that, in the event of a failure, could lead to the machinery behaving in an unexpected or unintended way.

1.2.2 Control devices  This section now states that from ‘each’ control position the operator must be able to check the danger zones, whereas the old Directive referred only to the ‘main’ control position.  This has implications for machines with multiple control positions, pendant or wireless controls.

1.2.3 Starting  This section has ben expanded.

1.2.4.2 Operational stop  This new section describes the situation where, for operational reasons, a stop is required that does not isolate the energy supply to the actuator(s).  Such stop conditions must be monitored and maintained.

1.2.4.4 Assembly of machinery  This is essentially the same as the section in the old Directive for Complex installations,’ with the term ‘assembly of machinery’ improving clarity.

1.3.9 Risks of uncontrolled movements  This new section refers to movements that might occur after a part of the machinery has stopped.

1.4 Required characteristics of guards and protective devices  This section contains some important changes as outlined below.

1.4.1 General requirements  This section now states explicitly that ‘guards must, where possible, protect against the ejection or falling of materials or objects and against emissions generated by machinery.’ In the old Directive, there were similar requirements elsewhere for movable and adjustable guards to protect against ejection, and emissions of dust, gases, etc’ was covered in section 1.5.13

1.4.2.1 Fixed guards  This section now states that ‘fixing systems must remain attached to the guards or machinery when the guards are removed.’  Various types of captive screws, quarter-turn fasteners and other fasteners are available, but machine builders will need to specify these with care if they are to find the optimum combination of purchase cost, installation cost and ease of use.

“it is overkill to require ALL such fixings to be captive.”

Using wording that is virtually identical to the text in the old Directive, the New Directive states that ‘Where possible, guards must be incapable of remaining in place without their fixings.’

“The absurdity of this has been pointed out on several occasions.”

When considering what type of fixings to use for fixed guards, bear in mind that the definition of a guard in the Machinery Directive is different from that in the harmonised standard EN 953 ( Guards.  General requirements for the design and construction of fixed and movable guards ).  Furthermore, EN 953 states: “Where it is foreseen (e.g maintenance) that the fixed guard will be removed then the fastenings shall remain attached to the guard or to the machinery.’ The standard can therefore be interpreted as not requiring retained fasteners to be used if it is not foreseen that the guards will be removed for maintenance, cleaning or other reasons.  Of course, the final choice of fixings and tools will depend on the outcome of the risk assessment.

1.4.2.2 Interlocking movable guards  This section replaces Section 1.4.2.2 ‘Movable guards’ of the old Directive.  Whereas movable guards were previously divided into Type A and Type B guards, the new text refers to interlocking movable guards and movable guards used in association with a guard locking device and an interlocking device.  A new addition to this section states: ‘Where it is possible for an operator to reach the danger zone before the risk due to the hazardous machinery functions has ceased, movable guards must be associated with a guard locking device in addition to an interlocking device that: prevents the start of hazardous machinery functions until the guard is closed and locked; and keeps the guard closed and locked until the risk of injury from the hazardous machinery has ceased.’

1.5.1 Electricity supply  This section now states that ‘the safety objectives set out in Directive 73/23/EEC shall apply to machinery.’ Note that Directive 73/23/EEC, the Low-Voltage Directive (LVD), has recently been the subject of a codification, requiring a new number 2006/95/EC.

1.5.7 Explosion  This section contains less than before, but note that it refers to ‘provisions of the specific Community Directives,’ i.e the ATEX Directives.

1.5.8 Noise and 1.5.9 Vibrations  These sections now state that levels of noise and vibrations, respectively, may be assessed with reference to comparative emissions data from similar machinery.

1.5.15 Risk of slipping, tripping or falling  This section now refers explicitly to handrails.

1.5.16 Lightning  This new section states that ‘machinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earth.’

1.7 Information  This section, previously ‘Indicators,’ is now more explicit about the format in which information and warnings must be displayed on the machinery.

1.7.1 Information and warnings on the machinery  Information written on the machinery (or displayed on a screen or provided via recorded voice messages or a voice synthesiser) must be provided in the official language or languages of the Member States in which the machinery is placed on the market and/or put into service.  If the machine user also requires such information in another language then this may be requested but it is outside the scope of the Machinery Directive.  1.7.2 Warning of residual risks  Warnings marked on the machine must comply with the same requirements as in 1.7.1

1.7.3 Marking of machinery  The fourth paragraph refers to information that is essential for safe use of the machinery.  This information must comply with the same requirements as in 1.7.1.

1.7.4 Instructions  Machine suppliers should not assume that users have facilities for reading health and safety-related instructions that are in an electronic format.  A paper copy should be supplied.  However, electronic documents offer advantages in terms of security and updates, so it is helpful to provide the instructions in an electronic format as well.

Instructions must be provided in the official language or language of the Member States in which the machinery is placed on the market and/or put into service.  However, instructions that are intended for use by specialised personnel for servicing and similar activities can instead be supplied in a language understood by those users.

1.7.4.1 General principles for the drafting of instructions  This new section covers material contained in the old Clause 1.7.4 and contains clearer information about the ‘Original instructions’ and the ‘Translation of the original instructions’ supplied with the machinery.

1.7.4.2 Contents of instructions  This new section covers material from the old Section 1.7.4 and is clearer, more explicit and more extensive.  For example, it states that each manual must contain, where applicable, (e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking correct functioning, (l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complimentary protective measures employed, (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, and (t) the specification of the spare parts to be used, when these affect the health and safety of operators.  Paragraph (3) states that the Declaration of Conformity (DoC) or a document setting out the contents of the DoC must be included, though this can be generic, as it does not need to contain the serial number and signature.  Note, however, that Annex II still requires the DoC (or Declaration of Incorporation for partly completed machinery) to be drawn up and Article 5 ( Placing on the market and putting into service ), paragraph (e), states that before the machinery is placed on the market and/or put into service the manufacturer or his authorised representative shall ‘draw up the EC declaration conformity in accordance with Annex II, part 1, section A and ensure it accompanies the machinery.’

There is an important change to the requirements relating to information about airborne noise emissions, found in (u).  Under the old Directive the sound power level had to be stated when it exceeded 85 dB(A), but the requirement now applies when the sound power level exceeds 80 dB(A).

1.7.4.3  This new section covers material contained in the old Section 1.7.4 and states that sales literature must not contradict the health and safety aspects of the instructions, and sales literature quoting performance characteristics must contain the same information on emissions as the instructions.

Chapter 2 – Supplementary EHSRs for Certain Categories of Machinery

2.1  This section now applies to machinery for foodstuffs, cosmetics and pharmaceutical products, whereas the old Directive referred only to agri-foodstuffs.

2.2.2  This new section relates to portable fixing and other impact machinery, which were excluded from the old Directive.

Chapter 3 – Supplementary EHSRs to Offset Hazards Due to the Mobility of Machinery

This chapter has been largely rewritten for clarity, but there are also some changes and additions such as references to control systems. 

Chapter 4 – Supplementary EHSRs to Offset Hazards Due to Lifting Operations

The opening remarks of this section in the new Directive do not contain the following sentence from the old Directive: ‘The load may consist of objects, materials or goods.’ The implication is that persons are now included.  In addition, the new Directive contains an additional definition for ‘carrier,’ which refers specifically to ‘persons and/or goods’ (Section 4.1.1 (g)).

4.1.2.8 Machinery serving fixed landings  This new section contains five sub-sections.

4.1.3 Fitness for purpose  This is a new section.

Chapter 6 – Supplementary EHSRs for machinery presenting particular hazards due to the lifting of persons

6.1.1 Mechanical strength  This section now states that ‘If ropes or chains are used to suspend the carrier, as a general rule, at least two independent ropes or chains are required, each with its own anchorage.’

Much of Chapter 6 has been rewritten for reason of clarity, but there is also a new section  6.4 Machinery serving fixed landings  with three sub-sections.

Annex II – Declarations

Note that there is no longer a separate declaration of conformity for safety components.  Because safety components are now listed in the scope of the Directive as item (c), and the definition of ‘machinery’ includes items (a) to (f) of the scope, the declaration of conformity for safety components is the same as that for ‘machinery’ (see 1.A below). 

1.A. EC Declaration of Conformity of the Machinery

The EC Declaration of Conformity must now state the place and date of the declaration.

“The version dates and technical content of the standards originally used will, in the majority of cases, have changed since that declaration of conformity was last updated.”

When listing the harmonised standards used, in the event of a standard not being applied in full the manufacturer should state which specifications have or have not been applied.

1.B Declaration of Incorporation of Partly Completed Machinery

This is new, as partly completed machinery was not part of the old Directive’s scope.  Note that there is no requirement to list the harmonised standards applied but, in most cases, to do so would assist the person compiling the technical file and CE marking the completed machine.  

There is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery).

Annex III – CE Marking

This Annex now states that the CE mark must be affixed ‘in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique.’

In addition, where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied, the CE marking must be followed by the notified body’s identification number.

“CE marking will be required for ALL of the products subject to the Directive, with the exception of partly completed machinery.”

Annex IV – Categories of Machinery to Which One of The Procedures Referred to in Article 12(3) and (4) Must Be Applied

Some items are reworded for clarity, but other more significant changes are as follows:

• Internal combustion engines for underground working are no longer listed, as they are now treated as partly completed machinery.
• Bimanual controls are no longer listed.
• Logic units to ensure safety functions are now included.
• Portable cartridge – operated fixing and other impact machinery are now included.
• Machinery for the manufacture of pyrotechnics is no longer listed.

Note that the list in Annex IV is exhaustive, so machinery not included within the categories listed, even if similar or presenting similar hazards, is subject instead to the procedure for assessment with conformity checks as set out in Article 12(2).  

Annex V –  Indicative List of the Safety Components Referred to in Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices, protective devices designed to detect the presence of persons, roll-over protective structures, and falling object protective structures), plus various types of guard, valves, extraction systems, monitoring devices, restraint systems, energy limiters, noise/vibration reduction systems, and various lift components.  Note that the list of items is indicative, so other products can be defined as ‘safety components’ by reference to Article 2(c); the list can also be updated by the Commission in accordance with Article 8(1)(a).

“The list includes equipment that may previously not have been considered to be a safety component.”

Annex VI – Assembly instructions for Partly Completed Machinery

This new Annex contains a simple description of what the instructions must contain in relation to incorporating the partly completed machinery in the final machinery.  It also states that the instructions must be in an official Community language acceptable to the manufacturer of the machinery of the machinery in which the partly completed machinery will be assembled, or his authorised representative. 

Annex VII Part A – Technical File for Machinery

The information contained in this new Annex was previously incorporated within the old Annex V ‘EC Declaration of Conformity.’ Note, however, that the new Directive states that the technical file must contain a general description of the machinery, even though this is also required in the instructions, a copy of which must be included in the technical file.

Whereas the old Directive only implied that a copy of the risk assessment should be included in the technical file, the new Directive states it explicitly.

The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be complied before the Declaration of Conformity can be drawn up).  For partly completed machinery, the technical file must contain both the declaration of incorporation and the relevant assembly instructions.

In the case of series manufactured machinery, the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive.

Part B – Relevant Technical Documentation for Partly Completed Machinery

This part of the Annex is new and its contents are broadly similar to Part A for machinery.  However, note the subtle difference in terminology: machinery requires a ‘technical file’ whereas partly completed machinery requires ‘technical documentation.’

Annex VIII – Assessment of Conformity with Internal Checks on the Manufacture of Machinery

This new Annex appears to relate to series machines (but see industry comment).  In essence, it states that for each machine a technical file shall be drawn up, and the manufacturer must take all measures necessary to ensure that the manufactured machinery complies with the technical file.

“The requirements of Annex VIII apply whether machines are manufactured as a single item with a unique specification or as a series of identical units.”

Annex IX – EC type-examination

This new Annex is similar to the old Annex VI but requires both the notified body and the manufacturer to be more proactive (see section 9.1, for example).

Sections 4 and 9.3 require both the manufacturer and the Notified Body to retain a copy of the EC type-examination certificate, the technical file and related documents for 15 years from the date of issue, in the case of 9.3) of the certificate.  The period of 15 years ensures that the documents are available for 10 years (the same period as for machinery CE marked using the other procedures) after the expiry of the EC type-examination certificate, which is the last date on which the certified type of machine may be manufactured.  The old Directive did not require certificates to be reviewed every five years (see Section 9.3), so there was no corresponding requirement to retain the certificate and documentation for 15 years.

Section 9.1 states that ‘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.’  This would include, for example, new or revised harmonised standards that have implications for the machinery examined.

Section 9.2 states that the manufacturer ‘has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.’

In addition, section 9.3 requires that ‘the manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.’

“Annex IX of the new Directive has introduced a requirement to validate the EC-type Examination Certificate every five years, with the possibility of a five-year extension each time.”

Annex X – Full Quality Assurance

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

This has the potential to be a more cost-effective route to compliance than EC type-examination, though the manufacturer will have to determine whether or not this is the case.

Annex XI – Minimum Criteria to be Taken into Account by Member States for the notification of Bodies

This new Annex is very similar to the old Annex VII but there are two new sections.  Section 8 states that notified bodies shall participate in co-ordinate in co-ordination activities and be involved directly or represented in the European standardisation process in order that they ‘know the situation in respect of relevant standards.’

Section 9 states that Member States must take all necessary steps to ensure that a notified body’s customer files are handed over to another notified body or made available to the Member State in the event of the notified body ceasing its activities.

Annex XII – Correlation Table

This table lists the correlations between the old and new Directives, though in some cases the contents of the correlating articles are not identical, and there is no means of identifying where new materials has been added.

Industry Comment

As well as the information that can be gleaned directly from comparing the old and new Directive, some less obvious but nevertheless useful interpretation is provided here by industry experts. 

Assemblies of Machinery

Robin Carver is the principal of Health & Safety Compliance Engineering and a member of the BSI Safety of Machinery MCE/003 committee.  He writes:

The Europe Machinery Directive, throughout its various incarnations, has always recognised ‘assemblies’ of machines but, in its latest manifestation as 2006/42/EC, it now clearly specifies the essential health and safety requirements for such assemblies.  These assemblies must be considered to be whole new machines and must therefore be CE marked.  Supporting guidance for manufacturing system assemblies has recently been published in the form of a harmonised standard EN ISO 11161:2007+ A1:2010, Safety of machinery.  Integrated manufacturing systems.  Basic requirements. 

An Integrated Manufacturing System (IMS) is an assembly of machines that together perform a specific manufacturing function – for example, bottling lines, canning lines, cartoning lines, packaging lines, component assembly systems, palletising systems, de-palletising systems, etc.  These may comprise new, partly completed and/or used machines arranged and controlled to function as an integral whole.’ Often it is the end user that takes on the task of integrating the various machines to create the complete line.  Because an integrated assembly of machines must be considered to be a whole new and different machine rather than just individual machines combined, it is, therefore, the integrator that must bear the burden of assessing and ensuring compliance of the final construction and declaring its compliance as an ‘integral whole’ by CE marking it in accordance with the Machinery Directive 2006/42/EC.  The problem is that end users are often unaware that they are responsible for CE marking assemblies of machinery or, if they do understand their obligations, they lack the competences to fulfil them.  

Implications of the new Machinery Directive

Paul Laidler, managing director of Laidler associates, writes:

The new Machinery Directive brings in many changes from what we are used to working to.  Many of these are to the essential health and safety requirements and it is too easy to get hung up on these without worrying about the less noticeable but equally significant changes. 

The first of these to highlight is the definition of the Authorised Representative which is now said to be ‘any natural and legal person in the Community,’ the key here being natural and legal.  There are also changes to the requirements of the Declaration.  One of the major changes here is that the Declaration must now include the name and address of the person who compiles the Technical File, ie carries out the CE Marking process, not just the person who signs the Declaration.  

It appears that the European Union is trying to make sure that there is someone within Europe who can be contacted and, if necessary, made liable should an incident occur.  

Changes to the exemptions list and also the newly added list of safety components make the position of some types of machine much clearer.  However, the safety component list includes equipment that may previously not have been considered to be a safety component.  Are manufacturers of these aware that they must now comply with the Machinery Directive ? 

On top of the changes to the Directive, all harmonised standards are being updated to reference both the new Directive and the amended standards.  Business need to be aware that the standards they are currently using may be out of date, if not now, then very soon.  Now is the time to act to update your systems and procedures.  

Risk Assessment, Conformity and EC Type Examination

Ian Murgatroyd, the European product manager for safety components at Rockwell Automation, writes:

The new Machinery Directive 2006/42/EC does not introduce any radical changes over the Directive that it will replace, namely 98/37/EC; however, any company needing to comply with the new Directive should consider the following.  

There is a subtle change to the requirement for risk assessment, which is now specifically detailed in the General Principles section of Annex I.  Previously there was a need to assess the hazards, but now the full risk assessment process is included.  In practise most organisations carry out a full risk assessment anyway, but now annex VII also requires the full risk assessment to be included in the technical file, whereas previously only the methods used to reduce the risks were needed.  Machine builders will therefore need to ensure that they have documented their risk assessment procedure.  

Another consideration for meeting the requirements of the new Machinery Directive will be for manufacturers of machinery to spend time and money in updating their EC declarations of conformity.  The version dates and technical content of the standards originally used to demonstrate compliance with the essential health and safety requirements will, in the majority of cases, have changed since that declaration of conformity was last updated.  In a few cases the standard’s number may also have changed (for example, EN 954-1 is transitioning to EN ISO 13849-1).  Although this work would need to have been undertaken without the change in the Directive, the introduction of the new Machinery Directive is a good time to update these details.  

If the manufacturer is using the EC Type Examination route he will now have to obtain a new EC Type Examination Certificate, which will require compliance with the essential health and safety requirements of the new Directive (and, most likely, the latest standards).  Furthermore, Annex IX of the new directive has introduced a requirement to validate the EC Type Examination Certificate every five years, with the possibility of a five-year extension each time.  

Ergonomics and the Machinery Directive

Jon Servern, the Editor of MachineBuilding.net writes:

Ergonomics was covered, somewhat briefly, in the old Machinery Directive 98/37/EC in Annex I, section 1.1.2 d, as follows: “Under the intended conditions of use, the discomfort, fatigue and psychological stress faced by the operator must be reduced to the minimum possible taking ergonomic principles into account.”  In the new Machinery Directive 2006/42/EC, this sentence remains in section 1.1.6, but with an additional reference to physical stress and five indents giving examples of the types of ergonomic principles to be taken into account (note that this list is not exhaustive): 

• allowing for the variability of the operator’s physical dimensions, strength and stamina, 
• providing enough space for movements of the parts of the operator’s body, 
• avoiding a machine-determined work rate, 
• avoiding monitoring that requires lengthy concentration, 
• adapting the man/machinery interface to the foreseeable characteristics of the operators. 

In addition, ergonomics should be addressed under many of the other essential health and safety requirements (EHRs) applicable to all machinery types – such as 1.1.4 (Lighting), 1.1.7 (Operating position), 1.1.8 (Seating), 1.2.2 (Control devices), 1.5.8 (Noise), 1.5.9 (Vibration), 1.6.2 (Access to operating positions and servicing points), 1.7 (Information) – plus numerous supplementary EHSRs relating to specific machine types (a full list is provided in the official guidance).  

The 2nd Guide to Application of the Machinery Directive 2006/42/EC (i.e the official guidance) is helpful in that it points out the ergonomic requirements, but it provides little advice on the steps to be taken when designing machinery.  As usual, a good starting point is the Harmonised Standards, compliance with which gives a presumption of conformity to the relevant EHSRs.  

More guidance has been developed by ErgoMach, a group of European experts on ergonomics and machinery.  This group contributed to the official guidance mentioned above and has prepared a series of Information Sheets that can be downloaded as PDF files from the ErgoMach website.

Fixings for Fixed Guards

Jeremy Procter is the Managing Director of Procter Machine Guarding, a Member of BSI’s MCE/3 committee and has 25 years’ experience of drafting machine safety standards.  He writes:

There are two aspects of the essential health and safety requirements in Annex I sub-clause 1.4.2.1 Fixed guards that give cause for concern.  First, the Directive states that ‘fixing systems must remain attached to the guards or to the machinery when the guards are removed’ – and there are no exceptions stated.  While captive fasteners offer clear advantages in some circumstances, in particular for guard sections that are designed to be removed on a routine basis, such as in the food industry, it is overkill to require ALL such fixings to be captive.  Adhering to this requirement will result in additional expense for machine builders, and more difficult replacement in the event of a fixing being damaged.  

Second, the Directive requires that ‘guards must be incapable of remaining in place without their fixings.’ This is qualified with the phrase ‘where possible,’ which covers almost every conceivable fixed guard.  Roof panels and other horizontal panels will therefore bizarrely appear to need fitting with springs or some other means of preventing them from remaining in place when the fixings are removed.  Although the absurdity of this has been pointed out on several occasions, it is likely that the Directive will remain unchanged and the standard EN 953 Safety of machinery.  Guards.  General requirements for the design and construction of fixed and movable guards has already been revised accordingly.  

In British health and safety legislation the concept of ‘reasonable practicability’ allows risk to be weighed against the money, time and trouble needed to control it.  If the phrase ‘where practicable’ could be used in the two aforementioned sentences in sub-clause 1.4.2.2 of the Directive Annex and the corresponding sub-clause in the standard, the situation would be much improved.  Unfortunately, the concept of reasonable practicability is not accepted in European legislation and standards, so these particular shortcomings of the Machinery Directive will probably remain, resulting in increased costs for machine builders and a negligible improvement in safety or more likely nobody outside the UK will take any notice of these requirements.  

CE Marking of Safety Components

Martin Palmer, the training manager at Pilz Automation Technology, writes:

Under the existing Machinery Directive safety components are required to have a Declaration of Conformity but not be CE marked.  However, safety components that incorporate electrical/electronic  componentry – such as safety relays – will be CE marked under the LVD and EMC Directives.  When the new Machinery Directive comes into force, CE marking will be required for ALL of the products subject to the directive, with the exception of partly completed machinery.  

Because most safety components (but not, for example, guards) already have a CE mark applied under the LVD or EMC Directives, machine builders will see no visual difference on these safety components after 29 December 2009, though the corresponding documentation will continue to reflect the version of the Machinery Directive in force at the time the component was placed on the market.  

Note that safety components are excluded from the scope of the new directive if they are supplied as identical spare parts by the manufacturer of the original machinery – see Article 1, paragraph 2(a).  

Self-certification and Internal Checks on Manufacture

Alistair McKerrell, an independent consultant and a member of BSI and European standards committees for safety of packaging machinery, writes:

Annex VIII of the Machinery Directive (Assessment of conformity with internal checks on the manufacture of machinery) is the ‘module’ to be used for self-certification of all non-Annex IV machines.  This is comparable with the modular approach to conformity assessment used in other Directives for product supply, such as pressure equipment and ATEX 95. 

Paragraph 3 of Annex VIII infers that the manufacturer must have a suitable and sufficient manufacturing quality system to ensure the safety-related aspects of the machine (or machines) specified in the technical file are incorporated correctly during construction.  A simple example would be systematic checks to ensure that the specified safety relays have been correctly installed in the control circuits.  

The requirements of Annex VIII apply whether machines are manufactured as a single item with a unique specification or as a series of identical units, despite the text appearing to imply series manufacture (as broadly understood in English).  

Further Information

Machinery directive 2006/42/ec.

The full text of Machinery Directive 2006/42/EC, together with the Corrigendum and Amendment, can be downloaded as a PDF file from the European Commission website .

Official Guidance

The European Commission assembled an editorial board to prepare guidance on the new Directive.  The first edition of the Guide to the Application of the Machinery Directive 2006/42/EC (running  to 335 pages) was published in December 2009, though this had no commentary on Annexes III to XI; the second edition (with 406 pages), published in June 2010, included this information and some other amendments.  It is intended that regular updates of the Guide will be published in order to present answers to questions agreed by the Machinery Committee and the Machinery Working Group.  While the Guide provides helpful explanations of the various clauses within the new Machinery Directive, it does not seek to highlight differences between the old and new Directives.

As well as the  Guide to application of the Machinery Directive 2006/42/EC,  there are also three guides: eg  Equipment used for lifting persons; Classification of equipment used for lifting loads with lifting machinery;  and  Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.   All of these guides can be downloaded as PDF files from the European Commission website .

In the UK the Department for Business, Energy & Industrial Strategy (BEIS, previously the Department for Business, Innovation and Skills (BIS)) has produced guidance on The Supply of Machinery (Safety) (Amendment) Regulations 2011, which can be downloaded as a PDF from the BEIS website .

Ergonomics Guidance

ErgoMach, a group of European experts on ergonomic and machinery, has contributed to the official guidance mentioned above and has also prepared a series of Information sheets that can be downloaded as PDF files from its website.

Harmonised Standards

An up-to-date list of harmonised standards as published in the Official Journal can be downloaded as a PDF file from the European Commission website.

White Papers

Procter Machine Guarding (see below) has published two White Papers containing guidance on complying with requirements in the new Machinery Directive and are available to download as free PDF files : CE marking of guards; and Fixings for fixed guards.

MachineBuilding.net

News about the Machinery Directive, standards and products to aid compliance is available from MachineBuilding.net.  The website is updated daily and can be browsed and searched via its user-friendly navigation, while the free monthly email newsletter brings the most interesting news straight to your desktop.  Both the website and newsletter are focussed on the needs of those specifying, designing, building, modifying and upgrading machinery. Website: www.machinebuilding.net

Useful resources

All can be downloaded from  www.machinesafety.co.uk/free-downloads/free-machine-safety-guides  or email [email protected]

Free Risk Assessment Calculator Based on the requirements of BS EN ISO 12100 and designed to be simple to use.

Free Safety Distance Calculator Establishes machine guard safety distances and heights in accordance with BS EN ISO 13857.

Free Guide to the New Machinery Directive 2006/42/EC To help companies comply with the Directive that came into force on 29 December 2009.

Free White Paper: Machinery Directive and Fixings for Fixed Guards Explaining the amended requirements for Guard Fixings under the new Machinery Directive.

Free White Paper: CE Marking of Machine Guards Explaining the requirements relating to CE marking of guards under the Machinery Directive.

Free White Paper: EN 349, Minimum Gaps to Avoid Crushing Explaining the requirements of the standard for minimum gaps to prevent crushing.

Free White Paper: Differences Between BS EN 953 and BS EN ISO 14120 Explaining what changes have been introduced in BS EN ISO 14120, which replaces and supersedes BS EN 953.

Free White Paper: Conveyor Guarding Explaining the hazards associated with conveyors, regulations and standards, and how to safeguard conveyors without adversely affecting productivity.

Free White Paper: The 2014 Edition of PD 5304 Explaining the changes in the new edition of BSI’s Guidance on safe use of machinery.

Free Guide to Work Shop Safety A guide to guarding small machine tools typically used in workshops.

Free Machine Accident Investigation Kit To help companies meet their statutory obligations and prevent future accidents.

Free Ergonomics Guidance European Commission publication Guidance on the application of the essential health and safety requirements on ergonomics. Download: http://eceuropa.eu/growth/sectors/mechanical-engineering/machinery/index_ex.htm

Procter Machine Safety Isabella Road Garforth, Leeds LS25 2DY UK Tel: +44 (0)2920 855 758 [email protected]

Procter Machine Safety 11 Pantglas Industrial Estate Bedwas, Caerphilly CF83 8XD UK Tel: +44 (0)2920 855 758 [email protected]

Satech Perimeter Guarding

Procter Machine Safety 11 Pantglas Industrial Estate Bedwas, Caerphilly CF83 8XD UK Tel: +44 ( 0)2920 855 754 [email protected]

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EN ISO 13849-1: Performance Level (PL)

The greater the risk, the higher the requirements of the control systems. The hazardous situation is classified into five levels , known as Performance Levels (PL), from PL "a" (low) to PL "e" (high). The required PL is determined and assigned as part of the risk assessment in accordance EN ISO 13849-1 .

EN ISO 13849-1/-2: Safety of machinery – Safety-related parts of control systems

As the successor to EN 954-1, EN ISO 13849-1 is the main safety standard for the design of safety-related control systems for machinery.

Performance Level

In contrast to the previous standard EN 954-1, which took a deterministic (reproducible) approach, EN ISO 13849-1 is based on a probabilistic approach to assessing safety-related control systems.

As well as dealing with electrical, electronic and programmable electronic systems, the standard also considers other control technologies, such as fluid power for example

The proven categories from EN 954-1 have been retained, but safety-related properties are also assessed quantitatively through statistical calculation methods. A Performance Level is determined, based on the categories. This is described by the following parameters :

• Category (structural requirement)
• Mean time to dangerous failure (MTTFd)
• Diagnostic coverage (DC) and
• Common cause failure (CCF)

EN ISO 13849-2 Safety of machinery - Safety-related parts of control systems

By validation we mean an evaluated examination, including analysis and testing of the safety functions and categories of safety-related parts of control systems.

Applicability of EN 954-1

In principle EN 954-1 lost its presumption of conformity with the Machinery Directive 2006/42/EC on 31.12.2011, so actually it may no longer be applied in a conformity assessment procedure for 2006/42/EC.  

Exception: In individual product standards for specific machine types (e.g. machine tools), application is still permitted under two conditions :

1) EN 954-1 must be noted in the normative references with the issue date

• EN 954-1:1996 Example: EN 12417:2001 + A2:2009 Machine tools – Safety – Machining centres

2) EN 954-1 and EN ISO 13849-1 are both listed in parallel in the normative references with the issue date

• EN 954-1:1996 and EN ISO 13849-1:2006 Example: EN ISO 23125:2015 – Machine tools – Safety – Turning machines

Reach your goal in six steps

The introduction of EN ISO 13849-1 has also resulted in new procedural requirements for machine design. The design of safety-related parts of control systems is an iterative process, which is completed in several steps .

Step 1 - Define the requirements of the safety functions

This is the most important step. First of all, the required properties must be defined for the safety functions. For safety gate guarding on a machine, for example, hazardous movements must be shut down when the safety gate is opened. It must not be possible for the machine to restart while the safety gate is open.

Step 2 - Determine the required Performance Level (PL)

The greater the risk, the higher the requirements of the control system. The contribution of reliability and structure can vary depending on the technology used. The level of each hazardous situation is classified in five stages from "a" to "e". With "a" the control function's contribution to risk reduction is low, with PL "e" it's high. The risk graph can be used to determine the required Performance Level (PL r ) for the described safety function.

Severity of injury (S) S1 = Slight (normally reversible) injury S2 = Serious (normally irreversible) injury, including death

Frequency and/or exposure to a hazard (F) F1 = Seldom to less often and/or exposure time is short F2 = Frequent to continuous and/or exposure time is long

Possibility of avoiding hazard or limiting harm (P) P1 = Possible under specific conditions P2 = Scarcely possible

Step 3 – Design and technical implementation of the safety functions

The "safety gate interlock" safety function described in Step 1 is realised through control measures. The safety gate interlock is implemented using a coded proximity switch such as the PSENcode. This provides the option to connect several safety gates in series without reducing the effectiveness of the monitoring functions. What's more, coding also offers comprehensive manipulation protection. The sensors are evaluated using a multifunctional safety system such as the PNOZmulti. The drive is shut down via two contactors with positive-guided contacts.

Step 4 – Determine and evaluate the performance level

To determine the achieved Performance Level, the safety function is separated into sensor, logic and actuator. Each of these subsystems contributes to the safety function. All the necessary performance data is available for Pilz components. Pilz provides a user-friendly calculation tool (PAScal) for this purpose.

Step 5 – Verification

This step determines the extent to which the achieved Performance Level matches the required Performance Level. The achieved PL must be greater than or equal to the PL r required from the risk assessment. This means a "green light" for the machine design.

Step 6 – Validation

Alongside the purely qualitative requirements for the design of safety systems, it is also important to avoid systematic failures. This happens during validation.

Do you require further information? Please read chapter 3.7! The English Safety Compendium offers knowledge around machine safety.

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Machinery safety

Summaries of EU Legislation

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SUMMARY OF:

Directive 2006/42/EC on machinery

WHAT IS THE AIM OF THE DIRECTIVE?

• It enables machinery that meets European Union (EU) health and safety requirements to be moved freely throughout the EU. This means that workers and the public are well protected when they use or come into contact with machinery.
• The health and safety requirements are compulsory , but the standards that give presumption of conformity with those requirements, the references of which are published in the Official Journal of the European Union , are voluntary .
• It only applies to products when they are first placed on the EU market .
• It helps the EU to be more innovative, efficient and competitive .
• The directive covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery.
• It does not cover other types of machinery, such as machinery used in fairgrounds, the nuclear industry, laboratories and mines or by the military or police.

Manufacturers’ obligations

Manufacturers must:

• carry out a risk assessment to identify which health and safety requirements apply to their machinery;
• keep the risk assessment in mind when designing and building their machinery;
• determine what limits there are on using the machinery;
• identify any possible hazards ;
• assess the risk of their machinery causing severe injury or damage and take action to make their machinery safer;
• make sure that their machinery complies with the essential health and safety requirements listed in Annex I to the directive;
• provide a technical document confirming that the machinery meets the directive’s requirements;
• make sure that they are applying conformity assessment procedures and that they are making all necessary information available, including instructions for assembly and use;
• check that they have filled in the declaration of conformity and that the CE conformity marking has been put on the machinery so that it can be used anywhere in the EU.

European Commission powers to adopt delegated and implementing acts

Under amending Regulation (EU) 2019/1243 , the European Commission is given the power to adopt delegated acts to amend the indicative list of safety components in Annex V to Directive 2006/42/EC.

To ensure uniform conditions for the implementation of Directive 2006/42/EC, the Commission is given powers to introduce necessary measures to deal with potentially hazardous machinery by means of implementing acts . Those powers must be exercised in accordance with Regulation (EU) No 182/2011 (see summary ).

FROM WHEN DO THE RULES APPLY?

Directive 2006/42/EC had to be transposed into national law by 29 June 2008. These rules should apply from 29 December 2009.

For further information, see:

• Machinery (European Commission)

Directive 2006/42/EC revised and replaced Directive 98/37/EC and its subsequent amendments.

MAIN DOCUMENT

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) (OJ L 157, 9.6.2006, pp. 24–86).

Successive amendments to Directive 2006/42/EC have been incorporated in the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, pp. 13–18).

Commission communication in the framework of the implementation of Directive 2006/42/EC of the European Parliament and of the Council on machinery, and amending Directive 95/16/EC (Publication of titles and references of harmonised standards under Union harmonisation legislation) (OJ C 54, 13.2.2015, pp. 1–79).

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82–128).

last update 28.04.2022

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• Business and industry
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• Supply of Machinery (Safety) Regulations 2008
• Office for Product Safety & Standards

Supply of Machinery (Safety) Regulations 2008: Great Britain

Updated 9 January 2023

© Crown copyright 2023

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected] .

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This publication is available at https://www.gov.uk/government/publications/supply-of-machinery-safety-regulations-2008/supply-of-machinery-safety-regulations-2008-great-britain

Guidance on the regulations as they apply to machinery being supplied in or into Great Britain.

January 2023

1. Introduction

This Guide is for businesses placing machinery on the market in Great Britain.

Read guidance on the regulations in Northern Ireland

This Guide is designed to help you understand The Supply of Machinery (Safety) Regulations 2008 as they apply in Great Britain (referred to in this document as the “2008 Regulations”). The 2008 Regulations set out the requirements that must be met before machinery can be placed on the GB market or put into service. The purpose of the legislation is to ensure safe machinery is placed on the market or put into service by requiring manufacturers to show how their machinery meet the ‘essential health and safety requirements’.

2. Legislative Background

The Supply of Machinery (Safety) Regulations 2008 implemented Directive 2006/42/EC on machinery. The EU Withdrawal Act 2018 preserved the Regulations and enabled them to be amended so as to continue to function effectively now the UK has left the EU. Accordingly, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 see footnote 1 fixed any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and made specific provision for the GB market.

The 2008 Regulations replaced the Supply of Machinery (Safety) Regulations 1995 and were amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 to apply solely to the GB market.

There is therefore one set of UK 2008 Regulations, but some of the provisions apply differently in NI for as long as the Northern Ireland Protocol is in force. References to the 2008 Regulations in this guidance are references to those Regulations as they apply in Great Britain.

The Regulations apply to:

a) machinery, described as:

(i) 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

(ii) an assembly as referred to in sub-paragraph (i), missing only the components to connect it on site or to sources of energy and motion

(iii) an assembly as referred to in sub-paragraph (i) or (ii), 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 structure

(iv) assemblies of machinery as referred to in sub-paragraphs (i), (ii) and (iii) or partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole

(v) 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

b) interchangeable equipment, described as:

devices which, after the putting into service of machinery or of a tractor, are assembled with that machinery or tractor by operators themselves in order to change its function or attribute a new function, in so far as they are not tools

c) safety components, described as components:

(i) which serve to fulfil a safety function

(ii) which are independently placed on the market

(iii) the failure or malfunction of which endangers the safety of persons, and

(iv) which are not necessary in order for the machinery to function, or for which other components which do not fall within the previous sub-paragraphs may be substituted in order for the machinery to function

d) lifting accessories, described as components or equipment that:

(i) are not attached to lifting machinery

(ii) allow a load to be held

(iii) are placed between the machinery and the load or on the load itself, or are intended to constitute an integral part of the load, and

(iv) are independently placed on the market

e) chains, ropes and webbing, described as being:

designed and constructed for lifting purposes as part of lifting machinery or lifting accessories

f) removable mechanical transmission devices, described as:

removable components for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing (when such components are placed on the market with a guard the components and the guard together shall be regarded as one product).

g) partly completed machinery, described as:

drive systems and other assemblies which:

(a) are almost machinery

(b) cannot in themselves perform a specific application, and

(c) are only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery

4. Requirements

The Regulations make it an offence for a ‘responsible person’ to supply machinery, partly completed machinery or safety components unless they comply with the 2008 Regulations.

Compliance with the 2008 Regulations includes ensuring that the essential health and safety requirements (EHSRs) are satisfied; carrying out the necessary conformity assessment procedures; drawing up a declaration of conformity; and ensuring the machinery has the UKCA or (alternatively until 11pm 31 December 2024 the CE marking) affixed.

5. Obligations of ‘responsible persons’

A ‘responsible person’ under the Regulations means the manufacturer (see definition of ‘manufacturer’ in the glossary section 12) of the machinery or the manufacturer’s authorised representative.

The obligations of responsible persons under the Regulations are:

• No responsible person shall place machinery on the GB market or put it into service unless it is safe.
• They must ensure that the essential health and safety requirements are satisfied in respect of it.
• They must ensure that the technical file is compiled and made available on request.
• They must provide information necessary to operate it safely.
• They must ensure that the relevant conformity assessment procedure is carried out.
• They must draw up a declaration of conformity and make sure that a copy of this accompanies the machinery.
• They must affix the relevant conformity marking to the machinery.
• For partly completed machinery, the responsible person must also ensure that assembly instructions are prepared, and a declaration of incorporation is drawn up and that both accompany the partly completed machinery until it is incorporated into machinery.

Manufacturers based in Northern Ireland can follow the legislation as it applies to Northern Ireland and place qualifying Northern Ireland goods on the GB market without any additional approvals. See further detail in Section 9 on Qualifying Northern Ireland Goods.

6. Obligations of authorised representatives

Manufacturers are able by written mandate to appoint authorised representatives to perform all or part of the obligations and formalities imposed on manufacturers (either as manufacturers or responsible persons) by the Regulations.

Mandated authorised representatives for the GB market can be based in GB or Northern Ireland but cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK, under the 2008 Regulations as they apply in GB.

No GB-based authorised representatives are recognised under EU law. This means GB-based authorised representatives cannot carry out tasks on the manufacturer’s behalf for machinery being placed on the Northern Ireland or EEA markets. Therefore, a GB manufacturer selling machinery to the EEA or placing on the NI market, who wishes to appoint an authorised representative to carry out tasks for them in respect of that machinery, must appoint an authorised representative based in Northern Ireland or the EEA.

7. Conformity assessment and marking – products placed on the GB market before 11pm 31 December 2024

Products placed on the market before 11pm 31 december 2024.

If you place an individual fully manufactured product on the EEA or the UK market (either in Northern Ireland or Great Britain) before 11pm 31 December 2024, you do not need to do anything new. These individual goods can continue to circulate on either market until they reach their end user and do not need to comply with the changes that take effect from 11pm 31 December 2024.

A fully manufactured good is ‘placed on the market’ when there is a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other rights in the product. This does not require physical transfer of the good.

You can usually provide proof of placing on the market on the basis of any relevant document ordinarily used in business transactions, including:

• contracts of sale concerning goods which have already been manufactured and meet the legal requirements
• documents concerning the shipping of goods for distribution

The relevant responsible person (manufacturer, authorised representative or person placing on the market or putting into service) bears the burden of proof for demonstrating that the good was placed on the EEA or UK market before 11pm 31 December 2024.

Products which are repaired, refurbished or exchanged without changing their original performance, purpose, or type, are not considered ‘new’ and therefore do not need to be recertified and remarked.

This includes if the product is temporarily exported for repair (as the product is not being placed on the GB market for the first time when re-imported).

If the product has been subject to important changes, substantially changing its original performance, purpose, or type, it will be considered as a ‘new’ product. Therefore, the modified product must comply with GB regulatory requirements, including the requirement for UKCA marking from 11pm 31 December 2024.

Repair, replacement and maintenance operations are often carried out using other products which are spare parts. Spare parts are considered to have been placed on the market at the time at which the original product or system they are ultimately intended to repair, replace or maintain was placed on the market.

This means that spare parts can comply with the same conformity assessment requirements that were in place at the time the original product or system they are ultimately intended to repair, replace or maintain was placed on the market.

The definition of a spare part will vary depending on the commercial context, but it is broadly determined by a product’s ultimate intended usage. Whether a product is ultimately intended to be used as a spare part should be evidenced by any document demonstrating this intended use, which should be produced when requested by market surveillance authorities.

8. Conformity assessment and marking – products placed on the GB market from 11pm 31 December 2024

Assessment through third-party organisations.

From 1 January 2021, machinery intended for the GB market should be conformity assessed by a UK approved body and UKCA marked, not CE marked. See footnote 2

Qualifying Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may be placed on the GB market after 11pm 31 December 2024. See further detail in Section 11 on Qualifying Northern Ireland Goods.

Rules around physically affixing the new UKCA marking mirror those which currently apply for the application of the CE marking although, until 31 December 2027, the UKCA marking may be affixed to a label affixed to the machinery or a document accompanying the machinery, rather than being affixed to the machinery itself (even where it is otherwise possible to affix it to the equipment itself).

Self-declaration

Where self-declaration of conformity is permitted in the Regulations, manufacturers placing machinery on the GB market, can affix the UKCA marking on the machinery before placing it on the GB market. Alternatively, until 11pm 31 December 2024, before placing it on the GB market, manufacturers can affix CE marking based on self-declaration of conformity with the EU requirements, where permitted.

It is possible to affix both the UKCA marking and the CE marking to the same machinery on the basis of self-declaration, where permitted, as long as the EU and GB requirements remain the same. When selling to the EU or placing on the NI market, the CE marking remains mandatory.

Reducing re-certification/re-testing costs for UKCA marking

The Government has introduced legislation to allow conformity assessment activities undertaken by EU-recognised Conformity Assessment Bodies (CABs), for CE certification before 11pm 31 December 2024, to be used by manufacturers, and other relevant persons, to declare existing product types as compliant with UKCA requirements. Products must still bear the UKCA marking and will need to undergo conformity assessment with a UK Approved Body at the expiry of the certificate or after 31 December 2027, whichever is sooner. For ongoing production, they will need to undergo conformity assessment with a UK Approved Body once any of the relevant CE certification has expired, or after 31 December 2027, whichever is sooner.

Before 11pm 31 December 2024, if an EU-recognised CAB has completed the relevant conformity assessment activities applying to a product, this would allow manufacturers to apply the UKCA mark without the need for any UK Approved Body involvement. They could continue to place their goods on the market on the basis of their existing CE certification following the end of this year, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner).

Where manufacturers are using conformity assessment under existing CE certification before 11pm 31 December 2024 as the basis to demonstrate compliance with UKCA requirements for their products, it is recommended they include in the UK Declaration of Conformity the list of relevant UK designated standards and equivalent EU harmonised standards that apply to their product, as well as details of the EU-recognised CAB (or CAB recognised under an EU Mutual Recognition Agreement with a third country) which carried out the conformity assessment procedures.

This measure applies across all relevant module types.

Read guidance on UKCA marking

9. Qualifying Northern Ireland Goods

The government committed to providing unfettered access for qualifying Northern Ireland goods to the rest of the UK market after 1 January 2021. Products that can be placed on the market in Northern Ireland in accordance with the legislation, as it applies to Northern Ireland, can be sold in the rest of the UK without any additional approvals.

This means that products that are qualifying Northern Ireland goods can be sold in the rest of the UK if any of the following apply:

• the CE marking is lawfully applied to the good on the basis of self-declaration
• any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (including a body in a country with which the EU has a relevant mutual recognition agreement) and a CE marking is affixed
• the certificate of conformity previously held by a UK approved body has been transferred to an EU-recognised notified body and a CE marking has been affixed
• any mandatory third-party conformity assessment was carried out by a UK-based body, and the good is therefore marked with the CE marking and with the new UKNI marking

This will be the case even if there are changes between the EU rules that the Northern Ireland Protocol applies to NI and the GB rules.

Read guidance on UKNI marking

NI businesses that are importing products from the EEA and placing them on the GB market must ensure that the relevant conformity assessment procedure has been carried out, that the technical documentation has been drawn up and that the machinery bears the CE marking. They will also have to comply with the importer labelling duties (see Section 6 on obligations of importers).

Read guidance on qualifying Northern Ireland goods

10. Approved Bodies

The UK has established a new framework for UK based bodies to assess machinery against GB rules. Existing UK notified bodies have been granted new UK ‘approved body’ status and are listed on a new UK database.

UK approved bodies are conformity assessment bodies which have been approved by the Secretary of State to carry out the procedures for conformity assessment and certification for the GB market as set out in the 2008 Regulations as amended.

These approved bodies retain their 4-digit identification number. New approved bodies will be assigned a number by the Office for Product Safety and Standards on behalf of the Secretary of State.

Approved bodies can assess products for the GB market against GB essential requirements (which are, as yet, the same as EU essential requirements).

UK approved bodies must be established in the UK and be independent of the manufacturer. Approved bodies must examine the technical documentation and supporting evidence in respect of machinery or partly completed machinery to assess the adequacy of the technical design.

Where, having issued a certificate or approval, an approved body finds that applicable requirements of the Regulations have not been met by a manufacturer, they must require the manufacturer to take corrective measures and/or suspend or withdraw the certificate or approval.

View the register of UK Approved Bodies

The register also contains details of bodies in other countries such as Australia, New Zealand, Canada, Japan, and the United States of America, which the UK is designating as Approved Bodies through Mutual Recognition Agreements.

11. Enforcement

For products intended for workplace use, the Health and Safety Executive (HSE) has a duty to enforce of the Regulations in Great Britain.

In Great Britain, local trading standards authorities have a duty to enforce the Regulations in relation to consumer goods.

Alternatively, the Office for Product Safety and Standards on behalf of the Secretary of State is able to enforce the Regulations. The Office of Rail Regulation is responsible for the enforcement of these Regulations in Great Britain where the Health and Safety (Enforcing Authority for Railways and Other Guided Transport Systems) Regulations 2006 make it the enforcing authority, within the meaning of section 18(7) of the 1974 Act, in relation to machinery or partly completed machinery for use in the operation of a railway, tramway or any other system of guided transport, as defined in those Regulations.

Regulators’ Code

Enforcing authorities must have regard to the Regulators’ Code when developing the policies and operational procedures that guide their regulatory activities in this area. They should carry out their activities in a way that supports those they regulate to comply and grow, including choosing proportionate approaches that reflect risk.

In responding to non-compliance that they identify, regulators should clearly explain what the non-compliant item or activity is, the advice being given, actions required, or decisions taken, and the reasons for these. Unless immediate action is needed to prevent a serious breach, regulators should provide an opportunity for dialogue in relation to the advice, requirements or decisions, with a view to ensuring that they are acting in a way that is proportionate and consistent. The Secretary of State takes account of the provisions of both the Regulators’ Code and the Growth Duty in exercising their regulatory functions.

Read the Regulators’ Code

A person committing an offence under the Regulations may be liable to a penalty. Penalties can include a fine or a prison sentence of up to two years for the most serious offences. It is matter for the enforcement authority to decide what action is appropriate in each case taking into account the circumstances of the case and the enforcement authorities’ own policies, operational procedures and practices in line with the Regulators Code. Should a prosecution take place, it is at the discretion of the court to decide the penalties imposed on the offender.

12. Glossary

• Approved Body – A conformity assessment body which has been approved by the Secretary of State.
• Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. Authorised representatives for the GB market must be based in the UK.

Declaration of conformity – A document prepared by the manufacturer which must detail, among other things, the following:

• the business name and full address of the manufacturer and, where appropriate, the manufacturer’s authorised representative
• a description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name
• Designated standard – A technical specification which is adopted by a recognised standardisation body or which is designated by the Secretary of State.
• Enforcement Authority – In Great Britain, for machinery in use in the workplace, this is the Health and Safety Executive. For products for consumer use this is local trading standards authorities or the Secretary of State. In Great Britain, in relation to machinery for use on railways, it is the duty of the Office of Rail Regulation to enforce these Regulations.
• Manufacturer – A person who designs or manufactures machinery or partly completed machinery, with a view to its being placed on the GB market under their own name or trademark or for their own use in the UK; or where there is no such person, the person who places the machinery or partly completed machinery on the GB market or puts it into service.
• Putting into service/Placing on the market – References to placing machinery or partly completed machinery on the market are references to making it available in GB for the first time with a view to distribution and whether for reward or free of charge. References to putting any machinery or partly completed machinery into service are references to the first time that it is used for its intended purpose in GB.
• Responsible Person – The manufacturer or their authorised representative, or the person placing the product on the GB market or putting the product into service in GB.
• Safe – Machinery that, when properly installed and maintained, and used for the purposes for which it is intended, or under conditions which can be reasonably foreseen does not endanger the health of, or result in death or injury to, any person or domestic animal or endanger property.
• UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods being placed on the GB market, in place of the CE marking which is the conformity marking used in Northern Ireland and the European Union.
• UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory third-party conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the Northern Ireland market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying Northern Ireland goods.

Machinery excluded from the Regulations

The Regulations do not apply to:

• safety components which are: a) intended to be used as spare parts to replace identical components and b) supplied by the manufacturer of the original machinery
• equipment specifically 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
• subject to paragraph 2 of Schedule 3, the following means of transport: a) agricultural and forestry tractors, in respect of the risks covered by Regulation 167/2013, b) motor vehicles as defined in regulation 4(1) of the Road Vehicles (Approvals) Regulations 2009, c) vehicles covered by Regulation 168/2013, d) motor vehicles exclusively intended for competition, and e) means of transport by air, on water and on rail networks
• seagoing vessels, mobile offshore units and machinery installed on board such vessels 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, in so far as they are covered by the Electrical Equipment (Safety) Regulations 2016: a) household appliances intended for domestic use, b) audio and video equipment, c) information technology equipment, d) ordinary office machinery, e) low-voltage switchgear and control gear, and f) electric motors
• the following types of high voltage electrical equipment: a) switch gear and control gear, and b) transformers

Essential Health and Safety Requirements relating to the design and construction of machinery

For the purposes of this Annex, the term ‘machinery’ incorporates machinery; interchangeable equipment; safety components; chains, ropes, and webbing; lifting accessories; and removable transmission devices.

To comply with the Regulations, machinery must satisfy the essential health and safety requirements (EHSRs) which apply to it. The full list of EHSRs is laid out in Schedule 2, Part 1 of the 2008 Regulations as amended by the Product Safety and Metrology etc. (Amendment etc) (EU Exit) Regulations 2019.

The listing in Schedule 2, Part 1 of the 2008 Regulations, as amended, begins with a crucially important statement of ‘General Principles’, reproduced in full below. This, in turn, explicitly requires the carrying out of a risk assessment, meaning that the responsible person should determine which are the EHSRs applicable to their machinery and in respect of which they must take measures.

General Principles

The responsible person must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

By the iterative process of risk assessment and risk reduction referred to above, the responsible person shall:

• Determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof
• Identify the hazards that can be generated by the machinery and the associated hazardous situations
• Estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence
• Evaluate the risks, with a view to determining whether risk reduction is required; and
• Eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b) of Annex I to Directive 2006/42/EC as set out in Schedule 2 to the 2008 Regulations.

The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the responsible person or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 of Annex I to Directive 2006/42/EC as set out in Schedule 2 to the 2008 Regulations and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 of Annex I to Directive 2006/42/EC as set out in Schedule 2 to the 2008 Regulations apply.

The essential health and safety requirements are mandatory. However, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.

The list of essential requirements is organised into several sections. The first section has a general scope and is applicable to all kinds of machinery. The other sections refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of the list in order to be sure of meeting all the applicable essential requirements. When machinery is being designed, the requirements of the general section and the requirements of one or more of the other sections shall be taken into account, depending on the results of the risk assessment carried out in accordance with the opening paragraph of these General Principles.

13. Footnotes:

1: The following legislative amendments and Government announcements apply:

• The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were amended by the Product Safety and Metrology etc. (Amendment to Extent and Meaning of Market) (EU Exit) Regulations 2020 to apply to Great Britain only, and not to Northern Ireland, in support of implementing The Protocol of Ireland and Northern Ireland (“The Northern Ireland Protocol”).
• The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were further amended by the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 to provide for a 24 month transition period for importer labelling (for goods from the EEA), UKCA marking, to amend the definition of “authorised representative” as well as introducing an end (in 12 months from the end of the Transition Period) to the recognition of goods meeting EU requirements, as well as introducing provisions for qualifying Northern Ireland goods.
• On 24 August 2021 the Government announced the transition period for UKCA marking would be extended until 31 December 2022. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 14 November 2022 the Government announced it would be extending this until 31 December 2024. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.
• On 20 June 2022, the Government announced the provisions for UKCA labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the provisions for UKCA labelling and importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.

2: On 24 August 2021 the Government announced the transition periods for UKCA marking and UKCA labelling would each be extended until 31 December 2022 and 31 December 2023 respectively. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 20 June 2022, the Government announced the provisions for UKCA labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the transition period for UKCA marking until 31 December 2024 and the provisions for UKCA labelling and importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.

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Dependability

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Introduction

The following documents are an extract of the dependability standards pertaining to risk. IEC 31010 refers to a number of risk techniques, some of which have dependability standards – see section R2 below. Other risk techniques within IEC 31010 are shown in section R3 below

R1.  Risk standards

R2.  Risk techniques within IEC 31010 with dependability standards

R3.  Other risk techniques within IEC31010

The IEC (International Electrotechnical Commission) is the world's leading organization that prepares and publishes globally relevant international standards for all electric and electronic devices and systems. It brings together 173 countries, representing 99,2% of the world population and 99,1% of world energy generation. Close to 20 000 experts cooperate on the global IEC platform and many more in each member country. They ensure that products work everywhere safely and efficiently with each other. The IEC also supports all forms of conformity assessment and administers four Conformity Assessment Systems that certify that components, equipment and systems used in homes, offices, healthcare facilities, public spaces, transportation, manufacturing, explosive environments and during energy generation conform to them. IEC work covers a vast range of technologies: power generation (including all renewable energy sources), transmission, distribution, smart grid and smart cities, batteries, home appliances, office and medical equipment, all public and private transportation, semiconductors, fibre optics, nanotechnology, multimedia, information technology, and more. It also addresses safety, EMC, performance and the environment.

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Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking

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Information collected automatically through this Application (or third-party services employed in this Application), which can include: the IP addresses or domain names of the computers utilized by the Users who use this Application, the URI addresses (Uniform Resource Identifier), the time of the request, the method utilized to submit the request to the server, the size of the file received in response, the numerical code indicating the status of the server's answer (successful outcome, error, etc.), the country of origin, the features of the browser and the operating system utilized by the User, the various time details per visit (e.g., the time spent on each page within the Application) and the details about the path followed within the Application with special reference to the sequence of pages visited, and other parameters about the device operating system and/or the User's IT environment.

The individual using this Application who, unless otherwise specified, coincides with the Data Subject.

The natural person to whom the Personal Data refers.

The natural or legal person, public authority, agency or other body which processes Personal Data on behalf of the Controller, as described in this privacy policy.

The natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of Personal Data, including the security measures concerning the operation and use of this Application. The Data Controller, unless otherwise specified, is the Owner of this Application.

The means by which the Personal Data of the User is collected and processed.

The service provided by this Application as described in the relative terms (if available) and on this site/application.

Unless otherwise specified, all references made within this document to the European Union include all current member states to the European Union and the European Economic Area.

This privacy policy relates solely to this Application.

Small sets of data stored in the User's device.