Machinery Safety Directive

Table of Contents


Scope

A machine is defined, in the strict sense (Art.2), as 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.

Products missing only the electric motor, requiring mounting or to be assembled with others are all regarded as machinery in the strict sense.

In addition to machinery in the strict sense, the MD brings into scope several other products (Art.1):

  • '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;
  • '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 for the function of the machinery , or for the specific function it may be substituted by normal components;

  • '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 considered as one product;
  • 'partly completed machinery' means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly com-pleted machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery that is in the scope of the Directive after incorporation;

There are some machinery excluded from the Directive – for example motor vehicles used on public roads military equipment, machines which are already covered by other, more specific, directives.

Some equipment falls within the scope of Low Voltage Directive (for example ‘ordinary office machinery’ and household appliance for domestic use) on the grounds that the risks they present are mainly electrical in nature.

It also possible that only health and essential requirements of the MD are applicable to medical devices, lifts, which are out of the scope of the MD, to the extent that the requirements of the MD are relevant and more specific than the one included in the Medical Devices directives.

Secondhand machinery is excluded from the scope of the Directive unless that machinery is refurbished or upgraded so that its original specification is changed.

Equipment manufactured for the manufacturer’s own use is not excluded from the requirements but may be subject to slightly lesser obligations with respect to marking and documentation.


The Directive: MD 2006/42/EC

The Machinery Directive (MD) 2006/42/EC of the European Parliament and of the Council on machinery has been applicable since 29th December 2009 replacing the former Machinery Directive 98/37/EC.

The Machinery Directive aims at the free market circulation of machinery within the European Economic Area and at the protection of workers and consumers using it.

Therefore, the Directive harmonizes the health and safety requirements for the design and construction of machinery at EU level to the primarily protection of persons.

There are specific requirements concern the protection of domestic animals and of property domestic animals and property in so far as they are liable to be exposed to the hazards generated by the machinery.

  • Article 1: Scope
  • Article 2: Definitions
  • Article 3: Specific Directives
  • Article 4: Market Surveillance
  • Article 5: Placing on the market and putting into service
  • Article 7: Obligations of Economic Operators (art.8-13)
  • Article 12: Procedure for assessing the conformity of machinery
  • Article 13: Procedure for partly completed machinery
  • Article 16: CE marking
  • Article 17: Non-Conformity of marking
  • Annex I: Essential Health and Safety requirements relating to design and construction of machinery
  • Annex II: Declarations
  • Annex III: CE marking
  • Annex IV: Category of machinery to which one of procedure referred to in Article 12 (3) and (4) must be applied
  • Annex V: Indicative list of the safety components referred to in Article 2 (2)
  • Annex VI Assembly instruction of party completed machinery

Path to EU Market Entry: Compliance

Under Article 12 of the Machinery Directive there are three routes for conformity assessment:

  1. the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII
  2. the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3
  3. the full quality assurance procedure provided for in Annex X

The second and third conformity assessment route require the involvement of a Notified Body.

Essential Requirements

The essential health and safety requirements (EHSRs)- set out in the Annex I of the MD- identify the potential hazards which may arise from the design and operation of machinery and give instructions on what hazards must be avoided. Therefore, they are applicable when the hazard concerned is present.

The EHSs range from general remarks common to all products to more specific requirements for certain categories of machinery.

They are presented in six sections :

  1. General remarks common to all type of machinery - such as safety principles, design to facilitate handling, ergonomics, control systems, protection against mechanical hazards, other hazards such as from electricity and other forms of energy, temperature, fire and explosion, emissions from noise, vibration, radiation and hazardous substances, maintenance, cleaning and information and markings / warnings
  2. Requirements applicable to certain classes of machinery- such as foodstuffs, cosmetics and pharmaceuticals;
  3. Requirements to offset hazards due to the mobility of machinery;
  4. Requirements to offset hazards to lifting operation;
  5. Requirements for machinery intended to work underground;
  6. Requirements for machinery lifting persons.

With the exception of the key EHSRs (1.1.2 Principles of safety integration, 1.7.3 Marking and 1.7.4 Instructions) which are always applicable, the EHSRs are applicable when the manufacturer’s risk assessment shows that the hazard concerned is present for a given model of machinery used under conditions foreseen by the responsible person or in foreseeable abnormal situation.

Then, the manufacturer needs to carry out a risk assessment- interactive process set out in the Annex I of the Directive- and compliance procedure for the risk areas associated to the relevant ESHRs. However, taking into account the state of the art, it may not be possible to meet all of the objectives set by the EHSRs. Where this is not possible, machinery must, as far as possible, be designed and constructed with the purpose of approaching the objectives of the EHSRs.

Harmonized Standard

Machinery manufactured in conformity with a harmonized standard – which have been published in the Official Journal of the European Union- shall be presumed to comply with the essential health and safety requirements covered by such a harmonized standard.

It there are no harmonized standard or they are missing or they do not exist for a product, it may be used national or international standards or specification but conformity with EHRS must be proved.

Due to the broad number of standards required to cover the full range of machines within the scope of the Directive, the European Harmonized Standards have been hierarchy classified into three types A, B and C.

Technical Documentation

The manufacturer compiles the technical documentation, which makes it possible to assess whether the machinery complies with the requirements of the Directive It contains at least the elements set out in the Annex VII.


Notified Body for Machinery

Two of the three conformity assessment procedures (as mentioned above) require the intervention of Notified Bodies in order to obtain the CE Marking under the Machinery Directive.

Nando Database for Machinery Directive Accredited Notified Bodies


Authorized Representatives for Machinery

At the discretion of the manufacturer, an Authorized Representative may be appointed by written mandate to undertake such activities as:

  • Keeping the Declaration of Conformity and the technical documentation available to the Competent Authorities at all times and for 10 years after the equipment is placed on the market
  • Accommodate any reasoned requests from the Competent Authorities relating the documentation or conformity of the pressure equipment
  • Cooperate with the Competent Authorities regarding and actions to be taken to eliminate and risks relate to the pressure equipment for which they are responsible under the mandate

The Authorized Representative should be clearly identified on the packaging to ensure efficient communication from end-users and EU economic operators in regards to the product(s) compliance.

The authorized representative may not draw up technical documentation as referred to in Article 6(2).

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.


Post-Market Surveillance

It is the responsibility of each brand owner to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves.

Post-Marketing surveillance activities include, but are not limited to:

  • Staying up-to-date on new requirements or legislative changes
  • Continual updating of the technical file as modifications are made to the product
  • Reporting of any incidents related to the product use
  • Removal of non-compliant batches from EU economics operators and end-user
  • Keeping technical file available for 10 years after the last batch entered the EU market

Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.


Risks of Non-Compliance

Evidently, non-compliant products enter the EU Market everyday - whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.

As there is no "approval" in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.

Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.

The main consequences include, but are not limited to:

  • Being publicly reported to the RAPEX
  • Warehousing Fees
  • Requested Withdrawal
  • Mandated Withdrawal
  • Product Recall (from end-users and/or the market)
  • Complete ban on marketing of the product
  • Destruction of the product
  • Fines
  • Revocation of the CE Marking

Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.


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