Machinery

Directive 2006/42/EC enables machinery that meets its health and safety requirements to be moved freely throughout the EU. This means that workers and the public are protected when they use or come into contact with machinery. It only applies to products when they are first placed on the EU market.

News
Proposal for a Regulation of the European Parliament and of the Council on machinery products - 21 April 2021
ANNEXES to the Proposal for a Regulation of the European Parliament and of the Council on machinery products - 21 April 2021
Commission Staff Working Document - Executive Summary of the Impact Assessment Report accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products - 21 April 2021

 

Scope

  1. This Directive applies to the following products:
    1. machinery;
    2. interchangeable equipment;
    3. safety components;
    4. lifting accessories;
    5. chains, ropes and webbing;
    6. removable mechanical transmission devices;
    7. partly completed machinery.
  2. The following are excluded from the scope of this Directive:
    1. safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;
    2. specific equipment for use in fairgrounds and/or amusement parks;
    3. machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
    4. weapons, including firearms;
    5. the following means of transport:
      • agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,
      • motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, with the exclusion of machinery mounted on these vehicles,
      • vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles, with the exclusion of machinery mounted on these vehicles,
      • motor vehicles exclusively intended for competition, and
      • means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;
    6. seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;
    7. machinery specially designed and constructed for military or police purposes;
    8. machinery specially designed and constructed for research purposes for temporary use in laboratories;
    9. mine winding gear;
    10. machinery intended to move performers during artistic performances;
    11. electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits:
      • household appliances intended for domestic use,
      • audio and video equipment,
      • information technology equipment,
      • ordinary office machinery,
      • low-voltage switchgear and control gear,
      • electric motors;
    12. the following types of high-voltage electrical equipment:
      • switch gear and control gear,
      • transformers.

 

Definitions

Safety component means a component:

  • which serves to fulfil 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, which may be updated in accordance with Article 8(1)(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.

Removable mechanical transmission device means a removable component for transmitting power between selfpropelled 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

Placing on the market means making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge.

Manufacturer means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer.

Putting into service means the first use, for its intended purpose, in the Community, of machinery covered by this Directive.

 

Article 5 - Placing on the market and putting into service

  1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:
    1. ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;
    2. ensure that the technical file referred to in Annex VII, part A is available;
    3. provide, in particular, the necessary information, such as instructions;
    4. carry out the appropriate procedures for assessing conformity in accordance with Article 12;
    5. draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;
    6. affix the CE marking in accordance with Article 16.
  2. Before placing partly completed machinery on the market, the manufacturer or his authorised representative shall ensure that the procedure referred to in Article 13 has been completed.
  3. For the purposes of the procedures referred to in Article 12, the manufacturer or his authorised representative shall have, or shall have access to, the necessary means of ensuring that the machinery satisfies the essential health and safety requirements set out in Annex I.
  4. Where machinery is also the subject of other Directives relating to other aspects and providing for the affixing of the CE marking, the marking shall indicate that the machinery also conforms to the provisions of those other Directives. However, where one or more of those Directives allow the manufacturer or his authorised representative to choose, during a transitional period, the system to be applied, the CE marking shall indicate conformity only to the provisions of those Directives applied by the manufacturer or his authorised representative. Particulars of the Directives applied, as published in the Official Journal of the European Union, shall be given on the EC declaration of conformity.

 

Article 16 - CE marking

  1. The CE conformity marking shall consist of the initials ‘CE’ as shown in Annex III.
  2. The CE marking shall be affixed to the machinery visibly, legibly and indelibly in accordance with Annex III.
  3. The affixing on machinery of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

 

ANNEX II - Declarations

1. CONTENT

EC DECLARATION OF CONFORMITY OF THE MACHINERY

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I, section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user.

The EC declaration of conformity must contain the following particulars:

  1. business name and full address of the manufacturer and, where appropriate, his authorised representative;
  2. name and address of the person authorised to compile the technical file, who must be established in the Community;
  3. description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name;
  4. a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;
  5. where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX and the number of the EC type-examination certificate;
  6. where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X;
  7. where appropriate, a reference to the harmonised standards used, as referred to in Article 7(2);
  8. where appropriate, the reference to other technical standards and specifications used;
  9. the place and date of the declaration;
  10. the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative.

2. CUSTODY

The manufacturer of machinery or his authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery.

The manufacturer of partly completed machinery or his authorised representative shall keep the original declaration of incorporation for a period of at least 10 years from the last date of manufacture of the partly completed machinery.

Consolidated harmonised standards summary list - 4 May 2022

Commission Implementing Decision (EU) 2021/1813 of 14 October 2021 amending Implementing Decision (EU) 2019/436 as regards harmonised standards for aircraft ground support equipment, cranes, mining tools, and other machinery drafted in support of Directive 2006/42/EC of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2015/27 - OJ L 366/109 of 15 October 2021

Commission Implementing Decision (EU) 2021/377 of 2 March 2021 amending Implementing Decision (EU) 2019/436 on harmonised standards for machinery drafted in support of Directive 2006/42/EC of the European Parliament and of the Council - OJ L 72 of 3 March 2021

Commission Implementing Decision (EU) 2020/480 of 1 April 2020 amending Implementing Decision (EU) 2019/436 on harmonised standards for machinery drafted in support of Directive 2006/42/EC - OJ L 102 of 2 April 2020, p. 6–13

Commission Implementing Decision (EU) 2019/1863 of 6 November 2019 amending and correcting Implementing Decision (EU) 2019/436 as regards the withdrawal of references of harmonised standards for machinery from the Official Journal of the European Union - O0J L 286 of 7 November 2019, p. 25-29

Commission Implementing Decision (EU) 2019/1766 of 23 October 2019 amending Implementing Decision (EU) 2019/436 as regards harmonised standard EN ISO 19085-3:2017 for numerically controlled boring and routing machines - OJ L 270 of 24 October 2019, p. 94–96

Commission Implementing Decision (EU) 2019/436 of 18 March 2019 on the harmonised standards for machinery drafted in support of Directive 2006/42/EC of the European Parliament and of the Council C/2019/1932 - OJ L 75 of 19 March 2019, p. 108–119

Commission communication in the framework of the implementation of the 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 C 092 of 9 March 2018

M440 Standardisation request to the European Committee for Standardisation - 04 February 2009