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Executive Orders

 

The Design of Technical Equipment*

Executive Order No. 561 of 24 June 1994 with subsequent amendments, issued by the Danish Working Environment Authority – unofficial version

THE COMPILATION OF EXECUTIVE ORDERS comprises the following:
  • No. 561 of 24 June 1994, which entered into force on 1 January 1995;
  • No. 669 of 7 August 1995, which entered into force on 16 August 1995; and
  • No. 831 of 27 November 1998, which entered into force on 5 December 1998.

Pursuant to sections 35(1), 46, 74, 84 and 86 of the Danish Working Environment Act, cf. Consolidated Act No. 184 of 22 March 1995, and as authorised under section 73 of the said Act, it is laid down as follows:

Part 1 – Repealed

Part 2 – CE marked machines and safety components

5. The rules in this Part shall apply to machines and separately marketed safety components as defined and delimited in Annex VIII.

6. When a machine or safety component is required to satisfy the provisions contained in this Part, cf. the second item in Annex VIII, the same shall also apply to its marketing in other Member States.

Construction, manufacture, ancillary equipment and design

7. -(1) The design of machinery and safety components shall satisfy the essential health and safety requirements specified in Annex I.

(2) However, a machine or safety component may be shown at trade fairs, exhibitions, etc., without satisfying subsection (1) hereof provided (a) clear notice(s) is/are displayed stating that the machine or safety component does not satisfy the legal requirements and cannot be acquired before it has been brought into conformity therewith. During demonstrations of its operation, adequate safety measures must have been taken to ensure the protection of persons.

8. -(1) A machine or safety component that is constructed in conformity with a harmonised standard that covers one or more of the requirements referred to in section 7(1) of this Executive Order shall be presumed to comply with the requirements concerned.

(2) For the purposes of this Executive Order, the term “harmonised standard” shall mean a European standard adopted by CEN or CENELEC on the basis of a remit from the Commission, and the reference number of which has been published in the Official Journal of the European Communities. The reference numbers of the Danish standards implementing a harmonised standard are published by the Danish Standards Association.

Marking and instructions for use

9. Every machine or safety component shall bear markings that comply with the requirements set out in Annex I.

10. Every machine or safety component shall be provided with instructions for use that at least satisfy the requirements set out in Annex I. The instructions for use must accompany the individual machine or safety component on delivery.

Documentation etc. for marketing

11. -(1) Before a machine or safety component is placed on the market, the manufacturer or his authorised representative established in the Community shall provide each individual machine or safety component with an EC declaration of conformity in accordance with the rules set out in sections 12-15 of this Executive Order, as evidence that the machine or safety component complies with the requirements set out in Annex I. The declaration of conformity must accompany the machine or safety component on delivery.

(2) Each individual machine shall also be provided with the CE mark in accordance with the rules set out in section 18 of this Executive Order. If the machine is covered by other regulations that prescribe the CE mark, the CE mark shall only be placed on the machine if the machine also satisfies the other regulations.

(3) It shall be incumbent upon any person who markets the machine or safety component to check and if necessary take steps to ensure that the documentation, etc. referred to in subsections (1) and (2) hereof is in order before the machine or safety component is placed on the market. A similar obligation shall apply to any person assembling machinery or parts thereof of various origins or constructing machines for his own use.

EC declaration of conformity

12. -(1) The EC declaration of conformity for a machine shall be drawn up in accordance with part A of Annex II, cf. however subsection (2) hereof.

(2) In the case of a machine that is intended to be incorporated into machinery or assembled with other machinery, the EC declaration of conformity shall be drawn up in accordance with part B of Annex II, unless the machine can function independently.

(3) In the case of a safety component, the EC declaration of conformity shall be drawn up in accordance with part C of Annex II.

13. -(1) The EC declaration of conformity for a machine or safety component cannot be drawn up until the requirements laid down in Annex V concerning the technical file and other documentation have been satisfied. See, however,  subsection (2) hereof.

(2) The EC declaration of conformity for a machine or safety component that is covered by Annex IV cannot be drawn up until the provisions set out in sections 14 and 15 of this Executive Order have been satisfied.

14. In cases where a machine or safety component covered by Annex IV has been constructed in conformity with harmonised standards, one of the following procedures shall be followed:

  1. A technical file is produced and sent to a notified certifying body within the Community in accordance with Annex VI, see item 5 (first sentence) and item 7 of that Annex. The certifying body confirms receipt of the file.
  2. A technical file is produced and submitted in accordance with Annex VI to a notified certifying body within the Community, which will verify that the relevant standards have been correctly applied and if so will draw up a certificate of adequacy for the file.
  3. A specimen of the machine or safety component is submitted to a notified certifying body within the Community for EC type-examination in accordance with Annex VI.

15. In cases where a machine or safety component covered by Annex IV has not been constructed - or has only partly been constructed - in conformity with harmonised standards, a specimen must be submitted for EC type-examination in accordance with Annex VI.

EC type-examination

16. -(1) The Director General of the Danish Working Environment Authority will approve one or more certifying bodies to undertake type-examination in Denmark in accordance with the provisions contained in this Executive Order.

(2) The certifying bodies mentioned in subsection (1) hereof shall satisfy the minimum requirements laid down in Annex VII.

(3) Approval under subsection (1) may be granted subject to conditions or limitations.

(4) Approval under subsection (1) hereof will be revoked by the Director General of the Danish Working Environment Authority if the body concerned no longer satisfies the requirements laid down in Annex VII.

17. -(1) The certifying body shall undertake type-examinations and issue EC type-examination certificates in accordance with the directions laid down in Annex VI.

(2) The certifying body concerned shall be informed of any change to the machine or safety component to which the certificate applies, cf. Annex VI. The certifying body shall determine whether the magnitude of the change is such in relation to the certificate granted as to require the machine or safety component to undergo a new type-examination.

(3) The certifying body shall have the power to revoke a type-examination certificate in cases where it is later found that the machine or safety component submitted as a basis for the type-examination certificate does not satisfy the requirements set out in Annex I.

CE marking

18. -(1) The CE mark shall be of the form specified in Annex III and shall be affixed to the machine so that it is distinct, visible and durable.

(2) No marks or inscriptions may be affixed to the machine that would diminish the visibility or legibility of the CE mark, or which might be misleading as regards the meaning or graphic design of the CE mark.

Part 3 - Repealed

Part 4 – Repealed

Part 5 - Repealed

Part 6 – Repealed

Part 7 - Repealed

The Danish Working Environment Authority, 24 June 1994

Erik Andersen/Charlotte Skjoldager

* The Executive Order contains provisions implementing Council Directive No. 89/392, Official Journal of the European Communities 1989, L 183, p. 9, as amended by Directive No. 91/368, Official Journal of the European Communities 1991, L 198, p. 16, Directive No. 93/44, Official Journal of the European Communities 1993, L 175, p. 12 and Directive No. 93/68/EEC, Official Journal of the European Communities 1993, L 220, p. 1; and provisions implementing Council Directive No. 89/655/EEC, Official Journal of the European Communities 1989, L 393, p. 13, as amended by Directive No. 95/63/EC, Official Journal of the European Communities 1995, L 335, p. 28.