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Supplementary Provisions to the EU Machinery Regulation Published in Denmark

This blog was originally posted on 25th June, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY EMILIA ASSENZA, SENIOR TEAM LEADER AND REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Introduction

Through Executive Order No. 727, Denmark is one of the first Member States to issue provisions to supplement the EU Machinery Regulation EU 2023/1230, set to apply from 20 January 2027.

The Order will apply to the same products in scope of the EU Machinery Regulation and aims to specify the following:

Language Requirements
Notifying Authority and Conformity Assessment Bodies
Penalties

Language Requirements

Instructions for use, safety information and the information set out in Annex III of the EU Machinery Regulation must be in Danish. However, the maintenance instructions intended for use by specialized personnel mandated by the manufacturer or its authorized representative may be supplied in one of the official languages of the Union which is understood by the specialized personnel.
Written and verbal information or warnings – as per Annex III, Part B, Section 1.7.1. of the EU Machinery Regulation – must be in Danish. An exception is made for computer screens or other interactive means of communication intended for use by specialized personnel mandated by the manufacturer or his authorized representative which may be written in one of the official languages of the Union understood by the specialized personnel.
Assembly instructions for partly completed machinery – as per Article 11(7) and Article 16(2)letter b – must be in a language approved by the manufacturer of the machine into which the partly completed machinery is to be incorporated, or by his representative.
The EU declaration of conformity – as per Article 21(2) – must be in Danish.
The EU declaration of incorporation – as per Article 22(2) – must be in Danish or English.

Notifying Authority and Conformity Assessment Bodies

The Danish Safety Technology Authority (Sikkerhedsstyrelsen) is the designated notifying authority as per Article 27 of the EU Regulation, responsible for appointing conformity assessment bodies. This Authority is also entitled to carry out inspections of notified bodies to ensure that they are compliant with the relevant provisions of the EU Machinery Regulation.

Conformity assessment bodies must be accredited by the Danish Accreditation Fund (DANAK). This Authority is also responsible for the assessment and monitoring of notified bodies.

Communication with the Safety Technology Authority must take place digitally, unless special circumstances occur.

Penalties

Unless a stricter penalty is established under other legislation, a fine is imposed on those who:

Do not comply with §§ 3-7, or
Do not comply with Articles 8, 10-16, 18, 19, 21-24, 25 (1-4), 43, 45(1) or 46(1-2).
Do not comply with orders issued in accordance with Articles 43(1) second paragraph, 45(1) or 46(1-2).

Companies and other legal entities can also be liable under the provisions of the 5th Chapter of the Penal Code.

What’s Next?

The Order, published on 15 June 2024, will enter into force on 1 July 2024. However, the language requirements set out in Sections 3-7 will apply from 20 January 2027. Also, Section 14 concerning the penalties provisions will enter into force on 20 October 2026.

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