European directives

The aim of the EC Directives is to harmonize the national legislation of the Member States so as to have common regulations concerning technical, economic, social aspects, etc. and to facilitate the free circulation of goods, service and people within the European Union.
A directive is a legislative act that establishes the objectives that all EU countries must achieve. For this reason it is mandatory to transpose it without modification; however, each country can decide how to transpose. In particular, with regard to work safety, the legislation distinguishes between two types of measures:

  • Social directive
  • Product directive

Social directives

Social directives are addressed to the employer and have as their objective the improvement of safety in the workplace environment. Are social directive: the General Directive 89/391 / EEC, concerning the implementation of measures aimed at the improvement of safety and health of workers and the particular Directive related to it 2009/104 / EC on the use of work equipment. Other social directives of interest are:

  • 2019/1832/UE “Personal protective equipment”
  • 90/269 CEE “Manual handling of loads”
  • 90/270 CEE “VDT equipment”

In Italy they have been transposed with the Legislative Decree 81/08 «Testo Unico Sicurezza».

Product directive

Product Directives establish:

  • The Essential Safety Requirements of products in order to circulate freely on the European market
  • Attestation conformity criteria

The fundamental directives for safety work equipment are:

  • 2006/42/EC “Machinery directive”
  • 2014/35/EU “Low Voltage Directive”
  • 2014/34/EU “Electromagnetic Compatibility Directive”
  • 2014/34/EU “ATEX directive”

Machinery directive

The “Machinery Directive” 2006/42/EC is meant for the manufacturers of machines and safety components, and has the following goals:

  • The definition of safety and health protection requirements for the improvement of the degree of protection offered to the operators of hazardous machinery
  • The design, manufacture and marketing in the European Union of machines and components complying with the minimum safety requirements laid down by the Directive itself
  • The free circulation in the Member States of machines and safety components complying with the Directive

The Machinery Directive:

  • Applies to all new machines and safety components that are sold, lent or hired, and to used machinery in case they are sold, rent or lent.
  • It sets forth the essential safety requirements relating to the design and manufacturing of machines and safety components and it defines the respective certification procedures.
  • It is mandatory for machines and for safety components.
  • Only products conforming to the Directive can be marketed or commissioned in the European Union

Certification procedures

The Machinery Directive:

  • Lays down stringent procedures for safety components and highly hazardous machines which are listed in Annex 4
  • Lays down simplified procedures for low and medium risk machines not included in annex 4
  • Requires that manufacturers prepare a technical dossier for each product stating the safety principles adopted in the design, manufacture, transport, use and maintenance of the machine or the safety component

Declaration of conformity

In order to certify the conformity of a product to the Directive, the manufacturer must:

  • Affix the CE mark to the product
  • Attach the CE declaration of conformity attesting compliance to the Directive

Certifications

The CE type certificates is valid for 5 years (Annex IX para. 9.3), the five-year period starting from the revision date of the certificate. After which a new verification will be required to maintain the certification.

Low voltage directive

2014/35/EU is aimed at ensuring that electrical materials are designed and manufactured so as to guarantee the protection of people against any risks of electrocution resulting from their use or from the influence of external agents on the electrical materials themselves.
This Directive applies to all electrical materials meant for use at a nominal voltage of between:

  • 50V and 1000V for alternating current
  • 75V and 1500V for direct current

Electromagnetic compatibility directive

The aim of “Electromagnetic Compatibility Directive” 2014/30/EU is to ensure that electrical devices are designed and manufactured so that:

  • Electromagnetic emissions are limited and low enough to permit other electrical devices to operate according to their intended purpose
  • The level of built-in immunity to external disturbances enables them to operate according to their intended
    purpose

This Directive applies to all electrical and electronic devices able to cause electromagnetic disturbances and whose operation can be affected by external factors.

ATEX directive

The ATEX Directive 2014/34/EU applies to all equipment intended for use in potentially explosive. It is in force since 30 March 2014.

The ATEX Directive 2014/34/EU specifies minimum safety requirements for electrical devices used in environments classified as dangerous regarding the aspect of risk of explosion due to the presence of gas or dust.

The Directive divides equipment into groups and categories.

The manufacturer must decide, according to the use, the group and the category of belonging.

  • Group 1: equipment intended for use in underground works, mines and their surface installations
  • Group 2: equipment intended for use in environments where it is likely to occur explosive atmospheres

These product groups are than categorized according to the level of protection from the risk of ignition of potentially explosive atmospheres.

The products in the group 2 are divided into three categories:

  • Category 1: equipment intended for high-risk areas where an explosive atmosphere is present long periods
  • Category 2: equipment intended for medium-risk areas where an explosive atmosphere may occur under normal operating conditions
  • Category 3: equipment intended for areas where an explosive atmosphere is only likely under abnormal circumstances
Accredited bodies

In each Member State, the role of the accredited Bodies is to assess and verify the compliance and the application of the European Directives.

Each State is responsible for the appointment and control of its own Bodies.
In Italy the authorized body to carry out accreditation activities is: Accredia. Accredia maintains a database with a list of all Italian organizations accredited for the various directives.

Notified bodies

Notified Bodies are authorized to examine and certify machines and safety components in compliance with the applicable Directives.

Each Member State of the European Union is required to:

  • Appoint the Notified Bodies by specifying their tasks
  • Submit a list of the Notified Bodies to the European Commission and to the other Member States

The European Commission publishes a Directory of all the Notified Bodies on the Official Journal of the European Commission, together with a list of the services, the machines and/or the safety components on which they are authorised to intervene.

The Member States of the European Union must make sure that these Bodies respect specified ethical and technical criteria.

Compliance with technical safety requirements of the directives is mandatory.