European Directives

A lot of products require CE marking before they can be sold in the EEA (EU + Iceland, Liechtenstein and Norway). The CE mark confirms that the product has been assessed and complies with EU safety, health and environmental requirements.

The CE marking is based on the specific Directives and the Regulation 765/2008 and the Decision 768/2008, which regulate the activities of all operators: manufacturers, notified bodies, accreditation bodies, national authorities in charge of market surveillance.


20 April 2016 was the end of the transitional period for the official coming into force of some new European Directives, while others are close to the coming into force of the implementation, regulated in Italy by the Circular of 21 March 2016 of the Ministry of Economic Development. Go to the page for all the Directives subject to implementation.


The new updated version of the Blue Guide - "Guide to the implementation of directives based on the New Approach and the Global Approach" - has been published in English.

Published for the first time in 2000, its aim was to facilitate the understanding of EU rules for the CE marking of products and their subsequent placing on the market, thereby promoting the protection of the health and safety of consumers and the environment.

The current version of April 2016 was drafted in close cooperation with national authorities and relevant parties.

Some of the new proposals include, for example:

New sections on the obligations of economic operators and accreditation;

The new revision of the current chapters such as standardization and market surveillance.

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Noise Certification - Directive 2000/14/EC

Directive 2005/88/EC is the harmonization of the laws of the Member States concerning the environmental noise emission of equipment designed to be used outdoors.

The standard revises the previous Directive 2000/14/EC.

The machinery and the equipment are divided into two lists:

art.12: equipment subjected to noise emission limits; the assessment of this limit takes place under the responsibility of a notified body according to various certification procedures established by art. 14. Directive 2005/88/EC lowered the emission limits set by the previous Directive 2000/14/EC;

art. 13: equipment only subjected to the obligation of marking the value of acoustic power generated.

However, the manufacturer shall

  • be responsible for the conformity of the product with the Directive, which includes the internal control of manufacture and the performance of sound level meter readings on the machinery/equipment produced, before it is placed on the market.
  • affix the CE marking to the machine/equipment after having prepared a technical file, carried out the tests required by the Directive and by the standards referred to therein, prepared and affixed the guaranteed sound power level mark (in accordance with the proportions laid down by the Directive) and prepared the EC Declaration of Conformity.

Red Certification - Directive 2014/53/EU

13 June 2017 was the deadline for the marketing of products within the scope of the Directive on the making available on the market of radio equipment (RED) 2014/53/EU and produced prior to its coming into force on 13 June 2016.

In particular, the focus is on everyday devices such as Wi-Fi, Bluetooth, ZigBee and RadioLan devices for which the harmonised standard ETSI EN 300 328 V2.1.1 "Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU" is applicable.

The ETSI EN 300 328 V2.1.1 standard is an important innovation that sets operating limits, performance and compliance requirements for widespread applications such as Wi-Fi modules, Bluetooth for mobile phones and tablets, modules for small domestic areas ZigBee and RadioLan radio links for the spread of broadband in remote areas. All these devices use the 2.4 GHz band.

With the harmonisation of the standard application of Module A is possible, even for the requirement on the effective use of the radio spectrum without the need to apply to the notified body for the issue of the "EU type examination certificate".

EMC certification - Directive 2014/30/EU

Directive 2014/30/EU represents the harmonisation of the laws of the Member States relating to electromagnetic compatibility. As of 20 April 2016, it replaced the previous edition 2004/108/EC, dated 29 April 2004, which, in turn, repealed Directive 89/336/EEC.

The standard sets out the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical elements (electromagnetic fields).

Photovoltaic systems and particularly inverters produce considerable disturbances, worsening the quality of the supply voltage for all users: domestic, residential, light and heavy industry. All equipment is subject to electromagnetic stress if not properly designed and protected.

The manufacturer may affix the CE marking to the equipment after having prepared a technical file, carried out an adequate risk analysis and prepared the EC Declaration of Conformity.

The interoperability of the rail system

Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 concerns the interoperability of the rail system within the Community.

The Directive aims to establish the conditions to be met in order to achieve interoperability of the rail system within the Community, which is compatible with the provisions of Directive 2004/49/EC.

These conditions cover the design, construction, putting into service, upgrading, renewal, operation and maintenance of those parts of the system, as well as the professional qualifications and health and safety conditions of the staff who contribute to the operation and maintenance of the system.

The interoperability constituents must be supported by an EC declaration of conformity to the Directive or a declaration of suitability for use.


CLP is the Regulation 1272/2008 and concerns the classification, labelling and packaging of dangerous substances and mixtures. It is based on the United Nations Globally Harmonized System (GHS – globally harmonized system – dell’ONU).

The purpose is to establish a common and coherent basis for determining the chemical hazard (the classification criteria) and for communicating the hazard (the labelling).

LVD certification - Directive 2014/35/EU

Directive 2014/35/EU, which as of 20 April 2016 replaced the previous Directive 2006/95/EC of the European Parliament and of the Council dated 12 December 2006, harmonises the laws of the Member States relating to electrical equipment designed for use within certain voltage limits.

The Directive defines "electrical equipment" as all components, appliances, installations and installations intended to be supplied with or subjected to an alternating voltage of between 50 Vrms and 1000 Vrms or a direct voltage of between 75 V and 1500 V.

The Directive does not apply to machines and power tools subject to the Machinery Directive 2006/42/EC.

The manufacturer is responsible for the conformity of the product with the essential safety requirements of the Directive, compliance with which is ensured by the full application of the harmonised standards establishing good construction practice and test and evaluation methods.

The manufacturer may affix the CE marking to the equipment after having prepared a technical file, carried out an adequate risk analysis and prepared the EC Declaration of Conformity.


Directive 2009/125/EC of the European Parliament and the Council of 21 October 2009 lays down a framework for the setting of ecodesign requirements for energy-related products - ERP (Energy Related Products).

It represents the most important initiative undertaken by the EU to improve energy efficiency by 20% by the year 2020 and covers the entire life cycle of the product:

  • acquisition of raw materials;
  • production;
  • transport and trade;
  • use and maintenance.

All products covered by specific directives, such as Low Voltage (household appliances, lighting equipment, electric motors also for industrial use, etc.), IT and R&TTE equipment (TV, telephones, home-theatre, battery chargers, etc.), Machinery, Gas appliances ( water heaters, boilers, etc.), are still subject to Directive 2009/125/EC and must also be evaluated according to this directive. The application is the responsibility of the manufacturer or, ultimately, the importer.

The manufacturer may apply the CE mark to the product after having applied one of the following procedures: control of the design or implementation of a management system, preparation of a technical file, carrying out the tests required by the directive and by the harmonised standards and drawing up the EC Declaration of Conformity.

RoHS certification - Directive 2011/65/EC

Directive 2011/65/EC of the European Parliament and the Council of 8 June 2011 sets out restrictions on the use of certain hazardous substances in electrical and electronic equipment.

The Directive establishes rules concerning the restriction of the use of hazardous substances in electrical and electronic equipment (EEE). Specifically, restrictions are placed on the following substances (weight percentage or concentration):

  • Lead (Pb) 0.1%;
  • Mercury (Hg) 0.1%;
  • Cadmium (Cd) 0.01%;
  • Hexavalent chromium (Cr6+);
  • Polybrominated biphenyls (PBB) 0.1%;
  • Polybrominated diphenyl ethers (PBDE) 0.1%.

The new RoHS Directive includes the obligation of the CE marking and the requirements for the declaration of conformity.

The manufacturer/importer/distributor shall ensure that the appropriate conformity assessment procedure has been applied and shall then affix the CE marking to the final product.

As of January 2013, electronic products with the CE mark must meet the requirements of this new Directive in addition to the requirements of the applicable separate directives (e.g. Low Voltage, R&TTE, etc.).

REACH certification - Regulation (EC) No 1907/2006

Regulation (EC) No 1907/2006 refers to the registration, evaluation, authorisation and restriction of chemicals.

The REACH Regulation has the following purposes:

  • to improve awareness of the hazards and risks caused by chemical products to ensure a high level of protection of human health and the environment;
  • to encourage the development of alternative methods other than the use of vertebrate animals for the hazard assessment of substances;
  • to maintain and strengthen the competitiveness and innovative capacities of the EU chemicals industry.

Registration is the key element of the REACH system.

Chemicals manufactured or imported in quantities of one tonne or more per year must be registered in a central database managed by the European Chemicals Agency. Without registration, the chemical cannot be manufactured or placed on the European market.

Registration requires that the industry (manufacturers and importers) commit to compiling a technical dossier, i.e. providing information on the properties, uses and precautions for the use of chemicals.

For chemicals requiring testing, a specific request must be sent to the European Chemicals Agency (ECHA), which has a role of technical and scientific coordination of the activities set out in the Regulation and organizes a database to collect and manage the data provided by industry.