PURPOSE: to align Directive 2006/95/EC on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits with the new legislative framework, which established a common framework for the marketing of products (Goods Package).
LEGISLATIVE ACT: Directive 2014/35/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits.
CONTENT: the Directive is part of a package aiming to recast eight directives in order to adapt them to the EU's new legislative framework on sectoral product harmonisation.
The recast seeks to further harmonise and simplify national laws applicable to:
· electromagnetic compatibility
· non-automatic weighing instruments
· lifts and safety components for lifts
· equipment for use in potentially explosive atmospheres
· electrical equipment designed for use within certain voltage limits.
The EU's "new legislative framework", which was adopted in 2008, is a general measure of the internal market with the objective of strengthening the effectiveness of the Union’s legislation on product safety and its implementation mechanisms. It aims to strengthen the safety of products available on the market, and ensures a better functioning internal market for instance through equal treatment of economic operators on the market.
It is made up of two complementary texts: regulation 765/2008 outlining the requirements concerning accreditation and surveillance for the marketing of products, and decision 768/2008/EC relating to a common framework for the marketing of products.
The main elements of the new Directive are as follows:
Purpose and scope: the purpose of this Directive is to ensure that electrical equipment on the market fulfils the requirements providing for a high level of protection of health and safety of persons, and of domestic animals and property, while guaranteeing the functioning of the internal market. This Directive shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, other than the equipment and phenomena listed in Annex II.
This Directive covers electrical equipment designed for use within certain voltage limits which is new to the Union market when it is placed on the market; that is to say it is either new electrical equipment made by a manufacturer established in the Union or electrical equipment, whether new or second-hand, imported from a third country. This Directive should apply to all forms of supply, including distance selling.
Obligations of economic operators and traceability requirements: the Directive clarifies the obligations of manufacturers and introduces obligations for importers and distributors:
· When placing their electrical equipment on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements set out in Annex I. Equipment which they have placed on the market must bear a type and serial or batch identification allowing their identification. Where the size or nature of the electrical equipment does not allow it, the required information shall be placed on the packaging or in a document accompanying the instrument.
· Before placing a product on the market, importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the instrument bears the CE marking and that it is accompanied by the required documents and by instructions and safety information.
· Manufacturers and importers shall indicate on the equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities. The instructions and safety information should be in a language which can be easily understood by end-users, as determined by the Member State concerned.
Economic operators who consider or have reason to believe that equipment which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring it into conformity, to withdraw or recall it, if appropriate.
EU declaration of conformity: the EU declaration of conformity shall have the model structure set out in Annex IV of the Directive. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.
CE marking: the Directive states that the CE marking shall be affixed visibly, legibly and indelibly to the electrical equipment or to its data plate. It shall be affixed before the equipment is placed on the market. As requested by the European Parliament, Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
Notified bodies: the Directive reinforces the notification criteria for notified bodies. It clarifies that subsidiaries or subcontractors must also comply with the notification requirements. Specific requirements for notifying authorities are introduced, and the procedure for notification of notified bodies is revised. The competence of a notified body must be demonstrated by an accreditation certificate. A conformity assessment body shall be a third-party body independent of the organisation or the electrical equipment it assesses. The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.
Market surveillance and the safeguard clause procedure: the Directive revises the existing safeguard clause procedure. It introduces a phase of information exchange between Member States, and specifies the steps to be taken by the authorities concerned, when a non-compliant article is found. Member States should take all appropriate measures to ensure that equipment may be placed on the market only if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, they do not endanger the health and safety of persons.
Restrictive measures in case of non-compliance: appropriate restrictive measures, such as withdrawal of the equipment concerned from the market should be taken in respect of the instrument concerned without delay.
Rules on penalties applicable to infringements by economic operators could include criminal penalties for serious infringements. The penalties provided for should be effective, proportionate and dissuasive.
Transitional provisions/products in stock: distributors should therefore be able to supply electrical equipment that has been placed on the market, namely stock that is already in the distribution chain, before the 20 April 2016.
ENTRY INTO FORCE: 18/04/2014.
TRANSPOSITION: 19/04/2016. Measures shall apply from 20.04.2016.