New approach directives

Published under Risk Management

Title:	The New Approach Directives include a large number of Directives, whose common element is that they rely principally on self-certification through the application of the well known CE-marking on compliant products. A full list of Directives can be found here: http://ec.europa.eu/enterprise/newapproach/ Since most of these Directives are applicable only to very specific product categories which are out of scope for this Report, this overview will focus on only one sample New Approach Directive, specifically the Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity
Source reference:	http://eur-lex.europa.eu/LexUriServ/ (for other New Approach Directives see: http://ec.europa.eu/enterprise/newapproach/)
Topic:	Conformity assessment of radio equipment and telecommunications equipment
Direct / indirect relevance	Indirect. The text requires the manufacturers, distributors or importers of radio equipment and telecommunications equipment to assess their suitability and safety prior to bringing them to the market, which may imply an obligation to conduct an RM/RA assessment with regard to product safety, non-interference and interconnectivity.
Scope:	Directly applicable to all EU Member States
Legal force:	EU Directive, requires transposition into national law
Affected sectors:	For the relevant provision: only the chemical sector
Relevant provision(s):	Article 3 – Essential requirements 1. The following essential requirements are applicable to all apparatus: (a) the protection of the health and the safety of the user and any other person, including the objectives with respect to safety requirements contained in Directive 73/23/EEC, but with no voltage limit applying; (b) the protection requirements with respect to electromagnetic compatibility contained in Directive 89/336/EEC. 2. In addition, radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference. 3. In accordance with the procedure laid down in Article 15, the Commission may decide that apparatus within certain equipment classes or apparatus of particular types shall be so constructed that: (a) it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the Community; and/or that (b) it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; and/or that (c) it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; and/or that (d) it supports certain features ensuring avoidance of fraud; and/or that (e) it supports certain features ensuring access to emergency services; and/or that (f) it supports certain features in order to facilitate its use by users with a disability. […] Article 6 - Placing on the market 1. Member States shall ensure that apparatus is placed on the market only if it complies with the appropriate essential requirements identified in Article 3 and the other relevant provisions of this Directive when it is properly installed and maintained and used for its intended purpose. It shall not be subject to further national provisions in respect of placing on the market. […] 3. Member States shall ensure that the manufacturer or the person responsible for placing the apparatus on the market provides information for the user on the intended use of the apparatus, together with the declaration of conformity to the essential requirements. […] 4. In the case of radio equipment using frequency bands whose use is not harmonised throughout the Community, the manufacturer or his authorised representative established within the Community or the person responsible for placing the equipment on the market shall notify the national authority responsible in the relevant Member State for spectrum management of the intention to place such equipment on its national market. This notification shall be given no less than four weeks in advance of the start of placing on the market and shall provide information about the radio characteristics of the equipment (in particular frequency bands, channel spacing, type of modulation and RF-power) and the identification number of the notified body referred to in Annex IV or V. Article 7 - Putting into service and right to connect 1. Member States shall allow the putting into service of apparatus for its intended purpose where it complies with the appropriate essential requirements identified in Article 3 and the other relevant provisions of this Directive. […] Article 10 - Conformity assessment procedures 1. The conformity assessment procedures identified in this Article shall be used to demonstrate the compliance of the apparatus with all the relevant essential requirements identified in Article 3. […]
Relevance to RM/RA:	The cited articles require that any apparatus (i.e. radio or telecommunications terminal equipment as defined in the Directive) meets specific safety standards. Furthermore, the Commission may decide to impose additional requirements on specific product types, including non-interference and data protection requirements. Thus, before introducing such apparatus on the EU market or putting it into service, the producer/importer/distributor of the product will need to assess which requirements apply, and if the product conforms to them following the prescribed conformity assessment procedures, followed (if successful) by the application of the well known CE marking. In specific cases, radio equipment must also be notified to the competent national authority in order to ascertain any spectrum issues. Finally, the end user must be duly informed of the intended use of the product, and of its compliance with applicable requirements.

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