Directive 98/34/EC

Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards

Published under Risk Management
Title: Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations; as modified and amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998
Source reference: http://europa.eu.int/eur-lex/pri/
(unofficial coordinated version see:
http://portal.etsi.org/public-interest/Documents/)
Topic: Regulatory practices with regard to standardisation
Direct / indirect relevance Indirect. The text contains standardisation requirements, some of which imply an obligation to implement certain RM/RA measures.
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 8

1. Subject to Article 10, Member States shall immediately communicate to the Commission any draft technical regulation, except where it merely transposes the full text of an international or European standard, in which case information regarding the relevant standard shall suffice; they shall also let the Commission have a statement of the grounds which make the enactment of such a technical regulation necessary, where these have not already been made clear in the draft.

[…]

Where, in particular, the draft seeks to limit the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, Member States shall also forward either a summary or the references of all relevant data relating to the substance, preparation or product concerned and to known and available substitutes, where such information may be available, and communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No 793/9317 in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC18, in the case of a new substance.

The Commission shall immediately notify the other Member States of the draft and all documents which have been forwarded to it; it may also refer this draft, for an opinion, to the Committee referred to in Article 5 and, where appropriate, to the committee responsible for the field in question.

[…]
Relevance to RM/RA: The cited article requires that a Member State considering a restriction on the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, must notify the Commission of this, along with certain additional information, including a risk evaluation.

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