S.L. 419.6 Art. 5Information to be given. Draft standards. Duties of the Authority. European standards. Exception. Communication of requirements. Further communications. Responsible person. Comments.

(1) The Commission and the standardization bodies referred to in Schedules I and II shall be informed of the new subjects for which the national bodies referred to in Schedule II have decided, by including them in their standards programme, to prepare or amend a standard, unless it is an identical or equivalent transposition of an international or European standard.

(2) The information referred to in subregulation (1) shall indicate, in particular, whether the standard concerned:

(a) will transpose an international standard without being the equivalent,

(b) will be a new national standard, or

(c) will amend a national standard.

(3) Upon request of the Commission, the Authority shall communicate to it all or part of the standards programmes.

(4) The Authority shall also make this information available to the Member States in a form which allows the different programmes to be assessed and compared.

(1) The Authority shall send to the standardization bodies 6. referred to in Schedules I and II and the Commission all draft standards on request.

(2) They shall also be kept informed by the body concerned of the action taken on any comments they have made relating to drafts.

(1) The Authority shall take all the necessary steps to 7. ensure that it:

(a) communicates information in accordance with regulations 5 and 6;

(b) publishes the draft standards in such a way that comments may also be obtained from parties established in other Member States;

(c) grants the other bodies referred to in Schedule II the right to be involved passively or actively (by sending an observer) in the planned activities;

(d) does not object to a subject for standardization in their work programme being discussed at European level in accordance with the rules laid down by the European standardization bodies and undertake no action which may prejudice a decision in this regard.

(2) In particular, any act of recognition, approval or use by reference to a national standard adopted in breach of subregulation

(1) and regulations 5 and 6, is prohibited.

(1) During the preparation of a European standard or after 8. its approval, the Authority shall not take any action which could prejudice the harmonization intended and, in particular, that it does not publish in the field in question a new or revised national standard which is not completely in line with an existing European standard.

(2) For the purposes of this regulation, the term "preparation of a European standard" shall refer to the request by the Commission to the European standards institution to draw up a European standard within a given time limit.

Regulation 8 shall not apply to the work of the Authority 9. undertaken at the request of the competent authority to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products.

(1) The Authority shall communicate all requests of the 10.

kind referred to in regulation 9 to the Commission as draft technical regulations and shall state the grounds for their enactment.

(2) The provisions of regulation 11(6) shall apply to the communication referred to in the subregulation (1).

(1) The competent authority shall communicate to the 11. Authority any draft technical regulation forthwith and it shall also let the Authority 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.

(2) The provisions of subregulation (1) shall not apply where the draft technical regulation merely transposes the full text of an international or European standard, in which case, information regarding the relevant standard shall suffice.

(3) Where appropriate, and unless it has already been sent with a prior communication, the competent authority shall simultaneously communicate the text of the basic legislative or regulatory provisions principally and directly concerned, should knowledge of such text be necessary to assess the implications of the draft technical regulations.

(4) The competent authority shall communicate the draft again under the foregoing provisions of this regulation, if they make changes to the draft that have the effect of significantly altering its scope, shortening the timetable originally envisaged for implementation, adding specifications or requirements or making the latter more restrictive.

(5) 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, the competent authority 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 measures 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. 793/93 in the case of an existing substance or Article 3(2) of Directive 67/548/EEC in the case of a new substance.

(6) The Authority shall be bound to communicate forthwith to the Commission the information received by the competent authority under the foregoing provisions of this regulation and, in any case, not later than the first working day following that of the reception of the information as aforesaid.

(7) Without prejudice and subject to subregulation (6), the Authority shall regulate its own procedure on dealing with the information received by the competent authorities.

(8) Such procedure shall be published and communicated to all the competent authorities.

(1) For the purposes of regulation 11, each competent 12. authority shall appoint a person, who shall be responsible for all the communication which would have to be made between the competent authority and the Authority pursuant to these regulations.

(2) Such person shall also be responsible for all the correspondence between the Authority and the competent authority: Provided that for the purposes of this regulation, "correspondence" shall strictly refer to all the correspondence, electronic or otherwise, arising out of the obligations under these regulations.

(1) Following communication to the Commission of a 13. draft technical regulation under the provisions of regulation 11, the Authority shall receive comments which would have been made by the Commission or the Member States, should this be the case.

(2) The Authority shall forward such comments to the competent authority responsible for the draft technical regulation and such competent authority shall take such comments into account as far as possible in the subsequent preparation of the technical regulations.

(3) The competent authority shall communicate the definitive text of a technical regulation to the Authority without delay.

(4) The Authority shall be bound to communicate forthwith to the Commission the definitive text of a technical regulation received and the provisions of regulation 11(3) shall apply mutatis to such communication. mutandis

(5) All the information supplied under this regulation and regulation 11 shall not be confidential except at the express request of the notifying competent authority. Any such request shall be supported by reasons.

(6) In such cases, if necessary precautions are taken, the Authority may seek expert advice from persons in the physical or legal sectors.

(7) When draft technical regulations form part of measures which are required to be communicated to the Commission at the draft stage under another Community act, the competent authority may make a communication to the Authority in terms of regulation 11(6) under that other Community act, provided that they formally indicate that the said communication also constitutes a communication for the purposes of this Directive.

(8) Such communication shall be made to the Authority and the Authority shall forward such communication to the Commission.

(9) The provisions of regulation 11(6) shall apply mutatis mutandis to the communication mentioned in subregulation (8).