Update of the supplement to the methodological guidelines

Completion of the methodological guidelines

References to technical standards, technical documents in draft regulations

In the event that the draft regulation contains references to national technical standards the promoter of the regulation is obliged to indicate in point 8 or 9 of the notification form 2015/1535/EU (formerly 98/34 notification form) the references to these technical standards together with the number of the Czech technical standard (or, if applicable, the designation of the technical standard) and the catalogue number (this is a unique identifier; it is indicated on the last page of the Czech technical standard). Furthermore, the promoter of the regulation is obliged to request in any written form and to clearly indicate to the Contact Point for Directive 2015/1535/EU (hereinafter referred to as the Contact Point) which specific documents it wishes to refer to the notification procedure under Directive 2015/1535/EU. The Contact Point, in cooperation with the Information Centre of the Office of the Ministry of Health and Consumer Protection, will generate from the database of standards the relevant Czech technical standards, in the header of which will be placed a non-removable protective element, indicating that the Czech technical standard is prohibited from further dissemination and that it serves only for notification purposes. Czech technical standards marked in this way will be uploaded by the Contact Point to the Trisv2 database under "Other text", which means that they will only be visible to the European Commission and the Contact Points for Directive 2015/1535/EU of other EU Member States.

If the draft regulation refers to technical documents or corporate standards, it is necessary for the promoter of the regulation to inform the Contact Point in writing and at the same time forward the actual texts of the technical documents and internal company standards to the EC for notification.

If the promoter of the regulation states in the draft regulation references to European standards, harmonised standards or international standards or international recommendations, as appropriate, it shall provide references to those technical standards and international recommendations in point 8 or 9 of notification form 2015/1535. The contact point will not refer to these technical standards and international recommendations in the context of the notification of the draft regulation to the EC, as it can be assumed that all Member States and the EC have access to these standards and recommendations.

However, if a European or harmonised standard or an international standard contains a national annex or a national note, the same procedure as described above for national technical standards must be followed; otherwise the national annex, the national note containing the product requirements, will not be notified to the European Commission.

If the draft regulation refers to European legislation, the promoter of the regulation is obliged to include those references in point 8 or 9 of the notification form 2015/1535.

ÚNMZ recommends that the promoters of the regulations in the case of notification of draft amendments, include references to national technical standards, European standards, harmonised standards or international standards containing a national annex or a national note in point 8 or 9 of notification form 2015/1535, even if they are referred to in the regulation being amended, and proceed in the same way as described above for national technical standards, as this is the only way to avoid potential problems.

The consultation with the EC resulted in a clear recommendation to the drafters not to refer to technical standards in the draft regulations, but to include product requirements directly in the text. As an example, Denmark has understood that references to national technical standards in draft regulations create barriers to trade and has moved away from such references.