RFU 0.100 status of RFU

RFU 0.100 status of RFU

Question: What are the acceptable purposes/contents of the RfUs and who are the addressees of the RfUs?

Solution:

1) Before bringing a Recommendation for Use sheet to the attention of the Horizontal Committee and after to the Machinery Working Group of the European Commission, the writers of the RfUs must apply the following tests:

1.1) Does the Recommendation for Use sheet add value, i.e. does it provide additional information that is not available in the directive or the relevant harmonised standard? The added values can be for example as follows: a) to support the interpretation of requirement(s) of standards and provide a solution; b) to provide a solution that supersedes a too generic requirement of a standard by providing an alternative solution for a specific application; c) to provide an additional solution besides those from the standard to meet the goal(s) of the MD in an alternative way. If the RfUs do not add value, the issues raised by the document should be included in the minutes of the meeting of the relevant Vertical Group but not presented as Recommendation for Use sheet.

1.2) Is the Recommendation for Use sheet of a horizontal nature, i.e. applicable to more than one Vertical Group? Such questions should be agreed and documented at Vertical Group level and passed to the chairman of the Horizontal Committee and the Technical Secretariat for agreement and submission as a horizontal document.

1.3) Are the wordings of the Recommendation for Use sheet clear and so that readers who have not attended the Vertical Group or Horizontal Committee meetings can easily understand the question and answer? 

1.4) Are the RfUs consistent with the actual safety level to be applied (e.g. wording of directive, standard, decision of the Machinery Working Group, publication of the European Commission, etc)? It is not permissible to specify a level of safety below that described in the above documents. Where realization of an adequate safety level can be achieved by a solution not described in a harmonized standard, evidence shall be provided in a transparent and comprehensible way that the Vertical Group solution meets the requirements and is therefore acceptable. Such evidence should be sufficient to support the solution in the event of challenge from a Member State. 

1.5) If the level of safety specified in the applicable standard appears to be too low, or if an aspect of a standard that is doubtlessly wrong or seems to not fully meet the goal of the MD, the relevant interested parties (CEN/CENELEC TC, European Commission) shall be informed immediately. Before decision is taken, the Vertical Group shall discuss the matter in order to reach a common agreement on how to proceed with the assessment of the conformity. However, if the questions require an urgent solution the notified body who detected the possible deficiency(ies) or mistake(s) can start within the VG members a quick enquiry in order to collect answers within a reasonable period of time (less than 3 months). If the question(s) are deemed to be of general interest, the Horizontal Committee shall also be informed. The Member States and the European Commission are automatically informed through the minutes of the meetings of the Horizontal Committee.

2) The RfUs, “endorsed” by the Machinery Working Group shall be sent firstly by the Technical Secretariat (TS) to the NBs who are responsible for their implementation. The TS shall send the “endorsed” RfUs to the CEN/CENELEC TCs and to the European Commission in order to be uploaded in EUROPA Website. The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that he said machinery meets the corresponding state of the art (Annex IX point 9.2). State of the art is described in the harmonised standards; RfUs provide explanations and rules for implementing the clauses of the harmonised standards.

3) The fact of a standard being transferred to the ISO does not change either its status or the status of RfUs.

4) If a manufacturer applies a technical solution described in a Recommendation for Use (RfU) which deviates from the technical solution described in a harmonised C-standard, he must submit an example of the machinery either for the EC type-examination referred to in Annex IX or for the Full quality assurance referred to in Annex X because the machinery would not totally comply with the harmonised C-standard.