This document gives guidance on the CEN procedure to manage claims of defective standards when those claims relate to health and/or safety.
The procedure is intended to be used for a ratified European Standard (issued by CEN).
The procedure applies to claim of harmful effect on health and/or safety in relation to the use of the European standard.
The procedure is not a substitute for:
- the "Appeal Mechanism" that might be used during the drafting phase of a European Standard by a CEN Member body or Partner in case an action or inaction is not in accordance with the CEN rules or its aims or is not in the best interest of the European market or such public concerns as safety, health or the environment;
- a "Formal Objection" that might be used by an EU Member State or the European Parliament against the listing of a European Standard in the Official Journal of the European Union.
The procedure defines the responsibilities of the actors within the CEN system and the different actions to be taken in order to treat such claims in the most effective and efficient manner.
2 TREATMENT OF CLAIMS (Flowchart)
The complete procedure to manage a claim is given in the attached flowchart. The actors involved, the maximum timescales foreseen for each step and the external organizations that may need to be involved in treating the claim and/or receive information about the claim and any corrective actions are given in the flowchart.
Additional information and important points of the procedure are highlighted below.
2.1 Origin of claim
Claim that a European Standard is defective in terms of health and/or safety can be made by any stakeholder.
The stakeholder making a claim shall provide objective evidence supporting its request.
2.2 Receipt of claim
All claims of defective standards shall be submitted to CEN Members or directly to CCMC.
As the focal point of the organization, CCMC is responsible for managing the procedure on behalf of the CEN system. Hence, the CEN Members are required to alert CCMC (the Director Standards) as soon as possible if such a claim is received or identified at national level.
On receipt of a claim, CCMC informs the secretariat of the relevant technical committee, if any, the CEN BT, the Sector Rapporteur and, when relevant, ISO.
CEN Members shall not take unilateral action at national level relating to a claim, especially withdrawing the national implementation of the EN.
The result of the treatment of a claim shall be communicated effectively and in a timely manner to the claimant and all relevant actors both inside and outside the CEN system.
The effective assessment of claims shall be undertaken thoroughly by the CEN system and all actors shall treat these claims as a priority, and provide a response to the originator as well as execute any corrective action as soon as possible. Due to the nature of such claims, and the need to include all relevant actors, the treatment of such claims is likely to take several weeks.
The flowchart foresees the following timescales:
- The result of the assessment of the admissibility of the claim is notified to the claimant within 1 week from the reception of the claim;
- The result of the assessment of the claim carried out by the responsible technical committee and approved by the CEN/BT is notified to the claimant as soon as the result is approved by the CEN/BT (within 7 weeks maximum).
2.4 Assessment of the admissibility of the claim
Following receipt of a claim, CCMC along with the leadership of the responsible technical committee and (as appropriate) Sector Rapporteur and, when relevant, ISO CS, makes an initial assessment to establish whether or not the claim relates to health and/or safety, and whether the description of facts and the relevant evidence are sufficient to declare the claim admissible for further assessment.
CCMC communicates the result of this assessment to the claimant, the CEN/BT and, if appropriate, ISO CS.
2.5 Assessment of the claim
In case of admissibility, CEN/BT shall consider the implications at national level, e.g. suspend the distribution of the standard subject to the claim as temporary preventive measure. In parallel, CCMC asks the responsible CEN technical committee to advise whether to:
- Withdraw the standard
If the technical committee advises that the European Standard shall be withdrawn, in particular it should give consideration to the existence of any previous edition of the standard, and if so, decide whether or not to recommend the re-adoption of a previous edition on the conditions that it is relevant, safe and appropriate for use.
- Modify the standard
If the technical committee advises that the standard requires modification then it shall also consider whether or not the standard should be withdrawn whilst it develops an amendment or revision to the standard. The technical committee shall also state the timetable for the modification.
- Take no action
If the technical committee advises that no action is necessary then in so doing it shall give a clear justification for this advice, on the understanding that this means that the technical committee concludes the standard poses no health and/or safety risk.
The technical committee communicates its advice and details of any corrective action to CCMC.
3 FOLLOW-UP ACTION
CCMC and (as appropriate) the Sector Rapporteur and ISO review the technical committee's advice and proposed corrective action. CCMC and other actors shall pay particular attention in the case that the responsible technical committee advises that no action is necessary in relation to the claim, and the justification.
CCMC asks the CEN/BT (by correspondence) to consider the technical committee's advice, proposed corrective action and timetable for that action and take the final decision.
CCMC, the responsible technical committee and the CEN Members implement the BT decision and CCMC informs the claimant and, when relevant, ISO CS.