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There are outstanding changes not yet made to Commission Decision of 17 January 1994 on common procedural rules for European technical approval (94/23/EC). Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
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the approval procedure,
the estimate of the time schedule necessary for the approval body to complete the approval procedure for the specific product,
an estimate of the cost for the handling of the approval procedure and the payment modalities.
In the event that the subject area has not already been approved as suitable for ETAs, or in the case of a product which differs significantly from harmonized standards or recognized national standards, the above information will only be given to the applicant after a decision on the possibility of issuing an ETA taken according to the procedure described in 3.2.
The applicant will be informed of the decision.
If the application is not accepted, the approval body must give the reasons. The applicant may then apply to another approval body.
It is the duty of the applicant to supply the approval body with the necessary documents and to support the approval body in its assessment task.
Should other aspects be taken into account, the relevant assessment shall be clearly differentiated from those related to the essential requirements, after an agreement between the members of EOTA. Such assessments would be voluntary.
The format of the ETA must correspond to the ‘general format’ as agreed by the Commission of the EC.
The content and format of the ETA must correspond to the relevant ETA guideline.
The approval body which issues the ETA sends it to:
all other EOTA bodies,
the General Secretariat who will send a copy to the Commission of the EC.
During a transitional period determined individually for each ETA guideline by EOTA, in order to ensure the comparability of the ETAs issued by the approval bodies, the draft ETA with the accompanying documents (test results) are submitted for prior consultation to the relevant EOTA bodies(2) and the General Secretariat asking for their comments within two months.
Should the Commission of the EC establish, under provisions of Article 5. 1 of the CPD and after the advice of the Standing Committee, a shortcoming in a given ETA due to a shortcoming of an ETA guideline, the approval bodies shall not issue any more ETAs on the basis of the above ETA guideline.
The content and format of the ETA must correspond to the ‘general format’ agreed by the Commission of the EC.
The approval body receiving a request according to point 2.4 or an application for an ETA introduced for the first time for a product of the family concerned must have preliminary consultation with the Technical Board in order that it can agree in principle on the granting of an ETA to that product and on the principle of the proposed attestation of conformity procedure.
If consensus is achieved in the Technical Board on applications according to Article 8.2a of the CPD, then the appropriate information as asked by the EC Commission is sent with the approval of the President of EOTA to the Commission of the EC to obtain authority to issue ETAs. If consensus cannot be achieved in the Technical Board it will be passed to the Executive Commission for decision, as to whether it should be submitted to the Commission of the EC.
In the case of applications for ETAs according to Article 8.2 b of the Directive, the Commission of the EC will confirm on the basis of the EOTA assessment and of the relevant information, whether a product of a family covered by harmonized standards or recognized national standards differs significantly from them and therefore if a European technical approval can be granted.
If agreement is achieved under 3.2.2 the approval body to whom an application is directed must have a preliminary discussion with the other relevant EOTA bodies in which is explained the manner it is intended to use to progress the application including the test programme, the performance requirements and the manner of fulfillment of the attestation of conformity foreseen.
The approval body takes into account the remarks formulated by the other EOTA bodies.
When the application for an ETA is for a product of a family for which the procedure laid down in 3.2.3 has already been established the ETA must be based on that established procedure.
Before issuing the ETA, the approval body sends the ETA draft to the relevant EOTA bodies and to the General Secretariat with the justifications provided by the applicant asking for their comments within two months.
The ETA is issued by the approval body when all the relevant EOTA bodies have given consent in writing taking account of the Directive, Annex II, paragraph 2, sentence 3.
Circulation of the ETA is in accordance with 3.1.2.
If there are objections which cannot be solved then the question is put on the Agenda of the Technical Board.
If in the Technical Board consensus is achieved the ETA is issued by the approval body.
If consensus cannot be achieved the subject is put on the Agenda of the Executive Commission who decides on any subsequent action.
If the Executive Commission cannot reach consensus, the matter shall be referred to the Standing Committee on Construction (the Directive, Article 9.2) via the Commission of the EC.
As far as the procedure is concerned, the provisions stated under 3.1 and 3.2 apply accordingly.
Relevant EOTA bodies: bodies nominated by the Member States to operate in the subject area.
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