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1. Request for a European technical assessment 1.1. When a manufacturer makes a request for a European technical assessment to any TAB for a product, and after the manufacturer and the TAB (‘responsible TAB’) have signed an agreement of commercial secrecy and confidentiality, unless the manufacturer decides otherwise, the manufacturer shall submit to the responsible TAB a technical file describing the product, its use as foreseen by the manufacturer and details of the factory production control the manufacturer intends to apply;

1.2. When a group of manufacturers or a manufacturers’ association (the ‘Group’) makes a request for a European technical assessment, it shall address the request to the organisation of TABs that will propose to the Group a TAB to act as the responsible TAB. The Group can either accept the proposed TAB or ask the organisation of TABs to propose an alternative TAB. Once the Group has accepted the responsible TAB proposed by the organisation of TABs, the members of the Group shall sign a commercial secrecy and confidentiality agreement with that TAB, unless the Group decides otherwise, and the Group shall submit to the responsible TAB a technical file describing the product, its use as foreseen by the Group and details of the factory production control that the members of the Group intend to apply; 1.3. In the absence of a request for a European technical assessment, when the Commission initiates the development of a European assessment document, it shall deliver to the organisation of TABs a technical file describing the product, its use and details to become applicable. The organisation of TABs shall, together with the Commission, agree on a TAB to act as the responsible TAB.

2. Contract For products referred to in Article 33(1), point (c), within 1 month from the reception of the technical file, in the cases referred to in points 1.1 and 1.2, a contract shall be concluded respectively between the manufacturer or the Group and the responsible TAB for the production of the European technical assessment, specifying the work programme for drawing up the European assessment document, including:

(a) the organisation of work within the organisation of TABs;

(b) the composition of the workgroup to be established within the organisation of TABs, designated for the product family in question; and (c) the coordination of TABs. In the case referred to in point 1.3, the responsible TAB shall submit to the Commission the work programme for drawing up the European assessment document with the same content and within the same deadline. Thereafter, the Commission shall have 30 working days to communicate to the responsible TAB its observations on the work programme, and the responsible TAB shall amend that work programme accordingly.

3. Communication of work programme

In the cases referred to in points 1.1 and 1.2, after agreement with the manufacturer and the Group respectively, the organisation of TABs shall inform the Commission of the work programme for drawing up the European assessment document and the schedule for its execution, indicating the assessment programme. That communication shall take place within three months of receipt of the request for a European technical assessment by a TAB, whereupon the TAB shall initiate the procedure laid down in points 1.1 and 1.2. In the case referred to in point 1.3, the organisation of TABs shall submit to the Commission the work programme for drawing up the European assessment document with the same content and within the same deadline as indicated in the previous subparagraph. The Commission shall then communicate to the organisation of TABs within 30 working days its observations on the work programme. After the responsible TAB and the organisation of TABs has been given the opportunity to comment, the responsible TAB shall amend the work programme accordingly.

4. The draft European assessment document

The organisation of TABs shall, by means of the working group coordinated by the responsible TAB, finalise a draft European assessment document which it shall communicate to the parties concerned within 6 months of the date the Commission was informed of the work programme in the cases referred to in points 1.1 and 1.2 or the date the Commission communicated to the responsible TAB its observations on the work programme in the case referred to in point 1.3.

5. Commission Participation

A Commission representative may participate, as an observer, in all the parts of the execution of the work programme. The Commission may request the organisation of TABs at any stage to abandon or modify the development of a certain European assessment document if the development is not in line with this Regulation or if the approach is not efficient or effective in terms of resources and final applicability. The Commission may request the organisation of TABs at any stage to merge parallel processes for the development of European assessment documents, or to split a single process in two, in order to increase the clarity of, or to ensure efficiency in, the development process or in the future application of the assessment document under consideration. Where the TABs involved do not agree on a European assessment document within the time limits provided, the organisation of TABs shall submit the matter to the Commission for resolution, including through instructions to the organisation of TABs on how to complete its work.

6. Member States consultation

In the case referred to in point 1.3, the Commission shall inform Member States on the development of the European assessment document after the finalisation of the work programme for it. When requested, Member States may, where appropriate, participate in its execution. Observations from the Member States shall be communicated to, and shall be dealt with by, the Commission. The organisation of TABs shall be informed by the Commission of any change in the work programme, required and agreed to by the Commission, within the time frame given to the Commission for commenting on the work programme before starting the development of the European assessment document.

7. Extension and delay Any delay in relation to the time limits set in points 1 to 4 of this Annex shall be reported by the working group to the organisation of TABs and to the Commission. If an extension of the time limits for developing the European assessment document can be justified, notably by the absence of a Commission decision on the applicable assessment and verification system for the product or by the need to develop a new test method, an extended time limit shall be set by the Commission.

8. Amendments and adoption of a draft European assessment document 8.1. In the cases referred to in points 1.1 and 1.2, the responsible TAB shall communicate the draft European assessment document to the manufacturer or the Group, respectively, who shall have 20 working days to react thereto. Thereafter, the organisation of TABs shall:

(a) if applicable, inform the manufacturer or the Group as to how their reactions have been taken into account;

(b) adopt the draft European assessment document;

(c) send a copy of it to the Commission.

8.2. In the case referred to in point 1.3, the responsible TAB shall:

(a) adopt the draft European assessment document;

(b) send a copy of it to the Commission.

9. Commission assessment of draft European assessment documents The Commission shall assess the submitted draft European assessment document and, within 30 working days of receipt, communicate its observations to the organisation of TABs. The organisation of TABs, after having been given the opportunity to comment, shall amend the draft accordingly and resend copies of the amended draft European assessment document in accordance with point 8.1(c) and 8.2(b).

10. Adoption of final European assessment document and publication The organisation of TABs shall adopt the final European assessment document and shall send a copy thereof to the Commission, together with a translation of its title in all the official languages of the Union, for publication of its reference in the Official Journal of the European Union without delay. The organisation of TABs shall publish the European assessment document within 90 days from the date of adoption, in one or more languages of the Union and, as a minimum, ensure that it remains accessible until all European technical assessments based on it cease to be valid.