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Internal design control (referred to in Article 8(2)) 1. This Annex describes the procedure whereby the manufacturer or its authorised representative who carries out the obligations laid down in point 2 ensures and declares that the product satisfies the relevant requirements of the applicable implementing measure. The EC declaration of conformity may cover one or more products and must be kept by the manufacturer.

2. A technical documentation file making possible an assessment of the conformity of the product with the requirements of the applicable implementing measure must be compiled by the manufacturer. The documentation must contain, in particular:

(a) a general description of the product and of its intended use;

(b) the results of relevant environmental assessment studies carried out by the manufacturer, and/or references to environmental assessment literature or case studies, which are used by the manufacturer in evaluating, documenting and determining product design solutions;

(c) the ecological profile, where required by the implementing measure;

(d) elements of the product design specification relating to environmental design aspects of the product;

(e) a list of the appropriate standards referred to in Article 10, applied in full or in part, and a description of the solutions adopted to meet the requirements of the applicable implementing measure where the standards referred to in Article 10 have not been applied or where those standards do not cover entirely the requirements of the applicable implementing measure;

(f) a copy of the information concerning the environmental design aspects of the product provided in accordance with the requirements specified in Annex I, Part 2; and (g) the results of measurements on the ecodesign requirements carried out, including details of the conformity of these measurements as compared with the ecodesign requirements set out in the applicable implementing measure.

3. The manufacturer must take all measures necessary to ensure that the product is manufactured in compliance with the design specifications referred to in point 2 and with the requirements of the measure which apply to it.