Changes from adopted text to adopted text

RemovedArticle 33: deleted / (deleted) / (deleted) / (deleted)

RemovedChapter IV – title: EUROPEAN ASSESSMENT DOCUMENTS

RemovedArticle 34: deleted

RemovedArticle 35 – paragraph 1: deleted

RemovedArticle 35 – paragraph 2 – subparagraph 1 – introductory part: Following a request for a European technical assessment by a manufacturer or a group of manufacturers or on initiative of the Commission, a European assessment document may be drawn up and adopted by the organisation of technical assessment bodies (‘TABs’) in agreement with the Commission for any kind or category of product not covered by:

RemovedArticle 35 – paragraph 2 – subparagraph 1 – point b: (b) a harmonised technical specification intended to be adopted in the next 1 year as from the date of verification with the Commission;

RemovedArticle 35 – paragraph 2 a (new): 2a. The Commission shall task EOTA and CEN with coordinating to ensure that there is no overlap between a European assessment document and harmonised standards or parts thereof.

RemovedArticle 35 – paragraph 3: 3. The organisation of TABs and the Commission may bundle or reject requests for the development of a European assessment document. The procedure for adopting a European assessment document shall comply with Article 36 and the procedure laid down in Annex IIIa.

RemovedArticle 35 – paragraph 3 a (new): 3a. Article 4(1) and (4), Article 6, Article 9 and Articles 11 to 17 shall apply to European assessment documents. Where the CE marking is issued on the basis of a European assessment document and a European technical assessment, the European assessment document shall be referred to in the declaration of performance and the declaration of conformity.

RemovedArticle 35 – paragraph 4: 4. The Commission is empowered to amend Annex IIIa by delegated act adopted in accordance with Article 87 to establish supplementary procedural rules for the development and adoption of a European assessment document, where this is necessary to ensure the good functioning of the European assessment documents system.

RemovedArticle 36 – paragraph 1 – subparagraph 1 – point b: (b) not to disclose the information protected by intellectual property rights, and protect commercial secrecy and confidentiality;

RemovedArticle 36 – paragraph 1 – subparagraph 1 – point d: (d) allow for adequate participation by the Member States and the Commission;

RemovedArticle 36 – paragraph 1 – subparagraph 2: The balancing of principles laid down in points (a) and (b) of this paragraph shall at least allow for the disclosure of the name of the product at the stage of the approval and the communication of the work programme, as set out in Annex IIIa, point 5 and the detailed contents of the draft European assessment document set out in Annex IIIa, point 5.

RemovedArticle 37 – paragraph 1 – point c: (c) where the product is not covered by any harmonised technical specification or European assessment document and where no such harmonised technical specification is intended to be adopted in the next year, or no such or European assessment document is already in the procedure of developing pursuant to Annex IIIa, the TAB shall apply the procedures set out in Annex IIIa or those established in accordance with Article 35(4).

RemovedArticle 38 – paragraph 2: 2. Only European assessment documents referred to in that list and published by either the Commission or by the organisation of TABs shall authorise the issuing of European technical assessments in accordance with Article 42 and trigger legal effects in accordance with Article 42(5), including with regard to the manufacturer who requested the development of the European assessment document. This legal effect of European assessment documents shall expire ten years after their first citation in the Official Journal of the European Union or immediately where the European technical document has been withdrawn unless they have been renewed in the last year prior to expiry and the Commission decides to maintain the listing.

RemovedArticle 38 – paragraph 2 a (new): 2a. In order to ensure the high quality of European assessment documents and to accommodate the confidentiality needs of the applicant for the related European technical assessment, before the reference to a new European assessment document is cited in the Official Journal of the European Union, a draft of the first European technical assessment based on that European assessment document shall be issued. If necessary, the final draft of the European assessment document shall be amended based on the experience gained with the issue of the first European technical assessment. The Commission, jointly with organisation of TABs, shall communicate the date of citation of the reference to the European assessment document.

RemovedArticle 40 – paragraph 1 – point a: (a) a description of the kind or category of product covered; and

RemovedArticle 40 – paragraph 1 – point b: (b) the list of essential characteristics, relevant for the intended use of the kind or category of product as set out by the manufacturer and agreed between the manufacturer and the organisation of TABs, and the methods and criteria for assessing the performance of the product in relation to those essential characteristics.

RemovedArticle 40 – paragraph 2: 2. Principles for the applicable factory production control to be applied shall be set out in the European assessment document, taking into account the conditions of the manufacturing process of the kind or category of product concerned.

RemovedArticle 40 – paragraph 3: 3. Where the performance of some of certain essential characteristics of the kind or category of products can appropriately be assessed with methods and criteria established in harmonised technical specifications or European assessment documents, those existing methods and criteria shall be incorporated as parts of the European assessment document.

RemovedArticle 42 – paragraph 1 – subparagraph 1: A European technical assessment shall be issued by a TAB, at the request of a manufacturer on the basis of a European assessment document, the reference of which has been cited in the Official Journal of the European Union in accordance with Article 38.

RemovedArticle 42 – paragraph 1 a (new): 1a. When a request for a European technical assessment is made, the procedure laid down in Annex IIIa shall apply.

RemovedArticle 43: deleted / (deleted) / (deleted) / (deleted)

RemovedArticle 44 – paragraph 1 – subparagraph 1: Member States may designate Technical Assessment Bodies (TABs) within their territories for one or several product areas listed in of Annex IV, Table 1. When the Member State decides to designate a TAB, it shall appoint one single authority in charge of technical assessment bodies (the “designated authority”).

RemovedArticle 44 – paragraph 3 – subparagraph 1: The designated authority shall monitor the activities and competence of the TABs designated in their respective Member State, and where necessary their subsidiaries and subcontractors, and evaluate them in relation to the respective requirements set out in this Chapter. The designated authority shall instruct the TABs wherever there is an infringement of law or common practice agreed between the Member States and the Commission. In case of repeated infringement of the law, it may revoke the designation of the TAB.

RemovedArticle 44 – paragraph 5: 5. The Commission may investigate the compliance of TABs with the requirements set out in this chapter, as well as the fulfilment by the responsible designated authorities of their monitoring obligations.

RemovedArticle 44 – paragraph 6: 6. TABs shall, upon request by the relevant designated authority, supply all relevant information and documents, required to enable the authority, the Commission and the Member States to verify compliance.

RemovedArticle 46 – paragraph 2 – subparagraph 1 – point i: (i) ensure that adopted European assessment documents and references to European technical assessments are kept publicly available.

RemovedArticle 46 – paragraph 6: 6. The Commission may make the financing of the organisation of TABs, regardless of via grants or public tenders, subject to the fulfilment of organisational and performance requirements, including with regard to a fair geographic distribution of TABs.

RemovedArticle 49 – paragraph 6 – subparagraph 1: The notifying authority shall have a sufficient number of competent personnel and sufficient funding at its disposal for the proper performance of its tasks.

RemovedArticle 49 – paragraph 6 – subparagraph 2: deleted

RemovedArticle 50 – paragraph 3 – subparagraph 1: A conformity assessment body shall be a third-party body independent of all business ties of the organisation or the construction product it assesses.

RemovedArticle 50 – paragraph 3 – subparagraph 2: deleted

RemovedArticle 50 – paragraph 3 – subparagraph 3: A conformity assessment body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such an independent body.

RemovedArticle 50 – paragraph 4 – subparagraph 1: A conformity assessment body, its top-level management and the personnel responsible for carrying out the third party tasks in the assessment and verification process shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of the products which it assesses, nor the representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of products for personal purposes.

RemovedArticle 50 – paragraph 4 – subparagraph 2: A conformity assessment body, its top-level management and the personnel responsible for carrying out the third party tasks in the assessment and verification process shall not become directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of those products, nor represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement and integrity related to the activities for which they have been notified nor provide consultancy services.

RemovedArticle 50 – paragraph 4 – subparagraph 3: A conformity assessment body shall ensure that activities of its parent or sister companies, its subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of its assessment and/or verification activities.

RemovedArticle 50 – paragraph 5: 5. A conformity assessment body and its personnel shall carry out the third party tasks in the assessment and verification process with the highest degree of professional integrity and requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their assessment and/or verification activities, especially from persons or groups of persons with an interest in the results of those activities.

RemovedArticle 50 – paragraph 6 – subparagraph 1: A conformity assessment body shall be capable of carrying out all the third party tasks in the assessment and verification process assigned to it in accordance with Annex V in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

RemovedArticle 50 – paragraph 6 – subparagraph 2 – point a: (a) the necessary competent personnel with technical knowledge and sufficient and appropriate experience to perform the third party tasks in the assessment and verification process;

RemovedArticle 50 – paragraph 6 – subparagraph 2 – point b: (b) the necessary description of procedures according to which the assessment process is carried out, ensuring the transparency and the ability of reproduction of these procedures. It shall have appropriate policies and procedures in place that distinguish between the tasks it carries out as a notified body and other activities, and it shall assign its personnel to those tasks.

RemovedArticle 50 – paragraph 6 – subparagraph 2 – point c: deleted

RemovedArticle 50 – paragraph 6 – subparagraph 3: A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the activities for which it intends to be notified in an appropriate manner and shall have access to all necessary equipment or facilities.

RemovedArticle 50 – paragraph 9: 9. A conformity assessment body shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the assessment and/or the verification performed.

RemovedArticle 50 – paragraph 10: 10. The personnel of the conformity assessment body shall be bound to observe professional secrecy with regard to all information gained in carrying out its tasks under Annex V, except in relation to the competent administrative authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

RemovedArticle 50 – paragraph 11: 11. A conformity assessment body shall participate in, and ensure that its assessment personnel is informed of, relevant standardisation activities, activities of the notified body coordination group established under this Regulation and shall apply as general guidance the administrative decisions and documents produced as a work result.

RemovedArticle 51 – title: Presumption of conformity of notified bodies

RemovedArticle 53 – paragraph 2: 2. The notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

RemovedArticle 55 – paragraph 2: 2. The application shall be accompanied by a description of the activities to be performed, the assessment and/or verification processes for which the body claims to be competent, an accreditation certificate, where one exists, issued by the national accreditation body within the meaning of Regulation (EC) No 765/2008, attesting that the body meets the requirements laid down in Article 50. The accreditation certificate shall relate only to the specific conformity assessment body applying for notification and not take account of the capacities or personnel of parent or sister companies. It shall be based, in addition to relevant harmonised standards, on the specific requirements and assessment tasks.

RemovedArticle 58 – paragraph 1: 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 50, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure to meet those requirements or to fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

RemovedArticle 59 – paragraph 3 a (new): 3a. Where the Commission finds that a notified body does not meet, or no longer meets, the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including withdrawal of notification, if necessary.

RemovedArticle 60 – paragraph 7: deleted

RemovedArticle 62: deleted / (deleted) / (deleted) / (deleted)

RemovedArticle 63 – paragraph 1: The Commission shall ensure that appropriate coordination and cooperation between bodies notified pursuant to Article 47 are put into place and properly operated in the form of a group of notified bodies. Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives. Coordination and cooperation in the groups referred to in paragraph 1 shall aim at ensuring the harmonised application of this Regulation.

RemovedArticle 63 – paragraph 2: deleted

RemovedArticle 63 – paragraph 3: Notified bodies shall take into account as general guidance the administrative decisions and documents produced by that group.

RemovedArticle 64 – paragraph 1 – introductory part: 1. A manufacturer may replace type testing or type calculation by appropriate technical documentation demonstrating that:

RemovedArticle 64 – paragraph 1 – point a: (a) for one or several essential characteristics of the product, which the manufacturer places on the market, that product is deemed to achieve a certain level or class of performance without testing or calculation, or without further testing or calculation, in accordance with the conditions set out to that end in the relevant harmonised technical specification; or

RemovedArticle 64 – paragraph 1 – point b: (b) the product, covered by a harmonised technical specification or by a European technical assessment, which the manufacturer places on the market is a system made of items, which the manufacturer assembles duly following precise instructions, including compatibility criteria in case of individual items, given by the provider of such a system or supplier of a component thereof, who has already tested that system or that item for one or several of its essential characteristics in accordance with the relevant harmonised technical specification or the European technical assessment. When these conditions are satisfied and when the manufacturer has notably verified that the precise compatibility criteria of the provider are met, the manufacturer is entitled to declare performance corresponding to all or part of the test results for the system or the item provided to them; or

RemovedArticle 64 – paragraph 1 – point b a (new): (ba) the construction product, covered by a harmonised standard, which the manufacturer places on the market corresponds to the product-type of another construction product, manufactured by another manufacturer and already tested in accordance with the relevant harmonised standard. When those conditions are fulfilled, the manufacturer is entitled to declare performance corresponding to all or part of the test results of this other product. The manufacturer may use the test results obtained by another manufacturer only after having obtained the authorisation of that manufacturer, who remains responsible for the accuracy, reliability and stability of those test results.