Notification
1. Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party tasks in the assessment and verification of performance, assessment of conformity and of the verification of environmental sustainability calculations for the purposes of this Regulation.
2. Member States shall inform the Commission of their procedures for the assessment and notification of bodies to be authorised to carry out these tasks and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
Notifying authorities
1. Member States shall designate a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment and notification of the bodies to be authorised to carry out third-party tasks in the assessment and verification process for the purposes of this Regulation, and the monitoring of notified bodies, including their compliance with requirements laid down in Articles 46 and 48.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by their national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity that body shall be a legal person and shall comply mutatis mutandis with the requirements laid down in Article 44. In addition, it shall have arrangements to cover liabilities arising out of its activities.
4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraphs 2 and 3.
Requirements relating to notifying authorities
1. The notifying authority shall be established in such a way that no conflicts of interest with notified bodies occur.
2. The notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
3. The notifying authority shall be organised in such a way that each decision relating to notification of a body to be authorised to carry out third-party tasks in the assessment and verification process is taken by competent persons different from those who carried out the assessment.
4. The notifying authority shall not offer or provide any activities that notified bodies perform, or consultancy services on a commercial or competitive basis.
5. The notifying authority shall safeguard the confidentiality of the information obtained. However, it shall, upon request, exchange information on notified bodies with the Commission, with notifying authorities of other Member States and with other competent national authorities which shall safeguard the confidentiality of the information received.
6. The notifying authority, including in the cases in which the notifying authority is the national accreditation body, shall assess only the specific conformity assessment body applying for notification and not take account of the capacities or personnel of parent or sister companies. The notifying authority shall assess that body in relation to all relevant requirements and third-party assessment and verification tasks.
7. The notifying authority shall have a sufficient number of competent personnel and sufficient funding at its disposal for the proper performance of its tasks.
Coordination of notifying and designating authorities
1. The Commission shall ensure that appropriate coordination and cooperation between the Member States’ national authorities responsible for notification policy and the notifying and designating authorities is put in place and operated in the form of a coordination group of notifying and designating authorities in the field of construction products. That group shall meet on a regular basis and at least annually.
Member States’ national authorities responsible for notification policy and the notifying and designating authorities under this Regulation shall participate in the activities of that group.
2. The Commission may establish the specific arrangements for the functioning of the coordination group of the notifying and designating authorities.
3. The Commission shall provide for the organisation of regular exchanges of experience between the Member States’ national authorities responsible for notification policy and the notifying and designating authorities.
Requirements relating to notified bodies
1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 12.
2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.
3. A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.
It shall not have any business ties with organisations that have an interest in the products it assesses, in particular with manufacturers, their trade partners and their shareholding investors.
However, a 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 a body. This shall not preclude the body from carrying out assessment and verification activities for competing manufacturers.
4. 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, or 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.
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 directly involved in the design, manufacture or construction, or 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. This shall apply in particular to consultancy services in relation to product families for which they have been notified.
Conformity assessment bodies shall ensure that activities of their parent or sister companies, their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their assessment or verification activities.
A conformity assessment body shall not delegate to a subcontractor or a subsidiary the establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of its personnel to specific tasks and the conformity assessment decisions.
5. Conformity assessment bodies and their 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. They shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their assessment or verification activities, especially from persons or groups of persons with an interest in the results of those activities.
6. 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 IX in relation to which it has been notified, irrespective of whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
At all times and for each assessment and verification system and for each kind or category of products, essential characteristics and tasks in relation to which it has been notified, the conformity assessment body shall have the following at its disposal:
(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;
(b)
the necessary description of the procedures in accordance with which the assessment process is carried out, ensuring the transparency and the ability of reproduction of those procedures, including a description of competence showing how relevant personnel, their status and tasks correspond to the conformity assessment tasks in relation to which the body intends to be notified;
(c)
appropriate policies and procedures to distinguish between the tasks it carries out as a conformity assessment body and its other activities;
(d)
procedures for the performance of activities, which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
The 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.
7. The personnel responsible for carrying out the activities in relation to which the body intends to be notified, shall have the following:
(a)
sound technical and vocational training covering all the third-party tasks in the assessment and verification process within the relevant scope for which the body has been notified;
(b)
satisfactory knowledge of the requirements of the assessments and verifications it carries out and adequate authority to carry out such operations, including appropriate knowledge and understanding of the applicable harmonised technical specifications, European assessment documents and of the relevant provisions of the Regulation;
(c)
the ability required to draw up the certificates, records and reports to demonstrate that the assessments and the verifications have been carried out.
8. Personnel responsible for taking assessment decisions shall:
(a)
be employed by the conformity assessment body under the national law of the notifying Member State;
(b)
not have any potential conflict of interest,
(c)
be competent to verify the assessments made by other staff, external experts or subcontractors;
(d)
be sufficient in number to ensure business continuity and a consistent approach to conformity assessments.
9. The impartiality of the body and its top-level management and of the assessment personnel shall be guaranteed.
The remuneration of the top-level management and assessment personnel of a body shall not depend on the number of assessments carried out or their results.
10. 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 or the verification performed.
11. The personnel of the conformity assessment body shall observe professional secrecy regarding all information obtained in carrying out its tasks under Annex IX, except in relation to the notifying authorities and other competent national authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.
12. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed about the relevant standardisation activities and the 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 of that group.
Presumption of conformity of notified bodies
Where a conformity assessment body to be authorised to carry out third-party tasks in the assessment and verification process demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official Journal of the European Union , harmonised technical specifications referred to in Article 5, European assessment documents, voluntary harmonised standards for product requirements the references of which have been published in the Official Journal of the European Union in accordance with Article 7(5) or (6) or the common specifications referred to in Article 8(1) or parts thereof, it shall be presumed to comply with the requirements set out in Article 46 in so far as the applicable documents cover those requirements.
Subsidiaries and subcontractors of notified bodies
1. Where a notified body subcontracts specific tasks connected with the third-party tasks in the assessment and verification process or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 46, and shall inform the notifying authority accordingly.
2. The notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established and monitor their competence in relation to its own as described in Article 46(6), point (b).
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
4. The notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment and monitoring of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IX.
Use of facilities outside the testing laboratory of the notified body
1. At the request of the manufacturer and where justified by technical, economic or logistic reasons related to the nature of the product or the test equipment, notified bodies may decide to carry out the tests referred to in Annex IX, for the assessment and verification systems 1+, 1 and 3 or have such tests carried out under their supervision, either in the manufacturing plants using the test equipment of the internal laboratory of the manufacturer or, with the prior consent of the manufacturer, in an external laboratory, using the test equipment of that laboratory.
Notified bodies carrying out such tests shall be specifically designated as competent to work away from their own test facilities and shall also in that regard comply with the requirements laid down in Article 46.
2. Before carrying out the tests referred to in paragraph 1, notified bodies shall verify whether the requirements of the test method are satisfied and shall evaluate whether:
(a)
test equipment has an appropriate calibration system and the traceability of the measurements is guaranteed; and
(b)
the quality of the test results is ensured.
Notified bodies shall assume full responsibility for the tests in their entirety, including the accuracy and traceability of calibration and measurements, and for the reliability of the test results.
Application for notification
1. A body to be authorised to carry out third-party tasks in the assessment and verification systems shall submit an application for notification to the notifying authority of the Member State in which it is established.
2. The application shall be accompanied by a description of the activities to be performed, the assessment and verification processes for which the body claims to be competent, the description of competence referred to in Article 46(6), point (b), as well as an accreditation certificate, where one exists, issued by the national accreditation body, attesting that the body fulfils the requirements laid down in Article 46. The accreditation certificate shall relate only to the precise legal body applying for notification and shall be based, in addition to relevant harmonised standards, on the specific requirements and tasks provided for in this Regulation.
3. Where the body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 46.
Notification procedure
1. Notifying authorities may notify only bodies which have satisfied the requirements laid down in Article 46.
2. Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
Exceptionally, for cases regarding groupings of essential characteristics set out in Annex X, for which the appropriate electronic tool is not available, a notification in other electronic form shall be accepted.
3. The notification shall include full details of the functions to be performed, reference to the relevant harmonised technical specification or to the relevant European assessment document and, for the purposes of the system set out in Annex IX, the essential characteristics for which the body is competent and the relevant attestation of that competence.
However, reference to the relevant harmonised technical specification or to the relevant European assessment document is not required in the cases regarding groupings of essential characteristics set out in Annex X.
4. Where a notification is not based on an accreditation certificate as referred to in Article 50(2), the notifying authority shall provide the Commission and the other Member States with all documentary evidence which attests to the body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 46.
5. The body concerned may perform the activities of a notified body if the Commission or the other Member States do not raise any objections within two weeks of a notification, where an accreditation certificate is used, or within two months of notification, where an accreditation certificate is not used.
Only such a body shall be considered a notified body for the purpose of this Regulation.
6. Valid notifications shall be included by the Commission in the list of notified bodies referred to in Article 52(2).
7. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification.
Identification numbers and lists of notified bodies
1. The Commission shall assign an identification number to a notified body.
It shall assign a single such number even where the body is notified under several Union acts.
2. The Commission shall make publicly available the list of bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.
The Commission shall ensure that that list is kept up-to-date.
Changes to the notification
1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 46, 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.
2. In the event of a restriction, suspension or withdrawal of a notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that that body’s files are either processed by another notified body or kept available for the responsible notifying and competent national authorities at their request.
Challenge of the competence of notified bodies
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
2. The notifying Member State shall provide the Commission, on request, with all information related to the basis for notification or the maintenance of the competence of the body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
4. Where the Commission ascertains 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.
Operational obligations of notified bodies
1. Notified bodies shall, in accordance with Annex IX carry out the following assessments and verifications:
(a)
assess the performance and the conformity of products;
(b)
verify the conformity of products;
(c)
verify the constancy of performance of products;
(d)
validate the environmental sustainability calculations undertaken by the manufacturer;
(e)
verify the compliance of the manufacturer with the obligations of this Regulation.
Those tasks are hereinafter referred to as ‘assessments and verifications’.
2. Assessments and verifications shall be carried out with transparency as regards the manufacturer, and in a proportionate manner, avoiding an unnecessary burden for economic operators. The notified bodies shall perform their activities taking due account of the size of the undertaking, the sector in which the undertaking operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
In so doing, the notified bodies shall nevertheless respect the degree of rigour required for the product by this Regulation and the part played by the product for the fulfilment of all basic requirements for construction works.
3. Where, in the course of the initial inspection of the manufacturing plant and of factory production control, a notified body finds that the manufacturer has not ensured the constancy of performance and conformity of the manufactured product, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or a validation report.
4. Where, in the course of the monitoring activity aiming at the verification of conformity and of the constancy of performance of the manufactured product, a notified body finds that a product no longer has the same performance to that of the product-type, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the validation report if necessary.
5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or validation reports, as appropriate.
6. When taking assessment decisions, including when deciding on the need to suspend or withdraw a certificate or validation report in light of possible instances of non-compliance, notified bodies shall apply clear and pre-determined criteria.
7. When requested by a manufacturer or provider to do so, notified bodies shall cooperate and share all relevant information with notified bodies that have recognised its assessments and verifications in accordance with Article 62. Notified bodies shall establish an agreement for that purpose.
Information obligations of notified bodies
1. Notified bodies shall inform the notifying authority of the following:
(a)
any refusal, restriction, suspension or withdrawal of certificates, validation reports or test reports;
(b)
any circumstances affecting the scope of, and conditions for, notification;
(c)
any request for information on assessment or verification activities carried out which they have received from competent national authorities; and
(d)
on request, third-party tasks in accordance with the assessment and verification systems carried out within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
2. Notified bodies shall provide the other bodies notified under this Regulation which carry out similar third-party tasks in accordance with the assessment and verification systems and for products covered by the same harmonised technical specification or the same European assessment document with relevant information on issues relating to negative results from these assessments and verifications, in particular, any refusal, restriction, suspension, or withdrawal of certificates, validation reports or of test reports, and, upon request, positive results from those assessments.
A notified body shall, upon request from another notified body, a competent national authority or the Commission inform the requesting party whether certificates, validation reports or test reports issued by it are valid, restricted, suspended or withdrawn.
3. Where the Commission or a competent national authority of a Member State submits a request to a notified body established on the territory of another Member State relating to an assessment carried out by that notified body, it shall send a copy of that request to the notifying authority of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The notifying authority shall ensure that such requests are resolved by the notified body unless there is a legitimate reason for not doing so.
4. Where notified bodies have or receive evidence that:
(a)
another notified body does not comply with the requirements laid down in Article 46 or its obligations;
(b)
a product placed on the market does not comply with this Regulation;
(c)
a product placed on the market, due to its physical condition, is likely to cause a serious risk,
they shall alert and share such evidence with the relevant market surveillance authority or notifying authority, as appropriate.
Implementing acts on notified bodies’ obligations
Where this is necessary to ensure a harmonised application of this Regulation and where the coordination group of notifying and designating authorities have not been able to resolve a dispute concerning their diverging practices, in accordance with Article 45, and only to the extent necessary to prevent diverging practices fragmenting the internal market for economic operators, the Commission may adopt implementing acts providing details on how to execute the obligations of notified bodies contained in Articles 55 and 56.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
Coordination of notified bodies
1. The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put into place and properly operated in the form of a group of notified bodies.
Notified bodies shall participate in the work of that group, directly or by means of designated representatives. Notifying authorities shall ensure that notified bodies participate in the work of that group.
2. Notified bodies shall apply as general guidance any relevant documents produced as a result of the work of the group referred to in paragraph 1.
3. Coordination and cooperation in the group referred to in paragraph 1 shall aim to ensure the harmonised application of this Regulation.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
