European assessment documents
1. The methods and criteria for assessing the performance of products, including used products, in relation to their essential characteristics may be laid down in European assessment documents provided that the products are not covered by:
(a)
a harmonised standard made mandatory by an implementing act referred to in Article 5(8);
(b)
an implementing act referred to in Article 6(1); or
(c)
a harmonised standard to be delivered in a period shorter than one year, in accordance with a standardisation request referred to in Article 5(2).
2. A product shall not be considered to be covered by harmonised standards or implementing acts referred to in paragraph 1 where:
(a)
the declared use of the product falls outside of the scope of the intended use set out in the harmonised standard or implementing act;
(b)
the materials used are not identical to the materials to be used in accordance with the harmonised standard or implementing act; or
(c)
the assessment method set out in the harmonised standard or implementing act is not appropriate for that product.
3. Following a request for a European technical assessment by a manufacturer, a group of manufacturers or a manufacturers’ association, or on the initiative of the Commission, the organisation of TABs may, in agreement with the Commission, draw up and adopt a European assessment document.
The basic requirements for construction works set out in Annex I and the list of predetermined environmental essential characteristics set out in Annex II shall constitute the basis for the preparation of European assessment documents. The development and adoption of a European assessment document shall follow the principles and the procedure set out in Article 32.
4. European assessment documents shall not be drawn up in relation to an essential characteristic of, or assessment method for, a product when there is another European assessment document covering the same essential characteristic or assessment method in relation to that specific product, the reference of which has either already been published in the Official Journal of the European Union , or which has been submitted to the Commission for assessment in accordance with Article 34(1).
5. The organisation of TABs and the Commission may merge or reject requests for the development of a European assessment document in accordance with point 5 of Annex VI.
6. From the date of mandatory application of a harmonised technical specification adopted in accordance with Article 5(8) or Article 6(1), covering the same product and the same intended use as a European assessment document, the European assessment document shall no longer be used for the purposes of this Regulation. In that case the Commission shall withdraw the reference of the European assessment document from the Official Journal of the European Union .
7. European assessment documents shall constitute the basis for European technical assessments set out in Article 37.
Principles and procedure for the development and adoption of European assessment documents
1. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall follow the procedure set out in Annex VI.
2. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall:
(a)
be transparent to Member States, the manufacturer concerned and to other manufacturers or stakeholders that request to be informed;
(b)
disclose confidential information to the Commission only when necessary to assess the compliance of a European assessment document with regulatory provisions and protect commercial secrecy and confidentiality;
(c)
specify appropriate mandatory time limits in order to avoid unjustified delay;
(d)
allow for adequate participation by the Member States and the Commission;
(e)
be cost-effective for the manufacturer; and
(f)
ensure sufficient collegiality and coordination amongst TABs designated for the product in question.
The balancing of requirements laid down in points (a) and (b) of the first subparagraph shall allow at least 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 point 3 of Annex VI, and for the disclosure of the detailed contents of the draft European assessment document set out in point 8 of Annex VI.
3. The TABs shall, together with the organisation of TABs, bear the full costs of the development and adoption of European assessment documents, unless such development is initiated by the Commission.
4. TABs and the organisation of TABs shall avoid the proliferation of European assessment documents where there is no technical justification for differentiating between products. They shall, in particular, give preference to extending the scope of existing European assessment documents over creating new European assessment documents.
5. The Commission is empowered to adopt, after consultations with the organisation of TABs, delegated acts in accordance with Article 89 to amend Annex VI in order to add additional procedural rules for the development and adoption of European assessment documents, where it is necessary to ensure the good functioning of the system of European assessment documents.
Obligations of the TAB receiving a request for a European technical assessment
1. When receiving a request for a European technical assessment from a manufacturer, a group of manufacturers or a manufacturers’ association, the TAB shall comply with the following requirements:
(a)
where the product is covered by a harmonised technical specification or a European assessment document cannot be drawn up in accordance with Article 31, the TAB shall inform the applicant that a European technical assessment cannot be issued;
(b)
where the product is fully covered by a European assessment document the reference of which has been published in the Official Journal of the European Union , the TAB shall inform the applicant that the referenced European assessment document will be used as the basis for the European technical assessment to be issued;
(c)
where the product is eligible for a European assessment document referred to in Article 31, and no such document is in the process of being developed, the TAB shall inform the applicant that the procedures set out in Annex VI will be initiated.
In the cases referred to in point (c) of the first subparagraph of this Article, but where a harmonised standard covering the same product is expected to be delivered in a period longer than one year as established in a standardisation request referred to in Article 5(2), the TAB shall inform the applicant about the possibility of a European assessment document no longer being used pursuant to Article 31(6).
2. In the cases referred to in paragraph 1, first subparagraph, points (b) and (c) of this Article, the TAB shall inform the organisation of TABs and the Commission of the content of the request and of the reference to a relevant delegated act determining the assessment and verification system referred to in Article 10(2), which the TAB intends to apply for that product, or of the lack of such delegated act.
3. If the Commission considers that an appropriate delegated act determining the assessment and verification system does not exist for the product, it may adopt a delegated act in accordance with Article 10(2).
Publication of references
1. The Commission shall, in accordance with point 9 of Annex VI, assess the compliance of European assessment documents with harmonised technical specifications, with this Regulation and with other Union law. Where a European assessment document is in conformity with applicable legal requirements, the Commission shall without delay publish a reference of that document in the Official Journal of the European Union . Where a reference to a European assessment documents cannot be published in the Official Journal of the European Union , the Commission may publish such a reference with restrictions.
2. Following publication in accordance with paragraph 1 of this Article, a European assessment document may, in accordance with Article 37, be used as a basis for a European technical assessment for a period of 10 years, unless the reference of the European assessment document has been withdrawn from the Official Journal of the European Union or that European assessment document is no longer used pursuant to Article 31(6). The organisation of TABs may in the last year of that period decide to submit the European assessment document for renewal. The Commission shall in that case reassess the European assessment document in accordance with paragraph 1 of this Article.
Content of the European assessment document
1. A European assessment document shall contain the following elements:
(a)
a description of the product or product category covered and its intended use; and
(b)
the list of essential characteristics, relevant for the intended use of the product or product category as agreed between the manufacturer and the organisation of TABs as well as predetermined environmental essential characteristics as set out in Annex II, and the methods and criteria for assessing the performance of the product or product category in relation to the essential characteristics listed.
2. The European assessment document shall set out:
(a)
the technical details necessary for the implementation of the assessment and verification systems that are to be applied in accordance with the delegated acts adopted under Article 10(2);
(b)
the guidelines, including technical details necessary for drawing up general product information, instructions for use and safety information as referred to in Annex IV;
(c)
the guidelines to ensure interoperability of the human and machine readable formats for the declaration of performance and conformity in accordance with paragraph 16(2), point (b).
3. Where the performance of the product can appropriately be assessed by reference to its essential characteristics, including assessment methods and criteria, already established for them in harmonised technical specifications or other European assessment documents, those existing essential characteristics and their methods and criteria shall be incorporated as parts of the European assessment document, unless it is technically necessary to deviate from that rule.
Where applicable, these principles shall also apply for threshold levels and classes of performance adopted in accordance with Article 5(5).
Formal objections against European assessment documents
1. A Member State shall inform the Commission of all of the following:
(a)
where it considers that a European assessment document does not entirely conform with applicable legal requirements or satisfy the demands to be met in relation to the essential characteristics to be covered in view of the basic requirements for construction works set out in Annex I and the predetermined environmental essential characteristics set out in Annex II;
(b)
where it considers that a European assessment document raises a major concern for health and safety of persons, the protection of the environment or consumer protection;
(c)
where it considers that a European assessment document does not fulfil the requirements set out in Article 31(1).
The Member State concerned shall substantiate its viewpoints. The Commission shall consult the other Member States on the issues raised by the Member State concerned.
2. In the light of the views of all the Member States, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the European assessment documents concerned in the Official Journal of the European Union .
3. The Commission shall inform the Member States and the organisation of TABs of its decision referred to in paragraph 2 and, where necessary, request the revision of the European assessment document concerned.
European technical assessment
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 published in the Official Journal of the European Union in accordance with Article 34.
Provided that there is a European assessment document the reference of which has been published in the Official Journal of the European Union in accordance with Article 34, a European technical assessment may be issued even in the case where a standardisation request has been issued. Such issuing shall be possible until the European assessment document is no longer used pursuant to Article 31(6).
2. When a request for a European technical assessment is made, the procedure laid down in Annex VI shall apply.
3. The European technical assessment shall include the performance to be declared, by levels or classes, or in a description, of those essential characteristics that are agreed by the manufacturer and the TAB receiving the request for the European technical assessment for the declared use, and the technical details necessary for the implementation of the assessment and verification system.
The European technical assessment shall also include the assessment of the performance for the predetermined environmental essential characteristics listed in Article 15(3).
4. The Commission may adopt implementing acts to establish the format of the European technical assessment.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
5. European technical assessments issued on the basis of a European assessment document remain valid for either five years after the end of the period set out in Article 34(2) or five years after the reference of the European assessment document is withdrawn from the Official Journal of the European Union .
When the relevant European assessment document for a product is no longer used pursuant to Article 31(6), that product may no longer be placed on the market on the basis of a European technical assessment.
6. Products covered by a European assessment document for which a European technical assessment has been issued may be CE marked and thereby obtain the same status as products CE marked on the basis of harmonised technical specifications, where the manufacturer satisfies the obligations set out in this Regulation. Where these obligations refer to harmonised technical specifications, the manufacturer shall refer to the European assessment document instead or, where the harmonised technical specifications are also relevant, in addition.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
