Construction Products Regulation (EU) N° 305/11
Key concepts of the CPR
The CPR builds upon the CPD and aims to break down technical barriers to trade in construction products within the European Internal Market. To achieve this, the CPR provides for four main elements:
- a system of harmonised technical specifications;
- an agreed system of conformity assessment for each product family;
- a framework of Notified Bodies;
- CE marking of products.
The CPR lays down conditions for the placing or making available on the market of construction products by establishing harmonised rules on how to express the performance of construction products. The CPR does not regulate the fitness for use of the products which remains with the responsibility of the individual Member States.
Actually, Member States retain the right to regulate the use of the products by establishing threshold values of performances of the construction product in relation to their essential characteristics for a specific intended use; however, such values shall be expressed consistently with the technical language as used in the harmonised technical specifications.
Harmonised technical specifications
Harmonised technical specifications for a product define methods of assessing and declaring the performance characteristics, which are already stated in the act of approval of the Mandate within the national regulations of at least one of the Member States, which affect the ability of construction products to meet the seven basic requirements for construction works:
- Mechanical resistance and stability
- Safety in case of fire
- Hygiene, health and environment
- Safety and accessibility in use
- Protection against noise
- Energy economy and heat retention
- Sustainable use of natural resources.
Harmonised standards and European Assessment Documents (EADs) are both harmonised technical specifications. The technical standard is drawn up and published by CEN/CENELEC based on requests (“Mandates”) issued by the European Commission. The Commission shall publish in the Official Journal of the European Union the list of references of harmonised standards which are in conformity with the relevant mandates. However, if standards cannot be produced or foreseen within a reasonable period of time due to technical barriers or delays, or if a product, generally an innovative one, deviates from the scope of a hEN or needs a particular method of assessment, an ETA (European Technical Assessment) may be issued on the basis of an EAD (European Assessment Document) at the request of the Manufacturer.
The first table ZA.1 of informative Annex ZA to the harmonised standard lists the essential characteristics and any threshold level that may be provided for by the Mandate issued to CEN/ CENELEC by the European Commission.
The parts of the standard which are not necessary to fulfil the Mandate are termed the voluntary (or non-harmonised) parts of the standard and they are not included in Annex ZA.
Likewise, Section 2 of the EAD lists the essential characteristics and the assessment and verification methods of performance.
It should be noted that the Manufacturer is not obliged to evaluate and declare all the performances relating to the list of essential characteristics reported in the harmonised technical specifications; however, the performance of at least one of the characteristics relevant to the declared intended use/s shall be declared.
The actual difference between a harmonised standard and an EAD lies in the mandatory CE marking of the construction product; specifically, a construction product that falls within the scope of a harmonised standard shall be compulsorily CE marked before it is placed on the market; on the contrary, if a construction product falls within the scope of an EAD, the Manufacturer retains the right to undertake the procedure leading to the CE marking of its product. As a first step of the procedure, he shall contact a TAB to apply for an ETA.
Declarations of Performance
By making a DoP (Declaration of Performance) the Manufacturer, importer or distributor is assuming legal responsibility for the conformity of the construction product with its declared performance. A copy of the Declaration of Performance of each product which is made available on the market shall be supplied either in paper form or by electronic means. Where a parameter is covered in the hEN or ETA, it is not permissible to quote any results obtained for that parameter using a different test method or different units.
It being understood that the Manufacturer shall declare the value of at least one essential characteristic of the product, the DoPs need not contain further values relating to characteristics for which regulations do not exist in a specific Member State. In these cases, a declaration of “No Performance Determined” (NPD) shall be made, as provided for in the standard.
Where applicable, the Declaration of Performance should be accompanied by information on the content of hazardous substances in the construction product to improve the possibilities for sustainable construction and to facilitate the development of environment-friendly products. Since for many substances, the necessary test methods have yet to be agreed, declaration should be limited to substances referred under REACH (Registration, Evaluation, Authorisation of Chemicals), available at www.reachteam.eu..
CE MARKING
The CE marking should be affixed to all construction products for which the Manufacturer has drawn up a Declaration of Performance.
By affixing the CE marking or having such marking affixed to a construction product, Manufacturers declare that they take responsibility for the conformity of that product with its declared performance and for the compliance with all applicable requirements pursuant to European Regulation No. 305/2011.
The declaration of conformity contains information in any form about the performance of the construction product in relation to the essential characteristics, as defined in the applicable harmonised technical specification and may be provided only if included and specified in the declaration of performance. For each essential characteristic the performance to be declared shall be expressed by level or class, or in a relevant description.
It is underlined that the CE marking of a product does not mean that the product is suitable for use but that it is consistent with the performances contained in the DoP and that the Manufacturer carries out continuous assessment and verification in order to ensure the constancy of performance of the product.
Assessment and Verification of Constancy of Performance
Manufacturers shall ensure that procedures are in place to ensure that series production maintains the declared performance. In this regard, the CPR provides five different systems of assessment and verification of constancy of performance (AVCP) with different degrees of involvement of third-party bodies in the assessment of the constancy of performance of the product based on the relevant technical specification.
For each product family, the system of AVCP is collectively agreed by the Member States and the European Commission on the basis of the implications of the product on health and safety and on the particular nature and production process of the product itself.
The five systems of AVCP and the degrees of involvement of Notified Bodies are shown below:
- System 1+
- the Manufacturer shall carry out:
- Factory Production Control (FPC);
- further testing of samples taken at the factory by the Manufacturer in accordance with the prescribed test plan;
- the notified product certification body decides on the issuing, restriction, suspension or withdrawal of the certificate of constancy of performance of the product based on the outcome of the assessments and verifications that it has carried out, as listed below:
- evaluation of the performance of the product based on tests (including sampling), calculations, tabulated values or descriptive documentation of the product;
- initial inspection of the manufacturing plant and of Factory Production Control;
- continuous surveillance, assessment and verification of Factory Production Control;
- audit-testing of samples taken by the notified product certification body at the manufacturing plant or at the Manufacturer’s warehouses.
- System 1
- the Manufacturer shall carry out:
- Factory Production Control;
- further testing of samples taken at the factory by the Manufacturer in accordance with the prescribed test plan;
- the notified product certification body decides on the issuing, restriction, suspension or withdrawal of the certificate of constancy of performance of the product based on the outcome of the assessments and verifications that it has carried out, as listed below:
- evaluation of the performance of the product based on tests (including sampling), calculations, tabulated values or descriptive documentation of the product;
- initial inspection of the manufacturing plant and of Factory Production Control;
- continuous surveillance, assessment and verification of Factory Production Control.
- System 2+
- the Manufacturer shall carry out:
- 4. evaluation of the performance of the product based on tests (including sampling), calculations, tabulated values or descriptive documentation of the product;
- 5. Factory Production Control;
- 6. further testing of samples taken at the factory by the Manufacturer in accordance with the prescribed test plan;
- the notified product certification body decides on the issuing, restriction, suspension or withdrawal of the certificate of constancy of performance of the product based on the outcome of the assessments and verifications that it has carried out, as listed below:
- initial inspection of the manufacturing plant and of Factory Production Control;
- continuous surveillance, assessment and evaluation of Factory Production Control.
- System 3
- the Manufacturer shall carry out Factory Production Control;
- the notified testing laboratory shall evaluate the performance based on the of tests (on the basis of the sampling carried out by the Manufacturer), calculations, tabulated values or descriptive documentation of the product.
- System 4
- the Manufacturer shall carry out:
- evaluation of the performance of the product based on tests, calculations, tabulated values or descriptive documentation of the product;
- Factory Production Control;
- no tasks for the Notified Body.
The procedures for conformity assessment and verification of the constancy of performance of the product are set out in the relevant harmonised technical specification.
Once the activities related to the system of assessment and verification of constancy of performance for construction products have been carried out, the Manufacturer shall draw up the DoP and CE-mark his product. Manufacturers shall keep the technical documentation and the declaration of performance for a period of 10 years after the construction product has been placed on the market.
Use of CE marking
As from 1 July 2013, construction products placed on the European Internal Market falling within the scope of application of a harmonised standard (hEN) or in accordance with an ETA will have to be accompanied by a Declaration of Performance when being placed on the market. CE Marking can only be affixed to a construction product when the Manufacturer has drawn up a declaration of performance.
Drawing up a DoP and affixing the CE marking is the responsibility of the Manufacturer. An importer or distributor shall be considered a Manufacturer for the purposes of the CPR and shall be subject to the obligations of a Manufacturer pursuant to Article 11, where he places a product on the market under his name or trademark or modifies a construction product already placed on the market in such a way that conformity with the declaration of performance may be affected. He is therefore bound to carry out all the activities aimed at obtaining the CE marking including the drafting of the DoP and the performance of the activities related to the verification and assessment of constancy of performance.
A Declaration of Performance may not be required for construction products covered by a harmonised standard where the construction product:
- is individually manufactured or custom-made in a non-series process in response to a specific order, and installed in a single identified construction work, by a Manufacturer who is responsible for the safe incorporation of the product into the construction works, in compliance with the applicable national rules and under the responsibility of those responsible for the safe execution of the construction works designated under the applicable national rules
- is manufactured on the construction site for its incorporation in the respective construction works in compliance with the applicable national rules and under the responsibility of those responsible for the safe execution of the construction works designated under the applicable national rules;
- the construction product is manufactured in a traditional manner or in a manner appropriate to heritage conservation and in a non-industrial process for adequately renovating construction works officially protected as part of a designated environment or because of their special architectural or historic merit, in compliance with the applicable national rules.
Pursuant to article 38 of the CPR, in relation to construction products falling within the scope of a harmonised standard and which are individually manufactured or custom-made in a non-series process in response to a specific order, the performance assessment part of the applicable AVCP system may be replaced by the Manufacturer by Specific Technical Documentation demonstrating compliance of that product with the applicable requirements and equivalence of the procedures used to the procedures laid down in the harmonised standards. If the AVCP system is 1+ or 1, the specific technical documentation must be verified by a notified product certification body.
Voluntary Marks
Voluntary marks are permitted provided that they fulfil a different function from that of the CE marking, are not liable to cause confusion with it, nor should they reduce the CE marking’s legibility or its visibility. Voluntary marks could contribute to improve the protection of users of the product, however the characteristics reported in the voluntary mark shall not fall under the scope of the harmonised standard in force.
Manufacturers and other economic operators
Manufacturers, agents, importers and distributors shall inform themselves about published harmonised technical specifications, the state of progress and the CE marking mandatory date which apply to their products. Product Contact Points established pursuant to Regulation (EC) No. 764/2008 in order to provide information about the technical rules applicable in the Member States, should also provide support in this regard.
Manufacturers will need to inform themselves about the essential characteristics whose performance must be compulsorily declared in the country of destination in relation to the intended use chosen for their product.
Other important information for the Manufacturer include:
- keeping the technical documentation for a period of 10 years after the construction product has been placed on the market;
- keeping a register of complaints, of non-conforming products and of any product recalls;
- allowing the identification and full traceability of the product;
- supplying safety instructions and information in the language of the Member State in which the product is being marketed;
- taking immediate corrective measures if a product is not in conformity with the DoP;
- ensuring that the product maintains its compliance with the DoP also after handling and stocking operations;
- providing all relevant information about a product if a request is made by a competent national authority;
- taking immediate measures if the declared performance of the mass-produced product deteriorates.
Importer and Distributor
The CPR gives responsibilities to importers and distributors as well requesting them to demonstrate that the Manufacturer has fulfilled all his obligations. The importer’s identifying data and appropriate contact information must appear on the product, on the labelling or on associated documents.
Other responsibilities of importers and distributors include:
- withdrawing a product from the market if they believe the product is not in conformity with the DoP;
- passing on all relevant documentation whenever they make an economic transaction;
- ensuring that the product maintains its compliance with the DoP after storage and distribution;
- providing all relevant information about a product if a request is made by a competent national authority;
- being able, for a period of 10 years, to provide the market surveillance authority with the contact information of the economic operator who supplied them with the construction product and of the economic operator to whom they supplied the product.
At least the last two bullet points shall apply to the agent who shall also provide a DoP.
Cost Reduction
To cut the costs, especially to micro-enterprises, of placing construction products on the market, simplified procedures have been introduced for products falling within the scope of a harmonised standard and are not safety critical. Provided that consistency of procedures is demonstrated, as far as AVCP system 3 is concerned, micro-enterprises manufacturing products covered by a harmonised standard may replace the determination of the product type with methods different from those defined in the harmonised standard. In such case, Manufacturers may also treat construction products to which system 3 applies as being in accordance with provisions for system 4.
If the construction product belongs to a family of construction products for which the applicable system for assessment and verification of constancy of performance is system 1 + or 1, the appropriate Technical Documentation shall be verified by a notified product certification body.
Subsequent measures address the sharing of test results among different Manufacturers and, subject to prior authorisation, the using of test results obtained by another Manufacturer or by suppliers of the whole system or parts of it, whenever the performance equivalence of the product-type can be demonstrated.
Finally, in some cases the Manufacturer places on the market a product consisting of a system made of components, covered by harmonised technical specifications, and he assembles the components duly following precise instructions given by the provider of such a system or of a component; in such cases, if the provider has already tested that system or that component for one or several of its essential characteristics in accordance with the relevant harmonised technical specification, the Manufacturer may use the test results obtained by the provider of the systems, subject to prior authorization of the provider himself.
Products Contact Points for Construction
Pursuant to article 9 of Regulation (EC) No. 764/2008, in order to provide assistance services to the sector operators in relation to the regulatory requirements essential in different Member States, Contact Points for Construction Products have been established in each country, as provided for in article 10 of the CPR. The list of Contact Points is published in the European Commission website (https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/contacts-list_en.
Notified Bodies
Notified Bodie shall be third-party bodies independent from the organisation or the construction product they assess; more specifically, they are product certification bodies, FPC certification bodies and testing laboratories which are considered to be competent to carry out the specific assessment tasks. Such bodies are first approved by their respective Member States and then notified to the European Commission and other Member States. They are referred to as «Notified Bodies».
Notified Bodies are required to participate in the ’Group of Notified Bodies‘ (GNB), with their European counterparts, to discuss practical implementation matters to achieve an unbiased approach to the assessment and verification of constancy of performance. Manufacturers who need to resort to a Notified Body in relation to the AVCP procedure will be able to approach any such body in Europe provided it has been notified for the appropriate harmonised technical specification requested and for the tasks related to the appropriate conformity assessment procedure.
With respect to the function of Notified Bodies involved in the AVCP for construction products, the CPR distinguishes between:
- product certification body: a Notified Body pursuant to Chapter VII of the CPR for the certification of constancy of performance;
- factory production control certification body: a Notified Body pursuant to Chapter VII of the CPR for the certification of factory production control;
- testing laboratory: a Notified Body pursuant to Chapter VII of the CPR that measures, examines, tests, calculates or otherwise assesses the performance of construction products.
Further information
Lists of harmonised technical specifications, Notified Bodies and TABs can be found in the NANDO website (https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=33 )
The lists, which are updated regularly, include details of the harmonised technical specifications and identification numbers of the Notified Bodies of each Member State, as well as the tasks for which they have been notified.
Mandatory qualification of products for structural use in Italy
According to the definition of Chapter 11 of the technical standards for construction (Ministerial Decree of 17 January 2018), the materials and products for structural use are those that allow the works in which they are permanently incorporated to meet the basic works requirement number 1 as a priority (BWR 1 ) “Mechanical strength and stability” referred to in Annex 1 of the CPR.
The Decree also quotes verbatim that “Materials and products for structural use shall be:
– uniquely identified by the Manufacturer, according to the procedures set out below;
– qualified under the responsibility of the Manufacturer, according to the procedures set out below;
– accepted by the Project Manager through the acquisition and verification of the identification and qualification documentation, as well as through acceptance tests, if any”.
In particular, with regard to identification and qualification, the following cases may occur:
- A) materials and products for which a harmonised European standard whose reference is published in the OJEU is available for the intended structural use. At the end of the coexistence period, they can be used in the works only if accompanied by the “Declaration of Performance” and the CE Marking, provided for in Chapter II of EU Regulation 305/2011;
- B) materials and products for structural use for which a harmonised European standard is not available or if this is in the coexistence period, for which qualification is instead envisaged according to the methods and procedures set out in these standards. This applies except in the case where, during the coexistence period of the specific harmonised standard, the Manufacturer has voluntarily opted for the CE marking;
- C) materials and products for structural use that are not part of type A) or B). In such cases the Manufacturer will be able to obtain the CE Marking on the basis of the relevant “European Technical Assessment” (ETA), or must obtain a “Technical Assessment Certificate” issued by the President of the Superior Council of Public Works, after preliminary investigation by the Italian Central Technical Service, also on the basis of Guidelines approved by the Superior Council of Public Works, where available; by decree of the President of the Superior Council of Public Works, with the assent of the competent Section, Guidelines relating to specific procedures for the issuing of the “Technical Assessment Certificate” are approved.
It should therefore be pointed out that, although in general terms the CE marking is not mandatory for construction products not covered by harmonised standards, as far as construction safety is concerned, the Italian legislator identifies the CE marking based on a relevant European Technical Assessment as a priority method for the qualification of construction products for structural use.