Guidance Paper K: European Commission December 2004
Guidance Paper K: European Commission December 2004
Guidance Paper K: European Commission December 2004
Single Market : regulatory environment, standardisation and New Approach December 2004
Construction
GUIDANCE PAPER K
(concerning the Construction Products Directive 89/106/EEC)
Preface
They are not judicially binding and they do not modify or amend
the Directive in any way. Where procedures are dealt with, this
does not in principle exclude other procedures that may equally
satisfy the Directive.
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GUIDANCE PAPER K
• This Guidance Paper was originally issued following consultation with the Standing
Committee on Construction at the 50th meeting on 5 July 2000, as document
CONSTRUCT 00/421.
• It has been revised (in particular addition of Annex 3 concerning specific aspects of the
attestation of conformity with regard to performance characteristics determined by
calculation) after consultation with the Standing Committee at the 60th meeting, on 26
October 2004, as document Construct 04/646.
1
Acronyms used in this Guidance Paper
AB: Approval Bodies (Bodies authorised by the Members States according to Article
10 of the CPD to issue European Technical Approvals)
ETA: European Technical Approval (CPD Chapter III type of “technical specification”)
NB: Notified Body (also called “Conformity Assessment Body” under other New
Approach Directives), which have been designated by Members States for tasks
to be carried out for the purpose of conformity assessment). According to the
CPD, Notified Bodies include certification bodies, inspection bodies and testing
laboratories,
2
THE ATTESTATION OF CONFORMITY SYSTEMS
AND THE ROLE AND TASKS OF THE NOTIFIED BODIES
IN THE FIELD OF THE CONSTRUCTION PRODUCTS DIRECTIVE
1. Scope
1.1 This Guidance Paper goes into detail on the various attestation of conformity (AoC)
systems within the context of the implementation of Council Directive 89/106/EEC
(hereafter referred to as the Construction Products Directive or CPD), as amended by
Council Directive 93/68/EEC.
1.2 It also addresses the relation between the AoC systems and the Notified Bodies. It
clarifies the role of the relevant Notified Body/Bodies under the different AoC systems.
1.3 The Guidance Paper refers, in particular, to Articles 13 and 18 and to Annex III of the
CPD. The full text of these provisions can be found on
http://europa.eu.int/comm/enterprise/construction/index.htm.
1.4 The Guidance Paper is intended for a number of different audiences, particularly Notified
Bodies and Regulators and enforcement authorities within the European Economic Area
(EEA). It is also of interest to technical specification writers (CEN/CENELEC and
EOTA members), for consideration together with the respective mandates,
manufacturers and other users for information purposes.
1.5 This document gives information which complements Guidance Paper A1 because it
describes the practical role of the notified bodies. It does not specify the criteria to be
used by Member States to examine bodies wishing to be considered for notification
(covered by Guidance Paper A).
2. Underlying Principles
2.1 The CPD identifies a complete set of attestation of conformity systems including all the
actors with their respective roles and tasks. Voluntary European or international
standards2, or documents produced on a horizontal level3 for new or global approach
directives, describing practices similar to those under the CPD, can be used as a starting
point where appropriate but are not obligatory.
2.2 This document is limited to aspects relating to CE marking under the Construction
Products Directive. Voluntary aspects that might be addressed in the technical
specifications are not dealt with.
2.3 The producer is fully responsible for the attestation that products are in conformity with
the requirements of a technical specification. The involvement of a third party, even to
3
provide an EC certificate of conformity, does not relieve the producer of any of his
obligations. However, under the CPD, responsibility for specific actions is given to a
third party for all systems of attestation of conformity (AoC) except system 4.
2.4 Whether or not there is third party intervention in attestation of conformity, all of the
tests and procedures required by the CPD and the technical specifications must be
performed and documented correctly. The documentation needs to be available for
notifying authorities and surveillance authorities where relevant.
2.5 In specifying the systems of AoC it has been recognised that the importance of the part
played by a product with respect to the essential requirements will not usually be the
same for each ER. Thus, within a given system of AoC certain tests of a product’s
performance have usually been allocated to the notified bodies and the rest to the
producer. Details of this allocation of tests need to be specified in the technical
specifications, elaborated on the basis of mandates from the Commission.
2.7 The term "Notified Body" is used only for organisations notified under article 18 of the
CPD to avoid confusion with the terminology used for organisations designated by
member states under article 10 of the CPD (ie EOTA Approval Bodies).
3.1 Initial type-testing (ITT) of the product (by the manufacturer or a notified body)
applicable to all AoC systems
(1) An Initial Type test is the complete set of tests or other procedures described in the
harmonised technical specification, determining the performance of samples of
products representative of the product type.
(2) An ITT verifies that a product complies with the harmonised technical
specification. It defines the performance of all harmonised characteristics to be
declared.
(3) Depending on the limitations of intended uses chosen by, and the specific markets
envisaged by the manufacturer, the scope of the ITT could be limited to those
applicable to the uses foreseen.
(4) A product range may cover several versions of the product, provided that the
differences between the versions do not affect the level of safety and the other
requirements concerning the performance of the product.
4 Intended use is defined in the IDs as referring to the roles(s) that the product is intended to play in the
fulfilment of the essential requirements.
4
(5) An initial type test (ITT) is not an assessment of the fitness for use of a product.
The ITT is rather a determination of the performance of a product, on the basis of
tests or other procedures described in the technical specifications.
(6) The ITT is only one element which determines whether or not a product can be
attested to be in conformity with a technical specification. However, the ITT does
play a fundamental role under the CPD as it provides the reference for the declared
performance of the product.
(1) Commission Decisions generally limit audit testing by Notified Bodies, under the
attestation of conformity procedures, to the premises of the manufacturer or his
authorised representative.
– The test results are compared with the declared performances of the product
derived from the initial type test.
– A test report is delivered, confirming that the findings are in conformity with
the technical specifications, the ITT and FPC provisions.
(1) In the CPD, factory production control means the permanent internal control of
production exercised by the manufacturer. Normally this includes testing by the
manufacturer, to assure compliance of the manufactured products with the
declared performances of the initial type test.
(2) Further details on factory production control can be found in Guidance Paper B:
"The definition of factory production control in technical specifications for
construction products."
5
product performance, including for products intended to be used as structural
components, other than those defined by the harmonised technical specifications5.
(1) Where feasible, in particular for construction products, which contribute to the
mechanical resistance and stability and/or fire resistance of works (structural
components and kits), performance characteristics may be determined by
calculation (see Guidance Paper L 3.1.2 first dash and 3.3). Such products are
distinguished from those products used for structural elements like masonry units,
cement, steel reinforcement, etc., for which the performance characteristics are
determined by testing (see Guidance Paper L, 3.1, second dash and 3.2).
(2) The hENs or ETAGs/CUAPs/ETAs need to lay down the methods for determining
the performances and to specify all the requirements, including conformity
assessment requirements regarding Initial Type Testing (ITT) and Factory
Production Control (FPC) in such a way that manufacturers establish and provide
the relevant declared performances (values, classes and parameters if relevant) in
the information accompanying the CE marking of products (Guidance Paper L
3.3.1).
(3) Regarding performance characteristics of structural components and kits, for which
the performance is established using a calculation method, in particular Eurocodes,
the declared performance is obtained by using one of the three methods described
in the Guidance Paper L, clause 3.3.
(4) CE marking and the accompanying documents for such structural products need to
provide all of the information necessary to use the product in works, or to integrate
the performance characteristics into the structural design of works or parts thereof
(see GP L 3.3.1).Related product technical specifications need to require this
information relevant for the calculation or the design assumptions of the EN
Eurocodes to be part of the information accompanying the CE marking.
(5) With regard to structural components and kits, as for any other construction
product, the technical specifications applicable to the product must provide for the
entire conformity assessment to be performed and documented according to the
provisions of the Directive (see clause 2.4 above). Therefore, the technical
specifications (hENs or ETAs) need to define the tasks linked to the attestation of
conformity of the product, also with regard to calculation.
(6) Since the task of performing conformity assessment by calculation partly requires
the availability of proven special technical competence, knowledge and experience
in this field, and necessary means and equipment, significantly different from those
needed for testing, Member States notifying a body need to indicate, after careful
examination, whether conformity assessment by calculation is a task assigned to
this approved body (Article 18(3)). They also need to include this availability in
their verification according to Annex IV, last paragraph, of the Directive.
5 Including no up-grade of the level of Attestation of Conformity fixed in the relevant Commission Decision.
6
(7) Determination of performance by calculation may not give ground to deviate from
the procedure of attestation of conformity, as generally provided for.
(2) The certification body6 in procedure (i) has to perform conformity assessment of
the product, and in procedure (ii), first possibility, has to do the assessment of the
capabilities of the manufacturer to assess ITT and FPC outcomes against the
product specifications and, when surveillance is required, periodically review this.
(3) Under procedure (i) and procedure (ii), first possibility, notified bodies (other than
the certification body) may work as sub-contractor to the certification body.
6 The involvement of the certification body is not intended to relieve any of the responsibilities for the
manufacturer but to reassure the users and the authorities that everything is satisfactory.
7
(4) Under procedure (ii) second possibility, the tests to be carried out in respect of any
one Essential Requirement are the responsibility of a notified test laboratory (see
4.2.2 (3) below). However, that laboratory may subcontract specific tests to other
laboratories.
(5) To facilitate referencing the various AoC systems in the Commission Decisions on
the Attestation of Conformity and in the corresponding mandates, the systems have
been given a number. Annex 1 recapitulates this numbering scheme.
(1) Under systems 1 and 1+, responsibility for the certification of the conformity of the
product (on the basis of tasks by the producer and the notified body) is given to a
third party.
(2) It is normal practice that various parties – producer, certification body, inspection
body, laboratory – carry out the individual tasks required to enable product
certification to take place. The certification body is responsible for assembling all
of the relevant information, verifying that tasks have been carried out according to
the technical specification and assessing and certifying the conformity of the
product.
(4) Under systems 1 and 1+, responsibility for product sampling for the ITT, in
accordance with the rules laid down in the technical specification, lies with the
certification body (often delegated to an inspection body), rather than the
producer.
(5) The result of the actions of the notified body under CPD Annex III.2(i) (Systems 1
and 1+) is in all cases a product conformity certificate. The only difference
between the commonly used terms 'system 1' and 'system 1+' are the methods used
by the notified body to assess the product (ie. 1+ includes audit testing).
(1) Under systems 2, 2+, 3 and 4, the responsibility for product sampling for the ITT
test, in accordance with the rules laid down in the technical specification, lies with
the manufacturer.
This second system (Annex III of the CPD) distinguishes between three
possibilities:
8
4.1.1 first possibility (Systems 2 and 2+)
(1) The result of the actions of the notified body under this first possibility is in
all cases a factory production control certificate. The only difference
between the commonly used terms 'system 2' and 'system 2+' are that
whereas both 2 and 2+ involve assessment of Factory Production Control,
system 2+ also involves surveillance.
(4) Certification of FPC does not involve assessment of the overall conformity
of a product with a technical specification – this remains the responsibility
of the producer.
(1) Under system 3, responsibility for the Initial Type Test (ITT) is given to a
third party or parties, rather than to the producer. All other responsibilities
fall on the producer.
(3) Having responsibility for the ITT does not necessarily mean that the third
party (or parties) has to carry out all of the tests required for a given
product type. It is quite normal for the producer to carry out some of the
7 In the absence of sampling rules (and other initial type testing or factory production control details) in the
technical specification, the Group of Notified Bodies shall provide appropriate common instructions to
producers. These common instructions will be communicated to the SCC for endorsement. Specification
writers could use these as basis for future amendments of the specifications.
9
testing himself. The technical specifications, elaborated on the basis of the
mandates from the Commission, will indicate which of the tests on
individual product characteristics may be performed by the producer, as
opposed to the notified laboratories (reports will always indicate who has
performed the test).
(4) For the tests to be carried out by a third party, the producer may address to
one or more notified laboratories, but the tests regarding the same Essential
Requirement must be carried out by the same laboratory (i.e. no more than
6 notified laboratories, one per Essential Requirement). This allows highly
specialised laboratories (e.g. for fire or acoustical testing) to be notified and
brought within the Group of Notified Bodies co-ordination process. The
producer needs to inform each notified laboratory of the identity of any
other notified laboratories used and to keep appropriate records.
(5) It is recalled that also any tests carried out by the manufacturer himself (or
the notified bodies) must be performed and reported in accordance with the
technical specification(s). The test reports need to make reference to the
sample identities referred to above.
(6) The complete ITT Report, assembled by the producer, needs to include all
of the test reports from the notified laboratories and the producer. Any
notified laboratory involved in the ITT may request to examine the full ITT
Report, in order to satisfy himself that all of the sample identities
correspond with those provided to it for testing. . If they are not from the
same batch, identification testing needs to allow the results to be compared
with the other parts of the testing8.
(1) Currently, different attestation and market surveillance systems are operational in
the Member States. Many of the 'third parties' involved in these schemes will
become Notified Bodies under article 18 of the Construction Products Directive. In
each national system, a certain terminology is used for these bodies.
8 This to allow the use of test results from different times during the development of new products
10
the range of intended uses that the producer chooses to make his product available
for.
(3) It is not relevant to compare the role and tasks of the types of Notified Bodies
under the CPD with existing terminology or practices in Member States as the
functions of the latter are not necessarily equal to traditions under national systems.
(4) The Notified Bodies for one and the same product(s) or product characteristic (or
type of test) need to regularly exchange their experience and the information
necessary to perform their tasks in a way that the procedures are consistent and
transparent and that the results are reproducible. This exchange should take place
in the respective Sector Group of the Group of Notified Bodies (GNB). Matters of
general interest should be put forward to the Advisory Group of the GNB.
(1) For various reasons Notified Bodies can appoint subcontractors that perform tasks
on their behalf. Annex 2 details the different types of Notified Bodies as defined in
Annex III of the CPD and their roles under the various AoC systems. In many
cases, Notified Bodies look for subcontractors to solve isolated problems (lack of
capacity in their own laboratories, inspections in a plant across the border…).
(2) A subcontracting notified body remains responsible for all the activities covered by
the notification. Subcontracting does not entail the delegation of powers or
responsibilities. Certificates and reports are always issued in the name and under
the responsibility of the subcontracting notified body but will indicate who has
performed the actual tasks. Serial subcontracting is prohibited in order to avoid
undermining the coherence of the system and the confidence in it.
(3) A notified body can subcontract strictly limited technical tasks (e.g. tests, factory
production control audits), as long as these can be defined as substantial and
coherent parts of the technical operation.
(2) This kind of subcontractor does not need notification but should demonstrate to
the respective Member State technical competence and impartiality by fulfilling the
requirements of annex IV of the CPD for the tasks that are contracted to them.
(3) The Notified Body needs in all cases to have a direct private-law contractual link
with its sub-contractors to ensure the fulfilling of its general responsibilities.
11
(4) This mechanism provides an answer where notified bodies seek solutions to enable
them to give a complete service to Industry. Council Decision 93/465/EC9 defines
a number of conditions on sub-contracting.
Adapting this to the specific case of the CPD this means that the subcontracting of
work needs to be subject to certain conditions guaranteeing:
- the ability of the body notified to exercise effective responsibility for the work
carried out under sub-contract.
(1) To perform tasks, Notified Bodies can make use of the services of other Notified
Bodies notified in the relevant area. The certificates or reports produced must
clearly indicate who has performed a particular task. The overall responsibility
remains with the sub-contracting Notified Body.
(1) All samples to be used for testing purposes need to be suitably marked to allow a
subsequent verification that the producer has fulfilled his obligations. This
demonstrates that the manufacturer has followed the rules in the harmonised EN or
ETA, that all tests have been carried out on the same batch of samples, if this is
specified, and that the samples are representative for the product to be placed on
the market.
(2) Sample-marking on the product will at least include production line, date and time
of the taking of the sample. The sample identity needs to be recorded in all test
reports to enhance trace ability.
(3) Products declared by the manufacturer to be defective may only be excluded from
sampling if they have been set aside and marked accordingly.
9 Council decision 93/465/EC concerning the modules for the various phases of the conformity assessment
procedures and the rules for affixing and use of the CE conformity marking, which are intended to be used
in the technical harmonisation directives.
12
(4) In the case of sampling by a Notified Body, the sampler needs to prepare and sign
a record on sampling that needs to be countersigned by the manufacturer or his
representative (when relevant). The record should at least include the following
information:
– Manufacturer and manufacturing plant
– Place of sampling
– If necessary, stock or batch quantity (from which the samples have been taken)
– Number or quantity of samples
– Identification of the construction product in accordance with the technical
specification
– Marking of the product by the manufacturer
– Marking of the samples by the sampler (when relevant)
– Where necessary, properties to be tested
– Place and date
– Signatures
– Registration number of the Notified Body
(1) The results of each test, independent of whether this test is part of the initial type
test or audit testing by the manufacturer or a third party, need to be recorded in a
"test report". The test report should at least include the following information:
– Manufacturer and manufacturing plant
– Identification of the construction product in accordance with the relevant
technical specification
– Information about
– sampling
– date of testing
– involved personnel
– applied testing methods according the relevant technical specification
– Identification of the organisation and personnel executing the test
– Place and date
– The results of the test, including analysis of these when relevant.
– Place and date of the delivery of the test report
– Registration number of the Notified Body (when relevant)
– Signature of the head of the testing laboratory and stamp (when relevant).
The test report must comply with the relevant clauses of the technical
specifications. The complete set of test reports will be kept by the manufacturer and
13
the certification body (when relevant) and will be made available to the inspection
body (where relevant) and market surveillance authorities on demand.
Test laboratories will keep the test reports that they have issued.
6.3 Note
Where possible, model reports and other model documentation should be developed by
the specification writers and should be included in the technical specifications.
As an interim solution and to avoid extra work for the specification writers, the test
reports may need to appear as separate documents developed by the relevant sector
groups and/or the Advisory Group of the Group of Notified Bodies. Suitable common
presentation should be assured by close collaboration between specification writers and
the GNB.
7. References
Guidance paper A: The Designation of Notified Bodies in the field of the Construction
Products Directive.
Guide to the implementation of Directives based on the New Approach and the Global
Approach.
-------------------------------
14
Annex 1: Attestation of Conformity Systems.
System Task for manufacturer Task for notified body Basis for CE marking
2 Initial type of testing of product Certification of factory production control on basis of initial inspection
Factory production control Manufacturers conformity Declaration
+
2+ Initial type testing of product Certification of factory production control on basis of certification of
Factory production control factory production control
Testing of samples according prescribed test plan initial inspection
continuous surveillance, assessment and approval of production control
1 factory production control Certification of product conformity on basis of tasks of the notified body and
Further testing of samples according prescribed test plan the tasks assigned to the manufacturer
First possibility:
(a) (tasks for the manufacturer)
(1) initial type-testing of the product; 7 M M
(2) factory production control; 8 M M
(3) testing of samples taken at the factory in accordance with a 9 M
prescribed test plan (*);
(b) (tasks for the notified body)
(4) certification of factory production control on the basis of:
KEY:
Y - Body is involved in these tasks or in certification based on them.
s - Body can undertake these tasks on behalf of a certification body.
17
ANNEX 3
11 This Annex could also be used as reference for products performance characteristics related to other
essential requirements (e.g. essential requirements n° 5 – acoustic or n°6 – thermal performances)
which are determined by calculation; however, in this case, the content of this guidance may need to
be adjusted to suit specific aspects of the products and the calculation methods concerned.
12 Characteristic and design values are defined in the Eurocodes.
18
– Method 3, which is as follows:
The declared information is presented by reference to design documents of the
works or client’s order (see Guidance Paper L, 3.3.4), regardless whether the
harmonised technical specification prescribes a calculation method to be used or not.
The manufacturer decides whether or not to accompany the CE marking with
information regarding the product performance characteristics, by reference to the
respective design documents (which may be based on harmonised calculation
methods, i.e. Eurocodes, applied by the designer of the works or the product
manufacturer, as agreed between the client and the manufacturer). If he does so, he
is also responsible and liable for the performance of the product with regard to its
design, which might mean that he ensures a verification of the design if he has
doubts about its correctness. If he does not, the responsibility regarding the design
of the product needs to be determined in the contract between the manufacturer and
the one who orders the manufacturing of the product (the user or the designer,
according to the given contractual relation) and/or, if relevant, according to the
national legal requirements applicable.
(2) The decision to include one, two, or all these three methods in technical specification, is
up to the specification or ETAG/CUAP writers. Nevertheless, they may exclude a
method, if this is duly justified for technical reasons. The conditions to be applied for
anyone of these methods need to be specified in the product hEN or ETAG/CUAP.
(3) This annex considers “initial type calculation” (ITC) as being performed on
representative types of the product and part of the ITT (i.e. the product performance
characteristics is determined by calculation and not by testing), while calculation
performed on individual manufactured product may be part of the factory production
control in analogy to “testing of samples taken at the factory” included in the Annex III
of the CPD as a control method for AoC systems 1+, 1 and, where relevant, 2+.
(4) The product hEN or ETAG/CUAP should indicate which parts of calculations and input
data have to be verified in the framework of the conformity assessment, and by whom,
and in which cases it is necessary to be done for individual manufactured products.
2. Principles
(5) Within the systems of attestation of conformity referred to in Annex III of the CPD, for
the “initial type testing” (ITT) of the product, calculations are to be considered as a part
of the ITT. ITC can usually be performed for a product range13. However, where
applicable, the product hEN or ETAG/CUAP should define small series production, for
which ITC should be limited to the demonstration of the manufacturer's ability to
perform the calculations specified in the harmonised technical specifications and his
ability to take into account parameters that may change with new (small) series.
(6) Similarly, calculation might be part of "audit testing" in system 1+, although in many
cases, performing new calculations by Notified Bodies should only be considered if
13 group of products produced by one manufacturer for which the test results for one or more characteristics
from any one product within the range are valid for all other products within this range
19
technically relevant, i.e. in case calculation methods, instruments or procedures changed
since ITC.
(7) Document procedures regarding calculation should also be covered in the manufacturer's
FPC system, similar to the provisions that apply when performances are determined by
testing.
3.1 Certification of conformity of the product (CPD III.2(i) - AoC systems 1 and 1+)
(9) Under the system of attestation of conformity 1 and 1+ of attestation of conformity, the
responsibility for the Initial Type Testing, including ITC, lies with the Notified Body.
3.1.1 Methods 1 and 3 (when the calculation method is not covered by the harmonised
technical specification):
(10) Regarding ITT, the Notified Body is responsible, in addition to performing tests, for
verifying that the manufacturer has used correct methods and procedures for the
determination of geometrical data of the product, and of the properties of the materials
and constituent products used, including sampling (where relevant) in accordance with
the provisions of the hEN or ETAG/CUAP..
(11) Regarding the initial inspection of the factory and of FPC and continuous surveillance,
assessment and approval of FPC, the Notified Body evaluates the permanent internal
control of production exercised by the producer.
(12) Regarding audit verification by/of calculation in place of audit testing (only system 1+),
the Notified body is responsible for regular determination of geometrical data of the
product, and of the properties of the materials and constituent products used, including
sampling (where relevant).
3.1.2 Methods 2 and 3 (when the calculation method is covered by the harmonised
technical specification):
(13) The Notified Body is responsible for the ITC according to the method given in the hEN
or ETAG/CUAP. It checks and validates the calculation (tools and results) used by the
manufacturer to design the product, by any appropriate means included in the hEN or
ETAG/CUAP, judging and, if deemed appropriate, performing independent calculations
for validation (see footnote 14, next page)and issuing the CE certificate of conformity.
The Notified Body must be qualified for structural calculations by using the methods laid
down in the technical specification and/or may be assisted by somebody who is so,
provided that it maintains responsibility and liability for this task.
20
In more detail, regarding ITT and, in particular Initial Type Calculation (ITC), the
Notified Body:
(a) Is responsible for the determination of geometrical data of the product, and of the
properties of the materials and constituent products used, including sampling
(where relevant). This provides input data for the calculations;
(b) Verifies that the calculation method used to determine the declared performances
of mechanical properties for a product range complies with the requirements given
in the hEN or ETAG/CUAP;
(c) Validates the input data used for the calculations (material and constituent product
properties, applied partial factors, etc.) and, where relevant, that it has been
processed with the correct tools (e.g. correct computer software);
(e) Provides an ITC report in accordance with item 6.2 of this Guidance Paper, so that
the certificate of conformity of the product can relate to the ITC report, which is a
part of the ITT report.
(14) Regarding the initial inspection of the factory and of FPC and continuous surveillance,
assessment and approval of FPC, the tasks of the Notified Body are those carried out
under system 2 or 2+ (see § 3.2 below), notwithstanding (13) and (15).
(15) Regarding audit verification by/of calculation in place of audit testing (only system 1+),
the Notified body:
(a) Is responsible for regular determination of geometrical data of the product, and of
the properties of the materials and constituent products, including sampling (where
relevant). This provides input data for the calculations;
(b) Verifies that the calculation method, applied to determine the declared mechanical
performances, by type of product, continues to comply with the requirements of
the hEN or ETAG/CUAP. This is of particular relevance in case the calculation
method referred to or the calculation instrument or procedures change, and might
be not necessary in other cases;
(c) Checks the constant compliance of input data for calculations (material and
constituent product properties, assumed actions, partial factors) and, where
relevant, of tools (e.g. computer software) to process them;
3.2 Declaration of conformity of the product (CPD III.2(ii) first possibility - AoC
systems 2 and 2+).
14 Taking into consideration manufacturers’ wishes resulting from those of stakeholders on a given market, or
according to an identified need, a Notified Body may perform itself a complete calculation or verification by
partial calculation or needs to do so.
21
(16) Under the systems of attestation of conformity 2 and 2+, the responsibility for Initial
Type Testing, including the ITC, lies with the manufacturer. The Notified Body does not
validate the related calculation.
3.2.1 Methods 1 and 3 (when the calculation method is not covered by the harmonised
technical specification):
(17) Regarding ITT, the manufacturer is responsible, for the methods and procedures used for
the determination of geometrical data of the product and of the properties of the
materials and constituent products, including sampling, and their indication as
information accompanying the CE marking, in accordance with the provisions of the
technical specification (hEN or ETA).
(18) Regarding initial inspection of the factory and of FPC (AoC system 2 and 2+) and
continuous surveillance, assessment and approval of FPC (only AoC system 2+), the
Notified Body evaluates the permanent internal control of production exercised by the
producer, in particular with regard to documented procedures for the selection of
representative samples according to the provisions of the hEN or ETAG/CUAP and the
determination of product and material properties necessary as input for calculations. He
checks whether the conditions of manufacturing the product allow the indications made
by the manufacturer as information accompanying the CE marking to comply with the
provisions of the technical specification.
3.2.2 Methods 2 and 3 (when the calculation method is covered by the harmonised
technical specification):
(19) The Notified Body is only responsible for certifying that Factory Production Control
complies with the requirements laid down in the product hEN or governing the ETA, on
the basis of an initial inspection of the factory and factory production control and, in the
case of system 2+, continuous surveillance, assessment and approval of the factory
production control. Part of the initial inspection of the factory is also to verify that the
manufacturer has undertaken an initial type calculation in accordance with the provisions
of the hEN or ETAG/CUAP.
(20) Regarding ITT and related sampling, including the necessary ITC for the product range
(as defined in hEN or ETA) and the determination of the input data for calculations
(material and constituent product properties, partial factors, etc.), are under the
responsibility of the manufacturer.
(21) Regarding the initial inspection of factory and of the Factory Production Control, the
Notified Body evaluates whether the production system enables the achievement of the
required product characteristics and the effective operation of FPC. In addition to
checking whether the ITC has been performed and whether the method and the
calculation process are documented15, when the FPC includes calculation of the
mechanical properties for the manufactured products (samples), the Notified body
verifies that the manufacturer established, uses and maintains a documented FPC system
in accordance with the product hEN or ETAG/CUAP ensuring:
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(a) the correct selection of representative samples;
(b) for the various products manufactured, the correct determination of product and
material properties necessary as input for calculations, for the individual products;
(d) that the calculation has been performed, that its basis (e.g. safety factors used) is
correct, and that the method, process and results used as a basis for performance
declarations are adequately documented and registered;
(e) that, in the case of electronic processing and reporting, only sufficiently
documented and validated software and properly functioning computer equipment
are used, and adequate measures of data protection and integrity are in place.
(22) Regarding the continuous surveillance, assessment and approval of FPC (only system 2+)
the tasks of the Notified Body are, with an appropriate frequency as specified in the
product hEN or ETAG/CUAP, to verify that the documentation regarding the
calculation method is still valid (regardless whether modified or not) and to check the
continued use and maintenance of a documented FPC system in accordance with the
product hEN or ETAG/CUAP ensuring (a) to (e) as listed in (21).
3.3. Declaration of conformity of the product, (CPD III.2(ii) second possibility - AoC
system 3)
3.3.1 Methods 1 and 3 (when the calculation method is not covered by the harmonised
technical specification):
(23) Regarding ITT, the Notified Body is responsible for the determination of geometrical
data of the product and of the properties of the materials and constituent products used
to manufacture the product. The manufacturer is responsible for sampling (if relevant).
3.3.2 Methods 2 and 3 (when the calculation method is covered by the harmonised
technical specification):
(a) Is responsible for the determination of geometrical data of the product and of the
properties of the materials and constituent products used. This provides input data
for the calculations;
(b) Verifies that the calculation method, applied to determine the declared
performances of mechanical strength for a product range complies with the
requirements given in the hEN or ETAG/CUAP;
(c) Validates the input data for calculations (material and constituent product
properties, partial factors for materials applied in resistance calculation) and, where
relevant, that it has been processed with the correct tools (e.g. correct computer
software);
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(d) Validates for endorsement16 the results of the Initial Type Calculation;
(e) Provides an ITC report in accordance with item 6.2 of this Guidance Paper, so that
the certificate of conformity of the product can relate to the ITC report, which is a
part of the ITT report.
3.4. Declaration of conformity of the product, (CPD III.2(ii) third possibility - AoC system 4)
(a) The ITT, including the Initial Type Calculation, is the task of the manufacturer.
(b) Structural calculations for the individual products manufactured on the basis of the
ITC, used for the evaluation of performances (declared values and classes
accompanying the CE marking) are part of the Factory Production Control.
(26) In the case of an ETA, with or without guideline, the Approval Body will usually have
validated the calculation method to be used, by using it directly to determine the product
characteristics when it undertakes the tasks to issue the ETA itself. Then, the role of the
Notified Body is restricted to assess, depending on the AoC system involved, the
conformity of the product and / or production with what has been specified in the ETA,
but it does not need to validate the calculation method used.
(27) In cases, where the manufacturer presents to the Approval Body a large range of
products, the Approval Body might include in the ETA itself the calculation method it
judges suitable, allowing the manufacturer to calculate himself product performances for
the entire product range. In this case the Approval Body already validates the calculation
method and the conditions under which it should be used, by introducing it in the ETA.
The role of the Notified Body is then limited to verifying that the manufacturer uses the
calculation method as indicated for determining the relevant product performance, but
does not need to validate the calculation method as such.
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16 The Notified Body may also perform itself, if he wishes, independent partial or complete calculations.
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