Transcript REGULATION (EU) No 305_5

October 1 – 3, 2013, Belgrade, Serbia
Fostering innovation skills in the wood sector supporting structures
REGULATION (EU) No 305/2011
on Construction Products
Dr Tatjana Kočetov Mišulić,
University of Novi Sad, Faculty of Technical Sciences
CPR(2011) vs CPD (1989)
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Content:
CPR & CPD:
Brief History…
Important issues of CPD…
Improvements by CPR…
Differences…
Innovative structures….
Questions for Discussions…
Jointly for our common future!
CPR(2011) & CPD (1989)
• CPD – Construction Product Directive (89/106 EEC)
• CPR – Construction Product Regulation (305/2011 EU)
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CPR get into force July 1st, 2013.
General idea of CPD / CPR :
elimination of technical barriers to trade between EU MS.
Aim of CPR :
Easier implementation of defined objectives in CP sector,
simplified mechanisms of implementation,
Enforcement the business activities of SMEs and other
enterprises.
Jointly for our common future!
Instruments of
EU-Council / EU-Commission*
• Regulations
(a binding legislative act that must be applied across the
EU).
• Directives
(legislative act that sets out a goal that all EU countries
must achieve, but it is up to the individual countries to
decide how).
• Decisions
• Recommendations
• Opinions
____________________________
* http://europa.eu/eu-law/decision-making/legal-acts/index_en.htm
Jointly for our common future!
Background CPD (1989)
• CPD, as EU-Directive from „New Approach 1985“, contains protective targets in
form of „Essential Requirements“ (ERs),
• „Harmonized“ European Standards (hENs) lay down the detailed requirements
on products (or ETAs)
• “Global Approach 1990” in the mandatory sector brings :
– Modular Concept (7) for Conformity Assessment procedures
– Notified (approved) Bodies
• in the voluntary sector:
– Mutual Recognition Agreements (MRAs)
• in both sectors:
- EN 45000 (new: EN ISO 17000) series and EN ISO 9000 series
• introduction of the CE-Marking: the manufacturer indicates therewith that
both the „Essential Requirements“ as well as the procedures for the
Attestation of Conformity of all relevant EU-Directives have been kept.
Jointly for our common future!
EU Quality infrastructure
Established to provide a free movements of goods, persons,
services and capital.
Supporting entities:
CEN/CENELEC/ETSI - international
non-profit associations as major
providers of European Standards
and technical specifications business facilitators in Europe with
Technical Committees for all
domains on standardization issues,
Notification, Accreditation and
Certification bodies, Testing
laboratories, Inspection bodies.. .
Jointly for our common future!
CPD basic issues:
• Field of application: CPD is applicable on construction
products, related to ERs, which are produced to be
incorporated in permanent manner in construction
works (building and civil engineering).
• Essential Requirements (ERs)
(explained by Interpretative Documents IDs)
• 1. Mechanical resistance and stability
• 2. Safety in case of fire
• 3. Hygiene, health and environment
• 4. Safety in use
• 5. Protection against noise
• 6. Energy economy and heat retention
Jointly for our common future!
Jointly for our common future!
Harmonized European Standards
Where the harmonized
technical
specifications
(eg. Annex ZA of hEN)
require a manufacturer
to involve a third party
before CE marking
then that third party
shall be
a Notified Body.
Jointly for our common future!
European Technical Approval*
• European Technical Approvals (ETAs) are based on ETA
Guidelines (ETAGs) or issued upon common agreement of the
Approval Bodies.
• ETA may be granted to products for which there is neither a
harmonized standard nor a recognized national standard, or
product differ significantly from recognized harmonized or
national standard.
KLH Massivholz GmbH
KLH Massivholzplaten ETA 06/0138
Examples : different type of Metal Anchors for
Use in Concrete, Structural Sealant Glazing
Systems, Internal Partition Kits, External Thermal
Insulation Composite Systems with Rendering,
Liquid Applied Roof Waterproofing Kits, Dowels
for structural joints, Fire retardant products, * …
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http://www.eota.eu/en-GB/content/home/2/
Jointly for our common future!
Notified bodies*
 bodies notified by Member States to the European Commission and the
other MS
 ...are authorized for Conformity Assessment Procedures with respect to
one or more New-Approach-Directive(s) relating to
– certification,
– inspections and/or
– testing
 …can be found in the EU-database NANDO: *
http://ec.europa.eu/enterprise/newapproach/nando/
• More generally, a Notified Body is a third-party, accredited body which is
entitled by an Accreditation Body. Upon definition of standards and
regulations, the Accreditation Body may allow a Notified Body to provide
verification and certification services - official certification mark or a
declaration of conformity.
Jointly for our common future!
Tasks of Notified bodies
 only notified bodies are to be involved in the conformity assessment
procedures under New-Approach-Directives (AoC)
 specific tasks in the framework of the modules or of the systems 1+, 1,
2+, 2 and 3 of the Construction Products Directive (e.g. initial type
testing, inspections, certification)
 the manufacturer is free to choose any notified body in a Member
State of the EU
Jointly for our common future!
Conformity Assessment Procedures in
Community Legislation („Modular Approach“)
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Systems for Attestation of Conformity for CP
Reference documents - series ISO 17000, EN 45000
according to Annex III of the Construction Products Directive (CPD) (6 preffered)
Systems
Tasks of the
manufacturer
 Factory Production
Control (FPC)
1
according to 2 i
 Testing of samples in
accordance with a
prescribed test plan
according to 2 ii
First possibility
2+
3
according to 2 ii
Second possibility
4
according to 2 ii
Third possibility
Result
 Certification of the product
on the basis of
 Initial inspection of the factory
and of the FPC + Sampling
 Initial type-testing (ITT)
 Continuous surveillance of FPC
 Audit-testing of samples
1+
2
Tasks of the
approved (= notified) body
 Certification of the FPC
 Initial type-testing (ITT)
on the basis of
 Factory Production
 Initial inspection of the factory
Control (FPC)
and of the FPC
 Testing of samples in
accordance with a
prescribed test plan
 Continuous surveillance of FPC
 Sampling for ITT
 Factory Production
Control (FPC)
 Initial type-testing (ITT)
 Initial type-testing (ITT)
 Factory Production
Control (FPC)
Jointly for our common future!
Declaration
of conformity
of the product
by the manufacturer
CE marking under CPD
• means that product fulfills the ERs of all relevant EU-Directives,
• is mainly addressed to the market surveillance authorities,
• has a single meaning, i.e. the compliance with all legal
provisions,
• is therefore affixed to the product or its packaging by the
manufacturer or supplier on his own responsibility,
• is the precondition for placing a product on the European
market (EEA),
• Is not a quality mark!
Jointly for our common future!
Reasons for CPR….1
• need for a harmonised legislative framework.
Mutual recognition – generally not sufficient to achieve free
circulation.
• need for clarification concerning the fundamental elements of CPD:
- performance based vs prescriptive approach,
- the meaning and the status of CE marking,
- the acceptance of CE marking by the national authorities and the
users of construction products as a reliable marking,
- the role of standards and European technical approvals;
Jointly for our common future!
Reasons for CPR….2
• Simplification of CPD:
- The systems of AoC have be simplified and reduced in number.
- The administrative procedures for ETA route for CE marking have to
be perceived and streamlined.
- Guidelines for European technical approval (ETAG) should disappear.
- Simplifying the “no performance determined” (NPD) option with
better definition will avoiding unnecessary costs for companies;
- Potential negative effect on SMEs has to be avoided with
appropriate treatment for specific non-series products.
• Need for reinforcing the credibility of the whole system
(strengthening the criteria, notification of bodies, better
coordination of market surveillance).
Jointly for our common future!
Essential Requirements (ERs) vs Basic
Requirements for Construction Works (BWR)
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1. Mechanical resistance and stability
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2. Safety in case of fire
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3. Hygiene, health and environment
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4. Safety in use
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5. Protection against noise
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6. Energy economy and heat retention +
• 7. Sustainable use of natural resources
CEN/TC 350 :
sustainability aspects
of new and existing
construction works and
standards for the
Environmental Product
Declaration EPD of
construction products
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The construction works must be designed, built and demolished in such a way that the use of
natural resources is sustainable and in particular ensure the following:
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(a) reuse or recyclability of the construction works, their materials and parts after demolition;
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(b) durability of the construction works;
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(c) use of environmentally compatible raw and secondary materials in the construction works.
Jointly for our common future!
CPR : hEN
• CPR : insurance of reliable information on CPs using the uniform assessment
methods of the performance.
• hEN - Harmonized European Standards provide a solid technical basis for
manufacturers for testing the performance of their products.
Using these standards the manufacturer will be in position to make the
Declaration of Performance (DoP). Template in Anex III.
• DoP : paper form, electronic or website.
• The harmonized European standards on CP (together with the relevant
horizontal standards on assessment methods) will allow:
• Expression of requirements (regulatory authorities in Member States),
• Declaration the product performance (manufacturers),
• Verification of compliance with such requirements (design engineers,
contractors).
Jointly for our common future!
CPR : ETA
• European Technical Assessment (ETA) is issued on basis of a EAD and shall
include:
• the performance to be declared, by levels or classes, or in a description, of
those essential characteristics agreed by the manufacturer and the TAB
receiving the request for the ETA for the declared intended use, and
• technical details necessary for the implementation of the system of
assessment and verification of constancy of performance.
• European Assessment Document (EAD) is a document containing at least:
• a general description of the construction product;
• the list of essential characteristics, relevant for the intended use of the
product as foreseen by the manufacturer and agreed between the
manufacturer and the organization of TABs;
• the methods and criteria for assessing the performance of the product in
relation to those essential characteristics
• principles for the applicable
factory production control to be applied.
Jointly for our common future!
CPR: EAD
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The procedure for developing and adopting European Assessment Documents
(EAD) shall notably:
be transparent and cost-effective for the manufacturer;
define appropriate mandatory time limits;
take appropriately into account the protection of commercial secrecy and
confidentiality.
European Assessment Documents adopted by the organisation of TABs shall be
sent to the Commission. An updated list of references of the final EADs will be
published by the Commission in the Official Journal of the European Union.
The European Technical Assessment is issued on basis of a EAD and shall include:
the performance to be declared, by levels or classes, or in a description, of those
essential characteristics agreed by the manufacturer and the TAB receiving the
request for the European Technical Assessment for the declared intended use, and
technical details necessary for the implementation of the system of assessment
and verification of constancy of performance.
Jointly for our common future!
… , NBs & TABs
• EAD (European Assessment Documents) replace ETAGs and CUAPs.
Route of CE marking remains voluntary. Principles for development of EADs are in
Annex II CPR, which lays down the timescale>
1 month to draw up the contract, 3 months to draw up an assessment plan, 6
months to final draft. (Before, no time scales are laid down at all.)
•The Notified Bodies (NB) designated under CPD are re-designated under the
Construction Products Regulation. Organization – GNB (Group of Notified Bodies)
A list of all officially designated Notified Bodies under the Construction Products
Regulation (CPR) is available in the database NANDO-CPR.
• A Technical Assessment Body (TAB) is in charge of the assessment and issue
the European Technical Assessment in a product area for which it has been
designated.
Existing ETA bodies will be re-designated as TABs. (“approval” – “assessment”).
List of TABs in NANDO). Organization of TABs (previously EOTA).
CPR : DoP – CE mark
• The Declaration of Performance (DoP) is the key concept in
the Construction Products Regulation (CPR) - and gives the essential
characteristics about the product delivered to the market
(instead of DoC – declaration of conformity in CPD)
• The manufacturer shall draw up a Declaration of Performance when a
product covered by a harmonised standard (hEN) or a European Technical
Assessment (ETA) is placed on the market.
• CPR clarifies that the year code applied with CE mark is the year in which it
was first affixed, so does not change every year.
• Manufactures will not have to change their mark each year.
• Exceptions from the requirements for CE marking: custom made products
in response to the specific order, on-site manufacture, traditional, heritage
type conservation projects.
Jointly for our common future!
Assessment and Verification of
Constancy of Performance (AVCP)
• CPR renames the concept of Attestation of Conformity (AoC),
removing the level 2, that was stated in very few standards.
• AVCP consists from 5 levels: 1+, 1, 2+, 3, 4. (Annex V).
• The simplification impact is relatively small.
SIMPLIFICATION PROCEDURES: SHAREING TEST COSTS
• It is allowed to manufacturer to avoid type testing in cases of
- “deemed to satisfy” by existing conditions or classifications,
- using data from another manufacturer for similar products with
permission,
- by using data established for components, in kit, or assemblies.
Jointly for our common future!
Obligation of economic actors CPR Ch. III
Economic
operators are defined as:
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manufacturer, importer, distributor, or authorized representative,
(Despite CPD, that placed most of responsibility on the manufacturer).
- CPR places responsibility also on agents, importers, distributors.
It will ensure the transfer of information from the source to the end user.
-Important especially for the manufacturers outside the EU, who put their
product into supply chain, without knowing where the product will en up.
Greater legal responsibility.
-Importers and distributors cannot sell non-compliant products, and must
assure themselves that manufacturer has done all required. Defined
responsibility of the importers.
-Authorized representative would be largely responsible for ensuring
conformity of the product, at local level.
Jointly for our common future!
Product contact points
• New concept, becomes from Mutual recognition of goods.
• Product contact points must be establish in each MS, with the
aim to provide information and advices, free of charge to
economic operators. In force from July, 1st, 2013.
Market surveillance
• Idea - Enforcing authority.
• EA shell take steps to prohibit / restrict / or withdrawn the
product from the market in the case of non compliance.
Jointly for our common future!
Micro - enterprises
• A micro enterprise is defined as having less than 10 employees
and less than or equal to 2 millions Euro turnover.
• CPR allows additional simplification for micro enterprises.
Where the hEN is level 3 or 4, than they may use alternative but
equivalent methods of type testing or it is possible to
downgrade the approach from levels 3 and 4 to „self declared“,
documented by manufactorer by „specific technical
documentation“.
• Applicability in practice?
• The question of demonstrated „equivalence“, and
concequencies...
Jointly for our common future!
General Consequences of CPR
• CE marking of construction products according to the technical
specification coordinated by manufacturers and distributors
(with some exceptions) is mandatory; furthermore, CE marking
is the only legally regulated marking which states that the
construction product achieves its declared performance.
• Innovative products have simplified and time defined route to
CE marking, trough ETAs & EAD.
• Simplification of the procedures and reduction of costs for SMEs
is evident.
• The improvements of market surveillance means the
enforcement of legislation.
• Improvement an transparency of established measures.
Jointly for our common future!
Useful links & references
• CPR: REGULATION (EU) No 305/2011 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL , of 9 March 2011 ., OJEU, 4.4.2011.
• Wolfgang HÖHNL, ON – Austrian Standards Institute: “EU-Quality
Infrastructure - Conformity Assessment and Conformity Assessment
Marks”, Novi Sad, 2008.
• Nando base> http://ec.europa.eu/enterprise/newapproach/nando/
• www.cenorm.eu
• www.cenorm.be
• www.iso.ch
Jointly for our common future!
T.Kocetov Misulic
Questions for Discussions…
• Expected facilitations for innovative products according
CPR, versus the previous practice / proper experience?
• Example: fire test on typical assembly of shear wall,
both sided test (5000e x 2). Size of valid series? Could
manufacturers organize themselves in groups or clusters,
for the purpose of testing (similar products)?
• Anchor type testing – could it be common for different
products / type of structures?
• Testing of wood properties according quality classes?
Size of sample, possibility of organizing…
•…..
• Your questions and remarks….
Jointly for our common future!
T. Kocetov Misulic