BUSINESS ASSURANCE
Valve Manufacturers Association of America
2016 Technical Seminar: EU’s New Legislation Framework (NLF)
- What this means to you.
Mike Norman
08 January 2016
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DNV GL © 2014
VMA
Technical
Session - March 2016
08 January
2016
SAFER, SMARTER, GREENER
Content
 Reasons for changing the Directives: History and development of the European
Regulations
 Main horizontal changes in the New Legislation framework (NLF)
 Specific changes for PED
 Considerations during the transfer from old to new directives
 What is applicable after 2016?
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IVS 2015 • International Conference on Valve and
14/03/2016
New PED and ATEX directives: why now and what is changing?
 HISTORY : The Common Market was launched in the 80’s
 Since 1987 some 27 Directives, adopted on the basis of the New Approach
and the Global Approach, have progressively come into force
 These Directives have the dual purpose of ensuring the free movement of
goods through technical harmonisation of entire product sectors, and of
guaranteeing a high level of protection
 The New Approach Directives were intended to be reviewed after 10-15 years
 Example:
 Machinery Directive (new directive 2009)
 Simple Pressure Vessels (new directive 2011)
 Toys (new directive 2011)
 Good news:
 The product scope, categorization and essential health and
safety requirements in PED and ATEX are not changed
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2008: Revision of the New Approach System: New Legislative
Framework (NLF)
 Two Acts were adapted by the European Parlament in 2008
 The Regulation 765/2008/EC is in force from 1 January 2010 in all Member States
 The Decision 768/2008/EC will have horizontal impact on future revisions of the
New Approach Directives
 Main elements of Regulation
 Accreditation strongly recommended for Notified Bodies
 Market surveillance is strengthened
 Main elements of Decision
 Strengthens the value of CE-marking
 Conformity assessment modules looked over
 Emphasis on Member State Control of Notified Body
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8 EU Product Directives to be aligned with the NLF 2016
Directive
Products
Revision
PED 97/23/EC
Pressure equipment
New PED (2014/68/EU) in force 19
July 2016
LD 95/16/EC
Lifts
New LD (2014/68/EU) in force 20
April 2016
R&TTE 99/5/EC
Radio equipment
Replaced by new Radio Eqipment
Directive 2014/53/EC in force 13 June
2016
EMC 2004/108/EC
Electromagnetic compability
New EMC (2014/30/EU) in force 20
April 2016
LVD 2006/95/EC
Low Voltage
New LVD (2014/35/EU) in force 20
April 2016
ATEX 94/9/EC
Devices in explosive
atmosphere
New ATEX (2014/34/EU) in force 20
April 2016
RCD 94/25/EC
Recreational Crafts
New RCD (2013/53/EU) in force 18
January 2016
MID 96/98/EU
Measurements instruments
New MID (2014/32/EU) in force 30
October 2016
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The Blue Guide
 The Blue Guide is an EU document presenting the European Legislative
Framework
 It was revised in 2014 as a consequence of the NLF
 Following the new Blue Guide we can identify some horizontal requirements
having an impact on new PED and ATEX as a consequence of the NLF:
1. Economical operators:
Manufacturer, Authorized representative, Importer, Distributor
2. Product requirements:
Traceability, Declaration of Conformity, CE-marking
3. Conformity assessment
Conformity assessment modules, Notified Bodies
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Main changes due to the NLF in PED and ATEX
1.Economical operators
 The Blue Guide clarifies 4 different economical operators: Manufacturer, Authorized
Representative, Importer and Distributor
 PED and ATEX only define the first two in current versions but will define all of them in the
new directives
 Here a summary:
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Main changes due to the NLF in PED and ATEX
2. Product requirements
Traceablity
 It is now even more clarified that the history of all components building up the
product must be traceable. This is needed to support market surveillance.
 The traceability requirements include labelling the product and identifying the
economic operators in the distribution chain
Declaration of Conformity/CE-marking
 The requirements from 768/2008 are now transferred into new PED and ATEX.
The traceability requirements to the product are clarified. The CE-marking
requirements are also clarified.
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Main changes due to the NLF in PED and ATEX
3. Conformity assessment
•
•
Notified Body requirements
The horizontal requirements on Notified Bodies in NLF and ISO 17065
will be implemented in the new PED/ATEX. This includes stricter
connection to accreditation and more focus on competences in the
Notified Bodies.
•
The requirements on Notified Bodies are developed in Art.24 – 38 in new
PED and Art.17 – 33 in new ATEX. These were previously expressed in
one Annex only.
•
The generic requirements on third-party organizations are aligned with
ISO 17065 (impartiality, competences, liability, secrecy, participation in
coordination activities)
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Specific for PED: Evaluation 2012
Main conclusions
• PED has successfully combined market integration with
maintaining the high levels of product safety
• Strong growth for the PE industry - 57% (average industrial
growth 1995-2010 32%)
• European PE industry competitive on global level – export double
the import
• The actors (manufacturers, Notified Bodies and authorities) are
not acting in a harmonized way – for example how the Conformity
Assessment is applied
• Market surveillance is lacking in many countries
• Globalization is a challenge
• Harmonized EN standards have not been quite succesful
• Only a smaller nr of NoBos are active in NoBo-cooperation
• Thus more market surveillance / authority control is
recommended
• Merger with SPVD (Single Pressure Vessels) is recommended
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Specific for PED: Group classification
•
The CLP (Classification, Labelling and Packaging) will be introduced in current PED from 1st
June 2015 as the Dangerous Substances directive – 67/548/EEC - is being replaced by the CLP
at this date.
•
Very few substances will actually change Fluid Group.
 At the last CABF (PED NoBo
meeting) the following
Guideline was drafted
 The PED definition of
”flammable” has been specific
for PED – it is now defined in
the same way in CLP
 NOTE: The flash point of a volatile material
is the lowest temperature at which it can
vaporize to form an ignitable mixture in air.
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Specific for PED: Change of some Conformity Assessment Modules
(CAM)
97/23/EC
2014/68/EU
Comments – changes with impact on NoBo
A1
A2
Unexpected visits to be performed at random intervals
B
B (production type)
NoBo is obliged to inform the manufacturers on changes in
relevant standards
B1
B (design type)
Same as B except type examination (certificate valid 10 years,
10 years storage of the technical file)
C1
C2
Unexpected visits to be performed at random intervals
 New connection Categories - CAM
 Category I = Module A
 Category II = Modules A2, D1, E1
 Category III = Modules B (design type) + D, B (design type) + F, B (production type) + E, B
(production type) + C2, H
 Category IV = Modules B (production type) + D, B (production type) + F, G, H1
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Transfer timeline
 There will be no transfer period: New PED and ATEX will be valid sharp
on the transfer date
 This means that products placed on the market until this date shall
be in conformance with the current directives
 Place on the market = making available on the market or putting into
service
 Thus the moment when the product is CE-marked
 Specific for PED: Two-steps transfer; Art.13 will be introduced in 2015
Year
Month
2015
2016
5
6
7
8
9 10 11 12 1
2
3
4
5
6
7
8
9 10 11 12
1 June 2015: Start of application of Art.13 (New Fluid Group classification)
18 July 2016: Deadline for member states to transpose new PED 19 July 2016: Start of full application for new PED
4
PED
ATEX
19 April 2016: Deadline for member states to transpose new ATEX 20 April 2016: Start of full application for new ATEX
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Transitional provisions
Equipment manufactured and certificates issued before the transfer date will
continue to be valid
PED Article 48:
1. Member States shall not impede the putting into service of pressure equipment and assemblies which comply with the
regulations in force in their territory at the date of application of Directive 97/23/EC and were placed on the market
until 29 May 2002.
2. Member States shall not impede the making available on the market and/or the putting into service of pressure
equipment or assemblies covered by Directive 97/23/EC which are in conformity with that Directive and which were
placed on the market before 1 June 2015.
3. Certificates and decisions issued by conformity assessment bodies under Directive 97/23/EC shall be valid under this
Directive.
ATEX Article 41:
1. Member States shall not impede the making available on the market or the putting into service of products covered by
Directive 94/9/EC which are in conformity with that Directive and which were placed on the market before 20 April
2016.
2. Certificates issued under Directive 94/9/EC shall be valid under this Directive.
NOTE: A Manufacturer issuing a Declaration of Conformity after the transfer should make
a reference to Art.48 resp. Art.41 if the DoC is based on Certificates issued before the
transfer
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Transfer period – Guidelines until transfer date
 The base principle is: Expected date for CE-marking decides if new PED/ATEX or
current PED/ATEX is the case
 For PED only: New Fluid classification based on CLP starts 1 June 2015:
Verification of Fluid Group based on CLP starts now for all new products
 For PED/ATEX: Check expected date for CE-marking. Prepare Declaration of
Conformity with references to 2014/68/EU resp. 2014/34/EU
 For PED only: If CE-marking after 19 July 2016 the applications for A1/C1/B1 will
be eventually certified to A2/C2/B (design type)
 NOTE: The ESR are unchanged so assessment activities remain as before. As
previously the current state of the art to used standards set the acceptance level
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Certificate validity after new PED
 NOTE: CE-marking may be performed to current PED until the certificate expires also
after 19 July 2016. Module B/B1 to current PED may serve as base for CE-marking to
new PED also after transfer to new PED
CAM
Issued before 19 July 2016
Issued after 19 July 2016
A1/C1
If limited validity the certificates are
valid until expiry.
If no limitation the validity
requirements stated on the
certificate must be checked
Replaced by A2/C2
B1
If limited validity the certificates are
valid until expiry.
If no limitation the validity
requirements stated on the
certificate must be checked
Replaced by B (design type)
B
Valid until expiry date (10 years)
Module B with reference to new PED
F/G
Valid until the conditions stated on
the certificate no longer remains
Module F/G with reference to new PED
Valid until recertification
Module D/D1/E/E1/H/H1with reference to
new PED
D/D1/E
/E1/H/
H1
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Summary of changes in new PED/ATEX and consequences thereof
1.
The reason for changing the directives is mainly implementing horizontal
requirements in the NLF
2.
The technical requirements are unchanged
3.
PED will change more than ATEX (Fluid Group classification and new Modules)
4.
The transfer to new directives is sharp on transfer date
5.
Manufacturers must prepare documentation in good time so only the new
directive will be referred to after transfer date
6.
Notified Body certificates referring to old directives remains valid until expiry
date
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IVS 2015 • International Conference on Valve and
14/03/2016
PED 2014/68/EU – Changes to some significant standards
Harmonized Product Standards (i.e. EN 13445, EN 1171, EN 13709, etc.) identify
supporting standards for materials, welding, NDE, etc.):
Welding
 EN ISO15614-1: 2004/A2:2012
 EN ISO15614-2:2005/AC:2009
 EN ISO15614-4:2005/AC:2007
 EN ISO15614 (parts 5, 6, 7, 8, 11)
Qualification of Welders
 EN ISO 9606-2:2004
 EN ISO 9606-3:1999
 EN ISO 9606-4:1999
 EN SIO 9606-5:2000
 NOTE: ISO 9606-1: 2013 is not yet harmonized, but is being applied as the
benchmark standard for qualification of welders, fusion welding: Steels
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PED 2014/68/EU – Changes to some significant standards
When Harmonized standards are not applied:
1. Consult the governing product standard (ASME/ANSI, API, etc.)
2. Follow the referenced welding standard (such as ASME IX)
3. Consult the appropriate Harmonized supporting standard, as if the product was
following a harmonized standard, such as EN ISO 15614-1:2004.
4. Conduct any technical testing required by the relevant harmonized supporting
standard which isn’t required by the non-harmonized governing standard. (often
include impact testing, macro-examination)
Note: Welding shops will see increasing pressure in new harmonized standards to
follow the Quality Requirements for Welding set out in EN 3834-1: 2005.
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Transfer period – Guidelines ATEX
 NOTE: The ESHR are unchanged so assessment activities remain as before. As
previously the current state of the art to used standards set the acceptance level
CAM
Issued before 18 April 2016
Issued after 18 April 2016
A+
Valid until expiry date (10 years).
Module A+ with reference to new ATEX
C
If limited validity the certificates are
valid until expiry.
If no limitation the validity
requirements stated on the
certificate no longer remains.
Module C with reference to new ATEX
B
If limited validity the certificates are
valid until expiry.
If no limitation, valid until the
requirements stated on the
certificate no longer remains.
Module B with reference to new ATEX
F/G
Valid until the conditions stated on
the certificate no longer remains.
Module F/G with reference to new ATEX
D/E
Valid until recertification.
Module D/E with reference to new ATEX
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EU’s New Legislation Framework (NLF)
- What this means to you.
DNV GL Business Assurance
[email protected]
403-615-0409
www.dnvgl.com
SAFER, SMARTER, GREENER
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