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08 January 2016 SAFER, SMARTER, GREENERDNV GL © 2014 VMA Technical Session - March 2016

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Mike Norman

BUSINESS ASSURANCE

Valve Manufacturers Association of America

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2016 Technical Seminar: EU’s New Legislation Framework (NLF)

- What this means to you.

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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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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)

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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 EqipmentDirective 2014/53/EC in force 13 June2016

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 explosiveatmosphere

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 ATEX1.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 ATEX2. 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 ATEX3. Conformity assessment

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• 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

At the last CABF (PED NoBomeeting) the followingGuideline was drafted

The PED definition of ”flammable” has been specificfor 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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• 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.

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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

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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

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Year

Month 4 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

ATEX 19 April 2016: Deadline for member states to transpose new ATEX 20 April 2016: Start of full application for new ATEX

2015 2016

PED

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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

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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 validityrequirements 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 validityrequirements 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

D/D1/E/E1/H/H1

Valid until recertification Module D/D1/E/E1/H/H1with reference to new PED

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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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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

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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

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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 validityrequirements 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.

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DNV GL Business Assurance

Mike.norman@dnvgl.com

403-615-0409