Valve Manufacturers Association of America

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1 BUSINESS ASSURANCE Valve Manufacturers Association of America 2016 Technical Seminar: EU s New Legislation Framework (NLF) - What this means to you. Mike Norman 1 VMA Technical Session - March 2016 SAFER, SMARTER, GREENER

2 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? 2 IVS 2015 International Conference on Valve and 14/03/2016

3 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 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 3

4 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 4

5 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

6 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 6

7 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: 7

8 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. 8

9 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 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 in new PED and Art in new ATEX. These were previously expressed in one Annex only. The generic requirements on third-party organizations are aligned with ISO (impartiality, competences, liability, secrecy, participation in coordination activities) 9

10 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 %) 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 10

11 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. 11

12 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 B1 B (production type) B (design type) NoBo is obliged to inform the manufacturers on changes in relevant standards 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 12

13 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 June 2015: Start of application of Art.13 (New Fluid Group classification) PED 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 13

14 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 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 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 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 14

15 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 15

16 Certificate validity after new PED NOTE: CE-marking may be performed to current PED until the certificate expires also after 19 July 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 B1 If limited validity the certificates are valid until expiry. If no limitation the validity requirements stated on the certificate must be checked 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 Replaced by B (design type) B Valid until expiry date (10 years) Module B with reference to new PED F/G D/D1/E /E1/H/ H1 Valid until the conditions stated on the certificate no longer remains Valid until recertification Module F/G with reference to new PED Module D/D1/E/E1/H/H1with reference to new PED 16

17 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 17 IVS 2015 International Conference on Valve and 14/03/2016

18 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 ISO : 2004/A2:2012 EN ISO :2005/AC:2009 EN ISO :2005/AC:2007 EN ISO15614 (parts 5, 6, 7, 8, 11) Qualification of Welders EN ISO :2004 EN ISO :1999 EN ISO :1999 EN SIO :2000 NOTE: ISO : 2013 is not yet harmonized, but is being applied as the benchmark standard for qualification of welders, fusion welding: Steels 18

19 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 : 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 :

20 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 B F/G If limited validity the certificates are valid until expiry. If no limitation the validity requirements stated on the certificate no longer remains. If limited validity the certificates are valid until expiry. If no limitation, valid until the requirements stated on the certificate no longer remains. Valid until the conditions stated on the certificate no longer remains. Module C with reference to new ATEX Module B with reference to new ATEX Module F/G with reference to new ATEX D/E Valid until recertification. Module D/E with reference to new ATEX 20

21 EU s New Legislation Framework (NLF) - What this means to you. DNV GL Business Assurance Mike.norman@dnvgl.com SAFER, SMARTER, GREENER 21