Directive (PED) The history and future of PED Certification A whitepaper The PED at a glance The Pressure Equipment Directive (PED) 97/23/EC is a fundamental piece of European legislation relating to the safety of pressure equipment throughout Europe. It covers the design, manufacture and conformity assessment of pressure equipment and assemblies of pressure equipment with a maximum allowable pressure greater than 0.5 bar and it is mandatory if the pressure equipment falls within the scope of the directive. However, there is a full list of exemptions in Article 1. The PED was implemented into UK law as the Pressure Equipment 1999. The regulations were subject to minor amendment (SI Regulations 1999 (SI 1999/2001). These Regulations were made 2003/1267) made 06 May 2002 and came into force on 30 May on 15th July 1999 and entered fully into force on 29 November 2002.
Why is the PED changing?
The PED is one of the New Approach Directives and is now over 17 Legal Requirements years old. The old directive 97/23/EC will be replaced by the new Important to note is that whilst the old directive will be replaced directive 2014/68/EU. by the new directive following a transition period, there is The change will implement alignment with the NLF (New already a legal requirement which is now in place and must be Legislative Framework 765/2008 and 768/2008) which aims to met. Article 13 of 2014/68/EU was effective 1st June 2015, and streamline and simplify the rules for putting pressure equipment relates to fluid classification, i.e. CLP regulations 1272/2008. on the market in the face of increasing competition from The new directive is required to be enacted into UK Law via a fraudulently certified equipment. Statutory Instrument (SI) by the UK Government. Until this is Further information can be found in the Blue Guide 2014 completed the directive is not enforceable with the exception http://ec.europa.eu/DocsRoom/documents/11502/attachments/1/ of Article 13 as this is already covered by the CLP Regulations translations/en/renditions/native 1278/2008, which has been enacted into UK Law via SI 2015 No. 399.
What are the main changes?
There are a wide variety of changes in descriptors cited in PED 97/23/EC requirements for manufacturers and 2014/68/EU, the main changes are: - Article 9 clause 2.1 have been replaced notified bodies restructured: • Fluid group classification will now follow by seventeen group 1 descriptors in - Module A1 is now Module A2 and the CLP Regulations 1278/2008 per 2014/68/EU Article 13 clause 1a. Fluid Module C1 is now Module C2 – both 2014/68/EU Article 13. This regulation group 2 remains the same, i.e. those new Modules A2 and C2 have introduced a division and categorisation fluids that aren’t in group 1. It is possible enhanced explanations relating structure for different fluid types, with the that some fluids may have changed to technical file requirements and aim of clearly and accurately identifying groups but most will remain the same. Notified Body involvement. and marking labelling and packaging for Further guidance on the impact of the - Module B – EC Type Examination and these fluids. The PED has been updated to CLP can be found on the HSE website: Module B1 – EC Design Examination recognise these new categorisations. http://www.hse.gov.uk/chemical- in 97/23/EC have been integrated The fluid groups cited in 2014/68/ classification/legal/clp-regulation.htm together under new Module B – EU EU remain the same, i.e. 1 and 2. Fluid Type Examination in 2014/68/EU. Group 1 still includes flammable, toxic • Distributors and importers are now included and have legal obligations There are two routes to this EU and oxidising fluids, and Fluid Group 2 Type Examination – Production Type includes all other fluids not captured in placed upon them (similar to Module B in 97/23/EC) and Group 1. • Some conformity assessment Design Type (similar to Module B1 in However, the seven Fluid Group 1 modules have been renamed and the 97/23/EC) What are the main changes? - All QA based Conformity Assessment - Module H1 now appears to be Designers and those compiling modules D/D1/E/E1/H/H1 require independent of Module H and refers technical files will need to consider specific documentation to be to a Design Examination – this would the impact of these words submitted with the application and appear to be a third type of design - The word “must” has been changed to impose additional requirements review independent of the new “shall” throughout the ESRs. on the Notified Body’s auditor Module B (Design Type) or (Production - All recitals, articles and annexes have competency/experience. For Modules Type) been restructured to align with the H and H1 the manufacturer shall • There are a few minor changes to the ‘reference provisions’ of the ‘NLF’; provide technical documentation Essential Safety Requirements (ESR): • 37 new recitals for one model of each type to be - The words “and risks” have been added • 31 new articles manufactured to Preliminary Observation 3. • One fewer annex.
Where to from here?
What manufacturers of pressure equipment Manufacturers should be aware that any previously issued need to do now certificate under PED 97/23/EC remains valid under 2014/68/EU per Article 48 clause 3. All manufacturers of pressure equipment need to be aware of the impending changes and familiarise themselves with the requirements of 2014/68/EU. e.g. making the necessary changes Legal Obligations to procedures, processes, forms, etc., identifying which of the There are legal obligations on all of the “Economic Operators”. changes (if any) will have an impact on their business. Any changes 2014/68/EU Article 2 item 22 defines these Economic Operators should only implemented when the Statutory Instrument (SI)_has as the Manufacturer, the Authorised Representative, the Importer been issued. and the Distributor and Chapter 2 Articles 6, 7, 8 and 9 define the Understand that Article 13 of 2014/68/EU was effective obligations of each of these Economic Operators. 01 June 2015 and is now a legal requirement per SI 2015 Early preparation is key No. 399. By starting to prepare for these changes now, you will be This relates to fluid classification, i.e. CLP regulations 1272/2008. better equipped to handle the impact of the new directive This will require all PED equipment manufacturers who CE mark on your company. their products to cite Article 13 of 2014/68/EU on their respective Declarations of Conformity in addition to PED 97/23/EC.
PED 2014/68/EU timescales
2014 2015 2016
27 June 2014 01 June 2015 19 July 2016 PED published in the Official Article 13 2014/68/EU enters in Balance of 2014/68/EU enters in to Journal (page 164) to force via the CLP Regulations force 1272/2008 Unknown at this time but expected to be before 19 July 2016 2014/68/EU enacted in to UK Law via Statutory Instrument by UK Government Support from BSI How BSI can help you through the changes We will continue to monitor the progress of these changes and We are also offering awareness sessions. Our Certification keep all our clients updated when more information is released Managers and other colleagues will be aware of any changes so from the European Commission and UK Government. This that we can let you know in advance about the impact that these information will be available on our website bsigroup.com/ped changes may have.
The role of a Notified Body (BSI)
BSI is a Notified Body for the PED and In the UK a Notified Body is a body which The details of all Notified Bodies and their numerous other EU Directives. We have a has been appointed by the department for scope of approval is listed on the Europa comprehensive scope for PED, being able Business Innovations and Skills (BIS), to website to carry out Notified Body activities under carry out one or more of the conformity all applicable Conformity Assessment assessment procedures cited in a directive. Modules.
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