13 July 2016
On the 19 July 2016, there will be a repeal of the Pressure Equipment Directive 97/23/EC and the start of full application of 2014/68/EU. From that date, all Lloyd’s Register assessments and inspections will be in accordance with the new 2014/68/EU Directive*.
In addition to gaining a new number (2014/68/EU) there are several other changes that have implications for manufacturers, importers and distributors of pressure equipment. These include how fluids are classified, what is required of manufacturers and Notified Bodies, and the procedures for conformity assessment.
There are two key drivers behind the new Pressure Equipment Directive:
- The current basis for the determination of fluid group (1 or 2) in PED Article 9 (i.e. Directive 67/548/EEC) has been replaced by a new Classification, Labelling and Packaging (CLP) Regulation [EC 1272/2008].
- The “New Legal Framework". This is a larger initiative by the European Union to bring nine EU “New Approach” Directives into alignment with the “New Legal Framework” (NLF), which was adopted in 2008 and aims to streamline and simplify the rules for putting pressure equipment on the market in the face of increasing competition from fraudulently certified equipment.
It is important to note that the changes are classified as an ‘alignment’ with the “New Legal Framework”, because it means there is no change in:
- The scope of the new Pressure Equipment Directive.
- Hazard Category Charts / Tables.
While there are no substantive changes to the essential safety requirements either, there is a change to the way that a manufacturer analyses and records the hazards and risks in order to identify those which apply to his equipment on account of pressure.
According to the new Pressure Equipment Directive, all existing approvals will remain valid. Article 48 states, “Certificates and decisions issued by Conformity Assessment Bodies (Notified Bodies) under Directive 97/23/EC shall be valid under this Directive.”
Below is a summary of the changes to the new Pressure Equipment Directive 2014/68/EU:
1. All recitals, articles and annexes have been restructured to align with the “reference provisions” of the “New Legal Framework”, i.e.:
- 37 new Recitals
- 31 new Articles
- One less Annex
2. Obligations of economic operators (eg manufacturers, authorised representatives, importers, distributors)
- Article 6: Obligations of manufacturers
- Article 7: Authorised representatives
- Article 8: Obligations of importers
- Article 9: Obligations of distributors
- Article 10: Cases in which obligations of manufacturers apply to importers and distributors
- Article 11: Identification of economic operators
3. Fluid classification changes (fluid group: liquid , gas, mixture) in line with the CLP Directive
4. Harmonisation of some of the conformity assessment procedures (modules) which have been aligned with definitions and terms of other EU Directives, eg:
- Module A1 is now Module A2 (Internal production control plus supervised pressure equipment checks at random intervals)
- Module B is now Module B EU-Type examination - production type
- Module B1 is now Module B EU-Type examination - design type
- Module C1 is now Module C2 (Conformity to type based on internal control plus supervised pressure equipment checks at random intervals)
- Module H now includes a requirement to submit a technical file for one model of each type of equipment with the application for assessment
5. The manufacturer is now under an obligation to analyse the hazards and risks in order to identify those which apply to his equipment on account of pressure, record them and he shall then design and construct it taking account of his analysis.
The new Pressure equipment Directive 2014/68/EC is available for download free of charge here: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2014.189.01.0164.01.ENG
In summary, the changes are required but are not as onerous as a completely new Directive. As a UK appointed notified body we confirm that Lloyd's Register is fully engaged in EU activities and will continue to update you as arrangements develop following the UK referendum vote on 23 June 2016.
For more information about the PED, visit our PED information center here.
*All Notified Body activities associated with EC Directives, including the PED, are performed under the accreditation held by Lloyd's Register Verification, Limited.