For the first time since 1997, the EU’s Pressure Equipment Directive (PED 97/23/EC) is now changing. In addition to gaining a new number – 2014/68/EU – there are several other changes that do affect manufacturers, importers and distributors of pressure equipment
While there are no changes to the essential safety requirements of the Directive, there is a substantial change to a fundamental safety philosophy of the PED. There is now an obligation for manufacturers to analyse the risks of pressure equipment as well as the hazards. This will take more investigation and interpretation to fully comprehend its impact on both manufacturers and Notified Bodies.
Timeline for the transition
The new PED was published in the EU Official Journal on 27th June 2014 and entered into force 20 days later. We are now in the ‘transposition’ stage which is the period in which the Member States have to introduce national laws, regulations and administrative provisions in order to give legal effect to the directive. The key dates are:
- Transposition deadline for 2014/68/EU Art. 13 (Fluid classification) – 28th February 2015
- Date of application – from 1st June 2015
- Transposition deadline for the rest of 2014/68/EU – 18th July 2016
- Date of application – from 19th July 2016
A wide variety of changes – Brief Introduction
The changes in the PED are widespread, ranging from how fluids are classified, what is required of manufacturers and notified bodies, to the procedures for conformity assessment. From a high level:
- Some conformity assessment modules have been renamed and the requirements for manufacturers and notified bodies restructured.
- All recitals, articles and annexes have been restructured to align with the ‘reference provisions’ of the ‘NLF’ (New Legal Framework). This is a larger initiative by the European Union to bring nine EC “New Approach” directives into alignment with the NLF which was adopted in 2008. According to the European Commission, the NLF aims to streamline and simplify the rules for putting pressure equipment on the market in the face of increasing competition from fraudulently certified equipment.
- Article 9 – Fluid Classification changes beginning 1st June, 2015. The current basis for the determination of fluid group (1 or 2) in PED Article 9 is being replaced by a new Classification, Labelling and Packaging Regulation from 1st June 2015.
Importers and distributors - New PED Approach
One feature of the ‘NLF’ is the recognition that it is not just manufacturers who have a role to play in ensuring that only safe, compliant products reach the EU market. For this to happen the whole supply chain must play its part, and so the new PED now incorporates the term “economic operators” and lays down legal obligations for each. You are considered as an economic operator under the PED if you are one of the following:
- A manufacturer
- An authorised representative for a manufacturer located outside of the European Union
- An importer
- A distributor
The revision also makes clear that when importers or distributors place pressure equipment (or assemblies) on the market under their own names or trademarks are to be considered as manufacturers. This will also be the case when importers or distributors modify the equipment in a certain way. In this respect, they will therefore have to take legal responsibility for the product’s compliance to PED, including conformity assessment.
New PED - Alternations in PED Certification Schemes (Modules)
This is how the modules now fall under each category:
- 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
What questions do you have?