Deadline June 1, 2015
The Classification of Pressure Equipment has changed with the new Directive because the Dangerous Substances Directive –67/548/EEC – that the PED currently uses to classify fluids as Group 1 or 2 is being replaced by the Classification, Labelling and Packaging (CLP) of Substances and Mixtures Regulation 9 EC No. 1272/2008.
Very few substances should change groups in the PED because of this change. Classification charts will remain the same.
New requirements will have to be applied to new equipment being placed on the market after June 1, 2015.
Four Types of 'Economic Operators" now Identified:
4. Authorized Representative for a manufacturer located outside the European Union
The NLF has recognized in the new Directive that not just manufacturers have a role to play to ensure that only safe, compliant products reach the EU market. The whole supply chain must be involved, labeled as "economic operators, with legal obligations for each.
The revision also makes clear that if an importer or distributor places pressure equipment or assemblies on the market under their own names or trademarks, or modifies the equipment in a certain way, they will be considered manufacturers and will therefore have to take legal responsibility for the product’s compliance including conformity assessment.
Module A1 has been renamed to A2
Module B1, design type, has been incorporated into Module B
Module B is now a combination of design and manual type
Module C1 has been renamed to C2
How Modules fall under Categories
- 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
Module B and B1 have been combined into one module.
There are changes to Quality Systems Requirements mentioned in modules D, D1, E, E1, G, H, and H1.
The terms EC Type-Examination and EC Design-Examination' have been replaced with the term "EU-Type Examination".
Risk analysis replaces Hazard analysis.
Notified body now has to notify and follow up on state of the art and inform the manufacturers of such changes.
Manufacturer has to keep the name and address of his customers at least 10-years and make it available for the relevant authorities.
- 2.2.3 (b) Under the calculation for pressure containment: Material Characteristics to be considered – ‘impact strength’ has been replaced by ‘bending rupture strength’
- 3.3 (b) Under markings: The requirement to provide ‘the product group’ has been changed to ‘the fluid group’ (understood to be the same thing)
While there are minor changes to the essential safety requirements, there is a 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.