Pressure Equipment Directive
Table of Contents
- The Directive: PED 2014/68/EU
- Path to EU Market Entry
- Authorized Representative
- Post-Marketing Surveillance
- Risks of Non-Compliance
The Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar.
Vessels, piping, safety accessories and pressure accessories are all included.
Typical examples of pressure equipment covered include:
- shell and water tube boilers
- heat exchangers
- pressure vessels
- process pipework
- electric heaters
- valves - isolation
- valves - control
- relief valves
- safety valves
- bursting discs
- buckling rods
- controlled safety pressure relief systems
- pressure switches
- temperature switches
- fluid level switches
The Directive (art.13) classifies a few categories for pressure equipment, based on:
- hazard level, which is determined based on stored energy (pressure-volume product)
- nature of the contained fluid.
The Directive does not apply to:
- assembly of pressure equipment on site and under the responsibility of the user, as in the case of industrial installations;
- equipment for military use, for use in transport;
- equipment which presents a relatively low hazard from pressurization and which is within the scope of another CE mark directive (e.g. the Machinery Directive, Atex Directive, Low Voltage Directive, Medical Lift, )
- vessels used for the transport of fluids while under pressure (i.e. containers used for the transport of fluids by road, rail, sea and air). These are subject to another directive, the Trans-portable Pressure Equipment Directive (TPED);
- simple pressure vessels, which are the subject of a separate directive;
- aerosol dispenser;
- several classes of equipment as set out in the article 1.2 of the PED 2014/68;
The Directive: PED 2014/68/EU
The new Pressure Equipment Directive (PED) 2014/68/EU of the European Parliament and of the Council on the market of pressure equipment replaces the former Pressure Equipment Directive 97/23/EC as from 19th July 2016.
The Pressure Equipment Directive (PED) applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure (PS) greater than 0.5 bar.
The purpose of the PED is to ensure common standards of safety in all pressure equipment sold within the European Economic Area. Manufacturers are therefore able to meet the requirements for approval in any member state of the EU, and do not have to repeat the process when selling goods in any other state.
• Chapter I: General Provisions (Art. 1-5)
• Chapter II: Obligations of Economic Operators (Art. 6-11)
• Chapter III: Conformity and classification of PED and assemblies (Art.12- 19)
• Chapter V: Notification of Conformity Assessment bodies (Art.20- 43)
• Chapter VI: Committee Procedure and delegated acts (Art.44- 46)
• Chapter VII: Transitional and Final Provisions (Art.47- 52)
• Annex I: Essential Safety Requirements
• Annex II: Conformity Assessment Tables
• Annex III: Conformity Assessment Procedures
• Annex IV: EU Declaration of Conformity
Path to EU Market Entry: Compliance
Assessment and conformity procedure are different for each category, in which the equipment is classified (Art.14):
Essential Safety Requirements
The Annex I of the Directive defines certain safety requirements about the design and perfor-mance of pressure equipment, such as:
- equipment must be designed for adequate strength taking into account internal/external pres-sure, ambient and operational temperatures, static pressure and mass of contents in operating and test conditions, traffic, wind, earthquake loading, corrosion and erosion, fatigue, decomposi-tion of unstable fluids;
- it must be ensured safe handling and operation of examination;
- adequate means shall be provided for the draining and venting of equipment;
- equipment must be provided with protection against exceeding the allowable limits of pressure;
- where necessary, pressure equipment must be designed and fitted with suitable accessories to meet damage-limitation requirements in the event of external fire;
Specific requirements are defined for materials used for the manufacturer of pressure equipment.
Pressure equipment or assemblies, which are in conformity with harmonized standards or parts thereof, which have been published in the Official Journal of the European Union, shall be presumed to be in con-formity with the essential safety requirements covered by those standards or parts thereof, referred to in Annex I.
The materials used for the manufacture of pressure equipment or assemblies which are in conformity with European approvals for materials, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the applicable essential safety requirements set out in Annex I.
There is a special category of pressure equipment and assemblies - below or equal to the limits set out in all the other categories - which must be designed and manufactured in accordance with the Sound Engineer-ing Practice (SEP) of a Member State to ensure safe use.
The Essential Safety Requirements of the Directive do not apply to product falls in the SEP category but can be a good guidance in absence of other instructions. A derogation it is also made for the CE marking of SEP, since Article 4 paragraph 3 explicitly prohibits CE marking of SEP pressure equipment.
The manufacturer shall draw up the technical documentation referred to in Annex III of the Directive.
At the discretion of the manufacturer, an Authorized Representative may be appointed by written mandate to undertake such activities as:
- Keeping the Declaration of Conformity and the technical documentation available to the Competent Authorities at all times and for 10 years after the equipment is placed on the market
- Accommodate any reasoned requests from the Competent Authorities relating the documentation or conformity of the pressure equipment
- Cooperate with the Competent Authorities regarding and actions to be taken to eliminate and risks relate to the pressure equipment for which they are responsible under the mandate
The Authorized Representative should be clearly identified on the packaging to ensure efficient communication from end-users and EU economic operators in regards to the product(s) compliance.
The authorized representative may not draw up technical documentation as referred to in Article 6(2).
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.
Traceability of the pressure equipment and assemblies should be guaranteed throughout the whole process in order to make market surveillance systematic and efficient for market surveillance authorities.
It is the responsibility of each manufacturer which is making product available on the EU Market under their own name to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves.
Manufacturers should keep their Authorized Representative apprised of any changes products design, manufacturer, labeling, etc that could potentially impact the compliance of their product.
As consumers use the products, any incidents reported by end-users should also be recorded within the respective technical documentation and, depending on the circumstances, reported to the Competent Authorities.
When a manufacturer becomes aware of non-compliant product entering the market, non-compliant batches, etc. they should take action immediately to resolve the situation.
Risks of Non-Compliance
Manufacturers illegally apply the CE Marking to their products everyday - either out of ignorance of the requirements placed upon them, assuming their producer's CE Mark extends to them by default (which is incorrect) or through blatant disregard for the applicable legislation(s). While the intent of the CE mark is to ensure free circulation, simply applying it without taking the appropriate measures to comply does not provide unbridled access to the EU Market.
Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.
The main consequences include, but are not limited to:
- Being publicly reported to the RAPEX
- Warehousing Fees
- Requested Withdrawal
- Mandated Withdrawal
- Product Recall (from end-users and/or the market)
- Complete ban on marketing of the product
- Destruction of the product
- Revocation of the CE Marking
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.