This document provides Inspectors with an interpretation of the exclusion under Regulation 4(2) of the Pressure Equipment Regulations 1999, and also clarification on when it applies
Regulation 4(2) implements Recital 5 of the Pressure Equipment Directive (PED) and states: “For the avoidance of doubt these Regulations shall not apply to the assembly of pressure equipment on the site and under the responsibility of the user.”
The reason for the exemption is that assembly on site by the user is not considered to be trade for the purpose of the Directive.
An "assembly" is defined in Article 188.8.131.52 in the Directive and in Regulation 2(1) in the PER as "several pieces of pressure equipment assembled by a manufacturer to form an integrated and functional whole". For the purposes of this definition, the assembly must be carried out by the manufacturer or by persons acting on behalf of the manufacturer.
Where the user is joining items of pressure equipment/assemblies (as defined in the PER) on their own site, then, in order to avoid confusion, the resulting product should be termed an "installation". Such an installation would fall under the exclusion in Reg 4(2) and would fall within the requirements of national legislation. The term "installation" is not a legal term used within the body of the Directive or within the PER. The term is used generally to indicate the difference between those assemblies which fall within the PER and those assemblies which fall outside the PER by virtue of Reg 4(2).
Inspectors should be aware of the following:
If, at some point in the future, the user places the installation on the market as an integrated and functional whole, solicitors office advice is that the installation remains outside the scope of the PER as in circumstances where the installation is expressly excluded at the point of first supply, subsequent supply should not treat the installation differently i.e. as if the installation had been placed on the market for the first time.
PER implements the Pressure Equipment Directive (PED) (Directive 97/23/EC), setting specific technical, conformity assessment, CE marking and ‘Declaration of Conformity’ requirements for ‘pressure equipment’.
PED/PER are about ensuring the free movement of safe pressure equipment within the internal market of the EU (ie placing safe pressure equipment on the market and putting it into service). They do not cover any non-pressure hazards which may be involved, nor continuing safe use of pressure equipment in service.
The Directive does not apply to the assembly of pressure equipment "on the site and under the responsibility of the user" by virtue of recital No 5 implemented in the PER by Regulation 4(2).
PED Recital 5 says:
‘Whereas this Directive relates also to assemblies composed of several pieces of pressure equipment assembled to constitute an integrated and functional whole; whereas these assemblies may range from simple assemblies such as pressure cookers to complex assemblies such as watertube boilers; whereas, if the manufacturer of an assembly intends it to be placed on the market and put into service as an assembly — and not in the form of its constituent non-assembled elements — that assembly must conform to this Directive; whereas, on the other hand, this Directive does not cover the assembly of pressure equipment on the site and under the responsibility of the user, as in the case of industrial installations;’
The exclusion for pressure equipment assembled on the site and under the responsibility of the user has been discussed at the European Commission Working Group for the PED. The Working Group has produced three guidelines dealing with the exclusion of pressure equipment in Recital No 5. These are guidelines 3/2, 3/8 and 3/9. The guidelines deal with four specific areas, namely joining operations on site, the definition of an assembly, the difference between an assembly and an installation, and the limits of an assembly. Taken together with solicitors advice, the guidelines provide the basis for the current interpretation of Recital No 5 and therefore of Regulation 4(2) PER.
No special organisational requirements
CCID, WERG, Safety Unit
Guideline 3/8 gives four criteria which help to define an "assembly". Items of pressure equipment are considered to form an "assembly" if all of the following apply:
The guideline makes it clear that it is irrelevant whether the manufacturer puts the assembly together in their workshop or at the user's site. As long as the assembly is being put together under the responsibility of the manufacturer, or on behalf of the manufacturer if sub-contractors are being used, then the resulting assembly will fall within the PER and will need to undergo an appropriate conformity assessment procedure.
Guideline 3/2 clarifies the situation with regard to the actual joining operations involved in the installation of pressure equipment/assemblies. There is a clear distinction made between joining individual components (which cannot be classified as pressure equipment/assemblies in their own right) and joining items of pressure equipment/assemblies.
The guideline states that the PER will always apply where the joining operation consists of joining individual components to form an item of pressure equipment, irrespective of whether the manufacturer or the user is carrying out the joining. (Where the user is carrying out the joining operations of individual components, then they have become a manufacturer of pressure equipment in their own right and the PER apply.) Where the user is joining items of pressure equipment/assemblies (as defined in the PER) on their own site, then the resulting product should be termed an "installation".
Guideline 3/9 makes it clear that there is no upper or lower limit to an assembly. The guideline states that an assembly may range from a simple standard product (e.g. a pressure cooker) all the way up to a large complex industrial plant. However, where the user takes the responsibility for the final assembly of pressure equipment/assemblies, then the resulting assembly (installation) will fall outside of the PER, irrespective of its size.