The Pressure Equipment Regulations S.L. 429.29 transpose Directive 2014/68/EU which covers pressure equipment and assemblies that are placed new on the European market, including also imports from a third country. It applies to the design, manufacture and conformity assessment of stationary pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar including vessels, piping, and their accessories.
These regulations namely apply to assemblies composed of several pieces of pressure equipment assembled to constitute an integrated and functional whole. Those assemblies may range from simple assemblies such as pressure cookers to complex assemblies such as water tube boilers. If the manufacturer of an assembly intends to place it on the market and put it into service as an assembly and not in the form of its constituent non-assembled elements, that assembly should comply with these Regulations. However, these Regulations should not apply to the assembly of pressure equipment on the site and under the responsibility of a user who is not the manufacturer, as in the case of industrial installations.
Aim of the Regulations
The Pressure Equipment Regulations aims to guarantee the free movement of products falling within its scope while ensuring a high level of safety. This will create a single European market in which the technical requirements for pressure equipment are identical. Consequently, manufactures can meet the requirements for approvals in any member state without the need to repeat the process when selling goods in any other state.
Obligations of Economic Operators
The regulations define specific requirements for all economic operators which are involved with the placing on the market of pressure equipment namely manufacturers, authorised representatives, importers, and distributors. All the parts have an important role in making sure that the product is safe for use as described below.
The obligations of manufacturers are as follows: ensure that the appropriate category of products are designed and manufactured in accordance with the essential safety requirements set out in Regulations; draw up the technical documentation referred and carry out the relevant conformity assessment procedure; draw up an EU declaration of conformity and affix the CE marking; keep the technical documentation and the EU declaration of conformity, for 10 years after the product has been placed on the market; label products with a type, batch or serial number or other element allowing their identification; indicate on the product, their name, registered trade name or registered trade mark and the postal address at which they can be contacted; provide instructions and safety information in at least the Maltese or English language.
An authorised representative is appointed with a written mandate by the manufacturer which includes a list of tasks to be carried out namely conformity assessments, CE markings, EU declaration of conformity and provisions for holding the EU declaration of conformity, together with the technical documentation for a period of 10 years after the last product has been manufactured.
The obligations of importers are clearly defined in the regulations and to a large extent they are similar to those of the manufacturer. The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of products but has a key role to play in guaranteeing the compliance of the imported products.
The obligations of the distributors are namely to: have a clear indication of a products being non-compliant; ensure that products bear the CE marking, where applicable; products are accompanied by the EU declaration of conformity by instructions and safety information;
Conformity of Pressure Equipment with the Regulations
These regulations deal namely with the presumption of conformity of pressure equipment or assemblies through the voluntary application of European harmonized standards (published in the Official Journal of the European Union). Therefore, pressure equipment or assemblies which are in conformity with the relevant harmonized standards are presumed to be in conformity with the essential safety requirements of the regulations. Manufacturers or other economic operators are free to choose other technical solutions to demonstrate compliance with the mandatory legal requirements, however the use of harmonized standards is commonly the preferred option.
Pressure equipment are classified into four categories according to the maximum allowable pressure PS, their volume V or nominal size DN and their group of fluids for which they are intended. Therefore, the appropriate conformity assessment procedure must be determined by the category of equipment.
EU Declaration of Conformity
The EU declaration of conformity is a legal document drawn up were applicable by the manufacturer or his authorised representative declaring that the pressure equipment or assembly fulfils the essential safety requirements set in the regulations. The EU declaration of conformity contains namely, the identification of the pressure equipment or assembly allowing its traceability, reference to relevant harmonised standards, the name and the identification number of the notified body, and the number of the certificate issued. Schedule IV to the regulations states what the EU declaration of conformity must contain as a minimum.