Pressure Equipment Directive

The Pressure Equipment Directive 2014/68/EU (PED) applies to the design, manufacture, and conformity assessment of pressure equipment and assemblies that exceed a maximum allowable gauge pressure of 0.5 bar. The directive has been transposed into the Pressure Equipment Regulations S.L. 429.29. PED applies to the following product categories as defined in Article 2.

1. Vessels: A housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment; a vessel may be composed of more than one chamber.
2. Piping: Refers to piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air are also considered as piping.
3. Safety Accessories: Devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices.
4. Pressure Accessories: Devices with an operational function and having pressure-bearing housings.
5. Assemblies: Several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.

Article 1(2) lays out the products excluded from the scope of PED. Products conforming to PED must bear the CE marking and where relevant proceeded by the notified body identification number. Economic operators are to fulfil their respective obligations stipulated in Chapter 2. The economic operator shall provide an EU Declaration of Conformity (DoC) to declare conformity with PED. Presumption of conformity with the essential safety requirements is demonstrated by the application of EU harmonised standards published in the OJEU. Economic operators may choose other technical solutions to demonstrate compliance with the PED essential safety requirements though doing so does not ensure presumption of conformity. An appropriate conformity assessment procedure shall be adopted based on the maximum allowable pressure (PS), their volume (V), nominal size (DN) and / or the fluid group used in the product. Refer to the conformity assessment tables found in Annex II of the directive.

Additional guidance on PED can be found in the PED Guidelines issued by the European Commission.

Simple Pressure Vessels Directive

The Simple Pressure Vessels Directive 2014/29/EU (SPVD) applies to a specific category of welded vessels, not intended to be fired, manufactured in series production, designed to contain unfired air or nitrogen at pressures exceeding 0.5 bar. SPVD also applies to parts and assemblies contributing to the strength of the pressure vessel made of non-alloy steel, non-alloy aluminium or non-age hardened aluminium alloys. The directive has been transposed into the  Simple Pressure Vessels Regulations S.L. 427.01. SPVD applies to vessels that meet the following criteria.

1. Vessels comprised of a cylindrical part of circular cross-section enclosed by flat end or dish-ends revolving around the axis of the cylindrical part.
2. Vessels with an internal pressure not exceeding 30 bar and a product of maximum pressure × volume (PS × V) not exceeding 10,000 bar·L.
3. Vessels intended to store air or nitrogen only, with an operating temperature no smaller than -50°C and no greater than 300°C for steel and no smaller than -50°C and no greater than 100°C for aluminium (or aluminium alloys).

The directive does not apply to vessels designed for nuclear use, vessels installed on ships and aircraft, or fire extinguishers.

In cases where the PS × V does not exceed 50 bar·L the product is excluded from the scope of SPVD and shall not be CE marked under SPVD. In such cases, the product shall still, at a minimum, satisfy the general safety requirement of the General Product Safety Regulation. If the PS × V does exceeds 50 bar·L, presumption of conformity with the essential safety requirements is demonstrated by the application of EU harmonised standards published in the OJEU. Economic operators may choose other technical solutions to demonstrate compliance with the SPVD essential safety requirements though doing so does not ensure presumption of conformity. The manufacturer shall adopt an appropriate conformity assessment procedure.

Products that fall under the scope of SPVD shall bear the CE marking proceeded by the notified body identification number and be accompanied by an EU Declaration of Conformity. Economic operators are to fulfil their respective obligations stipulated in Chapter 2.

Additional guidance on SPVD can be found in the SPVD Guidelines issued by the European Commission.

Transportable Pressure Equipment Directive

The Transportable Pressure Equipment Directive 2010/35/EU (TPED) sets out detailed rules concerning transportable pressure equipment to enhance safety and ensure free movement of such equipment within the Union.

The carriage of transportable pressure equipment by road in Malta is regulated by the Motor Vehicles (Carriage of Dangerous Goods by Road) Regulations. As per Directive 2008/68/EC the carriage of pressure equipment within the EU is to comply by the Annexes to the European Agreement on the Carriage of Dangerous Goods (ADR). In Malta, the competent authority as regards ADR is Transport Malta. TPED applies to the following product categories. The directive has been transposed into the Transportable Pressure Equipment Regulations S.L. 427.30. TPED and its provisions applies to the transportable pressure equipment specified in Article 1(2).

TPED does not apply to transportable pressure equipment placed on the market before the date of implementation of Directive 1999/36/EC (no longer in force). However, if the pressure equipment has been subject to a reassessment of conformity, then TPED and its provisions apply. TPED also does not apply equipment used exclusively to transport dangerous goods between the EU and other third countries carried out in accordance with Article 4 of Directive 2008/68/EC.

Products that fall under the scope of TPED shall bare a Pi (π) mark, signifying that the product is in conformity with the applicable conformity assessment requirements set out in the Annexes to Directive 2008/68/EC and TPED. Under TPED, reassessment of conformity is required when pressure equipment undergoes repair, modification, or periodic inspection as indicated in Annex III. Economic operators are to fulfil their respective obligations stipulated in Chapter 2.

Gas Appliances Regulation

The Gas Appliances Regulation (EU) 2016/426 (GAR) sets out requirements for products that burn gaseous fuels, including appliances used for cooking, heating, hot water production, and refrigeration. In Malta, gas appliances are regulated by the Appliances Burning Gaseous Fuels Regulations S.L. 427.97.

Appliances and fittings which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those standards or parts thereof.

Presumption of conformity with the essential requirements is demonstrated by the application of EU harmonised standards published in the OJEU. Economic operators may choose other technical solutions to demonstrate compliance with the GAR essential requirements though doing so does not ensure presumption of conformity. Before an appliance or a fitting regulated by GAR is placed on the market, the manufacturer shall submit the product to a conformity assessment procedure in accordance with Article 14. Gas appliances covered under GAR must bear the CE marking and be accompanied by a Declaration of Conformity. Economic operators are to fulfil their respective obligations stipulated in Chapter 2.

Additional guidance on GAR can be found in the Guidance Sheets issued by the European Commission.

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