Legal act: 
Directive 2014/68/EU

Consolidated act:
17/07/2014 

Scope

1. This Directive shall apply to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.
2. This Directive shall not apply to:
   1. pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines; this exclusion shall not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;
   2. networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;
   3. simple pressure vessels covered by Directive 2014/29/EU of the European Parliament and of the Council (1);
   4. aerosol dispensers covered by Council Directive 75/324/EEC (2);
   5. equipment intended for the functioning of vehicles defined by the following legal acts:
      1. Directive 2007/46/EC of the European Parliament and of the Council (3);
      2. Regulation (EU) No 167/2013 of the European Parliament and of the Council (1);
      3. Regulation (EU) No 168/2013 of the European Parliament and of the Council (2);
   6. equipment classified as no higher than category I under Article 13 of this Directive and covered by one of the following Directives:
      1. Directive 2006/42/EC of the European Parliament and of the Council (3);
      2. Directive 2014/33/EU of the European Parliament and of the Council (4);
      3. Directive 2014/35/EU of the European Parliament and of the Council (5);
      4. Council Directive 93/42/EEC (6);
      5. Directive 2009/142/EC of the European Parliament and of the Council (7);
      6. Directive 2014/34/EU of the European Parliament and of the Council (8);
   7. equipment covered by point (b) of Article 346(1) TFEU;
   8. items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
   9. well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure; this shall comprise the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;
   10. equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor; such equipment may include:
       1. engines including turbines and internal combustion engines;
       2. steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;
   11. blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaustgas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, remelting, de-gassing and casting of steel, iron and non-ferrous metals;
   12. enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;
   13. pressurised pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;
   14. ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;
   15. pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;
   16. exhaust and inlet silencers;
   17. bottles or cans for carbonated drinks for final consumption;
   18. vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar;
   19. equipment covered by Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by the International Maritime Dangerous Goods Code and the Convention on International Civil Aviation;
   20. radiators and pipes in warm water heating systems;
   21. vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.

Definitions

Making available on the market means any supply of pressure equipment or assemblies for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

Placing on the market means the first making available of pressure equipment or assemblies on the Union market.

Putting into service means the first use of pressure equipment or an assembly by its user.

Importer means any natural or legal person established within the Union who places pressure equipment or assemblies from a third country on the Union market.

Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment or assemblies available on the market.

Withdrawal means any measure aimed at preventing pressure equipment or assemblies in the supply chain from being made available on the market.

Article 17 - EU declaration of conformity

1. The EU declaration of conformity shall state that the fulfilment of essential safety requirements set out in Annex I has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex IV and shall contain the elements specified in the relevant conformity assessment procedures set out in Annex III and shall be continuously updated. It shall be translated into the language or languages required by the Member State in whose market the pressure equipment or assembly is placed or made available on the market.
3. Where pressure equipment or an assembly is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the pressure equipment or assembly with the requirements laid down in this Directive.

Article 18 - General principles of the CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 19 - Rules and conditions for affixing the CE marking

1. The CE marking shall be affixed visibly, legibly and indelibly to any of the following:
   1. each item of pressure equipment referred to in Article 4(1) or its dataplate;
   2. each assembly referred to in Article 4(2) or its dataplate. Where the affixing of the CE marking is not possible or not warranted on account of the nature of the equipment or assembly, it shall be affixed to the packaging and to the accompanying documents. The item or assembly referred to in points (a) and (b) of the first subparagraph shall be complete or shall be in a state permitting final assessment as described in point 3.2 of Annex I.
2. It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an assembly. Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.
3. The CE marking shall be affixed before the item of pressure equipment or the assembly is placed on the market.
4. The CE marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
5. The CE marking and, where applicable, the identification number referred to in paragraph 4 may be followed by any other mark indicating a special risk or use.
6. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.